[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Rules and Regulations]
[Pages 11639-11642]
[FR Doc No: 2018-05347]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 801, and 1100

[Docket No. FDA-2015-N-2002]
RIN 0910-AH94

Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination Products; Amendments to
Regulations Regarding ``Intended Uses''; Partial Delay of Effective
Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; partial delay of effective date.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing this final rule to delay the effective date of amendments to
the existing medical product ``intended use'' regulations, contained in
the final rule published January 9, 2017, until further notice. This
final rule delays the effective date of the amendments to allow further
consideration of the substantive issues raised in the comments received
regarding the amendments. This action does not delay the effective date
of the portions of the January 9, 2017, final rule that describe the
circumstances in which a product made or derived from tobacco that is
intended for human consumption will be subject to regulation as a drug,
device, or a combination product under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), which remains March 19, 2018.

DATES: Effective March 16, 2018, the amendments made to Sec. Sec.
201.128 and 801.4, revised at 82 FR 2193 (January 9, 2017), delayed at
82 FR 9501 (February 7, 2017) until March 21, 2017, and further delayed
at 82 FR 14319 (March 20, 2017) until March 19, 2018, are delayed
indefinitely. Section 1100.5, added at 82 FR 2193 (January 9, 2017),
delayed at 82 FR 9501 (February 7, 2017) until March 21, 2017, and
further delayed at 82 FR 14319 (March 20, 2017) until March 19, 2018,
is effective March 19, 2018.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kelley Nduom, Center for Drug
Evaluation and Research, Office of Regulatory Policy, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6221, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 9, 2017 (82 FR 2193), FDA
published a final rule entitled ``Clarification of When Products Made
or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination
Products; Amendments to Regulations Regarding `Intended Uses'''
(January 2017 final rule). The final rule added a new regulation (Sec.
1100.5 (21 CFR 1100.5)) to title 21 of the Code of Federal Regulations
(CFR) to describe the circumstances in which a product made or derived
from tobacco that is intended for human consumption will be subject to
regulation as a drug, device, or a combination product under the FD&C
Act. The rule also amended FDA's existing regulations describing the
types of evidence that may be considered in determining a medical
product's intended uses (Sec. Sec.  201.128 and 801.4 (21 CFR 201.128
(drugs) and 21 CFR 801.4 (devices))).
    In the Federal Register of February 7, 2017 (82 FR 9501), in
accordance with the memorandum of January 20, 2017, from the Assistant
to the President and Chief of Staff, entitled ``Regulatory Freeze
Pending Review,'' we delayed, until March 21, 2017, the effective date
of the final rule.
    On February 8, 2017, various industry organizations filed a
petition raising concerns with the January 2017 final rule, requesting
reconsideration and a stay pursuant to 21 CFR 10.33(b) and 10.35(b)
(see FDA-2015-N-2002-1977). The petition requests that FDA reconsider
the amendments to the ``intended use'' regulations and issue a new
final rule that, with respect to the intended use regulations at
Sec. Sec.  201.128 and 801.4, reverts to the language of the September
25, 2015, proposed rule. The petition also requests that FDA
indefinitely stay the rule because petitioners argue that (1) the final
rule was issued in violation of the fair notice requirement under the
Administrative Procedure Act (APA) (petition at pp. 10-13) and (2) the
``totality of the evidence'' language in the final rule is

a new and unsupported legal standard (petition at pp. 10, 13-21).\1\
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    \1\ For a more comprehensive discussion of the arguments raised
in the petition, please see the March 2017 final rule (82 FR 14319
at 14320 to 14321) and the January 2018 proposed rule (83 FR 2092 at
2095). Consistent with this rule, FDA is granting in part the
petition. Specifically, we are granting petitioners' request for an
indefinite stay of the effective date of the amendments to the
intended use regulations (see FDA-2015-N-2002).
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    In the Federal Register of March 20, 2017 (82 FR 14319), we further
delayed the effective date of the final rule until March 19, 2018, and
reopened the docket to invite additional public comment on the rule.
Fifteen comments were submitted to the docket in response. Two of the
comments submitted to the docket related to the new regulation included
in the final rule that describes circumstances in which a product made
or derived from tobacco that is intended for human consumption will be
subject to regulation as a drug, device, or a combination product under
the FD&C Act (Sec.  1100.5). Neither comment requested a delay in the
effective date of that new regulation. The remainder of the comments
related to the amendments to FDA's existing regulations describing the
types of evidence that may be considered in determining a medical
product's intended use (Sec. Sec.  201.128 and 801.4). Many of these
comments opposed what they described as a broadening from the September
25, 2015, proposed rule (see 80 FR 57756 at 57764 to 57765) of the
types of evidence that could be considered in determining intended use,
and specifically raised concerns with the ``totality of the evidence''
language included in the final rule.\2\
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    \2\ For a more comprehensive discussion of the comments
submitted to the reopened docket, please see the January 2018
proposed rule (83 FR 2092 at 2095).
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    To allow for further consideration of the substantive issues raised
in these comments, in the Federal Register of January 16, 2018 (83 FR
2092) (January 2018 proposed rule), we proposed to delay the effective
date of the amendments to the existing medical product ``intended use''
regulations contained in the January 2017 final rule, until further
notice (Sec. Sec.  201.128 and 801.4). We did not propose to delay the
effective date of the portions of the final rule that issued a new
regulation regarding products made or derived from tobacco that are
intended for human consumption (Sec.  1100.5). The Agency received 19
comments to the docket on the proposed delay, which are summarized
below.

II. Comments on the Proposed Rule and FDA Responses

A. Introduction

    We received 19 comments on the proposed delay from drug and device
industries, various associations and organizations, academia, and
individual submitters, including a health professional and consumers.
We describe and respond to the comments in sections II.B through II.D
of this document. We have numbered each comment to help distinguish
between different comments. We have grouped similar comments together
under the same number and, in some cases, we have separated different
issues discussed in the same comment and designated them as distinct
comments for purposes of our responses. The number assigned to each
comment or comment topic is purely for organizational purposes and does
not signify the comment's value or importance or the order in which
comments were received.

B. Description of Comments in Support of the Delay and FDA Response

    The majority of comments supported the proposed delay and included
specific proposals and recommendations for how FDA should address
issues related to intended use, and amendments to Sec. Sec.  201.128
and 801.4, going forward. In the following paragraphs, we discuss and
respond to such comments.
    (Comment 1) Many of the comments expressed support for the delay
based on legal concerns with the January 2017 final rule. Among these
legal concerns were arguments that the final rule: (1) Violates the
First Amendment by regulating truthful speech regarding lawful
activity; (2) violates the due process clause of the Fifth Amendment to
the extent that the types of evidence to be considered are not clearly
defined; (3) unlawfully interferes with the practice of medicine; (4)
departs from relevant statutory text, legislative history, case law,
and FDA past practices, and/or (5) was issued in violation of the
notice requirement under the APA based on the inclusion of the
``totality of the evidence'' language in that final rule. Many of these
arguments were based, at least in part, on what commenters described as
a broadening from the September 25, 2015, proposed rule (see 80 FR
57756 at 57764 to 57765) of the types of evidence that could be
considered in determining intended use, and specifically raised
concerns with the ``totality of the evidence'' language included in the
January 2017 final rule.
    (Response) We agree that it is appropriate to delay the effective
date of the final rule and we will consider the legal concerns raised
regarding the January 2017 final rule as we continue to work diligently
on the issues relating to intended use raised in the underlying
rulemaking.
    (Comment 2) Several of the comments supporting the delay also
included specific proposals and recommendations for how FDA should
address issues related to intended use, and specifically amendments to
Sec. Sec.  201.128 and 801.4, going forward. For example, these
comments stated that FDA should:
    a. Adopt the approach set forth in the September 2015 proposed rule
preamble and codified--including deletion of the ``knowledge''
sentences in Sec. Sec.  201.128 and 801.4--and ensure that all guidance
and policy documents are aligned with that approach;
    b. Withdraw the January 2017 final rule and the ``totality of the
circumstances'' test included in that rule;
    c. Revise Sec. Sec.  201.128 and 801.4 to make them ``more
consistent with applicable law''; and/or
    d. Clarify that certain types of evidence, such as the following,
do not constitute evidence of intended use: (i) Scientific exchange,
(ii) truthful, non-misleading communications, and/or (iii) mere
knowledge of unapproved use by third parties, including when in
combination with non-promotional communication.
    (Response) The wide-ranging proposals and recommendations for how
FDA should address issues related to intended use and Sec. Sec.
201.128 and 801.4 in these and other comments underscore the
complexities of the issues involved. We believe these comments provide
additional support for the delay of the effective date of amendments to
the existing medical product ``intended use'' regulations. The Agency
needs more time to consider the feedback we received, make sure that
our approach is guided by our public health mandate, and ensure the
clarity of our rules on the subject. We will consider these proposals
and recommendations as we continue to work diligently on the issues
relating to intended use raised in the underlying rulemaking.
    (Comment 3) One comment stated that the proposed rule should be
delayed due to several Federal lawsuits involving FDA and vaping firms.
That comment further asserted that FDA acted deceptively and violated
the Constitution, that FDA should provide clear rulemaking procedures,
that the

tobacco and medical products parts of the rule both should not be
addressed piecemeal and should be cleanly split, and that the docket
should be closed.
    (Response) To the extent the comment intended to support the delay
of the effective date of the medical product portions of the January
2017 final rule, we agree. However, to the extent the comment intended
to assert that the effective date of new Sec.  1100.5 should likewise
be delayed, the comment is outside the scope of this rulemaking. In any
event, we disagree that there is any reason to delay the effective date
of Sec.  1100.5. As noted in the January 2018 proposed rule, when FDA
reopened the docket for the January 2017 final rule, the Agency did not
receive any comments requesting that we further delay the effective
date of Sec.  1100.5 or that we make any changes to that regulation.
This comment likewise did not suggest any changes to the substance of
that regulation. To the extent the comment can be understood to relate
to the substance of the amendments to the intended use regulations, we
will consider them as we continue to work diligently on the issues
relating to intended use raised in the underlying rulemaking.

C. Description of Comment in Opposition to the Delay and FDA Response

    (Comment 4) One comment opposed the proposed delay and asked that
FDA not further delay implementation of the January 2017 final rule.
The comment expressed support for the January 2017 final rule, stating
that (1) the ``totality of evidence'' language does not lower the
relevant evidentiary standard and (2) there has been adequate notice
and opportunity to be heard regarding the final rule. The comment
recommended that FDA build on the approach it has adopted in the past
several years to address intended use issues and argued against the
removal of the ``knowledge'' sentences in Sec. Sec.  201.128 and 801.4.
    (Response) With respect to the request not to delay implementation
of the January 2017 final rule, under FDA regulations, the Commissioner
of Food and Drugs (Commissioner) is authorized to stay, including for
an indefinite time period, the effective date of any action if the stay
is in the public interest and the interest of justice (see Sec.
10.35(a) to (b), (e) to (f) (21 CFR 10.35(a) to (b), (e) to (f))). We
believe that the delay is reasonable and appropriate in light of the
complex issues under consideration and the wide range of concerns,
proposals, and recommendations we have received in comments from
stakeholders on these issues. In addition to these comments, the Agency
received a petition specifically requesting that the Commissioner
``indefinitely stay the Final Rule'' (petition at p. 1). The petition
raised a number of concerns with the January 2017 final rule, including
constitutional concerns and public health concerns related to what the
petition stated could be a chilling of valuable scientific speech.
While the Agency remains committed to providing clarity on issues
relating to intended use, we have determined that it best serves the
public health for the Agency to take additional time to carefully
consider all of these concerns and delay the effective date of the
January 2017 final rule. The petitioners raised significant concerns
with the text of the ``intended use'' amendments, which were echoed by
several additional commenters. The Agency does not believe that
indefinitely delaying the effective date of the January 2017 final rule
to consider these issues will create a public health risk. To the
contrary, the potential for confusion and uncertainty regarding the
text of the January 2017 final rule might affect FDA's medical product
jurisdiction in ways that FDA did not intend when it set out to clarify
the ``intended use'' regulations.
    Accordingly, the Commissioner has concluded that the delay is
warranted because it is in the public interest and the interest of
justice (see Sec.  10.35(e)). As noted above, we will consider the
concerns, recommendations, and proposals set forth in these comments as
we continue to work diligently on the issues relating to intended use
raised in the underlying rulemaking.

D. Description of Comments Outside the Scope of This Rulemaking and FDA
Response

    (Comment 5) Several comments supported FDA suspending rulemaking
and closing the docket to address issues related to a specific drug
product.
    (Response) These comments appear to concern product-specific issues
that are outside the scope of this rulemaking.

III. Effective/Compliance Date(s)

    This rule is effective March 16, 2018. As provided at 82 FR 14319,
March 20, 2017, the amendments to FDA's existing regulations describing
the types of evidence that may be considered in determining a medical
product's intended uses (Sec. Sec.  201.128 (drugs) and 801.4
(devices)) will take effect on March 19, 2018. In order to delay that
effective date, this final rule needs to be effective on or before
March 19, 2018, and therefore it is not possible for this rule delaying
that effective date to take effect 30 days from publication in the
Federal Register. Thus, the Commissioner finds good cause under 21 CFR
10.40(c)(4)(ii) to make this rule effective on the day of publication.

IV. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866. The final rule is not a regulatory or
deregulatory action for the purposes of Executive Order 13771.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this final rule will impose negligible costs, if any,
we certify that the final rule will not have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $148
million, using the most current (2016) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    We received no comments on the proposed rule that specifically
addressed our preliminary regulatory impact analysis. Therefore, we
retain our preliminary estimate that the final rule will maintain the
status quo for the medical product industries and impose no additional
burden on affected entities. In table 1, we provide the costs

and benefits of the final rule in the Regulatory Information Service
Center and Office of Information and Regulatory Affairs Consolidated
Information Center Accounting information.

                  Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
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                                                                                Units
                                                                 ------------------------------------
          Category              Primary       Low        High                  Discount     Period       Notes
                               estimate    estimate    estimate      Year        rate       covered
                                                                    dollars    (percent)    (years)
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Benefits:
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Monetized $millions/year  ..........  ..........  ..........  ..........           3          10
    Annualized..............  ..........  ..........  ..........  ..........           7  ..........
    Quantified..............  ..........  ..........  ..........  ..........           3  ..........
                             ------------------------------------------------------------------------
    Qualitative.............      Avoid potential unintended      ..........  ..........  ..........
                                         consequences
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Costs:
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Monetized $millions/year  ..........  ..........  ..........  ..........           3          10
    Annualized..............  ..........  ..........  ..........  ..........           7  ..........
    Quantified..............  ..........  ..........  ..........  ..........           3  ..........
                             ------------------------------------------------------------------------
    Qualitative.............       Negligible costs, if any       ..........  ..........  ..........
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Transfers:
    Federal.................  ..........  ..........  ..........  ..........           7  ..........
    Annualized..............  ..........  ..........  ..........  ..........           3  ..........
    Monetized $millions/year  ..........  ..........  ..........  ..........  ..........  ..........
                             ------------------------------------------------------------------------
    From/To.................  From:
                              To:
                             ------------------------------------------------------------------------
    Other...................  ..........  ..........  ..........  ..........           7  ..........
    Annualized..............  ..........  ..........  ..........  ..........           3  ..........
    Monetized $millions/year  ..........  ..........  ..........  ..........  ..........  ..........
                             ------------------------------------------------------------------------
    From/To.................  From:
                              To:
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Effects:
    State, Local or Tribal Government: None.....................................................................
    Small Business: None........................................................................................
    Wages: None.................................................................................................
    Growth: None................................................................................................
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V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.20(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

VIII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that would have a substantial direct effect on one
or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.

    Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05347 Filed 3-15-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Pages 59230-59237]
[FR Doc No: 2015-24926]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0056]

Qualification of Drivers; Exemption Applications; Vision

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

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

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SUMMARY: FMCSA announces receipt of applications from 59 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 November 2, 2015. 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-2015-0056 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: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<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. 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 59 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

Steven B. Anderson

    Mr. Anderson, 68, has had macular degeneration and a cataract in
his right eye since 1995. The visual acuity in his right eye is 20/60,
and in his left eye, 20/20. Following an examination in 2015, his
ophthalmologist stated, ``In conclusion I think you qualify from a
visual perspective for line item 4 for driving a commercial vehicle.''
Mr. Anderson reported that he has driven straight trucks for 45 years,
accumulating 135,000 miles, and tractor-trailer combinations for 45
years, accumulating 45,000 miles. He holds a Class A CDL from Idaho.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Harjot S. Aujla

    Mr. Aujla, 45, 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, ``The
patient has sufficient vision to operate a commercial vehicle.'' Mr.
Aujla reported that he has driven tractor-trailer combinations for 22
years, accumulating 2.02 miles. He holds a Class A CDL from Washington.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Thomas B. Berger

    Mr. Berger, 64, has central vision loss in his right eye due to a
traumatic incident in 1981. The visual acuity in his right eye is hand
motion, and in his left eye, 20/20. Following an examination in 2015,
his optometrist stated, ``He presented with a history of trauma to this
right eye in May of 1981. . . It is my opinion that if Mr. Berger has
been operating a commercial vehicle since 1981 he is definitely capable
of doing so today.'' Mr. Berger reported that he has driven straight
trucks for 45 years, accumulating 360,000 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.

Jay E. Biggers

    Mr. Biggers, 74, has had a corneal scar and transplant in his left
eye since childhood. The visual acuity in his right eye is 20/20, and
in his left eye, 20/400. Following an examination in 2015, his
optometrist stated, ``I certify that in my medical opinion, he has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Biggers reported that he has driven tractor-
trailer combinations for 33 years, accumulating 2.81 million miles. He
holds a Class A CDL from Idaho. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Timothy A. Bohling

    Mr. Bohling, 59, has had phthisis bulbi in his left eye due to a
traumatic incident in 1993. 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 believe that Mr. Bohling has
sufficient vision to perform the driving tasks of a commercial
vehicle.'' Mr. Bohling reported that he has driven straight trucks for
1.5 years, accumulating 30,000 miles. He holds an operator's license
from Colorado. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

Brian M. Bowman

    Mr. Bowman, 54, has had a central retinal detachment in his right
eye since 2005. The visual acuity in his right eye is hand motion, and
in his left eye, 20/20. Following an examination in 2014, his
optometrist stated, ``Visual Acuity unaided was: right: hand motion,
left: 20/20, Best corrected acuity was: right: hand motion, left: 20/
20+ Color vision is normal to red, green and amber, In my opinion,
patient has the ability to drive a car or commercial vehicle.'' Mr.
Bowman reported that he has driven straight trucks for 15 years,
accumulating 216,000 miles. He holds an operator's license from
Tennessee. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Gary Bozowski

    Mr. Bozowski, 65, 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, 20/70. Following an examination in 2015, his optometrist
stated, ``Given these findings, I do believe Mr. Bozowski had
sufficient vision to operate a commercial vehicle.'' Mr. Bozowski
reported that he has driven straight trucks for 40 years, accumulating
600,000 miles, and tractor-trailer combinations for 40 years,
accumulating one million 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.

Timothy V. Burke

    Mr. Burke, 64, has had bullous keratopathy and scarring in his left
eye since 1976. 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, ``I referred him to a corneal surgical specialist
for further evaluation due to a condition that is beyond my scope of
practice. . .Therefore, my records have been updated to indicate,
because of the specialist's statement, that `Mr. Burke should be
cleared to drive a commercial vehicle on the interstate.''' Mr. Burke
reported that he has driven tractor-trailer combinations for three
years, accumulating 360,000 miles. He holds a Class A CDL from
Colorado. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Timothy J. Burleson

    Mr. Burleson, 57, has had central pigment epithelial atrophy in his
right eye since 2012. The visual acuity in his right eye is 20/50, and
in his left eye, 20/20. Following an examination in 2015, his
ophthalmologist stated, ``I do think that Mr. Burleson has the vision
required to operate a commercial vehicle.'' Mr. Burleson reported that
he has driven tractor-trailer combinations

for 27 years, accumulating 877,500 miles. He holds a Class AM CDL from
Illinois. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Robert J. Burns

    Mr. Burns, 36, has had amblyopia in his left eye since birth. The
visual acuity in his right eye is 20/20, and in his left eye, 20/80.
Following an examination in 2015, his optometrist stated, ``He has a
longstanding history of amblyopia in his left eye. . .In my opinion,
Mr. Burns meets the requirements to perform safe driving tasks while
operating a commercial vehicle.'' Mr. Burns reported that he has driven
straight trucks for two years, accumulating 24,000 miles, and tractor-
trailer combinations for 3 years, accumulating 450,000 miles. He holds
a Class DA CDL from Kentucky. His driving record for the last 3 years
shows no crashes and one conviction for a moving violation in a CMV; he
exceeded the speed limit by 9 mph in a school zone.

Richard A. Congdon, Jr.

    Mr. Congdon, 58, has had a macular scar in his left eye since 2009.
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, ``Mr
[sic] Congdon has a long history of central vision loss in the left eye
but he has full peripheral vision in both, so a CDL vision restriction
waiver is requested.'' Mr. Congdon reported that he has driven straight
trucks for 18 years, accumulating 4,500 miles, and tractor-trailer
combinations for 18 years, accumulating 450,000 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.

James E. Copp

    Mr. Copp, 54, has had amblyopia in his right eye since birth. The
visual acuity in his right eye is 20/200, and in his left eye, 20/25.
Following an examination in 2015, his optometrist stated, ``I feel Mr.
Copp has sufficient vision to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Copp reported that he has driven
straight trucks for 14 years, accumulating 560,000 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.

Jose C. Costa

    Mr. Costa, 41, has had amblyopia in his left eye since birth. The
visual acuity in his right eye is 20/20, and in his left eye, 20/200.
Following an examination in 2014, his optometrist stated, ``Has
sufficient vision to operate a commercial vehicle.'' Mr. Costa reported
that he has driven straight trucks for three years, accumulating 6,000
miles. He holds an operator's license from Washington. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Thomas P. Davidson

    Mr. Davidson, 50, 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 ophthalmologist stated, ``Mr. Davidson is a
monocular patient who has sufficient vision in his right eye to perform
the driving tasks required to operate a commercial vehicle.'' Mr.
Davidson reported that he has driven straight trucks for 32 years,
accumulating 272,000 miles, and tractor-trailer combinations for 18
years, accumulating 54,000 miles. He holds a Class A CDL from New
Jersey. His driving record for the last 3 years shows one crash, to
which he contributed by failing to secure his load, and no convictions
for moving violations in a CMV.

Mark Davis

    Mr. Davis, 51, has a cataract in his right eye due to a traumatic
incident in childhood. The visual acuity in his right eye is 20/50, and
in his left eye, 20/20. Following an examination in 2015, his
optometrist stated, ``This is to certify that in my medical opinion his
vision is sufficient without corrective lenses to safely operate a
commercial vehicle.'' Mr. Davis reported that he has driven straight
trucks for 27 years, accumulating 175,500 miles. He holds a Class B CDL
from Maine. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

Stephen W. Deminie

    Mr. Deminie, 60, has had central serous retinopathy causing a
macular scar in his right eye since 1997. 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, ``Patient has operated a
commercial vehicle safely with current visual deficiency, so I feel he
has sufficient vision to continue to do so.'' Mr. Deminie reported that
he has driven tractor-trailer combinations for 26 years, accumulating
3.12 million miles. He holds a Class AM CDL from Texas. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Brad M. Donald

    Mr. Donald, 41, 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 optometrist stated, ``It is
my opinion that Mr. Donald has sufficient vision to perform driving
tasks required to operate a commercial vehicle.'' Mr. Donald reported
that he has driven straight trucks for 10 years, accumulating 600,000
miles, and tractor-trailer combinations for 10 years, accumulating
200,000 miles. He holds a Class CA CDL from Michigan. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Robert L. Ecker

    Mr. Ecker, 56, has had amblyopia in his right eye since childhood.
The visual acuity in his right eye is hand motion, and in his left eye,
20/20. Following an examination in 2015, his optometrist stated, ``Mr.
Eckles [sic] has a longstanding decrease in vision in the right eye
that has been reported stable for many years. My impression is that the
condition should remain as it is for years to come. He currently drives
the type of equipment that he is applying for a federal license to
drive, so, it is reasonable to assume that he can continue to safely
operate commercial vehicles.'' Mr. Ecker reported that he has driven
straight trucks for 10 years, accumulating 750,000 miles. He holds an
operator's license from Maryland. His driving record for the last 3
years shows no crashes and two convictions for moving violations in a
CMV; in one incident he exceeded the speed limit by 15 mph; in the
other he disregarded a highway sign.

John A. Gartner

    Mr. Gartner, 60, has had amblyopia in his right eye since
childhood. The visual acuity in his right eye is 20/150, and in his
left eye, 20/20. Following an examination in 2015, his optometrist
stated, ``It is my medical opinion that John has sufficient vision to
perform his driving tasks required to operate a commercial vehicle.''
Mr. Gartner reported that he has driven straight trucks for 30 years,
accumulating 300,000 miles, and tractor-trailer combinations for 20
years, accumulating

1.2 million 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.

Brian W. Gillund

    Mr. Gillund, 48, has had optic atrophy in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, light perception. Following an examination in 2015, his
optometrist stated, ``U.S. Department of Transportation. . .Due to the
fact that Brian can see 20/20 in his right eye and peripheral vision is
120 degrees with both eyes, he is able to operate and automobile or
truck legally under Minnesota Law.'' Mr. Gillund reported that he has
driven straight trucks for 27 years, accumulating 135,000 miles, and
tractor-trailer combinations for 27 years, accumulating 1.35 million
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.

Glenn F. Gorsuch

    Mr. Gorsuch, 52, has had a retinal detachment in his right eye due
to a traumatic incident in 2009. The visual acuity in his right eye is
counting fingers, and in his left eye, 20/20. Following an examination
in 2015, his ophthalmologist stated, ``Mr. Gorsuch is monocular,
meaning that he is seeing through only one eye with any level of
quality, and that this eye has a full 120 degree visual field by
Humphrey Visual field perimetry. . .I hope that this can be of
assistance in the continuation of his passing of his CDL license.'' Mr.
Gorsuch reported that he has driven tractor-trailer combinations for 33
years, accumulating 3.43 million 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.

Keith N. Hall

    Mr. Hall, 58, has had complete loss of vision in his left eye since
2010. 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, ``As his visual function is stable for the last several years,
it is of my opinion that Mr. Hall has sufficient vision to perform the
tasks required by a commercial vehicle.'' Mr. Hall reported that he has
driven straight trucks for 20 years, accumulating 300,000 miles, and
tractor-trailer combinations for 25 years, accumulating 2.5 million
miles. He holds a Class A CDL from Utah. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Steven E. Hayes

    Mr. Hayes, 57, has had a prosthetic left eye since childhood. The
visual acuity in his right eye is 20/15, and in his left eye, no light
perception. Following an examination in 2015, his optometrist stated,
``Steven Hayes does indeed have sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Hayes
reported that he has driven straight trucks for 38 years, accumulating
950,000 miles, and tractor-trailer combinations for 23 years,
accumulating 230,000 miles. He holds a Class A CDL from Indiana. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Francisco Hernandez, Jr.

    Mr. Hernandez, 48, has had 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,
``He show normal color vision, with no defects, is able to recognize
the colors of traffic control signals and devices and has sufficient
vision to operate a commercial vehicle.'' Mr. Hernandez reported that
he has driven straight trucks for 10 years, accumulating 350,000 miles,
and tractor-trailer combinations for 10 years, accumulating 650,000
miles. He holds a Class A CDL from New Mexico. His driving record for
the last 3 years shows no crashes and one conviction for a moving
violation in a CMV; he failed to yield to a traffic control device.

Mervin M. Hershberger

    Mr. Hershberger, 25, has a prosthetic right eye due to a traumatic
incident in 2010. The visual acuity in his right eye is no light
perception, and in his left eye, 20/20. Following an examination in
2015, his ophthalmologist stated, ``I certify that in my medical
opinion Mr. Mervin Hershberger has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr.
Hershberger reported that he has driven straight trucks for six years,
accumulating 72,000 miles, and tractor-trailer combinations for six
years, accumulating 72,000 miles. He holds a Class ABCD CDL from
Wisconsin. His driving record for the last 3 years shows one crash, for
which he was not cited and to which he did not contribute, and no
convictions for moving violations in a CMV.

Dean M. Hobson

    Mr. Hobson, 61, has a macula scar of posterior pole and a mature
cataract in his right eye due to a traumatic incident in 1972. The
visual acuity in his right eye is counting fingers, and in his left
eye, 20/20. Following an examination in 2015, his ophthalmologist
stated, ``Formal color vision testing using Ishihara plates is normal
and I feel the patient can recognized red, green and amber and it is my
medical opinion that he has sufficient vision to perform the driving
tasks required to operate a commercial vehicle.'' Mr. Hobson reported
that he has driven tractor-trailer combinations for 23 years,
accumulating 1.38 million miles. He holds a Class A CDL from Illinois.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Timmy R. Holley

    Mr. Holley, 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 2014, his optometrist stated,
``With corrective lenses Timothy has sufficient vision to perform
driving tasks required to operate a commercial vehicle.'' Mr. Holley
reported that he has driven straight trucks for 22 years, accumulating
66,000 miles, and tractor-trailer combinations for 23 years,
accumulating 23,000 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.

David E. Hopson

    Mr. Hopson, 50, has had vein occlusion in his left eye since 2006.
The visual acuity in his right eye is 20/20, and in his left eye, 20/
200. Following an examination in 2015, his optometrist stated, ``In my
opinion, Mr. Hopson is completely capable of operating commercial
equipment/machinery both on and off the highway.''
    Mr. Hopson reported that he has driven straight trucks for 25
years, accumulating 2.5 million miles, tractor-trailer combinations for
25 years, accumulating 3.75 million miles, and buses for one year,
accumulating 75,000 miles. He holds a Class AM CDL from Texas. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Amos S. Hostetter, Jr.

    Mr. Hostetter, 58, has had Coat's exudative and retinopathy in his
left eye since birth. The visual acuity in his

right eye is 20/15, and in his left eye, 20/125. Following an
examination in 2015, his ophthalmologist stated, ``In my professional
opinion, Amos has sufficient vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Hostetter reported that
he has driven straight trucks for 35 years, accumulating 420,000 miles,
and tractor-trailer combinations for 35 years, accumulating 420,000
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.

Isadore Johnson, Jr.

    Mr. Johnson, 73, has decreased vision in his right eye due to a
traumatic incident in childhood. 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, ``He has sufficient vision to perform the
driving tasks to operate a commercial vehicle.'' Mr. Johnson reported
that he has driven straight trucks for 53 years, accumulating 212,000
miles, and tractor-trailer combinations for 55 years, accumulating
990,000 miles. He holds a Class AM CDL from New York. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

William J. Kelly

    Mr. Kelly, 59, has had amblyopia in his right eye since birth. The
visual acuity in his right eye is light perception, and in his left
eye, 20/20. Following an examination in 2015, his optometrist stated,
``In my opinion, he has sufficient vision to perform the driving tasks
to operate a commercial vehicle.'' Mr. Kelly reported that he has
driven straight trucks for 34 years, accumulating 1.97 million miles.
He holds a Class B CDL from Connecticut. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Stephen C. Linardos

    Mr. Linardos, 52, has complete loss of vision in his left eye due
to a traumatic incident in 2011. The visual acuity in his right eye is
20/25, and in his left eye, no light perception. Following an
examination in 2015, his ophthalmologist stated, ``I
    Robert W. Jacey, MD certify in my medical opinion that Mr. Stephen
Linardos does have sufficient vision in right eye to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Linardos
reported that he has driven straight trucks for 27 years, accumulating
1.79 million miles, and tractor-trailer combinations for 27 years,
accumulating 3.24 million miles. He holds a Class A CDL from Florida.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Daniel C. Linares

    Mr. Linares, 59, has had glaucoma in his left eye since 2005. 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,
``VA is sufficient for a commercial vehicle.''
    Mr. Linares reported that he has driven tractor-trailer
combinations for 16 years, accumulating 506,880 miles. He holds a Class
A CDL from California. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Ray J. Liner

    Mr. Liner, 62, has had macular scar 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 2014, his ophthalmologist
stated, ``I feel Mr. Liner has adequate vision to drive a commercial
vehicle.'' Mr. Liner reported that he has driven straight trucks for 44
years, accumulating 114,400 miles. He holds a Class B CDL from
Louisana. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Robert E. Mayers

    Mr. Mayers, 58, 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, ``Right eye is prosthetic
since injury at age 4 years old. . .He has adapted well to the
condition. In my medical opinion, this patient is capable of driving a
commercial vehicle safely.''
    Mr. Mayers reported that he has driven straight trucks for 40
years, accumulating 400,000 miles, tractor-trailer combinations for 30
years, accumulating 150,000 miles, and buses for 40 years, accumulating
400,000 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.

Kraig P. Middleton

    Mr. Middleton, 66, has had a Lasik surgery complication in his left
eye since 2008. The visual acuity in his right eye is 20/20, and in his
left eye, 20/60. Following an examination in 2015, his optometrist
stated, ``To whom it may concern,
    Kraig Middleton, having an uncorrected visual acuity of 20/25 OU,
should be very capable of operating a commercial/passenger motor
vehicle based on his visual acuity.'' Mr. Middleton reported that he
has driven buses for four years, accumulating 39,996 miles. He holds a
chauffer's license from Michigan. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

James G. Miles

    Mr. Miles, 36, has had optic atrophy in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, light perception. Following an examination in 2015, his
optometrist stated, ``Mr. Miles has sufficient vision to perform the
driving task required to operate a commercial vehicle.'' Mr. Miles
reported that he has driven straight trucks for 18 years, accumulating
900,000 miles. He holds a Class B CDL from Tennessee. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Rogelio Rocha Monjaraz

    Mr. Monjaraz, 56, 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, 20/25. Following an
examination in 2015, his optometrist stated, ``It is my medical opinion
that Mr. Rocha has sufficient vision to perform the driving tasks
required to continue to operate a commercial vehicle.'' Mr. Monjaraz
reported that he has driven straight trucks for 30 years, accumulating
240,000 miles. He holds an operator's license from Maryland. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Pablo R. Murillo

    Mr. Murillo, 32, has had a chorioretinal scar and Coat's disease in
his left eye since childhood. 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, ``His right eye testing showed Within [sic]
normal limits with good reliability and visual field defects. I see no
contraindication with him driving a commercial vehicle and he is
obtaining a federal waiver.'' Mr. Murillo reported that he has driven
straight trucks for four years, accumulating 72,000 miles, and tractor-
trailer combinations for nine months, accumulating 18,750 miles. He
holds a

Class A CDL from Texas. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Wayne Nicolaisen

    Mr. Nicolaisen, 58, has had amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/400. Following an examination in 2015, his optometrist stated,
``Wayne Nicolaisen has sufficient vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Nicolaisen reported
that he has driven straight trucks for 42 years, accumulating 2.73
million miles, and tractor-trailer combinations for 41 years,
accumulating 2.67 million miles. He holds a Class A CDL from
Pennsylvania. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

John R. Ogno

    Mr. Ogno, 45, has had a retinal detachment in his left eye since
1982. The visual acuity in his right eye is 20/20, and in his left eye,
20/60. Following an examination in 2014, his optometrist stated, ``He
has sufficient vision to qualify for a commercial vehicle license.''
Mr. Ogno reported that he has driven straight trucks for 25 years,
accumulating 375,000 miles. He holds a Class B CDL from New Jersey. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Richard A. Parker II

    Mr. Parker, 24, has had optic neuropathy and a retinal scar 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, ``I believe that Richard Parker has sufficient
vision to safely drive and operate a commercial vehicle.'' Mr. Parker
reported that he has driven straight trucks for two years, accumulating
30,000 miles, and tractor-trailer combinations for two years,
accumulating 60,000 miles. He holds a Class A CDL from Kansas. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Vincent E. Perkins

    Mr. Perkins, 56, has a prosthetic left eye due to a traumatic
incident in 1980. 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, ``It is my opinion that Mr. Perkins
continues to maintain normal full vision in his right eye; that his
condition has been stable for decades; and he continues to have
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Perkins reported that he has driven straight
trucks for 23 years, accumulating 690,000 miles. He holds a Class B CDL
from Massachusetts. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

John R. Price

    Mr. Price, 36, has had aphakic, penetrating keratoplasy and
amblyopia in his left eye since childhood. The visual acuity in his
right eye is 20/20, and in his left eye, 20/200. Following an
examination in 2015, his optometrist stated, ``He has been driving a
commercial vehicle for 13 years with the use of right eye; and same
vision and fields for 13 years.'' Mr. Price reported that he has driven
straight trucks for 13 years, accumulating 118,300 miles. He holds an
operator's license from Arkansas. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Francis D. Reginald, Jr.

    Mr. Reginald, 45, has had amblyopia in his left eye since birth.
The visual acuity in his right eye is 20/25, and in his left eye, 20/
70. Following an examination in 2015, his optometrist stated, ``In my
medical opinion, Francis has sufficient vision to perform the driving
tasks required to operate a commercial vehicle.'' Mr. Reginald reported
that he has driven straight trucks for 19 years, accumulating 66,500
miles. He holds a Class B CDL from New Jersey. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Juan A. Rodriguez

    Mr. Rodriguez, 51, has had amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/400. Following an examination in 2015, his optometrist stated,
``It is in my medical opinion that Juan has sufficient visual abilities
to safely operate a commercial vehicle.'' Mr. Rodriguez reported that
he has driven straight trucks for 23 years, accumulating 276,000 miles.
He holds a Class D CDL from Connecticut. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Roger D. Rogers

    Mr. Rogers, 43, has had a macular scar and aphakia in his left eye
due to a traumatic incident in 2012. The visual acuity in his right eye
is 20/20, and in his left eye, 20/100. Following an examination in
2015, his optometrist stated, ``Mr. Rogers should have sufficient
vision to operate a commercial vehicle equipped with side mirrors.''
    Mr. Rogers reported that he has driven tractor-trailer combinations
for 18.5 years, accumulating 1.8 million miles. He holds a Class A CDL
from Pennsylvania. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Robert E. Rohrer

    Mr. Rohrer, 74, has retinal scarring in his left eye due to measles
in childhood. The visual acuity in his right eye is 20/30, and in his
left eye, counting fingers. Following an examination in 2015, his
optometrist stated, ``Because Mr. Rohrer has been without significant
vision in his left eye most of his life, I feel that it does not
interfere in his ability to drive a limousine professionally and has
sufficient vision and visual field to perform his driving tasks.'' Mr.
Rohrer reported that he has driven buses for seven years, accumulating
52,500 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.

David L. Roth

    Mr. Roth, 50, has had complete loss of vision in his left eye since
2008. The visual acuity in his right eye is 20/20, and in his left eye,
hand motion. Following an examination in 2014, his optometrist stated,
``In my opinion, due to his adaptation to his condition and that the
condition is stable, David Roth has sufficient vision to perform
driving tasks required to operate a commercial vehicle as long as his
vehicle has mirrors on the driver and passenger sides.'' Mr. Roth
reported that he has driven straight trucks for four years,
accumulating 180,000 miles, and tractor-trailer combinations for 25
years, accumulating 1.25 million 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.

James O. Russell, Jr.

    Mr. Russell, 57, has had amblyopia and optic nerve coloboma in his
right eye since birth. The visual acuity in his

right eye is 20/250, and in his left eye, 20/20. Following an
examination in 2015, his optometrist stated, ``Mr. Russell has
functioned all his life relying solely on the vision in his left eye to
compensate for the vision in the right eye. He has been driving a
commercial vehicle for over 20 years with no accidents, which would
indicate he has sufficient vision to perform the tasks required to
operate a commercial vehicle.'' Mr. Russell reported that he has driven
straight trucks for 10 years, accumulating 600,000 miles, and tractor-
trailer combinations for 20 years, accumulating 3.4 million 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.

Ronald B. Salter

    Mr. Salter, 54, has had a traumatic cataract, secondary glaucoma,
and 30 prism diopter exotrope in his right eye since 1979. 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, ``I
believe that Mr. Ronald has sufficient vision to perform the driving
tasks to operate a commercial vehicle.'' Mr. Salter reported that he
has driven tractor-trailer combinations for 20 years, accumulating 2.55
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.

Michael J. Schmelzle

    Mr. Schmelzle, 55, has had a retinal scar in his left eye since
1979. The visual acuity in his right eye is 20/20, and in his left eye,
20/1200. Following an examination in 2014, his optometrist stated, ``In
my medical opinion, Michael has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Schmelzle
reported that he has driven straight trucks for 40 years, accumulating
100,000 miles, and tractor-trailer combinations for 35 years,
accumulating 87,500 miles. He holds a Class A CDL from Kansas. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Ralph J. Schmitt

    Mr. Schmitt, 61, has had amblyopia and open angle glaucoma 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 2014, his
ophthalmologist stated, ``In my medical opinion, his vision is adequate
to perform driving tasks required to operative [sic] a commercial
vehicle as he has done in the past.'' Mr. Schmitt reported that he has
driven straight trucks for 44 years, accumulating 220,000 miles. He
holds an operator's license from Colorado. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Charles D. Theademan

    Mr. Theademan, 40, 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, 20/50. Following an examination in 2015, his optometrist
stated, ``Charles Theademan has been driving interstate commercial
vehicles successfully for 13 years. . .His visual acuity with
spectacles is 20/50+2 OS due to refractive amblyopia.'' Mr. Theademan
reported that he has driven tractor-trailer combinations for 12 years,
accumulating 1.2 million miles. He holds a Class A CDL from Washington.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Dwight Tullis

    Mr. Tullis, 62, has had a retinal detachment in his right eye since
1987. The visual acuity in his right eye is counting fingers, and in
his left eye, 20/20. Following an examination in 2015, his optometrist
stated, ``In my medical opinion he has sufficient vision to drive a
commercial vehicle.'' Mr. Tullis reported that he has driven straight
trucks for 25 years, accumulating 500,000 miles. He holds an operator's
license from Illinois. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Arnulfo J. Valenzuela

    Mr. Valenzuela, 41, has had a macular hole in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/100. Following an examination in 2015, his optometrist stated,
``It is my medical opinion that this non-progressive macular hole has
been there for many years and that he has sufficient vision to perform
the tasks to drive a commercial vehicle.'' Mr. Valenzuela reported that
he has driven straight trucks for five years, accumulating 475,000
miles, and tractor-trailer combinations for 11 years, accumulating 1.1
million miles. He holds a Class A CDL from Texas. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Danny L. Watson

    Mr. Watson, 49, has had amblyopia in his right eye since childhood.
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
opinion, Mr. Watson does have sufficient vision to perform the driving
tasks required to operate a commercial vehicle.'' Mr. Watson reported
that he has driven straight trucks for 29 years, accumulating 1.16
million miles, and tractor-trailer combinations for two years,
accumulating 10,000 miles. He holds a Class AM CDL from Tennessee. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Lorenzo A. Williams

    Mr. Williams, 52, has had amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/200. Following an examination in 2015, his ophthalmologist
stated, ``It is my medical opinion that Lorenzo Williams has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle with a large rearview mirror and commercial left and right side
mirrors.'' Mr. Williams reported that he has driven straight trucks for
30 years, accumulating 1.2 million miles, and tractor-trailer
combinations for 30 years, accumulating 2.7 million 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.

William E. Zezulka

    Mr. Zezulka, 68, has had a cancerous tumor in his left eye since
2005. The visual acuity in his right eye is 20/20, and in his left eye,
light perception. Following an examination in 2015, his optometrist
stated, ``In my professional medical opinion, William Zezulka's visual
capabilities are sufficient to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Zezulka reported that he has driven
straight trucks for 52 years, accumulating 1.06 million miles, and
buses for nine years, accumulating 135,000 miles. He holds a Class B
CDL from Minnesota. His driving record for the last 3 years shows non
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-2015-0056 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-2015-0056 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.

    Issued on: September 25, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-24926 Filed 9-30-15; 8:45 am]
BILLING CODE 4910-EX-P