[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Proposed Rules]
[Pages 4588-4592]
[FR Doc No: 2011-1628]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2010-1013-201064; FRL-9257-7]

Approval and Promulgation of Air Quality Implementation Plan;
Alabama; Disapproval of Interstate Transport Submission for the 2006
24-Hour PM[ihel2].[ihel5] Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: On September 23, 2009, the State of Alabama, through the
Alabama Department of Environmental Management (ADEM), provided a
letter to EPA with certification that Alabama's state implementation
plan (SIP) meets the interstate transport requirements with regard to
the 2006 24-hour particulate matter (PM2.5) national ambient
air quality standard (NAAQS). Specifically, the interstate transport
requirements under the Clean Air Act (CAA or Act) prohibit a state's
emissions from significantly contributing to nonattainment or
interfering with the maintenance of the NAAQS in any other state. In
this action, EPA is proposing to disapprove the portion of Alabama's
September 23, 2009, submission which was intended to meet the
requirement to address interstate transport for the 2006 24-hour
PM2.5 NAAQS.

DATES: Comments must be received on or before February 25, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2010-1013 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: EPA-R04-OAR-2010-1013, Regulatory Development Section, Air
Planning Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Ms. Lynorae Benjamin, Chief,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official

hours of business are Monday through Friday, 8:30 to 4:30, excluding
Federal holidays.
    Instructions: Direct your comments to Docket ID No. ``EPA-R04-OAR-
2010-1013.'' EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit through http://www.regulations.gov or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy at the Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 to 4:30,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: For information regarding the Alabama
SIP, contact Mr. Zuri Farngalo, Regulatory Development Section, Air
Planning Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960. Mr. Farngalo's telephone number is (404)
562-9152; e-mail address<EMAIL_ADDRESS>For information
regarding the PM2.5 interstate transport requirements under
section 110(a)(2)(D)(i), contact Mr. Steven Scofield, Regulatory
Development Section, at the same address above. Mr. Scofield's
telephone number is<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This section provides additional information
by addressing the following questions:

I. What action is EPA proposing in today's notice?
II. What is the background for this proposed action?
III. What is EPA's analysis of Alabama's submission for section
110(a)(2)(D)(i)(I) for the 2006 24-hour PM2.5 NAAQS?
IV. Proposed Action
V. Statutory and Executive Order Reviews

I. What action is EPA proposing in today's notice?

    On September 23, 2009, the State of Alabama, through ADEM, provided
a letter to EPA with certification that the Alabama SIP meets the
interstate transport requirements with regard to the 2006 24-hour fine
PM2.5 NAAQS.\1\ Specifically, Alabama certified that its
current SIP adequately addresses the elements of CAA section
110(a)(2)(D)(i)(I) for the 2006 24-hour PM2.5 NAAQS. CAA
section 110(a)(2)(D)(i)(I) requires that implementation plans for each
state contain adequate provisions to prohibit air pollutant emissions
from sources within a state from significantly contributing to
nonattainment in or interference with maintenance of the NAAQS (in this
case the 2006 24-hour PM2.5 NAAQS) in any other state. In
today's action, EPA is proposing to disapprove the portion of Alabama's
September 23, 2009, submission related to interstate transport for the
2006 24-hour PM2.5 NAAQS because EPA has made the
preliminary determination that this submission does not meet the
requirements of section 110(a)(2)(D)(i)(I) of the CAA for this NAAQS.
EPA's rationale for this proposed disapproval is provided in Section
III of this rulemaking.
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    \1\ Alabama's September 23, 2009, certification letter also
explained that Alabama's current SIP sufficiently addresses other
requirements of section 110(a)(2) for the 2006 24-hour
PM2.5 NAAQS, however, today's proposed action only
relates to the section 110(a)(2)(D)(i)(I) requirements for the 2006
24-hour PM2.5 NAAQS. EPA will address the other section
110(a)(2) requirements for the 2006 24-hour PM2.5 NAAQS
in relation to Alabama's SIP in rulemaking separate from today's
proposed rulemaking.
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II. What is the background for this proposed action?

    On December 18, 2006, EPA revised the 24-hour average
PM2.5 primary and secondary NAAQS from 65 micrograms per
cubic meter ([micro]g/m\3\) to 35 [micro]g/m\3\. Section 110(a)(1) of
the CAA requires states to submit ``infrastructure'' SIPs to address a
new or revised NAAQS within 3 years after promulgation of such
standards, or within such shorter period as EPA may prescribe. As
provided by section 110(k)(2), within 12 months of a determination that
a submitted SIP is complete under 110(k)(1), the Administrator shall
act on the plan. As authorized in sections 110(k)(3) of the Act, where
portions of the state submittals are severable, within that 12-month
period EPA may decide to approve only those severable portions of the
submittals that meet the requirements of the Act. When the deficient
provisions are not severable from the other submitted provisions, EPA
must propose disapproval of the submittals, consistent with sections
110(k)(3) of the Act.
    Section 110(a)(2) lists the elements that such new infrastructure
SIPs must address, as applicable, including section 110(a)(2)(D)(i),
which pertains to interstate transport of certain emissions. States
were required to provide submissions to address the applicable
110(a)(2) infrastructure requirements, including section
110(a)(2)(D)(i), by September 21, 2009.\2\
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    \2\ The rule for the revised PM2.5 NAAQS was signed
by the Administrator and publically disseminated on September 21,
2006. Because EPA did not prescribe a shorter period for 110(a) SIP
submittals, these submittals for the 2006 24-hour NAAQS were due on
September 21, 2009, three years from the September 21, 2006,
signature date.
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    On September 25, 2009, EPA issued a guidance entitled ``Guidance on
SIP Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-
Hour Fine Particle (PM2.5) National Ambient Air Quality
Standards (NAAQS)'' (2006 PM2.5 NAAQS Infrastructure
Guidance). EPA developed the 2006 PM2.5 NAAQS Infrastructure
Guidance to make additional recommendations to states

for making submissions to meet the requirements of section 110,
including 110(a)(2)(D)(i) for the revised 2006 24-hour PM2.5
NAAQS.
    As identified in the 2006 PM2.5 NAAQS Infrastructure
Guidance, the ``good neighbor'' provisions in section 110(a)(2)(D)(i)
require each state to submit a SIP that prohibits emissions that
adversely affect another state in the ways contemplated in the statute.
Section 110(a)(2)(D)(i) contains four distinct requirements related to
the impacts of interstate transport. Specifically, the SIP must prevent
sources in the state from emitting pollutants in amounts which will:
(1) Contribute significantly to nonattainment of the NAAQS in other
states; (2) interfere with maintenance of the NAAQS in other states;
(3) interfere with provisions to prevent significant deterioration of
air quality in other states; or (4) interfere with efforts to protect
visibility in other states.
    In the 2006 PM2.5 NAAQS Infrastructure Guidance, EPA
explained that submissions from states pertaining to the ``significant
contribution'' and ``interfere with maintenance'' requirements in
section 110(a)(2)(D)(i)(I) must contain adequate provisions to prohibit
air pollutant emissions from within the state that contribute
significantly to nonattainment or interfere with maintenance of the
NAAQS in any other state. EPA described a number of considerations for
states for providing an adequate demonstration to address interstate
transport requirements in the 2006 PM2.5 NAAQS
Infrastructure Guidance. First, EPA noted that the state's submission
should explain whether or not emissions from the state contribute
significantly to nonattainment or interfere with maintenance of the
NAAQS in any other state and, if so, address the impact. EPA stated
that the state's conclusion should be supported by an adequate
technical analysis. Second, EPA recommended the various types of
information that could be relevant to support the state's submission,
such as information concerning emissions in the state, meteorological
conditions in the state and the potentially impacted states, monitored
ambient concentrations in the state, and air quality modeling. Third,
EPA explained that states should address the ``interfere with
maintenance'' requirement independently, which requires an evaluation
of impacts on areas of other states that are meeting the 2006 24-hour
PM2.5 NAAQS, not merely areas designated nonattainment.
Lastly, EPA explained that states could not rely on the Clean Air
Interstate Rule (CAIR) to comply with CAA section 110(a)(2)(D)(i)
requirements for the 2006 24-hour PM2.5 NAAQS because CAIR
does not address this NAAQS. Recognizing that the demonstration
required may be a challenging task for the affected states, EPA also
noted in the 2006 PM2.5 NAAQS Infrastructure Guidance the
Agency's intention to complete a rule to address interstate pollution
transport in the eastern half of the continental United States.
    EPA promulgated CAIR on May 12, 2005 (see 70 FR 25162). CAIR
required states to reduce emissions of sulfur dioxide and nitrogen
oxides that significantly contribute to, and interfere with maintenance
of the 1997 PM2.5 NAAQS and/or ozone in any downwind state.
CAIR was intended to provide states covered by the rule with a
mechanism to satisfy their CAA section 110(a)(2)(D)(i)(I) obligations
to address significant contribution to downwind nonattainment and
interference with maintenance in another state with respect to the 1997
ozone and PM2.5 NAAQS. Many states adopted the CAIR
provisions and submitted SIPs to EPA to demonstrate compliance with the
CAIR requirements in satisfaction of their 110(a)(2)(D)(i)(I)
obligations for those two pollutants.
    EPA was sued by a number of parties on various aspects of CAIR, and
on July 11, 2008, the U.S. Court of Appeals for the District of
Columbia Circuit (DC Circuit or Court) issued its decision to vacate
and remand both CAIR and the associated CAIR Federal Implementation
Plans (FIPs) in their entirety. North Carolina v. EPA, 531 F.3d 836 (DC
Circuit, July 11, 2008). However, in response to EPA's petition for
rehearing, the Court issued an order remanding CAIR to EPA without
vacating either CAIR or the CAIR FIPs. North Carolina v. EPA, 550 F.3d
1176 (DC Circuit, December 23, 2008). The Court thereby left CAIR in
place in order to ``temporarily preserve the environmental values
covered by CAIR'' until EPA replaces it with a rule consistent with the
Court's opinion. Id. at 1178. The Court directed EPA to ``remedy CAIR's
flaws'' consistent with its July 11, 2008, opinion, but declined to
impose a schedule on EPA for completing that action. Id.
    In order to address the judicial remand of CAIR, EPA has proposed a
new rule to address interstate transport pursuant to section
110(a)(2)(D)(i), the ``Federal Implementation Plans to Reduce
Interstate Transport of Fine Particulate Matter and Ozone'' (Transport
Rule).\3\ As part of the proposed Transport Rule, EPA specifically
examined the section 110(a)(2)(D)(i) requirements that emissions from
sources in a state must not ``significantly contribute to
nonattainment'' and ``interfere with maintenance'' of the 2006 24-hour
PM2.5 NAAQS by other states. The modeling performed for the
proposed Transport Rule shows that Alabama significantly contributes to
nonattainment or interferes with maintenance of the 2006 24-hour
PM2.5 NAAQS in downwind areas.
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    \3\ See ``Federal Implementation Plans to Reduce Interstate
Transport of Fine Particulate Matter and Ozone; Proposed Rule,'' 75
FR 45210 (August 2, 2010).
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III. What is EPA's analysis of Alabama's submission for section
110(a)(2)(D)(i)(I) for the 2006 24-hour PM2.5 NAAQS?

    On September 23, 2009, the State of Alabama, through ADEM, provided
a letter to EPA with certification that Alabama's SIP meets the
interstate transport requirements with regard to the 2006 24-hour
PM2.5 NAAQS. In its submission, Alabama explains that
section 110(a)(2)(D)(i)(I) is met through Alabama's approved CAIR
provisions.
    However, CAIR was promulgated before the 24-hour PM2.5
NAAQS were revised in 2006, and as mentioned above CAIR does not
address interstate transport with respect to the 2006 PM2.5
NAAQS.\4\ EPA's 2006 PM2.5 NAAQS Infrastructure Guidance
explicitly notes that reliance on CAIR cannot be used to comply with
section 110(a)(2)(D)(i)(I) for the respective 2006 PM2.5
NAAQS. Because Alabama's submittal relies on CAIR to address the
requirements of 110(a)(2)(D)(i)(I) with respect to the 2006
PM2.5 NAAQS while CAIR does not address that NAAQS, this
submission is deficient.
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    \4\ Further, as explained above and in the Transport Rule
proposal 75 FR 45210 (August 2, 2010), the DC Circuit in North
Carolina v. EPA found that EPA's quantification of states'
significant contribution and interference with maintenance in CAIR
was improper and remanded the rule to EPA. CAIR remains in effect
only temporarily.
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    EPA also notes that several states in their submission claim that
controls planned for or already installed on sources within the state
to meet the CAIR provisions satisfied section 110(a)(2)(D)(i)(I) for
the 2006 24-hour PM2.5 NAAQS. However, states will not be
able to permanently rely upon the emissions reductions predicted by
CAIR, because CAIR was remanded to EPA and will not remain in force
permanently. EPA is in the process of developing a new Transport Rule
to address the concerns of the Court as

outlined in its decision remanding CAIR. For this reason, EPA cannot
approve Alabama's SIP submission pertaining to the requirement of
section 110(a)(2)(D)(i)(I) because it relies on CAIR for emission
reduction measures. Based upon our evaluation, EPA is proposing to
disapprove Alabama's certification that its SIP meets the requirements
of 110(a)(2)(D)(i)(I) of the CAA for the 2006 PM2.5 NAAQS.
The submitted provisions are severable from each other. Therefore, EPA
is proposing to disapprove those provisions which relate to the
110(a)(2)(D)(i)(I) demonstration and to take no action on the remainder
of the demonstration at this time.

IV. Proposed Action

    EPA is proposing to disapprove the portion of Alabama's September
23, 2009, submission, relating to section 110(a)(2)(D)(i)(I), because
EPA has made the preliminary determination that Alabama SIP does not
satisfy these requirements for the 2006 PM2.5 NAAQS.
Although EPA is proposing to disapprove the portion of Alabama's
September 23, 2009, submission, relating to section 110(a)(2)(D)(i)(I),
EPA does acknowledge the State's efforts to address this requirement in
its September 23, 2009, submission. Unfortunately, EPA does not believe
that states can sufficiently address the section 110(a)(2)(D)(i)(I)
requirement for the 2006 PM2.5 NAAQS by relying on CAIR. The
purpose of the Federal Transport Rule that EPA is developing and has
proposed is to support states efforts to address the section
110(a)(2)(D)(i)(I) requirement for the 2006 PM2.5 NAAQS. EPA
is not proposing to take any action on the remaining elements of the
submission, including the section 110 infrastructure, and section
110(a)(2)(D)(i)(II) portion regarding interference with measures
required in the applicable SIP for another state designed to prevention
of significant deterioration of air quality and protect visibility but
instead will act on those provisions in a separate rulemaking.
    Under section 179(a) of the CAA, final disapproval of a submittal
that addresses a requirement of a Part D Plan (42 U.S.C.A. Sec. Sec.
7501-7515) or is required in response to a finding of substantial
inadequacy as described in Sec.  7410(k)(5) (SIP call) starts a
sanctions clock. Section 110(a)(2)(D)(i)(I) provisions (the provisions
being proposed for disapproval in today's notice) were not submitted to
meet requirements for Part D, and therefore, if EPA takes final action
to disapprove this submittal, no sanctions will be triggered. However,
if this disapproval action is finalized, that final action will trigger
the requirement under section 110(c) that EPA promulgate a FIP no later
than 2 years from the date of the disapproval unless the state corrects
the deficiency, and the Administrator approves the plan or plan
revision before the Administrator promulgates such FIP. The proposed
Federal Transport Rule, when final, is the FIP that EPA intends to
implement to satisfy the 110(a)(2)(D)(i)(I) requirement for Alabama for
the 2006 PM2.5 NAAQS.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to act on state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law.

A. Executive Order 12866, Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the Executive Order.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq,
because this proposed SIP disapproval under section 110 and subchapter
I, part D of the CAA will not in-and-of itself create any new
information collection burdens but simply disapproves certain state
requirements for inclusion into the SIP. Burden is defined at 5 CFR
1320.3(b).

C. Regulatory Flexibility Act (RFA)

    The RFA generally requires an agency to conduct a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small not-for-profit
enterprises, and small governmental jurisdictions. For purposes of
assessing the impacts of today's rule on small entities, small entity
is defined as: (1) A small business as defined by the Small Business
Administration's regulations at 13 CFR 121.201; (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
impact on a substantial number of small entities. This rule does not
impose any requirements or create impacts on small entities. This
proposed SIP disapproval under section 110 and subchapter I, part D of
the CAA will not in-and-of itself create any new requirements but
simply disapproves certain State requirements for inclusion into the
SIP. Accordingly, it affords no opportunity for EPA to fashion for
small entities less burdensome compliance or reporting requirements or
timetables or exemptions from all or part of the rule. The fact that
the CAA prescribes that various consequences (e.g., higher offset
requirements) may or will flow from this disapproval does not mean that
EPA either can or must conduct a regulatory flexibility analysis for
this action. Therefore, this action will not have a significant
economic impact on a substantial number of small entities. EPA
continues to be interested in the potential impacts of this proposed
rule on small entities and welcome comments on issues related to such
impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. EPA has determined that the proposed disapproval action does
not include a Federal mandate that may result in estimated costs of
$100 million or more to either state, local, or tribal governments in
the aggregate, or to the private sector. This action proposes to
disapprove pre-existing requirements under state or local law, and
imposes no new requirements. Accordingly, no additional costs to state,
local, or tribal governments, or to the private sector, result from
this action.

E. Executive Order 13132, Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by state and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have

federalism implications'' is defined in the Executive Order to include
regulations 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.''
    This action does not have federalism implications. It will not 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, as
specified in Executive Order 13132, because it merely disapproves
certain state requirements for inclusion into the SIP and does not
alter the relationship or the distribution of power and
responsibilities established in the CAA. Thus, Executive Order 13132
does not apply to this action.

F. Executive Order 13175, Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
EPA is proposing to disapprove would not apply in Indian country
located in the state, and EPA notes that it will not impose substantial
direct costs on tribal governments or preempt tribal law. Thus,
Executive Order 13175 does not apply to this action.

G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it is not an
economically significant regulatory action based on health or safety
risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997).
This proposed SIP disapproval under section 110 and subchapter I, part
D of the CAA will not in-and-of itself create any new regulations but
simply disapproves certain state requirements for inclusion into the
SIP.

H. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA, Public Law 104-113, section 12(d) (15
U.S.C. 272 note) directs EPA to use voluntary consensus standards in
its regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. NTTAA directs EPA to
provide Congress, through the Office of Management and Budget,
explanations when the Agency decides not to use available and
applicable voluntary consensus standards. EPA believes that this action
is not subject to requirements of Section 12(d) of NTTAA because
application of those requirements would be inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA lacks the discretionary authority to address environmental
justice in this proposed action. In reviewing SIP submissions, EPA's
role is to approve or disapprove state choices, based on the criteria
of the CAA. Accordingly, this action merely proposes to disapprove
certain state requirements for inclusion into the SIP under section 110
and subchapter I, part D of the CAA and will not in-and-of itself
create any new requirements. Accordingly, it does not provide EPA with
the discretionary authority to address, as appropriate,
disproportionate human health or environmental effects, using
practicable and legally permissible methods, under Executive Order
12898.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Particulate matter, and Reporting and recordkeeping
requirements.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: January 14, 2011.
Gwendolyn Keyes Fleming,
Regional Administrator, Region 4.
[FR Doc. 2011-1628 Filed 1-25-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 44 (Friday, March 6, 2015)]
[Notices]
[Page 12227]
[FR Doc No: 2015-05373]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Spriza, Inc.; Order of Suspension of Trading

March 4, 2015.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Spriza, Inc. because of questions regarding the accuracy of assertions
by Spriza, Inc., including assertions regarding business relationships
in a company press release dated February 6, 2015, a Form 8-K and in a
video created by the company. Spriza, Inc. is a Nevada corporation with
its principal place of business located in El Segundo, California.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period commencing at 9:30
a.m. EST, on March 4, 2015 and terminating at 11:59 p.m. EDT, on March
17, 2015.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-05373 Filed 3-4-15; 4:15 pm]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Page 23415]
[FR Doc No: 2021-09155]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4495-DR; Docket ID FEMA-2021-0001]

Guam; Amendment No. 4 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the territory of Guam (FEMA-4495-DR), dated March 27, 2020, and
related determinations.

DATES: This amendment was issued March 11, 2021.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the territory of Guam is hereby amended to include Individual
Assistance limited to COVID-19 Funeral Assistance under Other Needs
Assistance for those areas determined to have been adversely affected
by the event declared a major disaster by the President in his
declaration of March 27, 2020.

    Individual Assistance limited to COVID-19 Funeral Assistance
under Other Needs Assistance for all areas in the territory of Guam
(already designated for Individual Assistance, limited to the Crisis
Counseling Program and emergency protective measures [Category B]
not authorized under other Federal statutes, including direct
Federal assistance).

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

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-09155 Filed 4-30-21; 8:45 am]
BILLING CODE 9111-23-P


1 TELECON Call To: Tom Schultz, Vice President of HPI/ CPI Marketing and Sales for USFilter ( 262) 521 8483 Call From: Jill Lucy, ERG, Inc. Project: National Strategy: 304( m) Detailed Studies Charge Number: 0<IP_ADDRESS> Date: December 2, 2003 Subject: Wastewater Treatment Technologies for the Petrochemical Industry I contacted Tom Schultz to gather some information on applicable wastewater treatment technologies for the petrochemical industry  including petroleum refineries and petroleum bulk stations and terminals ( PBSTs).

USFilter currently has 1500 installations in the petrochemical industry, including oil/ water separators, biological treatment, and solid waste management. The company has also installed wastewater reuse systems where the effluent is treated and then reused as make up water to cooling towers. Mr. Schultz will e mail some additional treatment technology information  industry brochures and technology maps that show typical treatment and wastewater steps.

I asked Mr. Schultz if he had any cost estimates in relation to flow rates for certain treatment systems. He stated that the costs depend on flow rate and application. He did not have any general costs since they tend to be very application specific. I told Mr. Schultz, I may contact him with more specific information and perhaps include him on a conference call with some colleagues  he said that would be fine.

I also asked Mr. Schultz some specific application questions as discussed below:

Desalter Wastewater: The first step in processing crude oil is to mix the crude with water to remove salt from the crude. The desalter wastewater ( or brine water) is separated from the crude. The desalter is designed to process oil with lighter specific gravity than some current crudes possess. Therefore, the brine water carries over some oil and emulsion which causes problems at the wastewater treatment plant. To break the emulsion, you must separate the oil from the brine water prior to the treatment plant. Typically, sites use an oil/ water separator along with a chemical conditioning program. 2 USFilter Telecon  December 2, 2003 Tank Bottom Water Discharge and Treatment: Mr. Schultz said there are some tank farms not close to sewer systems or POTWs that do discharge tank bottom waters ( i. e., water draws). It is not economical to truck the tank bottom waters to off site treatment facilities. Some sites place the tank bottom waters into the pipelines and pump to another facility with treatment. Sites that do treat and discharge their tank bottom waters use biological treatment.

Granulated Activated Carbon ( GAC) Treatment Systems: GAC treatment systems are used a lot for air emission control requirements. Sites may need to cover their wastewater treatment system to control volatile organic compound ( VOC) air emissions. The GAC treatment is used only if low levels of VOCs and hydrocarbons are present in the wastewater. If high levels of VOCs and hydrocarbons are present, more activated carbon is needed and this can be very expensive. Sites with high levels instead use biological treatment. Mr. Schultz did note that the petrochemical industry does use a lot of activated carbon.


[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Pages 20174-20177]
[FR Doc No: 2021-07760]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-Z-0025]

Making Permanent Regulatory Flexibilities Provided During the
COVID-19 Public Health Emergency by Exempting Certain Medical Devices
From Premarket Notification Requirements; Withdrawal of Proposed
Exemptions

AGENCY: Department of Health and Human Services (HHS), Food and Drug
Administration (FDA).

ACTION: Notice of withdrawal.

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SUMMARY: The Department of Health and Human Services (HHS or ``The
Department'') issued a Notice in the Federal Register of January 15,
2021, that, among other things, proposed to exempt 83 class II devices
and 1 unclassified device from premarket notification. This Notice
announces HHS's and the Food and Drug Administration's (FDA or ``the
Agency'') withdrawal of the proposed exemptions for the 83 class II
devices and 1 unclassified device. The comment period for the proposed
class II and unclassified device exemptions closed on March 15, 2021.
HHS and FDA are withdrawing the proposed exemptions after reviewing the
Notice, its comments, inquiries to FDA, and other relevant information,
and determining that the proposed exemptions and bases for them are
flawed.

DATES: The proposed exemptions of 83 class II devices and 1
unclassified device, published on January 15, 2021 (86 FR 4088), are
withdrawn as of April 16, 2021.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1660, Silver Spring, MD 20993, 301-796-
6380, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (``1976 amendments'') (Pub. L. 94-
295), and the Safe Medical Devices Act of 1990 (Pub. L. 101-629),
devices are classified into class I (``general controls'') if there is
information showing that the general controls of the FD&C Act are
sufficient to assure safety and effectiveness; into class II (``special
controls''), if general controls, by themselves, are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide such
assurance; and into class III (premarket approval), if there is
insufficient information to support classifying a device into class I
or class II and the device is a life sustaining or life supporting
device, or is for a use which is of substantial importance in
preventing impairment of human health, or presents a potential
unreasonable risk of illness or injury.
    Most generic device types that were on the market before the date
of the 1976 amendments (May 28, 1976) (generally referred to as
``preamendments devices'') have been classified by FDA under the
procedures set forth in section 513(c) and (d) of the FD&C Act through
the issuance of classification regulations into one of these three
regulatory classes. Devices introduced into interstate commerce for the
first time on or after May 28, 1976 (generally referred to as
``postamendments devices''), are generally classified through the
premarket notification process under section 510(k) of the FD&C Act (21
U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing
regulations in 21 CFR part 807 require persons who intend to market a
new device to submit a premarket notification (510(k)) containing
information that allows FDA to determine whether the new device is
``substantially equivalent'' within the meaning of section 513(i) of
the FD&C Act to a legally marketed device that does not require
premarket approval.
    Section 510(m)(2) of the FD&C Act allows FDA, on its own initiative
or in response to an exemption petition, to issue in the Federal
Register a notice of intent to exempt any type of class II device from
the requirement to submit a report under section 510(k) of the FD&C
Act, if the Agency determines that such a report is not necessary to
assure the safety and effectiveness of the device. Section 510(m)(2)
further provides that the public may comment on FDA's proposed
exemptions for 60 days after publication in the Federal Register and
that FDA shall issue an order setting forth the final determination
within 120 days.
    In addition, section 510(m)(1)(A) of the FD&C Act requires FDA to,
within

90 days after enactment in December 2016 and at least once every 5
years, publish a list of each type of class II device that FDA
determines no longer requires a report under section 510(k) to provide
a reasonable assurance of safety and effectiveness, along with a public
comment period of at least 60 days. Section 510(m)(3) provides that,
upon publication of the final list in the Federal Register, each type
of class II device listed shall be exempt from the requirement for a
report under section 510(k), and the classification regulation
applicable to each type of device shall be deemed amended to
incorporate such exemption. In accordance with these statutory
requirements, FDA published a notice of proposed class II exemptions in
the Federal Register on March 14, 2017 (82 FR 13609), and a final list
of its class II exemptions on July 11, 2017 (82 FR 31976).

II. Criteria for Exemption From Section 510(k) of the FD&C Act

    Section 510(m)(2) of the FD&C Act permits FDA to exempt class II
devices from the premarket notification requirements of section 510(k),
where the Agency has determined that such notification is not necessary
to assure the safety and effectiveness of the device. To make that
determination, FDA considers a number of factors, which the Agency
first described in the January 21, 1998, Federal Register notice (63 FR
3142), and explained in FDA's guidance issued on February 19, 1998,
entitled ``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (Class II 510(k)
Exemption Guidance).1 2 As described in those documents, FDA
generally considers the following factors to determine whether class II
device types should be exempted from premarket notification: (1) The
device does not have a significant history of false or misleading
claims or of risks associated with inherent characteristics of the
device; (2) characteristics of the device necessary for its safe and
effective performance are well established; (3) changes in the device
that could affect safety and effectiveness will either (a) be readily
detectable by users by visual examination or other means such as
routine testing, before causing harm, or (b) not materially increase
the risk of injury, incorrect diagnosis, or ineffective treatment; and
(4) any changes to the device would not be likely to result in a change
in the device's classification.
---------------------------------------------------------------------------

    \1\ On January 21, 1998, to comply with the requirements of the
Food and Drug Administration Modernization Act of 1997, FDA
published a list of class II devices exempt from premarket
notification. After the 21st Century Cures Act went into effect, in
compliance with the requirement of section 510(m)(1)(A), FDA
published a notice of proposed class II device type exemptions in
the Federal Register on March 14, 2017 (82 FR 13609), and a final
list of its class II exemptions on July 11, 2017 (82 FR 31976).
    \2\ The guidance for industry and Center for Devices and
Radiological Health (CDRH) is available at https://www.fda.gov/
files/medical%20devices/published/Procedures-for-Class-II-Device-
Exemptions-from-Premarket-Notification_Guidance-for-Industry-and-
CDRH-Staff-%28PDF-Version%29.pdf.
---------------------------------------------------------------------------

    FDA may also consider that, even when exempting devices, these
devices will still be subject to the limitations on exemptions. After
considering these factors, FDA determines whether specific device types
are appropriate for exemption from section 510(k) because a report
under section 510(k) is not necessary to assure the safety and
effectiveness of the device. FDA has published several lists of class
II device types exempted or proposed to be exempted from the premarket
notification requirements of section 510(k), including on January 21,
1998 (63 FR 3142), March 14, 2017 (82 FR 13609), and July 11, 2017 (82
FR 31976). Since enactment of section 510(m) of the FD&C Act, each time
that FDA has published a list of exemptions, it has reiterated the
above criteria that it evaluates and has documented the determination
that a 510(k) submission is not necessary to assure the safety and
effectiveness of the device.

III. Limitations on Exemptions

    Exemptions to the premarket notification requirements of 510(k)
apply only to those devices that have existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type. General limitations to exemptions for class II
devices are set forth in each of the device classification regulations
(Sec. Sec.  862.9 through 892.9 (21 CFR 862.9 through 892.9)). Thus, a
manufacturer of an exempted device is still required to submit a
premarket notification before introducing a device or delivering it for
introduction into commercial distribution when the device meets any of
the conditions described in Sec. Sec.  862.9 through 892.9.
    In addition, FDA may also partially limit an exemption within a
listed device type, taking into account the factors described in the
Class II 510(k) Exemption Guidance. For example, although FDA has
granted an exemption under 510(m)(2) to certain optical position/
movement recording systems, it limits that exemption to devices for
prescription use only (85 FR 44186, July 22, 2020). In those
situations, FDA determined that premarket notification is necessary to
provide a reasonable assurance of safety and effectiveness for a subset
of those devices of the listed device type.
    The exemption from the requirement of premarket notification does
not mean that the device is exempt from any other statutory or
regulatory requirements, unless such exemption is explicitly provided
by order or regulation. FDA's determination that premarket notification
is unnecessary to provide a reasonable assurance of safety and
effectiveness for certain devices is based, in part, on the assurance
of safety and effectiveness that other regulatory controls, such as
current good manufacturing practice requirements, provide.

IV. FDA's Enforcement Policy During the Public Health Emergency

    FDA has issued guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (COVID-19 PHE), some of
which set forth enforcement policies intended to help expand the
availability of certain devices by providing regulatory flexibility for
products that have already submitted premarket notification.\3\ For
each such enforcement policy, FDA has noted that it does not intend to
object to certain modifications to these devices or their indications
of use. For all of the guidance documents related to devices, FDA
specifically limited the policies to the duration of the COVID-19 PHE.
---------------------------------------------------------------------------

    \3\ FDA's guidances related to the COVID-19 PHE are available
at: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders.
---------------------------------------------------------------------------

    In one such guidance, FDA's ``Enforcement Policy for Ventilators
and Accessories and Other Respiratory Devices During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency'' (Ventilator
Guidance), FDA stated its intention not to object to limited
modifications to the indications, claims, functionality, or to the
hardware, software, or materials of class II FDA-cleared devices used
to support patients with respiratory failure or respiratory
insufficiency, without prior submission of a premarket notification
under section 510(k), where the modification will not create an undue
risk in light of the COVID-19 PHE.\4\ In addition, FDA's Ventilator
Guidance noted that FDA does not intend to object to changes in the
indicated shelf life and duration of use of these products for treating
individual patients, without

prior submission of a premarket notification under section 510(k) of
the FD&C Act and 21 CFR 807.81, where the change does not create an
undue risk in light of the COVID-19 PHE. FDA's Ventilator Guidance
provided examples of circumstances where FDA currently believes these
types of modifications would not create such an undue risk.
---------------------------------------------------------------------------

    \4\ The policies set forth in the Ventilator Guidance apply to
ventilators with the product codes CBK, MNT, NOU, NQY, MNS, ONZ,
BTL, BSZ, BZD, NFB, NHJ, NHK, and QAV.
---------------------------------------------------------------------------

    These enforcement policies are limited in scope and duration, and
they communicate FDA's nonbinding views about how it should allocate
its enforcement resources based on current facts and circumstances.
Such policies do not alter the legal obligation to comply with the
relevant requirements and do not preclude the Agency from taking action
to enforce those requirements where appropriate. These particular
enforcement policies were issued in response to a highly unusual set of
facts and circumstances: The most sweeping PHE to occur in over a
century. The public health threat caused by COVID-19, the disease
caused by the SARS-CoV-2 virus, is substantial. Global demand for
certain devices, such as ventilators, has increased significantly and
is a critical part of the response to the COVID-19 outbreak. FDA's
COVID-19 PHE guidance documents provide information, recommendations,
and policies to help address the urgent need for certain devices and
help expand the availability of those devices during the COVID-19 PHE.

V. The January 15, 2021, Notice and Reasons for Withdrawal

    On January 15, 2021, HHS published a Notice (the ``January 15,
2021, Notice'') (86 FR 4088) proposing to exempt 83 class II device
types and 1 unclassified device type from the 510(k) premarket
notification requirements. We did not find any evidence that HHS
consulted with, otherwise involved, or even notified FDA before issuing
the Notice. Some of these proposed exemptions include device types that
are indicated for a use in supporting or sustaining human life, such as
product code NQY (``Ventilator, Continuous, Minimal Ventilatory
Support, Home Use''). The determinations in the proposal were based
solely on a tally of adverse events in FDA's Manufacturer and User
Facility Device Experience database (MAUDE), and the conclusion was
based on the number of adverse events MAUDE tabulated. The Notice
stated that ``[g]iven the lack of any adverse event reports in MAUDE
for [certain of the] class II and the unclassified medical devices . .
. and the lack of non-death-related [sic] adverse event reports for
[certain other] class II devices . . . the Department has determined
that 510(k) premarket notification for the 84 [sic] class II devices
and the unclassified device . . . is no longer necessary to assure the
safety and effectiveness of those devices.'' (86 FR 4088 at 4096). The
January 15, 2021, Notice did not identify any limitations on any of the
84 proposed exemptions, nor did it indicate that HHS considered whether
any such limitations were appropriate.
    Upon review, HHS and FDA have determined that the proposed
exemptions in the January 15, 2021, Notice were published without
adequate scientific support, that the Notice contained errors and
ambiguities, and that the Notice is otherwise flawed, as described
below. This review was prompted primarily by two things. One is that
staff and leadership in FDA's Center for Devices and Radiological
Health that conduct regulatory oversight of these products identified
several issues described below and brought them to the Department's
attention. The other is that HHS has received dozens of inquiries about
the January 15, 2021, Notice, as part of comments on the Notice
submitted to the docket as well as inquiries sent to the contact listed
in that Notice, or to various FDA staff and FDA program email
addresses. For example, there were many comments and inquiries asking
about various potential errors and ambiguities, such as about
mismatched product descriptions, product codes, and regulatory
citations.
    The January 15, 2021, Notice relied solely upon adverse event
reports in MAUDE in determining that a 510(k) is no longer necessary to
assure the safety and effectiveness of the devices. Although adverse
event reports are a valuable source of information, the reports have
limitations, as noted in the January 15, 2021, Notice, including the
potential submission of incomplete, inaccurate, untimely, unverified,
or biased data. In addition, the incidence or prevalence of an event
cannot be determined from adverse event reports alone, due to
underreporting of events, inaccuracies in reports, lack of verification
that the device caused the reported event, and lack of information
about frequency of device use. As noted by several commenters, reliance
on adverse event reports in MAUDE is an inappropriate basis for
exemption because, for example, adverse events may be underreported for
certain devices, and a low number of reports in MAUDE may reflect the
low number of marketed devices, and not necessarily the risk of injury.
In addition, relying exclusively on MAUDE data leaves out other
important information regarding risk. For example, FDA routinely
considers recall information as part of its risk analyses, including
for class II 510(k) exemptions.
    Moreover, to exempt a device from 510(k) under the standard set
forth in section 510(m)(2) of the FD&C Act, FDA must determine that a
510(k) submission is no longer necessary to assure the safety or
effectiveness of the device. Not only is adverse event data inadequate
on its own for assessing safety, it may provide little or no
information about effectiveness, for purposes of proposing exemptions.
As some comments noted, inaccurate readings from certain devices,
including tonometers, electrocardiographs, electroencephalographs,
seizure monitoring systems, vestibular analysis apparatus, or cerebral
oximeters may contribute to erroneous clinical and surgical decisions,
but may not be reflected in MAUDE.
    To the extent adverse event data is a relevant factor in
determining whether to exempt a class II device type from premarket
notification, the January 15, 2021, Notice reflects an improperly
narrow consideration of the adverse event data. The Notice proposed to
exempt 50 class II device types based solely on a lack of death-related
adverse event reports available in MAUDE for the time period searched,
while failing to consider adverse event reports submitted under other
event types, including ``injury'' and ``malfunction.'' In just one
example, table 4.2 of the Notice states that for product code MOS
(erroneously described as ``Implanted Subcutaneous Securement
Catheter''), there were zero MAUDE reports submitted under ``death,''
but there were 73 other reports, including 13 submitted under
``malfunction'' and 52 under ``injury.'' While adverse event data
should not provide the sole basis for an exemption, FDA has considered
all adverse event data relevant to its determinations and has not
limited its consideration to only those adverse event reports submitted
under the ``death'' event type. This is because, for example, device
malfunctions or injuries that do not result in death still inform
whether a 510(k) submission is necessary to assure the safety or
effectiveness of the device. In addition, the event types in MAUDE are
supplied by the submitter, and thus death-related adverse events may be
mistakenly submitted under other event types, such as ``Other,'' if any
event type is specified at all.
    In considering whether exemption from 510(k) is appropriate for
class II device types, FDA has consistently taken into account both
safety and

effectiveness, and considers the factors identified in the January 21,
1998, FR notice (63 FR 3142), and as explained in FDA's guidance
``Procedures for Class II Device Exemptions from Premarket
Notification,'' including whether (1) the device has had a significant
history of false or misleading claims or of risks associated with
inherent characteristics of the device; (2) any device characteristics
necessary for its safe and effective performance are well established;
(3) any changes in the device that could affect safety and
effectiveness will either (a) be readily detectable by users by visual
examination or other means such as routine testing, before causing
harm, or (b) not materially increase the risk of injury, incorrect
diagnosis, or ineffective treatment; and (4) any changes to the device
would not be likely to result in a change in the device's
classification. These factors are relevant to understanding whether a
premarket notification is necessary to assure the safety and
effectiveness of a device. FDA has consistently used them since 1998,
when section 510(m) was first enacted. However, these factors were not
considered as part of the January 15, 2021, Notice. As mentioned above,
the January 15, 2021, Notice only considered one piece of information--
MAUDE data--which is a drastically narrower approach to the evaluation
of whether a device should be exempt than the factors FDA has
consistently considered.
    It was also an error for HHS to propose to exempt the unclassified
device type with product code LXV from the premarket notification
requirements. Unclassified devices require submission of a 510(k)
premarket notification. The January 15, 2021, Notice proposes to exempt
this unclassified device type from 510(k) under the process and
standard of 510(m). Section 510(m), however, provides only for the
exemption of class II devices. Unclassified devices are not class II
devices. Therefore, 510(m) does not provide the standard or process for
exemption of unclassified devices. The January 15, 2021, Notice did not
cite to any other statutory provision that authorizes the exemption of
unclassified devices from 510(k).
    As noted, the January 15, 2021, Notice contained numerous errors
and ambiguities, such as mismatched product descriptions, product
codes, and regulatory citations. For example, table 6 in the Notice
lists the 84 devices it proposed to exempt. One entry gives the Device
description as ``Oxygenator, Long Term Support Greater than 6 Hours,''
the Product code as ``BZG,'' and the section in 21 CFR as ``868.1840.''
The same table has a second listing for ``Oxygenator, Long Term Support
Greater than 6 Hours,'' this one giving the Product code as ``FXY'' and
the section in 21 CFR as ``878.4040.'' However, ``Oxygenator, Long Term
Support Greater than 6 Hours'' is Product code BYS and is classified in
21 CFR 870.4100. These errors and ambiguities make it difficult or
impossible in some circumstances to discern which class II devices the
Notice is proposing to exempt, as noted by some commenters.
    Finally, we did not find evidence that HHS consulted with or
otherwise involved FDA in its proposed exemption or the issuance of the
January 15, 2021, Notice. Section 1003(d) of the FD&C Act (21 U.S.C.
393(d)) provides that the Secretary ``shall be responsible for
executing'' the FD&C Act ``through the [FDA] Commissioner.'' Here, the
January 15, 2021, Notice is clearly an action ``executing'' the FD&C
Act. Moreover, it is particularly important that FDA have at least some
level of involvement in this type of an action given the expertise
needed in evaluating whether a submission under 510(k) of the FD&C Act
is necessary to assure the safety and effectiveness of a device.
    For these reasons, HHS and FDA are withdrawing the proposed
exemptions of the 83 class II devices and 1 unclassified device
published on January 15, 2021, at 86 FR 4088. Elsewhere in this issue
of the Federal Register, HHS and FDA are stating their belief that the
class I devices that are the subject of the January 15, 2021, Notice
meet the criteria for reserved class I devices and that it is
appropriate to reverse the determination of exemption for those
devices.

    Dated: April 12, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
    Dated: April 12, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07760 Filed 4-15-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61853-61854]
[DOCID:fr17oc08-78]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-31-000]

Farmers City Wind, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

October 10, 2008.
    This is a supplemental notice in the above-referenced proceeding of
Farmers City Wind, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888

First Street, NE., Washington, DC 20426, in accordance with Rules 211
and 214 of the Commission's Rules of Practice and Procedure (18 CFR
385.211 and 385.214). Anyone filing a motion to intervene or protest
must serve a copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 30, 2008.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-24662 Filed 10-16-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67472-67476]
[FR Doc No: 2015-27879]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0071]

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 28 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. They are unable to meet the vision requirement in
one eye for

various reasons. The exemptions will enable these individuals to
operate commercial motor vehicles (CMVs) in interstate commerce without
meeting the prescribed vision requirement in one eye. If granted, the
exemptions would enable these individuals to qualify as drivers of
commercial motor vehicles (CMVs) in interstate commerce.

DATES: Comments must be received on or before December 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-2015-0071 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
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 28 individuals listed in this notice have each
requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

II. Qualifications of Applicants

Bruce D. Amundson

    Mr. Amundson, 59, has had amblyopia in his left eye since birth.
The visual acuity in his right eye is 20/20, and in his left eye, 20/
400. Following an examination in 2015, his optometrist stated, ``Bruce
Amundson definitely has sufficient vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Amundson reported that
he has driven straight trucks for 43 years, accumulating 215,000 miles,
and tractor-trailer combinations for 15 years, accumulating 450,000
miles. He holds a Class A CDL from Iowa. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Terry M. Baldwin

    Mr. Baldwin, 51, has had optic nerve coloboma and retinal dysplasia
in his left eye since birth. 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, ``Since Mr. Baldwin has been living his
entire life with this left eye vision deficit, he has obviously made
compensatory adaptations to it and has sufficient vision to perform
driving tasks required to operate a commercial vehicle.'' Mr. Baldwin
reported that he has driven straight trucks for 12 years, accumulating
124,800 miles. He holds a Class C CDL from Pennsylvania. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Gene B. Clyde

    Mr. Clyde, 52, has had amblyopia in his right eye since birth. The
visual acuity in his right eye is 20/400, and in his left eye, 20/20.
Following an examination in 2015, his ophthalmologist stated, ``In my
medical opinion, this patient has been driving for over 30 years and
has not had any accidents and therefore would seem his vision is
sufficient for commercial driving.'' Mr. Clyde reported that he has
driven straight trucks for 27 years, accumulating 675,000 miles, and
tractor-trailer combinations for 8 years, accumulating 200,000 miles.
He holds a Class AM CDL from New York. His driving record for the last
3 years shows no crashes and 1 conviction for a moving violation in a
CMV; he failed to obey a traffic control.

Joseph Coelho Jr.

    Mr. Coelho, 55, 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 2015, his ophthalmologist stated, ``He has
had amblyopia of the left eye throughout his life. In my medical
opinion, Mr. Coelho is qualified to operate a commercial motor
vehicle.'' Mr. Coelho reported that he has driven straight trucks for
38 years, accumulating 380,000 miles, and tractor-trailer combinations
for 2 years, accumulating 30,000 miles. He holds a Class A CDL from
Rhode Island. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

Levi R. Coutcher

    Mr. Coutcher, 60, has had optic nerve atrophy in his left eye since
1995. The visual acuity in his right eye is 20/20, and in his left eye,
20/150. Following an examination in 2015, his optometrist stated, ``In
my opinion Levi Coutcher has sufficient vision to perform the tasks
required to operate a commercial vehicle safely.'' Mr. Coutcher
reported that he has driven straight trucks for 14 years, accumulating
210,000 miles, and tractor-trailer combinations for 14 years,

accumulating 840,000 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.

Leonard H. Culbertson

    Mr. Culbertson, 58, has optic neuropathy in his left eye due to a
traumatic incident in 1995. The visual acuity in his right eye is 20/
20, and in his left eye, counting fingers. Following an examination in
2015, his ophthalmologist stated, ``In my medical opinion he has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Culbertson reported that he has driven
straight trucks for 41 years, accumulating 410,000 miles, and tractor-
trailer combinations for 9 years, accumulating 1.13 million miles. He
holds a Class B CDL from Georgia. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Craig L. Dawson, Sr.

    Mr. Dawson, 50, has had central scotoma in his left eye since 2008.
The visual acuity in his right eye is 20/20, and in his left eye, 20/
100. Following an examination in 2015, his ophthalmologist stated, ``In
my medical opinion, Mr. Dawson does have sufficient vision to operate a
commercial vehicle.'' Mr. Dawson reported that he has driven straight
trucks for 25 years, accumulating 500,000 miles, and tractor-trailer
combinations for 25 years, accumulating 3 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.

Jason R. Gast

    Mr. Gast, 36, has a detached retina with subsequent repair in his
right eye due to a traumatic incident in 2000. 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, ``Therefore it is my
medical opinion that he has sufficient vision to perform the driving
tasks required to operate a commercial vehicle.'' Mr. Gast reported
that he has driven straight trucks for 14 years, accumulating 26,000
miles, and tractor-trailer combinations for 2 years, accumulating 4,000
miles. He holds a Class A CDL from Missouri. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Nirmal S. Gill

    Mr. Gill, 50, has had esotropia and strabismic amblyopia in his
right eye since birth. The visual acuity in his right eye is 20/400,
and in his left eye, 20/20. Following an examination in 2015, his
ophthalmologist stated, ``Patient has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Gill
reported that he has driven tractor-trailer combinations for 15 years,
accumulating 1.2 million 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.

Robert C. Green, Jr.

    Mr. Green, 58, has a prosthetic left eye due to a traumatic
incident in 1960. 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, ``He has sufficient vision to perform all
driving tasks required to operate a commercial vehicle.'' Mr. Green
reported that he has driven straight trucks for 28 years, accumulating
21,840 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.

Stanley Grubb

    Mr. Grubb, 62, has had refractive amblyopia in his left eye since
2002. The visual acuity in his right eye is 20/25, and in his left eye,
20/800. Following an examination in 2015, his optometrist stated,
``Patient has sufficient vision to drive a commercial vehicle.'' Mr.
Grubb reported that he has driven straight trucks for 43 years,
accumulating 774,000 miles, and tractor-trailer combinations for 43
years, accumulating 1.29 million miles. He holds a Class DA CDL from
Kentucky. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Louis M. Hankins

    Mr. Hankins, 53, has had a prosthetic left eye due to a traumatic
incident in 2001. 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 understand he has been driving on a CDL
. . . He has 110+ degrees of visual field on his right side. With side
mirrors he should be able to continue to drive without difficulty.''
Mr. Hankins reported that he has driven tractor-trailer combinations
for 31 years, accumulating 2.64 million 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.

Nathan H. Jacobs

    Mr. Jacobs, 60, has had esotropia 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, ``I
certify that in my medical opinion does have sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Jacobs reported that he has driven tractor-trailer combinations for
34 years, accumulating 51,000 miles. He holds an operator's license
from New Mexico. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Danny L. Keplinger

    Mr. Keplinger, 55, 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,
``In my professional opinion, Mr. Keplinger has sufficient vision to
operate a commercial vehicle.'' Mr. Keplinger reported that he has
driven tractor-trailer combinations for 14 years, accumulating 728,000
miles. He holds a Class AM CDL from Virginia. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Kimber S. Krushinski

    Mr. Krushinski, 58, has had amblyopia in his right eye since
childhood. The visual acuity in his right eye is 20/100, and in his
left eye, 20/20. Following an examination in 2015, his optometrist
stated, ``US Dept. Transportation . . . Horizontal visual field is
satisfactory for driving.'' Mr. Krushinski reported that he has driven
straight trucks for 20 years, accumulating 680,000 miles. He holds an
operator's license from New York. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Carmelo Lana

    Mr. Lana, 63, has had myopic degeneration and amblyopia in his left
eye since birth. The visual acuity in his right eye is 20/25, and in
his left eye, counting fingers. Following an examination in 2015, his
ophthalmologist stated, ``Myopic Degeneration Left and--congenital/
stable [sic] . . . Approved to operate commercial vehicle.'' Mr. Lana
reported that he has driven straight trucks for 43 years, accumulating
2.15 million miles,

and tractor-trailer combinations for 43 years, accumulating 2.15
million miles. He holds an operator's license from New Jersey. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Keith A. Lang

    Mr. Lang, 42, has a prosthetic left eye due to a traumatic incident
in 1997. 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, ``With best corrected vision of 20/20 -1 in the
right eye and appropriate spectacle correction, pt. [sic] is able to
operate a commercial vehicle.'' Mr. Lang reported that he has driven
straight trucks for 6 years, accumulating 300,000 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.

Nathan D. Langham

    Mr. Langham, 56, has a chorioretinal scar in his right eye due to a
traumatic incident in 1990. 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 certify that Nate Langham has sufficient vision
to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Langham reported that he has driven straight trucks for
10 years, accumulating 15,000 miles, and tractor-trailer combinations
for 15 years, accumulating 142,500 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.

Michael S. Lewis

    Mr. Lewis, 49, has had refractive amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/100, and in his
left eye, 20/15. Following an examination in 2015, his optometrist
stated, ``It is my medical opinion that Mr [sic] Lewis has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Lewis reported that he has driven tractor-trailer
combinations for 27 years, accumulating 1.27 million miles. He holds a
Class A CDL from North Carolina. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Hector J. Lopez

    Mr. Lopez, 60, has had macular degeneration in his left eye since
1995. The visual acuity in his right eye is 20/25, and in his left eye,
20/400. Following an examination in 2015, his optometrist stated, ``In
my medical opinion, he has sufficient vision to perform the driving
tasks required to operate a commercial vehicle at this time.'' Mr.
Lopez reported that he has driven tractor-trailer combinations for 23
years, accumulating 2.4 million miles. He holds an operator's license
from North Carolina. His driving record for the last 3 years shows no
crashes and 1 conviction for a moving violation in a CMV; he failed to
obey a traffic sign.

John V. Narretto, Jr.

    Mr. Narretto, 65, has had a retinal detachment in his left eye
since 2005. The visual acuity in his right eye is 20/20, and in his
left eye, counting fingers. Following an examination in 2015, his
ophthalmologist stated, ``I, Dr. David Fargason, certify in my medical
opinion that Mr. Narretto has sufficient vision to perform the driving
tasks required to operate a commercial vehicle.'' Mr. Narretto reported
that he has driven straight trucks for 32 years, accumulating 384,000
miles. He holds a Class A CDL from Louisiana. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Branden J. Ramos

    Mr. Ramos, 32, has had amblyopia in his right eye since childhood.
The visual acuity in his right eye is 20/100, and in his left eye, 20/
30. Following an examination in 2015, his optometrist stated, ``In my
medical opinion, I feel Mr. Ramos has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Ramos
reported that he has driven tractor-trailer combinations for 3 years,
accumulating 904,000 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.

Sonny Scott

    Mr. Scott, 46, has had an ocular aneurysm in his right eye since
1990. 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, ``It is my medical opinion that Mr. Scott has sufficient vision
to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Scott reported that he has driven straight trucks for 18
years, accumulating 337,500 miles. He holds an operator's license from
Ohio. His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Jarrod R. Seirer

    Mr. Seirer, 31, has complete loss of vision in his left eye due to
a traumatic incident in 2009. 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, ``In my medical opinion, Mr. Jarrod
Seirer has sufficient vision to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Seirer reported that he has driven
straight trucks for 1 year, accumulating 75,000 miles, and tractor-
trailer combinations for 11 years, accumulating 1.71 million 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.

Vince A. Thompson

    Mr. Thompson, 28, has had refractive amblyopia in his left eye
since birth. The visual acuity in his right eye is 20/20, and in his
left eye, hand motion. Following an examination in 2015, his
optometrist stated, ``Due to his refractive amblyopia the best
corrected acuity in the left eye is reduced, but this does not pose a
problem at this time. I would recommend yearly eye exams and see no
restrictions concerning his ability to safely operate a commercial
motor vehicle.'' Mr. Thompson reported that he has driven straight
trucks for 4 years, accumulating 120,000 miles, and tractor-trailer
combinations for 4 years, accumulating 120,000 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.

Daniel R. Viscaya

    Mr. Viscaya, 53, has had a retinal detachment in his left eye since
birth. 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, ``This patient can distinguish between red and
green signals and also has sufficient vision in order to operate a
commercial vehicle.'' Mr. Viscaya reported that he has driven straight
trucks for 18 years, accumulating 2.16 million miles, and tractor-
trailer combinations for 18 years, accumulating 2.16 million miles. He
holds a Class A CDL from North Carolina. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Carlos Vives

    Mr. Vives, 32, has had a cataract 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 2014, his
optometrist stated, ``Although the vision in his right eye is reduced,
I believe that he has enough peripheral awareness and adequate central
vision in the left eye to drive a commercial vehicle safely.'' Mr.
Vives reported that he has driven straight trucks for 3 years,
accumulating 136,500 miles. He holds an operator's license from New
Jersey. His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Otis H. Wright Jr.

    Mr. Wright, 58, 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, ``I do
not foresee any visual problems with Mr. Wright that would make him
unable to operate a commercial vehicle: Also, he has stated to never
have had any problems in the past when operating a commercial
vehicle.'' Mr. Wright reported that he has driven straight trucks for 7
years, accumulating 84,000 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.

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-2015-0071 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-2015-0071 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: October 21, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-27879 Filed 10-30-15; 8:45 am]
 BILLING CODE 4910-EX-P