[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Proposed Rules]
[Pages 17157-17161]
[FR Doc No: 2013-06419]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2009-0965; FRL-9792-4]

Approval of Air Quality Implementation Plans; Indiana;
Disapproval of State Implementation Plan Revision for ArcelorMittal
Burns Harbor

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: On December 10, 2009, Indiana submitted a request for a
revision to its sulfur dioxide (SO2) state implementation
plan (SIP) for the ArcelorMittal Burns Harbor facility in Porter
County, Indiana. This revision would remove the SO2 emission
limit for the blast furnace gas flare at the facility. For the reasons
discussed below, EPA is proposing to disapprove this requested
revision.

DATES: Comments must be received on or before April 19, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2009-0965, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77

West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are
only accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2009-0965. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
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 information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
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 email comment
directly to EPA without going through www.regulations.gov your email
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.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This Facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Mary Portanova, Environmental Engineer,
at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Mary Portanova, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What should I consider as I prepare my comments for EPA?
II. What is the background for this action?
III. What is EPA's evaluation of the State's submittal?
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews

I. What should I consider as I prepare my comments for EPA?

    When submitting comments, remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date, and page number).
    2. Follow directions--EPA may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. What is the background for this action?

    On December 10, 2009, the Indiana Department of Environmental
Management (IDEM) submitted a request to EPA, asking EPA to approve a
revision to its SO2 SIP. This revision would amend 326
Indiana Administrative Code (IAC) 7-4-14, Porter County SO2
Emission Limitations, by removing the SO2 emission limit for
the blast furnace flare at the ArcelorMittal Burns Harbor LLC
(ArcelorMittal) steel mill. In Indiana's current SO2 SIP,
which EPA approved on January 19, 1989 (54 FR 2112), the blast furnace
flare had a limit of 0.07 pounds of SO2 per million British
Thermal Units (lbs/mmBtu). The approved SO2 SIP also
contains SO2 emission limits for a number of combustion
units at ArcelorMittal, including blast furnace stoves, coke battery
underfire, and power station boilers. Indiana's December 10, 2009 SIP
revision request did not alter these emission limits.
    ArcelorMittal's blast furnace flare is used as a safety device to
reduce excess pressure in the blast furnace gas lines and as a method
for disposing of excess blast furnace gas. Blast furnace gas is
generated during the process of iron production in the blast furnace.
The gas is collected from the facility's blast furnace and used as
fuel, along with coke oven gas and natural gas, in the facility's blast
furnace stoves, power plant boilers, slab mill soaking pits, and coke
batteries. It should be noted that the existing SIP flare limit does
not restrict the total amount of blast furnace gas that may be burned
in the flare, or limit the frequency or duration of the flare's usage.
The actual SO2 emissions from the flare are determined by
the total amount of gases it burns, and the sulfur content of those
gases.

III. What is EPA's evaluation of the State's submittal?

    Section 110(l) of the Clean Air Act (CAA) states that the
Administrator shall not approve a SIP revision if it would interfere
with any applicable requirement concerning attainment of the national
ambient air quality standards (NAAQS) and reasonable further progress,
42 U.S.C. 7410(l). Under 40 CFR 51.112(a), each SIP must demonstrate
that the measures, rules, and regulations it contains are adequate to
provide for the timely attainment and maintenance of the NAAQS. For the
reasons discussed below, EPA believes that the State has not
demonstrated that this SIP revision submission satisfies the
requirements for approval under section 110(l) of the CAA.
    The State maintains that removing the blast furnace flare limit
from the SIP will not result in or allow an increase in actual
SO2 emissions, and that the emission limit for the flare is
redundant and unnecessary for continued protection of the
SO2 NAAQS. EPA disagrees with these claims. For the blast
furnace flare limit to be considered redundant, the sulfur content of
the blast furnace gas must be addressed elsewhere in the SIP, but this
is not the

case. There are limits on individual combustion sources that use blast
furnace gas, such as the blast furnace C and D stoves and the power
station boilers, in 326 IAC 7-4-14 (1)(B) and (C). These sources are
allowed to use a combination of blast furnace gas and coke oven gas,
and their emission limits reflect this combination. The emission limits
in 326 IAC 7-4-14 (1)(B) and (C) do not specifically limit the sulfur
content of either coke oven gas or blast furnace gas.
    The State, in the August 8, 2007, Second Notice of Comment Period
for the rulemaking action on the December 10, 2009, SIP revision
request, notes that ``ISG Burns Harbor LLC \1\ states that the sulfur
content present in raw materials processed at the blast furnace is
highly variable. Because the nature of the steelmaking process requires
a continuous addition of raw materials to the blast furnace, it is
technically infeasible to manage the sulfur content of materials
charged in the blast furnace to achieve compliance with the blast
furnace flare SO2 emission limit.'' If this variability
provides for the production of blast furnace gas exceeding 0.07 lbs/
mmBtu, and if some of this gas is occasionally flared, then the removal
of the flare limit could result in and allow an increase in actual
SO2 emissions from the flare.
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    \1\ The Burns Harbor facility was operated by ISG Burns Harbor,
LLC, in 2007.
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    The State asserts that because the facility fully intends to use
all the blast furnace gas it produces, the flare's emissions would be
infrequent and therefore inconsequential. However, in a June 29, 2011,
letter which IDEM forwarded to EPA, ArcelorMittal indicated that when a
boiler or stove must be curtailed or shut down, some blast furnace gas
may be redirected to the blast furnace flare. The letter also
acknowledged that the flare is necessary for the safe operation of the
blast furnace gas systems, as it is used to regulate pressure by
accommodating gas surges, which could present safety risks at the
boilers or stoves.
    EPA believes that unless gas pressure surges are impossible while
the stoves and boilers are operating normally, or unless the stoves and
boilers always revert to a lower rate of operation whenever a pressure
surge occurs, the flare's emissions may not be negligible for SIP
planning purposes. Since the stoves and boilers operate on a
combination of blast furnace gas, coke oven gas, and natural gas, their
full operating rates could be maintained with the other fuel gases
during pressure surges that affect the flow of blast furnace gas and
necessitate the use of the flare. Therefore, the December 10, 2009, SIP
revision request would enable an increase in allowable emissions.
    IDEM did not include a revised attainment demonstration of the
SO2 NAAQS with its December 10, 2009, submission. Instead,
it relied on its 1988 demonstration of attainment, which included a
detailed air dispersion modeling analysis of the steel mill. The 1988
modeling demonstration presumed that blast furnace gas and coke oven
gas would be used together in the units at ArcelorMittal which are
allowed to use both fuels. For example, the blast furnace stoves were
modeled at an emission rate corresponding to 60% blast furnace gas
usage and 40% coke oven gas usage. The SO2 emission rate
used for blast furnace gas combustion in the 1988 modeling analysis was
0.07 lbs/mmBtu. The blast furnace flare was modeled at its SIP emission
limit of 0.07 lbs/mmBtu. IDEM used an emission rate of 1.96 lbs/mmBtu
for coke oven gas in the 1988 analysis.
    IDEM asserts that the SO2 SIP emission limits in 326 IAC
7-4-14 (1)(B) and (C), which are applicable to the facility's
combustion sources, account for all of the blast furnace gas that the
facility can produce. Therefore, IDEM states, a limit on the flare is
unnecessary to protect the NAAQS. Although the company provided
evidence that recent gas production rates have kept the facility well
within its SIP emission limits, IDEM has not provided sufficient
information to EPA to confirm the company's maximum capacity for
producing either blast furnace gas or coke oven gas. The coke oven gas
production capacity is relevant because many of the stoves and boilers
are able to use both fuels, and the 1988 analysis modeled the
combustion units as using both fuels together in specific ratios. The
facility does not store either gas, so the gases must be combusted as
they are produced. IDEM did not provide EPA with any information
regarding the amount of flaring that actually occurred during the data
years. Regardless, the flare limit acts to address the sulfur content
of the blast furnace gas, rather than to limit the amount of time the
flare operates, or how much gas it combusts in total. If the flare
limit is removed, then ArcelorMittal could produce and use blast
furnace gas with sulfur content greater than 0.07 lbs/mmBtu. If
ArcelorMittal does so, and sends some of this gas to the flare, the
higher sulfur gas could lead to increased ambient impacts from the
flare which would not be covered by the 1989 modeling.
    A proposed SIP ``must demonstrate that the measures, rules, and
regulations contained in it are adequate to provide for the timely
attainment and maintenance of the national standard that it
implements.'' Montana Sulphur & Chemical Co. v. EPA, 666 F.3d 1174,
1189 (9th Cir. 2012). Courts have also recognized the importance of
including numerical emission limits in SIPs for flares. In the Montana
Sulphur case, the United States Court of Appeals for the Ninth Circuit
affirmed this concept, noting that flare emissions ``can affect
attainment, and limits on them reasonably can be required, particularly
where the state has relied on such limits to demonstrate attainment.''
Id.
    In conclusion, EPA disagrees with IDEM's assertion that
ArcelorMittal's blast furnace gas flare limit is redundant,
unnecessary, or that its removal would not result in or allow an
increase in actual SO2 emissions. The revised rule does not
adequately address the potential for variability in blast furnace gas
sulfur content, which could affect the validity of the emission rates
used in the existing attainment demonstration, thus undermining the
SIP's ability to ensure protection of the SO2 NAAQS. EPA
believes that the revised rule does not satisfy the requirements for
approval under section 110(l) of the CAA.

IV. What action is EPA taking?

    For the reasons discussed above, EPA is proposing to disapprove
Indiana's December 10, 2009, submittal requesting a SIP revision to
remove the SO2 emission limit on the blast furnace gas flare
at ArcelorMittal Burns Harbor in Porter County.

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 CAA 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 approve State choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves State law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by State
law.

Executive Order 12866: Regulatory Planning and Review

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

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).

Regulatory Flexibility Act

    The Regulatory Flexibility Act (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 (SBA) 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.
    We continue to be interested in the potential impacts of this
proposed rule on small entities and welcome comments on issues related
to such impacts.

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.

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.

Executive Order 13175: Consultation and 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.

Executive Order 13045: Protection of Children From Environmental Health
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.

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.

National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``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 OMB, 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.

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

    Executive Order 12898 (59 FR 7629 (Feb. 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 disapproves
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, Sulfur oxides.

    Dated: March 8, 2013.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2013-06419 Filed 3-19-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11810-11811]
[FR Doc No: 2016-04946]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1849]

Medical Devices and Clinical Trial Design for the Treatment or
Improvement in the Appearance of Fungally-Infected Nails; Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Medical Devices and
Clinical Trial Design for the Treatment or Improvement in the
Appearance of Fungally-Infected Nails.'' This guidance is intended to
provide recommendations regarding clinical trial design for medical
devices intended either to provide improvement in the appearance of
nails affected by onychomycosis or to treat onychomycosis (fungal nail
infection).

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-1849 for ``Medical Devices and Clinical Trial Design for the
Treatment or Improvement in the Appearance of Fungally-Infected
Nails.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Medical Devices and Clinical Trial Design for the Treatment or
Improvement in the Appearance of Fungally-Infected Nails'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Shlomit Halachmi, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G439, Silver Spring, MD 20993-0002, 301-
796-6338.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff

entitled ``Medical Devices and Clinical Trial Design for the Treatment
or Improvement in the Appearance of Fungally-Infected Nails.'' This
guidance is intended to provide recommendations regarding clinical
trial design for medical devices intended either (1) to provide
improvement in the appearance of nails affected by onychomycosis, or
(2) to treat onychomycosis (fungal nail infection).
    In the Federal Register on January 27, 2015 (80 FR 4281), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by April 27, 2015.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on medical devices and clinical trial design
for the treatment or improvement in the appearance of fungally-infected
nails. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Medical Devices and Clinical
Trial Design for the Treatment or Improvement in the Appearance of
Fungally-Infected Nails'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1400009 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 812 are approved under OMB control number
0910-0078; the collections of information in 21 CFR part 814, subparts
B and E are approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 814, subpart H are approved
under OMB control number 0910-0332; the collections of information
regarding adverse events have been approved under OMB control number
0910-0471; and the collections of information in 21 CFR part 801 have
been approved under OMB control number 0910-0485.
    The labeling recommendations of this guidance are not subject to
review by the Office of Management and Budget because they do not
constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the recommended
labeling is a ``public disclosure of information originally supplied by
the Federal Government to the recipient for the purpose of disclosure
to the public'' (see 5 CFR 1320.3(c)(2)).

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04946 Filed 3-4-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Rules and Regulations]
[Pages 76225-76230]
[FR Doc No: 2015-30819]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2013-0786; A-1-FRL-9936-08-Region 1]

Approval and Promulgation of Air Quality Implementation Plans;
Massachusetts; Transit System Improvements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the Commonwealth of
Massachusetts. This revision removes from the SIP the design aspect of
the Red Line/Blue Line Connector transportation control measure as a
requirement in the Massachusetts SIP, without substitution or
replacement, and in addition implements administrative changes that
lengthen the existing public process requirement so that a public
meeting on the annual update and status report be held within seventy-
five days of its July 1st submittal date and replaces references to the
Executive Office of Transportation (EOT) with references to the
Massachusetts Department of Transportation (MassDOT). This action is
being taken in accordance with the Clean Air Act.

DATES: This rule is effective on January 7, 2016.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2013-0786. All documents in the docket
are listed on the http://www.regulations.gov Web site. 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 through http://www.regulations.gov or at the U.S. Environmental Protection Agency,
EPA New England Regional Office, Office of Ecosystem Protection, Air
Quality Planning Unit, 5 Post Office Square-Suite 100, Boston, MA. EPA
requests that if at all possible, you contact the contact 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 a.m. to 4:30 p.m., excluding legal holidays.
    Copies of the documents relevant to this action are also available
for public inspection during normal business hours, by appointment at
the Air and Climate Division, Department of Environmental Protection,
One Winter Street, 8th Floor, Boston, MA 02108.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Planning
Unit, U.S. Environmental Protection Agency, EPA New England Regional
Office, Office of Ecosystem Protection, 5 Post Office Square-Suite 100,
(Mail code OEP05-2), Boston, MA 02109-3912, telephone number (617) 918-
1668, fax number<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

I. Background and Purpose
II. Response to Comments
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background and Purpose

    On December 1, 2014 (79 FR 71061), EPA published a Notice of
Proposed Rulemaking (NPR) for the Commonwealth of Massachusetts. The
NPR proposed approval of a revised version of 310 Code of Massachusetts
Regulations (CMR) 7.36, ``Transit System Improvements,'' effective
under Massachusetts law on October 25, 2013. An earlier version of this
rule had previously been approved by EPA into the Massachusetts SIP.
See 73 FR 44654.
    The revised regulation: (1) Deletes the SIP requirement to design
the Red Line/Blue Line Connector from the Blue Line at Government
Center to the Red Line at Charles Station; (2) lengthens by fifteen
days (from sixty days to within seventy-five days of the July 1
submittal date) the time period within which MassDEP must hold a public
meeting to take public comment on MassDOT's annual update and status
report for each project required by 310 CMR 7.36(2)(f) through (j) and
any project implemented pursuant to 310 CMR 7.36(4) and (5); and (3)
replaces references to the Commonwealth's Executive Office of
Transportation and EOT with Massachusetts Department of Transportation
and MassDOT, respectively. The formal SIP revision was submitted to EPA
by Massachusetts on November 6, 2013.
    EPA's role in reviewing SIP revisions is to approve state choices,
provided they meet the criteria of the Clean Air Act. An adequate SIP
revision is one that, among other things, meets the Clean Air Act
requirement under CAA section 110(l) that a SIP revision must not
interfere with any applicable requirement concerning attainment and
reasonable further progress (as defined in CAA section 171) in relation
to the national air quality standards (NAAQS) or any other applicable
requirement of the Act. The Commonwealth has flexibility to revise SIP-
approved transportation control measures (TCMs), provided the revisions
are consistent with attaining and maintaining compliance with the
NAAQS. EPA has determined that the removal of the design aspect of the
Red Line/Blue Line Connector from the SIP, as well as the
administrative revisions included in Massachusetts' November 6, 2013
SIP submittal, do not interfere with attainment or with reasonable
further progress or any other applicable Clean Air Act requirement.
Therefore, we are approving Massachusetts' revised 310 CMR 7.36,
``Transit System Improvements.''

II. Response to Comments

    EPA received forty-one comments on our December 1, 2014 NPR.
Comments were received from: U.S. Senators Elizabeth Warren and Edward
J. Markey; U.S. Representatives Michael Capuano and Katherine Clark;
Edward W. Deveau, Candidate for State Representative, 1st Suffolk
District; Boston Councilor Salvatore LaMattina; Massachusetts Port
Authority (Massport); Conservation Law Foundation (CLF); A Better City
(ABC); and Frederick Salvucci (former Secretary of Massachusetts
Department of Transportation). In addition, comments were received from
East Boston, Dorchester, and Medford, Massachusetts residents. Although
six of the forty-one comments were received after the public comment

period closed, all comments have been fully considered and responded to
in this final action.
    Copies of the public comments have been placed in the public docket
without change and are available online at http://www.regulations.gov,
docket number EPA-R01-OAR-2013-0786, document numbers EPA-R01-OAR-2013-
0786-0040 through EPA-R01-OAR-2013-0786-0080.
    Comment #1: Commenters urged the EPA to deny MassDEP's request to
amend the SIP and to continue to include the design aspect of the Red
Line/Blue Line Connector in the Commonwealth's program. Some of these
comments related to a desire to decrease traffic congestion and to
improve commuting convenience for riders of the mass transit system.
Other comments identified a concern about adverse impacts of the SIP
revision to lower income communities, sometimes raising the concept of
environmental justice in that context.
    Response #1: EPA acknowledges the commenters' support for the
design of the Red Line/Blue Line Connector, and the variety of reasons
for their support. However, the relevant question before EPA in
deciding whether or not to approve the proposed Massachusetts SIP
revision before us is whether Massachusetts' deletion of the design of
the Red Line/Blue Line Connector from the SIP would interfere with any
applicable requirement concerning attainment or reasonable further
progress, or any other applicable Clean Air Act requirement. See CAA
section 110(l). As noted in EPA's December 1, 2014 NPR, the previously
approved SIP requirement at issue is for the design aspect of a project
only; consequently, removing this particular requirement from the SIP
will not affect the total emission reductions achieved from the
projects included in the Massachusetts Transit System Improvements
Regulation and also would not interfere with any applicable requirement
concerning attainment, reasonable further progress, or any other
applicable Clean Air Act requirements, thereby satisfying the
requirements set forth in section 110(l) of the Clean Air Act.
Therefore, EPA is approving the revised regulation.
    Comment #2: Commenters expressed concern that removing the design
of the Red Line/Blue Line Connector from the SIP would free the MassDOT
(Massachusetts Department of Transportation) from its commitment to
move forward on the project, thus jeopardizing the prospects of the Red
Line/Blue Line Connector ever becoming a reality.
    Response #2: As noted above in our response to Comment #1, EPA's
role is to determine whether or not removing the commitment to design
the Red Line/Blue Line Connector from the SIP is consistent with the
requirements of the Clean Air Act. We note that the Massachusetts SIP
does not contain any provision requiring Massachusetts to implement and
operate the Red Line/Blue Line Connector. In fact, that requirement was
previously removed from the SIP after notice and comment, as discussed
in the notice of proposed rulemaking. We also, note, that approving the
removal of the requirement to design the Red Line/Blue Line Connector
from the SIP, does not preclude this project from moving forward at a
later date. Whether or not the project and/or its design is in the
Massachusetts SIP, the Commonwealth is free to implement the project in
the future if it so chooses.
    Comment #3: Commenters stated that full design of the Red Line/Blue
Line Connector is a commitment MassDOT made in 2006, and if MassDOT had
no intention of building the Red Line/Blue Line Connector, that would
have been the time to decline to take on the design as a legal
commitment.
    Response #3: Again, we note that EPA's role in reviewing SIP
revisions is to approve state choices, provided they meet the relevant
requirements of the Clean Air Act. However, for completeness, we also
note the following regarding MassDOT's stated rationale regarding this
project. MassDOT took a number of steps since 2006 to advance the Red
Line/Blue Line Connector design, including, but not limited to,
allocating resources to advance the conceptual design, completing a
Draft Environmental Impact Report, and forming and meeting with a
working group. MassDOT has estimated that $50 million would be needed
to complete the final design, far exceeding the $29 million last
identified in the Boston Metropolitan Planning Organization (MPO) 2009
Regional Transportation Plan (RTP). MassDOT determined as part of this
effort and as a result of its findings, that allocating additional and
scarce transportation funding to the final design of this particular
project is not justified at this time, and that emissions reductions
that will occur pursuant to other approved transportation control
measures are adequate.
    Comment #4: Commenters noted that they want all ``Big Dig''
mitigation requirements enforced by EPA and requested that EPA insist
that the Commonwealth of Massachusetts finish the final design plans
for the Red Line/Blue Line Connector project. Similarly, other
commenters stated that they wish to protest the possible negation of
the commitment, made during the Big Dig, to finally connect the Blue
Line to the Red Line at Charles Street in Boston, Massachusetts.
    Response #4: Again, EPA acknowledges the commenters' support for
the Red Line/Blue Line Connector project, but we reiterate that EPA's
role in reviewing SIP revisions is to approve state choices, provided
they meet the relevant requirements of the Clean Air Act. As explained
earlier, Massachusetts' proposed SIP revision and EPA's approval of it,
meet all relevant CAA requirements, including those contained within
CAA section 110(l). In addition, we note that not all of the mitigation
projects associated with the ``Depression of the Central Artery and
Third Harbor Tunnel Project'' (known as CA/THT or the Big Dig) were
submitted by the Commonwealth of Massachusetts to be part of its SIP,
and were not required to be under the CAA. Those mitigation measures
adopted into the Massachusetts SIP in 1991 (see October 4, 1994; 59 FR
2795) and modified in 2006 (see July 31, 2008; 73 FR 44654) are clearly
identified in the December 1, 2014 NPR (79 FR 71061).
    Comment #5: One commenter stated that MassDEP's proposed SIP
revision should be disapproved or denied by EPA as inconsistent with
the requirements of the CAA because Massachusetts has not offered a
substitution project or measure in place of, or in substitution for,
the design for the Red Line/Blue Line Connector project. Similarly,
another commenter noted that the air quality benefits from the Red
Line/Blue Line Connector project are implicit in the initial inclusion
of the design requirement into the SIP, and therefore cannot be removed
without substitution. Another commenter further commented that if the
original inclusion of the Red Line/Blue Line Connector project design
in the revised SIP helped the state achieve compliance with the NAAQS,
it would be inconsistent to remove it now without substitution.
    Response #5: As stated in EPA's December 1, 2014 NPR, because the
previously approved SIP requirement is for design of the project only,
removing this requirement from the SIP will not affect the total
emission reductions achieved from the totality of the projects included
in the Massachusetts Transit System Improvements Regulation and would
not interfere with any applicable requirement concerning attainment,
reasonable further progress, or any other

applicable Clean Air Act requirement, thereby satisfying the
requirements set forth in section 110(l) of the Clean Air Act.
Moreover, MassDEP has demonstrated that the requirements of SIP-
approved regulation 310 CMR 7.36, ``Transit System Improvements'' have
been met. That regulation contains specific provisions under 310 CMR
7.36 (5), ``Substitute Transit System Improvement Projects,'' and 310
CMR 7.36 (8), ``Determination of Air Quality Emission Reductions'' that
govern the requirements that MassDOT must meet when substituting for
certain projects required by 310 CMR 7.36. Those projects include the
Fairmount Line improvements outlined in 310 CMR 7.36(2)(h)1. and Green
Line Extension projects outlined in 310 CMR 7.36(2)(i). For those
projects, the substitution provisions are very specific and must
include a demonstration that the proposed substitute project will
achieve 110% of the emission reductions of NMHC, CO and NOX
that would have been achieved had all components of the project
required by 310 CMR 7.36 been completed. These substitution provisions
do not include the design of the Red Line/Blue Line Connector project
which MassDEP has concluded will achieve no air quality benefits. As
such, as discussed above in an earlier response to comment, no
substitution for this SIP revision is required under the SIP.
    Comment #6: A commenter noted that there will be a time in the not
too distant future when it will be apparent that the Red Line/Blue Line
Connector project must be built, either for Clean Air Act attainment
purposes, or for economic development and/or environmental justice
reasons. According to the commenter, since MassDOT clearly has no
intention of preparing for that moment, it must be forced to do so.
    Response #6: The transportation measure in the Massachusetts' SIP
is a requirement to design the Red Line/Blue Line Connector project.
EPA has no authority under the CAA or any other statute or regulation
to require the Commonwealth to build a particular transportation
measure which is not part of the approved SIP. Moreover, not including
a transportation project in the SIP does not in any way prevent the
Commonwealth from constructing the project. The legal analysis as to
whether or not EPA must, under the CAA, approve Massachusetts' SIP
revision in this instance, particularly because it is only a design
requirement with no air quality or emissions implications, does not
change in light of potential economic development or environmental
justice concerns.
    Comment #7: One commenter stated that the EPA should consider
requiring the Commonwealth to remain committed to complete the design
of the project while investigating innovative finance options for its
implementation.
    Response #7: The Commonwealth has flexibility to revise its SIP-
approved transportation control measures (TCMs), provided the revisions
are consistent with attaining and maintaining compliance with the
NAAQSs, reasonable further progress, and any other applicable
requirements of the CAA. EPA has no authority to require the
Commonwealth to investigate innovative finance options for the Red
Line/Blue Line Connector project's implementation.
    Comment #8: One commenter expressed that there was a very serious
harm caused by the MBTA's failure to complete in a timely manner the
final design for the Red Line/Blue Line Connector project, because the
Commonwealth's project to relocate Storrow Drive at Charles Street into
a straighter alignment is located in the same area identified in the
Blue-Red DEIS (Draft Environmental Impact Statement) as needed for an
underground rail track.
    Response #8: This comment is not germane to the requirements of the
CAA pursuant to which EPA must evaluate the Commonwealth's SIP
revision. As noted earlier, the SIP revision only relates to a
provision that requires design, not implementation, of a project.
However, for completeness, we note that completion of the design of the
Red Line/Blue Line Connector would not preserve the right of way for
the Red Line/Blue Line Connector, nor prevent any state, county or city
transportation project from incursion into the area defined as project
limits or right of way in the Red Line/Blue Line Connector design. The
Boston Metropolitan Planning Organization which includes the Mass DOT,
and the City of Boston must establish priority of transportation
projects and in their transportation planning avoid or mitigate
conflicts with future transportation projects.
    Comment #9: A commenter presented the idea of a pedestrian
connection between State Street and Downtown Crossing as an alternative
to the Red Line/Blue Line Connector project. As described by the
commenter, this alternative project would extend the existing Orange
Line Southbound platform at State Street to connect with the existing
Orange Line Northbound platform at Downtown Crossing. The commenter
notes that this connection would allow fare-paying riders to walk under
Washington Street between State Street and Downtown Crossing, thus
providing an alternative Red Line/Blue Line connection. The commenter
noted that the Jeffries Point Neighborhood Association (JPNA) strongly
supports the engineering and construction of the Red Line/Blue Line
Connector project. However, the commenter also noted that should the
EPA allow the Commonwealth to abandon the Red Line/Blue Line Connector,
it must mandate the Commonwealth to pursue alternatives, such as the
pedestrian tunnel outlined above.
    Response #9: As noted earlier, EPA's role in this rulemaking action
is to approve state choices, provided they meet the requirements of the
Clean Air Act. As we've explained, the CAA does not provide EPA with
the authority in the context of this particular SIP revision to require
the Commonwealth to implement any alternative project(s), including
those identified by a number of commenters. Thus, the issue of
alternatives to the Red Line/Blue Line Connector is not germane to
EPA's approval or disapproval of the Commonwealth's request to remove
the design of the Red Line/Blue Line Connector project from the
Massachusetts SIP without substitution or replacement.
    Comment #10: One commenter noted that with the announcement that
Boston was chosen as the U.S. delegate to host the 2024 Summer
Olympics, now is as good a time as any to revisit the Commonwealth's
transportation issues.
    Response #10: The Commonwealth's transportation planning efforts
will continue over time to evaluate and prioritize transportation
projects in the Boston area and across the Commonwealth. The removal of
the design of the Red Line/Blue Line Connector project is consistent
with Massachusetts Department of Transportation's planning process. The
CAA does not provide EPA with the authority to disapprove the
Commonwealth's SIP revision as a result of the possibility that Boston
may host the 2024 Olympic Games.
    Comment #11: One commenter asserted that there are clearly air
quality benefits associated with designing a transit project.
Specifically, the commenter stated:

    For a transit project to be constructed, it has to be designed
first. Frequently, funding becomes available for a transit project
only after it has been designed. Increasingly, only projects that
are shovel-ready are eligible to apply when Federal funding
opportunities arise. Thus, designing a transit project, more than
anything else, raises its chances of being

built. As a result, air quality benefits can be calculated by
applying a discounted percentage of those the constructed project
would produce . . . Even if discounted by ninety percent, the design
of the Connector would still provide emission reductions of 15.6
kilograms for carbon monoxide, 0.4 kilograms for nitrogen oxides,
and 0.9 kilograms for volatile organic compounds per day.

    Response #11: EPA agrees that designing a project and having the
project ``shovel-ready'' increases a project's chance of being
implemented, but disagrees that any air quality benefits necessarily
would be obtained or derived from a project which only involves the
requirement to design the project on paper. A project must be completed
and operational to derive any air quality benefits and the SIP revision
does not include removal of any provisions that require completion of
the project or its operation. EPA does not believe that estimating air
quality benefits or emissions reductions using discount factors
reflecting probabilities that a project will or will not occur is
appropriate in this context, and nothing in the CAA suggests that EPA
is obligated, or even has the authority, to do so.
    Comment #12: A commenter noted that, ultimately, the SIP has to
allow the Commonwealth to attain and/or maintain compliance with the
NAAQS and that MassDEP has not provided any modeling as part of this
proposal to amend the SIP to demonstrate that the remaining projects
are sufficient. The commenter further stated that to even be able to
evaluate this request to amend the SIP properly, EPA should require
MassDEP to remodel the air quality benefits expected from the projects
remaining in the revised SIP and then compare those benefits to those
of the remaining transit system improvement projects without the Red
Line/Blue Line Connector project.
    Response #12: The three changes being considered by EPA in this SIP
revision, (removal of the design of the Red Line/Blue Line Connector
from the Massachusetts SIP, without substitution or replacement;
implementation of administrative changes that lengthen the existing
public process by fifteen days; and replacement of references to the
Executive Office of Transportation (EOT) with references to the
Massachusetts Department of Transportation (MassDOT)), would not affect
the assumptions used in, or the results of, the air quality modeling
conducted when the transportation control measures currently in the
SIP, and which will remain in the SIP, were previously approved by EPA;
nor would any of the revisions EPA is approving in this final action
alter the air quality results.
    Comment #13: A number of commenters presented the merits of a
completed Red Line/Blue Line Connector project.
    Response #13: EPA acknowledges the potential benefits associated
with a completed Red Line/Blue Line Connector Project. However, the
project as defined in the Massachusetts SIP is only for design of the
Red Line/Blue Line Connector. EPA and the Massachusetts Department of
Environmental Protection have concluded that there are no air quality
benefits achieved by the inclusion in the Commonwealth's SIP of the
requirement to only design the Red Line/Blue Line Connector.
    Comment #14: One commenter expressed concern that, if EPA does not
enforce regulations which it encouraged the state to adopt in
conjunction with the largest highway construction project in recent
history, what reason is there to take EPA seriously when it talks about
new regulations about climate change? Additionally, the commenter
noted:

    It may be difficult to get Massachusetts to behave responsibly,
but the least the public should be able to expect out of EPA is that
it clearly find fault with the ridiculously delayed non-performance
of Massachusetts, and not endorse the cynical effort to drop a
commitment that has been included in Big Dig regulations since the
1990 final EIR (Environmental Impact Report) and 1991 DEP vent shaft
regulations, and the 1993 SIP, and part of the basis of the 2006
court settlement.

    Response #14: As noted in the December 1, 2014 NPR, the original
commitment to construct the Red Line/Blue Line Connector project was
changed to a design only commitment in a 2006 SIP revision, which was
approved by EPA on July 31, 2008 (73 FR 44654). Under consideration in
today's action is EPA's approval of the removal of the commitment to
design the Red Line/Blue Line Connector project. Climate change-related
regulations, and whether persons believe there are reasons to take
EPA's efforts to address climate change seriously, are not relevant to
today's action. Moreover, the commenter's reference to Massachusetts'
alleged ``ridiculously delayed non-performance,'' is misplaced because
it makes reference to projects that are either (1) no longer part of
the Massachusetts SIP and which have been replaced by other projects or
(2) addressed by provisions in the Massachusetts regulation at 310 CMR
7.36(4) ``Project Delays and Implementation of Interim Emission
Reduction Offset Projects and Measures.'' In the case of delayed
projects, MA DOT has submitted the appropriate ``petition to delay the
project,'' which identifies the necessary interim offset project(s);
has undergone the required public review, and has received approval by
the Massachusetts Department of Environmental Protection. And nothing
contained in the commenter's comment leads EPA to conclude that any
relevant requirement of the CAA is not being complied with or is being
violated. Finally, EPA believes that Massachusetts' administrative
record, which included a public hearing, a comment period and responses
to public comments, indicates that Massachusetts had rational reasons
for concluding that finishing the design for the Red Line/Blue Line
Connector would not be prudent.
    Comment #15: One commenter stated that inaction by Massachusetts on
the transit and other SIP commitments has caused substantially more
damage to air quality than the standard traffic and air quality
prediction methods predict. In particular, the commenter stated that
the delay in implementation of the original commitments has resulted in
land use adjustments that are less transit oriented than would have
been the case, and auto ownership patterns higher than would have been
the case, with lasting negative impacts that are not factored into the
standard models used by Massachusetts. Another commenter also stated,
``The situation cries out for at least a transparent re-evaluation of
the original 1990 commitments, and begs the question of the need for
much more aggressive implementation of transit improvements to get the
horse back into the barn, now that it has been allowed to run amuck in
the garden.''
    Response #15: As noted above, not all of the mitigation projects
associated with the ``Depression of the Central Artery and Third Harbor
Tunnel Project'' (known as CA/THT or the Big Dig) were submitted by the
Commonwealth of Massachusetts to be part of its SIP; nor were they
required to be by the CAA. Those mitigation measures adopted into the
Massachusetts SIP in 1991 (see October 4, 1994; 59 FR 2795) and
modified in 2006 (see July 31, 2008; 73 FR 44654) are clearly
identified in the December 1, 2014 NPR (79 FR 71061). EPA concluded in
the 1994 and 2008 approval actions, that the Massachusetts
transportation control measures incorporated into the SIP were
consistent with the requirements of the CAA, including CAA section
110(l) for the 2008 approval action. As noted earlier on several
occasions, today's

action is limited to EPA's approval of the removal of the commitment to
design the Red Line/Blue Line Connector project. EPA finds no basis or
authority under the CAA that would require the Agency to undertake the
steps and analysis suggested by the commenter as a result of the SIP
revision at issue today.
    Comment #16: One commenter recommended that the Commonwealth be
required to perform a comprehensive re-analysis of emerging congestion
on the center of the interstate network, including analysis of the
capacity of the system to handle the Everett Casino, The Seaport
Innovation District projected build-out, the Kendall square expected
build-out, additional parking under consideration at Logan Airport, and
identification of further needed transit investment to support these
added traffic generators.
    Response #16: Overall transportation planning considerations are
not germane to this SIP revision and EPA has no authority under the CAA
to require the Commonwealth to undertake such analyses in the context
of EPA's action on the Commonwealth's submitted SIP revision. Requiring
the Commonwealth, the Metropolitan Planning Organization, or the Cities
of Boston, Cambridge and Everett to conduct additional transportation
planning is outside EPA's authority to evaluate and approve the
Massachusetts SIP revision before EPA.

III. Final Action

    EPA is approving Massachusetts' revised 310 CMR 7.36, ``Transit
System Improvements,'' submitted on November 6, 2013, as a revision to
the Massachusetts SIP. This revised rule: (1) Deletes the existing SIP
requirement to design the Red Line/Blue Line Connector project from the
Blue Line at Government Center to the Red Line at Charles Station; (2)
lengthens by fifteen days the time period during which MassDEP must
hold a public meeting and take public comment on MassDOT's annual
update and status report; and (3) replaces references to Executive
Office of Transportation and EOT with references to Massachusetts
Department of Transportation and MassDOT, respectively.
    EPA's review of the material submitted on November 6, 2013 to
remove the ``design only'' of the Red Line/Blue Line Connector project
from the Massachusetts SIP; add administrative changes to lengthen
portions of the public process under 310 CMR 7.36(2)(i); and update
references to the appropriate State transportation agency, indicates
that these modifications would not interfere with any applicable
requirement concerning attainment, reasonable further progress, or any
other applicable Clean Air Act requirement.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
Massachusetts' regulation described in the amendments to 40 CFR part 52
set forth below. The EPA has made, and will continue to make, these
documents generally available electronically through http://www.regulations.gov and/or in hard copy at the appropriate EPA office
(see the ADDRESSES section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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 approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L.104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     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 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 8, 2016. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference,

Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: September 29, 2015.
H. Curtis Spalding,
Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart W--Massachusetts

0
2. Section 52.1120 is amended by adding paragraph (c)(143) to read as
follows:

Sec.  52.1120  Identification of plan.

* * * * *
    (c) * * *
    (143) Revisions to the State Implementation Plan submitted by the
Massachusetts Department of Environmental Protection on November 6,
2013.
    (i) Incorporation by reference.
    (A) Massachusetts Regulation 310 CMR 7.36 entitled ``U Transit
System Improvements,'' effective in the Commonwealth of Massachusetts
on October 25, 2013.
    (ii) Additional materials.
    (A) Letter from the Massachusetts Department of Environmental
Protection dated November 6, 2013 submitting a revision to the
Massachusetts State Implementation Plan.

0
3. In Sec.  52.1167, Table 52.1167 is amended by adding a new entry to
the existing state citation for 310 CMR 7.36 to read as follows:

Sec.  52.1167  EPA-approved Massachusetts State regulations.

* * * * *

                                                    Table 52.1167--EPA-Approved Rules and Regulations
                                                               [See notes at end of table]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Date  submitted   Date approved     Federal Register                           Comments/
          State citation                Title/subject          by state          by EPA            citation           52.1120(c)    unapproved  sections
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
310 CMR 7.36......................  Transit System                11/6/13          12/8/15   [Insert Federal                  143   Removes from the SIP
                                     Improvements.                                            Register citation].                    the commitment to
                                                                                design the Red Line/
                                                                                Blue Line Connector
                                                                                project.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: 1. This table lists regulations adopted as of 1972. It does not depict regulatory requirements which may have been part of the Federal SIP before
  this date.
2. The regulations are effective statewide unless otherwise stated in comments or title section.

[FR Doc. 2015-30819 Filed 12-7-15; 8:45 am]
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[Federal Register: July 31, 2007 (Volume 72, Number 146)]
[Notices]
[Page 41717]
[DOCID:fr31jy07-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ07-5-000]

East Kentucky Power Cooperative, Inc.; Notice of Filing

July 24, 2007.
    Take notice that on July 13, 2007, pursuant to Order No. 890, 18
CFR 35.28(e) and Rule 207 of the Rules of Practice and Procedure of the
Federal Energy Regulatory Commission, East Kentucky Power Cooperative,
Inc. filed revision to its ``safe harbor'' Open Access Transmission
Tariff, to be effective on July 13, 2007.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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>.
    Comment Date: 5 p.m. Eastern Time on August 3, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-14763 Filed 7-30-07; 8:45 am]

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[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Proposed Rules]
[Pages 14845-14847]
[FR Doc No: 2020-05331]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2019-0291; FRL-10006-47-Region 9]

Air Plan Approval; California; Mariposa County Air Pollution
Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Mariposa County Air Pollution Control
District (MCAPCD) portion of the California State Implementation Plan
(SIP). This revision concerns reporting of emissions of volatile
organic compounds (VOCs) and oxides of nitrogen (NOX) in
nonattainment areas. We are proposing to approve a local rule to
require submittal of emissions statements under the Clean Air Act (CAA
or the Act). We are taking comments on this proposal and plan to follow
with a final action.

DATES: Any comments must arrive by April 15, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2019-0291 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Nancy Levin, EPA Region IX, 75
Hawthorne Street, San Francisco, CA

94105. By phone:<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. The EPA's recommendations to further improve the rule
    D. Public comment and proposed action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the dates
that it was adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
           Local agency                Rule #                Rule title               Revised        Submitted
----------------------------------------------------------------------------------------------------------------
MCAPCD...........................             513  Emissions Statements.........        05/15/18        04/30/19
----------------------------------------------------------------------------------------------------------------

    On May 13, 2019, the EPA determined that Rule 513 met the
completeness criteria in 40 CFR part 51 Appendix V, which must be met
before formal EPA review.\1\
---------------------------------------------------------------------------

    \1\ Letter from Elizabeth J. Adams, EPA to Richard Corey, CARB,
dated May 13, 2019.
---------------------------------------------------------------------------

B. Are there other versions of this rule?

    We approved an earlier version of Rule 513, then numbered Rule 408
``Source Recordkeeping and Reporting,'' into the SIP on August 22, 1977
(42 FR 42219). The MCAPCD renumbered and adopted revisions to Rule 408
on May 15, 2018, and CARB submitted Rule 513 ``Emissions Statements''
on April 30, 2019. Submitted Rule 513 reorganizes the information
contained in SIP-approved Rule 408. It also removes a requirement for
sources to retain emissions reports submitted to the District, which is
not required by the Act.

C. What is the purpose of the submitted rule?

    Emissions of VOCs and NOX contribute to the production
of ground-level ozone, smog, and particulate matter, which harm human
health and the environment. Section 110(a) of the CAA requires states
to submit regulations that control VOC and NOX emissions.
Rule 513 establishes requirements for the owner or operator of any
stationary source that emits, or has the potential to emit, ``criteria
pollutants,'' \2\ to submit an annual written statement to the MCAPCD
showing actual emissions of VOC and NOX or operational data
to estimate actual emissions from that source. The rule was revised to
comply with CAA section 182(a)(3)(B). The EPA's technical support
document (TSD) has more information about this rule.
---------------------------------------------------------------------------

    \2\ The criteria pollutants are carbon monoxide, lead, nitrogen
dioxide, ozone, particulate matter, and sulfur dioxide.
---------------------------------------------------------------------------

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rule?

    Rules in the SIP must be enforceable (see CAA section 110(a)(2)),
must not interfere with applicable requirements concerning attainment
and reasonable further progress or other CAA requirements (see CAA
section 110(l)), and must not modify certain SIP control requirements
in nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193). Areas classified as Marginal
nonattainment or higher, such as the Mariposa County nonattainment
area, are subject to the requirements of CAA section 182(a)(3)(B).
    Guidance and policy documents that we used to evaluate
enforceability, revision/relaxation, and CAA requirements for the
applicable criteria pollutants include the following:
     ``Issues Relating to VOC Regulation Cutpoints,
Deficiencies, and Deviations,'' EPA, May 25, 1988 (the Bluebook,
revised January 11, 1990).
     ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
     ``(Draft) Guidance on the Implementation of an Emission
Statement Program,'' EPA, July 1992.

B. Does the rule meet the evaluation criteria?

    This rule is consistent with CAA requirements and relevant guidance
regarding enforceability and SIP revisions. The TSD has more
information on our evaluation.

C. The EPA's Recommendations To Further Improve the Rule

    The TSD includes recommendations for the next time the local agency
modifies the rule.

D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted rule because it fulfills all relevant
requirements. We will accept comments from the public on this proposal
until April 15, 2020. If we take final action to approve the submitted
rule, our final action will incorporate this rule into the federally
enforceable SIP.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the MCAPCD rule described in Table 1 of this preamble. The
EPA has made, and will continue to make, these materials available
through www.regulations.gov and at the EPA Region IX Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve state law
as meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735,

October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Nitrogen dioxide,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: March 2, 2020.
John W. Busterud,
Regional Administrator, Region IX.
[FR Doc. 2020-05331 Filed 3-13-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 30 (Wednesday, February 17, 2021)]
[Notices]
[Pages 9990-9991]
[FR Doc No: 2021-03082]

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

Federal Aviation Administration

Commercial Space Transportation Advisory Committee: Notice of
Public Meeting

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Notice of public meeting.

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

SUMMARY: This notice announces a meeting of the Commercial Space
Transportation Advisory Committee for March 23, 2021.

DATES: The March 23, 2021 meeting will be held from 9:30 a.m. to 4:00
p.m.
    Requests to attend the meeting must be received by March 9, 2021.

    Requests for accommodations to a disability must be received by
March 16, 2021.
    Requests to speak during the meeting must be submitted by March 9,
2021 to DOT and include a written copy of their remarks. Registrants in
the Zoom meeting room will have the opportunity to interact directly
with committee members.
    Requests to submit written materials to be reviewed during the
meeting must be received by DOT no later than March 9, 2021.

ADDRESSES: The March 23, 2021 meeting will be an internet-only meeting.
No physical meeting is planned. Instructions on how to attend the
meeting, copies of meeting minutes, and a detailed agenda will be
posted on the COMSTAC website at: https://www.faa.gov/space/additional_information/comstac/.

FOR FURTHER INFORMATION CONTACT: James Hatt, Designated Federal
Officer, U.S. Department of Transportation, at<EMAIL_ADDRESS>
(202) 549-2325. Any committee related request should be sent to the
person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The Commercial Space Transportation Advisory Committee was created
under the Federal Advisory Committee Act (FACA), in accordance with
Public Law 92-463. Since its inception, industry-led COMSTAC has
provided information, advice, and recommendations to the U.S.
Department of Transportation through FAA regarding technology,
business, and policy issues relevant to oversight of the U.S.
commercial space transportation sector.

II. Proposed Agenda

DOT/FAA Welcome Remarks
VIP Remarks
FAA Updates
Review of Taskers Assigned at Previous Meetings/COMSTAC Final
Recommendations
Public Comment
Future COMSTAC Business

III. Public Participation

    The meeting listed in this notice will be open to the public. The
US Department of Transportation is committed to providing equal access
to this meeting for all participants. If you need alternative formats
or services because of a disability, such as sign language,
interpretation, or other ancillary aids, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section.
    There will be at least thirty minutes allotted for oral comments
from members of the public joining a COMSTAC meeting. To accommodate as
many speakers as possible, the time for each commenter may be limited.
Individuals wishing to reserve speaking time during the meeting must
submit a request at the time of registration, as well as the name,
address, and organizational affiliation of the proposed speaker. If the
number of registrants requesting to make statements is greater than can
be reasonably accommodated during the meeting, the FAA Office of
Commercial Space Transportation may conduct a lottery to determine the
speakers. Speakers are requested to submit a written copy of their
prepared remarks for inclusion in the meeting records and for
circulation to COMSTAC members. All prepared remarks submitted on time
will be accepted and considered as part of the record. Any member of
the public may present a written statement to the committee at any
time.
    Issued in Washington, DC.
* * * * *

    Dated: February 10, 2021.
James A. Hatt,
Designated Federal Officer, Commercial Space Transportation Advisory
Committee, Federal Aviation Administration, Department of
Transportation.
[FR Doc. 2021-03082 Filed 2-16-21; 8:45 am]
BILLING CODE P