[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Rules and Regulations]
[Pages 2742-2753]
[FR Doc No: 2019-00786]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2017-0358; FRL-9988-69-OAR]
RIN 2060-AT66

National Emission Standards for Hazardous Air Pollutants:
Friction Materials Manufacturing Facilities Residual Risk and
Technology Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This action finalizes the residual risk and technology review
(RTR) conducted for the Friction Materials Manufacturing Facilities
source category regulated under national emission standards for
hazardous air pollutants (NESHAP). In addition, we are taking final
action addressing periods of startup, shutdown, and malfunction (SSM).
We are finalizing our proposed determination that the risks from the
category are acceptable and that the current NESHAP provides an ample
margin of safety to protect public health. We identified no new cost-
effective controls under the technology review to achieve further
emissions reductions. These final amendments include amendments to
revise reporting requirements for deviations. These amendments are made
under the authority of the Clean Air Act (CAA) and will improve the
effectiveness of the rule. The amendments are environmentally neutral.

DATES: This final rule is effective on February 8, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2017-0358. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed,
some information is not publicly available, e.g., confidential business
information (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 through https://www.regulations.gov, or in hard copy at
the EPA Docket Center, EPA WJC West Building, Room Number 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m. Eastern Standard Time (EST),
Monday through Friday. The telephone number for the Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the Docket Center is
(202) 566-1742.

FOR FURTHER INFORMATION CONTACT: For questions about this final action,
contact Korbin Smith, Sector Policies and Programs Division (D243-04),
Office of Air Quality Planning and Standards, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina, 27711;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; and email
address<EMAIL_ADDRESS>For specific information regarding the
risk modeling methodology, contact James Hirtz, Health and
Environmental Impacts Division (C539-02), Office of Air Quality
Planning and Standards, U.S. Environmental Protection Agency, Research
Triangle Park, North Carolina 27711; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; and email address<EMAIL_ADDRESS>For
information about the applicability of the NESHAP to a particular
entity, contact Sara Ayres, Office of Enforcement and Compliance
Assurance, U.S. Environmental Protection Agency, EPA WJC South
Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone
number:<PHONE_NUMBER>; and email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Preamble acronyms and abbreviations. We use multiple acronyms and
terms in this preamble. While this list may not be exhaustive, to ease
the reading of this preamble and for reference purposes, the EPA
defines the following terms and acronyms here:

CAA Clean Air Act
CFR Code of Federal Regulations
EPA Environmental Protection Agency
HAP hazardous air pollutant(s)
ICR Information Collection Request
km kilometer
MACT maximum achievable control technology
NAICS North American Industry Classification System
NESHAP national emission standards for hazardous air pollutants
NTTAA National Technology Transfer and Advancement Act
OMB Office of Management and Budget
PRA Paperwork Reduction Act
RFA Regulatory Flexibility Act
RFPC Railroad Friction Products Corporation
RTC response to comment
RTR residual risk and technology review
SSM startup, shutdown, and malfunction
tpy tons per year
UMRA Unfunded Mandates Reform Act

    Background information. On May 3, 2018, the EPA proposed revisions
to the Friction Materials Manufacturing Facilities NESHAP based on our
RTR. In this action, we are finalizing decisions and revisions for the
rule. We summarize some of the more significant comments we timely
received regarding the proposed rule and provide our responses in this
preamble. A summary of all other public comments on the proposal and
the EPA's responses to those comments is available in ``Summary of
Public Comments and Responses for Friction Materials Manufacturing
Facilities Risk and Technology Review,'' Docket ID No. EPA-HQ-OAR-2017-
0358. A ``track changes'' version of the regulatory language that
incorporates the changes in this action is available in the docket.
    Organization of this document. The information in this preamble is
organized as follows:

I. General Information
    A. Does this action apply to me?
    B. Where can I get a copy of this document and other related
information?
    C. Judicial Review and Administrative Reconsideration
II. Background
    A. What is the statutory authority for this action?
    B. What is the Friction Materials Manufacturing Facilities
source category and how does the NESHAP regulate HAP emissions from
the source category?
    C. What changes did we propose for the Friction Materials
Manufacturing Facilities source category in our May 3, 2018,
proposal?
III. What is included in this final rule?
    A. What are the final rule amendments based on the risk review
for the Friction Materials Manufacturing Facilities source category?
    B. What are the final rule amendments based on the technology
review for the Friction Materials Manufacturing Facilities source
category?
    C. What are the final rule amendments addressing emissions
during periods of SSM?
    D. What other changes have been made to the NESHAP?
    E. What are the effective and compliance dates of the standards?
IV. What is the rationale for our final decisions and amendments for
the Friction Materials Manufacturing Facilities source category?
    A. Residual Risk Review for the Friction Materials Manufacturing
Facilities Source Category
    B. Technology Review for the Friction Materials Manufacturing
Facilities Source Category
    C. SSM
V. Summary of Cost, Environmental, and Economic Impacts and
Additional Analyses Conducted
    A. What are the affected sources?
    B. What are the air quality impacts?
    C. What are the cost impacts?
    D. What are the economic impacts?
    E. What are the benefits?
    F. What analysis of environmental justice did we conduct?
    G. What analysis of children's environmental health did we
conduct?
VI. Statutory and Executive Order Reviews
    A. Executive Orders 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs
    C. Paperwork Reduction Act (PRA)
    D. Regulatory Flexibility Act (RFA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    J. National Technology Transfer and Advancement Act (NTTAA)
    K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    L. Congressional Review Act (CRA)

I. General Information

A. Does this action apply to me?

    Regulated entities. Categories and entities potentially regulated
by this action are shown in Table 1 of this preamble.

 Table 1--NESHAP and Industrial Source Categories Affected by This Final
                                 Action
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        NESHAP and  source category                NAICS \1\ code
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Friction Materials Manufacturing            33634, 327999, 333613.
 Facilities.
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\1\ North American Industry Classification System.

    Table 1 of this preamble is not intended to be exhaustive, but
rather to provide a guide for readers regarding entities likely to be
affected by the final action for the source category listed. To
determine whether your facility is affected, you should examine the
applicability criteria in the appropriate NESHAP. If you have any
questions regarding the applicability of any aspect of this NESHAP,
please contact the appropriate person listed in the preceding FOR
FURTHER INFORMATION CONTACT section of this preamble.

B. Where can I get a copy of this document and other related
information?

    In addition to being available in the docket, an electronic copy of
this final action will also be available on the internet. Following
signature by the EPA Administrator, the EPA will post a copy of this
final action at: https://

www.epa.gov/stationary-sources-air-pollution/friction-materials-
manufacturing-facilities-national-emission. Following publication in
the Federal Register, the EPA will post the Federal Register version
and key technical documents at this same website.
    Additional information is available on the RTR website at https://www.epa.gov/ttn/atw/rrisk/rtrpg.html. This information includes an
overview of the RTR program, links to project websites for the RTR
source categories, and detailed emissions and other data we used as
inputs to the risk assessments.

C. Judicial Review and Administrative Reconsideration

    Under CAA section 307(b)(1), judicial review of this final action
is available only by filing a petition for review in the United States
Court of Appeals for the District of Columbia Circuit (the Court) by
April 9, 2019. Under CAA section 307(b)(2), the requirements
established by this final rule may not be challenged separately in any
civil or criminal proceedings brought by the EPA to enforce the
requirements.
    Section 307(d)(7)(B) of the CAA further provides that only an
objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised during judicial review. This section also
provides a mechanism for the EPA to reconsider the rule if the person
raising an objection can demonstrate to the Administrator that it was
impracticable to raise such objection within the period for public
comment or if the grounds for such objection arose after the period for
public comment (but within the time specified for judicial review) and
if such objection is of central relevance to the outcome of the rule.
Any person seeking to make such a demonstration should submit a
Petition for Reconsideration to the Office of the Administrator, U.S.
EPA, Room 3000, EPA WJC South Building, 1200 Pennsylvania Ave. NW,
Washington, DC 20460, with a copy to both the person(s) listed in the
preceding FOR FURTHER INFORMATION CONTACT section, and the Associate
General Counsel for the Air and Radiation Law Office, Office of General
Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.

II. Background

A. What is the statutory authority for this action?

    Section 112 of the CAA establishes a two-stage regulatory process
to address emissions of hazardous air pollutants (HAP) from stationary
sources. In the first stage, we must identify categories of sources
emitting one or more of the HAP listed in CAA section 112(b) and then
promulgate technology-based NESHAP for those sources. ``Major sources''
are those that emit, or have the potential to emit, any single HAP at a
rate of 10 tons per year (tpy) or more, or 25 tpy or more of any
combination of HAP. For major sources, these standards are commonly
referred to as maximum achievable control technology (MACT) standards
and must reflect the maximum degree of emission reductions of HAP
achievable (after considering cost, energy requirements, and non-air
quality health and environmental impacts). In developing MACT
standards, CAA section 112(d)(2) directs the EPA to consider the
application of measures, processes, methods, systems, or techniques,
including, but not limited to, those that reduce the volume of or
eliminate HAP emissions through process changes, substitution of
materials, or other modifications; enclose systems or processes to
eliminate emissions; collect, capture, or treat HAP when released from
a process, stack, storage, or fugitive emissions point; are design,
equipment, work practice, or operational standards; or any combination
of the above.
    For these MACT standards, the statute specifies certain minimum
stringency requirements, which are referred to as MACT floor
requirements, and which may not be based on cost considerations. See
CAA section 112(d)(3). For new sources, the MACT floor cannot be less
stringent than the emission control achieved in practice by the best-
controlled similar source. The MACT standards for existing sources can
be less stringent than floors for new sources, but they cannot be less
stringent than the average emission limitation achieved by the best-
performing 12 percent of existing sources in the category or
subcategory (or the best-performing five sources for categories or
subcategories with fewer than 30 sources). In developing MACT
standards, we must also consider control options that are more
stringent than the floor under CAA section 112(d)(2). We may establish
standards more stringent than the floor, based on the consideration of
the cost of achieving the emissions reductions, any non-air quality
health and environmental impacts, and energy requirements.
    In the second stage of the regulatory process, the CAA requires the
EPA to undertake two different analyses, which we refer to as the
technology review and the residual risk review. Under the technology
review, we must review the technology-based standards and revise them
``as necessary (taking into account developments in practices,
processes, and control technologies)'' no less frequently than every 8
years, pursuant to CAA section 112(d)(6). Under the residual risk
review, we must evaluate the risk to public health remaining after
application of the technology-based standards and revise the standards,
if necessary, to provide an ample margin of safety to protect public
health or to prevent, taking into consideration costs, energy, safety,
and other relevant factors, an adverse environmental effect. The
residual risk review is required within 8 years after promulgation of
the technology-based standards, pursuant to CAA section 112(f). In
conducting the residual risk review, if the EPA determines that the
current standards provide an ample margin of safety to protect public
health, it is not necessary to revise the MACT standards pursuant to
CAA section 112(f).\1\ For more information on the statutory authority
for this rule, see 83 FR 19499.
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    \1\ The Court has affirmed this approach of implementing CAA
section 112(f)(2)(A): NRDC v. EPA, 529 F.3d 1077, 1083 (D.C. Cir.
2008) (``If EPA determines that the existing technology-based
standards provide an `ample margin of safety,' then the Agency is
free to readopt those standards during the residual risk
rulemaking.'').
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B. What is the Friction Materials Manufacturing Facilities source
category and how does the NESHAP regulate HAP emissions from the source
category?

    The EPA promulgated the Friction Materials Manufacturing Facilities
NESHAP on October 18, 2002 (67 FR 64498). The standards are codified at
40 Code of Federal Regulations (CFR) part 63, subpart QQQQQ. The
Friction Materials Manufacturing Facilities industry consists of
facilities that manufacture friction materials using a solvent-based
process. Friction materials are used in the manufacture of products
used to accelerate or decelerate objects. Products that use friction
materials include, but are not limited to, disc brake pucks, disc brake
pads, brake linings, brake shoes, brake segments, blocks, brake discs,
clutch facings, and clutches. The source category covered by this MACT
standard currently includes two facilities.

    The affected source is each friction material manufacturing solvent
mixer. The NESHAP regulates emissions of HAP through emission standards
for solvent, which are emitted from solvent mixers. Facilities subject
to the NESHAP must reduce the emissions by using solvent recovery or
another approved method. The emission standards are the same for new
and existing solvent mixers, but are different for small and large
solvent mixers. The emission limit for new, reconstructed, and existing
large solvent mixers requires each facility that operates a large
solvent mixer to limit HAP solvent emissions to the atmosphere to no
more than 30 percent of that which would otherwise be emitted in the
absence of solvent recovery and/or solvent substitution, based on a 7-
day block average. The emission limit for new, reconstructed, and
existing small solvent mixers requires facilities operating small
solvent mixers to limit HAP solvent emissions to the atmosphere to no
more than 15 percent of that which would otherwise be emitted in the
absence of solvent recovery and/or solvent substitution, based on a 7-
day block average.

C. What changes did we propose for the Friction Materials Manufacturing
Facilities source category in our May 3, 2018, proposal?

    On May 3, 2018, the EPA published a proposed rule in the Federal
Register for the Friction Materials Manufacturing Facilities NESHAP, 40
CFR part 63, subpart QQQQQ, that took into consideration the RTR
analyses. In the proposed rule, we proposed revisions to the SSM
provisions of the MACT rule in order to ensure that they are consistent
with the Court decision in Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir.
2008), which vacated two provisions in the EPA's ``General Provisions''
implementing CAA section 112 at 40 CFR part 63, subpart A, that
exempted sources from the requirement to comply with otherwise
applicable CAA section 112(d) emission standards during periods of SSM.
In addition, we proposed to revise the rule's reporting requirements
for deviations.

III. What is included in this final rule?

    This action finalizes the EPA's determinations pursuant to the RTR
provisions of CAA section 112 for the Friction Materials Manufacturing
Facilities source category. This action also finalizes other changes to
the NESHAP, including amendments to the SSM provisions of the MACT rule
and revisions to the rule's reporting requirements for deviations.

A. What are the final rule amendments based on the risk review for the
Friction Materials Manufacturing Facilities source category?

    The EPA proposed no changes to the 40 CFR part 63, subpart QQQQQ,
NESHAP based on the risk review conducted pursuant to CAA section
112(f). We are finalizing our proposed determination that risks from
the source category following implementation of MACT standards are
acceptable, considering all the health information and factors
evaluated, and also considering risk estimation uncertainty. The EPA
received no new data or other information during the public comment
period that affected our determinations. Therefore, we are not
requiring additional controls and, thus, are not making any revisions
to the existing standards, in order to meet the requirements of CAA
section 112(f). (However, as previously noted, we are making limited
changes in order to improve implementation and to conform our standards
to the 2008 Sierra Club ruling regarding SSM.)

B. What are the final rule amendments based on the technology review
for the Friction Materials Manufacturing Facilities source category?

    We determined that there are no developments in practices,
processes, and control technologies that warrant revisions to the MACT
standards for this source category. The EPA received no new data or
other information during the public comment period that affected our
determinations. Therefore, we are not finalizing revisions to the MACT
standards in order to meet the requirements of CAA section 112(d)(6).
(Again, however, we are making limited changes for other purposes, as
previously noted and explained in detail below.)

C. What are the final rule amendments addressing emissions during
periods of SSM?

    In its 2008 decision in Sierra Club v. EPA, 551 F.3d 1019 (D.C.
Cir. 2008), the Court vacated portions of two provisions in the EPA's
CAA section 112 ``General Provisions'' regulations governing the
emissions of HAP during periods of SSM. Specifically, the Court vacated
the SSM exemption contained in 40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1),
holding that under section 302(k) of the CAA, emissions standards or
limitations must be continuous in nature and that the SSM exemption
violates the CAA's requirement that some CAA section 112 standards
apply continuously.
    We have eliminated the SSM exemption in this rule. Consistent with
Sierra Club v. EPA, the EPA has established standards in this rule that
apply at all times. We have also revised Table 4 to subpart QQQQQ of
Part 63 (the General Provisions applicability table) in several
respects as is explained in more detail below. For example, we have
eliminated the incorporation of the General Provisions' requirement
that the source develop an SSM plan. We have also eliminated and
revised certain recordkeeping and reporting that are related to the SSM
exemption as described in detail in the proposal and summarized below.

D. What other changes have been made to the NESHAP?

    The EPA is promulgating revisions to the rule's reporting
requirements at 40 CFR 63.9540(c)(2) for deviations by requiring
facilities to now report the date, time, a list of affected sources or
equipment, an estimate of the quantity of each regulated pollutant
emitted over any emission limit, a description of the method used to
estimate the emissions, and the corrective action taken. In addition,
facilities must continue to report the number, duration, and cause of
deviations (including unknown cause, if applicable). To see how the
revised regulatory text compares to the previous text, see the
document, ``Redline Version Showing Proposed Changes to 40 CFR part 63
subpart QQQQQ,'' presenting 40 CFR 63.9540(c)(2), in Docket ID No. EPA-
HQ-OAR-2017-0358.

E. What are the effective and compliance dates of the standards?

    The revisions to the NESHAP being promulgated in this action are
effective on February 8, 2019. The compliance date for existing
affected sources, whether subject to the existing or new source limits
in the original rule, to comply with the revised requirements is no
later than 180 days after the effective date of the final rule.
Affected sources that commenced construction or reconstruction after
May 3, 2018, must comply with the all of the standards immediately upon
the effective date of the standard, February 8, 2019, or upon startup,
whichever is later.
    All affected existing facilities would have to continue to meet the
current requirements of 40 CFR part 63, subpart QQQQQ, until the
applicable compliance date of the amended rule. The final action is not
a ``major rule'' as defined by 5 U.S.C. 804(2), so the effective date
of the final rule will be the promulgation date as specified in CAA
sections 112(d)(10) and 112(f)(3). For

existing sources, we are finalizing two changes that would impact
ongoing compliance requirements for 40 CFR part 63, subpart QQQQQ. As
discussed elsewhere in this preamble, we are changing the requirements
for SSM by removing the exemption from the requirements to meet the
standard during SSM periods and by removing the requirement to develop
and implement an SSM plan. Our experience with similar industries shows
that this sort of regulated facility generally requires a time period
of 180 days to read and understand the amended rule requirements;
evaluate their operations to ensure that they can meet the standards
during periods of startup and shutdown as defined in the rule, and make
any necessary adjustments in their practice of reporting deviations per
the rule's revised requirements; adjust parameter monitoring and
recording systems to accommodate revisions; and update their operations
to reflect the revised requirements. From our assessment of the
timeframe needed for compliance with the entirety of the revised
requirements, the EPA considers a period of 180 days to be the most
expeditious compliance period practicable and, thus, is finalizing that
existing affected sources must be in compliance with all of this
regulation's revised requirements within 180 days of the regulation's
effective date.

IV. What is the rationale for our final decisions and amendments for
the Friction Materials Manufacturing Facilities source category?

    For each issue, this section provides a description of what we
proposed and what we are finalizing, the EPA's rationale for the final
decisions and amendments, and a summary of key comments and responses.
For all comments not discussed in this preamble, comment summaries and
the EPA's responses can be found in the comment summary and response
document available in the docket, EPA-HQ-OAR-2017-0358.

A. Residual Risk Review for the Friction Materials Manufacturing
Facilities Source Category

1. What did we propose pursuant to CAA section 112(f) for the Friction
Materials Manufacturing Facilities source category?
    For the 40 CFR part 63, subpart QQQQQ, category risk assessment
conducted at proposal, the EPA estimated risks based on actual and
allowable emissions from the two facilities subject to the Friction
Materials Manufacturing Facilities NESHAP. Allowable emissions for the
Railroad Friction Products Corporation (RFPC) at proposal were
estimated to be equal to actual emissions. Allowable emissions for
Knowlton Technologies LLC were set to the standard minimum of 70
percent of what otherwise would be emitted. The estimated inhalation
cancer risk to the individual most exposed to emissions from the source
category was less than 1-in-1-million. The assessment showed that no
people faced an increased cancer risk greater than 1-in-1 million due
to inhalation exposure to HAP emissions from this source category. The
risk analysis at proposal indicated very low cancer incidence (0.000005
excess cancer cases per year, or one excess case every 200,000 years),
as well as low potential for adverse chronic noncancer health effects.
The acute screening assessment indicated no pollutants or facilities
exceeding a hazard quotient value of 1. Therefore, we found there was
little potential concern of acute noncancer health impacts. In
evaluating the potential for multipathway effects, no HAP emissions
known to be persistent and bio-accumulative in the environment were
found in this source category. Therefore, we estimate that there is no
multipathway risk from HAP emissions from this source category.
Considering all the health risk information, the EPA proposed that the
risks from the Friction Materials Manufacturing Facilities source
category were acceptable, and that implementation of the existing
standards provide an ample margin of safety to protect public health.
2. How did the risk review change for the Friction Materials
Manufacturing Facilities source category?
    In response to comments on the proposed 40 CFR part 63, subpart
QQQQQ RTR, the EPA acknowledges that, although the EPA's method of
calculating cancer incidence was implemented correctly, with the
results presented correctly in the RTR risk report, we agree that the
average risk values provided for the demographic analysis were
calculated incorrectly. The EPA corrected the values for the
demographics analysis and provided those corrections in the final RTR
risk report for this source category. After making this correction, the
EPA finds that the risks presented by HAP emissions from this source
category are still acceptable and that the NESHAP protects public
health with an ample margin of safety. The demographic analysis
provides information about the demographic composition of the
populations exposed to HAP emissions from this source category. The
correction to the average risk values for the demographic analysis did
not affect any decision in this rulemaking. All other parts of the risk
review remained unchanged from proposal.
3. What key comments did we receive on the risk review, and what are
our responses?
    We received several comments regarding the proposed risk review and
our determination that no revisions were warranted under CAA section
112(f)(2). Generally, the comments misunderstood the type of data used
for the development of the risk review or suggested changes to the
underlying risk assessment methodology. After review of these comments,
we determined that no changes were necessary. The comments and our
specific responses can be found in the document, ``Summary of Public
Comments and Responses for Friction Materials Manufacturing Facilities
Risk and Technology Review,'' which is available in the docket for this
action.
    These comments resulted in the EPA correcting the demographic
analysis, which did not result in a change in the EPA's determination
that the risks for this source category are acceptable and that the
NESHAP protects public health with an ample margin of safety.
    Additionally, a stakeholder commented on how the EPA set allowable
emissions equal to actual emissions at RFPC. The EPA agrees with the
stakeholder that allowable emissions should have been calculated by
setting the solvent mixer emissions at 30 percent of the total solvent
used, which is the requirement in the rule. However, this would result
in a lower emissions calculation than what was used at proposal to
estimate risk at allowable emission levels. Therefore, the EPA has
determined that the proposal risk estimates for allowable emissions
were overestimated, and, since we found that even with this
overestimate that risks are acceptable and that the current standards
provide an ample margin of safety, it is not necessary to re-run the
model file in order to reflect such a correction.
    Lastly, one comment resulted in the EPA clarifying the inclusion of
emissions that do not come from affected sources in the source
category. The stakeholder points out that the EPA assumes fugitive
emissions are controlled under this standard. The EPA clarifies in the
response to comments (RTC) document that phenol and formaldehyde
emissions from Knowlton are non-affected source fugitive

emissions. Including phenol and formaldehyde in the risk model results
in a conservative assessment of risk presented by emissions that do not
come from the affected sources in the source category, but from other
points at the facility that are not subject to this NESHAP.
4. What is the rationale for our final approach and final decisions for
the risk review?
    We evaluated all the comments on the EPA's risk review and
determined that other than the change in the demographic analysis
calculation, which did not result in a change to the risk
determination, no changes to the review are needed. For the reasons
explained in the proposed rule, we determined that the risks from the
Friction Materials Manufacturing Facilities source category are
acceptable, and the current standards provide an ample margin of safety
to protect public health and prevent an adverse environmental effect.
Therefore, pursuant to CAA section 112(f)(2), we are finalizing our
risk review determination as proposed.

B. Technology Review for the Friction Materials Manufacturing
Facilities Source Category

1. What did we propose pursuant to CAA section 112(d)(6) for the
Friction Materials Manufacturing Facilities source category?
    Our review of the developments in technology for the Friction
Materials Manufacturing Facilities source category did not reveal any
changes in practices, processes, and controls that warrant revisions to
the emission standards. Because our review did not identify any cost-
effective practices, processes, or controls to reduce emissions in the
category since promulgation of the current NESHAP, we proposed that no
revisions to the NESHAP are necessary pursuant to CAA section
112(d)(6).
2. How did the technology review change for the Friction Materials
Manufacturing Facilities source category?
    The technology review did not change from proposal. Therefore, we
are finalizing our proposal determination that no revisions to the
NESHAP are necessary pursuant to CAA section 112(d)(6).
3. What key comments did we receive on the technology review, and what
are our responses?
    We received several comments regarding the proposed technology
review and our determination that no revisions were warranted under CAA
section 112(d)(6). We received no comments that identified improved
control technology, work practices, operational procedures, process
changes, or pollution prevention approaches to reduce emissions in the
category since promulgation of the current NESHAP. Generally, the
commenters misunderstood the role of the technology review and the
associated evaluations of technological advancements. After review of
these comments, we determined that no changes were necessary. The
comments and our specific responses can be found in the document,
``Summary of Public Comments and Responses for Friction Materials
Manufacturing Facilities Risk and Technology Review,'' which is
available in the docket for this action.
    Of the comments pertaining to the technology review, there were
several comments that addressed the EPA's discussion of non-solvent
mixers. Several comments addressed the concern that the EPA was
appearing to endorse facilities' averaging among mixers in order to
comply with the standard. The EPA stated in the RTC document and
reiterates here that compliance determinations are not part of the RTR,
that the current standards apply on a mixer-by-mixer basis, and that
the EPA is not proposing any changes to the source category or affected
source definitions in this action.
4. What is the rationale for our final approach for the technology
review?
    Our technology review looked for add-on control technology that was
not identified during the original NESHAP development and for
improvements to existing add-on controls. We also looked for new work
practices, operational procedures, process changes, pollution
prevention alternatives, coating formulations, or application
techniques that have the potential to reduce emissions. Since our
review did not identify any cost-effective improved control technology,
work practices, operational procedures, process changes, or pollution
prevention approaches to reduce emissions in the category since
promulgation of the current NESHAP, we proposed that no revisions to
the NESHAP are necessary pursuant to CAA section 112(d)(6). Since
proposal, no information has been presented to cause us to change the
proposed determination. Consequently, we are finalizing our CAA section
112(d)(6) determination as proposed.

C. SSM

1. What did we propose for the Friction Materials Manufacturing
Facilities source category?
    In its 2008 decision in Sierra Club v. EPA, 551 F.3d 1019 (D.C.
Cir. 2008), the Court vacated portions of two provisions in the EPA's
CAA section 112 General Provisions regulations governing the emissions
of HAP during periods of SSM. Specifically, the Court vacated the SSM
exemption contained in 40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1), holding
that under section 302(k) of the CAA, emissions standards or
limitations must be continuous in nature and that the SSM exemption
violates the CAA's requirement that some CAA section 112 standards
apply continuously.
    We proposed amendments to the Friction Materials Manufacturing
Facilities NESHAP to remove or revise provisions related to SSM that
are not consistent with the requirement that the standards apply at all
times. More information concerning SSM is in the preamble to the
proposed rule (83 FR 19499).
2. How did the SSM provisions change for the Friction Materials
Manufacturing Facilities source category?
    The SSM provisions did not change from proposal.
3. What key comments did we receive on the SSM provisions, and what are
our responses?
    We received one comment supporting our proposed changes to the SSM
provisions. The EPA acknowledges the comment supporting the proposed
changes.
4. What is the rationale for our final approach for the SSM provisions?
    We evaluated the comment on the EPA's proposed amendments to the
SSM provisions. For the reasons explained in the proposed rule, we
determined that these amendments remove or revise provisions related to
SSM that are not consistent with the requirement that the standards
apply at all times. More information concerning the proposed amendments
to the SSM provisions is in the preamble to the proposed rule (83 FR
19499). We are finalizing the amendments to remove or revise provisions
related to SSM, as proposed.

V. Summary of Cost, Environmental, and Economic Impacts and Additional
Analyses Conducted

A. What are the affected facilities?

    There are currently two friction materials manufacturing facilities
operating in the United States that are subject to the Friction
Materials Manufacturing Facilities NESHAP. The 40 CFR part 63, subpart
QQQQQ, affected source is the solvent mixers used for friction
manufacturing products. A new affected source is a completely new
friction products manufacturing source where previously no friction
products manufacturing had existed.

B. What are the air quality impacts?

    At the current level of control, the EPA estimates emissions of
total HAP are approximately 240 tpy. Because we are not finalizing
revisions to the emission limits other than to make them applicable
during SSM periods, we do not anticipate any air quality impacts as a
result of the proposed amendments, since facilities are already in
compliance with emission limits during all periods, including SSM.

C. What are the cost impacts?

    The two existing friction materials manufacturing facilities that
are subject to the final amendments would incur a net cost savings
resulting from the revised recordkeeping and reporting requirements.
The 2016 equivalent annualized value (in 2016 dollars) of these net
cost savings from 2019 through 2026 is $5,920 per year when costs are
discounted at a 7-percent rate, and $6,648 per year when costs are
discounted at a 3-percent rate. For further information on the costs
and cost savings associated with the requirements being revised, see
the memorandum, ``Economic Impact Analysis for Friction Material
Manufacturing Final Rule,'' and the document, ``Friction Materials
Manufacturing 2018 Supporting Statement,'' which are both available in
the docket for this action.

D. What are the economic impacts?

    As noted earlier, this action will result in a net cost savings to
affected entities. This cost savings is not expected to have adverse
economic impacts.

E. What are the benefits?

    The EPA did not change any of the emission limit requirements and
estimates the final changes to SSM, recordkeeping, reporting, and
monitoring are not economically significant. Because these final
amendments are not considered economically significant, as defined by
Executive Order 12866 and because no emission reductions were
estimated, we did not estimate any benefits from reducing emissions.

F. What analysis of environmental justice did we conduct?

    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.
    To examine the potential for any environmental justice issues that
might be associated with the source category, we performed a
demographic analysis, which is an assessment of risks to individual
demographic groups of the populations living within 5 kilometers (km)
and within 50 km of the facilities. In the analysis, we evaluated the
distribution of HAP-related cancer and noncancer risks from the
Friction Materials Manufacturing Facilities source category across
different demographic groups within the populations living near
facilities.\2\
---------------------------------------------------------------------------

    \2\ Demographic groups included in the analysis are: White,
African American, Native American, other races and multiracial,
Hispanic or Latino, children 17 years of age and under, adults 18 to
64 years of age, adults 65 years of age and over, adults without a
high school diploma, people living below the poverty level, people
living two times the poverty level, and linguistically isolated
people.
---------------------------------------------------------------------------

    The results of the demographic analysis was updated from proposal
to reflect corrections made to the analysis from comments received by
the EPA and are summarized in Table 2 below. These results, for various
demographic groups, are based on the estimated risks from actual
emissions levels for the population living within 50 km of the
facilities.

     Table 2--Friction Materials Manufacturing Facilities Source Category Demographic Risk Analysis Results
----------------------------------------------------------------------------------------------------------------
                                                                             Population with
                                                                            cancer risk at or   Population with
                                                                               above 1-in-1      chronic hazard
                                                                              million due to     index above 1
                                                             Nationwide          Friction           Friction
                                                                                Materials          Materials
                                                                              Manufacturing      Manufacturing
                                                                              Facilities \1\       Facilities
----------------------------------------------------------------------------------------------------------------
Total Population.......................................        317,746,049                  0                  0
Race by Percent:
White..................................................                 62                  0                  0
All Other Races........................................                 38                  0                  0
Race by Percent:
White..................................................                 62                  0                  0
African American.......................................                 12                  0                  0
Native American........................................                0.8                  0                  0
Other and Multiracial..................................                  7                  0                  0
Ethnicity by Percent:
Hispanic...............................................                 18                  0                  0
Non-Hispanic...........................................                 82                  0                  0
Income by Percent:
Below Poverty Level....................................                 14                  0                  0
Above Poverty Level....................................                 86                  0                  0
Education by Percent:

Over 25 and without High School Diploma................                 14                  0                  0
Over 25 and with a High School Diploma.................                 86                  0                  0
Linguistically Isolated by Percent:
Linguistically Isolated................................                  6                  0                  0
----------------------------------------------------------------------------------------------------------------
\1\ Based on actual emissions in the category.

    The results of the Friction Materials Manufacturing Facilities
source category demographic analysis indicate that emissions from the
source category do not expose people to a cancer risk at or above 1-in-
1 million based on actual or allowable emissions. Also, no people are
exposed to a chronic noncancer target organ-specific hazard index
greater than 1 based on actual or allowable emissions. The percentages
of the at-risk population are much smaller than their respective
nationwide percentages for all demographic groups.
    The EPA received comment on our proposed rule stating that we
ignored unacceptably disproportionate effects on environmental justice
communities. As noted above, we corrected our demographic analysis. For
this source category, cancer risks were less than 1-in-1 million and
the noncancer hazards were less than 1. At these risk levels, all
populations are exposed to an acceptable level with an ample margin of
safety without any demographic group (including Native American
Indians) being disproportionately impacted. A more detailed demographic
risk analysis may be conducted at the facility level if risk findings
for the source category indicate a level that is unacceptable without
an ample margin of safety.
    The EPA has, therefore, reaffirmed its determination that this
final rule will not have disproportionately high and adverse human
health or environmental effects on minority, low income, or indigenous
populations because it maintains the level of environmental protection
for all affected populations without having any disproportionately high
and adverse human health or environmental effects on any population,
including any minority, low income, or indigenous populations.
    The methodology and the results of the demographic analysis are
presented in a technical report, ``Risk and Technology Review--Analysis
of Demographic Factors for Populations Living Near Friction Materials
Manufacturing Facilities Source Category,'' available in Docket ID No.
EPA-HQ-OAR-2017-0358 for this action.

G. What analysis of children's environmental health did we conduct?

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because the EPA does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. This action's health and risk assessments are contained in
``Residual Risk Assessment for the Friction Materials Manufacturing
Facilities Source Category in Support of the 2018 Risk and Technology
Review Final Rule,'' available in Docket ID No. EPAHQ-OAR-2017-0358 for
this action.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is considered an Executive Order 13771 deregulatory
action. Details on the estimated cost savings of this final rule can be
found in the EPA's analysis of the potential costs and benefits
associated with this action.

C. Paperwork Reduction Act (PRA)

    The information collection activities in this rule have been
submitted for approval to OMB under the PRA. The Information Collection
Request (ICR) document that the EPA prepared has been assigned EPA ICR
number 2025.08. You can find a copy of the ICR in the docket for this
rule, and it is briefly summarized here. The information collection
requirements are not enforceable until OMB approves them.
    We are finalizing changes to the recordkeeping and reporting
requirements associated with 40 CFR part 63, subpart QQQQQ, in the form
of eliminating the SSM plan and reporting requirements and increasing
reporting requirements for the semiannual report of deviation. We also
recalculated the estimated recordkeeping burden for records of SSM to
more accurately represent the removal of the SSM exemption, which is
discussed in more detail in the memorandum, ``Email Correspondence
Estimating the Cost of SSM Reporting with Knowlton Technologies, LLC.''
    Respondents/affected entities: The respondents to the recordkeeping
and reporting requirements are owners or operators of facilities that
produce friction products subject to 40 CFR part 63, subpart QQQQQ.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart QQQQQ).
    Estimated number of respondents: Two facilities.
    Frequency of response: Initially and semiannually.
    Total estimated burden: The annual recordkeeping and reporting
burden for responding facilities to comply with all of the requirements
in the NESHAP, averaged over the 3 years of this ICR, is estimated to
be 535 hours (per year). Of these, 115 hours (per year) is the reduced
burden to comply with the rule amendments. Burden is defined at 5 CFR
1320.3(b).

    Total estimated cost: The annual recordkeeping and reporting cost
for responding facilities to comply with all of the requirements in the
NESHAP, averaged over the 3 years of this ICR, is estimated to be
$35,200 (rounded, per year), including $544 annualized capital or
operation and maintenance costs. This results in a decrease of $7,400
(rounded, per year) to comply with the amendments to the rule.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. There are no
small entities in this regulated industry.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local, or tribal governments, or the
private sector.

F. Executive Order 13132: Federalism

    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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. No tribal facilities are known to be engaged in
the friction material manufacturing industry that would be affected by
this action. Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because the EPA does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. This action's health and risk assessments are contained in
sections III.A and IV.A and B of this preamble.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This action involves technical standards. Therefore, the EPA
conducted a search to identify potentially applicable voluntary
consensus standards. However, the Agency identified no such standards.
Therefore, the EPA has decided to continue the use of the weighing
procedures based on EPA Method 28 of 40 CFR part 60, appendix A
(section 10.1) for weighing of recovered solvent. A thorough summary of
the search conducted and results are included in the memorandum titled
``Voluntary Consensus Standard Results for Friction Materials
Manufacturing Facilities Residual Risk and Technology Review,'' which
is available in the docket for this action.

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

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations, and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
    The documentation for this decision is contained in the technical
report, ``Friction Materials Manufacturing Demographic Analysis,''
which is available in the docket for this action.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedures,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: December 20, 2018.
Andrew R. Wheeler,
Acting Administrator.

    For the reasons stated in the preamble, title 40, chapter I, part
63 of the Code of Federal Regulations is amended as follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart QQQQQ--National Emission Standards for Hazardous Air
Pollutants for Friction Materials Manufacturing Facilities

0
2. Section 63.9495 is amended by revising paragraphs (a) and (b) and
adding paragraph (e) to read as follows:

Sec.  63.9495  When do I have to comply with this subpart?

    (a) If you have an existing solvent mixer, you must comply with
each of the requirements for existing sources no later than October 18,
2005, except as otherwise specified at this section and Sec. Sec.
63.9505, 63.9530, 63.9540, 63.9545, and Table 1 to this subpart.
    (b) If you have a new or reconstructed solvent mixer for which
construction or reconstruction commenced after October 18, 2002, but
before May 4, 2018, you must comply with the requirements for new and
reconstructed sources upon initial startup, except as otherwise
specified at this section and Sec. Sec.  63.9505, 63.9530, 63.9540,
63.9545, and Table 1 to this subpart.
* * * * *
    (e) Solvent mixers constructed or reconstructed after May 3, 2018,
must be in compliance with this subpart at startup or by February 8,
2019, whichever is later.

0
3. Revise Sec.  63.9505 to read as follows:

Sec.  63.9505  What are my general requirements for complying with this
subpart?

    (a) Before August 7, 2019, for each existing source and each new or
reconstructed source for which construction or reconstruction commenced
after October 18, 2002, but

before May 4, 2018, you must be in compliance with the emission
limitations in this subpart at all times, except during periods of
startup, shutdown, or malfunction. On and after August 7, 2019, for
each such source you must be in compliance with the emission
limitations in this subpart at all times. For new and reconstructed
sources for which construction or reconstruction commenced after May 3,
2018, you must be in compliance with the emissions limitations in this
subpart at all times.
    (b) Before August 7, 2019, for each existing source, and for each
new or reconstructed source for which construction or reconstruction
commenced after October 18, 2002, but before May 4, 2018, you must
always operate and maintain your affected source, including air
pollution control and monitoring equipment, according to the provisions
in Sec.  63.6(e)(1)(i). On and after August 7, 2019 for each such
source, and after February 8, 2019 for new and reconstructed sources
for which construction or reconstruction commenced after May 3, 2018,
at all times you must operate and maintain any affected source,
including associated air pollution control equipment and monitoring
equipment, in a manner consistent with safety and good air pollution
control practices for minimizing emissions. The general duty to
minimize emissions does not require you to make any further efforts to
reduce emissions if levels required by the applicable standard have
been achieved. Determination of whether a source is operating in
compliance with operation and maintenance requirements will be based on
information available to the Administrator which may include, but is
not limited to, monitoring results, review of operation and maintenance
procedures, review of operation and maintenance records, and inspection
of the source.
    (c) Before August 7, 2019, for each existing source, and for each
new or reconstructed source for which construction commenced after
October 18, 2002, but before May 4, 2018, you must develop a written
startup, shutdown, and malfunction plan according to the provisions in
Sec.  63.6(e)(3). For each such source, a startup, shutdown, and
malfunction plan is not required on and after August 7, 2019. No
startup, shutdown, and malfunction plan is required for any new or
reconstructed source for which construction or reconstruction commenced
after May 3, 2018.

0
4. Section 63.9530 is amended by revising paragraphs (a)(1) and (e) to
read as follows:

Sec.  63.9530  How do I demonstrate continuous compliance with the
emission limitation that applies to me?

    (a) * * *
    (1) For existing sources and for new or reconstructed sources for
which construction or reconstruction commenced after October 18, 2002,
but before May 4, 2018, before August 7, 2019, except for during
malfunctions of your weight measurement device and associated repairs,
you must collect and record the information required in Sec.
63.9520(a)(1) through (8) at all times that the affected source is
operating and record all information needed to document conformance
with these requirements. On and after August 7, 2019 for such sources,
and after February 8, 2019 for new or reconstructed sources that
commenced construction after May 3, 2018, you must collect and record
the information required in Sec.  63.9520(a)(1) through (8) at all
times that the affected source is operating and record all information
needed to document conformance with these requirements.
* * * * *
    (e) For existing sources and for new or reconstructed sources which
commenced construction or reconstruction after October 18, 2002, but
before May 4, 2018, before August 7, 2019, consistent with Sec. Sec.
63.6(e) and 63.7(e)(1), deviations that occur during a period of
startup, shutdown, or malfunction are not violations if you demonstrate
to the Administrator's satisfaction that you were operating in
accordance with Sec.  63.6(e)(1). The Administrator will determine
whether deviations that occur during a period of startup, shutdown, or
malfunction are violations, according to the provisions in Sec.
63.6(e). On and after August 7, 2019 for such sources, and after
February 8, 2019 for new or reconstructed sources which commence
construction or reconstruction after May 3, 2018, all deviations are
considered violations.

0
5. Section 63.9540 is amended by revising paragraphs (b)(4), (c)(2),
and (d) to read as follows:

Sec.  63.9540  What reports must I submit and when?

* * * * *
    (b) * * *
    (4) For existing sources and for new or reconstructed sources for
which construction or reconstruction commenced after October 18, 2002,
but before May 4, 2018, before August 7, 2019, if you had a startup,
shutdown, or malfunction during the reporting period and you took
actions consistent with your startup, shutdown, and malfunction plan,
the compliance report must include the information in Sec.
63.10(d)(5)(i). A startup, shutdown, and malfunction plan is not
required for such sources on and after August 7, 2019.
* * * * *
    (c) * * *
    (2) For existing sources and for new or reconstructed sources which
commenced construction or reconstruction after October 18, 2002, but
before May 4, 2018, before August 7, 2019, information on the number,
duration, and cause of deviations (including unknown cause, if
applicable), as applicable, and the corrective action taken. On and
after August 7, 2019 for such sources, and after February 8, 2019 for
new or reconstructed sources which commenced construction or
reconstruction after May 3, 2018, information on the number of
deviations to meet an emission limitation. For each instance, include
the date, time, duration, and cause of deviations (including unknown
cause, if applicable), as applicable, a list of the affected source or
equipment, an estimate of the quantity of each regulated pollutant
emitted over any emission limit, and a description of the method used
to estimate the emissions, and the corrective action taken.
    (d) For existing sources and for new or reconstructed sources which
commenced construction or reconstruction after October 18, 2002, but
before May 4, 2018, before August 7, 2019, if you had a startup,
shutdown, or malfunction during the semiannual reporting period that
was not consistent with your startup, shutdown, and malfunction plan,
you must submit an immediate startup, shutdown, and malfunction report
according to the requirements in Sec.  63.10(d)(5)(ii). An immediate
startup, shutdown, and malfunction report is not required for such
sources on and after August 7, 2019.
* * * * *

0
6. Section 63.9545 is amended by revising paragraph (a)(2) and adding
paragraph (a)(3) to read as follows:

Sec.  63.9545  What records must I keep?

    (a) * * *
    (2) For existing sources and for new or reconstructed sources which
commenced construction or reconstruction after October 18, 2002, but
before May 4, 2018, before August 7, 2019, the records in Sec.
63.6(e)(3)(iii)

through (v) related to startup, shutdown, or malfunction. For such
sources, it is not required to keep records in Sec.  63.6(e)(3)(iii)
through (v) related to startup, shutdown, or malfunction on and after
August 7, 2019.
    (3) After February 8, 2019 for new or reconstructed sources which
commenced construction or reconstruction after May 3, 2018, and on and
after August 7, 2019 for all other affected sources, in the event that
an affected unit fails to meet an applicable standard, record the
number of deviations. For each deviation, record the date, time and
duration of each deviation.
    (i) For each deviation, record and retain cause of deviations
(including unknown cause, if applicable), a list of the affected source
or equipment, an estimate of the quantity of each regulated pollutant
emitted over any emission limit, and a description of the method used
to estimate the emissions.
    (ii) Record actions taken to minimize emissions in accordance with
Sec.  63.9505, and any corrective actions taken to return the affected
unit to its normal or usual manner of operation.
* * * * *

0
7. Table 1 to subpart QQQQQ of part 63 is amended by:
0
a. Removing the entry ``Sec.  63.6(a)-(c), (e)-(f), (i)-(j)'';
0
b. Adding the entries ``Sec.  63.6(a)-(c), (i)-(j)'', ``Sec.
63.6(e)(1)(i)-(ii)'', ``Sec.  63.6(e)(1)(iii), (e)(2)'', ``Sec.
63.6(e)(3)'', ``Sec.  63.6(f)(1)'', and ``Sec.  63.6(f)(2)-(3)'' in
numerical order;
0
c. Removing the entry ``Sec.  63.8(a)(1)-(2), (b), (c)(1)-(3), (f)(1)-
(5)'';
0
d. Adding the entries ``Sec.  63.8(a)(1)-(2)'', ``Sec.  63.8(b)'',
``Sec.  63.8(c)(1)(i), (iii)'', ``Sec.  63.8(c)(1)(ii), (c)(2),
(c)(3)'', and ``Sec.  63.8(f)(1)-(5)'' in numerical order;
0
e. Removing the entry ``Sec.  63.10(a), (b), (d)(1), (d)(4)-(5),
(e)(3), (f)''; and
0
f. Adding the entries ``Sec.  63.10(a), (b)(1), (d)(1), (d)(4), (e)(3),
(f)'', ``Sec.  63.10(b)(2)(i), (ii), (iv), (v)'', ``Sec.
63.10(b)(2)(iii), (vi)-(xiv)'', and ``Sec.  63.10(d)(5)'' in numerical
order.
    The revisions and additions read as follows:

            Table 1 to Subpart QQQQQ of Part 63--Applicability of General Provisions to Subpart QQQQQ
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
              Citation                       Subject          Applies to subpart QQQQQ?         Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Sec.   63.6(a)-(c), (i)-(j)........  Compliance with         Yes........................
                                      Standards and
                                      Maintenance
                                      Requirements.

                                                  * * * * * * *
Sec.   63.6(e)(1)(i)-(ii)..........  SSM Operation and       No, for new or               Subpart QQQQQ requires
                                      Maintenance             reconstructed sources        affected units to
                                      Requirements.           which commenced              meet emissions
                                                              construction or              standards at all
                                                              reconstruction after May     times. See Sec.
                                                              3, 2018. Yes, for all        63.9505 for general
                                                              other affected sources       duty requirement.
                                                              before August 7, 2019, and
                                                              No thereafter.
Sec.   63.6(e)(1)(iii), (e)(2).....  Operation and           Yes........................
                                      Maintenance.
Sec.   63.6(e)(3)..................  SSM Plan Requirements.  No, for new or               Subpart QQQQQ requires
                                                              reconstructed sources        affected units to
                                                              which commenced              meet emissions
                                                              construction or              standards at all
                                                              reconstruction after May     times.
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before August 7, 2019, and
                                                              No thereafter.
Sec.   63.6(f)(1)..................  SSM Exemption.........  No, for new or               Subpart QQQQQ requires
                                                              reconstructed sources        affected units to
                                                              which commenced              meet emissions
                                                              construction or              standards at all
                                                              reconstruction after May     times.
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before August 7, 2019, and
                                                              No thereafter.
Sec.   63.6(f)(2)-(3)..............  Compliance with         Yes........................
                                      Nonopacity Emission
                                      Standards.

                                                  * * * * * * *
Sec.   63.8(a)(1)-(2)..............  Applicability and       Yes........................
                                      Relevant Standards
                                      for CMS.

                                                  * * * * * * *
Sec.   63.8(b).....................  Conduct of Monitoring.  Yes........................
Sec.   63.8(c)(1)(i), (iii)........  Continuous Monitoring   No, for new or
                                      System (CMS) SSM        reconstructed sources
                                      Requirements.           which commenced
                                                              construction or
                                                              reconstruction after May
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before August 7, 2019, and
                                                              No thereafter..
Sec.   63.8(c)(1)(ii), (c)(2),       CMS Repairs, Operating  Yes........................
 (c)(3).                              Parameters, and
                                      Performance Tests.

                                                  * * * * * * *
Sec.   63.8(f)(1)-(5)..............  Alternative Monitoring  Yes........................
                                      Procedure.

                                                  * * * * * * *
Sec.   63.10(a), (b)(1), (d)(1),     Recordkeeping and       Yes........................
 (d)(4), (e)(3), (f).                 Reporting
                                      Requirements.

                                                  * * * * * * *
Sec.   63.10(b)(2)(i), (ii), (iv),   Recordkeeping for       No, for new or               See Sec.   63.9545 for
 (v).                                 Startup, Shutdown and   reconstructed sources        recordkeeping
                                      Malfunction.            which commenced              requirements.
                                                              construction or
                                                              reconstruction after May
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before August 7, 2019, and
                                                              No thereafter.
Sec.   63.10(b)(2)(iii), (vi)-(xiv)  Owner/Operator          Yes........................
                                      Recordkeeping
                                      Requirements.

                                                  * * * * * * *
Sec.   63.10(d)(5).................  SSM reports...........  No, for new or               See Sec.   63.9540 for
                                                              reconstructed sources        malfunction reporting
                                                              which commenced              requirements.
                                                              construction or
                                                              reconstruction after May
                                                              3, 2018. Yes, for all
                                                              other affected sources
                                                              before August 7, 2019, and
                                                              No thereafter.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-00786 Filed 2-7-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Proposed Rules]
[Pages 59306-59307]
[FR Doc No: 2011-24640]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0347; Airspace Docket No. 11-ASO-11]

Proposed Establishment of Class D and E Airspace and Amendment of
Class E Airspace; Punta Gorda, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class D and E airspace and
amend existing Class E airspace at Punta Gorda, FL, to accommodate the
new air traffic control tower at Punta Gorda Airport. Controlled
airspace is necessary for the safety and management of instrument
flight rules (IFR) operations at the airport. This action also would
change the airport name and update the geographic coordinates of the
Punta Gorda Airport.

DATES: 0901 UTC. Comments must be received on or before November 10,
2011. The Director of the Federal Register approves this incorporation
by reference action under title 1, Code of Federal Regulations, part
51, subject to the annual revision of FAA, Order 7400.9 and publication
of conforming amendments.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey, SE., Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2011-0347; Airspace Docket No. 11-ASO-11, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 350, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: John Fornito, Airspace Specialist,
Operations Support Group, Eastern Service Center, Air Traffic
Organization, Federal Aviation Administration, P.O. Box 20636, Atlanta,
Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal. Communications should identify
both docket numbers (FAA docket number. FAA-2011-0347; Airspace Docket
No. 11-ASO-11) and be submitted in triplicate to the Docket Management
System (see ADDRESSES section for address and phone number). You may
also submit comments through the Internet at http://www.regulations.gov. Those wishing the FAA to acknowledge receipt of
their comments on this notice must submit with those comments a self-
addressed, stamped postcard on which the following statement is made:
``Comments to Docket No. The postcard will be date/time stamped and
returned to the commenter. All communications received before the
specified closing date for comments will be considered before taking
action on the proposed rule. The proposal contained in this notice may
be changed in light of the comments received. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/. Additionally, any person may obtain
a copy of this notice by submitting a request to the Federal Aviation
Administration (FAA), Office of Air Traffic Airspace Management, ATA-
400, 800 Independence Avenue, SW., Washington, DC 20591, or by calling
(202) 267-8783. Communications must identify both docket numbers for
this notice. Persons interested in being placed on a mailing list for
future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-
9677, to request a copy of Advisory Circular No. 11-2A, Notice of
Proposed Rulemaking Distribution System, which describes the
application procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class D airspace, Class E
surface area airspace and Class E airspace designated as an extension
to a Class D surface area at Punta Gorda Airport, Punta Gorda, FL.
Controlled airspace is necessary to support the operation of the new
air traffic control tower, and would enhance the safety and management
of IFR operations at the airport. Also, the airspace designation for
existing Class E airspace extending upward from 700 feet above the
surface would note the name change from Charlotte County Airport to
Punta Gorda Airport, Punta Gorda, FL and would adjust the geographic
coordinates to be in concert with the FAAs aeronautical database.
    Class D and E airspace designations are published in Paragraphs
5000, 6002, 6004, and 6005 respectively, of FAA Order 7400.9V, dated
August 9, 2011, and effective September 15, 2011, which is incorporated
by reference in 14 CFR 71.1. The Class D and E airspace designations
listed in this document will be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical

regulations for which frequent and routine amendments are necessary to
keep them operationally current. It, therefore, (1) Is not a
``significant regulatory action'' under Executive Order 12866; (2) is
not a ``significant rule'' under DOT Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a Regulatory Evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would establish Class D and E airspace and
amend existing Class E airspace at Punta Gorda Airport, Punta Gorda,
FL.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 will continue to read as
follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO FL D Punta Gorda, FL [New]

Punta Gorda Airport, FL
    (Lat. 26[deg]55'08'' N., long. 81[deg]59'27'' W.)

    That airspace extending upward from the surface up to and
including 2,500 feet MSL within a 4.5-mile radius of the Punta Gorda
Airport. This Class D airspace area is effective during specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

ASO FL E2 Punta Gorda, FL [New]

Punta Gorda Airport, FL
    (Lat. 26[deg]55'08'' N., long. 81[deg]59'27'' W.)

    That airspace extending from the surface up to and including
2,500 feet MSL within a 4.5-mile radius of Punta Gorda Airport. This
Class E airspace area is effective during specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D Surface Area.

* * * * *

ASO FL E4 Punta Gorda, FL [New]

Punta Gorda Airport, FL
    (Lat. 26[deg]55'08'' N., long. 81[deg]59'27'' W.)
    That airspace extending from the surface 2.4 mile either side of
the 036[deg] bearing from Punta Gorda Airport extending from the
4.5-mile radius to 7.0 miles northeast of the airport. This Class E
airspace area is effective during specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO FL E5 Punta Gorda, FL [Amended]

Punta Gorda Airport, FL
    (Lat. 26[deg]55'08'' N., long. 81[deg]59'27'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Punta Gorda Airport.

    Issued in College Park, Georgia, on September 16, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-24640 Filed 9-23-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27133-27135]
[FR Doc No: 2019-12299]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-6740 and FDA-2017-E-6744]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BAXDELA TABLETS--NDA 208610

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period

for BAXDELA TABLETS under NDA 208610 and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
12, 2019. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 9, 2019.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 12, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2017-E-6740 and FDA-2017-E-6744 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; BAXDELA TABLETS.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved NDA 208610 for marketing the human drug product,
BAXDELA TABLETS (delafloxacin meglumine) indicated in adults for the
treatment of acute bacterial skin and skin structure infections caused
by

designated susceptible bacteria. Subsequent to the NDA approvals, the
USPTO received patent term restoration applications for BAXDELA (U.S.
Patent Nos. 7,728,143 and 8,252,813) from Melinta Therapeutics, Inc.,
and the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated February 2,
2018, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approvals of BAXDELA TABLETS
and BAXDELA IV INJECTION represent the first permitted commercial
marketing or use of the products. Thereafter, the USPTO requested that
FDA determine the products' regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
BAXDELA TABLETS is 5,813 days. Of this time, 5,569 days occurred during
the testing phase of the regulatory review period, while 244 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    NDA 208610:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
July 22, 2001. Melinta Therapeutics, Inc., claims that July 27, 2001,
is the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was July 22, 2001, which was 30 days after FDA receipt of the first
IND.
    2. The date new drug application 208610 was initially submitted
with respect to the human drug product under section 505 of the FD&C
Act: October 19, 2016. FDA has verified the applicant's claim that the
new drug application (NDA) for BAXDELA (NDA 208610) was submitted on
October 19, 2016.
    3. The date the application was approved: June 19, 2017. FDA has
verified the applicant's claim that NDA 208610 was approved on June 19,
2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,307 or 1,001 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12299 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Rules and Regulations]
[Page 20782]
[DOCID:fr17ap08-5]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

17 CFR Parts 240 and 249

[Release 34-57526A; File No. S7-06-07]
RIN 3235-AJ80

Proposed Rule Changes of Self-Regulatory Organizations

AGENCY: Securities and Exchange Commission.

ACTION: Final rule; Correction.

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

SUMMARY: The Securities and Exchange Commission (``Commission'')
published in the Federal Register of March 27, 2008 (72 FR 16179), a
document concerning proposed rule changes by Self-Regulatory
Organizations submitted pursuant to Section 19(b)(7)(A) of the
Securities Exchange Act of 1934.

DATES: Effective Date: April 28, 2008.

FOR FURTHER INFORMATION CONTACT: John Roeser, Assistant Director, at
(202) 551-5630, Michou Nguyen, Special Counsel, at<PHONE_NUMBER>, or
Sherry Moore, Paralegal, at<PHONE_NUMBER>, Division of Trading and
Markets, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-6628.

SUPPLEMENTARY INFORMATION: This document corrects the comment due date
that was incorrectly stated in the sample 19(b)(7)(A) release published
with the final rule.
    In rule document E8-5998 beginning on page 16179 in the issue of
Thursday, March 27, 2008, make the following correction:
    On page 16196, in the third column, the phrase ``should be
submitted on or before April 17, 2008.'' is corrected to read ``should
be submitted on or before May 8, 2008.

     Dated: April 14, 2008.
Nancy M. Morris,
Secretary.
 [FR Doc. E8-8267 Filed 4-16-08; 8:45 am]

BILLING CODE 8010-01-P