[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20679-20680]
[FR Doc No: 2011-8818]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0157]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: Fast Track Drug Development
Programs: Designation, Development, and Application Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed collection of
information concerning requests by sponsors of investigational new
drugs and applicants for new drug approvals or biologics licenses for
fast track designation as provided in the guidance for industry on fast
track drug development programs.

DATES: Submit either electronic or written comments on the collection
of information by June 13, 2011.

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

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry: Fast Track Drug Development Programs:
Designation, Development, and Application Review--(OMB Control Number
0910-0389)--Extension

    Section 112(a) of the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Pub. L. 105-115) amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) by adding section 506 (21 U.S.C. 356).
The section authorizes FDA to take appropriate action to facilitate the
development and expedite the review of new drugs, including biological
products, intended to treat a serious or life-threatening condition and
that demonstrate a potential to address an unmet medical need. Under
section 112(b) of FDAMA, FDA issued guidance to industry on fast track
policies and procedures outlined in section 506 of the FD&C Act. The
guidance discusses collections of information that are specified under
section 506 of the FD&C Act, other sections of the Public Health
Service Act (the PHS Act), or implementing regulations. The guidance
describes three general areas involving collection of information: (1)
Fast track designation requests; (2) premeeting packages; and (3)
requests to submit portions of an application. Of these, fast track
designation requests and premeeting packages, in support of receiving a
fast track program benefit, provide for additional collections of
information not covered elsewhere in statute or regulation. Information
in support of fast track designation or fast track program benefits
that has previously been submitted to the Agency, may, in some cases,
be incorporated into the request by referring to the information rather
than resubmitting it.
    Under section 506(a)(1) of the FD&C Act, an applicant who seeks
fast track designation is required to submit a request to the Agency
showing that the product: (1) Is intended for a serious or life-
threatening condition and (2) has the potential to address an unmet

medical need. Mostly, the Agency expects that information to support a
designation request will have been gathered under existing provisions
of the FD&C Act, the PHS Act, or the implementing regulations. If such
information has already been submitted to the Agency, the information
may be summarized in the fast track designation request. The guidance
recommends that a designation request include, where applicable,
additional information not specified elsewhere by statute or
regulation. For example, additional information may be needed to show
that a product has the potential to address an unmet medical need where
an approved therapy exists for the serious or life-threatening
condition to be treated. Such information may include clinical data,
published reports, summaries of data and reports, and a list of
references. The amount of information and discussion in a designation
request need not be voluminous, but it should be sufficient to permit a
reviewer to assess whether the criteria for fast track designation have
been met.
    After the Agency makes a fast track designation, a sponsor or
applicant may submit a premeeting package which may include additional
information supporting a request to participate in certain fast track
programs. The premeeting package serves as background information for
the meeting and should support the intended objectives of the meeting.
As with the request for fast track designation, the Agency expects that
most sponsors or applicants will have gathered such information to meet
existing requirements under the FD&C Act, the PHS Act, or implementing
regulations. These may include descriptions of clinical safety and
efficacy trials not conducted under an investigational new drug
application (IND) (i.e., foreign studies), and information to support a
request for accelerated approval. If such information has already been
submitted to FDA, the information may be summarized in the premeeting
package. Consequently, FDA anticipates that the additional collection
of information attributed solely to the guidance will be minimal.
    Under section 506(c) of the FD&C Act, a sponsor must submit
sufficient clinical data for the Agency to determine, after preliminary
evaluation, that a fast track product may be effective. Section 506(c)
also requires that an applicant provide a schedule for the submission
of information necessary to make the application complete before FDA
can commence its review. The guidance does not provide for any new
collection of information regarding the submission of portions of an
application that are not required under section 506(c) of the FD&C Act
or any other provision of the FD&C Act. All forms referred to in the
guidance have a current OMB approval: FDA Forms 1571 (OMB control
number 0910-0014); 356h (OMB control number 0910-0338); and 3397 (OMB
control number 0910-0297).
    Respondents to this information collection are sponsors and
applicants who seek fast track designation under section 506 of the
FD&C Act. The Agency estimates the total annual number of respondents
submitting requests for fast track designation to the Center for
Biologics Evaluation and Research and the Center for Drug Evaluation
and Research is approximately 97, and the number of requests received
is approximately 118 annually. FDA estimates that the number of hours
needed to prepare a request for fast track designation is approximately
60 hours per request.
    Not all requests for fast track designation may meet the statutory
standard. Of the requests for fast track designation made per year, the
Agency granted 77 from 64 respondents, and for each of these granted
requests a premeeting package was submitted to the Agency. FDA
estimates that the preparation hours are approximately 100 hours per
premeeting package.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
       Reporting activity            Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
Designation Request.............              97            1.22             118              60           7,080
Premeeting Packages.............              64            1.20              77             100           7,700
                                 -------------------------------------------------------------------------------
    Total.......................                                                                          14,780
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8818 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Proposed Rules]
[Pages 27046-27049]
[FR Doc No: 2019-12269]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2019-0218; FRL-9994-95-Region 1]

Air Plan Approval; Maine; Reasonably Available Control Technology
for the 2008 Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve State Implementation Plan (SIP) revisions submitted by the
State of Maine for purposes of implementing the 2008 Ozone National
Ambient Air Quality Standards (NAAQS). The revisions consist of a
demonstration that Maine meets the requirements of reasonably available
control technology (RACT) for volatile organic compounds (VOCs), set
forth by the Clean Air Act (CAA or Act), with respect to the 2008 Ozone
standards. Additionally, we are proposing to approve a related
regulation that limits air emissions of VOCs from certain industrial
sources that use organic solvents in cleaning activities, and to
withdraw several previously approved source-specific RACT requirements
for sources that have ceased operation. This action is being taken
under the Clean Air Act.

DATES: Written comments must be received on or before July 11, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2019-2018 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www.epa.gov/dockets/commenting-epa-dockets. Publicly
available docket materials are available at https://www.regulations.gov
or at the U.S. Environmental Protection Agency, EPA Region 1 Regional
Office, Air and Radiation Division, Air Quality Branch, 5 Post Office
Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: David L. Mackintosh, Air Quality
Branch, U.S. Environmental Protection Agency, EPA Region 1, 5 Post
Office Square--Suite 100, (Mail code 05-2), Boston, MA 02109-3912, tel.
617-918-1584, email [email protected]

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background
II. Summary of Maine's SIP Revisions
III. EPA's Evaluation of the Submittal
    A. CTG VOC RACT Regulations
    B. Chapter 166: Industrial Cleaning Solvents
    C. Non-CTG VOC Major Sources
    D. Withdrawal of Defunct Source-Specific Requirements
IV. Proposed Action
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Background

    Maine is part of the Ozone Transport Region (OTR) under Section
184(a) of the CAA. Sections 182(b)(2) and 184 of the CAA require states
with Ozone nonattainment areas that are classified as moderate or
above, as well as areas in the OTR, to submit a SIP revision requiring
the implementation of reasonably available control technology (RACT)
for sources covered by a control techniques guideline (CTG) and for all
major sources. A CTG is a document issued by EPA which establishes a
``presumptive norm'' for RACT for a specific VOC source category. RACT
is defined as the lowest emission limitation that a particular source
is capable of meeting by the application of control technology that is
reasonably available considering technological and economic
feasibility.\1\ The CTGs usually identifies a particular control level
which EPA recommends as being RACT. States are required to address RACT
for the source categories covered by CTGs through adoption of rules as
part of the SIP.
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    \1\ See Memorandum from Roger Strelow, Assistant Administrator
for Air and Waste Management, U.S. EPA, to Regional Administrators,
U.S. EPA, ``Guidance for Determining Acceptability of SIP
Regulations in Non-Attainment Areas'' (Dec. 9, 1976); see also 44 FR
53761, 53762 (September 17, 1979).
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    On October 5, 2006 (71 FR 58745), EPA issued four new CTGs, which
applicable areas were required to address by October 5, 2007:
Industrial Cleaning Solvents; Offset Lithographic Printing and
Letterpress Printing; Flexible Package Printing; and Flat Wood Paneling
Coatings. On October 9, 2007 (72 FR 57215), EPA issued three more CTGs,
which applicable areas were required to address by October 9, 2008:
Paper, Film, and Foil Coatings; Large Appliance Coatings; and Metal
Furniture Coatings. On October 7, 2008 (73 FR 58841), EPA issued an
additional four CTGs, which applicable areas were required to address
by October 7, 2009: Miscellaneous Metal and Plastic Parts Coatings;
Fiberglass Boat Manufacturing Materials; Miscellaneous Industrial
Adhesives; and Automobile and Light-Duty Truck Assembly Coatings.
Lastly, on Oct 27, 2016 (81 FR 74798), EPA issued a new CTG for the Oil
and Natural Gas Industry, which applicable areas were required to
address by October 27, 2018.
    On March 27, 2008 (73 FR 16436), EPA revised the health-based NAAQS
for Ozone to 0.075 parts per million (ppm), averaged over an 8-hour
timeframe. EPA determined that the revised 8-hour standard would be
more protective of human health, especially with regard to children and
adults who are active outdoors and individuals with a pre-existing
respiratory disease such as asthma.
    On July 29, 2014 (79 FR 43945), EPA published a final rule
approving a request from Maine for an exemption from the requirements
for the control of nitrogen oxides (NOX) emissions contained
in section 182(f) of the CAA in relation to the 2008 8-hour Ozone
NAAQS, providing an exemption from nonattainment new source review
(NNSR) and RACT for major new sources of NOX emissions in
Maine.
    On March 6, 2015 (80 FR 12264), EPA published a final rule
outlining RACT requirements and requiring states in the OTR to certify
RACT requirements by July 20, 2014. This rule, referred to as the
``2008 Ozone implementation rule,''

contains a description of EPA's expectations for states with RACT
obligations. The 2008 Ozone implementation rule gives states several
options for meeting RACT requirements for the 2008 Ozone standard.
States may (1) establish new or more stringent rules that meet RACT
control levels for the 2008 standard; (2) certify, where appropriate,
that previously adopted RACT rules approved by EPA under a prior Ozone
standard represent adequate RACT control levels for the 2008 Ozone
NAAQS; or (3) submit a negative declaration in instances where there
are no sources in the state covered by a specific CTG source category.
States may use these options alone or in combination to demonstrate
compliance with RACT requirements.
    On October 26, 2015 (80 FR 65291), EPA revised the health-based
NAAQS for Ozone, setting it at 0.070 ppm averaged over an 8-hour time
frame. On December 6, 2018 (83 FR 62998), EPA published a final rule
that outlines the obligations for areas in nonattainment with the 2015
Ozone standard, as well as obligations for areas in the OTR. This rule,
referred to as the ``2015 Ozone implementation rule,'' requires states
in the OTR to certify RACT requirements by August 3, 2020.
    On February 3, 2017 (82 FR 9158), EPA published a final rule
finding that Maine, as well as 14 other states and the District of
Columbia, had failed to submit SIP revisions in a timely manner to
satisfy certain requirements for the 2008 Ozone NAAQS. With respect to
Maine, EPA found that the state had failed to submit two required SIP
elements: Non-CTG VOC RACT for Major Sources and CTG VOC RACT. Id. at
9162. This finding became effective March 6, 2017, and started a SIP
sanctions clock, which required the missing SIP elements to be
submitted and deemed complete before September 6, 2018. Id. at 9160-61.

II. Summary of Maine's SIP Revisions

    On August 31, 2018, Maine submitted a SIP revision to address its
outstanding RACT requirements for the 2008 Ozone NAAQS (i.e., a RACT
Certification). The approval of Maine's section 182(f) NOX
waver for the 2008 8-hour Ozone standard eliminated the need for Maine
to address NOX RACT in its 2018 Certification (79 FR 43945).
Therefore, the RACT Certification addresses non-CTG VOC RACT for Major
Sources and CTG VOC RACT. The submittal is based on (1) certification
that previously adopted RACT controls, which were approved by EPA for
the 1997 8-hour Ozone NAAQS, are based on currently available
technically and economically feasible controls and continue to
represent RACT for implementation of the 2008 Ozone NAAQS; (2) adoption
of more recent regulations that represent RACT controls; and (3)
negative declarations that there are no sources in the state covered by
specific CTG source categories (see section III below). Maine's
submittal includes a request for EPA approval of 06-096 Code of Maine
Rules (CMR) Chapter 166 ``Industrial Cleaning Solvents'' to address
EPA's 2006 CTG for Industrial Cleaning Solvents. Maine's submittal also
requests that EPA remove from the SIP several previously approved
source-specific RACT requirements for facilities that no longer exist
or, in one case, for a facility that no longer operates the process
controlled by the source-specific requirements.
    On September 4, 2018, EPA determined that Maine's SIP submittal was
administratively and technically complete. This determination stopped
the 18-month sanctions clock for Maine's two outstanding RACT SIP
submittal elements. Because the sanctions clock stopped before
September 6, 2018, sanctions did not become applicable in the state of
Maine from the February 2017 finding of failure to submit (82 FR 9158).
    On May 13, 2019, Maine modified its August 2018 SIP revision by
letter in which it withdrew an item in the submitted SIP Revision.
Specifically, on Table 3, ``Previously-Approved RACT Determinations for
Major Sources of VOC in Maine Now Permanently Closed or No Longer
Subject to RACT,'' Maine withdrew (i.e., removed) the row entitled
``United Technologies Corporation, Pratt and Whitney, North Berwick.''
As a result of this withdrawal, the United Technology, Pratt and
Whitney, North Berwick source-specific requirements approved by EPA
will remain in the Maine SIP.
    Maine's August 2018 SIP submittal does not address RACT
requirements for the 2015 Ozone standard, or the 2016 CTG for the Oil
and Natural Gas Industry and, therefore, these are not addressed in
today's notice.

III. EPA's Evaluation of the Submittal

A. CTG VOC RACT Regulations

    In Maine's August 2018 SIP revision, Table 1 lists each of the
state's VOC RACT regulations, the RACT basis for the regulation (e.g.,
CTG, ACT), the citation of EPA's approval of all but one of the
regulations (i.e., 06-096 CMR Chapter 166 ``Industrial Cleaning
Solvents,'' which we propose to approve in today's action), and
certifies that the state's current VOC RACT rules represent RACT under
the 2008 Ozone NAAQS. On May 22, 2012 (77 FR 30216), EPA approved
Maine's RACT Certification with respect to the 1997 Ozone NAAQS. In
this 2012 approval, EPA also approved regulations that address four
CTGs issued since the 1997 Ozone standard (i.e., Flat Wood Paneling
Coatings; Paper, Film, and Foil Coatings; Offset Lithographic Printing
and Letterpress Printing; and Metal Furniture Coatings). On November 5,
2014, (79 FR 65588), EPA approved Maine's regulations that address two
CTGs: Miscellaneous Industrial Adhesives and Flexible Package Printing.
On May 26, 2016 (81 FR 33394), EPA approved Maine regulations that
address two more CTGs: Metal and Plastic Parts Coatings; and Fiberglass
Boat Manufacturing Materials. This 2016 action also approved negative
declarations for two CTGs: Large Appliance Coatings; and Automobile and
Light-Duty Truck Assembly Coatings. In today's action, EPA is proposing
to approve 06-096 CMR Chapter 166, which Maine included in its August
2018 SIP submission to address the Industrial Cleaning Solvent CTG.
This is the last CTG that Maine is required to address for RACT
Certification with respect to the 2008 Ozone NAAQS. EPA has evaluated
Maine's CTG VOC regulations, which the state certifies as meeting RACT
for the 2008 Ozone standard and finds that they are sufficiently
consistent with recommendations in the respective EPA CTGs and are
based on currently available technologically and economically feasible
controls. Therefore, EPA proposes that they continue to represent RACT
in Maine for the 2008 Ozone standard.
    Maine's August 2018 submittal also included negative declarations
for the following CTG source categories: Auto and Light-Duty Truck
Assembly Coatings; Equipment Leaks from Natural Gas/Gasoline Processing
Plants; Fugitive Emissions from Synthetic Organic Chemical Polymer and
Resin Manufacturing Equipment; Large Petroleum Dry Cleaners; Leaks from
Petroleum Refinery Equipment; Manufacture of High-Density Polyethylene,
Polypropylene, and Polystyrene Resins; Manufacture of Pneumatic Rubber
Tires; Manufacture of Synthesized Pharmaceutical Products;
Manufacturing of Vegetable Oil; Petroleum Liquid Storage in External
Floating Roof Tanks; Refinery Vacuum Producing Systems, Wastewater
Separators, and Process Unit Turnarounds; SOCMI Air Oxidation

Processes; SOCMI Distillation and Reactor Processes; Surface Coating
for Insulation of Magnet Wire; Surface Coating of Automobiles and
Light-Duty Trucks; Surface Coating of Coils; Surface Coating of Large
Appliances; and Wood Furniture Manufacturing. These negative
declarations mean that Maine has no applicable stationary sources of
VOC that are covered by these CTGs.

B. Chapter 166: Industrial Cleaning Solvents

    Maine's new regulation 06-096 CMR Chapter 166, ``Industrial
Cleaning Solvents,'' expands the types of VOC emissions controlled for
industrial cleaning solvents to address the 2006 Industrial Cleaning
Solvents CTG. The regulation generally applies to an owner or operator
of a source that uses industrial cleaning solvents in cleaning
activities and, before controls, creates actual emissions of 3 tons or
more of VOC from cleaning activities during any calendar year. As
described in the regulation, exemptions can apply to cleaning
activities regulated by another source category. The emission limits
are achieved by (1) using solvents with a maximum VOC content limit of
50 grams VOC per liter (0.42 lg/gal), (2) using cleaning solvents with
a composite vapor pressure of 8.0 millimeters or less of mercury (mm
Hg) at 20 degrees Celsius, or (3) using an emission control system with
an overall control efficiency of at least 85 percent. Recordkeeping and
general work practices are also required for applicable sources. These
provisions are consistent with EPA's recommendations for such sources
in the 2006 Industrial Cleaning Solvents CTG. Thus, EPA proposes to
approve Chapter 166 into the Maine SIP. Adding this regulation to the
SIP satisfies the anti-backsliding requirements of Section 110(l) of
the CAA because the new regulation will achieve an equal or greater
amount of VOC reductions as compared to existing EPA-approved Maine
regulations applicable to cleaning activities.

C. Non-CTG VOC Major Sources

    Section 184(b)(2) of the CAA requires RACT be applied to any major
existing stationary source with the potential to emit 50 tons or
greater per year of VOC. Maine's Chapter 134, ``RACT for Facilities
that Emit VOCs,'' rule generally applies to Maine sources with
potential VOC emissions of 40 tons per year or greater that are not
regulated by a specific regulation. In 2012 (77 FR 30216), EPA approved
Chapter 134 as meeting RACT requirements for the 1997 Ozone NAAQS. EPA
proposes that Chapter 134 continues to represent RACT for applicable
major stationary sources of VOCs in Maine for the 2008 Ozone standard.
    Maine's EPA-approved Chapter 134 establishes several RACT options,
two of which set presumptive standards for VOC emissions reductions and
a third that allows a source to submit a variety of strategies as an
alternative compliance plan to reduce VOC emissions. Because the third
option describes a process by which RACT can be defined but does not
define RACT as required by the CAA, Maine must submit source-specific
requirements to EPA for all applicable sources that do not conform to
the presumptive RACT options outlined in the rule. EPA has approved
many such source-specific RACT determinations into the SIP. See 40 CFR
52.1020(d). A fourth option specifically addresses VOC RACT
requirements for pulp and paper processes, requiring that emissions
from the digester system, multiple effect evaporator systems,
condensate stripper systems, smelt tanks, and lime kilns be controlled
through incineration or wet scrubber systems in accordance with Maine's
Chapter 124 ``Total Reduced Sulfur Control from Kraft Pulp Mills.''
    Chapter 134 also includes provisions that exempt certain sources
from additional control requirements, such as for equipment or
processes that have met best available control technology (BACT), have
met lowest achievable emission rate (LAER), or are subject to a
separate RACT rule adopted by Maine and approved by EPA. Chapter 134
also exempts indirect contact wood kilns and wood yards (but not
groundwood operations) from requirements for additional controls
because it would not be technologically or economically practical to
attempt to enclose these areas and capture VOCs and route them to a
control device.
    Table 2 of Maine's SIP revision lists the major VOC sources in
Maine, along with their licensed (potential to emit) VOC emissions, and
notes which sources are subject to applicable RACT requirements and
which facilities have VOC-emitting equipment or processes that are
exempt from the total VOC emission determination in Chapter 134. After
reviewing existing stationary sources in Maine, the state determined
that all major sources of VOC are currently meeting RACT requirements.
EPA proposes that Chapter 134 and the previously-approved source-
specific determinations continue to represent RACT for these VOC
sources in Maine for the 2008 Ozone standard because no new control
technologies are known to be reasonably available considering
technological and economic feasibility for these sources since our last
approval.

D. Withdrawal of Defunct Source-Specific Requirements

    As explained above, Chapter 134 includes a process whereby a major
VOC source in Maine may seek a source-specific RACT determination
rather than be held to the specific emission limits or technology
standards that are set forth in the rule. Because of the generic nature
of this provision, RACT determinations established thereunder are
submitted to EPA as revisions to Maine's SIP. Over the years, EPA has
approved a number of such source-specific RACT determinations into the
Maine SIP. Several of the sources that have received such RACT
determinations are now either permanently closed or have ceased
operations of the regulated activity. In its August 2018 submittal,
Maine requested withdrawal of these previously SIP-approved source-
specific requirements. Six facilities have permanently closed: (1)
Prime Tanning Company, York County, Berwick, Maine; (2) JJ Nissen
Baking Company, Cumberland County, Portland, Maine; (3) Georgia Pacific
Corporation, Washington County, Baileyville (Woodland), Maine; (4)
Moosehead Manufacturing Company, Piscataquis County, Dover-Foxcroft,
Maine; (5) Moosehead Manufacturing Company, Piscataquis County, Monson,
Maine; and (6) Dexter Shoe Company, Penobscot County, Dexter, Maine. A
seventh facility--the McCain Foods USA, Inc., Tatermeal Facility in
Presque Isle--surrendered its license to operate its dryers used to
dehydrate primarily potato wastes to produce a material used as a
binder and nutritional supplement in animal feed. EPA proposes to
remove from the Maine SIP the source-specific RACT requirements
associated with these sources because the sources are permanently
closed or have ceased operations of the regulated activity and are,
therefore, no longer sources of emissions subject to non-CTG VOC RACT.
Withdrawing these requirements from the Maine SIP satisfies the anti-
backsliding requirements in Section 110(l) of the CAA because the
sources controlled no longer emit VOCs.

IV. Proposed Action

    EPA is proposing to approve 06-096 CMR Chapter 166, ``Industrial
Cleaning Solvents,'' into the Maine SIP at 40 CFR 52.1020(c), ``EPA
approved regulations.'' EPA is proposing to approve Maine's SIP
revision on the basis that Maine has met the RACT

requirements for the 2008 8-hour Ozone NAAQS as set forth by sections
182(b) and 184(b)(2) of the CAA. In addition, EPA is proposing to
approve ``Reasonably Available Control Technology (RACT) State
Implementation Plan (SIP) Revision Under the 2008 8-hour Ozone National
Ambient Air Quality Standard (NAAQS),'' as having satisfied the 2008 8-
hour NAAQS RACT requirements, and as an addition to the Maine SIP at 40
CFR 52.1020(e) ``Nonregulatory''.
    EPA is proposing to withdraw the following previously-approved
source-specific RACT requirements for ``Prime Tanning Company, York
County, Berwick, Maine'' (two approvals); ``JJ Nissen Baking Company,
Cumberland County, Portland Maine''; ``Georgia Pacific Corporation,
Washington County, Woodland, Maine''; ``Moosehead Manufacturing
Company, Piscataquis County, Dover-Foxcroft, Maine''; ``Moosehead
Manufacturing Company, Piscataquis County, Monson, Maine''; ``Dexter
Shoe Company, Penobscot County, Dexter, Maine'' (two approvals); and
``McCain Foods USA, Inc., Tatermeal Facility'', and to remove all
entries for these facilities which are currently listed in 40 CFR
52.1020(d) ``EPA-approved State Source specific requirements.''
    EPA is not proposing action with respect to the 2015 Ozone NAAQS or
with respect to the 2016 CTG for Oil and Natural Gas Industry. EPA is
soliciting public comments on the issues discussed in this notice or on
other relevant matters. These comments will be considered before taking
final action. Interested parties may participate in the Federal
rulemaking procedure by submitting written comments to this proposed
rule by following the instructions listed in the ADDRESSES section of
this Federal Register.

V. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference ``Reasonably Available Control Technology (RACT) State
Implementation Plan (SIP) Revision Under the 2008 8-Hour Ozone National
Ambient Air Quality Standard (NAAQS),'' and 06-096 CMR Chapter 166,
``Industrial Cleaning Solvents.'' The EPA has made, and will continue
to make, these documents generally available through https://www.regulations.gov and at the EPA Region 1 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     This action is not expected to be an Executive Order 13771
regulatory action because this action is not significant under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

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

    Dated: June 5, 2019.
Deborah A. Szaro,
Acting Regional Administrator, EPA Region 1.
[FR Doc. 2019-12269 Filed 6-10-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22886-22888]
[FR Doc No: 2019-10392]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1931]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA

Map Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        letter of map       Date of modification   Community
                                          No.               community          repository             revision                                   No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Colorado:
    Douglas.....................  Town of Castle Rock  The Honorable       Water Department,   https://msc.fema.gov/  Aug. 9, 2019.........       080050
                                   (18-08-0874P).       Jason Gray,         175 Kellogg         portal/
                                                        Mayor, Town of      Court, Castle      advanceSearch........
                                                        Castle Rock, 100    Rock, CO 80109.
                                                        North Wilcox
                                                        Street, Castle
                                                        Rock, CO 80104.
    Douglas.....................  Unincorporated       The Honorable Lora  Public Works        https://msc.fema.gov/  Aug. 9, 2019.........       080049
                                   areas of Douglas     Thomas, Chair,      Division, 100 3rd   portal/
                                   County (18-08-       Douglas County,     Street, Castle      advanceSearch.......
                                   0874P).              Board of County     Rock, CO 80104.
                                                        Commissioners,
                                                        100 3rd Street,
                                                        Castle Rock, CO
                                                        80104.
    Summit......................  Town of              The Honorable Eric  Public Works        https://msc.fema.gov/  Jul. 18, 2019........       080172
                                   Breckenridge (18-    Mamula, Mayor,      Department, 1095    advanceSearch.
                                   08-0752P).           Town of             Airport Road,
                                                        Breckenridge,       Breckenridge, CO
                                                        P.O. Box 168,       80424.
                                                        Breckenridge, CO
                                                        80424.
    Summit......................  Unincorporated       The Honorable       Summit County       https://msc.fema.gov/  Jul. 18, 2019........       080290
                                   areas of Summit      Thomas C.           Commons, 0037       advanceSearch.
                                   County (18-08-       Davidson,           Peak One Drive,
                                   0752P).              Commissioner,       Frisco, CO 80442.
                                                        Summit County
                                                        Board of
                                                        Commissioners,
                                                        P.O. Box 68,
                                                        Breckenridge, CO
                                                        80424.
Connecticut:
    Hartford....................  Town of Avon (18-01- Mr. Brandon         Town Hall, 60 West  https://msc.fema.gov/  Aug. 12, 2019........       090021
                                   2151P).              Robertson,          Main Street,        advanceSearch.
                                                        Manager, Town of    Avon, CT 06001.
                                                        Avon, 60 West
                                                        Main Street,
                                                        Avon, CT 06001.
    New Haven...................  Town of Cheshire     The Honorable Rob   Town Hall, 84       https://msc.fema.gov/  Aug. 9, 2019.........       090074
                                   (19-01-0468P).       Oris, Jr.,          South Main          advanceSearch.
                                                        Chairman, Town of   Street, Cheshire,
                                                        Cheshire Council,   CT 06410.
                                                        84 South Main
                                                        Street, Cheshire,
                                                        CT 06410.
Florida:
    Alachua.....................  Unincorporated       The Honorable       Alachua County      https://msc.fema.gov/  Aug. 21, 2019........       120001
                                   areas of Alachua     Charles ``Chuck''   Public Works        advanceSearch.
                                   County (19-04-       Chestnut, IV,       Department, 5620
                                   0622P).              Chairman, Alachua   Northwest 120th
                                                        County Board of     Lane,
                                                        Commissioners, 12   Gainesville, FL
                                                        Southeast 1st       32653.
                                                        Street,
                                                        Gainesville, FL
                                                        32601.
    Manatee.....................  Unincorporated       The Honorable       Manatee County      https://msc.fema.gov/  Jul. 31, 2019........       120153
                                   areas of Manatee     Priscilla Trace,    Building and        advanceSearch.
                                   County (18-04-       Chair, Manatee      Development
                                   5230P).              County Board of     Services
                                                        Commissioners,      Department, 1112
                                                        1112 Manatee        Manatee Avenue
                                                        Avenue West,        West, Bradenton,
                                                        Bradenton, FL       FL 34205.
                                                        34205.
    Monroe......................  City of Key West     The Honorable Teri  City Hall, 1300     https://msc.fema.gov/  Aug. 2, 2019.........       120168
                                   (19-04-0709P).       Johnston, Mayor,    White Street, Key   advanceSearch.
                                                        City of Key West,   West, FL 33041.
                                                        P.O. Box 1409,
                                                        Key West, FL
                                                        33041.
    Monroe......................  Unincorporated       The Honorable       Monroe County       https://msc.fema.gov/  Aug. 12, 2019........       125129
                                   areas of Monroe      Sylvia Murphy,      Building            advanceSearch.
                                   County (19-04-       Mayor, Monroe       Department, 2798
                                   1672P).              County Board of     Overseas Highway,
                                                        Commissioners,      Suite 300,
                                                        102050 Overseas     Marathon, FL
                                                        Highway, Suite      33050.
                                                        234, Key Largo,
                                                        FL 33037.
    Monroe......................  Village of           The Honorable Deb   Building            https://msc.fema.gov/  Aug. 15, 2019........       120424
                                   Islamorada (19-04-   Gillis, Mayor,      Department, 86800   advanceSearch.
                                   1674P).              Village of          Overseas Highway,
                                                        Islamorada, 86800   Islamorada, FL
                                                        Overseas Highway,   33036.
                                                        Islamorada, FL
                                                        33036.
Montana: Madison................  Town of Ennis (18-   The Honorable       Town Hall, 328      https://msc.fema.gov/  Aug. 16, 2019........       300044
                                   08-1265P).           Blake Leavitt,      West Main Street,   advanceSearch.
                                                        Mayor, Town of      Ennis, MT 59729.
                                                        Ennis, P.O. Box
                                                        147, Ennis, MT
                                                        59729.

Pennsylvania: Somerset..........  Township of Elk      The Honorable       Township Hall,      https://msc.fema.gov/  Oct. 7, 2019.........       422048
                                   Lick (19-03-0464P).  Allen Green,        1507 St. Paul       advanceSearch.
                                                        Chairman,           Road, Salisbury,
                                                        Township of Elk     PA 15558.
                                                        Lick, 1507 St.
                                                        Paul Road,
                                                        Salisbury, PA
                                                        15558.
South Carolina: Charleston......  City of Isle of      The Honorable       Building and        https://msc.fema.gov/  Aug. 21, 2019........       455416
                                   Palms (19-04-        Jimmy Carroll,      Planning            advanceSearch.
                                   1752P).              Mayor, City of      Department, 1207
                                                        Isle of Palms,      Palm Boulevard,
                                                        1207 Palm           Isle of Palms, SC
                                                        Boulevard, Isle     29451.
                                                        of Palms, SC
                                                        29451.
Tennessee: Shelby...............  City of Germantown   The Honorable Mike  Economic and        https://msc.fema.gov/  Jun. 28, 2019........       470353
                                   (18-04-6585P).       Palazzolo, Mayor,   Community           advanceSearch.
                                                        City of             Development
                                                        Germantown, 1930    Department, 1920
                                                        South Germantown    South Germantown
                                                        Road, Germantown,   Road, Germantown,
                                                        TN 38138.           TN 38138.
Texas:
    Comal.......................  City of New          The Honorable       City Hall, 550      https://msc.fema.gov/  Jul. 5, 2019.........       485493
                                   Braunfels (18-06-    Barron Casteel,     Landa Street, New   advanceSearch.
                                   3030P).              Mayor, City of      Braunfels, TX
                                                        New Braunfels,      78130.
                                                        550 Landa Street,
                                                        New Braunfels, TX
                                                        78130.
    Denton......................  City of Denton (18-  The Honorable       Engineering         https://msc.fema.gov/  Aug. 12, 2019........       480194
                                   06-4048P).           Chris A. Watts,     Department, 901-A   advanceSearch.
                                                        Mayor, City of      Texas Street,
                                                        Denton, 215 East    Denton, TX 76209.
                                                        McKinney Street,
                                                        Suite 100,
                                                        Denton, TX 76201.
    Denton......................  City of Fort Worth   The Honorable       Transportation and  https://msc.fema.gov/  Aug. 22, 2019........       480596
                                   (18-06-3549P).       Betsy Price,        Public Works        advanceSearch.
                                                        Mayor, City of      Department, 200
                                                        Fort Worth, 200     Texas Street,
                                                        Texas Street,       Fort Worth, TX
                                                        Fort Worth, TX      76102.
                                                        76102.
    Denton......................  City of Roanoke (18- The Honorable Carl  City Hall, 500      https://msc.fema.gov/  Aug. 22, 2019........       480785
                                   06-3549P).           ``Scooter''         South Oak Street,   advanceSearch.
                                                        Gierisch, Jr.,      Roanoke, TX 76262.
                                                        Mayor, City of
                                                        Roanoke, 108
                                                        South Oak Street,
                                                        Roanoke, TX 76262.
    Denton......................  Town of Northlake    The Honorable       Public Works        https://msc.fema.gov/  Aug. 22, 2019........       480782
                                   (18-06-3549P).       Peter Dewing,       Department, 1400    advanceSearch.
                                                        Mayor, Town of      FM 407,
                                                        Northlake, 1500     Northlake, TX
                                                        Commons Circle,     76247.
                                                        Suite 300,
                                                        Northlake, TX
                                                        76226.
    Denton......................  Town of Prosper (19- The Honorable Ray   Engineering         https://msc.fema.gov/  Aug. 22, 2019........       480141
                                   06-0890X).           Smith, Mayor,       Services            advanceSearch.
                                                        Town of Prosper,    Department, 409
                                                        P.O. Box 307,       East 1st Street,
                                                        Prosper, TX 75078.  Prosper, TX 75078.
    Tarrant.....................  City of Arlington    The Honorable Jeff  City Hall, 101      https://msc.fema.gov/  Aug. 5, 2019.........       485454
                                   (18-06-3453P).       Williams, Mayor,    West Abram          advanceSearch.
                                                        City of             Street,
                                                        Arlington, P.O.     Arlington, TX
                                                        Box 90231,          76010.
                                                        Arlington, TX
                                                        76004.
    Tarrant.....................  Unincorporated       The Honorable B.    Tarrant County      https://msc.fema.gov/  Jul. 26, 2019........       480582
                                   areas of Tarrant     Glen Whitley,       Administration      advanceSearch.
                                   County (19-06-       Tarrant County      Building, 100
                                   0403P).              Judge, 100 East     East Weatherford
                                                        Weatherford         Street, Fort
                                                        Street, Fort        Worth, TX 76196.
                                                        Worth, TX 76196.
    Williamson..................  City of Cedar Park   The Honorable       Engineering         https://msc.fema.gov/  Jul. 30, 2019........       481282
                                   (18-06-3176P).       Corbin Van          Department, 450     advanceSearch.
                                                        Arsdale, Mayor,     Cypress Creek
                                                        City of Cedar       Road, Building 1,
                                                        Park, 450 Cypress   Cedar Park, TX
                                                        Creek Road,         78613.
                                                        Building 1, Cedar
                                                        Park, TX 78613.
    Williamson..................  Unincorporated       The Honorable Bill  Williamson County   https://msc.fema.gov/  Jul. 22, 2019........       481079
                                   areas of             Gravell, Jr.,       Engineering         advanceSearch.
                                   Williamson County    Williamson County   Department, 710
                                   (19-06-0529P).       Judge, 710 South    South Main
                                                        Main Street,        Street, Suite
                                                        Suite 101,          101, Georgetown,
                                                        Georgetown, TX      TX 78626.
                                                        78626.
Utah: Carbon....................  City of Price (18-   The Honorable       Public Works        https://msc.fema.gov/  Aug. 15, 2019........       490036
                                   08-1056P).           Michael             Department, 432     advanceSearch.
                                                        Kourianos, Mayor,   West 600 South,
                                                        City of Price,      Price, UT 84501.
                                                        185 East Main
                                                        Street, Price, UT
                                                        84501.
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[FR Doc. 2019-10392 Filed 5-17-19; 8:45 am]
BILLING CODE 9111-12-P