[Federal Register Volume 86, Number 232 (Tuesday, December 7, 2021)]
[Proposed Rules]
[Pages 69200-69207]
[FR Doc No: 2021-26437]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2021-0751: FRL-9211-01-R10]

Air Plan Approval; Washington; Yakima Regional Clean Air Agency,
General Air Quality Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Washington State Implementation Plan (SIP)
that were submitted by the Department of Ecology (Ecology) in
coordination with the Yakima Regional Clean Air Agency (YRCAA). In
2014, 2015, 2016, and 2020, the EPA approved revisions to the General
Regulations for Air Pollution Sources promulgated by Ecology in the
Washington Administrative Code (WAC). In this action, the EPA proposes
to update the SIP for YRCAA's jurisdiction to reflect these changes to
the WAC. We also propose to update certain YRCAA regulations currently
in the SIP, remove obsolete regulations, and approve a small set of
YRCAA regulations to replace or supplement the corresponding WAC
regulations for sources in YRCAA's jurisdiction.

DATES: Comments must be received on or before January 6, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2021-0751 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt, EPA Region 10, 1200 Sixth
Avenue--Suite 155, Seattle, WA 98101, at<PHONE_NUMBER>, or
[email protected].

Table of Contents

I. Background for Proposed Action
II. Proposed Revisions, YRCAA Regulation 1
    A. Sections 1.01 Name of Agency, 1.02 Short Title, and 1.03
Policy
    B. Appendix A Definitions of Words and Phrases [Formerly Section
1.03 Definitions]
    C. Section 1.04 Applicability
    D. Sections 1.05 Roles and Responsibilities and 2.01 Authority
and Investigation
    E. Section 1.06 Records
    F. Section 1.07 General Provisions
    G. Section 2.02 Authority To Collect Fees
    H. Section 2.03 Applicable State and Federal Regulations
    I. Section 2.04 Public Participation in Permitting
    J. Section 2.05 Appeals
    K. Sections 3.01 General Rules and 3.08 Specific Dust Controls
    L. Section 4.01 Registration Program
    M. Section 4.03 Voluntary Limits on Emissions
    N. Sections 5.01 General Information, 5.02 Additional or
Alternative Enforcement Actions, and 5.03 Penalties
III. Applicability of Chapter 173-400 WAC
IV. The EPA's Proposed Action
    A. Regulations To Approve and Incorporate by Reference Into the
SIP
    B. Approved But Not Incorporated by Reference Regulations
    C. Regulations To Remove From the SIP
    D. Scope of Proposed Action
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Background for Proposed Action

    On January 27, 2014, Ecology submitted revisions to update the
General Regulations for Air Pollution Sources contained in Chapter 173-
400 WAC. The EPA approved these updates in three phases on October 3,
2014 (79 FR 59653), November 7, 2014 (79 FR 66291), and April 29, 2015
(80 FR 23721).\1\ Under the revised applicability provisions of WAC
173-400-020 approved into the SIP on October 3, 2014, the regulations
contained in Chapter 173-400 WAC apply statewide, ``. . . except for
specific subsections where a local authority has adopted and
implemented corresponding local rules that apply only to sources
subject to local jurisdiction as provided under Revised Code of
Washington (RCW) 70.94.141 and 70.94.331.'' \2\ Therefore, the EPA's
approval of Ecology's January 2014 submittal applied only to geographic
areas and source categories under Ecology's direct jurisdiction. We
stated that we would address the revised Chapter 173-400 WAC
regulations as they apply to local clean air agency jurisdictions on a
case-by-case basis in separate, future actions. Subsequent local clean
air agency actions related to Chapter 173-400 WAC include our approval
of the Benton Clean Air Agency (80 FR 71695, November 17, 2015),
Southwest Clean Air Agency (82 FR 17136, April 10, 2017), Puget Sound
Clean Air Agency (85 FR 22355, April 22, 2020), Northwest Clean Air
Agency (85 FR 36154, June 15, 2020), and Spokane Regional Clean Air
Agency (86 FR 24718, May 10, 2021).
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    \1\ In subsequent actions on October 6, 2016 (81 FR 69385) and
February 24, 2020 (85 FR 10302) we approved revisions to the WAC
that incorporated by reference the most recent changes to the
Federal regulations and other minor changes.
    \2\ These statutory provisions were subsequently re-codified to
RCW 70A.15.2040 and 70A.15.3000, with no substantive revisions to
the statutory text. For a more detailed discussion of applicability
see page 39352 of the EPA's proposed approval of WAC 173-400-020 (79
FR 39351, July 10, 2014).
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    On October 14, 2021, the Director of Ecology, as the Governor's
designee for SIP revisions, submitted a request to update the air
quality regulations in the SIP as they apply to YRCAA's jurisdiction in
40 CFR 52.2470(c), Table 10--Additional Regulations Approved for the
Yakima Regional Clean Air Agency (YRCAA) Jurisdiction. YRCAA's
jurisdiction consists of Yakima County, excluding Indian reservation
land or any other area where the EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. YRCAA also does not have
jurisdiction over certain facilities discussed in section IV.D. Scope
of Proposed Action of this document. We note that YRCAA regulatory
revisions related to outdoor burning, agricultural burning, and wood
heaters are outside the scope of this current action and addressed
separately.

II. Proposed Revisions, YRCAA Regulation 1

    The EPA last approved updates to YRCAA Regulation 1 on February 2,
1998 (63 FR 5269). Effective December 1, 2002, YRCAA repealed sections
2.04 Public Participation, 3.01 Emission Standards, 3.11 Monitoring,
Recordkeeping, and Reporting, and 4.02 New Source Review to rely on the
statewide provisions of Chapter 173-400 WAC. On October 8, 2020, YRCAA
adopted additional changes to align with the WAC and other clarifying
changes. The Washington State Register listing the most recent changes
to the YRCAA regulations is included in the docket for this action and
will not be described in detail here. A brief summary of the major
changes since our last SIP approval is provided below.

A. Sections 1.01 Name of Agency, 1.02 Short Title, and 1.03 Policy

    These changes reflect the name change from ``Yakima County Clean
Air Authority'' to ``Yakima Regional Clean Air Agency.'' YRCAA also
renumbered and modified the policy section (now section 1.03) since the
last version approved into the SIP. With respect to section 1.03, we
note that Ecology and YRCAA did not submit sub-section H related to the
State Environmental Policy Act (SEPA). These SEPA provisions are
outside the scope of the SIPs approved under Clean Air Act (CAA)
section 110. Lastly, we propose to approve YRCAA Regulation 1, section
1.03 Policy to replace WAC 173-400-010 Policy and Purpose.

B. Appendix A Definitions of Words and Phrases [Formerly Section 1.03
Definitions]

    As discussed above, in 2002, YRCAA repealed sections 2.04 Public
Participation, 3.01 Emission Standards, 3.11 Monitoring, Recordkeeping,
and Reporting, and 4.02 New Source Review to rely on the statewide
provisions of Chapter 173-400 WAC. To avoid potential inconsistency
with the WAC, YRCAA eliminated all definitions in the former section
1.03 Definitions that were duplicative with Chapter 173-400 WAC and
moved the remaining definitions to Appendix A. Similarly, on October 8,
2020, YRCAA eliminated all definitions in Appendix A that were
duplicative with Chapters 173-425, 173-430, and 173-433 WAC because the
WAC definitions already apply statewide. The EPA is proposing to
approve the revised Appendix A, with the exception of asbestos control
program definitions, which YRCAA did not submit for approval because
they are outside the scope of SIPs under CAA section 110.

C. Section 1.04 Applicability

    This section defines YRCAA's jurisdiction over certain sources
within Yakima County. It complements and is consistent with WAC 173-
400-020 Applicability. A full discussion of applicability as it relates
to the Energy Facility Site Evaluation Council (EFSEC), Indian country,
and sources directly regulated or permitted by Ecology is included in
section IV.D. Scope of Proposed Action of this document. The EPA is
proposing to approve section 1.04, but it does not replace WAC 173-400-
020 in YRCAA's jurisdiction because WAC 173-400-020 is broader in scope
in that it contains the criteria for when a local standard applies in
lieu of a provision of Chapter 173-400 WAC.

D. Sections 1.05 Roles and Responsibilities and 2.01 Authority and
Investigation

    These sections describe the roles, responsibilities, powers, and
duties of the board of directors, the air pollution control officer,
and any advisory councils appointed to advise and consult in
development and implementation of the regulations. As described in
section IV.B of this document, the EPA reviews and approves state and
local clean air agency submissions to ensure they provide adequate
enforcement authority and other general authority to implement and
enforce the SIP. However, regulations describing such agency
enforcement and other general authority are generally not incorporated
by reference to avoid potential conflict with the EPA's independent
authorities. The EPA is therefore proposing to approve but not
incorporate by reference sections 1.05 and 2.01.

E. Section 1.06 Records

    This section defines the policy for protecting records and making
them available to the public. Many of these provisions were approved
into the SIP under the former section 2.04 Confidentiality. YRCAA
subsequently consolidated all the record provisions into section 1.06
and repealed section 2.04. We are proposing to approve section 1.06
into the SIP and remove the repealed section 2.04 from the SIP. We are
also proposing to approve section 1.06 to replace WAC 173-400-175
Public Information within YRCAA's jurisdiction.

F. Section 1.07 General Provisions

    This section contains several general provisions, some of which
were previously approved into the SIP under the former section 2.03
Miscellaneous Provisions. Of note are the two sub-sections 1.07(B)(1)
and (2). Subsection 1.07(B)(1) states, ``No person shall make any false
material statement, representation or certification in any form, notice
or report required under Chapter 70A.15 RCW, or any ordinance,
resolution, regulation, permit or order in force pursuant thereto.''
This YRCAA provision, adapted to reflect local agency authority,
replaces the nearly identical text contained in WAC 173-400-105(6).
Subsection 1.07(B)(2) states, ``No person shall render inaccurate any
monitoring device or method required under Chapter 70A.15 RCW, or any
ordinance, resolution, regulation, permit, or order in force pursuant
thereto.'' This YRCAA provision replaces the nearly identical text
contained in WAC 173-400-105(8). The EPA is proposing to approve
section 1.07 and to approve sub-sections (B)(1) and (2) to replace WAC
173-400-105(6) & (8). We are also proposing to remove the subsequently
revoked section 2.03 from the SIP.

G. Section 2.02 Authority To Collect Fees

    Under section 110(a)(2)(L) of the CAA, the state, or local agencies
acting in lieu of the state, must demonstrate the ability to collect
adequate fees for permitting major sources. YRCAA therefore submitted
section 2.02 Authority to Collect Fees to demonstrate adequate fee
authority to implement the major source nonattainment new source review
program under WAC 173-400-800 through 173-400-860, should the need
arise in the future.\3\ Although the EPA reviews these submissions to
confirm adequate authority, the EPA generally does not include local or
state agency fees as part of the Washington SIP incorporated by
reference in 40 CFR 52.2470(c). We are therefore proposing to approve
section 2.02 as part of the approved but not incorporated by reference
portion of the SIP under 40 CFR 52.2470(e), and to remove from the SIP
the previously approved fee provisions at sections 13.01, 13.02, and
13.03.
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    \3\ There are currently no designated nonattainment areas in the
State of Washington to which WAC 173-400-800 through 173-400-860
would apply.

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H. Section 2.03 Applicable State and Federal Regulations

    This section replaces the revoked section 12.01 State Regulations,
which was approved into the SIP in 1998. Except for Chapter 173-400 WAC
discussed in more detail below, the remaining state WAC and federal
Code of Federal Regulations (CFR) provisions cited in section 2.03
would apply in YRCAA's jurisdiction according to the terms of the state
and federal regulations and do not need to be included as part of the
local agency SIP submission. Therefore, we are proposing to remove the
revoked section 12.01 from the SIP. For a full list of statewide WAC
provisions approved into the SIP, please see 40 CFR 52.2470(c) Table
1--Regulations Approved Statewide. For a list of updated Chapter 173-
400 WAC provisions proposed for approval in YRCAA's jurisdiction,
please see section IV.A Regulations to Approve and Incorporate by
Reference into the SIP in this document.

I. Section 2.04 Public Participation in Permitting

    As previously discussed, in 2002, YRCAA repealed section 2.04
Public Participation to rely on WAC 173-400-171 Public Notice and
Opportunity for Public Comment. On October 8, 2020, YRCAA reestablished
section 2.04, creating a cross reference to the provisions of WAC 173-
400-171 for permits issued under the new source review program. We are
proposing to approve section 2.04. However, section 2.04 will not
replace WAC 173-400-171, because the WAC is broader in scope and covers
public participation beyond just permitting.

J. Section 2.05 Appeals

    This section cites to Washington statutory provisions for the
appeals process, as well as the regulatory provisions of WAC 173-400-
250. As previously described with respect to sections 1.05 and 2.01,
the EPA reviews and approves state and local clean air agency
submissions to ensure they provide adequate general authority to
implement and enforce the SIP. However, regulations describing such
agency enforcement and other general authority are generally not
incorporated by reference to avoid potential conflict with the EPA's
independent authorities. The EPA is therefore proposing to approve but
not incorporate by reference section 2.05.

K. Sections 3.01 General Rules and 3.08 Specific Dust Controls

    Section 3.01 contains general rules applicable to all sources under
YRCAA's jurisdiction. Section 3.08 contains additional provisions to
address fugitive dust from construction and cattle feeding operations.
We note that YRCAA is not submitting, and the EPA is not proposing to
approve, subsections 3.01(D) Variance Process, 3.08(A)(3)(b)
Emergencies, and 3.08(B)(3) Emergencies. It is the EPA's longstanding
position that these types of provisions are not appropriate for
approval into the SIP. See 69 FR 17368, 17370 (April 2, 2004); see also
80 FR 33840, 33917-33918 (June 12, 2015). We also note that these
provisions, which add additional requirements to address a subset of
potential fugitive dust sources, do not replace the broader statewide
provisions of WAC 173-400-040(9) Fugitive Dust. With the exceptions
noted above, we are proposing to approve sections 3.01 and 3.08.

L. Section 4.01 Registration Program

    Section 4.01 contains the YRCAA-specific registration program,
which replaces the registration program of WAC 173-400-099 through 173-
400-104. Section 4.01 cites to and uses the source categories in WAC
173-400-100 for applicability. Section 4.01 also uses emissions
thresholds established in the WAC for determining annual or triennial
emissions reporting to support the federal Air Emissions Reporting
Requirements (40 CFR part 51, subpart A) and other local program
requirements. We are proposing to approve section 4.01, except for
requirements related to Toxic Air Pollutants, which YRCAA did not
submit because such provisions are outside the scope of CAA section 110
requirements for SIPs.

M. Section 4.03 Voluntary Limits on Emissions

    Section 4.03 replaces WAC 173-400-091 Voluntary Limits on
Emissions. Section 4.03 contains requirements nearly identical to the
WAC, but YRCAA adapted the language slightly to reflect local agency
implementation. We are proposing to approve section 4.03 to replace WAC
173-400-091 for sources within YRCAA's jurisdiction as it relates to
CAA section 110 requirements for SIPs.

N. Sections 5.01 General Information, 5.02 Additional or Alternative
Enforcement Actions, and 5.03 Penalties

    These sections describe YRCAA's compliance, enforcement, and
penalty authorities. As described in section IV.B of this document, the
EPA reviews and approves state and local clean air agency submissions
to ensure they provide adequate enforcement authority and other general
authority to implement and enforce the SIP. However, regulations
describing such agency enforcement and other general authority are
generally not incorporated by reference to avoid potential conflict
with the EPA's independent authorities. The EPA is therefore proposing
to approve but not incorporate by reference sections 5.01, 5.02, and
5.03.

III. Applicability of Chapter 173-400 WAC

    As previously discussed, a local clean air agency has the authority
under WAC 173-400-020 to establish local regulations to supplement, or
act in lieu of, the statewide Chapter 173-400 WAC provisions for
sources under its jurisdiction. YRCAA generally implements and enforces
Chapter 173-400 WAC, with a small set of YRCAA-specific provisions
replacing certain sections or subsections of Chapter 173-400 WAC. The
EPA is generally proposing to approve the most recent updates to
Chapter 173-400 WAC to apply within YRCAA's jurisdiction subject to the
exclusions and conditions discussed in section IV The EPA's Proposed
Action of this document. This approach is consistent with our previous
SIP actions for Benton Clean Air Agency (80 FR 71695, November 17,
2015), Southwest Clean Air Agency (82 FR 17136, April 10, 2017), Puget
Sound Clean Air Agency (85 FR 22355, April 22, 2020), Northwest Clean
Air Agency (85 FR 36154, June 15, 2020), and Spokane Regional Clean Air
Agency (86 FR 24718, May 10, 2021.

IV. The EPA's Proposed Action

A. Regulations To Approve and Incorporate by Reference Into the SIP

    The EPA is proposing to approve and incorporate by reference into
the Washington SIP at 40 CFR 52.2470(c)--Table 10--Additional
Regulations Approved for the Yakima Regional Clean Air Agency (YRCAA)
Jurisdiction, the YRCAA and Ecology regulations listed in Tables 1 and
2 of this document below for sources within YRCAA's jurisdiction. Table
1 shows the updated YRCAA regulations,

including those YRCAA provisions that replace sections or subsections
of Chapter 173-400 WAC.

                          Table 1--Updated Yakima Regional Clean Air Agency Regulations
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                                                                  State/local
       State/local citation               Title/subject         effective date             Explanation
----------------------------------------------------------------------------------------------------------------
                                                  Regulation 1
----------------------------------------------------------------------------------------------------------------
1.01.............................  Name of Agency.............        11/09/20
1.02.............................  Short Title................        11/09/20
1.03.............................  Policy.....................        11/09/20  Except sub-section H. Replaces
                                                                                WAC 173-400-010.
1.04.............................  Applicability..............        11/09/20
1.06.............................  Records....................        11/09/20  Replaces WAC 173-400-175.
1.07.............................  General Provisions.........        11/09/20  Replaces WAC 173-400-105(6) &
                                                                                (8).
2.04.............................  Public Participation in            11/09/20
                                    Permitting.
3.01.............................  General Rules..............        11/09/20  Except sub-section D.
3.08.............................  Specific Dust Controls.....        11/09/20  Except sub-sections
                                                                                3.08(A)(3)(b) and 3.08(B)(3).
4.01.............................  Registration Program.......        11/09/20  Excluding any provisions related
                                                                                to the regulation of Toxic Air
                                                                                Pollutants.
4.03.............................  Voluntary Limits on                11/09/20  Replaces WAC 173-400-091 (state
                                    Emissions.                                   effective 4/1/11). The 9/20/93
                                                                                version of WAC 173-400-091
                                                                                continues to be approved under
                                                                                the authority of CAA Section
                                                                                112(l) with respect to Section
                                                                                112 hazardous air pollutants.
                                                                                See 60 FR 28726 (June 2, 1995).
Appendix A.......................  Definitions of Words and           11/09/20  Except asbestos control program
                                    Phrases.                                     definitions.
Appendix B.......................  Definitions of Acronyms and        11/09/20
                                    Abbreviations.
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    Table 2 of this document shows the updated Chapter 173-400 WAC
provisions that YRCAA and Ecology requested apply to the SIP within
YRCAA's jurisdiction. We note that many of the exclusions listed in
Table 2 are identical to the exclusions for Ecology's direct
jurisdiction. These exclusions primarily relate to Toxic Air Pollutants
or other requirements which YRCAA and Ecology did not submit because
they are outside the scope of regulating criteria pollutants under CAA
section 110.\4\ Table 2 also excludes those parts of the WAC explicitly
replaced by the Regulation 1 provisions in Table 1 of this document.
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    \4\ See 79 FR 39351 (July 10, 2014).
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    The EPA previously approved Chapter 173-400 WAC as it applied to
YRCAA's jurisdiction on June 2, 1995 (60 FR 28726). We note that YRCAA
and Ecology did not submit updates for provision that remain unchanged
since our 1995 approval. These provisions are WAC 173-400-161, WAC 173-
400-190, WAC 173-400-205, and WAC 173-400-210. Similarly, YRCAA and
Ecology did not request updates to Chapter 173-400 WAC that have not
yet been approved by the EPA for Ecology's direct jurisdiction.\5\ For
those sections or subsections of Chapter 173-400 WAC that are not
updated as part of this action, the EPA will retain, unchanged, our
1995 approval of those sections or subsections as it applies to YRCAA's
jurisdiction.
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    \5\ YRCAA and Ecology did not request, and the EPA is not
proposing to approve updates to the following Chapter 173-400 WAC
sections or subsections to apply within YRCAA's jurisdiction at this
time: 173-400-030(6), (32), (38), (45), (83), (89), (97), (100),
(103), and (104); 173-400-040(2); 173-400-070; 173-400-081; WAC 173-
400-107; and 173-400-171(3)(o). See 85 FR 10302 (February 24, 2020)
for the most recent update of Chapter 173-400 WAC in the SIP.

       Table 2--Updated Washington Department of Ecology Regulations To Apply Within YRCAA's Jurisdiction
----------------------------------------------------------------------------------------------------------------
                                                                     State
          State citation                  Title/subject         effective date            Explanations
----------------------------------------------------------------------------------------------------------------
         Washington Administrative Code, Chapter 173-400--General Regulations for Air Pollution Sources
----------------------------------------------------------------------------------------------------------------
173-400-020......................  Applicability..............        12/29/12
173-400-025......................  Adoption of Federal Rules..         9/16/18
173-400-030......................  Definitions................         9/16/18  Except: 173-400-030(6); 173-400-
                                                                                030(32); 173-400-030(38); 173-
                                                                                400-030(45); 173-400-030(83);
                                                                                173-400-030(89); 173-400-
                                                                                030(96); 173-400-030(97); 173-
                                                                                400-030(100); 173-400-030(103);
                                                                                173-400-030(104).
173-400-036......................  Relocation of Portable             12/29/12
                                    Sources.
173-400-040......................  General Standards for               9/16/18  Except: 173-400-040(2); 173-400-
                                    Maximum Emissions.                           040(3); 173-400-040(5);

173-400-050......................  Emission Standards for              9/16/18  Except: 173-400-050(2); 173-400-
                                    Combustion and                               050(4); 173-400-050(5); 173-400-
                                    Incineration Units.                          050(6).
173-400-060......................  Emission Standards for             11/25/18
                                    General Process Units.
173-400-105......................  Records, Monitoring, and           11/25/18  Except 173-400-105(6) & (8).
                                    Reporting.
173-400-110......................  New Source Review (NSR) for        12/29/12  Except: 173-400-
                                    Sources and Portable                         110(1)(c)(ii)(C); 173-400-
                                    Sources.                                     110(1)(e); 173-400-110(2)(d);
                                                                                The part of WAC 173-400-
                                                                                110(4)(b)(vi) that says,
                                                                                ``not for use with
                                                                                materials containing toxic air
                                                                                pollutants, as listed in
                                                                                chapter 173-460 WAC,'';
                                                                                The part of 400-110 (4)(e)(iii)
                                                                                that says,
                                                                                ``where toxic air
                                                                                pollutants as defined in
                                                                                chapter 173-460 WAC are not
                                                                                emitted'';
                                                                                The part of 400-110(4)(f)(i)
                                                                                that says,
                                                                                ``that are not toxic
                                                                                air pollutants listed in
                                                                                chapter 173-460 WAC'';
                                                                                The part of 400-110
                                                                                (4)(h)(xviii) that says,
                                                                                ``, to the extent that
                                                                                toxic air pollutant gases as
                                                                                defined in chapter 173-460 WAC
                                                                                are not emitted'';
                                                                                The part of 400-110
                                                                                (4)(h)(xxxiii) that says,
                                                                                ``where no toxic air
                                                                                pollutants as listed under
                                                                                chapter 173-460 WAC are
                                                                                emitted'';
                                                                                The part of 400-110(4)(h)(xxxiv)
                                                                                that says,
                                                                                ``, or <=1% (by weight)
                                                                                toxic air pollutants as listed
                                                                                in chapter 173-460 WAC'';
                                                                                The part of 400-110(4)(h)(xxxv)
                                                                                that says,
                                                                                ``or <= % (by weight)
                                                                                toxic air pollutants'';
                                                                                The part of 400-110(4)(h)(xxxvi)
                                                                                that says,
                                                                                ``or <=1% (by weight)
                                                                                toxic air pollutants as listed
                                                                                in chapter 173-460 WAC'';
                                                                                400-110(4)(h)(xl), second
                                                                                sentence;
                                                                                The last row of the table in 173-
                                                                                400-110(5)(b) regarding
                                                                                exemption levels for Toxic Air
                                                                                Pollutants.
173-400-111......................  Processing Notice of               07/01/16  Except: 173-400-111(3)(h);
                                    Construction Applications                   The part of 173-400-111(8)(a)(v)
                                    for Sources, Stationary                      that says,
                                    Sources and Portable                         ``and 173-460-040,'';
                                    Sources.                                     173-400-111(9).
173-400-112......................  Requirements for New               12/29/12
                                    Sources in Nonattainment
                                    Areas--Review for
                                    Compliance with
                                    Regulations.
173-400-113......................  New Sources in Attainment          12/29/12  Except: 173-400-113(3), second
                                    or Unclassifiable Areas--                    sentence.
                                    Review for Compliance with
                                    Regulations.
173-400-117......................  Special Protection                 12/29/12
                                    Requirements for Federal
                                    Class I Areas.
173-400-118......................  Designation of Class I, II,        12/29/12
                                    and III Areas.
173-400-131......................  Issuance of Emission                 4/1/11
                                    Reduction Credits.
173-400-136......................  Use of Emission Reduction            4/1/11
                                    Credits (ERC).
173-400-151......................  Retrofit Requirements for           2/10/05
                                    Visibility Protection.

173-400-171......................  Public Notice and                   9/16/18  Except: The part of 173-400-
                                    Opportunity for Public                       171(3)(b) that says,
                                    Comment.                                     ``or any increase in
                                                                                emissions of a toxic air
                                                                                pollutant above the acceptable
                                                                                source impact level for that
                                                                                toxic air pollutant as
                                                                                regulated under chapter 173-460
                                                                                WAC'';
                                                                                173-400-171(3)(o); 173-400-
                                                                                171(12).
173-400-200......................  Creditable Stack Height and         2/10/05
                                    Dispersion Techniques.
173-400-560......................  General Order of Approval..        12/29/12  Except: The part of 173-400-
                                                                                560(1)(f) that says, ``173-460
                                                                                WAC''.
173-400-800......................  Major Stationary Source and          4/1/11  EPA did not review WAC 173-400-
                                    Major Modification in a                      800 through 860 for consistency
                                    Nonattainment Area.                          with the August 24, 2016 PM2.5
                                                                                implementation rule (81 FR
                                                                                58010); nor does YRCAA have an
                                                                                obligation to submit rule
                                                                                revisions to address the 2016
                                                                                PM2.5 implementation rule at
                                                                                this time.
173-400-810......................  Major Stationary Source and        07/01/16
                                    Major Modification
                                    Definitions.
173-400-820......................  Determining if a New               12/29/12
                                    Stationary Source or
                                    Modification to a
                                    Stationary Source is
                                    Subject to these
                                    Requirements.
173-400-830......................  Permitting Requirements....        07/01/16
173-400-840......................  Emission Offset                    07/01/16
                                    Requirements.
173-400-850......................  Actual Emissions Plantwide         07/01/16
                                    Applicability Limitation
                                    (PAL).
173-400-860......................  Public Involvement                   4/1/11
                                    Procedures.
----------------------------------------------------------------------------------------------------------------

B. Approved But Not Incorporated by Reference Regulations

    In addition to the regulations proposed for approval and
incorporation by reference above in this document, the EPA reviews and
approves state and local clean air agency submissions to ensure they
provide adequate enforcement authority and other general authority to
implement and enforce the SIP. However, regulations describing such
agency enforcement and other general authority are generally not
incorporated by reference so as to avoid potential conflict with the
EPA's independent authorities. We are proposing to include YRCAA
Regulation 1, sections 1.05, 2.01, 2.02, 2.05, 5.01, 5.02, and 5.03 in
40 CFR 52.2470(e), EPA Approved Nonregulatory Provisions and Quasi-
Regulatory Measures, as approved but not incorporated by reference
regulatory provisions.

C. Regulations To Remove From the SIP

    YRCAA and Ecology's October 14, 2021 submittal included a request
to remove several obsolete provisions from the SIP and to remove other
provisions that are not required SIP elements under CAA section 110. As
previously discussed, YRCAA and Ecology requested that the EPA: Remove
former section 1.03 which was replaced by Appendix A; remove former
section 2.03 which was replaced by the provisions of section 1.07;
remove former section 2.04 which was replaced by the provisions of
section 1.06; remove former section 5.12 which was replaced by section
3.08 and WAC 173-400-040; remove former sections 13.01, 13.02, and
13.03 which were replaced by the provisions of section 2.02; remove
former section 12.01 which was replaced by section 2.03 and is not a
required SIP element; and remove former sections 3.11, 4.02, 4.03,
5.06, 5.07, 5.08, and 5.11 in order to rely on Chapter 173-400 WAC. We
are also proposing to remove from 40 CFR 52.2470(c) the former sections
2.02, 2.05, 3.01, 3.02, 3.03, 3.04, 8.01, 8.02, 8.03, 8.04, and 8.05,
related to local agency enforcement and other general authority, now
consolidated in sections 1.05, 2.01, 2.02, 2.05, 5.01, 5.02, and 5.03
and proposed for approval in 40 CFR 52.2470(e), EPA Approved
Nonregulatory Provisions and Quasi-Regulatory Measures, as approved but
not incorporated by reference regulatory provisions. Lastly, we are
proposing to remove the former section 5.10 Sensitive Area Designation,
which allowed YRCAA to designate sensitive areas based on a
consideration of present and predicted ambient air quality, population
density and trends, distance of sources from public roads, recreational
areas and areas of human habitation, topographic and meteorological
conditions, and other pertinent variables. YRCAA has never used this
authority and eliminated it from Regulation 1 effective May 1, 2000. We
are also proposing to remove from

the SIP Chapter 173-400 WAC provisions approved by the EPA on June 2,
1995 (60 FR 28726) that we are proposing to replace with the local
agency corollaries discussed above. These provisions are WAC 173-400-
010 (replaced by section 1.03), 173-400-091 (replaced by section 4.03),
and 173-400-100 (replaced by section 4.01).

D. Scope of Proposed Action

    This proposed revision to the SIP applies specifically to the YRCAA
jurisdiction as described in the SIP at 40 CFR 52.2470(c)--Table 10. As
discussed in our October 3, 2014 action approving the general
provisions of Chapter 173-400 WAC, local air agency jurisdiction in
Washington is generally defined on a geographic basis; however, there
are exceptions (79 FR 59653, at page 59654). By statute, YRCAA does not
have authority for sources under the jurisdiction of the EFSEC. See
Revised Code of Washington Chapter 80.50. Under the applicability
provisions of WAC 173-405-012, 173-410-012, and 173-415-012, YRCAA also
does not have jurisdiction for kraft pulp mills, sulfite pulping mills,
and primary aluminum plants. For these sources, Ecology retains
statewide, direct jurisdiction. Ecology and EFSEC also retain
statewide, direct jurisdiction for issuing Prevention of Significant
Deterioration (PSD) permits. Therefore, the EPA is not approving into
40 CFR 52.2470(c)--Table 10 those provisions of Chapter 173-400 WAC
related to the PSD program. Specifically, these provisions are WAC 173-
400-116 and WAC 173-400-700 through 173-400-750, which the EPA has
already approved as applying statewide under 40 CFR 52.2470(c)--Tables
2 and 3.
    As described in an April 29, 2015 final action approving revisions
to the Washington SIP, jurisdiction to implement the visibility
permitting program contained in WAC 173-400-117 varies depending on the
situation. Ecology retains authority to implement WAC 173-400-117 as it
relates to PSD permits (80 FR 23721). However, for facilities subject
to major nonattainment new source review (NSR) under the applicability
provisions of WAC 173-400-800, we are proposing that YRCAA would be
responsible for implementing those parts of WAC 173-400-117 as they
relate to major nonattainment NSR permits. See 80 FR 23726. The EPA is
also proposing to modify the visibility protection Federal
Implementation Plan contained in 40 CFR 52.2498 to reflect the approval
of WAC 173-400-117 as it applies to implementation of the major
nonattainment NSR program in YRCAA's jurisdiction.
    With respect to the nonattainment NSR permitting program for major
stationary sources, the EPA approved WAC 173-400-800 through 173-400-
860 for Ecology's direct permitting jurisdiction on November 7, 2014
(79 FR 59653), with minor revisions to reflect updated federal
citations on October 6, 2016 (81 FR 69385). In connection with our
November 7, 2014 approval, we reviewed WAC 173-400-800 through 173-400-
860 pursuant to the federal regulatory requirements in existence at
that time and discussed the fact that the EPA's 2008 PM2.5
New Source Review Rule (73 FR 28321, May 16, 2008) had been remanded to
the EPA by the U.S. Court of Appeals for the District of Columbia
Circuit. See 79 FR 43345, 43347 (July 25, 2014) (proposed action); 79
FR 59653 (final action). EPA's 2008 PM2.5 New Source Review
Rule has since been replaced by a revised implementation rule published
August 24, 2016, which imposed additional NSR requirements for
PM2.5 nonattainment areas (81 FR 58010). Because there are
no designated nonattainment areas within YRCAA's jurisdiction for any
criteria pollutant, including PM2.5, the EPA did not review
WAC 173-400-800 through 173-400-860 for consistency with the newly
revised PM2.5 implementation rule; nor does Ecology or YRCAA
have an obligation to submit rule revisions to address the 2016
PM2.5 implementation rule at this time. We also note that
the federal major nonattainment NSR requirements remain unchanged for
all other criteria pollutants since our review and approval of WAC 173-
400-800 through 173-400-860. We are therefore proposing to approve WAC
173-400-800 through 173-400-860 in YRCAA's jurisdiction as meeting the
current major nonattainment NSR requirements for all criteria
pollutants with respect to the current area designations and
classifications in the YRCAA jurisdiction. New nonattainment
designations trigger nonattainment NSR SIP revisions, among other area
planning requirements.
    Lastly, this SIP revision is not approved to apply on any Indian
reservation land in Washington or any other area where the EPA or an
Indian tribe has demonstrated that a tribe has jurisdiction.

V. Incorporation by Reference

    In this document, the EPA is proposing to include in a final rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the regulations shown in the tables in section IV.A.
Regulations to Approve and Incorporate by Reference into the SIP of
this document. The EPA is also proposing to remove from the
incorporation by reference the regulations discussed in section IV.C.
Regulations to Remove from the SIP of this document. The EPA has made,
and will continue to make, these documents generally available through
https://www.regulations.gov and at the EPA Region 10 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 Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely 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);
     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 the
requirements would be inconsistent with the Clean Air Act; and
     Does not provide the 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, this proposed action would not apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000). Consistent
with EPA policy, the EPA provided an opportunity to request
consultation to the Confederated Tribes and Bands of the Yakama Nation
in a letter dated April 5, 2021.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: December 1, 2021.
Michelle L. Pirzadeh,
Acting Regional Administrator, Region 10.
[FR Doc. 2021-26437 Filed 12-6-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78133-78134]
[FR Doc No: 2016-26842]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER15-1777-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Heartland Consumers Power District
Formula Rate Compliance Filing to be effective 10/1/2015.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5128.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER15-2131-003; ER12-2037-008; ER12-2314-006; ER15-
2129-002; ER15-2130-003.
    Applicants: Milo Wind Project, LLC, Roosevelt Wind Project, LLC,
Slate Creek Wind Project, LLC, Spearville 3, LLC, Spinning Spur Wind
LLC.
    Description: Notice of Non-Material Change in Status of the EDF-RE
MBR Affilliates in SPP BAA.
    Filed Date: 10/31/16.
    Accession Number: 20161031-5301.
    Comments Due: 5 p.m. ET 11/21/16.

    Docket Numbers: ER17-257-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 767 2nd Rev--NITSA with
Basin Electric Power Cooperative to be effective 1/1/2017.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5000.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-258-000.
    Applicants: NorthWestern Corporation.
    Description: Tariff Cancellation: Notice of Cancellation: SA 312
8th Rev, NITSA with Southern Montana to be effective 1/1/2017.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5001.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-259-000.
    Applicants: Darby Power, LLC.
    Description: Sec.  205(d) Rate Filing: Darby Power, LLC Reactive
Service Filing to be effective 12/31/9998.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5046.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-260-000.
    Applicants: Gavin Power, LLC.
    Description: Sec.  205(d) Rate Filing: Gavin Power, LLC Reactive
Service Filing to be effective 12/31/9998.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5048.

    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-261-000.
    Applicants: Lawrenceburg Power, LLC.
    Description: Sec.  205(d) Rate Filing: Lawrenceburg Power, LLC
Reactive Service Filing to be effective 12/31/9998.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5049.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-262-000.
    Applicants: Waterford Power, LLC.
    Description: Sec.  205(d) Rate Filing: Waterford Power, LLC
Reactive Service Filing to be effective 12/31/9998.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5050.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-263-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Queue Position NQ139,
Original Service Agreement No. 4573 to be effective 10/26/2016.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5082.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-264-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: AEP Formula Rate Revisions
to be effective 7/1/2017.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5083.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-265-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-11-01_ETEC Tex-La RTO
Adder Request to be effective 1/1/2017.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5087.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-266-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA SA No.
3318, Queue No. X3-075 re: Assignment to Marina Energy to be effective
6/4/2014.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5088.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-267-000.
    Applicants: Southwestern Public Service Company.
    Description: Sec.  205(d) Rate Filing: Tri-County Formula Rate to
be effective 1/1/2017.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5097.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-268-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC.
    Description: Baseline eTariff Filing: Modifications to Purchase and
Sale Agreement with Niagara Mohawk to be effective 11/1/2016.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5126.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-269-000.
    Applicants: Pennsylvania Electric Company.
    Description: Baseline eTariff Filing: Penelec Modifications to
Purchase and Sale Agreement with Niagara Mohawk to be effective 11/1/
2016.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5127.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-270-000.
    Applicants: Jersey Central Power & Light.
    Description: Baseline eTariff Filing: JCP&L Modifications to
Purchase and Sale Agreement with Niagara Mohawk to be effective 11/1/
2016.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5129.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-271-000.
    Applicants: DATC Path 15, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Appendix I 2017 to
be effective 1/1/2017.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5130.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-272-000.
    Applicants: Startrans IO, LLC.
    Description: Sec.  205(d) Rate Filing: TRBAA 2017 Update to be
effective 1/1/2017.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5134.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-273-000.
    Applicants: Midcontinent Independent System Operator, Inc., Entergy
Services, Inc.
    Description: Sec.  205(d) Rate Filing: 2016-11-01_Filing to update
Entergy Schedule 41 to be effective 1/1/2017.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5160.
    Comments Due: 5 p.m. ET 11/22/16.

    Docket Numbers: ER17-274-000.
    Applicants: GenOn Energy Management, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Tariff to be
effective 12/1/2016.
    Filed Date: 11/1/16.
    Accession Number: 20161101-5162.
    Comments Due: 5 p.m. ET 11/22/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 1, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-26842 Filed 11-4-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93941-93942]
[FR Doc No: 2016-30770]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2474]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Associated
With Designated New Animal Drugs for Minor Use and Minor Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
23, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0605.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed

collection of information to OMB for review and clearance.

Reporting Associated With Designated New Animal Drugs for Minor Use and
Minor Species; 21 CFR Part 516 OMB Control Number 0910-0605--Extension

    The Minor Use and Minor Species (MUMS) Animal Health Act of 2004
(Pub. L. 108-282) amended the Federal Food, Drug, and Cosmetic Act to
authorize FDA to establish new regulatory procedures intended to make
more medications legally available to veterinarians and animal owners
for the treatment of minor animal species as well as uncommon diseases
in major animal species. This legislation provides incentives designed
to help pharmaceutical companies overcome the financial burdens they
face in providing limited-demand animal drugs. These incentives are
only available to sponsors whose drugs are ``MUMS-designated'' by FDA.
Minor use drugs are drugs for use in major species (cattle, horses,
swine, chickens, turkeys, dogs, and cats) that are needed for diseases
that occur in only a small number of animals either because they occur
infrequently or in limited geographic areas. Minor species are all
animals other than the major species; for example, zoo animals,
ornamental fish, parrots, ferrets, and guinea pigs. Some animals of
agricultural importance are also minor species. These include animals
such as sheep, goats, catfish, and honeybees. Participation in the MUMS
program is completely optional for drug sponsors so the associated
reporting only applies to those sponsors who request and are
subsequently granted ``MUMS designation.''
    Our regulations in 21 CFR part 516 specify the criteria and
procedures for requesting MUMS designation as well as the annual
reporting requirements for MUMS designees. Section 516.20 (21 CFR
516.20) provides requirements on the content and format of a request
for MUMS-drug designation; Sec.  516.26 provides requirements for
amending MUMS-drug designation; Sec.  516.27 provides for change in
sponsorship of MUMS-drug designation; Sec.  516.29 provides for
termination of MUMS-drug designation; Sec.  516.30 contains the
requirements for annual reports from sponsor(s) of MUMS-designated
drugs; and Sec.  516.36 sets forth consequences for insufficient
quantities of MUMS-designated drugs.
    Description of Respondents: The respondents to this information
collection are pharmaceutical companies that sponsor new animal drugs.
    In the Federal Register of August 22, 2016 (81 FR 56658), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
516.20; Content and format of                 15               5              75              16           1,200
 MUMS request...................
516.26; Requirements for                       3               1               3               2               6
 amending MUMS designation......
516.27; Change in sponsorship...               1               1               1               1               1
516.29; Termination of MUMS                    2               1               2               1               2
 designation....................
516.30; Requirements of annual                15               5              75               2             150
 reports........................
516.36; Insufficient quantities.               1               1               1               3               3
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,362
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this reporting requirement was derived in
our Office of Minor Use and Minor Species Animal Drug Development by
extrapolating the investigational new animal drug/new animal drug
application reporting requirements for similar actions by this same
segment of the regulated industry and from previous interactions with
the minor use/minor species community.

    Dated: December 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30770 Filed 12-21-16; 8:45 am]
 BILLING CODE 4164-01-P