[Federal Register: July 11, 2006 (Volume 71, Number 132)]
[Rules and Regulations]
[Page 38995-38997]
[DOCID:fr11jy06-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2006-0279; FRL-8192-1]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; VOC and NOX RACT Determinations for Eight Individual
Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is taking final action to approve revisions to the
Commonwealth of Pennsylvania State Implementation Plan (SIP). The
revisions were submitted by the Pennsylvania Department of
Environmental Protection (PADEP) to establish and require reasonably
available control technology (RACT) for eight major sources of volatile
organic compounds (VOC) and nitrogen oxides (NOX) pursuant
to the Commonwealth of Pennsylvania's (Pennsylvania's or the
Commonwealth's) SIP-approved generic RACT regulations. EPA is approving
these revisions in accordance with the Clean Air Act (CAA).

DATES: Effective Date: This final rule is effective on August 10, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2006-0279. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the electronic

docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or

in hard copy for public inspection during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
State submittal are available at the Pennsylvania Department of
Environmental Protection, Bureau of Air Quality, P.O. Box 8468, 400
Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Ellen Wentworth,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On April 27, 2006 (71 FR 24831), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed
approval of formal SIP revisions submitted by Pennsylvania on August 1,
1995, March 21, 1996, October 18, 1996, April 20, 1998, October 2,
1998, June 22, 1999, and February 4, 2003. These SIP revisions consist
of source-specific operating

permits issued by PADEP to establish and require RACT pursuant to the
Commonwealth's SIP-approved generic RACT regulations. The following
table identifies the sources and the individual operating permits (OPs)
which are the subject of this rulemaking.

                      Pennsylvania.--VOC and NOX RACT Determinations for Individual Sources
----------------------------------------------------------------------------------------------------------------
                                                   Operating permit (OP
         Source's name               County         No.) consent order      Source type       ``Major source''
                                                         (CO No.)                                pollutant
----------------------------------------------------------------------------------------------------------------
Pennsylvania Power & Light      Cumberland......  OP-21-2009...........  Combustion        VOC and NOX.
 Company--West Shore.                                                     Turbines.
Foster Wheeler Mt. Carmel, Inc  Northumberland..  OP-49-0002...........  Cogeneration      NOX.
                                                                          Facility.
Metropolitan Edison Company--   Northampton.....  OP-48-0006...........  Combustion        NOX.
 Portland.                                                                Turbines and
                                                                          Boilers.
Pennsylvania Power & Light      Lycoming........  OP-41-0004...........  Combustion        NOX.
 Company.                                                                 Turbine.
Pennsylvania Power & Light      Clinton.........  OP-18-0006...........  Combustion        NOX.
 Company.                                                                 Turbines.
Texas Eastern Transmission      Juniata County..  OP-34-2002...........  Compressor        NOX.
 Corporation.                                                             Station.
Pennsylvania Power & Light      Northampton.....  OP-48-0011...........  Combustion        VOC and NOX.
 Company.                                                                 Turbines and
                                                                          Diesel
                                                                          Generators.
Johnstown Corporation.........  Cambria.........  OP-11-000-034........  Steel Foundry...  VOC.
----------------------------------------------------------------------------------------------------------------

    An explanation of the CAA's RACT requirements as they apply to the
Commonwealth and EPA's rationale for approving these SIP revisions were
provided in the NPR and will not be restated here. No public comments
were received on the NPR.

II. Final Action

    EPA is approving the revisions to the Pennsylvania SIP submitted by
PADEP on August 1, 1995, March 21, 1996, October 18, 1996, April 20,
1998, October 2, 1998, June 22, 1999, and February 4, 2003, to
establish and require VOC and NOX RACT for eight sources
pursuant to the Commonwealth's SIP-approved generic RACT regulations.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it 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). This rule also does not
have tribal implications because it will not have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action also does not have Federalism implications because it does
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This action merely approves a state rule implementing a Federal
standard, and does not alter the relationship or the distribution of
power and responsibilities established in the Clean Air Act. This rule
also is not subject to Executive Order 13045 ``Protection of Children
from Environmental Health Risks and Safety Risks'' (62 FR 19885, April
23, 1997), because it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 804 exempts from section 801 the following types
of rules: (1) Rules of particular applicability; (2) rules relating to
agency management or personnel; and (3) rules of agency organization,
procedure, or practice that do not substantially affect the rights or
obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required
to submit a rule report regarding today's action under section 801
because this is a rule of particular applicability establishing source-
specific requirements for eight named sources.

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the

appropriate circuit by September 11, 2006. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
    This action, approving source-specific RACT requirements for eight
sources in the Commonwealth of Pennsylvania, may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: June 22, 2006.
William T. Wisniewski,
Acting Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart NN--Pennsylvania

0
2. In Section 52.2020, the table in paragraph (d)(1) is amended by
adding the entries for Pennsylvania Power & Light Company-West Shore;
Foster Wheeler Mt. Carmel, Inc.; Metropolitan Edison Company--Portland;
Pennsylvania Power & Light Company--Williamsport; Pennsylvania Power &
Light Company--Bald Eagle; Texas Eastern Transmission Corporation;
Pennsylvania Power & Light Company--Martins Creek; and Johnstown
Corporation, at the end of the table to read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (d) * * *
    (1) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                State
           Name of source                     Permit No.                  County           effective     EPA approval date      Additional explanation/
                                                                                date                              Sec.   52.2063 citation
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Pennsylvania Power & Light Company-- OP-21-2009.................  Cumberland............       6/7/95  7/11/06 [Insert page   52.2020(d)(1)(r).
 West Shore.                                                                                number where the
                                                                                document begins].
Foster Wheeler Mt. Carmel, Inc.....  OP-49-0002.................  Northumberland........      6/30/95  7/11/06 [Insert page   52.2020(d)(1)(r).
                                                                                number where the
                                                                                document begins].
Metropolitan Edison Company--        OP-48-0006.................  Northampton...........     12/14/94  7/11/06 [Insert page   52.2020(d)(1)(r).
 Portland.                                                                                number where the
                                                                                document begins].
Pennsylvania Power & Light Company.  OP-41-0004.................  Lycoming..............      6/13/95  7/11/06 [Insert page   52.2020(d)(1)(r).
                                                                                number where the
                                                                                document begins].
Pennsylvania Power & Light Company.  OP-18-0006.................  Clinton...............  ...........  7/11/06 [Insert page   52.2020(d)(1)(r).
                                                                                number where the
                                                                                document begins].
Texas Eastern Transmission           OP-34-2002.................  Juniata...............      1/31/97  7/11/06 [Insert page   52.2020(d)(1)(r).
 Corporation.                                                                                number where the
                                                                                document begins].
Pennsylvania Power & Light Company.  OP-48-0011.................  Northampton...........     12/14/94  7/11/06 [Insert page   52.2020(d)(1)(r).
                                                                                number where the
                                                                                document begins].
Johnstown Corporation..............  OP-11-000-034..............  Cambria...............      6/23/95  7/11/06 [Insert page   52.2020(d)(1)(r).
                                                                                number where the
                                                                                document begins.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 06-6086 Filed 7-10-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Rules and Regulations]
[Pages 2991-2993]
[FR Doc No: 2016-00656]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2014-0475; FRL-9941-36-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Allegheny County's Adoption of Control Techniques
Guidelines for Four Industry Categories for Control of Volatile Organic
Compound Emissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is converting a
conditional approval of a state implementation plan (SIP) revision
submitted by the Commonwealth of Pennsylvania on behalf of the
Allegheny County Health Department (ACHD) to a full approval. This SIP
revision includes amendments to the ACHD Rules and Regulations, Article
XXI, Air Pollution Control, and meets the requirement to adopt
reasonably available control technology (RACT) for sources covered by
EPA's control techniques guidelines (CTG) for the following categories:
miscellaneous metal and/or plastic parts surface coating processes;
automobile and light-duty truck assembly coatings; miscellaneous
industrial adhesives; and fiberglass boat manufacturing materials. Upon
review of the submittal, EPA found that the average monomer volatile
organic compound (VOC) content limits were referenced but not included
in the regulation for fiberglass boat manufacturing materials. ACHD has
revised the regulation and submitted the table of VOC content limits
for fiberglass boat manufacturing materials to EPA in order to address
specific RACT requirements for Allegheny County. Therefore, EPA is
converting the conditional approval of the revisions to the
Pennsylvania SIP to a full approval in accordance with the requirements
of the Clean Air Act (CAA).

DATES: This final rule is effective on February 19, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2014-0475. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through www.regulations.gov or may be viewed during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the state submittal are available at the
Allegheny County Health Department, Bureau of Environmental Quality,
Division of Air Quality, 301 39th Street, Pittsburgh, Pennsylvania
15201 and at the Pennsylvania Department of Environmental Protection,
Bureau of Air Quality Control, P.O. Box 8468, 400 Market Street,
Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Irene Shandruk,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 172(c)(1) of the CAA provides that SIPs for nonattainment
areas must include reasonably available control measures (RACM),
including RACT, for sources of emissions. Section 182(b)(2)(A) provides
that for certain nonattainment areas, states must revise their SIP to
include RACT for sources of VOC emissions covered by a CTG document
issued after November 15, 1990 and prior to the area's date of
attainment. In 2008, EPA developed new CTGs for miscellaneous metal and
plastic parts coatings, automobile and light-duty assembly coatings,
miscellaneous industrial adhesives, and fiberglass boat manufacturing
materials.

II. Summary of SIP Revision

    On November 15, 2013, the Pennsylvania Department of Environmental
Protection (PADEP) submitted to EPA on behalf of ACHD a SIP revision
concerning the adoption of the EPA CTGs for miscellaneous metal and/or
plastic parts surface coating processes, automobile and light-duty
truck assembly coatings, miscellaneous industrial adhesives, and
fiberglass boat manufacturing materials in Allegheny County. These ACHD
regulations, with a state effective date of June 8, 2013, are contained
in the ACHD Rules and Regulations, Article XXI, Air Pollution Control
sections 2105.83 (Control of VOC Emissions from Miscellaneous Metal
and/or Plastic Parts Surface Coating Processes), 2105.84 (Control of
VOC Emissions from Automobile and Light-Duty Truck Assembly Coatings),
2105.85 (Control of VOC Emissions from Miscellaneous Industrial
Adhesives),

and 2105.86 (Control of VOC Emissions from Fiberglass Boat
Manufacturing Materials) in order to establish: (1) Applicability for
miscellaneous metal and/or plastic parts surface coating processes,
automobile and light-duty truck assembly coatings, miscellaneous
industrial adhesives, and fiberglass boat manufacturing materials; (2)
exemptions; (3) record-keeping and work practice requirements; and (4)
emission limitations. Upon review of the November 15, 2013 submittal,
EPA found that the table of average monomer VOC content limits for
fiberglass boat manufacturing materials was referenced; however, the
table was erroneously not included in the regulation. Pursuant to
section 110(k)(4) of the CAA, PADEP submitted on behalf of ACHD a
letter dated July 16, 2014 committing to submit a SIP revision to EPA
addressing this error.
    On March 26, 2013 (78 FR 18241), EPA conditionally approved the SIP
revision concerning the adoption of these CTGs. On September 9, 2015,
PADEP submitted to EPA on behalf of ACHD a supplemental SIP revision
containing the regulation with the missing table of average monomer VOC
content limits, and thereby addressed its July 16, 2014 commitment. On
November 10, 2015, EPA published a notice of proposed rulemaking
converting the conditional approval to a full approval. 80 FR 69627.
Other specific requirements and the rationale for EPA's proposed
rulemaking action are explained in the NPR and will not be restated
here. No public comments were received on the NPR.

III. Final Action

    In this rulemaking action, EPA is converting to a full approval the
conditional approval of the Commonwealth of Pennsylvania SIP revision
submitted on November 15, 2013, as supplemented with the September 9,
2015 SIP submittal, which consists of amendments to the ACHD Rules and
Regulations, Article XXI, Air Pollution Control for adopting RACT for
sources covered by EPA's CTG standards for the following categories;
miscellaneous metal and/or plastic parts surface coating processes,
automobile and light-duty truck assembly coatings, miscellaneous
industrial adhesives, and fiberglass boat manufacturing materials.
Pursuant to section 110(k)(4) of the CAA, the conditional approval was
based upon a letter from PADEP on behalf of ACHD dated July 16, 2014
committing to submit to EPA an additional SIP revision to address the
deficiency in the regulation for fiberglass boat manufacturing
materials. On September 9, 2015, PADEP on behalf of ACHD, submitted a
supplemental SIP revision containing the table of monomer VOC content
limits for fiberglass boat manufacturing materials. EPA has determined
that ACHD has satisfied this condition. Therefore, EPA is removing the
conditional nature of its approval and replacing it with a full
approval of Allegheny County's adoption of CTGs for miscellaneous metal
and/or plastic parts surface coating processes, automobile and light-
duty truck assembly coatings, miscellaneous industrial adhesives, and
fiberglass boat manufacturing materials.

IV. Incorporation by Reference

    In this rulemaking, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference the ACHD
regulations regarding control of VOC emissions discussed in section II
of this preamble. EPA has made, and will continue to make, these
documents generally available through www.regulations.gov and/or may be
viewed at the EPA Region III office (see the ADDRESSES section of this
preamble for more information).

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely conditionally approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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 CAA; 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, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 21, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it

extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
    This action pertaining to ACHD's adoption of CTG standards for
miscellaneous metal and/or plastic parts surface coating processes,
automobile and light-duty truck assembly coatings, miscellaneous
industrial adhesives, and fiberglass boat manufacturing materials may
not be challenged later in proceedings to enforce its requirements.
(See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

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

    Dated: December 30, 2015.
Shawn M. Garvin,
Regional Administrator, Region III.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (c)(2) is amended by
revising the entries for ``2105.83,'' ``2105.84,'' ``2105.85,'' and
``2105.86'' under part E, subpart 7. The revisions read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (c) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                                                                Additional
    Article XX or XXI citation        Title/subject          State       EPA approval date     explanation/Sec.
                                                        effective date                         52.2063 citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
                                 Part E--Source Emission and Operating Standards

                                                  * * * * * * *
                                      Subpart 7--Miscellaneous VOC Sources

                                                  * * * * * * *
2105.83..........................  Control of VOC               6/8/13  1/20/16 [Insert      New regulation.
                                    Emissions from                       Federal Register
                                    Miscellaneous                        Citation].
                                    Metal and/or
                                    Plastic Parts
                                    Surface Coating
                                    Processes.
2105.84..........................  Control of VOC               6/8/13  1/20/16  [Insert     New regulation.
                                    Emissions from                       Federal Register
                                    Automobile and                       Citation].
                                    Light-Duty Truck
                                    Assembly Coatings.
2105.85..........................  Control of VOC               6/8/13  1/20/16  [Insert     New regulation.
                                    Emissions from                       Federal Register
                                    Miscellaneous                        Citation].
                                    Industrial
                                    Adhesives.
2105.86..........................  Control of VOC              6/19/15  1/20/16  [Insert     New regulation.
                                    Emissions from                       Federal Register
                                    Fiberglass Boat                      Citation].
                                    Manufacturing
                                    Materials.

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

* * * * *

Sec.  52.2023  [Amended]

0
3. Section 52.2023 is amended by removing paragraph (m).

[FR Doc. 2016-00656 Filed 1-19-16; 8:45 am]
 BILLING CODE 6560-50-P


MEMORANDUM

DATE:		November 24, 2014

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Gavin Lau, EPA Region 2/CASD-APB

SUBJECT:	November 11, 2014 Meeting Regarding Proposed Clean Power Plan for Existing Power Plants  --------------------------------------------------------------------------------

SUMMARY

      A meeting was held between EPA and organization listed below on November 11, 2014 to discuss the proposed Clean Power Plan for Existing Power Plants.  The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.        ATTENDEES

Neighbors Allied for Good Growth (NAGG)  -  Covering Greenpoint and Williamsburg neighborhoods in Brooklyn, NY


                           ICR SUPPORTING STATEMENT                         ENVIRONMENTAL PROTECTION AGENCY

1. Identification of Information Collection    	1(a) Title of Information Collection    Contractor Cumulative Claim and Reconciliation (Renewal), EPA ICR No. 0246.12, OMB Control No. 2030-0016.      	1(b) Short Characterization     	The Federal Acquisition Regulation (FAR) 4.804-5 states that the office administering a contract is responsible for initiating administrative close out following physical completion of the contract. Funds status review is a mandatory part of contract closeout. It includes settlement of interim or disallowed costs and settlement of indirect cost rates.    	  	After a contract completion under a cost reimbursement type contract, the contractor submits EPA Form 1900-10 which summarizes all cost incurred in performance of the contract and sets forth the final indirect rates. This form is reviewed by the contracting office to determine the final costs reimbursable to the contractor. A copy of the form is attached to this request.      2. 	Need and Use of the Collection    	2(a) Need/Authority for the Collection    	FAR 52.216-7 states that the Government will pay only the costs determined to be                                                                allowable by the contracting officer in accordance with FAR 31.2. Furthermore, FAR 52.216-7 states that indirect cost rates shall be established for each fiscal year at the close of a contractor's fiscal year. EPA Form 1900-10 summarizes this information for the entire contract period and provides a basis for cost review by contracting, finance, and audit personnel. As stated previously, FAR 4.804-5 mandates that the office administering the contract shall ensure that the costs and indirect cost rates are settled.      	2(b) Practical Utility/Users of the Data    	Information collected on the 1900-10 will be used by the contracting, financial, and audit personnel to determine the final amount of costs reimbursable to the contractor. EPA personnel and auditors from the Defense Contract Audit Agency (DCAA), if requested, will review the information in order to determine the final contract costs prior to final payment under the contract.

3. Non-Duplication, Consultations, and Other Collection Criteria                3(a)	Non-Duplication          Information collected is contract-specific. Cumulative contract cost information, as requested, is not available from any other source.                3(b)	Public Notice Required Prior to ICR Submission to OMB          	The Federal Register document required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published on 02/06/2015 (80 FR 6702).                3(c)	Consultations

The following vendors were contacted to discuss collection activities:

Firm Person Contacted Phone Great Lakes Environmental Center Ms. Linda Hays 231-941-2230 Environmental Mgt Support Mr. Thomas Heim 301-589-5318 ext.15 Battelle Memorial Institute Ms. Gina Crabtree 614-424-5097 Cadmus Group, Inc. Mr. Alan Seferian 617-673-7000                 Each firm indicated the financial information requested is kept routinely for company records and for audit purposes. Two of the firms contacted felt the information collection was burdensome as one indicated that the form was redundant to others previously submitted and the other indicated that their costs are tracked by period of performance rather than fiscal year.

	3(d)	Effects of Less Frequent Collection    	The information is collected only once at contract closeout. This information is required by the Federal Acquisition Regulation to be collected at that time.

	3(e)	General Guidelines

      These reporting or recordkeeping requirements do not violate any of the regulations promulgated by OMB under 5 CFR Part 1320, Section 1320.5.

	3(f)	Confidentiality/Sensitive Questions

       Information collected under this request, particularly cost and pricing data, is treated as CBI. This information is protected from public release in accordance with the Agency's confidentially regulation, 40 C.F.R. Part 2.201 et seq.          4.	The Respondents and the Information Requested    	4(a)	Respondents/SIC Codes    	All contractors who have completed an EPA cost reimbursement type contract will be required to submit EPA Form 1900-10. These contractors represent a wide range of industries which include, but are not limited to: 541511, Custom Computer Programming, 5416 Management and Consulting Services, 6215 Medical Laboratories, and 541380, Testing Laboratories.    	4(b) 	Information Requested    A copy of the reporting form is attached as Attachment A.   	        (i) 	Data Items    	Data requested in EPA Form 1900-10 (attached) has not changed since the last OMB review. This information includes major cost elements such as direct labor, direct material and supplies, equipment, travel, subcontract costs, consultant fees, indirect costs and fixed fees.  Indirect costs are broken down showing base year and rate for each cost center for each year of contract performance.            Please note that EPA has omitted the expiration date from form 1900-10. As stipulated in 5 CFR 1320.8(b)(1), the collection of information should display a currently valid OMB Control Number and, if appropriate, an expiration date. Due to the fact that this form has been in use for a number of years without change, and since the collection activity and use of the form continue to be required, it is not appropriate to include the expiration date on the form.    		(ii) 	Respondent Activities    	In order to complete the EPA Form 1900-10, respondents must total all costs incurred under the contract, including costs for direct labor, all equipment, materials and supplies, travel, subcontracts, consulting fees, indirect costs, and fees. During contract performance, this information is included on the contractor's monthly invoice for reimbursement. To calculate total contract costs, the contractor adds the cost from each invoice submitted under the contract. If costs were claimed on an invoice that was disallowed, the contractor would subtract the disallowed amount from the total.      	Negotiated indirect cost rates are applied to the base costs in order to determine the indirect costs for each cost center. This information is also contained in the contractor's invoices, and in correspondence concerning allowable costs and negotiated agreements on indirect rates. None of the information collected under this ICR must be created or researched. Rather, the data is compiled from various existing sources and summarized for this information collection. After the data is compiled, it must be reviewed for accuracy against existing records. It is customary business practice for a contractor to maintain the type of financial performance information required to complete EPA Form 1900-10.       5.	 The Information Collected  -  Agency Activities, Collection Methodology, and Information Management    	5(a) 	Agency Activities     	Once EPA Form 1900-10 is reviewed by the Agency, the data is reconciled with Agency records, and audited. If the information collected is correct, final contract payment is made.     	5(b) 	Collection Methodology and Management    	Information submitted is checked against Agency records such as invoices, correspondence, and negotiated agreements. Respondents have the option of reporting in their own computerized format provided all the required data is present. Completed forms, after review, become part of the contract files and will not be disclosed outside the Government.      	5(c)	 Small Entity Flexibility    	Data requested is required by the Federal Acquisition Regulation. It is not possible to develop separate or simplified requirements for small businesses or other small entities because the information required is necessary to complete the closing out of a contract, an alternate collection of information for small businesses is not appropriate.           5(d)	Collection Schedule    	Data is collected once at contract completion. Generally, this is after a five year period of performance.    6. 	Estimating the Burden and Cost of the Collection      		6(a) 	Estimating Respondent Burden Hours     Respondent burden hours are estimated at 6.3 hours per respondent. For the 5 respondents, total annual burden hours are estimated at 31.5.     5 Respondents x 6.3 hours per respondent = 31.5 Total Annual Burden Hours    		6(b)	Estimating the Respondent Burden Costs  			  Respondent burden costs are estimated at $688.13 per respondent. For the 5 respondents, total annual labor cost is estimated at $3,440.65.     5 Respondents x 688.13 labor cost per respondent = $3,440.65 Total Annual Labor Cost    		(i)   Estimating Labor Costs    The annual labor cost to all respondents is estimated at $3,440.65 based on the following calculations. Contractors may claim the cost of completing this form under the appropriate contract.        ACTIVITY                    TIME TO COMPLETE	         AVG RATE/HR    	     COST  1. Gather information		       105.0 minutes		    $119.18	           $208.56  2. Compile data	  	       135.0 minutes		    $119.18	           $268.15  3. Review data	  		         82.5 minutes		    $119.18	           $163.87  4. Complete form	  60.0 minutes	$47.55  	                $  47.55                Total	382.5 minutes		                  $688.13  Step 1 thru 3 of the collection activity is normally performed by an Administrative Manager. Administrative support personnel are responsible for completing step 4.     	The cost associated with this effort was estimated using a loaded hourly rate based upon the National Compensation Survey: Occupational Wages in the United States, 2013; published by the U.S. Department of Labor, Bureau of Labor Statistics. This data was published in the National Compensation Survey: Occupational Wages in the United States, 2013 in May of 2013, and represents the most current survey data available (http://www.bls.gov/cpi/ ).    	Since the labor rates used in this estimate are from 2013, a Consumer Price Index (CPI) escalation factor of 2.1% (based upon the CPI from May 2013 to May 2014) was applied for each year to determine an average wage for 2014. The escalated hourly labor rate is multiplied by an estimated loading factor of 2.95 (*see below) to reflect industries' overhead, fringe benefits, and general and administrative costs.      The following are the loaded labor rates used in the calculations in the table above:    Administrative Manager:  2013 = $39.57  2014 = ($39.57 x 1.021) = $40.40 x 2.95 = $119.18    Administrative Support:  2013 = $15.79  2014 = ($15.79 x 1.021) = $16.12 x 2.95 = $47.55    * 2.95 is a factor recommended by EPA cost analyst as representative of labor related burdens experienced by EPA contractors.    	The cost for each labor category was determined by first dividing the hourly labor rate by 60 minutes to obtain the per minute rate. Then, the per minute rate is multiplied by the minutes to complete each activity to obtain the cost.       	EPA processed approximately 5 contract closeouts in the previous year using EPA Form 1900-10. As indicated above, each form takes 382.5 minutes, or about 6.3 hours to complete. The 5 yearly actions, multiplied by the cost to process one action, $688.13, are used to determine the above annual cost burden to the respondents. The 5 yearly actions, multiplied by 6.3 hours equates to an annual hourly burden of 31.5 hours. The amount of time required to complete each of the tasks involved is based on consultations with contractors, contractor consultation with their subcontractors and Agency experience. Also respondents have pointed out that the complexity of the contract to be closed out and the timeliness of consulted subcontractors increases the amount of time needed to gather the required information. Most firms keep all of their financial data required for completion of this form in a computer database.            			(ii)   Estimating Capital and Operations and Maintenance Costs    	Operating and Maintenance Costs, which include such items as file storage, photocopying, and postage, are minimal for this effort, and are estimated at $12.00 per action for a total annual burden of $60.00 (5 yearly actions x $12.00).    5 Annual Respondents x $12.00 O&M = $60.00 Annual O&M Costs    			(iii)   Capital/Start-up Operating and Maintenance (O&M) Costs    	Because it will not be necessary for respondents to acquire any capital goods to provide the requested information, EPA included no capital or start-up costs in the burden estimate.    	    		6(c)	Estimating Agency Burden and Cost    	Annual agency burden is estimated at $132.25. This takes 30 minutes per response at $52.90 an hour for a cost of $26.45 per respondent.    Once the Agency receives the information, it is reviewed by the employee conducting contract close-out. Annual Agency burden is estimated at $132.25 calculated as follows:      ACTIVITY	TIME REQUIRED	RATE	COST    1. Review data against	30 minutes	$52.90	$26.45      Agency records    5 Yearly Actions x $26.45 cost = $132.25    	Generally, the individual closing out the contract is a GS-12 grade level. The wage rate was calculated by taking the GS-12 median hourly rate ($33.06) and multiplying it by a factor of 1.6 to account for benefits ($52.90). The cost per action was determined by first dividing the hourly labor rate by 60 minutes to obtain the per minute rate. Then the per minute rate is multiplied by the minutes to complete the review of one action to obtain the cost. As described above, 5 yearly actions were multiplied by the cost, $26.45, to review an action in order to calculate the Agency burden.    		6(d)	Estimating the Respondent Universe and Total Burden Costs    	EPA estimates that it will process approximately 5 respondent forms per year during the next three years for a total of 15 respondent forms. The average annual respondent burden and cost over the next three years is estimated to be 31.875 labor hours multiplied by 3 years (for estimated 15 respondents total) for a total of 95.625 respondent burden hours.    		6(e)	Bottom Line Burden Hours and Cost Tables  			  			(i)   Respondent Tally    		The average annual respondent burden for one year is estimated to be 31.875 labor hours  (for estimated 5 respondents total) with a labor cost of $3440.65.      Respondents  Hours  Labor Cost   O&M Cost  Total Cost  Annual  5  31.875  $3,440.65  $60  $3,500.65  3 Years  15  95.625  $10,321.95  $180  $10,501.95      			(ii)   The Agency Tally  	  	Annual agency cost is estimated at $132.25.   		    Agency Actions  Hours  Cost per Action  Total Cost  Annual  5  2.5  $26.45  $132.25  3 Years  15  7.5  $26.45  $396.75      		6(f)	Reasons for Change in Burden   	There is a decrease of 48 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This is due to the decreased number of contracts closed in the past period. However, there has been an increase of individual respondent burden hours of 2.375 hours (142.5 minutes per response). The increase in the burden from the previous approval is based on the respondents' increased time needed per action due is likely due to the complexity of some of the contracts to be closed out and the timeliness of consulted subcontractors; which results in more information to be compiled and reviewed, as well as increases the amount of time needed to gather the required information.   		  		6(g)	Burden Statement   	The annual public reporting and recordkeeping burden for this collection of information is estimated to average 6 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

 	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OARM-2011-0997, which is available for online viewing at www.regulations.gov, or in person viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the OEI Docket is<PHONE_NUMBER>. An electronic version of the public docket is available at www.regulations.gov.  This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OARM-2011-0997 and OMB Control Number 2030-0016 in any correspondence.   EPA Form 1900-10 (Rev. 3-06) Previous Edition is Obsolete            EPA   United States Environmental Protection Agency     Contractor's Cumulative Claim and Reconciliation              OMB No. 2030 - 0016 1. Contractor's Address (include zip code) 2. Contract No. 3. Total amounts claimed under this contract (less disallowances concurred by the contractor and disallowances not subject to appeal) and approved on Public Vouchers Nos.	to	(including completion vouchers).                         Item                                                                          Amount Direct Labor  $ Direct Material and Supplies  $ Equipment  $ Travel  $ Subcontract Costs  $ Other Direct Costs  $ Consultant Fees  $ Fixed Fee  $ Indirect Costs (Total From Section 4)  $ Total Amount Claimed  $ 4. Reconciliation of Indirect Costs Claimed.  Record the amount of indirect costs calculated, for each cost center, using negotiated final indirect cost rate(s).  Use provisional rate(s) if final rates are not negotiated for any fiscal year period(s).  Use the reverse side of this form, if necessary, to display all years and cost centers.           Cost Center   Cost Center    Cost Center     Cost Center                                                                     Cost Center FY -

Base

Rate

Indirect Costs

FY -

Base

Rate

Indirect Costs

FY -

Base

Rate

Indirect Costs

Totals

No monies or other benefits may be paid unless this report is completed and filed as required in the EPA billing instructions.   I certify that the information provided on this form and attachments thereto are accurate and complete.  I acknowledge that any knowingly false or misleading information may be punishable by fine and/or imprisonment under applicable law. Name and Title (Print or Type) Signature Date

Paperwork Reduction Act Notice       Public reporting burden for this collection of information is estimated to average 40 minutes per response, including the time for searching existing data sources, gathering and maintaining data, and completing and reviewing data.  Send comments regarding this burden estimate or any other aspect of this collection of information (including suggestions for reducing this burden) to:                                           (1)   Manager, Policy and Oversight Service Center (mail code 3802R)                                  U.S. Environmental Protection Agency                                  1200 Pennsylvania Avenue, NW                                  Washington, DC 20460; and

                  (2) Paperwork Reduction Project (OMB No. 2030-0016)                      Office of Information and Regulatory Affairs                      Office of Management and Budget                      Washington, DC 20503.

                     (2) Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, D.C.  200503.

                                  Cost Center    Cost Center                                   Cost Center                                   Cost Center                                   Cost Center FY

Base

Rate

Indirect Costs

FY -                                          Base

Rate

Indirect Costs

FY -

Base

Rate

Indirect Costs

FY -

Base

Rate

Indirect Costs

FY -

Base

Rate

Indirect Costs

      Totals                                       No monies or other benefits may be paid unless this report is completed and filed as required in the EPA billing instructions.


[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8724-8726]
[FR Doc No: 2016-03551]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2346]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BREO ELLIPTA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BREO ELLIPTA and is publishing this notice
of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic

or written comments and ask for a redetermination by April 22, 2016.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by August 22, 2016. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-E-2346 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; BREO ELLIPTA.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product BREO ELLIPTA
(vilanterol trifenate; fluticasone furoate). BREO ELLIPTA is indicated
for long-term, once-daily maintenance treatment of airflow obstruction
and for reducing exacerbations in patients with chronic obstructive
pulmonary disease. Subsequent to this approval, the USPTO received a
patent term restoration application for BREO ELLIPTA (U.S. Patent No.
7,439,393) from Glaxo Group Limited, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated March 19, 2015, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of BREO ELLIPTA represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
BREO ELLIPTA is 1,980 days. Of this time, 1,677 days occurred during
the testing phase of the regulatory review period, while 303 days
occurred during the approval phase. These periods of

time were derived from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: December 10, 2007. The applicant claims June 26, 2008, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was December 10, 2007, which was 30 days after FDA receipt of the first
IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: July 12,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for BREO ELLIPTA (NDA 204275) was initially submitted
on July 12, 2012.
    3. The date the application was approved: May 10, 2013. FDA has
verified the applicant's claim that NDA 204275 was approved on May 10,
2013.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 981 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03551 Filed 2-19-16; 8:45 am]
 BILLING CODE 4164-01-P


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Acetochlor

Multi-residue Method of Acetochlor Detection

Multi-residue Method of Acetochlor Detection

TECHNICAL SUMMARY REPORT

EPA METHOD 505:  VALIDATION FOR DETERMINATION OF ACETOCHLOR

Summary

EPA method 505, Analysis of Organohalide Pesticides and Commercial Polychlorinated  Biphenyl (PCB) Products in Water by Microextraction and Gas Chromatography, has been  applied to the analysis of acetochlor in distilled, tap and ground water.

Using the exact procedures described in EPA method 505, with final analysis performed  using the primary GC column (DB-1 equivalent, 30m x 0.32mm id, 1.0µm film) with  electron capture detection, acetochlor was quantitatively recovered from all three water  types to levels of between 0.2 and 1.0 µg litre-1, depending on the  temperature programme used for gas chromatographic analysis.

Recoveries from all types of water ranged from 73-125% with an overall mean recovery  of 98% and a cv of 12% (n = 36).  In all cases laboratory reagent blanks and control  samples were free from interferences at the retention time of acetochlor.

Using the above conditions, baseline separation was observed between acetochlor and  other closely related acetanilides alachlor and metolachlor.

Experimental Details

Sample Extraction

For all water types 35 ml of water was measured into precleaned 40 ml screw capped  glass vials.  Samples were fortified with acetochlor at levels between 0.5 and 5.0  µg litre-1 by addition of a standard solution in methanol via a glass  syringe.  Sodium chloride (6g) was added to each sample and the vials were shaken until  the sodium chloride dissolved.  Hexane (2mL) was added to each sample and the vials were  shaken vigorously for approximately 1 minute.  Samples were centrifuged at 2000 rpm for 2  minutes to aid separation.  The upper hexane layers were transferred to an autosampler  vial for analysis by GC/ECD.

GC Analysis

Instrument
Varian 3400 GC fitted with an electron capture detector.

Autosampler	Varian 8000.

Column
Rtx1 (DB-1 equivalent) 30m x 0.32mm id x 1.0µm df

Injection volume	1µL

Two temperature programmes were used.  Programme 1 is exactly as described in EPA  method 505.  Programme 2 was developed in-house in order to improve chromatography and to  optimize sensitivity.

Temp. Programme 1: 180°C (1 min) => 260°C @ 4°C min-1 => hold for 10  mins.   Acetochlor retention time = 16.5 minutes

Temp. Programme 2: 50°C (1 min) => 250°C @ 40°C min-1 => hold for 10  mins.  Acetochlor retention time = 8.1 minutes

Prior to analysis of the recovery samples a mixed standard solution of acetochlor and  two similar acetanilide herbicides, alachlor and metolachlor, were injected in order to  assess the resolution of these compounds from one another under the stated conditions  using both temperature programmes.

Results were assessed in terms of recovery value, cv of recovery values and resolution  of acetochlor from two similar acetanilide herbicides alachlor and metolachlor.

Experimental Results

Recovery Data

Results obtained from the analysis of acetochlor in distilled, tap and ground water  are detailed in Table 1.

Table 1 :  Recovery Data From the Analysis of Acetochlor in Distilled, Tap and  Ground Water

MATRIX
LEVEL
(µg litre-1)
RECOVERY (%)

Temperature
Programme 1
Temperature
Programme 2

DISTILLED WATER
5.0	85, 89	88

1.0	100

0.5	91, 107

0.2	96, 93

TAP WATER
5.0	106, 105	82

1.0	91	80

0.5	108, 103, 111

0.2	 119, 101

GROUND WATER
5.0	91, 110, 99	106, 73

1.0	86, 125	106, 109, 87, 89, 86, 80

0.5	106, 114

0.2	92, 100, 97

n = 36
cv = 12%
mean = 98%

Resolution

Both temperature programmes were found to give baseline resolution between acetochlor  and the two other acetanilides of similar structure, alachlor and metolachlor.

Minimum Detectable Level (MDL)

The MDL of the method was defined as the sample concentration which gave an instrumental response equivalent to 5x background noise.  Using temperature programme 1,  the MDL for acetochlor was approximately 1.0 µg litre-1. Using programme  2 the MDL was approximately 0.2 µg litre-1.

Conclusions

Using the procedures described in EPA method 505 acetochlor can be quantitatively,  accurately and precisely recovered from distilled, tap and ground water to levels of  between 0.2 - 1.0 µg litre -1, depending on the GC temperature programme  used.  The method has been shown to provide adequate separation of acetochlor from other  similar acetanilides, and is therefore suitable for use as a multi-residue method for the  analysis of acetochlor and other organohalide pesticides in water.

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