[Federal Register Volume 82, Number 154 (Friday, August 11, 2017)]
[Notices]
[Pages 37581-37582]
[FR Doc No: 2017-16958]

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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: ER13-1966-001.
    Applicants: NRG Wholesale Generation LP.
    Description: Compliance filing: Informational Filing Regarding
Planned Transfer to be effective N/A.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5112.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER15-2572-004.
    Applicants: GenOn Energy Management, LLC.
    Description: Compliance filing: Informational Filing Regarding
Planned Transfer to be effective N/A.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5108.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER15-2573-004.
    Applicants: GenOn Energy Management, LLC.
    Description: Compliance filing: Informational Filing Regarding
Planned Transfer to be effective N/A.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5109.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER16-209-004.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Central Power Electric Cooperative
Formula Rate Compliance Filing to be effective 1/1/2016.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5144.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER16-1774-003.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Western Farmers Electric
Cooperative Formula Rate Compliance Filing to be effective 7/1/2016.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5152.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER16-2665-003.
    Applicants: NRG Power Midwest LP.
    Description: Compliance filing: Informational Filing Regarding
Planned Transfer to be effective N/A.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5111.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-274-002.
    Applicants: GenOn Energy Management, LLC.
    Description: Compliance filing: Informational Filing Regarding
Planned Transfer to be effective N/A.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5110.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-1342-001.
    Applicants: Duke Energy Florida, LLC, Duke Energy Carolinas, LLC.
    Description: Compliance filing: Correct Loss Factor Tariff Records
to be effective 5/1/2017.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5077.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-2250-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-08-07_SA 2523 ITC-
Pheasant Run 4th Revised GIA (J075 J466) to be effective 7/24/2017.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5078.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-2251-000.
    Applicants: GenOn Energy Management, LLC.
    Description: Sec.  205(d) Rate Filing: Rate Schedule FERC No. 1 to
be effective 9/1/2017.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5093.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-2252-000.
    Applicants: NRG Power Marketing LLC.
    Description: Sec.  205(d) Rate Filing: Rate Schedule FERC No. 1 to
be effective 9/1/2017.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5094.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-2253-000.
    Applicants: NorthWestern Corporation.
    Description: NorthWestern Corporation submits Average System Cost
Filing for Sales of Electric Power to the Bonneville Power
Administration, FY 2018-2019.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5121.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-2254-000.
    Applicants: Southern California Edison Company.
    Description: Tariff Cancellation: Notices of Cancellation IFA & DSA
Mid Valley Landfill Project SA Nos. 73 & 74 to be effective 12/3/2017.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5127.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-2255-000.
    Applicants: PJM Interconnection, L.L.C.

    Description: Sec.  205(d) Rate Filing: Original Service Agreement
No. 4758, Queue Position No. AA2-177 to be effective 7/10/2017.
    Filed Date: 8/7/17.
    Accession Number: 20170807-5139.
    Comments Due: 5 p.m. ET 8/28/17.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF17-1266-000.
    Applicants: Escondido Bioenergy Facilty, LLC.
    Description: Form 556 of Escondido Bioenergy Facilty, LLC.
    Filed Date: 8/3/17.
    Accession Number: 20170803-5043.
    Comments Due: None Applicable.

    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: August 7, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-16958 Filed 8-10-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 181 (Wednesday, September 20, 2023)]
[Rules and Regulations]
[Pages 64793-64795]
[FR Doc No: 2023-20416]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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

Federal Register / Vol. 88, No. 181 / Wednesday, September 20, 2023 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 93

Staffing-Related Relief Concerning Operations at Ronald Reagan
Washington National Airport, John F. Kennedy International Airport,
LaGuardia Airport, and Newark Liberty International Airport, October
29, 2023, Through March 30, 2024 (Winter 2023/2024) and March 31, 2024,
Through October 26, 2024 (Summer 2024)

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation.

ACTION: Limited waiver of the slot usage requirement.

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SUMMARY: The FAA announces a limited, conditional waiver of the minimum
usage requirement that applies to Operating Authorizations or ``slots''
at John F. Kennedy International Airport (JFK), New York LaGuardia
Airport (LGA), and Ronald Reagan Washington National Airport (DCA) due
to post-pandemic effects on Air Traffic Controller (ATC) staffing at
the New York Terminal Radar Approach Control (TRACON) facility (N90).
In addition, the FAA is announcing a limited policy for prioritizing
returned operations at Newark Liberty International Airport (EWR) due
to post-pandemic effects on ATC staffing at N90 for purposes of
establishing a carrier's operational baseline in the next corresponding
season.

DATES: This action is effective September 20, 2023.

ADDRESSES: Requests may be submitted by mail to the Slot Administration
Office, System Operations Services, AJR-0, Room 300W, 800 Independence
Avenue SW, Washington, DC 20591, or by email to: [email protected].

FOR FURTHER INFORMATION CONTACT: For questions concerning this notice
contact: Al Meilus, Capacity and Slot Analysis, FAA ATO System
Operations Services, AJR-G5, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The New York Terminal Radar Approach Control facility (N90)
provides ATC services to overhead flights in the Northeast corridor and
to the New York City area airports, including JFK, LGA, and EWR. The
airspace complexity resulting from the close proximity of the major
commercial airports serving the New York City region is a significant
contributing factor to delays at JFK, LGA, and EWR. Against this
challenging backdrop, N90 is also facing staffing shortfalls that are
impacting its ability to efficiently manage the volume of air traffic
in this congested airspace. The FAA has made it a top priority to
address these capacity constraints, including by dedicating significant
resources to training a new air traffic controller workforce, and these
efforts remain ongoing. In addition, based on FAA observations of air
carrier operations and recent discussions with industry, there are
likely other contributing factors, including air carrier staffing
issues on the ground.
    With demand for air travel at a record high, additional measures
are necessary to ensure that the FAA is able to provide expeditious
services to aircraft operators and their passengers that traverse this
airspace during this time of transition. Early carrier schedules/
discussions indicate an increase in operations after October 29, 2023,
through most of the winter 2023/2024 scheduling season and for all of
the summer 2024 scheduling season. This being the case, the FAA expects
increased delays and cancellations in the New York region to exceed
those experienced over winter 2022/2023 and summer 2023 if a waiver
similar to the one in effect for summer 2023 is not in place for the
winter 2023/2024 and summer 2024 scheduling season to allow carriers to
reduce schedules without penalties for non-use of slots or previously
approved operating times. Reducing schedules will improve the alignment
between scheduled operations and actual operations, will help prevent
unnecessary delays, will help optimize the efficient use of the
airports' resources, and will help deliver passengers to their
destinations more reliably and on time.

Summary of Petitions Received

    On July 26th, 2023, the FAA received a petition from American
Airlines Inc. (American) requesting an extension of the initial summer
2023 waiver until the end of the IATA winter 2023/2024 season. American
contends that extending the relief will support operational integrity
in the New York region. In addition, American argues that the winter
season leads to unique operational challenges, particularly de-icing,
where ramp space increasingly is congested and aircraft have a limited
window to depart.
    On September 1, 2023, the FAA received a petition from Alaska
Airlines, Inc. (Alaska) sharing the concerns of other carriers
regarding the impact of ATC staffing on airspace management in the New
York Area for an additional waiver extension but requested a waiver
only through the winter 2023/2024 season. Alaska urges the FAA to use
the additional tools at its disposal to help minimize operational
disruptions before granting a long-term waiver. Alaska avers that a
long-term waiver would fail to appropriately maximize the use of
limited slots and potentially hinder new future competition in the New
York market.

Standard

    At JFK and LGA, slot-holding carriers must use each assigned slot
at least 80 percent of the time.\1\ The FAA will withdraw slots not
meeting the minimum usage requirements. The FAA may waive the 80
percent usage requirement in the event of a highly unusual and
unpredictable condition that is beyond the control of the slot-holding
air carrier, and which affects carrier operations for a period of five
consecutive days or more.\2\
---------------------------------------------------------------------------

    \1\ Operating Limitations at John F. Kennedy International
Airport, 87 FR 65161 (Oct. 28, 2022); Operating Limitations at New
York LaGuardia Airport, 87 FR 65159 (Oct. 28, 2022).
    \2\ At JFK, the FAA will determine historical rights to
operating authorizations and withdrawal of those rights due to
insufficient usage on a seasonal basis and in accordance with the
schedule approved by the FAA prior to the commencement of the
applicable season. See JFK Order, 87 FR at 65163. At LGA, the FAA
will withdraw any operating authorization not used at least 80
percent of the time over a two-month period. See LGA Order, 87 FR at
65160.

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    At DCA, the FAA also will recall any slot not used at least 80
percent of the time over a two-month period.\3\ The FAA may waive this
minimum usage requirement in the event of a highly unusual and
unpredictable condition that is beyond the control of the slot-holding
carrier, and which exists for a period of nine or more days.\4\
---------------------------------------------------------------------------

    \3\ See 14 CFR 93.227(a).
    \4\ See 14 CFR 93.227(j).
---------------------------------------------------------------------------

    In determining historical rights to allocated slots, including
whether to grant a waiver of the usage requirement, the FAA seeks to
ensure the efficient use of valuable aviation infrastructure and
maximize the benefits to both airport users and the traveling public.
The minimum usage requirement is expected to accommodate routine
cancellations under all but the most unusual circumstances. Carriers
proceed at risk if they make scheduling decisions in anticipation of
the FAA granting a slot usage waiver.

Analysis

    Due to the volume of originating and destination flights in the New
York City region, as well as the interdependency and complexity of the
airspace surrounding JFK, LGA, and EWR, delays caused in part by N90
staffing shortfalls are expected to significantly impact carriers'
ability to operate and meet minimum usage requirements in the winter
2023/2024 and summer 2024 scheduling seasons. Absent increased
flexibility, the FAA anticipates a high likelihood of congestion and
delay at JFK, LGA, and EWR.
    Typically, the 20 percent non-utilization allowed under the minimum
usage requirement accounts for cancellations due to ATC staffing
delays; however, the extent of N90 staffing shortfalls and the increase
in scheduled operations for the winter 2023/2024 season and expected
increase in schedules in the summer 2024 season present a highly
unusual and unpredictable condition beyond the control of carriers that
will impact operations through the entire winter 2023/2024 and summer
2024 scheduling seasons. A waiver of minimum slot usage requirements at
JFK and LGA, and a similar policy of prioritizing returned operations
at EWR, is necessary to allow carriers to reduce operations to enable
scheduling and operational stability. In addition, because New York
City-DCA is a high-frequency market for multiple carriers, the FAA
recognizes this market is a likely target for carriers to consolidate
flights while retaining their network connectivity. If carriers choose
to reduce their schedules in the New York City-DCA market, the FAA
encourages, to the extent practical, carriers to utilize their DCA
slots to operate to other destinations. However, if carriers choose not
to utilize their DCA slots elsewhere, the FAA may consider providing
relief to DCA slots that are impacted by the reduction in operations at
the New York City airports.
    Finally, carriers should be aware that the N90 staffing shortfalls
will not form a sufficient basis for further relief going forward in
the winter 2023/2024 and summer 2024 scheduling seasons because
carriers will have had sufficient opportunity to plan and take remedial
action under this waiver policy. The FAA does not foresee providing
additional post-hoc relief associated with ATC staffing given the
extraordinary relief provided here. Given this relief, operational
impacts associated with N90 staffing during the winter 2023/2024 and
summer 2024 scheduling season will not have been beyond carriers'
control and will not serve as a justification for a separate waiver.

Decision

    The FAA determined that the post-pandemic effects on N90 staffing
meet the applicable waiver standards and warrant a limited waiver of
minimum slot usage requirements at JFK and LGA to allow carriers to
return up to ten percent of their slots at each airport, as well as
impacted operations between DCA and the New York City airports. In
addition, the FAA has determined the post-pandemic effects on N90
staffing warrant a limited policy for prioritizing returned operations
at EWR to allow carriers to return up to ten percent of their approved
operating timings, for purposes of establishing a carrier's operational
baseline in the next corresponding season. Carriers seeking to return
their slots and approved operating timings must do so by October 13,
2023, for the winter 2023/2024 scheduling season (October 29, 2023,
through March 30, 2024); and by December 15, 2023, for the summer 2024
scheduling season (March 31 through October 26, 2024) to be eligible
for relief under this waiver. For DCA, this relief is available only
for flights impacted by operations to or from the New York City area
airports. If carriers utilizing the relief provided under this limited
waiver at EWR subsequently operate unapproved flights at that airport,
those carriers will forfeit their scheduling preference to an equal
number of returned, approved operating timings chosen at the FAA's
discretion for the subsequent equivalent traffic season. Furthermore,
the FAA expects carriers to up-gauge aircraft serving the affected
airports to the extent possible to maintain passenger throughput and
minimize the impact on consumers. The FAA also expects carriers to
maintain connections between the affected airports and regional
airports to the extent possible in support of continuous scheduled
interstate air transportation for small communities and isolated areas.
In addition, the FAA urges carriers to return scheduled operations in
the peak delay periods of the day. The following hours (in local time)
are the most prone to delay at each airport: EWR: 1400-2159, JFK: 1300-
2259, LGA: 1300-2159.
    The FAA will not reallocate the temporarily returned slots or
approved operating timings at JFK, LGA, or EWR, as the goal is to
reduce the volume of operations in the New York City region. Carriers
are encouraged to utilize their DCA slots in other markets before
returning them to the FAA. In the event DCA slots are returned under
this waiver, other carriers will have an opportunity to operate the
slots on an ad hoc basis without historic precedence.
    The FAA will treat as used the specific slots returned in
accordance with the conditions in this notice for the period from
October 29, 2023, through March 30, 2024 (winter 2023/2024) and March
31, 2024, through October 26, 2024 (summer 2024).
    The relief is subject to the following conditions:
    1. The specific slots and approved operating timings must be
returned to the FAA by October 13, 2023, for the winter 2023/2024
scheduling season; and by December 15, 2023, for the summer 2024
scheduling season.
    2. This waiver applies only to slots that have corresponding,
scheduled operations during the period of the grant. A carrier
temporarily returning a slot or approved operating time to the FAA for
relief under this waiver must identify corresponding scheduled
operations for winter 2023/2024, or approved slots or operating timings
for summer 2024. The FAA may validate information against published
schedule data prior to the issuance of this notice, and other
operational data maintained by FAA. Slots or operating times returned
without an associated scheduled and canceled operation will not receive
relief.
    3. Slots or approved operating timings newly allocated for initial
use since the

previous corresponding scheduling season are not eligible for relief.
    4. Slots authorized at DCA by Department of Transportation or FAA
exemptions are not eligible for relief.

    Issued in Washington, DC, on September 15, 2023.
Marc A. Nichols,
Chief Counsel.
Alyce Hood-Fleming,
Vice President, System Operations Services.
[FR Doc. 2023-20416 Filed 9-18-23; 4:15 pm]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 109 (Tuesday, June 7, 2011)]
[Notices]
[Page 32982]
[FR Doc No: 2011-14008]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3319-EM; Docket ID FEMA-2011-0001]

Alabama; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Alabama (FEMA-3319-EM), dated April 27,
2011, and related determinations.

DATES: Effective Date: April 27, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 27, 2011, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    On April 27, 2011, I determined that the emergency conditions in
certain areas of the State of Alabama resulting from severe storms,
tornadoes, and straight-line winds beginning on April 27, 2011, and
continuing, are of sufficient severity and magnitude to warrant an
emergency declaration under the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (``the Stafford
Act''). Therefore, I declared that such an emergency exists in the
State of Alabama.
    In order to provide Federal assistance, you were authorized to
provide appropriate assistance for required emergency measures,
authorized under Title V of the Stafford Act, to save lives and to
protect property and public health and safety, and to lessen or
avert the threat of a catastrophe in the designated areas.
Specifically, you were authorized to provide assistance for
emergency protective measures (Category B), limited to direct
Federal assistance, under the Public Assistance program. This
assistance excludes regular time costs for subgrantees' regular
employees.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you were
authorized to allocate from funds available for these purposes, such
amounts as you find necessary for Federal emergency assistance and
administrative expenses.
    Further, you were authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Joe M.
Girot, of FEMA is appointed to act as the Federal Coordinating Officer
for this declared emergency.
    The following areas of the State of Alabama have been designated as
adversely affected by this declared emergency:

    All 67 Counties in the State of Alabama for emergency protective
measures (Category B), limited to direct Federal assistance, under
the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

    Dated: June 1, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-14008 Filed 6-6-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52141-52142]
[FR Doc No: 2019-21233]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2006-0028]

MET Laboratories, Inc.: Grant of Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for MET Laboratories, Inc., as a Nationally
Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
October 1, 2019.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2110; email<EMAIL_ADDRESS>OSHA's web

page includes information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of MET Laboratories, Inc. (MET), as a NRTL. MET's expansion
covers the addition of three test standards to its scope of
recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification of the products.
    The agency processes applications by a NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding and, in the second
notice, the agency provides the final decision on the application.
These notices set forth the NRTL's scope of recognition or
modifications of that scope. OSHA maintains an informational web page
for each NRTL that details its scope of recognition. These pages are
available from the agency's website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    MET submitted three applications, one dated January 10, 2018 (OSHA-
2006-0028-0046), one dated May 18, 2018 (OSHA-2006-0028-0044), and
another one dated June 28, 2018 (OSHA-2006-0028-0045). The applications
expand MET's scope of recognition to include three additional test
standards. OSHA staff performed a detailed analysis of the applications
and reviewed other pertinent information. OSHA did not perform any on-
site reviews in relation to these applications.
    OSHA published the preliminary notice announcing MET's expansion
applications in the Federal Register on June 5, 2019 (84 FR 26159). The
agency requested comments by June 20, 2019, and received no comments in
response to this notice. OSHA now is proceeding with this final notice
to grant expansion of MET's scope of recognition.
    To obtain or review copies of all public documents pertaining to
the MET's applications, go to www.regulations.gov or contact the Docket
Office, Occupational Safety and Health Administration, U.S. Department
of Labor, 200 Constitution Avenue NW, Room N-3655, Washington, DC
20210; telephone<PHONE_NUMBER>. Docket No. OSHA-2006-0028 contains all
materials in the record concerning MET's recognition.

II. Final Decision and Order

    OSHA examined MET's expansion applications, its capability to meet
the requirements of the test standards, and other pertinent
information. Based on the review of this evidence, OSHA finds that MET
meets the requirements of 29 CFR 1910.7 for expansion of its scope of
recognition, subject to the limitation and conditions listed below.
OSHA, therefore, is proceeding with this final notice to grant
expansion of MET's scope of recognition. OSHA limits the expansion of
MET's scope of recognition to testing and certification of products for
demonstration of conformance to the test standards listed below in
Table 1.

 Table 1--List of Appropriate Test Standards for Inclusion in MET's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
                Test standard                     Test standard title
------------------------------------------------------------------------
UL 696.......................................  Electric Toys.
UL 962.......................................  Household and Commercial
                                                Furnishings.
UL 60079-7...................................  Explosive Atmosphere--
                                                Part 7: Equipment
                                                Protection by Increased
                                                Safety ``e''.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.
    The American National Standards Institute (ANSI) may approve the
test standards listed above as American National Standards. However,
for convenience, OSHA may use the designation of the standards-
developing organization for the standard as opposed to the ANSI
designation. Under the NRTL Program's policy (see OSHA Instruction CPL
1-0.3, Appendix C, paragraph XIV), any NRTL recognized for a particular
test standard may use either the proprietary version of the test
standard or the ANSI version of that standard. Contact ANSI to
determine whether a test standard is currently ANSI-approved.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
MET must abide by the following conditions of the recognition:
    1. MET must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. MET must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. MET must continue to meet the requirements for recognition,
including all previously published conditions on MET's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of MET, subject to the limitation and conditions
specified above.

III. Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice. Accordingly, the agency is issuing this notice pursuant to 29
U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912,
Jan. 25, 2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on September 25, 2019.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2019-21233 Filed 9-30-19; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Proposed Rules]
[Pages 32115-32116]
[FR Doc No: 2011-13844]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1987-0002; FRL-9315-7]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Intent To Delete the Coker's Sanitation
Service Landfills Superfund Site

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) Region III is
issuing an Intent To Delete the Coker's Sanitation Service Landfills
Superfund Site (Site) located in Cheswold, Kent County, Delaware, from
the National Priorities List (NPL) and requests public comments on this
proposed action. The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an appendix of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the
State of Delaware, through the Delaware Department of Natural Resources
and Environmental Control (DNREC), have determined that all appropriate
response actions under CERCLA, other than operation, maintenance, and
five-year reviews, have been completed. However, this deletion does not
preclude future actions under Superfund.

DATES: Comments must be received by July 5, 2011.

ADDRESSES:
    Submit your comments, identified by Docket ID no. EPA-HQ-SFUND-
1987-0002, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>, Attn: Darius Ostrauskas.

     Mail: U.S. Environmental Protection Agency, Region III,
Attn: Darius Ostrauskas (3HS23), 1650 Arch Street, Philadelphia, PA
19103-2029.
     Hand Delivery: U.S. Environmental Protection Agency,
Region III, Attn: Darius Ostrauskas (3HS23), 1650 Arch Street,
Philadelphia, PA 19103-2029, Phone:<PHONE_NUMBER>, Business Hours: Mon.
thru Fri.--9 a.m. to 4 p.m. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
1987-0002. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at:

U.S. EPA Region III, Library, 2nd Floor, 1650 Arch Street,
Philadelphia, PA 19103-2029,<PHONE_NUMBER>, Monday through Friday, 8
a.m. to 5 p.m.
The Dover Public Library, Reference Department, 45 South State Street,
Dover, DE 19901,<PHONE_NUMBER>, Monday through Thursday, 9 a.m. to 9
p.m., Friday and Saturday, 9 a.m. to 5 p.m., and Sunday, 1 p.m. to 5
p.m.

FOR FURTHER INFORMATION CONTACT: Darius Ostrauskas, Remedial Project
Manager (3HS23), U.S. Environmental Protection Agency, Region III, 1650
Arch Street, Philadelphia, PA 19103-2029,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' Section of
today's Federal Register, we are publishing a direct final Notice of
Deletion of the Coker's Sanitation Service Landfills Superfund Site
without prior Notice of Intent To Delete because EPA views this as a
noncontroversial revision and anticipates no adverse comment. We have
explained our reasons for this deletion in the preamble to the direct
final Notice of Deletion, and those reasons are incorporated herein. If
we receive no adverse comment(s) on this deletion action, we will not
take further action on this Notice of Intent to Delete. If we receive
adverse comment(s), we will withdraw the direct final Notice of
Deletion and it will not take effect. We will, as appropriate, address
all public comments in a subsequent final Notice of Deletion based on
this Notice of Intent to Delete. We will not institute a second comment
period on this Notice of Intent to Delete. Any parties interested in
commenting must do so at this time.
    For additional information, see the direct final Notice of
Deletion, which is located in the Rules section of this Federal
Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p. 193.

    Dated: April 29, 2011.
James W. Newsom,
Acting Regional Administrator, Region III.
[FR Doc. 2011-13844 Filed 6-2-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 9, 2006 (Volume 71, Number 89)]
[Notices]
[Page 26938-26939]
[DOCID:fr09my06-52]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-327-000]

Canyon Creek Compression Company; Notice of Propsoed Changes in
FERC Gas Tariff

May 2, 2006.
    Take notice that on April 28, 2006, Canyon Creek Compression
Company (Canyon) tendered for filing as part of its FERC Gas Tariff,
Third Revised Volume No. 1, the following tariff sheets, to become
effective June 1, 2006:

Fifteenth Revised Sheet No. 6.
Eighth Revised Sheet No. 6A.

    Canyon states that copies of the filing are being mailed to its
customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in

accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed in accordance with the provisions of Sec.  154.210 of the
Commission's regulations (18 CFR 154.210). Anyone filing an
intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-6972 Filed 5-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Pages 46820-46822]
[FR Doc No: 2011-19566]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0513]

Proposal To Refuse To Approve a Supplemental New Drug Application
for Bromday (Bromfenac Ophthalmic Solution), 0.09%; Opportunity for a
Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA), the Director of

the Center for Drug Evaluation and Research (the Center Director), is
proposing to refuse to approve a supplemental new drug application
submitted by ISTA Pharmaceuticals, Inc. (ISTA), for a new 2.4
milliliter (mL) fill size for Bromday (bromfenac ophthalmic solution),
0.09%. This notice summarizes the grounds for the proposal of the
Center for Drug Evaluation and Research (CDER) and offers ISTA an
opportunity to request a hearing on the matter.

DATES: Submit written requests for a hearing by September 2, 2011;
submit data in support of the hearing request by October 3, 2011.

ADDRESSES: Submit electronic or written requests for a hearing; any
data, information, and analyses justifying the hearing; and any other
comments. Submit electronic requests and supporting documents to http://www.regulations.gov, or submit written requests and supporting
documents to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Identify both electronic and written requests and the supporting
documents with the docket number in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 24, 2005, FDA approved ISTA's new drug application (NDA)
21-664 to market Xibrom (bromfenac sodium ophthalmic solution), 0.09%.
On October 16, 2010, FDA approved Bromday (bromfenac ophthalmic
solution), 0.09%, through a supplement to NDA 21-664. Xibrom and
Bromday are topical ophthalmic solutions supplied as sterile, aqueous
eye drops and approved for the treatment of postoperative inflammation
and reduction of ocular pain in patients who have undergone cataract
extraction. Xibrom is applied to the affected eye twice daily for 2
weeks beginning 24 hours after surgery, whereas Bromday is applied to
the affected eye once daily beginning 1 day before surgery and
continuing on the day of surgery and for 14 days thereafter. Xibrom
currently is approved in 2.5 mL and 5 mL fill sizes, but, as discussed
below, the Center is considering steps to address the safety concerns
relating to the larger fill size. Bromday is approved in a 1.7 mL fill
size.
    ISTA submitted supplement 15 to the Xibrom/Bromday NDA on October
18, 2010, seeking approval to market Bromday in a 2.4 mL fill size.
ISTA has stated--in its cover letter accompanying supplement 15 and in
its request for an opportunity for a hearing--that patients often have
cataract removal surgeries in both eyes, and that the 1.7 mL fill size
does not contain a sufficient volume of product to treat two eyes for a
full course of treatment. The Division of Anti-Infective and
Ophthalmology Products (DAIOP) \1\ within CDER issued a complete
response letter on February 18, 2011, determining that it could not
approve supplement 15 in its present form, stating: (1) That the data
submitted do not justify the need for increasing the fill volume and
creating a new trade size; (2) that current fill volume appears to
contain sufficient drug product for a full course of treatment; and (3)
that a single bottle of Bromday should not be used to treat more than
one eye in a postoperative setting. Furthermore, the February 18, 2011,
complete response letter states that ISTA is required to resubmit the
application or take other actions available under Sec.  314.110 (21 CFR
314.110) (i.e., withdraw the application or request an opportunity for
a hearing).
---------------------------------------------------------------------------

    \1\ Because of a recent reorganization in the Office of
Antimicrobial Products, the Division of Transplant and Ophthalmology
Products is now responsible for reviewing the supplement.
---------------------------------------------------------------------------

    On May 12, 2011, ISTA submitted a request for an opportunity for a
hearing under Sec.  314.110(b)(3) on whether there are grounds under
section 505(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355(d)) for denying approval of supplement 15.
Officials from CDER, including the Director of the Office of
Antimicrobial Products (OAP), Dr. Edward Cox, held a telephone
conference with ISTA on June 22, 2011, and explained that ISTA has not
adequately justified the need for a larger fill volume, and that CDER
believes that use of a single bottle of Bromday to treat two eyes
unacceptably and unnecessarily increases the risk of microbial
infection. Accordingly, CDER officials explained that, based on the
information before them, they intended to deny approval of supplement
15, but that they are considering whether to present the issue of fill
sizes for postoperative topical ophthalmic products to an advisory
committee. ISTA was asked whether it would agree to extend the 60-day
timeframe for FDA to respond to its request for notice of an
opportunity for a hearing (Sec.  314.110(b)(3)) until after an advisory
committee has met, but ISTA has not agreed to such an extension. CDER
continues to consider the issue as it relates to other postoperative
topical ophthalmic products.

II. Proposal To Refuse To Approve Supplement 15 to NDA 21-664

    Under Sec.  314.200(a) (21 CFR 314.200(a)), this notice describes
the reasons for the Center's proposal to refuse to approve supplement
15 to NDA 21-664 and the proposed grounds for the order.
    ISTA submitted supplement 15 to NDA 21-664, under section 505(b)(1)
of the FD&C Act, proposing to market Bromday in a 2.4 mL fill size.
ISTA was required to submit, among other things, ``full reports of
investigations which have been made to show whether or not such drug is
safe for use'' if supplied in the proposed larger fill size (section
505(b)(1)(A) of the FD&C Act). CDER has concluded, however, that ISTA
did not provide sufficient data, analysis, and information to determine
that Bromday would be safe for use if supplied in the proposed larger
fill size.
    Specifically, CDER believes that the existing fill size is adequate
to treat a single eye. CDER further believes that the proposed larger
fill size, for the purpose of treating two eyes with a single bottle,
may pose a potential risk of microbial infection associated with use of
the product, and that ISTA has not adequately justified the need for
that larger fill size. Microbial infection is a significant concern for
ophthalmic products with postoperative indications, because an eye
whose surface is compromised by a surgical procedure is more prone to
infection than an eye with an intact cornea.\2\
---------------------------------------------------------------------------

    \2\ See, for example, Yanoff, M. and Duker, Ophthalmology,
Mosby, 2009 and Arffa, R., Grayson's Diseases of the Cornea, Mosby,
1991.
---------------------------------------------------------------------------

    The contents of the Bromday bottle could become contaminated with
harmful bacteria if the patient accidentally causes the dropper tip to
come into contact with any nonsterile surface. Bromday contains
benzalkonium chloride as a preservative, but this ingredient only
reduces, and does not eliminate, the risk of microbial contamination.
Further, although the Bromday labeling advises that patients should
``not touch [the] dropper tip to any surface, as this may contaminate
the contents,'' patients may accidentally touch the dropper tip to the
surface of the eye or the skin around the eye, which may lead to
microbial contamination of the bottle contents. Accordingly, it is not
uncommon that

initially sterile topical solutions become contaminated with bacteria
during the course of treatment.\3\ If the product were to become
contaminated with bacteria present on or around the surface of one eye,
and the same bottle of product is used in both eyes, the patient could
transmit the bacteria from one eye to the other.
---------------------------------------------------------------------------

    \3\ Jokl D.H. et al., ``Bacterial Contamination of Ophthalmic
Solutions Used in an Extended Care Facility,'' British Journal of
Ophthalmology, 91:1308-1310, 2007.
---------------------------------------------------------------------------

    The clinical studies conducted by ISTA supporting approval of
Bromday and Xibrom specifically excluded treatment of both eyes and
excluded the concomitant use of other nonsteroidal anti-inflammatory
drugs. There are no data in the application supporting the safe use of
a single bottle in more than one eye. ISTA's supplement 15 contained no
information, data, or analysis relevant to these risks. As with any
NDA, the sponsor bears the burden of supplying necessary data and
information to demonstrate safety, and this includes satisfying CDER
that a specific safety concern has been adequately addressed.
Accordingly, the supplement lacks data, information, or analysis that
would allay CDER's concerns about the potential risks associated with
the larger fill size. We note that although we did not consider this
safety issue at the time of initial approval of Xibrom and certain
other products for which this issue may be relevant, as this issue
develops, we also intend to take appropriate steps with respect to
other products that raise the issue.

III. Notice of Opportunity for a Hearing

    For the reasons summarized previously, notice is given to ISTA
Pharmaceuticals, Inc., and to all other interested persons, that the
Center Director proposes to issue an order under section 505(d) of the
FD&C Act refusing to approve supplement 15 to NDA 21-664 on the grounds
that ISTA did not include data, information, or analysis sufficient to
show that Bromday would be safe for use as labeled if supplied in the
proposed 2.4 mL fill size. Specifically, the investigations conducted
by ISTA in support of supplement 15 do not include adequate tests by
all methods reasonably applicable to show whether or not Bromday would
be safe for use as labeled if supplied in the proposed 2.4 mL fill size
(section 505(d)(1) of the FD&C Act; Sec.  314.125(b)(2) (21 CFR
314.125(b)(2)), and ISTA did not provide sufficient information about
the proposed 2.4 mL fill size to permit CDER to determine whether
Bromday is safe for use under the conditions prescribed, recommended,
or suggested by its labeling if supplied in a 2.4 mL fill size (section
505(d)(4) of the FD&C Act; Sec.  314.125(b)(4)).
    ISTA may request a hearing before the Commissioner of Food and
Drugs (the Commissioner) on the Center Director's proposal to refuse to
approve supplement 15 to NDA 21-664. If ISTA decides to seek a hearing,
it must file: (1) A written notice of participation and request for a
hearing (see the DATES section of this document); and (2) the studies,
data, information, and analyses relied upon to justify a hearing (see
the DATES section of this document), as specified in Sec.  314.200. As
stated in Sec.  314.200(g), a request for a hearing may not rest upon
mere allegations or denials, but must present specific facts showing
that there is a genuine and substantial issue of fact that requires a
hearing to resolve. The failure to request a hearing within the time
provided and in the manner required by Sec.  314.200 constitutes a
waiver of the opportunity to request a hearing. If a hearing request is
not properly submitted, FDA will issue a notice refusing to approve
supplement 15 to NDA 21-664.
    The Commissioner will grant a hearing if there exists a genuine and
substantial issue of fact or if the Commissioner concludes that a
hearing would otherwise be in the public interest (Sec.
314.200(g)(6)). If a hearing is granted, it will be conducted according
to the procedures provided in 21 CFR parts 10 through 16 and 21 CFR
314.201.
    Paper submissions under this notice of opportunity for a hearing
must be filed in four copies. Except for data and information
prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C.
1905, submissions may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and on the Internet
at http://www.regulations.gov. This notice is issued under section
505(c)(1)(B) of the FD&C Act, Sec. Sec.  314.110(b)(3) and 314.200, and
under authority delegated to the Director of CDER.

    Dated: July 28, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19566 Filed 8-2-11; 8:45 am]
BILLING CODE 4160-01-P


From:		"Higgins, Cortney" <  HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>>

To:		Bill Schrock/RTP/USEPA/US@EPA

Cc:	Robin Dunkins/RTP/USEPA/US@EPA, "Frey, Nathan J." <  HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>>

Date:		07/17/2012 05:23 PM

Subject:	Interagency Comments on Pulp and Paper RTR

Hi Bill,

Attached is a redline document with comments on the pulp and paper RTR
preamble submitted for review.  Additionally, we received the following
comment on the cost estimates – can you explain the discrepancy?

I’ll be out of the office starting this Friday (7/19) and will return
on Monday, 7/23.  If you have any questions or want to send back
responses to the redline document during that time period, please send
to Nathan (copied on this email) and copy me.

Regards,

Cortney

Question about the Repeat Testing Cost estimate:

Using the RTI cost impact memo, p.14, Table 9 as the basis for the
estimating testing costs, it was not possible to replicate the costs
estimates from the memo (on p.16 of the RTI cost impact memo as $5.4M
capital costs, $1.3M/yr annualized costs).

That table didn’t include the number of mills in each of the 4
categories listed, so I counted the number of mills in each category
using Appendix C, p.48-56, of that same memo:

106 kraft, soda, and semichemical mills (including
semichemical+secondary fiber mills) or 103 kraft, soda, and semichemical
mills (NOT including semichemical+secondary fiber mills)

44 kraft mills using biotreatment (including those using
stripping+biotreatment) or              40 kraft mills using
biotreatment (NOT including those using stripping+biotreatment)

5 sulfite mills

73 mills bleaching with chlorinated compounds (e.g., ClO2)

I then multiplied the number of mills in each category by the testing
cost per mill to get a maximum and minimum estimate for repeat testing
costs:

Maximum case

Number of mills in category 	  	Capital cost per mill every 5 years
Subtotal of mill category capital costs every 5 years	Annualized capital
cost per mill, $/yr	Subtotal of mill category annualized capital costs,
$/yr

106	Kraft, soda, and semichemical mills (including
semichemical+secondary fiber mills) 	$ 42,000 	$4,452,000 	$ 10,243
$1,085,758

44	Kraft mills using biotreatment (including stripping+biotreatment)
$28,000 	$1,232,000 	$6,829 	$300,476

5	Sulfite mills 	$14,000 	$70,000 	$3,414 	$17,070

73	Mills bleaching with chlorinated compounds (e.g., ClO2) 	$20,000
$1,460,000 	$4,878 	$356,094

  	  	Total 	 $7,214,000 	  	$1,759,398

Minimum case

Number of mills in category 	  	Capital cost per mill every 5 years
Subtotal of mill category capital costs every 5 years	Annualized capital
cost per mill, $/yr	Subtotal of mill category annualized capital costs,
$/yr

103	Kraft, soda, and semichemical mills 	$42,000 	$4,326,000 	$10,243
$1,055,029

40	Kraft mills using biotreatment 	$28,000 	$1,120,000 	$6,829 	$273,160

5	Sulfite mills 	$14,000 	$70,000 	$3,414 	$17,070

73	Mills bleaching with chlorinated compounds (e.g., ClO2) 	$20,000
$1,460,000 	$ 4,878 	$ 356,094

  	  	Total 	$6,976,000 	  	$1,701,353

This estimated range of $7.0-7.2M in total capital costs of retesting is
higher than the $5.4M stated in the memo.  This range is also higher
than the $5.9M in total capital costs for the entire rule (including
reporting and recordkeeping costs of $0.5M) that is stated in the final
rule p.26.

________________________________________________

Cortney Higgins

Policy Analyst

OMB/OIRA/NRE

202.395.7856

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>