[Federal Register Volume 86, Number 104 (Wednesday, June 2, 2021)]
[Notices]
[Pages 29574-29577]
[FR Doc No: 2021-11552]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC21-30-000, RD-20-4-000]

Commission Information Collection Activities (FERC-725G); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory
Commission (Commission or FERC) is soliciting public comment on the
currently approved information collection, FERC-725G (Mandatory
Reliability Standards for the Bulk-Power System: PRC Reliability
Standards.).

DATES: Comments on the collection of information are due August 2,
2021.

ADDRESSES: You may submit copies of your comments (identified by Docket
No. IC21-30-000) by one of the following methods:
    Electronic filing through http://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery:
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Hand (Including Courier) Delivery: Deliver to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov. For user
assistance, contact FERC Online Support by email at
<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725G (Mandatory Reliability Standards for the Bulk-
Power System: Regional Reliability Standard PRC standards: PRC-006-5
Automatic Underfrequency Load-Shedding (UFLS), PRC-002-2, PRC-012-2,
PRC-019-2, PRC-023-4, PRC-024-1, PRC-025-2, PRC-026-1, and PRC-027-1.
    OMB Control No.: 1902-0252.
    Type of Request: Revisions and extension to the information
collection, as discussed in Docket No. RD20-4-000.
    Abstract: On August 8, 2005, Congress enacted into law the
Electricity Modernization Act of 2005, which is Title XII, Subtitle A,
of the Energy Policy Act of 2005 (EPAct 2005).\1\ EPAct 2005 added a
new section 215 to the FPA, which required a Commission-certified
Electric Reliability Organization (ERO) to develop mandatory and
enforceable Reliability Standards, which are subject to Commission
review and approval. Once approved, the Reliability Standards may be
enforced by the ERO subject to Commission oversight, or the Commission
can independently enforce Reliability Standards.\2\
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    \1\ Energy Policy Act of 2005, Public Law 109-58, Title XII,
Subtitle A, 119 Stat. 594, 941 (codified at 16 U.S.C. 824o).
    \2\ 16 U.S.C. 824o(e)(3).

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    The information collected by the FERC-725G is required to implement
the statutory provisions of section 215 of the Federal Power Act
(FPA).\[2]\ Section 215 of the FPA buttresses the Commission's efforts
to strengthen the reliability of the interstate bulk power grid.
    The FERC-725G information collection currently contains the
reporting and recordkeeping requirements for the following Reliability
Standards: PRC-002-2, PRC-006-5, PRC-012-2, PRC-019-2, PRC-023-4, PRC-
024-1, PRC-025-2, PRC-026-1, and PRC-027-1.

 PRC-002-2 Disturbance Monitoring and Reporting Requirements

    The purpose is to have adequate data available to facilitate
analysis of Bulk Electric System (BES) Disturb.

 PRC-006-5 Automatic Underfrequency Load Shedding

    To establish design and documentation requirements for automatic
Underfrequency Load Shedding (UFLS) programs to arrest declining
frequency, assist recovery of frequency following underfrequency events
and provide last resort system preservation measures.

 PRC-012-2 Remedial Action Schemes

    To ensure that Remedial Action Schemes (RAS) do not introduce
unintentional or unacceptable reliability risks to the Bulk Electric
System (BES).

 PRC-019-2 Coordination of Generating Unit or Plant
Capabilities, Voltage Regulating Controls, and Protection

    The purpose is to verify coordination of generating unit Facility
or synchronous condenser voltage regulating controls, limit functions,
equipment capabilities and Protection System settings.

 PRC-023-4 Transmission Relay Load-Ability

    Protective relay settings shall not limit transmission load-
ability; not interfere with system operators' ability to take remedial
action to protect system reliability and; be set to reliably detect all
fault conditions and protect the electrical network from these faults.

 PRC-024-1 Generator Frequency and Voltage Protective Relay
Settings

    The purpose is to ensure Generator Owners set their generator
protective relays such that generating units remain connected during
defined frequency and voltage excursions.

 PRC-025-2 Generator Relay Load-Ability

    The purpose is to set load-responsive protective relays associated
with generation Facilities at a level to prevent unnecessary tripping
of generators during a system disturbance for conditions that do not
pose a risk of damage to the associated equipment.

 PRC-026-1 Relay Performance During Stable Power Swings

    The purpose is to ensure that load-responsive protective relays are
expected to not trip in response to stable power swings during non-
Fault conditions.

 PRC-027-1 Coordination of Protection Systems for Performance
During Faults

    The purpose is to maintain the coordination of Protection Systems
installed to detect and isolate Faults on Bulk Electric System (BES)
Elements, such that those Protection Systems operate in the intended
sequence during Faults.
    Each of these Reliability Standards have three components that
impose burden upon affected industry:

 Requirements (e.g., denoted in each Reliability Standard as
R1, R2 . . .)
 Measures (e.g., denoted in each Reliability Standard as M1, M2
. . .)
 Evidence Retention

    These three components can be reviewed for the Reliability
Standards in NERC petitions in FERC's eLibrary system (http://www.ferc.gov/docs-filing/elibrary.asp) or on NERC's own website
(www.nerc.com).
    Type of Respondents: Generator owners, Planning coordinators,
Distribution providers, UFLS-only Distribution Providers, and
transmission owners in the Northeast Power Coordinating Council (NPCC)
Region.
    Estimate of Annual Burden: \3\ Our estimates are based on the NERC
Compliance Registry Summary of Entities as of February 5, 2021.
According to the NERC compliance registry, and Functions as of, which
indicates there are registered as GO, PC, DP and TO entities. The
individual burden estimates are based on the time needed to gather
data, run studies, and analyze study results to design or update the
underfrequency load shedding programs. Additionally, documentation and
the review of underfrequency load shedding (UFLS) program results by
supervisors and management is included in the administrative
estimations. These are consistent with estimates for similar tasks in
other Commission approved standards.
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    \3\ Burden is defined as 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. See 5
CFR 1320 for additional information on the definition of information
collection burden.
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RD20-4 (PRC-006-4)

    The revisions in the proposed Reliability Standards will align
these standards with the previously approved changes to the NERC
registration criteria \4\ by removing reference to entities \5\ that
are no longer registered with NERC. In proposed Reliability Standard
PRC-006-4, NERC adds the UFLS-only Distribution Provider as an
applicable entity. In two instances, NERC has proposed changes that
will promote consistent use of the term Planning Coordinator across the
Reliability Standards.\6\
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    \4\ Order on Electric Reliability Organization Risk Based
Registration Initiative and Requiring Compliance Filing, 150 FERC ]
61,213 (2015); Order on Compliance Filing, 153 FERC ] 61,024 (2015).
    \5\ NERC's risk-based registration initiative resulted in the
removal of the load-serving entity and purchasing-selling entity
from the NERC compliance registry.
    \6\ Standards Alignment with Registration Petition at 7.
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    The Commission's request to OMB will reflect the following:
     Addition to the burden associated with UFLS-only
distribution providers to proposed (in RD-20-4) Reliability Standard
PRC-006-4.\7\ The petition states that the currently effective standard
is applicable to planning coordinators, ``UFLS entities'' (which may
include transmission owners and distribution providers that own,
operate, or control UFLS equipment), and transmission owners that own
certain elements. In proposed Reliability Standard PRC-006-4, NERC
proposes to add the UFLS-only distribution provider as an applicable
UFLS entity.\8\
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    \7\ The burden associated with the Commission approved standard,
PRC-006-3, is included in FERC-725G.
    \8\ Standards Alignment with Registration Petition at 13.
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     Current, Reliability Standard PRC-006-5 \9\ (formerly PRC-
006-3) (Automatic Underfrequency Load Shedding)
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    \9\ PRC-006-5 was approved April 1, 2021 in RM21-1 which did not
trigger the PRA and therefore did not require prior OMB approval.
The current version of this standard, PRC-006-5, was approved by the
Commission on April 1, 2021. The only change was a revision to the
regional variance for the WECC region for PRC-006-4 modifications
that needs to be approved through OMB.
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    Commission estimates the annual burden and cost for the information
collection as follows:
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    \10\ The number of entities is being reduced in order to more
clearly identify the applicable entities in subsequent rows in this
table. As stated in the NERC Petition, ``[t]he currently effective
standard is applicable to Planning Coordinators, ``UFLS entities''
(which may include Transmission Owners and Distribution Providers
that own, operate, or control UFLS equipment), and Transmission
Owners that own certain Elements. In proposed Reliability Standard
PRC-006-4, NERC proposes to add the UFLS-Only Distribution Provider
as an applicable UFLS entity, consistent with the language in
Section III(b) of Appendix 5B of the NERC Rules of Procedure
(Statement of Compliance Registry Criteria) that the Reliability
Standards applicable to UFLS-Only Distribution Providers includes
prior effective versions of the PRC-006 standard.'' The changes are
not due to Docket No. RD20-4-000.
    \11\ The increases are not due to Docket No. RD20-4-000. They
are a program increase of 64 PCs (and the corresponding hrs.) in
order to correct and clarify the estimates.
    \12\ The program increase is due to adding 63 UFLS-only DPs due
to Docket No. RD20-4-000. In addition, 415 TOs and DPs were
originally estimated in FERC-725A due to Order No. 693. However, the
estimates and descriptions were not clearly spelled out, so we are
clarifying them. As a result, there are 315 hours (63 * 5 hours) and
the corresponding increase of 63 respondents of program increase due
to Docket No. RD20-4-000, and 2,075 hours (415 * 5 hours) of
increase due to adjustment.

                                               RD20-4 Net Changes for FERC-725G, OMB Control No. 1902-0252
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                                                                             Average  annual
                                             Average  annual number 1  of      number  of     Average annual total      Average      Total annual burden
    PRC regional reliability standards               respondents              responses per    number of responses   burden hours           hours
                                                                               respondent                            per response
                                           (1)............................               (2)       (1) * (2) = (3)             (4)
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PRC-006-4 (Automatic Underfrequency Load   -80 (TO & DP)..................                 1                   -80              47                -3,760
 Shedding) Reporting Requirement--program
 decrease 10.
PRC-006-4 (Automatic Underfrequency Load   -80 (TO & DP)..................                 1                   -80               5                  -400
 Shedding) Evidence Retention--program
 decrease 14.
PRC-006-4 (Automatic Underfrequency Load   64 (PC)........................                 1                    64              47                 3,008
 Shedding) R1-R7, R11-R15 Reporting
 Requirement--program increase &
 clarification 11.
PRC-006-4 (Automatic Underfrequency Load   64 (PC)........................                 1                    64               5                   320
 Shedding) R1-R7, R11-R15 Evidence
 Retention-program increase &
 clarification 14.
PRC-006-4 (Automatic Underfrequency Load   478 (TO, DP, UFLS-only DP).....                 1                   478               5                 2,390
 Shedding) R8-R10 Evidence Retention--
 program increase & clarification 12.
                                          --------------------------------------------------------------------------------------------------------------
    Net Changes for FERC-725G due to RD20- ...............................  ................    446 (net increase)  ..............  1,558 (net increase)
     4.
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 IC21-30-000 Renewal as Effected by RD20-4-000: Mandatory Reliability Standards for the Bulk-Power System: Regional Mandatory Reliability Standards for
the Bulk-Power System: Regional Reliability Standard PRC Standards: PRC-006-5, PRC-002-2, PRC-012-2, PRC-019-2, PRC-023-4, PRC-024-1, PRC-025-2, PRC-026-
                                                                    1, and PRC-02713
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                                                       Average annual
                                       Average annual     number of    Average annual   Average burden hours &     Total annual burden       Cost per
  Reliability standard & requirement     number 1 of    responses per   total number     cost ($) per response       hours & cost ($)     respondent ($)
                                         respondents     respondent     of responses                                    (rounded)
                                                  (1)             (2)     (1) * (2) =  (4).....................  (3) * (4) = (5)........       (5) / (1)
                                                                                (3)
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                                               PRC-006-5 (Current burden after net changes due to RD20-4)
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TO/DP/PC 14..........................             480               1             480  35 hrs.; $2,905.........  16,800 hrs.; $1,394,400          $2,905
                                      ------------------------------------------------------------------------------------------------------------------
    Net Changes for FERC-725G due to   ..............  ..............             926  ........................  18,358 hrs.; $1,523,714
     RD20-4.
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                                                                        PRC-023-4
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TO/GO/DP 15..........................           1,314               1           1,314  303 hrs.; $25,149.......  398,142 hrs.;                    25,149
                                                                                $33,045,786.
PC...................................              65               1              65  212 hrs.; $17,596.......  13,780 hrs.; $1,143,740          17,596
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                                                                       PRC-025-2
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GO/TO/DP 17..........................           1,314               1           1,314  4 hrs.; $332............  5,256 hrs.; $436,248...             332
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                                                                        PRC-019-2
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GO/TO................................           1,178               1           1,178  8.9 hrs.; $664..........  9,424 hrs.; $782,192...             664
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                                                                        PRC-024-1
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GO...................................           1,003               1           1,003  8 hrs.; $664............  8,024 hrs.; $665,992...             664
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                                                                        PRC-026-1
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GO/PC/TO.............................           1,189               1           1,189  18 hrs.; $1,494.........  21,402 hrs.; $1,776,366           1,494
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                                                                        PRC-002-2
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TO/GO/PC 18..........................           1,189            0.50           594.5  100 hrs.; $8,300........  59,450 hrs.; $4,934,350           8,300
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                                                                        PRC-012-2
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RC/PC/TO/GO/DP.......................           1,329               1           1,329  88 hrs.; $7,304.........  116,952 hrs.;                     7,304
                                                                                $9,707,016.
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                                                                        PRC-027-1
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TO/GO/DP.............................           1,314               1           1,314  44 hrs.; $3,652.........  57,816 hrs.; $4,798,728           3,652
                                      ------------------------------------------------------------------------------------------------------------------
    Total for FERC-725G..............  ..............  ..............       10,226.50  ........................  708,604 hrs.;
                                                                                $58,814,132.
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
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    \13\ The number of respondents on this table reflect information
taken from NERC Compliance Registry, while it may show a decrease
from previous years the 2021 values reflect treating standards as a
whole instead of by requirement which allow for aggregate values and
eliminating multiple counts of the same entity within a standard.
    \14\ Using NERC Compliance Registration data (February 5, 2021),
the number of respondents are for US unique entities and takes into
account the overlap between functions of the DP = Distribution
Provider, TO = Transmission Owner and PC= Planning Coordinator for a
total of 480.
    \15\ Using NERC Compliance Registration data (February 5, 2021),
the number of respondents are for US unique entities and takes into
account the overlap between functions of the DP = Distribution
Provider, TO = Transmission Owner and DP = Distribution Provider for
a total of 1,314. The number of hours also take into account line
terminal work needed to be done applicable TO, GO, or DP as per PRC-
023-1 approved in Order No. 773 March 18, 2010.
    \16\ Reliability Standard PRC-025-2 from FERC-725G2 (OMB No.
1902-0281)- a temporary place holder is now being placed back into
725G.
    \17\ According to the NERC compliance registry as of February 5,
2021, NERC has registered 379 distribution providers (DP), 1,003
generator owners (GO) and 321 transmission owners (TO). However,
under NERC's compliance registration program, entities may be
registered for multiple functions, so these numbers incorporate some
double counting. The number of unique entities responding will be
approximately 994 entities registered as a transmission owner, a
distribution provider, or a generator owner that is also a
transmission owner and/or a distribution owner. These values reflect
removing any year 1-2 costs and covers on-going cost from version
PRC-025-1 and PRC-025-2.
    \18\ Based on the Requirements of PRC-002-2 some entities do not
have to perform tasks annual so average response rate is set to
0.50.

    Dated: May 26, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-11552 Filed 6-1-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51325-51326]
[FR Doc No: 2023-16557]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0301]

Fixed-Combinations and Single-Entity Versions of Previously
Approved Antiretrovirals for the Treatment or Prevention of Human
Immunodeficiency Virus-One Under the President's Emergency Plan for
Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Fixed-
Combinations and Single-Entity Versions of Previously Approved
Antiretrovirals for the Treatment or Prevention of HIV-1 Under
PEPFAR.'' This draft guidance provides recommendations for applications
for single-entity antiretroviral (ARV) and ARV fixed-combination (FC)
drug products for the treatment or prevention of human immunodeficiency
virus-one (HIV-1) infection that are intended for procurement under the
President's Emergency Plan for AIDS Relief (PEPFAR). Specifically, this
draft guidance addresses versions of ARV drug products for which the
individual ARV drug product components are already FDA-approved and for
which substantial evidence of safety and efficacy of the specific drug
product or combination drug product already exists. When finalized,
this draft guidance will replace the previous final guidance for
industry entitled ``Fixed Dose Combinations, Co-Packaged Drug Products,
and Single-Entity Versions of Previously Approved Antiretrovirals for
the Treatment of HIV'' issued in October 2006.

DATES: Submit either electronic or written comments on the draft
guidance by November 1, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2004-D-0301 for ``Fixed-Combinations and Single-Entity Versions of
Previously Approved Antiretrovirals for the Treatment of HIV-1 Under
PEPFAR.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive

label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Sarita Boyd, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Fixed-Combinations and Single-Entity Versions of Previously
Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under
PEPFAR.'' This draft guidance provides recommendations for applications
for single-entity ARV and ARV FC drug products for the treatment of
HIV-1 infection that are intended for procurement under PEPFAR.
Specifically, this draft guidance addresses versions of ARV drug
products for which the individual ARV drug product components are
already FDA-approved and for which substantial evidence of safety and
efficacy of the specific drug product or combination drug product
already exists. The draft guidance discusses regulatory procedures
relevant to such applications and recommendations on how to identify
and address common issues. The recommendations in this draft guidance
primarily focus on the tentative approval of marketing applications
intended for procurement under PEPFAR, where there are patent or
exclusivity barriers to final marketing approval.
    When finalized, this draft guidance will replace the previous final
guidance for industry entitled ``Fixed Dose Combinations and Single-
Entity Versions of Previously Approved Antiretrovirals for the
Treatment of HIV,'' issued October 18, 2006 (71 FR 61483). Important
changes in this draft guidance compared to the 2006 final version
include the following:
     Addition of information about ARV drug products for
prevention of HIV-1 infection.
     Deletion of references to co-packaged products and focus
on single-entity ARV and ARV FC drug products currently most needed
under PEPFAR.
     Inclusion of a subsection that describes the processes for
making changes to applications after tentative approval.
     Addition of updated descriptions of regulatory
requirements and procedures in the main text of the document and
deletion of Attachments A, B, and C.
     Addition of updated information, for example, in the
section on chemistry, manufacturing, and controls, to be consistent
with other guidances for industry released after 2006.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Fixed-
Combinations and Single-Entity Versions of Previously Approved
Antiretrovirals for the Treatment or Prevention of HIV-1 Under
PEPFAR.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this draft guidance contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 for the submission of investigational
new drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 for the
submission of new drug applications, abbreviated new drug applications
and supplemental applications have been approved under OMB control
number 0910-0001. The collections of information for the submission of
controlled correspondence related to generic drug development have been
approved under OMB control number 0910-0797. The collections of
information pertaining to Prescription Drug User Fee Program have been
approved under OMB control number 0910-0297. The collections of
information pertaining to Generic Drug User Fee Program have been
approved under 0910-0727. The collections of information related to
expedited review programs for serious conditions have been approved
under OMB control number 0910-0765. The collections of information for
the submission of postmarketing adverse drug experience reporting have
been approved under OMB control number 0910-0230. The collections of
information in 21 CFR parts 210 and 211 pertaining to current good
manufacturing practice have been approved under OMB control number
0910-0139. The collections of information in 21 CFR 201.57 for the
submission of prescription drug product labeling have been approved
under OMB control number 0910-0572. The collections of information
pertaining to good clinical practice have been approved under OMB
control number 0910-0843.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16557 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P


Internal Written Procedures: SOPs and work practices for the inspection, adjustment, repair, replacement and cleaning of coke oven doors and jamb, as well as the use of sealants to stop and prevent leaks.
CBI
CBI
CBI
CBI
CBI
CBI
Unknown
EES-RiverRouge-MI
Shift Battery Foreman Daily Rounds and documenting on Battery Turn Report
Negligible
<$100K
2
14
730
Manager
Varies
EES-RiverRouge-MI
Onsite Door Repair
Negligible
<$100K
Varies
Varies
Varies
Skilled Trades
Varies
EES-RiverRouge-MI
Jamb and Door Cleaning Cycle Inspection
Negligible
<$100K
2
14
730
Manager
Varies
EES-RiverRouge-MI
Pusher Operator Pre-Job Inspection
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Inspect and Clean Pusher Side Door Cleaning Blades
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Boarding of Door Machine In and Out of Service
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Inspect and Clean Door Machine Door Cleaner Blades
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Cleaning and Inspection of Chuck Doors
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Cleaning of Oven Doors and Jambs (Automatic)
Negligible
<$100K
Varies
Varies
Varies
Operator
Varies
EES-RiverRouge-MI
Door Program
Negligible
<$500K
Varies
Varies
Varies
Operator & Contractor
Varies
EES-RiverRouge-MI
Adjustment of New or Repaired Doors
Negligible
<$100K
2
14
730
Skilled Trades & Operator
Varies
EES-RiverRouge-MI
Spare Door Inspection
Negligible
<$100K
2
14
730
Operator & Manager
Varies
EES-RiverRouge-MI
Door Jamb Inspection, Repair and Replacement
Negligible
<$100K
Varies
Varies
Varies
Skilled Trades, Operator & Contractor
Varies
USS-Clairton-PA
CBI
CBI
CBI
CBI
CBI
CBI
CBI
CBI

Table B-2. Specific Work Practice, Equipment, and Other Measures Used to Minimize Leaks from Doors
                                  Facility ID
       Indicate if currently using, tried in past, or considered in past
                        Describe how well it works/ed;
                        Describe why not using anymore
              Describe Measure (Work Practice/ Equipment /Other)
                         Capital Purchases and Year$;
                       Annual O&M Expenses and Year$
                               Labor (hrs/day);
                                  (hrs/week);
                                   (hrs/yr)

       Type of Labor (e.g., (technician, skilled worker, manager, etc.)
        Estimated Control Efficiency (%) of Work Practice or Equipment
1. A program for the inspection, adjustment, repair, and replacement of coke oven doors and jambs, and any other equipment for controlling emissions from coke oven doors, including a defined frequency of inspections, the method to be used to evaluate conformance with operating specifications for each type of equipment, and the method to be used to audit the effectiveness of the inspection and repair program for preventing exceedances
ABC-Tarrant-AL

Designed program works well
ABC currently uses our Work Practice Plan. In addition to these practices, ABC hired Montrose for our 3rd party 303 and Meth. 9 readings. These are done 7 days per week as well as our Environmental dept. readings completed daily by certified staff. ABC has implemented a daily work order plan for tracking problem doors and when and if they are to be repaired in place or replaced with a new door. ABC repairs doors onsite and keeps an inventory as stated in the WPP. ABC uses "smoke packers" to do "in situ" repairs and adjustments.
$27,000.00 per month (Montrose)
The other costs are incorporated into our oven budget

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using when required in accordance with Subpart L as detailed in the Work Practice Plan
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance.
Internal written procedures work well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
Excellent, door leaks can consistently meet zero over several days & door fires have greatly reduced
Doors are on a schedule or based on actual performance moved up to be repaired. They are taken out of service and sent to an offsite contractor to repair / adjust doors according to a specification
<$100K;
$100K-$250K
<8;
<40;
<2080
subcontractor
>50%
USS-Clairton-PA
Currently using
Works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
2. Procedures for identifying leaks that indicate a failure of the emissions control equipment to function properly, including a clearly defined chain of command for communicating information on leaks and procedures for corrective action
ABC-Tarrant-AL

ABC feels our designed program works well. ABC also takes into consideration any successful program can be affected by equipment failure or operator error and must deal with these inevitable failures.
ABC currently uses our Work Practice Plan. In addition to these practices, ABC hired Montrose for our 3rd party 303 and Meth. 9 readings. These are done 7days per week as well as our Environmental dept. readings completed daily by certified staff. ABC has implemented a daily work order plan for tracking problem doors and when and if they are to be repaired in place or replaced with a new door. ABC repairs doors onsite and keeps an inventory as stated in the WPP. ABC uses "smoke packers" to do "in situ" repairs and adjustments.
Work Practice and Equipment and implementation is described in WPP.
27,000.00 per month (Montrose)  The other costs are incorporated into our oven budget

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using when required in accordance with Subpart L as detailed in the Work Practice Plan
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance.
Internal written procedures work well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management and Environmental
Method 303 completed daily; additionally operations are empowered to identify and act to mitigate any door leaks regardless of whether they were observed during Method 303 inspection
<$100K;
<$100K
1;
7;
364
subcontractor / operators
>50%
USS-Clairton-PA
Currently using
works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
3. Procedures for cleaning all sealing surfaces of each door and jamb, including identification of the equipment that will be used and a specified schedule or frequency for the cleaning of sealing surfaces
ABC-Tarrant-AL

ABC feels our designed program works well. ABC also takes into consideration any successful program can be affected by equipment failure or operator error and must deal with these inevitable failures.
PSDM and CSDM clean jambs and doors after each push on each battery.
Work Practice and Equipment and implementation is described in WPP.

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using when required in accordance with Subpart L as detailed in the Work Practice Plan
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance.

Internal written procedures well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
SOPs are created and trained
SOPs for operations for each job type include these "specials" Operators are trained for over 6 months prior to being qualified to complete these SOPs
<$100K
<8;
<16;
<832
operators
>50%
USS-Clairton-PA
Currently using
works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
4. For batteries equipped with self-sealing doors, procedures for use of supplemental gasketing and luting materials, if the owner or operator elects to use such procedures as part of the program to prevent exceedances
ABC-Tarrant-AL

ABC feels our designed program works well. ABC also takes into consideration any successful program can be affected by equipment failure or operator error and must deal with these inevitable failures.
Supplemental door seal is used on each door and smoke packer uses materials and lute if needed.
Work Practice and Equipment and implementation is described in WPP

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using when required in accordance with Subpart L as detailed in the Work Practice Plan
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance.

Internal written procedures work well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management
<$100K;
<$100K
<8;
<40;
<2080
subcontractors / operators
>50%
USS-Clairton-PA
Currently using
Works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
5. For batteries equipped with hand-luted doors, procedures for luting and reluting, as necessary to prevent exceedances; procedures for maintaining an adequate inventory of the number of spare coke oven doors and jambs located onsite; and procedures for monitoring and controlling collecting main back pressure, including corrective action if pressure control problems occur
ABC-Tarrant-AL

Well
Smoke packer lutes and re-lutes doors as needed. Shift heaterman checks backpressure each shift and recorder output is watched on each battery by shift foreman. If controller fails, heaterman puts butterfly in manual and controls it manually until automatic controller is repaired.
Work Practice and Equipment and implementation is described in WPP

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using when required in accordance with Subpart L as detailed in the Work Practice Plan
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance.
Internal written procedures work well as shown by Method 303 results.

EES-River Rouge-MI
NA
NA
N/A
N/A
N/A
N/A
N/A
USS-Clairton-PA
Currently using
Works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
6. Flexible door seals
ABC-Tarrant-AL
Yes
Flexible seals works well if seal does not get bent in replacing door
Work Practice and Equipment and implementation is described in WPP

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Not using
N/A

EES-River Rouge-MI
Currently using
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management
<$100K;
<$100K
<8;
<16;
<832
operators
>50%
USS-Clairton-PA
Currently using
works
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
7. Complete overhaul of the doors; complete dismantling of all individual parts, cleaning and reassembling; readjustment of the sealing elements
ABC-Tarrant-AL

It works well - it is a totally remanufactured door.
If a door has been diagnosed by Ovens manager to need replacing. It is first taken to our door shop, dismantled and completely overhauled. If door is deemed bent, it is then hauled offsite, straightened and returned to our onsite door shop and refitted with new seal, bolts, etc..
pressure washer, presses, grinders, bolts, planers, seals and cranes.

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using
Works well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
This is part of door management program that is subcontracted
Work is subcontracted and usually per a schedule and repairs can be prioritized upon identification of repairs needed during inspection
$100K-$250K;
$100K-$250K
8;
40;
2080
operators / subcontractors
>50%
USS-Clairton-PA
Currently performing
Works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
8. Replacement of damaged door bricks; complete rebricking of the door may be necessary
ABC-Tarrant-AL
As needed

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using
Works well as shown by Method 303 results.

EES-River Rouge-MI
Currently Using
Operators inspect ovens on a planned schedule and/or if there is an identified issue
Work is subcontracted upon identification of repairs needed during inspection
$100K-$250K;
$100K-$250K
8;
40;
2080
operators / subcontractors
>50%
USS-Clairton-PA
N/A
No longer using bricks in any coke oven doors. Castable plugs are now used.
CBI
CBI
CBI;
CBI;
CBI
CBI
CBI
9. Careful cleaning of the door and its frame at each coke push
ABC-Tarrant-AL
Done each push

Cleans jambs and doors of excessive carbon to help in sealing and leakage.
CSDM and PSDM

CC-BurnsHarbor-IN
Used when equipment is available.
Works well as shown by Method 303 results

CC-Monessen-PA;
CC-Warren-OH
Currently using
Works well as shown by Method 303 results

EES-River Rouge-MI
Currently using
SOPs are created and trained
SOPs for operations for each job type include these "specials" Operators are trained for over 6 months prior to being qualified to complete these SOPs
<$100K;
<$100K
<8;
<16;
<832
Operators
>50%
USS-Clairton-PA
Currently using
Works well
CBI
CBI;

CBI;

CBI
CBI
10. Gas channels inside the doors
ABC-Tarrant-AL
N/A

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using
Works well as shown by Method 303 results

EES-River Rouge-MI
Not in Use
N/A
N/A
N/A
N/A
N/A
N/A
USS-Clairton-PA
Currently using
Works well
CBI
CBI;

CBI;
CBI
CBI

APPENDIX C
          INDIVIDUAL COMPANY RESPONSES SUBMITTED FOR WORK PRACTICES
                           FOR MINIMIZING LID LEAKS

      This appendix presents the tabulated individual company non-CBI CAA section 114 responses to questions about work practices for minimizing leaks from lids.

Table C-1. General Work Practice, Equipment, and Other Measures Used to Minimize Leaks from Lids

                                  Facility ID
             Work practice / Equipment / Other measure Description
                      Cost - Capital Purchases and Year$
                  Cost - Annual Operating Expenses
and Year$
                                Labor (hrs/day)
                               Labor (hrs/week)
                                Labor (hrs/yr)
       Type of Labor (e.g., (technician, skilled worker, manager, etc.)
               Estimated Control efficiency (%) of Work Practice
ABC-Tarrant-AL
CBI
CBI
CBI
CBI
CBI
CBI
CBI
CBI
CC-BurnsHarbor-IN
Internal Written Procedure: SOPs and work practices for inspection, sealing and replacement of lids.
CBI
CBI
CBI
CBI
CBI
CBI
Unknown
CC-Monessen-PA
Job Written SOPs for inspection, sealing and replacement of lids.
CBI
CBI
CBI
CBI
CBI
CBI
Unknown
CC-Warren-OH
Internal Written Procedure: SOPs and work practices for inspection, sealing and replacement of lids.
CBI
CBI
CBI
CBI
CBI
CBI
Unknown
EES-RiverRouge-MI
Inspection, Cleaning, Repair and Replacement of Topside Port Lids
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Sealing and Resealing of Topside Port Lids
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Audit of Lid Inspection and Repair Program
Negligible
<$100K
2
14
730
Manager
Varies
USS-Clairton-PA
CBI
CBI
CBI
CBI
CBI
CBI
CBI
CBI

Table C-2. Specific Work Practice, Equipment, and Other Measures Used to Minimize Leaks from Lids
                                  Facility ID
       Indicate if currently using, tried in past, or considered in past
                      Describe how well it works/ worked
                        Describe why not using anymore
              Describe Measure (Work Practice/ Equipment /Other)
                         Capital Purchases and Year$;
                       Annual O&M Expenses and Year$
                               Labor (hrs/day);
                                  (hrs/week);
                                   (hrs/yr)
       Type of Labor (e.g., (technician, skilled worker, manager, etc.)
        Estimated Control Efficiency (%) of Work Practice or Equipment
1. Procedures for equipment inspection and replacement or repair of topside port lids and port lid mating and sealing surfaces, including the frequency of inspections, the method to be used to evaluate conformance with operating specifications for each type of equipment, and the method to be used to audit the effectiveness of the inspection and repair program for preventing exceedances
ABC-Tarrant-AL

Replaced and Repaired as needed. If Lid is leaking it is cleaned and reluted. Larry Car is machine involved with Lids.

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using when required in accordance with Subpart L as detailed in the Work Practice Plan
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance.
Internal written procedures as detailed in Question 4 work well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
Operators inspect lids on a planned schedule and/or if there is an identified issue
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management
<$100K;
<$100K
1;
7;
365
Operators
>50%
USS-Clairton-PA
Currently using
Works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
2. Procedures for sealing topside port lids after charging, for identifying topside port lids that leak, and procedures for resealing
ABC-Tarrant-AL

Replaced and Repaired as needed.  If Lid is leaking it is cleaned and reluted.

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using when required in accordance with Subpart L as detailed in the Work Practice Plan
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance.
Internal written procedures as detailed in Question 4 work well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management
SOPs for operations for each job type include these "specials" Operators are trained for over 6 months prior to being qualified to complete these SOPs
<$100K;
<$100K
<8
<40
<2080
Subcontractors
>50%
USS-Clairton-PA
Currently using
Works well
CBI
CBI;
CBI
CBI
CBI
CBI
CBI
CBI
3. Using luted lids
ABC-Tarrant-AL
Yes
It either seals or doesn't. If it doesn't reseal the lid
 Larry Car is machine involved with
Lids.

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using
Works well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management
SOPs for operations for each job type include these "specials" Operators are trained for over 6 months prior to being qualified to complete these SOPs
<$100K;
<$100K
<8
<40
<2080
Subcontractors
>50%
USS-Clairton-PA
Currently using
We manually lute lids after charging with silica based liquid material (mud) to seal lids.
CBI
CBI;
CBI
CBI
CBI
CBI
CBI
CBI

APPENDIX D
  INDIVIDUAL COMPANY RESPONSES SUBMITTED FOR WORK PRACTICES FOR OFFTAKE LEAKS

      This appendix presents the tabulated individual company non-CBI CAA section 114 responses to general and specific work practices for offtakes.

Table D-1. General Work Practice, Equipment, and Other Measures Used to Minimize Leaks from Offtakes
                                  Facility ID
             Work practice / Equipment / Other measure Description
                      Cost - Capital Purchases and Year$
                  Cost - Annual Operating Expenses
and Year$
                                Labor (hrs/day)
                               Labor (hrs/week)
                                Labor (hrs/yr)
       Type of Labor (e.g., (technician, skilled worker, manager, etc.)
               Estimated Control efficiency (%) of Work Practice
ABC-Tarrant-AL
CBI
CBI
CBI
CBI
CBI
CBI
CBI
CBI
CC-BurnsHarbor-IN
Internal Written Procedure: SOPs and work practice for the installation, sealing and replacement of offtakes, caps and standpipes; procedures for stopping/preventing leaks.
CBI
CBI
CBI
CBI
CBI
CBI
Unknown
CC-Monessen-PA
Job Written SOPs for installation, sealing and replacement of offtakes, caps and standpipes; procedures for stopping/preventing leaks.
CBI
CBI
CBI
CBI
CBI
CBI
Unknown
CC-Warren-OH
Internal Written Procedure: SOPs and work practice for the installation, sealing and replacement of offtakes, caps and standpipes; procedures for stopping/preventing leaks.
CBI
CBI
CBI
CBI
CBI
CBI
Unknown
EES-RiverRouge-MI
Standpipe Inspection & Cleaning (Decarbonization)
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Standpipe Cap Inspection & Cleaning
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Gooseneck Inspection & Cleaning
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Damper & Main Inspection & Cleaning
Negligible
<$100K
Varies
Varies
Varies
Operator
Varies
EES-RiverRouge-MI
Oven Roof Inspection & Cleaning
Negligible
<$100K
Varies
Varies
Varies
Operator
Varies
EES-RiverRouge-MI
Charging Hole Inspection & Cleaning
Negligible
<$100K
2
2
104
Operator
Varies
EES-RiverRouge-MI
Liquor System Inspection & Cleaning
Negligible
<$100K
2
2
104
Operator
Varies
EES-RiverRouge-MI
Utilityman Offtake System Review
Negligible
<$100K
2
14
730
Operator
Varies
EES-RiverRouge-MI
Audit of Offtake System Inspection & Repair Program
Negligible
<$100K
2
2
104
Manager
Varies
EES-RiverRouge-MI
Dampering Ovens Prior to Push
Negligible
<$100K
2
14
730
Operator
Varies
USS-Clairton-PA
CBI
CBI
CBI
CBI
CBI
CBI
CBI
CBI

TABLE D-2. Specific Work Practice, Equipment, and Other Measures Used to Minimize Leaks from Offtakes
                                  Facility ID
       Indicate if currently using, tried in past, or considered in past
                      Describe how well it works/ worked
                        Describe why not using anymore
              Describe Measure (Work Practice/ Equipment /Other)
                         Capital Purchases and Year$;
                       Annual O&M Expenses and Year$
                               Labor (hrs/day);
                                  (hrs/week);
                                   (hrs/yr)
       Type of Labor (e.g., (technician, skilled worker, manager, etc.)
        Estimated Control Efficiency (%) of Work Practice or Equipment
1. Procedures for equipment inspection and replacement or repair of offtake system components, including the frequency of inspections, the method to be used to evaluate conformance with operating specifications for each type of equipment, and the method to be used to audit the effectiveness of the inspection and repair program for preventing exceedances
ABC-Tarrant-AL

Works well in preventing exceedances.
Standpipes & Caps are inspected by the Larry Car Operator prior to charging the oven. Cleaning will take place using high pressure water. Lid will be cleaned and stand pipe will be cleaned to maintain a 12 inch opening from the oven to the collecting main. Operator will check liquor spray, steam spray, standpipe, lid, and gooseneck. This is done before each charge. If there are problems, ABC has a work order system in place. Shift foreman puts in a work order for repairs and the repair process is started. Oven repair supervisors make visual observation daily to note possible problems and Oven Repair Dept. retains mechanics at their disposal to process and repair problems or potential problems that may arise.

CC-BurnsHarbor-IN
Currently using when required
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance. Internal written procedures as detailed in Question 4 work well as shown by Method 303 results.

CC-Monessen-PA
Currently using when required
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance. Various written Job SOPs work well as shown by Method 303 results.

CC-Warren-OH
Currently using when required
Work Practice Plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance. The measures detailed in Question 4 work well as shown by Method 303 results.

EES-River Rouge-MI
Currently using
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management and Environmental
Method 303 completed daily; additionally operations are empowered to identify and act to mitigate any offtake leaks regardless of whether they were observed during Method 303 inspection
<$100K;
<$100K
1;
7;
364
Subcontractor / operators
>50%
USS-Clairton-PA
Currently using
Works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
2. Procedures for identifying offtake system components that leak and procedures for sealing leaks that are detected
ABC-Tarrant-AL

Standpipes & caps are inspected by the Larry car operator prior to charging the oven. Cleaning will take place using high pressure water. Lid will be cleaned and stand pipe will be cleaned to maintain a 12 inch opening from the oven to the collecting main. Operator will check liquor spray, steam spray, standpipe, lid, and gooseneck. This is done before each charge. If there are problems, ABC has a work order system in place. Shift foreman puts in a work order for repairs and the repair process is started. Oven repair supervisors make visual observation daily to note possible problems and Oven Repair Dept. retains mechanics at their disposal to process and repair problems or potential problems that may arise.

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using
Using when required in accordance with Subpart L, as detailed in the Work Practice Plan

EES-River Rouge-MI
Currently using
SOPs are created and trained, inspection and repair triggered by levels of emissions, documentation is submitted to Management
SOPs for operations for each job type include these "specials" Operators are trained for over 6 months prior to being qualified to complete these SOPs
<$100K;
<$100K
1;
7;
364
subcontractor / operators
>50%
USS-Clairton-PA
Currently using
Works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
3. Procedures for dampering off ovens prior to a push
ABC-Tarrant-AL

Standpipes & caps are inspected by the Larry car operator prior to charging the oven. Cleaning will take place using high pressure water. Lid will be cleaned and stand pipe will be cleaned to maintain a 12 inch opening from the oven to the collecting main. Operator will check liquor spray, steam spray, standpipe, lid, and gooseneck. This is done before each charge. If there are problems, ABC has a work order system in place. Shift foreman puts in a work order for repairs and the repair process is started. Oven repair supervisors make visual observation daily to note possible problems and Oven Repair Dept. retains mechanics at their disposal to process and repair problems or potential problems that may arise.

CC-BurnsHarbor-IN;
CC-Monessen-PA;
CC-Warren-OH
Currently using
Work practice plan (Subpart L) not required to be implemented until the 2nd independent exceedance in any consecutive 6-month period. This plan has not been implemented in full over the last 5 years because there has not been a Subpart L exceedance. Internal written procedures/ various written job SOPs work well, as shown by Method 303 results.

EES-River Rouge-MI
Currently using
SOPs are created and trained by personnel in order to be qualified for their position, on the job training is extensive before allowing qualification
SOPs for operations for each job type Operators are trained for over 6 months prior to being qualified to complete these SOPs
<$100K;
<$100K
<8;
<40;
<2080
subcontractors
>50%
USS-Clairton-PA
Currently using
works well
CBI
CBI;
CBI
CBI;
CBI;
CBI
CBI
CBI
Note: WPP = work practice plan. OP = standard operating procedures

APPENDIX E

                      EU LEAK CONTROL PRACTICES FOR DOORS

      In the EU BAT document,[6] improving door seals by use of flexible door seals was cited as one BAT measure that could be used to reduce leaking doors. Emissions from flexible sealed doors were cited as a way to achieve much lower emissions than with conventional doors, where VE below 5 percent (using EPA Method 303) as a weekly average of all the coke oven doors was achievable. In the EU BAT document,[6] it was noted that VE values below 4 percent have been achieved at U.S. COB.

      In the EU BAT document,[6] it was also noted that periodically a complete oven overhaul should be considered for each oven every five years, on average, depending on the state of the ovens. In the EU BAT document,[6] it was stated that the overhaul entails leaving the oven empty for a week while the operations listed below are carried out. The maintenance can be performed in one time period or continuously. No fixed or minimum period of maintenance can be set. Maintenance should follow a systematic program and be carried out by specially-trained maintenance personnel. This was considered a common technique carried out by all coke operators in the EU.[6] It was stated in the EU BAT document[6] that an oven overhaul includes the following:

 Inspection of the oven;
 Degraphitizing of all deposits within the chamber (walls, ceiling, ascension pipes);
 Oxy-thermic welding of cracks, holes and surface damage of the refractory brickwork;
 Repair of the oven chamber floor by flooding with cement;
 Injection of dust into fine cracks;
 Complete overhaul of the doors; complete dismantling of all individual parts, cleaning and reassembling; readjustment of the sealing elements;
 Replacement of damaged door bricks; complete rebricking of the door may be necessary; and
 Use of coke oven chamber wall diagnosing-repairing apparatus.

      The costs cited in the EU BAT document[6] were converted to U.S. dollars in 2020 and resulted in cost estimates of $2.41 US$ per ton of coke produced, which translates to approximately $3M per yr per average U.S. by-product plant. In the EU BAT document,[6] it was noted that personnel costs for skilled workers carrying out the maintenance program are considerable, but that better skilled operators contribute to higher productivity and, thus, compensates for the higher hourly costs. No potential emission reductions were provided in the EU BAT document,[6] although it can assumed there would be a measurable amount but that it would vary by facility and the state of the ovens prior to the overhaul.

APPENDIX F

                DETAILS OF PROVEN TECHNOLOGY PROVIDED BY VENDOR


[Federal Register Volume 81, Number 85 (Tuesday, May 3, 2016)]
[Notices]
[Pages 26595-26597]
[FR Doc No: 2016-10271]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77722; File No. SR-NASDAQ-2016-034]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Granting Approval of a Proposed Rule Change Regarding Monthly
Distributions, Excess Returns, and Share Index Factors of Certain
AccuShares[supreg] Trust I Funds

April 27, 2016.
    On March 2, 2016, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify specific listing requirements applicable
to shares of certain funds issued by AccuShares[supreg] Trust I
(``AccuShares Trust''). The proposed rule change was published for
comment in the Federal Register on March 17, 2016.\3\ The Commission
received two comments on the proposed rule change.\4\ This order grants
approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 77353 (Mar. 11,
2016), 81 FR 14489 (``Notice'').
    \4\ In a comment letter dated March 27, 2016, an anonymous
commenter stated: ``Good.'' In another comment letter dated March
27, 2016, Dan Schumann stated: ``Please do NOT change any rules that
would limit-stop-prevent the trading of ETF's [sic].'' All comments
on the proposal are available at: http://www.sec.gov/comments/sr-nasdaq-2016-034/nasdaq2016034.shtml.
---------------------------------------------------------------------------

I. Background

    On February 18, 2015, the Commission approved an Exchange proposal
to adopt NASDAQ Rule 5713, which governs the listing and trading of
Paired Class Shares, and to list and trade shares of the following
seven funds issued by the AccuShares Trust pursuant to NASDAQ Rule
5713: (1) AccuShares S&P GSCI[supreg] Spot Fund; (2) AccuShares S&P
GSCI[supreg] Agriculture and Livestock Spot Fund; (3) AccuShares S&P
GSCI[supreg] Industrial Metals Spot Fund; (4) AccuShares S&P
GSCI[supreg] Crude Oil Spot Fund; (5) AccuShares S&P GSCI[supreg] Brent
Oil Spot Fund; (6) AccuShares S&P GSCI[supreg] Natural Gas Spot Fund;
and (7) AccuShares Spot CBOE[supreg] VIX[supreg] Fund (``VIX Fund,''
and collectively, ``AccuShares Funds'').\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 74299 (Feb. 18,
2015), 80 FR 9778 (Feb. 24, 2015) (SR-NASDAQ-2014-065). The Exchange
states that currently only shares of the VIX Fund are listed and
trading. See Notice, supra note 3, 81 FR at 14489 n.4.
---------------------------------------------------------------------------

    NASDAQ Rule 5713(c) defines a Paired Class Share as a security: (1)
That is issued by a trust on behalf of a segregated series (``Fund''),
as part of a pair of shares of opposing classes whose respective
underlying values move in opposite directions as the value of the
Fund's ``Underlying Benchmark'' \6\ varies from its starting level,
where (a) one constituent of the pair is positively linked to the
Fund's Underlying Benchmark (``Up Shares''), and (b) the other
constituent is inversely linked to the Fund's Underlying Benchmark
(``Down Shares''); (2) that is issued in exchange for cash; (3) the
issuance proceeds of which are invested and reinvested in highly rated,
short-term financial instruments that mature within 90 calendar days
and that serve the functions of (a) covering the Fund's expenses, (b)
providing income distributions to investors, based on income (after
expenses) from the financial instruments held by the Fund, (c)
providing cash proceeds for regular and special distributions to be
made in cash in lieu of Paired Class Shares, and (d) providing cash
proceeds to be paid upon the redemption of Paired Class Shares; (4)
that represents a beneficial interest in the Fund; (5) the value of
which is determined by the underlying value of the Fund that is
attributable to the class of which such security is a part, which
security underlying value will either (a) increase as a result of an
increase in the Underlying Benchmark and decrease as a result of a
decrease in the Underlying Benchmark (in the case of an Up Share), or
(b) increase as a result of a decrease in the Underlying Benchmark and
decrease as the result of an increase in the Underlying Benchmark (in
the case of a Down Share); (6) that, when timely aggregated in a
specified minimum number or amount of securities, along with an equal
number or amount of the securities of the opposite class that
constitute the other part of the pair, may be redeemed for a
distribution of cash on specified dates by authorized parties; and (7)
that may be subject to

mandatory redemption of all Paired Class Shares under specified
circumstances.
---------------------------------------------------------------------------

    \6\ An ``Underlying Benchmark'' is an index or other numerical
variable whose value reflects the value of assets, prices, price
volatility, or other economic interests. See NASDAQ Rule 5713(e).
---------------------------------------------------------------------------

    The custodian of an Accushares Fund uses a mathematical formula to
calculate the liquidation value attributable to each of its classes of
Paired Class Shares (``Class Value'') and to each share of each class
(``Class Value per Share'') at the end of each Regular Market Session.
The Class Value per Share of each Accushares Fund's Up Shares will have
a fixed one-to-one positive linear relationship with the fund's
Underlying Benchmark (``Up Share Index Factor''), and the Class Value
per Share of each fund's Down Shares will have a fixed one-to-one
inverse linear relationship with the fund's Underlying Benchmark
(``Down Share Index Factor,'' and together with the Up Share Index
Factor, collectively, ``Share Index Factors''). The Down Share Index
Factor will equal negative one times the Up Share Index Factor. Share
Index Factors are used to determine the Class Value and Class Value Per
Share of each Accushares Fund.\7\
---------------------------------------------------------------------------

    \7\ See Notice, supra note 3, 81 FR at 14491.
---------------------------------------------------------------------------

    The sponsor of an Accushares Fund establishes an Accushares Fund's
Share Index Factors at the inception of the fund's operation, and,
after any regular or special distribution, the fund resets its Share
Index Factors. For the VIX Fund, regular distributions are on the 15th
of every month.

II. Summary of the Proposed Rule Change

    In this proposal, NASDAQ proposes the following changes applicable
to the listing and trading of shares of certain AccuShares Funds.

A. Frequency of Regular Distributions 8
---------------------------------------------------------------------------

    \8\ See id., 81 FR at 14491-92.
---------------------------------------------------------------------------

    With respect to the listing requirements for the AccuShares
S&P[supreg] GSCI[supreg] Industrial Metals Spot Fund, AccuShares
S&P[supreg] GSCI[supreg] Crude Oil Spot Fund, and AccuShares
S&P[supreg] GSCI[supreg] Brent Oil Spot Fund (collectively,
``Distribution Funds''), the Exchange proposes to change the frequency
of regular distributions from quarterly to monthly.

B. Changes to the Underlying Benchmark 9
---------------------------------------------------------------------------

    \9\ See id., 81 FR at 14492-93.
---------------------------------------------------------------------------

    With respect to the listing requirements for the AccuShares
S&P[supreg] GSCI[supreg] Crude Oil Spot Fund and the AccuShares
S&P[supreg] GSCI[supreg] Natural Gas Spot Fund, the Exchange proposes
to change the respective Underlying Benchmarks, as follows: (1) For the
AccuShares S&P[supreg] GSCI[supreg] Crude Oil Spot Fund, the Exchange
proposes to change this fund's Underlying Benchmark from the ``S&P GSCI
Crude Oil Spot Index'' to the ``S&P GSCI Crude Oil Excess Return
Index;'' \10\ and (2) for the AccuShares S&P[supreg] GSCI[supreg]
Natural Gas Spot Fund, the Exchange proposes to change this fund's
Underlying Benchmark from the ``S&P GSCI Natural Gas Spot Index'' to
the ``S&P GSCI Natural Gas Excess Return Index.'' \11\
---------------------------------------------------------------------------

    \10\ As a result of the proposed change to the Underlying
Benchmark, the Exchange also proposes to change the name of this
fund to ``AccuShares S&P[supreg] GSCI[supreg] Crude Oil Excess
Return Fund.''
    \11\ As a result of the proposed change to the Underlying
Benchmark, the Exchange also proposes to change the name of this
fund to ``AccuShares S&P[supreg] GSCI[supreg] Natural Gas Excess
Return Fund.''
---------------------------------------------------------------------------

    According to the Exchange, both the spot and the excess return
variants of each respective Underlying Benchmark are computed from the
same underlying futures contracts at the same point in time. The
difference between the two variants occurs only on 5 trading days: The
5th through the 9th trading days of each month (``five-day period'').
During the five-day period, each Underlying Benchmark, whether monthly
return or excess return, moves its reference from the front-month
expiry contract to the next following contract (that is, the futures
contract for the next consecutive expiry month) in five equal
installments of 20% per day to capture the cost or the benefit from
rolling the nearby front-month expiry contract into the next following
expiry contract. In the excess return variant, the cost or benefit of
transacting out of the current or front-month expiry contract and into
the next or following futures contract is added to (or subtracted from)
the index value. In contrast, in the spot variant, this cost or benefit
is not added to (or subtracted from) the index value, and therefore
gives rise to the need for anticipatory hedging that is market makers
and authorized participants expect to result in increased bid/offer
spreads.

C. Changes to the VIX Fund 12
---------------------------------------------------------------------------

    \12\ See id., 81 FR at 14493.
---------------------------------------------------------------------------

    The Exchange proposes, with respect to the VIX Fund, that: (1) The
Share Index Factors be reset each Tuesday (as well as after regular and
special distributions); and (2) the regular distributions be made on
the third Tuesday of every month (rather than on the 15th of every
month) so that each monthly distribution date and the end of each
monthly measuring period coincide with a Share Index Factor reset.

III. Discussion and Commission Findings

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\13\ In particular, and as discussed further below, the
Commission finds that the proposed rule change is consistent with the
requirements of Section 6(b)(5) of the Act,\14\ which requires, among
other things, that the Exchange's rules be designed to promote just and
equitable principles of trade; to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities; to remove impediments to and perfect the mechanism of a
free and open market and a national market system; and, in general, to
protect investors and the public interest.\15\
---------------------------------------------------------------------------

    \13\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ The Commission notes that, other than the changes described
herein, all of the representations in support of the Prior Order
remain unchanged. See Notice, supra note 3, 81 FR at 14493 (noting
that, other than the three proposed changes, the ``representations
made in the original AccuShares Order and AccuShares Proposal remain
unchanged''). See supra note 5; see also Notice, supra note 3, 81 FR
at 14489 n.4 (citing to the AccuShares Order and AccuShares
Proposal).
---------------------------------------------------------------------------

    With respect to the proposed changes to the frequency of monthly
distributions for the Distribution Funds, the Commission believes that
the proposed changes are reasonably designed to: (1) Allow investors to
realize and reallocate gains from the Distribution Funds more
frequently; and (2) appropriately align the changes in the Class Values
per Share of both the Up Shares and the Down Shares with changes in the
corresponding Underlying Benchmark values. The Commission believes that
these more-frequent regular distributions may improve both trading in,
and hedging of, the shares, because monthly distributions and the
corresponding monthly Share Index Factor resets would more closely
align these funds with the most liquid monthly futures contracts. The
Commission notes that, in support of this proposed change, the Exchange
makes the following representations: (1) In each instance of a
distribution, the sponsor will continue to post a notice of the event
and its details on the sponsor's Web site (www.AccuShares.com); and (2)
each Accushares Fund engaging in a regular

distribution (or, a special distribution, corrective distribution, or
net income distribution) will continue to provide at least three
business days' advance notice (or longer advance notice as may be
required by the Exchange) \16\ of such an event, as currently
required.\17\
---------------------------------------------------------------------------

    \16\ The Exchange may determine that longer notice is advisable
in some circumstances (e.g., an extended market break).
    \17\ See Notice, supra note 3, 81 FR at 14492.
---------------------------------------------------------------------------

    With respect to the proposed changes to the Underlying Benchmarks
for the AccuShares S&P[supreg] GSCI[supreg] Crude Oil Spot Fund and the
AccuShares S&P[supreg] GSCI[supreg] Natural Gas Spot Fund, the
Commission agrees that the excess return variant--which, in contrast to
the spot variant, captures the cost or benefit of transacting out of
the current or front-month expiry contract and into the next or
following futures contract--is not a novel or unique index variant and
is one that is employed by other types of exchange-traded products.\18\
The Commission believes that the proposed changes to the Underlying
Benchmarks for the AccuShares S&P[supreg] GSCI[supreg] Crude Oil Spot
Fund and the AccuShares S&P[supreg] GSCI[supreg] Natural Gas Spot Fund
are reasonable because the excess return variant for these Underlying
Benchmarks, which contains the cost or benefit of the roll forward, is
reasonably designed to permit more efficient hedging with conventional
futures contracts.\19\
---------------------------------------------------------------------------

    \18\ See id., 81 FR at 14492 n.25 and accompanying text.
    \19\ The Exchange represents that the excess return variant is
an index variant that (1) has been used by and is familiar to market
makers and other market participants; and (2) is directly hedgeable
with conventional futures contracts, which contain the cost or
benefit of the roll forward. See id., 81 FR at 14492.
---------------------------------------------------------------------------

    With respect to the proposal to reset the Share Index Factors of
the VIX Fund more frequently (i.e., weekly), the Commission believes
that more frequent resets of the Share Index Factors for the VIX Fund
are reasonably designed to benefit market participants that trade
shares of the VIX Fund because the increased frequency may improve the
arbitrage function of the shares by aligning the setting of the Share
Index Factors with the expiry of each weekly VIX futures contract, and
because the Share Index Factor will reset with a frequency closer to
the daily measurements of spot VIX. The changes to the VIX Fund support
the prospect of improved and simplified arbitrage and hedging of VIX
Fund shares because the settlement of the shorter VIX futures will
coincide with each Share Index Factor reset. In addition, the
potentially improved hedgeability of the VIX Fund shares as a result of
the proposed changes is expected to bring the share trading prices
closer aligned with the corresponding share Class Values, which are
tied directly to changes in spot VIX values.
    The Commission notes that it received two comments regarding the
proposed rule change: one comment supporting the proposal; and another
comment addressing exchange-traded funds generally. The Commission
notes that the issue raised by the latter comment does not squarely
address the Paired Class Shares, which are the subject of this proposed
rule change.\20\
---------------------------------------------------------------------------

    \20\ See supra note 4.
---------------------------------------------------------------------------

    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act \21\ and the
rules and regulations thereunder applicable to a national securities
exchange.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-NASDAQ-2016-034) be, and it hereby
is, approved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-10271 Filed 5-2-16; 8:45 am]
 BILLING CODE 8011-01-P