[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37124-37126]
[FR Doc No: 2011-15799]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0610]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry on Postmarketing Adverse Event Reporting for Medical Products
and Dietary Supplements During an Influenza Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by July
25, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title ``Draft Guidance for Industry on Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During an
Influenza Pandemic.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance: Draft Guidance for Industry on Postmarketing
Adverse Event Reporting for Medical Products and Dietary Supplements
During an Influenza Pandemic; Availability--(OMB Control Number 0910-
New)

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Postmarketing Adverse Event Reporting for Medical
Products and Dietary Supplements During an Influenza Pandemic.'' In the
Federal Register of December 16, 2008 (73 FR 76364), FDA published
notice of the availability of a draft guidance of the same title. FDA
anticipates that during an influenza pandemic, industry and FDA
workforces may be reduced while reporting of adverse events related to
widespread use of medical products indicated for the treatment and
prevention of influenza may increase, although the extent of these
possible changes is unknown. The revised draft guidance discusses FDA's
intended approach to enforcement of adverse event reporting
requirements for drugs, biologics, medical devices, and dietary
supplements during an influenza pandemic.

II. Revisions to the 2008 Draft Guidance

    FDA is issuing a revised draft guidance that includes
recommendations for planning, notification, and documentation for firms
that report postmarketing adverse events. The revised draft guidance
recommends that each firm's pandemic influenza continuity of operations
plan (COOP) include instructions for reporting adverse events and a
plan for the submission of stored reports that were not submitted
within regulatory timeframes. The revised draft guidance recommends
that firms that are unable to fulfill normal adverse event reporting
requirements during an influenza pandemic do the following:
     Document the conditions that prevent them from meeting
normal reporting requirements,
     Notify the appropriate FDA organizational unit responsible
for adverse event reporting compliance when these conditions exist and
when the reporting process is restored, and
     Maintain records to identify what reports have been
stored.
    These recommendations represent collections of information under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520)
discussed in section IV of this document. In issuing this revised draft
guidance, FDA considered all comments that were submitted in response
to the December 2008 draft guidance. Most comments requested that
greater clarity be provided in certain sections; FDA has revised these
sections accordingly.
    This draft guidance does not address monitoring and reporting of
adverse events that might be imposed as a condition of authorization
for products authorized for emergency use under section 564 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb-
3). This draft guidance also does not address monitoring and reporting
of adverse events as required by regulations establishing the
conditions for investigational use of drugs, biologics, and devices.
(See 21 CFR parts 312 and 812.)
    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 Agency's current thinking on
postmarketing adverse event reporting for medical products and dietary
supplements during pandemic influenza. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Paperwork Reduction Act of 1995

    Under the PRA, Federal agencies must obtain approval from the
Office of Management and Budget (OMB) for each collection of
information that they

conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    The draft guidance explains FDA's approach to enforcement of
adverse event reporting requirements for drugs, biologics, medical
devices, and dietary supplements during an influenza pandemic,
including an intent not to object to changes in the timing of
submission of certain reports during some stages of the pandemic
response. The Agency recommends that each firm's pandemic influenza
COOP include instructions for reporting adverse events, including a
plan for the submission of stored reports that were not submitted
within regulatory timeframes. The draft guidance explains that firms
that are unable to fulfill normal adverse event reporting requirements
during an influenza pandemic should: (1) Maintain documentation of the
conditions that prevent them from meeting normal reporting
requirements; (2) notify the appropriate FDA organizational unit
responsible for adverse event reporting compliance when the conditions
exist and when the reporting process is restored; and (3) maintain
records to identify what reports have been stored.
    Based on the number of manufacturers that would be covered by the
draft guidance, we estimate that approximately 5,000 firms will add the
following to their COOP: (1) Instructions for reporting adverse events;
and (2) a plan for submitting stored reports that were not submitted
within regulatory timeframes. We estimate that each firm will take
approximately 50 hours to prepare the adverse event reporting plan for
its COOP.
    We estimate that approximately 500 firms will be unable to fulfill
normal adverse event reporting requirements because of conditions
caused by an influenza pandemic and that these firms will notify the
appropriate FDA organizational unit responsible for adverse event
reporting compliance when the conditions exist. Although we do not
anticipate such pandemic influenza conditions to occur every year, for
purposes of the PRA, we estimate that each of these firms will notify
FDA approximately once each year, and that each notification will takem
approximately 8 hours to prepare and submit.
    Concerning the recommendation in the draft guidance that firms
unable to fulfill normal adverse event reporting requirements maintain
documentation of the conditions that prevent them from meeting these
requirements and also maintain records to identify what adverse event
reports have been stored and when the reporting process is restored, we
estimate that approximately 500 firms will each need approximately 8
hours to maintain the documentation and that approximately 500 firms
will each need approximately 8 hours to maintain the records.
Therefore, the total recordkeeping burden that would result from the
draft guidance would be 258,000 hours.
    The draft guidance also refers to previously approved collections
of information found in FDA's adverse event reporting requirements in
21 CFR 310.305, 314.80, 314.98, 600.80, 606.170, 640.73, 1271.350, and
part 803. These regulations contain collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and are
approved under OMB control numbers 0910-0116, 0910-0291, 0910-0230,
0910-0308, 0910-0437, and 0910-0543. In addition, the draft guidance
also refers to adverse event reports for nonprescription human drug
products marketed without an approved application and dietary
supplements required under sections 760 and 761 of the FD&C Act (21
U.S.C. 379aa and 379aa-1), which include collections of information
approved under OMB control numbers 0910-0636 and 0910-0635.
    In the Federal Register of January 7, 2011 (76 FR 1170), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
                                     Number of     responses per   Total annual     burden  per     Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Notify FDA when normal reporting             500               1             500               8           4,000
 is not feasible................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

                                                       Table 2--Estimated Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                                                                        Number of      frequency per     Total annual      Hours per       Total hours
                                                                      recordkeepers    recordkeeping       records           record
--------------------------------------------------------------------------------------------------------------------------------------------------------
Add adverse event reporting plan to COOP...........................           5,000                1            5,000               50          250,000
Maintain documentation of influenza pandemic conditions and                     500                1              500                8            4,000
 resultant high absenteeism........................................

Maintain records to identify what reports have been stored and when             500                1              500                8            4,000
 the reporting process was restored................................
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............         258,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm,
or http://www.regulations.gov.

    Dated: June 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15799 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Notices]
[Pages 51808-51809]
[FR Doc No: 2013-20433]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

34th Meeting: RTCA Special Committee 206, Aeronautical
Information and Meteorological Data Link Services

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

ACTION: Meeting Notice of RTCA Special Committee 206, Aeronautical
Information and Meteorological Data Link Services.

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SUMMARY: The FAA is issuing this notice to advise the public of the
thirty-fourth meeting of the RTCA Special Committee 206, Aeronautical
Information and Meteorological Data Link Services.

DATES: The meeting will be held September 23-27, 8:30 a.m.-5:00 p.m.

ADDRESSES: The meeting will be held at United Airlines, 233 S. Wacker
Drive, Chicago, IL 60606.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 330-
0652/(202) 833-9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 206. The agenda will
include the following:

Sep 23, Monday--Opening Plenary

     Introduction and opening remarks
     Approval of previous meeting minutes and Action item
review
     Review and approve meeting agenda
     Sub-Groups status and week's plan
     Presentations
     SESAR Update
     Wake Vortex Safety System: Today and Tomorrow
     Flight Simulation Evaluation of AIS/MET Data Link Services
in the Terminal Area
     MIT/LL Winds Study to Support ATC Winds
     SC-214 Briefing
     TOR Changes
     Other business
     Sub-Groups meetings

Sep 24-26, Tuesday-Thursday--Sub-Groups Meetings (ALL SGs)

     Tuesday--SG4: Update on SE2020 Eddy Dissipation Rate (EDR)
     Turbulence Project (9:00-11:00 AM)
     Tuesday--SG1: Open session on wake progress (1:00 PM)
     Thursday--AIS and MET Delivery Architecture
Recommendations review

Sep 27, Friday, Closing Plenary

     Sub-Groups reports
     Appoval for AIS and MET Delivery Architecture
Recommendations document to enter FRAC
     Action item review
     Future meeting plans and dates
     Industry Coordination: Report on SAE G-10A ARP 6467 SFO
     Other business
     Adjourn
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting.
    Persons wishing to present statements or obtain information should
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. Members of the public may present a written statement to the
committee at any time.

    Issued in Washington, DC, on August 14, 2013.
Paige Williams,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2013-20433 Filed 8-20-13; 8:45 am]
BILLING CODE 4910-13-P


feasible controls available. The EPA is also proposing to deny the
Maryland petition because: (1) For those facilities with SCR, the EPA
has already implemented the control strategy identified in the
petitions as cost-effective, and (2) for the facilities with SNCR, the
EPA has already determined that operation of SNCR is not cost-effective
with respect to addressing transport obligations for the 2008 ozone
NAAQS and therefore is not required by the good neighbor provision with
respect to this NAAQS. The EPA requests comment on its proposed denial
of Maryland's and Delaware's CAA section 126(b) petitions, including
the bases for the decision described herein.
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    \61\ In this action, note however the EPA is not proposing to
determine whether the upwind states identified in any of the CAA
section 126(b) petitions have fully addressed their obligation to
prohibit emissions activity that contributes significantly to
nonattainment in or interference with maintenance by any other state
with respect to the 2008 and 2015 ozone NAAQS.
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VI. Determinations Under Section 307(b)(1)

    Section 307(b)(1) of the CAA indicates which Federal Courts of
Appeal have venue for petitions of review of final actions by EPA. This
section provides, in part, that petitions for review must be filed in
the Court of Appeals for the District of Columbia Circuit if (i) the
agency action consists of ``nationally applicable regulations
promulgated, or final action taken, by the Administrator,'' or (ii)
such action is locally or regionally applicable, if ``such action is
based on a determination of nationwide scope or effect and if in taking
such action the Administrator finds and publishes that such action is
based on such a determination.''
    The EPA proposes to find that any final action regarding these
pending section 126(b) petitions is ``nationally applicable'' or, in
the alternative, is based on a determination of ``nationwide scope and
effect'' within the meaning of section 307(b)(1). Through this
rulemaking action, the EPA interprets sections 110 and 126 of the CAA,
statutory provisions which apply to all states and territories in the
United States. In addition, the proposed action addresses emissions
impacts and sources located in seven States, which are located in
multiple EPA Regions and federal circuits. The proposed action is also
based on a common core of factual findings and analyses concerning the
transport of pollutants between the different states. Furthermore, the
EPA intends this interpretation and approach to be consistently
implemented nationwide with respect to section 126(b) petitions for the
2008 and 2015 ozone NAAQS. Courts have found similar actions to be
nationally applicable.\62\ Additionally, in the report on the 1977
Amendments that revised section 307(b)(1) of the CAA, Congress noted
that the Administrator's determination that an action is of
``nationwide scope or effect'' would be appropriate for any action that
has a scope or effect beyond a single judicial circuit. H.R. Rep. No.
95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-03. For these
reasons, the Administrator proposes to determine that any final action
related to this proposal is nationally applicable or, in the
alternative, is based on a determination of nationwide scope and effect
for purposes of section 307(b)(1).
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    \62\ See, e.g., Texas v. EPA, 2011 U.S. App. LEXIS 5654 (5th
Cir. 2011) (finding SIP call to 13 states to be nationally
applicable and thus transferring the case to the U.S. Court of
Appeals for the D.C. Circuit in accordance with CAA section
307(b)(1)).
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    Thus, the EPA proposes that pursuant to section 307(b)(1) any
petitions for review of any final actions regarding the rulemaking
would be filed in the Court of Appeals for the District of Columbia
Circuit within 60 days from the date any final action is published in
the Federal Register.

VII. Statutory Authority

    42 U.S.C. 7410, 7426, 7601.

    Dated: May 31, 2018.
E. Scott Pruitt,
Administrator.
[FR Doc. 2018-12374 Filed 6-7-18; 8:45 am]
 BILLING CODE 6560-50-P


From:
SINGLETON, KRIS E<EMAIL_ADDRESS>Sent:
Thursday, February 3, 2022 9:53 AM
To:
Jones, DonnaLee<EMAIL_ADDRESS>Cc:
BATTEN, KATIE M<EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
RE: Do you have time for a quick call

Hi Donna Lee,

I hope you are having a good start to the year as well and that you are staying safe during this winter storm!

Thanks for the additional feedback on these issues.  We are happy to provide more information explaining why Indiana Harbor does not have redundant HRSGs and why Jewell does not have any HRSGs.  These are issues that have been raised at various times by EPA and state agencies under other programs, so we have quite a bit of information on these points.  Please see our summary below for each facility guiding you through the attached documents.

Indiana Harbor
 First, please note that Indiana Harbor Coke Company (IHCC) was the first heat recovery plant in the world (i.e. a nonrecovery coke plant with HRSGs).  Accordingly, there are a number of design limitations and lessons learned that were incorporated into the heat recovery plants subsequently built at Haverhill, Granite City, and Middletown.
 The first attached document is a presentation from 2013 when SunCoke, IHCC, and Cokenergy (an independent company that owns and operates the HRSGs and pollution control equipment downstream of IHCC's coke ovens) were negotiating with the United States and Indiana to resolve alleged violations of bypass venting limits at the facility.  (Please treat this document as CBI as per the label.) At that time, EPA was interested in the feasibility of a redundant HRSG at IHCC, as SunCoke and EPA had agreed upon in principle for the Haverhill and Granite City facilities.
 The presentation to EPA describes some of the key differences between Indiana Harbor and the other SunCoke plants (slides 3-4), along with important considerations unique to IHCC including structural integrity of the ovens which were built on slag and not piled (slides 5-6, 10), equipment constraints such as smaller common tunnel size, induced draft fan limitations and SDA operation, lack of available space, and perhaps most importantly, structural limitations that prevent addition of more weight on top of the oven structure, concrete foundation, and other support structures.  A foundation study was actually conducted in December 2012 to evaluate the feasibility of adding another HRSG or other major equipment at the site, which concluded that it was impossible to do so (slide 13).  EPA and Indiana ultimately agreed that adding even one HRSG was not feasible for the reasons described on slides 17-22.
 Consequently, SunCoke, IHCC and Cokenergy agreed in the 2018 Consent Decree to permanently take on a slightly lower annual venting limit in their respective permits (and the state SIP regulations) by one percentage point from 14% to 13%.  Even so, there are exceptions for years in which a certain amount of HRSG retubing is undertaken by Cokenergy, in which case the annual limit reverts to 14%. The daily limit of 19% remained unchanged.  EPA and Indiana recognized in the course of negotiations that more aggressive reductions were not possible on a long term basis due to the technical feasibility issues and design constraints at the plant, and accepted that this reduction from 14% to 13% annual venting (in normal, non-HRSG retubing years) was the only feasible option to reduce venting at IHCC.

Jewell
 Jewell was requested in late 2020 to conduct a Four Factor Analysis (4FA) by the Virginia Department of Environmental Quality (VDEQ) as part of the second planning period for the Regional Haze program.  Our initial Four Factor Analysis conducted by ERM was submitted to VDEQ on March 1, 2021 and subsequently revised in response to comments and resubmitted in August 2021, along with a Response to Comments document with photos of the facility, both of which are attached.
 Although the Four Factor Analysis focused on potential ways of reducing SO2, the conclusions from that analysis are directly applicable to whether HRSGs (or similar equipment) could be installed at Jewell to reduce venting because in any of these cases, hot gases from the bypass vent stacks would have to be cooled (i.e. the purpose of a HRSG) prior to being treated with air pollution control equipment.
 As explained on p.7 of the revised Four Factor Analysis, HRSGs are even less practical at Jewell than other hypothetical means of cooling the flue gas because the heat would be wasted and the higher capital cost of the additional heat recovery equipment would not be justified.  There is no need or use for more coal drying capacity, or for steam or hot water generated from heat recovery at the facility. The plant lacks space for electrical generation through addition of a HRSG and steam turbine, and the area does not have the infrastructure to accommodate a grid interconnection.  Because HRSGs are not feasible, the hypothetical engineering analysis focused instead on cooling the flue gas by adding ambient air to the flue gas stream.
 As a result, the Four Factor Analysis evaluated the use of dilution air in conjunction with three hypothetical scenarios: dry sorbent injection, a spray dry absorber, and a circulating fluid bed scrubber.  The total minimum capital cost for theoretically installing these technologies at Jewell ranged from $325 million for DSI to $1.4 billion for a SDA.  Annual operating costs ranged from $70.6M for DSI to $248M for a SDA.  The costs per ton of SO2 removed were at least $21,000/ton in all cases.  See p.15.  ERM further determined that these cost estimates should be considered conservatively low.  See p.5. Although these estimates are for SO2 control, the same principles and equipment would apply in aiming to reduce bypass venting at Jewell.
 As part of the 4FA, Environmental Resources Management (ERM), a third party consultant retained by SunCoke to conduct the analysis, conducted a site visit in December 2020 and concluded that "Although the theoretical mechanisms for SO2 control are proven in practice elsewhere, the hypothetical design presented in this analysis should not be construed as in any way proven; in fact, it is unlikely that any such system could be constructed and operated in any feasible or reasonable manner."  See p.6.  This conclusion was based on numerous challenges unique to Jewell outlined on pp. 5-6, including the space constraints, the volume of air needed to sufficiently cool the gas stream, the impact of such equipment on oven structural integrity, water availability, electrical power demand, and other factors.
 As we've previously noted, the most significant problem is the space constraints at the plant.  ERM states on p.6 "there are many extreme challenges to applying any sort of control device at Jewell, and one of the most insurmountable challenges is the lack of space for new equipment. There is no space to accommodate the footprint of one or multiple control devices, nor is there space to include the multiple pieces of ancillary equipment, personnel and vehicles and maintenance access necessary to run and operate any of these units. As noted previously, the batteries are placed tightly in the river valley with extreme terrain on both sides of the valley. There is virtually no unused space on the property based on ERM's observations during a December 2020 site visit."  As a result of these issues, ERM found that "SO2 control technologies are considered to be both technically and economically infeasible." p.15.
 To further illustrate the space constraints that were raised in ERM's evaluation, we provided at the conclusion of our Response to Comments document a compilation of pictures of the site.  See PDF pp. 14-30 for those pictures.

Thanks again for your time in working through these issues as part of the RTR.  Please let us know if you have any additional questions or if more information would be helpful.

Kris

<< IHCC EPA Presentation Foundations 071613 Final.pdf Privileged and Confidential  -  For Settlement Purposes Only >>
<< Jewell Four Factor Analysis Revised Aug 2021 Final.pdf >>
<< Response to Comments w Facility Photos.pdf >>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Thursday, January 13, 2022 8:49 PM
To: SINGLETON, KRIS E<EMAIL_ADDRESS>Cc: BATTEN, KATIE M<EMAIL_ADDRESS>GABRIELLE RAYMOND<EMAIL_ADDRESS>Subject: RE: Do you have time for a quick call

Thank you for your input to the EU cost estimates for a new heat recovery plant. I thought the numbers might be low. I will still cite the EU estimates but will add yours also.

As you may know, we will be deliberating about the rule and possibly re-running analyses right up to proposal, therefore I don't want to risk telling you something that might change. However, you will be able to respond in as much detail as you like during the comment period. The comment period starts when the rule is published in the FR but EPA posts the EPA version of the file on our website when it is signed. I can let you know where and when that is so you can get a head start. Sometimes the FR office makes more editorial changes after it leaves EPA and before it is published, but these are usually small changes.

I know you told me that Jewell does not have the space to add HRSGs, but I don't recall why Indiana Harbor-East Chicago cannot have more HRSGs to avoid the high number of bypass hours allowed by the state or if there is any other reason for the high number of hours as compared to the other 3 facilities. While you are doing this, you may add to the explanation for Jewell if you like, especially if there is more than just a space issue.

Thanks for getting back to me. Hope you are having a good start to the new year.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.