Conference Call Documentation

Subject:  EPA / National Association of Clean Air Agencies (NACAA)
Conference Call on ICR Renewals for 40 CFR Part 70 & 71 – Summary of
Comments Received and EPA Response.

Date of Call: April 11, 2007.

Participants:

EPA:  Bill Harnett, Division Director, OAQPS; Michael Ling, Associate
Director, OAQPS; Jeff Herring, Environmental Scientist, OPG.

National Association of Clean Air Agencies (NACAA): Permitting Committee
Monthly Conference Call Attendees.

Purpose of Call:  EPA is in the process of revising the ICRs for part 70
and part 71 under title V of the Clean Air Act – both ICRs expire on
June 30, 2007, pursuant to ICR extensions granted by OMB.  At the time
of the call the first FR notice asking for comments had been issued and
EPA has seeking input before submitting the renewal ICR to OMB for
review and final approval.

Comments for NACAA and EPA response

NACAA Comment:  A representative from the Michigan DEQ, a State
permitting agency, asked EPA to clarify in the supporting statement for
the part 70 ICR that the burdens imposed by MACT, NSPS, CAM and other
federal rules and standards, such as requirements for monitoring,
recordkeeping and reporting (MRR) under those rules, are not burdens
counted under the part 70 ICR, although the burdens of writing permit
conditions to reflect those requirements should be counted.  She felt
that this was an important point that many NACAA reviewers had not fully
understood in the past, and that this clarification could help with
future consultations.

EPA Response:  EPA will revise the supporting statement for the part 70
ICR to clarify that the burdens of imposing applicable requirement
(e.g., MRR required by separate rules) covered by other ICRs should not
be counted as title V burdens.  EPA believes this could assist with
future consultations on part 70 burden.  Also, EPA notes that part 70
directly imposes recordkeeping and reporting requirements, such as
deviation reporting,  six-month monitoring reports, annual compliance
certification, and periodic monitoring in limited cases, thus part 70
burdens for MRR in the ICR will remain unchanged.

NACAA Comment:  A representative from Dayton Ohio (RAPCA), a regional
permitting agency, asked that EPA clarify that the part 70 requirement
for a “Statement of Basis” be listed in the supporting statement as
an activity clearly required by part 70 for permitting authorities when
they are writing permits for sources, but did not ask for any change on
burden estimate based on this clarification, as it appears to be covered
under programs administration or permit drafting activities.

EPA Response:  EPA will add “statement of basis” to the text
description of the permit drafting activity for permitting authorities.
This has always been a requirement of part 70 but the text of the
supporting statements did not have the level of detail necessary to
reflect this.

NACAA Comment:  A representative from Colorado APCD, a State permitting
agency, stated that he thought the burden hour estimates in Table 3 (of
the supporting statement) did not adequately reflect the burdens of
performing public participation (such as public hearing and public
comments) for permit renewals, significant modification, and to a lesser
extent, for minor permit modification – without specifying what the
new estimates should be.  Also he thought the burden-hour estimates for
administrative amendment are too low – he also did not specify a new
estimate.

EPA Response:  EPA told the callers we would re-examine these burden
estimates and determine if they warrant revision.  After review, we
decided to change the burden hours for permitting authorities for permit
renewal and significant modification from 60 hours per activity to 90
hours per activity and minor modification from 20 hours to 30 hours to
more adequately reflect the burdens of public participation, EPA review,
and/or affected state review and various notification activities related
to these tasks.  Also, we decided to not change the burden for
administrative amendment (5 hours) because there is no public, EPA, or
affected State review involved and this is usually accomplished through
correspondence.

NACAA Comment:  A representative form San Diego County APCD, a local air
permitting agency, asked that public petition-related activities
performed by EPA be clarified and more adequately reflected in the part
70 ICR. This commenter also asked for a follow-up call to provide a few
other detailed comments.  The call was held on April 17, with the caller
asking for a more detailed listing of the activities typically performed
by permitting agencies.  He clarified that he was not asking for a
different estimate of burdens, only that there be a more specific
listing of specific activities they perform, especially with respect to
the activities of program administration and drafting permits, within
the text description for the activities. He specifically mentioned
activities of date entry into EPA’s AFS permit data system, writing a
“statement of basis” for the permit, and enforcement activities
related to title V compliance reporting.

EPA Response:  EPA agrees to clarify EPA’s public petition-related
activities.  These activities have increased in recent years and will be
important for several years to come.  We told them we would review this.
 In response we decided to add programs oversight as a separate entry in
several tables related to EPA activities and to clarify and update EPA
burdens related to public petitions.  Also EPA has provided more detail
within the text description of various permitting authority activities
in the supporting statement.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2000 TRAVERWOOD DRIVE

ANN ARBOR, MI  48105-2498

									     OFFICE OF

									AIR AND RADIATION

5/19/16

MEMORANDUM

SUBJECT: Test Procedure Review with Cummins, Volvo, Navistar, Paccar,
Daimler Eaton and Allison

FROM: James Sanchez

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards
for Medium- and

Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents communication on May 19, 2016 between
representatives of Cummins, Volvo, Navistar, Paccar, Eaton, Allison,
Daimler, Caterpillar, Hino, EMA and EPA to discuss heavy-duty test
procedures proposed in the Phase 2 greenhouse gas and fuel efficiency
standards for heavy-duty vehicles notice of proposed rulemaking.

Participants:

Allison –

Caterpillar –

Cummins – Manik Narula, Jackie Yeager

Daimler – Gerald Freitag, Inderpal Singh

Eaton –

EMA – Tim Blubaugh

EPA – Houshun Zhang, James Sanchez

Hino – Mark Siddall

Navistar – Cortney Guzlas, Matt Hunkler

PACCAR – Mark Malowicki, Erin Luke

Volvo – Marc Miller, Tim Connors, Steve Berry, Tony Greszler

Discussion and follow-up items (with owner's name in bold):

GEM – Houshun

Debugging version is available

Shifting sensitivity to generic steady state map – Manik

Reviewed analysis of impact on engine cycles and vehicle CO2 results of
using generic steady state map for shifting in GEM – see slides
emailed previously

55/65 cycle average map speed/load coverage – Matt H.

Reviewed analysis of engine speed/torque coverage of cycle average maps
– see slides emailed previously

Topics for future calls:

(TBD) SwRI results (gasoline engine) – Houshun


Subject:	Meeting with Portland Cement Association and Affiliates  -  NESHAP Monitoring Issues

Location:	U.S. Environmental Protection Agency, Research Triangle Park, NC

Date: 		March 22, 2012

Participants:

Portland Cement Association (PCA)
Andy O'Hare, PCA
Dan Nugent, Buzzi Unicem
Mike Pelan, Lafarge
Satish Sheth, Cemex
Hector Ybanez, Holcim

U.S. Environmental Protection Agency (EPA)
Keith Barnett
Colin Boswell
Sharon Nizich
Robin Segall
Peter Westlin

RTI International
Matt Hakos
Mike Laney

A conference call was held with the PCA for the purpose of discussing monitoring issues identified by industry.  The list of issues identified by industry and submitted to EPA is attached.

                  PCA -- NESHAP Monitoring Issues (12-17-10)
                                   Parameter
                                     Issue
                                   Citation
                                  Requirement
                                     Issue
                                Recommendation
                                   Comments
PM (Kiln/Cooler)
Performance
§63.1348(a)(1); §63.1349(b)(1)
Use first 30 operating days with CEMS
There are many issues to discuss on PM CEMS that were not in the original proposal, so they were not in our original comments.
EPA needs to revisit PM CEMS as they apply to cement plants.
See Lafarge settlement terms for 30-day sum of PM Mass readings divided by  30 days of clinker production.

Additional question on the issue:  Throughout this section, the phrase "must be determined based on the first 30 operating days you operate" the CEM is used.  Does this mean that if a source is equipped with that monitor prior to the compliance date, it must use that data to determine initial compliance in the first 30 days of operation?
PM (Kiln/Cooler)
Performance
§63.1349(b)(1)
(iii) and (iv)
Discusses initial compliance based on first 30-days of CEMS; requires an emission rate computed for each run based on concentrations in gr/scf.  Includes equations for stack emissions and for stack+bypass emissions.
Is "each run" represented by each hour since the clinker data required is an hourly rate? Or each 15 minutes since §63.1350(b)(4) requires readings to be collected at least every 15 minutes.  Then hourly data to be summed to daily data and then averaged into a 30-day rolling average.
Clarify
PCA will provide suggested language
PM (Kiln/Cooler)
Compliance
§60.63(c)(1); §63.1348 (b)(2)(i); §63.1350(b)
PM CEMS per PS-11 and Procedure 2; Performance test method for PS-11 must be Method 5 or 5i; Relative Response Audits annually and Response Correlation Audits every 3 years;  §60.63 (f) also references PS-2
In order to range the PM CEMS for correlations the facility must operate short term above the PM limit by intentionally increasing PM emissions.  Such periods may include times prior to and after the test run to establish, verify and equilibrate the elevated emissions and to address testing issues or re-tests.  Also, PM correlation testing may require a minimum of 20 runs, which could require multiple weeks.
Expand §63.1357  · These periods should not be included in the compliance determination.  · EPA should explicitly state that it is acceptable to operate above the limit for this purpose.  · EPA should explicitly protect owners or operators against any enforcement actions, penalties. or citizens suits.
Partially covered in existing §63.1357 "Temporary, conditioned exemption from particulate matter and opacity standards"
PM (Kiln/Cooler)
Compliance
§60.63 (c)(3); §63.1350(b)(4)

NSPS  -  30-operating day rolling average =

NESHAP - Collect readings at least every 15 minutes.  Sum the hourly data to daily data and then into a 30-day rolling average.

Is there any inconsistency here between NSPS and NESHAP?

How do you have a reading every 15 minutes if the clinker rate is calculated hourly?  Or do you take the mass of PM each 15 minutes and add together then divide by the hourly clinker production?  Or is it actually 30-days worth of summed PM mass readings divided by 30-days of clinker production?  This is the only place and only parameter for which the EPA mentions how to do a 30-day rolling average.
Need to address the averaging methodology for all parameters.  Should be consistent.  Should not require 15-minute values, which conflicts with 60.8(g)(3) requiring reduction of CEMS data to hourly values.  Task Force agreed for clinker based emissions limits that rolling 30 day average should be the summed 30 days of mass emissions over the summed 30 days of clinker production.  Also address issue of PS-2 vs. PS-6.  Also see reporting requirements near bottom of this table.
See Lafarge settlement terms for 30-day sum of PM Mass readings divided by  30 days of clinker production.

1350(b)(4)- This paragraph must be modified to more clearly indicate that the PM 30-day average is computed by "Sum the hourly data ... into a 30-day average."
PM (Kiln/Cooler)
Compliance
§60.64(b)(1)
Compliance based on §60.63(c) (i.e., CEMS 30-day average); PM emission rate is calculated on an equation for main stack emissions.
Discusses compliance based on a CEMS 30-day rolling average in §60.63(c), but §60.64(b)(1) requires an emission rate computed based on concentrations in gr/scf and with no reference to 30 days.
Clarify. PS 11 requires evaluating performance relative to PM concentration, but recording in units of the standard. Equation should be flexible to work with units as reported by CEMS.
PCA will provide suggested language
PM (Kiln/Cooler)
Other
PS-11
PM correlation for CEMS
The cement industry asserts that changes in particle size, refractive index, particle density, etc. may adversely affect the representativeness of the PS 11 PM correlation over time, and that EPA has not adequately investigated these issues at the variety of kiln systems and plant configurations where PM CEMS will be required.
When such changes are suspected, the plant may choose to perform new correlation testing or other investigations, and a new correlation may be established, and the results of previous monitoring may be adjusted or rejected as non-representative.
PCA will provide suggested language
Opacity (RM/FM)
Performance
§63.1349(b)(2)
3-hr Method 9
§63.1348(a)(2) for initial opacity compliance only addresses those sources in §63.1345, which does not include RM and FM, but the Performance testing requirements under §63.1349(b)(2) is not restricted as such
§63.1348(a)(2) should address RM and FM at major sources.
PCA will provide suggested language
Opacity (RM/FM)
Compliance
§63.1348(b) (3)(i) §63.1350(f)(2)
Daily 6-minute VEs by Method 22 on mill sweep and air separator dust collectors.  If VEs observed retest w/in 24 hours.  If still VEs do 30-minute Method 9 and implement corrective action w/in 1 hour if  >10%
§63.1348(b)(3) for continuous opacity compliance only addresses those sources in §63.1345, which does not include RM and FM, but under §63.1348(b)(3)(i) it references §63.1350(f)(2) which is for RM and FM and under §63.1348(b)(3)(ii) and (iii) it references COMS and BLD in lieu of daily VEs which are for RM and FM.
§63.1348(b)(3) should also apply to RM and FM at major sources.
There is no specified opacity standard for Raw Mills and Finish Mills in 1345, but there are in 1350(f).  PCA will provide suggested language.
Opacity (RM/FM)
Compliance
§63.1350(f)
Indicates monitoring per O&M developed per §63.1350(p) and opacity emissions monitoring plan per §63.1350(o)
§63.1350(o) has nothing to do with emission monitoring plans.  §63.1350(p) is not an O&M plan it is an emissions monitoring plan.
Reference opacity emissions monitoring plan per §63.1350(p)
Make recommended change.
Opacity (Other)
Compliance
§63.1350(f)
Indicates monitoring per O&M developed per §63.1347.
Why not per opacity emissions monitoring plan per §63.1350(p)?
Reference opacity emissions monitoring plan per §63.1350(p)
Make recommended change.
D/F
Performance
§63.1348(a)(3)(ii) and (iii); §63.1349(b)(3)(iv) and (vi)
References temperature and injection rate operating limits in §63.1344
§63.1344 deals with Affirmative Defense
Make corrections
Make recommended change.
D/F
Compliance
§63.1348(b)(4); §63.1350(g)
Continuous temperature monitors at inlets to dust collectors. 3-hour rolling average.
Currently the requirement is a 3-hour rolling average temperature based on 180 successive one-minute averages (i.e., each minute compute a new 3-hour average using the previous 179 valid data points) and new rule is a 3-hour rolling average each hour calculated using the previous three hours of available 1-minute data (could be less than 180 data points).  For in-line mills each 3-hour rolling average begins anew when mill goes up or down.
Keep the current methodology.  Facilities are already set up to monitor that way.  Otherwise EPA needs to explain why they changed it and how it provides better compliance.
Per the definitions in §63.1341, "Rolling Average" means the average of all one-minute averages over the averaging period.

1350(g)(4) - Did EPA really mean to include the words "Each hour"?  It should be "each minute" to preserve the current methodology for D/F.
THC
Performance
§63.1348(a)(4)(i); §63.1349(b)(4)(i)
§63.1349(b)(4)(i)(A) states that compliance is demonstrated with a RATA when CEMS accuracy is w/in 20% or RATA is w/in 10% of the standard.  THC span (as propane) is 50 ppmvd.  §63.1349(b)(4)(i)(B)  states that initial compliance is based on the first 30 operating days with CEMS
Which is used for demonstrating compliance?
Make corrections
This is just an error by EPA, it means that the RATA is SUCESSFUL when the criteria are met, compliance with emission standard is based on the monitoring results
THC
Compliance
§63.1348(b)(6); §63.1350(i)(1)
THC CEMS per PS-8 and Procedure 1
PS-8 requirement is to be w/in 2.5% of the span of 50 ppmvd, which is only 1.25 ppmvd for the CD, where as previously acceptable PS-8A allowed 3 ppmvd for the CD.  The proposed NESHAP was for PS-8A, therefore we did not get an opportunity to comment on PS-8.
Allow previously acceptable PS-8A.
PS8A CD limits are +/- 3 ppm or +/13% of span, Span is 50 to 100 ppm.  Always used PS8A and 100 ppm span for cement plants burning hazardous waste.
THC
Compliance
§63.1350(i)(2)
For alkali bypass stack may use initial and subsequent performance tests.
Not mentioned for performance/initial compliance

PCA will provide suggested language
Alt. THC/ OHAPs
Performance
§63.1348(a)(4)(ii through v); §63.1349(b)(4)(ii)
Method 320 or ASTM D6348-03.  FTIR, three 1-hr runs mill-on & mill-off. Use average HAPs concentrations for initial compliance and weighted (mill-on and mill-off) average THC CEMS concentration to set site-specific THC limit.  Repeat every 30 months.
Method 320 quantitation limits > 9 ppm.  §63.1352 allows the alternate use of Method 18 "solely for use in applicability determinations" per §63.1340 (in which they never discuss applicability determinations).    Note:  the HAPs is based on the average value for mill-on/mill-off but the alternate THC CEMs value is based on a weighted average.  Also need to define "weighted average".
Allow alternate methods for compliance.  The HAPs concentrations should be for the weighted average for mill-on and mill-off values.  Define how "weighted average" is calculated.
What exactly is a weighted THC average for Mill on/Mill off?
Seek EPA insight and PCA will provide suggested language.
Alt. THC/ OHAPs
Performance
§63.1341 (Total Organic HAP definition)
Only the measured concentration of the listed analytes that are present at concentrations exceeding one-half the quantitation limit of the analytical method are to be used in the sum.  If any of the analytes are not detected or are detected at concentrations less than one-half the quantitation limit of the analytical method, the concentration of those analytes will be assumed to be zero for the purposes of calculating the total organic HAP for this subpart.
Method 320 quantitation limits > 9 ppm.
Allow alternate methods for compliance.
Requires definitions of "quantification limit" and "detection limit".  Encourages use of bad testers and poor test equipment to game the system.  Such data will not withstand any legal scrutiny.  Contrary to reasonable scientific principles and practices.  Method 18 must be allowed in rule or by response to petitions.
Alt. THC/ OHAPs
Compliance
§63.1348(b)(6); §63.1350(j)
THC CEMS per PS-8 and Procedure 1 (same as above) or PS-15 and Procedure 1.
Is the facility out of compliance until the alternate limit is set?  Must alternate limit be set prior to the compliance date?  The proposed NESHAP was for PS-8A, therefore we did not get an opportunity to comment on PS-8.
Provide sufficient time after the compliance date to set the alternate TCH limit without the facility being considered to be out of compliance.
The PS8 RATA which compares FID to FID is arbitrary.  If both the installed and test FIDs disagree when both are calibrated to known standards, which is correct?  What is the appropriate corrective action for a failed RATA?
Seek EPA insight and PCA will provide suggested language.
Hg
Performance
§63.1348(a)(5); §63.1349(b)(5)
Use first 30 operating days with CEMS, or 30 daily(?) sorbent traps
Are sorbent traps daily for the initial compliance?

Throughout this section, the phrase "must be determined based on the first 30 operating days you operate" the CEM is used.  Does this mean that if a source is equipped with that monitor prior to the compliance date, it must use that data to determine initial compliance in the first 30 days of operation?
Seek EPA insight and PCA will provide suggested language.
Hg

                                 63.1348(b)(7)
Demonstrate continuous compliance by a 30-day rolling average Hg emission rate (normal operation) and 7-day rolling average Hg concentration (startup/shutdown).
How does the facility utilize a sorbent trap system and demonstrate compliance with two different emissions standards over two different operating modes/periods?
Clarify
Once the facility switches from "startup mode" to "normal operation," the emissions standards change.  However, the sorbent traps do not capture the distinction between startup and normal operation.  Do the traps need to be replaced every time there is a change between startup mode and normal operation?  Should there be dual sorbent trap systems such that one is used for startup/shutdown operation and one is used for normal operation?
Seek EPA insight and PCA will provide suggested language.
Hg

                                 63.1348(b)(7)
Demonstrate continuous compliance by a 30-day rolling average Hg emission rate (normal operation) and 7-day rolling average Hg concentration (startup/shutdown).
Compliance with the Hg standard after that fact.
If this method provides acceptable data (it mimics the reference method and from my understanding has demonstrated average data availability of 95%), EPA should lengthen averaging periods to greater than 7 days for startup/shutdown (e.g., 30 days) and greater than 30-days for normal operation (e.g., 90 days).
Assuming a sorbent trap can operate for a period of 7 days (during normal operation), between 20-25% of the 30-day compliance period will be determined after the fact.  This leaves the facility with less opportunity to "adjust" the system in response to adverse compliance data.  A 90-day compliance period leaves 7-8% uncertainty during the "last" 7-day sorbent trap period.  With this approach, the facility has more opportunity to adjust the system.
HCl
Performance
§63.1348(a)(6)(i); §63.1349(b)(6)(i)
Wet scrubber.  Method 321 and establish operating parameters.  Initial compliance is the arithmetic average of all runs.  Repeat every 30 months.
 EPA has specified a "typical lower quantification range" of 0.1  -  1 ppm for Method 321, but has not provided a definition of how to calculate or procedure to determine the quantification range, particularly in the presence of water vapor and as effected by the sampling train/PM filter.
EPA should delete "typical lower quantification range, should revise Method 321 and include DL and PQL determination procedures, performance based

HCl
Performance
§63.1348(a)(6)(ii); §63.1349(b)(6)(ii)
No wet scrubber.  Use first 30 operating days with CEMS
HCl CEMS are not currently available that can meet the specified requirements or reliably continuously monitor HCl emissions at the levels required to demonstrate compliance with the standards.

No NIST Traceable cal gas.

PS-15 is not adequate, EPA acknowledges in Response to Comments that an HCl-specific PS is needed.
 EPA should provide documentation on HCl CEMS capable of meeting these requirements.

Need NIST traceable cal gas.

EPA should stay this requirement until HCl-specific PS is developed.
Note in the Proposed CISWI MACT the EPA stated:  "Although final performance specifications are not yet available for HCl CEMS and multi-metals CEMS, EPA is considering development of performance specifications."  EPA has proposed PS-13 (Specifications and Test Procedures for Hydrochloric Acid Continuous Monitoring Systems in Stationary Sources) of appendix B of 40 CFR part 60.

There is currently no known HCl CEM available that operates in the range specified by the rule. Thermo agrees with PCA assessment.
HCl
Compliance
§63.1348(b)(8)(i); §63.1350(l)(1)
No wet scrubber.  HCl CEMS per PS-15 and Procedure 1, except RATA requirements per section 11.1.1 and 12.0 of PS-15.

Allow other analytical techniques.
Argue against EPA's assertion that such CEMs are available.  Get statements from reputable CEMS manufacturers.  Note in the Proposed CISWI MACT the EPA stated:  "Although final performance specifications are not yet available for HCl CEMS and multi-metals CEMS, EPA is considering development of performance specifications."  EPA has proposed PS-13 (Specifications and Test Procedures for Hydrochloric Acid Continuous Monitoring Systems in Stationary Sources) of appendix B of 40 CFR part 60.

There is currently no known HCl CEM available that operates in the range specified by the rule. Thermo agrees with PCA assessment.
HCl
Other
§63.1352(a)
Allows the alternate use of Method 320 "solely for use in applicability determinations" per §63.1340
Method 320 is not appropriate for measurement of HCl especially at low concentrations, does not address the necessary considerations contained in Method 321
Method 320 for HCl should not be allowed.

Parameter Monitoring & Continuous Emission Rate Monitoring

§63.1350(n)(3)
CERM flow rate monitor 5% accuracy
Per RATA this should be 10%
Accuracy needs to be per RATA requirements.

Parameter Monitoring & Continuous Emission Rate Monitoring

§63.1350(o)(4&5)
Alternate Monitoring  -  Administrator will notify you of approval or denial within 90 days.....Neither submittal of the application or the Administrator's failure to approve or disapprove the application relieves you of the responsibility to comply with any provision...
Even if you submit information in a timely manner if the Administrator does not take action, the facility must still be in compliance.
If Administrator does not take action within the specified time-frame, the alternate method should be approved.
PCA will suggest language.
Parameter Monitoring & Continuous Emission Rate Monitoring

§63.1343(a)
Ensure appropriate corrections for moisture are made when measuring flowrates used to calculate particulate matter (PM) and mercury emissions.
Why only applicable to Hg and PM?  Also confirm that default moisture from annual RATA is acceptable.

Why is the moisture correction on PM and HCl only?  Concentration based standards.  Does this REQUIRE continuous moisture monitoring?
If moisture corrections are required, the default moisture from annual RATA is acceptable.
This is what EPA is proposing for GHG Reporting rule.

Seek insight from EPA and PCA will provide suggested language.
Emissions Monitoring Plan & other General Monitoring Requirements

§60.63 (f) (i)(1); §63.1350 (p)  §60.64(b)(4) cross references to §63.1350 (p)  also
Develop emissions monitoring plan, and submit upon request.
As referenced per other  NESHAP sections -  PM CEMS, Opacity and Clinker refer to  §63.1350(o), which has to do with alternate monitoring not emission monitoring plans
"(o)" should be "(p)"
Opacity emissions monitoring plan required  -  if using alternative monitoring.  Does this apply to prior AMRs?
Emissions Monitoring Plan & other General Monitoring Requirements

§60.63 (f) (i)(1)
Submit this site-specific monitoring plan, if requested, at least 60 days before the initial performance evaluation of your CMS.
Notice to regulators is usually 30 days before the test and that is the point at which the regulator might request the plan.
Change to 30 days.  If regulator requests plan less than 30 days prior to the tests, then the test does not need to be delayed.

Emissions Monitoring Plan & other General Monitoring Requirements

§63.1348 (b)(1)(i)
"...site specific monitoring plan required by §63.1350 (o)."
"(o)" is for alternate monitoring
"(o)" should be "(p)"

Emissions Monitoring Plan & other General Monitoring Requirements

§63.1350 (p)(2)
"...must also address (o)(2)(i) through (iii) of this section."
These sections do not exist.
"(o)" should be "(p)"

O&M Plan

§63.1347(a)
Develop O&M plan and submit for approval with part 70 permit application
1347(a)  - Most, if not all plants already have a Title V permit.  If the Title V permit has already been issued or a renewal application has already been deemed complete, must the OMP still be submitted to the Administrator for review and approval?  If approval is required, what does the Title V have to do with it and by what date must the plan be submitted?
Clarify
PCA will suggest language.
Performance Test Reporting & Other Reporting

§63.1349(d)
All reports must be signed by the "facility's manager"
How is "facility manager" defined?
Define "facility manager"
PCA suggests the same language as that under Part 75 for "designated representative"
Performance Test Reporting & Other Reporting

§63.1354(b)(9)(vi)
Semi-annual reports - (vi) Monthly rolling average mercury, THC, PM, and HCl (if applicable) emissions levels in the units of the applicable emissions limit for each kiln, clinker cooler, and raw material dryer.
Is this an average of the 30-day rolling averages calculated each day for that month, or is this an average of the daily values for the 30 (or 31) calendar days for the month?

Changes to SSM Semi-Annual Report formats effective 11/8/10?
Address this with issue of rolling averages for all parameters.
PCA will suggest language.
Operating Days

§63.1341; §63.1343
For 30-day rolling averages, operating days include only days of normal operation and do not include periods of operation during startup or shutdown.  The 30-day period means 30 consecutive operating days.
§63.1343(a)  -  the period of "consecutive" operating days applies Hg, PM and THC, but for HCl it does not reference "consecutive" operating days.
HCl should also be subject to "consecutive" operating days.
Address this with issue of rolling averages for all parameters.

The HCl discussion in 1343(a) makes no reference to "consecutive".  Why should HCl be computed differently than mercury, THC and/or PM?
Operating Days

§63.1341; §63.1343
For 7-day rolling averages, operating days include only days of operation during startup and shutdown and do not include periods of normal operation.  The 7-day period means 7 consecutive operating days.
§63.1343(a)  -  the period of "consecutive" operating days applies Hg, PM and THC, but for HCl it does not reference "consecutive" operating days.
HCl should also be subject to "consecutive" operating days.
Address this with issue of rolling averages for all parameters.

The HCl discussion in 1343(a) makes no reference to "consecutive".  Why should HCl be computed differently than mercury, THC and/or PM?
NOx - NSPS
Compliance
§60.64 (c)
Calculate and record the 30-operating day rolling emission rate of NOx as the total of all hourly emissions data for a cement kiln in the preceding 30 days, divided by the total tons of clinker produced in that kiln during the same 30-operating day period using Equation 3.
Refers to a NOx concentration in gr/scf.  Should be "...preceding 30-operating days...."
Clarify.  Equation should be flexible to work with units as reported by CEMS.
Gas concentrations should all be ppm not mg/m3 except Hg which is ug/m3.  When fixed it has no impact.
SO2 - NSPS
Compliance
§60.64 (c)
Calculate and record the 30-operating day rolling emission rate of SO2 as the total of all hourly emissions data for a cement kiln in the preceding 30 days, divided by the total tons of clinker produced in that kiln during the same 30-operating day period using Equation 3.
Refers to a SO2 concentration in gr/scf.  Should be "...preceding 30-operating days...."
Clarify.  Equation should be flexible to work with units as reported by CEMS.
Gas concentrations should all be ppm not mg/m3 except Hg which is ug/m3.  When fixed it has no impact.
Opacity (Other)
Other
§60.64(b)(4)
Any sources other than kilns (including associated alkali bypass and cooler) subject to the 10 percent opacity limit must follow the appropriate monitoring procedures in § 63.1350(f), (m)(1) through (4), (m)(10) through (11), (o), and (p) of this chapter.
Therefore, any miscellaneous source per §60.62(c), which would include those located at Area Sources constructed, reconstructed or modified after Aug. 17, 1971, are subject to the requirements in § 63.1350(f), (m)(1) through (4), (m)(10) through (11), (o), and (p).  Also, when would the complaince date be for existing facilities?
Should only apply to major sources.

§63.1340(b)(6)
§63.1340(b)(7)
§63.1340(b)(8)
Affected sources noted in these subsections can be at ANY portland cement plant.
Other sections (e.g., 63.1345) exclude these sources at area source facilities
Clarify in 63.1340 that these sources are only subject at Major source facilities
PCA will provide suggested language
Operating Days

§60.62(a); §63.1341; §63.1343
Operating day means any daily 24-hour period during which the kiln operates. Data attributed to an operating day includes all valid data obtained during the daily 24-hour period and excludes any measurements made when the kiln was not operating.
Poorly defined.  Does one-minute of operation constitute an operating day, or does a period that results in a valid CEMS data value constitute an operating day?  How is "operate" defined; when fuel is burning?  Startup and shutdown are in preamble but not defined in the rule.
Redefine
PCA will provide suggested language

§63.1343(a)
1343(a) defines the meaning of 30-day and 7-day rolling average as being consecutive for PM, mercury and THC only.  The section also indicates that an operating day includes all valid data obtained during the daily 24-hour period and excludes any measurements made when the kiln was not operating.
If data are excluded for a period that may comprise a day or more, how can it be consecutive if we must jump from one valid data set to the next?
Addition detail must be provided in this section to account for prolonged kiln down time.
PCA will provide suggested language

§63.1343(b)
Provides emissions limits and emission calculation methods for kiln and bypass stacks
Preamble notes "If a coal mill is heated with kiln exhaust, it is subject to all the emissions limits, and all associated monitoring, reporting, and recordkeeping requirements of this subpart." No provision for separately vented in-line coal mill in regulations.  Facilities with in-line coal mills vented separately from the main stack need to know what, if any, of the continuous monitoring requirements apply to the coal mill stack
Clarify if separately vented inline coal mill emissions need to be accounted.  If so, main stack monitoring should suffice, with the same concentrations as the kiln exhaust applied to the in-line coal mill percentage of total flow.
Reference Ash Grove alternative monitoring request
PM (Kiln/Cooler)

§63.1343(b)(2)
Alternate PM Limit
Only allows adjustment for flow from kiln and cooler  -  what about exhaust from coal mill and/or by-pass if they go to main stack.  An issue that came up in our internal discussions today.  For PM on a combined stack, when and how often is the alternate PM limit determined?  Do you use the average exhaust flows for the same first 30-day CEMS operating performance period for the initial compliance?  Is it conducted and changed annually based on the average flows measured for the RATA?
Allow adjustment for flow from all sources to the main stack.
PCA will work on developing proposed alternative language.
Current language establishes a different standard for each kiln based on site specific clinker factor and air flow.
HCl
Other
§63.1343 Table 1 Footnote 4
If the kiln does not have a HCl CEM, the emissions limit is zero.
This implies that if you have a wet scrubber and therefore do not need an HCl CEMS that your limit is zero  -  but you still have to prove compliance every 30-months by Method 321, and there will be some HCl in the emissions. Also note that the footnote only applies to #4  -  existing kiln startup and shutdown, and #6  -  new kiln normal operation.
Cannot have an emission limit of "zero".  Limit should also be 3 ppmvd.  Also applying to S/S at an existing kiln but normal operation at a new kiln is arbitrary.
The Footnote of 1343 (b) Table 1 states that emissions limit for HCl from major source kilns is ZERO in some cases, but not all.   Existing kilns under normal operations and new kilns during S/S are not footnoted.

§63.1348(a)(3)
§63.1346(c), (d) & (e)
(iii) If activated carbon injection is used and you are subject to a D/F emission limitation under §63.1343(b), you must demonstrate initial compliance with the activated carbon injection rate operating limits specified in §63.1344 by using the performance test methods and procedures in §63.1349(b)(3)(v). The average of the run injection rates will determine the applicable injection rate limit.
Although the definition "sorbent" broadly applies to ACI used to control any HAPs, 1348(a)(3) only indicates operating limits for ACI usage only apply if ACI is used for D/F compliance.  Need to clarify if ACI injection monitoring and limits only apply to D/F control strategies versus if ACI were used for THC or Hg compliance.
Clarify if ACI monitoring and injection rates only apply if ACI is necessary for D/F control.
Verify EPA intent and consider language changes that would help clarify that intent.

§63.1346(f)
Fly ash cannot be used in a cement kiln if it was from a process that used activated carbon to control Hg emissions, unless it can be shown that its use will not increase Hg emissions from the kiln. Once the kiln must comply with a mercury limit specified in § 63.1343, this paragraph no longer applies.
The last sentence of this section implies that this paragraph becomes effective on 11/8/10 and is no longer applicable after 9/9/13.
Need to confirm compliance dates and for portions of this citation.
This should be in technical correction of compliance dates.

§63.1348(a)(6)
HCl demonstration of initial compliance
Section only considers compliance using wet scrubbers and tray towers.  No consideration for compliance via dry sorbent injection.
Include initial compliance measures for alternative control techniques.
Was mentioned in the reconsideration supplemental list.   PCA will develop proposed alternative language.

§63.1348(a)(6)(ii)
If a source does not have a wet scrubber or tray tower, initial HCl compliance must be demonstrated using CEMS
Would using a dry scrubber also exempt the source from the HCl CEM requirement?
If so, rule should be appropriately revised to specify this.
Was mentioned in the reconsideration supplemental list.   PCA will develop proposed alternative language.

§63.1348(b)(1)(ii)
(ii) Except for periods of monitoring system malfunctions, repairs associated with monitoring system malfunctions, and required monitoring system quality assurance or quality control activities (including, as applicable, calibration checks and required zero and span adjustments), you must operate the monitoring system and collect data at all required intervals at all times the affected source is operating. Any period for which data collection is required and the operation of the CEMS is not otherwise exempt and for which the monitoring system is out-of-control and data are not available for required calculations constitutes a deviation from the monitoring requirements.
Any quantity of missing data is an automatic deviation under the Clean Air Act. The term deviation is too stringent for minor occurrences of monitoring missing data.

PCA will develop proposed alternative language.

§63.1349(d)
(d) Clinker Production Monitoring Requirements. If you are subject to an emissions limitation on particulate matter, mercury, NOx, or SO2 emissions (lb/ton of clinker), you must:
It does not seem appropriate for a MACT requirement to be triggered by NOx and SO2 limitations.
Request applicability for clinker production monitoring to not be triggered by NOx and SO2 limits.
PCA will propose removal of NOx and Sox reference

EPA's Policy Memo; May 16, 1995
facilities may switch to area source status at anytime until the "first compliance date" of the standard.
It is not clear whether the existing major sources can opt in as area sources of if once-in, always-in applies to the kilns.
Request clarification for once-in, always-in
Seek insight from EPA and PCA will provide suggested language.
Clinker Production Monitoring Requirements

§60.63 (b)(2);  §63.1350(d)(2)
Determine, record and maintain an accuracy of the system for clinker or kiln feed within 30 days of the effective date of this rule (for existing sources).  During each quarter determine, record and maintain ongoing accuracy.
Why must this be done within 30 days of the effective date of the rule if we do not have to comply with a clinker based emission limit for 3 years?
Should not be applicable until 3 years.
1350(d) -  Is raw feed monitoring really due by 12/8/10?  Or, is it really just that we only have to "Determine, record, and maintain a record of the accuracy of the system of measuring hourly clinker production " as literally written?  This would not impose the +/-5% accuracy provisions of the previous paragraph until 9/9/2013.

§63.1345
Emissions limits for affected sources other than kilns; in-line kiln/raw mills; clinker coolers; new and reconstructed raw material dryers; and raw and finish mills, and open clinker piles.
The owner or operator of each new or existing raw material, clinker, or finished product storage bin; conveying system transfer point; bagging system; and bulk loading or unloading system; and each existing raw material dryer, at a facility which is a major source subject to the provisions of this subpart must not cause to be discharged any gases from these affected sources which exhibit opacity in excess of ten percent.
Crushers are obviously not subject to the Subpart per 1340(c).  However, it is not obvious whether other sources associated with raw material handling and storage including screen, material transfer points, etc. are included or not.
Clarify when OOO ends and LLL begins
PCA will develop proposed alternative language.

63.1348(a)(1), (4), (5) and (6)
Initial compliance with the respective standard must be demonstrated based on "the first 30 operating days" of CEM operation
1) The requirement implies that the initial compliance demonstration can preceed the Complaince Date if the facility installs and certifies the CEM prior to that date..    2) The requirement does not make provisions for the occurrence of SU/SD events within the first 30 days of CEM operation.
The regulations should be revised to state that initial compliance is not required to be demonstrated before the Compliance date.  The regulation shouild be revised to reflect that the initial compliance demonstration should exclude SU/SD operating days
PCA will develop proposed alternative language.

63.1343(b)(2?)
Aternate PM limit for combined kiln/cooler emissions.
1) The prescribed formula relies on flow rate weighting per ton of "raw feed", but fails to define raw feed  How is this to be determined?   2)The basis for flow determination is also not defined.  It is unclear as to how the facility-specific PM limit is to be applied (i.e.. on a flow capacity basis or on an actual flow basis).
Clarify the term "raw feed" and clairfy that the limit is to be detyermined on a flow capacity basis.
PCA will develop proposed alternative language.

63.1350(d)(3)
"Record the daily clinker production rates and kiln feed rates."
Facilities that choose to monitor clinker production directly do not need to, and should not be required to, monitor and record kiln feed rates.
Clarify that moniytoring/recording of kiln feed rates is not required if clinker production is directly measured.
PCA will develop proposed alternative language.

63.1350(k)(1)
The span value of the Hg CEM "must include the intended upper limit" of the mercury concentration measurement range.
The term "intended limit" is so vague as to be impossible to determine what is needed to comply.
The regulation should be revised with a more definitive requirement for the upper limit and one that the regulated entity can plan for in acquiring commercially available equipment.
PCA will develop proposed alternative language.

63.1350(l)
Must comply with (m)(1) through (m)(4)
The regulation at (m)(3) requires the determination (and presumably recording) of 3-hour block averages.  Since the limit is on a 30-day RA basis, why are 3-hour blocks needed?
Eliminate the requirement for 3-hr block averages.

63.1349(b)(6)
The HCl PT requirements include collecting stack gas volumetric flow rate data.
The HCl standard is a ppm-based standard and does not rely on stack flow.  The requirement to collect flow data is superfluous.
Elimiate the requirement for flow data.

63.1350(g)
Each hour, calculate "the three-hour" average temperature
This revised requirement changesw the monitoring basis of the APCD temperature from a 180-minute RA to a 3-hour hourly RA.  It is unclear whether this revision will require a new "initial" performance test.
Revert back to the use of 180-minute RA or clarify that this change does not require a new inital PT.

63.1357
Temporary exemption from PM and opacity standards for purposes of PM-CEM correlation testing.
EPA failed to extend this exemption to clinker coolers.  Since these will now also require PM-CEMS, they need to be provided a similar exemption.
Revise the requirement to accomodate coolers.
PCA will develop proposed alternative language.


[Federal Register: October 15, 2009 (Volume 74, Number 198)]
[Rules and Regulations]
[Page 52885]
[DOCID:fr15oc09-6]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

New Animal Drugs for Use in Animal Feeds; Monensin; Tylosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Elanco Animal Health, A Division of Eli
Lilly & Co. The supplemental NADA revises limitations for liquid Type B
medicated cattle feeds containing tylosin phosphate.

DATES: This rule is effective October 15, 2009.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 12-491 for use of TYLAN (tylosin phosphate) Type A
medicated article. For liquid Type B medicated cattle feeds containing
tylosin phosphate, the supplement removes the presolubilization
instructions previously required for manufacture and reduces the expiry
from 8 weeks to 31 days. The supplemental NADA is approved as of
September 8, 2009, and the regulations in 21 CFR 558.625 are amended to
reflect the approval. In addition, the limitations for two-way
combination drug medicated liquid feeds containing tylosin and monensin
in 21 CFR 558.355 are amended to reflect the revised limitations for
tylosin liquid feeds.
    Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.355, revise paragraph (f)(3)(ii)(b) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) * * *
    (ii) * * *
    (b) Limitations. Feed only to cattle being fed in confinement for
slaughter. Feed continuously as sole ration at the rate of 50 to 480
milligrams of monensin and 60 to 90 milligrams of tylosin per head per
day. Combination drug liquid Type B medicated feeds may be used to
manufacture dry Type C medicated feeds as in Sec.  558.625(c) of this
chapter.
* * * * *

Sec.  558.625  [Amended]

0
3. In Sec.  558.625, remove and reserve paragraph (c)(2)(i); and in
paragraph (c)(3), remove ``8 weeks'' and in its place add ``31 days''.

    Dated: September 25, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-24716 Filed 10-14-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59401-59402]
[FR Doc No: 2021-23384]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0758]

Antimicrobial Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Antimicrobial Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.

DATES: The meeting will be held on November 30, 2021, from 9 a.m. to 5
p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-0758. The docket will close on November
29, 2021. Submit either electronic or written comments on this public
meeting by November 29, 2021. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before November 29, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of November 29, 2021. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before November 15, 2021, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments 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-2021-N-0758 for ``Antimicrobial Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), 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.'' FDA 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 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 the 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>.

FOR FURTHER INFORMATION CONTACT: Joyce Yu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:
301-847-8533, email: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will discuss Emergency Use Authorization (EUA) 000108, submitted by
Merck & Co. Inc., for emergency use of molnupiravir oral capsules for
treatment of mild to moderate COVID-19 in adults who are at risk for
progressing to severe COVID-19 and/or hospitalization.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before November 15, 2021, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before November 4, 2021.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by November 5, 2021.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Joyce Yu (see FOR FURTHER INFORMATION CONTACT) at least 7 days
in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23384 Filed 10-26-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 3, 2007 (Volume 72, Number 85)]
[Notices]
[Page 24638-24639]
[DOCID:fr03my07-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55675; File No. SR-Amex-2006-114]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Granting Approval to a Proposed Rule Change as Modified by Amendment
No. 1 Thereto Clarifying the Continued Listing Standards for Units

April 26, 2007.

I. Introduction

    On December 4, 2006, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change pursuant to Section 19(b)(1)
of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ On February 22, 2007, Amex filed Amendment No. 1 to the
proposed rule change. The proposed rule change, as amended, was
published for comment in the Federal Register on March 22, 2007 for a
21-day comment period.\3 \The Commission received no comments on the
proposal. This order approves the proposed rule change, as modified by
Amendment No. 1.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 55479 (March 15,
2007), 72 FR 13540 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    Section 1003(g) of the Amex Company Guide currently provides that
the Exchange will ``normally consider'' suspending or delisting units
if any of their component parts do not meet the applicable continued
listing standards. However, if one or more of the components is
otherwise qualified for listing, such component may remain listed. For
example, a unit comprised of both a common stock component and a debt
component would face suspension or delisting procedures if either the
common stock or the debt component no longer met its applicable
continued listing standards. As a result, if the debt component failed
to meet the continued listing standards for bonds, both the unit and
such debt component would be subject to suspension or delisting
procedures, but the common stock component could independently remain
listed and continue to trade on the Exchange, provided such common
stock component met the continued listing standards for equity
securities.
    The Exchange proposes to amend Section 1003(g) of the Amex Company
Guide so that, in the event a component of a unit does not meet its
continued listing standards, the Exchange would no longer ``consider''
suspending or delisting the unit, but would commence a formal continued
listing evaluation of such component and unit in accordance with
Section 1009 of the Amex Company Guide.\4\
---------------------------------------------------------------------------

    \4\ See Section 1009(j) of the Amex Company Guide. Section 1009
generally sets forth the suspension and delisting procedures,
timelines, and requirements applicable to issuers identified as
being below certain continued listing standards. For example, an
issuer of particular securities that receives notification from the
Exchange that it is below the continued listing criteria for such
securities must publicly announce receipt of such notification and
the policies and standards upon which the determination is based.
---------------------------------------------------------------------------

    The Exchange also proposes to add language to Section 1003(g) on
the applicability of certain continued listing standards relating to
components of units that have separated. Under the proposal, when units
in good standing begin to separate into their component securities, the
remaining units that are still intact and the components of those units
which have separated may all be separately listed and continue to
trade, provided that they meet the applicable continued listing
standards. The proposal specifies that, in determining whether an
individual component meets the continued listing distribution standards
(i.e., number of shares publicly held, number of public shareholders,
and aggregate market value of shares publicly held) set forth in
Section 1003(b) of the Company Guide,\5\ the units that are intact and
freely separable into their component parts will be aggregated with the
separately-traded components. For example, Amex stated that if 120,000
shares of common stock are publicly held after their separation from
their units, and 210,000 intact and freely separable units are publicly
held, the common stock would be credited with having 330,000 shares
publicly held, enabling it to satisfy one of the distribution standards
for common stock, which requires at least 200,000 shares of common
stock to be publicly held.\6\ If the units are no longer freely
separable and/or listed on the Exchange, the separately-traded
components would still be required to meet their applicable continued
listing standards, but the distribution values would not be
aggregated.\7\
---------------------------------------------------------------------------

    \5\ See, e.g., Section 1003(b)(i) of the Amex Company Guide (in
the case of common stock, requiring the number of shares publicly
held to be no less than 200,000, the total number of public
shareholders to be no less than 300, and the aggregate market value
of shares publicly held to be no less than $1,000,000 for more than
90 consecutive days). See also Sections 1003(b)(ii)-(v) of the Amex
Company Guide (setting forth the applicable distribution and market
value requirements for warrants, preferred stock, bonds, and closed-
end funds, respectively).
    \6\ See Section 1003(b)(i)(A) of the Amex Company Guide.
    \7\ See proposed Section 1003(g) of the Amex Company Guide. The
Commission notes that under proposed Section 1003(g), if in the
above example the units are no longer freely separable into common
stock, there would be no aggregation of units with the common stock
for purposes of evaluating whether the units and common stock meet
the continued listing standards.
---------------------------------------------------------------------------

    Despite the fact that the aggregated distribution values satisfy
the continued listing distribution standards, under the proposal, the
Exchange would also consider suspending trading in, or removing from
listing, an individual component or unit when the public distribution
or aggregate market value of such component or unit becomes so reduced
as to make continued listing inadvisable. In its review of the
advisability of the continued listing of an individual component or
unit under such circumstances, the Exchange proposes to take into
account the trading characteristics of the component or unit and
whether it would be in the public interest for trading in such
component or unit to continue.
    The Exchange also proposes to make technical revisions to Sections
1003(a), (c), (d) and (f) to consistently use the term ``issuer'' as
opposed to ``company.''

III. Discussion and Commission's 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.\8\ In particular, the Commission finds that the proposed rule
change, as amended, is consistent with the requirements of Section
6(b)(5) of the Act,\9\ which requires, among other things, that the
Exchange's rules be designed to promote just and equitable principles
of trade, 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.
---------------------------------------------------------------------------

    \8\ 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).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposal strengthens the
procedures applicable to units when their components fall below
continued listing standards, by providing that, in such instances, the
Exchange would commence a formal evaluation of the components and unit
pursuant to

Section 1009 of the Amex Company Guide.
    In addition, the proposal sets forth the application of continued
listing standards to individual components comprising units once some,
but not all, of the units have separated into their component parts, by
specifying that the units that are intact and freely separable into
their component parts will be counted toward the total distribution
numbers \10\ required for continued listing of the component. The rule
change recognizes the practical situation that as investors decide
whether to separate their unit, there may be a period of time at the
outset of the separation period when there may be less components
outstanding than necessary to meet the distribution requirements.
However, to immediately delist these components during the separation
period may be unfair to those investors who still have an opportunity
to separate their components and want to trade them in a public market.
The rule ensures that to be able to count the units for purposes of the
distribution requirements for the component parts, the units must be
freely separable into the components, so there is a reasonable basis
for assuming that as more units are separated, which adds liquidity to
the components, the distribution requirements for the components can,
in fact, be separately met.
---------------------------------------------------------------------------

    \10\ See supra note 5 and accompanying text.
---------------------------------------------------------------------------

    Under the rule however, if it appears that not enough units will be
separated to allow the components to meet the public distribution and
aggregate market value requirements independently or there are other
concerns, the rule makes clear that Amex should consider delisting the
components or unit. This recognizes the fact that although the rule
allows the aggregation of units and components for purposes of
distribution standards, Amex will need to ensure that there is some
minimal level of liquidity in each component and unit and should
consider delisting if the public distribution or the aggregate market
value of the components or unit has become so reduced as to make
continued listing on the Exchange inadvisable. In this regard, the
Exchange will take into account the individual distribution values and
the trading characteristics of the component or unit and whether it
would be in the public interest for continued trading of such component
or unit.\11\
---------------------------------------------------------------------------

    \11\ The Commission notes that minimum distribution requirements
are extremely important to ensure, among other things, the liquidity
of a security and an active public market. The changes being
approved for meeting the distribution standards applicable to units
and their components recognize the unique trading characteristics
and challenges that can occur in meeting the minimum standards
during the separation period of the units, while containing certain
protections to ensure certain minimum standards will be met.
---------------------------------------------------------------------------

    As Amex noted in its filing, the proposal should help to promote
transparency of the Exchange rules relating to the continued listing of
units and their components and provide clearer guidance for members and
investors trading in such units and/or components. Finally, the
technical changes to Section 1003 of the Company Guide ensure that the
rule's language will be consistent throughout. Based on the above, the
Commission believes the proposal promotes just and equitable principles
of trade in such securities and is designed to protect investors and
the public interest, consistent with Section 6(b)(5) of the Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-Amex-2006-114), as modified by
Amendment No. 1, be, and it hereby is, approved.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

J. Lynn Taylor,
Deputy Secretary.
 [FR Doc. E7-8397 Filed 5-2-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 78 (Wednesday, April 22, 2020)]
[Notices]
[Pages 22427-22429]
[FR Doc No: 2020-08466]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5573]

Technical Considerations for Demonstrating Reliability of
Emergency-Use Injectors Submitted Under a Biologics License
Application, New Drug Application, or Abbreviated New Drug Application;
Draft Guidance for Industry and Food and Drug Administration;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry and FDA entitled
``Technical Considerations for Demonstrating Reliability of Emergency-
Use Injectors Submitted under a BLA, NDA or ANDA.'' For injectable drug
or biological products that are intended to treat emergent, life-
threatening conditions, it is essential to ensure that the emergency-
use injector will reliably deliver the drug or biological product as

intended. This is particularly critical for drugs when failure of the
injector may prevent adequate delivery of a life-saving drug to a
patient. The draft guidance describes the technical considerations for
demonstrating reliability of emergency-use injectors under a biologics
license application (BLA), new drug application (NDA), or abbreviated
new drug application (ANDA).

DATES: Submit either electronic or written comments on the draft
guidance by June 22, 2020 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-2019-D-5573 for ``Technical Considerations for Demonstrating
Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or
ANDA: Guidance for Industry and FDA.'' 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.
     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.
    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: Patricia Love, Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5129, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or d5b6bab8b7bcbbb4a1bcbabb95b3b1b4fbb2baa3.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and FDA entitled ``Technical Considerations for Demonstrating
Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or
ANDA.'' For injectable drug or biological products that are intended to
treat emergent, life-threatening conditions, it is essential to ensure
that the injector will reliably deliver the drug or biological product
as intended. This is particularly critical for drugs when failure of
the emergency-use injector may prevent adequate delivery of a life-
saving drug to a patient. This guidance's focus is emergency-use
injectors marketed with the emergency-use drug/biological product as a
prefilled single entity combination product or as a co-packaged
combination product assigned to the Center for Drug Evaluation and
Research or the Center for Biologics Evaluation and Research with
market authorization under an approved NDA, ANDA, or BLA.
    The draft guidance describes the technical considerations for
demonstrating reliability of emergency-use injectors under an NDA,
ANDA, or BLA. For purposes of the draft guidance, reliability is
defined as the probability that the injector will perform as intended,
without failure, for a given time interval under specified conditions.
The document describes information and data that FDA recommends be
included in marketing applications to demonstrate that an emergency-use
injector is reliable, including the details of an example of an
acceptable approach for the mathematical model, statistics, fault tree
analysis, and use of certain current good manufacturing practice
requirements for combination products (21 CFR 4.4(b)(1)(ii) and (iv))
to establish reliability of the emergency-use injector.
    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 ``Technical Considerations for Demonstrating Reliability of
Emergency-Use Injectors Submitted under a BLA, NDA or ANDA.'' 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

    This draft guidance refers to currently approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 314 for NDAs have been approved under OMB control number 0910-
0001. The collections of information in 21 CFR part 601 for BLAs have
been approved under OMB control number 0910-0338. The collections of
information in 21 CFR part 814, subpart B, for premarket approval
applications have been approved under OMB control number 0910-0231. The
collections of information section 510(k) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(k)), subpart E for 510(k)
notifications, have been approved under OMB control number 0910-0120.
The collections of information in the guidance for industry and FDA
staff entitled ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844. The collections of information in 21 CFR part 820
have been approved under OMB control number 0910-0073.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents/combination-products-guidance-documents or https://www.regulations.gov.

    Dated: April 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08466 Filed 4-21-20; 8:45 am]
BILLING CODE 4164-01-P


October 8, 2004 Mr. Carey A. Johnston 4303T USEPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Subject: TWPE for PAC Releases Associated with Creosote Wood Preserving Facilities in SIC Code 2491 Dear Mr. Johnston:

I am writing you on behalf of our membership that treats with the wood preservative creosote. As we have been monitoring the Effluent Guidelines Program, several issues have arisen.

First issue deals with the toxic weighting factor ( TWF). In the Timber Industry memo that you provided the industry on June 8, 2004, the TWPE for the PACs associated with creosote were apparently calculated on the basis of a toxic weighting factor ( TWF) of approximately 66. This is confirmed on page 4 16 of the Technical Support Document for the 2004 Effluent Guideline Program Plan, which states that the Agency computed a TWF of 65.78 for the PACs associated with creosote. We have been unable to find the document that details the Agency's computation of the 65.78 TWF. Could you please direct us to the source for this number?

The second issue concerns PACs. In most, if not all cases, the PACs reported by creosote wood treating facilities are not based on any actual analyses for polycyclic aromatic compounds. In general, creosote releases are estimated based on some surrogate analyte, such as oil and grease or total phenols, since there is no standard method for the quantitation of creosote. We believe that PAC estimates were derived from creosote estimates, but we do not believe that everyone who reported for PACs took a consistent approach. Most of the surrogate analyses come from samples taken as part of required storm water sampling, and these are taken in the first 30 minutes of run off and this is expected to provide concentrations higher than a true average for all run off. SOUTHERN PRESSURE TREATERS ASSOCIATION P. O. Box 3219 206 Beverly Loop Pineville, LA 71361 3219 TEL 318 619 8589 FAX 318 767 1388 sptala@ bellsouth. net CHARTERED 1954 Given these shortcomings in the present estimating techniques, the industry is going to attempt to develop storm water data based on actual analyses for PACs. Analyses for the conventional surrogate parameters will be conducted concurrently so that a relationship can be established upon which adjustments to prior estimates of PACs can be made. The industry is going to undertake this data gathering during the balance of 2004, and we should have data to share with the Agency in early 2005.

We are confident that actual data coupled with a technically sound TWF will demonstrate to the Agency that the surface water impacts associated with this industry are very minimal and do not warrant the investment of Agency resources necessary to promulgate revised effluent standards for the Timber Products Processing Subcategory.

We would be happy to meet with you at any time to discuss these issues, but it may be most productive to wait until our new data is available. In the meantime, we would appreciate the opportunity to review the methodology used to develop the 65.78 toxic weighting factor used by the Agency.

Thank you for your time and consideration.

Sincerely,

Carl Johnson Executive Director Southern Pressure Treaters Association P. O. Box 3219 Pineville, LA 71361 3219 Office: 318 619 8589 Fax: 318 767 1388 Email: sptala@ bellsouth. net


[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68342-68344]
[FR Doc No: 2020-23838]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1862]

The Drug Supply Chain Security Act Pilot Project Program and
Enhanced Drug Distribution Security; Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the following virtual public meeting entitled ``The Drug
Supply Chain Security Act Pilot Project Program and Enhanced Drug
Distribution Security.'' The purpose of the public meeting is to
provide members of the pharmaceutical distribution supply chain and
other interested stakeholders an opportunity to discuss with FDA and
provide input on strategies and issues related to the enhanced drug
distribution security provisions of the Drug Supply Chain Security Act
(DSCSA) and the results of FDA's DSCSA Pilot Project Program.

DATES: The public meeting will be held on December 8 and 9, 2020, from
9 a.m. to 4 p.m., Eastern Time, each day, and will take place virtually
(by webcast only). Submit either electronic or written comments on this
public meeting by December 28, 2020.

ADDRESSES: The public meeting will be held virtually and hosted by FDA.
Registration to participate in this meeting and other information can
be found at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security. See the SUPPLEMENTARY INFORMATION section for
registration date and other information.
    Comments: To permit the widest possible opportunity to obtain
public comment, FDA is soliciting either electronic or written comments
on all aspects of the public meeting topics. You may submit comments as
follows. Please note that late, untimely filed comments will not be
considered. Electronic and written comments must be submitted on or
before December 28, 2020. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of December 28, 2020. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is on or
before that date.

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-2020-N-1862 for ``The Drug Supply Chain Security Act Pilot Project
Program and Enhanced Drug Distribution Security; Public Meeting;
Request for Comments.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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>.

FOR FURTHER INFORMATION CONTACT: Kristle Green, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the DSCSA (Title II, Pub. L. 113-54) was
signed into law. The DSCSA outlines critical steps for building an
electronic, interoperable system by 2023 to identify and trace certain
prescription drugs as they are distributed within the United States.
This system will enhance FDA's ability to protect U.S. consumers from
exposure to drugs that may be counterfeit, diverted, stolen,
intentionally adulterated, or otherwise harmful by improving the
detection and removal of potentially dangerous drugs from the drug
supply chain. Section 582(j) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360eee-1(j)), which was added by the DSCSA,
directs FDA to establish one or more pilot projects, in coordination
with authorized manufacturers, repackagers, wholesale distributors, and
dispensers, to explore and evaluate methods to enhance the safety and
security of the pharmaceutical distribution supply chain. Additionally,
section 582(i) of the FD&C Act directs FDA to hold public meetings to
enhance the safety and security of the pharmaceutical distribution
supply chain and provide opportunities for comment from members of the
pharmaceutical distribution supply chain and other interested
stakeholders. Section 582(h)(3) of the FD&C Act directs FDA to conduct
a public meeting and issue guidance addressing the system attributes
necessary to enable secure product tracing of product at the package
level.

II. Topics for Discussion at the Public Meeting

    FDA will hold a virtual public meeting on December 8 and 9, 2020,
on FDA's DSCSA Pilot Project Program and related enhanced drug
distribution security issues. The purpose of this public meeting is to
provide members of the pharmaceutical distribution supply chain and
other interested stakeholders an opportunity to discuss with FDA, and
provide input on, strategies and issues related to the enhanced drug
distribution security provisions of the DSCSA and FDA's DSCSA Pilot
Project Program. The public meeting will focus on the following topics
for discussion:
     Findings and lessons learned from FDA's DSCSA Pilot
Project Program.
     Other piloting or piloted activities related to DSCSA
implementation.
     System attributes necessary for enabling secure product
tracing of product at the package level. Examples of discussion topics
include, but are not limited to, the system attributes, circumstances,
and processes necessary for facilitating:
    [cir] Interoperability among trading partners in the pharmaceutical
distribution supply chain, FDA, and other appropriate Federal or State
official(s);
    [cir] enhanced product tracing activities involving the exchange of
data in a secure manner, including management and maintenance of the
data;
    [cir] the use of aggregation and inference for product tracing and/
or verification; and
    [cir] enhanced verification activities involving communications
between trading partners and FDA and exchange of data in a secure
manner, including management and maintenance of the data.

FDA may include additional discussion topics. Materials for the public
meeting will be provided on FDA's website at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security 7 days before the
public meeting.

III. Participating in the Public Meeting

    Registration: To request registration for the public meeting,
provide your information, including name, company or organization,
address, telephone number, and email address, to FDA at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security. FDA
may limit attendance to ensure manageability of the virtual public
meeting and breakout sessions. In addition, FDA may limit the number of
participants from each organization to help ensure that meeting
participants represent the diversity of the pharmaceutical supply chain
and other stakeholders. FDA recommends that

each organization determine who should register for the public meeting
to represent his/her organization. Registrants will receive
confirmation of participation for the meeting from FDA within 14 days
before the meeting. There is no registration fee for the public
meeting, and there will be no onsite registration. If registration
reaches maximum capacity, FDA will post a notice closing registration
for the meeting on FDA's website at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security.
    If you need special accommodations due to a disability, please
contact Kristle Green (see FOR FURTHER INFORMATION CONTACT) no later
than 7 days before the public meeting.
    Streaming Webcast of the Public Meeting: Portions of the public
meeting will be recorded and webcast on the day of the meeting.
Information on how to access the webcast will be available at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security
within 7 days before the public meeting. The webcast will be conducted
in listening mode only.

    Dated: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23838 Filed 10-27-20; 8:45 am]
BILLING CODE 4164-01-P