ENCLOSURE 3

PUBLIC PARTICIPATION RECORD

As required by 40 CFR 51.102(e), the complete record of testimony is
located at the Department of Environmental Quality.  The department
contact to access this information is the Director, Air Division.

As required by Section 2.1(h) of Appendix V of 40 CFR Part 51, below is
a summary of the testimony received and responses thereto.  Included is
a brief statement of the subject, the identification of the commenter,
the summary of the comment and the response (analysis and action taken).
 Each issue is discussed in light of all of the comments received that
affect that issue.  All comments have been reviewed and responses
developed based on an evaluation of the issues raised in consideration
of the overall goals and objectives of the air quality program and the
intended purpose of the document under review.

1. SUBJECT:  Sulfur dioxide (SO2) emissions.

COMMENTER:  National Park Service

TEXT:  DEQ has proposed addition of a caustic wet scrubber to control
SO2 emissions from the rotary kiln. We agree and fully support this
proposal.

RESPONSE:  Support for the proposal is appreciated.

2. SUBJECT:  Nitrogen oxide (NOX) emissions, cost effectiveness of
selective catalytic reduction (SCR) control.

COMMENTER:  National Park Service

TEXT:  We agree that SCR in a high-dust location on this rotary lime
kiln poses problems that render this approach technically infeasible in
this situation. There is a growing successful track record of SCR use in
the United States that indicates that spent catalyst and ammonia use are
not a significant risk if proper procedures are followed.

The following comments are directed to O-N Minerals' June 4, 2009
response to DEQ as it relates to the cost-effectiveness of a tail-end
SCR system located downstream of the existing baghouse.

Except as noted elsewhere, we accept O-N's estimated costs at face
value, and appreciate their effort to provide that information in such
detail.  We believe that O-N's operating cost for "Supplemental Natural
Gas Firing" may be overstated. We recently received an analysis of
tail-end SCR as it might be applied following a wet scrubber at Basin
Electric Power Cooperative's (BEPC) Leland Olds Station Unit #2 in North
Dakota. In that analysis, BEPC assumed that enough heat could be
recovered that the additional natural gas heating requirement to operate
SCR would be only 50°F. If we compare that Leland Olds estimate to the
200°F increase estimated by O-N, there is the potential to cut natural
gas use by 75%.

We believe that O-N has underestimated the effectiveness of SCR at 80%
control efficiency (305 tpy reduction). It is generally assumed that SCR
can attain at least 90% control--which should be especially likely in a
low-dust location. (The Leland Olds Unit #2 BART analysis assumed 90%
control.) A 90% reduction at O-N could result in up to 340 tpy removal.
We entered data into a spreadsheet that adjusts the O-N Minerals results
to account for reduced reheat cost and increased NOX removal. The
resulting

$5,100 per ton cost-effectiveness is substantially lower than the $7,500
per ton estimated by O-N Minerals.

Unless a control technology option is determined to be technically
infeasible, the full five-step BART process should be applied. In this
case, tail-end SCR is technically feasible and its costs are low enough
to justify an analysis of the visibility improvements that would result
from its application.

RESPONSE:  The comments offered by the National Park Service (NPS) do
not address--or change--our position as stated in our September 22, 2009
letter responding to NPS’s original comments (provided during NPS’
formal 60-day review period).  As detailed in the letter, SCR has not
been applied to or demonstrated on any kiln (cement or lime) in the
United States. The limited data derived from one European cement kiln
SCR application indicates poor performance (resulting in the SCR being
replaced by SNCR at that location).  We have found no use of SCR on a
lime kiln anywhere.  Accordingly, and as detailed in our 9/22/09 letter,
we find that SCR is not a candidate for technology transfer for BART
consideration.

Nonetheless, we offer the following responses to the points raised by
NPS during the public comment period.

It is uncertain that it would be technically feasible to retrofit the
existing rotary kiln setup at the Strasburg site to accommodate a heat
exchanger for the purpose of heating the baghouse exhaust.  Kiln heat is
already recovered and used to heat limestone in the preheater, so it is
unlikely that there would be enough residual heat to appreciably raise
the baghouse outlet stream temperature.  It is not reasonable to
conclude that O-N’s natural gas heating requirement would be 50°F
(i.e., would be reduced by 75%) based on the requirements of a
coal-fired boiler installation using heat recovery.

As stated in our 9/22/09 letter, we believe 80% is an appropriate
control efficiency basis for a novel application of SCR such as that on
a lime kiln.  There are data available from one application of SCR to a
kiln (a cement kiln, not a lime kiln) in Europe; the data show that the
SCR achieved an average control efficiency below 50%.  We also note that
several recent entries for applications of SCR on EPA’s RACT/BACT/LAER
Clearinghouse (RBLC) are listed at efficiencies below 90%, which
reflects the process-specific nature of SCR effectiveness.  As we
previously concluded, although SCR is capable of achieving 90% reduction
efficiency in certain applications, it would not be appropriate to apply
that standard to an application of SCR to a lime kiln.

The adjusted cost per ton value ($5,100) presented by NPS is based on
several assumptions.  First, it presumes that a heat exchanger retrofit
is technically feasible on the rotary kiln.  Secondly, NPS’s revised
calculation does not include an adjustment to capital costs to reflect
the cost of the retrofit, if it is feasible.  Finally, the revision is
based on 90% control efficiency, which, as explained above, we find to
be inappropriate in this case.  We therefore do not find the adjusted
cost per ton to be an accurate indicator of SCR control cost in O-N’s
case.

Modeling to assess the visibility improvement likely to result from
application of SCR at O-N has not been conducted, because SCR was
determined to be cost prohibitive.  Additionally, as detailed above, SCR
has not been applied to a lime kiln and we do not find it to be a
candidate for technology transfer consideration under the BART
guidelines.  The analysis conducted to determine BART for O-N is fully
consistent with the five-factor evaluative approach outlined in the BART
guidelines (40 CFR Part 51, Appendix Y).

3. SUBJECT:  Changes to permit conditions and SIP revisions.

COMMENTER:  O-N Minerals (Chemstone) Company

TEXT:  The proposed BART permit contains numerous and specific
conditions that we understand will become part of Virginia's state
implementation plan (SIP) once finalized and approved by the U.S.
Environmental Protection Agency (EPA).  Given that this facility in the
near and long term may undergo permit changes that could result in
future permit conditions that differ from those that incorporated in
this permit, we have previously suggested to DEQ that this permit
contain certain language to allow for permit modifications to minimize
the possibility of having to modify the SIP to accommodate future permit
requirements that may conflict with the BART permit as drafted.  We
appreciate that DEQ has considered this request previously and we
understand some regulatory options may exist to reduce the opportunity
for SIP revisions to be necessary.  However, we remain concerned that
future permitting efforts at the facility may require SIP revisions
before they can be implemented without such permit revision provisions
being incorporated in this permit.  Accordingly, we appreciate DEQ
reconsidering this aspect of the permit during this phase of the
process.

RESPONSE:  We understand O-N’s desire to simplify the administrative
SIP revision process that may be required to address future
modifications at the facility.  Nonetheless, there is no way to avoid
the need for a SIP revision if O-N wishes to change the terms of the
BART permit in the future.  We note that this is the case for any
facility holding an air permit that is part of Virginia’s SIP.

4. SUBJECT:  Scrubber installation date.

COMMENTER:  O-N Minerals (Chemstone) Company

TEXT:  We previously suggested that Condition 4 be revised to
accommodate the timeframes that the company is working under relative to
installation of an SO2 continuous emission monitoring system (CEMS) and,
if necessary, the design, engineering, permitting and installation of
add-on control equipment as applicable.

DEQ has not agreed to accept our proposed revision to this condition in
prior discussions.  We would prefer not to formally challenge the permit
or delay the revision to the SIP.  However, we cannot agree to the
proposed language of Condition 4 which would require us to install a
scrubber by September 10, 2010.  We must have time to demonstrate that a
scrubber is not necessary and obtain approval for the alternative
control technology.  If we cannot make that demonstration after a
reasonable period (including the requirement to install a CEM for SO2),
we will need adequate time to install the scrubber (assuming we continue
to operate the kiln).  We recommend that Condition 4 clearly state that
we have until September 10, 2011 to seek approval of alternative control
technology.  Therefore, we propose the following revised Condition 4:

4.  Emission Controls: Rotary Kiln - No later than September 10, 2010,
sulfur dioxide (SO2) emissions from the rotary kiln (U5) shall be
controlled to achieve the SO2 limits set forth in this permit.  Unless
the Director, Valley Regional Office, approves inherent process
scrubbing as an alternative control technology by September 10, 2011, a
wet scrubber shall be installed by September 10, 2012.  The wet scrubber
or other technology employed to meet the SO2 emission limits shall be
provided with adequate access for inspection and shall be in operation
when the rotary kiln is operating.

(9VAC5-80-850, 9VAC5-40-7580, 9VAC5-40-7590, and 9VAC5-40-7650)

We also think it is important to state our understanding that the
Director will agree that inherent process scrubbing is an approvable
control technology if our SO2 emissions are consistently within the
permit limits.  We agreed to install a CEMS to provide data to
demonstrate that inherent process scrubbing is effective and capable of
meeting the BART permit without additional controls.  Additionally, we
understand that given the newness of continuous emission monitoring for
SO2, occasional deviations of the SO2 limit should not preclude the
Director from granting approval.

RESPONSE:  We agree that an extension of the deadline to install a
scrubber is appropriate, provided that the emission limits determined to
represent BART for SO2 from the rotary kiln (Condition 23) are met by
September 10, 2010.  Accordingly, we have changed Condition 4 to read:

Emission Controls: Rotary Kiln – No later than September 10, 2010,
sulfur dioxide (SO2) emissions from the rotary kiln (U5) shall be
controlled to achieve the SO2 limits in Condition 23.  Unless the
Director, Valley Regional Office, approves inherent process scrubbing as
an alternative control technology by September 10, 2011, a wet scrubber
shall be installed by August 1, 2012.  The wet scrubber or other
technology employed to meet the SO2 limits shall be provided with
adequate access for inspection and shall be in operation when the rotary
kiln is operating.

(9 VAC 5-80-850, 9 VAC 5-40-7580, 9 VAC 5-40-7590 and 9 VAC 5-40-7650)

Note that the scrubber installation date has been changed to August 1,
2012 (instead of September 10, 2012 as proposed by O-N) to comply with
Virginia’s BART regulation (9 VAC 5-40-7590.4).

5. SUBJECT:  Wet scrubber.

COMMENTER:  O-N Minerals (Chemstone) Company

TEXT:  We also believe a wet scrubber will be sufficient and ask to
remove the reference to "caustic" in the appropriate conditions
including, but not limited to, Conditions 4, 9, 14, and 26j.

RESPONSE:  As requested, we have removed the word “caustic” from all
references to the scrubber throughout the permit.

TEMPLATES\SOURCE-SPECIFIC\PLN03

SRCESPEC\O-N MINERALS\ONM-SIP-3.DOC

 PAGE

 PAGE   2


[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 10977-10979]
[FR Doc No: 2021-03548]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2016]

Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for
Methanol, Including During the Public Health Emergency (COVID-19);
Guidance for Industry; 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 final guidance for industry entitled ``Policy for
Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol,
Including During the Public Health Emergency (COVID-19).'' This
guidance is intended to alert pharmaceutical manufacturers and
pharmacists in State-licensed pharmacies or Federal facilities who
engage in drug compounding to the potential public health hazard of
alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated
with or substituted with methanol. FDA is aware of reports of fatal
methanol poisoning of consumers who ingested alcohol-based hand
sanitizers that were manufactured with methanol or methanol-
contaminated ethanol and is concerned that other drug products
containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which
are widely used active ingredients in a variety of drug products, could
be similarly vulnerable to methanol contamination. As the COVID-19
pandemic has increased the demand for hand sanitizer products, the
demand for pharmaceutical alcohol as the active ingredient of those
products has also increased. The guidance outlines a policy intended to
help pharmaceutical manufacturers and pharmacists in State-licensed
pharmacies or Federal facilities who engage in drug compounding avoid
the use of pharmaceutical alcohol that is contaminated with or
substituted with methanol in drug products. Given the public health
emergency presented by coronavirus disease 2019 (COVID-19), this
guidance document is being implemented without prior public comment
because FDA has determined that prior public participation is not
feasible or appropriate, but it remains subject to comment in
accordance with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on February 23, 2021. The guidance document is immediately in
effect, but it remains subject to comment in accordance with the
Agency's good guidance practices.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2020-D-2016 for ``Policy for Testing of Alcohol (Ethanol) and
Isopropyl Alcohol for Methanol, Including During the Public Health
Emergency (COVID-19).'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on

https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the 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; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Francis Godwin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4342, Silver Spring, MD 20993-0002, 301-
796-5362; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Julie
Bailey, Center for Veterinary Medicine (HFV-140), Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Policy for Testing of Alcohol (Ethanol) and Isopropyl
Alcohol for Methanol, Including During the Public Health Emergency
(COVID-19).'' This guidance is intended to alert pharmaceutical
manufacturers \1\ and pharmacists in State-licensed pharmacies or
Federal facilities who engage in compounding to the potential public
health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl
alcohol (collectively ``pharmaceutical alcohol'' \2\) contaminated with
or substituted with methanol. FDA is aware of reports of fatal methanol
poisoning of consumers who ingested alcohol-based hand sanitizers that
were manufactured with methanol or methanol-contaminated ethanol and is
concerned that other drug products containing pharmaceutical alcohol,
which are widely used active ingredients in a variety of drug products,
could be similarly vulnerable to methanol contamination. As the COVID-
19 pandemic has increased the demand for hand sanitizer products, the
demand for pharmaceutical alcohol as the active ingredient of those
products has also increased.
---------------------------------------------------------------------------

    \1\ References to ``manufacturers'' includes registered
outsourcing facilities, repackers, relabellers, and suppliers of
alcohol.
    \2\ For the purposes of this guidance, we use the term
pharmaceutical alcohol to mean either ethanol (ethyl alcohol) or
isopropyl alcohol (2-propanol). Both are used as an active
ingredient in alcohol-based hand sanitizers and may be used in other
drug products as an active or inactive ingredient.
---------------------------------------------------------------------------

    The guidance outlines a policy intended to help pharmaceutical
manufacturers and pharmacists in State-licensed pharmacies or Federal
facilities who engage in compounding avoid the use of pharmaceutical
alcohol that is contaminated with or substituted with methanol in drug
products. The policy outlined in the guidance includes, but is not
limited to: (1) Performing a specific identity test that includes a
limit test for methanol on each container within each shipment of each
lot of pharmaceutical alcohol before the component is used in the
manufacture or preparation of drug products; (2) knowing the entities
in pharmaceutical manufacturers' supply chain for pharmaceutical
alcohol (i.e., knowing the identities and appropriately qualifying the
manufacturer of the pharmaceutical alcohol and any subsequent
distributor(s)); (3) ensuring that all personnel in pharmaceutical
manufacturing facilities (especially personnel directly responsible for
receipt, testing, and release of pharmaceutical alcohol) are made aware
of the importance of proper testing and the potential hazards if the
testing is not done; and (4) establishing finished product test methods
to ensure that when testing for ethanol or isopropyl alcohol content
(assay), the method also distinguishes between the active ingredient
and methanol. The policy outlined in this guidance applies to
pharmaceutical alcohols used as an active or inactive ingredient in a
drug.
    In light of the public health emergency related to COVID-19
declared by the Secretary of the Department of Health and Human
Services (HHS), FDA has determined that prior public participation for
this guidance is not feasible or appropriate and is issuing this
guidance without prior public comment (see section 701(h)(1)(C)(i) of
the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)). This
guidance document is being implemented immediately, but it remains
subject to comment in accordance with the Agency's good guidance
practices. FDA will review comments, and the guidance will be updated
accordingly.
    This guidance is intended to remain in effect for the duration of
the public health emergency related to COVID-19 declared by HHS,
including any renewals made by the Secretary in accordance with section
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
However, the recommendations and processes described in the guidance
are expected to assist the Agency more broadly in its efforts to ensure
that pharmaceutical alcohol that is contaminated with or substituted
with methanol is not used in drug products beyond the termination of
the COVID-19 public health emergency and reflect the Agency's current
thinking on this issue. Therefore, within 60 days following the
termination of the public health emergency, FDA intends to revise and
replace this guidance with any appropriate changes based on comments
received on this guidance and the Agency's experience with
implementation.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Policy for Testing of Alcohol (Ethanol)
and Isopropyl Alcohol for Methanol, Including During the Public Health
Emergency (COVID-19).'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001; the collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014; the collections
of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338; and the collections of information in 21 CFR parts
210 and 211 have been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or https://www.regulations.gov.

    Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03548 Filed 2-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 87 (Monday, May 8, 2017)]
[Rules and Regulations]
[Page 21309]
[FR Doc No: 2017-09212]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-0360]

Drawbridge Operation Regulation; Mill River, New Haven, CT

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Chapel Street Bridge across the
Mill River, mile 0.4 at New Haven, Connecticut. This deviation is
necessary to complete mortar and fender repairs as well as structural
steel work. This deviation allows the bridge to open for the passage of
vessels upon 2 hours of advance notice as well as a four day closure of
the draw to all vessel traffic.

DATES: This deviation is effective from 12:01 a.m. on May 8, 2017,
through 11:59 p.m. on May 30, 2017.

ADDRESSES: The docket for this deviation, USCG-2017-0360 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email James M. Moore, Bridge Management
Specialist, First District Bridge Branch, U.S. Coast Guard; telephone
212-514-4334, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The City of New Haven, the owner of the
bridge, requested a temporary deviation from the normal operating
schedule to facilitate rehabilitation of the bridge. The Chapel Street
Bridge, across the Mill River, mile 0.4 at New Haven, Connecticut
offers mariners a vertical clearance of 7.9 feet at mean high water and
14 feet at mean low water in the closed position. The existing
drawbridge operating regulations are listed at 33 CFR 117.213(d).
    Under this temporary deviation, the Chapel Street Bridge will open
for the passage of vessels requiring an opening provided 2 hours of
advance notice is furnished to the owner of the bridge; except that,
from 7:30 a.m. to 8:30 a.m. and 4:45 p.m. to 5:45 p.m., Monday through
Friday, except Federal holidays, the draw need not open for the passage
of vessel traffic. The bridge will remain closed to all vessels from
12:01 a.m. May 11, 2017 to 11:59 p.m. May 14, 2017.
    The bridge routinely opens for commercial vessels. Nevertheless,
outreach with mariners has indicated the requirement for 2 hours of
advance notice will not impede routine waterway operations. Mariners
also offered no objection to a four day closure of the draw in order to
complete the necessary repair work to the bridge.
    Vessels that can pass under the bridge without an opening may do so
at all times except during the full channel closure between May 11,
2017 and May 14, 2017. The bridge will be able to open for emergencies.
There is no alternate route for vessels to pass.
    The Coast Guard will also inform the users of the waterways through
our Local and Broadcast Notices to Mariners of the change in operating
schedule for the bridge so that vessel operators can arrange their
transits to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: May 3, 2017.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2017-09212 Filed 5-5-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: September 12, 2008 (Volume 73, Number 178)]
[Proposed Rules]
[Page 52934]
[DOCID:fr12se08-19]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Proposed Modification of the Asheville, NC, Class C Airspace
Area; Public Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of meeting.

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

SUMMARY: This notice announces a fact-finding informal airspace meeting
to solicit information from airspace users and others concerning a plan
to modify the Class C airspace area at Asheville, NC. The modification
would ensure that arriving aircraft are contained within Class C
airspace while flying instrument approaches to runways 16 and 34 at the
Asheville Regional Airport. The purpose of the meeting is to provide
interested parties an opportunity to present views, recommendations,
and comments to be considered by the FAA in developing a proposal. All
comments received during the meeting will be considered prior to
issuance of a notice of proposed rulemaking.

DATES: The informal airspace meeting will be held on Tuesday, October
14, 2008, beginning at 6:30 p.m. Comments must be received on or before
November 14, 2008.

ADDRESSES: The meeting will be held at the O.D. Lacey Griffin Building,
21 Aviation Way, Fletcher, NC 28732.
    Comments: Send comments on the proposal to Mark Ward, Manager,
Operations Support Group, Air Traffic Organization Eastern Service
Area, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia
30320.

FOR FURTHER INFORMATION CONTACT: Grey Pelkey, Manager, Asheville
Airport Traffic Control Tower, Asheville Airport, 61 Terminal Drive
Suite 2, Fletcher, NC 28732; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Meeting Procedures

    (a) The meeting will be open to all persons on a space-available
basis. There will be no admission fee or other charge to attend and
participate.
    (b) The meeting will be informal in nature and will be conducted by
one or more representatives of the FAA Eastern Service Area. A
representative from the FAA will present an informal briefing on the
planned modification to the Class C airspace at Asheville, NC. Each
participant will be given an opportunity to deliver comments or make a
presentation, although a time limit may be imposed. Only comments
concerning the plan to modify the Class C airspace area at Asheville,
NC, will be accepted.
    (c) Each person wishing to make a presentation to the FAA panel
will be asked to sign in and estimate the amount of time needed for
such presentation. This will permit the panel to allocate an
appropriate amount of time for each presenter. The meeting will not be
adjourned until everyone on the list has had an opportunity to address
the panel.
    (d) Position papers or other handout material relating to the
substance of these meetings will be accepted. Participants wishing to
submit handout material should present an original and two copies (3
copies total) to the presiding officer. There should be additional
copies of each handout available for other attendees.
    (e) The meeting will not be formally recorded. However, a summary
of comments made at the meeting will be filed in the docket.

Agenda for the Meeting

--Sign-in.
--Presentation of Meeting Procedures.
--FAA explanation of the proposed Class C modifications.
--Public Presentations and Discussions.
--Closing Comments.

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    Issued in Washington DC, on September 2, 2008.
Edith V. Parish,
Manager, Airspace and Rules Group.
[FR Doc. E8-21216 Filed 9-11-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 85 (Friday, May 2, 2014)]
[Rules and Regulations]
[Page 25014]
[FR Doc No: 2014-09721]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2013-0599; FRL-9909-16-Region 9]

Approval and Promulgation of Implementation Plans; California San
Francisco Bay Area and Chico Nonattainment Areas; Fine Particulate
Matter Emissions Inventories; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule; correction.

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SUMMARY: The Environmental Protection Agency (EPA) published a direct
final rule that appeared in the Federal Register on March 14, 2014. The
document approved revisions to the California State Implementation Plan
(SIP) concerning emissions inventories for the 2006 24-hour fine
particle National Ambient Air Quality Standard (NAAQS) for the San
Francisco Bay Area and Chico PM2.5 nonattainment areas. We
are approving these emissions inventories under the Clean Air Act (CAA
or the Act). An error in the amendatory instruction is identified and
corrected in this action.

DATES: This rule is effective on May 13, 2014 without further notice.

ADDRESSES: Docket: Generally, documents in the docket for this action
are available electronically at www.regulations.gov and in hard copy at
EPA Region IX, 75 Hawthorne Street, San Francisco, California 94105-
3901. While all documents in the docket are listed at
www.regulations.gov, some information may be publicly available only at
the hard copy location (e.g., copyrighted material, large maps), and
some may not be publicly available in either location (e.g., CBI). To
inspect the hard copy materials, please schedule an appointment during
normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Lisa Tharp, EPA Region IX, (415) 947-
4142<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA published a direct final rule on March
14, 2014 (79 FR 14404) approving revisions to the California State
Implementation Plan (SIP) concerning emissions inventories. In that
approval EPA erroneously added the incorrect paragraph numbers to Sec.
52.220, paragraph (c). Therefore the amendatory instruction is being
corrected to reflect the corrected section paragraph numbering.

Correction

    In the direct final rule published in the Federal Register on March
14, 2014 (79 FR 14404), the following corrections are made:
    1. On page 14409, third column, line 2 of amendatory instruction
number 2, correct ``adding paragraphs (c)(434) and (435) to'' to read
``adding paragraphs (c)(435) and (436) to'';
    2. On page 14409, third column, third line under the section
heading Sec.  52.220 Identification Plan, correct paragraph number
``(434)'' to read ``(435)''; and
    3. On page 14409, third column, line twenty-two under the section
heading Sec.  52.220 Identification Plan, correct paragraph number
``(435)'' to read ``(436)''.

    Dated: April 18, 2014.
Jared Blumenfeld,
Regional Administrator, EPA Region IX.
[FR Doc. 2014-09721 Filed 5-1-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61049-61050]
[FR Doc No: 2019-24564]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10624-026]

French Paper Company; Notice of Application Accepted for Filing,
Soliciting Motions To Intervene and Protests, Ready for Environmental
Analysis, and Soliciting Comments, Recommendations, Preliminary Terms
and Conditions, and Preliminary Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent Minor License.
    b. Project No.: 10624-026.
    c. Date filed: February 27, 2019.
    d. Applicant: French Paper Company (French Paper).
    e. Name of Project: French Paper Company Hydroelectric Project
(French Paper Project).
    f. Location: The French Paper Project is located on the St. Joseph
River in the City of Niles, Berrien County, Michigan. No federal lands
are occupied by the project works or located within the project
boundary.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Shane Fenske, President, French Paper
Company, P.O. Box 398, 100 French Street, Niles, MI 49120; (269) 683-
1100 or<EMAIL_ADDRESS>    i. FERC Contact: Jay Summers,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, recommendations, preliminary
terms and conditions, and preliminary fishway prescriptions using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-10624-026.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The French Paper Project consists of the following existing
facilities: (1) An 112 acre reservoir with a storage capacity of 864
acre-feet at a water surface elevation of 653.75 feet mean sea level;
(2) a 321-foot-long, 13-foot-high concrete spillway structure, topped
by 2.3-foot-high flashboards; (3) a 100-foot-wide, 600-foot-long intake
channel; (4) a 115-foot-wide, 55-foot-long, 56-foot-high powerhouse
with an operating head of 14 feet; (5) a floating debris boom at the
entrance to the intake channel and two separate trash racks at the
entrance to the powerhouse; (6) two vertical shaft propeller turbines
each coupled to a 400-kilowatt (kW) generator, one vertical shaft
propeller turbine coupled to a 300-kW generator, and one vertical shaft
Francis turbine coupled to a 200-kW generator, for a total installed
capacity of 1.3 megawatts; (7) a 6-foot-wide, 220-foot-long reinforced
concrete fish ladder; (8) a 480-volt to 12-kilovolt (kV) transformer
adjacent to the powerhouse; (9) a 0.16-mile-long, 3-phase, 3 wire 12-kV
overhead interconnection line, tying into Indiana Michigan Power
Company's transmission line adjacent to French Paper's property; and
(10) appurtenant facilities.
    The French Paper Project is operated in a run-of-river mode with an
estimated annual energy production of approximately 8,442.8 megawatt-
hours. French Paper proposes to continue operating the project in a
run-of-river mode and does not propose any new construction or
modifications to the project.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's website at http://www.ferc.gov using the eLibrary link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC
Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, and .214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title PROTEST,
MOTION TO INTERVENE, COMMENTS, REPLY COMMENTS, RECOMMENDATIONS,
PRELIMINARY TERMS AND CONDITIONS, or PRELIMINARY FISHWAY PRESCRIPTIONS;
(2) set forth in the heading the name of the applicant and the project
number of the application to which the filing responds; (3) furnish the
name, address, and telephone number of the person protesting or
intervening; and (4) otherwise comply with the requirements of 18 CFR
385.2001 through 385.2005. All comments, recommendations, terms and
conditions or prescriptions must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. A copy of all other filings in reference to this
application must be accompanied by proof of service on all

persons listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    o. Procedural Schedule: The application will be processed according
to the following revised Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations, preliminary      January 2019.
 terms and conditions, and preliminary
 fishway prescriptions.
Commission issues EA......................  June 2020.
Comments on EA............................  July 2020.
Modified terms and conditions.............  September 2020.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in 5.22: (1) A copy of the water
quality certification; (2) a copy of the request for certification,
including proof of the date on which the certifying agency received the
request; or (3) evidence of waiver of water quality certification.

    Dated: November 5, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-24564 Filed 11-8-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Notices]
[Page 30950-30951]
[DOCID:fr29my08-74]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-M-0467] (formerly Docket No. 2007M-0408), [Docket
No. FDA-2007-M-0481] (formerly Docket No. 2007M-0467), [Docket No. FDA-
2007-M-0480] (formerly Docket No. 2007M-0409), [Docket No. FDA-2007-M-
0472] (formerly Docket No. 2007M-0413), [Docket No. FDA-2007-M-0468]
(formerly Docket No. 2007M-0446), [Docket No. FDA-2007-M-0494]
(formerly Docket No. 2007M-0380), [Docket No. FDA-2007-M-0493]
(formerly Docket No. 2007M-0411), [Docket No. FDA-2007-M-0492]
(formerly Docket No. 2007M-0410), [Docket No. FDA-2007-M-0490]
(formerly Docket No. 2007M-0415), [Docket No. FDA-2007-M-0491]
(formerly Docket No. 2007M-0447]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in Table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT:  Samie Allen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at http://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the act. The 30-day
period for requesting reconsideration of an FDA action under Sec.
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA
begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from October 1, 2007, through December 31,
2007. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

 Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
     Made Available From October 1, 2007, through December 31, 2007.
------------------------------------------------------------------------
PMA No./Docket                                                 Approval
      No.          Applicant             TRADE NAME              Date
------------------------------------------------------------------------
P000009 (S4)/   Biotronik,      TACHOS DR ATRIAL TX          September
 2007M-0408      Inc.            IMPLANTABLE CARDIOVERTER     9, 2002
                                 DEFIBRILLATOR ICD SYSTEM
------------------------------------------------------------------------
P060031/2007M-  Bio-Rad         BIO-RAD MONOLISA ANTI-HBC    April 27,
 0467            Laboratories    EIA                          2007
------------------------------------------------------------------------
P060005/2007M-  Siemens         IMMULITE/IMMULITE 1000 &     May 11,
 0409            Medical         IMMULITE 2000 FREE PSA       2007
                 Solutions       ASSAYS
                 Diagnostics
------------------------------------------------------------------------
P060017/2007M-  Veridex, LLC    GENESEARCH BREAST LYMPH      July 16,
 0413                            NODE (BLN) ASSAY             2007
------------------------------------------------------------------------
P040040/2007M-  AGA Medical     AMPLATZER MUSCULAR VSD       September
 0446            Corp.                                        7, 2007
------------------------------------------------------------------------
P070009/2007M-  Obtech Medical  REALIZE ADJUSTABLE GASTRIC   September
 0380            GMBH            BAND MODEL 2200-X            28, 2007
------------------------------------------------------------------------
P070012/2007M-  Medtronic       EXPONENT SELF-EXPANDING      October 23,
 0411            Vascular        CAROTIC STENT SYSTEM WITH    2007
                                 OVER THE WIRE OR RAPID
                                 EXHANGE DELIVERY SYSTEM
------------------------------------------------------------------------
P060038/2007M-  Carbomedics,    MITROFLOW AORTIC             October 23,
 0410            Inc.            PERICARDIAL HEART VALVE      2007
------------------------------------------------------------------------
H990002/2007M-  Genzyme         EPICEL (CULTURED EPIDERMAL   October 25,
 0415            Biosurgery      AUTOGRAFTS)                  2007
------------------------------------------------------------------------
P060035/2007M-  Abbott          ARCHITECT CORE-M REAGENT     November 6,
 0447            Laboratories    KIT/CALIBRATORS/CONTROLS     2007
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.

    Dated: May 16, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12012 Filed 5-28-08; 8:45 am]

BILLING CODE 4160-01-S