[Federal Register Volume 86, Number 108 (Tuesday, June 8, 2021)]
[Notices]
[Pages 30456-30457]
[FR Doc No: 2021-11993]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-1639-009.
    Applicants: Constellation Mystic Power, LLC.
    Description: Compliance filing: Fourth Compliance Filing to be
effective 6/1/2022.
    Filed Date: 6/2/21.
    Accession Number: 20210602-5098.
    Comments Due: 5 p.m. ET 6/23/21.

    Docket Numbers: ER19-2716-001; ER19-1398-001; ER19-2717-001; ER20-
1399-001.
    Applicants: Madison BTM, LLC, Madison ESS, LLC, Rumford ESS, LLC,
Ocean State BTM, LLC.
    Description: Notice of Change in Status of Madison BTM, LLC, et al.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5382.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER20-1150-002.
    Applicants: The Dayton Power and Light Company, PJM
Interconnection, L.L.C.
    Description: Revised Refund Report of Dayton Power and Light
Company.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5388.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER20-2288-001.
    Applicants: Tatanka Ridge Wind, LLC.
    Description: Tatanka Ridge Wind, LLC submits Supplemental
Information re Notice of Non-Material Change in Status.
    Filed Date: 5/12/21.
    Accession Number: 20210512-5074.
    Comments Due: 5 p.m. ET 6/23/21.

    Docket Numbers: ER21-2051-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Tariff Cancellation: Notice of Cancellation of Service
Agreement Nos. 801 and 802 (Final) to be effective 12/31/9998.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5260.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER21-2052-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 6081; Queue No. AF2-246 to be effective 5/4/2021.
    Filed Date: 6/2/21.
    Accession Number: 20210602-5004.
    Comments Due: 5 p.m. ET 6/23/21.

    Docket Numbers: ER21-2053-000.
    Applicants: ITC Midwest LLC.
    Description: MISO Schedule 50 Cost Recovery Filing of ITC Midwest,
LLC.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5368.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER21-2054-000.
    Applicants: ITC Midwest LLC.
    Description: MISO Schedule 50 Cost Recovery Filing of ITC Midwest,
LLC.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5369.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER21-2055-000.
    Applicants: ITC Midwest LLC.
    Description: MISO Schedule 50 Cost Recovery Filing of ITC Midwest,
LLC.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5370.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER21-2056-000.
    Applicants: ITC Midwest LLC.
    Description: MISO Schedule 50 Cost Recovery Filing of ITC Midwest,
LLC.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5371.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER21-2057-000.
    Applicants: ITC Midwest LLC.
    Description: MISO Schedule 50 Cost Recovery Filing of ITC Midwest,
LLC.

    Filed Date: 6/1/21.
    Accession Number: 20210601-5372.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER21-2058-000.
    Applicants: Michigan Electric Transmission Company LLC.
    Description: MISO Schedule 50 Cost Recovery Filing of Michigan
Electric Transmission Company, LLC.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5373.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER21-2059-000.
    Applicants: ITC Midwest LLC.
    Description: MISO Schedule 50 Cost Recovery Filing of ITC Midwest,
LLC.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5374.
    Comments Due: 5 p.m. ET 6/22/21.

    Docket Numbers: ER21-2060-000.
    Applicants: Duke Energy Ohio, Inc., PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Duke Ohio submits
Interconnection Agreement, SA No. 3141 with EKPC to be effective 5/3/
2021.
    Filed Date: 6/2/21.
    Accession Number: 20210602-5036.
    Comments Due: 5 p.m. ET 6/23/21.

    Docket Numbers: ER21-2061-000.
    Applicants: Northern Indiana Public Service Company.
    Description: Sec.  205(d) Rate Filing: Filing of a CIAC Agreement
to be effective 6/1/2021.
    Filed Date: 6/2/21.
    Accession Number: 20210602-5084.
    Comments Due: 5 p.m. ET 6/23/21.

    Docket Numbers: ER21-2062-000.
    Applicants: Alabama Power Company.
    Description: Tariff Cancellation: Raven Solar Development (Wilcox
Solar) LGIA Termination Filing to be effective 6/2/2021.
    Filed Date: 6/2/21.
    Accession Number: 20210602-5105.
    Comments Due: 5 p.m. ET 6/23/21.

    Docket Numbers: ER21-2063-000.
    Applicants: Alabama Power Company.
    Description: Tariff Cancellation: Raven Solar Development (Taylor
Solar) LGIA Termination Filing to be effective 6/2/2021.
    Filed Date: 6/2/21.
    Accession Number: 20210602-5106.
    Comments Due: 5 p.m. ET 6/23/21.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RR21-5-000.
    Applicants: North American Electric Reliability Corporation.
    Description: North American Electric Reliability Corporation's
Report of Comparisons of Budgeted to Actual Costs for 2020 for NERC and
the Regional Entities.
    Filed Date: 6/1/21.
    Accession Number: 20210601-5381.
    Comments Due: 5 p.m. ET 6/22/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 2, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-11993 Filed 6-7-21; 8:45 am]
BILLING CODE 6717-01-P


"King, Heidi R."<EMAIL_ADDRESS> 03/12/2008 02:02 PM

To

Lydia Wegman/RTP/USEPA/US@EPA, Karen Martin/RTP/USEPA/US@EPA

cc

Subject

Edits for draft O3 NAAQS 3/12/2008

Lydia,

Edits for the draft  O3 NAAQS rule under review today.

Best regards,

heidi

p 240 line 13  "and crop yield reductions in sensitive vegetation"  ??

p 235 line 8  del "while"

p 235 line 10 insert period after "effects on crop yields".  Insert "However," before "EPA disagrees with comments ..."

p 235  line 11  del "in such assessments remain unchanged or generally"

p 226 line 2  "and crop yield reductions to"   ??

p 213  line 6  following "crop functions" insert "developed in the 1980s" before "were used for commodity crops ..."

p 209 line 19   following "ranged from 21 to 39 percent" insert "of the counties" before "during the four-year period..."

p 209 line 21  following "counties that met an 8-hour level of 0.07 ppm in those years, 11 to 30 percent" insert "of the counties" before "still had..."


[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Notices]
[Pages 19564-19565]
[FR Doc No: 2018-09366]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5913]

Assessing User Fees Under the Prescription Drug User Fee
Amendments of 2017; 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 ``Assessing
User Fees Under the Prescription Drug User Fee Amendments of 2017.''
This guidance concerns FDA's implementation of the Prescription Drug
User Fee Amendments of 2017 (PDUFA VI) and certain changes in policies
and procedures surrounding its application.

DATES: The announcement of the guidance is published in the Federal
Register on May 3, 2018.

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-2017-D-5913 for ``Assessing User Fees Under the Prescription Drug
User Fee Amendments of 2017; Guidance for Industry.'' 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.gpo.gov/fdsys/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 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 the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Peter Chen, Center for Drug Evaluation
and Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, Rm. 2112, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected]; 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, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Assessing User Fees Under the Prescription Drug User Fee
Amendments of 2017.'' This guidance concerns the implementation of the
PDUFA VI and certain changes in policies and procedures surrounding its
application. Because PDUFA VI created significant changes to the user
fee program, this guidance serves to provide an explanation about the
new fee structure and types of fees for which applicants are
responsible.
    PDUFA VI provides two different fee types that applicants pay:
Application and program fees. This guidance describes when these fees
are incurred and the process by which applicants can submit payments.
The guidance also provides information on consequences of failing to
pay PDUFA VI fees as well as the process for submitting a
reconsideration and appeals request.
    In the Federal Register of October 13, 2017 (82 FR 47748), FDA
announced the availability of a draft version of this guidance and
provided interested parties an opportunity to submit comments. We have
reviewed the comments submitted to the docket and determined that they
did not raise any relevant issues. This guidance does not include any
substantive changes from the draft guidance.
    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 assessing user fees under PDUFA VI. 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. This guidance
is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: April 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09366 Filed 5-2-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Page 10552]
[FR Doc No: 2010-4847]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Sixth Meeting--RTCA Special Committee 217: Joint With EUROCAE WG-
44 Terrain and Airport Mapping Databases

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 217: Joint with EUROCAE WG-44
Terrain and Airport Mapping Databases.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 217: Joint with EUROCAE WG-44 Terrain
and Airport Mapping Databases.

DATES: The meeting will be held on April 12th thru 16th, 2010, at 9
a.m.

ADDRESSES: The meeting will be held at Graf-Zeppelin-Haus (http://www.gzh.de), Kapit[auml]n Lehmann Raum, Olgastr. 20, D-88045
Friedrichshafen/Germany. Contact: Britta Eilmus<EMAIL_ADDRESS>Phone: +49-69-6060-9894, Mobile: +49-179-789-5474, Fax: +49-
7541-282-199

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036-5133; telephone<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a RTCA Special Committee 217: Joint with EUROCAE
WG-44 Terrain and Airport Mapping Databases meeting. The agenda will
include:

Monday, April 12

 Opening Plenary Session
     Chairmen's remarks and introductions
     Approve minutes from previous meeting
     Review and approve meeting agenda
     Committee Membership Records
     Schedule for this week
     Action Item Review
     Schedule for next meetings
 Presentations (Not linked to Working Group Activity)
     Tim Roe: FAA activity with taxi route databases, tied to
SC-214
     Garry Livack, Update on related Standards activities, i.e.
D-NOTAM (Aerodrome), D-Taxi, D-Traffic
     Andr[eacute] Bourdais, Proposal for Joint Task Force, SC-
217/SC-214, data exchange requirements
     Allan Hart, SESAR WP9
 Working Group Report Outs (Status)
     Applications
     Data Quality--Non-Numeric Requirements
     Data Quality--Numeric Requirements
     Guidance Materials
     Temporality
     Content
     Connectivity

Tuesday, April 13

 Specific Working Group Sessions
     Connectivity
     Content
     Applications
     Numerical Requirements
     Guidance Materials
     Data Quality

Wednesday, April 14

 Continuation of Specific Working Group Sessions (if
required)--Committee Coordination
     SC-186 ISRA Review and Response Planning
     SC-214 Requirements Review and Response Planning

Thursday, April 15

 Document Agreements
     DO-272, Revision C
     DO-291, Revision B
     DO-276, Revision B
     Road Map Review

Friday, April 16

 Closing Plenary Session
     Joint RTCA SC-217/EUROCAE WG-44

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on March 2, 2010
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. 2010-4847 Filed 3-5-10; 8:45 am]
BILLING CODE 4910-13-P