[Federal Register: March 21, 2006 (Volume 71, Number 54)]
[Notices]
[Page 14190-14191]
[DOCID:fr21mr06-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PH06-20-000]

DTE Energy Company; Notice of Petition for Exemption From the
Requirements of the Public Utility Holding Company Act of 2005

March 13, 2006.
    Take notice that on March 7, 2006, DTE Energy Company filed a
Petition for Exemption of the Requirements of The Public Utility
Holding Company Act of 2005, pursuant to 18 CFR 366.3(b)(4) 366.4(b)(1)
of the Commission's regulations.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or

protests must be filed on or before the comment date. On or before the
comment date, it is not necessary to serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 28, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-4029 Filed 3-20-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Notices]
[Pages 41120-41122]
[FR Doc No: 2022-14689]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR22-54-000.
    Applicants: Duke Energy Ohio, Inc.
    Description: Sec.  284.123(g) Rate Filing: DEO-Revised Operating
Statement to Reflect Change in State-Approved Rates to be effective 6/
1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5046.
    Comment Date: 5 p.m. ET 7/21/22.
    284.123(g) Protests Due: 5 p.m. ET 8/29/22.

    Docket Numbers: RP22-1000-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Compliance filing: Rate Schedule S-2 OFO Penalty Flow
Through Refund Report to be effective N/A.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5012.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1001-000.
    Applicants: Eastern Gas Transmission and Storage, Inc.
    Description: Compliance filing: EGTS--Operational Gas Sales
Report--2022 to be effective N/A.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5019.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1002-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Permanent Capacity Release
(WTG #617716 and 617729) to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5056.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1003-000.
    Applicants: Cove Point LNG, LP.
    Description: Sec.  4(d) Rate Filing: Cove Point--Modification of
GT&C--Fuel Retainage to be effective 8/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5057.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1004-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Sec.  4(d) Rate Filing: FPL Exhibit B Update--New
Contracts 128521 & 128522 to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5072.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1005-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various July
1 2022 Capacity Releases to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5073.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1006-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Sec.  4(d) Rate Filing: New Service Agreement--GRU to
be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5077.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1007-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreements
(PDC Permian_Targa) to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5079.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1008-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20220630 Negotiated Rate to be
effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5086.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1009-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Northern to
Emera eff 7-1-22 to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5089.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1010-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Update (Conoco July 2022) to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5107.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1011-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
(Devon) to be effective 8/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5110.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1012-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2022-06-30 Negotiated Rate
Agreement and Amendments to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5151.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1013-000.
    Applicants: MIGC LLC.
    Description: MIGC LLC submits 2022 Annual Fuel Retention Percentage
Tracker Filing.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5165.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1014-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various
Releases 7-1-22 to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5175.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1015-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Sec.  4(d) Rate Filing: Update Non-Conforming List and
Negotiated Rate Record to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5186.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1016-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: TETLP EPC AUG 2022 FILING to
be effective 8/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5203.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1017-000.
    Applicants: LA Storage, LLC.
    Description: Sec.  4(d) Rate Filing: Filing of Negotiated Rate,
Conforming IW Agreements 6.30.22 to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5213.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1018-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Cherokee
AGL--Replacement Shippers--Jul 2022 to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5231.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1019-000.
    Applicants: Gulf Shore Energy Partners, LP.
    Description: Sec.  4(d) Rate Filing: Change in Executed Service
Agreement to be effective 7/1/2022.

    Filed Date: 6/30/22.
    Accession Number: 20220630-5236.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1020-000.
    Applicants: Double E Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate & Non-
Conforming Agreements--MRC Permian Company to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5249.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1021-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: TPC 2022-06-30 Negotiated Rate
Agreement Amendment to be effective 7/1/2022.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5267.
    Comment Date: 5 p.m. ET 7/12/22.

    Docket Numbers: RP22-1022-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--UGI to DTE
eff 7-1-22 to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5001.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1023-000.
    Applicants: Cheyenne Plains Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Firm Variable Quantity
Transportation to be effective 8/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5006.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1024-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Conversion to Section-Based
Tariff to be effective 8/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5027.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1025-000.
    Applicants: Alliance Pipeline L.P.
    Description: Tariff Amendment: Alliance Cancellation of Sheet-Based
Tariff to be effective 8/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5033.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1026-000.
    Applicants: Eastern Gas Transmission and Storage, Inc.
    Description: Compliance filing: EGTS--2022 Overrun and Penalty
Revenue Distribution to be effective N/A.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5038.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1027-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Capacity
Release Agreements--7/1/2022 to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5063.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1028-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt (Jay-Bee
34447 to MacQuarie 53677) to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5088.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1029-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Amendment to NC Service Agmt
(Brewton 45719) to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5089.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1030-000.
    Applicants: Cove Point LNG, LP.
    Description: Compliance filing: Cove Point--2022 Penalty Revenue
Distribution to be effective N/A.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5090.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1031-000.
    Applicants: Transwestern Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Rate Case Filing to be
effective 8/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5099.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1032-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Release Agreements on 7-1-22 to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5120.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1033-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20220701 Section 4 Rate Case
Part 1 of 3 to be effective 8/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5131.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1034-000.
    Applicants: WTG Hugoton, LP.
    Description: Sec.  4(d) Rate Filing: Annual Fuel Retention
Percentage Filing 2022-2023 to be effective 6/30/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5135.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1035-000.
    Applicants: West Texas Gas Utility, LLC.
    Description: Annual Purchased Gas Cost Reconciliation Report of
West Texas Gas Utility, LLC.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5139.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1036-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: MMGS to Mitsui Name Change--
Agmt 142019 to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5157.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1037-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt (Osaka
46429 to ConocoPhillips 55428) to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5182.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1038-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Amendment to NC Neg Rate Agmt
(Uniper 46406) to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5184.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1039-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Narragansett dba National Grid
to dba Rhode Island Name Change--Agmt 210165 to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5197.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1040-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Superseding Neg Rate Agmt
Southern 49811 and Neg Rate Agmt FPL 55411 to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5227.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1041-000.
    Applicants: Crossroads Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Agreement
Housekeeping to be effective 8/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5277.

    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1042-000.
    Applicants: Portland Natural Gas Transmission System.
    Description: Sec.  4(d) Rate Filing: Narragansett name change to
dba Rhode Island Energy--NR/Non-Con Amendment to be effective 7/1/2022.
    Filed Date: 7/1/22.
    Accession Number: 20220701-5354.
    Comment Date: 5 p.m. ET 7/13/22.

    Docket Numbers: RP22-1043-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Remove Terminated Agreement--
7/31/2022 to be effective 8/5/2022.
    Filed Date: 7/5/22.
    Accession Number: 20220705-5045.
    Comment Date: 5 p.m. ET 7/18/22.

    Docket Numbers: RP22-472-000.
    Applicants: Interstate Gas Supply, Inc., Dominion Energy Solutions,
Inc.
    Description: Interstate Gas Supply, Inc. and Dominion Energy
Solutions, Inc. submit Second Status Report.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5291.
    Comment Date: 5 p.m. ET 7/12/22.

    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.

Filings in Existing Proceedings

    Docket Numbers: RP17-346-004.
    Applicants: Northwest Pipeline LLC.
    Description: Compliance filing: Northwest Pipeline: Unopposed
Petition to Amend Settlement Agreement to Extend to be effective N/A.
    Filed Date: 6/30/22.
    Accession Number: 20220630-5229.
    Comment Date: 5 p.m. ET 7/12/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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: July 5, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-14689 Filed 7-8-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 17, 2008 (Volume 73, Number 52)]
[Notices]
[Page 14292-14294]
[DOCID:fr17mr08-112]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57463; File No. SR-MSRB-2008-01]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Amendment to Rule G-8, on Books and Records, To
Delete Requirement To Maintain Copies of Form G-40

March 11, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 19, 2008, the Municipal Securities Rulemaking Board
(``MSRB'' or ``Board'') filed with the Securities and Exchange
Commission (``Commission'' or ``SEC'') the proposed rule change as
described in Items I, II and III below, which Items have been
substantially prepared by the MSRB. The MSRB has filed the proposal as
a ``non-controversial'' rule change pursuant to Section
19(b)(3)(A)(iii) of the Act,\3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).

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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB is filing with the Commission a proposed rule change
consisting of an amendment to Rule G-8, on books and records, to delete
the requirement that brokers, dealers and municipal securities dealers
maintain copies of Form G-40 and any amended forms as required by Rule
G-40, on e-mail contacts. The MSRB proposes that the amendment become
effective on March 21, 2008. The text of the proposed rule change is
available on the MSRB's Web site (http://www.msrb.org), at the MSRB,
and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the MSRB included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The MSRB has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Subparagraph (a)(xxii) under Rule G-8, on books and records,
requires that brokers, dealers and municipal securities dealers
(``dealers'') keep records reflecting copies of Form G-40 and any
amended forms as required by Rule G-40, on e-mail contacts. Rule G-40
provides for electronic communication between the MSRB and dealers by
imposing certain requirements on dealers.\5\ When the rule was first
adopted in 2002, dealers were required to submit their initial forms by
mail. The rule was subsequently amended in 2005 to require that all G-
40 submissions--both initial forms and any subsequent amendments--be
submitted electronically to the MSRB. Dealers accomplish this through
their individual electronic G-40 accounts. Because dealers are no
longer required to provide any paper submissions in connection with
Rule G-40, there is no reason to retain the current requirement under
Rule G-8(a)(xxii) that dealers maintain copies of Form G-40 and any
amended forms.\6\ Accordingly, the proposed rule change would delete
this requirement.
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    \5\ Dealers are required to use Form G-40 to appoint a ``Primary
Contact'' who must be either a Series 53-registered municipal
securities principal or a Series 51-registered municipal fund
securities limited principal. The rule also requires each dealer to
maintain an Internet e-mail account, and to review and, if
necessary, update its Primary Contact information within 17 business
days of each calendar year. The rule is based on similar FINRA
requirements; the Board attempts, whenever possible, to adopt rule
provisions and language similar to FINRA rules in order to ensure a
coordinated regulatory approach in areas of mutual regulation.
    \6\ In addition to certain quarterly reports provided to FINRA
and the bank regulatory agencies, the MSRB provides FINRA examiners
with secure, on-line access to each dealer's current G-40
information to assist in inspecting for dealer compliance with Rule
G-40.
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2. Statutory Basis
    The MSRB believes that the proposed rule change is consistent with
Section 15B(b)(2)(C) of the Act,\7\ which provides that the MSRB's
rules shall:
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    \7\ 15 U.S.C. 78o-4(b)(2)(C).

be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect
to, and facilitating transactions in municipal securities, to remove
impediments to and perfect the mechanism of a free and open market
in municipal securities, and, in general, to protect investors and
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the public interest.

The Board believes that by deleting the obsolete requirement to
maintain copies of Form G-40 and any amended forms, the proposed rule
change will facilitate dealer understanding and compliance with Rules
G-8 and G-40, as well as the inspection and enforcement thereof.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Board does not believe that the proposed rule change will
result in any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act since it would apply equally to
all brokers, dealers and municipal securities dealers.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change: (i) Does not significantly affect
the protection of investors or the public interest; (ii) does not
impose any significant burden on competition; and (iii) does not become
operative for 30 days from February 19, 2008, the date on which it was
filed, and the MSRB provided the Commission with written notice of its
intent to file the proposed rule change at least five business days
prior to the filing date, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6)
thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.\10\
---------------------------------------------------------------------------

    \10\ See Section 19(b)(3)(C) of the Act, 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2008-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-MSRB-2008-01. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the

public in accordance with the provisions of 5 U.S.C. 552, will be
available for inspection and copying in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of the MSRB. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-MSRB-2008-01 and should be submitted on or before April
7, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-5222 Filed 3-14-08; 8:45 am]

BILLING CODE 8011-01-P


Background Document from Technical Work Group

November 30, 2005

During the course of discussions of the Technical Work Group (TWG) and
subgroups, questions were raised that could impact the work of the TWG,
but that the group considered to be fundamental policy issues.  These
policy issues could potentially impact how pilot studies are designed,
how reporting limits (LQ, LD, or LC) are set, and how compliance is
evaluated.  The TWG requested this document be sent to the federal
advisory committee as background information.  The TWG is providing
commentary on the following issues:

Issue 1: Descriptive vs. Prescriptive

There are two fundamentally different approaches to how reporting limits
are set and used.  The two approaches are described as
“Prescriptive” and “Descriptive.”  Depending on which approach
is used, the work of the TWG is fundamentally shifted.

One proposed method is to examine both approaches in parallel and
present the results as such. However this would be a very large time and
cost intensive approach.  If the FACDQ were to decide on only one of
these approaches, the TWG would be able to focus its work more
effectively.

The Descriptive Approach – an approach where laboratory data is used
to describe that lab’s LQ, LD, and LC for that lab.  It is then up to
a client or agency to determine whether these values are acceptable.

Each laboratory determines their own specific LQ, LD, and/or LC by means
of a statistical procedure set in regulation for each analyte and
analytical method.

These descriptive estimates of LQ, LD, and LC change over time for a
specific laboratory.  The determination of the LQ, LD, and/or LC may be
periodic (e.g. once per year) or on-going (like a running average).

If any of these estimate were selected to act as the Compliance
Evaluation Threshold (CET), the CET would change depending on which
laboratory is analyzing the samples and the CET are reassessed over time
at a particular laboratory and vary between laboratories.

This is how the MDL is currently being used in CWA monitoring.

Using a descriptive approach would favor conducting a single-laboratory
pilot study design.  Because it is up to a single laboratory to describe
its own LQ, LD, and LC and demonstrate these meet reporting limits.

The Prescriptive Approach -- an approach where LQ, LD, and / or LC is
set in regulation and is the same for a given regulated analyte for all
laboratories.  It is important to note, the laboratory may not be
required to perform a formal LQ, LD, LC study for this approach; simply
validating their procedures and equipment meet the requirements being
prescribed.

These values would not change over time or between laboratories.

If LQ, LD, and/or LC are used as a CET, the CET is the same for all
permit holders irrespective which laboratory or instrumentation they use
or changes over time.

This is the approach used in the Information Collection Rule and the
Unregulated Chemical Monitoring Rule and the California Drinking Water
primacy program.

As outlined in B) Issue 2, the laboratory would on an ongoing basis
analyze a validation sample to demonstrate compliance.  That sample will
require a range of limits.

Using a prescriptive approach would probably favor a multi-laboratory
pilot study design as a regulator would require data from many
laboratories to sufficiently define and prescribe reporting limits for
the laboratories under its jurisdiction.

Combined Approach – It is possible to combine both approaches.  For
example, The California CWA primacy program has a mixture of these two
approaches.  The LQ is set prescriptively and the LC is set
descriptively.  Other permutations are also possible.

Issue 2: Verification of LQ, LD, and LC.

A second policy question that impacts the work of the TWG is: Do LQ, LD,
and LC need to be verified?  If a laboratory describes estimates of LQ,
LD and/or LC or if the laboratory has a prescribed LQ, LC, or LD; should
there be procedures in place to verify that the laboratory can actually
measure analytes at those levels in the way expected. If verification is
required then the TWG can recommend how to do this.  There are two
alternatives:

The individual laboratory does not verify the LC, LD, or LQ it is using
(whether descriptive or prescriptive) actually meets the definitions
used (e.g. a false positive rate of 1% for unspiked blanks and a 50%
false negative rate for spiked blanks at LC).  As with the current
Appendix B descriptive approach, the laboratory runs and keeps on file a
copy of the MDL studies it performed at a snapshot in time.  There is no
requirement in Appendix B to verify this value.

Each individual laboratory verifies LQ, LD, and/or LC by some
standardized procedure with performance characteristics. This may be
periodic or batch specific.

Using a descriptive approach, a laboratory may do a LC or LD
determination (e.g. an MDL study).  Then the laboratory would have run a
series of unspiked and spiked blanks to determine the false positive and
false negative rates and see if they match the expected rates.

Using a descriptive approach, a commonly used technique is to analyze
check solutions with a concentration at or below the LQ which must be
recovered within certain accuracy limits.  Blanks must not have higher
concentrations than LD or LC.  LC or LD must be no more than a fixed
fraction of LQ.  Laboratories must pass on a batch by batch basis these
QC requirements or the data may not be submitted.

Verification for a descriptive approach is generally very complex and
costly while verification under a prescriptive approach is a great deal
simpler and less expensive.

Using a prescriptive approach, the laboratory simply analyzes a
validation sample at or below the LQ, which must meet recovery
requirements set out by method or procedure.

Verification procedures have more commonly used historically with the
prescriptive rather than descriptive approach.

C) Issue 3: Lowest possible LQ, LD, or LC

Do LQ, LD, and LC need to be the “absolute lowest possible” for all
analytes in all situations?

Determining the lowest possible LQ, LD, or LC requires a great deal more
effort and cost.  This is true irrespective of whether this lowest
possible value is set descriptively or prescriptively.

Verification of LQ, LD, and LC is much more complicated the lower the
concentration is.  Also the verification techniques will be different
depending on whether one is seeking the lowest possible value in every
case.

The lowest possible LQ, LD, and LC would probably favor using a
descriptive approach and a single-laboratory study design.

Study design would be much simpler if LD and/or LC were only needed for
analytes with very low WQBELs.

WORKING DRAFT FOR DISCUSSION

Federal Advisory Committee on Detection and Quantitation Approaches and
Uses in Clean Water Act Programs

 PAGE

 PAGE   1

Technical Work Group

DRAFT FOR DISCUSSION

11/30/05


[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]
[Page 42957-42958]
[DOCID:fr25au09-128]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Ellis & Eastern Company (Waiver Petition Docket Number FRA-2009-0071)

    The Ellis & Eastern Company (EEC) seeks a waiver from compliance of
certain provisions of the Federal hours of service law (49 U.S.C.
Chapter 211; HSL). Although EEC requests waiver relief from the
requirements of Title 49 CFR 228.19, FRA believes EEC's intent was to
request relief from U.S.C. Sec.  21103(a)(4), and is therefore
processing the EEC's request as such. Section 21103(a)(4) states that a
train employee may not be required or allowed to remain or go on duty
after that employee has initiated an on-duty period each day for 6
consecutive days, unless that employee has had at least 48 hours off
duty at the employee's home terminal.
    EEC currently has 6 train employees who typically work two
assignments (0600 and 0700) Monday through Saturday, with an occasional
Sunday assignment during peak periods. EEC's request may be viewed at
http://www.regulations.gov under the docket number listed above.
    The HSL, at 49 U.S.C. 21108(a), contemplates that any request for a
waiver from its requirements will be a joint waiver involving the
relevant railroad carrier(s) and nonprofit employee labor
organization(s) representing the class or craft of directly affected
covered service employees. FRA understands that the covered service
employees affected by EEC's waiver request are not represented by any
employee labor organization, and accordingly, EEC's waiver request is
made solely by the carrier. FRA recognizes that the intent of 49 U.S.C.
21108(a) is to ensure that covered service employees are provided
meaningful input into any potential waiver of the HSL that would affect
their work schedules. Accordingly, before considering the requested
relief, FRA is requiring that within 30 days of the publication date of
this notice, EEC submit evidence to the docket demonstrating that it
has sought employee input into the waiver request, what that employee
input was, and that it has provided each covered employee affected by
the request with a copy of the waiver petition, along with information
on how to submit comments to FRA on the request. FRA will consider this
additional information, along with all other relevant factors, in
determining whether granting the requested relief would be in the
public interest and consistent with railroad safety.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0071) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.

     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC, on August 18, 2009.
John Leeds,
Director, Office of Safety Analysis.
[FR Doc. E9-20430 Filed 8-24-09; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 193 (Thursday, October 6, 2022)]
[Notices]
[Pages 60686-60688]
[FR Doc No: 2022-21791]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2061]

Review of Drug Master Files in Advance of Certain Abbreviated New
Drug Application Submissions Under Generic Drug User Fee Amendments;
Draft 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 draft guidance for industry entitled ``Review of
Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA.''
The purpose of this draft guidance is to provide information and
recommendations on the Generic Drug User Fee Amendments (GDUFA) III
program enhancements agreed upon by the Agency and industry in ``GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2023-2027'' (GDUFA III commitment letter), related to the early
assessment of certain Type II drug master files (DMFs) 6 months prior
to the submission of certain abbreviated new drug applications (ANDAs)
or prior approval supplements (PASs). This draft guidance describes the
process outlined in the GDUFA III commitment letter in greater detail
and provides recommendations to DMF holders on how to provide the
relevant information to FDA.

DATES: Submit either electronic or written comments on the draft
guidance by January 4, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-2061 for ``Review of Drug Master Files in Advance of Certain
ANDA Submissions Under GDUFA.'' 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 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: Ziyang Su, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave,
Bldg. 51, Room 4150, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Review of Drug Master Files in Advance of Certain ANDA
Submissions Under GDUFA.'' As described in the GDUFA III commitment
letter,\1\ FDA has agreed to performance goals and program enhancements
regarding aspects of the generic drug assessment program that build on
previous authorizations of GDUFA. These new enhancements to the program
are designed to maximize the efficiency and utility of each assessment
cycle, with the intent of reducing the number of assessment cycles for
ANDAs and facilitating timely access to generic medicines for American
patients. One of the enhancements included in the GDUFA III commitment
letter is a mechanism to enable assessment of DMFs in advance of
certain ANDA and PAS submissions.
---------------------------------------------------------------------------

    \1\ The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download.
---------------------------------------------------------------------------

    Historically, Type II active pharmaceutical ingredient DMFs have
posed a challenge for ANDA applicants because a DMF holder's response
time to Agency questions typically limits the likelihood that the DMF
will be found adequate in one ANDA assessment cycle, often precluding
approval of the ANDA in one assessment cycle. This new policy should
facilitate more DMFs to be found adequate in one assessment cycle,
thereby potentially promoting additional ANDA approvals in one
assessment cycle.
    The purpose of this draft guidance is to provide information and
recommendations on the early assessment of DMFs 6 months prior to the
submission of certain ANDAs or PASs. It describes the process outlined
in the GDUFA III commitment letter in greater detail and provides
recommendations on how to provide the relevant information to FDA.
    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 ``Review of
Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this draft guidance contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of

information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001.

III. Electronic Access

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

    Dated: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21791 Filed 10-5-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Notices]
[Pages 51285-51286]
[FR Doc No: 2017-24005]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2017-0027; OMB No. 1660-0013]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Exemption of State-Owned Properties Under
Self-Insurance Plan

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on a
reinstatement, without change, of a

previously approved information collection for which approval has
expired. FEMA will submit the information collection abstracted below
to the Office of Management and Budget for review and clearance in
accordance with the requirements of the Paperwork Reduction Act of
1995. The submission will describe the nature of the information
collection, the categories of respondents, the estimated burden (i.e.,
the time, effort and resources used by respondents to respond) and
cost, and the actual data collection instruments FEMA will use.

DATES: Comments must be submitted on or before December 4, 2017.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
[email protected].

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472,
email address [email protected] or
Suzan Krowel, Insurance Examiner, Federal Insurance and Mitigation
Administration, DHS/FEMA, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: State-Owned properties covered under an
adequate State policy of self-insurance satisfactory to FEMA are not
required to purchase flood insurance in accordance with Section
102(c)(1) of the Flood Disaster Protection Act of 1973 (42 U.S.C.
4012a(c)(1)). NFIP regulations, 44 CFR part 75, establish the standards
which a State's insurance plan must meet to be found exempt from the
requirement to purchase flood insurance coverage for State-owned
structures and their contents. To be eligible for the exemption, State
properties must be located in areas identified by the Administrator as
A, AO, AH, A1-30, AE, AR, AR/A1-30, AR/AE, AR/AO, AR/AH, AR/A, A99, M,
V, VO, V1-30, VE, and E zones, in which the sale of insurance has been
made available.
    This proposed information collection previously published in the
Federal Register on June 27, 2017 at 82 FR 29090 with a 60 day public
comment period. FEMA received one comment. The commenter advocated for
the extension of the State self-insurance exemption to all entities,
including small business. FEMA appreciates this comment but is unable
to extend the exemption because it is statutorily prescribed. This
information collection expired on September 30, 2017. FEMA is
requesting a reinstatement, without change, of a previously approved
information collection for which approval has expired. The purpose of
this notice is to notify the public that FEMA will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance.

Collection of Information

    Title: Exemption of State-Owned Properties Under Self-Insurance.
    Type of information collection: Reinstatement, without change, of a
previously approved collection for which approval has expired.
    OMB Number: 1660-0013.
    Form Titles and Numbers: None.
    Abstract: Application for exemption must be made by the Governor or
other duly authorized official of the State accompanied by sufficient
supporting documentation which certifies that the plan of self-
insurance upon which the application for exemption is based meets or
exceeds the standards in NFIP regulations at 44 CFR 75.11.
    Affected Public: State, Local or Tribal Government.
    Estimated Number of Respondents: 20.
    Estimated Number of Responses: 20.
    Estimated Total Annual Burden Hours: 5.
    Estimated Total Annual Respondent Cost: The estimated annual cost
to respondents for the hour burden is $8,547. There are no annual costs
to respondents operations and maintenance costs for technical services.
There is no annual start-up or capital costs. The cost to the Federal
Government is $3,920.10.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: October 30, 2017.
William Holzerland,
Information Management Division Director, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2017-24005 Filed 11-2-17; 8:45 am]
BILLING CODE 9110-11-P


"Baer, Mitchell"<EMAIL_ADDRESS> 09/28/2007 07:25 AM

To

"Johansson, Robert"<EMAIL_ADDRESS>Ron Evans/RTP/USEPA/US@EPA

cc

Subject

RE: RIA NAAQS Workshop

Rob, Ron

     I will be attending the workshop.

Mitch

Mitchell T. Baer, Ph.D., CCM

Acting Director

Office of Oil and Gas Analysis, PI-42

Office of Policy and International Affairs

U.S. Department of Energy

1000 Independence Ave. SW

Washington, D.C. 20585

202-586-5167 (phone)

202-586-5391 (fax)

<EMAIL_ADDRESS>

From: Johansson, Robert<EMAIL_ADDRESS> Sent: Thursday, September 27, 2007 5:26 PM

To: Baer, Mitchell<EMAIL_ADDRESS>Farrell, Amy L.; Laur, Michele - Washington, DC<EMAIL_ADDRESS><EMAIL_ADDRESS>Schwab, Margo

Subject: RIA NAAQS Workshop

Hi All,

Ron has asked that I get a head count for those that are planning on heading to RTP for the naaqs ria workshop.

Please let me or Ron know asap if you plan to attend.  Are there others from your agency that would be interested in attending?

Cheers,

Rob


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Page 45940]
[FR Doc No: 2017-21057]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Thirty Sixth RTCA SC-216 Aeronautical Systems Security Plenary

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

ACTION: Thirty Sixth RTCA SC-216 Aeronautical Systems Security Plenary.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Thirty Sixth RTCA SC-216 Plenary.

DATES: The meeting will be held November 13-17, 2017 9:00 a.m.-5:00
p.m. CET.

ADDRESSES: The meeting will be held at: EASA (Mon-Thu), Avenue de
Cortenbergh 100, 1040 Brussels, Belgium, EUROCONTROL (Fri), Rue de la
Fusee, 96, 1130 Bruxelles (Haren), Brussels, Belgium.

FOR FURTHER INFORMATION CONTACT: Karan Hofmann at<EMAIL_ADDRESS>or
202-330-0680, or The RTCA Secretariat, 1150 18th Street NW., Suite 910,
Washington, DC 20036, or by telephone at<PHONE_NUMBER>, fax at (202)
833-9434, or Web site at http://www.rtca.org. Registration is required.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Thirty Sixth RTCA SC-216 Plenary. The
agenda will include the following:

Monday, November 13, 2017--9:00 a.m.-5:00 p.m. (EASA)

1. Welcome and Administrative Remarks
2. Introductions
3. Agenda Review
4. Meeting-Minutes Review
5. Review Joint Action List
6. Continuation of Plenary or Working Group Sessions

Tuesday, November 14, 2017--9:00 a.m.-5:00 p.m. (EASA)

Continuation of Plenary or Working Group Sessions

Wednesday, November 15, 2017--9:00 a.m.-5:00 p.m. (EASA)

Continuation of Plenary or Working Group Sessions

Thursday, November 16, 2017--9:00 a.m.-5:00 p.m. (EASA)

Continuation of Plenary or Working Group Sessions

Friday, November 17, 2017--9:00 a.m.-12:00 p.m. (EUROCONTROL)

1. Schedule Update
2. Date, Place and Time of Next Meeting
3. New Business
4. Adjourn Plenary

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

    Issued in Washington, DC, on September 27, 2017.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2017-21057 Filed 9-29-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Pages 35311-35313]
[FR Doc No: 2020-12429]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1414]

Institutional Review Board Review of Individual Patient Expanded
Access Requests for Investigational Drugs and Biological Products
During the COVID-19 Public Health Emergency; Guidance for Institutional
Review Boards and Clinical Investigators; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Institutional Review Board (IRB) Review of Individual Patient
Expanded Access Requests for Investigational Drugs and Biological
Products During the COVID-19 Public Health Emergency.'' To facilitate
patient access to investigational drugs for treating COVID-19, FDA is
issuing this guidance to provide recommendations regarding the key
factors and procedures IRBs should consider when reviewing requests--
including when such reviews are conducted by a single-member of an
IRB--for individual patient expanded access. Given the public health
emergency presented by COVID-19, this guidance 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 June 9, 2020. The guidance is immediately in effect, but it
remains subject to comment in accordance with the Agency's good
guidance practices.

ADDRESSES: You may submit 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-1414 for ``Institutional Review Board (IRB) Review of
Individual Patient Expanded Access Requests for Investigational Drugs
and Biological Products During the COVID-19 Public Health Emergency.''
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 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 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: Juanita Marner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-8078.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Institutional Review Board (IRB) Review of Individual
Patient Expanded Access Requests for Investigational Drugs and
Biological Products During the COVID-19 Public Health Emergency.''
There is currently an outbreak of respiratory disease caused by a novel
coronavirus. The virus has been named SARS-CoV-2, and the disease it
causes has been named Coronavirus Disease 2019 (COVID-19). On January
31, 2020, the Department of Health and Human Services (HHS) issued a
declaration of a public health emergency related to COVID-19 and
mobilized the Operating Divisions of HHS. The public health emergency
declaration was renewed on April 21, 2020. In addition, on March 13,
2020, the President declared a national emergency in response to COVID-
19.
    FDA is issuing this guidance to provide recommendations regarding
the key factors and procedures IRBs, including for reviews conducted by
a single-member, should consider when reviewing individual patient
expanded access submissions for patient access to investigational drugs
for treating COVID-19.
    Under FDA regulations, three categories of expanded access are
available: Expanded access for individual (also known as single)
patients, including for emergency use; expanded access for
intermediate-size patient populations; and ``treatment'' expanded
access for larger populations. This guidance applies to individual
patient expanded access requests, as outlined in 21 CFR 312.310. The
recommendations in this guidance are intended to assist IRBs in
conducting efficient reviews of individual patient expanded access
requests.
    In light of the public health emergency related to COVID-19
declared by the Secretary of 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 statute and regulation.
    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 described in the guidance are expected to
assist the Agency more broadly in its continued efforts to facilitate
access to drugs through expanded access 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 ``Institutional Review Board (IRB) Review of
Individual Patient Expanded Access Requests for Investigational Drugs
and Biological Products During the COVID-19 Public Health Emergency.''
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 guidance refers to previously approved collections of
information found in FDA regulations. 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 312 have been approved under
OMB control number 0910-0014; the collections of information relating
to the protection of human subjects and IRBs have been approved under
OMB control number 0910-0130; and the collections of information in
FDA's guidance for industry on ``Individual Patient Expanded Access
Applications: Form FDA 3926'' have been approved under OMB control
number 0910-0814.

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/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or
https://www.regulations.gov.

    Dated: June 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12429 Filed 6-8-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30324-30325]
[FR Doc No: 2022-10653]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Meeting of the National Parks Overflights Advisory
Group

ACTION: Notice of meeting.

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SUMMARY: The Federal Aviation Administration (FAA) and the National
Park Service (NPS), in accordance with the National Parks Air Tour
Management Act of 2000, announce the next meeting of the National Parks
Overflights Advisory Group (NPOAG). This notification provides the
date, location, and agenda for the meeting.

DATES: The NPOAG will meet on June 22-23, 2022. The meeting will take
place in the Windsor Conference Room located in the lobby of the Fort
Collins Marriott, 350 East Horsetooth Road, Fort Collins, CO 80525. The
meeting will be held from 1:00 p.m. to 4:30 p.m. on June 22 and from
8:30 a.m. to 11:30 a.m. p.m. on June 23, 2022. This NPOAG meeting will
be open to the public. Because seating is limited, members of the
public wishing to attend will need to contact the person listed under
FOR FURTHER INFORMATION CONTACT by June 10, 2022 to ensure sufficient
meeting space is available to accommodate all attendees.

FOR FURTHER INFORMATION CONTACT: Keith Lusk, AWP-1SP, Special Programs
Staff, Federal Aviation Administration, Western-Pacific Region
Headquarters, 777 South Aviation Boulevard, Suite 150, El Segundo, CA
92045, telephone:<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The National Parks Air Tour Management Act of 2000 (NPATMA),
enacted on April 5, 2000, as Public Law 106-181, required the
establishment of the NPOAG within one year after its enactment. The Act
requires that the NPOAG be a balanced group of representatives of
general aviation, commercial air tour operations, environmental
concerns, and Native American tribes. The Administrator of the FAA and
the Director of NPS (or their designees) serve as ex officio members of
the group. Representatives of the Administrator and Director serve
alternating 1-year terms as chairperson of the advisory group.
    The duties of the NPOAG include providing advice, information, and
recommendations to the FAA Administrator and the NPS Director on;
implementation of Public Law 106-181; quiet aircraft technology; other
measures that might accommodate interests to visitors of national
parks; and at the request of the Administrator and the Director, on
safety, environmental, and other issues related to commercial air tour
operations over national parks or tribal lands.

Agenda for the June 22-23, 2022 NPOAG Meeting

    The agenda for the meeting will include, but is not limited to, an
update on ongoing park specific air tour management plans or voluntary
agreements, status of agency implementation of court approved plan/
schedule, update on environmental review process and special purpose
law consultations, and public comment review process.

Attendance at the Meeting and Submission of Written Comments

    Although this is not a public meeting, interested persons may
attend. Because seating is limited, if you plan to attend please
contact the person listed under FOR FURTHER INFORMATION CONTACT so that
meeting space may be made to accommodate all attendees. Written
comments regarding the meeting will be accepted directly from attendees
or may be sent to the person listed under FOR FURTHER INFORMATION
CONTACT.

Record of the Meeting

    If you cannot attend the NPOAG meeting, a summary record of the
meeting will be made available under the NPOAG section of the FAA ATMP
website at: http://www.faa.gov/about/office_org/headquarters_offices/arc/programs/air_tour_management_plan/parks_overflights_group/minutes.cfm or through the Special Programs Staff, Western-Pacific
Region, 777 South Aviation Boulevard, Suite 150, El Segundo, CA 90245,
telephone:<PHONE_NUMBER>.

    Issued in El Segundo, CA, on May 13, 2022.
Keith Lusk,
Program Manager, Special Programs Staff, Western-Pacific Region.
[FR Doc. 2022-10653 Filed 5-17-22; 8:45 am]
BILLING CODE 4910-13-P