[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Page 54655]
[FR Doc No: 2013-21544]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0477]

Center for Devices and Radiological Health: Draft Standard
Operating Procedure for Level 1, Immediately in Effect Guidance
Documents on Premarket Data Issues; Availability and Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the Draft Standard Operating Procedure (SOP) for Level
1, Immediately in Effect (IIE) Guidance Documents on Premarket Data
Issues. The SOP describes the Center for Devices and Radiological
Health's (CDRH's or the Center's) draft process to clarify and more
quickly inform stakeholders when CDRH has changed its expectations
relating to, or otherwise has new scientific information that could
affect, data submitted as part of an Investigational Device Exemption
(IDE) or premarket submission, including a Premarket Notification
510(k), a Premarket Approval (PMA), or a Humanitarian Device Exemption
(HDE) that needs to be disseminated in a timely manner.

DATES: The Agency encourages interested parties to submit information
and either electronic or written comments by October 21, 2013.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
access to the document. Submit electronic comments on the draft SOP to
http://www.regulations.gov. Submit written comments to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Task Force on the Utilization of Science in Regulatory Decision
Making (the Task Force) published a Preliminary Report and
Recommendations in August 2010. In the report, the Task Force noted
that when new scientific information changes CDRH's regulatory
thinking, it has been challenging for the Center to communicate the
change and its basis to all affected parties in a meaningful and timely
manner. The Task Force recommended that the Center make use of more
rapid tools for broad communication on regulatory matters, including
establishing a standard practice for communicating to all manufacturers
of a particular group of devices for which the Center has changed its
regulatory expectations on the basis of new scientific information.
    Currently, manufacturers typically learn of changes CDRH implements
regarding what data or how to gather specific data in support of an IDE
or premarket submission, including a Premarket Notification 510(k), a
PMA, or an HDE at the time of or soon after a decision is made through
individual engagement with the Center, often not until after they have
prepared that submission. Reviewers may implement these changes, such
as requesting new clinical data or using a new test method, on a case-
by-case basis, with immediate supervisory concurrence when it is
necessary to protect the public health. For example, a reviewer may
request that sponsors test their implantable device for durability
because new data demonstrate that this type of device is prone to
failure due to premature wear and tear of the technology. Although CDRH
may issue a detailed guidance document, the document may not be
published until a year or more after a Branch- or Division-level
decision has been made to request the information because of the
resource constraints in developing guidance documents.
    CDRH believes that timely communication with industry about changes
in premarket regulatory expectations is important. FDA's Good Guidance
Practices regulation provides a mechanism for communicating and
implementing certain changes in regulatory expectations quickly,
without requiring prior public comment. Under 21 CFR 10.115(g)(2), FDA
may issue a Level 1, IIE Guidance Document when prior public
participation is not ``feasible or appropriate.'' Under these
circumstances, CDRH intends to use the procedures described in Sec.
10.115(g)(2) to issue guidance documents addressing changes in
premarket regulatory expectations. CDRH has developed this SOP to
facilitate issuance of such guidance documents.
    On July 21, 2011 (76 FR 43693), CDRH issued a Standard Operating
Procedure for ``Notice to Industry'' Letters, which outlined a similar
process to clarify and quickly inform stakeholders of new CDRH
expectations (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259172.pdf). After
considering the comments received on that proposal, CDRH is now
announcing a draft SOP that meets the Center's needs and addresses
concerns raised regarding the original ``Notice to Industry'' proposal.

II. Electronic Access

    Persons interested in obtaining a copy of the draft SOP may do so
by using the Internet. The Draft Standard Operating Procedure for Level
1, Immediately in Effect Guidance Documents on Premarket Data Issues is
available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259172.pdf. The draft
SOP is also available from http://www.regulations.gov and can be
located using the docket number found in brackets in the heading of
this document.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21544 Filed 9-4-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 10, 2009 (Volume 74, Number 216)]
[Notices]
[Page 58015-58016]
[DOCID:fr10no09-59]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8978-6; Docket ID No. EPA-HQ-ORD-2009-0203]

Draft Toxicological Review of Trichloroacetic Acid: In Support of
the Summary Information in the Integrated Risk Information System
(IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of peer-review workshop.

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SUMMARY: EPA is announcing that Versar, Inc., an EPA contractor for
external scientific peer review, will convene an independent panel of
experts and organize and conduct an external peer-review workshop to
review the external review draft document titled, ``Toxicological
Review of Trichloroacetic Acid: In Support of Summary Information on
the Integrated Risk Information System (IRIS)'' (EPA/635/R-09/003A).
The draft document was prepared by the National Center for
Environmental Assessment (NCEA) within EPA's Office of Research and
Development. EPA previously announced the 60-day public comment period
(ending November 23, 2009) for the draft document in the Federal
Register on September 24, 2009 (74 FR 48735). EPA will consider public
comments and recommendations from the expert panel workshop as EPA
finalizes the draft document.
    The public comment period and the external peer-review workshop are
separate processes that provide opportunities for all interested
parties to comment on the document. EPA intends to forward public
comments submitted in accordance with the September 24, 2009, Federal
Register notice (74 FR 48735) to Versar, Inc. for consideration by the
external peer-review panel prior to the workshop.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination.
    Versar, Inc. invites the public to register to attend this workshop
as observers. In addition, Versar, Inc. invites the public to give oral
and/or provide written comments at the workshop regarding the draft
document under review. Space is limited, and reservations will be
accepted on a first-come, first-served basis. The draft document and
EPA's peer-review charge are available primarily via the Internet on
NCEA's home page under the Recent Additions and Publications menus at
http://www.epa.gov/ncea. In preparing a final report, EPA will consider
Versar's report of the comments and recommendations from the external
peer-review workshop and any public comments that EPA receives.

DATES: The peer-review panel workshop will be held on December 10,
2009, at 8:30 a.m. and end at 5 p.m.

ADDRESSES: The peer-review workshop will be held at the Marriott
Courtyard Arlington Crystal City/Reagan National Airport, 2899
Jefferson Davis Highway, Arlington, VA 22202; phone:<PHONE_NUMBER>. The
EPA contractor, Versar, Inc., is organizing, convening, and conducting
the peer-review workshop. To attend the workshop, register by December
4, 2009, by e-mail<EMAIL_ADDRESS>(subject line: Trichloroacetic
Acid Peer Review Workshop), by phone:<PHONE_NUMBER>, ext. 579 or toll
free at 1-800-2-VERSAR (1-800-283-7727), ext. 579, ask for the
Trichloroacetic Acid Peer Review Workshop Coordinator, Karie Riley, or
by faxing a registration request to<PHONE_NUMBER> (please reference the
``Trichloroacetic Acid Peer Review Workshop'' and include your name,
title, affiliation, full address, and contact information).
    The draft ``Toxicological Review of Trichloroacetic Acid: In
Support of Summary Information on the Integrated Risk Information
System (IRIS)'' is available primarily via the Internet on the National
Center for Environmental Assessment's home page under the Recent
Additions and Publications menus at http://www.epa.gov/ncea. A limited
number of paper copies are available from the Information Management
Team, NCEA; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>. If you
are requesting a paper copy, please provide your name, mailing address,
and the document title, ``Toxicological Review of Trichloroacetic Acid:
In Support of Summary Information on the Integrated Risk Information
System (IRIS).'' Copies are not available from Versar, Inc.
    Information on Services for Individuals with Disabilities: EPA
welcomes public attendance at the ``trichloroacetic acid peer-review
workshop'' and will make every effort to accommodate persons with
disabilities. For information on access or services for individuals
with disabilities, please contact Versar, Inc. by phone at<PHONE_NUMBER>
ext. 579 or by e-mail at<EMAIL_ADDRESS>preferably at least 10 days
prior to the meeting, to give as much time as possible to process your
request.

FOR FURTHER INFORMATION CONTACT: Questions regarding information,
registration, access or services for individuals with disabilities, or
logistics for the external peer-review workshop should be directed to
Versar, Inc., 6850 Versar Center, Springfield, VA 22151; by e-mail:
<EMAIL_ADDRESS>(subject line: Trichloroacetic Acid Peer Review
Workshop), by phone:<PHONE_NUMBER>, ext. 579 or toll free at 1-800-2-
VERSAR (1-800-283-7727), ext. 579, or ask for the Trichloroacetic Acid
Peer Review Workshop Coordinator, Karie Riley). To request
accommodation of a disability, please contact Ms. Karie Riley of
Versar, preferably at least 10 days prior to the meeting, to give as
much time as possible to process your request.
    If you have questions about the document, contact Diana Wong,
National Center for Environmental Assessment, (8601P), U.S. EPA, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone: 703-347-
8633; facsimile:<PHONE_NUMBER>; or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Information About IRIS

    IRIS is a database that contains potential adverse human health
effects information that may result from chronic (or lifetime) exposure
to specific chemical substances found in the environment. The database
(available on the Internet at http://www.epa.gov/iris) contains
qualitative and quantitative health effects information for more than
540 chemical substances that may be used to support the first two steps
(hazard identification and dose-response evaluation) of a risk
assessment process. When supported by available data, the database
provides oral reference doses (RfDs) and inhalation reference
concentrations (RfCs) for chronic health effects, and oral slope
factors and inhalation unit risks for carcinogenic effects. Combined
with specific exposure information, government and private entities can
use IRIS data to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

    Dated: October 29, 2009.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E9-27048 Filed 11-9-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Notices]
[Page 34519-34520]
[DOCID:fr17jn10-139]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary of Transportation

[DOT Docket No. DOT-OST-2010-0074]

The Future of Aviation Advisory Committee (FAAC) Subcommittee on
Environment; Notice of Meeting

AGENCY: U.S. Department of Transportation, Office of the Secretary of
Transportation.

ACTION: The Future of Aviation Advisory Committee (FAAC) Environment
Subcommittee; notice of meeting.

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SUMMARY: The Department of Transportation (DOT), Office of the
Secretary of Transportation, announces a meeting of the FAAC
Environment Subcommittee, which will be held at the office of The
Boeing Company in Arlington, Virginia. This notice announces the date,
time, and location of the meeting, which will be open to the public.
The purpose of the FAAC is to provide advice and recommendations to the
Secretary of Transportation to ensure the competitiveness of the U.S.
aviation industry and its capability to manage effectively the evolving
transportation needs, challenges, and opportunities of the global
economy. The Environment Subcommittee is charged with examining steps
and strategies that can be taken by aviation-sector stakeholders and
the Federal Government to reduce aviation's environmental footprint and
foster sustainability gains in cost-effective ways. This includes
consideration of potential approaches to promote effective
international actions through the International Civil Aviation
Organization.

DATES: The meeting will be held on June 30, 2010, from 9 a.m. to 12
p.m., Eastern Daylight time.

ADDRESSES: The meeting will be held at The Boeing Company, 1200 Wilson
Boulevard, Arlington, Virginia, 22209, in Room 816. The meeting
location is close to the Rosslyn Metro Station, on the Orange and Blue
Lines.
    Public Access: The meeting is open to the public. (See below for
registration instructions.)
    Public Comments: Persons wishing to offer written comments and
suggestions concerning the activities of the advisory committee or
environment subcommittee should file comments in the Public Docket
(Docket Number DOT-OST-2010-0074 at http://www.Regulations.Gov) or
alternatively through the<EMAIL_ADDRESS>e-mail. If comments and
suggestions are intended specifically for the Environment Subcommittee,
the term ``Environment'' should be listed in the subject line of the
message. In order to ensure that such comments can be considered by the
Subcommittee before its June 30, 2010, meeting, public comments must be
filed by 5 p.m. Eastern Daylight time on Monday, June 21, 2010.

SUPPLEMENTARY INFORMATION:

Background

    Under section 10(a)(2) of the Federal Advisory Committee Act (5
U.S.C. App. 2), we are giving notice of a meeting of the Environment
Subcommittee of the Future of Aviation Advisory Committee taking place
on June 30, 2010, from 9 a.m. to 12 p.m., at The Boeing Company, 1200
Wilson Boulevard, Arlington, Virginia, 22209, in Room 816. The agenda
includes--
    1. Discussion of topics offered by subcommittee members for
referral to the full Committee on the subject of meeting the
environmental and energy challenges needed to accommodate increases in
the demand for air transportation.
    2. Establishment of a plan and timeline for further work.
    3. Identification of priority issues for the second subcommittee
meeting.

Registration

    The meeting room can accommodate up to 18 members of the public.
Persons desiring to attend must pre-register through e-mail to
<EMAIL_ADDRESS>The term ``Registration: Environment'' should be listed
in the subject line of the message and admission will be limited to the
first 18 persons to pre-register and receive a confirmation of their
pre-registration. All foreign visitors must provide their nationality
when registering.
    Arrangements to attend by teleconference can be made by contacting
the person listed in the FOR FURTHER INFORMATION CONTACT section by 5
p.m. Monday, June 21, 2010. Callers outside the Washington metropolitan
area are responsible for paying long-distance charges. Minutes of the
meeting will be taken and will be made available to the public.

Requests for Special Accommodation

    The DOT is committed to providing equal access to this meeting for
all participants. If you need alternative formats or services because
of a disability, please send a request to<EMAIL_ADDRESS>with the term
``Special Accommodations'' listed in the subject line of the message by
close of business Monday, June 21, 2010.

FOR FURTHER INFORMATION CONTACT: Lynne Pickard, Deputy Director, Office
of Environment and Energy, Federal Aviation Administration, 800
Independence Avenue, SW., Washington DC 20591; telephone (202) 267-
3577; fax<PHONE_NUMBER><EMAIL_ADDRESS>
    Issued in Washington, DC, on June 11, 2010.
Pamela Hamilton-Powell,
Designated Federal Official, Future of Aviation Advisory Committee.
[FR Doc. 2010-14567 Filed 6-16-10; 8:45 am]
BILLING CODE P


Plant Name ORIS Code ESP Fabric Filter BARRY 3 1 GADSDEN 7 1 GORGAS 8 1 GREENE COUNTY 10 1 E C GASTON 26 1 COLBERT 47 1 WIDOWS CREEK 50 1 DOLET HILLS 51 1 CHARLES R LOWMAN 56 1 PLATTE 59 1 WHELAN ENERGY CENTER 60 1 ESCALANTE 87 1 HOLCOMB 108 1 CHOLLA 113 1 IRVINGTON 126 1 OKLAUNION 127 1 CROSS 130 1 SEMINOLE 136 1 APACHE STATION 160 1 GRDA 165 1 ST JOHNS RIVER POWER 207 1 LIMESTONE 298 1 Long Beach Generation LLC 341 JOLIET 29 384 1 ARAPAHOE 465 1 CAMEO 468 1 CHEROKEE 469 1 COMANCHE 470 1 VALMONT 477 1 MARTIN DRAKE 492 1 HAYDEN 525 1 NUCLA 527 1 STANTON ENERGY 564 1 BRIDGEPORT HARBOR 568 1 EDGE MOOR 593 1 INDIAN RIVER 594 1 BRANDON SHORES 602 1 CRYSTAL RIVER 628 1 CRIST 641 1 SCHOLZ 642 1 SMITH 643 1 BIG BEND 645 1 DEERHAVEN 663 1 C D MCINTOSH JR 676 1 BOWEN 703 1 HAMMOND 708 1 HARLLEE BRANCH 709 1 JACK MCDONOUGH 710 1 YATES 728 1 KRAFT 733 1 E D EDWARDS 856 1 COFFEEN 861 1 HUTSONVILLE 863 1 MEREDOSIA 864 1 CRAWFORD 867 1 JOLIET 9 874 1 KINCAID 876 1 POWERTON 879 1 WAUKEGAN 883 1 WILL COUNTY 884 1 FISK 886 1 JOPPA STEAM 887 1 BALDWIN 889 1 HAVANA 891 1 HENNEPIN 892 1 VERMILION 897 1 WOOD RIVER 898 1 DALLMAN 963 1 LAKESIDE 964 1 MARION 976 1 STATE LINE 981 1 1 CLIFTY CREEK 983 1 TANNERS CREEK 988 1 ELMER W STOUT 990 1 H T PRITCHARD 991 1 PETERSBURG 994 1 BAILLY 995 1 DEAN H MITCHELL 996 1 MICHIGAN CITY 997 1 CAYUGA 1001 1 EDWARDSPORT 1004 1 R GALLAGHER 1008 1 WABASH RIVER 1010 1 F B CULLEY 1012 1 1 WHITEWATER VALLEY 1040 1 FRANK E RATTS 1043 1 DUBUQUE 1046 1 LANSING 1047 1 MILTON L KAPP 1048 1 PRAIRIE CREEK 1073 1 SUTHERLAND 1077 1 COUNCIL BLUFFS 1082 1 GEORGE NEAL NORTH 1091 1 BURLINGTON 1104 1 AMES 1122 1 STREETER STATION 1131 1 MUSCATINE 1167 1 EARL F WISDOM 1217 1 FAIR STATION 1218 1 RIVERTON 1239 1 LA CYGNE 1241 1 LAWRENCE 1250 1 TECUMSEH 1252 1 KAW 1294 1 QUINDARO 1295 1 BIG SANDY 1353 1 E W BROWN 1355 1 GHENT 1356 1 GREEN RIVER 1357 1 PINEVILLE 1360 1 TYRONE 1361 1 CANE RUN 1363 1 MILL CREEK 1364 1 HENDERSON I 1372 1 ELMER SMITH 1374 1 PARADISE 1378 1 SHAWNEE 1379 1 COLEMAN 1381 1 HMP& L STATION 2 1382 1 ROBERT REID 1383 1 COOPER 1384 1 DALE 1385 1 Nelson Coal 1393 1 C P CRANE 1552 1 HERBERT A WAGNER 1554 1 R P SMITH 1570 1 CHALK POINT 1571 1 DICKERSON 1572 1 MORGANTOWN 1573 1 MOUNT TOM 1606 1 SOMERSET 1613 1 BRAYTON POINT 1619 1 SALEM HARBOR 1626 1 B C COBB 1695 1 DAN E KARN 1702 1 J H CAMPBELL 1710 1 J C WEADOCK 1720 1 J R WHITING 1723 1 CONNERS CREEK 1726 1 HARBOR BEACH 1731 1 MARYSVILLE 1732 1 MONROE 1733 1 RIVER ROUGE 1740 1 ST CLAIR 1743 1 TRENTON CHANNEL 1745 1 PRESQUE ISLE 1769 1 1 J B SIMS 1825 1 JAMES DE YOUNG 1830 1 ECKERT STATION 1831 1 ERICKSON 1832 1 SHIRAS 1843 1 SYL LASKIN 1891 CLAY BOSWELL 1893 1 1 M L HIBBARD 1897 1 BLACK DOG 1904 1 HIGH BRIDGE 1912 1 ALLEN S KING 1915 1 1 MINNESOTA VALLEY 1918 1 RIVERSIDE 1927 1 1 HOOT LAKE 1943 1 NORTHEAST STATION 1961 1 SILVER LAKE 2008 1 JACK WATSON 2049 1 ASBURY 2076 1 HAWTHORN 2079 1 MONTROSE 2080 1 SIBLEY 2094 1 LAKE ROAD 2098 1 LABADIE 2103 1 MERAMEC 2104 1 SIOU1 2107 1 BLUE VALLEY 2132 1 JAMES RIVER 2161 1 NEW MADRID 2167 1 THOMAS HILL 2168 1 CHAMOIS 2169 1 J E CORETTE 2187 1 LON WRIGHT 2240 1 SHELDON 2277 1 NORTH OMAHA 2291 1 REID GARDNER 2324 1 MOHAVE 2341 1 MERRIMACK 2364 1 SCHILLER 2367 1 B L ENGLAND 2378 1 DEEPWATER 2384 1 HUDSON 2403 1 1 MERCER 2408 1 FOUR CORNERS 2442 1 SAN JUAN 2451 1 DANSKAMMER 2480 1 GOUDEY 2526 1 GREENIDGE 2527 1 MILLIKEN 2535 1 C R HUNTLEY 2549 1 DUNKIRK 2554 1 LOVETT 2629 1 ROCHESTER 7 2642 1 ASHEVILLE 2706 1 CAPE FEAR 2708 1 LEE 2709 1 RO1BORO 2712 1 L V SUTTON 2713 1 W H WEATHERSPOON 2716 1 G G ALLEN 2718 1 BUCK 2720 1 CLIFFSIDE 2721 1 DAN RIVER 2723 1 MARSHALL 2727 1 RIVERBEND 2732 1 R M HESKETT 2790 1 LELAND OLDS 2817 1 MILTON R YOUNG 2823 1 STANTON 2824 1 1 CARDINAL 2828 1 WALTER C BECKJORD 2830 1 MIAMI FORT 2832 1 ASHTABULA 2835 1 AVON LAKE 2836 1 EASTLAKE 2837 1 LAKE SHORE 2838 1 CONESVILLE 2840 1 PICWAY 2843 1 O H HUTCHINGS 2848 1 J M STUART 2850 1 NILES 2861 1 R E BURGER 2864 1 W H SAMMIS 2866 1 1 MUSKINGUM RIVER 2872 1 KYGER CREEK 2876 1 BAY SHORE 2878 1 HAMILTON 2917 1 1 ORRVILLE 2935 MUSKOGEE 2952 1 NORTHEASTERN 2963 1 ELRAMA 3098 1 PORTLAND 3113 1 TITUS 3115 1 CONEMAUGH 3118 1 HOMER CITY 3122 1 SHAWVILLE 3131 1 KEYSTONE 3136 1 NEW CASTLE 3138 1 BRUNNER ISLAND 3140 1 1 MARTINS CREEK 3148 1 MONTOUR 3149 1 SUNBURY 3152 1 1 CROMBY 3159 EDDYSTONE 3161 1 HUNLOCK PWR STATION 3176 1 ARMSTRONG 3178 1 HATFIELD'S FERRY 3179 1 H B ROBINSON 3251 1 W S LEE 3264 1 CANADYS STEAM 3280 1 1 MCMEEKIN 3287 1 URQUHART 3295 1 WATEREE 3297 1 1 WILLIAMS 3298 1 DOLPHUS M GRAINGER 3317 1 JEFFERIES 3319 1 ALLEN 3393 1 BULL RUN 3396 1 CUMBERLAND 3399 1 GALLATIN 3403 1 JOHN SEVIER 3405 1 JOHNSONVILLE 3406 1 KINGSTON 3407 1 W A PARISH 3470 1 BIG BROWN 3497 1 1 CARBON 3644 1 CLINCH RIVER 3775 1 GLEN LYN 3776 1 POTOMAC RIVER 3788 1 BREMO POWER STATION 3796 1 CHESTERFIELD 3797 1 CHESAPEAKE 3803 1 YORKTOWN 3809 1 CENTRALIA 3845 1 JOHN E AMOS 3935 1 KANAWHA RIVER 3936 1 PHILIP SPORN 3938 1 ALBRIGHT 3942 1 FORT MARTIN 3943 1 HARRISON 3944 1 RIVESVILLE 3945 1 WILLOW ISLAND 3946 1 KAMMER 3947 1 MITCHELL 3948 1 MT STORM 3954 1 BLOUNT STREET 3992 1 SOUTH OAK CREEK 4041 1 VALLEY 4042 1 EDGEWATER 4050 1 NELSON DEWEY 4054 1 PULLIAM 4072 1 WESTON 4078 1 1 ALMA 4140 1 GENOA 4143 1 DAVE JOHNSTON 4158 1 NAUGHTON 4162 1 ENDICOTT 4259 1 J P MADGETT 4271 1 NAVAJO 4941 1 JAMES H MILLER JR 6002 1 PLEASANTS 6004 1 WHITE BLUFF 6009 1 DUCK CREEK 6016 1 NEWTON 6017 1 EAST BEND 6018 1 W H ZIMMER 6019 1 CRAIG 6021 1 1 COAL CREEK 6030 1 KILLEN STATION 6031 1 BELLE RIVER 6034 1 H L SPURLOCK 6041 1 WANSLEY 6052 1 BIG CAJUN 2 6055 1 R D MORROW 6061 1 NEARMAN CREEK 6064 1 IATAN 6065 1 JEFFREY ENERGY CENTE 6068 1 TRIMBLE COUNTY 6071 1 VICTOR J DANIEL JR. 6073 1 COLSTRIP 6076 GERALD GENTLEMAN 6077 1 1 KINTIGH 6082 1 R M SCHAHFER 6085 1 LEWIS & CLARK 6089 SHERBURNE COUNTY 6090 1 1 BRUCE MANSFIELD 6094 1 SOONER 6095 1 NEBRASKA CITY 6096 1 BIG STONE 6098 1 WYODAK 6101 1 BOARDMAN 6106 1 GIBSON 6113 1 MCINTOSH 6124 1 GIBBONS CREEK 6136 1 A B BROWN 6137 1 FLINT CREEK 6138 1 WELSH 6139 1 MARTIN LAKE 6146 1 MONTICELLO 6147 1 RUSH ISLAND 6155 1 HUNTER ( EMERY) 6165 1 1 ROCKPORT 6166 1 PLEASANT PRAIRIE 6170 1 CORONADO 6177 1 COLETO CREEK 6178 1 SAM SEYMOUR 6179 1 J T DEELY 6181 1 SAN MIGUEL 6183 1 RODEMACHER 6190 1 HARRINGTON STATION 6193 1 1 TOLK STATION 6194 1 SOUTHWEST 6195 1 LARAMIE RIVER 6204 1 MEROM 6213 1 PAWNEE 6248 1 WINYAH 6249 1 MAYO 6250 1 OTTUMWA 6254 1 SCHERER 6257 1 MOUNTAINEER 6264 1 ANTELOPE VALLEY 6469 1 INTERMOUNTAIN 6481 1 R D GREEN 6639 1 INDEPENDENCE 6641 1 SANDOW 6648 1 LOUISA 6664 1 WARRICK 6705 1 RAWHIDE 6761 1 SIKESTON 6768 1 HUGO 6772 1 D B WILSON 6823 1 TNP ONE 7030 1 J K SPRUCE 7097 1 COPE 7210 1 CLOVER 7213 1 Polk 7242 RICHARD GORSUCH 7286 1 GEORGE NEAL SOUTH 7343 1 Pinon Pine 7419 NEIL SIMPSON 2 7504 1 NORTH BRANCH POWER STATION 7537 1 USDOE SRS ( D Area) 7652 Celanese 7678 Cogen South 7737 BONANZA 7790 1 PIRKEY 7902 1 COLUMBIA 8023 1 1 BELEWS CREEK 8042 1 JIM BRIDGER 8066 1 HUNTINGTON 8069 1 GEN J M GAVIN 8102 1 RAY D NI1ON 8219 1 COYOTE 8222 1 SPRINGERVILLE 8223 1 NORTH VALMY 8224 1 CHESWICK 8226 1 ACE Cogeneration Company 10002 Logan Generating Plant 10043 1 John B Rich Memorial Power Station 10113 Colver Power Project 10143 Grant Town Power Plant 10151 1 Central Power and Lime Incorporated 10333 Foster Wheeler Mt Carmel Incorporated 10343 Cogentri1 Hopewell 10377 1 Cogentri1 Southport 10378 1 Cogentri1 Ro1boro 10379 1 Dwayne Collier Battle Cogeneration Facil 10384 Fort Drum H T W Cogeneration Facility 10464 1 Rumford Cogeneration Company 10495 Chambers Cogeneration Limited Partnershi 10566 Ebensburg Power Company 10603 1 Stockton CoGen Company 10640 1 Cambria CoGen 10641 1 AES Shady Point Incorporated 10671 Cedar Bay Generating Company L P 10672 AES Thames Incorporated 10675 AES BV Partners Beaver Valley 10676 AES Warrior Run Cogeneration Facility 10678 Morgantown Energy Facility 10743 1 Rio Bravo Jasmin 10768 Rio Bravo Poso 10769 LG& E Westmoreland Hopewell 10771 1 LG& E Westmoreland Altavista 10773 1 LG& E Westmoreland Southampton 10774 1 Kline Township Cogen Facil 50039 1 UDG Niagara Falls Cogeneration Facility 50202 1 Tobaccoville Utility Plant 50221 Fibertek Energy LLC 50651 Panther Creek Energy Facility 50776 TES Filer City Station 50835 Wheeler Frackville Energy Company Inc 50879 1 Northhampton Generating Company L P 50888 Yellowstone Energy Ltd Partnership 50931 Sunnyside Cogeneration Associates 50951 Scrubgrass Generating Company L P 50974 Indiantown Cogeneration Facility 50976 Mecklenburg Cogeneration Facility 52007 1 Cogentri1 of Richmond Incorporated 54081 Piney Creek Project 54144 1 SEI Birchwood Power Facility 54304 Mt Poso Cogeneration 54626 St Nicholas Cogeneration Project 54634 Westmoreland LG& E Partners Roanoke Valle 54755 1 Red Hills Generating Facility 55076 1 Wygen 1 55479 1 354 79 433


[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Page 4575]
[FR Doc No: 2022-01753]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3472-024]

Aspinook Hydro, LLC; Notice of Waiver Period for Water Quality
Certification Application

    On December 3, 2021, Aspinook Hydro, LLC. submitted to the Federal
Energy Regulatory Commission (Commission) evidence of its application
for a Clean Water Act section 401(a)(1) water quality certification
filed with Connecticut Department of Energy and Environmental
Protection (Connecticut DEEP), in conjunction with the above captioned
project. Pursuant to section 401 of the Clean Water Act \1\ and section
4.34(b)(5), 5.23(b), 153.4, or 157.22 of the Commission's
regulations,\2\ a state certifying agency is deemed to have waived its
certifying authority if it fails or refuses to act on a certification
request within a reasonable period of time, which is one year after the
date the certification request was received. Accordingly, we hereby
notify the Connecticut DEEP of the following:
---------------------------------------------------------------------------

    \1\ 33 U.S.C. 1341(a)(1).
    \2\ 18 CFR 4.34(b)(5)/5.23(b)/153.4/157.22.
---------------------------------------------------------------------------

    Date that Connecticut DEEP Received the Certification Request:
December 3, 2021.
    If Connecticut DEEP fails or refuses to act on the water quality
certification request on or before December 3, 2022, then the agency
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: January 24, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-01753 Filed 1-27-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Page 17359]
[FR Doc No: 2022-06533]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, the Securities
and Exchange Commission will hold an Open Meeting on Wednesday, March
30, 2022 at 11:30 a.m.

PLACE: The meeting will be webcast on the Commission's website at
www.sec.gov.

STATUS: This meeting will begin at 11:30 a.m. (ET) and will be open to
the public via webcast on the Commission's website at www.sec.gov.

MATTERS TO BE CONSIDERED: 1. The Commission will consider whether to
propose amendments regarding special purpose acquisition companies,
shell companies, the use of projections in Commission filings and a
rule addressing the status of special purpose acquisition companies
under the Investment Company Act of 1940.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Vanessa A. Countryman from the Office of the Secretary
at<PHONE_NUMBER>.

(Authority: 5 U.S.C. 552b.)

    Dated: March 23, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-06533 Filed 3-24-22; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70679-70680]
[FR Doc No: 2023-22566]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3941]

Advisory Committee; Digital Health Committee; Establishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of establishment.

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

SUMMARY: Under the Federal Advisory Committee Act, the Food and Drug
Administration (FDA or Agency) is announcing the establishment of the
Digital Health Advisory Committee. The Commissioner of Food and Drugs
(Commissioner) has determined that it is in the public interest to
establish such a committee. Duration of this committee is 2 years from
the date the Charter is filed, unless the Commissioner formally
determines that renewal is in the public interest.

DATES: Either electronic or written comments on the notice must be
submitted by December 11, 2023. FDA is establishing a docket for public
comment on this document. The docket number is FDA-2023-N-3941. The
docket will close on December 11, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 11, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-3941 for ``Advisory Committee; Digital Health Committee;
Establishment.'' Received comments, those filed in a timely manner,
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: James Swink, Office of Management,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: The Digital Health Advisory Committee
(Committee) provides advice to the Commissioner or designee, on complex
scientific and technical issues related to digital health technologies
(DHTs). This also may include advice on the regulation of DHTs, and/or
their use, including use of DHTs in clinical trials or postmarket
studies subject to FDA regulation. Topics relating to DHTs, such as
artificial intelligence/machine learning (AI/ML), augmented reality,
virtual reality, digital therapeutics, wearables, remote patient
monitoring, and software, may be considered by the Committee. The
Committee advises the Commissioner on issues related to DHTs,
including, for example, real-world data, real-world evidence, patient-
generated health data, interoperability, personalized medicine/
genetics, decentralized clinical trials, use of DHTs in clinical trials
for medical products, cybersecurity, DHT user experience, and Agency
policies and regulations regarding these technologies. The Committee
provides relevant expertise and perspective to improve Agency
understanding of the benefits, risks, and clinical outcomes associated
with use of DHTs. The Committee performs its duties by providing advice
and recommendations on new approaches to develop and evaluate DHTs and
to promote innovation of DHTs, as well as identifying risks, barriers,
or unintended consequences that could result from proposed or
established Agency policy or regulation for topics related to DHTs.
    The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are

selected by the Commissioner or designee from among authorities
knowledgeable in the fields of digital health, such as AI/ML, augmented
reality, virtual reality, digital therapeutics, wearables, remote
patient monitoring, software development, user experience, real-world
data, real-world evidence, patient-generated health data,
interoperability, personalized medicine/genetics, decentralized
clinical trials, cybersecurity, and implementation in clinical practice
of and patient experience with digital health, as well as other
relevant areas. Members will be invited to serve for overlapping terms
of up to 4 years. Non-Federal members of this committee will serve
either as special government employees or non-voting representatives.
Federal members will serve as regular government employees. The core of
voting members may include one technically qualified member, selected
by the Commissioner or designee, who serves as an individual, but who
is identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons.
    The Commissioner or designee shall also have the authority to
select from a group of individuals nominated by industry to serve
temporarily as non-voting members who are identified with and represent
industry interests. The number of temporary members selected for a
particular meeting will depend on the meeting topic.
    In announcing the establishment of this Advisory Committee under
the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.), FDA is also
soliciting public feedback on potential topics for this committee to
discuss and upon which to advise the Agency. The following topics may
include, but are not limited to:

 Transparency and bias management considerations, including
promoting health equity in DHTs
 Augmented reality and virtual reality technical and clinical
questions
 Transparency and labeling considerations for ``opaque box''
algorithms
 Digital therapeutics
 AI/ML
 Input on regulation of AI/ML-enabled devices
 Real-world data and real-world evidence
 Patient-generated health data
 Postmarket monitoring considerations for a total product
lifecycle approach to DHTs
 Interoperability
 Personalized medicine/genetics
 Wearables, remote patient monitoring, and internet of things
 Postmarket monitoring of DHTs
 Technologies to enable decentralized clinical trials
 Cybersecurity best practices in software development for
cloud-based software

    Elsewhere in this issue of the Federal Register, FDA is publishing
separate documents regarding: (1) Digital Health Advisory Committee:
Request for Nominations for Voting Members on a Public Advisory
Committee: Digital Health Advisory Committee; (2) Request for
Nomination of Individuals and Consumer Organizations for the Digital
Health Advisory Committee; and (3) Request for Nomination of
Individuals and Industry Organizations for the Digital Health Advisory
Committee.
    FDA intends to publish in the Federal Register a final rule adding
the Digital Health Advisory Committee to 21 CFR 14.100.

    Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22566 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Pages 59994-59995]
[FR Doc No: 2016-20976]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-2453-000]

Brady Interconnection, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Brady Interconnection, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 14, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC

Online service, please email<EMAIL_ADDRESS>or call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 25, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-20976 Filed 8-30-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: January 5, 2007 (Volume 72, Number 3)]
[Notices]
[Page 597-599]
[DOCID:fr05ja07-66]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55008; File No. SR-Amex-2006-98]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Approving Proposed Rule Change Relating to the Codification of Exchange
Policy Regarding Specialist Commissions

December 22, 2006.

I. Introduction

    On October 4, 2006, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Amex Rule 154 to codify policies
regarding specialist commissions. The proposed rule change was
published for comment in the Federal Register on October 25, 2006.\3\
The Commission received two comment letters regarding the proposal.\4\
On November 28, 2006, the Exchange submitted a response to the
comments.\5\ On December 5, 2006, one of the initial commenters
submitted a response to the Amex Response.\6\ This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 54618 (October 18,
2006), 71 FR 62492.
    \4\ See letter from Jonathan Q. Frey, Managing Partner, J.
Streicher & Co. L.L.C., to Nancy M. Morris, Secretary, Commission,
dated November 13, 2006 (``Streicher Letter I''), and Web comment
from William Silver, Managing Partner, Weiskopf, Silver Co, dated
November 6, 2006 (``Weiskopf Letter'').
    \5\ See letter from Neal L. Wolkoff, Chairman & Chief Executive
Officer, Amex, to Nancy M. Morris, Secretary, Commission, dated
November 28, 2006 (``Amex Response'').
    \6\ See letter from Jonathan Q. Frey, Managing Partner, J.
Streicher & Co. L.L.C., to Nancy M. Morris, Secretary, Commission,
dated December 5, 2006 (``Streicher Letter II'').
---------------------------------------------------------------------------

 II. Description

    The Exchange proposes to codify in new subparagraph (b) to Amex
Rule 154 its policies regarding situations where specialists may charge
a commission for trades that are executed in whole or in part.
Specifically, proposed Amex Rule 154(b) would prohibit a specialist
from: (i) Charging a commission on an off-floor order in equities that
is electronically delivered to the specialist unless the order requires
special handling by the specialist or the specialist provides a
service, and (ii) billing for electronically delivered orders in
equities that are executed automatically by the Exchange's order
processing facilities upon receipt. In addition, proposed Amex Rule
154(b) would reference Amex Rule 152(c), which prohibits specialists
from charging a commission where they act as principal in the execution
of an order entrusted to them as agent. Lastly, proposed Amex Rule
154(b) sets forth the types of orders specialists would be allowed to
bill a commission. In particular, these orders would include limit
orders that remain on the book for more than two minutes, market on
close or limit on close orders, tick sensitive orders, orders for non-
regular way settlement, stop or stop limit orders, orders stopped at
one price and executed at a better price, fill-or-kill, and immediate-
or-cancel orders, and orders for the account of a competing market
maker.

III. Summary of Comments

    The Commission received three comment letters regarding the
proposed rule change from two specialists. Two of these comment
letters, submitted by Streicher, opposed the proposed rule change for
the three reasons discussed below.\7\ The third comment letter,
submitted by Weiskopf, supported the proposed rule change, because
``the specialist's commission charges, if not competitive, have the
potential to drive business away from the exchange and eliminate an
important competitor from the market place.'' \8\ Weiskopf also stated
its view that the proposed rule change is ``a very constructive step
towards fostering greater competition in The National Market System.''
\9\
---------------------------------------------------------------------------

    \7\ See Streicher Letter I and Streicher Letter II.
    \8\ See Weiskopf Letter.
    \9\ Id.
---------------------------------------------------------------------------

    Streicher argued that the proposed rule change would ``adversely
impact investors by reducing the qualify [sic] of markets offered by
the Amex.'' In particular, Streicher argued that Amex's proposed
elimination of certain specialist commissions would harm investors by
putting pressure on specialists to increase spreads to offset the lost
commissions. Streicher stated that ``[w]hile an increase in spreads may
not be practical in highly competitive markets, many of the securities
listed on the Amex are thinly traded with most of their trading volume
taking place primarily on the Amex.'' According to Streicher, ``there
is often little effective competition from other markets'' for these
securities, and, thus, the resulting increased spreads will ``have an
adverse impact investors * * *.'' \10\
---------------------------------------------------------------------------

    \10\ Streicher Letter I at 2-3.
---------------------------------------------------------------------------

    In its response, the Exchange stated that the purpose of the
proposed rule change ``is to attract and maintain order flow to Amex
specialists by providing transparency, clarity and consistency to the
costs of doing business on the Exchange.'' The Exchange argued that
Streicher's position that the elimination of certain specialist
commissions would lead to specialists seeking higher spreads is flawed,
because ``it is against each specialist's own economic interest to
widen its spreads and thereby risk losing order flow.'' Furthermore,
the Exchange disagreed with Streicher's assertion that ``there is often
little effective competition from other markets'' and noted that
``[a]ll Amex listed securities trade in at least one additional market
center'' and that ``[t]he large majority of Amex issues trade on
multiple venues.'' The Exchange concluded that ``[w]idening of the
spreads in these securities will likely result in further market share
erosion as order flow providers mindful of their best execution
responsibilities direct their orders elsewhere.'' \11\
---------------------------------------------------------------------------

    \11\ Amex Response at 3-4.

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

    Streicher responded by taking issue with Exchange's assertion
regarding competition from other markets, by stating that many of the
other markets for Amex-listed securities ``frequently offer little more
than a means to internalize order flow using the quote established by
the Amex as the dominant marketplace for the security in question.''
Streicher also disagreed with Exchange's statement that ``it is against
each specialist's own economic interest to widen its spreads and
thereby risk losing order flow,'' by stating that there might be
circumstances in which ``a greater return on fewer orders might very
well make sense and be in [the commenter's] best economic interest.''
\12\
---------------------------------------------------------------------------

    \12\ Streicher Letter II at 3.
---------------------------------------------------------------------------

    Second, Streicher noted that Amex's purpose for this proposal is to
strengthen Amex's competitive position. However, Streicher asserted
that Amex's concerns regarding its competitive position would be better
addressed by current Amex Rules 26 and 27.\13\ The Exchange, however,
disagreed with Streicher, arguing that, while Amex Rules 26 and 27 are
``useful to the Exchange in its efforts to be competitive,'' the two
rules do not create the ``transparency and clarity'' that the current
proposal would provide.\14\
---------------------------------------------------------------------------

    \13\ Streicher Letter I at 3. Amex Rules 26 and 27 provide the
Exchange with the ability to: (1) limit or prohibit the awarding of
new allocations to specialists who fail to respond to competition by
offering competitive markets and competitively priced services, and
(2) remove allocations from specialists who fail to meet certain
levels of performance in handling of those securities.
    \14\ Amex Response at 4.
---------------------------------------------------------------------------

    Third, Streicher expressed concerns that the rule change would
``result in significant implementation costs'' that are ``difficult to
justify'' given the proposed rule change's temporary nature.\15\ The
Exchange, however, disputed Streicher's argument, indicating that the
implementation costs would be minimal since ``most if not all
specialist units'' have already complied with the proposed limitations
on specialist commissions.\16\ The Exchange also noted that it does not
intend for the proposed rule to remain in effect for a short period;
rather, the Exchange intends to expand the rule to apply to equities
and ETFs traded on the Exchange's Auction and Electronic Market
Integration Platform (``AEMI'') system.\17\ In response, Streicher
suggested that implementation costs would be saved if the Exchange
defers this proposed rule change and has one proposed rule change when
the Exchange ``is ready to finalize and allowable commission schedule
under AEMI.'' \18\
---------------------------------------------------------------------------

    \15\ Streicher Letter I at 3.
    \16\ Amex Response at 4.
    \17\ Id.
    \18\ Streicher Letter II at 3.
---------------------------------------------------------------------------

IV. Discussion

    The Commission has carefully reviewed the proposed rule change, the
comment letters received, and Amex's response, and the Commission finds
that the proposed rule change is consistent with the requirements of
Section 6 of the Act \19\ and the rules and regulations thereunder
applicable to a national securities exchange.\20\ In particular, the
Commission finds that the proposal is consistent with Section 6(b)(5)
of the Act,\21\ because it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. The Commission
also believes that the proposed rule change is consistent with Section
11(A)(a)(1)(C) of the Act \22\ which states that it is in the public
interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure, among other things,
economically efficient execution of securities transactions, and fair
competition among brokers and dealers, among exchange markets, and
between exchange markets and markets other than exchange markets.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f.
    \20\ In approving this proposed rule change the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f). The Commission notes that
it previously approved a similar proposed rule change relating to
commissions on options orders, filed by the Chicago Board Options
Exchange, Inc. See Securities Exchange Act Release No. 51235
(February 22, 2005), 70 FR 9687 (February 28, 2005) (Approval of
CBOE Rule 8.85(b)(iv)). In addition, the New York Stock Exchange,
Inc. (``NYSE'') recently adopted a rule prohibiting specialists from
charging commissions on orders in their speciality securities. See
Securities Exchange Act Release No. 54850 (November 30, 2006), 71 FR
71217 (December 8, 2006) (Notice of Filing and Immediate
Effectiveness of Amendments to NYSE Rule 123B and Adoption of NYSE
Rule 104B).
    \21\ 15 U.S.C. 78f(b)(5).
    \22\ 15 U.S.C. 78k-1(a)(1)(C).
---------------------------------------------------------------------------

    The Commission notes that the Exchange's proposed rule change
codifies the Exchange's policy regarding specialist commissions by
specifying the particular types of orders in which a specialist may
charge a commission and the types of orders in which a specialist may
not charge a commission. The Commission notes that the Streicher
Letters' concern expressed about the possibility of specialists
attempting to widen spreads to compensate for lost commissions. In this
regard, the Commission believes that competition for order flow among
competing markets should continue to provide an incentive for
specialists not to widen spreads.
    In addition, the Commission finds that the proposal is consistent
with Section 6(e)(1) of the Act,\23\ because it is not designed to
permit unfair discrimination between customers, issuers, brokers and
dealers, or to impose any schedule or fix rates of commissions,
allowances, discounts, or other fees to be charged by its members.
Section 6(e) of the Act \24\ was adopted by Congress in 1975 to
statutorily prohibit the fixed minimum commission rate system. As noted
on a report of the House of Representatives one of the purposes of the
legislation was to ``reverse the industry practice of charging fixed
rates of commission for transaction on the securities exchanges.'' \25\
The fixed minimum commission rate system allowed exchanges to set
minimum commission rates that their members had to charge their
customers, but allowed members to charge more. Amex's proposal, by
contrast, does not establish a minimum commission rate, but instead
prohibits the Exchange's specialists from charging a commission for
handling an order in equities that is executed on an opening or
reopening or an order in equities (or portion thereof) that is executed
against the specialist as principal, or for the execution of an off-
floor equities order delivered to the specialist through the Exchange's
electronic order routing systems, subject to certain exceptions.
Accordingly, the Commission does not believe that the Amex's proposal
constitutes fixing commissions, allowances, discounts, or other fees
for purposes of Section 6(e)(1) of the Act.\26\ The Commission also
notes that Amex's limits on fees that specialists may charge applies
only to members who choose to be specialists on Amex. By limiting fees,
the Amex is merely imposing a condition, which is consistent with the
Act, on a member's appointment as a specialist.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78f(e)(1).
    \24\ 15 U.S.C. 78f(e).
    \25\ H.R. Rep. No. 94-123, 94th Cong., 1st Sess. 42 (1975).
    \26\ 15 U.S.C. 78f(e)(1).
---------------------------------------------------------------------------

V. Conclusion

    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with the Act and the rules and regulations
thereunder applicable to a national securities exchange, and, in
particular,

with Sections 6(b)(5) and 6(e)(1) of the Act.\27\
    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\28\ that the proposed rule change (SR-Amex-2006-98) is approved.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78f(b)(5) and 78f(e)(1).
    \28\ 15 U.S.C. 78s(b)(2).
    \29\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\29\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. E6-22592 Filed 1-4-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Notices]
[Pages 12745-12746]
[FR Doc No: 2018-05954]

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

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: ER15-1308-005; ER10-2334-005; ER10-2897-007; ER11-
2765-003; ER11-3406-005; ER11-3407-005; ER12-1739-003; ER12-1865-006;
ER12-1923-004; ER12-1924-004 ER12-1925-004; ER12-2310-006; ER18-140-
004.
    Applicants: Bethel Wind Energy LLC, Kingfisher Wind, LLC, Elk Wind
Energy LLC, Zephyr Wind, LLC, Lackawanna Energy Center LLC, Big Savage,
LLC, Big Sky Wind, LLC, EverPower Commercial Services LLC, Highland
North LLC, Howard Wind LLC, Krayn Wind LLC, Mustang Hills, LLC, Patton
Wind Farm, LLC.
    Description: Notice of Non-Material Change in Status of the
BlackRock MBR Affiliates and New BlackRock Affiliates.
    Filed Date: 3/16/18.
    Accession Number: 20180316-5232.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER17-156-004.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2018-03-19_Additional Compliance
for Queue Reform Attachment X to be effective 1/4/2017.
    Filed Date: 3/19/18.
    Accession Number: 20180319-5117.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: ER17-827-001.
    Applicants: Midcontinent Independent System Operator, Inc., Entergy
Services, Inc.
    Description: Compliance filing: 2018-03-14_Entergy Operating
Companies Attachment O Errata Filing to be effective 6/1/2015.
    Filed Date: 3/14/18.
    Accession Number: 20180314-5198.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: ER17-827-003.
    Applicants: Midcontinent Independent System Operator, Inc., Entergy
Services, Inc.
    Description: Compliance filing: 2018-03-19_Filing to implement
Entergy settlement in ER17-2579; ER15-1436; et al to be effective 6/1/
2015.
    Filed Date: 3/19/18.
    Accession Number: 20180319-5120.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: ER18-581-001.
    Applicants: Public Service Company of New Mexico.
    Description: Tariff Amendment: Response to Deficiency Letters to be
effective 12/18/2017.
    Filed Date: 3/16/18.
    Accession Number: 20180316-5184.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER18-582-001.
    Applicants: Public Service Company of New Mexico.
    Description: Tariff Amendment: Response to Deficiency Letters to be
effective 12/18/2017.
    Filed Date: 3/16/18.
    Accession Number: 20180316-5186.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER18-583-001.
    Applicants: Public Service Company of New Mexico.
    Description: Tariff Amendment: Response to Deficiency Letters to be
effective 12/18/2017.
    Filed Date: 3/16/18.
    Accession Number: 20180316-5190.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER18-584-001.
    Applicants: Public Service Company of New Mexico.
    Description: Tariff Amendment: Response to Deficiency Letters to be
effective 12/20/2017.

    Filed Date: 3/16/18.
    Accession Number: 20180316-5192.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER18-585-001.
    Applicants: Public Service Company of New Mexico.
    Description: Tariff Amendment: Response to Deficiency Letters to be
effective 12/20/2017.
    Filed Date: 3/16/18.
    Accession Number: 20180316-5198.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER18-832-001.
    Applicants: Public Service Company of New Mexico.
    Description: Tariff Amendment: Response to Deficiency Letters to be
effective 1/29/2018.
    Filed Date: 3/16/18.
    Accession Number: 20180316-5201.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER18-907-001.
    Applicants: Public Service Company of New Mexico.
    Description: Tariff Amendment: Response to Deficiency Letters to be
effective 2/9/2018.
    Filed Date: 3/16/18.
    Accession Number: 20180316-5202.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER18-1128-001.
    Applicants: Portland General Electric Company.
    Description: Tariff Amendment: Amended NTTG Funding Agreement--
Amendment Filing to be effective 5/15/2018.
    Filed Date: 3/16/18.
    Accession Number: 20180316-5174.
    Comments Due: 5 p.m. ET 4/6/18.

    Docket Numbers: ER18-1139-000.
    Applicants: Northern Indiana Public Service Company.
    Description: Sec.  205(d) Rate Filing: Revisions to MBR Tariff to
be effective 2/16/2018.
    Filed Date: 3/19/18.
    Accession Number: 20180319-5071.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: ER18-1140-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 305 10th Rev--NITSA with
Stillwater Mining Company to be effective 5/19/2018.
    Filed Date: 3/19/18.
    Accession Number: 20180319-5157.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: ER18-1141-000.
    Applicants: Greenidge Generation LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Material Change to
be effective 1/10/2018.
    Filed Date: 3/19/18.
    Accession Number: 20180319-5167.
    Comments Due: 5 p.m. ET 4/9/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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: March 19, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-05954 Filed 3-22-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63589-63591]
[FR Doc No: 2023-20029]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4060]

Medical Devices With Indications Associated With Weight Loss
Guidances; Draft Guidances for Industry and Food and Drug
Administration Staff; 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 two draft guidances entitled ``Medical Devices with
Indications Associated with Weight Loss--Clinical Study and Benefit-
Risk Considerations'' and ``Medical Devices with Indications Associated
with Weight Loss--Non-Clinical Recommendations.'' These draft guidance
documents provide recommendations regarding clinical study design for
devices with indications for use associated with weight loss, include
discussion on how FDA considers the benefit-risk analysis to support
such indications, and provide recommendations for the non-clinical
testing to support premarket submissions for these medical devices.
These draft guidances are not final nor are they for implementation at
this time.

DATES: Submit either electronic or written comments on the draft
guidance by November 14, 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-2019-N-4060 for ``Medical Devices with Indications Associated with
Weight Loss--Clinical Study and Benefit-Risk Considerations'' and
``Medical Devices with Indications Associated with Weight Loss--Non-
Clinical Recommendations.'' 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,
240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Medical Devices with Indications Associated with Weight Loss--
Clinical Study and Benefit-Risk Considerations'' or ``Medical Devices
with Indications Associated with Weight Loss--Non-Clinical
Recommendations'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2604, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    These draft guidance documents provide recommendations regarding
clinical study design for devices with indications for use associated
with weight loss, include discussion on how FDA considers the benefit-
risk analysis to support such indications, and provide recommendations
for non-clinical testing to support premarket submissions for these
medical devices. These devices may be indicated for weight loss, weight
reduction, weight management, or obesity treatment in patients who are
overweight or have obesity. The recommendations and considerations
reflect current review practices and are intended to promote
consistency and facilitate efficient review of these submissions.
    Prior to drafting these guidances, FDA requested public comment on
a concept for balancing the benefit of weight loss with the risks of
adverse events in a discussion paper (September 2019, Docket No. FDA-
2019-N-4060). FDA considered public comments and incorporated the
feedback as appropriate in developing the draft guidance, ``Medical
Devices with Indications Associated with Weight Loss--Clinical Study
and Benefit-Risk Considerations.''
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidance
documents, when finalized, will represent the current thinking of FDA
on ``Medical Devices with Indications Associated with Weight Loss--
Clinical Study and Benefit-Risk Considerations'' and ``Medical Devices
with Indications Associated with Weight Loss--Non-Clinical
Recommendations.'' They do not establish any rights for any person and
are 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. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Medical Devices with Indications
Associated with Weight Loss--Clinical Study and Benefit-Risk
Considerations (document number GUI00021016)'' or ``Medical Devices
with Indications Associated with Weight Loss--Non-Clinical
Recommendations (document number GUI00019046)'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
812...............................  Investigational            0910-0078
                                     Device Exemption.
860, subpart D....................  De Novo                    0910-0844
                                     classification
                                     process.
``Requests for Feedback and         Q-Submissions and          0910-0756
 Meetings for Medical Device         Early Payor
 Submissions: The Q-Submission       Feedback Request
 Program''.                          Programs for
                                     Medical Devices.
800, 801, 809, and 830............  Medical Device             0910-0485
                                     Labeling
                                     Regulations; Unique
                                     Device
                                     Identification.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
50, 56............................  Protection of Human        0910-0130
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
58................................  Good Laboratory            0910-0119
                                     Practice (GLP)
                                     Regulations for
                                     Nonclinical
                                     Laboratory Studies.
------------------------------------------------------------------------

    Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20029 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 30, 2007 (Volume 72, Number 19)]
[Notices]
[Page 4250-4251]
[DOCID:fr30ja07-46]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-62-000AES Sparrows Point LNG, LLC; Docket Nos. CP07-
63-000, CP07-64-000, CP07-65-000, Mid-Atlantic Express, LLC]

Notice of Applications for Certificates of Public Convenience and
Necessity and Section 3 Authorization

January 23, 2007.
    Take notice that on January 8, 2007, AES Sparrows Point LNG, LLC,
(AES Sparrows Point) filed an application in Docket No. CP07-62-000
pursuant to Section 3(a) of the Natural Gas Act (NGA), and Parts 153
and 380 of the Commission's regulations for authorization to site,
construct and operate a liquefied natural gas (LNG) receiving terminal
and associated facilities to be located in Baltimore County, Maryland
as a place of entry for the importation of LNG.
    Also take notice that on January 8, 2007, Mid-Atlantic Express,
LLC, (Mid-Atlantic Express) filed pursuant to Section 7(c) of the NGA
and the Commission's regulations; (1) an application in Docket No.
CP07-53-000 for a certificate of public convenience and necessity; (i)
authorizing Mid-Atlantic Express to construct, own and operate the Mid-
Atlantic Express's pipeline under Part 157, Subpart A, (ii) approving
the pro forma Tariff submitted as Exhibit P of the application, and
(iii) approving the proposed initial rates for pipeline transportation
services; (2) an application in Docket No. CP07-54-000, for a blanket
certificate authorizing Mid-Atlantic Express to engage in certain self-
implementing routine activities under Part 157, Subpart F; and (3) an
application in Docket No. CP07-55-000, for a blanket certificate
authorizing Mid-Atlantic Express to transport natural gas, on an open
access and self-implementing basis, under Part 284, Subpart G.
    Any questions regarding these applications should be directed to
Christopher H. Diez, AES Sparrows Point LNG, LLC & Mid-Atlantic
Express, LLC, 140 Professional Parkway, Suite A, Lockport, New York
14094.
    These filings are available for review at the Commission's
Washington, DC offices or may be viewed on the Commission's Web site at
http://www.ferc.gov/ using the ``e-Library'' link. Enter the docket

number, excluding the last three digits, in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or Telephone:<PHONE_NUMBER>; Toll-free: 1-
866-208-3676; or for TTY, contact<PHONE_NUMBER>.
    AES Sparrows Point seeks authorization to site, construct and
operate a new LNG import terminal LNG Terminal, with an initial
delivery capacity of 1.5 billion cubic feet per day of natural gas, to
be located at the Sparrows Point industrial complex in Baltimore
County, Maryland. AES Sparrows Point's proposed LNG Terminal would be
located on an about 80 acre parcel located at the Sparrows Point
industrial complex, which is situated on the Sparrows Point peninsula
extending into the Chesapeake Bay east of the Port of Baltimore. The
LNG Terminal would include facilities to receive LNG from ocean-going
LNG ships, store the LNG onshore in full-containment tanks, re-vaporize
the LNG, and then deliver pipeline quality natural gas to the Mid-
Atlantic Express pipeline.
    Mid-Atlantic Express seeks authorization to construct and operate
an 88-mile natural gas pipeline that will transport regasified LNG from
the Terminal to interconnections with three existing interstate
pipelines in the vicinity of Eagle, Pennsylvania. Mid-Atlantic Express
conducted an open season for firm transportation capacity on its
proposed pipeline and AES Mid-Atlantic LNG Marketing, LLC, an affiliate
of Mid-Atlantic Express, submitted a bid for the entire capacity of the
Pipeline and was accepted as the sole customer of the project at this
point. Mid-Atlantic Express estimates that the cost of its pipeline
facilities will be about $415 million. The details of Mid-Atlantic
Express's proposed transportation services and the derivation of the
initial recourse rates for those services are shown in Exhibit P of
Mid-Atlantic Express's filing.
    AES Sparrows Point and Mid-Atlantic Express propose to commence
service in late 2010. AES Sparrows Point and Mid-Atlantic Express
request that the Commission issue a final order in these proceedings by
November 1, 2007 to enable them to begin construction in a timely
manner to achieve their proposed in-service date.
    On April 3, 2006, the Commission staff granted AES Sparrows Point's
and Mid-Atlantic Express's request to utilize the Pre-Filing Process
and assigned Docket No. PF06-22-000 to staff activities involving
Sparrows Point LNG's and Mid-Atlantic Express's combined project. Now,
as of the filing of Sparrows Point LNG's and Mid-Atlantic Express's
applications on

January 8, 2007, the Pre-Filing Process for this project has officially
concluded. And while the PF docket number is now closed, all of the
information contained in the Pre-Filing Process will become part of the
LNG terminal authorization and pipeline certificate proceeding(s). From
this time forward, Sparrows Point LNG's and Mid-Atlantic Express's
proceedings will be conducted in Docket Nos. CP07-62-000, CP07-63-000,
CP07-64-000, and CP07-65-000 as noted in the caption of this Notice.
All future correspondence should refer to these CP docket numbers only.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this Project. First, any person wishing to obtain legal status by
becoming a party to the proceeding for this project should file with
the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, a motion to intervene in accordance with the
requirements of the Commission's Rules of Practice and Procedure (18
CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR
157.10) by the comment date, below. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask for court review of Commission orders in the
proceeding.
    However, a person does not have to intervene to have comments
considered. The second way to participate is by filing with the
Secretary of the Commission, as soon as possible, an original and two
copies of comments in support of or in opposition to this project and/
or associated pipeline. The Commission will consider these comments in
determining the appropriate action to be taken, but the filing of a
comment alone will not serve to make the filer a party to the
proceeding. The Commission's rules require that persons filing comments
in opposition to the project provide copies of their protests only to
the party or parties directly involved in the protest.
    Protests and interventions may be filed electronically via the
Internet in lieu of paper; see 18 CFR 285.2001(a)(1)(iii) and the
instructions on the Commission's Web site under the ``e-filing'' link.
The Commission strongly encourages electronic filings.
    The Commission may issue a preliminary determination on non-
environmental issues prior to the completion of its review of the
environmental aspects of the project and associated pipeline. This
preliminary determination typically considers such issues as the need
for the project and its economic effect on existing customers of the
applicant, on other pipelines in the area, and on landowners and
communities. For example, the Commission considers the extent to which
the applicant may need to exercise eminent domain to obtain rights-of-
way for the proposed pipeline and balances that against the non-
environmental benefits to be provided by the project.
    If the Commission decides to set the application for a formal
hearing before an Administrative Law Judge, the Commission will issue
another notice describing that process. At the end of the Commission's
review process, a final Commission order approving or denying a
certificate will be issued.
    Comment Date: February 14, 2007.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-1362 Filed 1-29-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Notices]
[Pages 53149-53150]
[FR Doc No: 2016-19109]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0971]

Infectious Disease Next Generation Sequencing Based Diagnostic
Devices: Microbial Identification and Detection of Antimicrobial
Resistance and Virulence Markers; Draft Guidance for Industry and Food
and Drug Administration Staff; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the document entitled ``Infectious Disease Next
Generation Sequencing Based Diagnostic Devices: Microbial
Identification and Detection of Antimicrobial Resistance and Virulence
Markers; Draft Guidance for Industry and Food and Drug Administration
Staff,'' that appeared in the Federal Register of May 13, 2016. In the
document, FDA requested comments on FDA's recommendations to assist
industry in designing studies to establish the analytical and clinical
performance characteristics of infectious disease next generation
sequencing-based diagnostic devices for microbial identification and
detection of antimicrobial resistance and virulence markers. The Agency
is taking this action in response to a request for an extension to
allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the document published
May 13, 2016 (81 FR 29869). Submit either electronic or written
comments by September 12, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-0971 for ``Infectious Disease Next Generation Sequencing
Based Diagnostic Devices: Microbial Identification and Detection of
Antimicrobial Resistance and Virulence Markers; Draft Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Heike Sichtig, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4526, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 13, 2016 (81 FR 29869), FDA
published a document with a 90-day comment period to request comments
on the types of studies the FDA recommends to support a premarket
application of Infectious Disease Next Generation (NGS) Sequencing
Based Diagnostic

Devices (Infectious Disease NGS Dx devices). Specifically, FDA
recommends Infectious Disease NGS Dx devices that employ targeted or
agnostic (metagenomics) sequencing to identify the presence or absence
of infectious disease organisms, and/or detect the presence of absence
of antimicrobial resistance and virulence markers.
    The Agency received requests for a 30-day extension of the comment
period for the document. Each request conveyed concern that the current
90-day comment period does not allow sufficient time to develop a
meaningful or thoughtful response to the document on ``Infectious
Disease Next Generation Sequencing Based Diagnostic Devices: Microbial
Identification and Detection of Antimicrobial Resistance and Virulence
Markers; Draft Guidance for Industry and Food and Drug Administration
Staff.''
    FDA has considered the request and is extending the comment period
for the document on ``Infectious Disease Next Generation Sequencing
Based Diagnostic Devices: Microbial Identification and Detection of
Antimicrobial Resistance and Virulence Markers; Draft Guidance for
Industry and Food and Drug Administration Staff'' for 30 days, until
September 10, 2016. The Agency believes that a 30-day extension allows
adequate time for interested persons to submit comments without
significantly delaying regulation on these important issues.

    Dated: August 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-19109 Filed 8-10-16; 8:45 am]
 BILLING CODE 4164-01-P