[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21749-21753]
[FR Doc No: 2021-08467]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]

Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of Emergency Use Authorizations (EUAs) (the Authorizations)
for certain medical devices related to the Coronavirus Disease 2019
(COVID-19) public health emergency. FDA has issued the Authorizations
listed in this document under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). These Authorizations contain, among other things,
conditions on the emergency use of the authorized products. The
Authorizations follow the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS) that there is a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad, and
that involves the virus that causes COVID-19, and the subsequent
declarations on February 4, 2020, March 2, 2020, and March 24, 2020,
that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of the virus
that causes COVID-19, personal respiratory protective devices, and
medical devices, including alternative products used as medical
devices, respectively, subject to the terms of any authorization issued
under the FD&C Act. These Authorizations, which include an explanation
of the reasons for issuance, are listed in this document, and are
available on FDA's website at the links indicated.

DATES: These Authorizations are effective on their date of issuance.

ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
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    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA.
    Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (CDC) (to the extent feasible and appropriate given the
applicable

circumstances), FDA \2\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as may be prescribed by regulation are
satisfied. No other criteria for issuance have been prescribed by
regulation under section 564(c)(4) of the FD&C Act.
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    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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II. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

III. The Authorizations

    Having concluded that the criteria for the issuance of the
following Authorizations under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following products for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorizations in their entirety, including any
authorized fact sheets and other written materials, are available on
the internet from the FDA web page entitled ``Emergency Use
Authorization,'' available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. The lists that follow include
Authorizations issued from September 15, 2020, through February 15,
2021, and we have included explanations of the reasons for their
issuance, as required by section 564(h)(1) of the FD&C Act. In
addition, the EUAs that have been reissued can be accessed from FDA's
web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. FDA
is hereby announcing the following Authorizations for molecular
diagnostic and antigen tests for COVID-19, excluding multi-analyte
tests: \3\
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    \3\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the products may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the products, when used for diagnosing COVID-19, outweigh the known
and potential risks of such products; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
products.
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     Visby Medical, Inc.'s Visby Medical COVID-19, issued
September 16, 2020;
     GK Pharmaceuticals Contract Manufacturing Operations' GK
ACCU-RIGHT SARS-CoV-2 RT-PCR KIT, issued September 18, 2020;
     KimForest Enterprise Co., Ltd.'s KimForest SARS-CoV-2
Detection Kit v1, issued September 21, 2020;
     Vela Operations Singapore Pte. Ltd.'s ViroKey SARS-CoV-2
RT-PCR Test v2.0, issued September 22, 2020;
     Quadrant Biosciences Inc.'s Clarifi COVID-19 Test Kit,
issued September 22, 2020;
     Clear Labs, Inc.'s Clear Dx SARS-CoV-2 Test, issued
September 23, 2020;
     Genetrack Biolabs, Inc.'s Genetrack SARS-CoV-2 Molecular
Assay, issued September 25, 2020;
     National Jewish Health's SARS-CoV-2 MassArray Test, issued
September 29, 2020;
     Akron Children's Hospital's Akron Children's Hospital
SARS-CoV-2 Assay, issued September 29, 2020;
     CENTOGENE US, LLC's CentoSure SARS-CoV-2 RT-PCR Assay,
issued September 29, 2020;
     Aeon Global Health's Aeon Global Health SARS-CoV-2 Assay,
issued September 30, 2020;
     Alimetrix, Inc.'s Alimetrix SARS-CoV-2 RT-PCR Assay,
issued September 30, 2020;
     Tempus Labs, Inc.'s iC SARS-CoV2 Test, issued October 1,
2020;
     UMass Memorial Medical Center's UMass Molecular Virology
Laboratory 2019-nCoV rRT-PCR Dx Panel, issued October 1, 2020;
     SEASUN BIOMATERIALS, Inc.'s AQ-TOP COVID-19 Rapid
Detection Kit PLUS, issued October 5, 2020;
     University of California, Los Angeles's (UCLA's) UCLA
SwabSeq COVID-19 Diagnostic Platform, issued October 6, 2020;
     Access Bio, Inc.'s CareStart COVID-19 Antigen, issued
October 8, 2020;
     LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 RNA STAR Complete,
issued October 14, 2020;
     Celltrion USA, Inc.'s Sampinute COVID-19 Antigen MIA,
issued October 23, 2020;
     Agena Bioscience, Inc.'s MassARRAY SARS-CoV-2 Panel,
issued October 26, 2020;
     Lucira Health, Inc.'s Lucira COVID-19 All-In-One Test Kit,
issued November 17, 2020;
     Gravity Diagnostics, LLC's Gravity Diagnostics SARS-CoV-2
RT-PCR Assay, issued November 23, 2020;
     Cepheid's Xpert Omni SARS-CoV-2, issued November 27, 202;
     Luminostics, Inc.'s Clip COVID Rapid Antigen Test, issued
December 7, 2020;
     Laboratory Corporation of America's Pixel by LabCorp
COVID-19 Test Home Collection Kit, issued December 9, 2020;
     ResearchDx, Inc., DBA Pacific Diagnostics' PacificDx
Covid-19 Test, issued December 11, 2020;
     RCA Laboratory Services LLC dba GENETWORx's GENETWORx
Covid-19 Nasal Swab Test, issued December 15, 2020;
     Ellume Limited's Ellume COVID-19 Home Test, issued
December 15, 2020;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Ag Card Home Test, issued December 16, 2020;
     Materials and Machines Corporation of America's (DBA
MatmaCorp, Inc.) MatMaCorp COVID-19 2SF Test, issued December 17, 2020;
     Quidel Corporation's QuickVue SARS Antigen Test, issued
December 18, 2020;
     Quidel Corporation's Solana SARS-CoV-2 Assay, issued
December 23, 2020;
     Cepheid's Xpert Xpress SARS-CoV-2 DoD, issued December 23,
2020;
     Quanterix Corporation's Simoa SARS-CoV-2 N Protein Antigen
Test, issued January 5, 2021;

     Ortho Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic
Products SARS-CoV-2 Antigen Reagent Pack used in combination with the
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator, issued
January 11, 2021;
     SML GENETREE Co., Ltd.'s Ezplex SARS-CoV-2 G Kit, issued
January 13, 2021;
     Bio-Rad Laboratories, Inc.'s Bio-Rad Reliance SARS-CoV-2
RT-PCR Assay Kit, issued January 15, 2021;
     Ambry Genetics Laboratory's Ambry COVID-19 RT-PCR Test,
issued January 22, 2021;
     Clinomics USA Inc.'s Clinomics TrioDx RT-PCR COVID-19
Test, issued February 4, 2021;
     Visby Medical, Inc.'s Visby Medical COVID-19 Point of Care
Test, issued February 8, 2021;
     Grifols Diagnostic Solutions Inc.'s Procleix SARS-CoV-2
Assay, issued February 10, 2021;
     Assurance Scientific Laboratories' Assurance SARS-CoV-2
Panel DTC, issued February 13, 2021; and
     Gravity Diagnostics, LLC's Gravity Diagnostics SARS-CoV-2
RT-PCR for use with DTC kits, issued February 13, 2021.
    FDA is hereby announcing the following Authorizations for serology
tests: \4\
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    \4\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2 can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the products may be effective in diagnosing recent or prior
infection with SARS-CoV-2 by identifying individuals with an
adaptive immune response to the virus that causes COVID-19, and that
the known and potential benefits of the products when used for such
use, outweigh the known and potential risks of the products; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the products.
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     Jiangsu Well Biotech Co., Ltd.'s Orawell IgM/IgG Rapid
Test, issued September 23, 2020;
     Quotient Suisse SA's MosaiQ COVID-19 Antibody Magazine,
issued September 25, 2020;
     Nirmidas Biotech, Inc.'s Nirmidas COVID-19 (SARS-CoV-2)
IgM/IgG Antibody Detection Kit, issued September 29, 2020;
     NanoEntek America, Inc.'s FREND COVID-19 total Ab, issued
September 29, 2020;
     DiaSorin, Inc.'s DiaSorin LIAISON SARS-CoV-2 IgM Assay,
issued September 29, 2020;
     Thermo Fisher Scientific's OmniPATH COVID-19 Total
Antibody ELISA Test, issued October 2, 2020;
     ZEUS Scientific, Inc.'s ZEUS ELISA SARS-CoV-2 IgG Test
System Company, issued October 6, 2020;
     Genalyte, Inc.'s Maverick SARS-CoV-2 Multi-Antigen
Serology Panel v2, issued October 8, 2020;
     Beckman Coulter, Inc.'s Access SARS-CoV-2 IgM, issued
October 8, 2020;
     Abbott Laboratories Inc.'s AdviseDx SARS-CoV-2 IgM, issued
October 9, 2020;
     Quansys Biosciences, Inc.'s Q-Plex SARS-CoV-2 Human IgG (4
Plex), issued October 28, 2020;
     GenScript USA Inc.'s cPass SARS-CoV-2 Neutralization
Antibody Detection Kit, issued November 6, 2020;
     Innovita (Tangshan) Biological Technology Co., Ltd.'s
Innovita 2019-nCoV Ab Test (Colloidal Gold), issued November 23, 2020;
     Kantaro Biosciences, LLC's COVID-SeroKlir, Kantaro Semi-
Quantitative SARS-CoV-2 IgG Antibody Kit, issued November 24, 2020;
     Roche Diagnostics, Inc.'s Elecsys Anti-SARS-CoV-2 S,
issued November 25, 2020;
     ACON Laboratories, Inc.'s ACON SARS-CoV-2 IgG/IgM Rapid
Test, issued December 15, 2020;
     Quanterix Corporation's Simoa Semi-Quantitative SARS-CoV-2
IgG Antibody Test, issued December 23, 2020;
     Nirmidas Biotech, Inc.'s MidaSpot COVID-19 Antibody Combo
Detection Kit, issued December 31, 2020;
     Siemens Healthcare Diagnostics Inc.'s Dimension Vista
SARS-CoV-2 IgG (COV2G), issued January 8, 2021;
     Siemens Healthcare Diagnostics Inc.'s Dimension EXL SARS-
CoV-2 IgG (CV2G), issued January 8, 2021;
     ADVAITE, Inc.'s RapCov Rapid COVID-19 Test, issued January
11, 2021;
     Phadia AB's EliA SARS-CoV-2-Sp1 IgG Test, issued January
11, 2021;
     United Biomedical, Inc.'s UBI SARS-CoV-2 ELISA, issued
January 15, 2021; and
     Immunodiagnostic Systems Ltd's IDS SARS-CoV-2 IgG, issued
February 10, 2021.
    FDA is hereby announcing the following Authorizations for multi-
analyte in vitro diagnostics: \5\
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    \5\ As set forth in the EUAs, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the products may be effective
in diagnosing COVID-19 (through the simultaneous detection and
differentiation of SARS-CoV-2 and various other pathogens (see
individual EUAs for specific other pathogens)) and that the known
and potential benefits of the products when used for such a use,
outweigh the known and potential risks of the products; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the products.
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     Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV, issued
September 24, 2020;
     BioFire Diagnostics, LLC's BioFire Respiratory Panel 2.1-
EZ (RP2.1-EZ), issued October 2, 2020;
     Quidel Corporation's Sofia 2 Flu + SARS Antigen FIA,
issued October 2, 2020;
     GenMark Diagnostics, Inc.'s ePlex Respiratory Pathogen
Panel 2 (ePlex RP2 Panel), issued October 7, 2020;
     Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics RC COVID-19 +Flu RT-PCR, issued December 4, 2020;
     Hologic, Inc.'s Aptima SARS-CoV-2/Flu assay, issued
December 16, 2020;
     Princeton BioMeditech Corp.'s Status COVID-19/Flu, issued
February 4, 2021;
     Becton, Dickinson and Company's BD SARS-CoV-2/Flu for BD
MAX System, issued February 10, 2021;
     Thermo Fisher Scientific's TaqPath COVID-19, FluA, FluB
Combo Kit, issued February 10, 2021; and
     Bio-Rad Laboratories, Inc.'s Bio-Rad Reliance SARS-CoV-2/
FluA/FluB RT-PCR Assay Kit, issued February 11, 2021.
    FDA is hereby announcing the following Authorizations for other
medical devices:
     Duke University's COVIAGE, issued September 24, 2020; \6\
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    \6\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that COVIAGE may be effective in preventing healthcare providers'
exposure to pathogenic biological airborne particulates by providing
an extra layer of barrier protection in addition to personal
protective equipment, at the time of definitive airway management,
when performing airway-related medical procedures, or during certain
transport of patients with suspected or confirmed diagnosis of
COVID-19 and that the known and potential benefits of COVIAGE for
such use outweigh its known and potential risks; and (3) there is no
adequate, approved, and available alternative to the emergency use
of COVIAGE.
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     Dascena, Inc.'s COViage Hemodynamic Instability and
Respiratory Decompensation Prediction System (COViage), issued
September 24, 2020; \7\
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    \7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that COViage may be effective when used by healthcare providers as a
diagnostic aid to assist with the early identification of adult
COVID-19 patients (18 years of age or older who are admitted to the
hospital) who are likely to be diagnosed with hemodynamic
instability or respiratory decompensation, which are common
complications associated with COVID-19, and that the known and
potential benefits of COViage, for such use, outweigh the known and
potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of COViage when used by
healthcare providers as a diagnostic aid to assist with the early
identification of adult COVID-19 patients who are likely to be
diagnosed with hemodynamic instability or respiratory
decompensation, which are common complications associated with
COVID-19.

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     Beckman Coulter, Inc's Access IL-6, issued October 1,
2020; \8\
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    \8\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in treating COVID-19, by assisting
in identifying severe inflammatory response in patients with
confirmed COVID-19 illness to aid in determining the risk of
intubation with mechanical ventilation, and that the known and
potential benefits of the product when used for such use, outweigh
the known and potential risks of the product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
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     Spectrum Solutions LLC's SDNA-1000 Saliva Collection
Device, issued October 8, 2020; \9\
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    \9\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in diagnosing COVID-19 by serving
as an appropriate means to collect, stabilize, and maintain during
transport, unprocessed saliva specimens suspected of containing
SARS-CoV-2 RNA, and that the known and potential benefits of the
products when used for such use, outweigh the known and potential
risks of the product; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
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     Roxby Development, LLC's Zoe-Ann Decontamination System,
issued October 20, 2020; \10\
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    \10\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Zoe-Ann Decontamination System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
healthcare providers to prevent exposure to SARS-CoV-2 and other
pathogenic biological airborne particulates, and that the known and
potential benefits of this product, when used for such use, outweigh
the known and potential risks of the use of such product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the Zoe-Ann Decontamination System for
decontaminating compatible N95 respirators for single-user reuse by
healthcare providers to prevent exposure to SARS-CoV-2 and other
pathogenic biological airborne particulates during filtering
facepiece respirator shortages during the COVID-19 pandemic.
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     DNA Genotek Inc.'s OMNIgene[middot]ORAL OM-505 and OME-505
(OMNIgene[middot]ORAL) saliva collection devices, issued October 14,
2020; \11\
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    \11\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in diagnosing COVID-19 by serving
as an appropriate means to collect, stabilize, and maintain during
transport, saliva specimens suspected of containing SARS-CoV-2 RNA,
and that the known and potential benefits of the product when used
for such use, outweigh the known and potential risks of the product;
and (3) there is no adequate, approved, and available alternative to
the emergency use of the product.
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     Clinical Enterprise, Inc.'s EmpowerDX At-Home COVID-19 PCR
Test Kit, issued on October 15, 2020; \12\
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    \12\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in diagnosing COVID-19 by serving
as an appropriate means to collect and transport human specimens so
that an authorized laboratory can detect SARS-CoV-2 RNA from the
self-collected human specimen, and that the known and potential
benefits of the product when used for such use, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
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     binx health, Inc.'s binx health At-Home Nasal Swab COVID-
19 Sample Collection Kit, issued October 20, 2020; \13\
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    \13\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in diagnosing COVID-19, by serving
as an appropriate means to collect and transport human nasal swab
specimens so that an authorized laboratory can detect SARS-CoV-2 RNA
from the self-collected specimen, and that the known and potential
benefits of the product when used for diagnosing COVID-19, outweigh
the known and potential risks of the product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
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     DNA Genotek Inc.'s ORAcollectRNA OR-100 and
ORAcollectRNA ORE-100 saliva collection devices, issued October
28, 2020; \14\
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    \14\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in diagnosing COVID-19 by serving
as an appropriate means to collect, stabilize, and maintain during
transport, saliva specimens suspected of containing SARS-CoV-2 RNA,
and that the known and potential benefits of the product when used
for such use, outweigh the known and potential risks of the product;
and (3) there is no adequate, approved, and available alternative to
the emergency use of the product.
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     Terumo Cardiovascular's CAPIOX Emergency Bypass System
(CAPIOX EBS), issued November 21, 2020; \15\
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    \15\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the CAPIOX EBS may be effective in treating COVID-19 by
providing long-term (> 6 hours) respiratory or cardiopulmonary
support to treat patients 18 years or older with COVID-19 who have
acute respiratory failure or acute cardiopulmonary failure where
other available treatment options have failed, and continued
clinical deterioration is expected or the risk of death is imminent,
and that the known and potential benefits of the CAPIOX EBS for such
use, outweigh the known and potential risks; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the CAPIOX EBS when there are shortages of FDA-cleared
alternatives during the COVID-19 pandemic.
---------------------------------------------------------------------------

     RapidRona, Inc.'s RapidRona Self-Collection Kit, issued
November 23, 2020; \16\
---------------------------------------------------------------------------

    \16\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in diagnosing COVID-19, by serving
as an appropriate means to collect and transport human nasal swab
specimens so that an authorized laboratory can detect SARS-CoV-2 RNA
from the self-collected specimen, and that the known and potential
benefits of the product when used for diagnosing COVID-19, outweigh
the known and potential risks of the product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
---------------------------------------------------------------------------

     3B Medical, Inc.'s Lumin LM3000 Bioburden Reduction UV
System (``Lumin LM3000''), issued December 3, 2020; \17\
---------------------------------------------------------------------------

    \17\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Lumin LM3000 may be effective at bioburden reduction of
compatible N95 respirators for single-user reuse by healthcare
providers to supplement CDC reuse recommendations to prevent
exposure to SARS-CoV-2 and other pathogenic biological airborne
particulates, and that the known and potential benefits of this
product, when used for such use, outweigh the known and potential
risks of the use of such product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
Lumin LM3000 for bioburden reduction of compatible N95 respirators
for single-user reuse by healthcare providers to supplement CDC
reuse recommendations to prevent exposure to SARS-CoV-2 and other
pathogenic biological airborne particulates during filtering
facepiece respirator shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------

     Ecolab Inc.'s Bioquell Technology System, issued December
4, 2020; \18\
---------------------------------------------------------------------------

    \18\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Bioquell Technology System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
healthcare providers to prevent exposure to SARS-CoV-2 and other
pathogenic biological airborne particulates, and that the known and
potential benefits of this product, when used for such use, outweigh
the known and potential risks of the use of such product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the Bioquell Technology System for decontaminating
compatible N95 respirators for single-user reuse by healthcare
providers to prevent exposure to SARS-CoV-2 and other pathogenic
biological airborne particulates during filtering facepiece
respirator shortages during the COVID-19 pandemic.

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

     SCONE Medical Solutions Inc.'s SCONE, issued December 18,
2020; \19\
---------------------------------------------------------------------------

    \19\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that SCONE may be effective in preventing healthcare providers
exposure to pathogenic biological airborne particulates by providing
an extra layer of barrier protection in addition to personal
protective equipment, at the time of definitive airway management,
when performing airway-related medical procedures, or during certain
transport for a maximum duration of use of 30 minutes, of patients
with suspected or confirmed diagnosis of COVID-19 and that the known
and potential benefits of SCONE for such use outweigh its known and
potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of SCONE.
---------------------------------------------------------------------------

     Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur IL6
assay, issued December 18, 2020; \20\
---------------------------------------------------------------------------

    \20\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in treating COVID-19, by assisting
in identifying severe inflammatory response in patients with
confirmed COVID-19 illness to aid in determining the risk of
intubation with mechanical ventilation, and that the known and
potential benefits of the product when used for such use, outweigh
the known and potential risks of the product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
---------------------------------------------------------------------------

     Yale New Haven Health System's Yale New Haven Health
FILTERING FACEPIECE RESPIRATOR Decontamination System, issued January
15, 2021; \21\ and
---------------------------------------------------------------------------

    \21\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Yale New Haven Health filtering facepiece respirator
decontamination system may be effective at decontaminating
compatible N95 respirators for multiple-user reuse by healthcare
providers to prevent exposure to SARS-CoV-2 and other pathogenic
biological airborne particulates, and that the known and potential
benefits of this product, when used for such use, outweigh the known
and potential risks of the use of such product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the Yale New Haven Health filtering facepiece respirator
Decontamination System for decontaminating compatible N95
respirators for multiple-user reuse by healthcare providers to
prevent exposure to SARS-CoV-2 and other pathogenic biological
airborne particulates during filtering facepiece respirator
shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------

     Everlywell, Inc.'s Everlywell COVID-19 Test Home
Collection Kit DTC, issued February 13, 2021.\22\
---------------------------------------------------------------------------

    \22\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the product may be effective in diagnosing COVID-19, by serving
as an appropriate means to collect and transport human specimens so
that an authorized laboratory can detect SARS-CoV-2 RNA from the
home-collected human specimen, and that the known and potential
benefits of the product when used for diagnosing COVID-19, outweigh
the known and potential risks of the product and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.

    Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08467 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 199 (Tuesday, October 19, 2021)]
[Notices]
[Pages 57817-57818]
[FR Doc No: 2021-22730]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 349-177]

Alabama Power Company; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-project use of project lands and waters.

    b. Project No: 349-177.
    c. Date Filed: July 28, 2021, as supplemented on September 13,
2021.
    d. Applicant: Alabama Power Company.
    e. Name of Project: Martin Dam Hydroelectric Project.
    f. Location: The Village development on Lake Martin in Tallapoosa
County, Alabama.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Unzell Kelley,<PHONE_NUMBER>,
[email protected].
    i. FERC Contact: Mark Carter,<PHONE_NUMBER>, [email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: November 15, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include docket number P-349-177. Comments emailed to Commission staff
are not considered part of the Commission record.
    k. Description of Request: Alabama Power Company proposes to
authorize The Village, LLC to modify the layout of boat docking
facilities adjacent to The Village's residential development. The
Village currently maintains 15,423 square feet of boat docks on the
lake but is proposing to remove two group docks (measuring 10,405
square feet) and replace with several smaller docks and boardwalks
(measuring 7,133 square feet) for a net decrease of 3,272 square feet
of overwater dock footprint. The proposed boat dock layout would
accommodate 72 watercraft in total, which would be an increase in 24
watercraft compared to the existing authorization.
    l. Locations of the Application: In addition to publishing the full
text of this document in the Federal Register, the Commission provides
all interested persons an opportunity to view and/or print the contents
of this document via the internet through the Commission's Home Page
(http://www.ferc.gov) using the ``elibrary'' link. Enter the docket
number excluding the last three digits in the document field to access
the document. At this time, the Commission has suspended access to the
Commission's Public Reference Room, due to the proclamation declaring a
National Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact FERC
at [email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659. Agencies may obtain copies of the application directly
from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: October 13, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-22730 Filed 10-18-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51620-51621]
[FR Doc No: 2017-24141]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

------------------------------------------------------------------------
          Docket No.                File date     Presenter or requester
------------------------------------------------------------------------
                               Prohibited
------------------------------------------------------------------------
1. CP17-101-000...............        10-16-2017  Lower Raritan
                                                   Watershed
                                                   Partnership.
2. CP15-554-000...............        10-17-2017  William S. Moore,
                                                   Carol M. Moore.
3. P-2100-000.................        10-17-2017  Pacific Fishery
                                                   Management Council.
4. P-2082-000.................        10-23-2017  Copco Lake Fire
                                                   Protection District.
5. P-2082-000.................        10-23-2017  Copco Lake Fire
                                                   Protection District.
6. CP15-558-000...............        10-25-2017  Chamber of Commerce
                                                   Southern New Jersey.
7. CP15-554-000, CP16-10-000..        10-27-2017  Bert Carlson.
------------------------------------------------------------------------
                                 Exempt
------------------------------------------------------------------------
1. CP15-93-000................        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
2. CP16-38-000................        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
3. CP15-514-000...............        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
4. CP16-10-000................        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
5. CP16-357-000...............        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
6. CP16-22-000................        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
7. CP16-361-000...............        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
8. CP15-555-000...............        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
9. CP15-138-000...............        10-19-2017  U.S. House
                                                   Representative Alex
                                                   X. Mooney.
10. P-2305-000................        10-19-2017  U.S. House
                                                   Representative Mike
                                                   Johnson.
11. CP17-41-000...............        10-19-2017  FERC Staff.\1\
12. CP16-22-000...............        10-23-2017  City of Waterville,
                                                   Ohio, Mayor Lori A.
                                                   Brodie.
13. CP17-101-000..............        10-24-2017  New Jersey Senator Bob
                                                   Smith.

14. CP16-38-000...............        10-24-2017  U.S. House
                                                   Representative David
                                                   B. McKinley, P.E.
------------------------------------------------------------------------
\1\ Telephone Call Summary for call on October 18, 2017 with U.S. Fish
  and Wildlife Service representatives.

    Dated: October 31, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-24141 Filed 11-6-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29576-29578]
[FR Doc No: 2017-13564]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002; Internal Agency Docket No. FEMA-B-1726]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Title
44, Part 65 of the Code of Federal Regulations. The LOMR will be used
by insurance agents and others to calculate appropriate flood insurance
premium rates for new buildings and the contents of those buildings.
For rating purposes, the currently effective community number is shown
in the table below and must be used for all new policies and renewals.

DATES: These flood hazard determinations will become effective on the
dates listed in the table below and revise the FIRM panels and FIS
report in effect prior to this determination for the listed
communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at

both the online location and the respective community map repository
address listed in the table below. Additionally, the current effective
FIRM and FIS report for each community are accessible online through
the FEMA Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: May 30, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Chief executive                         Online location of
        State and county           Location and  case      officer  of        Community map        letter of  map       Effective date of     Community
                                          No.               community          repository             revision             modification          No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona:
    Maricopa....................  City of Peoria (17-  The Honorable       City Hall, 8401     http://                Aug. 25, 2017........       040050
                                   09-0311P).           Cathy Carlat,       West Monroe         www.msc.fema.gov/
                                                        Mayor, City of      Street, Peoria,     lomc.
                                                        Peoria, 8401 West   AZ 85345.
                                                        Monroe Street,
                                                        Peoria, AZ 85345.
    Maricopa....................  City of Scottsdale   The Honorable W.J.  Scottsdale          http://                Aug. 25, 2017........       045012
                                   (17-09-0074P).       ``Jim'' Lane,       Planning Records,   www.msc.fema.gov/
                                                        Mayor, City of      7447 East Indian    lomc.
                                                        Scottsdale, City    School Road,
                                                        Hall, 3939 North    Suite 100,
                                                        Drinkwater          Scottsdale, AZ
                                                        Boulevard,          85251.
                                                        Scottsdale, AZ
                                                        85251.
    Maricopa....................  Unincorporated       The Honorable       Flood Control       http://                Sep. 1, 2017.........       040037
                                   Areas of Maricopa    Denny Barney,       District of         www.msc.fema.gov/
                                   County (16-09-       Chairman, Board     Maricopa County,    lomc.
                                   2971P).              of Supervisors,     2801 West Durango
                                                        Maricopa County,    Street, Phoenix,
                                                        301 West            AZ 85009.
                                                        Jefferson Street,
                                                        10th Floor,
                                                        Phoenix, AZ 85003.
    Pinal.......................  Unincorporated       The Honorable       Pinal County        http://                Aug. 23, 2017........       040077
                                   Areas of Pinal       Stephen Miller,     Department of       www.msc.fema.gov/
                                   County (16-09-       Chairman, Board     Public Works, 31    lomc.
                                   2973P).              of Supervisors,     North Pinal
                                                        Pinal County, 135   Street, Florence,
                                                        North Pinal         AZ 85132.
                                                        Street, Florence,
                                                        AZ 85132.
California:
    Butte.......................  Unincorporated       The Honorable Bill  Butte County        http://                Aug. 30, 2017........       060017
                                   Areas of Butte       Connelly,           Department of       www.msc.fema.gov/
                                   County (17-09-       Chairman, Board     Public Works, 7     lomc.
                                   0110P).              of Supervisors,     County Center
                                                        Butte County,       Drive, Oroville,
                                                        5280 Lower          CA 95965.
                                                        Wyandotte Road,
                                                        Oroville, CA
                                                        95966.
    Calaveras...................  Unincorporated       The Honorable       Calaveras County    http://                Aug. 28, 2017........       060633
                                   Areas of Calaveras   Michael C.          Planning            www.msc.fema.gov/
                                   County (17-09-       Oliveira,           Department, 891     lomc.
                                   0086P).              Chairman, Board     Mountain Ranch
                                                        of Supervisors,     Road, San
                                                        Calaveras County,   Andreas, CA 95249.
                                                        891 Mountain
                                                        Ranch Road, San
                                                        Andreas, CA 95249.
Illinois:
    Will........................  Village of           The Honorable       Village Hall,       http://                Aug. 18, 2017........       170771
                                   Plainfield (15-05-   Michael P.          24401 West          www.msc.fema.gov/
                                   7793P).              Collins, Village    Lockport Street,    lomc.
                                                        President,          Plainfield, IL
                                                        Village of          60544.
                                                        Plainfield, 24401
                                                        West Lockport
                                                        Street,
                                                        Plainfield, IL
                                                        60544.
Iowa:
    Ringgold....................  Unincorporated       The Honorable Paul  Ringgold County     http://                Aug. 18, 2017........       190903
                                   Areas of Ringgold    Dykstra,            Courthouse, 109     www.msc.fema.gov/
                                   County (17-07-       Chairperson,        West Madison        lomc.
                                   0216P).              County Board of     Street, Mount
                                                        Supervisors,        Ayr, IA 50854.
                                                        County
                                                        Courthouse, 109
                                                        West Madison
                                                        Street, Mount
                                                        Ayr, IA 50854.
Kansas:
    Riley.......................  City of Ogden (16-   The Honorable       City Hall, 222      http://                Aug. 10, 2017........       200301
                                   07-1213P).           Robert R. Pence,    Riley Avenue,       www.msc.fema.gov/
                                                        Jr., Mayor, City    Ogden, KS 66517.    lomc.
                                                        of Ogden, 222
                                                        Riley Avenue,
                                                        Ogden, KS 66517.
    Riley.......................  Unincorporated       Mr. Ron Wells,      Riley County        http://                Aug. 10, 2017........       200298
                                   Areas of Riley       Chair, Riley        Office Building,    www.msc.fema.gov/
                                   County (16-07-       County              110 Courthouse      lomc.
                                   1213P).              Commissioners,      Plaza, Manhattan,
                                                        3609 Anderson       KS 66502.
                                                        Avenue,
                                                        Manhattan, KS
                                                        66503.
Michigan:
    Kalamazoo...................  City of Kalamazoo    The Honorable       City Hall, 241      http://                Aug. 22, 2017........       260315
                                   (16-05-5168P).       Bobby J.            West South          www.msc.fema.gov/
                                                        Hopewell, Mayor,    Street,             lomc.
                                                        City of             Kalamazoo, MI
                                                        Kalamazoo, 241      49007.
                                                        West South
                                                        Street,
                                                        Kalamazoo, MI
                                                        49007.
Missouri:

    St. Louis...................  City of Des Peres    The Honorable       City Hall, 12325    http://                Sep. 5, 2017.........       290347
                                   (17-07-0868P).       Richard G. Lahr,    Manchester Road,    www.msc.fema.gov/
                                                        Mayor, City of      Des Peres, MO       lomc.
                                                        Des Peres, 12325    63131.
                                                        Manchester Road,
                                                        Des Peres, MO
                                                        63131.
New Jersey:
    Passaic.....................  City of Paterson     The Honorable Jose  City Hall, 155      http://                Aug. 25, 2017........       340404
                                   (17-02-0940P).       Torres, Mayor,      Market Street,      www.msc.fema.gov/
                                                        City of Paterson,   Paterson, NJ        lomc.
                                                        City Hall, 155      07505.
                                                        Market Street,
                                                        Paterson, NJ
                                                        07505.
Oregon:
    Multnomah...................  City of Portland     The Honorable       Bureau of           http://                Aug. 24, 2017........       410183
                                   (17-10-0646X).       Charlie Hales,      Environmental       www.msc.fema.gov/
                                                        Mayor, City of      Services, 1221      lomc.
                                                        Portland, 1221      Southwest 4th
                                                        Southwest 4th       Avenue, Room 230,
                                                        Avenue, Room 340,   Portland, OR
                                                        Portland, OR        97204.
                                                        97204.
Texas:
    Dallas......................  City of Dallas (17-  The Honorable       Department of       http://                Aug. 25, 2017........       480171
                                   06-0526P).           Michael S.          Public Works, 320   www.msc.fema.gov/
                                                        Rawlings, Mayor,    East Jefferson      lomc.
                                                        City of Dallas,     Boulevard, Room
                                                        1500 Marilla        321, Dallas, TX
                                                        Street, Suite       75203.
                                                        5EN, Dallas, TX
                                                        75201.
Wisconsin:
    Brown.......................  Village of Bellevue  The Honorable       Village Hall, 2828  http://                Sep. 1, 2017.........       550627
                                   (16-05-4339P).       Steve Soukup,       Allouez Avenue,     www.msc.fema.gov/
                                                        President,          Bellevue, WI        lomc.
                                                        Village Board,      54311.
                                                        2828 Allouez
                                                        Avenue, Bellevue,
                                                        WI 54311.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-13564 Filed 6-28-17; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57346-57348]
[DOCID:fr30se05-161]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52508; File No. SR-NASD-2005-089]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Order Granting Approval to Proposed Rule Change and
Amendment No. 1 Thereto, and Notice of Filing and Order Granting
Accelerated Approval to Amendment Nos. 2, 3, and 4 Thereto, Relating to
NASD's Direct Authority for the Activities Related to or in Support of
Trading in Over-the-Counter Equity Securities

September 26, 2005.

I. Introduction

    On July 19, 2005, the National Association of Securities Dealers,
Inc. (``NASD'') 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 NASD's Plan of Allocation and Delegation
of Functions by the NASD to Subsidiaries (``Delegation Plan'') and
certain NASD rules to reflect the NASD's direct authority for the
activities related to or in support of trading in over-the-counter
(``OTC'') equity securities,\3\ including, but not limited to, the OTC
Bulletin Board (``OTCBB''). Currently, this authority is delegated to
The Nasdaq Stock Market, Inc. (``Nasdaq''). On July 22, 2005, the NASD
filed Amendment No. 1 to the proposed rule change.\4\ The proposed rule
change, as amended, was published for comment in the Federal Register
on July 29, 2005.\5\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The term ``OTC equity securities'' herein refers to OTC
Equity Securities as defined in NASD Rule 6610, including, but not
limited to, OTC Bulletin Board securities.
    \4\ Amendment No. 1, which replaced and superceded the original
filing in its entirety, revised NASD Rule 11890 to transfer the
authority to nullify or modify transactions in OTC equity securities
under certain circumstances to the NASD; made conforming changes to
Interpretive Material (``IM'') 11890-1 and 11890-2; revised NASD
Rule 6620 in light of the changes to NASD Rule 11890 contained in
Amendment No. 1; and made several minor and technical changes to the
filing.
    \5\ See Securities Exchange Act Release No. 52119 (July 25,
2005), 70 FR 43918 (``Notice'').
---------------------------------------------------------------------------

    The Commission received two comment letters in response to the
proposal.\6\ On September 13, 2005, the NASD filed Amendment No. 2 to
the proposed rule change.\7\ On September 23, 2005, the NASD filed
Amendment Nos. 3 and 4 to the proposed rule change.\8\ The amended rule
text set forth in Amendment No. 2 and the text of Amendment Nos. 3 and
4 are available on the NASD's Web site (http://www.nasd.com), at the

NASD's Office of the Secretary, and at the Commission's Public
Reference Room.
---------------------------------------------------------------------------

    \6\ See Letter from R. Cromwell Coulson, Chief Executive
Officer, Pink Sheets LLC, to Jonathan G. Katz, Secretary,
Commission, dated August 31, 2005 (``Pink Sheets Letter''), and
Letter from William A. Vance, President and Kimberly Unger,
Executive Director, The Security Traders Association of New York,
Inc., to Jonathan G. Katz, Secretary, Commission, dated September
19, 2005 (``STANY Letter'').
    \7\ In Amendment No. 2, the NASD revised the text of NASD Rule
11890 and IM-11890-2 to reflect amendments to those provisions that
were approved by the Commission shortly before publication of the
Notice. See Securities Exchange Act Release No. 52141 (July 27,
2005), 70 FR 44709 (August 3, 2005) (SR-NASD-2004-009). These recent
revisions to NASD Rule 11890 and IM-11890-2 do not affect the
substance of the instant proposed rule change. In addition,
Amendment No. 2 changed the effective date of the proposed rule
change from September 1, 2005 to October 1, 2005, and proposed
amendments to NASD Rule 11890(b)(1) and (2) to clarify the time
frame for action by Nasdaq or NASD officials under those paragraphs
of NASD's clearly erroneous rule.
    \8\ In Amendment No. 3, the NASD made a non-substantive change
to Exhibit 4 that was included in Amendment No. 2 to reflect changes
to the text of NASD Rule 11890 submitted in Amendment No. 2. The
NASD subsequently filed Amendment No. 4 to make a non-substantive
edit to the formatting of the text of IM-11890-2.
---------------------------------------------------------------------------

    This order approves the proposed rule change, as amended. In
addition, the Commission provides notice of filing of Amendment Nos. 2,
3, and 4, grants accelerated approval to Amendment Nos. 2, 3, and 4,
and solicits comments from interested persons on Amendment Nos. 2, 3,
and 4.

II. Description of the Proposal

    Pursuant to the Delegation Plan, activities related to or in
support of the trading in OTC equity securities, including, but not
limited to, operation of the OTCBB \9\ (collectively, ``OTC equity
operations''), have been delegated from the NASD to Nasdaq. In this
context, OTC equity operations include services such as trade
reporting, comparison, quote collection and dissemination, as
applicable, and the related rulemaking functions in this area.
---------------------------------------------------------------------------

    \9\ The OTCBB provides an electronic quotation medium for
subscribing members to enter, update, and display quotations in
individual securities on a real-time basis. Such quotation entries
may consist of a priced bid and/or offer, an unpriced indication of
interest, or a bid/offer accompanied by a modifier to reflect
unsolicited customer interest. The OTCBB is not an issuer listing
service and therefore does not maintain a relationship with quoted
issuers or impose quantitative listing standards as do Nasdaq and
the exchanges. To be eligible for quotation on the OTCBB, issuers
must be current in their filings with the Commission or applicable
regulatory authority.
---------------------------------------------------------------------------

    Under the proposal to amend the Delegation Plan, the NASD would
assume direct authority for OTC equity operations rather than delegate
this authority to Nasdaq. In addition, the NASD would delegate to NASD
Regulation, Inc. (``NASDR'') the rulemaking authority relating to
trading practices for OTC equity securities. The NASD intends, however,
to contract with Nasdaq to have it continue to provide certain
operational systems and support, OTCBB quotation and trade reporting
platform and certain other services that Nasdaq currently provides with
respect to OTC equity operations.
    The NASD also proposes to: (1) Amend NASD Rule 6545 to transfer
trading and quotation halt authority for OTCBB-eligible securities from
Nasdaq to the NASD; (2) amend NASD Rule 11890 to transfer from Nasdaq
to the NASD the ability to nullify or modify a transaction in an OTC
equity security in certain circumstances; (3) amend NASD Rule 11890 to
incorporate revisions to that rule that were approved by the Commission
shortly before publication of the Notice and to clarify the time frame
for action by NASD or Nasdaq officials to nullify or adjust the terms
of a trade under paragraph (b) of NASD Rule 11890; \10\ (4) amend NASD
Rule 6620(f) to conform the portion of the rule governing reporting of
cancelled trades to reflect the proposed changes to NASD Rule 11890;
and (5) amend NASD Rule 7010(p)(3) to transfer the authority to set
certain fees for historical research reports for OTCBB-eligible
securities from Nasdaq to the NASD.
---------------------------------------------------------------------------

    \10\ See Amendment No. 2, supra note 7.
---------------------------------------------------------------------------

    The NASD intends that the proposed rule change, as amended, will
become effective on October 1, 2005, pending Commission approval prior
to that date.

III. Summary of Comments and the NASD's Response

    The Commission received two comment letters relating to the NASD's
proposed rule change as modified by Amendment No. 1.\11\ The Pink
Sheets Letter and STANY Letter supported the NASD's proposed rule
change.
---------------------------------------------------------------------------

    \11\ See Pink Sheets Letter and STANY Letter, supra note 6.
---------------------------------------------------------------------------

    The Pink Sheets Letter further suggested that the Nasdaq Quotation
Dissemination Service (``Service'') disseminate real-time trade and
volume data for non-Nasdaq American Depositary Receipts (``ADRs'') that
are traded in the over-the-counter market, which currently are
disseminated at the end of the trading day. In addition, the Pink
Sheets Letter stated that the Service should disseminate real-time
trade and volume data for odd-lot transactions in all OTC equity
securities

that are sold for a price greater than $200 per share. The Pink Sheets
Letter noted that the Service currently disseminates such information
for securities that are quoted on the OTCBB, but not for other OTC
equity securities.
    The STANY Letter shared the views presented in the Pink Sheets
Letter relating to the dissemination of trade and volume data for OTC
equity securities. Specifically, the STANY Letter stated that it
believed that no valid reason existed for Nasdaq to distinguish between
the data it disseminates for domestic OTC equity securities and ADRs
traded in the over-the-counter market, and that Nasdaq should
disseminate real-time trade and volume data for odd-lot transactions in
OTC equity securities, including Pink Sheets securities, that are sold
for a price greater than $200 per share.
    The Pink Sheets Letter also recommended that the NASD prepare a
Notice to Members to remind broker-dealers about their obligation not
to participate in unlawful securities distributions. Further, the Pink
Sheets Letter recommended that NASDR review this issue with a view to
proposing rules that would preclude the participation of broker-dealers
in unlawful distributions of securities by their customers. In
addition, the Pink Sheets Letter advocated extending trade halt
authority under NASD Rule 6545 to all OTC equity securities, rather
than limiting it to OTCBB-eligible securities, and to extend the
authority to situations where fraudulent or manipulative acts are
strongly suspected, rather than relying on actions by other markets.
Further, the Pink Sheets Letter suggested limiting such trade halt
authority to four days so that ``piggyback'' eligibility under Rule
15c2-11 under the Act \12\ is not affected. Finally, the Pink Sheets
Letter recommended that the NASD's authority to cancel clearly
erroneous trades pursuant to NASD Rule 11890 should extend until the
settlement date for the transactions in question.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.15c2-11.
---------------------------------------------------------------------------

    In Amendment No. 2, the NASD noted that because the recommendations
in the Pink Sheets Letter are outside the scope of the proposed rule
change, it is not specifically responding to those recommendations in
the context of the proposed rule change. The NASD, however, indicated
that it will review and analyze the recommendations set forth in the
Pink Sheets Letter in the same manner in which it would consider any
requests for rulemaking, and, based on such review and analysis, will
determine whether further action on those recommendations is
appropriate.\13\
---------------------------------------------------------------------------

    \13\ The Commission notes that the NASD did not respond to the
STANY Letter because it was submitted after the NASD had filed
Amendment No. 2. As noted above, the STANY Letter adopted the views
of the Pink Sheets Letter with respect to the dissemination of trade
and volume data for OTC equity securities.
---------------------------------------------------------------------------

IV. Discussion and Commission Findings

    The Commission finds that the proposed rule change, as amended, is
consistent with the provisions of Section 15A(b)(6) of the Act,\14\
which requires, among other things, that NASD rules must be designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, and, in general, to protect
investors and the public interest.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78o-3(b)(6).
    \15\ In approving this proposed rule change, as amended, the
Commission notes that it has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    Under the proposal, the NASD will assume direct authority for OTC
equity operations that it previously had delegated to Nasdaq. The NASD
represents that, pursuant to a contractual arrangement with Nasdaq,
Nasdaq will continue to provide certain operational systems and
support, including the OTCBB quotation and trade reporting platform and
certain other services that Nasdaq currently provides with respect to
OTC equity operations. In addition, the NASD proposes to delegate to
NASDR the authority to develop and adopt rule changes to establish
trading practices with respect to OTC equity securities. The Commission
believes that the proposal by the NASD to assume direct responsibility
for OTC equity operations, including operation of the OTCBB, and to
delegate to NASDR the authority to develop and adopt rule changes to
establish trading practices with respect to OTC equity securities is
consistent with the Act. In the Commission's view, since the NASD is
the self-regulatory organization with authority over and responsibility
for the oversight of the OTC equity market, it is reasonable for the
NASD to revise its Delegation Plan to assume direct authority for OTC
equity operations and to delegate to NASDR rulemaking authority for
trading practices involving OTC equity securities.
    In addition, the proposal would amend NASD Rule 11890 to grant the
NASD direct authority to determine, on its own motion, whether certain
transactions in OTC equity securities should be modified or nullified
in the event of a disruption or malfunction of any NASD quotation,
communication, or trade reporting system or in the event of
extraordinary market conditions in which nullification or modification
of transactions may be necessary for the maintenance of a fair and
orderly market or the protection of investors and the public interest.
The proposal also provides a process by which a determination under
NASD Rule 11890 could be appealed to the Uniform Practice Code
(``UPC'') Committee, unless the Executive Vice President who makes the
initial determination specifies at that time that the number of
affected transactions is such that immediate finality is necessary to
maintain a fair and orderly market and to protect investors and the
public interest. The Commission believes that the assumption of direct
authority by the NASD to nullify or modify the terms of trades in OTC
equity securities under certain conditions is appropriate and should
help clarify for OTC equity market participants the NASD's authority to
nullify or modify the terms of clearly erroneous transactions in OTC
equity securities.
    The proposal would amend certain other rules, including NASD Rule
6620(f) and NASD Rule 7010(p)(3), to reflect the transfer of authority
from Nasdaq to the NASD with respect to the reporting of trades
cancelled pursuant to NASD Rule 11890 and the authority to set fees for
historical research reports for OTCBB-eligible securities,
respectively. The Commission believes that these changes are
appropriate to conform the applicable rule text to reflect the
assumption of direct responsibility for OTC equity securities by the
NASD.
    The Commission finds good cause for approving Amendment Nos. 2, 3,
and 4 to the proposed rule change prior to the thirtieth day after the
date of the publication of notice thereof in the Federal Register. The
Commission notes that Amendment No. 2 is a non-substantive amendment to
revise the effective date of the proposed rule change; to reflect
changes to NASD Rule 11890 and IM-11890-2 that were approved by the
Commission shortly before publication of the Notice; and to clarify the
timeframe for NASD or Nasdaq officials to act on their own motion to
nullify or modify the terms of a trade under NASD Rule 11890. Further,
Amendment No. 3 is a non-substantive amendment to revise Exhibit 4
contained in Amendment No. 2 to reflect the changes to the text of NASD
Rule 11890 submitted in

Amendment No. 2, and Amendment No. 4 is a non-substantive amendment to
IM-11890-2. The Commission therefore believes that it is appropriate to
accelerate approval of Amendment Nos. 2, 3, and 4 so that the proposed
rule change, as amended, may be implemented in full without delay.

V. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether Amendment Nos. 2,
3, and 4 to the proposed rule change, as amended, are consistent with
the Act. Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2005-089 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-9303.
    All submissions should refer to File Number SR-NASD-2005-089. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Nasdaq. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASD-2005-089 and should be submitted on or before
October 21, 2005.

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-NASD-2005-089), as amended,
be, and it hereby is, approved, and Amendment Nos. 2, 3, and 4 are
hereby approved on an accelerated basis.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-5334 Filed 9-29-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Rules and Regulations]
[Pages 26868-26869]
[FR Doc No: 2014-10822]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 395

Notice of Regulatory Guidance: Automatic On-Board Recording
Devices

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of regulatory guidance.

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

SUMMARY: FMCSA issues regulatory guidance on two issues involving
roadside inspection of commercial motor vehicles (CMVs) equipped with
automatic on-board recording devices (AOBRDs) to assist drivers with
hours-of-service (HOS) recordkeeping and compliance. All prior Agency
interpretations and regulatory guidance, including memoranda and
letters, may no longer be relied upon to the extent they are
inconsistent with this guidance.

DATES: This regulatory guidance is effective May 12, 2014.

FOR FURTHER INFORMATION CONTACT: Mr. Thomas Yager, Chief, Driver and
Carrier Operations Division, Federal Motor Carrier Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590, phone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Legal Basis

    The Motor Carrier Safety Act of 1984 (Pub. L. 98-554, Title II, 98
Stat. 2832, October 30, 1984) (the 1984 Act) authorizes the Secretary
of Transportation to regulate CMVs and equipment, and the drivers and
motor carriers that operate them 49 U.S.C. 31136(a)]. Section 211 of
the 1984 Act also gives the Secretary broad power to ``prescribe
recordkeeping and reporting requirements'' and to ``perform other acts
the Secretary considers appropriate'' (49 U.S.C. 31133(a)(8) and (10)).
The Administrator of FMCSA has been delegated authority under 49 CFR
1.87(f) to carry out the functions vested in the Secretary by 49 U.S.C.
chapter 311, subchapters I and III, relating to CMV programs and safety
regulation.

Background

    Motor carriers began to use automated HOS recording devices in the
mid-1980s to replace paper records. The Federal Highway Administration,
the agency at that time responsible for motor carrier safety
regulations, published a final rule in 1988 that defined AOBRDs and set
forth performance standards for their use (53 FR 38670, September 30,
1988).

AOBRD Display, Recording, and Printing Requirements

    FMCSA has been informed that inspection officials sometimes request
drivers to provide printouts from AOBRDs, or to email or fax records of
duty status (RODS) to an enforcement official. The Agency has also been
advised that, in some cases, inspection officials have issued citations
to CMV drivers because their AOBRDs did not display certain
information.
    The Federal Motor Carrier Safety Regulations (FMCSRs) have never
required AOBRDs to be capable of providing printed records at the
roadside, although a driver may voluntarily do so if his/her AOBRD has
that capability. Such printed information must meet the display
requirements of Sec.  395.15.
    The AOBRD requirements for recording--but not displaying--
information reflect mid-1980s information technology. These
requirements were developed when small electronic displays were
relatively

uncommon and costly, and the amount and type of information they could
display were limited. The earliest displays could show only text, not
graphics--hence the requirement for the ``time and sequence of duty
status'' rather than the Sec.  395.8 graph grid. The additional
information that is recorded but not displayed is intended for use
during an audit of the carrier's HOS records.

Regulatory Guidance

    FMCSA amends the April 4, 1997, publication to add questions 5 and
6 production of records during a roadside inspection.

PART 395--HOURS OF SERVICE OF DRIVERS

    Add Sec.  395.15 Questions 5 and 6, to read as follows:
    Question 5: What information is required to be displayed on the
AOBRD?
    Guidance:
    (1) Section 395.15(i)(5) requires that AOBRDs with electronic
displays must be capable of displaying the following: ``(i) Driver's
total hours of driving today; (ii) The total hours on duty today; (iii)
Total miles driving today; (iv) Total hours on duty for the 7
consecutive day period, including today; (v) Total hours on duty for
the prior 8 consecutive day period, including the present day; and (vi)
The sequential changes in duty status and the times the changes
occurred for each driver using the device.''
    (2) While Sec.  395.15(c) requires additional information be
recorded by the AOBRD, only the specific information listed in Sec.
395.15(i)(5) must be displayed.
    (3) The two provisions differ because of the data display
limitations of a minimally compliant AOBRD.
    Question 6: Must an AOBRD be capable of providing a hardcopy
printout?
    Guidance: No, the FMCSRs do not require AOBRDs to provide a
hardcopy printout for an enforcement official. As long as the
information made available for display on the AOBRD meets the
requirements of Sec.  395.15(i)(5), the driver and motor carrier are
not required to provide additional RODS documentation to an enforcement
official at the roadside. However, an enforcement official may request
that additional information be provided by email, fax, or similar means
within 48 hours for follow-up after the conclusion of the roadside
inspection.

    Issued on: April 28, 2014.
Anne S. Ferro,
Administrator.
[FR Doc. 2014-10822 Filed 5-9-14; 8:45 am]
BILLING CODE 4910-EX-P