[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Notices]
[Pages 74346-74352]
[FR Doc No: 2020-25603]

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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 and reissuance 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, and in
some cases reissued, 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 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 and reissuance, are listed in this document, and are available
on FDA's website at the links indicated.

DATES: These Authorizations are applicable on their date of issuance/
reissuance.

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. 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 (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.
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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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    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.

III. 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.

IV. The Authorizations

    Having concluded that the criteria for the issuance and, in some
cases reissuance, 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, in some cases reissued, from May 16, 2020,
through September 14, 2020, and we have included explanations of the
reasons for their issuance, as required by section 564(h)(1) of the
FD&C Act. FDA is hereby announcing the following Authorizations for
molecular diagnostic

and antigen tests for COVID-19, excluding multianalyte 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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     Color Genomics, Inc.'s Color SARS-CoV-2 LAMP Diagnostic
Assay, issued May 18, 2020, and reissued July 24, 2020;
     Quidel Corp.'s Lyra Direct SARS-CoV-2 Assay, issued May
18, 2020;
     P23 Labs, LLC's P23 Labs TaqPath SARSd-CoV-2 Assay, issued
May 21, 2020, and reissued July 10, 2020;
     SEASUN BIOMATERIALS, Inc.'s AQ-TOP COVID-19 Rapid
Detection Kit, issued May 21, 2020;
     SolGent Co., Ltd.'s DiaPlexQ Novel Coronavirus (2019-nCoV)
Detection Kit, issued May 21, 2020;
     BioCore Co., Ltd.'s BioCore 2019-nCoV Real Time PCR Kit,
issued May 21, 2020;
     Exact Sciences Laboratories' SARSd-CoV-2 (N gene
detection) Test, issued May 22, 2020, and reissued August 3, 2020;
     dba SpectronRx's Hymon SARSd-CoV-2 Test Kit, issued May
22, 2020;
     PrivaPath Diagnostics, Inc.'s LetsGetChecked Coronavirus
(COVID-19) Test, issued May 28, 2020, and reissued August 14, 2020;
     Gravity Diagnostics, LLC's Gravity Diagnostics COVID-19
Assay, issued June 1, 2020;
     Phosphorus Diagnostics LLC's Phosphorus COVID-19 RT-qPCR
Test, issued June 4, 2020;
     Genetron Health (Beijing) Co., Ltd.'s Genetron SARSd-CoV-2
RNA Test, issued June 5, 2020;
     Euroimmun US Inc.'s EURORealTime SARSd-CoV-2, issued June
8, 2020;
     ChromaCode Inc.'s HDPCR SARSd-CoV-2 Assay, issued June 9,
2020;
     Illumina, Inc.'s Illumina COVIDSeq Test, issued June 9,
2020;
     Tide Laboratories, LLC's DTPM COVID-19 RT-PCR Test, issued
June 10, 2020;
     TBG Biotechnology Corp.'s ExProbe SARSd-CoV-2 Testing Kit,
issued June 10, 2020;
     Cue Health, Inc.'s Cue COVID-19 Test, issued June 10,
2020;
     RTA Laboratories Biological Products Pharmaceutical and
Machinery Industry's Diagnovital SARSd-CoV-2 Real-Time PCR Kit, issued
June 12, 2020;
     Kaiser Permanente Mid-Atlantic States's KPMAS COVID-19
Test, issued June 13, 2020, and reissued September 9, 2020;
     Applied BioCode, Inc.'s BioCode SARSd-CoV-2 Assay, issued
June 15, 2020;
     The Ohio State University Wexner Medical Center's OSUWMC
COVID-19 RT-PCR test, issued June 17, 2020;
     Omnipathology Solutions Medical Corp.'s Omni COVID-19
Assay by RT-PCR, issued June 17, 2020;
     Jiangsu Bioperfectus Technologies Co., Ltd.'s COVID-19
Coronavirus Real Time PCR Kit, issued June 18, 2020;
     3B Blackbio Biotech India Ltd., a subsidiary of Kilpest
India Ltd.'s TRUPCR SARSd-CoV-2 Kit, issued June 18, 2020;
     HealthQuest Esoterics's HealthQuest Esoterics TaqPath
SARSd-CoV-2 Assay, issued June 23, 2020;
     University of Alabama at Birmingham Fungal Reference Lab's
FRL SARS CoV-2 Test, issued June 23, 2020;
     Gencurix, Inc.'s GenePro SARSd-CoV-2 Test, issued June 23,
2020;
     University of Texas MD Anderson Cancer Center, Molecular
Diagnostics Laboratory's MD Anderson High-throughput SARSd-CoV-2 RT-PCR
Assay, issued June 24, 2020;
     Diagnostic Solutions Laboratory, LLC's DSL COVID-19 Assay,
issued June 25, 2020;
     PreciGenome LLC's FastPlex Triplex SARSd-CoV-2 detection
kit (RT-Digital PCR), issued June 25, 2020;
     PlexBio Co., Ltd.'s IntelliPlex SARSd-CoV-2 Detection Kit,
issued June 25, 2020;
     Inform Diagnostics, Inc.'s Inform Diagnostics SARSd-CoV-2
RT-PCR Assay, issued June 26, 2020;
     Acupath Laboratories, Inc.'s Acupath COVID-19 Real-Time
(RT-PCR) Assay, issued June 29, 2020;
     LifeHope Labs' LifeHope 2019-nCoV Real-Time RT-PCR
Diagnostic Panel, issued June 29, 2020;
     Psomagen, Inc.'s Psoma COVID-19 RT Test, issued June 30,
2020;
     TNS Co., Ltd.'s (Bio TNS) COVID-19 RT-PCR Peptide Nucleic
Acid (PNA) kit, issued June 30, 2020;
     The Kroger Co.'s Kroger Health COVID-19 Test Home
Collection Kit, issued June 30, 2020;
     CENTOGENE US, LLC's CentoFast-SARSd-CoV-2 RT-PCR Assay,
issued July 1, 2020;
     Becton, Dickinson and Co.'s BD Veritor System for Rapid
Detection of SARSd-CoV-2, issued July 2, 2020;
     Laboratorio Clinico Toledo's Laboratorio Clinico Toledo
SARSd-CoV-2 Assay, issued July 6, 2020;
     Gene By Gene's Gene By Gene SARSd-CoV-2 Detection Test,
issued July 7, 2020;
     Access Bio, Inc.'s CareStart COVID-19 MDx RT-PCR, issued
July 7, 2020;
     Enzo Life Sciences, Inc.'s AMPIPROBE SARSd-CoV-2 Test
System, issued July 7, 2020;
     Clinical Research Sequencing Platform (CRSP), LLC at the
Broad Institute of MIT and Harvard's CRSP SARSd-CoV-2 Real-time Reverse
Transcriptase (RT)-PCR Diagnostic Assay, issued July 8, 2020;
     BioSewoom, Inc.'s Real-Q 2019-nCoV Detection Kit, issued
July 9, 2020;
     UCSF Health Clinical Laboratories, UCSF Clinical Labs at
China Basin's SARSd-CoV-2 RNA DETECTR Assay, issued July 9, 2020;
     Boston Medical Center's BMC-CReM COVID-19 Test, issued
July 10, 2020;
     KogeneBiotech Co., Ltd.'s PowerChek 2019-nCoV Real-time
PCR Kit, issued July 13, 2020;
     Trax Management Services Inc.'s PhoenixDx SARSd-CoV-2
Multiplex, issued July 13, 2020;
     Compass Laboratory Services, LLC's Compass Laboratory
Services SARSd-CoV2 Assay, issued July 13, 2020;
     Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics PF SARSd-CoV-2 Assay, issued July 15, 2020, and reissued
August 21, 2020;
     Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics RC SARSd-CoV-2 Assay, issued July 15, 2020, and reissued
August 21, 2020;
     Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics HA SARSd-CoV-2 Assay, issued July 15, 2020, and reissued
August 21, 2020;
     Boston Heart Diagnostics' Boston Heart COVID-19 RT-PCR
Test, issued July 16, 2020;
     Access Genetics, LLC's OraRisk COVID-19 RT-PCR, issued
July 17, 2020;
     DiaCarta, Inc.'s QuantiVirus SARSd-CoV-2 Multiplex Test
Kit, issued July 21, 2020;
     Helix OpCo LLC's (dba Helix's) Helix COVID-19 Test, issued
July 23, 2020;
     Jiangsu CoWin Biotech Co., Ltd.'s Novel Coronavirus
(SARSd-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence
Probing), issued July 24, 2020;
     LabCorp's COVID-19 RT-PCR Test, reissued July 24, 2020
(original issuance March 16, 2020);
     Eli Lilly and Co.'s Lilly SARSd-CoV-2 Assay, issued July
27, 2020;

     Sandia National Laboratories' SNL-NM 2019 nCoV Real-Time
RT-PCR Diagnostic Assay, issued July 27, 2020;
     Clinical Reference Laboratory, Inc.'s CRL Rapid Response,
issued July 30, 2020;
     University of California San Diego Health's UCSD RC SARSd-
CoV-2 Assay, issued July 31, 2020;
     Xiamen Zeesan Biotech Co., Ltd.'s SARSd-CoV-2 Test Kit
(Real-time PCR), issued July 31, 2020;
     ISPM Labs, LLC dba Capstone Healthcare's Genus SARSd-CoV-2
Assay, issued August 3, 2020;
     Poplar Healthcare's Poplar SARSd-CoV-2 TMA Pooling assay,
issued August 3, 2020;
     Cleveland Clinic Robert J. Tomsich Pathology and
Laboratory Medicine Institute's Cleveland Clinic SARSd-CoV-2 Assay,
issued August 3, 2020;
     Ethos Laboratories' Ethos Laboratories SARSd-CoV-2 MALDI-
TOF Assay, issued August 3, 2020;
     Wren Laboratories LLC's Wren Laboratories COVID-19 PCR
Test, issued August 3, 2020;
     Vela Operations Singapore Pte Ltd.'s ViroKey SARSd-CoV-2
RT-PCR Test, issued August 5, 2020;
     Helix OpCo LLC's (dba Helix) Helix COVID-19 NGS Test,
issued August 6, 2020;
     George Washington University Public Health Laboratory's
GWU SARSd-CoV-2 RT-PCR Test, issued August 7, 2020;
     Quest Diagnostics Infectious Disease, Inc.'s SARSd-CoV-2
RNA, Qualitative Real-Time RT-PCR, reissued August 7, 2020 (original
issuance March 17, 2020);
     Alpha Genomix Laboratories' Alpha Genomix TaqPath SARSd-
CoV-2 Combo Assay, issued August 10, 2020;
     Solaris Diagnostics' Solaris Multiplex SARSd-CoV-2 Assay,
issued August 10, 2020;
     Biomeme, Inc.'s Biomeme SARSd-CoV-2 Real-Time RT-PCR Test,
issued August 11, 2020;
     LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 RNA STAR, issued
August 11, 2020;
     Pro-Lab Diagnostics' Pro-AmpRT SARSd-CoV-2 Test, issued
August 13, 2020;
     Yale School of Public Health, Department of Epidemiology
of Microbial Diseases' SalivaDirect, issued August 15, 2020, and
reissued August 28, 2020;
     ZhuHai Sinochips Bioscience Co., Ltd.'s COVID-19 Nucleic
Acid RT-PCR Test Kit, issued August 17, 2020;
     LumiraDx UK Ltd.'s LumiraDx SARSd-CoV-2 Ag Test, issued
August 18, 2020;
     Assurance Scientific Laboratories' Assurance SARSd-CoV-2
Panel, reissued August 19, 2020 (original issuance May 15, 2020);
     Guardant Health, Inc.'s Guardant-19, issued August 21,
2020;
     DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT-PCR
Test, issued August 21, 2020;
     Texas Department of State Health Services, Laboratory
Services Section's Texas Department of State Health Services SARSd-CoV-
2 Assay, issued August 21, 2020;
     Fluidigm Corp.'s Advanta Dx SARSd-CoV-2 RT-PCR Assay,
issued August 25, 2020;
     QDx Pathology Services' QDX SARSd-CoV-2 Assay, issued
August 25, 2020;
     Cuur Diagnostics' Cuur Diagnostics SARSd-CoV-2 Molecular
Assay, issued August 26, 2020;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Ag Card, issued August 26, 2020;
     Patients Choice Laboratories, LLC's PCL SARSd-CoV-2 Real-
Time RT-PCR Assay, issued August 28, 2020;
     DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT PCR
CE Test, issued August 28, 2020;
     T2 Biosystems, Inc.'s T2SARSd-CoV-2 Panel, issued August
31, 2020;
     MiraDx's MiraDx SARSd-CoV-2 RT-PCR assay, issued August
31, 2020;
     Mammoth Biosciences, Inc.'s SARSd-CoV-2 DETECTR Reagent
Kit, issued August 31, 2020;
     BayCare Laboratories, LLC's BayCare SARSd-CoV-2 RT PCR
Assay, issued August 31, 2020;
     Detectachem Inc.'s MobileDetect Bio BCC19 (MD-Bio BCC19)
Test Kit, issued September 1, 2020;
     OPTOLANE Technologies, Inc.'s Kaira 2019-nCoV Detection
Kit, issued September 1, 2020;
     Bioeksen R&D Technologies Ltd.'s Bio-Speedy Direct RT-qPCR
SARSd-CoV-2, issued September 2, 2020;
     BillionToOne, Inc.'s qSanger-COVID-19 Assay, issued
September 4, 2020;
     Verily Life Sciences' Verily COVID-19 RT-PCR Test, issued
September 8, 2020; and
     Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s
Wantai SARSd-CoV-2 RT-PCR Kit, issued September 9, 2020.
    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) SARSd-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 SARSd-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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     Healgen Scientific LLC's COVID-19 IgG/IgM Rapid Test
Cassette (Whole Blood/Serum/Plasma), issued May 29, 2020;
     Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-
CoV-2 Total (COV2T), issued May 29, 2020;
     Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-
CoV-2 Total (COV2T), issued May 29, 2020;
     Hangzhou Biotest Biotech Co., Ltd.'s RightSign COVID-19
IgG/IgM Rapid Test Cassette, issued June 4, 2020;
     Vibrant America Clinical Labs' Vibrant COVID-19 Ab Assay,
issued June 4, 2020;
     Siemens Healthcare Diagnostics Inc.'s Dimension Vista
SARSd-CoV-2 Total antibody assay (COV2T), issued June 8, 2020;
     Siemens Healthcare Diagnostics Inc.'s Dimension EXL SARSd-
CoV-2 Total antibody assay (CV2T), issued June 8, 2020;
     InBios International, Inc.'s SCoV-2 Detect IgG ELISA
[enzyme-linked immunosorbent assay], issued June 10, 2020;
     Cellex Inc.'s qSARSd-CoV-2 IgG/IgM Rapid Test, reissued
June 12, 2020 (original issuance April 1, 2020);
     Emory Medical Laboratories' SARSd-CoV-2 RBD IgG test,
issued June 15, 2020;
     Biohit Healthcare (Hefei) Co. Ltd.'s Biohit SARSd-CoV-2
IgM/IgG Antibody Test Kit, issued June 18, 2020;
     Hangzhou Laihe Biotech Co., Ltd.'s LYHER Novel Coronavirus
(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), issued
June 19, 2020;
     Babson Diagnostics, Inc.'s Babson Diagnostics aC19G1,
issued June 23, 2020;
     Beckman Coulter, Inc.'s Access SARSd-CoV-2 IgG, issued
June 26, 2020;
     InBios International, Inc.'s SCoV-2 Detect IgM ELISA,
issued June 30, 2020;
     Assure Tech.'s (Hangzhou Co., Ltd.) Assure COVID-19 IgG/
IgM Rapid Test Device, issued July 6, 2020;
     Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2
IgG CLIA Kit, issued July 8, 2020;
     Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s
WANTAI SARSd-CoV-2 Ab Rapid Test, July 10, 2020;

     Salofa Oy's Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM
Rapid Test Cassette, issued July 13, 2020;
     Luminex Corp.'s xMAP SARSd-CoV-2 Multi-Antigen IgG Assay,
issued July 16, 2020;
     Megna Health, Inc.'s Rapid COVID-19 IgM/IgG Combo Test
Kit, issued July 17, 2020;
     Access Bio, Inc.'s CareStart COVID-19 IgM/IgG, issued July
24, 2020;
     Xiamen Biotime Biotechnology Co., Ltd.'s BIOTIME SARSd-
CoV-2 IgG/IgM Rapid Qualitative Test, issued July 24, 2020;
     Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-
CoV-2 IgG (COV2G), issued July 31, 2020;
     Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-
CoV-2 IgG (COV2G), issued July 31, 2020;
     Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s
WANTAI SARSd-CoV-2 Ab ELISA, issued August 5, 2020;
     bioM[eacute]rieux SA's VIDAS SARSd-CoV-2 IgM, issued
August 6, 2020;
     bioM[eacute]rieux SA's VIDAS SARSd-CoV-2 IgG, issued
August 6, 2020;
     Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2
IgM CLIA Kit, issued August 17, 2020;
     BioCheck, Inc.'s BioCheck SARSd-CoV-2 IgG and IgM Combo
Test, issued August 17, 2020;
     Biocan Diagnostics Inc.'s Tell Me Fast Novel Coronavirus
(COVID-19) IgG/IgM Antibody Test, issued August 25, 2020;
     TBG Biotechnology Corp.'s TBG SARSd-CoV-2 IgG/IgM Rapid
Test Kit, issued August 31, 2020;
     University of Arizona Genetics Core for Clinical Services'
COVID-19 ELISA pan-Ig Antibody Test, issued August 31, 2020;
     Sugentech, Inc.'s SGTi-flex COVID-19 IgG, issued September
3, 2020;
     BioCheck, Inc.'s BioCheck SARS-CoV-2 IgG Antibody Test
Kit, issued September 9, 2020;
     BioCheck, Inc.'s BioCheck SARS-CoV-2 IgM Antibody Test
Kit, issued September 9, 2020; and
     Shenzhen New Industries Biomedical Engineering Co., Ltd.'s
MAGLUMI 2019-nCoV IgM/IgG, issued September 14, 2020.
    FDA is hereby announcing the following Authorizations for
multianalyte 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, influenza A virus, and/or influenza B
virus nucleic acids 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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     Centers for Disease Control and Prevention's Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay, issued July 2, 2020;
     Roche Molecular Systems, Inc.'s cobas SARS-CoV-2 &
Influenza A/B, issued September 3, 2020; and
     Roche Molecular Systems, Inc.'s cobas SARS-CoV-2 &
Influenza A/B Nucleic Acid Test for use on the cobas Liat System,
issued September 14, 2020.
    FDA is hereby announcing the following Authorizations for personal
respiratory protective devices: \6\
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    \6\ 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 authorized respirators may
be effective in preventing healthcare personnel (HCP) exposure to
pathogenic biological airborne particulates during Filtering
Facepiece Respirator (FFR) shortages, and that the known and
potential benefits of the authorized respirators, when used to
prevent HCP exposure to such particulates during FFR shortages
during 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 this product.
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     Certain Non-National Institute of Industrial and
Occupational Safety (NIOSH)-Approved Disposable Filtering Facepiece
Respirators Manufactured in China, reissued June 6, 2020 (original
issuance April 3, 2020). A current list of respirator models authorized
by this EUA is available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixa; and
     Certain Imported, Non-NIOSH Approved Disposable Filtering
Facepiece Respirators, reissued June 6, 2020 (original issuance March
24, 2020). A current list of respirator models authorized by this EUA
is available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#exhibit1.
    FDA is hereby announcing the following Authorizations for other
medical devices:
     Baxter Healthcare Corp.'s Prismaflex ST Set, issued May
20, 2020; \7\
---------------------------------------------------------------------------

    \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 the Prismaflex ST Set may be effective to treat patients in an
acute care environment during the COVID-19 pandemic, and that the
known and potential benefits of the Prismaflex ST Set, when used for
such use, outweigh the known and potential risks of the Prismaflex
ST Set; and (3) there is no adequate, approved, and available
alternative to the emergency use of the product.
---------------------------------------------------------------------------

     STERIS Corp.'s AMSCO Medium Steam Sterilizers + the STERIS
STEAM Decon Cycle, issued May 21, 2020; \8\
---------------------------------------------------------------------------

    \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 STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers
may be effective at decontaminating compatible N95 respirators for
single-user reuse by HCPs to prevent exposure to SARS-CoV-2 and
other pathogenic biological airborne particulates for a maximum of
10 decontamination cycles per respirator, and that the known and
potential benefits of this product, when used as described, 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 product.
---------------------------------------------------------------------------

     Certain Gowns and Other Apparel, issued May 22, 2020; \9\
---------------------------------------------------------------------------

    \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 authorized gowns and other apparel worn by HCPs may be
effective at preventing the transfer of microorganisms, bodily
fluids, and particulate material in low or minimal risk situations
by providing minimal-to-low barrier protection to HCP and patients
to prevent the spread of COVID-19, and that the known and potential
benefits of gowns and other apparel for such use, outweigh the known
and potential risks of such products; and (3) there is no adequate,
approved, and available alternative to the emergency use of these
products.
---------------------------------------------------------------------------

     CLEW Medical Ltd.'s CLEWICU System, issued May 26, 2020;
\10\
---------------------------------------------------------------------------

    \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 CLEWICU System may be effective in treating COVID-19, when
used by HCP in the intensive care unit (ICU) as a diagnostic aid to
assist with the early identification of adult patients who are
likely to be diagnosed with respiratory failure or hemodynamic
instability which are common complications associated with COVID-19,
and that the known and potential benefits of the CLEWICU System, 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 product.
---------------------------------------------------------------------------

     Abiomed, Inc.'s Impella RP System, issued May 29, 2020;
\11\
---------------------------------------------------------------------------

    \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 Impella RP may be effective in providing temporary right
ventricular support for up to 14 days in critical care patients with
a body surface area >=1.5 m2, for the treatment of acute right heart
failure or decompensation caused by complications related COVID-19,
including pulmonary embolism, and that the known and potential
benefits of the Impella RP, 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 product.

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

     Roche Diagnostics' Elecsys IL-6, issued on June 2, 2020;
\12\
---------------------------------------------------------------------------

    \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 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 this product when used for such use, outweigh
the known and potential risks of this product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
---------------------------------------------------------------------------

     Battelle Memorial Institute's Battelle CCDS Critical Care
Decontamination System (``Batelle Decontamination System''), reissued
June 6, 2020 \13\ (original issuance March 29, 2020);
---------------------------------------------------------------------------

    \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 Battelle Decontamination System may be effective at
decontaminating compatible N95 respirators for multiple-user reuse
by HCPs 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 product.
---------------------------------------------------------------------------

     STERIS Corp.'s STERIS Sterilization System, reissued June
6, 2020 \14\ (original issuance April 9, 2020);
---------------------------------------------------------------------------

    \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 STERIS Sterilization Systems may be effective at
decontaminating compatible N95 respirators for single-user reuse by
HCPs 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 product.
---------------------------------------------------------------------------

     Stryker Instruments' STERIZONE VP4 N95 Respirator
Decontamination Cycle, reissued June 6, 2020 \15\ (original issuance on
April 14, 2020);
---------------------------------------------------------------------------

    \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 STERIZONE VP4 N95 Respirator Decontamination Cycle may be
effective at preventing exposure to pathogenic biological airborne
particulates by decontaminating, for a maximum of 2 decontamination
cycles per respirator, comparable N95 respirators that are
contaminated with SARS-CoV-2 or other pathogenic microorganisms, and
that the known and potential benefits of this product, when used as
described, outweigh the known and potential risks; and (3) there is
no adequate, approved, and available alternative to the emergency
use of the product.
---------------------------------------------------------------------------

     Advanced Sterilization Products, Inc.'s (ASP) STERRAD
100S, NX, and 100NX Sterilization Systems (``ASP STERRAD Sterilization
Systems''), reissued June 6, 2020 \16\ (original issuance April 11,
2020);
---------------------------------------------------------------------------

    \16\ As set forth in this 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 ASP STERRAD Sterilization Systems may be effective at
decontaminating, for a maximum of 2 decontamination cycles per
respirator, compatible N95 respirators for single-user reuse by HCP
to prevent exposure to SARS-CoV-2 and other pathogenic biological
airborne particulates, and that the known and potential benefits of
the ASP STERRAD Sterilization Systems, 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 product.
---------------------------------------------------------------------------

     Stryker Sustainability Solutions' (SSS) SSS VHP N95
Respirator Decontamination System, issued May 27, 2020, reissued June
6, 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 SSS VHP N95 Respirator Decontamination may be effective at
decontaminating compatible N95 respirators for multiple-user reuse
by HCP 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 as described, outweigh the known
and potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
---------------------------------------------------------------------------

     Sterilucent, Inc.'s Sterilucent HC 80TT Hydrogen Peroxide
Sterilizer (``Sterilucent Sterilization System''), reissued June 6,
2020 \18\ (original issuance April 20, 2020);
---------------------------------------------------------------------------

    \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 Sterilucent Sterilization System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
HCP to prevent exposure to pathogenic biological airborne
particulates, and that the known and potential benefits of this
device, 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
product.
---------------------------------------------------------------------------

     Duke University Health System's Duke Decontamination
System for Decontamination and Reuse of N95 Respirators with Hydrogen
Peroxide Vapor (``Duke Decontamination System''), reissued June 6, 2020
\19\ (original issuance May 7, 2020);
---------------------------------------------------------------------------

    \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 the Duke Decontamination System may be effective at
decontaminating compatible N95 respirators for multiple-user reuse
by HCP 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 product.
---------------------------------------------------------------------------

     Technical Safety Services LLC's 20-CS Decontamination
System, issued June 13, 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 20-CS Decontamination System may be effective at
decontaminating compatible N95 respirators for multiple-user reuse
by HCPs 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 as described, 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 product.
---------------------------------------------------------------------------

     Oceanetics, Inc.'s Negative-pressure Respiratory System
with Advanced Ventilation Return (``NRSAVR-100''), issued June 13,
2020; \21\
---------------------------------------------------------------------------

    \21\ As set forth in the EUA, 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 NRSAVR-100 may be
effective in preventing HCP exposure to pathogenic biological
airborne particulates by providing an extra layer of barrier
protection in addition to PPE, at the time of definitive airway
management, or when performing medical procedures, or during
transport of patients with suspected or confirmed diagnosis of
COVID-19 and that the known and potential benefits of the NRSAVR-100
for such use outweigh its known and potential risks; and (3) there
is no adequate, approved available alternative to the emergency use
of this product.
---------------------------------------------------------------------------

     US Army and MHS's COVID-19 Airway Management Isolation
Chamber (CAMIC), issued May 19, 2020 and reissued to US Army Medical
Research Development Command June 22, 2020; \22\
---------------------------------------------------------------------------

    \22\ As set forth in the EUA, 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 CAMIC may be effective in
preventing HCP exposure to pathogenic biological airborne
particulates by providing an extra layer of barrier protection in
addition to PPE when transporting or performing medical procedures
on patients who are known or suspected to have COVID-19, and that
the known and potential benefits of the CAMIC for such use outweigh
its known and potential risks; and (3) there is no adequate,
approved available alternative to the emergency use of the product.

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

     electroCore, Inc.'s gammaCore Sapphire CV, issued July 10,
2020; \23\
---------------------------------------------------------------------------

    \23\ 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 gammaCore Sapphire CV may be effective for acute emergency
use at home or in a healthcare setting to treat adult patients with
known or suspected COVID-19 who are experiencing exacerbation of
asthma-related dyspnea and reduced airflow, and for whom approved
drug therapies are not tolerated or provide insufficient symptom
relief as assessed by their HCP, by using non-invasive Vagus Nerve
Stimulation (nVNS) on either side of the patients neck, and that the
known and potential benefits of this product for such use outweigh
the known and potential risks of such product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
---------------------------------------------------------------------------

     Michigan State University Animal Care Program's MSU
Decontamination System, issued July 24, 2020; \24\
---------------------------------------------------------------------------

    \24\ 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 MSU Decontamination System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
HCP 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 product.
---------------------------------------------------------------------------

     IkonX, Inc.'s Airway Dome, issued July 24, 2020; \25\
---------------------------------------------------------------------------

    \25\ 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 Airway Dome may be effective in preventing HCP exposure to
pathogenic biological airborne particulates by providing an extra
layer of barrier protection in addition to PPE, 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 the Airway Dome for such use outweigh its known and
potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
---------------------------------------------------------------------------

     Abiomed, Inc.'s Impella Left Ventricular (LV) Support
Systems, issued August 3, 2020; \26\
---------------------------------------------------------------------------

    \26\ 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 Impella LV Support Systems may be effective when used by
HCP in the hospital setting for providing temporary LV unloading and
support to treat critical care patients with confirmed COVID-19
infection who are undergoing ECMO treatment and who develop
pulmonary edema while on V-A ECMO support or late cardiac
decompensation from myocarditis while on V-V ECMO support, and that
the known and potential benefits of the Impella LV Support System,
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 product.
---------------------------------------------------------------------------

     Disposable, single-use surgical masks, issued August 5,
2020.\27\ A current list of surgical masks authorized by this EUA is
available here: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixasurgicalmasks;
---------------------------------------------------------------------------

    \27\ 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 authorized surgical masks may be effective for use in
healthcare settings by HCPs as PPE to provide a physical barrier to
fluids and particulate materials to prevent HCP exposure to
respiratory droplets and large particles during surgical mask
shortages resulting from the COVID-19 pandemic, and that the known
and potential benefits of the authorized surgical masks, when used
consistent with the scope of the authorization, outweigh the known
and potential risks of such product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
products.
---------------------------------------------------------------------------

     Baxter Healthcare Corp.'s Prismaflex HF20 Set, issued
August 10, 2020; \28\
---------------------------------------------------------------------------

    \28\ 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 and multiple organ failure, including acute kidney injury,
to humans infected by this virus; (2) Based on the totality of
scientific evidence available to FDA, it is reasonable to believe
that the Prismaflex HF20 Set (cartridge, including hemodialyzer plus
tubing set) may be effective at providing continuous renal
replacement therapy (CRRT) to treat low weight patients who have low
blood volume and who have acute renal failure, fluid overload, or
both, and who cannot tolerate a larger extracorporeal circuit volume
in an acute care environment during the COVID-19 emergency and that
the known and potential benefits of the Prismaflex HF20 Set, when
used for such use, outweigh the known and potential risks of the
Prismaflex HF20 Set; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
---------------------------------------------------------------------------

     NovaSterilis, Inc.'s Nova2200 using the NovaClean
decontamination process for decontaminating compatible N95 respirators,
issued August 20, 2020; \29\ and
---------------------------------------------------------------------------

    \29\ As set forth in the EUA, 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 Nova2200 may be effective
at decontaminating compatible N95 respirators for single-user reuse
by HCP 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 product.
---------------------------------------------------------------------------

     Color Genomics, Inc.'s Color COVID-19 Self-Swab Collection
Kit, issued August 31, 2020.\30\
---------------------------------------------------------------------------

    \30\ As set forth in the EUA, 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 this 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 this product when used for
such use, outweigh the known and potential risks of this product;
and (3) there is no adequate, approved, and available alternative to
the emergency use of the product.

    Dated: November 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25603 Filed 11-19-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Rules and Regulations]
[Pages 33105-33108]
[FR Doc No: 2021-13108]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0448; Project Identifier MCAI-2021-00044-T;
Amendment 39-21591; AD 2021-12-04]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD
was prompted by a report that corrosion was found on the horizontal
flange on the front spar lower boom, between the rebate strap and the
lower boom, and

resulted in bulging. This AD requires doing a detailed visual
inspection to detect any bulging, loose, and missing countersunk
fastener heads at the left-(LH) and right-hand (RH) outer wing lower
skin of the front spar between certain wing stations, and applicable
on-condition actions, as specified in a European Union Aviation Safety
Agency (EASA), which is incorporated by reference. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD becomes effective July 9, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 9,
2021.
    The FAA must receive comments on this AD by August 9, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material incorporated by reference (IBR) in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0448.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0448; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0014, dated January 13, 2021
(EASA AD 2021-0014) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes.
    This AD was prompted by a report that corrosion was found on the
horizontal flange on the front spar lower boom, between the rebate
strap and the lower boom, and resulted in bulging. The FAA is issuing
this AD to address corrosion on the horizontal flange, which could lead
to reduced structural integrity of the wing torsion box structure. See
the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0014 specifies procedures for doing a detailed visual
inspection to detect any bulging, loose, and missing countersunk
fastener heads at the LH and RH outer wing lower skin of the front spar
between wing station (WSTA) 10110 and WSTA 11190; and applicable on-
condition actions. On-condition actions include repetitive detailed
visual inspections of the LH and RH outer wing lower skin, at the front
spar between WSTA 10110 and WSTA 11190, if bulging between 0.5 mm and 3
mm is found; a detailed visual inspection to detect corrosion at the
front spar lower boom and rebate strap if any bulging, loose, or
missing countersunk fastener head, or bulging in excess of 3 mm, is
found; and repair of any corrosion damage. EASA AD 2021-0014 also
specifies reporting inspection findings. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this AD because the FAA evaluated
all pertinent information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2021-0014 described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use certain civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with other manufacturers and CAAs. As a
result, EASA AD 2021-0014 is incorporated by reference in this AD. This
AD, therefore, requires compliance with EASA AD 2021-0014 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this AD. Using
common terms that are the same as the heading of a particular section
in EASA AD 2021-0014 does not mean that operators need comply only with
that section. For example, where the AD requirement refers to ``all
required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2021-0014 that is required for compliance with it is
available at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0448.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules

effective in less than thirty days, upon a finding of good cause.
    There are currently no domestic operators of these products.
Accordingly, notice and opportunity for prior public comment are
unnecessary, pursuant to 5 U.S.C. 553(b)(3). In addition, for the
foregoing reason, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days.

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0448; Project Identifier MCAI-
2021-00044-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Tom
Rodriguez, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. If an
affected airplane is imported and placed on the U.S. Register in the
future, the FAA provides the following cost estimates to comply with
this AD:

                 Estimated Costs for Required Actions *
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
2 work-hours x $85 per hour = $170....              $0             $170
------------------------------------------------------------------------
* Table does not include estimated costs for reporting.

    The FAA estimates that it takes about 1 work-hour per product to
comply with the reporting requirement in this AD. The average labor
rate is $85 per hour. Based on these figures, the FAA estimates the
cost of reporting the inspection results to be $85 per product.
    The FAA has received no definitive data on which to base the cost
estimates for the on-condition actions and repairs specified in this
AD.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to
Information Collection Clearance Officer, Federal Aviation
Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2021-12-04 Fokker Services B.V.: Amendment 39-21591; Docket No. FAA-
2021-0448; Project Identifier MCAI-2021-00044-T.

(a) Effective Date

    This airworthiness directive (AD) becomes effective July 9,
2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Fokker Services B.V. Model F28 Mark 0070
and 0100 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by a report that corrosion was found on the
horizontal flange on the front spar lower boom, between the rebate
strap and the lower boom, and resulted in bulging. The FAA is
issuing this AD to address corrosion on the horizontal flange, which
could lead to reduced structural integrity of the wing torsion box
structure.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0014, dated January 13, 2021 (EASA AD 2021-0014).

(h) Exceptions to EASA AD 2021-0014

    (1) Where EASA AD 2021-0014 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (2) of EASA AD 2021-0014 requires additional
actions for bulging ``between 0.5 mm and 3 mm,'' this AD requires
those additional actions for bulging 0.5 mm or more and 3.0 mm or
less.
    (3) The ``Remarks'' section of EASA AD 2021-0014 does not apply
to this AD.
    (4) Paragraph (5) of EASA AD 2021-0014 specifies to report
inspection results within a certain compliance time. For this AD,
report the inspection results of each inspection accomplished in
this AD at the applicable time specified in paragraph (h)(4)(i) or
(ii) of this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (ii) If the inspection was done before the effective date of
this AD: Submit the report within 30 days after the effective date
of this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j) of this
AD. Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Fokker
Services B.V.'s EASA Design Organization Approval (DOA). If approved
by the DOA, the approval must include the DOA-authorized signature.

(j) Related Information

    For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0014,
dated January 13, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0014, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2021-0448.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 27, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-13108 Filed 6-23-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 18 (Wednesday, January 28, 2015)]
[Notices]
[Pages 4562-4563]
[FR Doc No: 2015-01453]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12486-008--Idaho]

Twin Lakes Canal Company; Notice of Proposed Restricted Service
List for a Programmatic Agreement for Managing Properties Included in
or Eligible for Inclusion in the National Register of Historic Places

    Rule 2010 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure, 18 CFR 385.2010, provides
that, to eliminate unnecessary expense or improve administrative
efficiency, the Secretary may establish a restricted service list for a
particular phase or issue in a proceeding. The restricted service list
should contain the names of persons on the service list who, in the
judgment of the decisional authority establishing the list, are active
participants with respect to the phase or issue in the proceeding for
which the list is established.
    The Commission staff is consulting with the Idaho State Historic
Preservation Officer (SHPO) and the Advisory Council on Historic
Preservation (Council) pursuant to the Council's regulations, 36 CFR
part 800, implementing section 106 of the National Historic
Preservation Act, as amended, (16 U.S.C. 470 f), to prepare and execute
a Programmatic Agreement for managing properties included in, or
eligible for inclusion in, the National Register of Historic Places for
the proposed Bear River Narrows Hydroelectric Project (Project No.
12486).
    The Programmatic Agreement, when executed by the Commission,
Council, and the SHPO would satisfy the Commission's section 106
responsibilities for all individual undertakings carried out in
accordance with the license until the license expires or is terminated
(36 CFR 800.13[e]). The Commission's responsibilities pursuant to
section 106 for the proposed Bear River Narrows Hydroelectric Project
would be fulfilled through the Programmatic Agreement, which the
Commission proposes to draft in consultation with certain parties
listed below.
    Twin Lakes Canal Company, as licensee for the proposed Bear River
Narrows Hydroelectric Project, is invited to participate in
consultations to develop the Programmatic Agreement and to sign as a
concurring party to the Programmatic Agreement. For purposes of
commenting on the Programmatic Agreement, we propose to restrict the
service list for the aforementioned project as follows:
    John Eddins, or Representative, Office of Planning and Review,
Advisory Council on Historic Preservation, 1100 Pennsylvania Ave., NW,
Suite 809, Washington, DC 20004.
    Jason Walker, or Representative, Brigham Tribal Office,
Northwestern Band of the Shoshoni Nation, 707 N. Main Street, Brigham
City, UT 84302.
    Tim Murphy, or Representative, USDI Bureau of Land Management,
Idaho State Office, 1387 South Vinnell Way, Boise, ID 83709.
    Nathan Small, or Representative, Shoshone-Bannock Tribes, Fort Hall
Reservation, P.O. Box 306, Fort Hall, ID 83203.
    Sam Whittington, or Representative, Denver Service Center, National
Park Service, 12795 Alameda Parkway, Lakewood, CO 80225.
    Lindsey Manning, or Representative, Shoshone-Paiute Tribes, Duck
Valley Reservation, P.O. Box 219, Owyhee, NV 89832.
    R. Dirk Bowles, or Representative, District # 3, Franklin County
Commissioner, 39 West Oneida, Preston, ID 83263.
    Darwin Sinclair, Jr., or Representative, Shoshone Business Council,
Wind River Reservation, P.O. Box 538, Fort Washakie, WY 82514.
    Jody Williams, or Representative, Holland & Hart LLC, 222 South
Main Street # 2200, Salt Lake City, UT 84111.
    Ken Reid, or Representative, Idaho State Historical Society, 210
Main Street, Boise, ID 83702.
    Mark Sturtevant, or Representative, PacifiCorp Energy, 825 NE
Multnomah, Suite 1500, Portland, OR 97232.
    Allie Hansen, or Representative, Bear River-Battle Creek Monument
Assoc., 330 W. 2nd South, Preston, ID 83263.
    Nick Josten, or Representative, 2742 Saint Charles Ave. , Idaho
Falls, ID 83404.
    Any person on the official service list for the above-captioned
proceeding may request inclusion on the restricted service list, or may
request that a restricted service list not be established, by filing a
motion to that effect within 15 days of this notice date. In a request
for inclusion, please identify the reason(s) why there is an interest
to be included.
    Any such motions may be filed within 15 days from the date of this
notice. The Commission strongly encourages electronic filing. Please
file comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,
202-502-8659. In lieu of electronic filing, please send a paper copy
to: Secretary, Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426. The first page of any filing should include
docket numbers P-12486-008.
    If no such motions are filed, the restricted service list will be
effective at the end of the 15-day period. Otherwise, a further notice
will be issued ruling on any motion or motions filed within the 15-day
period.

    Dated: January 21, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-01453 Filed 1-27-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 7, 2007 (Volume 72, Number 173)]
[Notices]
[Page 51426-51427]
[DOCID:fr07se07-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP07-438-000]

Questar Pipeline Company; Notice of Application

August 30, 2007.
    Take notice that on August 23, 2007, Pipeline Company (Questar
Pipeline), and Questar Gas Company (Questar Gas) (the Applicants), 180
East 100 South, Salt Lake City, Utah 84111, jointly filed in Docket No.
CP07-438-000, an application, pursuant to section 7(b) of the Natural
Gas Act (NGA), seeking authority for Questar Pipeline to abandon
Jurisdictional Lateral (JL) 4, by sale, to Questar Gas. The applicants
also seek a determination that, upon acquisition, the JL 4 facilities
will be considered non-jurisdictional under section 1(b) of the NGA,
all as more fully set forth in the application which is on file with
the Commission and open to public inspection. This filing may also 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, call<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Specifically, the JL 4 is an 8-inch diameter pipeline that extends
approximately 14.63 miles northeast from Questar Pipeline's existing
North Baxter Compressor Station delivery area to Questar Pipeline's
Nightingale Compressor Station. This pipeline is located on Questar
Pipeline's northern transmission system in the vicinity of Rock
Springs, Sweetwater County, Wyoming.
    Any questions regarding this application should be directed to L.
Bradley Burton, Manager, Federal Regulatory Affairs, Questar Pipeline
Company, 180 East 100 South, P.O. Box 45360, Salt Lake City, Utah
84145-0360, at<PHONE_NUMBER>, or by fax at<PHONE_NUMBER>, or e-mail
<EMAIL_ADDRESS>
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project

provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should

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

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 30, 3007.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-17658 Filed 9-5-07; 8:45 am]

BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2565 PLYMOUTH ROAD

ANN ARBOR, MICHIGAN 48105-2498

OFFICE OF

AIR AND RADIATION

MEMORANDUM

SUBJECT:	Heavy-Duty Hybrid Onboard Diagnostics

FROM:		Amy Kopin

TO:		The Docket

DATE:		July 15, 2011

	On April 28th, 2011 we held a conference call with the California Air
Resources Board (CARB) to discuss concerns raised by hybrid
manufacturers, engine manufacturers, and related industry trade groups
regarding heavy-duty onboard diagnostic (OBD) requirements and timing.
Concerns were raised during the comment period for the heavy-duty
greenhouse gas notice of proposed rulemaking that heavy-duty hybrid
applications may not be able to meet the 2013 heavy-duty OBD regulations
that were published in the 2009 OBD Final Rulemaking.,  Specifically,
their comments include a request for a delay of the application of HD
OBD requirements for hybrid applications until 2020.  Attendees from the
EPA and CARB are shown in the table below.

 Attendee 	Affiliation

Cleophas Jackson 	EPA – Compliance and Innovative Strategies Division

Anthony Neam 	EPA – Assessment and Standards Division

Amy Kopin 	EPA – Assessment and Standards Division

Lucina Negrete	CARB

Jack Kitowski	CARB

Michael McCarthy	CARB

Joe Calavita	CARB

Jessica Dean	CARB

Michael Regenfuss	CARB

Ajay Chaudhary	CARB

 U.S. EPA, NHTSA, and DOT, “Greenhouse Gas Emission Standards and Fuel
Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles,”
republished December 29, 2010.  Available here:
http://origin.www.gpo.gov/fdsys/pkg/FR-2010-12-29/html/2010-32726.htm

 U.S. EPA, “Control of Air Pollution from New Motor Vehicles and New
Motor Vehicles Engines; Final Rule Regulations Requiring Onboard
Diagnostic Systems on 2010 and Later Heavy-Duty Engines Used in Highway
Applications Over 14,000 Pounds; Revisions to Onboard Diagnostic
Requirements for Diesel Highway Heavy-Duty Vehicles Under 14,000
Pounds,” published February 24, 2009.  Available here:
http://www.epa.gov/otaq/regs/im/obd/regtech/hd-obd-frm-02-24-09-notice-7
4-fr-8310.pdf


[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38323-38324]
[FR Doc No: 2014-15790]

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

Coast Guard

[USCG-2014-0543]

Great Lakes Pilotage Advisory Committee

AGENCY: Coast Guard, DHS.

ACTION: Committee Management; Notice of Federal Advisory Committee
Meeting.

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

SUMMARY: The Great Lakes Pilotage Advisory Committee will meet on July
23-24, 2014, in Washington, DC to discuss matters relating to Great
Lakes pilotage, including review of proposed Great Lakes pilotage
regulations and policies. These meetings will be open to the public.

DATES: The Great Lakes Pilotage Advisory Committee will meet on
Wednesday July 23rd, 2014, from 10:00 a.m. to 5:00 p.m., and on
Thursday July 24th from 9:00 a.m. to 5 p.m. Please note that the
meeting may close early if the committee completes its business. Pre-
registration, all submitted written materials, comments and requests to
make oral presentations at the meeting should reach Ms. Michelle
Birchfield, Great Lakes Pilotage Advisory Committee Alternate
Designated Federal Officer on or before July 18, 2014. Any written
material submitted by the public will be distributed to the committee
and become part of the public record.

ADDRESSES: The meeting will be held at U.S. Coast Guard Headquarters
located at 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593
in conference room 4R14-18. All visitors to Coast Guard Headquarters
will have to pre-register to be admitted to the building. Please
provide your full name, date of birth and Social Security number by
close of business on July 18, 2014, to the contact person listed in FOR
FURTHER INFORMATION CONTACT below. Additionally, all visitors to Coast
Guard Headquarters must provide identification in the form of
government-issued picture identification card for access to the
facility. Please allow at least 30 minutes before the planned start of
the meeting in order to pass through security.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the person listed in FOR FURTHER INFORMATION CONTACT below as soon as
possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the committee as listed in the
``Agenda''

section below. Comments must be submitted in writing no later than July
18, 2014, and must be identified by [USCG-2014-9110] and may be
submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Same as mail address above between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov, and use
``USCG-2014-0543'' in the ``Search'' box, press Enter, and then click
on the item you wish to view.
    Public comments will be heard during the meeting on July 23 and
July 24, 2014. Speakers are requested to limit their comments to 5
minutes. Please note that the public comment period may end before the
period allotted, following the last call for comments. Contact the
individual listed in the FOR FURTHER INFORMATION CONTACT: section below
to register as a speaker.

FOR FURTHER INFORMATION CONTACT: Commandant (CG-WWM-2), ATTN: Ms.
Michelle Birchfield, Great Lakes Pilotage Advisory Committee Alternate
Designated Federal Officer, U.S. Coast Guard Stop 7509, 2703 Martin
Luther King Jr. Avenue SE., Washington, DC 20593-7509; telephone 202-
372-1537, fax<PHONE_NUMBER>, or email at<EMAIL_ADDRESS>
If you have questions on viewing or submitting material to the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone 202-
366-9826 or 1-800-647-5527.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix, Public Law
92-463, 86 Stat, 770 as amended. The Great Lakes Pilotage Advisory
Committee was established under the authority of 46 U.S.C. 9307, and
makes recommendations to the Secretary of Homeland Security and the
Coast Guard on matters relating to Great Lakes pilotage, including
review of proposed Great Lakes pilotage regulations and policies.
    Further information about Great Lakes Pilotage Advisory Committee
is available by going to the Web site: https://www.facadatabase.gov.
Click on the search tab and type ``Great Lakes'' into the search form.
Then select ``Great Lakes Pilotage Advisory Committee'' from the list.
A copy of all meeting documentation will also be available at https://homeport.uscg.mil/GLPAC. Alternatively, you may contact Ms. Michelle
Birchfield as noted in the FOR FURTHER INFORMATION CONTACT: section
above.

Agenda

    The Great Lakes Pilotage Advisory Committee will meet to review,
discuss, deliberate and formulate recommendations as appropriate on
topics contained in the below agenda:
     Ice Operations: Closing of 2013 and Opening of 2014
Seasons
    [cir] Debrief
    [cir] US/Canada coordination
    [cir] Lessons learned
    [cir] Great Lakes Pilotage Management System (GLPMS, or Klein)
Migration
     Review General Regulations
    [cir] Update on effort to align with Federal Pilot requirements and
credentialing
    [cir] Required Reporting to USCG
    [ssquf] Financial and operational reporting
    [ssquf] Accident reporting
     Discussion of Pilotage Governance
    [cir] Working Rules
    [cir] Geographic areas of responsibility
    [cir] Observance of mandatory change points for safety
     Pilotage requirements for yachts
     Commencement of revenue audits
     Proposed changes to the ratemaking methodology
     Billing for pilot boat operations
     Funding capital improvements
     Improving recruitment and retention
     Continuing raining, education and professional development
    Public comments or questions will be taken throughout the meeting
as the committee discusses the issues. There will also be a public
comment period at the end of each day.
    Minutes: Minutes from the meeting will be available for public view
and copying within 90 days following the meeting at https://homeport.uscg.mil/GLPAC.

    Dated: June 30, 2014.
G.C. Rasicot,
Director, Marine Transportation Systems, U.S. Coast Guard.
[FR Doc. 2014-15790 Filed 7-3-14; 8:45 am]
BILLING CODE 9110-04-P