39040 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

temporary order to control brorphine as 

a Schedule I substance under the CSA. 

Eutylone (bk-EBDB) (chemical name: 

1-(1,3-benzodioxol-5-yl)-2- 

(ethylamino)butan-1-one) is a designer 

drug of the phenethylamine class. 

Eutylone is a synthetic cathinone with 

chemical structural and 

pharmacological similarities to 

Schedule I and II amphetamines and 

cathinones, such as to 3,4- 

Methylenedioxymethamphetamine, 

methylone, and pentylone. Eutylone 

emerged in the United States illicit, 

synthetic drug market in 2014 as 

evidenced by its identification in drug 

seizures. Other evidence indicates that 

eutylone, like other Schedule I synthetic 

cathinones, is abused for its 

psychoactive effects. Adverse effects 

associated with synthetic cathinones 

abuse include agitation, hypertension, 

tachycardia, and death. Eutylone is not 

approved for medical use in the United 

States. As a positional isomer of 

pentylone, eutylone is controlled in 

Schedule I of the CSA. 

BMDP (chemical name: 3,4- 

Methylenedioxy-N-benzylcathinone) is 

a designer drug of the phenethylamine 

class. BMDP is a synthetic cathinone 

with chemical structural and 

pharmacological similarities to 

Schedule I and II amphetamines (e.g., 

methamphetamine and 3,4- 

methylenedioxymethamphetamine) and 

cathinones (e.g., methylone). Law 

enforcement has seen an increase in the 

encounters of BMDP in 2019 in the 

United States illicit, synthetic drug 

market as evidenced by its identification 

in drug seizures. BMDP has no 

commercial or approved medical uses, 

and it is not controlled under the CSA. 

However, if BMDP is found to meet the 

criteria outlined in Title 21 of the 

United States Code, section 802(32) (21 

U.S.C. 802(32)), and it is intended for 

human consumption, it may be treated 

as a Schedule I controlled substance 

analogue for the purpose of Federal law 

pursuant to 21 U.S.C. 813. 

Mitragynine and 7- 

hydroxymitragynine are the main active 

constituents of the plant Mitragyna 

speciosa, commonly known as kratom, 

an indigenous plant of Southeast Asia. 

Kratom is abused for its ability to 

produce opioid-like effects. Kratom is 

available in several different forms to 

include dried/crushed leaves, powder, 

capsules, tablets, liquids, and gum/ 

resin. Kratom is an increasingly popular 

drug of abuse and readily available on 

the recreational drug market in the 

United States. Evidence suggests that 

kratom is abused individually and with 

other psychoactive substances. Kratom 

does not have an approved medical use 

in the United States and has not been 

studied as a treatment agent in the 

United States. Kratom has a history of 

being used as an opium substitute in 

Southeast Asia. In the United States, 

kratom is misused to self-treat chronic 

pain and opioid withdrawal symptoms. 

Consumption of kratom can lead to a 

number of health impacts, including, 

among others, respiratory depression, 

vomiting, nervousness, weight loss, and 

constipation. Kratom has been reported 

to have both narcotic and stimulant-like 

effects, and withdrawal symptoms may 

include hostility, aggression, excessive 

tearing, aching of muscles and bones, 

and jerky limb movements. Kratom is 

not a controlled substance under the 

CSA. 

Phenibut (chemical name: Betaphenyl-gamma-aminobutyric acid HCl) 

is a neuropsychotropic drug that is used 

in Russia to treat alcohol withdrawal, 

anxiety, insomnia, and vestibular 

disorders. It has anxiolytic and 

nootropic (cognition enhancing) effects. 

Phenibut acts as a gamma-aminobutyric 

acid (GABA)-mimetic, primarily at 

GABA(B) and, to some extent, at 

GABA(A) receptors. Phenibut is sold 

online as a supplement to improve 

cognitive function, memory, creativity 

in healthy persons, and used to selfmedicate anxiety, insomnia, and alcohol 

cravings. There are reports of people 

taking phenibut arriving to emergency 

departments with agitation, 

intoxication, altered mental status, and 

withdrawal, and also reports of 

phenibut in toxicology urinalysis 

reports from a prison facility, where 

inmates were abusing multiple drugs, 

including phenibut. There is no 

approved medical use for phenibut in 

the United States, and phenibut is not 

a controlled substance under the CSA. 

IV. Opportunity To Submit Domestic 

Information 

As required by paragraph (d)(2)(A) of 

the CSA, FDA, on behalf of HHS, invites 

interested persons to submit comments 

regarding the 11 drug substances. Any 

comments received will be considered 

by HHS when it prepares a scientific 

and medical evaluation for drug 

substances that is responsive to the 

WHO Questionnaire for these drug 

substances. HHS will forward such 

evaluation of these drug substances to 

WHO, for WHO’s consideration in 

deciding whether to recommend 

international control/decontrol of any of 

these drug substances. Such control 

could limit, among other things, the 

manufacture and distribution (import/ 

export) of these drug substances and 

could impose certain recordkeeping 

requirements on them. 

Although FDA is, through this notice, 

requesting comments from interested 

persons, which will be considered by 

HHS when it prepares an evaluation of 

these drug substances, HHS will not 

now make any recommendations to 

WHO regarding whether any of these 

drugs should be subjected to 

international controls. Instead, HHS will 

defer such consideration until WHO has 

made official recommendations to the 

Commission on Narcotic Drugs, which 

are expected to be made in late 2021. 

Any HHS position regarding 

international control of these drug 

substances will be preceded by another 

Federal Register notice soliciting public 

comments, as required by paragraph 

(d)(2)(B) of the CSA. 

Dated: July 19, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15685 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of Emergency Use 

Authorizations (EUAs) (the 

Authorizations) for certain medical 

devices related to the Coronavirus 

Disease 2019 (COVID–19) public health 

emergency. FDA has issued the 

Authorizations listed in this document 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). These 

Authorizations contain, among other 

things, conditions on the emergency use 

of the authorized products. The 

Authorizations follow the February 4, 

2020, determination by the Secretary of 

Health and Human Services (HHS) that 

there is a public health emergency that 

has a significant potential to affect 

national security or the health and 

security of U.S. citizens living abroad, 

and that involves the virus that causes 

COVID–19, and the subsequent 

declarations on February 4, 2020, March 

2, 2020, and March 24, 2020, that 

circumstances exist justifying the 

authorization of emergency use of in 

vitro diagnostics for detection and/or 


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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39041 

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. 

2The 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. 

diagnosis of the virus that causes 

COVID–19, personal respiratory 

protective devices, and medical devices, 

including alternative products used as 

medical devices, respectively, subject to 

the terms of any authorization issued 

under the FD&C Act. These 

Authorizations, which include an 

explanation of the reasons for issuance, 

are listed in this document, and can be 

accessed on FDA’s website from the 

links indicated. 

DATES: These Authorizations are 

effective on their date of issuance. 

ADDRESSES: Submit written requests for 

single copies of an EUA to the Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4338, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request or include a fax number to 

which the Authorization may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Authorization. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

301–796–8510 (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 lifethreatening 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. 

Once the Secretary of HHS has 

declared that circumstances exist 

justifying an authorization under 

section 564 of the FD&C Act, FDA may 

authorize the emergency use of a drug, 

device, or biological product if the 

Agency concludes that the statutory 

criteria are satisfied. Under section 

564(h)(1) of the FD&C Act, FDA is 

required to publish in the Federal 

Register a notice of each authorization, 

and each termination or revocation of an 

authorization, and an explanation of the 

reasons for the action. Under section 

564(h)(1) of the FD&C Act, revisions to 

an authorization shall be made available 

on the internet website of the FDA. 

Section 564 of the FD&C Act permits 

FDA to authorize the introduction into 

interstate commerce of a drug, device, or 

biological product intended for use 

when the Secretary of HHS has declared 

that circumstances exist justifying the 

authorization of emergency use. 

Products appropriate for emergency use 

may include products and uses that are 

not approved, cleared, or licensed under 

section 505, 510(k), 512, or 515 of the 

FD&C Act (21 U.S.C. 355, 360(k), 360b, 

or 360e) or section 351 of the PHS Act 

(42 U.S.C. 262), or conditionally 

approved under section 571 of the FD&C 

Act (21 U.S.C. 360ccc). FDA may issue 

an EUA only if, after consultation with 

the HHS Assistant Secretary for 

Preparedness and Response, the 

Director of the National Institutes of 

Health, and the Director of the Centers 

for Disease Control and Prevention 

(CDC) (to the extent feasible and 

appropriate given the applicable 

circumstances), FDA 2 concludes: (1) 

That an agent referred to in a 

declaration of emergency or threat can 

cause a serious or life-threatening 

disease or condition; (2) that, based on 

the totality of scientific evidence 

available to FDA, including data from 

adequate and well-controlled clinical 

trials, if available, it is reasonable to 

believe that (A) the product may be 

effective in diagnosing, treating, or 

preventing (i) such disease or condition; 

or (ii) a serious or life-threatening 

disease or condition caused by a 

product authorized under section 564, 

approved or cleared under the FD&C 

Act, or licensed under section 351 of the 

PHS Act, for diagnosing, treating, or 

preventing such a disease or condition 

caused by such an agent; and (B) the 

known and potential benefits of the 

product, when used to diagnose, 

prevent, or treat such disease or 

condition, outweigh the known and 

potential risks of the product, taking 

into consideration the material threat 

posed by the agent or agents identified 

in a declaration under section 

564(b)(1)(D) of the FD&C Act, if 

applicable; (3) that there is no adequate, 

approved, and available alternative to 

the product for diagnosing, preventing, 

or treating such disease or condition; (4) 

in the case of a determination described 

in section 564(b)(1)(B)(ii), that the 

request for emergency use is made by 

the Secretary of Defense; and (5) that 

such other criteria as may be prescribed 

by regulation are satisfied. No other 

criteria for issuance have been 

prescribed by regulation under section 

564(c)(4) of the FD&C Act. 

II. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorizations are aavailable on the 

internet and can be accessed from 

https://www.fda.gov/emergencypreparedness-and-response/mcm-legalregulatory-and-policy-framework/ 

emergency-use-authorization. 


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39042 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

3As 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 lifethreatening 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. 

4As set forth in the EUAs for these products, FDA 

has concluded that: (1) SARS–CoV–2 can cause a 

serious or life-threatening disease or condition, 

including severe respiratory illness, to humans 

infected by this virus; (2) based on the totality of 

scientific evidence available to FDA, it is reasonable 

to believe that the products may be effective in 

diagnosing recent or prior infection with SARS– 

CoV–2 by identifying individuals with an adaptive 

immune response to the virus that causes COVID– 

19, and that the known and potential benefits of the 

products when used for such use, outweigh the 

known and potential risks of the products; and (3) 

there is no adequate, approved, and available 

alternative to the emergency use of the products. 

5As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening 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 

T-Detect COVID Test may be effective in diagnosing 

recent or prior infection with SARS–CoV–2 by 

identifying individuals with a T-cell immune 

response to the virus that causes COVID–19, and 

that the known and potential benefits of your 

product when used for such use, outweigh the 

known and potential risks of the T-Detect COVID 

Test; and (3) there is no adequate, approved, and 

III. The Authorizations 

Having concluded that the criteria for 

the issuance of the following 

Authorizations under section 564(c) of 

the FD&C Act are met, FDA has 

authorized the emergency use of the 

following products for diagnosing, 

treating, or preventing COVID–19 

subject to the terms of each 

Authorization. The Authorizations in 

their entirety, including any authorized 

fact sheets and other written materials, 

can be accessed from the FDA web page 

entitled ‘‘Emergency Use 

Authorization,’’ available at https://

www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The lists that follow 

include Authorizations issued from 

February 16, 2021, through May 31, 

2021, and we have included 

explanations of the reasons for their 

issuance, as required by section 

564(h)(1) of the FD&C Act. In addition, 

the EUAs that have been reissued can be 

accessed from FDA’s web page: https:// 

www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. 

FDA is hereby announcing the 

following Authorizations for molecular 

diagnostic and antigen tests for COVID– 

19, excluding multianalyte tests: 3

• University of Illinois Office of the 

Vice President for Economic 

Development and Innovation’s 

covidSHIELD, issued February 24, 2021; 

• Viracor Eurofins Clinical 

Diagnostics’s Viracor SARS–CoV–2 

Assay DTC, issued February 26, 2021; 

• Quidel Corporation’s QuickVue AtHome COVID–19 Test, issued March 1, 

2021; 

• Clinical Research Sequencing 

Platform (CRSP), LLC at the Broad 

Institute of the Massachusetts Institute 

of Technology and Harvard’s CRSP 

SARS–CoV–2 Real-time Reverse 

Transcriptase (RT)-PCR Diagnostic 

Assay (Version 3), issued March 5, 2021; 

• Cue Health Inc.’s Cue COVID–19 

Test for Home and Over The Counter 

(OTC) Use, issued March 5, 2021; 

• Color Health, Inc.’s Color SARS– 

CoV–2 RT–LAMP Diagnostic Assay 

DTC, issued March 19, 2021; 

• Twist Bioscience Corporation’s 

SARS–CoV–2 NGS Assay, issued March 

23, 2021; 

• STS Lab Holdco’s (a subsidiary of 

Amazon.com Services LLC), Amazon 

Real-Time RT–PCR Test for Detecting 

SARS–CoV–2, issued March 25, 2021; 

• DiaSorin, Inc.’s LIAISON SARS– 

CoV–2 Ag, issued March 26, 2021; 

• Abbott Diagnostics Scarborough, 

Inc.’s BinaxNOW COVID–19 Ag 2 Card, 

issued March 31, 2021; 

• Quidel Corporation’s QuickVue AtHome OTC COVID–19 Test, issued 

March 31, 2021; 

• Abbott Diagnostics Scarborough, 

Inc.’s BinaxNOW COVID–19 Antigen 

Self Test, issued March 31, 2021; 

• Abbott Diagnostics Scarborough, 

Inc.’s BinaxNOW COVID–19 Ag Card 2 

Home Test, issued March 31, 2021; 

• Thermo Fisher Scientific’s 

Amplitude Solution with the TaqPath 

COVID–19 High-Throughput Combo Kit, 

issued April 9, 2021; 

• Lucira Health, Inc.’s Lucira 

CHECK√IT COVID–19 Test Kit, issued 

April 9, 2021; 

• PerkinElmer Genomics’s 

PerkinElmer SARS–CoV–2 RT-qPCR 

Reagent Kit, issued April 12, 2021; 

• Qorvo Biotechnologies, LLC.’s 

Omnia SARS–CoV–2 Antigen Test, 

issued April 13, 2021; 

• Clinical Enterprise, Inc.’s Clinical 

Enterprise SARS–CoV–2 RT–PCR Assay 

DTC, issued April 13, 2021; 

• Clinical Enterprise, Inc.’s Clinical 

Enterprise SARS–CoV–2 RT–PCR Assay, 

issued April 13, 2021; 

• LGC, Biosearch Technologies’ 

Biosearch Technologies SARS–CoV–2 

Real-Time and End-Point RT–PCR Test, 

issued April 15, 2021; 

• Synergy Diagnostic Laboratory, 

Inc.’s (DBA SynergyDx), SynergyDx 

SARS–CoV–2 RNA Test, issued April 

16, 2021; 

• Synergy Diagnostic Laboratory, 

Inc.’s (DBA SynergyDx), SynergyDx 

SARS–CoV–2 RNA Test DTC, issued 

April 16, 2021; 

• Celltrion USA, Inc.’s Celltrion 

DiaTrust COVID–19 Ag Rapid Test, 

issued April 16, 2021; 

• Southern California Permanente 

Medical Group’s Kaiser Permanente 

High Throughput SARS–CoV–2 Assay, 

issued April 19, 2021; 

• PathogenDx, Inc.’s DetectX-Rv, 

issued April 20, 2021; 

• InBios International, Inc.’s SCoV–2 

Ag Detect Rapid Test, issued May 6, 

2021; 

• Phosphorus Diagnostics LLC’s 

Phosphorous COVID19 RT-qPCR Test 

DTC, issued May 17, 2021; 

• Salofa Oy’s Sienna-Clarity COVID– 

19 Antigen Rapid Test Cassette, issued 

May 20, 2021; 

• Harvard University Clinical 

Laboratory’s Quaeris SARS–CoV–2 

Assay, issued May 21, 2021; 

• Thermo Fisher Scientific Inc.’s 

TaqPath COVID–19 Pooling Kit, issued 

May 25, 2021. 

FDA is hereby announcing the 

following Authorizations for serology 

tests: 4

• Abbott Laboratories Inc.’s AdviseDx 

SARS–CoV–2 IgG II, issued March 1, 

2021; 

• Beckman Coulter, Inc.’s Access 

SARS–CoV–2 IgG II, issued March 22, 

2021; 

• Siemens Healthcare Diagnostics 

Inc.’s Atellica IM SARS–CoV–2 IgG 

(sCOVG), issued March 23, 2021; 

• Symbiotica, Inc.’s COVID–19 SelfCollected Antibody Test System, issued 

April 5, 2021; 

• Inova Diagnostics, Inc.’s QUANTA 

Flash SARS–CoV–2 IgG, issued April 

19, 2021; 

• QIAGEN, GmbH’s QIAreach AntiSARS–CoV–2 Total Test, issued May 11, 

2021; 

• ZEUS Scientific, Inc.’s ZEUS ELISA 

SARS–CoV–2 Total Antibody Test 

System, issued May 11, 2021; 

• DiaSorin, Inc.’s LIAISON SARS– 

CoV–2 TrimericS IgG, issued May 19, 

2021; 

• NOWDiagnostics, Inc.’s ADEXUSDx 

COVID–19 Test, issued May 24, 2021. 

FDA is hereby announcing the 

following Authorization for a T-cell 

immune response test: 

• Adaptive Biotechnologies 

Corporation’s T-Detect COVID Test, 

issued March 5, 2021.5


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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39043 

available alternative to the emergency use of the TDetect COVID Test. 6There are FDA-approved/cleared tests for 

Influenza A virus (with subtype differentiation), 

and other organisms, such as Influenza B virus, 

Respiratory Syncytial virus (RSV) A and RSV B, 

Coronaviruses 229E, OC43, NL63 and HKU1, 

Human Metapneumovirus, Rhinovirus/Enterovirus, 

Adenovirus, Parainfluenza virus Types 1, 2, 3, and 

4, Human Bocavirus, Chlamydophila pneumoniae, 

and Mycoplasma pneumoniae but there are no FDA 

approved/cleared multiplexed tests for 

simultaneous qualitative detection and 

differentiation of SARS–CoV–2, and these 

additional pathogens targeted by the products (see 

individual EUAs for specific other pathogens). 

Respiratory infections caused by the 

aforementioned pathogens and SARS–CoV–2 can 

have similar clinical presentation and diagnostic 

considerations. Thus, to differentially detect SARS– 

CoV–2, information from a test that detects and 

differentiates the virus that causes COVID–19 and 

other respiratory pathogens is needed. For example, 

the common influenza viruses that cause seasonal 

epidemics of flu, influenza A and B, is needed 

during the flu season that coincides with the 

COVID–19 pandemic. 

7As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19, 

through the simultaneous detection and 

differentiation of nucleic acids from SARS–CoV–2 

and other respiratory viral and bacterial organisms 

and that the known and potential benefits of the 

product when used for diagnosing COVID–19, 

outweigh the known and potential risks of the 

product; and (3) there is no adequate, approved, 

and available alternative to the emergency use of 

the product. The NxTAG Respiratory Pathogen 

Panel + SARS–CoV–2 is intended for the 

simultaneous detection and differentiation of 

nucleic acid from SARS– CoV–2 and the following 

organism types and subtypes: Influenza A, 

Influenza A H1, Influenza A H3, Influenza B, 

Respiratory Syncytial Virus A, Respiratory 

Syncytial Virus B, Coronavirus 229E, Coronavirus 

OC43, Coronavirus NL63, Coronavirus HKU1, 

Human Metapneumovirus, Rhinovirus/Enterovirus, 

Adenovirus, Parainfluenza virus 1, Parainfluenza 

virus 2, Parainfluenza virus 3, Parainfluenza virus 

4, Human Bocavirus, Chlamydophila pneumoniae, 

and/or Mycoplasma pneumoniae. 

8As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19 

through the simultaneous detection and 

differentiation of SARS–CoV–2, influenza A virus, 

influenza B virus and/or RSV nucleic acids and that 

the known and potential benefits of the product 

when used for diagnosing COVID–19, outweigh the 

known and potential risks of the product; and (3) 

there is no adequate, approved, and available 

alternative to the emergency use of the product. 

9As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19 

through the simultaneous detection and 

differentiation of SARS–CoV–2, and/or influenza A 

virus and influenza B virus protein antigens and 

that the known and potential benefits of the product 

when used for such a use, outweigh the known and 

potential risks of the product; and (3) there is no 

adequate, approved, and available alternative to the 

emergency use of the product. 

10As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19 

and that the known and potential benefits of the 

product when used for diagnosing COVID–19, 

outweigh the known and potential risks of the 

product; and (3) there is no adequate, approved, 

and available alternative to the emergency use of 

the product. 

11As 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 GetMyDNA 

COVID–19 Test Home Collection Kit may be 

effective in diagnosing COVID–19, by serving as an 

appropriate means to collect and transport human 

specimens so that an authorized laboratory can 

detect SARS–CoV–2 RNA from the home-collected 

human specimen, and that the known and potential 

benefits of the GetMyDNA COVID–19 Test Home 

Collection Kit when used for diagnosing COVID–19, 

outweigh the known and potential risks of the 

GetMyDNA COVID–19 Test Home Collection Kit; 

and (3) there is no adequate, approved, and 

available alternative to the emergency use of the 

GetMyDNA COVID–19 Test Home Collection Kit. 

12As 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 Color 

COVID–19 Self-Swab Collection Kit DTC may be 

effective in diagnosing COVID–19, by serving as an 

appropriate means to collect and transport human 

specimens so that an authorized laboratory can 

detect SARS–CoV–2 RNA from the home-collected 

human specimen, and that the known and potential 

benefits of the Color COVID–19 Self-Swab 

Collection Kit DTC when used for diagnosing 

COVID–19, outweigh the known and potential risks 

of the Color COVID–19 Self-Swab Collection Kit 

DTC; and (3) there is no adequate, approved, and 

available alternative to the emergency use of the 

Color COVID–19 Self-Swab Collection Kit DTC. 

13As 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 Tiger Tech 

COVID Plus Monitor, when used by trained 

personnel, may be effective at preventing exposure 

to and spread of SARS–CoV–2 by identifying 

certain biomarkers in asymptomatic individuals 

over the age of 5, when performed following a 

temperature reading that does not meet the criteria 

for fever in settings where temperature check is 

being conducted in accordance with CDC and local 

institutional infection prevention and control 

guidelines, and that the known and potential 

benefits of such product, when used as described 

in the Scope of Authorization of the authorization 

letter, outweigh the known and potential risks; and 

(3) there are no adequate, approved, and available 

alternatives to the emergency use of the Tiger Tech 

COVID Plus Monitor. 

14As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening 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 

AerosolVE Device may be effective in preventing 

healthcare provider exposure to pathogenic 

biological airborne particulates by providing an 

extra layer of barrier protection in addition to 

personal protective equipment, at the time of 

definitive airway management, or when performing 

airway-related medical procedures, or during 

certain transport (when end-tidal CO2 monitoring is 

not available) for a maximum duration of use of 30 

minutes, of patients with suspected or confirmed 

diagnosis of COVID–19 and that the known and 

potential benefits of the AerosolVE Device 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 AerosolVE 

Device. During the public health emergency, it 

would not be feasible to require healthcare 

providers to limit use of the AerosolVE Device to 

patients with suspected or confirmed COVID–19; 

therefore, the authorization does not restrict use to 

such patients. 

15As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening 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 

IBU may be effective in preventing healthcare 

provider exposure to pathogenic biological airborne 

particulates by providing an extra layer of barrier 

protection in addition to personal protective 

equipment, at the time of definitive airway 

management, 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 IBU for 

Continued 

FDA is hereby announcing the 

following Authorizations for 

multianalyte in vitro diagnostics: 6

• Luminex Molecular Diagnostics, 

Inc.’s NxTAG Respiratory Pathogen 

Panel + SARS–CoV–2, issued March 3, 

2021; 7

• Abbott Molecular Inc.’s Alinity m 

Resp-4-Plex, issued March 4, 2021; 8

• Becton, Dickinson and Company’s 

(BD’s) BD Veritor System for Rapid 

Detection of SARS–CoV–2 & Flu A+B, 

issued March 24, 2021; 9

• NeuMoDx Molecular, Inc.’s 

NeuMoDx Flu A–B/RSV/SARS–CoV–2 

Vantage Assay, issued March 25, 

2021.10

FDA is hereby announcing the 

following Authorizations for other 

medical devices: 

• GetMyDNA’s GetMyDNA COVID– 

19 Test Home Collection Kit, issued 

March 9, 2021; 11

• Color Health, Inc.’s Color COVID– 

19 Self-Swab Collection Kit DTC, issued 

March 19, 2021; 12

• Tiger Tech Solutions, Inc.’s Tiger 

Tech COVID Plus Monitor, issued 

March 19, 2021.13

• Inspire Rx, LLC’s Inspire Rx, LLC 

Portable Negative Pressure Isolation & 

Procedural Tent System, (referred to as 

the ‘‘AerosolVE Device’’), issued March 

29, 2021; 14

• J. Peter Rubin, MD, MBA, FACS at 

the University of Pittsburgh’s Individual 

Biocontainment Unit (‘‘IBU’’), issued 

April 1, 2021; 15


khammond on DSKJM1Z7X2PROD with NOTICES
39044 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

such use outweigh its known and potential risks; 

and (3) there are no adequate, approved, and 

available alternatives to the emergency use of the 

IBU. During the public health emergency, it would 

not be feasible to require healthcare providers to 

limit the IBU use for patients with suspected or 

confirmed COVID–19; therefore, the authorization 

does not restrict use to such patients. 

16As 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 SalivaDirect 

At-Home Collection Kit may be effective in 

diagnosing COVID–19, by serving as an appropriate 

means to collect and transport human specimens so 

that an authorized laboratory can detect SARS– 

CoV–2 RNA from the self-collected human 

specimen, and that the known and potential 

benefits of the SalivaDirect At-Home Collection Kit 

when used for diagnosing COVID–19, outweigh the 

known and potential risks of the SalivaDirect AtHome Collection Kit; and (3) there is no adequate, 

approved, and available alternative to the 

emergency use of the SalivaDirect At-Home 

Collection Kit. 

17As 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 Color 

COVID–19 Self-Swab Collection Kit with Saline 

may be effective in diagnosing COVID–19, by 

serving as an appropriate means to collect and 

transport human specimens so that an authorized 

laboratory can detect SARS–CoV–2 RNA from the 

self-collected human specimen, and that the known 

and potential benefits of the Color COVID–19 SelfSwab Collection Kit with Saline when used for 

diagnosing COVID–19, outweigh the known and 

potential risks of the Color COVID–19 Self-Swab 

Collection Kit with Saline; and (3) there is no 

adequate, approved, and available alternative to the 

emergency use of the Color COVID–19 Self-Swab 

Collection Kit with Saline. 

18As set forth in the EUA, FDA has concluded: 

(1) SARS–CoV–2 can cause a serious or lifethreatening 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 

ISOCUBE may be effective in preventing healthcare 

provider exposure to pathogenic biological airborne 

particulates by providing an extra layer of barrier 

protection in addition to personal protective 

equipment, at the time of definitive airway 

management, or 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 ISOCUBE for such use outweigh its 

known and potential risks; and (3) there are no 

adequate, approved, and available alternatives to 

the emergency use of the ISOCUBE. During the 

public health emergency, it would not be feasible 

to require healthcare providers to limit the 

ISOCUBE use for patients with suspected or 

confirmed COVID–19; therefore, the authorization 

does not restrict use to such patients. 

19As set forth in the EUA, FDA has concluded: 

(1) SARS–CoV–2 can cause a serious or lifethreatening 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 

NPS may be effective in preventing healthcare 

provider exposure to pathogenic biological airborne 

particulates by providing an extra layer of barrier 

protection in addition to personal protective 

equipment, at the time of definitive airway 

management, when performing airway-related 

medical procedures, or during certain transport for 

a maximum duration of use of 1 hour, of patients 

with suspected or confirmed diagnosis of COVID– 

19 and that the known and potential benefits of the 

NPS for such use outweigh its known and potential 

risks; and (3) there are no adequate, approved, and 

available alternatives to the emergency use of the 

NPS. During the public health emergency, it would 

not be feasible to require healthcare providers to 

limit use of the NPS to patients with suspected or 

confirmed COVID–19; therefore, the authorization 

does not restrict use to such patients. 

20As 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 Pinpoint 

by Phosphorus COVID–19 Test Home Collection Kit 

DTC may be effective in diagnosing COVID–19, by 

serving as an appropriate means to collect and 

transport human specimens so that an authorized 

laboratory can detect SARS–CoV–2 RNA from the 

self-collected human specimen, and that the known 

and potential benefits of the Pinpoint by 

Phosphorus COVID–19 Test Home Collection Kit 

DTC when used for diagnosing COVID–19, 

outweigh the known and potential risks of the 

Pinpoint by Phosphorus COVID–19 Test Home 

Collection Kit DTC; and (3) there is no adequate, 

approved, and available alternative to the 

emergency use of the Pinpoint by Phosphorus 

COVID–19 Test Home Collection Kit DTC. 

21As set forth in the amendment, FDA has 

concluded (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 tests may be effective in 

diagnosing COVID–19 for the indications set forth 

in the appendices of the amendment letter, and that 

the known and potential benefits of the authorized 

tests when used for such use, outweigh the known 

and potential risks of the authorized tests included 

in the amendment; and (3) there are no adequate, 

approved, and available alternatives to the 

emergency use of the authorized tests included in 

the amendment. 

• Yale School of Public Health, 

Department of Epidemiology of 

Microbial Diseases’ SalivaDirect AtHome Collection Kit, issued April 9, 

2021; 16

• Color Health, Inc.’s Color COVID– 

19 Self-Swab Collection Kit with Saline, 

issued April 14, 2021; 17

• Prep Tech, LLC’s ISOCUBE SS and 

ISOCUBE ONE (‘‘ISOCUBE’’), issued 

May 4, 2021; 18

• Breegi Scientific, Inc.’s Negative 

Pressure SteriDome (NPS), issued May 

6, 2021; 19

• Phosphorus Diagnostics LLC’s 

Pinpoint by Phosphorus COVID–19 Test 

Home Collection Kit DTC, issued May 

17, 2021.20

Finally, FDA is hereby announcing an 

amendment to certain EUAs to allow 

certain authorized molecular diagnostic 

SARS–CoV–2 tests to be distributed and 

used to pool anterior nasal respiratory 

specimens from asymptomatic 

individuals as part of a serial testing 

program after developers submit a 

complete notification, including 

meeting required validation data, as set 

forth in the amendment letter. The 

amendment ‘‘Amending Certain EUAs 

for RT–PCR Molecular-Based Diagnostic 

Tests to Authorize the Detection of 

Nucleic Acid from SARS–CoV–2 from 

Pooled Anterior Nasal Respiratory 

Specimens for Screening When Used as 

Part of a Serial Testing Program,’’ was 

issued to ‘‘Developers of MolecularBased Diagnostic Tests Authorized for 

Emergency Use for Coronavirus Disease 

2019 (COVID–19) as of Today’s Date’’ on 

April 20, 2021.21

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15680 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6395] 

Request for Applications for New 

Members of the Clinical Trials 

Transformation Initiative/Food and 

Drug Administration Patient 

Engagement Collaborative 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; request for applications. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency), in 

collaboration with the Clinical Trials 

Transformation Initiative (CTTI), is 

requesting applications of patient 

advocates interested in participating on 

the Patient Engagement Collaborative 

(PEC). The PEC is an ongoing, 

collaborative forum coordinated through 

the Office of Patient Affairs, Office of 

Clinical Policy and Programs (OCPP), 

Office of the Commissioner, and is 

hosted by CTTI. Through the PEC, the 

patient community and regulators are 

able to discuss an array of topics 

regarding increasing meaningful patient 

engagement in medical product 

development and regulatory discussions 

at FDA. The activities of the PEC may 

include, but are not limited to, 

providing diverse perspectives on topics 

such as systematic patient engagement, 

transparency, and communication; 

providing considerations for 

implementing new strategies to enhance 

patient engagement at FDA; and 

proposing new models of collaboration 

in which patients and patient advocates 

are partners in non-product specific 


khammond on DSKJM1Z7X2PROD with NOTICES