4952 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

is currently in commercial distribution 

in the United States. 

• The establishment is willing to 

participate in an onsite or hybrid 

assessment. 

B. Requests To Participate 

Drug product manufacturers that are 

eligible and interested in participating 

in the voluntary QMM Prototype 

Assessment Protocol Evaluation 

Program should submit a request 

directly to Conchetta Newton (see FOR

FURTHER INFORMATION CONTACT). To be 

considered for this program, a request 

should include all the following 

information: (1) a contact person (name 

and email); (2) manufacturing 

establishment address; (3) FDA 

Establishment Identifier and Data 

Universal Numbering System Numbers; 

(4) a brief description of the business 

operations (e.g., manufacturing, testing, 

re/packaging, re/labeling, sterilizing, 

storing, distributing, or salvaging) 

conducted at the establishment; and (5) 

confirmation that the establishment 

features the characteristics discussed in 

section II.A of this notice. 

C. Selection Process 

FDA intends to select participants 

that reasonably reflect the diversity of 

the industry. FDA intends to notify each 

establishment of FDA’s decision on 

their request to participate in the 

voluntary QMM Prototype Assessment 

Protocol Evaluation Program within 90 

days of receipt. FDA intends to select up 

to nine volunteer participants for this 

program. 

D. FDA-Participant Interactions 

FDA intends to notify selected 

participants of their selection and 

confirm participation. This notification 

will include more information about 

engagement with the Agency, including 

an orientation and a pre-assessment 

questionnaire to assist the establishment 

in preparing for the assessment, 

logistical information such as options 

for dates and times to schedule the 

assessment, and recommendations for 

establishment personnel that should be 

available during the assessment. Teams 

of three assessors will conduct the 

prototype assessment protocol over a 

period that is expected to be up to five 

business days. Each team will be 

composed of CDER staff, or a 

combination of CDER staff and 

contractors. Following completion of 

the assessment, each participating 

establishment will receive a report 

summarizing areas of strength and 

growth opportunities. In addition, 

approximately 6 months after the 

assessment, FDA will followup with a 

virtual meeting to get feedback on the 

prototype assessment protocol, the 

report, and any limitations encountered. 

This will help the Agency evaluate use 

of the protocol, including whether it 

enables meaningful assessment of the 

establishment’s quality management 

practices and if feedback for the 

establishment is actionable. 

III. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

* 1. Quality Management Maturity for 

Finished Dosage Forms Pilot Program for 

Domestic Drug Product Manufacturers; 

Program Announcement,’’ 85 FR 65824, 

October 16, 2020, https://www.federal

register.gov/d/2020-22976. 

* 2. ‘‘Quality Management Maturity for 

Active Pharmaceutical Ingredients Pilot 

Program for Foreign Facilities; Program 

Announcement,’’ 85 FR 65828, October 16, 

2020, https://www.federalregister.gov/d/ 

2020-22977. 

3. J. Maguire, A. Fisher, D. Harouaka, N. 

Rakala, et al., 2023, ‘‘Lessons from CDER’s 

Quality Management Maturity Pilot 

Programs,’’ AAPS Journal, 25(14), January 10, 

2023, https://doi.org/10.1208/s12248-022- 

00777-z. 

Dated: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01423 Filed 1–24–24; 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 or Agency) is 

announcing the issuance of Emergency 

Use Authorizations (EUAs) (the 

Authorizations) for certain medical 

devices related to Coronavirus Disease 

2019 (COVID–19). 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 

Authorization follows the February 4, 

2020, determination by the Secretary of 

Health and Human Services (HHS), as 

amended on March 15, 2023, 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 the virus that causes COVID– 

19, and the subsequent declarations on 

February 4, 2020, March 2, 2020, and 

March 24, 2020, that circumstances 

exist justifying the authorization of 

emergency use of in vitro diagnostics for 

detection and/or diagnosis of the virus 

that causes COVID–19, personal 

respiratory protective devices, and 

medical devices, including alternative 

products used as medical devices, 

respectively, subject to the terms of any 

authorization issued under the FD&C 

Act. These Authorizations, which 

include an explanation of the reasons 

for issuance, are listed in this document, 

and 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 

Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed 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: Kim 

Sapsford-Medintz, Office of Product 

Evaluation and Quality, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3216, 

Silver Spring, MD 20993–0002, 301– 

796–0311 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 


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Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 4953 

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. 

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 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 (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 lifethreatening 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 lifethreatening 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 available on the 

internet and can be accessed from 

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

emergency-use-authorization. 

III. The Authorizations 

Having concluded that the criteria for 

the issuance of the following 

Authorizations under section 564(c) of 

the FD&C Act are met, FDA has 

authorized the emergency use of the 

following products for diagnosing, 

treating, or preventing COVID–19 

subject to the terms of each 

Authorization. The Authorizations in 

their entirety, including any authorized 

fact sheets and other written materials, 

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 

April 14, 2023, through December 8, 

2023, 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 


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4954 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

3As 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 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 EUA for this product, 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 product 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 

nucleocapsid protein antigens, and that the known 

and potential benefits of the product when used for 

diagnosing COVID–19, 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. 

5As set forth in the EUA for this product, 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 product may be effective in 

diagnosing COVID–19 through the simultaneous 

qualitative detection and differentiation of SARS– 

CoV–2, influenza A virus and/or influenza B virus 

RNA, and that the known and potential benefits of 

the product when used for diagnosing COVID–19, 

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. 

diagnostic and antigen tests for COVID– 

19, excluding multianalyte tests: 3

• Azure Biotech, Inc.’s Azure Fatep 

COVID–19 Antigen Pen Home Test, 

issued April 14, 2023; 

• MedArbor, LLC dba MedArbor 

Diagnostics’ MedArbor Diagnostics 

SARS–CoV–2 Assay, issued April 19, 

2023; 

• Princeton BioMeditech Corp’s 

Status COVID–19 Antigen Rapid Test 

for Home Use, issued April 24, 2023; 

• University of Massachusetts’ ICTC 

SARS–CoV–2 RT–PCR Assay, issued 

April 26, 2023; 

• Drexel University College of 

Medicine’s SARS–CoV–2 DUCoM–PDL 

Modified Tetracore Assay, issued on 

April 28, 2023; 

• Access Medical Laboratories, Inc.’s 

Global Direct RT–PCR Test, issued on 

May 3, 2023; 

• Nano-Ditech Corporation’s NanoCheck COVID–19 Antigen At-Home 

Test, issued on May 12, 2023; 

• BioTeke USA, LLC’s Bio-Self 

COVID–19 Antigen Home Test, issued 

on May 22, 2023; 

• Acutis Diagnostics’ SARS–CoV–2 

Acutis Multiplex Assay, issued on June 

06, 2023; 

• Michigan State University 

laboratories, Department of Medicine 

Olin Student Health Center’s In-Dx 

SARS–CoV–2 RT–LAMP Assay, issued 

on June 08, 2023; 

• Discover Labs’ Discover Labs 

COVID–19 Assay, issued on June 30, 

2023; 

• Immunostics Inc.’s Swab-N-Go 

Home Test COVID–19 Ag, issued on 

July 17, 2023; 

• Alphadera Labs, LLC’s ALPHADx 

SARS–COV–2RT–PCR Test, issued on 

July 20, 2023; 

• Laboratory Corporation of 

America’s Clear Dx SARS–CoV–2 WGS 

v3.0 Test, issued on August 1, 2023; and 

• 3EO Health, Inc.’s 3EO Health 

COVID–19 Test, issued on September 

19, 2023. 

• Tangen Biosciences, Inc.’s 

TangenDx SARS–CoV–2 Molecular Test, 

issued September 29, 2023; 

• SD Biosensor, Inc.’s STANDARD Q 

COVID–19 Ag Test 2.0, issued 

September 29, 2023; 

• MAWD Laboratories’ MAWD 

Laboratories SARS–CoV–2 Dual Target 

by RT–PCR, issued on October 13, 2023; 

• RCA Laboratory Services LLC dba 

GENETWORx’s Gx HTIQ SARS–CoV–2 

Test, issued December 08, 2023; and 

• RCA Laboratory Services LLC dba 

GENETWORx’s Gx HTKB SARS–CoV–2 

Test, issued on December 08, 2023. 

FDA is hereby announcing the 

following Authorizations for 

multianalyte tests: 

• Princeton BioMeditech Corp’s 

ViraDx SARS–CoV–2/Flu A+B Rapid 

Antigen Test, issued on September 8, 

2023.4

• Roche Molecular Systems’s cobas 

SARS–CoV–2 & Influenza A/B v2, 

issued on November 16, 2023.5

Dated: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01426 Filed 1–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–0449] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CABENUVA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for CABENUVA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 25, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

July 23, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 25, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 


khammond on DSKJM1Z7X2PROD with NOTICES