Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 8205 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0008] 

Ophthalmic Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting—FSYX Ocular 

Pressure Adjusting Pump System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Ophthalmic Devices Panel of the 

Medical Devices Advisory Committee. 

The general function of the committee is 

to provide advice and recommendations 

to the Agency on FDA’s regulatory 

issues. The meeting will be open to the 

public. 

DATES: The meeting will take place 

virtually on March 21, 2024, from 9 a.m. 

to 6 p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee 

meetings, including information 

regarding special accommodations due 

to a disability may be accessed at: 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Akinola Awojope, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5214, Silver Spring, 

MD 20993–0002, Akinola.Awojope@

fda.hhs.gov, 301–636–0512, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On March 21, 

2024, the committee will discuss and 

make recommendations on information 

related to the De Novo request by 

Balance Ophthalmics, Inc. for the safety 

and effectiveness of the FSYX Ocular 

Pressure Adjusting Pump (FSYX OPAP) 

System. The FSYX OPAP System is 

indicated as adjunctive therapy for the 

reduction of intraocular pressure (IOP) 

during use in adult patients with openangle glaucoma and IOP ≤21 mmHg. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down and select the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 5, 2024. Oral 

presentations from the public will be 

scheduled on March 21, 2024, between 

approximately 1 p.m. and 2 p.m. Eastern 

Time. Those individuals interested in 

making formal oral presentations should 

notify the contact person (see FOR

FURTHER INFORMATION CONTACT). The 

notification should include a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before February 26, 2024. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

February 27, 2024. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact AnnMarie 

Williams at Annmarie.Williams@

fda.hhs.gov or 240–507–6496 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

The conditions for issuance of a waiver 

under 21 CFR 10.19 are met. 

Dated: February 1, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02361 Filed 2–5–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0150] 

Revocation of Two Authorizations of 

Emergency Use of In Vitro Diagnostic 

Device for Detection and/or Diagnosis 

of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorization (EUAs) (the 

Authorizations) issued to Southern 

California Permanente Medical Group, 

for the Kaiser Permanente High 

Throughput SARS–CoV–2 Assay, that 


ddrumheller on DSK120RN23PROD with NOTICES1
8206 Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 

includes the Kaiser Permanente Saliva 

Home Collection Kit, and Drexel 

University College of Medicine, for the 

SARS–CoV–2 DUCoM–PDL Modified 

Tetracore Assay. FDA revoked the 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) as 

requested by the Authorization holder. 

The revocations, which include an 

explanation of the reasons for each 

revocation, are reprinted at the end of 

this document. 

DATES: The revocation of the 

Authorization for the Southern 

California Permanente Medical Group’s 

Kaiser Permanente High Throughput 

SARS–CoV–2 Assay, that includes the 

Kaiser Permanente Saliva Home 

Collection Kit, is effective as of 

September 29, 2023. The revocation of 

the Authorization for the Drexel 

University College of Medicine for the 

SARS–CoV–2 DUCoM–PDL Modified 

Tetracore Assay is effective as of 

October 5, 2023. 

ADDRESSES: Submit written requests for 

a single copy of the revocations 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 

revocations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocations. 

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: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) 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. 

On April 19, 2021, FDA issued the 

Authorization to Southern California 

Permanente Medical Group, for the 

Kaiser Permanente High Throughput 

SARS–CoV–2 Assay, that includes the 

Kaiser Permanente Saliva Home 

Collection Kit, subject to the terms of 

the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

July 23, 2021 (86 FR 39040), as required 

by section 564(h)(1) of the FD&C Act. 

On April 28, 2023, FDA issued the 

Authorization to Drexel University 

College of Medicine, for the SARS– 

CoV–2 DUCoM–PDL Modified Tetracore 

Assay, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on January 25, 2024 

(89 FR 4952), as required by section 

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

Subsequent updates to the 

Authorizations were made available on 

FDA’s website. The authorization of a 

device for emergency use under section 

564 of the FD&C Act may, pursuant to 

section 564(g)(2) of the FD&C Act, be 

revoked when the criteria under section 

564(c) of the FD&C Act for issuance of 

such authorization are no longer met 

(section 564(g)(2)(B) of the FD&C Act), 

or other circumstances make such 

revocation appropriate to protect the 

public health or safety (section 

564(g)(2)(C) of the FD&C Act). 

II. Authorizations Revocation Requests 

In a request received by FDA on May 

11, 2023, Southern California 

Permanente Medical Group requested 

the withdrawal of, and on September 

29, 2023, FDA revoked, the 

Authorization for the Southern 

California Permanente Medical Group’s 

Kaiser Permanente High Throughput 

SARS–CoV–2 Assay, that includes the 

Kaiser Permanente Saliva Home 

Collection Kit. Because Southern 

California Permanente Medical Group 

notified FDA that they have stopped 

distributing the Kaiser Permanente 

Saliva Home Collection Kit at the end of 

May 2023 and have also stopped 

receiving and processing the kits and 

requested FDA withdraw the Southern 

California Permanente Medical Group’s 

Kaiser Permanente High Throughput 

SARS–CoV–2 Assay, that includes the 

Kaiser Permanente Saliva Home 

Collection Kit, FDA has determined that 

it is appropriate to protect the public 

health or safety to revoke this 

Authorization. 

In a request received by FDA on 

September 29, 2023, Drexel University 

College of Medicine requested the 

withdrawal of, and on October 5, 2023, 

FDA revoked, the Authorization for the 

Drexel University College of Medicine’s 

SARS–CoV–2 DUCoM–PDL Modified 

Tetracore Assay. Because Drexel 

University College of Medicine notified 

FDA that they have discontinued the 

use of SARS–CoV–2 DUCoM–PDL 

Modified Tetracore Assay at Drexel 

University, Drexel Medicine Diagnostics 

and requested FDA withdraw the Drexel 

University College of Medicine’s SARS– 

CoV–2 DUCoM–PDL Modified Tetracore 

Assay, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocations are available on the internet 

at https://www.regulations.gov/. 

IV. The Revocations 

Having concluded that the criteria for 

revocation of the Authorizations under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUA of 

Southern California Permanente 

Medical Group’s Kaiser Permanente 

High Throughput SARS–CoV–2 Assay, 

that includes the Kaiser Permanente 

Saliva Home Collection Kit, and Drexel 

University College of Medicine’s SARS– 

CoV–2 DUCoM–PDL Modified Tetracore 

Assay. The revocation in its entirety 

follows and provide an explanation of 

the reasons for revocation, as required 

by section 564(h)(1) of the FD&C Act. 

BILLING CODE 4161–01–P 


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Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 8207 


ddrumheller on DSK120RN23PROD with NOTICES1EN06FE24.022</GPH>

U.S. FOOD & DRUG 

APM!NISTIIAT!ON 

September 29, 2023 

Kenneth Van Hom, PhD, D(ABMM) 

Technical Director, Microbiology 

Southern California Permanente Medical Group 

Regional Reference Laboratories, Chino Hills 

13000 Peyton Drive 

Chino Hills, CA 91709 

Re: Revocation ofEUA203058 

Dear Dr. Van Hom: 

This letter is in response to the request from Southern California Permanente Medical Group, in 

a letter received May 11, 2023, that the U.S. Food and Drug Administration (FDA) tenninate the 

EUA for the Kaiser Pennanente High Throughput SARS-CoV-2 Assay, that includes the Kaiser 

Petmanente Saliva Home Collection Kit, issued on April 19, 2021 and subsequently re-issued on 

September 21, 2021. Southem Califomia Pennanente Medical Group indicated that they have 

stopped distributing the Kaiser Pennanente Saliva Home Collection Kit at the end of May 2023 

and have also stopped receiving and processing the kits as of the date of this letter, and requested 

that the EUA be terminated. 

The authorization of a device for emergency use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked when circumstances make such revocation appropriate to protect tl1e public health or 

safety (section 564(g)(2)(C) of the Act). Because Southern Califomia Permanente Medical 

Group bas requested that FDA tern1inate the EUA for the Kaiser Pennanente High Tirroughput 

SARS-Co V-2 Assay, FDA has detennined that it is appropriate to protect tl1e public health or 

safety to revoke this authorization. Accordingly, FDA hereby revokes EUA203058 for the Kaiser 

Permanente High Throughput SARS-CoV-2 Assay, pursuant to section 564(g)(2)(C) of the Act. 

As of the date of this letter, the Kaiser Penuanente High Throughput SARS-CoV-2 Assay is no 

longer authorized for emergency use by FDA. 

Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(l) 

ofthe Act 

Sincerely, 

!Isl! 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

Food and Drug Administration 
8208 Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 

Date: February 1, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02356 Filed 2–5–24; 8:45 am] 

BILLING CODE 4161–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1031] 

Reporting Amount of Listed Drugs and 

Biological Products Under Section 

510(j)(3) of the Federal Food, Drug, and 

Cosmetic Act; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Reporting Amount of Listed Drugs and 

Biological Products Under Section 

510(j)(3) of the Federal Food, Drug, and 

Cosmetic Act; Guidance for Industry; 

Availability.’’ This guidance addresses 

the process through which registrants of 

drug establishments should submit 

reports to FDA on the amount of each 

listed drug manufactured, prepared, 


ddrumheller on DSK120RN23PROD with NOTICES1EN06FE24.023</GPH>

-·■ U.S. FOOD & DRUG . ADMIN1$TllATIOI\I 

Donald C. Hall, Jr. Ph.D. 

Director of Operations 

Drexel Medicine -Diagnostics 

College of Medicine, Drexel tJnhrersity 

245 N. 15th Street, Room 510& 

Philadelphia; PA 19102 

Re: Revocation ofEUA220099 

Dear Dr. Hall: 

October 5, 2023 

This letter is in response to the request frori1 Drexel University College of Medicine, in 1:111 email 

receive_d September 29, 2023, that the U.S. Food and Drug Administration (FDA) withdraw the 

EUA for the- SARS~Co V-2 DUCoM-PDL Modified T etracore Assay,. issued on April 19, 2021. 

Drexel University College of Medicine indicated that they have discontinued use of the SARSCoV-2 DUCoM•PDL Modified Tetracore Assay at Drexel University, DrexelMedicine 

Diagnostics.located at 245 N. 15th Street, Room 5401, Philadelphia, PA 19102. 

The authorization ofa device for emergency use under section 564ofthe Federal Food, Drug, 

and Cos111etic Act (the Act) (21 U.S.C. 360bbb~3) may, pursua11t to section 564(g)(2) of the Act, 

be revoked when circumstances make such revocation. appropriate to protect the public health or 

safety (section 564(g)(2)(C) ofthe Act), Because Drexel University College ofMedicine has. 

requested that FDA withdraw the EUA for the SARS•CoV-2 DUCoM-PDL Modified Tetracore 

Assay; FDA has determined that it is appropriate to protect the public health or safety to revoke 

this authorization. Accordingly, FDA hereby revokes EUA220099 for the SARS-Co\M 

DUCoM-PDL M<xiified TetraCQte Assay, pursuant to section 564(g)(2)(G) of the Act; As of the 

date of this letter, the SARS•Co V-2DlJCoM•PDL Modified Tetracore Assay is no longer 

authorized for emergency use by FDA. 

N◊tice of this. revocation will be published in the Federal Register, pursuant to section 564(h)(l) 

of the Act. • • 

Sincerely, 

I!$/! 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

FoQd and Drug Administration