Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices 14273 

2021–P–0959), under 21 CFR 10.30, 

requesting that the Agency determine 

whether MPI DMSA KIDNEY REAGENT 

(Technetium Tc-99m Succimer Kit), 

Injectable, was withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that MPI DMSA KIDNEY 

REAGENT (Technetium Tc-99m 

Succimer Kit), Injectable, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that MPI DMSA KIDNEY 

REAGENT (Technetium Tc-99m 

Succimer Kit), Injectable, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of MPI 

DMSA KIDNEY REAGENT (Technetium 

Tc-99m Succimer Kit), Injectable, from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have reviewed the available 

evidence and determined that this drug 

product was not withdrawn from sale 

for reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list MPI DMSA KIDNEY 

REAGENT ((Technetium Tc-99m 

Succimer Kit), Injectable, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to MPI DMSA KIDNEY REAGENT 

((Technetium Tc-99m Succimer Kit), 

Injectable, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: March 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05324 Filed 3–11–22; 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 

Devices 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 

Authorizations (EUAs) (the 

Authorizations) issued to LifeHope Labs 

for the LifeHope 2019-nCoV Real-Time 

RT–PCR Diagnostic Panel, and 

Omnipathology Solutions Medical 

Corporation for the Omni COVID–19 

Assay by RT–PCR. FDA revoked these 

Authorizations under the Federal Food, 

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

The revocations, which include an 

explanation of the reasons for each 

revocation, are reprinted in this 

document. 

DATES: The Authorization for the 

LifeHope 2019-nCoV Real-Time RT– 

PCR Diagnostic Panel is revoked as of 

February 7, 2022. The Authorization for 

the Omni COVID–19 Assay by RT–PCR 

is revoked as of February 14, 2022. 

ADDRESSES: Submit written requests for 

a single copy of the revocations 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 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: 

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, 

240–402–8155 (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, 

nuclear, and radiological 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 June 

29, 2020, FDA issued an EUA to 

LifeHope Labs for the LifeHope 2019- 

nCoV Real-Time RT–PCR Diagnostic 

Panel, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on November 20, 2020 

(85 FR 74346), as required by section 

564(h)(1) of the FD&C Act. On June 17, 

2020, FDA issued an EUA to 

Omnipathology Solutions Medical 

Corporation for the Omni COVID–19 

Assay by RT–PCR, subject to the terms 

of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

November 20, 2020 (85 FR 74346), 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. EUA Revocation Requests 

In a request received by FDA on 

January 6, 2022, LifeHope Labs 

requested discontinuation of, and on 

February 7, 2022, FDA revoked, the 

Authorization for the LifeHope 2019- 

nCoV Real-Time RT–PCR Diagnostic 

Panel. Because LifeHope Labs notified 

FDA that it is no longer using the 

LifeHope 2019-nCoV Real-Time RT– 

PCR Diagnostic Panel and requested 

FDA discontinue the LifeHope 2019- 

nCoV Real-Time RT–PCR Diagnostic 

Panel, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

In requests received by FDA on 

February 7, 2022, and February 9, 2022, 

Omnipathology Solutions Medical 

Corporation requested revocation of, 

and on February 14, 2022, FDA revoked, 

the Authorization for the Omni COVID– 

19 Assay by RT–PCR. Because 

Omnipathology Solutions Medical 

Corporation notified FDA that it is no 

longer using the Omni COVID–19 Assay 

by RT–PCR and requested FDA revoke 

the EUA for the Omni COVID–19 Assay 

by RT–PCR, FDA has determined that it 


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14274 Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices 

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 

LifeHope Labs for the LifeHope 2019- 

nCoV Real-Time RT–PCR Diagnostic 

Panel and of Omnipathology Solutions 

Medical Corporation for the Omni 

COVID–19 Assay by RT–PCR. The 

revocations in their entirety follow and 

provide an explanation of the reasons 

for each revocation, as required by 

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

BILLING CODE 4164–01–P 


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Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices 14275 

Dated: March 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05310 Filed 3–11–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics 

AGENCY: Centers for Disease Control and 

Prevention. 

ACTION: Notice of meeting. 

SUMMARY: Pursuant to the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) announces the following 

advisory committee meeting. This 

meeting is open to the public. The 

public is welcome to obtain the link to 

attend this meeting by following the 

instructions posted on the Committee 

website: https://ncvhs.hhs.gov/ 

meetings/full-committee-meeting-10/. 

Name: National Committee on Vital 

and Health Statistics (NCVHS), Meeting 

of the full Committee. 

DATES: The meeting will be held 

Wednesday, March 30, 2022: 11:00 

a.m.–3:00 p.m. EST. 

ADDRESSES: Virtual open meeting. 

FOR FURTHER INFORMATION CONTACT: 

Substantive program information may 

be obtained from Rebecca Hines, MHS, 

Executive Secretary, NCVHS, National 

Center for Health Statistics, Centers for 

Disease Control and Prevention, 3311 

Toledo Road, Hyattsville, Maryland 

20782, or via electronic mail to vgh4@

cdc.gov; or by telephone (301) 458– 

4715. Summaries of meetings and a 

roster of Committee members are 

available on the home page of the 


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