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TABLE 3—CDRH GUIDANCES AND COLLECTIONS—Continued 

COVID–19 guidance 

title 

CFR cite referenced 

in COVID–19 

guidance 

Another guidance 

referenced in 

COVID– 

19 guidance 

OMB 

Control 

No(s). 

New Collection 

covered by PHE 

PRA Waiver 

807, subparts A through D .... ................................................ 0910–0625 

807, subpart E ....................... ................................................ 0910–0120 

820 ......................................... ................................................ 0910–0073 

830 and 801.20 ...................... ................................................ 0910–0720 

Manufacturer voluntary reporting to FDA of viral transport 

media manufacturing capacity information. 

Manufacturer voluntary reporting to FDA of sterile phosphate buffered saline/saline 

manufacturing capacity information. 

Policy for Coronavirus Disease–2019 Tests During 

the Public Health Emergency (Revised November 

2021) (document number 

20010–R4).

Emergency Use Authorization 

of Medical Products and 

Related Authorities; Guidance for Industry and Other 

Stakeholders.

0910–0595 

Administrative Procedures for 

Clinical Laboratory Improvement Amendments of 

1988 Categorization.

0910–0607 

803 ......................................... Medical Device Reporting ...... 0910–0437 

Confirmation to FDA that the 

developer of a diagnostic or 

serology test on FDA’s notification lists and for which 

an Emergency Use Authorization (EUA) request was 

submitted, wants FDA to 

continue reviewing its EUA 

request. 

IV. Electronic Access 

Persons with access to the internet 

may obtain COVID–19-related guidances 

at: 

• FDA web page entitled ‘‘COVID–19- 

Related Guidance Documents for 

Industry, FDA Staff, and Other 

Stakeholders,’’ available at https://

www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19- 

related-guidance-documents-industryfda-staff-and-other-stakeholders; 

• FDA web page entitled ‘‘Search for 

FDA Guidance Documents’’ available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or 

• https://www.regulations.gov. 

Dated: January 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01146 Filed 1–20–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0049] 

Revocation of Five 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 


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Authorizations) issued to Cellex Inc. for 

the Cellex q–SARS–CoV–2 IgG/IgM 

Rapid Test, BioMe ́rieux SA for the 

SARS–COV–2 R–GENE, Siemens 

Healthcare Diagnostics Inc. for the 

Atellica IM SARS–CoV–2 IgG (COV2G), 

Siemens Healthcare Diagnostics Inc. for 

the ADVIA Centaur SARS–CoV–2 IgG 

(COV2G), and Cepheid for the Xpert 

Omni SARS–CoV–2. 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 Cellex 

q–SARS–CoV–2 IgG/IgM Rapid Test is 

revoked as of December 10, 2021. The 

Authorizations for the SARS–COV–2 R– 

GENE, Atellica IM SARS–CoV–2 IgG 

(COV2G), and ADVIA Centaur SARS– 

CoV–2 IgG (COV2G) are revoked as of 

December 17, 2021. The Authorization 

for the Xpert Omni SARS–CoV–2 is 

revoked as of December 20, 2021. 

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 April 

1, 2020, FDA issued an EUA to Cellex 

Inc. for the Cellex q–SARS–CoV–2 IgG/ 

IgM Rapid Test, subject to the terms of 

the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

June 5, 2020 (85 FR 34638), as required 

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

On May 6, 2020, FDA issued an EUA to 

BioMe ́rieux SA for the SARS–COV–2 R– 

GENE, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on July 14, 2020 (85 FR 

42407), as required by section 564(h)(1) 

of the FD&C Act. On July 31, 2020, FDA 

issued an EUA to Siemens Healthcare 

Diagnostics Inc. for the Atellica IM 

SARS–CoV–2 IgG (COV2G), 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 July 31, 2020, FDA issued 

an EUA to Siemens Healthcare 

Diagnostics Inc. for the ADVIA Centaur 

SARS–CoV–2 IgG (COV2G), 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 November 27, 2020, FDA 

issued an EUA to Cepheid for the Xpert 

Omni SARS–CoV–2, subject to the terms 

of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

April 23, 2021 (86 FR 21749), 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 

On December 7, 2021, Cellex 

requested withdrawal of, and on 

December 10, 2021, FDA revoked, the 

Authorization for the Cellex q–SARS– 

CoV–2 IgG/IgM Rapid Test. Because 

Cellex requested that FDA withdraw the 

Authorization and FDA understands the 

product is no longer being distributed, 

FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

On December 10, 2021, FDA received a 

request from BioMe ́rieux SA for the 

revocation of, and on December 17, 

2021, FDA revoked, the Authorization 

for the SARS–COV–2 R–GENE. Because 

BioMe ́rieux SA notified FDA that 

BioMe ́rieux SA has decided to no longer 

commercially support the authorized 

product and requested FDA revoke the 

Authorization, FDA has determined that 

it is appropriate to protect the public 

health or safety to revoke this 

Authorization. On December 9, 2021, 

FDA received a request from Siemens 

Healthcare Diagnostics Inc. for the 

voluntary removal of, and on December 

17, 2021, FDA revoked, the 

Authorization for the Atellica IM SARS– 

CoV–2 IgG (COV2G). Because Siemens 

Healthcare Diagnostics Inc. notified 

FDA that Siemens Healthcare 

Diagnostics Inc. has decided to no 

longer market the authorized product 

and requested FDA voluntarily remove 

the Atellica IM SARS–CoV–2 IgG 

(COV2G) from FDA’s list of authorized 

devices, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

On December 9, 2021, FDA received a 

request from Siemens Healthcare 

Diagnostics Inc. for the voluntary 

removal of, and on December 17, 2021, 

FDA revoked, the Authorization for the 

ADVIA Centaur SARS–CoV–2 IgG 

(COV2G). Because Siemens Healthcare 

Diagnostics Inc. notified FDA that 

Siemens Healthcare Diagnostics Inc. has 

decided to no longer market the 

authorized product and requested FDA 

voluntarily remove the ADVIA Centaur 

SARS–CoV–2 IgG (COV2G) from FDA’s 

list of authorized devices, FDA has 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. On December 

17, 2021, FDA received a request from 

Cepheid for the revocation of, and on 

December 20, 2021, FDA revoked, the 

Authorization for the Xpert Omni 

SARS–CoV–2. Because Cepheid has 

notified FDA that Cepheid has not 

commercially distributed any of the 

Xpert Omni SARS–CoV–2 product due 

to the current public clinical needs 

being met by Cepheid’s other EUA tests 

that are available and requested FDA 

revoke the EUA for the Xpert Omni 

SARS–CoV–2, 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 EUAs for 


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Cellex Inc.’s Cellex q–SARS–CoV–2 IgG/ 

IgM Rapid Test, BioMe ́rieux SA’s 

SARS–COV–2 R–GENE, Siemens 

Healthcare Diagnostics Inc.’s Atellica IM 

SARS–CoV–2 IgG (COV2G), Siemens 

Healthcare Diagnostics Inc.’s ADVIA 

Centaur SARS–CoV–2 IgG (COV2G), and 

Cepheid’s Xpert Omni SARS–CoV–2. 

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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Dated: January 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01139 Filed 1–20–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

[OMB No. 0915–0298—Revision] 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Maternal and Child 

Health Bureau Performance Measures 

for Discretionary Grant Information 

System 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than March 22, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Samantha Miller, the acting 

HRSA Information Collection Clearance 

Officer at (301) 443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information collection request title for 

reference. 

Information Collection Request Title: 

Maternal and Child Health Bureau 

(MCHB) Performance Measures for 

Discretionary Grant Information System 

(DGIS), OMB No. 0915–0298—Revision. 

Abstract: Approval from OMB is 

sought to implement minor revisions to 

the MCHB Performance Measures for 

DGIS. Most of these measures are 

specific to certain types of programs and 

are not required of all grantees. The 

measures are categorized by domain 

(Adolescent Health, Capacity Building, 

Child Health, Children with Special 

Health Care Needs, Lifecourse/ 

Crosscutting, Maternal/Women Health, 

and Perinatal/Infant Health), in addition 

to some program-specific measures. 

Grant programs are assigned domains 

based on their activities and individual 

grantees respond to only a limited 

number of performance measures that 

are relevant to their specific program. 

Need and Proposed Use of the 

Information: The performance data 

collected through the DGIS serves 

several purposes, including grantee 

monitoring, program planning, 

performance reporting, and the ability to 

demonstrate alignment between MCHB 

discretionary programs and the Title V 

MCH Services Block Grant program. 

HRSA is making the following changes 

to the current OMB package for MCHB 

DGIS to more closely align data 

collection forms with current program 

activities: 

Removing the following existing 

forms: Core 1 (Grant Impact), Capacity 

Building 2 (Technical Assistance), 

Capacity Building 7 (Direct Annual 

Access to Maternal and Child Health 

(MCH) Data), Training Form 13 (Diverse 

Adolescent Involvement (LEAHspecific)), Financial Form 2 (Project 

Funding Profile), and Financial Form 4 

(Project Budget and Expenditures); 

Adding the following new form: 

Training Form 14 (Teleconsultation and 

Training for Mental and Behavioral 

Health) and Leadership, Education, and 

Advancement in Undergraduate 

Pathways Training Program Trainee 

Information Form; 

Revising the following existing forms: 

F2F (Family to Family Form 1), 

Financial Form 1 (MCHB Project Budget 

Details), Financial Form 4 (new name: 

MCH Discretionary Grant Project 

Abstract), and MCH Training Program 

Data Forms; 

Revising and Renumbering the 

following forms: Core 3 (Health Equity) 

will become the new Core 1 (Health 

Equity), Financial Form 3 (Budget 

Details by Types of Individuals Served) 

will become the new Financial Form 2 

(Budget Details by Types of Individuals 

Served), Financial Form 5 (Number of 

Individuals Served (Unduplicated)) will 

become the new Financial Form 3 

(Number of Individuals Served 

(Unduplicated)), and Financial Form 6 

(Project Abstract) will become the new 

Financial Form 4 (Project Abstract); and 

Renumbering the following forms: 

Core 2 (Quality Improvement) will 

become the new Capacity Building 4 

(Quality Improvement), Capacity 

Building 3 (Impact Measurement) will 

become the new Capacity Building 2 

(Impact Measurement), Capacity 

Building 4 (Sustainability) will become 

the new Capacity Building 3 

(Sustainability), and Training 14 

(Medium-Term Trainees Skill and 

Knowledge (PPC-Specific)) will become 

the new Training 13 (Medium-Term 

Trainees Skill and Knowledge (PPCSpecific)). 

Non-substantive revisions also 

include updates to terminology, goals, 

benchmark data sources, and 

significance sections included in the 

measures’ detail sheets. A performance 

measure detail sheet defines and 

describes each performance measure. 

Forms and detail sheets showing the 

proposed revisions are available upon 

request. 

This revision will facilitate more 

efficient and accurate reporting of 

information related to capacity building 

activities, financial and demographic 

data, and training activities. 

Likely Respondents: The grantees for 

MCHB Discretionary Grant Programs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 


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