Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 12461 

Dated: February 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04635 Filed 3–3–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–D–1825 and FDA– 

2020–D–1136] 

Guidance Documents Related to 

Coronavirus Disease 2019; 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 FDA 

guidance documents related to the 

Coronavirus Disease 2019 (COVID–19) 

public health emergency (PHE). This 

notice of availability (NOA) is pursuant 

to the process that FDA announced, in 

the Federal Register of March 25, 2020, 

for making available to the public 

COVID–19-related guidances. The 

guidances identified in this notice 

address issues related to the COVID–19 

PHE and have been issued in 

accordance with the process announced 

in the March 25, 2020, notice. The 

guidances have been implemented 


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U.S. FOOD & DRUG 

ADMINISTRATION 

Michael Campbell 

Head of Regulatory Affairs & Quality 

Quotient Suisse SA 

Route de Crassier 13 

Eysins, VD 1262 

S,vitzerland 

Re: Revocation ofEUA201083 

Dear Michael Campbell: 

January 11, 2022 

This letter is in response to a request from Quotient Suisse SA, received December 22, 2021, that 

the U.S. Food and Drug Administration (FDA) terminate the MosaiQ COVID-19 Antibody 

Magazine-EUA201083 issued on September 25, 2020 and amended April 27, 2021 and 

September 23, 202 l. Quotient Suisse SA decided not to continue to commercially support the 

MosaiQ COVID-19 Antibody Magazine. 

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 the public health or 

safety (section 564(g)(2)(C) of the Act). Because Quotient Suisse SA has notified FDA that 

Quotient Suisse SA has decided not to continue to commercially support the product and 

requested FDA terminate the MosaiQ COVID-19 Antibody Magazine - EUA20 I 083, FDA has 

determined that it is appropriate to protect the public health or safety to revoke this authorization. 

Accordingly, FDA hereby revokes EUA201083 for the MosaiQ COVID-19 Antibody Magazine, 

pursuantto section 564(g)(2)(C) of the Act. As of the date of this letter, the MosaiQ COVID-19 

Antibody Magazine is no longer authorized for emergency use by FDA. 

Notice of this revocation will be published in the Federal Register, pursuantto section 564(h)( 1) 

of the Act. 

Sincerely, 

/s/ 

Jacqueline A. ff Shaughnessy, Ph.D. 

Acting Chief Scientist 

Food and Drug Administration 
12462 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 

1Secretary of Health and Human Services, 

‘‘Determination that a Public Health Emergency 

Exists’’ (originally issued on January 31, 2020, and 

subsequently renewed), available at: https://

www.phe.gov/emergency/news/healthactions/phe/ 

Pages/default.aspx. 

2Proclamation on Declaring a National 

Emergency Concerning the Novel Coronavirus 

Disease (COVID–19) Outbreak (March 13, 2020), 

available at: https://trumpwhitehouse.archives.gov/ 

presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. On February 24, 2021, 

there was a Presidential Declaration continuing the 

national emergency concerning the COVID–19 

pandemic beyond March 1, 2021. See Continuation 

of the National Emergency Concerning the 

Coronavirus Disease 2019 (COVID–19) Pandemic 

(February 24, 2021), available at https://

www.federalregister.gov/documents/2021/02/26/ 

2021-04173/continuation-of-the-nationalemergency-concerning-the-coronavirus-disease2019-covid-19-pandemic. 

without prior comment, but they remain 

subject to comment in accordance with 

the Agency’s good guidance practices. 

DATES: The announcement of the 

guidances is published in the Federal 

Register on March 4, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the name of the guidance 

document that the comments address 

and the docket number for the guidance 

(see table 1). Received comments will be 

placed in the docket(s) and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Dockets Management Staff between 9 

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

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see § 10.115(g)(5) 

(21 CFR 10.115(g)(5))). 

Submit written requests for single 

copies of these guidances to the address 

noted in table 1. Send two selfaddressed adhesive labels to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911, or Kimberly Thomas, Center 

for Drug Evaluation and Research 

(CDER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6220, Silver Spring, MD 20993– 

0002, 301–796–2357. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On January 31, 2020, as a result of 

confirmed cases of COVID–19, and after 

consultation with public health officials 

as necessary, the Secretary of Health 

and Human Services (HHS), pursuant to 

the authority under section 319 of the 

Public Health Service Act (42 U.S.C. 

247d), determined that a PHE exists and 

has existed since January 27, 2020, 

nationwide.1 On March 13, 2020, there 

was a Presidential declaration that the 

COVID–19 outbreak in the United States 

constitutes a national emergency, 

beginning March 1, 2020.2

In the Federal Register of March 25, 

2020 (85 FR 16949) (the March 25, 2020, 

notice) (available at https://

www.govinfo.gov/content/pkg/FR-2020- 

03-25/pdf/2020-06222.pdf), FDA 

announced procedures for making 

available FDA guidances related to the 

COVID–19 PHE. These procedures, 

which operate within FDA’s established 

good guidance practices regulations, are 

intended to allow FDA to rapidly 

disseminate Agency recommendations 

and policies related to COVID–19 to 

industry, FDA staff, and other 

stakeholders. The March 25, 2020, 

notice stated that due to the need to act 

quickly and efficiently to respond to the 

COVID–19 PHE, FDA believes that prior 

public participation will not be feasible 

or appropriate before FDA implements 

COVID–19-related guidances. Therefore, 

FDA will issue COVID–19-related 

guidances for immediate 

implementation without prior public 

comment (see section 701(h)(1)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 371(h)(1)(C)) and 

§ 10.115(g)(2)). The guidances are 

available on FDA’s web pages entitled 


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Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 12463 

‘‘COVID–19-Related Guidance 

Documents for Industry, FDA Staff, and 

Other Stakeholders’’ (available at 

https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders) and ‘‘Search for FDA 

Guidance Documents’’ (available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments). 

The March 25, 2020, notice further 

stated that, in general, rather than 

publishing a separate NOA for each 

COVID–19-related guidance, FDA 

intends to publish periodically a 

consolidated NOA announcing the 

availability of certain COVID–19-related 

guidances that FDA issued during the 

relevant period, as included in table 1. 

This notice announces COVID–19- 

related guidances that are posted on 

FDA’s website. 

II. Availability of COVID–19-Related 

Guidance Documents 

Pursuant to the process described in 

the March 25, 2020, notice, FDA is 

announcing the availability of the 

following COVID–19-related guidances: 

TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY

Docket No. Center Title of guidance Contact information to request single copies 

FDA–2020–D–1825 ....... CBER ....... Investigational COVID–19 Convalescent 

Plasma (Revised January 7, 2022).

Office of Communication, Outreach and Development, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002, 1–800–835–4709 or 

240–402–8010; email ocod@fda.hhs.gov. 

FDA–2020–D–1136 ....... CDER ....... COVID–19 Public Health Emergency 

Policy on COVID–19-Related Sanitation Tunnels (February 2022).

druginfo@fda.hhs.gov. Please include the docket number FDA–2020–D–1136 

and complete title of the guidance in the request. 

Although these guidances have been 

implemented immediately without prior 

comment, FDA will consider all 

comments received and revise the 

guidances as appropriate (see 

§ 10.115(g)(3)). 

These guidances are being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidances represent the current thinking 

of FDA. They do not establish any rights 

for any person and are not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

III. Paperwork Reduction Act of 1995 

A. CBER Guidance 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information (listed in table 2). 

Therefore, clearance by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501–3521) is not 

required for this guidance. The 

previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations and guidance have been 

approved by OMB as listed in the 

following table: 

TABLE 2—CBER GUIDANCE AND COLLECTIONS

COVID–19 guidance title CFR cite referenced in COVID–19 

guidance 

Another guidance title referenced 

in COVID–19 guidance 

OMB control 

No(s). 

Investigational COVID–19 Convalescent Plasma 

(Updated: January 7, 2022).

21 CFR part 312 ............................

21 CFR parts 606 and 630 ............

........................................................ 0910–0014 

0910–0116 

Form FDA 3926 ............................. 0910–0814 

B. CDER Guidance 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information (listed in table 3). 

Therefore, clearance by OMB under the 

PRA is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations and guidances have been 

approved by OMB as listed in the 

following table: 

TABLE 3—CDER GUIDANCES AND COLLECTIONS

COVID–19 guidance title CFR cite referenced in 

COVID–19 guidance Another guidance referenced in COVID–19 guidance OMB control No(s). 

COVID–19 Public Health Emergency 

Policy on COVID–19-Related Sanitation Tunnels (February 2022).

21 CFR part 312 ......... —Enforcement Policy for Sterilizers, Disinfectant Devices, and 

Air Purifiers During the Coronavirus Disease 2019 (COVID– 

19) Public Health Emergency (March 2020).

—COVID–19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID–19 Related 

Drugs and Biological Products (May 2020).

0910–0001 

0910–0014 

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 


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12464 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 

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

• https://www.regulations.gov. 

Dated: February 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04637 Filed 3–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Advisory Committee on 

Seniors and Disasters and National 

Advisory Committee on Individuals 

With Disabilities and Disasters; Notice 

of Meeting 

AGENCY: Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), Department of Health 

and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: The National Advisory 

Committee on Seniors and Disasters 

(NACSD) and the National Advisory 

Committee on Individuals With 

Disabilities and Disasters (NACIDD), or 

Committees, were established by 

sections 2811B and 2811C, respectively, 

of the Public Health Service (PHS) Act, 

as amended by the Pandemic and All 

Hazards Preparedness and Advancing 

Innovation Act (PAHPAIA) of 2019. The 

Committees are governed by the 

provisions of the Federal Advisory 

Committee Act (FACA) and the General 

Services Administration FACA Final 

Rule. The Committees evaluate issues 

and programs and provide findings, 

advice, and recommendations to the 

Secretary of HHS to support and 

enhance all-hazards public health and 

medical preparedness, response, and 

recovery. The NACSD provides focus on 

the unique needs of older adults, while 

the NACIDD focuses on helping HHS 

meet the needs of people with 

disabilities (PWD). The Secretary of 

HHS has formally delegated authority to 

operate the NACSD and the NACIDD to 

ASPR. 

DATES: The NACSD and NACIDD will 

conduct a joint, virtual, inaugural public 

meeting on March 30, 2022. The newly 

appointed members of the two advisory 

committees will be sworn in as Special 

Government Employees, followed by 

presentations and discussion of 

challenges, opportunities, and priorities 

for national public health and medical 

preparedness, response, and recovery 

specific to the needs of older adults and 

PWD in disasters. On April 1, 2022, the 

NACIDD will hold a second public 

meeting session dedicated specifically 

to addressing the needs of PWD; on 

April 6, 2022, the NACSD will hold a 

second public meeting session 

specifically to the needs of older adults. 

Agendas for all meeting and meeting 

registration links will be available on 

the Committees respective web page, 

https://www.phe.gov/nacsd and https:// 

www.phe.gov/nacidd. 

ADDRESSES: Members of the public may 

attend the meetings via a toll-free phone 

number or Zoom teleconference, which 

requires pre-registration. The meeting 

links to pre-register will be posted on 

https://www.phe.gov/nacsd and https:// 

www.phe.gov/nacidd. Members of the 

public may provide written comments 

or submit questions for consideration 

via email to the NACSD (NACSD@

hhs.gov) or the NACIDD (NACIDD@

hhs.gov). Members of the public are also 

encouraged to provide comments after 

the meetings. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Maxine Kellman, NACSD Designated 

Federal Official, 202–260–0447, 

NACSD@hhs.gov; Tabinda Burney, 

NACIDD Designated Federal Official, 

202–699–1779, NACIDD@hhs.gov. 

Office of the Assistant Secretary for 

Preparedness and Response (ASPR), 

Department of Health and Human 

Services (HHS), Washington, DC. 

SUPPLEMENTARY INFORMATION: The 

NACSD and the NACIDD invite those 

who are involved in or represent 

academia, professional groups, 

advocacy organizations, or U.S. state, 

tribal, territorial, or local government to 

request up to four minutes to address 

the committees via Zoom. Requests to 

provide remarks during the public 

meetings must be sent via email to the 

NACSD (NACSD@hhs.gov) or the 

NACIDD (NACIDD@hhs.gov) at least 15 

days prior to the meeting along with a 

brief description of the topic. We would 

specifically like to request inputs from 

the public on challenges, opportunities, 

and strategic priorities for national 

public health and medical 

preparedness, response, and recovery 

specific to the needs of people with 

disabilities and/or older adults before, 

during, and after disasters. Presenters 

who are selected for the public meetings 

will have audio only for up to four 

minutes during the meeting. Slides, 

documents, and other presentation 

material sent along with the request to 

speak will be provided to the committee 

members separately. Please indicate 

additionally whether the presenter will 

be willing to take questions from the 

committee members (at their discretion) 

immediately following their 

presentation (for up to four additional 

minutes). 

Dawn O’Connell, 

Assistant Secretary for Preparedness and 

Response. 

[FR Doc. 2022–04651 Filed 3–3–22; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Collaborative Islet 

Transplant Registry Special Emphasis Panel. 

Date: March 15, 2022. 

Time: 2:30 p.m. to 4:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institutes of Health/NIDDK, 

6707 Democracy Blvd., Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Peter J. Kozel, Ph.D., Chief, 

Training and Mentored Research Section, 

Scientific Review Branch, Division of 

Extramural Activities, 6707 Democracy Blvd., 

Room 7009, Bethesda, MD 20892, kozelp@

mail.nih.gov, 301–594–4721. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 1, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–04623 Filed 3–3–22; 8:45 am] 

BILLING CODE 4140–01–P 


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