Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 3303 

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 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Operational Policy, Office of 

Regulatory Affairs, Food and Drug 

Administration, Element Building, 

12420 Parklawn Dr., Rockville, MD 

20852. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Chris Henderson, Office of Regulatory 

Affairs, Food and Drug Administration, 

Element Building, 12420 Parklawn Dr., 

Rockville, MD 20857 240–402–8186, 

Christopher.henderson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and FDA 

staff entitled ‘‘Collecting and Providing 

702(b) Portions of FDA Official 

Samples—Questions and Answers.’’ 

Section 702 of the FD&C Act (21 U.S.C. 

372) authorizes FDA to conduct 

examinations and investigations and to 

collect samples. Under section 702(b) of 

the FD&C Act, when FDA collects a 

sample of a food, drug, or cosmetic for 

analysis, FDA must, upon request, 

provide a part of such official sample for 

examination or analysis by any person 

named on the label of the article, or the 

owner thereof, or his attorney or agent. 

Additionally, FDA was authorized to 

establish, by regulation, reasonable 

exceptions to, and impose reasonable 

terms and conditions relating to, the 

requirement to collect and provide a 

702(b) portion of an official sample to 

the owner, as necessary for the proper 

administration of the provisions of the 

FD&C Act. FDA’s regulation at 21 CFR 

2.10 was issued to establish those 

reasonable exceptions, and terms and 

conditions, and to implement section 

702(b) of the FD&C Act. 

This draft guidance is intended to 

assist industry and FDA staff with 

issues and questions related to the 

requirements for FDA to collect and 

provide portions of official samples 

under section 702(b) of the FD&C Act 

and its implementing regulation in 21 

CFR 2.10. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Collecting and Providing 702(b) 

Portions of FDA Official Samples— 

Questions and Answers.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/search-general-and-crosscutting-topics-guidance-documents, 

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. 2022–01143 Filed 1–20–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–D–1137, FDA– 

2020–D–1138, FDA–2020–D–0987] 

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 

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 January 21, 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 


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3304 Federal Register / Vol. 87, No. 14 / Friday, January 21, 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. 

(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 Erica Takai, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5456, Silver Spring, MD 20993– 

0002, 301–796–6353. 

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 

‘‘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–1137 ........ CBER ........... Policy for Certain REMS Requirements During 

the Tocilizumab Shortage Related to the 

COVID–19 Public Health Emergency (December 2021).

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. 


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Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 3305 

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

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

FDA–2020–D–1138 ........ CDRH ........... Enforcement Policy for Viral Transport Media 

During the Coronavirus Disease (COVID–19) 

Public Health Emergency (Revised November 

2021).

CDRH-Guidance@fda.hhs.gov. Please include 

the document number 20038–R2 and complete title of the guidance in the request. 

FDA–2020–D–0987 ........ CDRH ........... Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised November 2021).CDRH-Guidance@fda.hhs.gov. Please include 

the document number 20010–R4 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). 

Policy for Certain REMS Requirements During the Tocilizumab Shortage 

Related to the COVID–19 Public Health Emergency (December 2021).

21 CFR part 314 (New Drug Applications 

and Abbreviated New Drug Applications).

.................................... 0910–0001 

21 CFR parts 210, 211 and 610 (Current 

Good Manufacturing Practices).

.................................... 0910–0139 

21 CFR part 600 (Adverse Experience Reports)..................................... 0910–0308 

21 CFR part 601 (Biologic License Applications)..................................... 0910–0338 

B. CDRH Guidances 

The guidances listed below refer to 

previously approved FDA collections of 

information. These 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 table 

below (table 3). These guidances also 

contain a new collection of information 

not approved under a current collection. 

These new collections of information 

have been granted a public health 

emergency (PHE) waiver from the PRA 

by the Department of Health and Human 

Services (HHS) on March 19, 2020, 

under section 319(f) of the PHS Act. 

Information concerning the PHE PRA 

waiver can be found on the HHS 

website at https://aspe.hhs.gov/publichealth-emergency-declaration-prawaivers. 

TABLE 3—CDRH 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). 

New Collection 

covered by PHE 

PRA Waiver 

Enforcement Policy for Viral 

Transport Media During the 

Coronavirus Disease 2019 

(COVID–19) Public Health 

Emergency (Revised November 2021) (document 

number 20038–R2).

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 

800, 801, and 809 ................. ................................................ 0910–0485 

803 ......................................... ................................................ 0910–0437 

806 ......................................... ................................................ 0910–0359 


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3306 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 

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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