39048 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 30, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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 Docket No. FDA– 

2021–P–0424 for ‘‘Medical Devices; 

Exemption from Premarket Notification: 

Powered Patient Transport, All Other 

Powered Patient Transport.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket 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. 

FOR FURTHER INFORMATION CONTACT: Dan 

Reed, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1526, Silver Spring, 

MD 20993–0002, 240–402–4717. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 15, 2021, FDA 

published a notice with a 60-day 

comment period requesting comments 

by August 16, 2021. Comments on the 

notice will inform FDA’s response to a 

petition requesting exemption from 

premarket notification requirements for 

powered patient transport, all other 

powered patient transport. 

In the Federal Register of June 30, 

2021, FDA corrected the docket number 

associated with the notice (86 FR 

34770). FDA has considered the 

requirements associated with receipt of 

a petition requesting exemption from 

premarket notification requirements 

under section 510(m) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

360(m)). Due to the correction to the 

docket number, the Agency is extending 

the comment period for the notice, until 

August 30, 2021. The Agency believes 

that an extension allows adequate time 

for interested persons to submit 

comments from the date of the 

correction to the notice issued June 30, 

2021, without delaying our 

consideration of these important issues. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15646 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–D–1136 and FDA– 

2020–D–1137] 

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 July 23, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 


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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39049 

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. 

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 self-addressed 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: 

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, or 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. 

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, 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/regulatoryVerDate Sep<11>2014 16:49 Jul 22, 2021 Jkt 253001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\23JYN1.SGM 23JYN1

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39050 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

information/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–1136 ........ CDER ........... Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID–19 

Public Health Emergency Questions and Answers (Updated May 2021).

druginfo@fda.hhs.gov. Please include the docket 

number FDA–2020–D–1136 and complete title 

of the guidance in the request. 

FDA–2020–D–1137 ........ CBER ........... Emergency Use Authorization for Vaccines to 

Prevent COVID–19 (Updated May 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. 

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. CDER 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 guidances have been 

approved by OMB as listed in the 

following table: 

TABLE 2—CDER GUIDANCES AND COLLECTIONS

COVID–19 

guidance title 

CFR cite 

referenced in COVID–19 

guidance 

Another guidance title referenced in COVID–19 guidance OMB control 

Nos. 

Manufacturing, Supply Chain, 

and Drug and Biological 

Product Inspections During 

COVID–19 Public Health 

Emergency Questions and 

Answers (Updated May 

2021).

21 CFR 314.50, 314.94, 

314.95, 314.125, 314.127; 

21 CFR 601.2 and 601.20.

—Prioritization of the Review of Original ANDAs, Amendments, and Supplements.

—Requests for Expedited Review of New Drug Application 

and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes.

—Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA).

0910–0001 

0910–0014 

0910–0338 

0910–0045 

0910–0139 

0910–0759 

—Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products.

—Changes to an Approved Application: Biological Products.

—Changes to an Approved NDA or ANDA; Questions and 

Answers.

—Changes to an Approved NDA or ANDA. 

—CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.

—Changes to an Approved Application: Biological Products: 

Human Blood and Blood Components Intended for Transfusion or for Further Manufacture.

—CMC Postapproval Manufacturing Changes for Specified 

Biological Products To Be Documented in Annual Reports.

—Chemistry, Manufacturing, and Controls Changes to an 

Approved Application: Certain Biological Products.

—Immediate Release Solid Oral Dosage Forms; Scale-Up 

and Postapproval Changes: Chemistry, Manufacturing, and 

Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.

—SUPAC–IR: Questions and Answers about SUPAC–IR 

Guidance.


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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39051 

TABLE 2—CDER GUIDANCES AND COLLECTIONS—Continued 

COVID–19 

guidance title 

CFR cite 

referenced in COVID–19 

guidance 

Another guidance title referenced in COVID–19 guidance OMB control 

Nos. 

—SUPAC–SS: Nonsterile Semisolid Dosage Forms; ScaleUp and Postapproval Changes: Chemistry, Manufacturing, 

and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation.

—SUPAC–MR: Modified Release Solid Oral Dosage Forms; 

Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In 

Vivo Bioequivalence Documentation.

—SUPAC: Manufacturing Equipment Addendum.

—Remote Interactive Evaluations of Drug Manufacturing and 

Bioresearch Monitoring Facilities During the COVID–19 

Public Health Emergency.

B. CBER 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 (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 3—CBER GUIDANCES AND COLLECTIONS

COVID–19 

guidance title 

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

COVID–19 guidance 

OMB control 

Nos. 

Emergency Use Authorization for Vaccines to Prevent COVID–19 (Updated 

May 2021).

21 CFR 314.420 ......................................

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

21 CFR parts 210, 211, and 610 ............

Emergency Use Authorization of Medical 

Products and Related Authorities.

0910–0001 

0910–0014 

0910–0139 

21 CFR part 600 .....................................

21 CFR part 601 .....................................

0910–0308 

0910–0338 

0910–0595 

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: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15649 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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 

Neurological Disorders and Stroke Special 

Emphasis Panel; NINDS BRAIN Review 

Meeting (U01 and R01 Applications). 

Date: August 12–13, 2021. 

Time: 10:00 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Mir Ahamed Hossain, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Rockville, MD 20852, 

(301) 496–9223, mirahamed.hossain@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: July 20, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–15744 Filed 7–22–21; 8:45 am] 

BILLING CODE 4140–01–P 


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