Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39047 

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 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Mohamed Ghorab, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3141, 

Silver Spring, MD, 20993–0002, 240– 

402–8940; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Field 

Alert Report Submission: Questions and 

Answers.’’ The FAR regulations found 

in § 314.81(b)(1) (21 CFR 314.81(b)(1)) 

and 21 CFR 314.98(b) establish an early 

warning system to help FDA fulfill its 

responsibility to protect patient health. 

Under these regulations, NDA and 

ANDA applicants must submit certain 

information to FDA about distributed 

drug products regulated by the Center 

for Drug Evaluation and Research or the 

Center for Biologics Evaluation and 

Research. 

The guidance addresses the FAR 

submission requirements and focuses on 

topics such as the incidents and 

possible/actual quality issues that 

require submission of a FAR, the 

contents of the FAR, who submits the 

FAR, and when, where, and how they 

should submit it. The guidance also 

addresses followup and final FARs, 

which are not required under 

§ 314.81(b), and recommends their 

submission to inform FDA of the status 

of root cause investigations and 

corrective actions taken, if any. 

This guidance finalizes the draft 

guidance issued on July 19, 2018 (83 FR 

34142). In response to public comments, 

FDA made minor editorial changes and 

clarified that the FAR requirements 

apply to all products under an NDA or 

ANDA, including positron emission 

tomography drugs, designated medical 

gases, and combination products 

containing a drug constituent part. 

Although not the focus of this guidance, 

FDA notes that FAR requirements also 

apply to certain combination products 

under 21 CFR part 4, subpart B. For 

additional information about these 

products, see the guidance for industry 

and FDA staff ‘‘Postmarketing Safety 

Reporting for Combination Products,’’ 

available at https://www.fda.gov/media/ 

111788/download, and the 

Postmarketing Safety Reporting for 

Combination Products web page at 

https://www.fda.gov/combinationproducts/guidance-regulatoryinformation/postmarketing-safetyreporting-combination-products. FDA 

may consider whether additional 

adjustments are needed to guidance or 

FAR-related instructions for biologics 

license applications or device 

applications for combination products 

that contain a drug constituent part as 

the Agency gains experience with safety 

reporting for such products. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Field Report Alert 

Submission.’’ 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 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. 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 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15645 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0424] 

Medical Devices; Exemption From 

Premarket Notification: Powered 

Patient Transport, All Other Powered 

Patient Transport; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice that appeared in the Federal 

Register of June 15, 2021. In the notice, 

FDA requested comments by August 16, 

2021. The Agency is taking this action 

in response to a correction to the 

notice’s docket number that appeared in 

the Federal Register of June 30, 2021, to 

allow interested persons time to submit 

comments in response to the corrected 

notice. 

DATES: FDA is extending the comment 

period on the notice published June 15, 

2021 (86 FR 31722). Submit either 

electronic or written comments by 

August 30, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 30, 

2021. The https://www.regulations.gov 


khammond on DSKJM1Z7X2PROD with NOTICES
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: 


khammond on DSKJM1Z7X2PROD with NOTICES