50134 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 

reclassification order published in the 

Federal Register following 

consideration of comments and any 

panel recommendations or comments. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

§ 860.123; supporting data for reclassification petitions ...... 6 1 6 497 2,982 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19221 Filed 9–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0944] 

Pediatric Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Pediatric Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ The document 

announced a meeting of the Pediatric 

Advisory Committee. The document 

was published with the incorrect docket 

number and end time of the meeting. 

This document corrects those errors. 

FOR FURTHER INFORMATION CONTACT: 

Marieann Brill, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5154, Silver Spring, 

MD 20993, 240–402–3838, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). Please call the 

Information Line for up-to-date 

information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Tuesday, August 10, 

2021, in FR Doc. 2021–16984 (86 FR 

43666), the following corrections are 

made. 

1. On page 43666, in the first column, 

in the header of the document, and in 

the third column under ‘‘Instructions,’’ 

‘‘Docket No. FDA–2020–N–1648N’’ is 

changed to ‘‘Docket No. FDA–2021–N– 

0944’’. 

2. On page 43666, in the first column, 

the DATES portion of the document is 

changed to: ‘‘The meeting will be held 

on September 17, 2021, from 10 a.m. to 

3 p.m. Eastern Time.’’ 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19216 Filed 9–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0918] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Labeling 

Requirements for Prescription Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with labeling 

requirements for prescription drugs. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 8, 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 November 8, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 8, 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. 


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