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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 1ESTIMATED 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

1 There
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. 202119221 Filed 9321; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

the third column under Instructions, Docket No. FDA2020N1648N is changed to Docket No. FDA2021N
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.

Food and Drug Administration Docket No. FDA2021N0944

FR Doc. 202119216 Filed 9321; 8:45 am
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments;
Correction AGENCY:

Food and Drug Administration,
HHS.
ACTION:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Notice.

Docket No. FDA2021N0918

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, 2404023838, or FDA
Advisory Committee Information Line, 18007418138 3014430572 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. 202116984 86 FR
43666, the following corrections are made.
1. On page 43666, in the first column, in the header of the document, and in SUMMARY:

sradovich on DSKJLST7X2PROD with NOTICES

BILLING CODE 416401P

VerDate Sep<11>2014

00:30 Sep 04, 2021

Jkt 253001

Agency Information Collection Activities; Proposed Collection;
Comment Request; Labeling Requirements for Prescription Drugs AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

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.
SUMMARY:

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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.

ADDRESSES:

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 elses 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 HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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