Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction, 50134 [2021-19216]
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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
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. 2021–19221 Filed 9–3–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
Food and Drug Administration
[Docket No. FDA–2021–N–0944]
[FR Doc. 2021–19216 Filed 9–3–21; 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. FDA–2021–N–0918]
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
SUMMARY:
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BILLING CODE 4164–01–P
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:
PO 00000
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U:\07SEN1.SGM
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 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.
07SEN1
]]>Agencies
[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Page 50134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19216]
-----------------------------------------------------------------------
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
