Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs, 50134-50136 [2021-19218]
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<![CDATA[
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:
sradovich on DSKJLST7X2PROD with NOTICES
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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Sfmt 4703
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
Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices
• 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 Docket No. FDA–2021–N–
0918 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Labeling
Requirements for Prescription Drugs
and Biological Products.’’ 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-201509-18/pdf/2015-23389.pdf.
50135
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
Labeling Requirements for Prescription
Drugs
OMB Control Number 0910–0572—
Revision
This information collection supports
FDA regulations governing the labeling
of prescription drugs. The regulations
are codified in 21 CFR part 201, subpart
B (21 CFR 201.50 through 201.58) and
set forth both general requirements, as
well as specific content and format
requirements. The regulations also
provide for requesting a waiver from
any labeling requirement and do not
apply to biological products that are
subject to the requirements of section
351 of the Public Health Service Act.
We are revising the information
collection to include burden associated
with regulations applicable to medical
gas labeling found in § 201.328 (21 CFR
201.328) and established by a final rule
in the Federal Register of November 18,
2016 (81 FR 81685 at 81694). While we
included corresponding changes and
adjustments resulting from the final rule
to the information collection approved
under OMB control number 0910–0139
as it pertains to good manufacturing
practice requirements and regulations in
part 211 (21 CFR part 211), we did not
make corresponding changes and
adjustments to this information
collection with regard to burden that
may be associated with labeling
requirements found in § 201.328 (81 FR
81685 at 81694).
To assist respondents with the
information collection we continue to
develop and issue guidance documents,
available from our searchable guidance
database at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents. All Agency
guidance documents are issued
consistent with our good guidance
practice regulations found in 21 CFR
10.115, which provide for public
comment at any time.
We estimate the burden of the
information collection as follows:
sradovich on DSKJLST7X2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR Section
Labeling requirements for prescription drugs;
§§ 201.56 and 201.57.
Labeling of medical gas containers; § 201.328 ............
VerDate Sep<11>2014
00:30 Sep 04, 2021
Jkt 253001
PO 00000
Frm 00124
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
414
1.326
549
3,349 .....................
1,838,601
260
1,663
432,380
0.17 (10 minutes) ..
43,238
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50136
Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity/21 CFR Section
Total ......................................................................
1 There
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–19218 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–0965]
sradovich on DSKJLST7X2PROD with NOTICES
Number of
responses per
respondent
........................
........................
Total annual
responses
432,929
Average burden
per response
...............................
Total hours
1,881,839
are no capital costs or operating and maintenance costs associated with this collection of information.
New drug product and biological
product applicants must: (1) Design and
create prescription drug labeling
containing ‘‘Highlights,’’ ‘‘Contents,’’
and ‘‘Full Prescribing Information’’; (2)
test the designed labeling (for example,
to ensure that the designed labeling fits
into carton-enclosed products); and (3)
submit it to FDA for approval. Based on
our experience with the information
collection, we estimate 414 applicants
will prepare an average of 549
prescription drug labels and assume it
will require 3,349 hours to design, test,
and submit to FDA as part of a new drug
application or a biologics license
application. Similarly, new medical gas
containers must meet applicable
requirements found in part 211, as well
as specific labeling requirements in
§ 201.328. We estimate that 260
respondents will incur burden for the
design, testing, production, and
submission of labeling for new medical
gas containers as required under
§ 201.328 and assume an average of 10
minutes (0.17) is required for these
activities.
Our estimated burden for the
information collection reflects an
overall increase resulting from an
increase in submissions for new product
labeling as well as from the revision to
include burden associated with
requirements in § 201.328.
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Number of
respondents
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
VerDate Sep<11>2014
00:30 Sep 04, 2021
Jkt 253001
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Vaccines and Related Biological
Products Advisory Committee. The
general function of the committee is to
provide advice and recommendations to
the Agency on FDA’s regulatory issues.
The meeting will be open to the public.
FDA is establishing a docket for public
comment on this document.
Consistent with FDA’s regulations,
this notice is being published with less
than 15 days prior to the date of the
meeting based on a determination that
convening a meeting of the Vaccines
and Related Biological Products
Advisory Committee as soon as possible
is warranted. This Federal Register
notice could not be published 15 days
prior to the date of the meeting due to
a recent submission of a request to
supplement the approved Biologics
License Application for COMIRNATY
for administration of a third dose, or
‘‘booster’’ dose, of the COVID–19
vaccine, in individuals 16 years of age
and older and the need for prompt
discussion of such submission given the
COVID–19 pandemic.
DATES: The meeting will be held on
September 17, 2021, from 8:30 a.m. to
3:45 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform. The
online web conference meeting will be
available at the following link on the
day of the meeting: https://youtu.be/
WFph7-6t34M.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0965.
The docket will close on September 16,
2021. Submit either electronic or
written comments on this public
meeting by September 16, 2021. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before September 16, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
September 16, 2021. Comments received
by mail/hand delivery/courier (for
SUMMARY:
PO 00000
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Sfmt 4703
U:\07SEN1.SGM
written/paper submissions) will be
considered timely if they are received
on or before that date.
Comments received on or before
September 13, 2021, will be provided to
the committee. Comments received after
September 13, 2021, and by September
16, 2021, will be taken into
consideration by FDA. In the event that
the meeting is canceled, FDA will
continue to evaluate any relevant
applications, submissions, or
information, and consider any
comments submitted to the docket, as
appropriate.
You may submit comments as
follows:
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
07SEN1
]]>Agencies
[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50134-50136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19218]
-----------------------------------------------------------------------
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.
[[Page 50135]]
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 Docket No. FDA-
2021-N-0918 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Labeling Requirements for Prescription
Drugs and Biological Products.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Labeling Requirements for Prescription Drugs
OMB Control Number 0910-0572--Revision
This information collection supports FDA regulations governing the
labeling of prescription drugs. The regulations are codified in 21 CFR
part 201, subpart B (21 CFR 201.50 through 201.58) and set forth both
general requirements, as well as specific content and format
requirements. The regulations also provide for requesting a waiver from
any labeling requirement and do not apply to biological products that
are subject to the requirements of section 351 of the Public Health
Service Act.
We are revising the information collection to include burden
associated with regulations applicable to medical gas labeling found in
Sec. 201.328 (21 CFR 201.328) and established by a final rule in the
Federal Register of November 18, 2016 (81 FR 81685 at 81694). While we
included corresponding changes and adjustments resulting from the final
rule to the information collection approved under OMB control number
0910-0139 as it pertains to good manufacturing practice requirements
and regulations in part 211 (21 CFR part 211), we did not make
corresponding changes and adjustments to this information collection
with regard to burden that may be associated with labeling requirements
found in Sec. 201.328 (81 FR 81685 at 81694).
To assist respondents with the information collection we continue
to develop and issue guidance documents, available from our searchable
guidance database at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. All Agency guidance documents are issued
consistent with our good guidance practice regulations found in 21 CFR
10.115, which provide for public comment at any time.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR Section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling requirements for prescription drugs; 414 1.326 549 3,349................................... 1,838,601
Sec. Sec. 201.56 and 201.57.
Labeling of medical gas containers; Sec. 260 1,663 432,380 0.17 (10 minutes)....................... 43,238
201.328.
---------------------------------------------------------------------------------------------------------
[[Page 50136]]
Total..................................... .............. .............. 432,929 ........................................ 1,881,839
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
New drug product and biological product applicants must: (1) Design
and create prescription drug labeling containing ``Highlights,''
``Contents,'' and ``Full Prescribing Information''; (2) test the
designed labeling (for example, to ensure that the designed labeling
fits into carton-enclosed products); and (3) submit it to FDA for
approval. Based on our experience with the information collection, we
estimate 414 applicants will prepare an average of 549 prescription
drug labels and assume it will require 3,349 hours to design, test, and
submit to FDA as part of a new drug application or a biologics license
application. Similarly, new medical gas containers must meet applicable
requirements found in part 211, as well as specific labeling
requirements in Sec. 201.328. We estimate that 260 respondents will
incur burden for the design, testing, production, and submission of
labeling for new medical gas containers as required under Sec. 201.328
and assume an average of 10 minutes (0.17) is required for these
activities.
Our estimated burden for the information collection reflects an
overall increase resulting from an increase in submissions for new
product labeling as well as from the revision to include burden
associated with requirements in Sec. 201.328.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19218 Filed 9-3-21; 8:45 am]
BILLING CODE 4164-01-P
