Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling Requirements for Prescription Drugs, 70504-70505 [2021-26730]
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70504
Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices
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–
2020–D–1518 for ‘‘Development of AntiInfective Drug Products for the Pediatric
Population.’’ Received comments 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.
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
VerDate Sep<11>2014
17:03 Dec 09, 2021
Jkt 256001
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 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:
Hiwot Hiruy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
240–402–0872; 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 final guidance for industry entitled
‘‘Development of Anti-Infective Drug
Products for the Pediatric Population.’’
The purpose of this guidance is to
provide general recommendations on
the development of anti-infective drug
products for pediatric patients. The
guidance addresses enrollment
strategies, extrapolation of efficacy,
safety database, and other
considerations to help facilitate
pediatric anti-infective drug product
development.
This guidance finalizes the draft
guidance of the same title issued on
June 30, 2020 (85 FR 39193). FDA
provided clarifying edits to the final
guidance and included additional
information after considering comments
received on the draft guidance. Changes
from the draft to the final guidance
include updates to efficacy
extrapolation from adult to pediatric
patients (including from one pediatric
subpopulation to another), safety data
collection, additional considerations for
studies, and recommendations for
conducting juvenile toxicology studies.
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 ‘‘Development of
Anti-Infective Drug Products for the
Pediatric Population.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
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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 parts 312 and
314 and 21 CFR 201.56 and 201.57 have
been approved under OMB control
numbers 0910–0014, 0910–0001, and
0910–0572, respectively.
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/
regulatory-information/search-fdaguidance-documents, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26737 Filed 12–9–21; 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; Submission for Office of
Management and Budget Review;
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 that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 10,
2022.
SUMMARY:
E:\FR\FM\10DEN1.SGM
10DEN1
70505
Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0572. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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.
In the Federal Register of September
7, 2021 (86 FR 50134), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR section
Total annual
responses
Average burden per
response
Total hours
Labeling requirements for prescription drugs;
§§ 201.56 and 201.57.
Labeling of medical gas containers; § 201.328 ....
414
1.326
549
3,349 .............................
1,838,601
260
1,663
432,380
0.17 (10 minutes) .........
73,505
Total ...............................................................
........................
........................
432,929
.......................................
1,912,106
1 There
jspears on DSK121TN23PROD with NOTICES1
Number of
responses per
respondent
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
VerDate Sep<11>2014
17:03 Dec 09, 2021
Jkt 256001
§ 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.
Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26730 Filed 12–9–21; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1096]
Chronic Rhinosinusitis With Nasal
Polyps: Developing Drugs for
Treatment; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Chronic
Rhinosinusitis with Nasal Polyps:
Developing Drugs for Treatment.’’ The
purpose of this draft guidance is to
assist sponsors in the clinical
development of drugs for the treatment
of chronic rhinosinusitis with nasal
polyps (CRSwNP). Specifically, this
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70504-70505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26730]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0918]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 10, 2022.
[[Page 70505]]
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0572. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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.
In the Federal Register of September 7, 2021 (86 FR 50134), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Labeling requirements for 414 1.326 549 3,349........... 1,838,601
prescription drugs; Sec.
Sec. 201.56 and 201.57.
Labeling of medical gas 260 1,663 432,380 0.17 (10 73,505
containers; Sec. 201.328. minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. 432,929 ................ 1,912,106
----------------------------------------------------------------------------------------------------------------
\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: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26730 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P
