Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Guidance for Industry; Availability, 42375-42376 [2023-13884]
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Federal Register / Vol. 88, No. 125 / Friday, June 30, 2023 / Notices
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
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’’).
[FR Doc. 2023–13936 Filed 6–29–23; 8:45 am]
BILLING CODE 4164–01–P
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; 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 final
guidance for industry entitled ‘‘Chronic
Rhinosinusitis With Nasal Polyps:
Developing Drugs for Treatment.’’ The
purpose of this guidance is to assist
sponsors in the development of drugs or
biological products for the treatment of
chronic rhinosinusitis with nasal polyps
(CRSwNP). Specifically, this guidance
addresses FDA’s current thinking
regarding trial population and design,
effectiveness, statistical analysis, and
safety for drugs being developed for the
treatment of CRSwNP. This guidance
finalizes the draft guidance of the same
title issued on December 10, 2021.
DATES: The announcement of the
guidance is published in the Federal
Register on June 30, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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
VerDate Sep<11>2014
19:33 Jun 29, 2023
Jkt 259001
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
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–
2021–D–1096 for ‘‘Chronic
Rhinosinusitis With Nasal Polyps:
Developing Drugs for Treatment.’’
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
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
42375
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
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:
Rekha Jhamnani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3395,
Silver Spring, MD 20993–0002, 301–
796–5636; or Diane Maloney, 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 guidance for industry entitled
‘‘Chronic Rhinosinusitis With Nasal
Polyps: Developing Drugs for
Treatment.’’ The guidance provides
recommendations for sponsors
developing products for the treatment of
CRSwNP. Specifically, this guidance
represents FDA’s current thinking
regarding trial population and design,
effectiveness, statistical analysis, and
safety for drugs being developed for the
treatment of CRSwNP. This guidance
does not address the clinical
development of drugs for the treatment
E:\FR\FM\30JNN1.SGM
30JNN1
42376
Federal Register / Vol. 88, No. 125 / Friday, June 30, 2023 / Notices
of chronic rhinosinusitis without nasal
polyps or allergic fungal rhinosinusitis.
This guidance finalizes the draft
guidance of the same title issued on
December 10, 2021 (86 FR 70505). FDA
considered comments received on the
draft guidance in this finalized
guidance. Chronic rhinosinusitis is
characterized by inflammation of the
nasal mucosa and paranasal sinuses and
can be further divided into chronic
rhinosinusitis with and without nasal
polyps. Nasal polyps are inflammatory
hyperplastic growths that protrude into
the nasal passages. Symptoms of
CRSwNP include nasal congestion,
nasal discharge, facial pain or pressure,
and loss of smell. Nasal polyps have
associated morbidity that can have
substantial impact on day-to-day
functioning. Because of differences in
natural history and treatment between
chronic rhinosinusitis with and without
nasal polyps, this guidance specifically
addresses aspects of trial design, safety
and efficacy assessment for CRSwNP.
Changes from the draft to the final
guidance include considerations for
efficacy assessments for CRSwNP.
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 ‘‘Chronic
Rhinosinusitis With Nasal Polyps:
Developing Drugs for Treatment.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
information contained in 21 CFR part
312 relating to investigational new drug
applications have been approved under
OMB control number 0910–0014. The
collections of information in 21 CFR
part 314 relating to new drug
applications have been approved under
OMB control number 0910–0001. The
collections of information contained in
21 CFR part 601 relating to biologics
license applications have been approved
under OMB control number 0910–0338.
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/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13884 Filed 6–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0438]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before August 29, 2023.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
SUMMARY:
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
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990-New-60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: FY2020 Teen
Pregnancy Prevention (TPP) Program
Performance Measures.
Type of Collection: Extension.
OMB No.: 0990–0438.
Abstract: The Office of Population
Affairs (OPA), in the Office of the
Assistant Secretary for Health (OASH),
U.S. Department of Health and Human
Services (HHS), requests a renewal
clearance for the collection of
performance measures specifically for
FY2020 Teen Pregnancy Prevention
(TPP) Program grantees. Collection of
performance measures is a requirement
of all TPP awards and is included in the
NOFOs. The data collection will allow
OPA to comply with federal
accountability and performance
requirements, inform stakeholders of
grantee progress in meeting TPP
program goals, provide OPA with
metrics for monitoring TPP grantees,
and facilitate individual grantees’
continuous quality improvement efforts
within their projects. OPA requests
clearance for one year to cover reporting
during the no-cost extension period of
the awards.
ANNUALIZED BURDEN HOUR TABLE
ddrumheller on DSK120RN23PROD with NOTICES1
Forms
(if necessary)
Grantees
Grantees
Grantees
Grantees
Grantees
Grantees
Grantees
Respondents
(if necessary)
(partners and sustainability)
(training) ..............................
(dissemination) ....................
(Stakeholder Engagement)
( Reach and Demographics)
(Dosage) .............................
(Fidelity and Quality) ...........
VerDate Sep<11>2014
19:33 Jun 29, 2023
Number of
respondents
All TPP grantees ................................
All TPP Grantees ...............................
All TPP Grantees ...............................
All TPP Grantees ...............................
Tier 1 and Tier 2 Phase II Grantees ..
Tier 1 and Tier 2 Phase II Grantees ..
Tier 1 and Tier 2 Phase II Grantees ..
Jkt 259001
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Fmt 4703
Sfmt 4703
Number of
responses per
respondents
90
90
90
90
64
64
64
E:\FR\FM\30JNN1.SGM
2
2
2
2
2
2
2
30JNN1
Average
burden per
response
15/60
15/60
30/60
15/60
3
2
2
Total
burden
hours
45
45
90
45
384
256
256
Agencies
[Federal Register Volume 88, Number 125 (Friday, June 30, 2023)]
[Notices]
[Pages 42375-42376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13884]
-----------------------------------------------------------------------
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; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Chronic
Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.'' The
purpose of this guidance is to assist sponsors in the development of
drugs or biological products for the treatment of chronic
rhinosinusitis with nasal polyps (CRSwNP). Specifically, this guidance
addresses FDA's current thinking regarding trial population and design,
effectiveness, statistical analysis, and safety for drugs being
developed for the treatment of CRSwNP. This guidance finalizes the
draft guidance of the same title issued on December 10, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on June 30, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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 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-2021-D-1096 for ``Chronic Rhinosinusitis With Nasal Polyps:
Developing Drugs for Treatment.'' 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-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.
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 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: Rekha Jhamnani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3395, Silver Spring, MD 20993-0002, 301-
796-5636; or Diane Maloney, 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 guidance for industry
entitled ``Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs
for Treatment.'' The guidance provides recommendations for sponsors
developing products for the treatment of CRSwNP. Specifically, this
guidance represents FDA's current thinking regarding trial population
and design, effectiveness, statistical analysis, and safety for drugs
being developed for the treatment of CRSwNP. This guidance does not
address the clinical development of drugs for the treatment
[[Page 42376]]
of chronic rhinosinusitis without nasal polyps or allergic fungal
rhinosinusitis.
This guidance finalizes the draft guidance of the same title issued
on December 10, 2021 (86 FR 70505). FDA considered comments received on
the draft guidance in this finalized guidance. Chronic rhinosinusitis
is characterized by inflammation of the nasal mucosa and paranasal
sinuses and can be further divided into chronic rhinosinusitis with and
without nasal polyps. Nasal polyps are inflammatory hyperplastic
growths that protrude into the nasal passages. Symptoms of CRSwNP
include nasal congestion, nasal discharge, facial pain or pressure, and
loss of smell. Nasal polyps have associated morbidity that can have
substantial impact on day-to-day functioning. Because of differences in
natural history and treatment between chronic rhinosinusitis with and
without nasal polyps, this guidance specifically addresses aspects of
trial design, safety and efficacy assessment for CRSwNP. Changes from
the draft to the final guidance include considerations for efficacy
assessments for CRSwNP.
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 ``Chronic Rhinosinusitis With Nasal Polyps:
Developing Drugs for Treatment.'' It does not establish any rights for
any person and is not binding on FDA or the public. 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 contained in 21 CFR part 312 relating to investigational
new drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 relating to new
drug applications have been approved under OMB control number 0910-
0001. The collections of information contained in 21 CFR part 601
relating to biologics license applications have been approved under OMB
control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13884 Filed 6-29-23; 8:45 am]
BILLING CODE 4164-01-P