Notice2023-13884
Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Guidance for Industry; Availability
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Published
June 30, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This guidance finalizes the draft guidance of the same title issued on December 10, 2021.
Full Text
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<title>Federal Register, Volume 88 Issue 125 (Friday, June 30, 2023)</title>
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[Federal Register Volume 88, Number 125 (Friday, June 30, 2023)]
[Notices]
[Pages 42375-42376]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13884]
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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; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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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draft guidance of the same title issued on December 10, 2021.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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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