Notice2021-26733
Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Primary source
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Published
December 10, 2021
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this draft guidance addresses FDA's current recommendations regarding trial design, safety, and efficacy considerations for CRSwNP clinical trials.
Full Text
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<title>Federal Register, Volume 86 Issue 235 (Friday, December 10, 2021)</title>
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[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70505-70507]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26733]
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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Treatment; Draft Guidance for Industry; Availability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.
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SUMMARY: 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the availability of a draft guidance for industry entitled ``Chronic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purpose of this draft guidance is to assist sponsors in the clinical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
[[Page 70506]]
draft guidance addresses FDA's current recommendations regarding trial
design, safety, and efficacy considerations for CRSwNP clinical trials.
DATES: Submit either electronic or written comments on the draft
guidance by February 8, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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 to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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 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 draft guidance for industry
entitled ``Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs
for Treatment.'' This draft guidance provides recommendations for
sponsors developing drugs for the treatment of CRSwNP. Specifically,
this draft guidance represents FDA's current recommendations regarding
trial population, design, effectiveness, statistical analysis, and
safety for drugs being developed for the treatment of CRSwNP. This
draft guidance does not address the clinical development of drugs or
therapeutic biological products for the treatment of chronic
rhinosinusitis without nasal polyps or allergic fungal rhinosinusitis.
Chronic rhinosinusitis is characterized by inflammation of the
nasal mucosa and paranasal sinuses and can be further divided into
chronic rhinosinusitis with nasal polyps without nasal polyps. Nasal
polyps are inflammatory hyperplastic growths that protrude into the
nasal passages. Symptoms of chronic rhinosinusitis with nasal polyps
include nasal congestion, nasal discharge, facial pain or pressure, and
loss of smell. Nasal polyps have associated morbidity that can have
substantial effect on day-to-day functioning. Treatment goals include
reduction of symptoms, systemic corticosteroid use, and surgery as well
as improved quality of life. Because of differences in natural history
and treatment between chronic rhinosinusitis with and without nasal
polyps, this draft guidance specifically addresses aspects of trial
design, safety, and efficacy assessment for CRSwNP.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA
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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 draft guidance contains no new 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 draft guidance. The previously
approved collections of information are subject to review by OMB under
the PRA. The collections of information in 21 CFR part 312 for
investigational new drug applications have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR
parts 314 and 601 for applications for FDA approval to market a new
drug or biologic have been approved under OMB control numbers 0910-0001
and 0910-0338, respectively.
III. Electronic Access
Persons with access to the internet may obtain the draft 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: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26733 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P
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