[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draft guidance of the same title issued on December 10, 2021.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