Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Guidance for Industry; Availability, 42375-42376 [2023-13884]

Download as PDF 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 This guidance finalizes the draft guidance of the same title issued on December 10, 2021.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 PO 00000 Frm 00091 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
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