Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, 70505-70507 [2021-26733]

Download as PDF 70505 Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0572. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Labeling Requirements for Prescription Drugs OMB Control Number 0910–0572— Revision This information collection supports FDA regulations governing the labeling of prescription drugs. The regulations are codified in 21 CFR part 201, subpart B (21 CFR 201.50 through 201.58) and set forth both general requirements, as well as specific content and format requirements. The regulations also provide for requesting a waiver from any labeling requirement and do not apply to biological products that are subject to the requirements of section 351 of the Public Health Service Act. We are revising the information collection to include burden associated with regulations applicable to medical gas labeling found in § 201.328 (21 CFR 201.328) and established by a final rule in the Federal Register of November 18, 2016 (81 FR 81685 at 81694). While we included corresponding changes and adjustments resulting from the final rule to the information collection approved under OMB control number 0910–0139 as it pertains to good manufacturing practice requirements and regulations in part 211 (21 CFR part 211), we did not make corresponding changes and adjustments to this information collection with regard to burden that may be associated with labeling requirements found in § 201.328 (81 FR 81685 at 81694). To assist respondents with the information collection we continue to develop and issue guidance documents, available from our searchable guidance database at https://www.fda.gov/ regulatory-information/search-fdaguidance-documents. All Agency guidance documents are issued consistent with our good guidance practice regulations found in 21 CFR 10.115, which provide for public comment at any time. In the Federal Register of September 7, 2021 (86 FR 50134), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of the information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/21 CFR section Total annual responses Average burden per response Total hours Labeling requirements for prescription drugs; §§ 201.56 and 201.57. Labeling of medical gas containers; § 201.328 .... 414 1.326 549 3,349 ............................. 1,838,601 260 1,663 432,380 0.17 (10 minutes) ......... 73,505 Total ............................................................... ........................ ........................ 432,929 ....................................... 1,912,106 1 There jspears on DSK121TN23PROD with NOTICES1 Number of responses per respondent are no capital costs or operating and maintenance costs associated with this collection of information. New drug product and biological product applicants must: (1) Design and create prescription drug labeling containing ‘‘Highlights,’’ ‘‘Contents,’’ and ‘‘Full Prescribing Information’’; (2) test the designed labeling (for example, to ensure that the designed labeling fits into carton-enclosed products); and (3) submit it to FDA for approval. Based on our experience with the information collection, we estimate 414 applicants will prepare an average of 549 prescription drug labels and assume it will require 3,349 hours to design, test, and submit to FDA as part of a new drug application or a biologics license application. Similarly, new medical gas containers must meet applicable requirements found in part 211, as well as specific labeling requirements in § 201.328. We estimate that 260 respondents will incur burden for the design, testing, production, and submission of labeling for new medical gas containers as required under VerDate Sep<11>2014 17:03 Dec 09, 2021 Jkt 256001 § 201.328 and assume an average of 10 minutes (0.17) is required for these activities. Our estimated burden for the information collection reflects an overall increase resulting from an increase in submissions for new product labeling as well as from the revision to include burden associated with requirements in § 201.328. Dated: December 6, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–26730 Filed 12–9–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 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. 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 SUMMARY: E:\FR\FM\10DEN1.SGM 10DEN1 70506 Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices 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: • 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’’). jspears on DSK121TN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:03 Dec 09, 2021 Jkt 256001 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-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 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 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 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-today 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 E:\FR\FM\10DEN1.SGM 10DEN1 Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices 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 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: 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jspears on DSK121TN23PROD with NOTICES1 [Docket No. FDA–2020–D–2307] Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory DecisionMaking for Drug and Biological Products; Draft Guidance for Industry; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; reopening of the comment period. ACTION: VerDate Sep<11>2014 17:03 Dec 09, 2021 Jkt 256001 The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled ‘‘Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance of Industry,’’ published in the Federal Register on September 30, 2021. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period on the draft guidance published September 30, 2021 (86 FR 54219). Submit either electronic or written comments by January 24, 2022. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 24, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 24, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 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: PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 70507 • 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– 2020–D–2307 for ‘‘Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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-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 E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70505-70507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26733]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:
     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 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

[[Page 70507]]

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 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: 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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