[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36590-36592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4656]


Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug 
Development Programs for Treatment; Revised Draft Guidance for 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the availability of a revised draft guidance for industry entitled 
``Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug 
Development Programs for Treatment.'' This draft guidance is intended 
to revise and replace the current draft guidance for industry entitled 
``Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing 
Effectiveness of Drugs for Treatment'' issued on December 5, 2019. This 
draft guidance provides recommendations for drug development programs 
for drugs intended to treat patients with interstitial cystitis/bladder 
pain syndrome (IC/BPS).

DATES: Submit either electronic or written comments on the draft 
guidance by August 4, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.

[[Page 36591]]

     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-2019-D-4656 for ``Interstitial Cystitis/Bladder Pain Syndrome: 
Establishing Drug Development Programs 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 the draft 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. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jeannie Roule, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5332, Silver Spring, MD 20993-002, 301-
796-3993.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Interstitial Cystitis/Bladder Pain Syndrome: 
Establishing Drug Development Programs for Treatment.'' IC/BPS is a 
complex, poorly understood heterogeneous syndrome of unknown etiology. 
This draft guidance provides recommendations to assist applicants in 
developing products intended for treatment of IC/BPS. As with the 2019 
draft guidance, this draft guidance incorporates advice FDA received at 
a December 2017 advisory committee meeting on appropriate patient 
selection criteria and trial design features, including enrollment 
criteria and acceptable efficacy endpoints for drugs intended to treat 
IC/BPS.
    This draft guidance encourages sponsors to assess dosing 
strategies, explore multiple efficacy endpoints, and collect safety 
information during early drug development to inform design strategy and 
selection of clinically meaningful endpoints for later clinical trials. 
This draft guidance also provides advice on enrollment criteria, 
efficacy endpoints, and other considerations for clinical trials to 
support an IC/BPS indication. This draft guidance provides 
recommendations based on the Agency's current thinking on the 
development of patient-reported outcomes to evaluate patient symptoms 
to demonstrate a clinically meaningful change with treatment for this 
condition.
    This draft guidance revises and provides updates to the draft 
guidance entitled ``Interstitial Cystitis/Bladder Pain Syndrome (IC/
BPS): Establishing Effectiveness of Drugs for Treatment'' issued on 
December 5, 2019 (84 FR 66681). FDA considered comments received on the 
2019 draft guidance in revising the draft guidance. Changes from the 
2019 draft guidance include discussion of early drug development 
considerations, selection of patient outcomes for development, and 
clarification of evaluation of Hunner's lesions. In addition, editorial 
changes made to improve clarity include revised references to current 
Agency guidances on patient-reported outcomes and updated clinical 
considerations.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the current thinking of FDA on 
``Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug 
Development Programs 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 in 21 CFR part 312 relating investigational new drug 
applications, including clinical trial design and study protocols, have 
been approved under OMB control number 0910-0014.

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/regulatory-
information/search-fda-

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guidance-documents, or https://www.regulations.gov.

    Dated: May 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11899 Filed 6-2-23; 8:45 am]
BILLING CODE 4164-01-P