[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Development Programs for Treatment; Revised Draft Guidance for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the availability of a revised draft guidance for industry entitled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 This draft guidance is intended
to revise and replace the current draft guidance for industry entitled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draft guidance provides recommendations for drug development programs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DATES: Submit either electronic or written comments on the draft
guidance by August 4, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.
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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