[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66681-66682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26264]
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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
Effectiveness of Drugs for Treatment; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled
``Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing
Effectiveness of Drugs for Treatment.'' There is pharmaceutical and
stakeholder interest in the development of new drugs for patients with
IC/BPS. This draft guidance provides FDA's recommendations for clinical
trials intended to establish clinical effectiveness and safety for
drugs intended to treat IC/BPS.
DATES: Submit either electronic or written comments on the draft
guidance by February 3, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2019-D-4656 for ``Interstitial Cystitis/Bladder Pain Syndrome (IC/
BPS): Establishing Effectiveness of 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.
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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the
[[Page 66682]]
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.
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: Margaret Kober, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5376, Silver Spring, MD 20993-0002, 301-
796-0934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS):
Establishing Effectiveness of Drugs for Treatment.'' IC/BPS is a
complex, poorly understood syndrome of unknown etiology. This draft
guidance provides recommendations for establishing effectiveness for
drugs intended to treat patients with IC/BPS. This draft guidance
incorporates recommendations the FDA received at a December 2017
advisory committee meeting on trial design features (see the meeting
material available at https://www.fda.gov/advisory-committees/advisory-committee-calendar/december-7-2017-meeting-bone-reproductive-and-urologic-drugs-advisory-committee-12062017-12062017), including
enrollment criteria and acceptable efficacy endpoints for drugs
intended to treat IC/BPS.
This draft guidance includes key considerations in trial design
including enrollment criteria and efficacy endpoint selection. The
draft guidance also provides general recommendations on design features
and statistical considerations. This draft guidance also provides the
FDA's current recommendations on the use of patient-reported outcome
instruments to evaluate patient symptoms to demonstrate a clinically
meaningful change with treatment.
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 on ``Interstitial
Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of
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
This draft guidance refers to previously approved collections that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
Dated: November 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26264 Filed 12-4-19; 8:45 am]
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