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Notice2022-09237

Ulcerative Colitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

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Published
April 29, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Ulcerative Colitis: Developing Drugs for Treatment." This draft guidance addresses FDA's current thinking about necessary attributes of clinical trials for developing drugs for the treatment of ulcerative colitis in adults, including recommendations for trial population, trial design, and efficacy and safety considerations. This draft guidance replaces the draft guidance for industry entitled "Ulcerative Colitis: Clinical Trial Endpoints," which is being withdrawn.

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<title>Federal Register, Volume 87 Issue 83 (Friday, April 29, 2022)</title>
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[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25490-25491]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09237]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0140]


Ulcerative Colitis: Developing Drugs for Treatment; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Ulcerative 
Colitis: Developing Drugs for Treatment.'' This draft guidance 
addresses FDA's current thinking about necessary attributes of clinical 
trials for developing drugs for the treatment of ulcerative colitis in 
adults, including recommendations for trial population, trial design, 
and efficacy and safety considerations. This draft guidance replaces 
the draft guidance for industry entitled ``Ulcerative Colitis: Clinical 
Trial Endpoints,'' which is being withdrawn.

DATES: Submit either electronic or written comments on the draft 
guidance by June 28, 2022 to ensure that the Agency considers your 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:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2022-D-0140 for ``Ulcerative Colitis: Developing Drugs for 
Treatment.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kelly Richards, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5378, Silver Spring, MD 20993, 240-402-
4276, or Stephen Ripley, Center for

[[Page 25491]]

Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Ulcerative Colitis: Developing Drugs for Treatment.'' This 
guidance addresses FDA's current thinking about necessary attributes of 
clinical trials for developing drugs for ulcerative colitis in adults 
including recommendations for trial population, trial design, and 
efficacy and safety considerations. This draft guidance replaces the 
draft guidance for industry entitled ``Ulcerative Colitis: Clinical 
Trial Endpoints,'' issued on August 8, 2016 (81 FR 52449), which is 
being withdrawn.
    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 ``Ulcerative 
Colitis: 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 in 21 CFR part 312 have been approved under OMB control 
number 0910-0014. FDA receives information described in FDA's guidance 
entitled ``Patient-Reported Outcome Measures: Use in Medical Product 
Development to Support Labeling Claims'' to support the medical 
product's effectiveness and to support claims in approved medical 
product labeling; the collections of information in 21 CFR 314.50(d)(5) 
and 21 CFR 601.2 have been approved under OMB control numbers 0910-0001 
and 0910-0338, respectively, and the collections of information in 21 
CFR 201.56 and 201.57 for medical product labeling have been approved 
under OMB control number 0910-0572. The collections of information in 
21 CFR parts 50 and 56 for protection of human subjects in clinical 
trials and institutional review board considerations have been approved 
under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

    Dated: April 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09237 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P


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