[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65361-65362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17733]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-0342]
Bacillus Calmette-Gu[eacute]rin-Unresponsive Nonmuscle Invasive
Bladder Cancer: Developing Drug and Biological Products 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Revised Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Bacillus
Calmette-Gu[eacute]rin-Unresponsive Nonmuscle Invasive Bladder Cancer:
Developing Drug and Biological Products for Treatment.'' The purpose of
this guidance is to assist sponsors in the development of drug and
biological products for the treatment of patients with bacillus
Calmette-Gu[eacute]rin (BCG)-unresponsive nonmuscle invasive bladder
cancer (NMIBC). This draft guidance reflects proposed revisions to the
final guidance entitled ``BCG-Unresponsive Nonmuscle Invasive Bladder
Cancer: Developing Drugs and Biologics for Treatment,'' published in
February 2018, and incorporates changes based on review experience as
well as the evolving landscape of drug development in bladder cancer,
as noted by external experts.
DATES: Submit either electronic or written comments on the draft
guidance by October 8, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2018-D-0342 for ``BCG-Unresponsive Nonmuscle Invasive Bladder
Cancer: Developing Drug and Biological Products 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
[[Page 65362]]
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; 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: Sundeep Agrawal, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-348-3914; or James
Myers, Center of 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 ``BCG-Unresponsive Nonmuscle Invasive Bladder Cancer:
Developing Drug and Biological Products for Treatment.'' The purpose of
this guidance is to assist sponsors in the development of drugs and
biologics for the treatment of patients with BCG-unresponsive NMIBC.
This guidance addresses select statistical and clinical trial design
issues specific to BCG-unresponsive NMIBC. These topics are further
addressed in the International Council for Harmonisation guidances for
industry entitled ``E9 Statistical Principles for Clinical Trials''
(September 1998) and ``E10 Choice of Control Group and Related Issues
in Clinical Trials'' (May 2001), respectively.
This draft guidance reflects proposed changes to FDA's guidance
entitled ``BCG-Unresponsive Nonmuscle Invasive Bladder Cancer:
Developing Drugs and Biologics for Treatment,'' published in February
2018, and incorporates FDA's current recommendations based on the
Agency's experience as well as the evolving landscape of drug
development in this space, as noted by external experts. This guidance,
when finalized, will replace the final guidance titled BCG-Unresponsive
Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for
Treatment published in February 2018.
Key changes include the following: (1) clarification on use of BCG
substrains, (2) considerations for trial design and conduct in the
setting of a recent worldwide shortage of BCG, (3) clarification on use
of single arm vs. randomized trial designs (with more emphasis on
randomized control trials), and (4) clarifications on assessing and
reporting responses and assessing endpoints for trials.
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 ``BCG-
Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and
Biological Products 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR parts 50 and 56 have been approved under OMB control number
0910-0130; the collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001; the collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 601
have been approved under OMB control number 0910-0338; and the
collections of information pertaining to submission of a biologics
license application under section 351(k) of the Public Health Service
Act (42 U.S.C. 262(k)) have been approved under OMB control number
0910-0718.
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-guidance-documents, or https://www.regulations.gov.
Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17733 Filed 8-8-24; 8:45 am]
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