[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Revised Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Bacillus 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 This draft guidance reflects proposed revisions to the 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DATES: Submit either electronic or written comments on the draft 
guidance by October 8, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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]
BILLING CODE 4164-01-P