Notice2022-13752
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment; Guidance for Industry; Availability
Primary source
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Published
June 28, 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 final guidance for industry entitled "Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment." This guidance is intended to facilitate the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma and provides recommendations for the sponsor on this topic. The guidance includes recommendations regarding eligibility criteria, choice of comparator, followup imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. This guidance finalizes the draft guidance of the same title issued on October 2, 2020.
Full Text
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<title>Federal Register, Volume 87 Issue 123 (Tuesday, June 28, 2022)</title>
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[Federal Register Volume 87, Number 123 (Tuesday, June 28, 2022)]
[Notices]
[Pages 38412-38414]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1496]
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant
Treatment; 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 final guidance for industry entitled ``Renal Cell
Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment.''
This guidance is intended to facilitate the development of drugs and
biologics for the adjuvant treatment of renal cell carcinoma and
provides recommendations for the sponsor on this topic. The guidance
includes recommendations regarding eligibility criteria, choice of
comparator, followup imaging assessments, determination of disease
recurrence, analyses of disease-free survival, and interpretation of
trial results. This guidance finalizes the draft guidance of the same
title issued on October 2, 2020.
DATES: The announcement of the guidance is published in the Federal
Register on June 28, 2022.
ADDRESSES: You may submit either electronic or written comments on
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Agency guidances 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-2020-D-1496 for ``Renal Cell Carcinoma: Developing Drugs and
Biologics for Adjuvant 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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research (CBER), 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Sundeep Agrawal, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2379, Silver Spring, MD 20993-0002, 240-
402-4683; or Stephen Ripley, Center for 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 guidance for industry
entitled ``Renal Cell Carcinoma: Developing Drugs and Biologics for
Adjuvant Treatment.'' This guidance provides recommendations to
sponsors regarding the development of drugs regulated by CDER and CBER
for the adjuvant treatment of renal cell carcinoma. The guidance
includes recommendations regarding eligibility criteria, choice of
comparator, followup imaging assessments, determination of disease
recurrence, analyses of disease-free survival (DFS), and interpretation
of trial results. Although FDA may consider endpoints other than DFS
for the adjuvant treatment of renal cell carcinoma, this guidance is
focused on clinical trials with DFS as the primary efficacy endpoint.
Adjuvant renal cell carcinoma clinical trials are an active area of
research. There is significant variability in the design, conduct, and
analysis of these trials, including the eligibility criteria,
radiological disease assessments, the definition of disease recurrence,
and the date used to define the DFS endpoint. Consistency in these
aspects within and across trials may facilitate interpretation of trial
results. These issues were discussed at an FDA-National Cancer
Institute public workshop held on November 28, 2017. This final
guidance provides recommendations on these issues to facilitate
adjuvant renal cell carcinoma clinical trials. This guidance finalizes
the draft guidance entitled ``Renal Cell Carcinoma: Developing Drugs
and Biologics for Adjuvant Treatment'' issued on October 2, 2020 (85 FR
62310). FDA considered comments received on the draft guidance as the
guidance was finalized. The final guidance includes changes to improve
clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Renal Cell Carcinoma: Developing Drugs and
Biologics for Adjuvant 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.
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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; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: June 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13752 Filed 6-27-22; 8:45 am]
BILLING CODE 4164-01-P
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