Use of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development; Guidance for Industry; Availability, 94738-94740 [2024-28033]
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94738
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total
hours 2
Recordkeeping—54.6 ......................................................
712
1
712
0.25
178
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.
Third-Party Disclosure Burden
Under § 54.4(b), clinical investigators
supply to the sponsor of a covered study
financial information sufficient to allow
the sponsor to submit complete and
accurate certification or disclosure
statements. Clinical investigators are
accustomed to supplying such
information when applying for research
grants. Also, most people know the
financial holdings of their immediate
family and records of such interests are
generally accessible because they are
needed for preparing tax records. For
these reasons, FDA estimates that the
time required for this task may range
from 5 to 15 minutes; we used the
median, 10 minutes, for the average
burden per disclosure (see table 4). To
estimate the number of respondents for
each FDA Center, we took the median
number of investigators for each
application type, multiplied each
median number of investigators by the
number of affected applications for that
application type, then summed those
products to get the total number of
respondents for the Center.
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours 2
54.4(b)—Clinical Investigators .........................................
13,646
1
13,646
0.17
2,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
The burden for this information
collection request has changed since the
last OMB approval. We have adjusted
our estimated burden for the
information collection to reflect the
number of submissions we received in
the last few years. These adjustments
result in an increase of 557 total annual
responses and a corresponding increase
of 87 total hours.
Dated: November 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–28034 Filed 11–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0084]
khammond on DSK9W7S144PROD with NOTICES
Use of Circulating Tumor
Deoxyribonucleic Acid for CurativeIntent Solid Tumor Drug Development;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Use of
Circulating Tumor DNA for Curative-
SUMMARY:
VerDate Sep<11>2014
21:22 Nov 27, 2024
Jkt 265001
Intent Solid Tumor Drug Development.’’
This guidance is intended to help
sponsors planning to use circulating
cell-free plasma derived tumor DNA
(ctDNA) as a biomarker in cancer
clinical trials conducted under an
investigational new drug application
(IND) and/or to support marketing
approval of drugs and biological
products for treating solid tumor
malignancies in the early-stage
(curative-intent) setting. This guidance
finalizes the draft guidance entitled
‘‘Use of Circulating Tumor DNA for
Early-Stage Solid Tumor Drug
Development’’ issued on May 2, 2022.
DATES: The announcement of the
guidance is published in the Federal
Register on November 29, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
PO 00000
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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–
2022–D–0084 for ‘‘Use of Circulating
E:\FR\FM\29NON1.SGM
29NON1
khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices
Tumor Deoxyribonucleic Acid for
Curative-Intent Solid Tumor Drug
Development.’’ 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
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-201509-18/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 this 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
VerDate Sep<11>2014
21:22 Nov 27, 2024
Jkt 265001
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002; or
Office of Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed 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: Paz
Vellanki, Center for Drug Evaluation
and Research (HFD–150), Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–9366; James
Myers, 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; or Center for
Devices and Radiological Health,
CDRHClinicalEvidence@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Use of
Circulating Tumor DNA for CurativeIntent Solid Tumor Drug Development.’’
This guidance is intended to help
sponsors planning to use circulating
cell-free plasma derived tumor DNA
(ctDNA) as a biomarker in cancer
clinical trials conducted under an IND
and/or to support marketing approval of
drugs and biological products for
treating solid tumor malignancies in the
early-stage (curative-intent) setting.
Certain patients with early-stage solid
tumors can be cured with local therapy
alone (e.g., surgery, radiation, or
chemoradiation), other patients require
(neo)adjuvant systemic therapy in order
to be cured, and others may progress to
metastatic disease despite surgery and/
or systemic therapy. ctDNA is tumorderived fragmented DNA shed into a
patient’s bloodstream that is not
associated with cells. ctDNA quantity
can vary among individuals and
depends on the type of tumor, location,
stage, tumor burden, and response to
therapy. ctDNA as a biomarker has a
number of potential regulatory and
clinical uses in the early-stage setting
that may assist and expedite drug
development. In the early-stage cancer
setting, ctDNA may be used to detect a
certain targetable alteration, to enrich a
high- or low-risk population for study in
a trial, to reflect a patient’s response to
treatment, or, potentially, as an early
marker of efficacy.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
94739
This guidance finalizes the draft
guidance entitled, ‘‘Use of Circulating
Tumor DNA for Early-Stage Solid
Tumor Drug Development,’’ issued on
May 2, 2022 (87 FR 26207). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include edits to further
explain the rationale for writing a
guidance on use of ctDNA for solid
tumor drug development specific to the
early-stage, curative-intent disease
setting. The part of the guidance that
discusses assay considerations was also
clarified to indicate that while a major
focus of this section pertains to
assessment of molecular residual
disease (MRD), there may be other uses
of ctDNA in the early-stage disease
setting. In addition, editorial changes
were made 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 ‘‘Use of Circulating
Tumor DNA for Curative-Intent Solid
Tumor Drug Development.’’ 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; the collections of
information in 21 CFR part 800 have
been approved under OMB control
number 0910–0625; 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.
E:\FR\FM\29NON1.SGM
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94740
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: November 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–28033 Filed 11–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4687]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medicated Feed
Mill License Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of medicated feed
mill license reporting.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
January 28, 2025.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 28, 2025. Comments received by
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:22 Nov 27, 2024
Jkt 265001
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
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–
2024–N–4687 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Medicated Feed Mill License
Application.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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.govinfo.gov/content/pkg/FR-201509-18/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.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
E:\FR\FM\29NON1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Pages 94738-94740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28033]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0084]
Use of Circulating Tumor Deoxyribonucleic Acid for Curative-
Intent Solid Tumor Drug Development; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Use of
Circulating Tumor DNA for Curative-Intent Solid Tumor Drug
Development.'' This guidance is intended to help sponsors planning to
use circulating cell-free plasma derived tumor DNA (ctDNA) as a
biomarker in cancer clinical trials conducted under an investigational
new drug application (IND) and/or to support marketing approval of
drugs and biological products for treating solid tumor malignancies in
the early-stage (curative-intent) setting. This guidance finalizes the
draft guidance entitled ``Use of Circulating Tumor DNA for Early-Stage
Solid Tumor Drug Development'' issued on May 2, 2022.
DATES: The announcement of the guidance is published in the Federal
Register on November 29, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2022-D-0084 for ``Use of Circulating
[[Page 94739]]
Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug
Development.'' 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 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 this 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; or
Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
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: Paz Vellanki, Center for Drug
Evaluation and Research (HFD-150), Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9366; James
Myers, 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; or Center for Devices and Radiological
Health, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Use of Circulating Tumor DNA for Curative-Intent Solid Tumor
Drug Development.'' This guidance is intended to help sponsors planning
to use circulating cell-free plasma derived tumor DNA (ctDNA) as a
biomarker in cancer clinical trials conducted under an IND and/or to
support marketing approval of drugs and biological products for
treating solid tumor malignancies in the early-stage (curative-intent)
setting.
Certain patients with early-stage solid tumors can be cured with
local therapy alone (e.g., surgery, radiation, or chemoradiation),
other patients require (neo)adjuvant systemic therapy in order to be
cured, and others may progress to metastatic disease despite surgery
and/or systemic therapy. ctDNA is tumor-derived fragmented DNA shed
into a patient's bloodstream that is not associated with cells. ctDNA
quantity can vary among individuals and depends on the type of tumor,
location, stage, tumor burden, and response to therapy. ctDNA as a
biomarker has a number of potential regulatory and clinical uses in the
early-stage setting that may assist and expedite drug development. In
the early-stage cancer setting, ctDNA may be used to detect a certain
targetable alteration, to enrich a high- or low-risk population for
study in a trial, to reflect a patient's response to treatment, or,
potentially, as an early marker of efficacy.
This guidance finalizes the draft guidance entitled, ``Use of
Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development,''
issued on May 2, 2022 (87 FR 26207). FDA considered comments received
on the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include edits to further explain the
rationale for writing a guidance on use of ctDNA for solid tumor drug
development specific to the early-stage, curative-intent disease
setting. The part of the guidance that discusses assay considerations
was also clarified to indicate that while a major focus of this section
pertains to assessment of molecular residual disease (MRD), there may
be other uses of ctDNA in the early-stage disease setting. In addition,
editorial changes were made 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 ``Use of Circulating Tumor DNA for Curative-
Intent Solid Tumor Drug Development.'' 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; the collections
of information in 21 CFR part 800 have been approved under OMB control
number 0910-0625; 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.
[[Page 94740]]
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: November 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28033 Filed 11-27-24; 8:45 am]
BILLING CODE 4164-01-P
