Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry; Availability, 83884-83885 [2024-24111]
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83884
Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
are hereby withdrawn as of November
18, 2024. Introduction or delivery for
introduction into interstate commerce of
Helium, USP, without an approved new
drug application or an approved new
animal drug application violates
sections 505(a), 512(a), 301(a), and
301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a),
360b(a)(1), 331(a), and 331(d)). Any
Helium, USP manufactured by Linde,
Inc. pursuant to these applications that
is in inventory on November 18, 2024
may continue to be dispensed until the
inventories have been depleted or the
drug product has reached its expiration
date or otherwise become violative,
whichever occurs first.
Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24106 Filed 10–17–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2303]
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 ‘‘Core
Patient-Reported Outcomes in Cancer
Clinical Trials.’’ This final guidance
provides recommendations to sponsors
regarding the collection of a core set of
patient-reported clinical outcomes
(herein referred to as core patientreported outcomes) in cancer clinical
trials and related considerations for
instrument selection and trial design.
This final guidance focuses on patientreported outcome (PRO) measures and
is specific to registration trials for anticancer therapies intended to
demonstrate an effect on survival, tumor
response, or delay in the progression of
a malignancy.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on October 18, 2024.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
VerDate Sep<11>2014
16:48 Oct 17, 2024
Jkt 265001
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
Core Patient-Reported Outcomes in
Cancer Clinical Trials; Guidance for
Industry; Availability
AGENCY:
Electronic 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–
2020–D–2303 for ‘‘Core PatientReported Outcomes in Cancer Clinical
Trials.’’ 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
‘‘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. 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:
Vishal Bhatnagar, Oncology Center of
Excellence, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2113, Silver Spring,
MD 20993–0002, 240–402–3696; or
James Myers, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7910.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18OCN1.SGM
18OCN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Core Patient-Reported Outcomes in
Cancer Clinical Trials.’’ This final
guidance provides recommendations to
sponsors regarding the collection of a
core set of PROs in cancer clinical trials
and related considerations for
instrument selection and trial design.
The final guidance recommendations
supplement previous guidance on use of
PRO measures in clinical trials by
providing additional considerations
specific to the cancer clinical trial
setting. The final guidance is intended
to facilitate generation of high-quality
data on a core set of patient-reported
symptom and functional impacts that
are important contributors to a patient’s
health-related quality of life.
Although this final guidance focuses
on PRO measures, some of the
recommendations may be relevant to
other clinical outcome assessments (i.e.,
clinician-reported outcome, observerreported outcome, performance
outcome) in cancer clinical trials. The
final guidance is specific to registration
trials for anti-cancer therapies intended
to demonstrate an effect on survival,
tumor response, or delay in the
progression of a malignancy.
Cancer clinical trials typically employ
standardized efficacy assessments using
overall survival and tumor measures,
and safety assessments provided by
clinician reporting of adverse events.
FDA acknowledges the added value of
incorporating PRO measurement of
symptoms and functional impacts into
the benefit/risk assessment in
appropriately designed trials; however,
heterogeneity in PRO assessment
strategies has lessened the regulatory
utility of PRO data from cancer trials.
Systematic assessment of a core set of
PROs can facilitate high-quality data on
patient-reported symptoms and
functional impacts. In published
literature, FDA authors have previously
described a core set of PROs that may
be important contributors to a patient’s
health-related quality of life and that
may be sensitive to the effect of the
disease and treatment under study.
FDA is issuing this final guidance to
provide FDA’s current thinking on the
core PROs, considerations for
instrument selection to measure the core
PROs, trial design considerations such
as assessment frequency, and labeling
considerations. The core PROs
recommended in the guidance are
disease-related symptoms, symptomatic
adverse events, overall side effect
impact summary measure, physical
function, and role function.
VerDate Sep<11>2014
16:48 Oct 17, 2024
Jkt 265001
In the Federal Register of June 10,
2021 (86 FR 30944), FDA announced the
availability of the draft guidance of the
same title dated June 2021. FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include
recommendations to consult FDA when
selecting adverse events for reporting,
edits to include hematological
malignancies, and minor, editorial
changes to improve clarity.
This final guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This final guidance represents the
current thinking of FDA on ‘‘Core
Patient-Reported Outcomes in Cancer
Clinical Trials.’’ 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 (44 U.S.C. 3501–
3521). 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
0910–0338.
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/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 11, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24111 Filed 10–17–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
83885
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–0761]
Determination That TAVIST
(Clemastine Fumarate) Tablet, 2.68
Milligrams, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that TAVIST
(clemastine fumarate) tablet, 2.68
milligrams (mg), was not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
this drug product, and it will allow FDA
to continue to approve ANDAs that refer
to the product as long as they meet
relevant legal and regulatory
requirements.
SUMMARY:
Awo
Archampong-Gray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243,
Silver Spring, MD 20993–0002, 301–
796–0110, Awo.Archampong-Gray@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18OCN1.SGM
18OCN1
Agencies
[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83884-83885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24111]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2303]
Core Patient-Reported Outcomes in Cancer Clinical Trials;
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 ``Core
Patient-Reported Outcomes in Cancer Clinical Trials.'' This final
guidance provides recommendations to sponsors regarding the collection
of a core set of patient-reported clinical outcomes (herein referred to
as core patient-reported outcomes) in cancer clinical trials and
related considerations for instrument selection and trial design. This
final guidance focuses on patient-reported outcome (PRO) measures and
is specific to registration trials for anti-cancer therapies intended
to demonstrate an effect on survival, tumor response, or delay in the
progression of a malignancy.
DATES: The announcement of the guidance is published in the Federal
Register on October 18, 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-2020-D-2303 for ``Core Patient-Reported Outcomes in Cancer Clinical
Trials.'' 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. 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: Vishal Bhatnagar, Oncology Center of
Excellence, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 2113, Silver Spring, MD 20993-0002, 240-402-3696; or
James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7910.
SUPPLEMENTARY INFORMATION:
[[Page 83885]]
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Core Patient-Reported Outcomes in Cancer Clinical Trials.''
This final guidance provides recommendations to sponsors regarding the
collection of a core set of PROs in cancer clinical trials and related
considerations for instrument selection and trial design. The final
guidance recommendations supplement previous guidance on use of PRO
measures in clinical trials by providing additional considerations
specific to the cancer clinical trial setting. The final guidance is
intended to facilitate generation of high-quality data on a core set of
patient-reported symptom and functional impacts that are important
contributors to a patient's health-related quality of life.
Although this final guidance focuses on PRO measures, some of the
recommendations may be relevant to other clinical outcome assessments
(i.e., clinician-reported outcome, observer-reported outcome,
performance outcome) in cancer clinical trials. The final guidance is
specific to registration trials for anti-cancer therapies intended to
demonstrate an effect on survival, tumor response, or delay in the
progression of a malignancy.
Cancer clinical trials typically employ standardized efficacy
assessments using overall survival and tumor measures, and safety
assessments provided by clinician reporting of adverse events. FDA
acknowledges the added value of incorporating PRO measurement of
symptoms and functional impacts into the benefit/risk assessment in
appropriately designed trials; however, heterogeneity in PRO assessment
strategies has lessened the regulatory utility of PRO data from cancer
trials. Systematic assessment of a core set of PROs can facilitate
high-quality data on patient-reported symptoms and functional impacts.
In published literature, FDA authors have previously described a core
set of PROs that may be important contributors to a patient's health-
related quality of life and that may be sensitive to the effect of the
disease and treatment under study.
FDA is issuing this final guidance to provide FDA's current
thinking on the core PROs, considerations for instrument selection to
measure the core PROs, trial design considerations such as assessment
frequency, and labeling considerations. The core PROs recommended in
the guidance are disease-related symptoms, symptomatic adverse events,
overall side effect impact summary measure, physical function, and role
function.
In the Federal Register of June 10, 2021 (86 FR 30944), FDA
announced the availability of the draft guidance of the same title
dated June 2021. FDA considered comments received on the draft guidance
as the guidance was finalized. Changes from the draft to the final
guidance include recommendations to consult FDA when selecting adverse
events for reporting, edits to include hematological malignancies, and
minor, editorial changes to improve clarity.
This final guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This final guidance
represents the current thinking of FDA on ``Core Patient-Reported
Outcomes in Cancer Clinical Trials.'' 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 (44 U.S.C. 3501-3521). 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 0910-0338.
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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: October 11, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24111 Filed 10-17-24; 8:45 am]
BILLING CODE 4164-01-P