Core Patient-Reported Outcomes in Cancer Clinical Trials; Draft Guidance for Industry; Availability, 30944-30945 [2021-12166]
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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
as the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was November 26,
2006, which was 30 days after FDA
receipt of the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): July 19, 2016. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
EVENITY (BLA 761062) was initially
submitted on July 19, 2016.
3. The date the application was
approved: April 9, 2019. FDA has
verified the applicant’s claim that BLA
761062 was approved on April 9, 2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,550 days, 1,575
days or 1,827 days of patent term
extension.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12199 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2303]
Core Patient-Reported Outcomes in
Cancer Clinical Trials; Draft 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 draft
guidance for industry entitled ‘‘Core
Patient-Reported Outcomes in Cancer
Clinical Trials.’’ This draft guidance
provides recommendations to sponsors
regarding the collection of a core set of
patient-reported clinical outcomes in
cancer clinical trials and related
considerations for instrument selection
and trial design. This 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. The draft
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 draft
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.
DATES: Submit either electronic or
written comments on the draft guidance
by August 9, 2021 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:
SUMMARY:
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 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
‘‘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
E:\FR\FM\10JNN1.SGM
10JNN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
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 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, 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. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
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
Janice Kim, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2329, Silver Spring,
MD 20993–0002, 301–796–9628; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Core Patient-Reported Outcomes in
Cancer Clinical Trials.’’ This draft
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.
Although this draft 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
draft 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 assessment using
overall survival and tumor measures,
and safety assessments provided by
clinician reporting of adverse events.
FDA acknowledges the potential 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. FDA
has 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.1
FDA is issuing this draft 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 draft guidance are
disease-related symptoms, symptomatic
adverse events, overall side effect
impact summary measure, physical
function, and role function.
This draft guidance is being issued
consistent with FDA’s good guidance
1 Kluetz, P.G., A. Slagle, E.J. Papadopoulos, et al.,
2016, ‘‘Focusing on Core Patient-Reported
Outcomes in Cancer Clinical Trials: Symptomatic
Adverse Events, Physical Function, and DiseaseRelated Symptoms,’’ Clinical Cancer Research,
22(7):1553–1558.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
30945
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent 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. 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 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12166 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–5832]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XPOVIO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for XPOVIO and is publishing this
notice of that determination as required
SUMMARY:
E:\FR\FM\10JNN1.SGM
10JNN1
Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30944-30945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12166]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2303]
Core Patient-Reported Outcomes in Cancer Clinical Trials; Draft
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 draft guidance for industry entitled ``Core
Patient-Reported Outcomes in Cancer Clinical Trials.'' This draft
guidance provides recommendations to sponsors regarding the collection
of a core set of patient-reported clinical outcomes in cancer clinical
trials and related considerations for instrument selection and trial
design. This 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. The draft
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 draft 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.
DATES: Submit either electronic or written comments on the draft
guidance by August 9, 2021 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-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
[[Page 30945]]
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 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, 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. The draft guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft 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
Janice Kim, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2329, Silver
Spring, MD 20993-0002, 301-796-9628; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Core Patient-Reported Outcomes in Cancer Clinical Trials.''
This draft 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. Although this
draft 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 draft 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
assessment using overall survival and tumor measures, and safety
assessments provided by clinician reporting of adverse events. FDA
acknowledges the potential 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. FDA
has 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.\1\
---------------------------------------------------------------------------
\1\ Kluetz, P.G., A. Slagle, E.J. Papadopoulos, et al., 2016,
``Focusing on Core Patient-Reported Outcomes in Cancer Clinical
Trials: Symptomatic Adverse Events, Physical Function, and Disease-
Related Symptoms,'' Clinical Cancer Research, 22(7):1553-1558.
---------------------------------------------------------------------------
FDA is issuing this draft 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 draft guidance are disease-related symptoms, symptomatic adverse
events, overall side effect impact summary measure, physical function,
and role function.
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 ``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. 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
0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either 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, or https://www.regulations.gov.
Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12166 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P