Inclusion of Older Adults in Cancer Clinical Trials; Draft Guidance for Industry; Availability, 13167-13168 [2020-04603]
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18:31 Mar 05, 2020
Jkt 250001
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default.htm. (Select this meeting from
the posted events list.)
Dated: March 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04638 Filed 3–5–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5572]
Inclusion of Older Adults 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Clinical Trials; Draft Guidance for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announcing the availability of a draft
guidance for industry entitled
‘‘Inclusion of Older Adults in Cancer
Clinical Trials.’’ This draft guidance
provides recommendations regarding
the inclusion of older adult patients in
clinical trials of drugs for the treatment
of cancer. For the purpose of this draft
guidance, older adults are those age 65
years and older. The draft guidance
emphasizes the particular importance of
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
13167
including adults over age 75 years in
cancer clinical trials. Specifically, this
draft guidance includes
recommendations for including an
adequate representation of older adults
in cancer clinical trials to better enable
evaluation of the benefit-risk profile of
cancer drugs in this population.
DATES: Submit either electronic or
written comments on the draft guidance
by May 5, 2020 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draft guidance before it begins work on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–
2019–D–5572 for ‘‘Inclusion of Older
Adults in Cancer Clinical Trials.’’
E:\FR\FM\06MRN1.SGM
06MRN1
lotter on DSKBCFDHB2PROD with NOTICES
13168
Federal Register / Vol. 85, No. 45 / Friday, March 6, 2020 / Notices
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.
• 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.
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 the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
VerDate Sep<11>2014
18:31 Mar 05, 2020
Jkt 250001
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:
Harpreet Singh, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2137,
Silver Spring, MD 20993–0002, 240–
402–3561; 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:
that a strategy for inclusion of older
adults be informed by any known
information for older adults. The draft
guidance includes recommendations for
inclusion of older adults related to early
clinical development; clinical trials,
including considerations for trial
design, recruitment, and developing and
reporting discrete age subgroups; and
the postmarket setting.
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 ‘‘Inclusion of Older Adults 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.
I. Background
II. Paperwork Reduction Act of 1995
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Inclusion of Older Adults in Cancer
Clinical Trials.’’ This draft guidance
provides recommendations for
stakeholders, including sponsors and
institutional review boards, responsible
for the development and oversight of
clinical trials regarding the inclusion of
older adult patients (i.e., age 65 years
and older) in clinical trials of drugs for
the treatment of cancer. The draft
guidance emphasizes the particular
importance of including adults over age
75 years in cancer clinical trials.
Enrolling an adequate representation
of the range of patients in a clinical trial
that may be exposed to a drug after
approval can maximize the
generalizability of the trial results. It
provides the ability to understand the
drug’s benefit-risk profile across the
patient population likely to use the drug
in clinical practice. Including
information in the labeling describing
use in older adults helps to promote the
safe and effective use of these products
and better informs treatment decisions
in clinical practice.
Older adults are underrepresented in
cancer clinical trials despite
representing a growing segment of the
population of cancer patients.
Therefore, more information is needed
to better inform treatment decisions for
older adults with cancer. The issue
persists in oncology despite FDA’s
efforts to increase the inclusion of older
adults in clinical trials.
The draft guidance recommends that
sponsors of cancer trials consider the
age demographics of their target
population early in development and
This draft guidance refers to
previously approved FDA collections of
information. These 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; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; and
the collections of information in 21 CFR
201.56 and 201.57 have been approved
under OMB control number 0910–0572.
PO 00000
Frm 00040
Fmt 4703
Sfmt 9990
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: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04603 Filed 3–5–20; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\06MRN1.SGM
06MRN1
Agencies
[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13167-13168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04603]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-5572]
Inclusion of Older Adults 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 ``Inclusion
of Older Adults in Cancer Clinical Trials.'' This draft guidance
provides recommendations regarding the inclusion of older adult
patients in clinical trials of drugs for the treatment of cancer. For
the purpose of this draft guidance, older adults are those age 65 years
and older. The draft guidance emphasizes the particular importance of
including adults over age 75 years in cancer clinical trials.
Specifically, this draft guidance includes recommendations for
including an adequate representation of older adults in cancer clinical
trials to better enable evaluation of the benefit-risk profile of
cancer drugs in this population.
DATES: Submit either electronic or written comments on the draft
guidance by May 5, 2020 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-2019-D-5572 for ``Inclusion of Older Adults in Cancer Clinical
Trials.''
[[Page 13168]]
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.
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.
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 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: Harpreet Singh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2137, Silver Spring, MD 20993-0002, 240-
402-3561; 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 ``Inclusion of Older Adults in Cancer Clinical Trials.'' This
draft guidance provides recommendations for stakeholders, including
sponsors and institutional review boards, responsible for the
development and oversight of clinical trials regarding the inclusion of
older adult patients (i.e., age 65 years and older) in clinical trials
of drugs for the treatment of cancer. The draft guidance emphasizes the
particular importance of including adults over age 75 years in cancer
clinical trials.
Enrolling an adequate representation of the range of patients in a
clinical trial that may be exposed to a drug after approval can
maximize the generalizability of the trial results. It provides the
ability to understand the drug's benefit-risk profile across the
patient population likely to use the drug in clinical practice.
Including information in the labeling describing use in older adults
helps to promote the safe and effective use of these products and
better informs treatment decisions in clinical practice.
Older adults are underrepresented in cancer clinical trials despite
representing a growing segment of the population of cancer patients.
Therefore, more information is needed to better inform treatment
decisions for older adults with cancer. The issue persists in oncology
despite FDA's efforts to increase the inclusion of older adults in
clinical trials.
The draft guidance recommends that sponsors of cancer trials
consider the age demographics of their target population early in
development and that a strategy for inclusion of older adults be
informed by any known information for older adults. The draft guidance
includes recommendations for inclusion of older adults related to early
clinical development; clinical trials, including considerations for
trial design, recruitment, and developing and reporting discrete age
subgroups; and the postmarket setting.
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 ``Inclusion of
Older Adults 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
This draft guidance refers to previously approved FDA collections
of information. These 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; the collections
of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338; and the collections of information in 21 CFR 201.56
and 201.57 have been approved under OMB control number 0910-0572.
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: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04603 Filed 3-5-20; 8:45 am]
BILLING CODE 4164-01-P