Geriatric Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry; Availability, 57864-57866 [2020-20435]
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57864
Federal Register / Vol. 85, No. 180 / Wednesday, September 16, 2020 / Notices
Estimated Total Annual Burden
Hours: 6,160.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 1397 through 1397e.
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–20447 Filed 9–15–20; 8:45 am]
BILLING CODE 4184–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20387 Filed 9–15–20; 8:45 am]
BILLING CODE 4164–01–P
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that KOSELUGO
(selumetinib, AZD6244), manufactured
by AstraZeneca Pharmaceuticals, LP,
meets the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that KOSELUGO
(selumetinib, AZD6244), manufactured
by AstraZeneca Pharmaceuticals, LP,
meets the criteria for a priority review
voucher.
KOSELUGO (selumetinib, AZD6244)
is indicated for the treatment of
pediatric patients 2 years of age and
older with neurofibromatosis type 1
who have symptomatic, inoperable
plexiform neurofibromas.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about KOSELUGO
(selumetinib, AZD6244), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1621]
Geriatric Information in Human
Prescription Drug and Biological
Product Labeling; Draft Guidance for
Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Geriatric
Information in Human Prescription
Drug and Biological Product Labeling.’’
This draft guidance is intended to assist
applicants of human prescription drug
and biological products in determining
the appropriate placement and content
of geriatric information in labeling. The
goal of this draft guidance is to provide
SUMMARY:
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recommendations to help ensure that
appropriate information on the use of
prescription drugs and biological
products in geriatric patients is
consistently placed in the proper
sections and subsections within labeling
so that the information is clear and
accessible to health care practitioners
and includes content that guides the
safe and effective use in geriatric
patients. This draft guidance provides
additional examples of geriatric use
statements in labeling and examples of
when the labeling regulations authorize
FDA to permit applicants to omit or
revise specific information otherwise
required in the Geriatric Use subsection.
We are withdrawing the guidance for
industry entitled ‘‘Content and Format
for Geriatric Labeling’’ (October 2001)
and replacing it with this draft
guidance.
Submit either electronic or
written comments on the draft guidance
by November 16, 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:
DATES:
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
E:\FR\FM\16SEN1.SGM
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jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 180 / Wednesday, September 16, 2020 / Notices
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–1621 for ‘‘Geriatric Information
in Human Prescription Drug and
Biological Product Labeling.’’ 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.
VerDate Sep<11>2014
18:20 Sep 15, 2020
Jkt 250001
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,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Eric
Brodsky, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6485, Silver Spring,
MD 20993–0002, 301–796–0855; 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
‘‘Geriatric Information in Human
Prescription Drug and Biological
Product Labeling.’’
Until the late 1990s, the majority of
drug labeling contained minimal or no
geriatric use information to guide safe
and effective use in the geriatric
population. In 1997, the FDA issued a
final rule creating a Geriatric Use
subsection of labeling to facilitate access
to geriatric use information and improve
the safe and effective use of prescription
drugs and biological products in
geriatric patients by specifying a
location for summarizing geriatric use
information in labeling (62 FR 45313,
August 27, 1997). This regulation was
intended to promote the consistent
inclusion of all relevant geriatric
information in labeling and to provide
information on possible differences in
the safety, effectiveness,
pharmacodynamics, and/or
pharmacokinetics between geriatric and
younger adult patients in labeling.
In 2001, the FDA issued the nowwithdrawn guidance for industry
entitled ‘‘Content and Format for
Geriatric Labeling,’’ which provided
recommendations on the content and
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57865
format of geriatric use information in
the Geriatric Use subsection in the
PRECAUTIONS section. In 2006, FDA
published a final rule amending the
requirements for the content and format
of labeling for human prescription drug
and biological products (71 FR 3922,
January 24, 2006). This rule is known as
the physician labeling rule because it
addresses prescription drug labeling
that is used by physicians and other
health care practitioners. Under this
rule, the Geriatric Use subsection was
relocated in the USE IN SPECIFIC
POPULATIONS section of labeling.
This draft guidance replaces the
withdrawn guidance for industry
entitled ‘‘Content and Format for
Geriatric Labeling’’ and provides
additional examples of geriatric use
statements in labeling and examples of
when the regulations authorize FDA to
permit applicants to omit or revise
specific information otherwise required
in the Geriatric Use subsection.
This draft guidance provides
recommendations on how to incorporate
geriatric use information in labeling
based on the following two scenarios:
• Scenario 1: the drug is approved for
use in adult patients generally,
including geriatric patients or a subset
of the geriatric population or
• Scenario 2: the drug is approved for
a geriatric-specific indication [i.e., for a
specific indication, the drug is indicated
for use only in geriatric patients (or a
subset of the geriatric population) and
not in younger adult patients]
The Geriatric Use subsection of
labeling regulations (21 CFR
201.57(c)(9)(v)) uses a variety of terms to
refer to patients 65 years of age and
older (e.g., geriatric patients, elderly
patients, persons 65 years of age and
older). Some terms may be sensitive or
controversial among certain groups.
Please comment and provide a rationale
for the use of any of these terms or other
terms to refer to patients 65 years of age
and older in labeling.
This draft guidance provides several
recommended options for summarizing
geriatric exposure information in the
Geriatric Use subsection. Please
comment and provide a rationale for the
use of any of these geriatric exposure
examples or other geriatric exposure
examples. Please describe when
binning, nested cutoff, or other
approaches should be used to
summarize geriatric exposure
information in this subsection.
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
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57866
Federal Register / Vol. 85, No. 180 / Wednesday, September 16, 2020 / Notices
on the ‘‘Geriatric Information in Human
Prescription Drug and Biological
Product Labeling.’’ 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 collections of
information found in FDA regulations.
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 collection of
information in 21 CFR 201.56 and
201.57 for preparing and submitting
labeling has 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
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20435 Filed 9–15–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–0177]
Eosinophilic Esophagitis: Developing
Drugs for Treatment; Guidance for
Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Eosinophilic Esophagitis: Developing
Drugs for Treatment.’’ This guidance is
intended to describe the Agency’s
current thinking and recommended
approach for the development of drugs
and therapeutic biologics for the
treatment of patients with eosinophilic
esophagitis. This guidance finalizes the
draft guidance of the same name issued
February 6, 2019.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:20 Sep 15, 2020
Jkt 250001
The announcement of the
guidance is published in the Federal
Register on September 16, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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–0177 for ‘‘Eosinophilic
Esophagitis: Developing Drugs for
Treatment.’’ 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
PO 00000
Frm 00048
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.
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:
Erica Lyons, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5373, Silver Spring,
MD 20993–0002, 301–796–8023.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16SEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Notices]
[Pages 57864-57866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20435]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1621]
Geriatric Information in Human Prescription Drug and Biological
Product Labeling; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (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 ``Geriatric
Information in Human Prescription Drug and Biological Product
Labeling.'' This draft guidance is intended to assist applicants of
human prescription drug and biological products in determining the
appropriate placement and content of geriatric information in labeling.
The goal of this draft guidance is to provide recommendations to help
ensure that appropriate information on the use of prescription drugs
and biological products in geriatric patients is consistently placed in
the proper sections and subsections within labeling so that the
information is clear and accessible to health care practitioners and
includes content that guides the safe and effective use in geriatric
patients. This draft guidance provides additional examples of geriatric
use statements in labeling and examples of when the labeling
regulations authorize FDA to permit applicants to omit or revise
specific information otherwise required in the Geriatric Use
subsection. We are withdrawing the guidance for industry entitled
``Content and Format for Geriatric Labeling'' (October 2001) and
replacing it with this draft guidance.
DATES: Submit either electronic or written comments on the draft
guidance by November 16, 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
[[Page 57865]]
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-1621 for ``Geriatric Information in Human Prescription Drug
and Biological Product Labeling.'' 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 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, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Eric Brodsky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6485, Silver Spring, MD 20993-0002, 301-
796-0855; 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 ``Geriatric Information in Human Prescription Drug and
Biological Product Labeling.''
Until the late 1990s, the majority of drug labeling contained
minimal or no geriatric use information to guide safe and effective use
in the geriatric population. In 1997, the FDA issued a final rule
creating a Geriatric Use subsection of labeling to facilitate access to
geriatric use information and improve the safe and effective use of
prescription drugs and biological products in geriatric patients by
specifying a location for summarizing geriatric use information in
labeling (62 FR 45313, August 27, 1997). This regulation was intended
to promote the consistent inclusion of all relevant geriatric
information in labeling and to provide information on possible
differences in the safety, effectiveness, pharmacodynamics, and/or
pharmacokinetics between geriatric and younger adult patients in
labeling.
In 2001, the FDA issued the now-withdrawn guidance for industry
entitled ``Content and Format for Geriatric Labeling,'' which provided
recommendations on the content and format of geriatric use information
in the Geriatric Use subsection in the PRECAUTIONS section. In 2006,
FDA published a final rule amending the requirements for the content
and format of labeling for human prescription drug and biological
products (71 FR 3922, January 24, 2006). This rule is known as the
physician labeling rule because it addresses prescription drug labeling
that is used by physicians and other health care practitioners. Under
this rule, the Geriatric Use subsection was relocated in the USE IN
SPECIFIC POPULATIONS section of labeling.
This draft guidance replaces the withdrawn guidance for industry
entitled ``Content and Format for Geriatric Labeling'' and provides
additional examples of geriatric use statements in labeling and
examples of when the regulations authorize FDA to permit applicants to
omit or revise specific information otherwise required in the Geriatric
Use subsection.
This draft guidance provides recommendations on how to incorporate
geriatric use information in labeling based on the following two
scenarios:
Scenario 1: the drug is approved for use in adult patients
generally, including geriatric patients or a subset of the geriatric
population or
Scenario 2: the drug is approved for a geriatric-specific
indication [i.e., for a specific indication, the drug is indicated for
use only in geriatric patients (or a subset of the geriatric
population) and not in younger adult patients]
The Geriatric Use subsection of labeling regulations (21 CFR
201.57(c)(9)(v)) uses a variety of terms to refer to patients 65 years
of age and older (e.g., geriatric patients, elderly patients, persons
65 years of age and older). Some terms may be sensitive or
controversial among certain groups. Please comment and provide a
rationale for the use of any of these terms or other terms to refer to
patients 65 years of age and older in labeling.
This draft guidance provides several recommended options for
summarizing geriatric exposure information in the Geriatric Use
subsection. Please comment and provide a rationale for the use of any
of these geriatric exposure examples or other geriatric exposure
examples. Please describe when binning, nested cutoff, or other
approaches should be used to summarize geriatric exposure information
in this subsection.
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
[[Page 57866]]
on the ``Geriatric Information in Human Prescription Drug and
Biological Product Labeling.'' 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 collections of
information found in FDA regulations. 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
collection of information in 21 CFR 201.56 and 201.57 for preparing and
submitting labeling has 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20435 Filed 9-15-20; 8:45 am]
BILLING CODE 4164-01-P
