[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]


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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Product Labeling; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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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the availability of a draft guidance for industry entitled ``Geriatric 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 This draft guidance is intended to assist applicants of 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The goal of this draft guidance is to provide recommendations to help 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 This draft guidance provides additional examples of geriatric 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replacing it with this draft guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by November 16, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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