Notice2026-01576
Agency Information Collection Activities; Proposed Collection; Comment Request; Medication Guides for Prescription Drug Products
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Published
January 27, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with Medication Guides for prescription drug products.
Full Text
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<title>Federal Register, Volume 91 Issue 17 (Tuesday, January 27, 2026)</title>
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[Federal Register Volume 91, Number 17 (Tuesday, January 27, 2026)]
[Notices]
[Pages 3511-3513]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01576]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6869]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medication Guides for Prescription Drug Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with
Medication Guides for prescription drug products.
DATES: Either electronic or written comments on the collection of
information must be submitted by March 30, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 30, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
[[Page 3512]]
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2025-N-6869 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medication Guides for
Prescription Drug Products.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#336361726047525555735557521d5b5b401d545c45"><span class="__cf_email__" data-cfemail="134341524067727575537577723d7b7b603d747c65">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medication Guide Requirements for Prescription Drug Product Labeling
OMB Control Number 0910-0393--Extension
This information collection supports FDA regulations pertaining to
the distribution of patient labeling, called Medication Guides, for
human prescription drug and biological products used primarily on an
outpatient basis, and required for products that pose a serious and
significant public health concern. The regulations are codified in part
208 (21 CFR part 208): Medication Guides for Prescription Drug Products
and set forth general requirements including both content and format,
as well as provide for exemptions and deferrals. Medication Guides
provide patients with important information about drug products,
including the drug's approved uses, contraindications, adverse drug
reactions, and cautions for specific populations, and are required in
accordance with Agency regulations.
To assist both consumers and industry with understanding the
applicable regulatory requirements and purpose of Medication Guides, we
have developed resources and made them available on our website at
<a href="https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labeling-resources#medication-guides">https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labeling-resources#medication-guides</a>. Among the
resources, we include the guidance document entitled Medication Guides
--Distribution Requirements and Inclusion in Risk Evaluation and
Mitigation Strategies (REMS) (November 2011) (available at <a href="https://www.fda.gov/media/79776/download">https://www.fda.gov/media/79776/download</a>), as well as a discussion of the
distinction between Medication Guides and Consumer Medication
information. The regulations, guidance, and informational resources are
[[Page 3513]]
intended to improve the public health by enabling patients to use
certain medications most safely and effectively.
As part of the new drug application process (21 CFR part 314), we
review Medication Guides to determine whether the labeling for certain
prescription drug products and biological products comply with the
applicable regulations.
Description of Respondents: Respondents to this collection of
information are holders and sponsors of applications, distributors of
prescription drug products, and authorized dispensers of prescription
drug products (pharmacists).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity; 21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Content and format of a 70 1 70 320 22,400
Medication Guide; Sec. 208.20
Exemptions and deferrals; Sec. 1 1 1 4 4
208.26(a)......................
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Total....................... .............. .............. 71 .............. 22,404
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on our evaluation of data from our records, we estimate that,
in the next three years, 70 holders of applications will prepare and
submit one Medication Guide annually for our review. We estimate that
the application holders will spend approximately 320 hours to prepare
and submit the Medication Guide. In addition, we estimate that, in the
next three years, one sponsor of one of the new or supplementary
applications will request an exemption under Sec. 208.26(a) from at
least some of the Medication Guide format or content requirements,
annually. We estimate that the sponsor will spend approximately 4 hours
to prepare and submit the request for exemption. Our estimated burden
for the information collection reflects an overall increase of 9,280
hours and a corresponding increase of 29 responses/records. We
attribute this adjustment to an increase in the number of submissions
we received over the last few years.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Number of disclosures Total annual Average burden
Activity; 21 CFR section respondents per disclosures per disclosure Total hours
respondent \2\
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Distributor provides 191 9,000 1,719,000 1.25............. 2,148,750
Medication Guides to
authorized dispensers; Sec.
208.24(c).
Authorized dispenser provides 88,736 5,705 506,238,880 0.05 (3 minutes). 25,311,944
Medication Guides to
patients; Sec. 208.24(e).
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Total.................... .............. .............. 507,957,880 ................. 27,460,694
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers may not sum due to rounding.
We estimate that, in the next three years, 191 distributors will
provide Medication Guides to approximately 9,000 authorized dispensers,
annually. We estimate that the dispensers will spend approximately 1.25
hours to prepare and distribute the Medication Guides. Under 21 CFR
201.24(e), authorized dispensers are required to provide a Medication
Guide directly to the patient (or the patient's agent) upon dispensing
a product for which a Medication Guide is required. We estimate that,
in the next three years, 88,736 authorized dispensers will provide
Medication Guides to approximately 5,705 patients, annually. We
estimate that authorized dispensers will spend approximately 3 minutes
to provide the Medication Guide to a patient.
We have increased our estimated burden associated with disclosures
to reflect an increase in related submissions over the past 3 years.
Brian Fahey,
Associate Commissioner for Legislation.
[FR Doc. 2026-01576 Filed 1-26-26; 8:45 am]
BILLING CODE 4164-01-P
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