[Federal Register Volume 91, Number 125 (Wednesday, July 1, 2026)]
[Notices]
[Pages 40000-40002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-13346]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6869]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 31, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0393. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medication Guide Requirements for Prescription Drug Product Labeling
OMB Control Number 0910-0393--Reinstatement with change
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. Agency regulations codified in part
208 (21 CFR part 208): Medication Guides for Prescription Drug Products
set forth general requirements applicable to both content and format
elements for Medication Guides, as well as provide for exemption and
deferral requests. Medication Guides provide patients with important
information about drug products, including the drug's approved uses,
contraindications, adverse drug reactions, cautions for specific
populations, and are required in accordance with applicable
regulations.
To assist consumers and industry with understanding regulatory
requirements applicable to, and the purpose of, Medication Guides, we
have developed resources and made them available on our website at
https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-
drugs/patient-labeling-resources#medication-guides. Among the
resources, we include the guidance document titled Medication Guides--
Distribution Requirements and Inclusion in Risk Evaluation and
Mitigation Strategies (REMS) (November 2011), (available at https://
www.fda.gov/media/79776/download), as well as a discussion of the
distinction between Medication Guides and Consumer Medication
information. The regulations in 21 CFR part 208, the associated
guidance document, and the informational resources are intended to
enable patients to use medications most safely and effectively.
Included among the requirements in 21 CFR part 314 that govern
applications for FDA approval to market a new drug is the submission of
any Medication Guide (see 21 CFR part
[[Page 40001]]
314.50), as applicable under 21 CFR part 208, as well as any
supplemental changes (see 21 CFR 314.70). The Agency uses the
information submitted to determine whether the Medication Guide
complies with applicable regulatory requirements. Information
collection activities applicable to regulations in 21 CFR part 314 are
currently approved in OMB control no. 0910-0001. In this request FDA is
accounting for information collection burden we believe attributable to
regulatory requirements 21 CFR part 208.
In the Federal Register of January 27, 2026 (91 FR 3511), we
published a 60-day notice requesting public comment on the proposed
collection of information. We received a number of comments. Some
comments discussed FDA's proposed rule (RIN 0910-AH68) that issued on
May 31, 2023, ``Medication Guides: Patient Medication Information
(PMI),'' (88 FR 35694). While we reviewed these comments in the context
of this reinstatement request, we have also added them to the
rulemaking docket (FDA-2019-N-5959) for continued consideration. Other
comments communicated general support for improving the content,
clarity, and readability of Medication Guides, including the use of
electronic delivery. Finally, some comments questioned the accuracy of
FDA's burden assessment attributable to authorized dispensers who
provide Medication Guides to patients. FDA is most appreciative of all
public input regarding its information collection activities and as a
result of these latter comments, together with a reexamination of
previous submissions for OMB review and approval of ICR 0910-0393, we
have significantly revised our assessment of the disclosure burden
attributable to requirements established in 21 CFR part 208 for
distributors and authorized dispensers of Medication Guides.
Our 60-day notice states that respondents to the information
collection are sponsors of new drug applications, distributors of
prescription drug products, and authorized dispensers of prescription
drug products. We determined the number of respondents to the annual
recordkeeping requirements based on the number of new drug sponsors
whose product applications we believe are subject to the requirements
in 21 CFR 208, consistent with internal Agency data and a recent
preliminary regulatory impact analysis in support of rulemaking RIN
0910-AH68. We retain those estimates provided in our 60-day notice, as
reflected below in table 1.
At the same time, we have adjusted our assessment of disclosure
burden. Specifically, we previously calculated burden we believe
attributable to requirements in 21 CFR 208.24 and applied our
assessment to distributors and authorized dispensers collectively. Upon
reexamination of the information collection requirements applicable to
21 CFR part 208.24, we have separated burden to align with tasks that
apply to manufacturers, distributors, and authorized dispensers,
respectively, as reflected below in table 2.
We estimate the burden of the collections of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity; 21 CFR Section 208 Number of responses per Total annual burden per Total hours
(obtaining the PMI) 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.
Noting that 5 CFR 1320.3(m) defines a recordkeeping requirement to
include the reporting to the Federal government regarding such records,
we have characterized the submission of Medication Guides to FDA as
reporting activity required as a function of certain NDA submissions
(currently approved under OMB control no. 0910-0001). Based on our
evaluation of internal data, 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
expend 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 assume sponsors will expend an
average of 4 hours annually to prepare and submit a request for
exemption.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Activity; 21 CFR Section 208 Number of disclosures Total annual Average
(Providing the PMI for respondents per disclosures burden per Total hours
Distribution) respondent disclosure \2\
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Manufacturer ensures that 70 9,000 630,000 1.25 787,500
Medication Guides are provided
in adequate supply to
authorized dispensers, or
provides means to produce
Medication Guide; Sec.
208.24(b)(1) and (b)(2)........
Distributor provides Medication 191 9,000 1,719,000 1.25 2,148,750
Guides or means to produce to
authorized dispensers Sec.
208.24(c)......................
Dispensing Medication Guide to 88,736 5,705 506,238,880 .0027 1,366,845
patient 208.24(e)..............
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Total....................... .............. .............. 508,587,880 .............. 4,303,095
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Figures have been rounded to the nearest one, one-thousandth.
[[Page 40002]]
Assuming that the same 70 application holders of products requiring
Medication Guides must ensure that distributors and authorized
dispensers are provided with an adequate supply or means to produce the
required Medication Guide, as required under 21 CFR 208.24(b)(1) and
(b)(2), we calculate an average of 9,000 disclosures annually and an
average of 1.25 hours per disclosure, as reflected in row 1, table2.
Similarly, assuming 12% of 1,600 distributors (191), based on
figures consistent with, accounted for, and approved in OMB control
number 0910-0806 (Pharmaceutical Distribution Supply Chain) will ship
drug products that require a Medication Guide and must provide the
Medication Guide or the means to produce it to authorized dispensers,
as required under 21 CFR 208.24(c), we calculate an average of 9,000
disclosures annually and an average of 1.25 hours per disclosure, as
reflected in row 2, table 2.
Regarding authorized dispensers, we currently assume 88,736
authorized dispensers based on informal data and reports from various
pharmacy trade associations and have retained this figure. We also
retain our estimated average of 5,705 patients to whom Medication
Guides will be distributed annually. However, we have revised the time
we attribute necessary to the task of dispensing Medication Guides to
patients, as required under 21 CFR part 208.24(e). FDA originally
proffered 5 seconds in its proposed rule of August 24, 1995 (60 FR
44182) inviting comment under the Paperwork Reduction Act of 1980. In
our final rule on December 1, 1998 (63 FR 66378), after enactment of
the Paperwork Reduction Act of 1995, FDA again estimated 5 seconds of
burden for the task of dispensing a Medication Guide to a patient and
invited public comment. No comments were posted to the rulemaking
docket (Legacy Docket No. 93-0371; RIN 0910-AA37) regarding the 5-
second estimate.
Upon further review, we find that in 2008 FDA revised its original
estimate from 5 seconds to 3 minutes based on a public comment that the
estimate had remained unchanged since 1998, ``while the program
continue[d] to expand in an unchecked manner,'' (emphasis added), and
that FDA's estimate failed to consider ``realities pharmacists face in
complying with the program'' (emphasis added). See Docket No. FDA-2008-
N-0162. We are now adjusting that estimate to 10 seconds noting the
following:
As required by the PRA of 1995, FDA has confined its
estimate of burden attributable to that we believe is required by 21
CFR 208.24(e), which entails the task of dispensing the Medication
Guide. Effort that may be attributable to counseling patients,
dispensing literature not required by 21 CFR 208.24(e), and to patients
reading the Medication Guide is not included in our estimate.
As provided for by the PRA of 1995, FDA believes that
tasks that may be associated with dispensing a Medication Guide, such
as counseling patients, dispensing literature not required by our
regulations, and recordkeeping that may be required by other
authorities such as State licensing agents and the Drug Enforcement
Administration, to be usual and customary as part of the practice of
pharmacy. Therefore, we estimate no burden for efforts relating to
tasks that fall beyond the scope of 21 CFR part 208.
FDA does account for various tasks that may be performed
by authorized dispensers in its active collection inventory including
OMB control numbers 0910-0800 (Human Drug Compounding Under Sections
503A and 503B of the Federal Food, Drug, and Cosmetic Act); 0910-0806
(Pharmaceutical Distribution Supply Chain); and 0910-0858 (Human Drug
Compounding, Repackaging, and Related Activities Regarding Sections
503A and 503B of the Federal Food, Drug, and Cosmetic Act); and
FDA believes that the advent of technology has
facilitated, not prolonged, the effort necessary in satisfying existing
requirements under 21 CFR part 208.
Upon adjusting our estimates accordingly, the information
collection reflects a decrease of 22,938,375 hours and an increase of
4,829,782 responses annually. We believe these estimates are consistent
with current submission figures and the specific tasks required in 21
CFR part 208.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-13346 Filed 6-30-26; 8:45 am]
BILLING CODE 4164-01-P