Notice2022-21840
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61040-61041]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21840]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0902]
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 November 7, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#cc9c9e8d9fb8adaaaa8caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="217173607255404747614745400f4949520f464e57">[email protected]</span></a>.
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--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. Applicable regulations are codified
at part 208 (21 CFR part 208): Medication Guides for Prescription Drug
Products, and set forth general content and format requirements, as
well as provide for exemptions and deferrals. Medication Guides provide
patients with important written 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 consumers and industry with understanding applicable
regulatory requirements in part 208 pertaining to developing,
distributing, and submitting certain Medication Guides, we have
developed the guidance document entitled ``Medication Guides--
Distribution Requirements and Inclusion in Risk Evaluation and
Mitigation Strategies (REMS)'' (available at <a href="https://www.fda.gov/media/79776/download">https://www.fda.gov/media/79776/download</a>). The guidance document includes: (1) a discussion of
the applicable regulations; (2) FDA enforcement policy with regard to
Medication Guides associated with products dispensed to healthcare
professionals, or patient caregivers, instead of being dispensed
directly to the patient for self-administration; and (3) Medication
Guides required as part of a risk evaluation and mitigation strategy.
In the Federal Register of March 22, 2022 (87 FR 16199), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 61041]]
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 41 1 41 320 13,120
Medication Guide; Sec. 208.20
Exemptions and deferrals; Sec. 1 1 1 4 4
208.26(a)......................
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Total....................... .............. .............. 42 .............. 13,124
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Upon evaluation of the information collection, we have removed
burden we attributed to reporting associated with supplements and other
changes to approved abbreviated new drug applications, new drug
applications, and biologics license applications (21 CFR
314.70(b)(3)(ii) and 601.12(f)). We now account for burden associated
with these regulatory provisions in OMB control numbers 0910-0001 and
0910-0338 and have decreased the burden associated with this collection
accordingly.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Number of disclosures Total annual Average
Activity; 21 CFR section respondents per disclosures burden per Total hours
respondent disclosure \2\
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Distribute Medication Guides to 191 9,000 1,719,000 1.25 2,148,750
authorized dispensers; Sec.
208.24(c)......................
Distribute and Dispense 88,000 5,705 502,040,000 0.05 (3 25,102,000
Medication Guides to Patients; minutes)
Sec. 208.24(e)...............
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Total....................... .............. .............. 503,759,000 .............. 27,250,750
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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 have decreased our estimated burden associated with disclosures
to reflect a decrease in related submissions over the past 3 years.
Dated: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21840 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P
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