Document ID: FDA-2011-N-0902-0016
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products
Posted Date: 2022-10-07T04:00Z

[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61040-61041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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--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 https://www.fda.gov/media/79776/download). 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)......................
                                 -------------------------------------------------------------------------------
    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)...............
                                 -------------------------------------------------------------------------------
    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