[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16199-16201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0902]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medication Guides for Prescription Drug Products

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

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 revision 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: Submit either electronic or written comments on the collection 
of information by May 23, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 23, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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 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 Docket No. FDA-
2011-N-0902 for ``Agency Information Collection Activities; Proposed 
Collection; Comment Request; Medication Guide Requirements for 
Prescription Drug Product Labeling.'' 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 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

[[Page 16200]]

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: 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 revision 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. Applicable regulations are codified 
at 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 21 CFR 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 a discussion of the 
applicable regulations; 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 Medication Guides 
required as part of a risk evaluation and mitigation strategy.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    Activity; 21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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
           Activity; 21 CFR section               Number of    disclosures per   Total annual       Average burden per disclosure \2\       Total hours
                                                 respondents      respondent      disclosures
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Distribute Medication Guides to authorized                191            9,000       1,719,000  1.25....................................       2,148,750
 dispensers; Sec.   208.24(c).
Distribute and Dispense Medication Guides to           88,000            5,705     502,040,000  0.05 (3 minutes)........................      25,102,000
 Patients; 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.


[[Page 16201]]

    We have decreased our estimated burden associated with disclosures 
to reflect a decrease in related submissions over the past 3 years.

    Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06034 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P


