Notice2022-06034
Agency Information Collection Activities; Proposed Collection; 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
March 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 55 (Tuesday, March 22, 2022)</title>
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[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16199-16201]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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 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 <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
[[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,
<a href="/cdn-cgi/l/email-protection#1a4a485b496e7b7c7c5a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="eabab8abb99e8b8c8caa8c8e8bc4828299c48d859c">[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 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 <a href="https://www.fda.gov/media/79776/download">https://www.fda.gov/media/79776/download</a>). 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
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