Document ID: FDA-2011-N-0902-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug
Product Labeling; Medication Guide Requirements
Posted Date: 2019-08-21T04:00Z

[Federal Register Volume 84, Number 162 (Wednesday, August 21, 2019)]
[Notices]
[Pages 43608-43609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18000]

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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; Prescription Drug 
Product Labeling; Medication Guide Requirements

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 (PRA).

DATES: Fax written comments on the collection of information by 
September 20, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 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, 
PRAStaff@fda.hhs.gov.

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.

Prescription Drug Product Labeling; Medication Guide Requirements

OMB Control Number 0910-0393--Extension

    FDA regulations require the distribution of patient labeling, 
called Medication Guides, for certain prescription human drug and 
biological products used primarily on an outpatient basis that pose a 
serious and significant public health concern. Medication Guides 
provide patients the most important information about drug products, 
including the drugs' approved uses, contraindications, adverse drug 
reactions, and cautions for specific populations. These regulations are 
intended to improve the public health by providing information 
necessary for patients to use certain medications safely and 
effectively.
    The regulations contain the following reporting requirements that 
are subject to the PRA:
     Sec.  208.20 (21 CFR 208.20)--Applicants must submit draft 
Medication Guides for FDA approval according to the prescribed content 
and format.
     Sec. Sec.  314.70(b)(3)(ii) and 601.12(f) (21 CFR 
314.70(b)(3)(ii) and 21 CFR 601.12(f))--Application holders must submit 
changes to Medication Guides as supplements to their applications to 
FDA for approval.
     Sec.  208.24(c) (21 CFR 208.24(c))--Each distributor or 
packer who receives Medication Guides, or the means to produce 
Medication Guides, from a manufacturer under paragraph (b) of this 
section shall provide those Medication Guides to each authorized 
dispenser to whom it ships a drug product.

[[Page 43609]]

     Sec.  208.24(e) (21 CFR 208.24(e))--Each authorized 
dispenser of a prescription drug product for which a Medication Guide 
is required must provide a Medication Guide directly to each patient 
when dispensing the product to the patient or to the patient's agent, 
unless an exemption applies under Sec.  208.26 (21 CFR 208.26).
     Sec.  208.26(a)--Requests may be submitted for an 
exemption or a deferral from particular Medication Guide content or 
format requirements.
    In the Federal Register of October 26, 2018 (83 FR 54110), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received encouraging the use 
of ``provider-neutral language'' in places where terms such as 
``doctor'' or ``physician'' are used suggesting that these terms may 
cause some confusion for patients. We are appreciative of this 
recommendation; however, we decline to implement such changes.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         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                       61               1              61             320          19,520
 Medication Guide--Sec.   208.20
Supplements and Other Changes to             155               1             155              72          11,160
 an Approved Application--Sec.
 Sec.   314.70(b)(3)(ii) and
 601.12(f)......................
Exemptions and Deferrals--Sec.                 1               1               1               4               4
 208.26(a)......................
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    Total.......................  ..............  ..............  ..............  ..............          30,684
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                       Number of
                          21 CFR section                               Number of      disclosures     Total annual     Average burden      Total hours
                                                                      respondents   per respondent     disclosures     per disclosure
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Distributing Medication Guide to Authorized Dispenser--Sec.                    191           9,000         1,719,000              1.25         2,148,750
 208.24(c)........................................................
Distributing and Dispensing a Medication Guide to Patient--Sec.             88,736           5,705       506,238,880  0.05 (3 minutes)        25,311,944
 208.24(e)........................................................
                                                                   -------------------------------------------------------------------------------------
    Total.........................................................  ..............  ..............  ................  ................        27,460,694
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated annual reporting burden for the information 
collection reflects an overall increase of 4,664 total hours. We 
attribute this adjustment to an increase in the number of submissions 
we received over the last few years. Based on a review of the 
information collection since our last request for OMB approval, we have 
made no adjustments to our annual third-party disclosure burden 
estimate.

    Dated: August 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18000 Filed 8-20-19; 8:45 am]
 BILLING CODE 4164-01-P