[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67762-67763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27945]


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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; 
Submission for Office of Management and Budget Review; 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 (the PRA).

DATES: Fax written comments on the collection of information by 
December 3, 2015.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

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 requiring distribution of 
FDA approved patient medication information. These Medication Guides 
inform patients about the most important information they should know 
about these products in order to use them safely and effectively. 
Included is information such as the drug's approved uses, 
contraindications, adverse drug reactions, and cautions for specific 
populations, with a focus on why the particular product requires a 
Medication Guide. These regulations are intended to improve the public 
health by providing information necessary for patients to use certain 
medication safely and effectively.
    The regulations contain the following reporting requirements that 
are subject to the PRA:
     21 CFR 208.20--Applicants must submit draft Medication 
Guides for FDA approval according to the prescribed content and format.
     21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application 
holders must submit changes to Medication Guides to FDA for prior 
approval as supplements to their applications.
     21 CFR 208.24(c)--Each distributor or packer that 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 
container of drug product.

[[Page 67763]]

     21 CFR 208.24(e)--Each authorized dispenser of a 
prescription drug product for which a Medication Guide is required, 
when dispensing the product to a patient or to a patient's agent, must 
provide a Medication Guide directly to each patient unless an exemption 
applies under 21 CFR 208.26.
     21 CFR 208.26(a)--Requests may be submitted for exemption 
or deferral from particular Medication Guide content or format 
requirements.
    In the Federal Register of May 29, 2015 (80 FR 30688), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment.
    One comment requested clarification of FDA's burden estimates for 
21 CFR 208.24(c)--how the burden estimates were calculated and 
clarification of the definitions of ``respondent,'' ``average burden 
per respondent,'' and ``disclosures per respondent''. The comment asked 
whether ``respondent'' means the total number of individual warehouses 
owned and operated by all wholesale distribution companies or the 
number of wholesale distribution companies (which have multiple 
warehouses). The comment asked whether ``disclosures per respondent'' 
includes every instance that a Medication Guide is provided with any 
drug in 1 year or if it means the number of different types of drugs 
that a distributor would sell in a year for which a manufacturer was 
required to develop and supply a Medication Guide. The comment said 
that the number of ``disclosures per respondent'' would vary greatly 
depending on whether the word ``respondent'' means individual 
warehouses or wholesale distribution companies.
    Concerning the burden hour estimates, the comment asked whether 
1.25 hours (average burden per disclosure) includes the varying ways 
that wholesale distributors receive and distribute Medication Guides 
with shipments. The comment said that Medication Guides are provided to 
wholesale distributors from the manufacturer by multiple methods: For 
example, they are sometimes included with the package insert alone, 
provided in the package with the drug, or as loose leaf sheet(s) of 
paper and bulk-shipped to the wholesale distributor as a separate 
shipment or placed within the container in which the prescription 
product is shipped to the wholesale distributor. The comment said that 
if the Medication Guide is included on tear-off sheets or as loose-leaf 
paper, wholesale distributors would be responsible for coordinating the 
movement of those papers, taking significantly more time.
    FDA Response: FDA has used, in part, information previously 
provided by stakeholders to determine the burden estimates. The 191 
respondents under 21 CFR 208.24(c) in table 2 refers to the number of 
distribution centers. The 1.25 hour estimate for the ``average burden 
per respondent'' includes considerations such as the burden to receive, 
process, copy, store, select, and ship Medication Guides. The burden is 
an average estimate to address the various scenarios for distributing 
Medication Guides including electronically and in paper format. The 
``disclosures per respondent'' refers to the number of instances 
Medication Guides are provided to distributors in a format that is 
physically separate from the drug product and must be handled and 
processed separately. Because the comment did not indicate if the 
calculations were overestimated or underestimated, we continue to use 
191 for the number of respondents, 9,000 for the number of disclosures 
per respondent, and 1.25 hours as the average burden per disclosure.

                                 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                       57               1              57             320          18,240
 Medication Guide--208.20.......
Supplements and Other Changes to             108               1             108              72           7,776
 an Approved Application--
 314.70(b)(3)(ii), 601.12(f)....
Exemptions and Deferrals--                     1               1               1               4               4
 208.26(a)......................
    Total.......................  ..............  ..............  ..............  ..............          26,020
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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                          Average
        21 CFR Section            Number of     disclosures  per   Total annual     burden per      Total hours
                                 respondents       respondent       disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
208.24(c)....................             191              9,000       1,719,000            1.25       2,148,750
Distributing and Dispensing a          88,736              5,000     443,680,000         0.05 (3      22,184,000
 Medication Guide--208.24(e).                                                           minutes)
    Total....................  ..............  .................  ..............  ..............      24,332,750
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27945 Filed 11-2-15; 8:45 am]
 BILLING CODE 4164-01-P