
[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24961-24962]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10022]


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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 (the PRA).

DATES: Fax written comments on the collection of information by May 29, 
2012.

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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@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 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. The estimates for the burden hours imposed by 
the following regulations are listed in table 1 of this document:
     21 CFR 208.20--Applicants must submit draft Medication 
Guides for FDA approval according to the prescribed content and format.
     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.
     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.
    In the Federal Register of December 21, 2011 (76 FR 79194), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received the following comments:
    (Comment 1) One comment states that FDA's hourly burden estimate of 
3 minutes per Medication Guide for pharmacists to comply with the 
requirements is miscalculated, although more in line with current 
practices versus previous FDA estimates.
    (Response) Because the comment did not indicate if the 
miscalculation was over-or under-estimated or provide alternative 
burden estimates for pharmacy time associated with distribution of a 
Medication Guide, we continue to use 3 minutes as the estimated burden 
for pharmacists to distribute Medication Guides to patients.
    (Comment 2) One comment said that there are distributor costs to 
comply with the Medication Guide requirements and FDA's estimate omits 
Sec.  208.24(c), which provides that ``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, or the means to produce Medication Guides, to 
each authorized dispenser to whom it ships a container of drug 
product.'' The comment states that the December 21, 2011, notice of 
proposed information collection (76 FR 79194) does not include an 
estimate for the reporting requirements of Sec.  208.24(c) and that the 
requirement should be included in FDA's assessment.
    (Response) FDA has re-evaluated Sec.  208.24(c) with regards to 
information collection burden on distributors and packers and 
determined that Sec.  208.24(c) does not contain an additional 
collection of information subject to the reporting requirements of the 
PRA. A ``collection of information'' includes an Agency request or 
requirement that members of the public submit reports, keep records, or 
provide information to third parties or the public by or for an Agency. 
Therefore, the manufacturer is responsible for providing information to 
third parties (Sec.  208.24(a)), i.e., Medication Guides, and the 
distributor or packer distributes the Medication Guides with the 
shipment of drugs to the dispensers. Thus, Sec.  208.24(c) is not 
subject to the reporting requirements of the PRA.
    (Comment 3) One comment says that FDA should reassess the need to 
provide Medication Guides with each prescription refill and states 
there are situations where it is not necessary due to certain 
circumstances. The comment states that Medication Guides should be a 
tool to enhance the level of care to consumers, rather than a hindrance 
to pharmacists in their ability to provide quality patient care.
    (Response) FDA agrees and directs the comment to the guidance made 
available to the public entitled ``Medication Guides--Distribution 
Requirements and Inclusion in Risk Evaluation and Mitigation Strategies 
(REMS).'' In this guidance, FDA articulates the circumstances under 
which FDA intends to exercise enforcement discretion regarding the 
requirement to provide Medication Guides in certain settings.

[[Page 24962]]

    (Comment 4) One comment states that Medication Guides increasingly 
become accessible online for download and print and the costs for 
printing, including paper, toner, administrative, and software costs, 
have shifted from the manufacturers to the pharmacies.
    (Response) While Medication Guides are increasingly available 
online for download and printing, the FDA does not agree that a 
financial and acquisition burden has shifted to or been created for 
dispensers. The comment mischaracterizes the cost to dispensers 
associated with the distribution of Medication Guides. For purposes of 
information collection requests under the PRA, capital costs are costs 
for equipment, machinery, and construction that, if not for FDA's 
request or requirement, the respondent would not incur. Capital costs 
do not include costs to achieve regulatory compliance. The costs 
presented by the comment are not capital costs because they are costs 
associated with achieving regulatory compliance with requirements of 
the FD&C Act, not costs associated specifically with equipment, 
machinery, and construction needed to retain appropriate substantiating 
evidence.
    (Comment 5) One comment states that the length of Medication Guides 
continues to be burdensome and hinders a pharmacist from utilizing a 
potentially effective tool. The comment stresses the need for a 
succinct, one-page document that can be easily integrated into current 
pharmacy practice workflow.
    (Response) FDA generally agrees with the comment and is currently 
in the process of evaluating whether a one-page solution can be 
implemented.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                  Number of
        21 CFR section            Number of     responses per    Total annual     Average burden    Total hours
                                 respondents     respondent        responses       per response
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208.20.......................              25               1  25                320                       8,000
314.70(b)(3)(ii), 601.12(f)..               5               1  5                 72                          360
208.24(e)....................          59,000           5,000  295 million       3 minutes            14,750,000
208.26(a)....................               1               1  1                 4                             4
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ................  ...............      14,758,364
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10022 Filed 4-25-12; 8:45 am]
BILLING CODE 4160-01-P


