Notice: Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prescription Drug Product Labeling: Medication Guide 
Requirements

Federal Register: Volume 76, Number 245 (Wednesday, December 21, 2011)
                  Pages 79194-79195

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on regulations requiring the 
distribution of patient labeling, called Medications Guides, for 
certain products that pose a serious and significant public health 
concern requiring distribution of FDA-approved patient medication.

DATES: Submit either electronic or written comments on the collection 
of information by February 21, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.regulations.gov. Submit written comments on the 
collection of information to Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), 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 extension of an existing collections 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: (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 assumption 
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.

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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 79195]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
             21 CFR Section                   Number of       responses per      Total annual responses    Average burden per response     Total hours
                                             respondents       respondent                                           (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: December 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32548 Filed 12-20-11; 8:45 am]
BILLING CODE 4160-01-P