[Federal Register: January 12, 2005 (Volume 70, Number 8)]
[Notices]               
[Page 2174-2175]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja05-111]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0003]

 
Agency Information Collection Activities; Proposed Collection; 
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 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 Medication Guides, for certain 
products that pose a serious and significant public health concern 
requiring distribution of FDA-approved patient medication information.

DATES: Submit written or electronic comments on the collection of 
information by March 14, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the 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: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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 
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.
    Prescription Drug Product Labeling; Medication Guide Requirements 
(OMB Control Number 0910-0393)--Extension
    FDA regulations require the distribution of 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

[[Page 2175]]

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, and 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 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(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.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual frequency     Total Annual        Hours Per
  21 CFR Section      Respondents        per response        Responses           Response         Total Hours
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208.20                            35               1.34                 47                242             11,374
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314.70(b)(3)(ii)                   3                  1                  3                 24                 72
 601.12(f)
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208.24(e)                     55,000                 20          1,100,000              .0014               1540
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208.26(a)                          1                  1                  1                  4                  4
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Total                                                                                                     12,990
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: January 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-659 Filed 1-11-05; 3:26 pm]

BILLING CODE 4160-01-S