[Federal Register Volume 66, Number 186 (Tuesday, September 25, 2001)]
[Notices]
[Pages 49024-49025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23885]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0393]


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.

DATES: Submit written or electronic comments on the collection of 
information by November 26, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 Information 
Resources Management (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: (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 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 are 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 314.70(b)(3)(ii) and 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 
Sec. 208.26 (21 CFR 208.26).
    Section 208.26(a)--Requests may be submitted for exemption or 
deferral from particular Medication Guide content or format 
requirements.

[[Page 49025]]



                                                     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                                                          8                  1                    8               242                1,936
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314.70(b)(3)(ii) and 601.12(f)                                  3                  1                    3                24                   72
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208.24(e)                                                  55,000                  8.3            460,000                  .0014             644
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208.26(a)                                                       1                  1                    1                 4                    4
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  Total                                                                                                                                    2,656
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-23885 Filed 9-24-01; 8:45 am]
BILLING CODE 4160-01-S