[Federal Register Volume 66, Number 241 (Friday, December 14, 2001)]
[Notices]
[Pages 64840-64841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0393]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below 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: Submit written comments on the collection of information by 
January 14, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 No. 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.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                       Annual Frequency      Total Annual
                 21 CFR Section                   No. of Respondents     per Response          Responses      Hours per Response      Total Hours
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208.20                                                    8                   1                   8                 242               1,936
314.70(b)(3)(ii) and 601.12(f)                            3                   1                   3                  24                  72
208.24(e)                                            55,000                   8.3           460,000                    .0014            644
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.

    In the Federal Register of September 25, 2001 (66 FR 49024), the 
agency requested comments on the proposed collections of information. 
FDA received one comment on the September 25, 2001, notice. The

[[Page 64841]]

comment stated that clarification is needed as to whether Medication 
Guides would be needed for medical devices that have a prescription 
drug either as a coating or incorporated into the material of the 
device, or as a component in a kit. The comment said that some of these 
types of products might be considered combination products.
    FDA requested comments on the information collection burden 
estimates described in the notice. Because the comment does not pertain 
to the burden estimates, FDA has forwarded the comment to Docket Number 
93N-0371, ``Prescription Drug Product Labeling; Medication Guide 
Requirements.'' FDA appreciates the comment and will consider it as 
part of its Medication Guide program.

    Dated: December 7, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-30852 Filed 12-13-01; 8:45 am]
BILLING CODE 4160-01-S