[Federal Register Volume 70, Number 108 (Tuesday, June 7, 2005)]
[Notices]
[Pages 33181-33182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0003]


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.

DATES: Fax written comments on the collection of information by July 7, 
2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance. 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.

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

[[Page 33182]]

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                             8                  1                  8                320              2,560
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314.70(b)(3)(ii)                   2                  1                  2                 72                144
 and 601.12(f)
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208.24(e)                     55,000                 20          1,100,000              .0014              1,540
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208.26(a)                          1                  1                  1                  4                  4
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Total                                                                                                      4,248
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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 January 12, 2005 (70 FR 2174), FDA 
requested comments for 60 days on the information collection. No 
comments were received on this information collection.
    FDA estimates that, on average, approximately 8 products annually 
would be classified as serious and significant and thus require 
Medication Guides. FDA's regulatory impact analysis estimated that 
applicants would require approximately 2 months of full-time effort 
(320 hours) to develop (i.e., develop for submission to FDA for review 
and approval) each Medication Guide. Based on an average annual 
professional labor cost of $70,000, the cost of developing each 
Medication Guide would be approximately $11,666 for a total cost of 
$93,328.
    In addition, FDA estimates that the sponsor of one of the new or 
supplementary applications will request an exemption from at least some 
of the Medication Guide format or content requirements. FDA estimates 
that this will entail approximately 4 hours of work, or about $200.
    In addition, FDA estimates that two existing Medication Guides 
annually might require minor change under 21 CFR 314.70(b)(3)(ii) or 21 
CFR 601.12(f), necessitating 3 days (72 hours) of full-time effort per 
Medication Guide, for a total of 144 hours or $5,250.
    Under section 204.24(e) authorized dispensers are required to 
provide a Medication Guide directly to the patient (or the patient's 
agent) upon dispensing a product for which a Medication Guide is 
required. Thus, the final rule imposes a third-party reporting burden 
on authorized dispensers, who, for the most part, will be pharmacists. 
FDA estimates that, on average, it would take a pharmacist 
approximately 5 seconds (.0014 hour) to provide a Medication Guide to a 
patient.

    Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11267 Filed 6-6-05; 8:45 am]
BILLING CODE 4160-01-S