[Federal Register: September 25, 2001 (Volume 66, Number 186)]
[Notices]
[Page 49024-49025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se01-62]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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