[Federal Register: June 22, 2004 (Volume 69, Number 119)]
[Notices]
[Page 34682-34683]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn04-95]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0079]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Specific Requirements
on Content and Format of Labeling for Human Prescription Drugs of
Geriatric Use Subsection in the Labeling
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
22, 2004.
ADDRESSES: The Office of Management and Budget (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 L. 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.
Specific Requirements on Content and Format of Labeling for Human
Prescription Drugs of Geriatric Use Subsection in the Labeling--(OMB
Control Number 0910-0370)--Extension
Section 201.57(f)(10) (21 CFR 201.57(f)(10)) requires that the
``Precautions'' section of prescription drug labeling must include a
subsection on the use of the drug in elderly or geriatric patients
(aged 65 and over). The information collection burden imposed by this
regulation is necessary to facilitate the safe and effective use of
prescription drugs in older populations. The geriatric use subsection
enables physicians to more effectively access geriatric information in
physician prescription drug labeling.
Section 201.57(f)(10) requires that a specific geriatric
indication, if any, that is supported by adequate and well-controlled
studies in the geriatric population must be described under the
``Indications and Usage'' section of the labeling, and appropriate
geriatric dosage must be stated under the ``Dosage and Administration''
section of the labeling. The ``Geriatric use'' subsection must cite any
limitations on the geriatric indication, need for specific monitoring,
specific hazards associated with the geriatric indication, and other
information related to the safe and effective use of the drug in the
geriatric population. The data summarized in this subsection of the
labeling must be discussed in more detail, if appropriate, under
``Clinical Pharmacology'' or the ``Clinical Studies'' section. As
appropriate, this information must also be contained in
``Contraindications,'' ``Warnings,'' and elsewhere in ``Precautions.''
Specific statements on geriatric use of the drug for an indication
approved for adults generally, as distinguished from a specific
geriatric indication, must be contained in the ``Geriatric use''
subsection and must reflect all information available to the sponsor
that is relevant to the appropriate use of the drug in elderly
patients. These statements are described further in Sec.
201.57(f)(10).
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual
21 CFR Section No. of Respondents Response Responses Hours per Response Total Hours
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201.57(f)(10) NDAs 73 1.48 108 8 864
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[[Page 34683]]
201.57(f)(10) ANDAs 96 4.67 449 2 898
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Total .................... .................... .................... .................... 1,762
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.
In the Federal Register of March 9, 2004 (69 FR 11021), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Dated: June 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-14078 Filed 6-21-04; 8:45 am]
BILLING CODE 4160-01-S