[Federal Register: June 22, 2004 (Volume 69, Number 119)]
[Page 34682-34683]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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.  

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                  Annual Frequency per      Total Annual
              21 CFR Section                 No. of Respondents         Response              Responses        Hours per Response        Total Hours
201.57(f)(10) NDAs                                  73                     1.48                108                     8                   864

[[Page 34683]]

201.57(f)(10) ANDAs                                 96                     4.67                449                     2                   898
Total                                       ....................  ....................  ....................  ....................       1,762
\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]