[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Notices]               
[Page 11021-11022]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr04-87]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0079]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Specific Requirements on Content and Format of 
Labeling for Human Prescription Drugs; Addition 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 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 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 the ``Geriatric Use'' subsection in the 
labeling for human prescription drugs.

DATES: Submit written or electronic comments on the collection of 
information by May 10, 2004.

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.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20857. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: 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 these topics: (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.

Specific Requirements on Content and Format of Labeling for Human 
Prescription Drugs; Addition 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\
------------------------------------------------------------------------
                              Annual
   21 CFR       No. of      Frequency      Total    Hours per    Total
  Section     Respondents      per        Annual     Response    Hours
                             Response    Responses
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201.57(f)(1  73            1.48         108         8          864
 0)--new
 drug
 applicatio
 ns (NDAs)
------------------------------------------------------------------------

[[Page 11022]]


201.57(f)(1  96            4.67         449         2          898
 0)--abbrev
 iated new
 drug
 applicatio
 ns (ANDAs)
------------------------------------------------------------------------
Total        ............  ...........  ..........  .........  1,762
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.


    Dated: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5195 Filed 3-8-04; 8:45 am]

BILLING CODE 4160-01-S