[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1142-1143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-264]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1674]


Agency Information Collection Activities; Proposed Collection; 
Specific Requirements on Content and Format of Labeling for Human 
Prescription Drugs; Addition of ``Geriatric Use'' Subsection in the 
Labeling; Comment Request

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 comments or electronic comments on the collection 
of information by March 6, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
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 L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600

[[Page 1143]]

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.

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 consists of designing, testing, and submitting the geriatric 
use subsection of the labeling. The 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.

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR Section               No. of       Responses per   Total Annual      Hours per      Total Hours
                                    Respondents     Respondent       Responses       Response
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201.57(f)(10)--new drug                83               1.49          124               8             992
 applications
201.57(f)(10)--abbreviated new        117               3.96          464               2             928
 drug applications
Total                                                                                              1,920
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 \1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-264 Filed 1-4-01; 8:45 am]
BILLING CODE 4160-01-F