[Federal Register Volume 66, Number 72 (Friday, April 13, 2001)]
[Notices]
[Pages 19176-19177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9119]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 [Docket No. 00N-1674]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments on the collection of information by May 
14, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (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; Addition of ``Geriatric Use'' Subsection in the 
Labeling (OMB Control No. 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

[[Page 19177]]

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.

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

    In the Federal Register of January 5, 2001 (66 FR 1142), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.

    Dated: April 6, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-9119 Filed 4-12-01; 8:45 am]
BILLING CODE 4160-01-S