[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Notices]
[Pages 17428-17429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9349]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 89N-0474]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by May 
11, 1998.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention: 
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 section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Geriatric Use Labeling for Human Prescription Drugs--21 CFR 
201.57(f)(10)

    In a final rule published on August 27, 1997 (62 FR 45313), FDA 
amended its regulations governing the content and format of labeling 
for human prescription drug products, including biological products, to 
include information on the appropriate use of drugs for persons age 65 
years and older. The regulations facilitate access to this information 
by establishing a new ``Geriatric Use'' subsection in the labeling. The 
purpose of the regulation that will become effective on August 27, 
1998, is to promote safe and effective use of prescription drugs among 
older people.
    The regulations were issued under FDA's authority to regulate the 
labeling of prescription drugs and biological products, including 
sections 502(a), (f), and (j), and 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352(a), (f), and (j), and 355) and section 351 
of the Public Health Service Act (42 U.S.C. 242).
    In the final rule (62 FR 45313 at 45324), FDA requested comments on 
the information collection provisions of the new regulations. No 
comments were received in response to this request.
    Respondents to this collection of information will be business, and 
other for-profit organizations, including small business and 
manufacturers.FDA estimated the burden of this collection of 
information as follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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201.57(f)(10)                         290               1             290             120          34,800       
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1There are no capital costs or operating and maintenance costs associated with this collection of information.  



[[Page 17429]]

    Dated: April 2, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-9349 Filed 4-8-98; 8:45 am]
BILLING CODE 4160-01-F