[Federal Register Volume 61, Number 82 (Friday, April 26, 1996)]
[Notices]
[Pages 18611-18612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10302]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0010]


Agency Information Collection Activities; Proposed Collection; 
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, 
Federal agencies are required to publish notice in the Federal Register 
concerning each collection of information and to allow 60 days for 
public comment in response to the notice. This notice solicits comments 
on a survey of male and female consumers regarding various formats for 
presenting risk and benefit information in drug labeling.

DATES: Submit written comments by June 25, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
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:
Charity B. Smith, Office of Information Resources Management (HFA-250), 
Food and Drug Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, 
MD 20857, 301-827-1686.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide 60-day notice in the Federal Register concerning 
each proposed collection of information. ``Collection of information'' 
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information listed below.

    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

[[Page 18612]]

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 the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. The Marketing Practices and Communications Branch of FDA's 
Division of Drug Marketing, Advertising, and Communications is studying 
the effectiveness of various formats for the presentation of risk and 
benefit information for over-the-counter (OTC) and prescription drugs 
to male and female patients through patient labeling. To gain 
information about the value and utility of benefit and risk information 
presented in several formats, three studies will be undertaken. In each 
study subjects will examine materials varied by one or more risk 
formatting variables for one prescription and one OTC drug. Subjects 
will be recruited at large shopping malls. They will be brought to a 
private interview room where they will examine the materials, and a 
structured interview will be conducted. Equal numbers of subjects of 
each gender will be included in each study. In addition, there will be 
a control group for each study that receives ``no-risk'' information 
labels for the drugs. There will be 2,160 experimental subjects and 540 
control subjects, for a total of 2,700 respondents.

                                        Estimated Annual Reporting Burden                                       
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                                                                 Annual                                         
                                                               frequency      Total      Hours per              
                     No. of respondents                           per         annual      response   Total hours
                                                                response    responses                           
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2,700.......................................................            1            1           .5        1,350
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    Dated: April 19, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-10302 Filed 4-25-96; 8:45 am]
BILLING CODE 4610-01-M