[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Pages 67836-67837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0467]


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.

DATES: Submit written comments on the collection of information by 
January 23, 1997.

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: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Geraldine M. Hogan, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1481.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collection of information to OMB for review and 
clearance.

Gender Differences in Perception of Risks Communicated by 
Prescription and Over-the-Counter (OTC) Drug Labels

    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 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. The 
original study design was to use male-oriented and female-oriented 
drugs with 2,700 respondents. Based on focus group responses, the 
design was refined. It was determined that more accurate information 
would be obtained by assessing males' and females' responses to gender-
neutral drugs. Accordingly, the sample size has been reduced to 960. 
The annual estimated hour burden for respondents is 480 hours.

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours 
                                                     Response        Responses       Response                   
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960                                                     1               1               0.5           480       
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There are no capital costs or operating and maintenance costs associated with this collection.                  



[[Page 67837]]

    Dated: December 19, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32684 Filed 12-23-96; 8:45 am]
BILLING CODE 4160-01-F