[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
