[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Annual frequency Total Hours per No. of respondents per annual response Total hours response responses ---------------------------------------------------------------------------------------------------------------- 2,700....................................................... 1 1 .5 1,350 ---------------------------------------------------------------------------------------------------------------- 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