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Agency Information Collection Activities; Proposed Collection; Comment Request; National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




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 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for Start Printed Page 61491public comment in response to the notice. This notice solicits comments on the National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products.


Submit either electronic or written comments on the collection of information by December 6, 2010.


Submit either electronic or written comments on the collection of information to Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

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Jonna Capezzuto, Office of Information Management , Food and Drug Administration, 1350 Piccard Dr., P150-400B Rockville, MD 20850, 301-796-3794,

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Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (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 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 through the use of automated collection techniques, when appropriate, and other forms of information technology.

National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products

Risks and benefits are inherent in all FDA-regulated medical products, including drugs, biologics, and medical devices (e.g., pacemakers, implantable cardiac defibrillators, contact lenses, infusion pumps). FDA plays a critical oversight role in managing and preventing injuries and deaths related to medical product use. However, the users of FDA-regulated products are ultimately the ones who determine which products are used and how they are potentially misused. For this reason, it is critical that the public understand the risks and benefits of FDA-regulated medical products to a degree that allows them to make rational decisions about product use.

FDA's responsibility includes communicating about medical products. This encompasses communications that FDA generates and those it oversees through regulation of product manufacturers' and distributors' communications. Activities include, but are not limited to, recall notices, warnings, public health advisories and notifications, press releases, and information made available on its Web site. FDA also regulates communications drafted and disseminated by manufacturers and distributors of many medical products, including all the communications (advertising and labeling) about prescription drugs, biologics, and restricted medical devices, and a subset of communications (omitting advertising) about nonprescription drugs and other medical devices. In order to conduct educational and public information programs relating to these responsibilities, as authorized by Section 1003(d)(2)(D) of the Federal Food Drug and Cosmetic Act (21 U.S.C. section 393), it is beneficial for FDA to conduct research and studies relating to health information as authorized by section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)).

In conducting such research, FDA will employ nationally representative surveys of consumers to assess whether the information being disseminated by both the agency and the entities it regulates is appropriately reaching targeted audiences in an understandable fashion. Specifically, the surveys will assess public understanding about the benefits and risks of medical products and FDA's role in regulating these products. The surveys will assess behaviors and beliefs related to the use of medical products, when consumers desire emerging risk information, the likelihood of reporting serious side effects that might be associated with medical product use, perceptions of the credibility of FDA and other potential sources of risk and benefit information, and satisfaction with FDA's communications-related performance.

Parallel surveys of 1,500 non-institutionalized U.S. adults will be administered. One survey of 1,500 subjects will be a telephone survey, and the second survey of another 1,500 subjects will be conducted with members from an Internet panel. Both survey samples will be constructed to be representative of the U.S. population, and both will take approximately 15 minutes to administer. Results from each survey will be compared to provide insight into the best methodology for future studies.

The information collected will be used by FDA in the development of more effective risk communication strategies and messages. The surveys will provide FDA insight as to how well the public understands and incorporates risk/benefit information into their belief structures, and how well the public understands the context within which FDA makes decisions on medical product recalls and warnings. Using this information, the agency will more effectively design messages and select formats and distribution channels that have the greatest potential to influence the target audience's attitudes and behavior in a favorable way. Frequency of Response: On occasion. Affected Public: Individuals or households; Type of Respondents: Members of the public.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden1

Type of ResponseNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
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Telephone survey1,50011,5000.25375
Internet panel survey1,50011,5000.25375
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on FDA's and the contractor's experience with previous surveys. Prior to administering the surveys with the entire sample, FDA plans to conduct pretests with up to 30 adults; these are meant to evaluate the effectiveness of the programming of the interview protocol, online filters, and skip patterns.

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Dated: September 30, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-25007 Filed 10-4-10; 8:45 am]