Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by July 29, 2011.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-New and title “National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products.” Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3794. JonnaLynn.Capezzuto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products—(OMB Control Number 0910-NEW)

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. 393(d)(2)(D)), 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 noninstitutionalized 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.

In the Federal Register of October 5, 2010 (75 FR 61490), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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