Document ID: FDA-2010-N-0502-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Consumer Surveys on Understanding Risks and Benefits of FDA-Regulated Medical Products
Posted Date: 2011-06-29T04:00Z

[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38186-38187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16251]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0502]

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.

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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

[[Page 38187]]

information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
       Type of respondent            Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses      per response
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Pretests........................              30               1              30   0.25 (15 min.)              8
Screener........................           6,700               1           6,700   0.10 (6 min.)             670
Telephone survey................           1,500               1           1,500   0.25 (15 min.)            375
Internet panel survey...........           1,500               1           1,500   0.25 (15 min.)            375
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    Total.......................  ..............  ..............  ..............  ..............           1,428
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16251 Filed 6-28-11; 8:45 am]
BILLING CODE 4160-01-P