[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61490-61492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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

[[Page 61491]]

public 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.

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

ADDRESSES:  Submit either electronic or written comments on the 
collection of information to http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management , Food and Drug Administration, 1350 Piccard Dr., P150-400B 
Rockville, MD 20850, 301-796-3794, [email protected].

SUPPLEMENTARY INFORMATION: 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 Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                   Type of Response                        Respondents         per Response          Responses           Response         Total Hours
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Pretests                                                               30                     1                 30               0.25                  8
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[[Page 61492]]

 
Screener                                                            6,700                     1              6,700               0.10                670
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Telephone survey                                                    1,500                     1              1,500               0.25                375
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Internet panel survey                                               1,500                     1              1,500               0.25                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.

    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.

    Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25007 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S