[Federal Register Volume 75, Number 133 (Tuesday, July 13, 2010)]
[Notices]
[Pages 39952-39953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16973]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0344]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications on Medical Devices and
Radiation-Emitting 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 public comment in response to the notice. This
notice solicits comments on communication studies involving medical
devices and radiation-emitting products regulated by FDA. This
information will be used to explore concepts of interest and assist in
the development and modification of communication messages and
campaigns to fulfill the agency's mission to protect the public health.
DATES: Submit either electronic or written comments on the collection
of information by September 13, 2010.
ADDRESSES: Submit electronic 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[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.
[[Page 39953]]
Testing Communications on Medical Devices and Radiation-Emitting
Products--(OMB Control Number 0910-New)
FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)(D)) to conduct
educational and public information programs relating to the safety of
regulated medical devices and radiation-emitting products. FDA must
conduct needed research to ensure that such programs have the highest
likelihood of being effective. Improving communications about medical
devices and radiation-emitting products will involve many research
methods, including individual indepth interviews, mall-intercept
interviews, focus groups, self-administered surveys, gatekeeper
reviews, and omnibus telephone surveys.
The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about medical device
and radiation-emitting product use. Knowledge of consumer and health
care professional decisionmaking processes will provide the better
understanding of target audiences that FDA needs to design effective
communication strategies, messages, and labels. These communications
will aim to improve public understanding of the risks and benefits of
using medical devices and radiation-emitting products by providing
users with a better context in which to place risk information more
completely.
Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the developmental stage. Respondents will be
asked to give their reaction to the messages in either individual or
group settings.
Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
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Total Operating &
Section of the act No. of Annual Frequency Total Annual Hours per Total Hours Maintenance
Respondents per Response Responses Response Costs\1\
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1003(d)(2)(D) 16,448 1 16,448 0.1739 2,860 $25,239
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Total 16,448 1 16,448 0.1739 2,860 $25,239
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\1\ There are no capital costs associated with this collection of information.
Annually, FDA projects about 30 studies using a variety of research
methods, and lasting an average of 0.17 hours each (varying from 0.08-
1.5 hours). The operating and maintenance costs include contractor
expenses for designing and conducting information collection
activities, specifically, drawing samples, training interviewers,
collecting and analyzing information, and reporting and disseminating
findings. FDA estimates the burden of this collection of information
based on prior recent experience with the various types of data
collection methods described earlier. FDA is requesting this burden so
as not to restrict the agency's ability to gather information on public
sentiment for its proposals in its regulatory and communications
programs.
Dated: July 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16973 Filed 7-12-10; 8:45 am]
BILLING CODE 4160-01-S