[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34083-34085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14410]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0401]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Communications Usability Testing, as
Used by the Food and Drug Administration
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 a generic clearance to collect information
that will provide tools to test the usability of FDA communications on
specific topics and to assist in the development and modification of
communication messages to promote public health and compliance with
regulations.
DATES: Submit either electronic or written comments on the collection
of information by August 9, 2011.
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
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comments should be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
[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.
Data To Support Communications Usability Testing, as Used by the Food
and Drug Administration--(OMB Control Number 0910-NEW)
FDA plans to use the data collected under this generic clearance to
inform its communications campaigns on a variety of topics related to
products that the FDA regulates. FDA expects the data to help staff
message developers achieve FDA communication objectives. FDA also plans
to use the data to help tailor print, broadcast, and electronic media
communications in order for them to have powerful and desired impacts
on target audiences. The data will not be used for the purposes of
making policy or regulatory decisions.
The information collected will serve two major purposes. First, as
formative research it will provide the critical knowledge needed about
target audiences. FDA must explore audiences' beliefs, perceptions, and
decision-making processes on specific topics in order to meet the basic
objectives of its risk communication campaigns. Such knowledge will
provide the needed target audience understanding to design effective
communication strategies, messages, and product labels. These
communications will aim to improve public understanding of the risks
and benefits of using various FDA-regulated products by providing users
with a better context in which to place risk information more
completely.
Second, as pretesting, it will give FDA some information about 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 may be
asked to give their reaction to the messages in person or online.
FDA's Centers and Offices will use this mechanism to test the
usability of messages about FDA-regulated products for consumers,
patients, industry representatives, or health care professionals. The
data will not be used for the purposes of making policy or regulatory
decisions.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
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Number of Average burden
Survey type Number of responses per Total annual per response (in Total hours
respondents respondent responses hours)
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In-Person Surveys............................................. 7,500 1 7,500 1 7,500
Remote Online Surveys......................................... 67,000 1 67,000 30/60 33,500
Screener Only \1\............................................. 500 1 500 5/60 42
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Total..................................................... ................ ................ ................ ................ 41,0412
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\1\ These participants take the screener (which will be compromised of Demographic and/or Introductory Question, Attachments 5 and 6) but are not
selected for the full survey.
There will be two lengths of surveys conducted, depending on
whether the survey is in person or remote and online. An in-person
survey will last an average of 60 minutes and take place at an FDA
computer or at a nongovernmental location; a remote survey will last
approximately 30 minutes and take place at the participant's computer.
These estimates were determined through analysis of times from previous
usability surveys using similar questions, survey of usability
professionals to ascertain average times for users to perform tasks,
and a pilot survey of 10 internal users comprised of staff from the
Centers for Disease Control and Prevention (CDC) and CDC contractors.
Some remote surveys will take much less time. The majority of usability
surveys conducted at CDC were done remotely; thus FDA estimates that in
the future more surveys will be done remotely rather than in person.
Estimate of survey respondents was based on an estimate of the
ideal number of usability surveys that FDA would conduct over a 3-year
period. Factored in were initial surveys and subsequent followup
surveys utilizing a satisfactory level of participants. Because FDA has
not conducted these types of surveys at the level needed previously, it
is anticipated that most of FDA's communications will require some sort
of usability survey. Additionally, FDA anticipates conducting a number
of important baseline surveys for its home Web page and other highly
trafficked subsites in order to redesign these pages as part of FDA's
priority to more effectively utilize its Web site.
Annually, FDA projects about 125 studies using the variety of test
methods listed above. FDA is requesting this burden so as not to
restrict the Agency's
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ability to gather information on public sentiment for its proposals in
its regulatory and communications programs.
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14410 Filed 6-9-11; 8:45 am]
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