[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

[[Page 34084]]

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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