
[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Notices]
[Pages 52332-52333]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0591]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 
September 21, 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: ``Data to Support Communications Usability Testing, as Used by 
the Food and Drug Administration.'' Also include the FDA 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, 
Juanmanuel.vilela@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.

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 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 
decisionmaking 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 on-line.
    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.
    In the Federal Register of June 10, 2011 (76 FR 34083), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 52333]]



                                  Table 1--Estimated Annual Reporting Burden 1
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
           Survey type              respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        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 \2\...............             500               1             500            5/60              42
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    Total.......................  ..............  ..............  ..............  ..............          41,042
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ These participants take the screener (which will be comprised of Demographic and/or Introductory Questions,
  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, a 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 previously. 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: August 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21379 Filed 8-19-11; 8:45 am]
BILLING CODE 4160-01-P


