Document ID: FDA-2011-N-0494-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data to Support Communications to Educate Consumers on How to Safely Purchase Drugs Online
Posted Date: 2011-07-12T04:00Z

[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Notices]
[Pages 40920-40921]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17415]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0494]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Data To Support Communications To Educate Consumers on 
How To Safely Purchase Drugs Online

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 on ``Data to Support 
Communications to Educate Consumers on How to Safely Purchase Drugs 
Online.'' This data collection will obtain baseline knowledge of the 
Internet users' knowledge, attitudes, and practices with regard to 
online pharmacies, and then will collect ongoing data for tracking 
changes in knowledge, attitudes, and practices as a

[[Page 40921]]

function of an integrated public outreach campaign FDA will roll out to 
educate consumers on how to safely purchase drugs online.

DATES: Submit either electronic or written comments on the collection 
of information by September 12, 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 comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
P150-400B, 301-796-3792, Elizabeth.Berbakos@fda.hhs.gov.

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 To Educate Consumers on How To Safely 
Purchase Drugs Online--(OMB Control Number 0910--New)

    FDA has planned an integrated public outreach campaign to improve 
the safe use of online pharmacies for drug purchases. In order to 
effectively evaluate this campaign, FDA must understand individuals' 
knowledge, attitudes, and practices with regard to online pharmacies 
both at the start of the campaign and on an ongoing basis. This will 
enable FDA to gauge progress toward educating the public on safely 
purchasing from online pharmacies. An online survey panel will be 
employed to collect this information, which serves the need for direct 
and quantitative measurement of our target population, and which, as a 
quantitative research tool has some major benefits:
     To focus on our target population of adults who use the 
Internet.
     To collect data quickly and efficiently with minimal cost 
to the government.
     To reduce burden to the public by providing a means to 
complete the survey at a time and place of their choosing.
    FDA will use online data collection to establish a baseline and 
evaluate the success of its messages and distribution methods for its 
outreach campaign, which educates consumers about how to safely 
purchase drugs online. Additionally, FDA will use this method to help 
tailor messages and communications vehicles to have both a more 
powerful and desired impact on target audiences. 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
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Survey Study.......................................................           5,000                1            5,000    .33 (20 min.)            1,650
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Annually, FDA projects one survey study. FDA is requesting this 
data collection 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 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17415 Filed 7-11-11; 8:45 am]
BILLING CODE 4160-01-P