Document ID: FDA-2011-N-0067-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data to Support Drug Product Communications
Posted Date: 2011-02-08T05:00Z

[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6800-6801]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2663]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0067]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Data To Support Drug Product Communications, 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 
to support communications used by FDA about drug products. This data 
collection will informally gauge public opinion on a variety of 
subjects related to consumer, patient, or healthcare professional 
perceptions and use of drug and biological products and related 
materials, including, but not limited to, direct-to-consumer 
prescription drug promotion, physician labeling of prescription drugs, 
Medication Guides, over-the-counter drug labeling, emerging risk 
communications, patient labeling, online sales of medical products, and 
consumer and professional education.

DATES: Submit either electronic or written comments on the collection 
of information by April 11, 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., 
PI50-400B, Rockville, MD 20850, 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 Drug Products Communications, as Used by the Food and 
Drug Administration (OMB Control Number 0910-New)

    Testing of communication messages in advance of a communication 
campaign provides an important role in improving FDA communications as 
they allow for an in-depth understanding of individuals' attitudes, 
beliefs, motivations, and feelings. The methods to be employed include 
individual in-depth interviews, general public focus group interviews, 
intercept interviews, self-administered surveys, gatekeeper surveys, 
and professional clinician focus group interviews. The methods to be 
used serve the narrowly defined need for direct and informal opinion on 
a

[[Page 6801]]

specific topic and as a qualitative research tool have two major 
purposes:
     To obtain information that is useful for developing 
variables and measures for formulating the basic objectives of risk 
communication campaigns, and
     To assess the potential effectiveness of messages and 
materials in reaching and successfully communicating with their 
intended audiences.
    FDA will use these methods to test and refine its ideas and to help 
develop messages and other communications, but will generally conduct 
further research before making important decisions such as adopting new 
policies and allocating or redirecting significant resources to support 
these policies.
    FDA's Center for Drug Evaluation and Research, Center for Biologics 
Evaluation and Research, Office of the Commissioner, and any other 
Centers or Offices will use this mechanism to test messages about 
regulated drug products on a variety of subjects related to consumer, 
patient, or health care professional perceptions and about use of drug 
products and related materials, including but not limited to, direct-
to-consumer prescription drug promotion, physician labeling of 
prescription drugs, Medication Guides, over-the-counter drug labeling, 
emerging risk communications, patient labeling, online sale of medical 
products, and consumer and professional education.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
              Number of respondents                frequency per   Total annual      Hours per      Total hours
                                                     response        responses       response
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19,822..........................................               1          19,822            0.24           4,757
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Annually, FDA projects about 45 communication studies using the 
variety of test methods listed previously in this document. 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: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2663 Filed 2-7-11; 8:45 am]
BILLING CODE 4160-01-P