Document ID: FDA-2011-N-0067-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data to Support Drug Product Communications, as Used by the Food and Drug Administration
Posted Date: 2011-06-03T04:00Z

[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32217-32218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13812]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Data To Support Drug 
Product Communications, as Used by the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 July 5, 
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 Drug Product Communications, 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: 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: 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 Drug Product 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 indepth understanding of individuals' attitudes, 
beliefs, motivations, and feelings. The methods to be employed include 
individual indepth 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 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.
    In the Federal Register of February 8, 2011 (76 FR 6800), 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 32218]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                                                                        Number of      responses per     Total annual    per  response     Total hours
                                                                       respondents       respondent       responses      (in hours) \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys.................................................          19,822                1           19,822            14/60            4,757
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of minutes per response]/60''.

    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: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13812 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P