Document ID: FDA-2014-N-0345-0002
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: 2014-09-30T04:00Z

[Federal Register Volume 79, Number 189 (Tuesday, September 30, 2014)]
[Notices]
[Page 58786]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23236]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0345]

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.

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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 October 
30, 2014.

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 emailed to oirasubmission@omb.eop.gov. 
All comments should be identified with the OMB control number 0910-
0695. Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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 0910-0695)--Extension

    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 specific topic and, as a qualitative research tool, have two major 
purposes:
    (1) To obtain information that is useful for developing variables 
and measures for formulating the basic objectives of risk communication 
campaigns; and
    (2) 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 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.
    Annually, FDA projects about 45 communication studies using the 
variety of test methods listed 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.
    In the Federal Register of April 7, 2014 (79 FR 19096), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment; however, this 
comment did not address the information collection.
    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
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Interviews/Surveys..............          19,822               1          19,822        0.24 (14           4,757
                                                                                        minutes)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: September 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23236 Filed 9-29-14; 8:45 am]
BILLING CODE 4164-01-P