Document ID: FDA-2014-N-0345-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Drug Product Communications as
Used by the Food and Drug Administration
Posted Date: 2014-04-07T04:00Z

[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19096-19097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07705]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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, 
including each proposed extension of an existing 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.

DATES: Submit either electronic or written comments on the collection 
of information by June 6, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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, including 
each proposed extension of an existing 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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                            Number of
                                              Number of     responses   Total annual     Average
                 Activity                    respondents       per        responses    burden per    Total hours
                                                           respondent                   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.

[[Page 19097]]

    Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07705 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P