[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19096-19097]
From the Federal Register Online via the Government Publishing 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, [email protected].
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]
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