[Federal Register Volume 75, Number 160 (Thursday, August 19, 2010)]
[Notices]
[Pages 51271-51272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20482]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0420]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications on the Food and Drug
Administration/Center for Veterinary Medicine's Regulated Products Used
in Animals
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 communication studies involving FDA/Center
for Veterinary Medicine (CVM) regulated products intended for use in
animals. This information will be used to explore concepts of interest
and assist in the development and modification of communication
messages and campaigns to fulfill the Agency's mission in protecting
the public health.
DATES: Submit either electronic or written comments on the collection
of information by October 18, 2010.
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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, Rockville, MD 20850, 301-796-3793.
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.
Testing Communications on the Food and Drug Administration/Center for
Veterinary Medicine's Regulated Products Used in Animals--21 U.S.C. 393
(d)(2)(D)--(OMB Control Number-0910-NEW )
CVM has authorization under section 903(d)(2)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D) to conduct
educational and public information programs relating to the safety of
CVM-regulated products. Further, CVM is authorized to conduct this
needed research to ensure that these programs have the highest
likelihood of being effective. Thus, CVM concludes that improving
communications about the safety of regulated animal drugs, feed, food
additives, and devices will involve many research methods, including
individual indepth interviews, mall-intercept interviews, focus groups,
self-administered surveys, gatekeeper reviews, and omnibus telephone
surveys.
The information collected will serve three major purposes. First,
as formative research, it will provide critical knowledge needed about
target audiences to develop messages and campaigns about the use of
animal drugs, feed, food additives, and devices. Knowledge of both the
consumer and the veterinary professional decisionmaking processes will
provide a better understanding of target audiences that FDA will need
in order to design effective communication strategies, messages, and
labels. These communications will aim to improve public understanding
of the risks and benefits of using regulated animal drugs, feed, food
additives, and devices by providing users with a better context in
which to place risk information more completely. Second, as initial
testing, it will allow FDA to assess the potential effectiveness of
messages and materials in reaching and successfully communicating with
their intended audiences. Testing messages with a sample of the target
audience will allow
[[Page 51272]]
FDA to refine messages while still in the developmental stage.
Respondents will be asked to give their reaction to the messages in
either individual or group settings. Third, as evaluative research, it
will allow FDA to ascertain the effectiveness of the messages and the
distribution method of these messages in achieving the objectives of
the message campaign. Evaluation of campaigns is a vital link in
continuous improvement of communications at FDA.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 U.S.C. 393(d)(2)(D) Respondents per Response Responses Response Total Hours
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Individual indepth interviews 360 1 360 .75 270
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General public focus group interviews 144 1 144 1.5 216
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Intercept interviews: Central location 600 1 600 .25 150
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Intercept Interviews: Telephone\2\ 10,000 1 10,000 .08 800
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Self-administered surveys 2,400 1 2,400 .25 600
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Gatekeeper reviews 400 1 400 .50 200
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Omnibus surveys 2,400 1 2,400 .17 408
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Total (general public) 2,644
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Total veterinarian/scientific expert focus group interviews 144 1 144 1.5 216
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Total Burden 2,860
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ These are brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1-800 number.
FDA's estimate for the annual reporting burden of the proposed
collection of information requirements is based on recent prior
experience with the various types of data collection methods described
previously. FDA projects about 30 studies for which the annual
reporting burden is estimated to be 2,860 hours.
Dated: August 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20482 Filed 8-18-10; 8:45 am]
BILLING CODE 4160-01-S