Document ID: FDA-2010-N-0420-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Testing Communications on Food and Drug Administration/Center for Veterinary Medicines Regulated Products Used in Animals
Posted Date: 2010-08-19T04:00Z

[Federal Register: August 19, 2010 (Volume 75, Number 160)]
[Notices]               
[Page 51271-51272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au10-52]                         

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

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.

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

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    No. of         Annual Frequency       Total Annual       Hours per
                   21 U.S.C. 393(d)(2)(D)                        Respondents         per Response          Responses         Response       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individual indepth interviews                                               360                     1                360             .75             270
--------------------------------------------------------------------------------------------------------------------------------------------------------
General public focus group interviews                                       144                     1                144             1.5             216
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intercept interviews: Central location                                      600                     1                600             .25             150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intercept Interviews: Telephone\2\                                       10,000                     1             10,000             .08             800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Self-administered surveys                                                 2,400                     1              2,400             .25             600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Gatekeeper reviews                                                          400                     1                400             .50             200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Omnibus surveys                                                           2,400                     1              2,400             .17             408
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total (general public)                                                                                                                             2,644
-----------------------------------------------------------------------------------------------------------------------------------------
Total veterinarian/scientific expert focus group interviews                 144                     1                144             1.5             216
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Burden                                                                                                                                       2,860
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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