Document ID: FDA-2010-N-0420-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Testing Communications on FDA-Regulated Products Used in Animals
Posted Date: 2010-12-20T05:00Z

[Federal Register: December 20, 2010 (Volume 75, Number 243)]
[Notices]               
[Page 79378-79379]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de10-940]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0420]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Testing 
Communications on FDA-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 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 January 
19, 2011.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Testing Communications on FDA-Regulated Products Used in 
Animals.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@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.

Testing Communications on FDA-Regulated Products Used In Animals--(OMB 
Control Number 0910-New)

    FDA's Center for Veterinary Medicine (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 in-depth 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 decision-making 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

[[Page 79379]]

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 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.
    In the Federal Register of August 19, 2010 (75 FR 51271), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received comments from two individuals 
and one trade association. FDA acknowledges one request for additional 
details on the necessity and purpose of the information to be 
collected, but notes that comments were invited on FDA's request for a 
generic clearance related to the formative testing of communications 
about veterinary products and products for animals. Under this generic 
clearance, details of individual studies (research questions, target 
audiences, methodologies, and consultants) will be tailored to specific 
communications-related questions. For each study FDA requests under 
this clearance, FDA will provide OMB with these details on the 
information collection. The communication development process will 
inform the purpose of the data collection and the means by which the 
data will be collected. For very early message development, qualitative 
research such as in-depth interviews or focus groups will be 
appropriate. At later communication development stages, more 
quantitative data collection would be more useful. FDA plans to use the 
data collected under this generic clearance to inform its 
communications campaigns. The data will not be used for the purposes of 
making policy or regulatory decisions.
    Audience targets are also informed by the specific research 
question. Nonetheless, FDA provided more information by specifying some 
of the groups more likely to be targeted in tasks under this generic 
clearance, including: Consumers, pet owners, large animal producers, 
veterinarians, animal distributors, pet shop owners, stockyards staff 
and owners, abattoir owners or staff, grocery meat purchasers, 
agricultural extension agents, and professors of food science and 
related fields.
    Furthermore, comments related to ways to enhance the data 
collection and to assess FDA's estimate of burden indicated that FDA 
should not limit itself to in-house expertise. FDA acknowledges that 
assistance may be requested from experts in other Government agencies. 
Depending on the specific research question to be addressed, FDA may 
consult experts in the United States Department of Agriculture and the 
United States Environmental Protection Agency.
    FDA received a comment relating to the cruelty and sadism of animal 
testing. In response to this comment, FDA notes that its notice was for 
public comment on data collection related to communication studies. No 
animal testing is involved.
    FDA received a comment that made a series of complaints against the 
Agency unrelated to its notice for public comment. Accordingly, those 
comments are not addressed in this document.
    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     Total
     21 U.S.C. 393(d)(2)(D)          respondents      per response        responses          response      hours
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Individual in-depth interviews..               360                 1             360                  .75  270
General public focus group                     288                 1             288                 1.50  432
 interviews.....................
Intercept interviews: Central                  200                 1             200                  .25   50
 location.......................
Intercept interviews: Telephone              2,000                 1           2,000                  .08  160
 \2\............................
Self-administered surveys.......             2,400                 1           2,400                  .25  600
Gatekeeper reviews..............               300                 1             300                  .50  150
Omnibus surveys.................             1,200                 1           1,200                  .17  204
Total (general public)..........  ................  ................  .................  ................  1,866
Veterinarian/scientific expert                 288                 1             288                 1.50  432
 focus group interviews.........
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    Total (overall).............  ................  ................  .................  ................  2,298
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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.

    Dated: December 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31891 Filed 12-17-10; 8:45 am]
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