Document ID: FDA-2010-N-0420-0008
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Testing
Communications on Food and Drug Administration-Regulated Products
Used in Animals
Posted Date: 2014-11-04T05:00Z

[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65405-65406]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26141]

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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 Food and Drug Administration-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 
December 4, 2014.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0689. 
Also include the FDA 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, 8455 Colesville Rd.; COLE-14526, Silver 
Spring, MD 20993-0002 PRAStaff@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/Center for Veterinary Medicine (CVM)-
Regulated Products Used in Animals (21 U.S.C. 393 (d)(2)(D))--OMB 
Control Number 0910-0689--Reinstatement

    FDA is authorized by section 1003(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. FDA must conduct needed research to ensure that such programs 
have the highest likelihood of being effective. FDA expects 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 
FDA-regulated products for use in animals. Knowledge of consumer and 
veterinary professional decision-making processes will provide the 
better understanding of target audiences that FDA needs to design 
effective communication strategies, messages, labels, and labeling. 
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 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 June 16, 2014 (79 FR 34312) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was submitted; however, it was 
not responsive to the four collection of information topics solicited 
and therefore is not discussed in this document.
    FDA estimates the burden of this collection of information based on 
recent prior experience with the various types of data collection 
methods described in this document:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
     21 U.S.C. 393(d)(2)(D)          Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Individual Indepth Interviews...             360               1             360            0.75             270
General Public Focus Group                   288               1             288             1.5             432
 Interviews.....................
Intercept Interviews: Central                600               1             600            0.25             150
 Location.......................
Intercept Interviews: Telephone.      \2\ 10,000               1          10,000            0.08             800
Self-Administered Surveys.......           2,400               1           2,400            0.25             600

[[Page 65406]]

 
Gatekeeper Reviews..............             400               1             400            0.50             200
Omnibus Surveys.................           2,400               1           2,400            0.17             408
Total (General Public)..........          16,448  ..............          16,448  ..............           2,860
Veterinarian/Scientific Expert               288               1             288            0.75             216
 Focus Group Interviews.........
Total (Veterinarians/Scientific              288               1             288  ..............             216
 Experts).......................
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    Total (Overall).............          16,736               1          16,736  ..............           3,076
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\1\ There are no capital costs or operating or 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.

    Annually, FDA projects about 30 studies with 16,736 respondents, 
using a variety of research methods and lasting an average of 0.17 
hours each (varying from 0.08-1.5 hours).

    Dated: October 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26141 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P