[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Notices]
[Pages 34312-34313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13929]


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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 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 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-
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 to protect the public health.

DATES: Submit written or electronic comments on the collection of 
information by August 15, 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 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 FDA/Center for Veterinary Medicine (CVM)--
Regulated Products Used in Animals--21 U.S.C. 393(d)(2)(D) (OMB Control 
Number 0910-0689)--Extension

    FDA is authorized by section 393(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

[[Page 34313]]

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.
    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
            21 U.S.C. 393(d)(2)(D)                Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
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Individual Indepth Interviews................             360               1             360  0.75 (45 minutes)........................             270
General Public Focus Group Interviews........             288               1             288  1.5......................................             432
Intercept Interviews: Central Location.......             600               1             600  0.25 (15 minutes)........................             150
Intercept Interviews: Telephone..............      \2\ 10,000               1          10,000  0.08 (5 minutes).........................             800
Self-Administered Surveys....................           2,400               1           2,400  0.25 (15 minutes)........................             600
Gatekeeper Reviews...........................             400               1             400  0.50 (30 minutes)........................             200
Omnibus Surveys..............................           2,400               1           2,400  0.17 (10 minutes)........................             408
Total (General Public).......................          16,448  ..............          16,448  .........................................           2,860
Veterinarian/Scientific Expert Focus Group                288               1             288  0.75.....................................             216
 Interviews.
Total (Veterinarians/Scientific Experts).....             288               1             288  .........................................             216
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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 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.

    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: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13929 Filed 6-13-14; 8:45 am]
BILLING CODE 4164-01-P