
[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5462-5463]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01445]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0876]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Pretesting of Tobacco 
Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 (the PRA).

DATES: Fax written comments on the collection of information by 
February 25, 2013.

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 0910-0674. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@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.

Pretesting of Tobacco Communications--(OMB Control Number 0910-0674)--
Extension

    In order to conduct educational and public information programs 
relating to tobacco use, as authorized by section 1003(d)(2)(D) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
393(d)(2)(D)), and to develop stronger health warnings on tobacco 
packaging as authorized by the Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act), it is beneficial for FDA to conduct 
research and studies relating to the control and prevention of disease 
as authorized by section 301 of the Public Health Service Act (42 
U.S.C. 241(a)). In conducting such research, FDA will employ formative 
pretests to assess the likely effectiveness of tobacco communications 
with specific target audiences.
    The information collected will serve two major purposes. First, as 
formative research it will provide the critical knowledge needed about 
target audiences. FDA must first understand critical influences on 
people's decisionmaking process when choosing to use, not use, or quit 
using tobacco products. In addition to understanding the decisionmaking 
processes of adults, it is also critical to understand the 
decisionmaking processes among adolescents (ages 13 to 17), where 
communications will aim to discourage tobacco use before it starts. 
Knowledge of these decisionmaking processes will be applied by FDA to 
help design effective communication strategies, messages, and warning 
labels. 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. Pretesting 
messages with a sample of the target audience will allow FDA to refine 
messages while they are still in the developmental stage. By utilizing 
appropriate qualitative and quantitative methodologies, FDA will be 
able to: (1) Better understand characteristics of the target audience--
its attitudes, beliefs, and behaviors--and use risk communications; (2) 
more efficiently and effectively design messages and select formats 
that have the greatest potential to influence the target audience's 
attitudes and behavior in a favorable way; (3) determine the best 
promotion and distribution channels to reach the target audience with 
appropriate messages; and (4) expend limited program resource dollars 
wisely and effectively.
    In the Federal Register of August 17, 2012 (77 FR 49819), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Three comments were received, which included 
one comment that was not PRA-related and beyond the scope of this 
document, and one comment that was in full support of pretesting 
tobacco communications. The third commenter indicated that the 
authorizing statute was incorrectly identified. The correct authorizing 
statute is section 1003(d)(2)(D) of the FD&C Act. The commenter also

[[Page 5463]]

indicated that there was not enough information provided about the 
design and methodology of the pretests and the studies to effectively 
comment on the collection of information. In response, the information 
collection is for a broad spectrum of pretests and studies using a 
variety of methodologies and is dependent on the material being tested 
and the target audience. Each separate collection and pretest will be 
submitted for OMB review and approval prior to the collection or 
pretest being released to the public.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Individual In-Depth Interviews             360               1             360  0.75 (45                     270
                                                                                 minutes).
General Public Focus Group                 144               1             144  1.5 hours.......             216
 Interviews.
Intercept Interviews: Central              600               1             600  0.25 (15                     150
 Location.                                                                       minutes).
Intercept Interviews:                   10,000               1          10,000  0.08 (5 minutes)             800
 Telephone \2\.
Self-Administered Surveys.....           2,400               1           2,400  0.25 (15                     600
                                                                                 minutes).
Gatekeeper Reviews............             400               1             400  0.50 (30                     200
                                                                                 minutes).
Omnibus Surveys...............           2,400               1           2,400  0.17 (10                     408
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total (General Public)....          16,304  ..............  ..............  ................           2,644
----------------------------------------------------------------------------------------------------------------
Physician Focus Group                      144               1             144  1.5 hours.......             216
 Interviews.
                               ---------------------------------------------------------------------------------
    Total (Physician).........             144  ..............  ..............  ................             216
                               ---------------------------------------------------------------------------------
        Total (Overall).......          16,448  ..............  ..............  ................           2,860
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Brief interviews with callers to test message concepts and strategies following their call-in request to the
  FDA Center for Tobacco Products 1-800 number.

    The number of respondents to be included in each new pretest will 
vary, depending on the nature of the material or message being tested 
and the target audience. However, for illustrative purposes, table 1 
provides examples of the types of studies that may be administered and 
estimated burden levels that may be incurred during each year of the 3-
year period. Time to read, view, or listen to the message being tested 
is built into the ``Hours per Response'' figures.

    Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01445 Filed 1-24-13; 8:45 am]
BILLING CODE 4160-01-P


