[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]
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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.
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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 (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\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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).
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Total (General Public).... 16,304 .............. .............. ................ 2,644
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Physician Focus Group 144 1 144 1.5 hours....... 216
Interviews.
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Total (Physician)......... 144 .............. .............. ................ 216
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Total (Overall)....... 16,448 .............. .............. ................ 2,860
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\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