Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pretesting of Tobacco Communications, 5462-5463 [2013-01445]
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5462
Federal Register / Vol. 78, No. 17 / Friday, January 25, 2013 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ANA Project Impact Assessment Survey ........................................................
85
1
6
510
Estimated Total Annual Burden
Hours: 510.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–01577 Filed 1–24–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with
[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.
VerDate Mar<15>2010
18:39 Jan 24, 2013
Jkt 229001
ACTION:
Notice.
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.
SUMMARY:
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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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
E:\FR\FM\25JAN1.SGM
25JAN1
Federal Register / Vol. 78, No. 17 / Friday, January 25, 2013 / Notices
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
5463
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
responses per
respondent
Number of
respondents
Activity
Individual In-Depth Interviews ...........
General Public Focus Group Interviews.
Intercept Interviews: Central Location.
Intercept Interviews: Telephone 2 .....
Self-Administered Surveys ................
Gatekeeper Reviews .........................
Omnibus Surveys ..............................
Total annual
responses
Average burden per response
Total hours
360
144
1
1
360
144
0.75 (45 minutes) .............................
1.5 hours ..........................................
270
216
600
1
600
0.25 (15 minutes) .............................
150
10,000
2,400
400
2,400
1
1
1
1
10,000
2,400
400
2,400
0.08
0.25
0.50
0.17
(5 minutes) ...............................
(15 minutes) .............................
(30 minutes) .............................
(10 minutes) .............................
800
600
200
408
Total (General Public) ................
16,304
........................
........................
...........................................................
2,644
Physician Focus Group Interviews ...
144
1
144
1.5 hours ..........................................
216
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with
[Docket No. FDA–2012–N–0032]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Antimicrobial
Animal Drug Distribution Reports
Under Section 105 of the Animal Drug
User Fee Amendments of 2008
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
18:39 Jan 24, 2013
Jkt 229001
ACTION:
Notice.
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.
SUMMARY:
Fax written comments on the
collection of information by February
25, 2013.
DATES:
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 0910–0659 and
title, ‘‘Antimicrobial Animal Drug
Distribution Reports Under Section 105
of the Animal Drug User Fee
Amendments of 2008.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
PO 00000
Frm 00057
Fmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. Antimicrobial
Animal Drug Distribution Reports
Under Section 105 of the Animal Drug
User
SUPPLEMENTARY INFORMATION:
Sfmt 4703
Fee Amendments of 2008—(OMB
Control Number 0910–0659)—Extension
Section 105 of the Animal Drug User
Fee Amendments of 2008 (ADUFA II)
(Pub. L. 316) amended section 512 of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360b) by,
among other things, creating section
512(l)(3) to require that the sponsor of
each new animal drug that contains an
antimicrobial agent submit an annual
report to FDA on the amount of each
antimicrobial active ingredient in the
drug that is sold or distributed for use
in food-producing animals, including
information on any distributor-labeled
product. The legislation was enacted to
address the problem of antimicrobial
resistance and to help ensure that FDA
has the necessary information to
examine safety concerns related to the
use of antibiotics in food-producing
animals (154 Congressional Record
H7534).
Each report must specify: (1) The
amount of each antimicrobial active
ingredient by container size, strength,
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[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
