Agency Information Collection Activities; Proposed Collection; Comment Request; Pretesting of Tobacco Communications, 49819-49820 [2012-20206]

Download as PDF 49819 Federal Register / Vol. 77, No. 160 / Friday, August 17, 2012 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 201.25(d) 2 1 2 24 48 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 13, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–20205 Filed 8–16–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0876] Agency Information Collection Activities; Proposed Collection; Comment Request; Pretesting of Tobacco Communications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on pretesting of tobacco communications. DATES: Submit either electronic or written comments on the collection of information by October 16, 2012. ADDRESSES: Submit electronic comments on the collection of information to https:// 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: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– erowe on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:52 Aug 16, 2012 Jkt 226001 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. 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, including each proposed extension of an existing 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. 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 903(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) and to develop stronger health warnings on tobacco packaging PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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. FDA estimates the burden of this collection of information as follows: E:\FR\FM\17AUN1.SGM 17AUN1 49820 Federal Register / Vol. 77, No. 160 / Friday, August 17, 2012 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Individual In-Depth Interviews .............................. General Public Focus Group Interviews ............... Intercept Interviews: Central Location .................. Intercept Interviews: Telephone ........................... Self-Administered Surveys ................................... Gatekeeper Reviews ............................................ Omnibus Surveys ................................................. 360 144 600 2 10,000 2,400 400 2,400 1 1 1 1 1 1 1 360 144 600 10,000 2,400 400 2,400 0.75 (45 minutes) ......... 1.5 hours ...................... 0.25 (15 minutes) ......... 0.08 (5 minutes) ........... 0.25 (15 minutes) ......... 0.50 (30 minutes) ......... 0.17 (10 minutes) ......... 270 216 150 800 600 200 408 Total (General Public) ................................... Physician Focus Group Interviews ....................... Total (Physician) ............................................ 16,304 144 144 ........................ 1 ........................ ........................ 144 ........................ ....................................... 1.5 hours ...................... ....................................... 2,644 216 216 Total (Overall) ................................................ 16,448 ........................ ........................ ....................................... 2,860 1 There are no capital costs or operating and maintenance costs associated with this collection of information. interviews with callers to test message concepts and strategies following their call-in request to the FDA Center for Tobacco Products 1–800 number. 2 Brief 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: August 13, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–20206 Filed 8–16–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health erowe on DSK2VPTVN1PROD with NOTICES National Institute of Dental & Craniofacial Research; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Dental and Craniofacial Research Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections VerDate Mar<15>2010 17:52 Aug 16, 2012 Jkt 226001 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Dental and Craniofacial Research Council. Date: September 21, 2012. Open: 8:30 a.m. to 12:00 p.m. Agenda: Report to the Director, NIDCR. Place: National Institutes of Health, Building 31, 31 Center Drive, 6th Floor, 10, Bethesda, MD 20892. Closed: 1:00 p.m. to Adjournment. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, 31 Center Drive, 6th Floor, 10, Bethesda, MD 20892. Contact Person: Alicia J. Dombroski, Ph.D., Director, Division of Extramural Activities, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892. Information is also available on the Institute’s/Center’s home page: https:// www.nidcr.nih.gov/about, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: August 13, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–20275 Filed 8–16–12; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of meetings of the National Center for Advancing Translational Sciences Advisory Council. The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Cures Acceleration Network Review Board. Date: September 14, 2012. Time: 8:30 a.m. to 2:30 p.m. Agenda: Report from the Acting Institute Director. Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 6, Bethesda, MD 20892. Contact Person: Jane A. Steinberg, Ph.D., Executive Secretary, National Center for E:\FR\FM\17AUN1.SGM 17AUN1

Agencies

[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Notices]
[Pages 49819-49820]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20206]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection;
Comment Request; Pretesting of Tobacco Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on pretesting of tobacco
communications.

DATES: Submit either electronic or written comments on the collection
of information by October 16, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to https://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: 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: 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, including
each proposed extension of an existing 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.

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 903(d)(2)(D) of the
Federal Food, Drug, and Cosmetic 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.
FDA estimates the burden of this collection of information as
follows:

[[Page 49820]]

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: \2\ 10,000 1 10,000 0.08 (5 minutes) 800
Telephone.
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: August 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20206 Filed 8-16-12; 8:45 am]
BILLING CODE 4160-01-P

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