Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pretesting of Tobacco Communications, 5462-5463 [2013-01445]

Download as PDF 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]


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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.

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

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