Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications, 70873-70875 [2014-28106]

Download as PDF 70873 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices Island; Megan Padden, Vice President, Sentara Health Plans; Jeanne Ryer, Director, New Hampshire Citizens Health Initiative, University of New Hampshire; Carla Smith, Executive Vice President, Healthcare Information and Management Systems Society (HIMSS); Winston Wong, Medical Director, Community Benefit Director, Kaiser Permanente and Darlene Yee-Melichar, Professor & Coordinator, San Francisco State University. The agenda for the December 15, 2014 meeting will include the following: • Welcome and listening session with CMS leadership • Recap of the previous (May 22, 2014) meeting • Affordable Care Act initiatives • An opportunity for public comment • Meeting summary, review of recommendations and next steps Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102–3). Dated: November 25, 2014. Marilyn Tavenner, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2014–28217 Filed 11–26–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Notice of Allotment Percentages to States for Child Welfare Services State Grants Administration on Children, Youth and Families, Administration for Children and Families, Department of Health and Human Services. ACTION: Biennial publication of allotment percentages for States under the Title IV–B subpart 1, Child Welfare Services State Grants Program (CFDA No. 93.645). tkelley on DSK3SPTVN1PROD with NOTICES AGENCY: VerDate Sep<11>2014 16:58 Nov 26, 2014 Jkt 235001 As required by section 423(c) of the Social Security Act (42 U.S.C. 623(c)), the Department is publishing the allotment percentage for each State under the Title IV–B Subpart 1, Child Welfare Services State Grants Program. Under section 423(a), the allotment percentages are one of the factors used in the computation of the Federal grants awarded under the Program. DATES: Effective Dates: The allotment percentages shall be effective for Fiscal Years 2016 and 2017. FOR FURTHER INFORMATION CONTACT: Deborah Bell, Grants Fiscal Management Specialist, Office of Grants Management, Office of Administration, Administration for Children and Families, telephone (202) 401–4611. SUPPLEMENTARY INFORMATION: The allotment percentage for each State is determined on the basis of paragraphs (b) and (c) of section 423 of the Act. These figures are available on the ACF homepage on the internet: http:// www.acf.dhhs.gov/programs/cb/. The allotment percentage for each State is as follows: SUMMARY: Allotment percentage State Alabama .................................... Alaska ....................................... Arizona ...................................... Arkansas ................................... California ................................... Colorado ................................... Connecticut ............................... Delaware ................................... District of Columbia .................. Florida ....................................... Georgia ..................................... Hawaii ....................................... Idaho ......................................... Illinois ........................................ Indiana ...................................... Iowa .......................................... Kansas ...................................... Kentucky ................................... Louisiana .................................. Maine ........................................ Maryland ................................... Massachusetts .......................... Michigan ................................... Minnesota ................................. Mississippi ................................ Missouri .................................... Montana .................................... Nebraska .................................. Nevada ..................................... New Hampshire ........................ New Jersey ............................... New Mexico .............................. New York .................................. North Carolina .......................... North Dakota ............................ Ohio .......................................... Oklahoma ................................. Oregon ...................................... Pennsylvania ............................ Rhode Island ............................ South Carolina .......................... PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 59.09 43.55 58.45 59.17 46.42 47.68 32.05 49.91 14.17 53.25 57.54 49.44 60.03 47.77 56.92 49.95 50.53 59.39 54.18 54.46 39.19 35.95 56.28 46.65 62.12 54.83 56.05 47.91 55.86 43.36 37.68 59.43 38.88 56.69 40.07 54.34 53.45 55.52 48.37 47.52 59.92 State Allotment percentage South Dakota ............................ Tennessee ................................ Texas ........................................ Utah .......................................... Vermont .................................... Virginia ...................................... Washington ............................... West Virginia ............................ Wisconsin ................................. Wyoming ................................... American Samoa ...................... Guam ........................................ N. Mariana Islands ................... Puerto Rico ............................... Virgin Islands ............................ 48.15 55.94 51.20 59.34 49.39 44.92 46.94 60.16 51.83 41.14 70.00 70.00 70.00 70.00 70.00 Christopher Beach, Senior Grants Policy Specialist, Division of Grants Policy, Office of Administration. [FR Doc. 2014–28135 Filed 11–26–14; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0987] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications AGENCY: Food and Drug Administration, HHS. 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. DATES: Fax written comments on the collection of information by December 29, 2014. 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–NEW and title ‘‘Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications.’’ Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: E:\FR\FM\28NON1.SGM 28NON1 70874 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications—(OMB Control Number 0910—NEW) 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 (21 U.S.C. 393(d)(2)(D)), FDA’s Center for Tobacco Products (CTP) will create and use a variety of media to inform and educate the public, tobacco retailers, and health professionals about the risks of tobacco use, how to quit using tobacco products, and FDA’s role in regulating tobacco. To ensure that these health communication messages have the highest potential to be received, understood, and accepted by those for whom they are intended, the Center for Tobacco Products will conduct research and studies relating to the control and prevention of disease. In conducting such research, FDA will employ formative pretests. Formative pretests are conducted on a small scale, and their focus is on developing and assessing the likely effectiveness of communications with specific target audiences. This type of research involves: (1) Assessing audience knowledge, attitudes, behaviors, and other characteristics for the purpose of determining the need for and developing health messages, communication strategies, and public information programs and (2) pretesting these health messages, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. Formative pretesting is a staple of best practices in communications research. Obtaining feedback from intended audiences during the development of messages and materials is crucial for the success of every communication program. The purpose of obtaining information from formative pretesting is that it allows FDA to improve materials and strategies while revisions are still affordable and possible. Formative pretesting can also avoid potentially expensive and dangerous unintended outcomes caused by audiences’ interpreting messages in a way that was not intended by the drafters. By maximizing the effectiveness of messages and strategies for reaching targeted audiences, the frequency with which tobacco communication messages need to be modified should be greatly reduced. The information collected will serve the primary purpose of providing FDA information about the perceived effectiveness of messages, advertisements, and materials in reaching and successfully communicating with their intended audiences. Quantitative testing messages and other materials with a sample of the target audience will allow FDA to refine messages, advertisements, and materials, including questionnaires or images, directed at consumers while the materials are still in the developmental stage. In the Federal Register of July 17, 2014 (79 FR 41696), FDA published a 60-day notice requesting public comment on the proposed collection of information. Four comments were received, but only two comments were PRA-related. (Comment 1) One comment was supportive of the information collection, stating they ‘‘support CTP’s proposal to conduct formative pretests to ensure that health communication messages are received, understood and accepted by the intended audiences’’ and that they believe the proposed information collection is necessary and will have practical utility. The comment also stated that CTP’s projection of the burden of the proposed collection effort seems reasonable. In addition, the comment suggested that FDA consult with FDA’s Risk Communication Advisory Committee on proposed information collections. (Response) FDA agrees that the request in this collection of information is necessary and that the proposed burden is reasonable. Consultation with other U.S. Department of Health and Human Services (HHS) Agencies, FDA advisory committees, and/or the public will occur when appropriate. (Comment 2) One comment was supportive of the data collection stating that the ‘‘collections are, in fact, essential.’’ That comment also made suggestions about what the specific goals of messages tested in information collections included under this generic collection should focus on, and suggested that those collections be made available for further public comments. (Response) FDA agrees that the request in this collection of information is essential to the mission of FDA as a science-based Agency in its implementation of the Tobacco Control Act. Although we appreciate suggestions for the content of future submissions submitted under this generic clearance, ultimately such decisions will be driven by needs determined by the Agency in consultation with other HHS Agencies and the public when appropriate. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Self-Administered Surveys ....................................... 30,300 1 30,300 0.33 (20 minutes) ...... 9,999 tkelley on DSK3SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The number of respondents to be included in each new survey will vary, depending on the nature of the material or message being tested and the target audience. Dated: November 20, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28106 Filed 11–26–14; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:31 Nov 26, 2014 Jkt 235001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1904] Agency Information Collection Activities; Proposed Collection; Comment Request; Comparing Food Safety Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information and allow 60 days for public comment. This notice invites comments on the proposed data collection entitled ‘‘Comparing Food Safety Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers.’’ DATES: Submit either electronic or written comments on the collection of information by January 27, 2015. ADDRESSES: Submit electronic comments on the collection of information to http:// 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUMMARY: SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES I. Background 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. VerDate Sep<11>2014 17:31 Nov 26, 2014 Jkt 235001 ‘‘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 before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical utility; (2) the accuracy of our 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. Comparing Food Safety Knowledge, Attitude, and Behavior Among EnglishDominant Hispanics, SpanishDominant Hispanics, and Other Consumers—(OMB Control Number 0910—NEW) We conduct research and educational and public information programs relating to food safety and nutrition under our broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(b)(2)), to protect the public health by ensuring that foods are ‘‘safe, wholesome, sanitary, and properly labeled,’’ and in section 903(d)(2)(C) of the FD&C Act (21 U.S.C. 393(d)(2)(C)), to conduct research relating to foods, drugs, cosmetics, and devices. Our current food safety education and outreach programs and materials generally are developed and provided for the English-speaking population in the United States (Ref. 1). To better protect public health and to help consumers practice safe food handling, we need empirical data on how different population groups understand, perceive, PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 70875 and practice food safety and food handling. An emerging and important demographic trend in the United States is the increase in Hispanics. Recent estimates suggest that Hispanics (defined as those who identify themselves as of Hispanic or Latino origin) are the largest and fastest growing minority group in the nation; the proportion of the U.S. population that was Hispanic was 14 percent in 2005 and is projected to increase to 29 percent in 2050 (Ref. 2). Data from the Centers for Disease Control and Prevention indicate that, in the past two decades, Hispanics were one of the population groups that often experienced higher incidence rates (per 100,000 population) of bacterial causes of foodborne illness than Caucasians (Ref. 3). These bacterial causes include Campylobacter, Listeria monocytogenes, Shigella, and Salmonella. While some Hispanics living in the United States use the English language exclusively, or more often than Spanish (Englishdominant Hispanics), other U.S. Hispanics predominantly use the Spanish language in their daily lives (Spanish-dominant Hispanics) (Ref. 4). Since most U.S. food labels, including safe food handling instructions, are in English, Spanish-dominant Hispanics’ understanding and use of safe food handling instructions may differ from that of English-dominant Hispanics and of non-Hispanics who use English exclusively. In addition, Hispanics may have certain food handling practices that may increase their risk of foodborne illness (Ref. 5). FDA needs an understanding of how different population groups perceive and behave in terms of food safety and food handling to inform possible measures that we may take to better protect public health and to help consumers practice safe food handling. FDA is aware of no consumer research on a nationwide level on how different population groups understand, perceive, and practice food safety and food handling. This study is intended to provide answers to research questions such as whether and how much Spanish-dominant Hispanics, Englishdominant Hispanics, and Englishspeaking non-Hispanics differ in their knowledge, attitude, and behavior toward food safety and food handling among the three population groups, and the role that demographic and other factors may play in any differences. The proposed study will use a Webbased instrument to collect information E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70873-70875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28106]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Generic Clearance for 
the Collection of Quantitative Data on Tobacco Products and 
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.

DATES: Fax written comments on the collection of information by 
December 29, 2014.

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-NEW and 
title ``Generic Clearance for the Collection of Quantitative Data on 
Tobacco Products and Communications.'' Also include the FDA docket 
number found in brackets in the heading of this document.

[[Page 70874]]


FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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.

Generic Clearance for the Collection of Quantitative Data on Tobacco 
Products and Communications--(OMB Control Number 0910--NEW)

    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 (21 U.S.C. 393(d)(2)(D)), FDA's 
Center for Tobacco Products (CTP) will create and use a variety of 
media to inform and educate the public, tobacco retailers, and health 
professionals about the risks of tobacco use, how to quit using tobacco 
products, and FDA's role in regulating tobacco.
    To ensure that these health communication messages have the highest 
potential to be received, understood, and accepted by those for whom 
they are intended, the Center for Tobacco Products will conduct 
research and studies relating to the control and prevention of disease. 
In conducting such research, FDA will employ formative pretests. 
Formative pretests are conducted on a small scale, and their focus is 
on developing and assessing the likely effectiveness of communications 
with specific target audiences. This type of research involves: (1) 
Assessing audience knowledge, attitudes, behaviors, and other 
characteristics for the purpose of determining the need for and 
developing health messages, communication strategies, and public 
information programs and (2) pretesting these health messages, 
strategies, and program components while they are in developmental form 
to assess audience comprehension, reactions, and perceptions.
    Formative pretesting is a staple of best practices in 
communications research. Obtaining feedback from intended audiences 
during the development of messages and materials is crucial for the 
success of every communication program. The purpose of obtaining 
information from formative pretesting is that it allows FDA to improve 
materials and strategies while revisions are still affordable and 
possible. Formative pretesting can also avoid potentially expensive and 
dangerous unintended outcomes caused by audiences' interpreting 
messages in a way that was not intended by the drafters. By maximizing 
the effectiveness of messages and strategies for reaching targeted 
audiences, the frequency with which tobacco communication messages need 
to be modified should be greatly reduced.
    The information collected will serve the primary purpose of 
providing FDA information about the perceived effectiveness of 
messages, advertisements, and materials in reaching and successfully 
communicating with their intended audiences. Quantitative testing 
messages and other materials with a sample of the target audience will 
allow FDA to refine messages, advertisements, and materials, including 
questionnaires or images, directed at consumers while the materials are 
still in the developmental stage.
    In the Federal Register of July 17, 2014 (79 FR 41696), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Four comments were received, but only two 
comments were PRA-related.
    (Comment 1) One comment was supportive of the information 
collection, stating they ``support CTP's proposal to conduct formative 
pretests to ensure that health communication messages are received, 
understood and accepted by the intended audiences'' and that they 
believe the proposed information collection is necessary and will have 
practical utility. The comment also stated that CTP's projection of the 
burden of the proposed collection effort seems reasonable. In addition, 
the comment suggested that FDA consult with FDA's Risk Communication 
Advisory Committee on proposed information collections.
    (Response) FDA agrees that the request in this collection of 
information is necessary and that the proposed burden is reasonable. 
Consultation with other U.S. Department of Health and Human Services 
(HHS) Agencies, FDA advisory committees, and/or the public will occur 
when appropriate.
    (Comment 2) One comment was supportive of the data collection 
stating that the ``collections are, in fact, essential.'' That comment 
also made suggestions about what the specific goals of messages tested 
in information collections included under this generic collection 
should focus on, and suggested that those collections be made available 
for further public comments.
    (Response) FDA agrees that the request in this collection of 
information is essential to the mission of FDA as a science-based 
Agency in its implementation of the Tobacco Control Act. Although we 
appreciate suggestions for the content of future submissions submitted 
under this generic clearance, ultimately such decisions will be driven 
by needs determined by the Agency in consultation with other HHS 
Agencies and the public when appropriate.
    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 per response          Total hours
                                              respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Self-Administered Surveys.................          30,300                1           30,300   0.33 (20 minutes).......................           9,999
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents to be included in each new survey will 
vary, depending on the nature of the material or message being tested 
and the target audience.

    Dated: November 20, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28106 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P