DP15-006 Amendment 1.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

Investigating New Approaches for Tobacco Surveillance Systems

RFA-DP-15-006

Application Due Date: 02/09/2015

Signature Date

Investigating New Approaches for Tobacco Surveillance Systems

RFA-DP-15-006

TABLE OF CONTENTS

Part 1. Overview Information

Key Dates Required Application Instructions Executive Summary

Part 2. Full Text

Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Investigating New Approaches for Tobacco Surveillance Systems Activity Code

AMENDMENT I. QUESTIONS FROM POTENTIAL APPLICANTS AND CDC RESPONSES

added to Section VIII. Other Information on February 4, 2015

U01 Activity Code

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-006

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.305 Category of Funding Activity:

Health FOA Purpose This funding opportunity announcement seeks to design and test new format, content and modes of administration for tobacco surveillance systems. The newly developed system(s) will be used by public health professionals and researchers to describe the patterns and correlates of tobacco use behaviors in the U.

S. population and inform and evaluate tobacco prevention and control policies and interventions designed to reduce the burden of death, disease and disability associated with the consumption of tobacco products.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-15-006, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/09/2015

Application Due Date: 02/09/2015

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/24/2015 http://www.grants.gov

Secondary Review: 05/25/2015

Estimated Start Date: 09/30/2015

Expiration Date: 02/10/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

Purpose. The purpose of this announcement is to design and test new format, content and mode of administration for tobacco surveillance systems. The new and improved system (s) will be used by public health professionals and researchers to describe the patterns and correlates of tobacco-related indicators in the U. S. population and inform and evaluate tobacco prevention and control programs, policies, and interventions designed to reduce the burden of death, disease and disability associated with tobacco use.

Mechanism of Support. The funding mechanism is a cooperative agreement.

Funds Available and Anticipated Number of Awards. The CDC intends to commit approximately $3,500,000 (direct and indirect) over the entire project period. It is anticipated that one award will be made to a single recipient for up to $700,000 in FY2015. The Award issued under this FOA is contingent upon availability of funds and a sufficient number of meritorious applications. The total amount awarded will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. The total funding (direct and indirect) for the first year (12 month budget period) is approximately $700,000. The estimated total funding (direct and indirect) for the entire project period is $3,500,000. The project period will run from 09/30/2015 to 09/29/2020.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1 are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the application will be the “contact PI” for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS Number) is allowed.

Application Type. New Special Date(s). N/A Application Materials. See Section IV.1 for application materials.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIII1A http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV1

Application Materials. See Section IV.1 for application materials.

Hearing Impaired. Telecommunications for the hearing impaired are available at:

TTY: (770) 488-2783.

This FOA will be posted at http://www.cdc.gov/chronicdisease/about/foa.htm

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

Awards for this FOA are made under the authorization of Sections 301(a) of the Public Health Service Act as amended, 42 U.S.C. 241(a).

1. Background and Purpose

The burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products. Despite the fact that cigarette smoking alone causes more than 480,000 deaths per year, an estimated 42.1 million adults (18.1%) currently smoke cigarettes (1-4).

Although there have been declines in cigarette smoking in recent decades, the use of other forms of combustible (e.g., cigar products, pipe tobacco, hookah) and non-combustible (e.g., smokeless tobacco) tobacco products have either increased or stayed the same (5-6). Additionally, although the long-term effects are still under investigation, available data demonstrate that the prevalence of use of some emerging non-cigarette tobacco products, such as electronic nicotine delivery systems (ENDS), has increased rapidly in recent years (7).

There is a need to update existing tobacco surveillance systems. Current surveillance instruments do not use standardized tobacco use scales, thus generating inconsistent estimates for tobacco use behaviors across systems (8). For example, survey questions that assess the prevalence of current smokers have not been updated for several years. There is also a growing debate among public health professionals about how the frequency of smoking should be assessed to capture the true prevalence of tobacco use. Since 1992, a smoker has been defined as someone “who has smoked at least 100 cigarettes or more in his/her entire life and smoked now every day or some days”. There is a concern that the existing national surveys are not capturing smokers who have not smoked at least 100 cigarettes in their lifetime, and may be capturing smokers who smoked more than 30 days ago. Additionally, most national surveys have focused on cigarette smoking or smokeless tobacco use; however, it is important to adequately assess the use of other types of tobacco products, such as cigars, traditional pipe tobacco, and other combustible tobacco products. The thresholds for what defines an ever established user of the product (i.e., 20 cigars, 100 cigarettes) for the different tobacco products are important to determine former users of the product and for comprehensive tobacco prevention and control efforts in general.

Limited data are available to detect emerging trends in the use of non-cigarette tobacco products, such as ENDS, or the specific factors that influence behaviors to initiate or maintain the use of these products, particularly among youth and young adults. For example, at the present time empirical data are insufficient to ascertain whether harm perceptions or exposure to e-cigarette industry promotions are associated with risk of using ENDS. In addition, it is unclear whether youth are using ENDS first and then progressing to use conventional cigarettes. It is also unknown whether established cigarette smokers successfully use ENDS to quit smoking conventional cigarettes, what proportion of conventional cigarette smokers use both ENDS and conventional cigarettes and do not reduce or quit cigarette consumption, or what proportion of former cigarette smokers relapse by using ENDS or other non-conventional tobacco products.

Detecting and monitoring the use of emerging products, such as ENDS, is a challenge due to the cultural differences in perceptions, attitudes, and nomenclature currently used to describe these products. Inaccuracies in the assessment of these products have resulted from limited understanding of the best nomenclature to use http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV1 http://www.cdc.gov/chronicdisease/about/foa.htm in surveillance, evaluation, and research instruments. An additional challenge has been the lack of discrete measures for use of non-cigarette products, which limits the opportunity for determining dose-response effects on death and disease attributed to tobacco use.

There is a growing need for new, more rapid, less-expensive methods for monitoring various tobacco products (9). Electronic health records (EHRs) are rapidly becoming the standard of care for office-based medical practices, and office-based EHRs provide an opportunity to potentially be used for population health surveillance including tobacco surveillance (10). Many entities including local, regional, and national governments, large health care organizations, insurance companies, and academic research centers are exploring ways to use data from EHRs to monitor health and inform health care policies and programs (11).

This is in alignment with the meaningful use of EHRs as part of The American Reinvestment & Recovery Act (ARRA) which was enacted on February 17, 2009.

To support CDC’s vision of a society free of tobacco-related death, disease, and disability there is a need for more timely and relevant data to inform the endgame strategies outlined in the 2014 Surgeon General’s Report on the Health Consequences of Smoking (1). A modernized surveillance capacity is essential to sustain the national capability to produce and disseminate valid and timely data on tobacco use behaviors that are germane to the rapidly changing and increasingly diversified tobacco landscape in the United States.

In alignment with this effort, WHO also advances its tobacco control efforts by embracing the MPOWER framework as the structure for implementing the Framework Convention on Tobacco Control (12).

The six evidence-based MPOWER strategies include:

Monitor tobacco use and prevention policies Protect people from secondhand smoke Offer help to quit tobacco use Warn about the dangers of tobacco Enforce bans on tobacco advertising, promotion and sponsorship Raise taxes on tobacco

The purpose of this funding opportunity is to support applications that design and test new format(s), content and mode of administration(s) for updated tobacco surveillance systems. The system(s) developed will be used by public health professionals and researchers to describe the patterns and correlates of tobacco use behaviors in the U. S. population and inform and evaluate tobacco prevention and control policies and interventions designed to reduce the burden of death, disease and disability associated with the consumption of tobacco products.

Healthy People 2020 and other National Strategic Priorities

Healthy People 2020: Tobacco Use: Reduce illness, disability, and death related to tobacco use and secondhand smoke exposure. The Healthy People 2020 Tobacco Use objectives are organized into three key areas (13) :

1. Tobacco Use Prevalence: Implementing policies to reduce tobacco use and initiation among youth and adults.

TU-1 Reduce tobacco use by adults.

TU-2 Reduce tobacco use by adolescents.

TU-3 Reduce the initiation of tobacco use among children, adolescents, and young adults.

TU-4 Increase smoking cessation attempts by adult smokers.

TU-5 Increase recent smoking cessation success by adult smokers.

TU-6 Increase smoking cessation during pregnancy.

TU-7 Increase smoking cessation attempts by adolescent smokers.

2. Health System Changes: Adopting policies and strategies to increase access, affordability, and use http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=41 http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=41 http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=41 of smoking cessation services and treatments.

TU-9 Increase tobacco screening in health care settings.

TU-10 Increase tobacco cessation counseling in health care settings.

3. Social and Environmental Changes: Establishing policies to reduce exposure to secondhand smoke, increase the cost of tobacco, restrict tobacco advertising, and reduce illegal sales to minors.

TU-11 Reduce the proportion of nonsmokers exposed to secondhand smoke.

TU-14 Increase the proportion of smoke-free homes Increase the proportion of smoke-free homes.

TU-18 Reduce the proportion of adolescents and young adults in grades 6 through 12 who are exposed to tobacco marketing.

TU-19 Reduce the illegal sales rate to minors through enforcement of laws prohibiting the sale of tobacco products to minors.

CDC’s Winnable Battles: To keep pace with emerging public health challenges and to address the leading causes of illness, injury, disability, and death, the Centers for Disease Control and Prevention (CDC) initiated an effort to achieve measurable impact on selected Winnable Battles.

These Winnable Battles were chosen based on the magnitude of the health problems and our ability to make significant progress to improve outcomes. There are also evidence-based strategies available now to address the critical health challenges presented by each of the Winnable Battles areas. CDC has identified reducing tobacco use as a Winnable Battle (14).

Priorities of the Office on Smoking and Health: As the lead federal agency for comprehensive tobacco prevention and control, the Centers for Disease Control and Prevention (CDC), Office on Smoking and Health (OSH) develops, conducts, and supports strategic efforts to protect the public's health from the harmful effects of tobacco use. To achieve these goals, OSH works collaboratively with state and national partners and networks in providing strategic leadership, a solid science base, and technical assistance to advance evidence-based interventions at the state and local levels.

This project would help inform those efforts by generating strategic surveillance data that supports the following priorities of OSH:

Educating the public about the dangers of tobacco use and promoting quitting.

Ending combusted tobacco use, including long-term dual use, and increasing awareness, information and action on electronic nicotine delivery systems (ENDS), including e-cigarettes.

Enhancing tobacco control surveillance, research, and evaluation.

Updating surveillance instruments to obtain valid and reliable estimates of factors associated with tobacco use initiation, maintenance and cessation.

Advancing and sustaining tobacco control programs.

Assisting national, state, and local tobacco control partners to build sustainable capacity and infrastructure for comprehensive tobacco control programs by providing an evidence base for interventions to prevent tobacco use, promote cessation, expand smoke-free environments, and reduce tobacco-related disparities.

Public Health Impact http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=41

The range of tobacco products available to the U.S. marketplace has been greatly expanded in recent years and continues to change at a rapid pace. Current tobacco surveillance systems have been successful in monitoring and evaluating tobacco use patterns and correlates for the use of traditional tobacco products;

however, there is a need for updated surveillance to capture new behaviors and correlates related to the use of conventional tobacco products as well as the rapidly changing market of new products and related indicators. There is also a need for new modes of administration of surveillance questionnaires to shorten the timeframe between data collection and dissemination. This project has the potential to enhance the infrastructure of current and future surveillance systems, which will ensure scientifically robust surveillance, evaluation, and research of the diversity of tobacco product use in the United States. The research also has the potential to strengthen efforts at the global, national, state, and local levels to effectively monitor tobacco use and to use this information to inform public health policy, planning, and practice.

Relevant Work

Increasing the capacity to conduct rapid response surveillance is a key strategy for monitoring the tobacco use epidemic at the federal, state, and local levels. The CDC’s Office on Smoking and Health (OSH) has been working towards building rapid response surveillance capacity at the federal level. This effort is intended to enhance tobacco control’s ability to promptly assess the effect and impact of policies, current trends, programs, and interventions.

2. Approach

The overarching aim of this funding opportunity is to identify new tobacco use surveillance content, format and mode of administration that would result in enhanced national tobacco use surveillance capacity that captures the rapidly changing and increasingly diverse tobacco product landscape and the expanding surveillance opportunities and technologies now available in the United States.

Objectives/Outcomes

Objective 1: To document the strengths, limitations and opportunities for improvement of current tobacco surveillance systems. This may include activities such as:

a) conducting a systematic review of the literature, emerging science and existing surveillance instruments focused on tobacco use metrics and scales, including case definitions, use thresholds, and nomenclature for traditional and emerging tobacco products that is sensitive to cultural diversity,

b) Identifying new, improved methods for collecting data that uses electronic media and ultimately lessens the burden on study participants, and

c) Developing an inventory of existing tobacco-related surveys (both federal and non-federal) that provides data, questionnaires, and information on employed methods. This may serve as a clearing house of currently available tobacco surveys (federal and non-federal).

Objective 2: To utilize existing or establish new partnerships with agencies and organizations that are engaged in tobacco prevention and control surveillance, evaluation, and research to conduct qualitative research. This may include key informant interviews and focus groups to assess cultural differences in perceptions, attitudes, and vernacular associated with tobacco products and use behaviors. The qualitative research may also include focus groups about use behaviors with emerging products to determine associations with the continuum of tobacco use behaviors.

Objective 3: To develop new survey tools or questionnaires that supports the systematic collection of data on the continuum of tobacco use behaviors for multiple tobacco products among U.S. adults, young adults and youth. The goal of this objective is to develop tools that will result in the capability to obtain valid and reliable estimates of tobacco use behaviors and correlates in the current climate of diverse tobacco products.

The research strategies can include qualitative and quantitative methods, such as focus groups, key informant interviews, and cognitive testing.

Objective 4: To test new, improved methods for collecting data that uses electronic media and ultimately lessens the burden on study participants.

Objective 5: To pilot test the survey questions, and develop a report with recommendations regarding the feasibility for tobacco surveillance systems. The findings should describe the data sources examined, barriers encountered to integrate the new questions, and a summary of pilot data including identification of important gaps in information or systems. The recommendations should address specifically:

a) The potential usefulness of the surveillance system for the National Tobacco Control Program,

b) The potential usefulness of the surveillance system for other interested public and private organizations operating at local, state, and national level, and

c) The feasibility of using electronic platforms designed to reduce the burden on survey respondents and foster rapid data collection and dissemination of findings.

Objective 6: To disseminate results in peer-reviewed publications, reports, websites, and presentations to multiple audiences, including federal, state, and local tobacco control programs. Dissemination strategies may include a secure web portal or similar web-based technology to foster data sharing and information exchange between a wide audience with an interest in tobacco prevention and control, including public health practitioners, health-care providers, educators, decision-makers and the American public. The proposed web-based data access portal is intended to allow submitting web-queries and download tobacco-related surveillance data.

Target Population

The target population is U.S. adults and youth.

Collaboration/Partnerships

Applicants are expected to collaborate and form partnerships or consortia with eligible organizations within the public health system to conduct the proposed research and implement research outcomes to enhance tobacco surveillance systems. Applicants should discuss how the proposed research will be informed by input from professional partners, including formulation of the research questions and design, as an aspect of their collaboration with public health practitioners and researchers to ensure the relevance, appropriateness, and feasibility of the proposed research for supporting the enhanced surveillance.

Evaluation/Performance Measurement

Applicants are expected to propose a plan that measures performance with goals, objectives, milestones and outputs for each phase of the proposed research and a plan for how to evaluate the impact of the research findings on the content, format and mode of administration of the revised surveillance system when implemented. Resources to assist the development of the evaluation plan are available at www.cdc.gov/eval.

Translation Plan

Applicants are expected to submit progress reports to CDC documenting the methodology, results, conclusions and recommendations emanating from this project. Applicants are expected to present research findings at relevant conferences and meetings and publish research findings in peer-reviewed journals.

Some of the information collection conducted under this FOA is expected to be subject to the Paperwork Reduction Act of 1995 (PRA) (Pub. L. No. 96-511, 94 Stat. 2812, codified at 44 U.S.C. §; ;3501-3521).

References:

U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of1.

http://en.wikipedia.org/wiki/Title_44_of_the_United_States_Code http://www.law.cornell.edu/uscode/44/3501-3521.html

U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Coordinating Center for Health Promotion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014. http://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf.

1.

U.S. Department of Health and Human Services. Preventing tobacco use among youth and young adults. Atlanta, GA: US Department of Health and Human Services, CDC; 2012. Available at http ://www.cdc.gov/tobacco/data_statistics/sgr/2012/index.htm.

2.

U.S. Department of Health and Human Services. The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Coordinating Center for Health Promotion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2006. Available at http://www.cdc.gov/tobacco/data_statistics/sgr/2006/index.htm.

3.

Centers for Disease Control and Prevention. Best Practices for Comprehensive Tobacco Control Programs — 2014. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014. Available at http://www.cdc.gov/tobacco/stateandcommunity/best_pract ices/index.htm.

4.

Agaku IT, King BA, Dube SR. Current cigarette smoking among adults - United States, 2005 - 2012.

Morbidity & Mortality Weekly Report 2014; 63(2):30-34.

5.

Arrazola RA, Dube SR, King BA. Tobacco Product Use Among Middle and High School Students — United States, 2011 and 2012. Morbidity & Mortality Weekly Report 2013; 62(45):893-897.

6.

Corey C, Wang B, Johnson SE, Apelberg B, Husten C, King BA, McAfee TA, Bunnell R, Arrazola RA, Dube SR. Notes from the Field: Electronic Cigarette Use Among Middle and High School Students — United States, 2011–2012. Morbidity & Mortality Weekly Report 2013 / 62(35);729-730

7.

Delnevo CD, Bauer UE. Monitoring the tobacco use epidemic III. The host: data sources and methodological challenges, Preventive Medicine, vol. 48, no. 1, pp.S16-S23, 2009.

8.

CDC. Rapid Response Surveillance in Tobacco Control. Atlanta, GA: US Department of Health and Human Services, CDC; 2012. Available at https://nctoh.confex.com/nctoh/2012/webprogrampreliminary/Paper2419.html.

9.

McVeigh KH, Newton-Dame R, Perlman S, Chernov C, Thorpe L, Singer J, Greene C. Developing an Electronic Health Record-Based Population Health Surveillance System. New York: New York City Department of Health and Mental Hygiene, 2013.

10.

Gfroerer J, Dube SR, King BA, Garrett BE, Babb S, McAfee TA. Vital Signs: Current Cigarette Smoking Among Adults Aged ≥18 Years with Mental Illness — United States, 2009–2011. Morbidity & Mortality Weekly Report 2013 / 62(05);81-87

11.

WHO Report on the Global Tobacco Epidemic, 2008: The MPOWER package. Geneva, World Health Organization, 2008.

12.

US Department of Health and Human Services. Tobacco use objectives. Healthy People 2020.

Washington, DC: US Department of Health and Human Services. http://www.healthypeople.gov/2020 /topicsobjectives2020/objectiveslist.aspx?topicId=41.

13.

Centers for Disease Control and Prevention. Winnable Battles Progress Report 2010-2015. Available at http://www.cdc.gov/winnablebattles/targets/pdf/winnablebattlesprogressreport.pdf

14.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

http://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf http://www.cdc.gov/tobacco/data_statistics/sgr/2012/index.htm http://www.cdc.gov/tobacco/data_statistics/sgr/2012/index.htm http://www.cdc.gov/tobacco/stateandcommunity/best_practices/index.htm http://www.cdc.gov/tobacco/stateandcommunity/best_practices/index.htm http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=41 http://www.cdc.gov/winnablebattles/targets/pdf/winnablebattlesprogressreport.pdf

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $3,500,000

Anticipated Number of Awards: 1

In 2015 the CDC intends to commit a total of approximately $700,000 (direct and indirect) for the first 12 month budget period for one award.

If an applicant requests a funding amount greater than the ceiling of the award range for the first year ($700,000),HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

The CDC intends to commit a total of approximately $3,500,000 (direct and indirect) for the five (5) year project period (09/30/2015 to 09/29/2020).

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $700,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 5 year(s) Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http:// ecfr.gpoaccess.gov /cgi/t/text/ text-idx?c=ecfr& sid=512ff78311f427c00454772dcf21523a&rgn=div8 &view=text&node=48:1.0.1.6.34.0.1.18& idno=48

2. Foreign Organizations Foreign Organizations are not eligible to apply.

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

N/A

4. Justification for Less than Maximum Competition

N/A

5. Responsiveness

If an applicant requests a funding amount greater than the ceiling of the award range for the first year ($700,000),HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform

Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

https://www.sam.gov/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

3. Letter of Intent Due Date for Letter of Intent: 01/09/2015

Michael A. Brown, M.P.H.

Scientific Program Official Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Hwy, NE Mailstop F-80 Atlanta, GA 30341 Telephone: (770) 488-5118 E-mail: mab5@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities mailto:mab5@cdc.gov

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

Research Plan Applicants’ research plan should address activities that will be conducted over the entire 5-year project period.

1) Describe planned approach to identifying existing surveillance data sources or existing surveillance systems for tobacco use.

2) Describe each data source or system, including accessibility, frequency for data collection, the data elements (variables) available from each source or system, and the respective mode of administration and response rates. Document key similarities and differences, as well as strengths and limitations, of the data sources and data elements for the various systems.

3) Describe the planned approach to assess cultural, regional, and other differences in perceptions, attitudes, and vernacular associated with new and emerging tobacco products and use behaviors across subpopulations.

4) Describe the planned approach to identify various definitions for tobacco use in diverse populations and to incorporate this information into surveillance instruments for pilot testing of validity, reliability and mode of administration using electronic media.

5) Describe planned protocol for assessing various electronic modes of administration or new methods to collect data related to tobacco use that will reduce burden on survey respondents and support rapid dissemination of findings. Identify approaches to establishing a denominator (population base) for new surveillance systems that may use new methods, such as internet panels.

6) Describe approach for integrating all major data sources into a functional surveillance system.

Include a rationale for the proposed structure and selection of proposed data elements.

7) Describe planned approach for conducting and evaluating a pilot test of the surveillance system.

Include measures for evaluating validity and reliability of information collected related to new and emerging tobacco products and associated use behaviors.

8) Describe planned approach for developing a web portal or similar web-based technology to foster data sharing and information exchange between a wide audience with an interest in tobacco prevention and control, including public health practitioners, health-care providers, educators, decision-makers and the American public.

9) Prepare a plan to disseminate the findings, such as in peer-reviewed publications, reports, websites, and presentations to multiple audiences, including federal, state, and local tobacco control programs.

10) Describe a management and staffing plan that includes roles and responsibilities for each key team member.

11) Describe the project’s timeline with specific activities and expected accomplishments for each year.

12) Provide a budget that includes at least one trip per year to Atlanta, Georgia.

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

8. Format for Attachments…