RFA-DP-15-008PRCSIPSAMENDMENT pdf 09 20 16 A.docx

NOTICE

This Funding Opportunity Announcement (FOA) is being published on Grants.gov for INFORMATION PURPOSE ONLY! NO APPLICATIONS WILL BE SOLICITED FOR THIS FOA

Centers for Disease Control

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

PPHF 2015: Nutrition, Physical Activity & Obesity Based Activities - Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements (SIPS) - financed in part by 2015 Prevention and Public Health Funds RFA-DP-15-008 Application Due Date: 09/30/2016

PPHF 2015: Nutrition, Physical Activity & Obesity Based Activities - Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements (SIPS) - financed in part by 2015 Prevention and Public Health Funds RFA-DP-15-008

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 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 PPHF 2015: Nutrition, Physical Activity & Obesity Based Activities - Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements (SIPS) - financed in part by 2015 Prevention and Public Health Funds Activity Code U48

AMENDMENT 3 (7.13.2015)

NOTIFICATION FOR INCLUSION OF APPROPRIATE INFORMATION REGARDING THE PREVENTION AND PUBLIC HEALTH FUND (PPHF). NO ACTION REQUIRED BY APPLICANTS.

Selections will be made based on applications previously received.

Amendment 2 (1.) Notice of withdrawal of SIP 15-008 “Mycoplasma Genitalium Among Men With Non-gonococcal Urethritis (NGU) Attending STD Clinics in the US”. Note: CDC will not be able to receive any applications to SIP-008, and (2.) CDC answers to Questions submitted regarding the SIP FOA. The Q&As are located at the end Section VIII Other Information.

Amendment 1 to increase funds for SIPs15-007, 15-008, & 15-009.

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-008

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.135 93.542 Category of Funding Activity:

Health FOA Purpose This RFA will provide supplemental funding to Prevention Research Centers (PRCs) to design, test, and disseminate effective applied public health prevention research strategies to include behavioral interventions, environmental or system-wide solutions, and strategies that address major causes of disease and disability. Research strategies align with public health priorities such as the Healthy People 2020 topic areas: Cancer; Community Health; HIV and Sexual Health; and Nutrition, Obesity, and Physical Activity.

Key Dates

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: 05/15/2015 Secondary Review: 06/15/2015 Estimated Start Date: 09/30/2015 Expiration Date: 04/09/2015 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 12 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. This RFA will provide supplemental funding to Prevention Research Centers (PRCs) to design, test, and disseminate effective applied public health prevention research strategies to include behavioral interventions, environmental or system-wide solutions, and strategies that address major causes of disease and disability.

Mechanism of Support. Cooperative agreement.

Funds Available and Anticipated Number of Awards. The CDC intends to commit a total of approximately $4,300,000 (direct and indirect) for the entire project period.The estimated total funding (direct and indirect) for the first year (12 month budget period) for all SIP proposals is $ 1,975,000. It is estimated that $910,000 will be PPHF funds: $660,000 NCHHSTP and $250,000 DNPAO. It is anticipated that up to 11 awards will be made. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards 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 $1,975,000. It is estimated that $910,000 will be PPHF funds. The estimated total funding (direct and indirect) for the entire project period is $4,300,000. The estimated project period will run from 09/30/2015 to 09/29/2019.

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, but to institutions/organizations. 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.A PRC may apply for multiple SIPs; however, a separate application must be submitted for each SIP. A PRC may submit only one application per SIP.

Application Type. New Special Date(s). A summary of the questions and answers will be published as an FOA amendment prior to the application receipt date. Questions and answers will be shared via e-mail with the PRC PI’s and any additional e-mail contacts.

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 Section 1706 of the Public Health Service Act, 42 U.S.C. 300u-5.

Section 4002 of the Patient Protection and Affordable Care Act, Public Law 111-148. (as amended.)

1. Background and Purpose The purpose of the Prevention Research Centers (PRC) program’s Special Interest Projects (SIPs) is to support supplemental projects in health promotion and disease prevention research. A major focus of this supplemental funding program is to design, test, and disseminate effective applied public health prevention research strategies.

1. Background and Purpose The PRC Program was established by Congress in 1984 (Public Law 98-551) to conduct research in The PRC Program was established by Congress in 1984 (Public Law 98-551) to conduct research in health promotion, disease prevention, and methods of appraising health hazards and risk factors. Congress mandated that the centers be located at academic health centers capable of providing multidisciplinary faculties with expertise in public health, relationships with professionals in other relevant fields, graduate training and demonstrated curricula in disease prevention, and a capability for residency training in public health or preventive medicine. 1 The PRCs also serve as demonstration sites for the use of new and innovative applied public health research and activities for disease prevention and health promotion. CDC administers the PRC Program and provides leadership, technical assistance, and oversight.2 Funded PRCs are able to compete for SIPs, research projects sponsored by CDC, HHS, and other federal agencies, to conduct research and other activities in priority areas. Funded PRCs are encouraged to apply for SIPs that expand and strengthen their PRC’s mission and increase their applied public health research activities.

The SIP mechanism, created in 1993, allows the PRCs to compete for research projects sponsored by CDC organizational units and other HHS agencies. A SIP is a health promotion and disease prevention research project that focuses on a topic of interest or a gap in knowledge or research. It can also support the development of effective state and local public health strategies.

Prevention research includes applied public health research that develops and evaluates health promotion and disease prevention and control strategies that are community- and population-based. It can involve testing interventions for efficacy, effectiveness, or translational power; may focus on primary, secondary, or tertiary prevention; or may improve health and prevent disease through approaches that involve changes to individual behavior, policy or environmental structure, health systems, or socio-economic factors. Prevention research may provide initial evidence of the efficacy or effectiveness of a health promotion or prevention strategy, raise current evidence to a higher level, or provide evidence of the effectiveness of a practice-based strategy.

This FOA is expected to fund research that will focus on developing and evaluating the evidence for strategies that improve population health outcomes in the Healthy People 2020 topic areas of Cancer; HIV and Sexual Health; and Nutrition, Obesity, and Physical Activity. The following are the current SIPS and associated topic areas:

Cancer Prevention and Care: SIP 15-001, 15-002, 15-003, 15-004, and 15-005;

Community Health: SIP 15-006;

HIV and Sexually Transmitted Disease (STD): SIP 15-007, 15-008, and 15-009 Nutrition, Obesity, and Physical Activity: SIP 15-010 and 15-011 Healthy People 2020 and other National Strategic Priorities The US Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) seeks competitive supplement cooperative agreement applications for the Health Promotion and Disease Prevention Research Centers Program. This FOA aligns with the following public health priorities:

1. Healthy People 2020 Objectives related to health promotion and disease prevention3.

2. The National Prevention Strategy4.

3. CDC’s Winnable Battles which cover health topics of HIV; motor vehicle injuries; nutrition, physical activity, and obesity; teen pregnancy; and tobacco5.

4. The NCCDPHP Domains of a) epidemiology and surveillance, b) environmental approaches that promote health and support and reinforce healthful behaviors, c) health system interventions to improve the effective delivery and use of clinical and other preventive services, and d) strategies to improve community-clinical linkages.

Public Health Impact Accomplishing the objectives of these projects will:

SIP 15-001 Integrating Self-Management Education with Cancer Survivorship Care Planning Understanding the feasibility of referring cancer survivors to self-management (SM) programs at the time care plans are delivered and identifying the barriers and facilitators associated with scalability of a SM program to a larger, diverse population of cancer survivors may be used to guide modifications to existing SM programs and inform best practices in survivorship care for cancer survivors.

SIP 15-002 Economic Impact of Clinical Trials Among Children Diagnosed with Cancer Understanding the long-term economic impact of health benefits related to clinical trial enrollment among children aged 0-19 years with a cancer diagnosis can be used to help the decision process of whether to enroll children with cancer in clinical trials decrease morbidity and mortality.

SIP 15-003 Using Cancer Registry Data to Promote Proactive Tobacco Cessation among Adult Cancer Survivors Using cancer registry data to understand the effectiveness of proactive tobacco cessation interventions in groups of cancer survivors at high risk of tobacco use identified can inform the development of tobacco cessation services in cancer survivorship plans.

SIP 15-004 Utilizing Targeted Community Interventions to Increase Breast and Cervical Cancer Screening Among Muslim Women Provide the public health community (including clinicians) with culturally appropriate materials and strategies that are effective in serving Muslim women; provide evidence-based risk-reduction messages and strategies for increasing breast and cervical cancer screening among Muslim women; and increase public health capacity of community health workers to serve as healthcare navigators for Muslim communities.

SIP 15-005 Economic Costs of Quality Assurance in Lung Cancer Screening Programs Provide an economic conceptual model that can be applied in multiple practice settings, for the costs of implementing and maintaining quality assurance and medical outcomes audit programs for lung cancer screening with low dose computed tomography (LDCT).

SIP 15-006 Building Local Community Health Leadership for Action on Preventing Chronic Disease Increase the knowledge, skills, attitudes, perceptions, and a leadership capacity of participants to mitigate the negative effects of social determinates of health to achieve community-wide outcomes and impact.

SIP 15-007 HPV Vaccine Impact among Men who have Sex with Men (MSM) Understanding of the impact of HPV vaccine among young men who have sex with men (MSM), and the prevalence of oral, anal, and serologic HPV infections among MSM aged 18-26 years, can inform policy decisions for HPV vaccination and assist in the development of new policy. Increasing knowledge of HPV-associated diseases and uptake of HPV vaccine among MSM aged 18-26 years knowledge of HPV-associated diseases and uptake of HPV vaccine among MSM aged 18-26 years can reduce the risk of HPV associated cancers in this population.

SIP 15-008 Mycoplasma genitalium Among Men with Non-gonococcal Urethritis (NGU) Attending STD Clinics in the US These findings from this project will have important implications for screening and treatment recommendations of M. genitalium infections in the United States.

SIP 15-009 Serosorting and Other Seroadaptive Behaviors Among Men Who Have Sex With Men (MSM) in the US-designing a Brief Survey Tool for Use in Clinical Practice This survey tool will enable clinical providers and DIS to quickly and accurately determine seroadaptive behaviors and practices among MSM patients and provide targeted and tailored HIV prevention messaging and risk-reduction strategies.

SIP 15-010 Planning, Implementing and Evaluating Physical Activity and Public Health Training Courses Build a well-trained group of researchers and practitioners that can advance the field of physical activity and CDC’s mission by increasing public awareness and knowledge about the importance of physical activity, and increasing physically active behaviors among the general population.

SIP 15-011 Implementation and Evaluation of a Mall Walking Program Increase access to mall walking programs in a community or neighborhood without an existing program, and determine the costs, barriers and facilitating factors associated with implementation of mall walking programs.

References

1. Health Promotion and Disease Prevention Amendments of 1984, Pub. L. no. 98-551, 98 Stat. 2815,October 30, 1984. Available at: http://history.nih.gov/research/downloads/PL98-551.pdf. Accessed March 1, 2013.

2. National Center for Chronic Disease Prevention and Health Promotion, Prevention ResearchCenters At-a-Glance 2011. Centers for Disease Control and Prevention Website. http://www.cdc.gov/chronicdisease/resources/publications/aag/prc.htm. Accessed March 1, 2013.

3. Topics and Objectives Index. Healthy People 2020 Website.http://www.healthypeople.gov/2020/topicsobjectives2020/default.aspx. Accessed March 1, 2013.

4. National Prevention Strategy: America's Plan for Better Health and Wellness. Centers for Disease Controland Prevention Website. http://www.cdc.gov/features/preventionstrategy/. Accessed March 1, 2013.

5. Winnable Battles. Centers for Disease Control and Prevention Website. http://www.cdc.gov/winnablebattles/. Accessed March 1, 2013

Relevant Work

2. Approach The experimental approach and research objectives for each SIP are detailed in the individual descriptions contained in Section IX. Special Interest Project Descriptions of this announcement.

Objectives/Outcomes Target Population Collaboration/Partnerships Evaluation/Performance Measurement Translation Plan Section II. Award Information

scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. 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: $1,975,000 Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications. The CDC intends to commit a total of approximately $4,300,000 (direct and indirect) for the entire project period (09/30/2015 to 09/29/2019).

In 2015 the CDC intends to commit a total of approximately $1,975,000 (direct and indirect). The SIPs addressing Nutrition, Physical Activity, and Obesity (NPAO) are financed by 2015 Prevention and Public Health Funds. Anticipated number of awards is 11.

SIP 15-001 Integrating Self-Management Education with Cancer Survivorship Care Planning It is anticipated that approximately $825,000 is available to fund 1 Prevention Research Center(s) for the 3-year project period. The average award for the recipient is expected to be approximately $275,000. Funding may vary and is subject to change. The year one ceiling is $275,000.

SIP 15-002 Economic Impact of Clinical Trials Among Children Diagnosed with Cancer It is anticipated that approximately $250,000 is available to fund 1 Prevention Research Center for the 2-year project period. The average award for the recipient is expected to be approximately $125,000. Funding may vary and is subject to change. The year one ceiling is $125,000.

SIP 15-003 Using Cancer Registry Data to Promote Proactive Tobacco Cessation among Adult Cancer Survivors It is anticipated that approximately $600,000 is available to fund 1 Prevention Research Center(s) for the 3-year project period. The average award for the recipient is expected to be approximately $200,000 for FY2015, $250,000 for FY2016, and $150,000 for FY2017. Funding may vary and is subject to change. The year one ceiling is $200,000.

SIP 15-004 Utilizing a Targeted Media Campaign and Community Health Workers to Increase Breast and Cervical Cancer Screening Among Muslim Women It is anticipated that approximately $500,000 is available to fund 1 Prevention Research Center for the 3-year project period. The average award for the recipient is expected to be approximately $100, 000 for year one, $150,000 for year two, and $250,000 for year three. Funding may vary and is subject to change. The year one ceiling is $100,000.

SIP 15-005 Economic Costs of Quality Assurance in Lung Cancer Screening Programs It is anticipated that approximately $250,000 is available to fund 1 Prevention Research Center for the 1-year project period. The award for the recipient is expected to be approximately $250,000. Funding may vary and is subject to change. The year one ceiling is $250,000.

SIP 15-006 Building Local Community Health Leadership for Action on Preventing Chronic Disease It is anticipated that approximately $300,000 is available to fund 1 Prevention Research Center for the 2-year project period. The award for the recipient is expected to be approximately $150,000. Funding may vary and is subject to change. The year one ceiling is $150,000.

SIP 15-007 HPV Vaccine Impact among Men who have Sex with Men (MSM) It is anticipated that approximately $660,000 will be available to fund 1 Prevention Research Center for the 2-year project period. The average award for the recipient is expected to be approximately $280,000. Funding may vary and is subject to change. The year one ceiling is $330,000.

SIP 15-008 Mycoplasma Genitalium Among Men With Non-gonococcal Urethritis (NGU) Attending STD Clinics in the US It is anticipated that approximately $375,000 is available to fund 1 Prevention Research Center for the 2 year project period. The average award for the recipient is expected to be approximately $225,000 for the first year and $150,000 for the second year. Funding may vary and is subject to change. The year one ceiling is $250,000.

SIP 15-009 Serosorting and Other Seroadaptive Behaviors Among Men Who Have Sex With Men (MSM) in the US-designing a Brief Survey Tool for Use in Clinical Practice It is anticipated that approximately $225,000 is available to fund 1 Prevention Research Center(s) for the 1-year project period. The average award for the recipient is expected to be approximately $225,000. Funding may vary and is subject to change. The year one ceiling is $225,000.

SIP 15-010 Planning, Implementing and Evaluating Physical Activity and Public Health Training Courses It is anticipated that approximately $400,000 is available to fund 1 Prevention Research Center for the 4-year project period. Year 1 and Year 3 funding will be approximately $150,000 to support planning and delivery of the courses, Year 2 and Year 4 funding will be approximately $50,000 to support evaluation and course assessment, and close out of course delivery. Funding may vary and is subject to change. The Year one ceiling is $150,000.

SIP 15-011 Implementation and Evaluation of a Mall Walking Program It is anticipated that approximately $200,000 is available to fund 1 Prevention Research Center for the 2-year project period. The average award for the recipient is expected to be approximately $100,000 - $150,000. Funding may vary and is subject to change.The year one ceiling is $150,000. Note: Any purchase of equipment will need to be returned to CDC at the conclusion of the study.

Funding may vary and is subject to change.

Awards issued under this FOA are contingent upon the availability of funds and submission of a sufficient number of meritorious applications. The total number of awards will depend upon the quality, duration, and costs of the applications received. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award may vary.

Funding varies by SIP and a range of $100,000 to $275,000 (total costs); amount that you will not exceed. This ceiling is for the first 12-month project period. Ceilings for individual SIPs are noted above.

Anticipated Number of Awards: 11 Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

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/sites/default/files/grants/grants/policies-regulations/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: Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

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

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

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Only applicants funded as PRCs under CDC Program Announcement DP14-001 are eligible to compete for Special Interest Projects (SIPS) supplemental funding. Competition is limited to Prevention Research Centers funded under CDC Program Announcement DP14-001 because they are uniquely positioned to perform, oversee, and coordinate applied public health research that promotes the field of health promotion and chronic disease prevention research due to their established relationships with community partners.

4. Justification for Less than Maximum Competition Competition is limited to Prevention Research Centers funded under CDC Program Announcement DP14-001 because they are uniquely positioned to perform, oversee, and coordinate applied public health research that promotes the field of health promotion and chronic disease prevention research due to their established relationships with community.

5. Responsiveness An application will be responsive if it meets the following requirements:

Complies with items 1, 2, 3, and 10 of this section (see Section III. Eligibility Information). The budget for the application Budget Year does not exceed the ceiling amount for the specific SIP (see Section II. Award Information).

Unresponsive applications will not be entered into the review process. You will be notified that your 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.

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/sites/default/files/grants/grants/policies-regulations/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.

Only applicants affiliated with institutions funded as PRCs under CDCProgram Announcement DP14-001 are eligible to compete for Special Interest Projects (SIPs) supplemental funding. A Prevention Research Center may apply for multiple SIPs; however, a separate application must be submitted for each SIP. A PRC may submit only one application per SIP.

Although the financial plans of the CDC provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

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 Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern 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.

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.

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. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm Do not include “hyperlinks” in any part of your submission, as they do not show when the application is uploaded into Grants.gov.

Separate Application Submissions Required Applicants must submit a separate application package for each selected Special Interest Project (SIP) through www.Grants.Gov, including pertinent, required PDF attachments.

SF424 Research and Related (R&R) Face Page Form Instructions for completing the SF424 Research and Related (R&R) Face Page form are provided in the SF424 (R&R) Application Guide. In addition, applicants must complete four fields on the Face Page as follows:

Field # 4.a. (Federal Identifier): Enter the 8-character, alpha-numeric portion only of your organization’s grant number (located on the Notice of Grant Award). Example: DP001234 (Do not enter spaces or other characters in this field).

Field # 4.b. (Agency Routing Identifier): Enter the SIP Project Number (for example, SIP 11-040) and a descriptive title for the SIP. Field 4.b. will accommodate a maximum of 75 characters.

Field # 8 (Type of Application): Select “New” only for each submission.

Field # 11 (Descriptive Title of Applicant’s Project): Applicants must enter the exact project title as used in their original PRC application (including spacing and punctuation). The original PRC title can be found on the Notice of Award.

These responses are necessary for SIP applications to be submitted and processed electronically. If your application is incomplete or non-responsive to these four requirements, it will not be processed timely.

3. Letter of Intent Due Date for Letter of Intent: 03/06/2015 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions SIP number and title of SIP proposal The letter of intent should be sent to:

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 30342 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 Subjects7. Inclusion of Women and Minorities 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.

The Research Plan narrative is comprised of components 2 and 3 above. Note that the Research Strategy is divided into three parts: 1) Significance, 2) Innovation, and 3) Approach.

A research plan for each SIP is located in Section IX Special Interest Project Descriptions.

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 12 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 Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123). Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant 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).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center ( 1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact TIMS at 770-488-2700; ogstims@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless ofrejection or success).

a. If the status states “rejected,” do #2a or #2b.

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA(pgotim@cdc.gov) explaining why the submission failed. b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 09/30/2016 Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

11. Funding Restrictions Applicants are advised that any activities involving standard information collection (i.e., surveys, questionnaires, data requests, etc.) from 10 or more non-federal individuals/entities are subject to Paperwork Reduction Act (PRA) requirements and may require the CDC to coordinate an OMB/PRA approval request.

General FY 15 Appropriations Act Provisions HHS recipients must comply with all terms and conditions outlined in their grant award, including grant policy terms and conditions contained in applicable Department of Health and Human Services (HHS) Grant Policy Statements, requirements imposed by program statutes and regulations, and HHS grant administration regulations, as applicable; as well as any requirements or limitations in any applicable appropriations acts.

Consolidated Appropriations Act: General Provisions Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act

Cap on Researchers Salaries Section 203: None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II.

Gun Control Prohibition Section 217: None of the funds made available in this title may be used, in whole or in part, to advocate or promote gun control.

Prevention and Public Health Fund Reporting Requirements SEC. 218:

(a) The Secretary shall establish a publicly accessible Web site to provide information regarding the uses offunds made available under section 4002 of the Patient Protection and Affordable Care Act of 2010 (‘‘ACA’’).

(b) With respect to funds provided under section 4002 of the ACA, the Secretary shall include on theWebsite established under subsection (a) at a minimum the following information:

(1) In the case of each transfer of funds under section 4002(c), a statement indicating the program or activityreceiving funds, the operating division or office that will administer the funds, and the planned uses of the funds, to be posted not later than the day after the transfer is made.

(2) Identification (along with a link to the full text) of each funding opportunity announcement, request forproposals, or other announcement or solicitation of proposals for grants, cooperative agreements, or contracts intended to be awarded using such funds, to be posted not later than the day after the announcement or solicitation is issued.

(3) Identification of each grant, cooperative agreement, or contract with a value of $25,000 or more awardedusing such funds, including the purpose of the award and the identity of the recipient, to be posted not later than 5 days after the award is made.

(4) A report detailing the uses of all funds transferred under section 4002(c) during the fiscal year, to beposted not later than 90 days after the end of the fiscal year.

(c) With respect to awards made in fiscal years 2013 through 2015, the Secretary shall also include on theWebsite established under…