RFA-DP-19-006 02 20 19 FINAL A.pdf

Centers for Disease Control

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

Health Promotion and Disease Prevention Research Centers: 2019 Special Interest Project Competitive Supplements (SIPS)

RFA-DP-19-006

Application Due Date: 02/26/2019

Health Promotion and Disease Prevention Research Centers: 2019 Special Interest Project Competitive Supplements (SIPS)

RFA-DP-19-006

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 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) Notice of Funding Opportunity (NOFO) Title Health Promotion and Disease Prevention Research Centers: 2019 Special Interest Project Competitive Supplements (SIPS) Activity Code U48 Amendment 1:

* Questions from Potential Applicants and CDC Responses added to Section VIII. Other Information.

Amendment 2: Application updates Page 4,15,22 of 120

Notice of Funding Opportunity Type Reissue of DP19-001 Agency Notice of Funding Opportunity Number

RFA-DP-19-006

Assistance Listings (CFDA) Number(s) 93.135 Category of Funding Activity:

Health NOFO Purpose This NOFO will provide supplemental funding to Prevention Research Centers (PRCs) to conduct Special Interest Projects (SIPs) to design, test, evaluate, disseminate, and translate effective applied public health prevention research strategies to include interventions (i.e.

programs, practices, policies, or strategies) and tools developed in real-world settings to address the leading causes of illness, disability, and death in the United States. Research strategies align with public health priorities such as the Healthy People 2020 topic areas: Aging, Dementias and Alzheimer's Disease; Epilepsy; Cancer; Nutrition and Physical Activity; and Substance Abuse - Alcohol.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-19-006, 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 https://www.grants.gov

Letter of Intent Due Date:

Application Due Date:

needed for this service.

01/21/2019

02/26/2019

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

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time 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: 05/01/2019

Secondary Review: 06/03/2019

Estimated Start Date: 09/30/2019

Expiration Date:

Due Dates for E.O. 12372:

02/27/2019 Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf 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 (See Part 2, Section IV, 7. Page Limitations).

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

A link to this NOFO will be available at https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm

Executive Summary

Purpose. Public health practioners need scalable, feasible intervention and tools.

Applied public health prevention researchers can engage communities to develop and evaluate health promotion and disease prevention interventions, disseminate new science, and translate proven effective interventions into public health practice and policy for population health benefit. This NOFO will provide supplemental funding to Prevention Research Centers (PRCs) to conduct Special Interest Projects (SIPs) to design, test, evaluate, disseminate, and translate effective applied public health prevention research interventions (i.e. programs, practices, policies, or strategies) and tools developed in real-world settings that address the leading causes of illness, disability, and death in the United States.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. The estimated total level of funding (direct and indirect for entire project period in dollars) that is available for the NOFO is $32,725,000. The estimated total funding (direct and indirect) for the first year (12 month budget period for all SIP proposals is $7,095,000. It is anticipated that up to 24 awards will be made. Awards issued under this NOFO 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.

o Budget and Project Period. The estimated total funding (direct and indirect) for the first 12 month budget period, 9/30/2019 - 9/29/2020, is $7,095,000. The estimated total funding (direct and indirect) for the entire project period, 9/30/2019 to 9/29/2024, is $32,725,000.

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.A.

are eligible to apply.

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A

• 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 only 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.The PI may be different from the prime grant (DP19-001) as long as the PI is registered in eRA Commons, and the application is submitted by an eligible institution (normally identified by a unique DUNS number).

• Number of Applications. Applicants may apply to more than one SIP; however, a separate application is required for each SIP.

• Application Type. New

• Special Date(s).Informational conference calls for eligible applicants:

o January 10, 2019, 2:00-4pm EST; webinar link/conference number/participant code information will be provided at a later date.

o Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1-888-232-6348.

• Application Materials. See Section IV.1 for application materials. Please note that Form D is to be used when downloading the application package. http://grants.nih.gov/grants / how-to-apply-application-guide/forms-d/general-forms-d.pdf%20

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 1706 of the Public Health Service Act, as amended, 42 U.S.C. 300u-5, academic health centers, as defined in 42 U.S.C 300u-5(d) and Section 799B, as amended 42 U.S.C 295p.

1. Background and Purpose 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 faculty 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. The PRCs also serve as demonstration sites for the use of new and innovative applied public research and activities for disease prevention and health promotion.

CDC administers the PRC Program and provides leadership, technical assistance, and oversight.

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 http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 their applied public health research activities.

The purpose of the PRC program's SIP mechanism is to support supplemental projects in health promotion and disease prevention research. A major focus of this supplemental funding program is to design, test, evaluate, translate and/or disseminate effective applied public health prevention research strategies. The SIP mechanism, created in 1993, allows the PRCs to compete for research projects sponsored by CDC organizational units and other HHS agencies.

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.

Healthy People 2020 and other National Strategic Priorities This NOFO supports efforts that align with the following public health priorities:

Healthy People 2020

Social Determinants of Health: economic stability; education; social and community context; health and health care, neighborhood and built environment.

Health topics: cancer, dementia including Alzheimer's disease; disability and health (includes epilepsy); educational and community based programs; health-related quality of life and well-being; nutrition and weight status; older adults; physical activity;

sexually transmitted disease; substance abuse - alcohol.

CDC's Health Impact in 5 Years (HI-5) Initiative

Interventions addressing the social determinants of health, and interventions changing the context. https://www.cdc.gov /policy/hst/hi5/interventions/index.html.

National Center for Chronic Disease Prevention and Health Promotion's Four Domains of Chronic Disease Prevention -

Domain 1: epidemiology and surveillance;

Domain 2: environmental approaches that promote health and support and reinforce healthful behaviors;

Domain 3: health system interventions to improve the effective delivery and use of clinical and other preventive services; and Domain 4: strategies to improve community-clinical linkages.

https://www.cdc.gov/chronicdisease/resources/publications/four-domains.htm.

This NOFO is expected to fund research that will focus on developing and evaluating the evidence for strategies that improve population health outcomes. Information on specific Healthy People 2020 and other National Strategic Priorities are described for each Special Interest Projects in Section IX. Special Interests Project Descriptions. This NOFO includes the Healthy People 2020 topic areas of Healthy Aging, Dementias and Alzheimer's Disease;

Epilepsy; Cancer; Nutrition, Obesity, and Physical Activity. The following are the current SIPs and associated topic areas:

Healthy Aging, Dementias and Alzheimer's Disease: 19-001 Epilepsy: 19-002, 19-003 Cancer Prevention and Care: 19-004, 19-005, 19-006, 19-007, 19-008, 19-009 Nutrition, Obesity, and Physical Activity: 19-010, 19-011 Substance Abuse - Alcohol: 19-012

Public Health Impact Accomplishing the objectives of these projects will result in improvements in the delivery and outcomes of public health programs and practice:

SIP 19-001. Improving Cognitive Impairment Detection and Referral to Resources among Older Adults: Applying the KAER Model in a Clinical Health Care System This project will conduct research in which the project findings may help to inform future health care system approaches towards better detection and diagnosis of cognitive impairment among older adults. These findings can be used to improve care management for people with cognitive impairment and connect those people with a cognitive impairment and their families with available resources.

SIP 19-002. Managing Epilepsy Well 2.0 (MEW) Network - Coordinating Center This project will support and conduct epilepsy self-management intervention research and dissemination. The Coordinating Center will lead activities to foster collaboration across, and evaluate the impact of multiple MEW Network Collaborating Centers engaged in conducting replication studies of epilepsy self-management programs. Additionally, the Coordinating Center will lead partnerships with epilepsy and chronic disease stakeholders to raise awareness of epilepsy self-management strategies and program, and lead public awareness and dissemination strategies for the MEW Network programs and resources.

SIP 19-003. Managing Epilepsy Well 2.0 (MEW) Network - Collaborating Center More effectiveness studies of epilepsy self-management programs are essential prior to widespread program adoption by health care providers or community-based providers. The project will fund the Managing Epilepsy Well Network Collaborating Centers to conduct replication studies and related research to increase the evidence of CDC Managing Epilepsy

Well (MEW) Network epilepsy self-management programs.

SIP 19-004. Cancer Prevention and Control Research Network Coordinating Center This project will coordinate the efforts of the Cancer Prevention and Control Research Network (CPCRN), a national network of academic, public health, and community partners that work together, with the ultimate goal to reduce the burden of cancer, especially among those disproportionately affected. The project will support a coordinating center that will facilitate collaborative research and network discussions related to the development of research expertise in the application of proven cancer prevention and control interventions, SIP 19-005. Cancer Prevention and Control Research Network Collaborating Center This project will fund the Cancer Prevention and Control Research Network, a national network of academic, public health, and community partners that work together to conduct community engaged research, with the ultimate goal to reduce the burden of cancer, especially among those disproportionately affected.

SIP 19-006. Evaluating Community Clinical Linkage Interventions in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) This project will evaluate the implementation, effectiveness, costs, cost-effectiveness, and potential scalability of CCL interventions. If found effective, these interventions can be scaled to increase screening among underserved women who are traditionally hard-to-reach and not accessing primary care services. Expanding effective and cost-effective CCL interventions nationally will increase the overall reach and impact of the NBCCEDP.

SIP 19-007. Improving cancer survivor treatment and outcomes by ensuring appropriate emergency/acute care treatment This project seeks to improve care and outcomes among all US cancer survivors by providing an evaluation of implementation practices for reducing hospital related infections among survivors, and improving overall care for survivors. This will translate into increasing the length and quality of life among all US men and women with cancer. This results of this project will enable recipients of the National Comprehensive Cancer Control Program actively engaged in survivorship work (i.e., to improve improving care and outcomes) to engage with medical organizations who serve clinical providers treating cancer survivors and educate and raise awareness for recommended activities related to reducing and/or informing avoidable and unavoidable acute care.

SIP 19-008. Feasibility Testing of a Model Cancer Surveillance Report Using Electronic Health Record Data The project will demonstrate the feasibility of a model cancer surveillance report on performance measures that state and CDC cancer prevention and control programs could use to plan interventions to improve cancer prevention and control.

SIP 19-009. Assessing the Lifetime Economic Burden in Men with Metastatic Prostate Cancer, including Pain Management The results of this project will provide information to understand the full economic impact of mPC in different life stages on the society, health care system, patient, and their family. Further, economic data would also provide information to decision makers on costs related to palliative care, psychological support, other forms of symptom management, pain management, and therapeutic interventions to treat mPC. In addition, by using mathematical modeling, results can provide policy-makers with needed evidence about the expected future burden of mPC in the U.S. from 2020 to 2030 by life stage and race/ethnicity. The results of this study will provide public health policymakers with new insights about the future trajectory of mPC resource use and cost, and how this might differ for patients across life stages and in different racial/ethnic groups. Findings can thereby inform the development of interventions, outreach programs, or other actions targeted to addressing drivers of mPC morbidity, mortality, and cost specific to life stage and race/ethnicity. Further, by using mathematical modeling to evaluate the cost-effectiveness of new treatments for mPC, the value of new treatments by life stage and by race/ethnicity for prostate cancer cancer survivors can be assessed.

SIP 19-010. Nutrition and Obesity Policy Research and Evaluation Network (NOPREN) This project seeks to conduct a research study for nutrition and obesity policy research and evaluation addressing food insecurity. It will build the evidence base for effective policy implementation components to prevent obesity and improve nutrition for all Americans, informs high impact, scalable and cost-effective strategies for preventing obesity and improving nutrition and reducing health and societal costs associated with overweight and obesity. It will also provide a framework and platform to communicate and disseminate research findings related to nutrition and obesity that can lead to policy, systems or environmental changes and more rapidly move evidence into intervention programs, shortening time from science to service in real world settings.

SIP 19-011. Physical Activity Policy Research and Evaluation Network (PAPREN) This project will inform high impact, scalable and cost-effective strategies for increasing population levels of physical activity and reducing health and societal costs associated with inadequate levels of physical activity. The Coordinating Center will conduct physical activity research. It will also provide a framework and platform to communicate and disseminate research findings related to physical activity that can lead to policy, systems or environmental changes and more rapidly move evidence into intervention programs, shortening time from science to service in real world settings.

SIP 19-012. Supporting and Evaluating Initiatives to Prevent Overservice of Alcohol The proposed research would broaden the scientific base regarding the effectiveness of varying approaches to preventing overservice or overservice enforcement to reduce binge drinking and related harms.

Relevant Work As appropriate, this information will be provided for each SIP in the individual descriptions contained in Section IX. Special Interests Project Descriptions of this announcement.

2. Approach As appropriate, the information that follows (up to Section II. Award Information) will be provided for each SIP in the individual descriptions contained in Section IX.

Special Interests Project Descriptions of this announcement to include:

Objectives/Outcomes Public Health Priorities Target Population Collaboration/Partnerships Recruitment Plan Annual Action Plan Evaluation*/Performance Measurement Dissemination Plan Translation Plan

SIP recipients may be asked to participate in the PRC Program Evaluation Reporting System (PERS) to collect data that are used to evaluate Special Interest Projects.

References:

References for individual SIPS can be found in the Section IX. Special Interest Project Descriptions.

Objectives/Outcomes See individual SIPS in the Section IX. Special Interest Project for detailed information.

Target Population See individual SIPS in the Section IX. Special Interest Project for detailed information.

Collaboration/Partnerships See individual SIPS in the Section IX. Special Interest Project for detailed information.

Evaluation/Performance Measurement

See individual SIPS in the Section IX. Special Interest Project for detailed information.

Translation Plan See individual SIPS in the Section IX. Special Interest Project for detailed information.

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.

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: $32,725,000

Anticipated Number of Awards: 24

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

Award Ceiling: $7,095,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, 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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Public and State controlled institutions of higher education Private institutions of higher education http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

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

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 organizations meeting the following characteristics are eligible to apply for Special Interest Projects (SIP) supplemental funding:

Applicants currently funded under CDC PRC Program Notice of Funding Opportunity RFA- DP-19-001 are eligible to compete for SIP supplemental funding. Competition is limited to PRCs funded under RFA-DP-19-001 because they are uniquely positioned to perform, oversee, and coordinate applied public health promotion and chronic disease prevention research due to their established relationships with community partners.

For an applicant to be even considered they must be responsive to the information here.

Special eligibility requirement(s) may apply to each SIP proposal (see Section IX. Special Interest Project Descriptions).

If an application is incomplete or does not meet the responsiveness criteria in the special eligibility requirements listed in this section, it will be deemed non-responsive and will not enter into the peer review process.

4. Justification for Less than Maximum Competition Competition is limited to recipients funded under RFA-DP-19-001 because they are uniquely positioned to perform, oversee, and coordinate applied public health promotion and chronic disease prevention research due to their established relationships with community partners.

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 application’s budget for the first 12 months does not exceed the ceiling amount for the specific SIP (see Section II. Award Information).

If an application is incomplete or does not meet these requirements, it will be considered nonresponsive and will not enter into the peer review process.

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/.

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 Principle Investigator (PD/PI) 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 eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons 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 https://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 https://www.grants.gov

Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

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 recipient 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 recipient 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/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity 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 http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only applicants funded as a PRC under CDC RFA-DP-19-001 are eligible to compete for Special Interest Projects (SIPs) supplemental funding.

Only one SIP application is permitted per PRC institution (normally identified by a unique DUNS number).

As defined in the HHS Grants Policy Statement, (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet .html), 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 NOFO 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 In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf, except where instructed in this Notice of Funding Opportunity 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 package associated with this NOFO includes all applicable mandatory and optional forms.

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

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Duplication of Effort Applicants are responsible for reporting if this application will result in programmatic, http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

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.

SF 424 Research & 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 11040) 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. An introduction is not required.

• Field # 11 (Descriptive Title of Applicant’s Project): Applicants must enter the title of their SIP application. If an applicant selects NEW on #8 (Type of Application) of the RR SF424 Cover Page, as Introduction file in the Research Plan is not required.

• These responses are necessary for SIP applications to be submitted and processed electronically. If your application is incomplete or non-responsive to these four http://www.grants.gov/ requirements, it will not be processed. NOTE: These special instructions have been changed for this announcement. Please read carefully and include these required changes in your application.

3. Letter of Intent Due Date for Letter of Intent: 01/21/2019 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 above and in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant SIP number and title Descriptive title of proposed SIP research project Name, address, and telephone number of the Lead SIP PD/PI Name, address, and telephone number of the PRC PD/PI Names of other key personnel Participating institutions Number and title of this funding opportunity: RFA-DP-19-006, Health Promotion and

Disease Prevention Research Centers 2019 Supplemental Special Interest Projects

(SIPS)

The letter of intent should be sent electronically to:

Natalie Darling Scientific Program Official Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Highway, NE Mailstop F-80 Atlanta, GA 30342 Telephone: (770)-488-5740 Email: ndh6@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

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 components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/generalforms-e.pdf and https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, 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 NOFO.

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 time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here:

https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

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 (R&R) Application Guide unless otherwise specified in the FOA. All instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf must be followed along with any additional instructions provided in the FOA.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

Descriptions of the data to be produced in the proposed project How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights) Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified

Examples of DMPs may be found here: University of California https://dmp.cdlib.org , or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php

RESEARCH PLAN

The applicant’s research plan should address activities that will be conducted over the entire project period. 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.

Research Plan components for each SIP are listed in Section IX. Special Interest Project Descriptions of this NOFO. The performance period of one to five years for each SIP is also specified in Section IX.

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 NOFO must be followed. For this specific NOFO, 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 30 pages for all appendices.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application.