RFA-DP-21-004.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Health Promotion and Disease Prevention Research Centers: 2021 Special Interest Project

Competitive Supplements (SIPS)

RFA-DP-21-004

Application Due Date: 02/24/2021

Health Promotion and Disease Prevention Research Centers: 2021 Special Interest Project

Competitive Supplements (SIPS)

RFA-DP-21-004

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Health Promotion and Disease Prevention Research Centers: 2021 Special Interest Project Competitive Supplements (SIPS) Activity Code U48

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-DP-21-004

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), currently funded under RFA-DP-19-001, 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 2030 topic areas: Adolescent Health, Arthritis, Cancer Prevention and Care, Drug and Alcohol Use, Maternal, Infant and Child Health, Mental Health and Mental Disorders, Physical Activity, and Health care access and quality.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-21-004, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/25/2021

Application Due Date: 02/24/2021 https://www.grants.gov

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: 04/09/2021

Secondary Review: 05/14/2021

Estimated Start Date: 09/30/2021

Expiration Date: 02/25/2021 Due Dates for E.O. 12372: 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 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.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

Executive Summary

Purpose. Public health practitioners need scalable, feasible interventions 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), currently funded under RFA-DP-19-001, 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 2030 topic areas: Adolescent Health, Arthritis, Cancer Prevention and Care, Drug and Alcohol Use, Maternal, Infant and Child Health, Mental Health and Mental Disorders, Physical Activity, and Health care access and quality.

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 $9,080,000. The estimated total funding (direct and indirect) for the first year (12 month budget period for all SIP proposals is $3,710,000. It is anticipated that up to 12 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 o Budget and Project Period. The estimated total funding (direct and indirect) for the first 12 month budget period, 9/30/2021 - 9/29/2022, is $3,710,000. The estimated total funding (direct and indirect) for the entire project period, 9/30/2021 to 9/29/2024, is $9,080,000. See section Section VIII. Other Information - Special Interests Project Descriptions for the funding amount and project period for each individual SIP.

o 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.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A 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.

Number of Applications. Applicants may apply to more than one SIP; however, a separate application is required for each SIP. Multiple applications for the same SIP from the same institution are not permitted (eg, only one application per SIP per institution is allowed).

Application Type. New Special Date(s). Pre-Application Informational Call is scheduled for January 14, 2021;

1:30-3:30pm. Call-in information to be provided.

Application Materials. See Section IV.1 for application materials. Please note that

Form F is to be used when downloading the application package, https://grants.nih.gov /grants/how-to-apply-application-guide/forms-f/research-forms-f.pdf

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 CDC Prevention Research Centers (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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/research-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/research-forms-f.pdf 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 2030 and other National Strategic Priorities This NOFO supports efforts that align with the following public health priorities:

Healthy People 2030

Social Determinants of Health: health care access and quality Health topics: adolescent health, arthritis, cancer, drug and alcohol use; maternal, infant, and child health, mental health and mental disorders, physical activity, and health care access and quality

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 care system interventions; and Domain 4: community programs linked to clinical services o https://www.cdc.gov/chronicdisease/center/nccdphp/how.htm

The following are the current SIPs and associated topic areas:

Adolescent Health: 21-001 Alcohol Use: 21-002 Arthritis: 21-003 https://www.cdc.gov/policy/hst/hi5/interventions/index.html

Cancer Prevention and Care: 21-004, 21-005, 21-006 Epilepsy: 21-007 Lupus: 21-008 Maternal, Infant and Child Health: 21-009 Health Care Access and Quality: 21-010

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 21-001: Integrating social emotional well being w/ physical activity & nutrition practices in school-based out-of-school time (OST) programs: a demonstration project.

This project will contribute to findings on the feasibility, appeal, and effectiveness of an integrated approach (i.e. offering physical activity and serving foods in ways that support social-emotional climate and learning, SEL/SEC). Findings will increase the understanding of the social and emotional competencies and skills that guide youth?s relationships with themselves and the influence of these competencies and skills on academic engagement and achievement as well as health behaviors and outcomes. If this approach is found to be effective, efforts to bring it to scale could benefit the millions of youth who participate in OST programming.

SIP 21-002: Examining Contexts of Alcohol Availability and Accessibility This project will contribute findings on how the context of alcohol availability or aspects of the delivery of alcoholic beverages impacts excessive drinking and related harms. This will inform state and local public health options for regulating the availability of alcohol to create healthier communities.

SIP 21-003: Evaluating alternative delivery models for arthritis-appropriate evidence-based physical activity and self-management interventions With the 2020 COVID-19 pandemic, arthritis-appropriate evidence-based programs (AAEBIs) are being redesigned to overcome barriers imposed by social distancing and shelter in place.

These interventions are largely being delivered online which may be barrier to some adults with arthritis, especially those with poor physical and mental health outcomes. This project will 1) identify strategies for recruitment and retention of hard to reach populations to AAEBIs; and 2) assess whether there is sufficient evidence for wide-scale dissemination of packaged AAEBIs delivered in alternative modes. These results will advance AAEBI dissemination even in the absence of the COVID-19 epidemic.

SIP 21-004: Development, Evaluation and Dissemination of an Evidence-Based Intervention to Increase Sun Safety among Outdoor Workers This project will investigate strategies to implement sun safety interventions among underserved and understudied work sectors. This can contribute to the increase in the availability and implementation of evidence-based interventions to improve sun safety and reduce ultraviolet (UV) exposure among underserved and understudied sectors of outdoor workers.

SIP 21-005: Feasibility of a Model Cancer Screening Surveillance Report Using All-Payer Claims Data This project will demonstrate the feasibility of a model cancer screening surveillance report that uses data from an all-payer claim database (APCD). The model cancer screening surveillance report could provide an applied prevention research tool to improve public health practice in communities with disparities in cancer screening. If successful, the model surveillance report could be used by state cancer programs and their stakeholders to plan and evaluate health system, clinic, and community interventions to improve cancer screening.

SIP 21-006: Increasing Genetic Counseling Referrals Among Patients At-Risk for BRCA- Associated Cancers The purpose of this project is to increase appropriate referrals to genetic counseling for those patients who have a family cancer history or a mutation probability score (based on a risk algorithm) and assess if system-level interventions to increase access address racial/ethnic disparities in referral and utilization of cancer genetic services. It is expected that with the implementation of evidence-based changes at the health care system level,?such as automated referrals, electronic health record (EHR) enhancements, and changes in clinical processes,?this project will improve the timely identification and referral of patients at high risk for BRCA-related cancers to genetic counseling.

SIP 21-007: Epilepsy incidence and etiology: important information for public health prevention and health promotion in the US community This project will inform incidence and social determinants of epilepsy including risk factors and protective factors that affect epilepsy incidence. Information about epilepsy incidence (any types from all ages) and related risk and protective factors from large, population representative pediatric and/or adult epilepsy data in the U.S. will provide invaluable information for academic researchers, advocacy groups, and other government agencies to help better guide interventions or services for preventing epilepsy, treating and rehabilitating people with epilepsy, and minimizing their health disparities and adverse outcomes.

SIP 21-008: Examining approaches to improve care and management of people with lupus This project will inform prevention research topics that can improve care and management of adults with lupus. The proposed research will improve understanding of how psychosocial characteristics, physical activity, counseling for physical activity, and self-management may impact lupus outcomes. Public health professionals can use these findings to develop approaches to potentially intervene and improve outcomes among adults with lupus.

SIP 21-009: Mental Health of Mothers Study (MHOMS) and Substance Use Evaluation Network This project builds upon and extends the work funded by Division of Reproductive Health (DRH), Program in Support of Mom (PRISM, DP 15-005), that compares depression outcomes and treatment rates between the PRISM intervention (enhanced standard of care) and Massachusetts Child Psychiatry Access Program for Moms (MCPAP for Moms, i.e., usual care). The project provides information on how state perinatal psychiatric access programs impact treatment engagement and other individual-level maternal outcomes.

SIP 21-010: Engagement of Community Health Workers to Reduce Racial Discrimination and Improve Hypertension Management This project provides research evidence and validated indicators for community engagement with community health workers (CHWs) in order to reduce racial discrimination and improve the well being and management of hypertension (HTN) among racial and ethnic minority groups disproportionately affected by HTN.

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

2. Approach Specific information for the following is provided in Section VIII- Other Information - Special Interests Project Descriptions for each SIP:

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

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.

Objectives/Outcomes Specific information for each SIP is provided in Section VIII- Other Information - Special Interests Project Descriptions for each SIP.

Target Population Specific information for each SIP is provided in Section VIII- Other Information - Special Interests Project Descriptions for each SIP.

Collaboration/Partnerships Specific information for each SIP is provided in Section VIII- Other Information - Special Interests Project Descriptions for each SIP.

Evaluation/Performance Measurement Specific information for each SIP is provided in Section VIII- Other Information - Special

Interests Project Descriptions for each SIP.

Translation Plan Specific information for each SIP is provided in Section VIII- Other Information - Special Interests Project Descriptions for each SIP.

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: $9,080,000

Anticipated Number of Awards: 12 The anticipated number of awards for each SIP is shown in Section VIII. Other Information - Special Interests Project Descriptions of this announcement.

SIP funding will be awarded as a supplement to recipients currently funded under RFA-DP-19- 001.

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

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $3,785,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 3 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.

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Public and State controlled institutions of higher education Private institutions of higher education

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. Additional Information on Eligibility Competition is limited to the 26 institutions currently funded under CDC RFA-DP-19-001.

CDC Grant # PRC Recipient U48 DP006377 Emory University U48 DP006393 Georgia State University U48 DP006376 Harvard University U48 DP006384 Johns Hopkins University U48 DP006411 Morehouse School of Medicine U48 DP006396 New York University School of Medicine - CUNY U48 DP006404 University of Alabama, Birmingham

U48 DP006413 University of Arizona U48 DP006374 University of California, San Francisco U48 DP006399 University of Colorado, Denver U48 DP006392 University of Illinois, Chicago U48 DP006389 University of Iowa U48 DP006382 University of Maryland, College Park U48 DP006381 University of Massachusetts Medical School, Worcester U48 DP006397 University of Michigan, Ann Arbor U48 DP006414 University of Minnesota U48 DP006379 University of New Mexico U48 DP006400 University of North Carolina Chapel Hill U48 DP006394 University of Rochester U48 DP006401 University of South Carolina at Columbia U48 DP006408 University of Texas Houston U48 DP006398 University of Washington U48 DP006383 University of Wisconsin, Madison U48 DP006395 Washington University at St. Louis U48 DP006391 West Virginia University U48 DP006380 Yale University

The institution name, EIN, and DUNS of the SIP applicant must match the information of the institution funded under RFA-DP-19-001 as listed in the Notice of Award.

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 VIII. Other Information for 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

A SIP application will be responsive if it meets the following requirements:

Each SIP application, and SF 424 (R&R) must be submitted as a New Application (field 8) and must include the correct SIP number in Field 4.a (Federal Identifier), and the SIP Title Field 4.b (Agency Routing Identifier), as listed below and in Section VIII. Other Information - Special Interest Project Descriptions. In Box 4c. of the SF 424 (R&R), applicant must enter the currently funded PRC award number.

SIP 21-001: Integrating social emotional well being w/ physical activity & nutrition practices in school-based out-of-school time (OST) programs: a demonstration project.

SIP 21-002: Examining Contexts of Alcohol Availability and Accessibility SIP 21-003: Evaluating alternative delivery models for arthritis-appropriate evidence-based physical activity and self-management interventions SIP 21-004: Development, Evaluation and Dissemination of an Evidence-Based

Intervention to Increase Sun Safety among Outdoor Workers SIP 21-005: Feasibility of a Model Cancer Screening Surveillance Report Using

All-Payer Claims Data SIP 21-006: Increasing Genetic Counseling Referrals Among Patients At-Risk for

BRCA-Associated Cancers SIP 21-007: Epilepsy incidence and etiology: important information for public health prevention and health promotion in the US community SIP 21-008: Examining approaches to improve care and management of people with lupus SIP 21-009: Mental Health of Mothers Study (MHOMS) and Substance Use

Evaluation Network SIP 21-010: Engagement of Community Health Workers to Reduce Racial

Discrimination and Improve Hypertension Management

The institution name, EIN, DUNS, and System for Award Management (SAM) registration of the SIP applicant must match the information of the PRC institution funded under RFA-DP-19- 001, as listed in the Notice of Award.

The PRC PI/PD of record, as listed on the Notice of Award, must be listed as the SIP PD/PI on the SIP application. Additional PD/PIs are permitted, but would be referred to as a Co-PD/PI.

The Research Strategy component of the Research Plan is limited to 12 pages.

If an application requests a funding amount greater than the ceiling for the first 12 months for the specific SIP (see Section VIII. Other Information - Special Interest Project Descriptions), HHS/CDC will consider the application non-responsive and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

Special eligibility requirement(s) apply to the following SIP proposals (see Section VIII.

Other Information - Special Interest Project Descriptions).

SIP 21-001

The applicant must provide documented evidence of access to the study population (e.g., school-based OST program(s)) and an existing relationship with the identified OST program(s) in the form of memorandum of agreement, contract or letter of support with/from an OST program/(s) for the project period. The evidence should be labeled and placed in Appendix A. Letters of support or MOUs must demonstrate willingness to participate in evaluation activities.

o The applicant must provide demonstrated prior experience (i.e., reports, publication) conducting and/or evaluating interventions with K-12 school or OST settings, as evidenced in the Research & Related Senior/Key Person Section of the SF424 (R&R). The evidence should be labeled and placed in Appendix A.

SIP 21-003

Access to current AAEBI licensing agreements.

o Responsiveness Criteria: Letter (s) of support or a memorandum of agreement demonstrating access to current AAEBI licensing agreements. Evidence should be clearly labeled and placed in Appendix A of the application.

Access to the proposed study populations for the entire study duration.

o Responsiveness Criteria: Letter (s) of support or memorandum of agreement from collaborating organizations documenting access to the proposed population for the entire course of the research project. Evidence should be clearly labeled and placed in Appendix A of the application.

SIP 21-004

Access to one or more worksites and their outdoor workers to conduct the intervention is required. Evidence of this access should be a letter of support or memorandum of agreement; this evidence should be placed in Appendix A of the application.

SIP 21-005

Access to All Payers Claims Data (APCD) or equivalent Responsiveness Criteria: In Appendix A, the applicant must provide documentation

(e.g. a current letter of support or memorandum of agreement) that the applicant will have access to the critical datasets for the study.

SIP 21-006

Applicant must provide documented evidence, in the form of letters of support, or memorandum of understanding from each cancer center, health system, or clinic where the intervention will be implemented.

o The evidence should demonstrate that the health system has agreed to participate in the study and will implement the intervention in accordance with the study protocol. Evidence should be clearly labeled and placed in Appendix A.

SIP 21-007

Evidence of access to study populations and/or specified data source o The applicant must provide documentation, e.g. a letter of support or memorandum of agreement, demonstrating evidence of access to the study population and existing administrative claims and other data relevant for the project, necessary to carry out the proposed study. The evidence must be clearly labeled and placed in Appendix A of the application.

Evidence of expertise in epilepsy o The applicant must provide evidence that the project team includes experts in epilepsy research, as evidenced in the Research & Related Senior/Key Person Section of the SF424 (R&R). The evidence must be clearly labeled and placed in Appendix A of the application.

SIP 21-009

The institution must demonstrate previous or current relationships/collaborations with state perinatal psychiatric access programs. Responsiveness Criteria: Evidence of this criteria can be demonstrated through Letters of Support or Memoranda of Understanding.

If an application is incomplete or does not meet these requirements, it will be considered non-responsive 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://cage.dla.mil/

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/index.html .

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 https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov 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 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).

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

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 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 PRC institutions currently funded under RFA-DP-19-001 are eligible to apply for Special Interest Projects (SIPs) supplemental funding detailed in this NOFO.

Each currently funded PRC institution may only submit one application per SIP. The institution name, EIN, DUNS, and System for Award Management (SAM) registration of the SIP applicant must match the information of the PRC institution funded under RFA-DP-19-001, as listed in the Notice of Award.

The PRC PI/PD of record, as listed on the Notice of Award, must be listed as the SIP PD/PI on the SIP application. Additional/Co-SIP PD/PIs are permitted, but would be referred to as a Co-

SIP PD/PI.

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-f/general-forms-f.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.

https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf 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-f/general-forms-f.pdf

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, 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.

Applicants must submit only one application per SIP. If an applicant submits more than one application for the same SIP, CDC will only accept the application with the later timestamp.

A revision to an already submitted SIP application is allowable, but it will replace the previously submitted application.

SF 424 Research & Related (R&R) Face Page Form Instructions for completing the SF 424 Research and Related (R&R) Face Page form are provided in the SF 424 (R&R) Application Guide.

Each SIP application, and SF 424 (R&R) must be submitted as a New Application (field 8) and must include the correct SIP number in Field 4.a (Federal Identifier), and the SIP Title Field 4.b (Agency Routing Identifier). In Box 4c. of the SF 424 (R&R), applicant must enter the currently funded PRC grant number (refer to Section III. Eligibility Information, 3. Additional Information on Eligibility, for the grant number).

http://www.grants.gov/

3. Letter of Intent Due Date for Letter of Intent: 01/25/2021 Although a letter of intent (LOI) is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC staff to estimate the potential review workload and plan the peer review.

By the date listed above and in Part 1. Overview Information, prospective applicants are asked to submit an LOI electronically that includes the following information:

o Name of Applicant (PRC Institution) o SIP number and title o Descriptive title of proposed SIP research project o Name, address, and telephone number of PI of Record/ PRC PD/PI and SIP Co-

SIP PD/PI

o Names of other key personnel o Participating institutions o Number and title of this notice of funding opportunity: RFA-DP-20-004, Health

Promotion and Disease Prevention Research Centers 2021 Supplemental Special Interest Projects (SIPS)

The LOI should be sent electronically to:

Natalie Darling, MPH Scientific Program Official Extramural Research Program Operations and Services (ERPOS) Centers for Disease Control and Prevention 4770 Buford Highway, NE Mailstop F-80 Atlanta, GA 30341 Email: ndarling@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-f/general-forms-f.pdf and http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf 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-f/general-forms-f.pdf and here: http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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 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:

• A description of the data to be collected or generated in the proposed project;

• Standards to be used for the collected or generated data;

• Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights -this section should address access to identifiable and de-identified data);

• Statement of the use of data standards that ensure all released data have appropriate documentation that https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf describes the method of collection, what the data represent, and potential limitations for use;

and

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

Examples of DMPs may be found here: USGS, http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans

Data Management Plan CDC requires awardees for projects that involve the collection or generation of public health data with federal funds to submit a Data Management Plan (DMP) prior to the initiation of…