RFA-MD-15-014_ NIMHD Transdisciplinary Collaborative Centers for Health Disparities Research on Chronic Disease Prevention (U54)

Department of Health and Human ServicesPart 1. Overview InformationParticipating Organization(s)

National Institutes of Health (NIH (http://www.nih.gov))

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD (http://www.nimhd.nih.gov/))

Funding Opportunity Title

NIMHD Transdisciplinary Collaborative Centers for Health DisparitiesResearch on Chronic Disease Prevention (U54)

Activity Code

U54 (http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u54&Search.x=0&Search.y=0&Search_Type=Activity) Specialized Center- CooperativeAgreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MD-15-014

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information onEligibility.

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Key Dates

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.307

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications to establish specializedTransdisciplinary Collaborative Centers (TCCs) for health disparities research focused on chronicdisease prevention, with an emphasis on developing, implementing and disseminating community-based multilevel interventions.

Posted Date

August 4, 2015

Open Date (Earliest Submission Date)

November 16, 2015

Letter of Intent Due Date(s)

November 16, 2015

Application Due Date(s)

December 16, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applicationsallowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errorsfound in the application during the submission process by the due date.

AIDS Application Due Date(s)

December 16, 2015 by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement aredue on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errorsfound in the application during the submission process by the due date.

Scientific Merit Review

March 2016

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for theelectronic preparation and submission of multi-project applications through Grants.gov to NIH.Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSISTreplaces the Grants.gov downloadable forms currently used with most NIH opportunities and providesmany features to enable electronic multi-project application submission and improve data quality,including: pre-population of organization and PD/PI data, pre-submission validation of many agencybusiness rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide(http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed to do otherwise (inthis FOA or in a Notice from the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/))and where instructions in the Application Guide are directly related to the Grants.gov downloadable formscurrently used with most NIH opportunities. Conformance to all requirements (both in the ApplicationGuide and the FOA) is required and strictly enforced. Applicants must read and follow all applicationinstructions 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. Applications that do not comply with these instructions may be delayed or notaccepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use theASSIST system to prepare, submit and track your application online. You can download an applicationpackage from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and trackyour application in eRA Commons. Or, you can use other institutional system-to-system solutions toprepare and submit your application to Grants.gov and track your application in eRA Commons. Learnmore (http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm#2).

Apply Online Using ASSIST Problems accessing or using ASSIST should be directed to the eRACommons Help Desk (/grants/ElectronicReceipt/support.htm#desk).

Advisory Council Review

May 2016

Earliest Start Date

July 1, 2016

Expiration Date

December 17, 2015

Due Dates for E.O. 12372

Not Applicable

http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm#2

http://grants.nih.gov/grants/guide/

http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000

http://grants.nih.gov/grants/ElectronicReceipt/support.htm#desk

Table of ContentsPart 1. Overview InformationPart 2. Full Text of the Announcement

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

Part 2. Full Text of AnnouncementSection I. Funding Opportunity DescriptionBackgroundAlthough scientific and technological advances have improved the health of the U.S. population overall,racial/ethnic minority populations, socioeconomically disadvantaged populations and rural populationscontinue to experience a disproportionate share of many chronic diseases and adverse health conditions.As the Nation’s steward of biomedical and behavioral research, NIH has devoted considerable resourcesto characterize the root causes of health disparities, uncovering complex webs of interconnected factors(e.g., biological, behavioral, social and environmental factors) acting at multiple levels across the lifecourse. As an important next step, research is needed that capitalizes on this knowledge to developinterventions that reduce and eventually eliminate health disparities.

Tackling the complex drivers of health disparities requires a transdisciplinary framework that cuts acrossscientific and organizational silos to integrate multiple disciplines– biology, behavioral and social sciences,epidemiology, data science, public health, health care delivery, economics, environmental science, publicpolicy, etc. It also requires strong collaborations between researchers, community organizations, healthservice providers, public health agencies, policymakers and other stakeholders to ensure that relevant,contextually appropriate research is conducted and, more importantly, that findings can be translated intosustainable community and system-level changes that promote health equity.

To pursue these objectives, NIMHD Transdisciplinary Collaborative Centers (TCCs) for health disparitiesresearch comprise regional coalitions of research institutions and consortium partners focused on priorityresearch areas in minority health and health disparities. The TCC program's overarching goal is to developand disseminate effective interventions that can be implemented in real-world settings.

Chronic diseases and conditions are among the most common, costly, and preventable of all healthproblems. Seven of the top 10 causes of death in 2010 were chronic diseases. By investing in preventionand early diagnosis and treatment of the most common chronic diseases, the U.S. could decreasetreatment costs by $218 billion per year and reduce the economic impact of disease by $1.1 trillionannually. Reducing disparities in chronic diseases should start with health disparity populations at high riskfor chronic diseases such as cardiovascular diseases, diabetes, cancer, chronic pulmonary disease,arthritis etc. For example, many health risks are associated with obesity. However, the prevalence of

obesity among non-Hispanic black and Hispanic adults is significantly higher than among non-Hispanicwhite adults. Cigarette smoking is the leading cause of preventable death in the United States. Yet, moreadults who live below the poverty level are current cigarette smokers compared to those who live at orabove the poverty level. Also, hypertension, a precursor to cardiovascular disease, is more prevalent andnot as well controlled in non-Hispanic blacks, versus non-Hispanic whites. Non-Hispanic blacks have amuch higher prevalence of uncontrolled blood pressure when compared with non-Hispanic whites. Womenfrom poor, low-income, and middle-income households are less likely to receive a mammogram comparedwith women from high-income households.

Research ObjectivesChronic diseases/conditions are defined broadly as conditions that last one year or more and requireongoing medical attention or limit activities of daily living or both. For the purposes of this FOA, chronicdiseases/conditions that disproportionately affect health disparity populations include but are not limited todiabetes, cancer, cardiovascular diseases, kidney disease, HIV/AIDS, asthma, depression and other mentalillnesses, substance abuse and addiction disorders.

Current science advances in developmental biology, life-course science and environmental epigeneticsexpand our understanding of the possible etiologies and mechanisms of many chronic diseases andconditions. The advances also build a persuasive case for reframing public health research efforts toemphasize health promotion and chronic disease prevention.

This initiative encourages investigators using a transdisciplinary, collaborative and systems approach toaddress disparities in chronic disease prevention. Priorities will be given to primary and secondaryprevention activities that aim to prevent disease from occurring or aim to find and treat disease early. Notreatment costs will be covered. Multilevel approaches are encouraged in order to better understand andappropriately intervene to eliminate health disparities. Multilevel interventions are interventions withmultiple components designed to affect factors in two or more levels of the local ecology that contribute towellness and illness, with the goal to effect changes within and between different levels. Dynamicinterventions involving individual, family/team/group, community, state, or national levels may account formultidimensional influences on individual risk factors and population level macro-social factors. Forexample, evidence suggests that population-level behavior changes can best be achieved by changingphysical and social environments for four key risk factors: tobacco use, unhealthy diet, lack of physicalactivity, and harmful use of alcohol. Increasingly, there is recognition that single-level interventions are notadequate to reduce health inequalities. Multilevel interventions that take into account complex interactionsat multiple ecological levels can better address social determinants of health.

This FOA encourages working extensively with community partners to implement community-basedmultilevel interventions. For the purposes of this FOA, community is defined as a group of people withdiverse characteristics who are linked by social ties, shared common perspectives, and engage in jointaction in geographical locations. Each TCC will identify a community with existing evidence of a highprevalence or incidence of chronic diseases or conditions and lack of prevention and health promotioninterventions or resources. In the project’s first year, each TCC is expected to carry out a comprehensiveneeds assessment in that community (including social stratification, community ecological context, culturalfactors, environmental factors, health-related policies, etc.), identify barriers to access and utilization ofhealth promotion or preventive care services, build extensive partnership within the community, andacquire baseline data on multiple chronic diseases including clinical data, biomarkers, or othermeasureable outcomes as necessary. Multimodal methods should be used to triangulate findings and

identify the underlying mechanisms of disparities. Based on that information and collaboration with localcommunity partners, in years 2-5 each TCC will initiate and implement multilevel interventions at individual,family/team/group, community, or higher levels (at least three or more levels) to improve chronic diseaseprevention and promote health equity.

Given that TCCs for health disparities research are focused on regional approaches and collective impact,priority will be given to multilevel interventions that target 500 or more participants within the selectedcommunity(ies), and to projects targeting communities without previous government-sponsoredcommunity-wide interventions.

Each TCC must consist of multidisciplinary teams of personnel from community organizations andacademic institutions, health service providers and systems, and state and local public health agencies toaddress disparities through a multilevel approach that utilizes community, academic, and governmentalresources. Each TCC must include the following components: Administrative Core, Consortium Core,Methodology Core, Intervention Projects, and Dissemination Core.

The Administrative Core will oversee activities providing overall project evaluation; ensuring thatcomponent plans are implemented according to proposed timelines; submitting annual progressreports; monitoring progress on intervention projects, and ensuring that TCC-supported research iscarried out in compliance with applicable federal regulations and policies.The Consortium Core will serve as a focal point for organizing and nurturing productive workingrelationships with consortium partners. Consortium Core leadership is expected to include membersof all consortium partner organizations including NIMHD scientific staff. Research shows thatdiverse teams working together to capitalize on innovative ideas and distinct perspectivesoutperform homogenous teams. Moreover, involving community stakeholders in needs assessment,project planning and design, implementation, and dissemination of results enhances theirparticipation in research and facilitates development of workable multilevel interventions.The Methodology Core will formulate appropriate theoretical framework, study design, data analysisplan, and assessment of community-based multilevel interventions. Investigators must carefullydetermine the unit of intervention and the unit of analysis according to their research questions. Thesystematic appraisal of costs and benefits of community-based multilevel intervention is needed.Intervention Projects will promote prevention research and related activities aimed at initiating andimplementing multilevel interventions in community settings, working in close collaboration withcommunity partners, health service providers, public health agencies, policymakers and otherconsortium partners as appropriate. Each TCC is required to have at least two projects with differentinterventions. Multiple chronic disease/conditions are encouraged.The Dissemination Core will identify, develop effective methods, systems, infrastructures, andstrategies to disseminate research findings and to overcome barriers to the adoption, adaptation,integration of evidence-based multilevel interventions.

NOTE: TCC awards will not support cores that duplicate institutional resources or cores supported byother federal funding if those resources are already available for use by TCC participants.

To promote optimal use of TCC resources, TCC investigators are strongly encouraged to collaborate withother federally-funded investigators who have expertise and/or interest in multilevel chronic diseaseprevention and health disparities or other resources that can be leveraged to help achieve TCC objectives.

Although delineation of the region and populations(s) under study is determined by the applicant,applications must specify in which of the 10 established HHS regions the proposed work will occur

(http://www.hhs.gov/about/regions/). Applicant-defined regions may fall within a single HHS region oracross multiple regions.

REGION I: CT, ME, MA, NH, RI, VT REGION II: NJ, NY, PR, VI REGION III: DE, D.C., MD, PA, VA, WV REGION IV: KY, MS NC, TN, AL, FL, GA, SC REGION V: IL, IN, MI, MN, OH, WI REGION VI: AR, LA, NM, OK, TX REGION VII: IA, KS, MO, NE REGION VIII: CO, MT, ND, SD, UT, WY REGION IX: AZ, CA, HI, NV, and the six U.S. Associated Pacific jurisdictions REGION X: AK, ID, OR, WA

To ensure that all TCCs, including those established through this FOA, contribute optimally and effectivelyto national minority health and health disparities research efforts, the overall direction and scope ofactivities supported by this initiative will be coordinated and monitored by a TCC Program CoordinatingCommittee consisting of TCC PDs/PIs and NIMHD program staff. The TCC Program CoordinatingCommittee will meet at least annually to assess progress toward program goals and promote informationexchange across regions.

In addition, TCCs established through this initiative are expected to work together to address disparities inchronic disease prevention through a Multilevel Chronic Disease Prevention (MCDP) CoordinatingCommittee comprising the PD(s)/PI(s) of each TCC and NIH program staff. This committee will identifyissues that have broad applicability across participating TCCs, and will establish the following sub-committees, each of which will include at least one NIH project scientist:

Executive Committee, consisting of the chair of the MCDP Coordinating Committee, the TCCPDs/PIs, the NIH Program Officer(s), to meet quarterly via teleconference.Research Methodology Committee, consisting of key personnel from each TCC Methodology Coreand NIH program staff and responsible for development of consistent definitions, theoreticalframeworks, key approaches, and analytic methods.Publications Committee responsible for developing a publications policy approved by theCoordinating Committee at the beginning of the project period and reviewing all abstracts,presentations and manuscript submissions by MCDP TCC investigators.

The NIMHD will conduct a Technical Assistance webinar for prospective applicants in August 2015 at adate and time to be determined. Information about the webinar will be posted on the NIMHD website atwww.nimhd.nih.gov (http://www.nimhd.nih.gov).

Section II. Award InformationFunding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific orprogrammatic involvement. Substantial involvement means that, after award, NIH scientific or programstaff will assist, guide, coordinate, or participate in project activities.

http://www.nimhd.nih.gov/

NIH grants policies as described in the NIH Grants Policy Statement(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11120) will apply to the applications submitted andawards made in response to this FOA.

Section III. Eligibility Information1. Eligible ApplicantsEligible OrganizationsHigher Education Institutions

Public/State Controlled Institutions of Higher EducationPrivate Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support asPublic or Private Institutions of Higher Education:

Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Application Types Allowed

New

The OER Glossary (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11116) and the SF424 (R&R)Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIMHD intends to commit $5,000,000 in FY 2016 to fund 2-3 awards.

Award Budget

Application budgets are limited to $1,500,000 in direct costs annually, exclusive of consortium indirectcosts.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is5 years.



Small BusinessesFor-Profit Organizations (Other than Small Businesses)

Governments

State GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or Possession

Other

Independent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional Organizations

Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11118), are allowed.

Required RegistrationsApplicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424(R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completedprior to the application being submitted. Registration can take 6 weeks or more, so applicants shouldbegin the registration process as soon as possible. The NIH Policy on Late Submission of GrantApplications (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-035.html) states that failure tocomplete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) (http://fedgov.dnb.com/webform) - Allregistrations require that applicants be issued a DUNS number. After obtaining a DUNS number,applicants can begin both SAM and eRA Commons registrations. The same DUNS number must beused for all registrations, as well as on the grant application.System for Award Management (SAM) (https://www.sam.gov/portal/public/SAM/) (formerly CCR) –Applicants must complete and maintain an active registration, which requires renewal at leastannually. The renewal process may require as much time as the initial registration. SAM registrationincludes the assignment of a Commercial and Government Entity (CAGE) Code for domesticorganizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11176) – Foreign organizations mustobtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-035.html


http://fedgov.dnb.com/webform


https://www.sam.gov/portal/public/SAM/

eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123) - Applicants musthave an active DUNS number and SAM registration in order to complete the eRA Commonsregistration. Organizations can register with the eRA Commons as they are working through theirSAM or Grants.gov registration. eRA Commons requires organizations to identify at least oneSigning Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account inorder to submit an application.Grants.gov (http://www.grants.gov/applicants/organization_registration.jsp) – Applicants must havean active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizationalofficials to either create a new account or to affiliate their existing account with the applicant organizationin eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRACommons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research asthe Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization todevelop an application for support. Individuals from underrepresented racial and ethnic groups as well asindividuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/PrincipalInvestigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of theSF424 (R&R) Application Guide.

2. Cost SharingThis FOA does not require cost sharing as defined in the NIH Grants Policy Statement.(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11126)

3. Additional Information on EligibilityNumber of ApplicationsOnly one application per organization (normally identified by having a unique DUNS number or NIH IPFnumber) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. Thismeans that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the reviewof an overlapping new (A0) or resubmission (A1) application.A resubmission (A1) application that is submitted before issuance of the summary statement fromthe review of the previous new (A0) application.An application that has substantial overlap with another application pending appeal of initial peerreview (see NOT-OD-11-101 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-101.html)).

Section IV. Application and Submission Information1. Requesting an Application Package

http://www.grants.gov/applicants/organization_registration.jsp




Applicants can access the SF424 (R&R) application package associated with this funding opportunity usingthe “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11127).

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov toNIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application SubmissionIt is critical that applicants follow the instructions in the SF424 (R&R) Application Guide(http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), including Supplemental Grant ApplicationInstructions (https://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf) except whereinstructed in this funding opportunity announcement to do otherwise and where instructions in theApplication Guide are directly related to the Grants.gov downloadable forms currently used with most NIHopportunities. 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – ApplicationGuide, Electronic Submission of Grant Applications (http://grants.nih.gov/grants/guide/url_redirect.htm?id=41137).

Letter of IntentAlthough a letter of intent is not required, is not binding, and does not enter into the review of a subsequentapplication, the information that it contains allows IC staff to estimate the potential review workload andplan the review.

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

Descriptive title of proposed activityName(s), address(es), and telephone number(s) of the PD(s)/PI(s)Names of other key personnelParticipating institution(s)Number and title of this funding opportunity

The letter of intent should be sent to:

Maryline Laude-Sharp, PhD Telephone: 301-451-9536Fax: 301-480-4049Email: [email protected] (mailto:[email protected])

Page LimitationsComponent Types Available in ASSIST Research Strategy/Program

Plan Page Limits

Overall 12

Admin Core 12

Core (use for Consortium Core, Methodology 6 (per core)



mailto:[email protected]


https://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf

Core (use for Consortium Core, MethodologyCore, and Dissemination Core)

6 (per core)

Project (use for Intervention Project) 12 (per project)

Additional page limits described in the SF424 Application Guide and the Table of Page Limits(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11133) must be followed.

Instructions for the Submission of Multi-Component ApplicationsThe following section supplements the instructions found in the SF424 (R&R) Application Guide, andshould be used for preparing a multi-component application.

The application should consist of the following components:

Overall: requiredAdministrative Core: requiredConsortium Core: requiredMethodology Core: requiredDissemination Core: requiredIntervention Project: required, minimum of two, maximum of three

Overall ComponentWhen preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additionalinstructions, as noted.

SF424 (R&R) Cover (Overall)Complete entire form.

PHS 398 Cover Page Supplement (Overall)Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table inOverall component.

Research & Related Other Project Information (Overall)Follow standard instructions.

Project/Performance Site Location(s) (Overall)Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image ineRA Commons compiled from data collected in the other components will be generated uponsubmission.

Research & Related Senior/Key Person Profile (Overall)Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable tothis FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of theassembled application image in eRA Commons will be generated upon submission.

Budget (Overall)The only budget information included in the Overall component is the Estimated Project Funding


section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commonscompiled from detailed budget data collected in the other components will be generated uponsubmission.

PHS 398 Research Plan (Overall)Specific Aims: Describe the overall composition, objectives, specific aims, and expected outcomes ofthe proposed TCC. Identify the health disparity population(s) to be included in the proposed projectsand describe the chronic diseases/conditions of focus. Delineate the geographic region to be covered,including the HHS region(s) where the proposed work will occur.

Research Strategy: Identify and delineate the roles of consortium partners. Provide the scientificrationale for selecting the partners and the population(s) to be included. Describe how the proposedTCC structure and activities will facilitate productive collaborations, bringing together people withexpertise in multilevel chronic disease prevention.

Describe steps taken prior to or during the development of the application to gain substantivecommunity input on (1) identification of research topics of importance to the study population(s), and(2) identification of relevant contextual factors (e.g., social stratification, community ecological context,cultural factors, environmental factors, health-related policies, etc.) to be considered alongsideindividual risk factors.

Explain how the various TCC activities taken together as a whole will significantly contribute to theintegration of chronic disease prevention interventions taking into account the dynamic interplaybetween biological, behavioral, social and environmental health risk and protective factors experiencedacross the life course.

Explain how the proposed TCC activities will enhance inclusion of health disparity populations inchronic disease prevention and health promotion research.

Provide an overview of the proposed collaborative intervention projects and describe plans to promotesynergy among them. Describe the scientific rationale and the process used to select the proposedintervention projects, as well as plans and procedures to monitor and assess progress on thoseprojects. It is expected that under-performing projects will be discontinued and replaced by newprojects with greater potential as the program evolves and matures.

Identify collaborating NIMHD-supported investigators in the region (if any) who have expertise inmultilevel chronic disease prevention or other relevant resources that could be leveraged to helpachieve TCC goals and objectives and avoid unnecessary duplication. Describe plans for leveragingany existing core facilities or other shared research resources that are available to support theproposed activities.

Describe the applicant organization's commitment and capabilities for regional coordination andcollaboration, particularly with community-based organizations, federal, state and local agencies andprivate sector partners. Applicant organizations that currently hold federally-funded center awardsshould describe center expertise and resources available to support the proposed TCC activities, aswell as how TCC activities are distinct from those of the existing center(s).

Letters of Support: Provide a letter or memorandum of agreement/understanding (MOA/U) for each

proposed consortium partner organization, signed by an authorized official of that organization,describing its expectations for the partnership and its roles and responsibilities on the project.

The application should also include a detailed statement from the applicant organization's leadershipdescribing its commitment to the establishment and maintenance of the proposed center. Supportmay include but is not limited to provision of professional release time, support staff, facilities, andother resources that will contribute to the proposed TCC activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the ResourceSharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendixas described in the SF424 (R&R) Application Guide.

Administrative CoreWhen preparing your application in ASSIST, use Component Type ‘Admin Core.’


SF424 (R&R) Cover (Administrative Core)Complete only the following fields:

Applicant InformationType of Applicant (optional)Descriptive Title of Applicant’s ProjectProposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt fromFederal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachmentindicating it is required. However, eRA systems only enforce this requirement in the Overall componentand applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment foradditional entries.

Research & Related Senior/Key Person Profile (Administrative Core)In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ withCategory of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.In the additional Senior/Key Profiles section, list Senior/Key persons that are working in thecomponent.

Include a single Biographical Sketch for each Senior/Key person listed in the applicationregardless of the number of components in which they participate. When a Senior/Key person islisted in multiple components, the Biographical Sketch can be included in any one component.If more than 100 Senior/Key persons are included in a component, the Additional Senior KeyPerson attachments should be used.

Budget (Administrative Core)Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/KeyPersons in section A and 100 Equipment Items in section C prior to using attachments for additionalentries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)Specific Aims: Describe aims to ensure effective management, coordination and support of the TCC'schronic disease prevention research program and related consortium activities.

Research Strategy: Describe the TCC’s organizational and governance structure and explain the rolesand responsibilities of Administrative Core personnel. Describe the processes to be used to allocateand prioritize fiscal and other resources, as well as procedures for ensuring timely and effectivecommunication between TCC consortium participants. Include a management plan that describes thecomposition and roles of the Steering Committee, as well as any community advisory boards or othercommittees proposed to help manage TCC activities. Do not name potential members of the SteeringCommittee in the application.

Describe how the Administrative Core will manage, coordinate and supervise the entire range ofproposed TCC activities, monitor progress on intervention projects, and ensure that component plansare implemented according to proposed timelines.

Include an evaluation plan to monitor progress on proposed TCC activities. The evaluation plan isintended to facilitate ongoing TCC project management to ensure successful completion of the statedaims. Describe how the evaluation will be conducted, logic models for the TCC as a whole and foreach proposed core, principal measures and metrics to be used to assess achievement of short- andlong-term goals, and potential sources of data. The plan should address administrative functioning(process) as well as scientific accomplishments (outcomes) in the following key areas: translationalactivities; scope and impact of research; innovation; collaboration and communication; integration andsynergy; and funds management. Describe key milestones and expected outcomes for each area asappropriate.

NOTE: Under the cooperative agreement mechanism, NIMHD staff will work with TCC award recipientsto develop complementary evaluation methods and measures addressing the scientific impact of theTCC program at regional and national levels.

Resource Sharing Plan: Individuals are required to comply with the instructions for the ResourceSharing Plans as provided in the SF424 (R&R) Application Guide.


Planned Enrollment Report (Administrative Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)Not Applicable

Consortium CoreWhen preparing your application in ASSIST, use Component Type ‘Core.’


SF424 (R&R) Cover (Consortium Core)

Complete only the following fields:


PHS 398 Cover Page Supplement (Consortium Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Consortium Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt fromFederal regulations?’ questions.


Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachmentindicating it is required. However, eRA systems only enforce this requirement in the Overallcomponent and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Consortium Core)

List all performance sites that apply to the specific component.


Research & Related Senior/Key Person Profile (Consortium Core)

In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ withCategory of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.In the additional Senior/Key Profiles section, list Senior/Key persons that are working in thecomponent.Include a single Biographical Sketch for each Senior/Key person listed in the applicationregardless of the number of components in which they participate. When a Senior/Key person islisted in multiple components, the Biographical Sketch can be included in any one component.If more than 100 Senior/Key persons are included in a component, the Additional Senior KeyPerson attachments should be used.

Budget (Consortium Core)

Budget forms appropriate for the specific component will be included in the application package.


PHS 398 Research Plan (Consortium Core)

Specific Aims: Describe the aims and objectives that will be pursued to establish the Core as aregional focal point for organizing and nurturing productive working relationships with a broad cross-section of community organizations, health disparity populations, health service providers, publichealth agencies and other stakeholders with an interest in eliminating health disparities. Describe aimsto ensure effective management, coordination and support of the TCC's multilevel chronic diseaseprevention research program and related consortium activities.

Research Strategy: Explain the scientific rationale for including the consortium partners in researchinvolving the proposed study population(s). Summarize the strengths of the proposed consortium,including relevant expertise, relationships with the study population(s), and experience participating inproductive regional collaborations and partnerships.

Describe specific opportunities to establish or strengthen associations with federal agencies, state andlocal health departments and other relevant agencies with expertise and/or interest in the proposedresearch, implementation and dissemination activities. Describe strategies and procedures forassessing the effectiveness of partnerships on an ongoing basis and resolving disputes ormisunderstandings between partner organizations.

Letters of Support: Letters or memoranda of agreement/understanding signed by authorizedrepresentatives of consortium partner organizations are to be included in the application's OverallComponent and should not be duplicated in the Consortium Core component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the ResourceSharing Plans as provided in the SF424 (R&R) Application Guide


Planned Enrollment Report (Consortium Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Consortium Core)

Not Applicable

Methodology CoreWhen preparing your application in ASSIST, use Component Type ‘Core.’


SF424 (R&R) Cover (Methodology Core)



PHS 398 Cover Page Supplement (Methodology Core)


Research & Related Other Project Information (Methodology Core)



Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachmentindicating it is required. However, eRA systems only enforce this requirement in the

Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Methodology Core)



Research & Related Senior/Key Person Profile (Methodology Core)


Budget (Methodology Core)



PHS 398 Research Plan (Methodology Core)

Specific Aims: Describe the aims and objectives that will be responsible for development ofconsistent definitions, theoretical framework, key approaches, and analytic methods for multilevel

chronic disease prevention.

Research Strategy: Describe the roles and responsibilities of key members involved in this core, aswell as any additional collaboration with regional partners with methodology expertise. Core leadershipshould include individuals that are likely to be critical to the research methods and study design.Expertise on economic evaluation is needed.

Describe a comprehensive needs assessment in the community (including social stratification,community ecological context, cultural factors, environmental factors, health-related policies, etc.).Describe how to identify barriers to access and utilization of health promotion or preventive careservices and acquire baseline data on multiple chronic diseases (including clinical data, biomarkers, orother measureable outcomes as necessary). Multimodal methods should be used to triangulatefindings and identify the underlying mechanisms of disparities.

Describe the theoretical or conceptual model supporting the multilevel chronic disease prevention, aswell as the levels proposed in the intervention and the analytic plan to address its impact on individual-level and contextual factors, the interaction between them and how they influence each otherdynamically. Describe the capabilities of data collection, integration and analysis. Describe thescalability and sustainability of the proposed study design to reduce disparities in chronic diseaseprevention.



Planned Enrollment Report (Methodology Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Methodology Core)

Not Applicable

Intervention ProjectWhen preparing your application in ASSIST, use Component Type ‘Project.’


SF424 (R&R) Cover (Intervention Project)



PHS 398 Cover Page Supplement (Intervention Project)


Research & Related Other Project Information (Intervention Project)



Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachmentindicating it is required. However, eRA systems only enforce this requirement in the Overall componentand applications will not receive an error if omitted in other components

Project /Performance Site Location(s) (Intervention Project)



Research & Related Senior/Key Person Profile (Intervention Project)


Budget (Intervention Project)



PHS 398 Research Plan (Intervention Project)

Specific Aims: State concisely the overall goals of the proposed intervention project. Identify thehealth disparity population(s) to be included and the chronic disease(s) or condition(s) under study. Listsuccinctly the specific objectives, e.g., to test a stated hypothesis, create a novel design, solve aspecific problem relating to health disparities, challenge an existing paradigm, address a critical barrierto progress in the field of chronic disease prevention and health promotion as it relates to healthdisparities, or develop new technology.

Research Strategy: For research involving human subjects, describe steps taken prior to and/orduring the development of the application to obtain substantive community input into (1) identificationof research topics of importance to the proposed study population(s), and (2) identification of relevantcontextual factors (e.g., social stratification, community ecological context, cultural factors,environmental factors, health-related policies, etc.) that mediate the effects of interventions targeting

health disparities populations.

Explain how the proposed collaborations will serve to advance scientific knowledge of the interplaybetween biological, behavioral, social and environmental risk and protective factors experiencedacross the life course.

Describe the multilevel approach used in the project. Describe in detail all levels proposed to receiveinterventions and how the partners are going to support such interventions to reduce health disparities.Describe what type of prevention, primary or secondary, are adopted. Also describe what chronicdisease/condition is being targeted and what potential clinical and other outcome is anticipated.Describe the timeline of the proposed multilevel intervention and what resources are already availableto develop and conduct such interventions.

Explain how the project will complement and synergize with other intervention projects included in theapplication, and how its successful completion will advance the TCC's overall aims and objectives.Also address plans for leveraging TCC infrastructure and resources to ensure successful completion ofthe project's stated aims.

Applications with foreign components that involve data collection in foreign sites must state how theproposed activities will help improve minority health or reduce health disparities in the United States.Applications that do not include this information are non-responsive to the FOA



Planned Enrollment Report (Intervention Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reportsas described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Intervention Project)

When conducting clinical research, follow all instructions for completing Cumulative InclusionEnrollment Report as described in the SF424 (R&R) Application Guide.

Dissemination CoreWhen preparing your application in ASSIST, use Component Type ‘Core.’


SF424 (R&R) Cover (Dissemination Core)



PHS 398 Cover Page Supplement (Dissemination Core)


Research & Related Other Project Information (Dissemination Core)



Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachmentindicating it is required. However, eRA systems only enforce this requirement in the Overall componentand applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Dissemination Core)



Research & Related Senior/Key Person Profile (Dissemination Core)


Budget (Dissemination Core)



PHS 398 Research Plan (Dissemination Core)

Specific Aims: Describe the aims and objectives that will be pursued to support regionaldissemination of multilevel chronic disease prevention, including new interventions developed throughcollaborative intervention projects, in collaboration with relevant communities, service providers, otherpartner organizations and policy makers.

Research Strategy: Describe the roles and responsibilities of consortium partners involved in thiscore, as well as any additional collaboration with health service providers, public health agencies,policymakers and other relevant stakeholders. Core leadership should include individuals fromorganizations that are likely to be critical to the dissemination process and able to use knowledge

generated through research to make informed decisions about policies, programs and/or practices.

Describe strategies to use research findings to inform policy and to promote diffusion, adoption andsustainability of effective multilevel interventions in relevant communities within the proposed region.Address ethical considerations for (1) development and/or utilization of variables and measures instudy populations, and (2) communicating research results to the scientific community and the laypublic. Describe plans to ensure protection of study participants and communities from unintendedharms, including risks associated with stigma.

Describe strategies to keep various stakeholders informed, on an ongoing basis, of needs and capacityassessments, as well as results from intervention projects. Describe steps to assess the effectivenessof community- or system-level dissemination of interventions and/or health education efforts.



Planned Enrollment Report (Dissemination Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Dissemination Core)

Not Applicable

3. Submission Dates and TimesSee Part I. Section III.1 for information regarding the requirements for obtaining a Dun and BradstreetUniversal Numbering System (DUNS) Number and for completing and maintaining an active System forAward Management (SAM) registration. Part I. Overview Information contains information about Key Dates.Applicants are encouraged to submit applications before the due date to ensure they have time to makeany application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128) (the online portal to find and apply for grants across all Federal agencies) using ASSIST or otherelectronic submission systems. Applicants must then complete the submission process by tracking thestatus of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123), NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons toensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)This initiative is not subject to intergovernmental review.(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142)




5. Funding RestrictionsAll NIH awards are subject to the terms and conditions, cost principles, and other considerations describedin the NIH Grants Policy Statement (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11120).

Pre-award costs are allowable only as described in the NIH Grants Policy Statement(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11143).

6. Other Submission Requirements and InformationApplications must be submitted electronically following the instructions described in the SF424 (R&R)Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and fundingconsideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf(http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf).

Applicants must complete all required registrations before the application due date. Section III.Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submissionprocess, visit Applying Electronically (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144). If youencounter a system issue beyond your control that threatens your ability to complete the submissionprocess on-time, you must follow the Guidelines for Applicants Experiencing System Issues(http://grants.nih.gov/grants/ElectronicReceipt/support.htm#guidelines).

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credentialfield of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure toregister in the Commons and to include a valid PD/PI Commons ID in the credential field will preventthe successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is thesame number used in the organization’s profile in the eRA Commons and for the System for AwardManagement (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11146) for avoiding commonerrors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructionsby the Center for Scientific Review and responsiveness by NIMHD, NIH. Applications that are incomplete,non-compliant and/or nonresponsive will not be reviewed.

Post Submission MaterialsApplicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-030.html).

Section V. Application Review Information


http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf





http://grants.nih.gov/grants/ElectronicReceipt/support.htm#guidelines

1. CriteriaOnly the review criteria described below will be considered in the review process. As part of the NIHmission (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11149), all applications submitted to theNIH in support of biomedical and behavioral research are evaluated for scientific and technical meritthrough the NIH peer review system.

Overall Impact - OverallReviewers will provide an overall impact score to reflect their assessment of the likelihood for the center toexert a sustained, powerful influence on the research field(s) involved, in consideration of the followingreview criteria and additional review criteria (as applicable for the center proposed).

Scored Review Criteria - OverallReviewers will consider each of the review criteria below in the determination of scientific merit, and give aseparate score for each. An application does not need to be strong in all categories to be judged likely tohave major scientific impact. For example, a project that by its nature is not innovative may be essential toadvance a field.

SignificanceDoes the project address an important problem or a critical barrier to progress in the field? If the aimsof the project are achieved, how will scientific knowledge, technical capability, and/or clinical practicebe improved? How will successful completion of the aims change the concepts, methods,technologies, treatments, services, or preventative interventions that drive this field?

How likely is the project to yield new insights into the community-based multilevel intervention toaddress reduction of disparities in chronic disease prevention in one or more health disparitypopulations?

How and to what extent are the proposed activities likely to enhance inclusion of health disparitiespopulations in chronic disease prevention research?

Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partnerorganizations raise confidence that each partner organization is actively engaged and committed toachieving the project's stated aims?

Investigator(s)Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early StageInvestigators or New Investigators, or in the early stages of independent careers, do they haveappropriate experience and training? If established, have they demonstrated an ongoing record ofaccomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , dothe investigators have complementary and integrated expertise; are their leadership approach,governance and organizational structure appropriate for the project?

Does the proposed team include people with demonstrated expertise in prevention research, multilevelintervention methodology, population health disparities, big data and novel technology, and thescience of translation, implementation and dissemination? Have the PD(s)/PI(s) demonstrated a historyof productive working relationships as scientific collaborators, both in academic settings and inconsortia that include community-based organizations and other stakeholders? Do the partnershipsmatch with the resources needed for the specific intervention project?


Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partnerorganizations describe adequate qualifications, roles and responsibilities of senior/key personnel andother significant contributors at those organizations and raise confidence that their involvement willfacilitate achievement of the stated aims?

InnovationDoes the application challenge and seek to shift current research or clinical practice paradigms byutilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field ofresearch or novel in a broad sense? Is a refinement, improvement, or new application of theoreticalconcepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the application propose an innovative conceptual framework, novel strategies or approaches forintegrating individual and contextual level data such that chronic disease prevention interventions areappropriately informed by multilevel factors that influence health outcomes?

ApproachAre the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish thespecific aims of the project? Are potential problems, alternative strategies, and benchmarks forsuccess presented? If the project is in the early stages of development, will the strategy establishfeasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1)the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals onthe basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified interms of the scientific goals and research strategy proposed?

Taken together as a whole, are the proposed TCC activities likely to promote community-basedmultilevel interventions that take into account the dynamic interplay between biological, behavioral,social and environmental health risk and protective factors experienced across the life course? Are theresearch designs creative to capture the complexities of different factors?

Is it likely that the proposed TCC activities are sustainable, scalable, and affordable? Is what isproposed likely to reduce, eliminate or prevent a disparity, based on the supporting theoretical orconceptual model?

Is there convincing evidence of substantive community input into the selection of proposed researchtopics and the identification of relevant community and/or population-level contextual factors to beexamined alongside individual risk factors?

Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partnerorganizations describe adequate roles and responsibilities of each organization in carrying out theproposed TCC activities and raise confidence that their involvement will facilitate achievement of thestated aims?

EnvironmentWill the scientific environment in which the work will be done contribute to the probability of success?Are the institutional support, equipment and other physical resources available to the investigatorsadequate for the project proposed? Will the project benefit from unique features of the scientificenvironment, subject populations, or collaborative arrangements?

Does the applicant organization describe its commitment to the establishment and maintenance of theproposed center in terms that raise confidence in the prospects for success?

Additional Review Criteria - OverallAs applicable for the project proposed, reviewers will evaluate the following additional items whiledetermining scientific and technical merit, and in providing an overall impact score, but will not giveseparate scores for these items.

Protections for Human SubjectsFor research that involves human subjects but does not involve one of the six categories of researchthat are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement ofhuman subjects and the proposed protections from research risk relating to their participationaccording to the following five review criteria: 1) risk to subjects, 2) adequacy of protection againstrisks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained,and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categoriesof research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification forthe exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. Foradditional information on review of the Human Subjects section, please refer to the Guidelines for theReview of Human Subjects (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11175).

Inclusion of Women, Minorities, and Children When the proposed project involves human subjects and/or NIH-defined clinical research, thecommittee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis ofsex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it isjustified in terms of the scientific goals and research strategy proposed. For additional information onreview of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in ClinicalResearch (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11174).

Vertebrate AnimalsThe committee will evaluate the involvement of live vertebrate animals as part of the scientificassessment according to the following five points: 1) proposed use of the animals, and species,strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for theappropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) proceduresfor limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct ofscientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/orcomfortable restraining devices; and 5) methods of euthanasia and reason for selection if notconsistent with the AVMA Guidelines on Euthanasia. For additional information on review of theVertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11150).

BiohazardsReviewers will assess whether materials or procedures proposed are potentially hazardous to researchpersonnel and/or the environment, and if needed, determine whether adequate protection is proposed.

ResubmissionsNot Applicable




RenewalsNot Applicable

RevisionsNot Applicable

Additional Review Considerations - OverallAs applicable for the project proposed, reviewers will consider each of the following items, but will notgive scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign OrganizationsNot Applicable

Select Agent ResearchReviewers will assess the information provided in this section of the application, including 1) the SelectAgent(s) to be used in the proposed research, 2) the registration status of all entities where SelectAgent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer ofSelect Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the SelectAgent(s).

Resource Sharing PlansReviewers will comment on whether the following Resource Sharing Plans, or the rationale for notsharing the following types of resources, are reasonable: 1) Data Sharing Plan(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11151); 2) Sharing Model Organisms(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11152); and 3) Genomic Data Sharing Plan .

Budget and Period of SupportReviewers will consider whether the budget and the requested period of support are fully justified andreasonable in relation to the proposed research.

Administrative Core Additional Review Criteria - Administrative CoreAs applicable for the project proposed, reviewers will evaluate the following additional items whiledetermining scientific and technical merit, and in providing an overall impact score for the AdministrativeCore, but will not give separate scores for these items.

Are strategies to ensure effective management, coordination and support of the TCC's multilevelchronic disease prevention program and related consortium activities well described and likely tosucceed? Do the proposed approaches for coordinating and supervising TCC activities raiseconfidence that each component's aims will be achieved within the project period?

Is the TCC organizational and governance structure adequately described and appropriate forsupporting the stated aims? Does the management plan adequately describe the composition androles of the TCC Steering Committee and any other committees proposed to help manage TCCactivities? Are appropriate resources and processes in place to ensure that TCC-supported researchwill be carried out in compliance with applicable federal regulations and policies?

Does the applicant include an evaluation plan with a logic model that incorporates appropriate



performance targets, objectives, and intervention outcomes (including economic evaluation)? Is theproposed evaluation plan well-conceived and described in sufficient detail to judge its utility forongoing project management? Is its execution likely to facilitate successful completion of the TCC'sstated aims?

Consortium Core Additional Review Criteria - Consortium CoreAs applicable for the project proposed, reviewers will evaluate the following additional items whiledetermining scientific and technical merit, and in providing an overall impact score for the ConsortiumCore, but will not give separate scores for these items.

Are the aims and objectives of the Core well described as a regional focal point for organizing andnurturing productive working relationships with community organizations, minority and health disparitypopulations, health care provider organizations, for-profit or non-profit organizations and otherstakeholders with an interest in using multilevel chronic disease prevention approaches to improvehealth equity? Are the proposed strategies to keep consortium partners and other stakeholdersinformed on an ongoing basis of TCC activities adequately described and likely to be effective? Doesthe applicant involve more than one community-based organization/American Indian TribalGovernment, either as the applicant or partnering organization?

Are consortium partner organizations and their respective roles and contributions clearly articulated? Isthe scientific rationale for including the consortium partners in research involving the proposed studypopulation(s) clear and consistent with the overall objectives of the proposed TCC? Do consortiumparticipants have relevant expertise, working relationships with the study population(s), and experienceparticipating in productive collaborations and partnerships? Does the Consortium Core leadershipinclude qualified representatives from consortium partner organizations?

Methodology Core Additional Review Criteria - Methodology CoreAs applicable for the project proposed, reviewers will evaluate the following additional items whiledetermining scientific and technical merit, and in providing an overall impact score for the MethodologyCore, but will not give separate scores for these items.

Is there existing evidence of a high prevalence or incidence of chronic diseases or conditions and lackof prevention and health promotion interventions or resources in the community identified? Is theredocumentation that these communities have a higher prevalence or worse outcomes than othercommunities? Does the community include significant representation from one or more US healthdisparity populations (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives,Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantagedpopulations and rural populations)? Do the proposed interventions involve 500 or more participantswithin the community?

Are the theoretical or conceptual models provided supporting the multilevel chronic diseaseprevention? Are the levels proposed in the intervention adequate and reasonable? Can the analyticplan address the impact on different levels and the interaction between them and how they influence

each other dynamically? Can the proposed study design improve the scalability and sustainability ofcommunity-based multilevel intervention?

Does the Core encourage and sustain active participation of investigators and partners to explore newmethodologies or approaches, generate baseline data to support the study design and programevaluation, and implement promising multilevel interventions in community settings?

Intervention ProjectOverall Impact - Intervention ProjectReviewers will provide an overall impact score to reflect their assessment of the likelihood for the project toexert a sustained, powerful influence on the research field(s) involved, in consideration of the followingreview criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Intervention ProjectReviewers will consider each of the review criteria below in the determination of scientific merit, and give aseparate score for each. An application does not need to be strong in all categories to be judged likely tohave major scientific impact. For example, a project that by its nature is not innovative may be essential toadvance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aimsof the project are achieved, how will scientific knowledge, technical capability, and/or clinical practicebe improved? How will successful completion of the aims change the concepts, methods,technologies, treatments, services, or preventative interventions that drive this field?

Does the application describe steps taken prior to and/or during the development of the application toobtain substantive community input into (1) identification of research topics of importance to theproposed study population(s), and (2) identification of relevant contextual factors (e.g., socialstratification, community ecological context, cultural factors, environmental factors, health-relatedpolicies, etc.) that mediate the effects of interventions targeting health disparities populations?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early StageInvestigators or New Investigators, or in the early stages of independent careers, do they haveappropriate experience and training? If established, have they demonstrated an ongoing record ofaccomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , dothe investigators have complementary and integrated expertise; are their leadership approach,governance and organizational structure appropriate for the project?

Does the application explain how the proposed collaborations will serve to advance scientificknowledge of the interplay between biological, behavioral, social and environmental risk and protectivefactors experienced across the life course?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms byutilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of

research or novel in a broad sense? Is a refinement, improvement, or new application of theoreticalconcepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish thespecific aims of the project? Are potential problems, alternative strategies, and benchmarks forsuccess presented? If the project is in the early stages of development, will the strategy establishfeasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1)the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals onthe basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified interms of the scientific goals and research strategy proposed?

Does the application describe the multilevel approach used in the project, including details on all levelsproposed to receive interventions and how the partners are going to support such interventions toreduce health disparities? What types of prevention, primary or secondary, are adopted? What chronicdisease/condition is being targeted and what potential clinical and other outcomes are anticipated? Isthe timeline of the proposed multilevel intervention included, and does the application describeresources already available to develop and conduct such interventions?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success?Are the institutional support, equipment and other physical resources available to the investigatorsadequate for the project proposed? Will the project benefit from unique features of the scientificenvironment, subject populations, or collaborative arrangements?

Additional Review Criteria - Intervention ProjectAs applicable for the project proposed, reviewers will evaluate the following additional items whiledetermining scientific and technical merit, and in providing an overall impact score for the InterventionProject, but will not give separate scores for these items.

Complementarity of Intervention Projects

Does the application explain how the project will complement and synergize with other interventionprojects included in the application, and how its successful completion will advance the TCC's overallaims and objectives?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of researchthat are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement ofhuman subjects and the proposed protections from research risk relating to their participationaccording to the following five review criteria: 1) risk to subjects, 2) adequacy of protection againstrisks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained,and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categoriesof research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for

the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. Foradditional information on review of the Human Subjects section, please refer to the Guidelines for theReview of Human Subjects (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11175).

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, thecommittee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis ofsex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it isjustified in terms of the scientific goals and research strategy proposed. For additional information onreview of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in ClinicalResearch (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11174).

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientificassessment according to the following five points: 1) proposed use of the animals, and species,strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for theappropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) proceduresfor limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct ofscientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/orcomfortable restraining devices; and 5) methods of euthanasia and reason for selection if notconsistent with the AVMA Guidelines on Euthanasia. For additional information on review of theVertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11150).

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to researchpersonnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Intervention ProjectAs applicable for the project proposed, reviewers will consider each of the following items, but will not givescores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research




Reviewers will assess the information provided in this section of the application, including 1) the SelectAgent(s) to be used in the proposed research, 2) the registration status of all entities where SelectAgent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer ofSelect Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the SelectAgent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for notsharing the following types of resources, are reasonable: 1) Data Sharing Plan(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11151); 2) Sharing Model Organisms(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11152); and 3) Genomic Data Sharing Plan .

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified andreasonable in relation to the proposed research.

Dissemination Core Additional Review Criteria - Dissemination CoreAs applicable for the project proposed, reviewers will evaluate the following additional items whiledetermining scientific and technical merit, and in providing an overall impact score for the DisseminationCore, but will not give separate scores for these items.

Are the proposed activities likely to promote or enhance dissemination of multilevel chronic diseaseprevention in collaboration with relevant communities, service providers, other partner organizationsand policy makers? Are steps to assess the effectiveness of dissemination efforts adequatelydescribed and appropriate?

Is there an appropriate plan to dissemination project findings to the community at large (rather thanjust community partners)? Does the application adequately address ethical considerations for (1)development and/or utilization of variables and measures in study populations, and (2) communicatingresearch results to the scientific community and the lay public? Are plans to ensure protection ofparticipating communities or groups from unintended harms, including risks associated with stigma,adequately addressed?

2. Review and Selection ProcessApplications will be evaluated for scientific and technical merit by (an) appropriate Scientific ReviewGroup(s), convened by NIMHD in accordance with NIH peer review policy and procedures(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11154), using the stated review criteria. Assignmentto a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications deemed to have the highestscientific and technical merit (generally the top half of applications under review) will be discussedand assigned an overall impact score.Will receive a written critique.




Appeals (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html) of initial peer review will notbe accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete foravailable funds with all other recommended applications submitted in response to this FOA. Followinginitial peer review, recommended applications will receive a second level of review by the National AdvisoryCouncil on Minority Health and Health Disparities. The following will be considered in making fundingdecisions:

Scientific and technical merit of the proposed project as determined by scientific peer review.Availability of funds.Relevance of the proposed project to program priorities. Geographic distribution of award recipients.

3. Anticipated Announcement and Award DatesAfter the peer review of the application is completed, the PD/PI will be able to access his or her SummaryStatement (written critique) via the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

Information regarding the disposition of applications is available in the NIH Grants Policy Statement(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11156).

Section VI. Award Administration Information1. Award NoticesIf the application is under consideration for funding, NIH will request "just-in-time" information from theapplicant as described in the NIH Grants Policy Statement(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11157).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organizationfor successful applications. The NoA signed by the grants management officer is the authorizing documentand will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.Selection of an application for award is not an authorization to begin performance. Any costs incurredbefore receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extentconsidered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on theAward Conditions and Information for NIH Grants (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11158) website. This includes any recent legislation and policy applicable to awards that is highlightedon this website.

2. Administrative and National Policy RequirementsAll NIH grant and cooperative agreement awards include the NIH Grants Policy Statement(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11120) as part of the NoA. For these terms ofaward, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A:General (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11157) and Part II: Terms and Conditions









of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, andActivities (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11159). More information is provided atAward Conditions and Information for NIH Grants (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11158).

Cooperative Agreement Terms and Conditions of Award

(http://nih-extramural-intranet.od.nih.gov/d/nih/topics/coop/index.htm)The following special terms of awardare in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administrationregulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an"assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmaticinvolvement with the award recipients is anticipated during the performance of the activities. Under thecooperative agreement, the NIH purpose is to support and stimulate the recipients' activities byinvolvement in and otherwise working jointly with the award recipients in a partnership role; it is not toassume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, thedominant role and prime responsibility resides with the recipients for the project as a whole, althoughspecific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

Coordinating project activities technically, scientifically and administratively at the recipientinstitution and coordinating project activities at other sites that may be supported by the award.Defining objectives and approaches; collecting and analyzing data; and publishing results,interpretations, and conclusions of studies conducted under the terms and conditions of the award.Ensuring that appropriate Institutional Review Board approvals and certifications for researchinvolving human subjects for all participating sites, collaborators or partners are obtained.Selecting external members for and participating in the TCC Consortium Steering Committee.Organizing an annual face-to-face meeting of the TCC Consortium Steering Committee.Consulting with NIMHD to ensure compliance with relevant grant policies and regulations.Participating in the TCC Program Coordinating Committee meetings and other PD/PI meetingsconvened by NIMHD.

Recipients will retain custody of and have primary rights to the data and software developed under theseawards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normalstewardship role in awards, as described below:

NIMHD will assign a Program Official (see below) and Project Scientist(s) to the TCC award. The ProjectScientist(s) will have substantial scientific involvement during the conduct of this activity, through technicalassistance, advice, and coordination. Project Scientists(s) will:

Review and comment on critical stages in the program implementation;Assist in the interaction between the recipient and investigators at other institutions to promotecollaborations;Assist in coordinating access to other resources available through statewide, regional, or nationalspecialized cores or resources;

http://nih-extramural-intranet.od.nih.gov/d/nih/topics/coop/index.htm



Retain the option of recommending termination of support if technical performance orimplementation falls below acceptable standards, or when specific key resources cannot beeffectively implemented in a timely manner;Retain the option to recommend additional infrastructure support within the constraints of theapproved research and negotiated budget;Convene meetings/workshops to address emerging areas of high priority.

Additionally, the NIMHD program official will be responsible for the normal scientific and programmaticstewardship of the award and will be named in the award notice. The Program Official will:

Assist with the NIMHD’s monitoring of compliance of award-supported activities;Evaluate progress by reviews of technical or fiscal reports or by site visits to determine thatperformance is consistent with objectives, terms and conditions of the award;Help ensure that activities proposed for development or implementation do not overlap or duplicateactivities supported by other peer-reviewed funding mechanisms;Provide assistance in reviewing and commenting on all major transitional changes of TCC activitiesprior to implementation to ensure consistency with the goals of this FOA;Link the approaches developed from the TCC to other NIMHD-supported activities to ensure thatinformation is shared and utilized on the widest basis possible;Monitor institutional commitments and resources to help ensure that the TCC receives the maximumchance of stabilization and success;Assist with the NIMHD’s monitoring of financial oversight of the Program.

Areas of Joint Responsibility include:

Establishing a TCC Steering Committee consisting of: 1) the PD(s)/PI(s); 2) two or more membersrepresenting consortium partner organizations, with at least one representative from a non-researchinstitution, 3) two external members selected by the PD(s)/PI(s); 4) the NIMHD Program Official; and5) the NIH Project Scientist(s). Each committee member will have one vote except for the NIH staffmembers, who will share one vote. The TCC Steering Committee will convene by telephone asneeded and will meet in person at least once a year.Identifying and facilitating partnerships with other NIMHD award recipients in the respective regionswith expertise and/or interest in multilevel chronic disease prevention and health disparities or otherrelevant resources and expertise that could be leveraged to facilitate achievement of the TCCProgram goals and objectives. Organizing and participating in the TCC Program Coordinating Committee meetings at least annuallyto discuss matters of mutual interest and promote information exchange across regions.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award)between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panelcomposed of three members will be convened. It will have three members: a designee of the SteeringCommittee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in therelevant area who is chosen by the other two; in the case of individual disagreement, the first member maybe chosen by the individual award recipient. This special dispute resolution procedure does not alter therecipient's right to appeal an adverse action that is otherwise appealable in accordance with PHSregulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. ReportingWhen multiple years are involved, awardees will be required to submit the Research Performance ProgressReport (RPPR) (http://grants.nih.gov/grants/rppr/index.htm) annually and financial statements as requiredin the NIH Grants Policy Statement. (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11161)

A final progress report, invention statement, and the expenditure data portion of the Federal FinancialReport are required for closeout of an award, as described in the NIH Grants Policy Statement(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11161).

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes arequirement for awardees of Federal grants to report information about first-tier subawards and executivecompensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIHgrants and cooperative agreements are required to report to the Federal Subaward Reporting System(FSRS) available at www.fsrs.gov (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11170) on allsubawards over $25,000. See the NIH Grants Policy Statement(http://grants.nih.gov/grants/guide/url_redirect.htm?id=11171) for additional information on this reportingrequirement.

Section VII. Agency ContactsWe encourage inquiries concerning this funding opportunity and welcome the opportunity to answerquestions from potential applicants.

Application Submission ContactseRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking anapplication, documenting system problems that threaten submission by the due date, post submissionissues)Finding Help Online: http://grants.nih.gov/support/ (http://grants.nih.gov/support/) (preferred method ofcontact)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (http://www.grants.gov/contactus/contactus.jsp) (Questions regardingGrants.gov registration and submission, downloading forms and application packages)Contact Center Telephone: 800-518-4726 Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx (https://grants-portal.psc.gov/ContactUs.aspx) Email: [email protected] (mailto:[email protected])

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)Email: [email protected] (mailto:[email protected]) (preferred method of contact)Telephone: 301-435-0714

Scientific/Research Contact(s)Xinzhi Zhang, MD, PhD National Institute on Minority Health and Health Disparities (NIMHD)Telephone: 301-594-6136 Email: [email protected] (mailto:[email protected])

Peer Review Contact(s)


http://grants.nih.gov/grants/rppr/index.htm






http://www.grants.gov/contactus/contactus.jsp

https://grants-portal.psc.gov/ContactUs.aspx

http://grants.nih.gov/support/


Maryline Laude-Sharp, PhDNational Institute on Minority Health and Health Disparities (NIMHD)Telephone: 301-451-9536Email: [email protected] (mailto:[email protected])

Financial/Grants Management Contact(s)Priscilla Grant, JDNational Institute on Minority Health and Health Disparities (NIMHD)Telephone: 301-594-8412 Email: [email protected] (mailto:[email protected])

Section VIII. Other InformationRecently issued trans-NIH policy notices (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11163)may affect your application submission. A full list of policy notices published by NIH is provided in the NIHGuide for Grants and Contracts (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11164). All awardsare subject to the terms and conditions, cost principles, and other considerations described in the NIHGrants Policy Statement (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11120).

Authority and RegulationsAwards are made under the authorization of Sections 301 and 405 of the Public Health Service Act asamended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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Documents

RFA-MD-15-014_ NIMHD Transdisciplinary Collaborative Centers for Health Disparities Research on Chronic Disease Prevention (U54)