DHA-22-MHSR-Submittal Instructions.pdf

NOTICE OF FUNDING OPPORTUNITY

for the

Department of Defense (DoD)

Defense Health Agency (DHA)

Research and Development Directorate (J-9)

Military Health System Research (MHSR)

Table of Contents

A. Program Description

MHS Description

MHSR Priority Topic Areas

Clinical Priority Areas

B. Estimated Timeline for the Grants Process

C. Federal Award Information

D. Eligibility Information

Eligible Applicants

Number of Submission

Other Infomration

E. Application and Submission Information

Application Package

Content and Form of Application Submission

Submission Dates and Times

F. Application Review Information

Proposal Evaluation Criteria and Selection Information

Scientific Technical Review

Programmatic Review

G. Federal Award Information

H. Federal Awarding Agency Contact(s)

I. Other Information

MHSR Resources:

DoD Research Data Resources

J. Proposal Submission Checklist

K. Appendix: Statement Of Substantial Involvement

Recipient Responsibilities

DHA Responsibilities

A. PROGRAM DESCRIPTION

The Military Health System Research (MHSR) Initiative provides grants for topic areas directed by the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Defense Health Agency (DHA). The intent of this initiative is to foster research capability and capacity within the Military Health System (MHS) that supports the MHS transition to an integrated health system focused on the Quadruple Aim: improved health readiness, better health, better care, and lower cost.

The MHSR seeks studies on factors that affect the access, economics/cost, quality, variation and outcomes of military health care delivery. This includes how policies, social factors, financing systems, organizational structures and processes, health technologies, and behaviors influence the military health care delivery to DoD beneficiaries – i.e., individual service members, families, communities, and populations.

The goal is to identify and further characterize the factors that influence the efficiency and effectiveness of care delivery. Knowledge obtained from this research supports evidence-based policy and decision-making at the strategic and front-line levels. This Notice of Funding Opportunity (NOFO) seeks rigorous health system research through collaborations that have the potential to innovate military and civilian health care. The goal is also to enhance data-driven evidence that optimizes the MHS delivery of health care and the improvement of beneficiary health. This NOFO is intended to solicit Intramural and Extramural Military Health System Research aligned with DHA priority research areas.

MHS Description The MHS is one of America’s largest and most complex health care systems that provides universal access to 9.5 million beneficiaries, which include Service members (Active and Reserve) and their families, retirees and their families, survivors, and certain former spouses (https://www.tricare.mil/Plans/Eligibility). The MHS currently operates 475 hospitals and clinics, and 248 dental clinics located on military installations around the world. These facilities are subject to the same requirements for accreditation as other United States (US) hospitals with demands to improve quality, safety, costs, and outcomes, including the additional requirement to improve military medical readiness for 1.3 million Active Duty Service members. The National Defense Authorization Act for Fiscal Year (FY) 2017, Section 702, requires the consolidation of all Services’ Military Treatment Facilities (MTFs) under the DHA.

The MHS is managed by the TRICARE health care program, which provides comprehensive coverage to all DoD beneficiaries. The TRICARE health care program brings together 51 inpatient hospitals and medical centers (37 in the US), 424 ambulatory care and occupational health clinics (373 in the US), 248 dental clinics (204 in US), and 251 veterinary facilities (206 in US). TRICARE works with its network and non-network TRICARE-authorized civilian health care professionals, institutions, pharmacies, and suppliers (often referred to as “purchased care”) to provide access to the full array of high-quality health care services while maintaining the capability to support military operations.

According to 2018 data, the MHS provided 103.9 million outpatient visits, 979.6 thousand inpatient admissions, delivered 107.1 thousand babies, and filled 115.6 million prescriptions to a spectrum of beneficiaries that include: Active Duty (1.38 M) and their family members (1.68 M), Guard/Reserve (0.19 M) and their family members (0.78 M), and retirees and their family members (5.49 M). Data on the 9.5 million beneficiaries and the TRICARE health plan is captured in the Military Data Repository.

https://www.tricare.mil/Plans/Eligibility

TRICARE has several different plans, including TRICARE Prime, TRICARE Select, and TRICARE for Life (TFL).

TRICARE Prime is comparable to the health maintenance organization benefits offered in many areas.

TRICARE Prime’s point-of-service option permits enrollees to obtain care from TRICARE authorized providers other than the assigned Primary Care Manager (PCM) without a referral, but with deductibles and cost shares significantly higher than those under TRICARE Prime. TRICARE Select is a fee-for-service plan available within the US through any TRICARE authorized provider, where patient costs vary based upon sponsor’s military status. TFL is the Medicare wraparound coverage for TRICARE-eligible beneficiaries who have both Medicare Parts A and B as their primary health care coverage. In most instances, Medicare pays first, then TRICARE pays second for TRICARE covered services. Most TRICARE health plans meet the requirements for minimum essential coverage under the Affordable Care Act.

For further details on TRICARE plan options see: https://www.tricare.mil/Plans/HealthPlans.

To access the current Annual Evaluation of the TRICARE Program see: https://www.health.mil/Military- Health-Topics/Access-Cost-Quality-and-Safety/Health-Care-Program-Evaluation/Annual-Evaluation-of-the-TRICARE-Program.

MHSR Priority Topic Areas To be considered for funding, proposals must specifically address at least one of the Priority Topic Areas cited below and delineate how the research aims to address the Priority Topic Area(s):

a. Health System Reform -

The impact of the significant changes in policy or structure of the MHS, such as the consolidation under a single management structure, of health care utilization, quality, cost, health outcomes, manpower/staffing, health care readiness, or graduate medical, dental, and health education;

including potential comparisons to similar activities within the private sector. The impact of policy changes such as to the TRICARE benefit structure on utilization and cost that includes the introduction of co-pays, deductibles, and expansion of benefits.

b. Economics and Cost -

Research on the factors that shape the MHS, drive demand and utilization, and influence cost in either TRICARE direct or purchased care systems; issues related to efficiency, effectiveness, value and behavior in the production, and consumption of health and health care in terms of costs, charges and expenditures; and the impact of technologies on care delivery and cost. Research that delineates value-based care within the MHS in both purchased and direct care; pre and post studies looking at difference in the structure of the TRICARE contract and the impact on patient care.

c. Quality -

Research which examines the degree to which health services for individuals and populations are safe, effective, patient-centered, timely, efficient, and equitable with the outcome of increasing the likelihood of improved health. The impact of standardizing clinical practice through clinical practice guidelines, evidence-based practices, and process improvements, on the health of the population/sub-population.

https://www.tricare.mil/Plans/HealthPlans https://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Health-Care-Program-Evaluation/Annual-Evaluation-of-the-TRICARE-Program https://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Health-Care-Program-Evaluation/Annual-Evaluation-of-the-TRICARE-Program https://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Health-Care-Program-Evaluation/Annual-Evaluation-of-the-TRICARE-Program

d. Outcomes -

Health outcome research identifies and measures the relationship between treatments or interventions delivered, and the improvements in health care delivery that impact the achievement of the Quadruple Aim “better health” in geographic markets or sub-population levels of the MHS with comparisons to private sector efforts. Health outcomes research incorporates clinical outcomes, financial impact, patient health, quality of life, and measurement of indicators that predict results important to patients and patient experience.

e. Variation -

Studies that examine the regional, facility, or Service differences in health care. Unwarranted variation or differences in quality, utilization, cost, or outcomes within the MHS and the implications to the health of the population and the system of care.

f. Health Readiness -

Burden of disease and associated health and risk factors within the MHS populations. Implications of disease burden as an indicator of medical readiness, potential impact to staffing, network utilization, and cost for direct care and/or purchased care, potential comparisons to private sector in similar markets.

Clinical Priority Areas The proposals must emphasize one of the listed Clinical Priority Areas:

a. Behavioral Health

b. Cardiovascular Care

c. Complex Pediatrics

d. Critical Care/Trauma

e. Dental

f. Military-Specific Care

g. Neuro-musculoskeletal

h. Oncology

i. Primary Care

j. Specialty Care

k. Surgical Services

l. Women and Infant

Proposals must address one or more of the MHSR priority topic areas and one of the clinical priority areas listed. Letters of Intent (LOIs) applicants that do not meet this requirement will not be asked to submit a full proposal.

B. ESTIMATED TIMELINE FOR THE GRANTS PROCESS

It is incumbent upon the award recipients to ensure they have the appropriate agreements (e.g., Memorandum of Agreement or MOAs) and vehicles for accepting and obligating the Research, Development, Test and Evaluation (RDT&E) funds of the Defense Health Program.

General timeline for this announcement is subject to change.

• February 1, 2021 NOFO posted on https://www.grants.gov

• March 2, 2021 Deadline for receipt of LOI (5 weeks)

• March 15, 2021 Release of invitations to submit full proposals (2 weeks)

• May 31, 2021 Deadline for receipt of full proposals (11 weeks)

• August 2, 2021 Completion of scientific and programmatic reviews (9 weeks)

• September 6, 2021 Begin notification of grant award winners

C. FEDERAL AWARD INFORMATION

For FY 2021, the DHA Research and Development Directorate (J-9) is seeking to award grants to a number of successful candidates by September 30, 2021. Total available funds for grants under this notice are anticipated to be $10,000,000, but are subject to availability of DHA funds in FY 2022. It is anticipated that several awards will result from this NOFO, which will include both extramural and intramural grant awards.

• Any eligible applicants (as detailed below) can submit one or two LOIs but only one LOI will be considered.

• Full proposals will only be accepted from eligible applicants who submitted an LOI and received an invitation to submit a full proposal.

• The DHA reserves the right to fund all, some, or none of the proposals submitted, may elect to fund only part of any or all proposals, and may incrementally or fully fund any or all proposals under this NOFO.

This funding opportunity will result in grants. General guidance and procedures for proposal submission are described at www.grants.gov. If an award results in a cooperative agreement, the government will have substantial involvement in the project as outlined in Appendix of this notice.

D. ELIGIBILITY INFORMATION

Eligible Applicants LOIs and Full Proposals for this funding opportunity may be submitted by investigators, uniformed or civilian staff who work for DoD or non-DoD organizations, as defined below. DHA encourages applications from Minority Serving Institutions (MSI) that include Historically Black Colleges and Universities and others as defined at: https://www.doi.gov/pmb/eeo/doi-minority-serving-institutions-program.

http://www.grants.gov/ https://www.doi.gov/pmb/eeo/doi-minority-serving-institutions-program https://www.doi.gov/pmb/eeo/doi-minority-serving-institutions-program

a. Extramural Organization: An eligible non-DoD organization. Examples of extramural organizations include academic institutions, nonprofit organizations, and other federal government organizations (other than DoD).

• Federally Funded Research and Development Centers (FFRDCs) are not eligible to directly receive awards under this NOFO. However, teaming arrangements between FFRDCs and eligible organizations are allowed if permitted under the sponsoring agreement between the federal government and the specific FFRDC.

• Government agencies within the US: Local, state, and non-DoD federal government agencies are eligible to the extent that proposals do not overlap with their fully-funded internal programs. Such agencies are required to explain how their proposals do not overlap with their internal programs.

b. Intramural DoD Organization: A facility or group of facilities owned, leased, or otherwise used by Office of the Secretary of Defense, the Military Departments, the Defense Agencies, and all other organizational entities within the DoD; to include DoD laboratories, DoD MTFs, and/or DoD activities embedded within a civilian medical center.

Number of Submissions An eligible applicant may submit up to two LOIs for consideration, but only one (1) LOI may be selected from the submitting extramural and/or intramural organization under this announcement.

a. For applicants with dual appointments with a Federal Agency and a university, please identify the "single" organization or affiliation which will have legal authority over funds resulting from the award.

b. It is recommended that extramural organizations partner with DoD partners to improve understanding of the context of the research.

c. A full proposal from a DoD intramural applicant must include a succession plan that discusses the transfer of the research in the event the applicant deploys or has a change of duty station. Additionally, a letter of support from their commanding officer is required.

Other Information

a. There is no cost sharing or match requirement.

b. All partnership or contract agreements are the responsibility of the applicant’s organization and should be in place prior to receiving the award of funds.

c. Grants will be awarded to organizations, not to individuals.

d. This funding opportunity is a multi-step process.

• LOIs will be subject to a general review to determine if the research intent aligns with DHA’s priority research area and objectives.

• If selected, the applicant will be invited to submit a full proposal for a technical merit review, which includes both scientific and programmatic review.

• Resubmission of the LOI or failure to submit a full proposal by the proposal deadline will result in immediate dismissal from further review.

E. APPLICATION AND SUBMISSION INFORMATION

Application Package This notice contains the information required for submission of the LOI to dha.ncr.j-9.mbx.hsr@mail.mil.

For full proposal submission requirements and procedures, see direction through the website:

https://www.grants.gov.

Content and Form of Application Submission

a. LOI Content Requirement:

1) General Information Required

• Contact information for the Principal Investigator (PI), including organization, DoD affiliation, if any, and a succession plan for military personnel associated with the research. A succession plan states what will occur in the event the PI deploys or has a permanent change of duty station.

• If a proposal is from an MSI, clearly state the investigator's institutional status within the MSI in the LOI template.

• Provide the organization’s resource manager/comptroller or equivalent Business Official and Authorized Organizational Representative (AOR) responsible for program administration. (If awarded, this person will be identified in Block 5 of the SF-424 form.)

• Performing organization (i.e., site at which the PI will perform the proposed work) and the submitting organization (i.e., organization submitting the LOI(s) on behalf of the PI).

2) Collaborators and Key Personnel

• Include information on name, organization, and role of all collaborators and key personnel associated with the LOI proposal (including co-investigators, mentors, collaborators, consultants, and sub-awardees, if applicable).

• Briefly describe the role of the PI, co-PIs (if applicable), key personnel, sub-awards (if applicable), and consultants (if applicable) on the research team, including the expertise each brings to the proposed project. Explain how the team’s expertise is appropriate and complementary for achieving the research goals. Also, briefly provide information on the primary institution and facility where the research is expected to be performed.

3) Narrative (5-page limit) The LOI page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, and drawings) used to briefly describe the project. Inclusion of URLs in the narrative that provide additional information confer an unfair competitive advantage and, thus, are prohibited and will result in rejection of the LOI.

The LOI Narrative should include the following:

• Priority Topic Area(s): Identify the FY 2021 DHA MHSR Priority Topic Area(s) that the proposed research addresses.

• Alignment with Clinical Priority Areas: Explain how the proposed research is relevant to the identified MHSR and clinical priority areas and supports the MHS.

mailto:dha.ncr.j-9.mbx.hsr@mail.mil https://www.grants.gov/

• Research Plan: Briefly state ideas and reasoning on which the proposed work is based. Include:

o Background/Rationale: Briefly present the ideas and reasoning behind the proposed research. Include relevant military and civilian literature citations, preliminary and/or pilot data, and/or other evidence that led to the development of the proposed research. Any preliminary data should be from the PI and member(s) of the collaborating team.

o Hypothesis, Specific Aims, and Objectives: Clearly state the proposed research hypothesis and/or objectives and the specific aims/tasks. Aims are statements of intent (i.e., what the research hopes to achieve). Objectives are statements that define measurable outcomes (i.e., the steps that will be taken to achieve the desired outcome).

o Theoretical Rationale, Scientific Methods, and Design: Briefly describe the research approach with information on proposed methods and analysis/evaluation strategies. Describe anticipated outcomes of how this study will enhance knowledge in designated priority areas, as well as expected outcomes. Include a description of study population for studies involving human subjects, include a description of the size and characteristics of the subject population. Include all data sources that require data sharing agreements.

• Military Relevance and Impact: Describe, if successful, the extent to which the study could impact healthcare research, improve military health care, or promote the Quadruple Aim. Describe how the proposed study will directly or indirectly benefit military Service members and other beneficiaries, as well as how the knowledge can be utilized across the MHS.

• Timeline and Estimated Total Budget: Provide the estimated total budget and a timeline to achieve the research plan. Sub-awards and contracts may not exceed 30% of the total estimated budget.

4) Supporting Documentation

• References Cited (one-page limit): List the references cited (including URLs if available) in the LOI narrative using a standard reference format that includes the full citation (i.e., author[s], year published, title of reference, source of reference, volume, chapter, page numbers, and publisher, as appropriate).

• List Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms, and symbols used.

• PI(s) and Key Personnel Biographical Sketches (five-page limit per individual): Upload file as “Biosketch_LastName.pdf.” The NIH Biographical Sketch (non-fellowship) may be used (https://grants.nih.gov/grants/forms/biosketch.htm). Biographical Sketches should be used to demonstrate background and expertise through education, positions, publications, and previous work accomplished. Bold or highlight publications relevant to the proposed project.

https://grants.nih.gov/grants/forms/biosketch.htm

A MHSR program committee will review all LOIs submitted. PIs whose LOI best aligns with the stated priority areas as demonstrated by clear objectives, aims, and appropriate methods will then be invited to submit full proposals for consideration of an award. All full proposals must be submitted through the website: https://www.grants.gov. Proposals will not be accepted by mail or in person. Uninvited proposals will not be reviewed or considered for an award.

b. Full Proposal Content Requirement:

1) All full proposals must be submitted through the website: https://www.grants.gov.

Proposals will not be accepted by mail or in person. Uninvited proposals will not be reviewed or considered for an award.

2) For this funding opportunity, each proposal submission must include the complete proposal package requirements established at https://www.grants.gov. The completed proposal package shall be submitted by the AOR.

3) The proposal package includes the following mandatory components:

• SF-424 Research and Related (R&R) Application for Federal Assistance Form

• R&R Other Project Information Form o Project Summary/Abstract o Project Narrative o Bibliography & References Cited o Facilities & Other Resources o Equipment

• Project/Performance Site Location

• R&R Personal Data Form

• R&R Senior/Key Person Profile (Expanded) Form

• R&R Attachments

• R&R Multi-Year Budget Form – for years one and two

• R&R Sub-Award Budget Attachment Form

See General Submission Instructions for more information about each form. All forms can be found on https://www.grants.gov.

4) Other Notices:

• Each applicant (unless the applicant is an individual or federal awarding agency that is excepted from those requirements under 2 code of federal regulation (CFR) §25.110(b) or (c), or has an exception approved by the federal awarding agency under 2 CFR §25.110(d)) is required to:

o be registered in the System for Award Management (SAM) before submitting its application;

o provide a valid unique entity identifier (UEI) in its application; and o continue to maintain an active SAM registration with current information at all times during which it has an active federal award or an application or plan under consideration by a federal awarding agency.

• An award will not be made to an applicant until the applicant has complied with all applicable UEI and SAM requirements and, if an applicant has not fully complied with the requirements by the time DHA is ready to make award, the DHA Grants Officer may determine that the applicant is not qualified to receive a federal award and use that determination as a basis to make an award to another applicant.

Submission Dates and Times

a. LOI Submissions All LOIs must be submitted by the PI through the DHA MHSR program mailbox (dha.ncr.j- 9.mbx.hsr@mail.mil) by 2 March 2021, 5 PM EST. PIs and organizations identified in the LOI must be the same as those intended for the subsequent proposal submission. Any changes after submission of the LOI requires contacting the DHA J-9 Technical Representative through the DHA MHSR program mailbox (dha.ncr.j-9.mbx.hsr@mail.mil). A change in PI or organization after submission of the LOI will be allowed only at the discretion of the J-9 Technical Representative.

b. Proposal Submissions

1) All full proposal submissions must be submitted to https://www.grants.gov by 31 May 2021, 5 PM EST.

2) The LOI and full proposal submission process should be started early to avoid missing deadlines, which will result in proposal rejection.

3) There will be no grace periods. Applicants must be familiar with requirements from https://www.grants.gov, including the need for an active SAM registration and an UEI as a Data Universal Numbering System is being phased out.

c. LOIs/Proposals Rejections. LOIs or Proposals may be rejected due to any of the following:

1) LOI Narrative is missing.

2) LOI Narrative exceeds page limit.

3) LOI was submitted by an ineligible organization.

4) Submission of a proposal for which a LOI was not received.

5) Submission of an approved LOI in lieu of a full proposal.

6) Project Narrative is missing.

7) Budget is missing.

8) Personnel from proposing or collaborating organizations are found to have contacted persons involved in the review process to gain protected evaluation information or to influence the evaluation process.

9) The proposal fails to conform to this NOFO description to the extent that appropriate review cannot be conducted.

10) Total costs as shown on the DoD Military Budget Form exceed the maximum allowed by this funding opportunity.

11) PI transition plan and command letters of support are missing.

12) Inclusion of URLs, with the exception of links in References Cited and

Publication and/or Patent Abstract sections.

mailto:dha.ncr.j-9.mbx.hsr@mail.mil mailto:dha.ncr.j-9.mbx.hsr@mail.mil mailto:dha.ncr.j-9.mbx.hsr@mail.mil

13) Page size is larger than 8.5 inches x 11.0 inches. (Approximately 21.59 cm x

27.94 cm.)

14) The PI does not meet the eligibility criteria.

Sections exceeding the specified page limits will have any pages after the limit removed before review.

d. All applicants will receive an acknowledgment from www.grants.gov upon receipt of LOI or proposal submissions.

e. The following funding restrictions apply:

1) The maximum period of performance is two years.

2) The anticipated total costs (direct and indirect) should be budgeted for the entire period of performance. Indirect costs are to be budgeted in accordance with the organization’s negotiated rate. No budget will be approved by the government exceeding the stated total costs or using an indirect rate exceeding the organization’s negotiated rate.

3) All direct and indirect costs of any sub-award (sub-grant or sub-contract) must be included in the total costs of the primary award.

4) The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum two years.

5) Regardless of the period of performance or number of collaborators proposed, the applicant may not exceed the maximum allowable total costs.

6) Funding to intramural organizations for selected proposals will be executed through the Military Interdepartmental Purchase Request (MIPR) or Funding Authorization Document (FAD) process. Transfer of funds is contingent upon appropriate safety and administrative approvals. Intramural applicants and collaborators are reminded to coordinate receipt and commitment of funds through their respective resource managers.

• It is expected that any contracted services and/or Interservice Support

Agreements (ISA) from intramural agencies will NOT EXCEED 30% of the proposed total budget unless approved via waiver during the proposal submission process. Arriving at the 30% mark can be by year, combination of years, or all in one year, as long as it does not exceed the total budget in calculating the total costs, or include donated/contributed personnel time.

• Intramural applicants must provide a detailed Federal Agency Financial Plan after the budget justification information in the Detailed Budget and Justification Form. Proposals must provide a plan delineating how all FY 2022 RDT&E funds will be obligated. The plan must include the funding mechanism(s) and contractual arrangements that will be used to carry over funds between fiscal years, if applicable.

• Applicants must provide Letters of Organizational Support from the following:

o Resource Manager/Comptroller: Provide a letter of support from the applicant institution’s Resource Manager/Comptroller Office (or appropriate financial point of contact) assuring that the institution http://www.grants.gov/ will be able to accept these funds, if awarded. If funds are to be sent to multiple sites, include a letter from each site.

o Commander(s): Provide a letter (or letters) of support from appropriate MTF, Installation Commander, or equivalent Commanders/Directors to ensure access to the facility, research population, and other necessary resources. The Commander should be aware of all submissions and should confirm that the proposed work is both feasible from a technical perspective and relevant from a programmatic and Command perspective.

o Sub-awards to intramural agencies and other federal agencies may be executed through a direct fund transfer (e.g., MIPR, FAD process, or ISA (DD form 1144)). Direct transfer of funds from the recipient to a federal agency is not allowed except under very limited circumstances. See www.grants.gov for additional information on budget considerations for proposals involving federal agencies.

f. For this award mechanism, direct costs may be requested for (not all-inclusive):

1) Salary, including contract personnel (federal salaries paid by the parent organization may not be reimbursable)

2) Research supplies

3) Equipment

4) Research-related subject costs

5) Clinical research costs

6) Support for multidisciplinary collaborations, including travel

7) Travel costs for up to one investigator to travel to one scientific/technical meeting per year

8) Travel costs are intended for the PI or his/her designee only, justification must be provided if other personnel are included in the travel budget

F. APPLICATION REVIEW INFORMATION

Proposal Evaluation Criteria and Selection Information All full proposals will be evaluated using a two-tier review process. The first tier is a peer review of proposals against established criteria for determining technical merit. The second tier is a programmatic review that makes recommendations for funding to the DHA J-9 and the OASD(HA), based on (a) scientific and technical merit and (b) the relevance to the mission of the HA/DHA and the MHS Quadruple Aim. The highest-ranked proposals from the first tier of review may not automatically be recommended for funding depending on the second tier, programmatic review.

All review processes are conducted confidentially to maintain the integrity of the merit-based selection process. Personnel at the applicant or collaborating organizations are prohibited from contacting persons involved in the review process to gain evaluation information or to influence the evaluation process. Violations of these prohibitions will result in rejection of the organization’s proposal.

Violations by applicants that compromise the confidentiality of the review process or are otherwise improper may also result in suspension or debarment from federal awards.

Scientific Technical Review

a. General

1) To determine scientific and technical merit, the evaluators will assess and grade/evaluate Full Proposals according to the criteria below, but the government reserves the right to reconsider in light of its needs.

2) To be considered for funding, proposals must address one or more of the MHSR priority topic areas AND one of the clinical priority areas, listed above in the Program Description.

3) Proposals will be scored and ranked based on how well each proposal addresses the priority areas and the requested elements along with the strength of the science listed in the Application and Submission section above.

4) Highly ranked, well-justified projects that address all of the requested proposal elements will receive higher ranking scores.

b. Criteria. Full proposals will be evaluated according to the following criteria:

• Research Objectives

• Theoretical Rationale

• Scientific Design and Methods

• Impact/Outcomes

• Personnel and Facilities

• Budget

• Succession Plan

• Proposal Clarity

Programmatic Review

• To make funding recommendations, programmatic reviewers will use the following criteria:

o Ratings and evaluations of the peer reviewers (e.g., the scored scientific review) o Relevance to the mission of the MHS/DHA o Relative innovation and impact o Proposed project timelines o Open Source/License/Architecture

• The above considerations are not listed in any order of importance. Other factors taken into consideration may include the critical nature of the project, alignment to DoD’s initiative, and availability of funding.

G. FEDERAL AWARD INFORMATION

Once the successful applicants have been selected, they will be notified by the DHA Grants Office of their award. A notification letter will outline and address any Pre-Award costs, and grant authorization to begin performance. Pre-Award monies spent will be at the non-federal entity’s own risk. The notice of the federal award signed by the DHA Grants officer is the authorizing document.

See the General Submission Guidance for administrative and national policy requirements at www.grants.gov

Reporting for this grant opportunity is as follows:

• Quarterly, annual, and final technical progress reports will be required.

• Reports are to include financial status, and dissemination and implementation plans.

• In addition to written progress reports, in-person presentations may be requested.

H. FEDERAL AWARDING AGENCY CONTACT(S)

• DHA Acquisition (J-4) Contracting/Grants/Agreements Officer Mr. Nicholas R. Ceciliani

• DHA MHSRP Technical Representative

Dr. Diana M. Luan

• Please email all questions to the:

DHA MHSR, Program Mailbox dha.ncr.j-9.mbx.hsr@mail.mil

• GRANTS.GOV Contact Center

Questions related to proposal submission through the GRANTS.GOV portal should be directed to the GRANTS.GOV Contact Center, which is available 24 hours a day, 7 days a week (closed on US federal holidays).

Phone: 800-518-4726; International: 1-606-545-5035

Email: SUPPORT@GRANTS.GOV

I. OTHER INFORMATION

The following internet addresses may help the applicant understand more about the funding opportunity and program initiatives.

http://www.grants.gov/ mailto:dha.ncr.j-9.mbx.hsr@mail.mil mailto:support@grants.gov

MHSR Resources:

Applicants wishing to learn more about health system research delivery are encouraged to consult the following:

• AcademyHealth (https://www.academyhealth.org/evidence): The science of study that determines what works, for whom, at what cost, and under what circumstances. It studies how our health system works, how to support patients and providers in choosing the right care, and how to improve health through care delivery. This site offers additional information on health services research topics and provides additional resources.

• Health Services Research Journal (http://www.hsr.org/): The official journal for AcademyHealth and the flagship journal for Health Research & Education Trust is published six times a year.

• Health Services Research & Public Health Information Programs (https://www.nlm.nih.gov/hsrph.html): A free health services research and public health resource containing a research portal and database run by the National Information Center on Health Services Research and Health Care Technology at the National Library of Medicine.

• U.S. Department of Veterans Affairs Health Services Research & Development (https://www.hsrd.research.va.gov/for_researchers/default.cfm): The Department of Veterans Affairs (VA) Health Services Research and Development Service (HSR&D) pursues research that underscores all aspects of VA healthcare: patient care, care delivery, health outcomes, cost, and quality. HSR&D research also addresses critical issues for veterans returning home from Iraq and Afghanistan with conditions that may require care over their lifetimes. Within VA HSR&D, researchers focus on identifying and evaluating innovative strategies that lead to accessible, high quality, cost-effective care for veterans and the nation.

• VA/DoD Collaboration Guidebook for Healthcare Research (https://www.med.navy.mil/sites/nmcp/Dept/Shared%20Documents/CID/VA-DoD- Guidebook-2013.pdf): The purpose of this guidebook is to help facilitate collaborative human subject healthcare research between the VA and the DoD.

• Agency for Healthcare Research and Quality (AHRQ)(https://www.ahrq.gov) AHRQ is the Federal agency charged with improving the safety and quality of American’s health care system.

• Patient-Centered Outcomes Research Institute (PCORI) (https://www.pcori.org/ ) PCORI funds research that offers patients and caregivers the information they need to make important health care decisions.

DoD Research Data Resources:

Applicants are encouraged to consider leveraging resources available through existing DoD and/or VA.

These resources include:

• Military Data Repository (MDR) is a centralized data repository that captures, validates, integrates, distributes, and archives corporate health care data. The MDR and MHS Mart (M2) are the most comprehensive health care databases that provide the opportunity to study the impacts of universal access to care and has the potential to influence U.S. health care. (https://www.health.mil/Military-Health-Topics/Technology/Support-Areas/MDR- M2-ICD-Functional-References-and-Specification-Documents)) https://www.academyhealth.org/evidence http://www.hsr.org/ https://www.nlm.nih.gov/hsrph.html https://www.hsrd.research.va.gov/for_researchers/default.cfm https://www.med.navy.mil/sites/nmcp/Dept/Shared%20Documents/CID/VA-DoD-Guidebook-2013.pdf https://www.med.navy.mil/sites/nmcp/Dept/Shared%20Documents/CID/VA-DoD-Guidebook-2013.pdf https://www.ahrq.gov/ https://www.pcori.org/ https://www.health.mil/Military-Health-Topics/Technology/Support-Areas/MDR-M2-ICD-Functional-References-and-Specification-Documents https://www.health.mil/Military-Health-Topics/Technology/Support-Areas/MDR-M2-ICD-Functional-References-and-Specification-Documents

• DaVINCI is a database that combines DoD data with VA data to create a robust data platform for interagency collaboration and research on issues impacting those who were Active Duty. Information about DaVINCI is found at https://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/2441-notes.pdf.

• Defense Manpower Data Center (DMDC) is a database that contains information regarding military personnel and their families for the purposes of health care, retirement funding and other administrative requirements. Information about DMDC can be found at https://www.dmdc.osd.mil/appj/dwp/index.jsp.

• Millennium Cohort Study (MCS) and the Millennium Cohort Family Study together make up the Millennium Cohort Program (MCP) at the Naval Health Research Center, San Diego, CA.

The MCS is the largest prospective health study in U.S. military history with approximately 200,000 participants. This is a prospective research study and database that examines the impact of military exposures and deployments on long-term health outcomes. Access to MCS data and bio-specimens requires collaboration with one of the MCS investigators and approval of the MCS oversight committee by way of a preproposal/proposal process.

http://millenniumcohort.org

• Deployment Health Survey Data at the Psychological Health Center of Excellence brings together large datasets from the military for longitudinal analysis of health and psychological health issues that inform readiness. In collaboration with the Army Analytics Group Research Facilitation Lab Person-Event Data Environment provides a virtual platform that integrates large limited datasets and provides a platform for research and analysis. More Additional information can be found at :

https://www.pdhealth.mil/research/health-services-population-research.

• Multi-Institutional Research: A partnership with a DoD training installation or local academic institution or federal/national laboratory is allowed. Note, regardless of location, any work that is to be performed by associated non-DoD organizations must be limited to work performed under existing service contracts, under Cooperative Agreements, Cooperative Research and Development Agreement or Material Transfer Agreements. An awardee may, in accordance with his/her research project, use the funds to collaborate with Federal (DoD and non-DoD) and non-Federal entities in order to execute the research.

If the proposed research is multi-institutional, plans for communication, funding, and data transfer between the collaborating institutions, as well as how data, specimens, and/or imaging products obtained during the study will be handled, must be included in the appropriate sections of the proposal. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional research. A letter of support from an authorized representative of each respective organization must be enclosed with the submitted proposal. Participating institutions must be willing to resolve potential intellectual and material property issues and to remove any barriers that may interfere with achieving high levels of cooperation to ensure successful completion of this award.

https://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/2441-notes.pdf https://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/2441-notes.pdf https://www.dmdc.osd.mil/appj/dwp/index.jsp http://millenniumcohort.org/ https://www.pdhealth.mil/research/health-services-population-research

No proprietary information should be provided in the LOI. It is expected that proprietary information will be included in the proposal if selected. Proprietary information should be identified in the proposal by the applicant.

The government is not obligated to make any federal award as a result of the announcement. Only the Grants Officer can bind the federal government to the expenditure of funds.

J. PROPOSAL SUBMISSION CHECKLIST*

Action Page

Limit Completed

Letter of Intent

LO

I

Letter of Intent (LOI) Template

LOI Narrative 5

References Cited 1

List of Abbreviations, Acronyms, and Symbols

Key Personnel Biographical Sketches 5 per individual

Full Proposal

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Pr op os al

R&R SF 424 Form

R&R Other Project Information Form

Technical and Lay Abstracts: Upload attachment in step 7 with file name “Abstract.pdf”.

1 page each

Project Narrative: Upload attachment in step 8 with file name “ProjectNarrative.pdf”.

Bibliography & References Cited: Upload attachment in step 9 with file name “BibRef.pdf”.

Facilities and Other Resources: Upload attachment in step 10 with file name “Support.pdf".

None unless otherwise listed

R&R Attachment Form

List of Abbreviations, Acronyms, and Symbols: Upload as Attachment 1 with file name “ListAbbr.pdf”.

Statement of Work: Upload as Attachment 2 with file name “SOW.pdf.”

Outcomes and Impact Statement: Upload as Attachment 3 with file name “Impact.pdf.”

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Pr op

Data and Research Resource-Sharing Plan: Upload as Attachment 4 with file name “Sharing.pdf.”

Conflicts of Interest: Upload as Attachment 5 with file name “COI.pdf”.

Data Management: Upload as Attachment 6 with file name “DataManage.pdf”.

Post-Award Project Knowledge Transition Plan: Upload as Attachment 7 with file name “Transition.pdf”.

R&R Personal Data Form

R&R Senior/Key Person Profile (Expanded) Form (Mandatory for external organizations)

Attach PI Biographical Sketch with file name “Biosketch_LastName.pdf” to the appropriate field.

Attach PI Current & Pending Support with file name “Support_LastName.pdf” to the appropriate field.

Attach Biographical Sketch with file name “Biosketch_LastName.pdf” for each senior/key person to the appropriate field.

5 pages per biographi cal sketch

Attach Current & Pending Support (Support_LastName.pdf) for each senior/key person to the appropriate field.

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R&R Budget Form Upload attachments with file name:

“Budget Step_LastName.pdf”, where step is the corresponding letter in the form and last name is the last name of the PI.

R&R Attachment:

Letter of Organizational Support for Military Partners:

Resource from Manager/Comptroller or appropriate financial (If Applicable)

R&R Attachment:

Letter of Organizational Support for Military Partners:

MTF, Installation Commander or equivalent Commanders/Directors (If Applicable)

* See updated information at: www.grants.gov

K. APPENDIX: STATEMENT OF SUBSTANTIAL INVOLVEMENT

The following outlines the substantial involvement if award results in a cooperative agreement.

Recipient Responsibilities The Recipient is responsible for:

• Performing the activities supported by this award, including providing the required personnel, facilities, equipment, supplies, and services

• Defining the approaches and plan, submitting the plans to the DHA MHSR Program Manager for review, and incorporating DHA comments

• Managing and conducting project activities

• Providing all deliverables specified in the award on a timely basis

• Participating in all briefings specified in the award Project Objectives and attending and reporting project status at program/project review meetings as deemed necessary by the DHA Program Manager.

• Submitting technical reports to the DHA MHSR Program Manager and incorporating DHA comments.

• Presenting the project results at appropriate technical conferences or meetings as directed by the DHA MHSR Program Manager.

• Providing all knowledge products and results.

DHA Responsibilities

DHA is responsible for:

• Reviewing project plans, in a timely manner, and recommending alternate approaches to the work effort if the plans do not address critical Health Service Research issues.

• Suggesting specified kinds of direction or redirection of the work if duplication of efforts or interrelated activity is identified.

• Reviewing, in a timely manner, technical reports and other deliverables and providing comments to the Recipient.

• Conducting project and program review meetings to ensure adequate progress and that the work accomplishes the program and project objectives. Recommending alternate approaches to work or shifting work emphasis, if needed.

• Promoting and facilitating MHSR socialization, including disseminating program results through presentations and publications.

• Serving as a scientific/technical liaison between awardees and other program or industry staff.