FY23_ MHSR_NOFO_FAQs.pdf

FREQUENTLY ASKED QUESTIONS (FAQs)

23-DHA-MHSR

1. Where can I find the Notice Of Funding Opportunity (NOFO) details and updates related to Military

Health System Research (MHSR)?

You can find them at the following website by entering “23-DHA-MHSR” into the keyword search field: https://www.grants.gov/web/grants/search-grants.html. Select the "Package" tab, click "Preview," and then select "Download Instructions," to view the submittal instructions associated with this NOFO.

2. Is this NOFO for an intramural, extramural, or a combination award?

The NOFO is for both intramural and extramural research.

3. Who is eligible to apply for a NOFO research grant?

Any research investigator, uniformed or civilian staff, who works for an extramural non-DoD organization, or an intramural DoD organization, as defined in FY23 NOFO “Eligibility” section:

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 United States: 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.

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

• DHA encourages applications from Minority-Serving Institutions (MSI) that include Historically Black Colleges and Universities (HBCUs) and other institutions, as defined at:

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

b. Intramural DoD Organization: A facility or group of facilities owned, leased, or otherwise used by the

Office of the Secretary of Defense, the Military Departments, the Defense Agencies, and all other organizational entities within the DoD. This includes DoD laboratories, DoD Military Treatment Facilities (MTFs), and/or DoD activities embedded within a civilian medical center.

• 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.

c. Additional Information: For applicants with dual appointments with a Federal agency and a university, please identify the "single" organization or affiliation that will have legal authority over funds resulting from the award.

• Government agencies within the United States: 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.

• There is no cost-sharing or match requirement.

All partnership or contract agreements are the responsibility of the applicant’s organization and https://www.grants.gov/web/grants/search-grants.html should be in place prior to receiving the award of funds.

4. In the recently released NOFO (23-DHA-MHSR), Section “C.2” states: “Any eligible applicant may submit one or two letters of intent (LOIs), but only one will be considered.” Does this eligibility criterion also limit an institution to two LOIs and one subsequent proposal, or does it limit only the PI?

An eligible PI may submit up to two (2) LOIs for consideration, but only one (1) LOI may be selected for full proposal submission. There are no institutional limitations. Multiple PIs from the same institution may each submit up to two LOIs.

5. What is the funding cap?

The funding cap is estimated to be $10 million for the entire FY23 MHSR grant. The number of proposals funded depends on the programmatic decisions and availability of funds. The intent is to maximize the number of high-impact, high-quality proposals.

6. Is this funding opportunity open to U.S. applicants only, or are international applicants eligible to apply?

As indicated in the synopsis, awards will be made to U.S. entities only.

7. The NOFO states that one of the topics of interest, ”variation” must involve studies that examine variation in quality, utilization, costs, or outcomes within the Military Health System (MHS) and the implications on health care. Are Veterans Administration (VA) hospitals, TRICARE network providers, part of the MHS? If not, could you refer me to a list of facilities that are within the

MHS?

The MHS does not include the network of VA hospitals. To find out more about the MHS, please go to: https://www.health.mil/About-MHS.

8. As we prepare our LOI, we are wondering whether we are able to access data in the Military Data

Repository (MDR), which is referenced in the proposal. Is this data available to researchers? Are there any costs associated with accessing data? How would we accomplish this? Would we request a data export to allow us to work with the data in our secure environment, or would we have to work with the data through a firewall of some sort, allowing it to reside where it is? Having this information would allow us to prepare a more accurate budget.

There is no Government fee associated with access to the MHS data. Any costs associated with the security and maintenance of the data in accordance with DoD/DHA specifications are a function of the associated individual institution’s indirect costs. Data storage must meet NIST 800.171 standards. Access to MHS data requires a data-sharing agreement (DSA) through a DSA application (DSAA). For more information and details related to accessing DHA data, please visit the following sites:

Data-Sharing Agreement Application:

https://health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing- Application

Data Functional References and Specifications:

https://health.mil/Military-Health-Topics/Technology/Support-Areas/MDR-M2-ICD-Functional- References-and-Specification-Documents

9. The funding call states that the period of performance is a maximum of 2 years. Does that exclude the possibility of option years that the DHA could fund in case the cooperative agreement does not meet its goals for the first 2 years?

At this time, DHA is not able to commit to option year extensions.

https://www.health.mil/About-MHS https://health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application https://health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application https://health.mil/Military-Health-Topics/Technology/Support-Areas/MDR-M2-ICD-Functional-References-and-Specification-Documents https://health.mil/Military-Health-Topics/Technology/Support-Areas/MDR-M2-ICD-Functional-References-and-Specification-Documents

10. Do private companies, which is a service-disabled, veteran-owned, small-business-certified organization, qualify for this NOFO?

For-profit organizations are not eligible for this opportunity.

11. Should the LOI include a key personnel description, and biographical sketches?

Key personnel descriptions are required in the LOI. Biographical sketches will be accepted if they provide all of the information requested in the NOFO. As stated in the NOFO: “Briefly describe the role of the PI, co-PIs (if applicable), key personnel, subawards (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.”

12. We read that “Sub-awards and contracts may not exceed 30% of the total estimated budget.” Does that refer to each individual subaward, or to all of them collectively?

The sum total of all subawards and contracts cannot exceed 30% of the budget.

13. The "Related Documents" page on Grants.Gov provides a Research Writing Plan document, which links to National Institutes of Health (NIH) guidance for an R01 grant. This guidance describes a “specific aims” page and 12 additional pages, including those that discuss significance, innovation, and approach. Can you confirm that this is the appropriate and expected format?

Please follow the NIH R01 guidance for writing the proposal. Use the margins and fonts specified in the NIH guidance for all sections. While the narrative allows for 20 pages, a 20-page narrative is not required. The narrative may be fewer than 20 pages.

14. Should I complete two separate abstracts?

Yes. Please provide a Technical Research Abstract and a Lay Abstract, using the Project Abstract (V1.2 ) and label them accordingly. Note the two abstracts on the Attachments (V1.2) document.

15. Is there an additional or different Project Narrative required in the "Project Narrative attachment form" for this application?

The FY23 NOFO requires a “Project Narrative” with a 20-page limit, and with the file name “ProjectNarrative.pdf.” There is no need for the additional “project narrative attachment form” at this time.

16. What are the specific requirements for the Abstract?

The Technical Abstract (one-page limit) requires:

Background: State the ideas and theoretical reasoning behind the proposed work.

Objective/Hypothesis: State the objective/hypothesis to be tested. Provide evidence or a rationale that supports the objective/hypothesis.

Specific Aims/Milestones: State the specific aims/milestones of the project.

Project Design: Describe the project design.

Relevance: Explain the potential relevance of the proposed work to the Military Health System.

Impact: Explain the potential impact of the proposed work on advancing the Quadruple Aim.

For the Lay Abstract (one-page limit): Lay abstracts should be written using the following outline, in language that readers without a background in science or medicine can readily understand. The Lay abstract should not repeat the technical abstract.

Describe the objectives and rationale for the research.

Describe the applicability and potential impact of the research.

o What types of population/subpopulation of beneficiaries will it help, and how will it help them?

Include the currently available statistics related to the research.

o What are the potential changes to cost, quality, outcomes, etc.?

o What is the projected timeline to achieve the expected outcome?

Describe how the proposed project will benefit the Military Health System and assist in meeting the Quadruple Aim.

17. What are the requirements for the statement of work (SOW)?

The SOW outlines and establishes the submitter’s performance expectations, including milestones, for the work to be funded under this award. It also establishes general objectives and sets specific goals and conditions for each year of the project. The SOW for all award types will be incorporated into the award document and, as such, is subject to release under the Freedom of Information Act.

The SOW should include a list of major tasks that support the proposed specific aims, followed by a series of step-by-step subtasks that relate to the major tasks and milestones within the period of performance. An outline should be included showing the work to be accomplished during each year of the award.

The SOW should describe only the work for which funding is being requested by this proposal and, as applicable, should also:

o Include the following information for each study site/subaward site: Organization; organization address; investigator(s); collaborator(s); consultant(s); description of research with animals, human anatomical substances, and/or human subjects or cadavers to be conducted at the site;

and key personnel responsible for each major task and each subtask to be performed at the site.

o Indicate the number (and type, if applicable) of research subjects (animal or human) and/or human anatomical samples projected or required for each task and at each site.

o Indicate, as applicable, the estimated time to complete each task. Time should be included for local and DHA regulatory review and approval.

For studies involving human subjects, include a subtask that allows at least 2 to 3 months for regulatory review and approval by the DHA IRB. This does not include the additional time required for local IRB review and approval.

The Government reserves the right to request a revised SOW format or additional information.

18. Does the “Letter of Organizational Support” use the same attachment form as the SOW, Outcomes/Impact statement, etc.?

Yes. Use the same form for the SOW or Impact Statement, with the file name “LetterOrgSupport.”

The letter (or letters, if applicable) of organizational support should be signed by the Department Chair or appropriate organization official, confirming the laboratory space, equipment, and other resources available for the project.

If the project involves collaboration with a Military Facility (MHS facility, research laboratory, treatment facility, dental treatment facility, or a DoD activity embedded within a civilian medical center), collaborating DoD researchers must obtain a letter from their commanding officer or Military Facility director authorizing their participation in the research project. This letter must be included with the proposal.

A letter for each organization involved in the project should be provided.

19. What are the specific language requirements for the Conflict of Interest (COI) section?

Provide details with the proposal submission of all potential or actual COIs, along with a plan to resolve or mitigate them. An assistance agreement will not be awarded if the Grants Officer determines that a COI cannot be mitigated to the Grants Officer’s satisfaction.

Personnel involved in the review process or with making funding recommendations are prohibited from assisting in any proposal, including, but not limited to, concept design, proposal development, budget preparation, and the development of any supporting documentation.

20. Is there an additional or different Project Narrative required in the "Project Narrative Attachment Form" for this application?

The FY22 NOFO requires “Project Narrative” with a 20-page limit, with the file name “ProjectNarrative.pdf.” There is no need for the additional “Project Narrative Attachment Form” at this time.

21. What is the requirement for line spacing?

Line spacing should be no more than 6 lines per inch.

22. In the NOFO Instructions, a “Post-Award Project Knowledge Transition Plan” is requested. Is this required for both intramural and extramural applicants?

Yes, Intramural proposals must provide a succession plan in the event the PI or the research team is deployed or transferred. It is not required, but recommended for external applicants. All proposals must discuss how the research results will be transmitted to the Military Health System, and how it can or will change the way the system delivers care.