FAQs_22-DHA-MHSR.pdf

FREQUENTLY ASKED QUESTIONS (FAQS) 22-DHA-MHSR

1. QUESTION: Where do you find the Notice Of Funding Opportunity (NOFO) details and updates for Military Health System Research?

RESPONSE: You can find it at the following website with key words: 22-DHA-MHSR:

https://www.grants.gov/web/grants/search-grants.html

If you select the "Package" tab, click "Preview" and then select "Download Instructions" you can see the submittal instructions associated with this NOFO.

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

RESPONSE: The NOFO is for both intramural and extramural research.

3. QUESTION: In the recently released NOFO (22-DHA-MHSR), Section C indicates: Any eligible applicants (as detailed below) can submit one or two letters of intent (LOIs) but only one LOI will be considered. Is this eligibility criterion limiting an institution to two LOIs and one subsequent proposal or is this limitation at the Principal Investigator (PI) level (limiting a PI to two LOIs/one proposal but allowing multiple submissions from the institution)?

RESPONSE: An eligible PI may submit up to two (2) LOIs for consideration, but only one

(1) LOI may be selected for submission of full proposal under this announcement. There are no institutional limitations.

4. QUESTION: What is the funding cap?

RESPONSE: The total funding cap is $10M. The number funded will be dependent upon the programmatic decisions and availability of funds. The intent is to maximize the number of high impact, high quality proposals.

5. QUESTION: Is this funding opportunity open to US applicants only or are international applicants eligible to apply?

RESPONSE: As indicated in the synopsis, awards with be made to US entities only.

6. QUESTION: The NOFO states that one of the topics of interest, Variation, has to involve studies that examine the variation in quality, utilization, cost or outcomes within the Military Health System (MHS) and the implications to healthcare. Could you remind me whether Veterans Administration (VA) hospitals (which I understand are TRICARE network providers) would be considered to be "within the MHS" as far as this NOFO is concerned? If not, could you refer me to a list of facilities that would be considered "within the MHS" for the purpose of this NOFO?

RESPONSE: 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

7. QUESTION: As we prepare our LOI, we have questions as to if and how we would be able to access data in the Military Data Repository (MDR), which is referenced in the proposal.

Would this data be made an available to the researchers? Would there be any costs associated https://www.grants.gov/web/grants/search-grants.html https://www.health.mil/About-MHS with accessing the data? How would we access the data, e.g., 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.

RESPONSE: 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 associated individual institution’s indirect costs. Data storage must meet NIST 800.171 standards. Access to MHS data requires a data sharing agreement (DSA) for access to the data enclave or to have limited data sets. For more information and details for 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

8. QUESTION: The funding call states that the period of performance is a maximum of two years. Does that exclude the possibility of option years that the DHA can exercise to fund in case the cooperative agreement meets its goals for the first two years?

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

9. QUESTION: In looking at eligibility to apply, do private companies such as ours, who are

SDVOSB (i.e., service-disabled veteran-owned small business) certified, qualify?

RESPONSE: For profit organizations are not eligible for this opportunity.

10. QUESTION: Can non-DoD/DHA entity apply provided the research is conducted at an MTF or does the PI have to be embedded in the DHA?

RESPONSE: How you establish your partnership is up to you. You can determine if you want to want to be the primary PI then submit as an intramural PI, if the university partner will be the primary PI then the submission is extramural. You will need to submit all the appropriate IRB and DSA documents, including the appropriate clearances for the university to work within the military medical treatment facility (MTF). All contractual relationships between you and the university are your responsibility.

11. QUESTION: Should the LOI include a key personnel description or will biographical sketches be sufficient for this proposal?

RESPONSE: As stated in the NOFO: “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.”

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

12. QUESTION: We understand that per the announcement instructions the Letter of Intent (LOI) needs to be submitted via the Principal Investigators (PI) email address. We wanted to ensure the program has the information about the our organization's role in representing the PI and submitting the full proposal on the PI’s behalf, negotiating and managing the grant on the PI’s behalf if this proposal gets recommended for funding. Please advise if the following statement should be included in the LOI and if this information will help in avoiding any confusion regarding our organization's role.

RESPONSE: The PI’s home organization determines the category of the proposal, extramural or intramural as defined below. Funding will only be sent to the primary PI’s organization. The contractual arrangements between the PI and other organizations on the proposal team is the responsibility of the PI.

• 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.

• 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.

13. QUESTION: Can you please provide a template for the LOI?

RESPONSE: Please see the attached LOI format.

LETTER OF INTENT TEMPLATE

Principal Investigator (PI) and Facilities Information

PI Name (last, first, middle initial):

Click here to enter text.

Organization:

Click here to enter text.

DoD Affiliation: Organization Address:

DHA ☐ Click here to enter text.

Services ☐

Not applicable ☐

PI Contact Information:

Email: Click here to enter text.

Phone: Click here to enter text.

Location of Work (if different from above):

Click here to enter text.

Organizational Resource Manager (Comptroller or equivalent Business Official):

Click here to enter text.

Contracting Organization (if different from above):

Click here to enter text.

Authorized Organizational Representative

(AOR):

Click here to enter text.

Alternate Submitter (if applicable):

Click here to enter text.

Succession Plan for military PI in the event of a Permanent Change of Station (PCS):

Not applicable ☐ Click here to enter text.

Collaborators and Key Personnel Describe the role of the PI, co-PIs (if applicable), key personnel, sub-awards (if applicable), and consultants (if applicable) in 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 facility where the research is expected to be performed.

Collaborator Name:

Click here to enter text.

Collaborator Organization:

Email: Click here to enter text. Role: Click here to enter text.

Collaborator Organization:

Collaborator Organization:

Collaborator Organization:

Collaborator Organization:

LETTER OF INTENT NARRATIVE

Please refer to the NOFO for detailed narrative requirements and instructions on what to include in each of the following sections. Please limit total narrative response to 5 pages.

MHSR Priority Topic Area(s): Click here to enter text.

Alignment with FY 22 MHSR Clinical Priority Areas:

Research Plan:

Background/Rationale: Click here to enter text.

Hypothesis: Click here to enter text.

Specific Aims: Click here to enter text.

Objectives: Click here to enter text.

Theoretical Rationale, Scientific Methods, and Design: Click here to enter text.

Military Relevance and Impact: Click here to enter text.

Timeline and Estimated Total Budget: Click here to enter text.

Alignment with FY 22 MHSR Clinical Priority Areas: