RFA CE-25-030 Questions and Answers.pdf

RFA CE-25-030 Questions and Answers

1. Can you please provide additional information for this grant? How would we be able to apply to this grant?

More information about the grant opportunity can be found here on grants.gov under the notice of funding opportunity (NOFO) number RFA-CE-25-030. The full announcement can be found under section “Related Documents” which provides additional guidance for applying and navigating the application process. Application submissions can be accessed by pressing the red buttons to apply and/or subscribe for updates and access to the research application portal.

2. Are the funding awards for firearm violence prevention (RFA-CE-25-021 and RFA-CE-25-030) only R01 and K01 awards?

RFA-CE-25-030 is an R01 award. RFA-CE-25-021 (Title: Research Grants for Preventing Violence and Violence Related Injury) is also an R01 award but is not limited to only firearm violence prevention.

We encourage reviewing the NOFOs on www.grants.gov to see if there are any opportunities that align with your work. More specific information to determine eligibility and relevance can be found when selecting each grant opportunity number.

3. Is the letter of intent required to apply? Is there a preferred format to use?

A letter of intent is not mandatory, nor is it binding or a factor in the review of an application. We encourage applicants to submit a letter of intent because the details it provides help CDC Injury Center staff to plan for the scientific and technical merit peer review process. Please see Section IV:

Application and Submission Information > 3. Letter of Intent on page 21 of the full announcement for more information.

Interested applicants are encouraged to submit a letter of intent containing the following details:

• Descriptive title of proposed research

• The objective(s) the application will address

• A brief description (one to two paragraphs) of the proposed research, including its objectives

• Contact information of the Principal Investigator/Project Director (name, address, and telephone number)

• Name(s) of all other Senior/Key Personnel

• Name(s) of participating institutions

• Number and title of this funding opportunity

Due Date for Letter Of Intent 11/01/2024

The letter of intent should be sent electronically to: Aisha Wilkes, MPH Scientific Review Official National Center for Injury Prevention and Control (NCIPC) Email: ncipc-peer-review@cdc.gov.

https://www.grants.gov/search-results-detail/353877?ACSTrackingID=DM132193&ACSTrackingLabel=Copy+of+Copy+of+ERPO+Information+Sharing+Newsletter+-&deliveryName=DM132193 http://www.grants.gov/ mailto:ncipc-peer-review@cdc.gov

4. Once the letter of intent (LOI) has been submitted on 11/01, when can we expect an authorization to proceed with our grant response?

Authorization is not needed for applicants as a LOI is not mandatory. You will receive an acknowledgement, but we encourage you to continue to prepare your application regardless.

5. Do you have any availability to meet with us?

We unfortunately are unable to meet with potential applicants but will happily assist you with any questions you would like to send via email at NCIPC_ERPO@cdc.gov.

6. Can I send a summary of my proposed project for RFA-CE-25-030?

a. Similar questions: Is this [study of interest] acceptable for this NOFO (e.g., retrospective observational study to evaluate effectiveness of the current policy, study that proposes to adapt an existing evidence-based intervention to be used for the primary prevention of firearm injury and test for effectiveness in the new population or setting)? Will the grant support adding prevention monitoring equipment at a site and rigorously evaluating those strategies?

We are not able to provide guidance or information on the appropriateness of your proposal or aims for the NOFO. However, we can point you to sections of the NOFO that may address your inquiries:

• Section I: Funding Opportunity Description > 2. Approach starting on page 8 to understand the objectives and intent of the NOFO

• Section III: Eligibility Information > 5. Responsiveness starting on page 17 to review aspects of an application that would be considered responsive and nonresponsive to the NOFO

• Section V: Application Review Information starting on page 28 to understand the scientific review criteria

As a reminder, “research funded under this Notice of Funding Opportunity (NOFO) should rigorously evaluate the effectiveness of innovative and promising strategies to keep individuals, families, schools, and communities safe from firearm-related injuries, deaths, violence, or crime.” It is ultimately incumbent on the applicant to justify the appropriate methods of their approach and research.

7. Can you provide any guidance on what criteria we should consider/reference for determining if our proposal would be classified as a clinical trial?

Please refer to NIH's Definition of a Clinical Trial | Grants & Funding, which provides guidance on the criteria to consider when determining if a study should be classified as a clinical trial. Additionally, please be sure to review Section I: Funding Opportunity Description > 2. Approach on page 8 and Section V: Application Review Information > 1. Criteria on page 28 as it is incumbent upon the applicant to justify that their selected methodology and data analysis are appropriate for their mailto:NCIPC_ERPO@cdc.gov https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/definition#:%7E:text=NIH%20Definition%20of%20a%20Clinical%20Trial%20A%20research,those%20interventions%20on%20health-related%20biomedical%20or%20behavioral%20outcomes.

research. These sections describe the expectations for the research and the criteria the Peer Review panel will use to determine the scientific merit of each proposal.

8. If the study mostly only includes outcomes related to firearm access (e.g., primary prevention strategy focuses on decreasing access to firearms through secure storage), but not related victimization or injuries or mortality, would such a study be acceptable?

As stated in Section I: Funding Opportunity Description > 2. Approach > Objectives/Outcomes on page 9, “access” and “secure storage and other safety practices” are appropriate outcome measures of firearm-related behavior. Please be sure to justify the relevance of your outcomes of interest to the NOFO and in preventing violence or injuries.

9. Does a new collaboration have a chance to get this grant? Or does a strongly established collaboration have a much higher chance?

We cannot speak to likelihood of receiving funding, but please see Section III: Eligibility Information > 5. Responsiveness starting on page 17 of the NOFO and Section V: Application Review Information > 1. Criteria starting on page 28 for how your application will be reviewed and scored.

Additionally, for more information regarding collaborations in general, please see Section I: Funding Opportunity Description > 2. Approach > Collaboration/Partnerships starting on page 11.

Collaborations and partnerships must be substantiated with a signed Data Sharing Agreement, Letter of Support (LOS), or Memorandum of Understanding (MOU).

10. Do we need Letters of Support plus MOUs from partners? Or would letters of support be sufficient?

Either/or is sufficient. As stated in Section I: Funding Opportunity Description > 2. Approach > Collaboration/Partnerships on page 12 of the NOFO, “the roles and responsibilities described for each partnering entity must be substantiated with a signed Data Sharing Agreement, Letter of Support (LOS), or Memorandum of Understanding (MOU), and be included in the Letter of Support section of the application. The Data Sharing Agreement, Letter of Support (LOS), or Memorandum of Understanding (MOU) must describe the partner’s commitment of resources, time, and personnel to the proposed research. Applications that do not include a signed Data Sharing Agreement, Letter of Support, or Memorandum of Understanding from each partnering entity may not be recommended for funding during the second level of review (see Section V. Application Review Information 4. Review and Selection Process).”

11. For the “Report on Programmatic, Budgetary, and Commitment Overlap” (NOFO Page 27) – Is programmatic overlap allowable at application stage with commitment to resolve if awarded?

The research team is waiting to hear on an award decision from DOJ for a similar project design proposed at different study sites.

The NOFO states on page 27 (see Duplication of Efforts), “Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e., grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year. Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source…Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.”

12. Applicant institutions can submit only one application with the same contact PD/PI. Could one contact PI submit an application to another CDC R01 with the same deadline and have both reviewed?

Yes, applications are reviewed individually in response to each NOFO and thus contact PIs can apply to multiple NOFOs. However, as stated on p. 20 (see Number of Applications), applicant institutions submitting applications with essentially the same proposed research to two or more CDC/ATSDR NOFOs will not be funded under more than one NOFO.

13. I have a first-authored peer-reviewed publication about intimate partner violence survivors of color who endured abuse with firearms and ongoing risk of intimate partner homicide. Would this count to meet the NCIPC’s requirements for PIs for this solicitation.

a. Furthermore, my co-PI has a strong background and many peer-reviewed publications associated with firearm injury prevention specific to community violence. Collectively, would the two of us meet the NCIPC’s requirements for PIs and Co-PIs for this solicitation?

b. Another individual on our team who will not be a PI, but instead will be a Co-investigator has no peer-reviewed publications related to firearm violence currently in print, but has one forthcoming. Can they be included on our team given this context?

Please see Section III: Eligibility Information > 5. Responsiveness on page 18 for more information related to PI and/or Co-PI eligibility. As it states, “the knowledge, experience, and expertise necessary to conduct this research and achieved proposed objectives must be documented with at least one first-authored, peer-reviewed publication as defined by the NIH National Library of Medicine in the relevant area of firearm-related injury prevention. Experience requirements may be demonstrated through the combined experiences of a Principle and Co-Principal Investigator” should they be documented in the appropriate SF-424 Biographical Sketch. We also recommend looking at Section V: Application Review Information > 1. Criteria > Investigator(s) on page 29 to see how expertise among PD/PIs, collaborators, and other researchers are reviewed.

https://www.nlm.nih.gov/oet/ed/stats/03-700.html https://www.nlm.nih.gov/oet/ed/stats/03-700.html

The other individual may be included on your team. As stated on page 13 of the NOFO, “Applications should demonstrate that the research staff have the necessary skills and experience to ensure quality and timeliness of proposed activities.”

14. Can a non-US Resident affiliated with a US institution serve as Co-I or PI?

All awards for this NOFO will be made to eligible institutions. Information on eligibility criteria can be found in Section III: Eligibility Information > 1. Eligible Applicants. For information on PD/PI eligibility, please see Section III: Eligibility Information > 5. Responsiveness and Section III:

Eligibility Information > 8. Eligible Individuals in Organizations/Institutions. Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, including sexual orientation and gender identity minorities as well as individuals with disabilities are always encouraged to apply.

15. Under Funding Option B, it states the funding may cover data collection costs as well as program implementation related costs. Therefore, if we are evaluating a training program related to the prevention of firearm related violence, some or all of the budget may cover the cost of running that program? In other words, the budget can be a combination of data collection and program implementation costs or one or the other?

The Executive Summary on page 3 NOFO states that Funding Option B will support research projects that require new data collection and/or implementing prevention activities to evaluate effectiveness. These projects will be funded up to $650,000 per year (direct and indirect costs) for a period of performance for up to 3 years.

16. Is this considered a training grant with limited 8% IDC rate? Or is that based on what is proposed?

This is not considered a training grant. The language you are referring to in Section V: Application Review Information > 3. Additional Review Considerations on page 33 of the NOFO states, “indirect costs on training grants are limited to a fixed rate of 8% of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and sub-awards in excess of $25,000.” This language is template/standard language included in all NOFOs and only applies to training grants. Please also note that applicants should use the negotiated rate and provide a copy of the latest federally approved rate and the allocation plan approved letter.

17. What are the limitations on using the grant funds to support programmatic activities that constitute the intervention being studied?

Please note that Funding Option A will support research activities that rely on existing data provided they do not support implementation of prevention activities. These projects will be funded up to $350,000 per year (direct and indirect costs) for a period of performance of up to 2 years. Funding Option B will support research that requires support for new data collection activities and/or the implementation of prevention activities. These projects will be funded up to $650,000 per year (direct and indirect costs) for a period of performance of up to 3 years.

Additionally, it is incumbent on the applicant to justify the appropriate methods of their research and approach to the funding option of choice as well as to the intent and objectives of the NOFO (please see Section I: Funding Opportunity Description > 2. Approach starting on page 8 of the NOFO for more information).

18. Where should the evaluation/performance management plan and translation plan be included in the application package? Should they be stand-alone attachments, incorporated into the “Research Strategy” attachment, or another option?

Please follow the directions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV: Application and Submission Information starting on page 20. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

19. What are the formatting guidelines for the submission? Double or single spaced? Font size?

CDC does not have specific formatting guidelines, other than requiring all text attachments to the Adobe application forms be submitted as PDFs and conform to agency-specific formatting requirements noted in the SF424 (R&R) Application Guide. More information can be found in Section IV: Application and Submission Information > 8. Format for Attachments on page 23 of the NOFO and NIH’s How to Apply – Application Guide.

20. Are all the NIH Clinical Trial documents required if going after Funding Option B? (e.g., inclusion of individuals across the lifespan, inclusion of women and minorities, recruitment and retention plans, inclusion enrollment plan, protection of human subjects, statistical design and power, dissemination plan, etc.)

Please see Section IV: Application and Submission Information starting on page 20 of the NOFO for more information regarding required documents for a successful application submission for this opportunity. This full announcement includes all applicable components for this NOFO, required and optional. Additionally, it is critical that all applicants follow the instructions in the SF424 (R&R) Application Guide (How to Apply – Application Guide) unless otherwise instructed in the NOFO to do otherwise. We encourage you to use ASSIST for your application submission, as all required and optional forms will appear as separate tabs at the top of the Application Information screen.

https://grants.nih.gov/grants-process/write-application/how-to-apply-application-guide https://grants.nih.gov/grants-process/write-application/how-to-apply-application-guide https://grants.nih.gov/grants-process/write-application/how-to-apply-application-guide

21. We noticed there are no formatting requirements for the narrative. Will proposal narratives be submitted through a portal?

Application materials are submitted a system or platform going through grants.gov and eRA Commons. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. Please see Section IV: Application and Submission Information > 1. Address to Request Application Package on page 20 of the NOFO for more information regarding application portal systems.

22. We are running into issues where NOFO requests items that do not align with NIH & ASSIST applicant guidance, so referencing the application instructions do not address our questions (e.g. Is a cover letter required? Where to state FWAs, etc.)

We apologize for the inconsistency between CDC and NIH/ASSIST guidelines! Applicants should adhere to all instructions in the NOFO and application guide - where they conflict, follow the information in the NOFO. CDC unfortunately does not have visibility of the ASSIST Platform. NOFO required elements can be summited in the "Other Plan(s)” Section or “Appendix” to ensure all required elements are included.

Problems with grants.gov can be resolved by contacting the Grants.gov Contact Center at 1-800- 518- 4726 or by email at support@grants.gov. Please also see Section VII. Agency Contacts in the NOFO which includes contact information from Grants.gov and eRA Commons for technical support.

Also please see Section IV. Application and Submission Information in the NOFO for additional information on who to contact in the event of technical difficulties.

23. What is an eRA commons number? I received an email stating that the eRA commons number was missing.

If you do not have an eRA Commons ID, please see Section III: Eligibility Information > 6. Required Registrations on page 18 of the NOFO for more information regarding eRA Commons and other applicable registrations (i.e., SAM.gov and grants.gov). As a note, applicant organizations must register with eRA Commons first prior to principal investigators creating an account and receiving an eRA Commons ID. The “How to Apply – Applications Guide” link on page 3 under Required Application Instructions has additional information that might be of help when you click Prepare to Apply > Register.

If you have an eRA Commons ID and are having issues with obtaining it, please contact the NIH eRA Service desk at: Toll-free: 1-866-504-9552; Phone: 301-402-7469 | http://grants.nih.gov/support/index.html | Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time. For assistance with your electronic application or for more information on the electronic submission process, visit https://grants.nih.gov/grants/how-to-apply-application-guide.html.

http://grants.nih.gov/support/index.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

24. When does this grant start, would this be for 2025?

The anticipated start date is September 30, 2025.

25. Will a similar RFA to rigorously evaluate the effective of innovative strategies to prevent firearm related violence be offered next year or is this type of RFA offered every other year?

We are unable to speak to funding opportunities that may or may not be made available in the future that are not currently forecasted on the grants.gov website. Please monitor the grants.gov website to know if this RFA will be posted again. Additionally, we invite you to view our NCIPC website regarding our funded programs, and encourage you to sign up for our ERPO newsletter to remain informed about upcoming funding announcements.

• Visit CDC News & Updates | CDC

• Search for the topic “Injury Center Funding Announcements”

• Enter your email address to subscribe.

https://www.grants.gov/search-grants https://www.cdc.gov/injury-violence-prevention/programs/injury-center-nofos.html https://www.cdc.gov/injury-violence-prevention/programs/injury-center-nofos.html https://tools.cdc.gov/campaignproxyservice/subscriptions.aspx