RFA-DP-24-138 QA FINAL.pdf

RFA-DP-24-138 QUESTIONS AND ANSWERS

Contents

APPLICATION

BUDGET

FORMAT

INVESTIGATOR(S)

MEASUREMENT

MISCELLANEOUS

POPULATION

REQUIREMENTS

SCIENTIFIC

SYSTEM

APPLICATION

Q1. The SF424 (R&R) Instructions state that the Data Management Plan is recommended not to exceed 2 pages. The template linked in the FOA is over 2 pages. Will CDC accept a Data Management Plan up to 4 pages in length?

a. Answer: Applicants are not required to use the template. It is critical that applicants follow the instructions in the How to Apply - Application Guide (https://grants.nih.gov/grants/how-to-apply-application-guide.html) except where instructed to do otherwise in the 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. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. All page limitations described in the NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 12 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 25 pages for all appendices. Pages that exceed page limits described in the NOFO will be removed and not forwarded for peer review, potentially affecting an application's score. The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

i. A description of the data to be collected or generated in the proposed project;

ii. Standards to be used for the collected or generated data;

iii. Mechanisms for providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);

iv. A statement (required) of any limitations you may encounter with sharing data collected or generated under this award with CDC (such as legal, regulatory, policy, or technical concerns);

v. Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and

vi. Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

b. The AR-25 https://www.cdc.gov/grants/additional-requirements/ar-25.html outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

c. NOFO Section(s): Required Application Instructions; Section IV. Application and Submission Information, 5. PHS 398 Research Plan Component and 7. Page Limitations; Section VI. Award Administration Information, 3. Additional Policy Requirements

d. Page(s): 3 and 27-28 and 43

Q2. The Budget Form in the required package does not appear to be editable. Is this a grants.gov issue? Is there another location to download editable versions of the required documents? The PDF forms cannot be edited.

a. Answer: Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors. To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

b. If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

http://grants.nih.gov/support/index.html. Email: commons@od.nih.gov. Phone:

301-402-7469 or (toll-free) 1-866-504-9552. Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

c. NOFO Section(s): Section IV. Application and Submission Information

d. Page(s): 24-25

Q3. Is the Equipment Form required if there will be no equipment utilized?

a. Answer: A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen. Please use the form and instructions for SF 424 (R&R) FORMS-H for applications due on or after January 25, 2023.

b. NOFO Section(s): Section IV. Application and Submission Information, 4.

Required and Optional Components

c. Page(s): 26 http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

Q4. The Resource Sharing Plan and the requirements in Activity 3.2 appear to refer to the same research dissemination plan. Will CDC allow applicants to include this plan in the Resource Sharing Plan attachment, and refer to this attachment in the write-up for Activity 3.2?

a. Answer: CDC does not expect applicants to repeat information. The resource sharing plan section should be limited to information required in that section.

b. NOFO Section(s): N/A

c. Page(s): N/A

Q5. Can CDC please clarify where the Data Management Plan should be attached within the

PHS 398 Research Plan Form? The SF424 (R&R) Form H instructions refer to the Data Management Plan in both 10. Resource Sharing Plan(s) and 11. Other Plan(s). Please clarify in which of these sections this plan should be attached.

a. Answer: Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application.

b. NOFO Section(s): Section IV. Application and Submission Information, 5. PHS 398 Research Plan Component

c. Page(s): 27

BUDGET

Q6. We saw the RFA-DP-24-138 call, and are extremely interested in applying. We wanted to confirm that the funding is up to $500,000 per year for up to 5 years (so the maximum possible award would be $2,500,000)?

a. Answer: Yes, with an award ceiling of $500,000 per budget period (12 months), the total funding amount could be $2,500,000 (subject to funds availability, satisfactory progress, and the determination of continued funding).

b. NOFO Section(s): Executive Summary, and Section II. Award Information

c. Page(s): 4 and 19

Q7. Could this grant fall under a training grant? Clarifying to budget appropriately for indirects.

a. Answer: These are not training grants.

b. NOFO Section(s): N/A

FORMAT

Q8. The formatting instructions state that type density “must be no more than 15 characters per linear inch (including characters and spaces). The font size requirements state that “smaller text in figures, graphs, diagrams and charts is acceptable, as long as it is legible when the page is viewed at 100%”. If text smaller text included in graphics, images, diagrams, and charts is more than 15 characters per inch due to its smaller size, is this acceptable as long as the text is legible at 100%?

a. Answer: It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. The application guide can be found at https://grants.nih.gov/grants/how-to-apply-application-guide.html. Please be sure to review the 'Application Process' for detailed information on formatting requirements regarding fonts.

b. NOFO Section(s): Section IV. Application and Submission Information

c. Page(s): 25

INVESTIGATOR(S)

Q9. Page 4 of the NOFO states there will only be one PD/PI for each application. Can you clarify whether co-PD/PIs are allowed?

a. Answer: It is anticipated that research supported under this NOFO will involve collaboration with both CDC and external partners (e.g., education and public health agencies, youth-serving organizations, healthcare providers, individuals, community members, governmental, non-governmental and private sector partners) on projects for the purpose of implementing and evaluating strategies aligned with CDC’s What Works in Schools (WWIS) approach for successful implementation in local education agencies and schools serving rural or AI/AN adolescents to address students’ health behaviors, experiences, and outcomes, and supporting translation and dissemination of the studies' findings. You can have multiple PIs, but one contact PI will be issued a notice of award.

b. NOFO Section(s): Executive Summary; Section I. Funding Opportunity Description, 2. Approach

c. Page(s): 4 and 17

MEASUREMENT

Q10. On pages 15 and 16 of the NOFO, Long-Term Outcome (LTO) 2 states: Improve health outcomes among youth, specifically to include, but not limited to: decreased sexual risk behavior, improved mental health, decreased violence-related behaviors and experiences, decreased substance use, and increased protective behaviors and factors.

Do all of these listed outcomes need to be measured as part of the proposed research/evaluation project?

a. Answer: The statement from the NOFO on pages 15-16 note "to include [emphasis added], but not limited to".

b. NOFO Section(s): Section I. Funding Opportunity Description, 2. Approach

c. Page(s): 15-16

Q11. Do proposed projects need to address all priority domains (sexual and reproductive health, behavioral and mental health including suicide-related behaviors, substance use, violence, and protective factors) outlined in the table beginning on page 12 of the RFA?

a. Answer: The strategies (as shown in program NOFO 24-139) focus on sexual/reproductive health and mental/behavioral health, while the outcomes they can impact also address suicide, violence, and substance use. As stated in the NOFO Purpose on pages 1-2, “This Notice of Funding Opportunity (NOFO) supports research to implement and evaluate strategies aligned with CDC’s What Works in Schools (WWIS) approach for successful implementation in local education agencies and schools serving rural or American Indian and/or Alaska Native (AI/AN) adolescents to address students’ health behaviors, experiences, and outcomes, particularly those related to sexual and reproductive health and mental and behavioral health, as well as suicidality, substance use, and experiences of violence [emphasis added]. The purpose of the research is to build the evidence base for innovative, school-based or school-linked strategies that promote the health of youth across multiple health domains while also supporting translation and dissemination of the research findings. Strategies may include programs, policies, or practices that seek to improve sexual and reproductive health as well as improve mental and behavioral health in a manner that also addresses health equity among youth in local education agencies and schools serving rural or AI/AN adolescents. Additionally, strategies may also seek to reduce suicidality, substance use and experiences of violence among school-aged adolescents.” Additionally, page 11 notes that “This NOFO will support studies aimed at implementing and evaluating strategies aligned with WWIS approach, including adaptations addressing sexual and reproductive health and mental and behavioral health [emphasis added], in local education agencies and schools serving one of the…populations…". Lastly, was indicated, there is also a table of outcomes of interest on page 12.

b. NOFO Section(s): Section I. Funding Opportunity Description, 1. Background and Purpose and 2. Approach

c. Page(s): 1-2 and 5-12

Q12. For each priority domain that a proposed project addresses, do all bulleted student health behaviors and experiences of interest within each priority domain need to be addressed, as outlined in the table beginning on page 12 of the RFA?

a. Answer: Please see the answer to Q11.

b. NOFO Section(s): Section I. Funding Opportunity Description, 1. Background and Purpose and 2. Approach

Q13. The NOFO’s Background and Purpose discusses the co-occurrence of sexual risk behaviors with violence, mental health, suicide, and substance use. Furthermore, the WWIS Approach includes Mental Health, Sexual Risk, Substance Use, Suicidality, and Violence. Do the funded research/evaluation projects under this NOFO required to explicitly address all of these risk behaviors/outcomes, or can a proposed research/evaluation project evaluate strategies, based on the WWIS, that explicitly address some of these areas (e.g., improving mental health and reducing suicidality)?

a. Answer: Please see the answer to Q11.

b. NOFO Section(s): Section I. Funding Opportunity Description, 1. Background and Purpose

MISCELLANEOUS

Q14. I am new to Grant writing. I was wondering if you know of any grants available to organizations like mine. If you can help me in anyway, it would be greatly appreciated.

a. Answer: Unfortunately, we are unable able to speak to funding opportunities or mechanisms that may be appropriate for organizations like yours. Please consider reviewing opportunities on grants.gov to see if there are any appropriate opportunities that align with your work. You may also view our website regarding some of our funded programs: https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm

Q15. Could you provide a copy of the following announcement: RFA-DP-24-138

Demonstration Projects to Research and Evaluate Strategies Aligned with CDC’s What Works in Schools Approach?

a. Answer: Please navigate to grants.gov and search for the NOFO. Once you see it in the search results, please click the hyperlinked opportunity number. The grant opportunity page will appear. You’ll see blue buttons. Please click the blue button that reads “Related Documents”. Please click the link that has “full revised announcement” in its title.

b. NOFO Section(s): N/A

POPULATION

Q16. When identifying schools serving rural adolescents, what definitions of “rural” are allowable? Can we utilize the National Center for Education Statistics classifications rather than the HRSA and Federal Office of Rural Health definition?

a. Answer: Page 11 states: “Applicants who select to implement and evaluate strategies aligned with the WWIS approach for schools serving rural adolescents are expected to work primarily in school districts and schools not included within an urban area. Additional guidance from HRSA and the Federal Office of Rural Health can be found at: https://www.hrsa.gov/rural-health/about-us/what-is-rural .” CDC cannot provide specific instructions beyond this requirement, and applications received will be evaluated in peer review.

b. NOFO Section(s): Section I. Funding Opportunity Description, 2. Approach

c. Page(s): 11

Q17. I had a question regarding the Rural Area requirement listed on page 11 regarding the need to primarily work in rural areas defined by HRSA/Office of Rural Health. Although the counties within my and my regional office's jurisdiction are all not technically rural solely off of population, many of our towns in the outer regions of these counties qualify for Rural Health funding and would be prime school districts for the work the grant entails.

a. Answer: Please see the answer to Q16.

b. NOFO Section(s): Section I. Funding Opportunity Description, 2. Approach

REQUIREMENTS

Q18. Must proposed Senior/Key Personnel from a sub-recipient also be registered with the eRA Commons if they are not the applicant organization completing the submission (rather they are contributing to the content of the submission and are collaborators but not responsible for submitting the application)?

a. Answer: If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its UEI number to the recipient organization.

b. NOFO Section(s): Section III. Eligible Information, 7. Universal Identifier Requirements and System for Award Management (SAM)

c. Page(s): 23

Q19. Does the NOFO prohibit an organization from submitting as a prime on one application AND a sub on another?

a. Answer: The NOFO states: Only one application per institution (normally identified by having a unique entity identifier [UEI]) is allowed. Multiple applications from different divisions of the same institution will be returned without further consideration by CDC. The one application per institution with a unique UEI number condition only applies to the prime applicant organization.

b. NOFO Section(s): Section III. Eligibility Information, 10. Number of Applications

Q20. Does the NOFO prohibit an organization from submitting on two bids as a sub?

a. Answer: Please see the answer to Q19.

b. NOFO Section(s): Section III. Eligibility Information, 10. Number of Applications

Q21. Can CDC please describe expectations of formal reporting frequency (outside of updates on a regular basis)? For example, will annual reports be required by CDC? Will quarterly progress reports be required/expected by CDC?

a. Answer: Please review Section VI. Award Administration Information, particularly item #5. Reporting, for a detailed description of the reporting requirements and frequency.

b. NOFO Section(s): Section VI. Award Administration Information, 5. Reporting

c. Page(s): 45

Q22. Will a final written evaluation report at the conclusion of the cooperative agreement period of performance (aligned with Activity 2, #5 on page 16 of 53) be sufficient for CDC?

a. Answer: Please review Section VI. Award Administration Information, particularly item #5. Reporting, for a detailed description of the reporting requirements due at the end of the project period.

b. NOFO Section(s): Section VI. Award Administration Information, 5. Reporting

c. Page(s): 45

Q23. Can CDC confirm is the Data Management Plan intended for quantitative data only or should we include plans for management of qualitative data as well?

a. Answer: Applicants that plan to collect public health data must submit a Data

Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds. For purposes of this announcement, “public health data” means digitally recorded factual material commonly accepted in the scientific community as a basis for public health findings, conclusions, and implementation. “Public health data” can include both quantitative and qualitative data.

b. NOFO Section(s): Section IV. Application and Submission Information, 5. PHS 398 Research Plan Component; Section VI. Award Administration Information, 3.

Additional Policy Requirements

c. Page(s): 27 and 42-43

Q24. Per Page 25 of the NOFO, “Additionally, applicants focusing on schools serving AI/AN adolescents associated with tribal communities must provide an official letter from a currently elected tribal leader or a tribal resolution to demonstrate support from the Tribe, where appropriate.” Can applicants provide an existing Memorandum of Understanding (MOU) in lieu of a Letter of Support to demonstrate tribal support for a proposed project

a. Answer: Yes. A MoU is acceptable.

b. NOFO Section(s): Section IV. Application and Submission Information, 2.

Content and Form of Application Submission

c. Page(s): 25

SCIENTIFIC

Q25. Does the curriculum need to focus on sexual health education, or would CDC consider a curriculum that takes a more holistic approach on promoting positive health behaviors across reproductive and mental health and respect for others?

a. Answer: Please review pages 6 and 7 of the NOFO, which provides a description of the WWIS program and includes the strategies of interest.

b. NOFO Section(s): Section I. Funding Opportunity Description, 1. Background and Purpose

c. Page(s): 6-7

Q26. Does CDC anticipate that schools/school districts will implement WWIS each year of the period of performance?

a. Answer: We do expect implementation to take place in most years, but we understand that a reasonable amount of planning may need to take place in Year 1 with participating schools/school districts.

Q27. The NOFO mentions that the WWIS approach may be adapted for rural or AI/AN communities. Can CDC provides examples or guidance on how WWIS approach can be modified?

a. Answer: We are unable to provide specific examples of adaptation. However, to date, this evaluation evidence highlights the potential for schools and school districts to positively impact youth health behaviors and experiences by applying the WWIS approach, yet gaps remain in understanding program implementation, adaptation, and effectiveness for tailored adolescent groups. Specifically, studies are needed to examine the effectiveness of WWIS in schools serving rural adolescents and AI/AN. This NOFO supports studies to implement and evaluate strategies aligned with CDC’s WWIS approach for successful implementation in school districts and schools serving rural or AI/AN adolescents to address health behaviors, experiences, and outcomes, and supports translation and dissemination of the studies' findings. The extent to which adapatation is needed and, if needed, the type of adaptation needed, is something the recipients of the this research NOFO and their partnering schools/districts will help identify.

Please review Section I of the NOFO for more details.

b. NOFO Section(s): Section I. Funding Opportunity Description

c. Page(s): 5-19

Q28. Is there an expectation that we will work to support the school district in which we receive the letter from?

a. Answer: Research studies supported by this NOFO are expected (1) to implement and evaluate strategies aligned with CDC’s What Works in Schools (WWIS) approach for successful implementation in local education agencies and schools serving rural or AI/AN adolescents to address health behaviors, experiences, and outcomes, and (2) to support translation and dissemination of the studies' findings.

b. NOFO Section(s): Section I. Funding Opportunity Description, 2 Approach

Q29. Are the scored review criteria listed in order of importance? Are each of these criteria weighted differently, or equally?

a. Answer: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the review criteria listed in the NOFO along with the additional review criteria (as applicable for the project proposed). Reviewers will consider each of the review criteria in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

b. NOFO Section(s): Section V. Application Review Information

c. Page(s): 33

Q30. Can you clarify whether the comparison group should be a true control group or if the comparison should be pre and post?

a. Answer: The NOFO does not provide further specifications on the comparison group(s) beyond what is stated on page 12: "Studies are expected to employ a quasi-experimental design (i.e., use of comparison group(s)) and use implementation science frameworks, theories, principles, and methods." Please note the outcomes listed on page 16 of the NOFO as well as the criteria outlined in Section V. Application Review Information for details to keep in mind when preparing a proposal.

b. NOFO Section(s): Section I. Funding Opportunity Description, 2. Approach;

Section V. Application Review Information, 1. Criteria

c. Page(s): 12, 16, and 33-36

SYSTEM

Q31. What is the turn around time for the three letters from Grant.gov?

a. Answer: The emails are system generated, and it depends on the system.

Please follow the instructions within the NOFO, and ensure you submit your applications early enough to address any potential errors. Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems. The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes.

b. NOFO Section(s): Section IV. Application and Submission Information, 9.

Submission Dates & Times

c. Page(s): 28-29

Q32. I am trying to apply for the grant on grant.gov and I am getting a message stating that the page can’t be found.

a. Answer: 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.

b. NOFO Section(s): Section VII. Agency Contacts, Section IV. Application and Submission Information

c. Page(s): 52