JG-25-137_Amendment Q&A.docx

CENTER FOR GLOBAL HEALTH

EXTRAMURAL RESEARCH PROGRAM OFFICE

RFA-JG-25-137 - Innovative Approaches for TB Prevention and Case Finding to END TB Q & A Document Q&A Amendment Note:

The purpose of this amendment is to publish responses to questions submitted during the Q&A period of this NOFO as outlined on pg. 5/50.

The purpose of this amendment is to also revise in the NOFO the use of the term “sub-clinical TB” and “subclinical TB” to “asymptomatic TB” throughout the document, in line with the World Health Organization Global TB Report 2024.

1. Is there any guidance on a preferred number of countries to be included in a proposal?

Yes. Funding preference will be given to those applications proposing research in at least one of the GTB (Global Tuberculosis Branch) priority countries. See bullet 2 on pg. 33/50.

1. Will applications including only one country be considered?

Yes. As stated on pg. 11/50, “CDC will only consider proposals including work in the countries listed above; if proposals include work in countries not listed above, they will not be considered for funding.”

1. The NOFO states, “CDC will only consider proposals including work in the countries listed above; if proposals include work in countries not listed above, they will not be considered for funding.” The first sentence implies that priority countries must be included, and leaves open the possibility that other countries could also be included. The second sentence seems to close that door. Could you please clarify whether a proposal that focuses on priority countries, but also includes other countries, will not be considered?

This NOFO focuses on specific countries where GTB can apply its core strengths to maximize impact. Therefore, CDC will not consider applications proposing work in countries that are not listed in the NOFO, and preference would be given to those priority countries that are prefixed with an asterisk (*), which is described under Population of Focus on pg. 11/50.

1. Is there any expectation/preference that these components would be addressed by proposals for study conduct in conjunction with the Tuberculosis Trials Consortium or other CDC standing research networks?

The focus of this NOFO is to fund studies that propose to halt progression of TB disease (Component A) and improve case finding and course of TB disease (Component B). Please refer to Objectives /Outcomes on pg. 9/50. As stated in the NOFO on pg. 11/50, applicants may propose other objectives with research activities or outcomes from those listed under Objectives/Outcomes for each thematic component.

There is no expectation/preference that the thematic components of the NOFO be addressed by proposals for study conducted in conjunction with the Tuberculosis Trials Consortium or other CDC standing research networks. As noted on pg. 12/50, collaboration with other partners is expected to avoid duplication and promote synergies across proposed activities. Furthermore, applicants are subject to report if this application will result in programmatic, budgetary, or commitment overlap with another application or award. Any overlap is not permitted and will be resolved by the CDC with the applicant and the PD/PI prior to award. See Duplication of Efforts on pg. 25/50 for more information.

1. The NOFO states that “Data use and data sharing agreements should be developed at the time of individual protocol development. It is expected all data should be de-identified and retained at CDC until all analyses are completed, and planned manuscripts are published. All data should be archived under the CDC retention policy guidelines.” Could you please confirm that data will be stored at CDC rather than in some other repository or with the project teams?

Yes, as stated in the NOFO on pg. 12/50, it is expected all data should be de-identified and retained at CDC until all analyses are completed, and planned manuscripts are published. All data should be archived under the CDC retention policy guidelines. Also see AR-25 https://www.cdc.gov/grants/additional-requirements/ar-25.html for more information regarding the requirements for data accessibility, storage, and preservation.

1. It is clearly noted that, “Applications proposing funding in excess of $1,000,000 for Year 1 per thematic component will be deemed “nonresponsive” and will not move forward to scientific peer review.” Study costs are often distributed unequally across a 5-year period, with costs being highest in middle years and lower in first and last years. Will CDC consider unresponsive applications that propose funding in excess of $1,000,000 in any year, if the total over 5 years remains at <=$5 million?

No. As stated on pg. 13-14/50, “Applications proposing funding in excess of $1,000,000 for Year 1 per thematic component will be deemed “nonresponsive” and will not move forward to scientific peer review.” This is also noted under Responsiveness on pg. 16/50. For this NOFO, applicants should develop a proposal to spend up to $1,000,000 for one thematic component per budget year. Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

1. Can you please confirm that, given that one award will be given for component A and a second award for component B, that the maximum that can be applied for any project is a $5 million total budget? Or can an applicant exceed $5 million for the total 5-year project, keeping less than $1 million for year 1 as per question 6?

No, the applicant cannot exceed $5 million ceiling per component for the total 5-year project period. As noted on pg.13-14/50 for this NOFO, applicants should develop a proposal to spend up to $1,000,000 for one thematic component per budget year. Applications proposing funding in excess of $1,000,000 for Year 1 per thematic component will be deemed “nonresponsive” and will not move forward to scientific peer review. The same is noted under Responsiveness on pg. 16/50.

1. Would TPT for RR/MDR-TB be within scope of component A? Would screening and case finding for RR/MDR-TB be within scope of component B?

Yes, as outlined under Objectives/Outcomes on pg. 9/50, TPT falls under the scope of Component A and screening and case finding falls under the scope of Component B.

1. Regarding the series of bullets about things that recipients may be asked to do (bottom p. 6-top p. 7), how does that apply or how is that relevant to this NOFO?

The activities listed beginning on pg. 6/50 outline programmatic activities that recipients may be requested to participate in as part of HHS/CDC’s work with host countries and other key partners. As stated on pg. 6/50: “In an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC also supports coordination with and among partners and integration of activities that promote Global Health Initiative principles.”

1. Regarding local partnerships and capacity building, can you confirm if it is preferred for local organizations to be included as part of the research consortium and as such hold budget? Can you confirm if any preference for a South-based organization to serve as PI or lead applicant versus that of a North-based organization?

Involving local organizations is up to the discretion of the applicant. As stated in the NOFO on pg. 8/50 “Applicants are encouraged to request support for the development of local research capacity necessary for the conduct of the proposed study/studies, and to propose studies that are feasible with maximum impact within the local capacity and context.” and on pg. 12/50 under Collaboration/Partnerships: “Applicants should clearly specify how local partners will lead or assist these projects, how research capacity will be strengthened at local institutions, and how research findings will be disseminated to have maximum impact on public health.”

Funding preference for this NOFO is outlined under Funding Priorities starting on pg. 32/50:

“Funding preference will be given to those applications proposing research:

2. That includes work in countries listed below will be considered for funding.

*Botswana, Cambodia, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, *Eswatini, *Ethiopia, Ghana, *Haiti, *India, *Kenya, *Lesotho, *Malawi, *Mozambique, *Namibia, *Nigeria, Philippines, *Rwanda, *South Africa, South Sudan, *Tanzania, *Uganda, *Vietnam, *Zambia, and *Zimbabwe *Bold indicates a GTB priority country. Priority countries are high TB, drug-resistant TB (DR TB), and TB/HIV burden countries with a strong on the ground DGHT program presence.

2. That is located in at least one of the GTB priority countries (See bold countries above).

3. That includes several objectives under each thematic component.

4. That includes populations at increased/higher risk for TB as defined in the Target Population (Section I). These include (but are not limited to): Persons exposed to active TB disease (household contacts and social contacts), children, pregnant and breast feeding women, PLHIV, racial and ethnic minorities, healthcare workers, older adults, migrants or mobile populations, and those with co-morbid health conditions that increase the risk for TB or complicate TB treatment and care (e.g., diabetes mellitus, undernutrition, alcohol use disorders, substance use disorders, other respiratory diseases).

5. That demonstrates a publication history of high-quality TB research supporting changes in policy or improve public health practice.”

1. As per page 49 of the NOFO, inquires with the CDC scientific research contacts is encouraged. Can you confirm if inquiries are allowed after the December 12 NOFO question submission deadline?

As noted on page 5/50 under Special Date(s) December 12, 2024, by 11:59 pm ET was the cutoff date for applicants to submit their questions by email to cgherpo@cdc.gov. Questions received after this time will not be considered for response. All changes, updates including the Q/A will be added as an amendment to the NOFO and will be posted on grants.gov within two weeks after December 12, 2024.

1. Must all elements of the expected objectives be addressed to be considered eligible? For example, would research evaluating new diagnostic tools need to contribute to the understanding of the burden of post-TB lung disease? // Are applicants required to address all objectives listed under the Component they are applying for, or may a select subset of the objectives be chosen to be addressed?

Eligibility criteria does not require all elements of the expected objectives to be addressed. Pg. 11/50 of the NOFO also states that “Applicants may propose other objectives with research activities or outcomes from those listed above for each thematic component. However, as stated under Funding Priorities on pg. 33/50, funding preference will be given to those applications proposing research “that includes several objectives under each thematic component”.

1. The NOFO refers to the project as research. Can we include elements of implementation and scale-up in the latter years of the project based on the performance of the tools being evaluated?

It is at the applicant’s discretion if they would like to include elements of implementation and scale-up in latter years of the project. As stated in the Approach on pg. 8/50, “It is expected the research findings will be broadly disseminated and translated into public health practice to facilitate the development and implementation of new and better program models, or program improvement strategies, with immediate implementation within local communities of practice. There should be an opportunity to look at real-time data and the possibility of sharing early findings with programs to make real-time impact.”

14. Is there a preference for applications that include research in multiple priority countries?

As indicated on pg. 32/50, funding preference will be given to those applications proposing research that includes work in countries listed in the NOFO, in at least one GTB priority country (highlighted in bold on pg. 32-33/50).

Including research in multiple countries is at the discretion of the applicant. Applicants are free to propose work in as many priority countries noted under Population of Focus on pg. 11/50 they deem feasible within their intended scope of work and supported by projected budget ceiling as noted on pg. 13/50. Funding will not be adjusted by the number of countries proposed.

15. Pages 3 and 22 of RFA indicates that “The Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices” but does not indicate page limitations for other required, non-appendices sections. Can CDC clarify if the other sections – such as Specific Aims and Other Research Plan Sections, e.g. Multiple PD/PI Leadership Plan, Consortium/Contracting Arrangements, Letters of Support, Resource Sharing Plan(s), Data Management Plan, etc. – are included in this 25-page limit?

Specific Aims, Multiple PD/PI Leadership Plan, Consortium/Contracting Arrangements, Letters of Support, Resource Sharing Plan(s), Data Management Plan, etc. – are not included in this 25-page limit. See Page Limitations on pg.22/50.

16. Are all of the “Other Research Plan Sections” listed on page 21 of the RFA required, or may applicants select to include those that are relevant to their applications?

Applicants may select to include other research plans they deem relevant to their application.

17. No guidance of criterion is included in the RFA for the “Other Research Plan Sections” listed on page 21. Can CDC please share their expectations for these sections?

It is up to the discretion of the applicant to include other research plans they deem relevant to their application.

18. Letters of support are listed under “Other Research Plan Sections” on page 21 of the RFA, but no additional guidance is provided. Can CDC clarify what is expected for these letters of support? Are these letters to indicate institutional commitments of consortium partners/sub-awardees, or support of in-country stakeholders that will support/collaborate with this award?

Letters of support are not required as part of an applicant’s submission. It is at the discretion of the applicant to include letters of support and what these would entail.

19. Can CDC please clarify whether letters of intent and applications should be submitted through eRA/ASSIST, Grants.gov, or both? The RFA number is not currently available when searched in ASSIST.

A. As noted on pg.20/50, letter of intent must be sent to:

Lata Kumar Director, Extramural Research Program Office Office of the Associate Director of Science Global Health Center Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS H21-9 Atlanta, GA 30329 Email: lek7@cdc.gov

B. Application submission:

The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes. Applicants will use a platform or system to submit applications.

Applicants are able to access, view, and track the status of their applications in the eRA Commons.

Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

ASSIST—NIH system is used to access, prepare, and submit application forms. When using ASSIST all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

See pages pg. 20-23/50 for detailed instructions on application submissions.

C. Here is the link to the RFA in Grants.gov.

20. Can CDC please clarify whether applicants should submit a budget for only Year 1, or the entire 5-year period of performance?

As stated on pg. 13-14, applicants should develop a proposal to spend up to $1,000,000 for one thematic component per budget year and the anticipated period of performance is 5 years.