DFOP0017890_Advancing_Global_Health_APS_Round_3_QA.pdf

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“Advancing Global Health” APS, Round 3 Q&A Please be sure to read the Q&A for Round 1, Round 2a, and Round 2b first as those amendments contain many questions relevant to the preparation of your SOI. We do not answer duplicate questions, so it’s critical that you read all Q&A documents.

Addendum K: NTD Q&A

1. The Addendum states that the 2019 End NTDs Act identifies 17 priority NTDs, and lists these explicitly; rabies is not included among them, although it is recognized as an NTD by WHO and referenced as an example NTD in other versions of End NTDs Act legislation (e.g. H.R. 826, 116th Congress). Could you please clarify whether rabies is considered in scope under this Addendum, and if so, whether prevention-focused programming (e.g. mass dog vaccination to interrupt zoonotic transmission to humans) would be considered consistent with the Addendum's "elimination/interruption of transmission" objective, given that funding for control-only strategies is explicitly excluded?

This APS is specific for NTDs specified in the congressional act, which was signed into law under Public Law 116-94 (Further Consolidated Appropriation Act, 2020). The definition of NTDs and list of NTDs is found under section 303(2).

2. Given that projects may have a performance period of up to five years while Addendum K prioritizes NTDs that can be eliminated within approximately three years, may years four and five support activities required to preserve and document gains achieved during the elimination period, including post-treatment or post-interruption surveillance, verification/validation readiness, elimination-dossier support, integration into national surveillance systems, and sustainable transition to country management?

Activities that could be considered for support are specified in the APS. The SOI does not require a detailed plan for all five years of the project period. The SOI should focus on achieving the objective and sub-objectives as appropriate.

3. For a broad-based integrated SOI, may an applicant propose country-specific packages addressing multiple priority NTDs at different points on the elimination continuum, provided that each disease-country component has a defined elimination, interruption-of-transmission, or control-to-elimination pathway, measurable milestones, and a realistic timeline, and that routine disease-control activities are not proposed as stand-alone objectives?

Applicants can propose country-specific packages addressing multiple priority NTDs at different points on the elimination spectrum as long as those activities are clearly tied to the objectives and priorities specified in the Addendum.

4. For a coherent multi-country SOI, may shared regional functions—such as epidemiological and technical assistance, laboratory quality assurance and reference capacity, integrated surveillance and data systems, workforce development, supply-chain support, operational research, and cross-country learning—be supported where those functions directly serve and are allocable to defined country-level NTD elimination outcomes?

Shared regional functions should be specified in SOIs. These shared functions should be tied to the objectives in the Addendum.

5. Where an NTD program is currently classified in a control phase, Addendum K permits strategic activities that demonstrate transition toward elimination. Does GHSD expect such a component itself to achieve elimination within the three-year priority period, or may it be responsive where the award closes a defined epidemiological, diagnostic, operational, or implementation evidence gap and establishes a demonstrable and time-bound transition to an elimination pathway?

For NTD programs that are classified in a control phase, the Addendum permits strategic activities to demonstrate transition toward elimination. It is a GHSD preference to see evidence-based pathways demonstrating that elimination could be achieved in the timeframe of this project.

6. For country selection and targeting at the SOI stage, may applicants identify priority countries and indicative subnational geographies using the best available national and WHO/ESPEN evidence, with final districts, transmission zones, implementation units, or disease-specific targets refined during consultative program design or Phase 2 in coordination with national NTD programs as updated surveillance and program data become available?

At the SOI stage, applicants should identify priority countries and indicative subnational geographies using the best available evidence.

7. Addendum K says that country co-investment is not required in Year 1 but that sustainability plans must include specific expectations for country co-investment beginning in Year 2. For a multi-country project, may those expectations be tailored by country and disease program, and may qualifying country contributions include government-financed personnel, facilities, laboratories, surveillance systems, logistics, commodities, existing program budgets, or other in-kind/public resources in addition to incremental cash financing?

Country co-investment is expected as part of the five-year process. Proposed co-investment should be tailored to the individual situation of each country’s NTD program and should be targeted to achieve sustainability long-term.

8. For countries or disease programs that have already met an epidemiological elimination threshold but have not yet completed formal verification/validation, may Addendum K support the remaining surveillance, evidence-quality, dossier, institutional-capacity, and sustainability requirements necessary to obtain and preserve formal recognition of elimination?

Applicants should support those activities needed to meet, demonstrate, and maintain elimination goals, particularly when they help address sub-objective A: strengthen surveillance, laboratory, supply chain, and health system capacity for NTD detection, monitoring and response to accelerate elimination.

9. We would like to better understand the elimination requirement outlined in the Addendum.

In our context, complete national elimination of the diseases we are considering targeting — dengue and scabies — is not realistic within the five-year project period. In addition, the Government of Bangladesh’s current approach focuses primarily on disease control. Would a phased approach towards elimination, starting with defined geographic areas to demonstrate progress and generate evidence that can inform eventual national scale-up, be acceptable in this context?

Dengue and scabies are not currently targeted for elimination by global programs. GHSD may consider funding programs in countries that do not have elimination targets at the global level if their national guidelines specify elimination targets and they have a plan for achieving elimination. Additionally, GHSD may consider funding strategic activities to demonstrate the feasibility (proof-of-concept) of transitioning the program from control to elimination.

10. Under the ownership and sustainability clause, is the national government's investment from Year two mandatory? Or would co-investment from the participating organisation/consortium be considered sufficient to meet this requirement?

Country co-investment is expected as part of the five-year process. It should be tailored to the individual situation of each country’s NTD program, and it should be targeted to achieve sustainability long-term.

11. Sub-objective B refers to the identification and evaluation of innovative tools that accelerate progress toward elimination, and the Addendum states that activities demonstrating a programme could transition from control to elimination will be considered.

Where a new diagnostic tool is required to close a defined evidence gap for a national programme's transition from control to elimination, would the following be allowable costs:

(a) multi-country, multi-site validation studies in targeted geographies to generate country-level and WHO policy evidence; and (b) the technology transfer activity required to establish a manufacturer of record, where that transfer is a prerequisite for the tool being available at the scale the validation studies require? If (b) is not allowable, may it be included as a cost-shared or leveraged non-federal contribution?

GHSD will consider funding strategic activities to demonstrate the feasibility (proof-of-concept) of transitioning the program from control to elimination. GHSD will not fund the evaluation of the accuracy of new diagnostic tools. GHSD may consider an evaluation of the use of a new diagnostic tool in a multi-country setting as a strategy to generate elimination evidence that can be used to develop country or international level policies. Cost-sharing from other sources would be acceptable.

12. Sub-objective A includes strengthening supply chains and systems for commodities required for NTD detection and elimination. Where a WHO-recommended rapid diagnostic test essential to a national elimination programme has been discontinued by its manufacturer, leaving no equivalent commercially available product, would activities to restore supply continuity be allowable — specifically, securing a manufacturer of record, and the technical work required to bring the test to current regulatory and performance standards for WHO prequalification? We are asking whether commodity continuity of this kind is treated as eligible health systems and supply chain strengthening, or as product development outside the scope of this Addendum.

Activities that help accelerate progress towards elimination goals and enhance program sustainability will be considered. It is important to link proposed supply chain activities to the broader goals specified in the Addendum.

13. Can proposals for the NTDs APS include vector control efforts leverating wolbaccia mosquitoes cultivation/expansion?

The goal of the Addendum is to support implementation of activities that will lead to elimination of NTDs. Vector control efforts including Wolbachia mosquito cultivation and expansion can be considered as long as the applicant is able to demonstrate how the strategy will result in elimination of NTDs within the next three years.

14. Will you consider other countries outside of those listed in the Addendum K, such as Guyana which is only 3 years away from eliminating Lymphatic Filariasis?

This Addendum is limited to the countries specified in the announcement.

15. For diseases such as schistosomiasis and STH, would projects be eligible where current programming remains partly focused on control but the proposed investment is specifically designed to demonstrate and enable a transition toward elimination? What level of evidence or likelihood of achieving elimination within the project period would be expected?

For NTD programs that are classified in a control phase, the Addendum permits strategic activities that demonstrate transition toward elimination.

16. From Year 2 onward, is there a minimum expected level or percentage of country co-investment, or should applicants propose country-specific commitments based on fiscal capacity and existing domestic contributions?

Country co-investment is expected as part of the five-year process. It should be tailored to the individual situation of each country’s NTD program, and it should be targeted to achieve sustainability long-term, being cognizant of the fact that some programs will achieve sustainability faster than others.

17. Can the project work with the CDC and the CDC receive funding for technical assistance and laboratory testing?

CDC is not eligible to receive funding through this Addendum.

18. The Addendum discusses priority neglected tropical diseases and references countries where elimination efforts are sought. Are SOIs expected to focus only on the NTDs specifically identified within Addendum K, or are projects addressing additional NTDs included on the broader WHO list of neglected tropical diseases also eligible for consideration, provided they align with the objectives of the Addendum?

This APS is specific for NTDs specified in the congressional act, which was signed into law under Public Law 116-94 (Further Consolidated Appropriation Act, 2020). The definition of NTDs and list of NTDs is found under section 303(2). Those are the 17 NTDs specified in the Addendum. The focus of the SOI should be those diseases that have elimination targets or for which strategic activities could provide proof-of-concept of the feasibility of transition to elimination.

19. Does GHSD have a preference for SOIs that propose multi-country and/or multi-region approaches, or will country-specific submissions be considered equally competitive if they demonstrate strong alignment with the Addendum's objectives and anticipated outcomes?

GHSD does not have a preference for multi-country, multi-region, or country-specific approaches. Applicants may propose the geographic scope that they believe is most appropriate to achieving the objectives and anticipated outcomes of the Addendum.

Multi-country or multi-region approaches should demonstrate a clear rationale for the proposed scope and how the approach will achieve results across the proposed geographies. Country-specific SOIs will be considered equally competitive when they demonstrate strong alignment with the Addendum's objectives and anticipated outcomes.

All SOIs will be evaluated according to the selection criteria outlined in Section F of the

APS.

20. Are single country proposals accepted?

Single country SOIs are accepted.

21. Could NTDs that are transitioning from control to elimination be included as priority NTDs, along with those in the pre-elimination phase?

Applicants can consider including NTDs that are transitioning from control to elimination. Strategic activities to demonstrate the feasibility (proof-of-concept) of transitioning the program from control to elimination will be considered.

22. Could GHSD provide the list of eligible co-investment options from the country governments?

Co-investment is primarily focused on financial resources that the country contributes to meet those invested by the U.S. government.

23. Paraguay is not listed among the countries in the Western Hemisphere. Can Paraguay participate in a proposal that includes countries in the list like Bolivia and Guatemala?

This Addendum is limited to the countries specified in the announcement.

24. We have read Addendum K and we understand that a main focus is to propose interventions that accelerate the elimination of transmission, in our case, onchocerciasis. Could the main applicants be based in the UK, or should they be based in the endemic countries of interest?

Do we need to include co-applicants based in the USA?

Under Section B of the APS Advancing Global Health U.S. and foreign organizations are eligible to apply.

25. Would it be possible for the project to focus on a community intervention trial -- comparing community-based interventions to measure the epidemiological impact of Mass Drug Administration (MDA) with different drugs (e.g., ivermectin vs. moxidectin) with or without vector control? Would proposing a suit of interventions tailored to the epidemiological characteristics of each study site under consideration, and aimed at accelerating the elimination of transmission be preferable?

Community intervention trials as well as a suite of interventions tailored to the epidemiological characteristics of each study site can be considered as long as they support the objectives and sub-objectives specified in the Addendum.

26. How should we interpret the prohibition on “control” activities? For example, would activities designed to generate evidence, tools or systems that enable a transition from control to elimination be considered?

Strategic activities to demonstrate the feasibility (proof-of-concept) of transitioning the program from control to elimination will be considered.

27. Would State consider a U.S. university-led consortium, with core activities conducted by local entities, to be competitive or is the expectation that US organizations and US universities serve as technical/research subrecipients?

Under Section B of the APS Advancing Global Health, U.S. and foreign organizations are eligible to apply. GHSD has not established a preferred organizational type or consortium structure, and U.S. organizations and universities are not required to participate solely as technical or research subrecipients.

28. What level of specificity is expected in the SOI regarding country government commitment?

The SOI should provide as much information as it can that demonstrates government commitment or country co-investment.

29. Will GHSD identify which NTDs and geographic areas in Tanzania it considers sufficiently close to elimination, or should applicants select and justify diseases and implementation units using Tanzania Ministry of Health and WHO/ESPEN data?

Applicants should propose the NTDs and geographical locations where they plan to implement the project. These selections should align with the objectives and sub-objectives of the Addendum.

30. Because schistosomiasis and soil-transmitted helminthiases are often characterized as control programs, what evidence should an SOI provide to demonstrate a credible transition to elimination—for example, prevalence thresholds, transmission-interruption milestones, precision mapping, stop-MDA criteria, or post-treatment surveillance?

Schistosomiasis and soil-transmitted helminthiases are classified as elimination as public health problem diseases, and thus SOIs for these NTDs are consistent with the Addendum objectives.

31. Within the listed geographies, does GHSD have an existing assessment of which countries should be prioritized for each NTD based on their proximity to elimination, or does it expect applicants to determine and substantiate this prioritization independently?

GHSD does not have predetermined priorities for which NTDs should be prioritized in which country. Applicants should determine and substantiate this prioritization independently utilizing available data.

32. Where multiple NTDs could credibly be targeted within a country, would GHSD favor an integrated country-level elimination program or a more tightly focused intervention around the disease with the clearest near-term pathway to elimination?

GHSD does not have a preference on the type of elimination program as long as the SOI prioritizes high-impact geographies, vulnerable populations, and efficient delivery approaches that strengthen integration with existing health and community platforms where appropriate.

33. For proposals covering multiple eligible countries, does GHSD prefer a regional SOI, separate country-level SOIs, or a multi-country, multi-region SOI? For instance, would a focused multi-region proposal covering selected countries where the applicant has strong implementation capacity be viewed differently from a broader proposal that covers all countries in a specified region?

Applicants are free to decide which approach they would prefer to take, carefully weighing the risks and benefits specific to their capabilities and proposed program of work. There would be a preference for those SOIs that can clearly demonstrate impact in the time frame of the APS.

34. Does GHSD have a preference between SOIs that address both sub-objectives A and B for a focused disease, as opposed to SOIs that address a single sub-objective across multiple eligible NTDs? Would either approach be viewed more favorably in the evaluation?

Applicants are free to decide which approach they would prefer to take, carefully weighing the risks and benefits specific to their capabilities and proposed program of work. There would be a preference for those SOIs that can clearly demonstrate impact in the time frame of the APS.

35. Would GHSD consider proposals in which a significant component of the intervention is embedded delivery support to governments, including strengthening coordination, performance management, data-driven decision-making and cross-ministerial delivery mechanisms to advance both sub objectives A and B?

GHSD will consider approaches that include embedded delivery support to governments, including activities that strengthen coordination, performance management, data-driven decision-making, and cross-ministerial delivery mechanisms, provided that such activities are clearly linked to the objectives and anticipated outcomes of the Addendum.

Applicants should describe how these activities will support implementation of the priority interventions, strengthen government capacity and ownership, and contribute to sustainable results.

36. Could GHSD clarify the level at which applicants should define the principal outcome (e.g., achievement of epidemiological thresholds required for validation, interruption of transmission within selected subnational geographies)?

Applicants are free to present and define principal outcomes (e.g., achievement of epidemiological thresholds required for validation, interruption of transmission) as long as long as these are in line with country guidelines

37. How many SOIs may a single eligible organization submit under this addendum? For example, may an organization submit separate SOIs addressing different sub-objectives, countries, diseases, or program approaches?

The Addendum does not specify the number of SOIs that an organization may submit.

However, each SOI should present a distinct and clearly defined approach that is responsive to the objectives and anticipated outcomes of the Addendum.

38. Are applicants permitted to propose activities in countries or geographic areas that are not included in the targeted geography list where there is a clear regional or cross-border rationale? For instance, submitting an ASEAN regional proposal with Indonesia listed as the priority country.

This Addendum is limited to the countries specified in the announcement.

39. At the SOI stage, to what extent must implementation partners, subrecipients, technical partners, and host-government counterparts be identified and formally committed? Would indicative partner roles be sufficient, or are named and confirmed partners expected?

At the SOI stage sufficient documentation of commitments should be made to demonstrate that the applicant has the organizational capacity to implement the project and the ability to achieve the objectives.

40. Under sub-objective B, in what circumstances are operational research and/or evaluation expected by GHSD when introducing new innovative tools? For example, is it expected to demonstrate feasibility, gain regulatory approval, or otherwise?

Sub-objective B requires demonstration of the ability to accelerate progress toward NTD elimination and improve operational effectiveness. All activities required to accomplish this should be included.

41. What will the Bureau of Global Health Security & Diplomacy accept as evidence of a Dengue program transitioning from Control toward Elimination?

Strategic activities to demonstrate the feasibility (proof-of-concept) of transitioning the program from control to elimination will be considered.

42. Is there an expected funding range for individual projects under Addendum K?

The Addendum does not specify funding range for individual projects. Applicants should apply for the funding required to complete the objectives specified in their proposals.

43. Are there any parameters on budget split between research and implementation?

The Addendum does not specify parameters on the split between research and implementation.

44. Are there any parameters for the funds spend in USA, UK and Low- and Middle-Income Countries (LMICs)?

The Addendum does not specify parameters on where funds should be spent.

45. The Addendum states that priority will be given to NTDs that can be eliminated within the next three years. It also allows programmes that demonstrate a transition from control to elimination. For leprosy, would the call consider: Sub-national elimination? Elimination as a public-health problem in defined areas? Or Achievement of clearly defined transition-to-elimination milestones within the project period?

Applicants should specify the level at which their proposal is targeting elimination (e.g., national, sub-national). Although national level elimination is preferable, demonstrating elimination in a defined area is a measurable and meaningful impact, as long as the elimination is sustainable by country NTD programs.

46. Can we focus on selected high-burden districts and provinces within an eligible country rather than proposing nationwide implementation, considering the applicant can demonstrate that funding in those locations offers better pathway towards measurable milestones for elimination at the sub-national level?

Applicants may target their proposal as they deem appropriate.

47. May organizations submit an SOI as a consortium or group of partners? If so, should one organization serve as the lead applicant and award recipient, with the others participating as subrecipients or implementing partners?

Organizations may submit an SOI as a consortium or group of partners. The Addendum does not state how and if consortium should be organized to respond to this addendum.

Applicants should clearly describe the roles and responsibilities of each consortium member or partner and how the proposed structure will support successful implementation and achievement of the Addendum's objectives.

48. We are considering activities addressing soil-transmitted helminthiases, schistosomiasis, and trachoma in Ethiopia. Although these diseases may not currently be on a nationwide path to elimination, certain high-prevalence districts may be positioned to achieve elimination targets with focused support. Would a geographically targeted proposal for such districts be considered responsive to the Addendum?

Applicants may target their proposal as they deem appropriate. The Addendum does not specify how geographic areas should be prioritized.

49. Beyond the requirements in Section D of the main APS, will GHSD provide any Addendum K-specific guidance regarding the expected content or structure of the SOI—for example, the level of detail expected on geographic targeting, elimination milestones, partnerships, sustainability, monitoring, and indicative costs?

The requirements for SOIs are outlined in Section D of the APS and the applicable Addendum. GHSD does not anticipate issuing additional Addendum-specific requirements regarding the structure or format of the SOI.

50. Does the Department have a preference for SOIs that group multiple countries around a specific priority NTD, shared elimination-stage challenge, or technical issue—rather than proposing country-specific activities? If so, what factors should applicants use to justify a multi-country approach?

GHSD does not have a preference. Applicants should propose the approach that they have the organizational capacity to implement and the ability to achieve. See Section D of the APS Advancing Global Health.

51. Among the priority NTDs and eligible countries identified in Addendum K, are there particular diseases, elimination milestones, intervention types, or geographic areas that GHSD considers to be of highest strategic interest? In particular, should applicants only prioritize opportunities in countries with a credible pathway to achieving elimination as a public health problem or interruption of transmission within the next 3 years?

The priorities of GHSD are specified in Addendum K. Applicants should prioritize activities to meet the objectives of the Addendum in the timeframe of the APS.

52. Does GHSD anticipate supporting a diversified portfolio of awards under Addendum K, including both (a) focused, potentially smaller-scale projects addressing a discrete technical, operational, innovation, surveillance, or geographically targeted “last-mile” elimination challenge, and (b) broader, multi-country and/or integrated NTD initiatives? If so, are applicants encouraged to propose projects at different scopes and funding levels, commensurate with the scale, evidence base, and anticipated elimination impact of the proposed approach?

GHSD does not have a preference on the size and format of the awards as long as these awards are designed to meet the goals and objectives of the Addendum.

53. Addendum K states that its goal is “to accelerate progress toward the elimination and interruption of transmission of priority NTDs” and that control programs will not be supported. For the purposes of this Addendum, does GHSD define “priority NTDs” as only those that can be eliminated at a national level within the next three years determined by GHSD, U.S. bilateral priorities, or host-government elimination plans?

Priority NTDs would be those with an eradication, interruption of transmission or elimination as a public health problem goal. Strategic activities to demonstrate the feasibility (proof-of-concept) of transitioning the program from control to elimination will be considered.

54. For SOIs that include surveillance, laboratory, supply-chain, workforce, data-system, or other health-systems-strengthening activities, what level of linkage to disease-specific elimination outcomes is expected? Would GHSD consider an HSS-focused SOI competitive if it demonstrates a direct, measurable, and time-bound contribution to elimination milestones for one or more priority NTDs?

GHSD would consider an HSS-focused SOI that demonstrates a direct, measurable, and time-bound contribution to elimination milestones for one or more priority NTDs.

Applicants submitting stand-alone HHS-focus SOIs would need to demonstrate the impact of the project on elimination commensurate for the level of funding requested.

55. While individual governments lead their national NTD programmes, the WHO establishes the global standards, indicators, and validation/verification criteria. Please confirm whether the SOI may reference WHO technical guidance and/or describe coordination with Ministry of Health structures in which WHO may participate, provided that WHO, its regional/country offices, and WHO-administered projects receive no U.S. government funds and are not named as formal partners, subrecipients, contractors, or implementers.

Executive order 14155 withdraws the U.S. from WHO and instructs the Secretary and the Director of the OMB to pause the future transfer of any U.S. government funds, support, or resources to the WHO. Applicants should prioritize activities to meet the objectives of the Addendum in the timeframe of the APS. SOIs will be evaluated in accordance with the review criteria (Section F) in the APS.

56. Addendum K indicates that recipient-government co-investment is not required in Year 1, but that projects should develop sustainability plans that include expectations for country co-investment beginning in Year 2. Could GHSD please clarify its expectations regarding the demonstration of increasing government ownership and domestic financing over the life of the award?

Country co-investment is expected as part of the five-year process. It should be tailored to the individual situation of each country’s NTD program, and it should be targeted to achieve sustainability long-term.

57. At the SOI stage, what evidence of future government ownership and financing is expected?

At the SOI stage, the minimal requirement is that a sustainability plan be developed if one is not already in place. Country co-investment is expected as part of the five-year process. It should be tailored to the individual situation of each country’s NTD program, and it should be targeted to achieve sustainability long-term.

58. Addendum K states that “co-investment for NTDs may be counted toward overall bilateral health MOU co-investment commitments where applicable.” May recipient-government NTD expenditures or in-kind contributions be counted toward those commitments when they support the same NTD elimination objectives but are financed through non-U.S.

Government sources and are not funded under the proposed Department of State award? If so, please clarify the requirements for attribution, allowability, valuation, documentation, timing, and avoidance of double counting.

The country ownership and sustainability concept supported by the MOU and by the overall bilateral health MOU process requires domestic resources and financing commitments to complement U.S. government support. Committed, stable co-investments from domestic sources should meet that requirement.

59. May eligible contributions include donated medicines; government or government-supported personnel time; campaign logistics; MDA delivery costs; commodity storage and distribution; routine surveillance; laboratory and diagnostic services; and other domestically financed NTD programme expenditures?

The country ownership and sustainability concept supported by the MOU and by the overall bilateral health MOU process requires domestic resources and financing commitments to complement U.S. government support. Committed, stable co-investments from domestic sources should meet that requirement.

60. For donated medicines, please clarify whether eligibility depends on the donor, donation mechanism, transfer of title, delivery timing, or the availability of verifiable valuation documentation.

Issues related to donated medicines will be addressed once donations are secured.

61. Addendum K notes that priority will be given to NTDs that can be eliminated within the next three years, while also encouraging operational research and activities that support transition from control to elimination. Would GHSD consider operational research projects competitive where they address a critical evidence gap preventing elimination, even if the disease programme is unlikely to achieve elimination within the project period itself?

The sub-objectives under the Addendum are designed to support the main objective of accelerating the elimination of priority NTDs. An operational research project will be considered if it is designed to support ongoing or planned NTD elimination activities.

62. For NTDs supported by established pharmaceutical donation programs, should applicants assume that donated medicines will continue to be available through existing WHO and national mechanisms and focus proposed USG resources on the operational, technical, supply-chain, community engagement, last-mile delivery, monitoring, and surveillance requirements necessary to achieve elimination? Will there be any limitations on USG-funded partners coordinating with WHO on donated medicines? Are there circumstances in which applicants should budget for pharmaceutical procurement?

GHSD does not anticipate asking country programs to obtain donated drugs through new mechanisms when one already exists. GHSD will not place limitations on U.S.

government-funded applicants coordinating with WHO as long as U.S. government funds are not used to pay for that coordination.

63. The Addendum emphasizes accelerating elimination and interruption of transmission and indicates that interventions should have a credible pathway toward elimination. Should applicants propose activities only for diseases/geographies where elimination or interruption of transmission is reasonably achievable within the five-year award period, or may projects support countries that are making measurable progress toward longer-term elimination targets beyond the award period?

Although the priority of the Addendum is to fund program activities that will achieve elimination targets within the timeframes specified, any activity that contributes toward accelerating the elimination of priority NTDs will be considered. Applicants will be expected to demonstrate the impact of the programs during the award period.

64. The Addendum calls for integrated approaches and leveraging existing health platforms.

Does GHSD expect NTD activities to be integrated primarily into government health systems and existing NTD programs, or does it also encourage integration with community health, malaria, immunization, WASH, nutrition, surveillance, and other established delivery platforms where these provide an efficient pathway to reach populations relevant to NTD elimination?

GHSD encourages applicants to consider whatever integration approaches make sense in the context of each particular country. Considerations for integration include all of the possibilities suggested in the question, particularly if they facilitate the development of a sustainable program.

65. What types of outcomes does GHSD expect applicants to propose at the SOI stage to demonstrate that an intervention will materially accelerate elimination? Does GHSD expect disease-specific epidemiological outcomes, achievement of WHO elimination milestones, coverage/access outcomes, or a combination of these?

GHSD expects applicants to propose outcomes that can demonstrate in the context of the proposed work. Demonstration of program impact (i.e., disease-specific epidemiological outcomes) is preferred.

66. Would a specialized SOI centered on community-based surveillance, early detection, reporting, investigation, referral, and response for priority NTDs be eligible where it is directly linked to elimination or interruption of transmission? And if so, may CBS be the principal intervention, or must it be paired with direct NTD service-delivery interventions?

GHSD will consider SOIs centered on community-based surveillance, early detection, reporting, investigation, referral, and response for priority NTDs, provided that the proposed approach is directly linked to achieving the Addendum’s objectives, including elimination or interruption of transmission.

67. Would multi-country or cross-border approaches be considered, particularly where mobile populations or shared transmission areas create surveillance and response gaps?

Multi-country and/or cross-border approaches will be considered as long as they are responsive to the Addendum’s objectives.

68. What evidence and indicators should applicants use to demonstrate that community-based surveillance addresses a last-mile elimination barrier rather than routine disease control?

Applicants will need to provide the evidence that they feel is necessary to demonstrate that community-based surveillance addresses a last-mile elimination barrier.

69. What evidence of host-government engagement, country ownership, and future co-investment is expected at the SOI stage?

At the SOI stage, the minimal requirement is that a sustainability plan be developed if one is not already in place. Country co-investment is expected as part of the five-year process. It should be tailored to the individual situation of each country’s NTD program, and it should be targeted to achieve sustainability long-term.

70. Dengue is listed among the priority NTDs under the Addendum. Could GHSD clarify what types of dengue interventions or elimination objectives would be considered eligible, given that control strategies are not allowable and the Addendum prioritizes interruption of transmission and elimination.

Priority NTDs would be those with an eradication, interruption of transmission or elimination as a public health problem goal. Strategic activities to demonstrate the feasibility (proof-of-concept) of transitioning the program from control to elimination will be considered.

71. When deciding which NTDs can be eliminated within 3 years, what is the definition of “elimination” that will be used to evaluate the submissions?

NTD programs that target eradication, interruption of transmission or elimination as a public health problem are considered as ‘elimination’ programs when making funding decisions. Applicants may target their proposal as they deem appropriate. Although national level elimination is preferable, demonstrating elimination in a defined area is a measurable and meaningful impact, as long as the elimination is sustainable by country NTD programs.

72. Not all countries listed on the APS Addendum K have a Global Health bi-lateral MOU with the US Government. Yet, the initiative seeks to strengthen the strategic bi-lateral partnerships. Will priority be given to countries with US Government Global Health MOUs?

Priority countries are listed in the Addendum.

73. When considering contracting with country governments, will the standard Public

International Organization (PIO) agreement framework and provisions be in place?

Standard Public International Agreement framework and provisions are only used with specific international organizations.

74. The Addendum specifies interventions in “strategically targeted high-burden settings.”

What is considered “strategic” and “high burden” in this context?

The targeted geographic areas and the priority NTDs mentioned in the Addendum constitute the strategically targeted high-burden settings for the purpose of the SOI.

75. What range of award sizes does GHSD anticipate making, given the total pool of up to USD 162,000,000, and up to 25 awards?

GHSD does not anticipate establishing a standard award size under this Addendum. The total estimated funding available is up to USD $162,000,000, with up to 25 awards anticipated.

76. May an SOI target more than one country, or should applicants propose single-country programming?

An SOI may target more than one country.

77. What form of documentation is required for collaborators e.g. government institutions-specifically, does a statement indicating we will collaborate with named institutions suffice?

See 1.d: List of Partner Roles and Responsibilities under Section D of the APS Advancing Global Health.

78. The Addendum identifies eligible countries and the 17 NTDs but does not specify priority disease-country combinations. Should applicants independently identify and justify the disease-country combinations with the greatest potential to achieve elimination within the intended timeframe, or does GHSD have priority combinations it wishes applicants to address? Relatedly, does GHSD have a preference among single-country, multi-country/regional, or highly specialized SOIs focused on a common last-mile barrier such as surveillance, diagnostics, persistent transmission hotspots, or cross-border transmission?

GHSD does not have pre-identified priority disease-country combinations. Applicants should apply for those NTDs and countries for which they have the capacity to achieve the objectives of the Addendum in the timeframe specified. GHSD also does not have a preference between single/multicounty proposals and highly specialized proposals.

79. The Addendum calls for country co-investment beginning in Year 2 and strengthening country capacity to plan, cost, finance, coordinate, and manage NTD programs. Could you clarify what forms of country co-investment may be recognized - for example, direct budget allocations, health insurance reimbursement, government personnel, commodities, laboratory inputs, logistics, or integration of NTD functions into routine health-system budgets? At the SOI stage, what evidence of government commitment or alignment with existing bilateral health MOU co-investment commitments does State expect applicants to demonstrate?

At the SOI stage, the minimal requirement is that a sustainability plan be developed if one is not already in place. Country co-investment is expected as part of the five-year process. It should be tailored to the individual situation of each country’s NTD program, and it should be targeted to achieve sustainability long-term. Committed, stable co-investments from domestic sources should meet that requirement.

80. For a SOI submission for Addendum K, would you consider an SOI involving Brucella as a Neglected Tropical Disease although Brucella is not identified in your program description as an NTD?

Only those diseases identified in the Congressional legislation and specified in the Addendum will be considered.

81. For diseases with mixed control and elimination status by country, such as schistosomiasis and onchocerciasis, what evidence or documentation is required to demonstrate that proposed activities advance elimination rather than constitute ineligible control programming?

The focus of the project should be those diseases that have elimination targets or for which strategic activities could provide proof-of-concept of the feasibility of transition to elimination. For this Addendum, those NTDs that have a program goal of eradication, interruption of transmission, or elimination as a public health problem are considered as meeting the elimination criterion.

82. Can sustainable transition and country ownership serve as an SOI’s primary organizing approach, provided the project also demonstrates measurable progress toward elimination?

Any proposal that is able to demonstrate measurable progress towards elimination will be reviewed and considered.

83. May an SOI focus primarily on one sub-objective, including Sub-objective B with only a limited Sub-objective A component, or are applicants expected to address both sub-objectives?

An applicant may focus on one or both of the sub-objectives, provided that the proposal contributes to the overarching objectives specified in the Addendum.

84. Under Sub-objective B, will GHSD fund original development of new tools and interventions, or does it primarily envision adapting, evaluating, and scaling existing approaches in program settings?

GHSD will consider SOIs focusing on sub-objective B that are able to demonstrate the ability to accelerate progress toward NTD elimination or improve operational effectiveness in the timeframe of the APS.

85. Is operational research under Sub-objective B expected to generate broadly generalizable and potentially publishable evidence, or may it focus on program-embedded learning that improves the applicant’s own implementation?

While development of broadly generalizable recommendations would be the ideal, operational research that meets the requirements of the sub-objective to accelerate progress toward NTD elimination or improve operational effectiveness in the timeframe of the APS is important whether generalizable or not.

86. Are cross-country or regional technical functions, such as data systems, financing support, learning platforms, supply-chain support, or operational research, fundable alongside country-specific activities?

Activities required to support achievement of the objectives specified in the Addendum could be considered for inclusion.

87. How specific must proposed countries, diseases, partners, activities, and budgets be at the SOI stage?

See Section D (Application Contents and Format) of the APS Advancing Global Health, for expectations regarding the application at the SOI stage of development.

88. Is there an expected award-size range or funding ceiling within the overall $162 million and five-year parameters, or should applicants propose budgets based entirely on the scale of their concepts?

GHSD does not anticipate establishing an expected award-size range or funding ceiling for individual awards within the overall funding available under the Addendum.

Applicants should develop budgets based on the scope, scale, and anticipated outcomes of their proposed approaches and provide a level of funding that is reasonable and commensurate with the proposed activities. Actual award amounts will depend on the scope and quality of the proposed approaches, as well as the availability of funds.

89. What criteria will determine whether an SOI enters the consultative design process rather than standard review, and how would that process affect the review and award timeline?

GHSD will determine the appropriate review and engagement process for each SOI based on the proposed approach and its alignment with the objectives and anticipated outcomes of the Addendum. Where GHSD determines that additional consultation with an applicant would strengthen the proposed approach, GHSD may invite the applicant to participate in a consultative design process. Participation in such a process does not guarantee an award. The timing and duration of any consultative design process may vary depending on the approach and the nature of the consultation required. GHSD will communicate applicable next steps and timelines to applicants invited to participate.

90. The APS indicates that up to 25 awards may be made. Does the Department currently anticipate making closer to that maximum, or a smaller number of larger awards?

The Department anticipates making up to 25 awards, subject to the availability of funds and the quality, scope, and number of meritorious SOIs received. The final number and size of awards will depend on the approaches selected and the funding required to support those approaches. Applicants should develop their proposed budgets based on the scope and scale of their proposed approach rather than on an assumption about the number of awards that will be made.

91. Can funds be used to support elimination of NTDs that are not reliant on MDA?

The focus of the project should be those diseases that have elimination targets or for which strategic activities could provide proof-of-concept of the feasibility of transition to elimination. For this Addendum, those NTDs that have a program goal of eradication, interruption of transmission, or elimination as a public health problem are considered as meeting the elimination criterion. Please refer to the Addendum K Goals and Objectives section for a more detailed description of strategies that we anticipate will be proposed.

92. Will recipients be permitted to allocate a modest, specified portion of Addendum K funding for the procurement of standard medical supplies (such as topical treatments, antibiotics, medicine, and wound-care dressings) to treat non-priority diseases in the field?

Expenditures should be linked to the goals of the Addendum. If the purchase of the supplies contributes to the objective of the Addendum to accelerate the elimination of priority NTDs through integrated, high impact interventions and supports the overarching approach to…