BAA-GH-OAA-2024 Innovative Health Practices.pdf

Re-Issue Date: June 25, 2024 Open Period: June 25, 2024 thru February 20, 2028

USAID Global Health Bureau’s Broad Agency Announcement for Research and Development

BAA-GH-OAA-2024 Innovative Health Practices

I. Overview

The United States Agency for International Development (USAID) is issuing this Broad Agency Announcement (BAA) to seek participants to co-create, co-design, co-invest, and collaborate on creating, piloting, and scaling innovative research and development interventions utilizing innovative health practices to help reduce disease and mortality rates worldwide. USAID invites organizations and companies to submit an Expression of Interest (EOI) and participate in generating novel tools and approaches that accelerate and sustain improved health outcomes in low-and-middle-income countries (LMICs).

The intent of the BAA is to allow co-creation and co-design to the maximum extent to create high quality, effective partnerships with great efficiency in time and resources. USAID is seeking new applications of research & development, science, partnerships, and innovative practices in global health that provide the best value to the Government. USAID will invite selected for-profit and non-profit, public and private organizations, as detailed below, to co-create innovative research and development (R&D) solutions to the Problem and Challenge Statements stated in this BAA, including those organizations that have ideas, expertise, resources, and/or funding to add to potential solutions. In particular, this BAA welcomes co-creation from local partners based in LMICs, including the private sector, faith-based organizations, and other non-traditional USAID partners, to increase the presence and voices of local populations in solving their own health challenges.

The intent of the BAA is to enable and encourage co-creation and co-design in order to generate high quality ideas and effective partnerships with improved efficiency in time and resources. Other types of collaboration can also include co-investing:

Co-Investing: USAID wants to align goals with the partners under this BAA, to facilitate shared responsibility, shared risk, and shared resourcing. Shared resourcing requires that cash and other resources, both tangible and intangible, such as in-kind contributions, expertise, intellectual property, brand value, high-value coordination, and access to key people, places, and information, are directed towards reaching the solution to the Problem/Challenge. Co-investing does not require equal shared resources (such as 1:1 leverage), but rather resource contributions that are appropriate to the specific project’s objectives, considering the comparative advantages brought by the participation of each party.

A. Federal Agency Name:

The United States Agency for International Development (USAID)

B. Opportunity Title: Innovative Health Practices

Research and Development BAA for Innovative Health Practices 2024

C. Opportunity Number: BAA-GH-OAA-2024 Innovative Health Practices

D. Authority:

This BAA is issued under Federal Acquisition Regulations (FAR) Part 35.016 (c).

This is not a FAR Part 15 Procurement.

E. Catalog of Federal Domestic Assistance (CFDA) Number:

98.001 USAID Foreign Assistance Programs for Overseas

II. Problem and Challenge Statements

PROBLEM STATEMENT:

The global community has made great strides in reducing mortality around the world over the last 50 years, but progress in developing countries lags far behind that seen in developed countries. Every year an estimated 303,000 women die during pregnancy and childbirth, 5.9 million children die, and an even greater number become infected with life threatening diseases like HIV/AIDS, malaria, diarrhea, pneumonia, and tuberculosis, among others. The vast majority of deaths due to these largely preventable causes occur in developing countries where access to health services is often poor. Outbreaks of emerging infectious diseases like Ebola and Zika only serve to further compound these health challenges, taxing already stressed health systems and elevating the risk of disease epidemics of global proportions.

CHALLENGE:

Harness the power of research and development (R&D), innovation, and innovative practices in health, including science, technology, market-based approaches, and financing, to generate new knowledge, tools, and approaches that can reduce LMIC mortality down to the levels seen in high-income countries (HICs). USAID and its partners will work to identify promising R&D approaches that will help to achieve USAID’s goals of preventing child and maternal deaths, controlling the HIV/AIDS epidemic, and combating infectious diseases. The proposed concepts will be locally-oriented and aim to work in support of, and alongside, populations to find appropriate and lasting solutions to their own health challenges.

III. The BAA Process

The amount of resources made available under this BAA will depend on the concepts received and the availability of funds from USAID and other resource partners. Some award types may not include any funding.

Interested parties can not submit “Expressions of Interest (EOI)” to this BAA document, as this announcement is not a funding opportunity.

The award process under this BAA has the following steps (DO not submit an EOI)

STAGE 1 - SUBMISSION OF EXPRESSIONS OF INTEREST (EOIs)

Please submit an expression of interest addressing the criteria below, in the format required in Section VII. More than one expression of interest can be submitted.

USAID will review the Expressions of Interest to determine the extent to which each Expression of Interest addresses the criteria/eligibility stated below. Not all organizations that submit an Expression of Interest will be invited to proceed to Stage 2. Due to the number of Expressions of Interest received, USAID is unable to provide details on why Expressions of Interest were not selected.

Criteria for Expressions of Interest:

1. Expressions of Interest must indicate the research or development idea which will work towards discovering potential solutions to the Problem and Challenge Statements, by increasing knowledge and understanding of potential solutions, exploiting scientific discoveries or improvements in technology, materials, processes, methods, devices, or techniques, advancing the state of the art, or using scientific and technical knowledge in the design, development, testing, or evaluation of a potential new product or service (or of an improvement in an existing product or service).

2. Potential partners will submit an Expression of Interest in response to an addendum to the USAID Global Health Broad Agency Announcement for Innovative Health Practices (2024). The release of this BAA is not an invitation for Expressions of Interest. Addenda released under this BAA will communicate specific requirements for Expressions of Interest, including but not limited to any additional details regarding the selection criteria, dates, times, and points of contact for submission.

Any awards issued under this solicitation will be for Applied Research or Development, as those terms are defined in 48 USC 35.001, as follows:

“Applied research” means the effort that:

(a) normally follows basic research1, but may not be severable from the related basic research;

(b) attempts to determine and exploit the potential of scientific discoveries or improvements in technology, materials, processes, methods, devices, or techniques;

and

(c) attempts to advance the state of the art. When being used by contractors in cost principle applications, this term does not include efforts whose principal aim is the

1 The primary aim of basic research is a fuller knowledge or understanding of the subject under study, rather than any practical application of that knowledge. (FAR 2.101) design, development, or testing of specific items or services to be considered for sale;

these efforts are within the definition of “development,” given below.

“Development” means the systematic use of scientific and technical knowledge in the design, development, testing, or evaluation of a potential new product or service (or of an improvement in an existing product or service) to meet specific performance requirements or objectives. It includes the functions of design engineering, prototyping, and engineering testing; it excludes subcontracted technical effort that is for the sole purpose of developing an additional source for an existing product.

USAID is particularly interested in innovative means and attempts to advance the state of the art, including novel approaches such as innovative financing, private sector engagement, human-centered design, digital health and technology solutions, and other approaches that can help USAID better understand the subject under study, improve processes, and develop and launch new products or services.

3. Expressions of Interest must demonstrate the potential to have a significant impact (e.g.

breakthroughs, not incremental improvements), that ultimately could achieve even greater impact at scale.

4. Expressions of Interest must indicate the background and expertise of the organization and outline the managerial and technical staff or team engaged in the endeavor.

5. Expressions of Interest must indicate what co-investment resources are available to bear on the solution, including those from the submitting organization and those from other third-party businesses, donors, foundations, or other organizations. Such resources include cash and other resources, both tangible and intangible, such as in-kind contributions, expertise, intellectual property, brand value, high-value coordination, and access to key people, places, and information.

6. USAID will also consider the reputation of an organization and its past performance in assessing the ability of the organization to contribute to the co-creation.

STAGE 2 - CO-CREATION AND CO-DEVELOPMENT OF THE CONCEPT PAPER

During Stage 2, key stakeholders will Co-Create potential solutions to the Problem/Challenge by brainstorming and innovating solutions and resources, potentially leading to concept papers that USAID or other resource partners will consider for funding.

Co-Creation USAID will review the Expressions of Interest and will select those organizations that USAID determines have addressed the criteria/eligibility stated within the BAA to an extent that the organization will make a significant contribution to the Co-Creation.

The Co-Creation will also include USAID and other co-investment organizations that may be able to contribute cash and other resources, both tangible and intangible, such as in-kind contributions, expertise, intellectual property, brand value, high-value coordination, and/or access to key people, places, and information.

Co-Creations may take the form of a workshop, conference, meeting, or other method at the discretion of the USAID. For this BAA, the Co-Creation is expected to occur after an Expression of Interest is approved, but before the concept is further developed and refined. The potential partner, USAID, represented by the Activity Manager, and potentially others will work together to write and/or revise the Concept Paper, and jointly present the Concept Paper to USAID’s Peer and Scientific Review Board. Unless otherwise noted, organizations are responsible for all costs incurred by the organization to participate in the Co-Creation.

Co-Development of Concept Papers Working together, USAID and the potential partner(s) will collaborate on Concept Paper(s), taking a holistic approach to addressing the Problem/Challenge based on learnings from the Co-Creation, and identifying creative approaches to resourcing projects. Such Concept Papers will consider and include additional implementing and co-investment partners to complement the project, including reasonable cost sharing, leverage, or other exchange of resource arrangements.

Not all organizations that participate in the Co-Creation may be invited to submit a Concept Paper for review by the Peer and Scientific Review Board (Stage 3).

The Concept Paper, generally 5-10 pages, will further detail and explain the project.

STAGE 3 - REVIEW BY THE PEER AND SCIENTIFIC REVIEW BOARD

USAID and the organizations connected with each Concept Papers will present the Concept Paper to the Peer and Scientific Review Board, comprised of experts from USAID, partners, and/or outside parties. The Peer and Scientific Review Board will review Concept Papers and recommend which applicants should be considered Apparently Successful Partners. Using its technical expertise, the Peer and Scientific Review Board will recommend whether to move forward with the project, including revisions/additions to the project, and potential partners and resources.

Not all organizations that present a Concept Paper to the Peer and Scientific Review Board will be invited to move to Stage 4.

STAGE 4: AWARD DETERMINATION

USAID will review the Peer and Scientific Review Board’s recommendations and consider other information, such as resource availability and Agency priorities, and will make a determination whether to move forward with the Concept Paper. For Concept Papers that demonstrate a valid innovation to address the Problem/Challenge Statement, the Contracting/Agreement Officer will assess the partner’s responsibility and identify the anticipated instrument type to facilitate project design.

Request for Additional Information. USAID will work with partners identified by the Peer and Scientific Review Board, and co-design the project and assist the partner to provide additional information with respect to the proposer’s technical approach, capacity, management and organization, past performance, and budget, as well as representations and certifications, as needed.

Final Review and Negotiation. The USAID Contract/ Agreement Officer will engage in final review, negotiation, responsibility, cost reasonableness, etc., and will co-develop/craft an award instrument with the Apparently Successful Partner. If the Apparently Successful Applicant and USAID cannot arrive at a mutually agreeable arrangement, USAID may cancel the project at no cost to the Government.

Award. Awards under this BAA will be made to the Apparently Successful Partner on the basis of their ability to achieve solutions to the Problems/Challenges, as provided in the relevant BAA Addenda. The standard clauses or provisions for awards are generally prescribed by law and regulation and will vary considerably by award type. Information regarding clauses and provisions will be offered to the Apparently Successful Applicant when the award type is identified.

Concept Papers identified for negotiation may result in a contract, grant, cooperative agreement, Global Development Alliance agreement, Development Innovation Agreement, Inter-Agency Agreement, Government-to-Government Agreement, Donor-to-Donor Agreement, Memorandum of Understanding or alternative agreement type, depending upon the nature of the work proposed, the required degree of Government involvement, and other factors. The USAID Contracting/Agreement Officer will determine award instrument type and negotiate instrument terms and conditions with award nominees. USAID may select the award instrument it deems most appropriate.

IV. Additional Considerations

A. Expressions of Interest are not evaluated against other Expressions of Interest, but solely whether USAID believes that the submitter will be a valuable contributor to the co-creation process. USAID may limit the number of initial submissions selected to move forward based on efficiencies.

B. Concept Papers are not evaluated against other Concept Papers, but solely based on USAID’s determination that the Concept Paper will successfully address the Problem and Challenges set forth in the relevant BAA Addenda. USAID may limit the number of Concept Papers selected to move forward based on efficiencies.

C. Decisions regarding USAID’s pursuit of a particular project, technology or relationship are based on all available information, evidence, data, and resulting analysis.

D. Eligibility Information. Public, private, for-profit, and nonprofit organizations, as well as institutions of higher education, public international organizations, non-governmental organizations, U.S. and non-U.S. governmental organizations, multilateral and international donor organizations are eligible under this BAA. All organizations must be determined to be responsive to the BAA and sufficiently responsible to perform or participate in the final award type.

V. Specific Rights Reserved for the Government under this BAA

The Government reserves specific rights, in addition to rights described elsewhere in this document or by law or regulation, including:

1. The right to award multiple awards, a single award, or no awards.

2. The right to make awards without discussions, or to conduct discussions and/or negotiations, whichever is determined to be in the Government’s interest.

3. The right to accept proposals in their entirety or to select only portions of proposals for award or co-investment.

4. The right to select for award an instrument type that is appropriate to the specific development context, partner relationship, and proposal selected for award.

Instrument types include, but are not limited to, contracts, grants, cooperative agreements, public-private partnerships, Inter-Agency Agreements, Government to Government Agreements, Donor to Donor Agreements, and Memorandums of Understanding. In addition, the Government may craft a new instrument type to meet the needs of a specific relationship.

5. The right to co-create projects with one or more proposers under the BAA, when it is in the best interest of the Government.

6. The right to request any additional, necessary documentation upon initial review.

Such additional information may include, but is not limited to, a further detailed proposal, budget, and representations and certifications.

7. The right to fund or co-invest in proposals in phases, with options for continued work at the end of one or more of the phases.

8. The right to award instruments under this BAA that do not commit or exchange monetary resources.

9. The right to remove organizations from the BAA process if USAID determines it is no longer in the best interests of the Government to proceed with the organization.

VI. Information Protection:

USAID’s goal is to facilitate research and development that will lead to innovative, and potentially commercially viable, solutions. Understanding the sensitive nature of submitters’ information, USAID will work with organizations to protect intellectual property.

Expressions of Interest should be free of any intellectual property that submitter wishes to protect, as the Expressions of Interest will be shared with USAID partners as part of the selection process. However, once submitters have been invited to advance beyond co-creation, submitters can work with USAID to identify proprietary information that requires protection. Therefore, organizations making submissions under this BAA grant to USAID a royalty-free, nonexclusive, and irrevocable right to use, disclose, reproduce, and prepare derivative works, and to have or permit others to do so to any information contained in the Expressions of Interest submitted under the BAA. If USAID further engages with the organization regarding its submission, the parties can negotiate further intellectual property protection for the organization’s intellectual property.

Organizations must ensure that any submissions under this BAA are free of any third-party proprietary data rights that would impact the license granted to USAID herein.

Section VII. Expression of Interest Information This BAA will have addenda issued under the subject matter discussed above. Do not respond directly to this document. Expression of Interest (EOI)information will be available within each addendum issued under this BAA.