oppEP-IDS-18-001-cfda93.360-cidEP-IDS-18-001-061704-instructions.docx

U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority

Funding Opportunity Announcement and Cooperative Agreement Application Instructions

Funding Opportunity Title:

BARDA Division of Research, Innovation and Ventures (DRIVe) Accelerator Network

Catalog of Federal Domestic Assistance (CFDA) Number:

93.360

Funding Opportunity Number: EP-IDS-18-001 Application Due Date: May 18, 2018

Contents

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority Section 301 of the Public Health Service (PHS) Act (42 U.S.C. 241), “Research and Investigations”; Section 319L of the PHS Act (42 U.S.C. 247d-7e), “Biomedical Advanced Research and Development Authority.”

Executive Summary

The Biomedical Advanced Research and Development Authority (BARDA), Division of Research, Innovation and Ventures (DRIVe) is releasing this “DRIVe Accelerator Network” Funding Opportunity Announcement (FOA) to solicit applicants interested in working with BARDA DRIVe to stimulate the public good by creating or leveraging a network of accelerators across America to promote national health security innovation. In order to address the serious 21st century health threats facing our nation, BARDA DRIVe invests in innovative, transformative tools and technologies to disrupt the current paradigm of how we approach health security threats, enabling us to increase our capability and capacity to prepare for and respond to such threats. Collectively, these will be referred to as health security products and technologies and include such focuses as solving sepsis and earlier diagnosis and treatment of infection.

Applicants who enter agreements with BARDA will become members of the Accelerator Network to:

· Support BARDA DRIVe health security products and technologies as they navigate research, development, and regulatory pathways;

· Provide wrap-around services to assist the R&D efforts (such as technical and business advice, access to facilities and incubator spaces, integration services);

· Identify and foster innovations in early health security product and technology development; and

· Cultivate the community of those making a difference in health security products, technologies and innovations

The DRIVe Accelerator Network will leverage key regional hubs across the US where health security products and technologies in biotechnology, life science research, and medical innovations are most heavily occurring, and will increase the growth potential in other regions across the US. In this way, accelerators distributed around the country will be physically networked among, and can make connections between, BARDA DRIVe product and technology developers/innovators and the community of experts who can provide support to them.

This FOA describes DRIVe’s desired approach to create an accelerator network to support the DRIVe R&D portfolio for rapidly advancing new and innovative medical technologies, products, and approaches from proof-of-concept discovery to mature clinical candidates. The goal will be to populate the R&D pipeline with candidate health security products and technologies that are ready to advance to later-stage funding outside of the accelerator network for clinical development and commercialization, to revolutionize our capability and capacity for national health security preparedness and response.

Project Overview

The current pipeline of health security products, technologies and innovations is insufficient to counter the serious 21st century health threats facing our nation. BARDA DRIVe addresses this crisis by incentivizing innovative research and development in the field of health security. BARDA’s newest division, DRIVe, will stimulate public-private partnership collaborations that spur innovation and investment in health security products and technologies. A component of this is the DRIVe Accelerator Network where accelerators work together with DRIVe to identify promising innovation(s) and provide wrap-around technical and business development support services to projects funded by DRIVe. DRIVe support teams will bring together a network of multiple accelerators, building on their individual strengths, and empower them to work directly with R&D projects funded by DRIVe. Technology candidates that graduate from the support of the DRIVe accelerator network will be better positioned for advanced R&D investment, clinical development, and commercialization.

The DRIVe Accelerator Concept:

As depicted in Figure 1, DRIVe will work with a network of accelerators to help DRIVe’s product developers overcome the challenges and barriers to clinical development and commercialization. Accelerators will work with these developers in several ways:

Technical Advice Administrative Support Outreach, Networking

Business/Financial Guidance The Accelerator Network

Figure 1. DRIVe Accelerator Concept. Early-stage products, technologies, or innovations may enter the accelerator network at various stages of maturity. The accelerator will assist/expedite the development of these products such that they are poised to graduate from the accelerator network for follow-on clinical development and commercializationResources

· Project Specific Acceleration:

· Identify promising products and technologies of interest to address DRIVe’s National Health Security Initiative

· Promote DRIVe funding opportunities

· Support product/technology developers awarded under the separate DRIVe BAAs directly through gap analysis; review their study results, give technical guidance

· Help identify and connect product developers and technology innovators across a network of life-science and medical technology resources

· Make connections to downstream investors, corporate and strategic partners, incubators, etc.

· Acceleration across Projects:

· Recognize and prioritize common needs across the product development community, e.g. “understanding fundamentals of a changing regulatory and reimbursement environment,” “how to develop a financing strategy,” etc.

· Develop and deliver support to the community via workshops, webinars, etc.

· Accelerating by Community:

· Arrange physical or virtual meet ups, providing a means to make connections with fellow practitioners

· Facilitate introductions to potential investors, collaborators, experienced biotech executives and individuals, etc.

The support needs of companies in BARDA’s DRIVe portfolio will vary widely: some will be well-established pharmaceutical or medical technology companies, others serial entrepreneurs with successful track records, while others have exciting technologies but very little in the way of business acumen or experience. A tailored package of support will be developed for each, with some packages being more intensive than others.

DRIVe will form novel public-private partnerships with companies and organizations of all sizes, with various levels of experience and resources. Many smaller entities, by their nature, may have truly innovative products and technologies but face financial, business and operational challenges that prevent them from applying for advanced BARDA funding to develop their products. These entities may need assistance securing additional technical and business resources, capital and networking to fully develop their promising innovations. The types of challenges they encounter can range from developing a network of technical expertise, uncertain strategic and regulatory vision, the ability to attract funding and other resources, and/or business acumen to successfully bring their product through early R&D and position it for advanced development and commercialization. These risks are further compounded by the technical risks of developing first-in-kind products based on novel technologies. Because of this, many good ideas with great science never make it to the market. The DRIVe Accelerator Network aims to help overcome these barriers. The Government in Washington, DC, is not geographically positioned to effectively provide this type of support to these innovative companies that might be located across the country. Thus we will look to our forward deployed Accelerator Network, made up of individual accelerators with a proven track record to provide assistance to these product developers funded by DRIVe.

The BARDA DRIVe Accelerator Network will be made up of non-dilutive[footnoteRef:1], non-equity, non-government entities that provide support to R&D performers and product developers for R&D activities and enable the product developers to retain full ownership and control of their company. Awardees under this announcement will be prohibited from equity positions in any product development companies funded by BARDA. [1: Non-dilutive funding is financing that does not require the sale of your company's shares, and hence does not cause dilution of the existing shareholders.]

BARDA DRIVe will lead the management and integration of the accelerator network. Resulting awards will be cooperative agreements (where unlike grants, BARDA will have substantial involvement) for accelerators to provide, on a cost-share basis, technical and business services to BARDA DRIVe R&D portfolio projects. BARDA DRIVe funds these projects separately, not through the accelerator network (thus making it different from the CARB-X model). The product developers are able to retain full ownership and control of their company while working with the accelerators.

BARDA DRIVe will provide direct funding to the accelerators (the cooperative agreement recipients) who will then provide direct support and in-kind services to the BARDA DRIVe R&D portfolio of early-stage product developers and innovators (awardees from other BARDA DRIVe funding mechanisms under separate Broad Agency Announcements). The purpose of the accelerator is to assist and expedite the development of these products/technologies/innovations through the stages of technology development such that their products mature to the point of clinical development outside the accelerator. The accelerators will advise and guide BARDA DRIVe’s developers/innovators, facilitate access to key industry stakeholders, and identify and address risks to ensure that product candidates become adequately poised for clinical development. The product developers and innovators will gain business and management acumen, technical expertise on cross-cutting or project-specific issues, networking opportunities, and access to state of the art facilities, with the goal of emerging as a promising new candidate product capable of attracting additional financing via traditional approaches.

Opportunities for New Accelerators BARDA DRIVe has identified three priorities for the Accelerator Network to bolster our product developers: 1) wide US geographic coverage, reflecting the regions of current and expected future DRIVe-X companies; 2) comprehensive accelerator services; and 3) a broad range of support in operational effectiveness required for efficient and effective drug and medical device discovery and development. We are especially interested in receiving applications from accelerators that provide services in the top fourteen regions we have identified, as shown in Figure 2, and also in other regions that have growth potential.

Figure 2. Fourteen leading BioTech/Innovation regional hubs

Applicants should identify their primary geographic region, and will be reviewed alongside other applications from that region. Applicants should be willing to commit resources (i.e. cost-sharing including in-kind services) to support the product developers, and will be accountable for that commitment.

Applicants should have the following current qualifications, experience and capability and/or have the ability to provide the following:

Geographic Location

· Region Specific Accelerators: Applicants who are physically located within one of the fourteen desired geographic regions will be rated highly. BARDA prefers to award a cooperative agreement to an accelerator within each of the fourteen preferred geographic regions. The applicant must identify the region to which they are applying. A region is defined as within 50 radial miles of one of the cities identified in Table 1 below.

· Other Regional Hubs with Growth Potential: Applicants not based in one these 14 geographical regions may still apply under “Other Regional Hubs.” Widening the network’s geographic areas to these other hubs will expand and diversify the locations of medical technology and health security innovation. BARDA intends, therefore, to award additional cooperative agreement(s) in the other regional hubs with growth potential. Awards will be made considering criteria described herein. Applicants applying under the “Other Regional Hubs” location designation must identify their region in their application.

Table 1. Fourteen leading biotechnology regional hubs + Other Regions.

Ability to provide functions typical of a Life Science/MedTech Accelerator

· An existing biotechnology or life science accelerator with a consortium of academic, biotechnology, and pharmaceutical companies to fund R&D activities to help progress candidate products and aid these companies in overcoming business and technical hurdles that smaller companies and academic start-ups may face.

· Each accelerator may interact with some or all DRIVe product developers.

· Interact with an extensive support network.

· Bring innovative approaches to supporting companies in the discovery and development of solutions to address DRIVe Impact Areas (e.g. Solving Sepsis, Early Notification to Act, Control and Treat, eradicating the need for animal testing, Pharmacy on Demand, and others); including helping them access additional private and public funding sources.

· Provide research and development support for DRIVe partners who are helping to overcome major challenges in the national health security ecosystem with breakthrough solutions, and rapidly accelerating the identification, development and delivery of novel solutions to all citizens for priority areas of concern. These include the development of new therapeutics and vaccines, first-in class drugs, new combination therapies, advanced diagnostic systems, wearable sensors, medical devices and other health technologies that have the potential to revolutionize national health security.

· Support developers of non-traditional therapeutics and innovative, disruptive strategies to treat or prevent illness.

Internal Capabilities:

· Provide industry standard services and capabilities commensurate with the stage of candidate development.

· Leverage a network comprised of subject matter experts in clinical product development, diagnostics, and vaccines against bacterial pathogens.

· Provide scientific and technical expertise in the area of medicinal chemistry, preclinical testing, pharmacokinetics, toxicology, diagnostic/device development, and manufacturing (e.g. for IND enabling studies and clinical trial material).

· Business consulting services that function to aid early stage entrepreneurs in establishing a business plan/model and position the company for external opportunities. The accelerator should provide business, financial, strategic consulting services while also linking entrepreneurs with key stakeholders developing products and technologies addressing DRIVe’s areas of interest. These services should help accelerate innovation and mitigate corporate and business development risks inherent to startup companies.

· A physical and virtual environment that is programmed to increase collaboration and spur health security innovation by leveraging the best practices from incubators, accelerators, technical hubs, co-working sites.

· Access to translational partners for advanced development including venture capital (VC) firms, other product development partnerships, large pharmaceutical companies, etc.

· Incentivizing strategies to bring in new researchers and candidates to work with VC and the bio-pharmaceutical and medical technology industries.

· Mechanisms to incentivize innovation and identify early potential research through workshops, hosted challenges, tech days, seminars, etc.

External Capabilities:

· A robust and extensive R&D network of partners able to provide the following expertise on an ad hoc basis:

· Systems integration services for bringing together novel technologies at the intersection of biochemistry, engineering and analytics

· Diagnostic development and engineering, including characterization, feasibility demonstration, reagent and assay development – extending to wearable sensors, at-home testing, etc.

· Support for new innovations in early detection and treatment

· Pharmacy on demand services and solving sepsis

· Non-clinical, clinical and systems engineering testing and demonstrations at alpha/beta prototype and full system levels

· Alternatives to animal models for advancing health technologies

· Regulatory support to assist in the development of regulatory pathways and preparation of submissions [e.g. Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications].

· Access to innovators and industry partners and the ability to leverage partnerships and resources to successfully advance promising products for follow-on R&D investment, including business capital and USG funding

Please note that potential Accelerators are not expected to be proficient in all areas mentioned above currently, but must be able to establish the capabilities through partnership and teaming during the application phase. DRIVe envisions that every $1 of funding from DRIVe to each accelerator in the DRIVe Accelerator Network will be matched with $1 to $2 of non-dilutive funding contributed by the accelerator (may include in-kind support services). (See Section III.2, Cost Sharing or Matching) Metrics BARDA has developed Key Performance Parameters (KPP) to define the metrics for the accelerator network. Meeting all threshold objectives is required to ensure a successful program. The four KPPs summarized in Table 2 below are deemed essential for the successful implementation of the accelerator network and each individual accelerator. Applicants should describe in their applications how they intend to meet these KPPs (for detailed application instructions and content, see Section III of this FOA, “APPLICATION AND SUBMISSION INFORMATION.”)

Table 2: DRIVe Accelerator Network Key Performance Parameters

(Minimally Acceptable Performance) Objective (Optimal or Ideal Level of Performance)

The Accelerator will provide introductions to follow-on support and/or R&D transition partner prior to graduation from accelerator.

Accelerator to provide strategic, regulatory and business development and support services to innovators after selection through graduation.

The Innovator will secure follow-on support and/or R&D transition partner prior to graduation from accelerator.

Accelerator Portfolio Metrics:

On an annual basis BARDA will conduct a performance evaluation of each accelerator in the DRIVe Accelerator Network. The accelerators will be measured on several different parameters. First, the ability of the accelerator to track their services to each of the product developers and provide summaries on a regular basis of these interactions, relationships built, guidance provided, etc. Also, the value-based impact of hours spent on the outcomes, will be considered. This data will be helpful in assessing how well the accelerators are operating (i.e. within cost and schedule parameters). The effectiveness of the strategic, regulatory and business development support services of the accelerators will also be regularly assessed. This may include a review of external services provided through the accelerator for the innovators to determine if the services are helpful in maturing the business and product development strategy.

Management of the Agreement:

This is a new public-private partnership. BARDA is providing the recipient [the accelerator] funding via a cooperative agreement to assist the BARDA DRIVe portfolio of product candidates as they progress through R&D and technology development.

Project Meetings

· Regular Status Update Teleconferences. A conference call between the DRIVe Program and the recipient (accelerator) shall occur at regular frequencies, for example monthly, as directed by the DRIVe project officer. During this call, the accelerator will discuss the activities during the reporting period, any problems that have arisen and the activities planned for the ensuing reporting period. The accelerator POC may choose to include other key personnel on the conference call to give detailed updates on specific projects or the project officer may make this request.

· Kick-off and Regular Project Meetings. The Recipient and the Government shall participate in Project Meetings to coordinate the performance of the agreement. These meetings may include face-to- face meetings at the accelerator’s site. Such meetings may include, but are not limited to, meetings of the accelerator to discuss technical approach, operational capability and initial portfolio that accelerator will support. Site visits to the accelerator facilities will occur as needed, and meetings with the accelerator and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. These meetings will also formulate and agree on the activities for the subsequent three months. In order to facilitate review of agreement activities, the accelerator will provide data, reports, and presentations to groups of outside experts (subject to appropriate non-disclosure agreements) USG personnel as requested by the project officer.

· Continuation Application Review Presentation (CARP): On an annual basis prior to the allocation of additional continuation funding, the Government will invite the accelerator to give a presentation at a CARP meeting attended by BARDA DRIVe Team, and select, invited interagency representatives (the accelerator is authorized to budget for travel to these meetings). The accelerator’s key personnel will attend and present progress/tracking under the agreement over the corresponding period of time. The accelerator will discuss successes and challenges identified with the programs in their portfolio and present their action plan for the coming year to align with the issued BARDA DRIVe portfolio priorities. The CARP will evaluate progress against the accelerator’s progress milestones as defined in their cooperative agreement, and make a recommendation on the action plan and budget allocation.

Table 3. Technical and Portfolio Review Meeting Schedule

· Accelerator Staff

· Agenda and Meeting minutes

(e.g. Quarterly)

· Accelerator Staff & invited product developers

· Agenda and Meeting minutes

· Quarterly Technical Progress Report

CARP

(Annual Review)

· DRIVe and partner members

· Agenda and Meeting minutes

· Portfolio and Technical Progress Report

· Funding and Product Asset Allocation

Reporting Table Attachment G contains a table of reports that BARDA will include in the final agreement.

Sharing of agreement reports within United States Government (USG) In an effort to build a robust medical countermeasure pipeline through increased collaboration, DRIVe and BARDA may share technical reports with Government entities responsible for medical countermeasure development. In accordance with agreements of confidentiality among US Government entities, BARDA may share technical reports with colleagues within the US Government. This provision applies to all reports and data developed during performance including reports and data paid for by the accelerator under the matching and cost sharing arrangements.

Example of DRIVe, Substantial involvement

· Provide funding to the accelerator and/or in-kind services to product developers supported by the accelerator,

· Share pertinent information related to the performance of the accelerator between agencies on a regular basis.

· BARDA staff may participate in all technical meetings with the accelerator.

· Identify and release strategic priorities to the accelerator on an annual basis that identify focus areas and potential technology types to address strategic gaps

· Capture and integrate knowledge between the accelerators and DRIVe to improve DRIVe’s “advantaged insight” to support better portfolio decisions and product acceleration

AWARD INFORMATION

Total Estimated Project Cost (FY2018-FY2023): $1.5M/year = $7.5M total Total Funding Amount (FY2018): $1.5M Anticipated Number of Awards: 15 - 20 Project Period Length: 5 years Budget Period Length: 1 year

Ceiling of Individual Award Range per year per Accelerator: $75K Anticipated Start Date: June 1, 2018 Expected Duration of Support: 5 years Type of Application Sought: Cooperative Agreement Funding beyond the first year is dependent on availability of appropriated funds in subsequent fiscal years, satisfactory awardee performance, endorsement at the Continuation Application Review Presentation and a decision that continued funding is in the best interest of the Federal Government.

1. Cooperative Agreement Award The Federal Grant and Cooperative Agreement Act of 1977, 31 U.S.C. 6305, defines the cooperative agreement as similar to a grant in that an item of value is transferred to a recipient to carry out a public purpose. However, a cooperative agreement is used whenever substantial federal involvement with the recipient during performance is anticipated. The difference between grants and cooperative agreements is the degree of federal programmatic involvement rather than the type of administrative requirements imposed.

The administrative and funding mechanism used for this program will be the cooperative agreement for which substantial BARDA programmatic involvement with awardees is anticipated during the performance period. This award is subject to the awardee(s) and collaborative requirements and responsibilities set forth in the Cooperative Agreement outlined in the program announcement under this funding opportunity and are hereby incorporated by reference as terms and conditions of this award.

BARDA Responsibilities BARDA will be responsible for the review and approval of program activities including, but not limited to, the proposed use of funds and activities to meet the terms and conditions of the award. BARDA will also approve timelines and review progress of the program as well as monitor reporting requirements. Progress evaluation will include the development of timelines and milestones and the oversight of proposed activities through monthly reports and on-site joint visits with Recipient staff and program managers and others in the United States Government (USG) as needed.

BARDA Activities:

BARDA staff collaborator(s) and/or designee(s) activities for this program are as follows:

· Participate in orientation and/or summary update meetings with the Accelerators on expectations, regulations and key management requirements, as well as reporting requirements, formats and contents.

· Participate in regular teleconferences, face to face Technical Project Review meetings, as discussed in “Management of the Agreement” section of this FOA.

· Oversee activity for the Accelerator, assisting with strategic guidance and direction to the Accelerator.

· Identify and release strategic priorities to the Accelerator on an annual basis that identify focus areas and potential technology types to address strategic gaps

· Participate in the development, review and approval of the Accelerator’s work plan and budget, and monitoring and evaluation plan.

· Provide awardee with technical assistance and consultation in identification of appropriate resources outside of both the Accelerator and HHS to support Accelerator activities.

· Coordinate activities and synergies with the Accelerator and BARDA DRIVe product developers.

· Work cooperatively with the Accelerator to assure that all necessary information and progress resulting from this agreement is provided to BARDA in a format that will allow the Department of Health and Human Services to assess the continuing benefits and communicate the successes of the agreement to the general public.

Accelerator’s Responsibilities The Accelerator has the primary responsibility for defining objectives and approaches for planning, conducting, identifying and addressing risks and gaps, and fostering R&D product developers in the BARDA DRIVe portfolio, so that they become better positioned for follow-on clinical development. The BARDA DRIVe product developers will retain custody of and primary rights to any data developed under this award, subject to US Government rights of access consistent with U.S. law and current Department of Health and Human Services (HHS) and Public Health Service (PHS) regulations and policies.

Accelerators will be responsible for coordinating activities approved under the award. The Accelerator will be responsible for developing achievable program plans. The Accelerator will also be responsible for tracking that all activities and processes follow the terms and conditions of the agreement, and satisfactorily adhere to budget and monitoring reporting plans. Accelerators will compile their results into monthly and annual reports.

The Accelerators will be responsible for planning and participating collaboratively with BARDA under this agreement. Through participation in regular teleconferences, Face to Face Review meetings, and annual CARP meetings as outlined in the “Management of the Agreement” section of this FOA, the Accelerator will work with BARDA in order to make progress toward its goal of executing the Accelerators annual work plans.

The following is a summary of the annual program requirements for Accelerators:

· Submit tracking reports of activities.

· Submit required progress reports and program and financial data.

· Have in place fiscal and programmatic systems to document accountability and performance.

ELIGIBILITY INFORMATION

1. Listed below are the eligible applicants that can apply for this funding opportunity:

· US Based

· Nonprofit with 501C3 IRS status (other than institution of higher education)

· For profit companies

· Small, minority, and women-owned businesses

· Universities

· Colleges

· Research institutions Cost Sharing or Matching:

· Cost sharing is highly encouraged for this award. There is no minimum requirement however; BARDA anticipates a minimum of at least 50/50 cost sharing from each awardee. Any cost share proposed in the application will be binding in the notice of award.

· BARDA encourages Applicants to propose innovative ways to leverage federal funding to attract additional capabilities/incentives to bolster the Accelerator’s. This may include identification of external opportunities or leveraging funding at the state or local level (e.g. public, private, etc.).

· BARDA envisions that every $1 of BARDA funding will ideally be matched by up to $2 of non-dilutive funding contributed by Alliance members of the Accelerator, [footnoteRef:2] and may include in-kind services. [2: In-kind support may be used for match. In-kind support includes the value of goods and services donated to the operation of the Accelerator, including but not limited to office space, volunteer secretarial services, pro bono accounting services, and other volunteer services to support the organization’s/entity’s work. All matches must follow the federal cost principles (see Attachment B of this FOA). Applicants cannot submit match that would not be an allowable purchase with ASPR funds. A match level over the ideal amount will not result in a higher peer review score. All proposed match is an obligation on the part of the applicant. The HHS Grants Policy Statement provides information on allowable costs, volunteer rates, and conflict of interest issues. This document is http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf. Federal funds, including those passed through a state or local government, cannot be used toward the required match. ]

· The accelerator must identify at least one full time employee that will be 90% dedicated to the DRIVe Accelerator award and be focused on identifying and supporting product and technology innovation relevant to DRIVe’s National Health Security focus.

· The Accelerator will be responsible for tracking and reporting on cost sharing/matching funding expenditures and reporting this quarterly. All cost sharing/matching funding expenditures reported to the government must be allocable to the agreement, as defined in Attachment B: Budget Narrative/Justification Sample Format Mandatory Meetings:

If awarded, the Accelerator is required to attend every two week teleconferences, Face to Face Technical Quarterly Review meetings, and other meeting outlined in the “Management of the Agreement:” section of this FOA.

Screening and Responsiveness Criteria Application Screening Criteria

Applications that fail to meet the screening criteria described below will not be reviewed and will receive no further consideration.

1. Applications must be submitted electronically via http://www.grants.gov by May 18, 2018, at 11:59PM EDT

2. A pre-application video teleconference will be held on Thursday, May 3, 2018. This meeting is designed to address any questions associated with the application process. RSVP to this meeting no later than Tuesday, May 1, 2018, by emailing Ms. Donna Boston at donna.boston@hhs.gov, using subject Line: “RSVP for Accelerator Pre-Application Video Teleconference Workshop.” Please include Names, Titles, and Organizations, Email, Phone, location of accelerator. A conference call number will be provided to those who respond via email.

3. The Project Narrative section of the Application must be double-spaced, on 8 ½” x 11” plain white paper with 1” margins on both sides, and a font size of not less than 11.

4. The Project Narrative must not exceed 10 pages. NOTE: The Project Work Plan, Letters of Commitment, budget narrative and justification forms, Vitae of Key Project Personnel and Other Relevant Annexes are not counted as part of the Project Narrative for purposes of the 10-page limit.

Application Responsiveness Criteria

Applications that do not meet the following responsiveness criteria will be administratively eliminated and will not be reviewed:

· Applications submitted after the due date and time will not be reviewed.

· Applications submitted by non-eligible entities will not be reviewed.

· Applications submitted by individuals will not be reviewed.

· Applications failing to include the required forms will not be reviewed.

· Applications that fail to indicate their specific geographic region(s) or “Other Region” will not be reviewed

· BARDA will not accept applications with a Project Narrative that exceeds 10 pages. NOTE: The Project Work Plan, Letters of Commitment, budget narrative and justification forms, Vitae of Key Project Personnel and Other Relevant Annexes are not counted as part of the Project Narrative for purposes of the 10-page limit. Show these documents as attachments to clearly note that the project narrative does not exceed 10 pages.

APPLICATION AND SUBMISSION INFORMATION

1. Application Package

Application materials can be obtained from www.grants.gov. You must register with grants.gov prior to submitting an application. Applicants previously registered must assure that the registration is still valid and up-to-date. Registration and re-registration may take up to 10 working days to process. Failure to submit the application on time due to late registration will result in ASPR not accepting the application.

Applications must be submitted electronically through www.grants.gov by the application deadline of May 18, 2018 at 11:59PM EDT. ASPR will not accept any applications that are not submitted electronically via www.grants.gov.

Grants.gov (http://www.grants.gov) will automatically send applicants a tracking number and date of receipt verification electronically once the application has been successfully received and validated in http://www.grants.gov. After ASPR retrieves your application form from http://www.grants.gov, a return receipt will be emailed to the applicant contact. This will be in addition to the validation number provided by http://www.grants.gov.

1. Required registrations:

Central Contractor Registration and Data Universal Numbering System Requirements Except for those entities exempt from requirements listed at 2 CFR §25.110(b) or (c) ( individuals), effective October 1, 2010, HHS requires all entities that plan to apply for and ultimately receive federal grant funds from any HHS Operating/Staff Division (OPDIV/STAFFDIV) or receive subawards directly from recipients of those grant funds to:

· Be registered in the Central Contractor Registration (CCR) prior to submitting an application of plan;

· Maintain an active CCR registration with current information at all times during which it has an active award or an application or plan under consideration by an OPDIV/STAFFDIV; and

· Provide its Data Universal Numbering System (DUNS) number in each application or plan it submits to the OPDIV/STAFFDIV.

An award cannot be made until an applicant has complied with these requirements. At the time an award is ready to be made, if the intended recipient has not complied with these requirements, the OPDIV/STAFFDIV may determine that the applicant is not qualified to receive an award; and may use that determination as a basis for making an award to another applicant.

Applicants must provide a Dun and Bradstreet (DUNS) number to apply for a grant or cooperative agreement from the federal government. ASPR applicants are required to provide their DUNS number on the face page of the application. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access the Dun and Bradstreet website at http://www.dnb.com/get-a-duns-number.html or call 1-866-705-5711. To expedite the process, let Dun and Bradstreet know that you are a public/private nonprofit organization getting ready to submit a federal grant application. In addition, you must be registered in the System for Award Management (SAM). Registration in the System for Award Management (SAM) is mandatory. Failure to register with SAM will lead to an application being deemed ineligible and will not proceed to peer review. Due to the possibility of heavy traffic at the sam.gov website, applicants are strongly encouraged to register well in advance of the application due date. SAM information must be updated at least every 12 months to remain active (for both recipients and sub-recipients). Once you update your record in SAM, it will take 48 to 72 hours to complete the validation processes. Grants.gov will reject submissions from applicants who are not registered in SAM or those with expired SAM registrations (Entity Registrations). The DUNS number you use on your application must be registered and active in SAM for the anticipated start date of the award. To create a user account, Register/Update an entity and/or Search Records go to SAM, at http://www.sam.gov or by phone at 1-877-252-2700.

Grants.gov registration – All entities must register and/or renew registration with grants.gov prior to submitting an application. Grantees previously registered must assure that the registration is still valid and up-to-date. Registration and re-registration take up to 10 working days to process. Failure to submit the application on time due to late registration will result in ASPR not accepting the application.

Content and Form of Application Submission (See section VIII. OTHER INFORMATION)

The following document and sections need to be submitted to ASPR in order to be considered for funding; forms are available on grants.gov within the application package:

· Application for Federal Assistance – Standard Form SF 424. By signing the SF 424 the applicant agrees not only to assurances and certification, as described on the form, but to all the requirements for this specific appropriation including, but not limited to, the insurance statement as seen on Attachment E.

· Budget Information – Standard Form SF 242A

· Assurances (Non-Construction Programs) - Standard Form SF 424B

· If human subjects are involved you must complete and submit Attachment G.

**Project Narrative**

The Project Narrative must be double-spaced, on 8 ½” x 11” paper with 1” margins on both sides, and a font size of not less than 11. You can use smaller font sizes to fill in the Standard Forms and Sample Formats. ASPR will not accept applications with a Project Narrative that exceeds 10 pages. The Monitoring and Evaluation Plan, Curriculum Vitae of Key Personnel, and other Annexes are not counted as part of the Project Narrative for purposes of the 10-page limit, but all of the other sections noted below are included in the limit.

The components of the Project Narrative counted as part of the page limit include:

Abstract Goal(s) and Objective(s) Proposed Approach, Work Plan, and Timeline of Proposed Activities – these plans may be in narrative or chart form (see attachments for suggested formats). Any forms submitted to meet this required section will be counted as part of the page limitation. Applicants should provide the following:

1) Their approach to provide support services – e.g. technical, business, and regulatory advice – to a diverse R&D portfolio of medical product candidates to supporting health security innovation

2) The geographic region selected for main hub of activity, and any other regions in which they operate

3) Their approach to and/or track record of performing the functions of a product Accelerator.

4) Their approach to and/or experience of the organization in evaluating early stage technologies from a scientific and regulatory perspective to assess risks and gaps in R&D by BARDA DRIVe product developers.

5) Their approach to and/or track record of supporting the business and entrepreneurial needs of innovators, provide wrap-around support capabilities and services (e.g. technical, strategic, business, access to stakeholders.)

6) Their approach to and/or track record of leveraging the best practices from incubators, accelerators, technical hubs, co-working sites, etc. to promote innovation and collaboration.

7) Their approach to and/or track record of fostering a physical and virtual environment that is programed to increase collaboration and spurs product innovation

8) Their approach to and/or track record of bringing multiple parties together, forming alliances, identifying external funding opportunities which could demonstrate their ability to maximize impact of the Accelerator.

Evaluation Plan – these plans may be in narrative or chart form (see “Attachments I” for suggested formats). Any forms submitted to meet this required section will be counted as part of the 10 page limitation. Please provide definitive and measurable metrics that tie towards progress related to the 9 parameters listed above.

Any Other Relevant Annexes that do not count toward the page limit include:

· Key Personnel CV –critical personnel or technical consultants that are part of this project

· Letters of Commitment – only required between collaborating agencies proposing cost sharing/matching.

· Budget Narrative – see suggested format in attachment section

· Self-monitoring plan and contingency activities identified to ensure project completion and funding outlays are completed within the 12 month project period

· Other documents, as needed

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether or not the project meets the minimum requirements for grants/cooperative agreements under Section 319L of the Public Health Service Act. The Project Narrative should provide a clear and concise description of the project. ASPR recommends that the project narrative include the following components.

**Abstract**

This section should include a brief (no more than 200 words maximum) description of the proposed project, including: goal(s), objectives, outcomes, and products to be developed. Detailed instructions for completing the abstract are included in Attachment D of this document.

**Goal and Objectives**

This section should consist of a description of the project’s goal(s) and major objectives. Unless the project involves multiple, complex interventions, we recommend you have only one overall goal. The goal and objectives stated in Section I “Funding Opportunity Description” are suggestions and the applicant is free to modify, edit or propose other goal and objectives, but they must similarly align with the ones proposed in this Funding Opportunity Announcement.

**Workplan and Timeline of Proposed Activities**

Each proposed cooperative agreement should have clear timelines for execution and completion.

The Project Work Plan should reflect and be consistent with the Project Narrative and Budget and should cover all of the project period. It should include a statement of the project’s overall goal, anticipated outcome(s), key objectives, and the major tasks / action steps that will be pursued to achieve the goal and outcome(s). For each major task / action step, the work plan should identify timeframes involved (including start- and end-dates), and the lead person responsible for completing the task. Please use the Sample Work Plan format included in Attachment C.

**Organizational Capability**

The application must indicate in which geographic region of the United States the applicant is located.

Each application should include an organizational capability statement. The organizational capability statement should describe how the applicant agency (or the particular division of a larger agency which will have responsibility for this project) is organized, the nature and scope of its work and/or the capabilities it possesses.

This description should cover capabilities of the applicant agency not included elsewhere in the narrative, such as any current or previous relevant experience and/or the record of the project team in producing cogent and useful reports, publications, or other products.

This section should also include a clear delineation of the roles and responsibilities of project staff, consultants and partner organizations, and how they will contribute to achieving the project’s objectives and outcomes. It should specify who would have day-to-day responsibility for key tasks such as: leadership of the project; monitoring the project’s on-going progress; preparation of reports; and communications with other partners and BARDA. Curriculum vitae for key project personnel should feature in the annexes.

Annexes ** Personnel**

Please attach short curriculum vitae for key project staff only (no more than one page each). Neither curriculum vitae nor an organizational chart will count towards the narrative page limit.