PKG00251284-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:

2019 BARDA Division of Research, Innovation and Ventures (BARDA DRIVe) Accelerator Network Expansion

Catalog of Federal Domestic Assistance (CFDA) Number:

93.360

Funding Opportunity Number: EP-IDS-19-003 Application Due Date: July 23, 2019

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 Division of Research, Innovation, and Ventures (DRIVe) was established by the Biomedical Advanced Research and Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR), within the United States Department of Health and Human Services (HHS).

BARDA is responsible for developing and procuring technologies and countermeasures to protect the nation against natural and man-made threats. BARDA has delivered solutions to protect our country and the world from threats like Anthrax, Smallpox, Ebola, Pandemic Influenza, and many others. BARDA's mission is accomplished through successful public-private partnerships with industry to share risk, improve efficiency, and accelerate development all while sustaining a marketplace that guarantees continued access to the vaccines, therapeutics, diagnostics, and other medical products that are vital to our national health security.

Launched in June 2018, DRIVe stimulates public-private partnerships that spur innovation and investment in health security products and technologies. The current pipeline of health security products, technologies and innovations is insufficient to counter the serious 21st century health threats facing our nation. DRIVe is working to address this crisis by incentivizing innovative research and development in the field of health security. 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 BARDA DRIVe.

The original DRIVe Accelerator Network consists of the following eight organizations, located in key regional hubs across the US where health security products and technologies in biotechnology, life science research, and medical innovations are heavily concentrated: The Center for Biotechnology at Stonybrook (Long Island, NY); First Flight Venture Center (Raleigh, NC); Life Science Washington Institute (Seattle, WA); MedTech Innovator (Los Angeles, CA); Massachusetts Medical Device Development Center (Lowell, MA); New Orleans BioInnovation Center (New Orleans, LA); Texas Medical Center Innovation Institute (Houston, TX); and University City Science Center (Philadelphia, PA).

BARDA now wishes to expand the network to add members from regions of the country that are not in our current network but could further the impact and reach of DRIVe to other important hubs of biotech/life science innovation and activity. The positive impacts of the DRIVe Accelerator Network to date are significant and are only expected to grow with the 2019 expansion of the network, through: 1) the ability to reach a broader audience of stakeholders and innovators than BARDA could otherwise connect with through traditional means, and 2) the ability to empower entrepreneurs, innovators, and researchers to create and commercialize innovative medical technologies to address unmet health security needs.

The purpose of this Funding Opportunity Announcement (FOA) for the “2019 DRIVe Accelerator Network Expansion” is to solicit applicants interested in working with BARDA DRIVe in this capacity. It describes BARDA’s desired approach to expand the existing accelerator network, explains the envisioned roles and responsibilities of an accelerator, and provides details on how interested parties may apply.

Figure 1: Current DRIVe Accelerator Network

Project Overview

Advances in medical technology can take years to find their way to the clinic and patients because of high costs associated with developments and significant commercial risks. The successful launch of a new medical technology product or service depends on successful progression through an innovation pathway – from identifying a need through to product launch. Accelerators can help to bridge that gap by providing access to stakeholders, potential investors, and access to otherwise-hard-to-obtain resources.

DRIVe wishes to collaborate with accelerators who can provide BARDA DRIVe-funded developers with technical and entrepreneurial support, which may in turn enable these innovators to cross the valley of death – allowing the progress of science from the laboratory bench to the point where it provides the basis of a commercially successful business or product.

The DRIVe Accelerator Network leverages key regional hubs across the US where health security products and technologies in biotechnology, life science research, and medical innovations are heavily occurring. These accelerators are distributed around the country and are physically networked among, and can make connections between, BARDA and the innovators in their network. Accelerators are also able to provide access to a community of experts who can provide support to DRIVe funded product developers.

The support needs of companies in the DRIVe portfolio vary widely: some will be well-established pharmaceutical or medical technology companies, others are serial entrepreneurs with a successful track record, while others have exciting technologies but not much business acumen or experience. A tailored package of support will be developed for each, with some packages being more intensive than others. In developing a response to this announcement, applicants should be able to articulate an approach to support these varying levels of need that are both within and outside of the context of their respective organization’s existing accelerator programs (i.e. providing support through a cohort program or on an ad hoc basis).

Applicants who enter agreements with BARDA will:

· Identify, promote and foster innovations in early and mid-stage health security product and technology development (feasibility must already be established);

· 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, legal and business advice, access to facilities and incubator spaces, integration services); and

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

The DRIVe Accelerator Network is made up of non-government entities that do NOT take equity positions. Awardees under this FOA will be prohibited from taking equity positions in any product development companies funded by BARDA. Should a member of the DRIVe Accelerator Network have programs that fund companies (inclusive of prizes), such funding must also be non-dilutive. Alternatively, a clear strategy should be articulated which demonstrates a legal separation between the DRIVe funded accelerator and the funding program, mechanism, or entity.

BARDA DRIVe will lead the management and integration of the accelerator network. Resulting awards from this FOA will be cooperative agreements. Unlike grants, BARDA will be substantially involved in managing these cooperative agreements.

Opportunities for New Accelerators BARDA DRIVe has identified three priorities for the Accelerator Network to bolster our portfolio of innovative health security products and technologies: 1) wide US geographic coverage, comprised of the regions of densest life science/med tech activity and potentially current and expected future BARDA DRIVe funded companies; 2) comprehensive accelerator services (both inside and outside the context of established accelerator programs); and 3) a broad range of support required for efficient and effective discovery of novel drugs, devices, diagnostics and affiliated technologies. Based on our market research and the needs of the public health emergency framework, we are targeting certain ASPR regional coordination and special pathogen centers for placement of additional Year 2019 accelerators. We will not accept applications in regions where there is an existing accelerator working with BARDA DRIVe, see Table 1. Applicants not based in one the identified regions of interest and not located within an ineligible region (see Table 1) may still apply under “Other Regional Hubs.” Applicants applying under the “Other Regional Hubs” location designation must identify their region in their application.

Table 1 – Regions of Interest

San Francisco Bay Area, CA

Spokane, WA

Washington, DC

Figure 2 – 2019 DRIVe Accelerator Expansion Regions of Interest

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 DRIVe funded product developers and will be accountable for that commitment. To be considered, all applicants will be expected to:

· Be an existing medtech, biotechnology or life science accelerator[footnoteRef:1] 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, legal and technical hurdles that smaller companies and academic start-ups may face. [1: It is important to note that, despite the name, in FY18 DRIVe selected and awarded grants, for the Accelerator Network, a variety of entrepreneurial support organizations that are similar to accelerators in purpose, but not strictly in form or operation. The awardees’ models include accelerators, incubators, makerspaces, and virtual or hybrid forms of these organizations. Most grant recipients offer cohort-based programs, demo days, and mentoring and networking services, but not all offer services in the form of what is traditionally defined as an accelerator or accelerator program. For the purpose of this plan, the term “accelerator” is meant to be all encompassing of the operational environments and capabilities as described in this FOA.]

· Bring innovative approaches to supporting companies in the discovery and development of solutions to address BARDA DRIVe Impact Areas (e.g. Solving Sepsis, Early Notification to Act, Control and Treat, and other disruptive innovation in health security); including helping them access additional private and public funding sources.

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

· Possess robust outreach mechanisms including accelerator hosted conferences (and other hosted events), social media (Twitter, LinkedIn, Facebook), websites, and use of digital mailing lists (listservs).

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

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

· Project Specific Acceleration:

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

· Promote and amplify BARDA and DRIVe opportunities and initiatives

· Support product/technology developers awarded under the separate BARDA 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.

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

· 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 the BARDA DRIVe areas of interest. These services should help accelerate innovation and mitigate corporate and business development risks inherent to startup companies.

· Ability to provide ad-hoc assistance to companies entering mid-stage or have progressed beyond the start-up phase. The focus of this type of ad-hoc assistance includes facilitated access to clinical, regulatory, operational, and/or legal expertise as well as assistance with fundraising.

· 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.

Internal Capabilities:

· A physical and/or 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.

· Access to co-working, lab, and incubator spaces.

External Capabilities:

· A robust and extensive R&D network of partners with the ability 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

· Access to clinical trials networks and expertise

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

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

· Access to clinical samples

· 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].

· Reimbursement expertise

· Clinical operations expertise

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. BARDA DRIVe envisions that every $1 of funding from BARDA 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 IV 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, legal 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 a monthly basis, the accelerator will report on BARDA DRIVe-related accelerator activities, status and progress. Accelerators will report on outreach efforts, social media analytics, accelerator-led events, and general program status.

On an annual basis BARDA DRIVe will conduct a performance evaluation of each accelerator in the BARDA 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, technical 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:

BARDA will provide funding to the successful applicant(s) from this FOA [the accelerator(s)] via a cooperative agreement to prospect for and assist the BARDA DRIVe portfolio of product candidates as they progress through R&D and technology development. To execute the cooperative agreement, it can be anticipated that BARDA and the selectee(s) will confer regularly as follows:

Project Meetings

· Regular Status Update Teleconferences. A conference call between the BARDA DRIVe Program and the recipient (accelerator) shall occur at regular frequencies, for example monthly, as directed by the BARDA 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)

· BARDA 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, BARDA 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 BARDA DRIVe Substantial involvement

· 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 BARDA DRIVe to improve BARDA DRIVe’s “advantaged insight” to support better portfolio decisions and product acceleration Other Information:

A pre-application video teleconference will be held on Tuesday June 25, 2019. This meeting is designed to address any questions associated with the application process. RSVP to this meeting no later than Monday, June 24, 2019, 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.

AWARD INFORMATION

Total Estimated Project Cost (FY2019-FY2024): approximately $100K/year/awardee = $500K total/awardee Total Funding Amount (FY2019): $0.5M Anticipated Number of Awards: up to 5 Project Period Length: 5 years Budget Period Length: 1 year

Ceiling of Individual Award per year per Accelerator: $100K Floor of Award per year per Accelerator: $75K Anticipated Start Date: Sep. 1, 2019 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.

Accelerator 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. 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 $1 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 BARDA DRIVe Accelerator award and be focused on identifying and supporting product and technology innovation relevant to BARDA 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 regular teleconferences, and other meetings 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 July 23, 2019, at 11:59PM EDT.

2. 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.

3. 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) 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 July 23, 2019, 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:

Applicants must register with the System for Award Management (SAM) and Grants.gov (see below for all registration requirements).

GET REGISTERED

You are required to complete three (3) registration processes:

Dun & Bradstreet Data Universal Numbering System (to obtain a DUNS number);

System for Award Management (SAM);and Grants.gov If this is your first time submitting an application, you must complete all three registration processes. If you have already completed registrations for DUNS and SAM, you need to ensure that your accounts are still active, and then register in Grants.gov. If your organization is not registered by the deadline, the application will not be accepted.

The organization must maintain an active and up-to-date SAM and DUNS registrations in order for ASPR to make an award.

1.1 Dun & Bradstreet Data Universal Numbering System (DUNS) Registration Applicants are required to obtain a valid DUNS Number, also known as the Unique Entity Identifier, and provide that number in 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 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. The DUNS number you use on your application must be registered and active in the System for Award Management (SAM).

1.2 System for Award Management (SAM) Registration

You must also register with the System for Award Management (SAM) and continue to maintain active SAM registration with current information during the period of time your organization has an active federal award or an application under consideration by an agency. To create a SAM user account, Register/Update your account, and/or Search Records, go to https://www.sam.gov.

It is also highly recommended that you renew your account prior to the expiration date. SAM information must be active and up-to-date, and should 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 rejects electronic submissions from applicants with expired registrations.

1.3 Grants.gov Registration

Grants.gov is an online portal for submitting federal grant applications. It requires a one-time registration in order to submit applications. While Grants.gov registration is a one-time only registration process, it consists of multiple sub-registration processes (i.e., DUNS number and SAM registrations) before you can submit your application.

You can register to obtain a Grants.gov username and password at http://www.grants.gov/web/grants/register.html.

If this is your first time submitting an application through Grants.gov, registration information can be found at the Grants.gov “Applicants” tab.

The person submitting your application must be properly registered with Grants.gov as the Authorized Organization Representative (AOR) for the specific DUNS number cited on the SF-424 (first page). See the Organization Registration User Guide for details at the following Grants.gov link: http://www.grants.gov/web/grants/applicants/organization-registration.html.

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.

Application Screening Criteria

Applications must be submitted electronically via http://www.grants.gov by July 23, 11:59 pm EST.]

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 support 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, inclusive of existing programs and how they could be leveraged for DRIVe.

4) Their approach to and/or experience of the organization in evaluating early and mid-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, entrepreneurial, legal, and technical needs of innovators, provide wrap-around support capabilities and services (e.g. technical, strategic, business, access to stakeholders). Please also articulate how this support can be provided to BARDA DRIVe funded product developers inside and outside the context of existing programs at your organization.

6) Their approach to and/or track record of leveraging the best practices of incubators, accelerators, technical hubs, co-working sites, etc. to promote innovation and collaboration. Inclusive of partnerships, sponsors, and activities that engage their local and non-local networks.

7) Their approach to and/or track record of fostering a physical and/or virtual environment that is programmed to increase collaboration and spurs product innovation. Inclusive of the ability to provide access to clinical networks as well as co-working, wet lab, dry lab, and fabrication spaces.

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. Inclusive of relationships with venture capital or other sources of investment and use of or access to events to provide platforms for fundraising/access to networking.

9) Their approach to outreach and marketing including accelerator hosted conferences (and other hosted events), social media (Twitter, LinkedIn, Facebook), websites, and use of digital mailing lists (listservs).

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. Also include information about any contractual organization(s) that will have a significant role(s) in implementing the project and achieving project goals. Please ensure to include key personnel not only for the operations of the Accelerator but also the key consultants with the technical expertise in the functional areas of drug or device development. The Accelerator must identify at least one full time employee that will be 90% dedicated to the BARDA DRIVe Accelerator award and be focused on identifying and supporting product and technology innovation relevant to BARDA DRIVe’s National Health Security focus.

**Letters of Commitment**

Include confirmation of the commitments to the project (should it be funded) made by key collaborating organizations, agencies and Alliance Members in this part of the application. Any organization that is specifically named to have a significant role in carrying out the project should be considered an essential collaborator. If a partner proposes contributing towards your cost share, than this contribution is part of your proposal, the partners cost share must be included in the Letter of Commitment and will be considered binding if an award is made by USG.