FAZD Center Open Call for Proposals OPEN CALL FOR PROPOSALS

Transcription

1 FAZD Center Open Call for Proposals OPEN CALL FOR PROPOSALS

2 February 1, GENERAL INFORMATION Granting Institution: Research Opportunity: Response Date: Point of Contact: Open call website: DHS Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD) CEEZAD Open Call for Proposals White papers are due February 29, 2016 by 5:00pm CST. A list of other important dates relevant to this Open Call for Proposals may be found on Page 2 of this announcement. Dr. Steven Ellsworth, Associate Director Center of Excellence for Emerging and Zoonotic Animal Diseases Kansas State University College of Veterinary Medicine 1800 Denison Ave Mosier Hall K-224 Manhattan, KS ellswort@vet.k-state.edu OVERVIEW The Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD) is now considering white papers for funding research and development (R&D) and education projects that can be completed within a 12-month period with possibility to extend for a second year. All white papers and proposals will be evaluated through a highly competitive peer review process. Successful projects will be in a developmental or transition-to-application phase related to transformative, evolving, and/or maturing R&D technologies that demonstrate significant improvement and/or enhancements to the CEEZAD portfolio in the CEEZAD mission or the operations of CEEZAD stakeholders, within focus in areas discussed below. This open call for proposals outlines CEEZAD s current research priorities that can be addressed either through new projects or extensions of currently- or previously-funded efforts. International and highly collaborative submissions are encouraged. 1

3 The Proposal Submission, Selection, and Retention Process A two-phased proposal selection process will be used for this solicitation to minimize the cost and effort for prospective offerors. White papers submitted as a part of this process will be reviewed by the CEEZAD management team to determine if the project satisfies the basic criteria described in this announcement. CEEZAD reserves the right to reject submissions that do not comply with submission instructions outlined within this document. Offerors of white paper proposals that are judged to be most relevant to the stated mission and exhibit scientific soundness will be contacted and encouraged to submit of a full proposal. The offeror will receive a response as to whether or not the white paper has been selected for a full proposal by April 1, The offeror must then send a letter of intent within 1 week (by April 8, 2016) if offeror chooses to submit a full proposal. The deadline for full proposal submission is May 15, 2016 at 5 PM CT; proposals will not be accepted after the stated deadline for submission. Following review by members of the CEEZAD External Advisory Board, full proposals which meet acceptance criteria will be held for 1 year for potential funding. During this time, if the content of the proposal meets a funding entity need, the proposal will be submitted to the entity for consideration for funding. It should be understood that funding is not currently available to fund any proposals; however, should funding become available and the topics described below become a priority for funding, then CEEZAD will work with stakeholders to support successfully reviewed proposals. The scope of work and budgets in the full proposal should reflect actual research or educational/outreach activities that, ideally, will be fully accomplished within 12 months. All candidates will be required to submit to CEEZAD the full proposal documentation. This request for documentation, along with full proposal templates, will be ed to the candidates after a letter of intent has been received. The White Paper should clearly state the main goal of the project, the relevance to CEEZAD s mission and the scientific basis for the proposed research (see enclosed White Paper Template). The precise objectives and major milestones should be clearly outlined. Submissions should briefly describe the experimental plan, anticipated outcomes and their impact on advancement of countermeasures against high impact pathogens. Priority will be given to projects of high impact in the area of countermeasure development for transboundary animal diseases (TAD), projects already at an advanced stage of development that delineate clear, practical outcomes within one year of completion, projects with high potential to leverage additional matching funds, and those with demonstrated capability to engage stakeholders and end-users. Priority will be given to applied projects with feasible practical outcomes, but basic research projects with state-of-the-art approaches and high impact potential will also be considered. The impact, relevance, and unique contribution of the proposed research, educational effort, and/or technical concept must be clearly articulated in the initial white paper. In addition, the white paper should clearly state how the proposed effort differs from similar efforts and/or solutions and what specific advances or innovations will be produced. 2

4 Selection of white papers/full proposals will be based on several overarching criteria: 1. Alignment with CEEZAD s mission; 2. Relevance and significance of proposed effort; 3. Scientific merit; 4. Benefits to CEEZAD stakeholders (industry, USDA, DHS, etc.); 5. Technical approach and risks; 6. Customer engagement and requirements; 7. Achievement of Key Performance Parameters; 8. Potential for technology transition; 9. Budget -proportional to work being performed and resources used; and 10. Qualifications of personnel and adequate facilities. Preference will be given to proposals that demonstrate significant resource leveraging, encourage a collaborative research environment, and exhibit cross-cutting approaches within CEEZAD thematic research areas. Important Dates (subject to change) February 29, White papers due for Review. April 1, Offerors notified of white paper status; those accepted asked to prepare a full proposal. April 8, Letter of Intent to prepare full proposal due from Offerors of accepted white papers. May 15, Full proposals due for Review (must be received by 5 PM CT). June 30, Notification of whether full proposal selected for match-up with task orders. 3. AWARD INFORMATION CEEZAD reserves the right to select for award and fund all, some, or none of the full proposals received in response to this announcement. Proposal development costs will not be reimbursed. Technical and cost proposals (or any other material) submitted in response to this announcement will not be returned. It is the policy of CEEZAD to treat all proposals as proprietary information and to disclose their contents only for evaluation purposes. Offerors may mark any proprietary or business sensitive data if necessary. CEEZAD is funded through a cooperative agreement with the Department of Homeland Security (DHS). CEEZAD is not able to fund other federal government agencies. For selected projects, subawards containing the DHS terms and conditions, as well as Kansas State University terms and conditions, will be issued. The award ceiling is $250,000 per project. These are total costs (direct and approved institutional indirect) and must be proportional to the work being performed. A second year of funding is possible for exceptional projects that make significant, agreed-upon progress the first year with up to $250,000 of additional funding per project. 3

5 Proposals must address the specific research aims described below and costs must be proportional to the proposed project. ****White papers, letters of intent, and full proposals must be submitted via to See Page 9 for a complete description of required proposal components. **** For questions concerning the submission process, contact Dr. Steven Ellsworth (POC) at or ellswort@vet.k-state.edu. 4. RESEARCH THEME AREAS CEEZAD supports research across four main themes. Below are brief summaries of the theme areas of significant interest to help guide proposal development of broad spectrum countermeasures, with particular interest for this RFP highlighted. In your submission, you will be asked to identify the theme and/or specific topic area that fits your proposed research and/or educational program. Theme 1 Vaccines: The goal of the Vaccines Theme is to develop vaccines against transboundary, zoonotic, and/or newly emerging threat agents of livestock and poultry. Candidate vaccines should focus on high impact diseases; diseases of specific interest include African swine fever, classical swine fever, heartwater disease, and diseases caused by Hendra and Nipah viruses in animals. Research should focus on yielding novel vaccine candidates and rapid update platforms for the prevention and control of these high impact diseases and have a potential for supporting the DIVA concept. Other research areas of interest include those that focus on the development of more effective vaccine approaches, enable cross-serotype protection (universal vaccines), or provide rapid onset of immunity. Research in this area could include the development of species-specific immunomodulators or similar technologies to enhance or accelerate immunity in the face of an outbreak. Theme II Detection: Projects in this thematic area will lead to the development of next generation diagnostic technologies to detect known and unknown threats, enable microbial forensics, and support Differentiating Infected from Vaccinated Animals (DIVA). Of particular interest are approaches that will yield unbiased diagnostic platforms and testing capabilities for field and/or NAHLN or reference laboratory use, with multiplexing being most desirable. Technologies will generally employ sensitive molecular and immunological detection assays for the identification, characterization, and comparison of foreign animal, emerging, and/or zoonotic pathogens. Diseases of particular interest are those listed under Theme I above and Ebola virus in livestock. Tests developed from this research should enhance end-users ability to screen, detect, prevent, control, and recover from transboundary, zoonotic, and/or emerging bio-threats. Also of interest are cross-cutting platforms or technology that yields a broader understanding of basic host-pathogen biology that can enable the development of new detection technologies/products which could enable new or cutting edge control strategies. Strategic sampling and bioinformatics analyses to derive the mechanics of transmission dynamics and potential virulence between and among species and the environment are also of high value. Ability to upload field data might be considered. Additional areas of interest include improved sample collection and recovery for biological samples to facilitate storage and transport without cold chain, and improved sample preservation and preparation to remove inhibitors or background material from appropriate matrices. 4

6 Theme III - Epidemiology/Modeling: We seek computer models and epidemiologic/economic analyses designed to inform or enhance transboundary animal disease policy development, planning or decisionmaking during disease outbreaks. This includes improved decision tools and risk assessment models with robust architecture and data. Specific areas of interest are risk analysis of intentional release or natural introduction of TAD/vector-borne disease in the US. Specific areas of interest also include support for training exercises, and development of information technology to enhance the ability of decision makers to capture and assimilate large volumes of data, or to analyze bioinformatics laboratory or field data for epidemiological or forensic purposes. Projects focused on the collection and analysis of data needed to inform or parameterize animal disease spread models and the development and implementation of techniques for the verification and validation of animal disease spread and economic models. Diseases of particular interest are listed under Theme I. Theme IV - Education and Outreach Overlay (EOO): Several areas of workforce development, training, and education programs in foreign animal, emerging, and/or zoonotic diseases are needed. This theme provides contemporary, science-based education and training curricula and innovative delivery mechanisms to a diverse spectrum of communities involved in foreign animal and zoonotic disease control. Areas of particular interest include: TAD courses/training for workers in BSL 3 and BSL 4 facilities (technicians, animal care personnel, Engineering/Facility Technical Support personnel) and IT programs that can be used in the National Bio- and AgroDefense (NBAF) facility (under construction in Manhattan, KS) for Supervisory Control and Data Acquisition (SCADA) functions. Novel and Cross-Cutting Research: CEEZAD will consider White Papers demonstrating novel and cross-cutting research that will significantly improve countermeasures and inform policy development against high impact TADs. Cross cutting proposals include those that integrate two or more CEEZAD research focus areas, outlined above. Novel research White Papers include new concepts and approaches in development of vaccines and diagnostics for high impact TAD; platforms that allow rapid changes to vaccine specificity; antivirals, improved methods of biosurveillance; advanced models for decision making; high impact educational programs designed to increase awareness of TADs and novel methods/programs to train the future NBAF workforce. Priority will be given to those projects with potential for high impact and in a transition-to-application phase; those that have the potential to leverage additional funding; those that offer matching funds; those that have collaborations with other CEEZAD research themes and/or Centers of Excellence; increase diversity; and those in which the PIs have demonstrated the capacity to identify and work with end-users, and deliver products within short project periods, and defined timeframes. Increased consideration will also be given to projects at advanced stages whose products have clear feasibility for technology transition to government and/or industry stakeholders. 5

7 CEEZAD Theme Points of Contact s sent to the Point of Contact shall indicate in the subject line: CEEZAD Open Call for Proposals Theme I III: Steven Ellsworth, DVM, MS, ellswort@vet.k-state.edu Igor Morozov, DVM, PhD, imorozov@vet.k-state.edu Theme IV: Jessica Green, DVM, PhD, jlgreen@vet.k-state.edu 5. RESEARCH COMPLIANCE All funded projects involving biosafety, recombinant DNA (rdna), animal care and use, biological select agents and toxins, and/or human subject research must meet institutional and funding agency compliance requirements. Compliance documents must be submitted with full proposals (template will be provided upon request for full proposal documentation). Regulatory compliance requirements are monitored by the DHS Regulatory Compliance Office (RCO) and are primarily based on existing compliance-related materials and oversight mechanisms. Copies of approval documents issued by Institutional Biosafety Committee (IBC), Institutional Animal Care and Utilization Committee (IACUC), or Institutional Review Board (IRB) must be submitted to CEEZAD prior to initiation of research. Applicants are strongly encouraged to submit their IBC, IACUC, or IRB applications as early as possible to avoid a potential delay in the start of research due to pending institutional compliance approval. In addition, all projects will be reviewed for compliance with newly established government guidelines for identifying potential dual use research of concern. 6. CEEZAD REQUIRED WHITE PAPER PROPOSAL COMPONENTS Principal investigators must first submit a white paper following approved format and guidelines for review. If CEEZAD agrees that the proposed project falls under CEEZAD s mission, an invitation for a full proposal will be requested. Proposals that do not adhere to instructions, are incomplete, or exceed writing limits will not be reviewed. The white paper form is located on the CEEZAD Center Open Call website and attached below. If a white paper is accepted, the offeror will be sent the necessary forms for the submission of a full proposal. Upon request for a full proposal, offerors should submit letters of collaboration or letters of support from federal partners for regulated items (e.g., select agents, assays, diagnostics, vaccines). Higher consideration will be given to proposals that can document collaboration and support. Required documentation for white papers: White Paper: White Paper Form (Attachment #1) 6

8 PI & Co-PI Biographical Sketch NIH Format (Attachment #2) 7