NIH Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) (U54)

WHAT:        Limited Submission Proposal for the NIH Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) (U54) 

WHO:          Texas A&M University faculty, including TAES, TEES and TTI personnel. 

WHY:          Applicants may request budgets with direct costs of up to $10 million dollars per year for a maximum period of five years. 

WHEN:        Internal proposal deadline of April 14, 2008. 

HOW:          Faculty should submit internal proposal via email for review by the internal selection committee.    

THE FINE PRINT: 

The funding agency, NIH, has limited the number of proposals to one per institution. 

BRIEF PROGRAM DESCRIPTION:  The NIH Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (REC) (U54) Program is designed to establish and maintain strong infrastructure and multifaceted research and development activities to provide scientific information and translational research capacity that will facilitate the next generation of therapeutics, diagnostics and vaccines against the NIAID Category A-C Priority Pathogens and emerging infectious disease (EID) agents.   

The Centers will be provided with support to:  develop and conduct programs of investigator-directed research; train researchers and other personnel for biodefense and emerging infectious diseases research activities; develop and maintain core facilities that support the research and training activities of the RCE and make available these core facilities to qualified investigators from academia, biotechnology companies, the pharmaceutical industry and other appropriate entities in the geographic area; develop translational research capacity for testing and validating vaccine, diagnostic and therapeutic concepts for biodefense and emerging infectious diseases; and be prepared and available to provide facilities and scientific support to first-line responders in the event of a national biodefense or EID emergency. 

NIH invites research institutions and groups of investigators to form consortia to develop and submit new or renewal applications for program that address fundamental research and development questions that are expected to yield the information required to counter the threat of bioterrorism and EID.  Applications may focus solely on biodefense or may include a mix of biodefense and EID.  Further, consortia must document:  institutional commitment, organizational capabilities, ability to develop and/or maintain core facilities, plans for training investigators and other participants in the national biodefense and EID effort, and interdisciplinary coordination and collaboration, particularly linkages to federal, state and local agencies, as well as the academic and private sectors.   

Examples of relevant research areas include:  basic biology of less well studied NIAID Category A-C A Priority Pathogens and EID agents; mechanisms of pathogenesis, with emphasis on the less well studied agents; basic aspects of the innate and adaptive immune responses; rapid, sensitive and specific approaches for detection and identification for use in a clinical setting; target identification for diagnostics, therapeutics and vaccines, including assay development; development of new animal models for pathogenesis studies, for therapeutics and vaccine evaluation, and for rapid diagnostic studies; preclinical studies to facilitate translation of research findings into clinical interventions; and testing through small phase 1 clinical trials of potential therapeutics, diagnostics and vaccines.  With regard to project development projects that address the following strategies are of particular interest:  broad spectrum activity, broad spectrum technology and broad spectrum platforms.   

Another requirement is that each application must propose a research program that includes at least five research projects, which together will enable the RCE to contribute significantly to the NIAID biodefense and emerging infectious diseases mission.  Also, a necessary component of the Center’s success will be availability of adequate access to BSL3/4 biocontainment facilities.  Two additional requirements include the identification and support of developmental research projects (pilot projects) that take advantage of emergent technology and new research opportunities, and the submission of a developmental research plan that describes procedures for:  soliciting applications for developmental research projects from the region, selecting the most promising projects for funding and monitoring the success/productivity of the projects.  At least two distinct types of career development activities (individual career development support program and group career development activities) must be a part of the application. 

Applicants may request budgets with direct costs of up to $10 million dollars per years for a maximum period of five years.  RCE resources may not be used to develop clinical research infrastructure or conduct Phase 2, 3 or 4 clinical trials.  In addition, projects such as human disease surveillance, public health, animal health, health care delivery and environmental surveillance, will not be supported. 

More information can be found here.       

Internal Selection Procedures and Deadlines

April 11, 2008:  Deadline for an email of intent, including the names of the PI and co-PIs, title of internal proposal and a 1-3 sentence description of the project.  Send email of intent.

April 14, 2008: Deadline to obtain signatures of approval from your department head and college dean to submit an internal proposal to the Office of Sponsored Projects for review by the internal selection committee.  The internal proposal should include:

(1)     An executive summary, up to three pages, based on the proposal description as outlined in the NIH program announcement;

(2)     Summary budget;

(3)     Project and Management Plans (including team members);

The form for completing the internal proposal is here.

This completed form should be submitted electronically for review by the internal selection committee.

Please read the RFP carefully for specific requirements of the program here.       

Selection of a proposal will be based on NIH guidelines.  The needs of the university’s reinvestment plan will also be taken into account. 

During the selection process, the internal selection committee may contact departments and colleges for their opinions and commitments.  They may also request additional information from PIs.

April 25, 2008: The Internal Selection Committee will notify PIs of the result of the internal competition.

May 3, 2008:  Deadline for optional, but recommended, letter of intent.

June 3, 2008:  Deadline for full proposal.