ANNOUNCEMENT: BIODEFENSE COUNTERMEASURE DEVELOPMENT: PROJECT BIOSHIELD RELEASE DATE: July 23, 2004 NOTICE: NOT-AI-04-044 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) RECEIPT DATE: September 23, 2004 DESCRIPTION The Project BioShield Act of 2004, enacted on July 21, 2004, authorizes the Secretary, Department of Health and Human Services (DHHS), through the program carried out by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), to expedite peer review of grants, contracts, and cooperative agreements to perform, administer, or support research and development of countermeasures determined by the Secretary to be a priority to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security, or adverse health consequences that may arise from using such a countermeasure. Consistent with this new authority, the NIAID is announcing two new grant initiatives, THERAPEUTICS FOR CDC CATEGORY A AGENTS: BIOSHIELD ACCELERATED PRODUCT DEVELOPMENT PROTECTING THE IMMUNE SYSTEM AGAINST RADIATION: BIOSHIELD ACCELERATED PRODUCT DEVELOPMENT This notice provides information regarding the overall objectives and key features of these new NIAID initiatives. More detailed information and instructions on project eligibility, application requirements, and application submission and award procedures is provided at http://www.niaid.nih.gov/biodefense/bioshield.htm. THERAPEUTICS FOR CDC CATEGORY A AGENTS: BIOSHIELD ACCELERATED PRODUCT DEVELOPMENT In FY 2005, the NIAID intends to commit up to $10 million to support research projects focused on the design and/or preclinical development of therapeutics for CDC Category A agents (http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm). Support will be provided for discrete steps in the process of identifying new therapeutic modalities directed against CDC Category A agents, with potentially broad spectrum activity. Types of projects to be supported under this initiative include, but are not limited to, target validation, assay development, high throughput screening, lead series selection, lead optimization, preclinical evaluation in relevant animal models, toxicology evaluation, as well as other relevant Investigational New Drug (IND) enabling studies. Target identification is supported under other NIH mechanisms and will NOT be supported under this initiative. In addition, clinical trials will not be supported under this initiative. Up to $1.5 million in total costs per award will be provided for a project period of up to eighteen (18) months. Potential applicants MUST obtain NIAID approval to submit an application by contacting the NIAID staff person listed below. Written permission will be provided by NIAID and must be included with the application. Dr. Michael Kurilla Division of Microbiology and Infectious Diseases National Institute for Allergy and Infectious Diseases 6610 Rockledge Drive, Room 5030 Bethesda, MD 20892-6601 Tel: 301-451-3744 Fax: 301-496-8050 Email: mkurilla@niaid.nih.gov Detailed information and instructions on project eligibility, application requirements, and application submission and award procedures is provided at http://www.niaid.nih.gov/biodefense/bioshield.htm. PROTECTING THE IMMUNE SYSTEM AGAINST RADIATION: BIOSHIELD ACCELERATED PRODUCT DEVELOPMENT In FY 2005, NIAID intends to commit up to $4 million to support research projects focused on practical methods for pre-exposure protection of the immune system against damage by radiological or nuclear terrorist attacks, and/or practical methods to replace hematopoietic stem cells, their progeny, or mature cells of the immune system following exposure to immunosuppressive radiation. Applicants must have already obtained supportive data for a promising compound or approach to achieve the objective, and must be prepared to conduct mechanistic studies and/or validation studies in animal models of radiation damage that are on the pathway to U.S. Food and Drug Administration (FDA) approval. Discovery research will NOT be supported under this initiative. Up to $1.5 million in total costs per award will be provided for a project period of up to eighteen (18) months. Potential applicants MUST obtain NIAID approval to submit an application by contacting the NIAID staff person listed below. Written permission will be provided by NIAID and must be included with the application. Dr. Helen Quill Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6610 Rockledge Drive, Room 3013 Bethesda, MD 20892-6601 Tel: 301-496-7551 Fax: 301-480-2381 Email: hquill@niaid.nih.gov Detailed information and instructions on project eligibility, application requirements, and application submission and award procedures is provided at http://www.niaid.nih.gov/biodefense/bioshield.htm. APPLICATION SUBMISSION, REVIEW, AND AWARD A letter application of no more than ten (10) pages must be submitted by September 23, 2004. The letter application MUST be sent directly to NIAID at the address provided in the special instructions. Do NOT send the application to the Center for Scientific Review. The letter must identify the countermeasure to be investigated, the supporting preliminary data, the approach to product development, the management and staffing plan for the development effort, and the direct and total costs (with a ceiling of $1.5 million total costs per project) for the project period. An expedited review process will provide for peer review of applications approximately two (2) months after receipt. Awards will be expedited to the fullest extent possible. Award dates will be determined, in part, by the submission of additional documentation and assurances by the successful applicants to meet funding, policy and regulatory requirements.
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