and Human Services (HHS)
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: [email protected]
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: [email protected]
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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