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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