CENTERS FOR MEDICAL COUNTERMEASURES AGAINST RADIATION: REQUEST FOR
INFORMATION (RFI)
RELEASE DATE: April 9, 2004
NOTICE: NOT-AI-04-027
RESPONSE DUE DATE: June 1, 2004
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/default.htm)
The National Institute of Allergy and Infectious Diseases (NIAID) of the
National Institutes of Health (NIH) is planning to establish a network of
Centers for Medical Countermeasures Against Radiation (CMCR) using the
cooperative agreement (U19) mechanism. This program is part of a larger
national plan to develop effective medical products to prevent and treat
injury resulting from radiation after terrorist attack or accidental exposure
to radiological or nuclear materials. The proposed network would support
individual multi-project research centers conducting cross-disciplinary work
in a variety of areas relevant to radiobiology and radiation epidemiology. In
October 2004, the NIAID plans to issue a Request for Applications to
establish these centers, with a receipt date for applications in February
2005, and an anticipated award date in September 2005.
Growing terrorist threats have highlighted gaps in the research and
development of medical countermeasures for protection of the US civilian
population against radiation. Few products are currently available for
prevention of radiation injury, for treatment of post-exposure injury, or for
the rapid identification of exposed individuals requiring treatment. Through
this Request for Information (RFI), the NIAID would like to obtain
information that is relevant to establishing the CMCR program, and to
identify interested sources that are already developing products or research
in this area, or that could facilitate the CMCR program and aid in the
planning of this new initiative.
This RFI is for information and planning purposes only and should not be
construed as a solicitation or as an obligation on the part of the
Government. The Government does not intend to award a cooperative agreement
on the basis of responses to this RFI nor otherwise pay for the preparation
of any information submitted or for the Government’s use of such information.
Background
There is an immediate need to develop new products for the biological
measurement, prevention, and treatment of radiation injury caused by
different levels of exposure to varied subsets of the civilian population,
including healthy adults, pregnant women, young children, the elderly, and
the chronically ill. The intent of the proposed CMCR program is to support
multidisciplinary research groups or consortia at academic, commercial, or
government institutions, providing core resources and new infrastructure
where feasible, as well as support within each center for basic and
translational research projects, relevant drug screen assay development,
animal model development, and multidisciplinary training programs. The
network of centers will be managed by a central steering committee to
facilitate synergistic interactions and rapid progress towards new product
development. Research results will be available to the general research
community, as outlined in the current NIH policy on data sharing, to further
facilitate rapid progress.
Examples of research areas for the CMCR include:
1. automated biology-based diagnostic assays/dosimeters for ready
measurement of radiation injury;
2. radioprotectant and post-exposure therapeutic drugs or combinations of
drugs;
3. therapeutic antibiotic or probiotic regimens;
4. innate and adaptive immune enhancement/reconstitution protocols;
5. hematopoietic stem cell expansion and storage for immune reconstitution;
6. stem cell expansion for mitigation of late organ toxicity;
7. mechanisms of radiation injury and host response;
8. rapid drug-screening assays to identify radioprotectants and
radiotherapeutics;
9. small and large animal model development; and
10. long-term medical effects.
The NIAID is planning to use a cooperative agreement (U19) mechanism to
establish 3-5 centers in FY 2005 and 2-3 centers in FY 2007. Modest planning
grants (P20) will also be available in FY 2005 for groups needing support to
coordinate research programs that will be competitive for FY 2007 U19 awards.
Information Requested
Information in the following areas will aid the NIAID in the design of the
announcement for CMCR centers and planning grants. We ask interested
organizations to identify critical criteria that should be included in the
announcement, and to describe their interests as well as their current and
potential capabilities to meet these criteria. Information need not be
limited to these areas. Single institutions or consortia may be considered.
Academic, government, and commercial groups are encouraged to respond.
Please restrict your response to 10 pages or less. Longer responses might not
be evaluated.
1. Research areas
a. Describe your interest and scientific capability to conduct basic and/or
translational research in any of the areas listed above, or in additional
areas relevant to radiobiology/radiation epidemiology. Prior work and current
technical capabilities of personnel may be described.
b. Describe your interest and scientific capability to develop or improve
animal models for radiobiology research or to test candidate compounds for
IND development and FDA approvals.
c. Describe the criteria by which you would judge the usefulness of a
research project, product candidate, drug-screening assay, or new animal
model.
d. Describe how a center should prioritize and coordinate its research
program; and how a steering committee should operate to facilitate synergy
and rapid progress.
2. Equipment/Techniques
a. Describe your current facilities and equipment, and discuss the range of
reagents, assays, animal models, techniques, and technologies available.
b. Describe the core facilities you would need to establish or expand to
conduct a comprehensive center program.
3. Multidisciplinary Training
Describe your capacity for a cross-disciplinary training program in
radiobiology/radiation epidemiology. Include information on laboratory
training and formal coursework, as well as appropriate teaching staff,
potential applicants at the pre- and post-doctoral levels, and future
potential to expand the program.
4. Infrastructure
Describe additional research resources you would need, including physical
facilities, animal isolation units, large equipment, administrative support,
and other infrastructure requirements.
Responses
Responses should be identified with this Notice identifier (NOT-AI-04-027),
and are due by June 1, 2004. Please submit three (3) copies of your written
response to:
Helen Quill, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3013, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601 (use 20817 for express mail)
Telephone: 301-496-7551
FAX: 301-480-2381
E-mail: [email protected]
E-mail responses will also be accepted.
Acknowledgement of receipt of responses will not be made, nor will
respondents be notified of the Government’s assessment of the information
received. However, should such an announcement materialize, no basis for
claims against the Government shall arise as a result of a response to this
request for information or the Government’s use of such information as either
part of our evaluation process or in developing specifications for any
subsequent announcement. Responses will be held in a confidential manner. Any
proprietary information should be so marked.
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