Notice Number: NOT-AI-07-033
Release Date: May 24, 2007
Submission of Information Date: June 29, 2007
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/)
The Department of Health and Human Services (HHS) is charged with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures for Weapons of Mass Destruction. This key role was identified in the 1National Strategy to Combat Weapons of Mass Destruction,
2Biodefense for the 21st Century and 3National Strategy for Medical Countermeasures against Weapons of Mass Destruction, which together are the President’s blueprint for addressing the Nation’s Chemical, Biological, Radiological, and Nuclear (CBRN) defense programs.
To address this mission, HHS has undertaken a two-stageapproach to planning to efficiently integrate the requirements for, and the advanced development and procurement of, medical countermeasures for all CBRN threat agents. This included publication of the HHS Public Health Emergency Medical Countermeasures Enterprise Strategy for Chemical, Biological, Radiological and Nuclear Threats (HHS PHEMCE Strategy) in the Federal Register on March 20, 2007. Developed In collaboration with public and private stakeholders, the HHS PHEMCE Strategy establishes the goals and objectives that HHS will use to ensure that medical countermeasures are available for effective use against the highest priority CBRN threats facing the nation. The second stage in this process was the development of the HHS PHEMCE Implementation Plan, published in the Federal Register on April 23, 2007. This document details HHS priorities for research, development and acquisition of medical countermeasure against CBRN threats.Countermeasures against radiological and nuclear threats and particularly countermeasures to treat or mitigate the acute radiation syndrome were identified as being among the top priorities.
On October 14, 2004, the NIH convened an expert panel to review the “4NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiation and Nuclear Threats”. This strategic plan and research agenda outline a flexible, collaborative, and comprehensive NIH research and product development program focused on medical therapies and diagnostics to counter radiological and nuclear threats. On behalf of the NIH, the National Institute of Allergy and Infectious Diseases (NIAID) is charged with implementing this research agenda and with developing medical countermeasures against radiation injury.
Among the most important medical countermeasures against acute radiation syndrome are those that will treat or mitigate its hematopoietic component. Certain radiation exposures can cause severe damage to the bone marrow, which can have dramatic effects on circulating blood cells, including erythrocytes, neutrophils, lymphocytes, and platelets. Platelets play an essential role in hemostasis and thrombosis. As the level of circulating platelets drops below 20,000/mm3 (a condition referred to as “severe thrombocytopenia”), the risk to an affected individual for catastrophic hemorrhage increases markedly. Severe thrombocytopenia is clearly a contributor to mortality following radiation exposure. Currently, there is no approved therapeutic drug for this radiation-induced complication in the Strategic National Stockpile.
This is a Request for Information (RFI) only. It is not a request for proposals and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned.
Acute Radiation Syndrome (ARS), also referred to as radiation sickness, is an acute illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a relatively short time period. Such exposure can result in the depletion of hematopoietic stem cells and progenitors, leading to severe neutropenia and thrombocytopenia. Severe neutropenia increases the risk of sepsis and death due to opportunistic infections, while thrombocytopenia increases the risk of hemorrhage and death due to bleeding. Both conditions are likely to be major contributors to mortality in untreated individuals exposed to doses of radiation that affect the hematopoietic system.
Currently there is no approved post-exposure drug for radiation-induced thrombocytopenia. The only therapies currently available to patients are platelet concentrates or fresh whole blood transfusions. In small accidents, supportive transfusion has become the standard of care. The logistical requirements for providing these transfusions to large numbers of victims after a mass casualty event, however, would be challenging, and emergency preparedness experts believe that an effective pharmacologic therapy that prevented or mitigated radiation-induced thrombocytopenia would offer dramatic advantages. Therefore, the NIH has an interest in identifying sources of therapeutics likely to be effective in preventing or reducing the development of thrombocytopenia, when administered after acute exposure to radiation. Radiation doses proposed for study should be those that would be sufficient to induce the hematopoietic syndrome.
To support NIAID’s development of medical countermeasures against radiation injury, identifying therapeutics that are effective when given ≥12-24 hours after radiation exposure are of particular interest.
The NIAID is looking for compounds or techniques that demonstrate the following advantages:
Data obtained from this RFI will be used by the NIH in making recommendations and decisions regarding research and development of radiation countermeasures to meet the nation's biodefense needs.
Interested organizations that have current and potential capabilities in the following areas are invited to submit a capability statement to the NIAID.
Areas of research and development that are of interest include, but are not limited to, the following:
Studies in animal models should be detailed to demonstrate efficacy of the proposed products to minimize damage and restore normal function. Clinical studies using human tissue samples or data from irradiated patients may be provided if the results are likely to be relevant to the treatment of humans exposed to terrorist, accidental radiological, or nuclear attack.
Please also submit information on:
This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to make any award on the basis of responses nor otherwise pay for the preparation of any information submitted or for the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement 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 requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked.
Information must be submitted by June 29, 2007. Responses should be limited to 10 pages and marked with this RFI identifier NOT-AI-07-033. Responses are preferred in electronic format and can be e-mailed to the attention of the technical contact person:
Dr. Andrea DiCarlo-Cohen
Biologist, DAIT, NIAID, NIH, DHHS
6610 Rockledge Drive, Room 4056-A
Bethesda, MD 20892-7612
Phone (301) 451-9191
Please ensure that at least two copies of all responses are submitted: one to the technical contact person, Dr. Andrea DiCarlo-Cohen, and one to the primary grants management point of contact:
Gregory P. Smith
Grants Management Program, DEA, NIAID, NIH, DHHS
6700B Rockledge Drive, Room 2109
Bethesda, MD 20892-7612 (Express mail: Use Zip Code 20817-7612)
Phone: (301) 402-5540
Fax: (301) 493-0597
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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