Notice Number: NOT-NS-05-004

Key Dates
Release Date: Januray 26, 2005
Receipt Date: March 15, 2005 and July 15, 2005
Earliest Award Date: May 16, 2005 and September 15, 2005

Purpose

Program Description

The National Institutes of Health announces the availability of one-year administrative supplements for research aimed at developing medical countermeasures to a chemical terrorist attack. Given the NIH's role as the steward of medical and behavioral research for the Nation and the interest of the Department of Health and Human Services in counterterrorism-related research, the NIH is committed to improving our understanding of, and treatments for, the harmful effects of chemical threat agents. The short-term supplemental funds provided under this initiative are intended to support pilot research related to the parent grant that will lead to the development of independent research proposals. These s upplements are one-time awards and will not extend to subsequent budget periods.

Principal Investigators with Research Project (R01), Javits Award (R37), Exploratory/Development (R21), Phase II SBIR (R44), Phase II STTR (R42), Program Project (P01), Specialized Center (P50 or U54), and Cooperative Agreement (U01) grants funded by the NINDS or NIEHS are eligible to apply. Principal Investigators with g rants that are in the last year of the project period at the time of submission should contact the Programmatic Contact listed below. Grants that are in a no-cost extension will not be considered for support under this supplement program.

Applications must describe the relationship between the effects of the chemical agent and the mission of the participating NIH Institute. Proposed studies must demonstrate how they will advance efforts to develop medical countermeasures to chemical agents that are probable candidates for use in a terrorist attack. Evidence should be presented that the results of the supplemental assistance will enhance the pursuit of the Specific Aims of the original research project, without constituting an expansion of scope. Applicants are strongly encouraged to contact the Program Official listed below at the NIH Institute to which the parent grant is assigned for a description of more specific research interests.

Research may include, but is not limited to, basic and pre-clinical studies on chemical threat agents such as organophosphate nerve agents (e.g. sarin, VX), metabolic poisons (e.g. cyanide), choking agents (e.g. phosgene, chlorine), blistering agents (e.g. sulfur mustard), incapacitating agents (e.g. BZ), other toxic industrial chemicals (e.g. pesticides, metals, solvents), and plant/animal toxins (e.g. ricin, botulinum, brevetoxin). Since special biosafety certifications may be required to conduct research on some of these chemical agents, applicants may choose to collaborate with laboratories that are certified to work with restricted chemical agents. One such laboratory is the U.S. Army Medical Research Institute of Chemical Defense, Collaborative Research Program and Facility, Edgewood, MD (Contact Dr. David A. Jett at the address below for further information).

Appropriate projects include, but are not limited to, studies to characterize the mechanisms of chemical effects; development of compounds that could be used for pre- or post-exposure treatment; characterization of the pathophysiology and natural progression of chemical agent-induced damage to tissues; and examination of delayed effects or long-term effects of low-dose exposure to individual chemical agents or combinations of agents. A link between the agent and the harmful effects on human health must already have been established.

The NINDS currently supports a broad range of basic research related to counterterrorism, such as studies on peripheral and central cholinergic pathways, status epilepticus (persistent seizures), neuropathology, neurodegeneration, neuroprotection, and neuroimaging. This Notice represents a renewal of the NINDS Counterterrorism Supplement program established in Fiscal Year 2003. The NINDS encourages the submission of applications for supplemental funds for research directly related to the prevention, detection, diagnosis, and treatment of neurological dysfunction caused by chemical agent exposure and studies of the mechanisms by which these agents disrupt normal neurological function. Additional information on chemical agents, toxins, and infectious agents that affect the nervous system is available at http://www.ninds.nih.gov/funding/research/counterterrorism/index.htm

The NIEHS is interested in receiving applications related to detection and measurement of the released agent in the environment (real- or near-time exposure assessment); development of biomarkers of exposure that can be used in assessment of injury and disease progression; pharmacokinetic measurement; understanding the genetic basis of the difference in susceptibility to these chemical agents to enhance our understanding of the extent and severity of potential response across the human population; modifying pathways involved in detoxification and clearance in humans or animal models so as to reduce harmful effects of chemical agents; and short-term and long-term metrics to monitor effectiveness of therapy.

How to Apply

Applicants should submit an original and five copies of a complete application, signed by an authorized business official at their institution, to the contact person from the NIH funding component listed at the end of this Notice. DO NOT SEND ADMINISTRATIVE SUPPLEMENTS TO THE CENTER FOR SCIENTIFIC REVIEW. The following sections should be included:

1. A cover page (i.e. page 1 of PHS Form 398) citing this NOTICE and requesting an administrative supplement, including the PI name, grant number and title, amount requested, name and title of the institutional official, and phone, email, and address information for both the PI and institutional official. Documentation of approval from the Institutional Animal Care and Use Committee (IACUC) for any proposed animal studies must be provided.

2. A description of the project (5 page limit), including Abstract; Background & Significance (i.e. rationale for the choice of agent, experimental model, study conditions, outcome measures, and relevance of the proposed study to counterterrorism); Research Design & Methods (description of the agent selected, model in which the agent will be studied, conditions of experimental exposure, protective treatment, and outcome measures).

3. Description of the source, storage, use, and disposal of the agent, and inclusion of any necessary approvals or biosafety certifications.

4. Specific Aims of the original grant.

5. Description of the relationship of the project to the Specific Aims of the parent grant.

6. A modular budget with appropriate justifications for requested direct costs (see Budget Information below).

Applications that do not include the sections listed above will not be reviewed.

Review Criteria

Applications will be reviewed administratively, and it is expected that for successful applications a resulting supplemental Notice of Grant Award will be issued within two months of the receipt deadline. All funding decisions are final and are not subject to appeal. Review criteria will include the relevance of the proposed research to improving our understanding of, and treatments for, the harmful effects of chemical threat agents.

Budget Information

Supplements will be awarded as direct costs in modular amounts of $25,000 and are one-time awards. Facilities and Administrative will be awarded based upon the Direct Cost amount approved for award. For R01s, R21s, R37s, R42s, R44s, and U01s, the maximum request for direct costs is $50,000. For P01s, P50s, and U54s, the maximum is $100,000 (a maximum of $50,000 per subproject). Although the awarded budgets will be modular, applicants should provide a budget justification that details the budget items requested, including facilities and administrative costs. If the planned experiments will not be fully supported by the supplemental funds from the NIH , the sources and amounts of additional funds should be specified.

In Fiscal year 2005, NINDS and NIEHS will commit a total of $800,000 combined towards this program. Awards pursuant to this Notice are contingent upon the availability of funds and the receipt of applications of high scientific merit.

Inquiries

Direct inquiries regarding the program to:

National Institute of Neurological Disorders and Stroke
Dr. David A. Jett
NINDS
6001 Executive Blvd. NSC Room 2152
Bethesda, MD 20892 (USPS)
Rockville, MD 20852 (FedEx and other couriers)
Tel: (301) 496-3102
Fax: (301) 594-5929
Email: jettd@ninds.nih.gov

National Institute of Environmental Health Sciences
Dr. Dennis R. Lang
NIEHS
79 Alexander Drive
Room 3431, MD EC-20
Research Triangle Park, NC 27709
Tel: 919-541-7729
Fax: 919-541-2843
Email: lang4@niehs.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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