NOT-NS-05-012: RFI: Preclinical Development Facility for Medical Countermeasures Against Chemical Threats

Department of Health
and Human Services (HHS)

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RFI: Preclinical Development Facility for Medical Countermeasures Against Chemical Threats

Notice Number: NOT-NS-05-012

Key Dates
Release Date: September 2, 2005

Issued by
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)

The National Institute of Neurological Disorders and Stroke (NINDS) is considering issuing a contract for preclinical studies of new or improved pharmaceutical preparations to be used as medical countermeasures against chemical agents that could be used in a terrorist attack. As a first step, the Institute is attempting to identify expert sources to conduct safety, pharmacokinetic/biodistribution, and developmental chemistry studies with candidate drugs.

Background

The increased risk of a terrorist attack in the U.S. involving chemical agents has created new challenges for many departments and agencies across the federal government. Within the Department of Health and Human Services (DHHS), the NIH is leading the development of new and improved therapeutics designed to treat the conditions caused by potential chemical agents of terrorism. The NIH Chemical Threats program is part of the larger biodefense program coordinated by the NIAID that includes Biological and Radiation/Nuclear threats.

Our intent is to fund a preclinical testing facility that will conduct safety, pharmacokinetic/biodistribution, and developmental chemistry studies with candidate drugs. The preclinical testing facility will not conduct any efficacy studies with drugs, or any studies with the chemical agents themselves. Candidate drugs that will be tested in this facility will have been previously shown to be efficacious by studies conducted within other NINDS programs that utilize models for, or actual, chemical agents. Candidate drugs will be supplied to the contractor by the NINDS.

Requirements

This facility would provide several functions:

conduct cGLP absorption, distribution, metabolism, and excretion, including PK/PD studies, in a range of animal species for candidate drugs;
conduct cGLP toxicology safety studies for candidate drugs;
conduct cGMP optimization and control studies including synthesis, composition, formulation and packaging, and stability;
prepare study reports and recommendations for countermeasure modification if necessary.

Types of potential facilities

ADME Tox (numbers 1, 2, and 3 above)
Developmental Chemistry (number 4 only)
Facility capable of both A) and B)

Information Requested

Information in the following areas will aid in the design of solicitations for a preclinical test facility. The information supplied in any response to this request should address, but not be limited to, the following (Three Page Limit):

One paragraph introductory description of general background and research interest related to this program.
Summary of capabilities and resources related to items 1-5 listed above.
Quality of the scientific and infrastructure capabilities in support of this program, including GLP and cGMP.
Whether you are a Type A, B, or C facility as described above.
Other comments and suggestion on the general program outline given above.

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 award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or 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.

All respondents are asked to indicate the type and size of your business or organization, e.g., Large Business, Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other non-profit organization.

Responses should be identified with RFI No. NOT-NS-05-012, and are due by September 19, 2005. Please submit three (3) copies of your response, to Helene Braun, Contract Specialist, Contracts Management Branch, National Institute of Neurological Disorders and Stroke, NIH, 6001 Executive Boulevard, Room 3287, Bethesda, MD 20892-9531 (For Fedex or courier, use: Rockville, MD 20852). Email responses will also be accepted at hb106s@nih.gov.

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