RFP Announcement: Potential for Environmental and Therapeutic Agents to Induce Immunotoxicity, RFP-NIH-ES-05-01

Notice Number: NOT-ES-05-001

Key Dates
Release Date: September 27, 2004

Issued by
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)

The purpose of this notice is to announce a request for proposal (RFP NIH-ES-05-01). The NIEHS, National Institutes of Health (NIH), is soliciting offers for a contract to conduct studies of the potential for environmental and therapeutic agents to induce immunotoxicity in laboratory animals. The contractor shall provide all the necessary services, qualified personnel, materials, equipment, and facilities as needed to examine the immune system in laboratory animals following exposure to xenobiotics. The contractor shall evaluate the Potential to Induce Immunotoxicity through studies on Immunomodulation, Hypersensitivity and Autoimmunity. The contractor shall evaluate xenobiotics for their ability to modulate immune function following adult or perinatal exposures. The contractor shall perform Immunopathology studies and measure standard toxicity parameters including body weight, selected organ weights and hematological profile. Extended histopathology of the lymphoid tissues should be performed for all test articles. The contractor shall assess Humoral and Cell Mediated Immunity, quantitate splenic cellularity, splenic differentials, and B cell, T cell, T cell subsets, NK cells and monocyte enumeration by cytometric analysis, and evaluate Non-specific Immunity The contractor shall assess the ability of identified immunomodulators to alter disease resistance following challenge with at least two established host resistance models. The contractor shall examine the allergenic and immunogenic potential of test articles of interest in BALB-C mice and matching controls using the mouse ear swelling test and the LLNA. The contractor should have the ability to utilize rodent models for autoimmune disease (e.g. NZB mice for human SLE, NOD mouse for insulin-dependent diabetes or Brown-Norway rat for mercury-induced glomerulonephritis) and monitor for the development or exacerbation of autoimmune disease using appropriate pathological and biochemical tests. Immunology is a developing science and, as such, it is expected that new and improved methodology will be required to maintain "state of the art" evaluation. In addition, the validation of methods to determine the potential for xenobiotics to induce or potentiate autoimmune disease should be given a high priority. Alternatively, follow-up studies to help establish cellular and/or molecular mechanisms of action for immune perturbations observed during immune function testing may be appropriate. Novel screening strategies including the use of molecular techniques would be desirable. The Offeror shall have a working testing laboratory and animal facility in place that has the analytical equipment, clinical laboratory equipment, necropsy, and histology facilities necessary to conduct GLP immunotoxicology studies of environmental agents, and staff with appropriate expertise to expose, care for, and process large numbers of animals. Award of one three (3) year, with five (5) additional one year options, performance based, cost-reimbursement, term form, level of effort contract on July 1, 2005 is planned. The estimated level of effort is 42,432 direct labor hours for the three year base period and 70,720 direct labor hours for the additional five option years. The contract will contain two additional options; one for evaluation of additional xenobiotics and a second for evaluation of new and improved technology. These two options, which may be executed once in each of years 2 through 8 of the contract, will offer an additional 19,992 direct labor hours for the evaluation of xenobiotics (2856 hours each time it is exercised) and an additional 4,284 direct labor hours for the evaluation of new technology (612 hours each time it is exercised). Expected release date of the RFP is approximately October 8, 2004 with proposals due November 8, 2004. Interested organizations should fax a request for RFP NIH-ES-05-01 to the attention of Mr. David Sedgley, Contract Specialist at (919) 541-2712 or send an e-mail request to sedgley@nih.gov. All responsible sources may submit a proposal, which shall be considered by the Agency. The electronic version of the FedBizOpps notice will be available on the Internet at: http://www.niehs.nih.gov/dert/rcb/rfp.htm. An electronic copy of the RFP will be posted to this site on or about October 8, 2004. This requirement is unrestricted. NAICS Code is 541710.

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