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
[email protected]. 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.
