STUDIES TO EVALUATE THE HEALTH EFFECTS OF CHEMICALS IN DEVELOPING ANIMALS FOR THE NATIONAL TOXICOLOGY PROGRAM Release Date: June 12, 2001 NOTICE: NOT-ES-01-007 RFP NIH-ES-01-10 National Institute of Environmental Health Sciences The NIEHS is soliciting offers for a contract to conduct studies which will assist the National Toxicology Program (NTP) in evaluating the effects of exposure to chemicals during critical phases of development which may result in long term alterations in reproductive, neurological, and/or immunological endpoints. As a general approach, the treatment period could be as broad as to include exposure of pregnant dams (rats or mice) followed by direct exposure to the offspring for as long as puberty (PND42), at which point dosing may cease in some studies and in other cases the dosing may be longer. Animals destined for autoimmunity endpoints may be housed for a specified time period up to one year. Measures for reproductive toxicity, immunotoxicity and neurotoxicity may be collected from the same animals or may require different animal groups. A chemical- specific protocol outline will be provided by the Government for each chemical studied under this contract. The types of chemicals to be studied may include but shall not be limited to industrial solvents, plasticizers, food preservatives and colorants, drugs, pesticides, and heavy metals. In general, studies shall involve daily (gavage) or continuous (dosed feed or water) dosing periods or in rare cases subcutaneous/intraperitoneal injection of rats or mice. Treatment regimens, species used, endpoints to be measured etc. shall vary depending on specific chemicals to be tested and study goals. Offerors should be aware that the actual mix of studies would vary each year according to the types of chemicals selected for study. It is anticipated that approximately the followings mix of studies shall be conducted each year. Two range finding perinatal toxicity studies one by the gavage route and another by either dosed feed, or dosed water in rats or mice. Two definitive perinatal toxicity studies by gavage, dosed feed or drinking water to evaluate neurologic and reproductive function in rats or mice. Two definitive perinatal toxicity studies by gavage, dosed feed or drinking water to evaluate neurobehavioral and immunologic function in rats or mice. The Government may, depending on need and availability of funds, exercise one option in each year of the contract for the conduct of one additional range finding study and up to two definitive studies (one Definitive Perinatal Toxicity study for Neurologic and Reproductive Function, and one Definitive Perinatal Toxicity study for Neurobehavioral and Immunologic function.) similar to the ones in the base contract. The contractor shall conduct studies in accordance with the general requirements and recommendations for lab animal management contained in "Specifications for the conduct of studies to evaluate the toxic and carcinogenic potential of chemical, biological and physical agents in laboratory animals for the National Toxicology Program" dated September 2000. The Offeror shall have a working laboratory in place by the date of proposal submission. The Principal Investigator, Toxicologist, Chemist, Veterinarian, Health and Safety Officer and Quality Assurance Unit Officer shall be employees of the contract laboratory (i.e., not consultants or subcontractors). The daily interaction and constant coordination of efforts needed amongst these discipline areas throughout the in-life portion of the studies makes it critical that they be physically and organizationally together. Award of one cost-reimbursement, level of effort type contract on February 28, 2002 on an open competition basis is contemplated as a result of this solicitation. The estimated level of effort is 173,500 hours for the base contract and 86,750 labor hours for all options. The estimated period of performance is five years for the base contract (and if all options are exercised). Interested organizations should telefax a request for RFP NIH-ES-01-10 to the attention of Ms. Melissa Pittman, Procurement Technician at (919) 541-2712 or send an e-mail request to pittman@niehs.nih.gov. The electronic version of the CBD synopsis is 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 June 22, 2001. All responsible sources may submit a proposal which shall be considered by the Agency. Expected release date of the RFP is June 22, 2001 with proposals due August 7, 2001. This requirement is unrestricted. The NAICS is 541710.
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