NON-Clinical ADME Studies

The National Institute on Drug Abuse (NIDA) plans to solicit proposals to perform nonclinical absorption, distribution, metabolism and elimination (ADME) studies to support its medications development program. The nonclinical ADME studies for this requirement typically include bioavailability and pharmacokinetic studies, mass balance studies, tissue distribution studies, in vivo evaluation of permeability, in vitro and vivo metabolism studies, and toxicokinetics analysis of new potential medications. In addition, this requirement also involves analytical services which includes structure identification of major metabolites by mass spectrometry or nuclear magnetic resonance (NMR), and the development of sensitive and specific assays for a potential medication and its metabolites in biological matrices using methods such as high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), liquid chromatography with tandem mass spectrometry (LC/MS/MS), gas chromatograph-mass spectrometry (GC-MS). To handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Research Registration for Chemical Analysis or Research Registration for Schedules II to V. Also, offerors must demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. All offerors must be in compliance with the NIH guidelines on the care and use of laboratory animals and, the laboratory must be operated according to the FDA's Good Laboratory Practices Program. NIDA anticipates the award of one cost reimbursement contract for a period of 3-years with 2 twelve-month option periods. The contract will include additional quantity options as well. RFP No. N01DA-9-8883 will be available electronically on or about September 2, 2008. You can access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov) or through the NIDA website (URL: http://www.nida.nih.gov/RFP/RFPList.html). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Response to the RFP will be due on or about November 3, 2008. NIDA will consider proposals submitted by any responsible offeror. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. This advertisement does not commit the Government to award a contract.