NONCLINICAL ADME STUDIES RELEASE DATE: August 28, 2003 NOTICE: NOT-DA-03-027 National Institute on Drug Abuse (NIDA) RFP Number: N01DA-4-8842 PROPOSAL RECEIPT DATE: October 13, 2003 The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified businesses 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 evaluation, mass balance studies, tissue distribution studies, in vitro and in vivo metabolism studies and toxicokinetics of new medications. It may also include in vitro evaluation of permeability and protein binding. In addition, this requirement also involves analytical services which includes structure identification of major metabolites by mass spectrometry or nuclear magnetic resonance (NMR), the development of sensitive and specific assays for a drug 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). These studies will be performed in accordance with pertinent FDA guidance and regulations. NIDA and NIDA sponsored investigators use the data obtained for submissions to the FDA. The reports shall be acceptable in format and substance for submission to the FDA in support of IND and NDA applications. To handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA 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 comply with the FDA's Good Laboratory Practices Program. NIDA anticipates one award for a three-year contract with two options of one year each. Additional quantity options are included also. RFP No. N01DA-4-8842 will be available electronically on or about August 29, 2003. 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). Please note that NIDA uses the streamlined RFP format which includes only the work statement, deliverables, reporting requirements, special requirements, mandatory qualifications, technical evaluation criteria, and other necessary proposal preparation instructions. All information required for the submission of a proposal is contained in or accessible through the streamlined RFP package. Response to the RFP will be due on or about October 13, 2003. NIDA will consider proposals submitted by any responsible offeror. This notice does not commit the government to award a contract.
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