Non-Clinical ADME Studies

The National Institute on Drug Abuse (NIDA), Division of Therapeutics and Medical Consequences of Drug Abuse (DTMC) intends to solicit proposals from qualified businesses to perform non-clinical Absorption, Distribution, Metabolism, 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, and toxicokinetic analysis of new potential medications. In addition, this project also involves analytical services which include 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).
In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Registration for Chemical Analysis or Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances.
NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ) task order contract. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. NIDA anticipates that at least one task order will be awarded with the initial contract.
RFP No. N01DA-16-8931 will be available electronically on or about March 30, 2016. You can access the RFP through FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after release of the RFP. NIDA will consider proposals submitted by any responsible offeror.
Based upon market research, the Government is not using the policies contained in FAR 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

Contracting Officer Address: 
National Institute on Drug Abuse
NIDA R&D Contracts Management Branch
6001 Executive Blvd.
Room 4211, MSC 9559
Bethesda, Maryland  20892-9559