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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