NOT-DA-02-024: IN VITRO METABOLISM AND METABOLITE QUANTIFICATION

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

IN VITRO METABOLISM AND METABOLITE QUANTIFICATION

Release Date: April 18, 2002

NOTICE:  NOT-DA-02-024

RFP AVAILABLE:  N01DA-2-8830

National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)

The National Institute on Drug Abuse (NIDA) is soliciting proposals 
from qualified businesses to provide in vitro metabolism and analytical 
services to the medications development program of NIDA. The successful 
offeror must follow pertinent FDA guidance and regulations (e.g. Good 
Laboratory Practice regulations). The in vitro metabolism services for 
this contract include metabolite profiling for interspecies comparison 
using hepatocytes, microsomes, and S9, CYP 450 phenotyping reaction, 
CYP 450 inhibition, and CYP 450 induction of new medications. Also, it 
may include evaluation of in vitro metabolism by other systems such as 
hepatic cytosol, hepatic mitochondrial fraction (S9 fraction) or Phase 
II reactions (glucuronidation, sulfation, acetylation, methylation, 
conjugation with glutathione, conjugation with amino acids). The 
analytical services for this contract include identification of major 
metabolites by using mass spectrometry or nuclear magnetic resonance 
(NMR). It also includes the development of sensitive and specific 
assays for a drug and its metabolites in biological matrices using 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), 
etc.  NIDA and NIDA sponsored investigators will use the data obtained 
for submissions to the FDA. The reports shall be adequate in format and 
substance for submission to the FDA in support of IND and NDA 
applications.  In order 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 and 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-2-8830 will be available 
electronically on or about May 3, 2002. 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 a 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 June 17, 2002.  NIDA will consider proposals submitted by any 
responsible offeror.  This advertisement does not commit the Government 
to award a contract.  See Note 26.

Point of Contact:

Kenneth E. Goodling, Contracting Officer
National Institute on Drug Abuse, NIH
Contracts Management Branch, OPRM
6001 Executive Blvd., Room 3105, MSC 9543
Bethesda, Maryland  20892-9543
E-mail: kg25d@nih.gov
Telephone: (301) 443-6677
Fax:  (301) 443-7595
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