MODIFICATION
A -- In Vitro Metabolism and Metabolite Quantification
- Notice Date
- 5/14/2002
- Notice Type
- Modification
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Blvd, Rm 3105 (MSC 9543), Bethesda, MD, 20892-9543
- ZIP Code
- 20892-9543
- Solicitation Number
- N01DA-2-8830
- Response Due
- 6/28/2002
- Archive Date
- 7/13/2002
- Point of Contact
- Kenneth Goodling, Contracting Officer, Phone (301)443-6677, Fax (301)443-7595,
- E-Mail Address
-
kg25d@nih.gov
- Description
- The National Institute on Drug Abuse 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 14, 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 28, 2002. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. See Note 26.
- Record
- SN00076631-W 20020516/020514213258 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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