SOURCES SOUGHT
A -- In Vitro Metabolism and Metabolite Quantification
- Notice Date
- 3/15/2002
- Notice Type
- Sources Sought
- 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
- Reference-Number-SSDA028830
- Response Due
- 4/1/2002
- Archive Date
- 4/16/2002
- 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 seeking information in the form of capability statements from qualified Small Businesses (NAICS 541710, small business size standard is 500 employees) to provide in vitro metabolism and analytical services to the medications development program of NIDA. Pertinent FDA guidance and regulations (e.g. Good Laboratory Practice regulations) must be followed. The in vitro metabolism services for this project include metabolite profiling for interspecies comparison using hepatocytes and microsomes, CYP 450 phenotyping reaction, CYP 450 inhibition, and CYP 450 induction of new medications. It may also include evaluation of in vitro metabolism by other systems such hepatic cytosol, hepatic mitochondrial fraction, or Phase II reactions (glucuronidation, sulfation, acetylation, methylation, conjugation with glutathione, conjugation with amino acids). The required analytical services include structure identification of major metabolites by 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 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). NIDA and NIDA sponsored investigators 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 be in compliance with the FDA's Good Laboratory Practices Program. Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as principal investigator and/or project director; (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration, including security. Any other specific and pertinent information as pertains to this particular are of procurement that would enhance our consideration and evaluation of the information submitted. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate the interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial that the organization has performed, references, i.e., names, titles, telephone numbers and any other information which would serve to document the organizations capability, e.g., awards, commendations, etc. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a request for proposals. The Government does not intend to award a contract on the basis of responses under this announcement nor otherwise pay for the preparation of any information submitted or the Government's use of the information. Any proprietary information should be so marked. Interested organizations submitting a capability statement in response to this sources sought announcement are required to identify their size status. Written capability statements must be submitted no later than April 1, 2002 to the NIDA Contracting Officer at: If using U.S. Postal Service: National Institute on Drug Abuse, NIH Contracts Management Branch, OPRM 6001 Executive Boulevard Room 3105, MSC 9543 Bethesda, Maryland 20892-9543 OR, if hand-delivered or delivery service: National Institute on Drug Abuse, NIH Contracts Management Branch, OPRM 6001 Executive Boulevard, Room 3105 Rockville, Maryland 20852
- Record
- SN00043382-W 20020317/020315213152 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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