Sources Sought Announcement This is a SOURCES SOUGHT NOTICE to determine the availability of small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having the capability to provide in vitro evaluation of permeability (Blood Brain Barrier, Caco2, and P-glycoprotein), 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 as 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), and 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 area of procurement that would enhance our consideration and evaluation of the information submitted should be provided. 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 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 neither intends to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information submitted for the Government’s use. Any proprietary information should be so marked. Interested organizations submitting a capability statement in response to this sources sought announcement must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Codes, 5) business size and status; 6) capability information in response to the requirement and 7) type of small business. Please submit written capability statements by January 16, 2009 to the NIDA Contracting Officer at the address below: If using U.S. Postal Service: Craig Sager, Contracting Officer National Institute on Drug Abuse, NIH NIDA R&D Contracts Management Branch Neurosciences Office of Acquisition 6101 Executive Boulevard Room 260, MSC 8402 Bethesda, Maryland 20892-8402 Or, if hand delivered or delivery service: Craig Sager, Contracting Officer National Institute on Drug Abuse, NIH NIDA R&D Contracts Management Branch Neurosciences Office of Acquisition 6101 Executive Boulevard, Room 260 Rockville, Maryland 20852

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