SOURCES SOUGHT
A -- NonClinical ADME Studies
- Notice Date
- 4/24/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Blvd. Room #3105, Bethesda, MD, 20892-9543
- ZIP Code
- 20892-9543
- Solicitation Number
- Reference-Number-48842
- Archive Date
- 5/23/2003
- Point of Contact
- Teneshia Alston, Contract Specialist, NIDA/NIH, Phone 301 443 6677, Fax 301 443 7595, - Kenneth Goodling, Contracting Officer, Phone (301)443-6677, Fax (301)443-7595,
- E-Mail Address
-
TAlston@nida.nih.gov, kg25d@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Institute on Drug Abuse (NIDA) seeks information in the form of capability statements from qualified Small Businesses (NAICS 541710, small business size standard is 500 employees). Offerors must provide services to perform nonclinical absorption, distribution, metabolism and elimination (ADME) studies to support NIDA?s medications development program. The nonclinical ADME studies for this contract typically include bioavailability and pharmacokinetic evaluation, mass balance studies, tissue distribution studies, in vivo metabolite identification and toxicokinetics of new medications. It may also include in vitro evaluation of permeability and protein binding. In addition, this contract also involves analytical services which includes structure identification of major metabolites by mass spectrometry or nuclear magnetic resonance (NMR). This 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). The Contractor performs these studies 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. 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 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 relevant information pertaining to this particular area of procurement that would improve our consideration and evaluation of the information presented. 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 based on responses under this announcement nor otherwise pay for the preparation of any information sent or the Government?s use of the information. Any proprietary information should be so marked. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Offerors must send written capability statements by May 8, 2003 to the NIDA Contracting Officer to: 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
- SN00311033-W 20030426/030424213402 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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