SOURCES SOUGHT
A -- Analytical Services Center for Medications Development
- Notice Date
- 8/30/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard Room 260 - MSC 8402, Bethesda, MD, 20892, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- N01DA-8-8875
- Response Due
- 9/17/2007
- Archive Date
- 10/2/2007
- Description
- The National Institute on Drug Abuse (NIDA) seeks capability statements from qualified Small Businesses (e.g., small, small disadvantaged businesses, woman-owned small businesses, 8(a), HUB Zone small businesses, veteran-owned small businesses, service-disabled veteran owned small businesses, etc.) having the capability to develop and validate new assay methods for new medications in biological fluids and to perform quantitative assays for samples collected from pharmacokinetic studies and clinical trials to support medication development for treating drug addiction. Sample matrixes include, but not limited to, plasma and urine. Targeted analytes include, but not limited to, potential therapeutic compounds, illicit drugs, and their metabolites. Mass spectrometric methods are generally required to provide high degree of specificity as well as sensitivity to quantify the drug in low nanogram or pictogram range. The analytical laboratory should have automated equipments in handling sample preparation and injection as well as computer software for data acquisition and report generation. The contractor should have sufficient equipment and personnel to ensure high throughput of samples. The assay must be carried out in compliance with cGLP regulations. Appropriate FDA's guidance regarding assay validation must be followed. The contractor shall provide secured facilities appropriate for storing biological samples and analytical data as well as computerized systems for tracking samples from receipt to final data report. In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Registration for Chemical Analysis, or a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous similar projects and work in the field of drug abuse; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as project director and other key positions; (3) Facilities: Availability and description of facilities and equipment required to conduct this type of work. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. 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 interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving 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 preparing any information sent for the Government?s use. Any proprietary information should be so marked. Interested organizations presenting a capability statement 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, and 6) capability information in response to the requirement. Please submit written capability statements by September 17, 2007 to the NIDA Contracting Officer.
- Record
- SN01390387-W 20070901/070830220608 (fbodaily.com)
- Source
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