SOURCES SOUGHT
A -- Pharmacokinetic and Pharmacodynamic Studies for Medication Development
- Notice Date
- 2/24/2006
- 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
- ZIP Code
- 20892
- Solicitation Number
- Reference-Number-6-8867
- Response Due
- 3/10/2006
- Archive Date
- 3/25/2006
- Description
- Sources Sought Announcement 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 carry out clinical studies to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of new medications for drug abuse treatment. As medications are often taken with other treatment drugs or drugs of abuse (such as cocaine, methamphetamine, etc), information on the extent and nature of the interaction between the medications and other treatment drugs/drugs of abuse will also be a focus of this contract. Such studies require the intravenous administration of abused drugs, such as cocaine and methamphetamine, to human subjects. Since a prerequisite for PK studies is the availability of specific assay methods for the quantitative determination of drugs and their metabolites in biological fluids (e.g. plasma, urine, feces, saliva, sweat, etc), this project also includes the development and validation of analytical methods, identification of metabolites, and quantification of drug/metabolites in biological samples collected from the clinical studies. All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations. The work will require an OHRP (Office for Human Research Protections) -approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects and a board certified physician on the project. To handle substances under the Controlled Substances Act of 1970, DEA Research Registration for Schedules II to Vwill be required. NIDA may also require 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 March 10, 2006 to the NIDA Contracting Officer.
- Record
- SN00994103-W 20060226/060224211859 (fbodaily.com)
- Source
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