SOURCES SOUGHT
A -- Medications Development for Stimulatn Dependence 3 (MDS 3)
- Notice Date
- 9/14/2007
- 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-8-8878
- Response Due
- 10/5/2007
- Archive Date
- 10/20/2007
- Description
- 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 in-house capabilities and experience to provide all of the necessary services to support investigational sites for the Medications Development for Stimulant Dependence 3 (MDS 3). The program is for additional clinical investigational sites to conduct inpatient human pharmacology clinical trials and outpatient safety and efficacy clinical trials for investigational and marketed compounds for the treatment of (1) stimulant abuse and dependence (i.e., cocaine or methamphetamine), (2) codependence with alcohol and stimulants, (3) nicotine dependence and (4) marijuana abuse and dependence. Specifically, these investigational sites will conduct either Phase 1 and/or Phase 2/3 clinical trials. The phase 1 clinical trials will evaluate any significant pharmacodynamic interactions between the investigational agent and concurrent treatment with a stimulant infusion by assessing safety and cardiovascular response. The Phase 2/3 clinical trials will evaluate the clinical utility and safety of investigational agents to either reduce the use of stimulants or to prevent relapse to stimulant use in the target population. The clinical data generated from these efforts may support future New Drug Application (NDA) submissions to the Food and Drug Administration (FDA). Investigational New Drug (IND) submissions to the FDA may be the responsibility of the contractor at NIDA?s request. In summary, the main focus of these efforts will be to evaluate the potential efficacy and safety profiles of investigational agents as pharmacotherapy treatment for stimulant abuse and dependence, nicotine dependence and marihuana abuse and dependence. Interested organizations must show experience in establishing clinical trials sites and conducting clinical trials as described above, and include maintaining efficient, responsive and secured systems for coordinating clinical trials, as well as the collection of scientific information. Experience must also include effective coordination with various individuals for conducting the clinical trials, as well as effective subject relations and problem resolution skills. 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, specific clinical trial work performed, and work in the therapeutic area of addiction science; (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 October 5, 2007 to the NIDA Contracting Officer.
- Record
- SN01406975-W 20070916/070915193424 (fbodaily.com)
- Source
-
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