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FBO DAILY ISSUE OF FEBRUARY 04, 2007 FBO #1896
SOLICITATION NOTICE

A -- CONDUCTING CLINICAL TRIALS FOR FDA PROTOCOL INSCOP-001-C WITH THE PHARMACOTHERAPEUTICS GROUP WHICH IS PART OF THE HUMAN ADAPTATION AND COUNTERMEASURES DIVISION

Notice Date
2/2/2007
 
Notice Type
Solicitation Notice
 
NAICS
621511 — Medical Laboratories
 
Contracting Office
NASA/Lyndon B. Johnson Space Center, Houston Texas, 77058-3696, Mail Code: BH
 
ZIP Code
00000
 
Solicitation Number
NNJ07183284R
 
Response Due
2/15/2007
 
Archive Date
2/2/2008
 
Small Business Set-Aside
N/A
 
Description
NASA/JSC has a requirement for medical services to complete clinical trials for FDA approval of a drug for motion sickness. These services must be conducted in accordance with FDA guidance. NASA/JSC intends to purchase these services from Medical Data Science Pharma Services (MDS), one of the leaders in the field of clinical trials. MDS has a dedicated full time clinical trial staff, which is designed to attend to all the needs of a clinical trial from inception to conclusion, including doctors, nurses, nurse assistants, medical technicians, psychological support, dietary experts, project managers and contract managers. Competition is impracticable for the following reasons: (a) MDS is to conduct the clinical trial portion of FDA protocol INSCOP-001-C, which was submitted to FDA in 2006; (b) Since the proposed clinical trails is for a drug undergoing the approval process for clinical use, but has not yet been approved for this purpose by the FDA, it is imperative that the trials be in accordance with FDA guidelines. The clinical trial is an efficacy trial in prolonged-6 degree head down bed rest subjects, a condition which simulates microgravity environment, and appropriate measures must be taken to provide for the needs of the subjects. The selected facility for the trials must meet the following requirements: (a) be approved for FDA clinical trials; (b) must be in good standing with the FDA; (c) must have a staff trained in FDA clinical trial procedures; (d) must have a favorable history with industry; and (e) must have extensive experience in dealing with the FDA on behalf of contractors. The Government does not intend to acquire a commercial item using FAR Part 12. See Note 26. Interested organizations may submit their capabilities and qualifications to perform the effort in writing to the identified point of contact not later than 4:30 p.m. local time on 2/15/07. Such capabilities/qualifications will be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination by the Government not to compete this proposed effort on a full and open competition basis, based upon responses to this notice, is solely within the discretion of the Government. Oral communications are not acceptable in response to this notice. All responsible sources may submit an offer which shall be considered by the agency. An Ombudsman has been appointed. See NASA Specific Note "B". Any referenced notes may be viewed at the following URLs linked below.
 
Web Link
Click here for the latest information about this notice
(http://prod.nais.nasa.gov/cgi-bin/eps/bizops.cgi?gr=D&pin=73#123264)
 
Record
SN01225177-W 20070204/070202221957 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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