SOURCES SOUGHT
B -- Toxicology Study for Development of New Radiotracer
- Notice Date
- 8/3/2010
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- National Institutes of HealthNational Institute on Drug AbuseBethesdaMD20892-7511
- ZIP Code
- 20892-7511
- Solicitation Number
- NIHDA2010179
- Response Due
- 8/18/2010
- Archive Date
- 9/17/2010
- Point of Contact
- LINDSAY, CAROL A 443-740-2451, clindsay@intra.nida.nih.gov
- E-Mail Address
-
LINDSAY, CAROL A
(clindsay@intra.nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Announcement for The National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Intramural Research Program for which the agency is seeking a contractor who has the ability to conduct toxicology studies necessary for the development of a new radiotracer for positron emission tomographic studies for human administration. In order to apply for an exploratory Investigation New Drug Application (eIND) basic preclinical toxicology in rodents and other species must be performed to demonstrate safety of the compound at doses that are anticipated to be administered in clinical trials.The vendor would perform basic toxicological evaluations using good laboratory practices (GLP) and generate appropriate documentation of the results of the studies suitable for submission with the eIND application to the FDA. Special qualifications of the vendor include experience in performing basic toxicology studies necessary for FDA submissions. The facilities must be GLP or the equivalent to comply with FDA mandated standards for conduct of these studies. The vendor should have experience working with government, academic and industry scientists in preparing data for review and submission. The vendor must have experience in preparing documents describing the types of data collected in graph and table formats as well as descriptions of the experimental techniques and procedures. Data and summary findings as well as presentation documents and PowerPoint presentations will also be required. The vendor should be geographically accessible to the Baltimore Washington area so that the study investigator sponsors can conveniently meet with the vendor to access the adequacy of the facilities and to meet to discuss procedures and results. Also proximity to the NIH will help in the event of untoward complications in the conduct of the experiments. The North American Industry Classification System (NAICS) Code is 541990, All Other Professional, Scientific, and Technical Services. Interested Small Business concerns should respond with a capability statement no later than August 18, 2010 with length no longer than 10 pages. Capability statements must reference similar work that has been performed by the contractor, the dollar value of that work, and contract information for references knowledgeable about the quality of work completed. All business concerns who respond to this announcement will receive notification of how NIH intends to proceed with this requirement. Please reference the sources sought number on all related correspondence. No collect calls will be accepted. No facsimile transmissions will be accepted. This notice is for information and planning purposes only and does not commit the Government to award a contract now or in the future. THIS IS NOT A REQUEST FOR PROPOSALS. The Government does not intend to award a contract based on responses under this announcement. 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 and NAICS Codes Certifications. RESPONDENTS MUST SUBMIT CAPABILITY STATEMENT VIA E-MAIL and include Notification# NIHDA2010179 to Carol Lindsay at clindsay@intra.nida.nih.gov no later than August 18, 2010, 4:30 PM Eastern Time for consideration.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA/NIHDA2010179/listing.html)
- Record
- SN02227416-W 20100805/100803235903-a001d63374b1fe1578282827ae9a1120 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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