MODIFICATION
B -- Toxicology Study for Development of New Radiotracer
- Notice Date
- 9/1/2010
- Notice Type
- Modification/Amendment
- 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
- NIHDA2010181
- Response Due
- 9/9/2010
- Archive Date
- 10/9/2010
- Point of Contact
- Carol Lindsay, Phone: 443-740-2451
- E-Mail Address
-
clindsay@mail.nih.gov
(clindsay@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Combined Synopsis/ Solicitation 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. Please referrence the Combined Synopsis/Solicitation # NIHDA2010181 on all related correspondence. No collect calls will be acceptged. No facsimile transmission will be accepted. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the government intent to pay for any informationsubmitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. RESPONDENTS MUST SUBMIT INFORMATION VIA EMAIL TO Carol Lindsay at clindsay@intra.nida.nih.gov no later than September 11, 2010 4:30 pm Eastern Time for consideration. Please include Solicitation No. NIHDA2010181 on all submitted correspondence
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA/NIHDA2010181/listing.html)
- Record
- SN02263887-W 20100903/100901235453-c24c617d456ab03e9a831b0ac8b68d1c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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