MODIFICATION
B -- Liver Toxicity Test Services
- Notice Date
- 8/6/2010
- Notice Type
- Modification/Amendment
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, NCTR-50 RM422 HFT-320, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 10-223-SOL-00268
- Archive Date
- 8/26/2010
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- 1) What are the three specific enzymatic assays that need to be tested? Three cytotoxicity endpoints are cytoplasmic enzyme release, cellular ATP content, and caspase activation. The enzymes to be analyzed in cytoplasmic enzyme release are the ones commonly measured in clinical and preclinical studies to reflect liver toxicity, including ALT, ALP, AST, TBL and LDH. 2) Do the assays need to be validated, or are the results being used for only research purposes? GLP or not ( it is mentioned that it's subject to FDA approval) Non GLP, research only, thus no validation is required as long as the company has a good track record in this line of business, 3) Are all 25 drugs to test on hepatocytes being sent at once? Yes 4) Who is providing hepatocytes and should we create a cell bank? The company should have the source of hepatocytes for this experiment. We only provide the drugs. 5) Is there a protocol (conc., time etc.) for this toxicity study already available or would the contractor develop it? The contractor will develop a protocol that will be reviewed by the FDA. 6) What should be done with RNA after extraction? Put in the Pax-gene tube and send to FDA. 7) When is the anticipated award date? What is the period of performance? The Anticipated award date is September. The work shall be completed within 10 weeks from receipt of government provided compounds. We do not know how long IRB approval may take. The government will not send the compounds until IRB approval is issued. 8) Are there any proposal instructions? Proposal instructions are contained in the solicitation. A firm should provide technical, past performance and price information as instructed in the solicitation. Technical proposal should be as detailed as possible for the government to determine technical acceptability and provide reference for similar work that may be contacted by the government.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/10-223-SOL-00268/listing.html)
- Place of Performance
- Address: Contractor facility, United States
- Record
- SN02231348-W 20100808/100806234813-5e28046c56994f31b8196a72fa71608a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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