SOLICITATION NOTICE
B -- Studying T-Cell Markers in HCV Re-Challenged Chimpanzees and Association with Clearance
- Notice Date
- 6/4/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1074269
- Archive Date
- 7/3/2010
- Point of Contact
- Lisa Ko, Phone: 301-827-5095
- E-Mail Address
-
Lisa.Ko@fda.hhs.gov
(Lisa.Ko@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent to sole source by the U.S. Food and Drug Administration (FDA). FDA intends to award a purchase order to University of Louisiana at Lafayette: New Iberia Research Center (NIRC), in the amount of $50,200.00. The Office of Vaccines Research and Review, Division of Viral Products requires unique access to chimpanzees for research purposes with deliverables in the form of biological samples and data analysis for their project titled "Studying T-Cell Markers in HCV Re-Challenged Chimpanzees and Association with Clearance." The project requires the use of chimpanzees that have previously recovered from a genotype 1a hepatitis C virus infection and the continuation of studies on one particular animal from an initial vaccine study that was conducted in 2008, specifically animal #91A025. Animal #91A025 recovered from the HCV infection after vaccination and we wish to study further the specific immune responses in this animal if it is again exposed to HCV. Hepatitis C virus (HCV) will be administered i/v to 3 animals that have previously cleared an HCV infection; one of these animals should be animal #91A025. The animals will be maintained and housed by the contractor throughout the study time; all procedures will be performed by contractor staff. The animals will be screened prior to inoculation in an initial health check and blood will be tested in routine chemistry assays by the contractor. The chimpanzees will be isolated from other animals not on study. Blood (weekly) and liver biopsies (every other week) will be obtained and shipped to the FDA for subsequent analysis. Pre challenge samples will be taken for 2 weeks prior to rechallenge and the animal will be followed for 10 weeks post rechallenge. The total study time will be 13 weeks. During this time there will be 13 bleeds and 7 liver biopsies for each animal. A sample of plasma will be retained by the contractor and tested for alanine amino transferase. The results of these tests will be sent to the FDA. The contractor will supply 39 blood samples and 21 liver biopsies from 3 chimpanzees following infection with hepatitis C virus. Animal #91A025 can only be obtained from the New Iberia Research Center (NIRC) and is proprietary to NIRC. The study must be conducted at the same facility for all 3 animals for the results to remain consistent. The vendor is located at P.O. 13610, New Iberia, LA, 70562-3610. In accordance with FAR 6.302-1 the Government is contemplating an award on a sole source basis for the following reasons: a. The Office of Vaccines Research and Review, Division of Viral Products requires unique access to chimpanzees for research purposes with deliverables in the form of biological samples and data analysis and the continuation of studies on one particular animal, #91A025 which can only be obtained from the New Iberia Research Center (NIRC) and is proprietary to NIRC. b. There is a current legitimate need for this study and the use of chimpanzees that have previously recovered from a genotype 1a hepatitis C virus infection, one of which is specifically animal #91A025. c. The study must be conducted at the same facility for all 3 animals to result in consistent and valid findings. The NAICS code is 62511. This notice is not a request for competitive quotes, no solicitation document is available and telephone requests will not be accepted. However, sources may submit descriptive literature, fully documenting their capability to perform these services, which will be considered by the Agency. A determination to compete this procurement based on response(s) to this notice is solely within the discretion of the Government. A solicitation will be issued to University of Louisiana at Lafayette: New Iberia Research Center (NIRC) no less than 15 days after the date of this notice unless the Government determines to conduct a competitive procurement. All written inquiries must be received via email no later than Wednesday, June 16, 2010 at 2PM ET to the attention of Contract Specialist, Lisa Ko at lisa.ko@fda.hhs.gov. No fax or traditional mail submissions shall be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1074269/listing.html)
- Record
- SN02168973-W 20100606/100604235017-0defeed8d1fdf222dce924cf2f278ea4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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