SOLICITATION NOTICE
B -- Service for Animal Studies in the Pandemic Flu Project
- Notice Date
- 7/27/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing 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
- FDA-09-1055658
- Archive Date
- 8/25/2009
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, streamlined procedures for evaluation and solicitation for commercial items-as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is being issued using simplified acquisition procedures 13.5. This solicitation is a Request for Quotations (RFQ). The solicitation document and incorporation provisions and clauses are those in effect through Federal Acquisition Circular 05-35. The associated North American Classification System (NAICS) code for this procurement is 541380. This procurement will be full and open competition. The Food and Drug Administration is seeking contractors to provide service for animal studies on an ongoing project entitled: Pandemic Flu and Blood Study: Pilot Studies to Determine Viremia and Potential Transfusion Transmission in H5N1 Infection using Small Animal Model. Background: In the past few years, H5N1 strains of avian influenza have been shown to infect poultry in several parts of Asia and a highly pathogenic form for humans emerged in 1997. Human infections of this virus have been identified since then. Unlike other influenza viruses, H5N1 exhibits a wide range of unique pathologic features including hypercytokinemia, hemophagocytosis and neurologic involvement in some cases suggesting that pathogenesis and modes of spread of this virus may be different than seasonal flu strains. The potential for transmission of pandemic flue through blood transfusion and blood products is not known. H5N1 has been detected in blood of persons acutely infected with H5N1 virus using sensitive PCR methods. The possibility of a viremic period, before the onset of clinical symptoms and/or after symptom resolution, remains an important concern regarding blood safety. This knowledge gap in transfusion safety needs to be addressed in order to understand the infectivity of H5N1 in blood. Results from appropriate animal model studies could provide insights into the viremic period following H5N1 infection using an animal model that could help define a deferral period after exposure to pandemic influenza strains. Statement of Work: This is a continuation of a project by the FDA, which included a study with 32 mice and a study with 24 ferrets, each at two dose levels, has been completed. For the in vitro part, the following samples will be analyzed. The Contractor shall be trained to work under BioSafety Level 3 conditions. The contractor shall perform EID50 titers on all the tissues collected in the mouse and ferret study. 1.Mouse Study EID 50 of all lungs, spleen, brain, nasal turbinates and ileum (32 x 5 samples) RNA blood (88 samples) EID50 of blood samples (27 samples) RNA of lung (8), nasal turbinate (14) and brain (14) (14 each x 2 = 28 + 8 = 36 samples (including re-cutting of samples for RNA processing) 2.Ferret Study EID50 of 43 blood samples of 12 ferrets EID50 of 43 nasal wash, 12 lungs, 12 brains and 12 nasal turbinates (total = 122) RNA blood (144 samples) RNA of 47 + 7 tissues (12 lungs, 12 nasal turbinates, 12 brains and 11 spleen and 7 extra for verification) Technical Criteria: The offeror’s ability to have a BSL-3 laboratory to include controlled access double door entry with change room and shower, use of respirators, decontamination of all wastes, and showering out of all personnel. The offeror’s ability to have a USDA certified laboratory to handle mouse and ferret tissue infected with avian influenza A (H5N1) virus. The Contractor’s facility shall be registered with CDC and the USDA to work with both animal and human risk group 3 pathogens. All exhaust air is HEPA filtered. All laboratories are negative relative to the hallways and all waste are to be destroyed in high-efficiency incinerators after being autoclaved. Past Performance: The offeror shall identify up to three projects comparable to the scope of work. The anticipated award type will be a firm fixed price purchase order. The Period of Performance of this contract is for base year and one option year. Award will be made to the party whose quote offers the best value to the Government, technical, price and other factors considered. The Government may award this contract other than lowest price technically acceptable quote. The Government will evaluate information based on the following critieria: 1) Technical Capability factor described to “Meet or Exceed the Requirement,” 2) Past Performance and 3) Price. Technically Capability and Past Performance when combined are significantly more important than price. QUESTIONS DEADLINE: All questions must be received by email (Tara.Hobson@fda.hhs.gov) before 4:30pm EST on July 31, 2009. Telephone calls will not be accepted. QUOTATIONS DUE: All quotations are due, via email to: Tara.Hobson@fda.hhs.gov, no later than 4:30pm EST on August 10, 2009. Vendors must be registered in the Central Contractor Register (CCR) prior to the award of the contract. You may register by going to www.ccr.gov. PROVISIONS AND CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation.. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.217-9, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, 52.22-50, 52.225-13, 52.239-1 and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1055658/listing.html)
- Place of Performance
- Address: 8800 Rockville Pike, Rockville, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01888712-W 20090729/090727235845-1e1ba5447bc1bc26c66f70c2f7b2304f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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