SOLICITATION NOTICE
B -- Assay Costs for 16 patients
- Notice Date
- 1/8/2004
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- NIH-NIDDK-04-162
- Response Due
- 1/22/2004
- Archive Date
- 2/6/2004
- Point of Contact
- Desiree Harris, Purchasing Agent, Phone 301-594-7727, Fax 301-480-4226, - Desiree Harris, Purchasing Agent, Phone 301-594-7727, Fax 301-480-4226,
- E-Mail Address
-
harrisde@extra.niddk.nih.gov, harrisde@extra.niddk.nih.gov
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIH-NIDDK-04-162, and is issued as a Request for Quotation (RFQ). This procurement is being conduced under Simplified Acquisition Procedures in accordance with FAR Part 13. This solicitation will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2001-14. This acquisition is 100% small business set-aside and the NAICS code is 8999 with a small business size standard $11.5 million. It is the intent of the National Institutes of Health (NIH) to purchase the services of AC2993 Assay Cost for 16 patients from Esoterix Clinical Trial Services C/o Tony Perfetto 20 Lake Drive East Windsor, New Jersey. The service will be for a Base Year with two (2) option years. Statement of Work Protocol: ?Effect of AC2993 (synthetic exendin-4) administered alone or in combination with rapamycin and FK506, on islet function in patients with type 1 diabetes? Company: Esoterix Inc. Clinical Trials Services Background information We are studying patients with type 1 diabetes mellitus (T1DM). AC2993 (synthetic exendin-4) has been shown in preclinical and in preliminary human studies to have several potentially beneficial antidiabetic actions. We plan to study the effects of AC2993 alone, immunosuppressive drugs alone, as well as the combination of AC2993 and immunosuppressive drugs on insulin secretion and glycemia control using precise laboratory assay measures. Esoterix Laboratories has been specified in the scientific CRADA as the lab that should run the laboratory tests for this study based on their ability to provide assay analyses that meet the protocol?s stringent scientific requirements for measures. Work to be done We will study 16 patients with T1DM who have measurable circulating C peptide. We will include only patients with clear T1DM as assessed by laboratory evidence of anti-islet cell antibodies, normal insulin sensitivity, and by insulinopenia. We plan to assess endogenous islet function by performing frequent arginine stimulated C peptide tests, and will monitor anti-islet immunity by periodically monitoring anti-islet autoantibody levels and by freezing lymphocytes for subsequent T-cell assays currently being developed. The NIH laboratory will provide peripheral blood from our patients and ship the samples to the vendor. This will be an ongoing project. The purchase order will run for three years from the starting date listed on the purchase order. AC2993 Assay Costs Mixed Meal/Acetaminophen: (Labs to be obtained at baseline x1, 4 month run-in x1, Test period A- x 1, and Test period B x 1: 11 samples each per study) Time: -10, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes) Assay Cost per Sample Quantity Total* Acetaminophen 44 Proinsulin 44 C-Peptide 44 Insulin RIA 44 Insulin ICMA 44 Glucagon 44 Total per patient Total X 16 patients: Arginine Stimulation: (Labs to be obtained at baseline x1, x3 in run-in phase, x4 in test phase A, x 3 in test phase B- six: 8 samples per study x 11 studies) Assay Cost per Sample Quantity Total /Patient C-Peptide 88 Total per patient Total X 16 patients: Monthly Blood Draws: (Labs to be obtained at baseline x1, x4 in run-in phase, x6 in test phase A, x 6 in test phase B) Assay Cost per Sample Quantity Total Anti GAD/Insulin Ab/ICA512/IA2 17 Total per patient: Total X 16 patients: Euglycemic Clamp: (end of run-in, test phase A and test phase B) Assay Cost per Sample Quantity Total Insulin RIA ~36 Total per patient: Total X 16 patients: On-site Visit: Travel Plus Expenses: 1 Charge Contractor requirements The vendor is responsible for accepting the samples and using established scientific procedures to run samples. This study is an official clinical trial under 21CFR Part 11. Therefore, samples should be run at a clinical trial laboratory that can comply with 21CFR Part 11 requirements and provide a complete audit trail of all study events. ? Please provide data on the quality control measures for each of the samples listed above. ? Please specify the following charges per sample: o Antibodies against GAD65, insulin / and ICA512/IA2 o C-Peptide o Proinsulin o Insulin RIA o Insulin ICMA o Glucagon o Acetaminophen Government responsibilities The NIH laboratory will send the blood samples to the vendor by express shipment. Ordinarily, we will send small numbers of samples (1-5 blood samples). However, on occasion, we might send larger numbers of samples (for example 20-50). These samples will be sent to the vendor when the patients are seen. This is scheduled according to the availability of patients, and is therefore not predictable. Deliverables The vendor must provide the following to the correct Government contracts: ? Per sample reports faxed to the contract site within 24 hours (when applicable) of receipt of the sample. ? Transfer data electronically to allow direct entry into our data base as well as comply with all issues of patient confidentiality This notice of intent is not a request for competitive quotations however, all responses received, within 15 days from the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed acquisition is based upon responses to this notice and is solely for the purpose of determining whether to conduct a competitive acquisition. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications ? Commercial Items with its offer. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions ? Commercial Items, applies to this acquisition. The FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders ? Commercial Items ? Deviation for Simplified Acquisitions, applies to this acquisition. The clauses are available in full text at http://www.arnet.gov/far. Interested vendors capable of furnishing the government with the item specified in this synopsis should submit their quotation to the below address. Quotations will be due fifteen (15) calendar days from the publication date of this synopsis or January 22, 2004. The quotation must reference ?Solicitation Number? NIH-NIDDK-04-162. All 8(a) small businesses may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to the National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd., Room 774B, Bethesda, Maryland 20817, Attention: Desiree Harris. Faxed copies will not be accepted.
- Record
- SN00500528-W 20040110/040108211946 (fbodaily.com)
- Source
-
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