SOLICITATION NOTICE
B -- serum samples
- Notice Date
- 8/27/2009
- Notice Type
- Combined Synopsis/Solicitation
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1062247
- Archive Date
- 9/26/2009
- Point of Contact
- William T. Lee, Phone: 3014435863, Doreen Williams,
- E-Mail Address
-
william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov
(william.lee@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, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This solicitation is issued as a Request for Proposal (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541711, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This solicitation is posted full and open to all qualified businesses and will be awarded as a Firm Fixed Price Purchase Order. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Center for Drug Evaluation and Research (CDER) has requested the following service: Project Title: Collection of serum samples from chronic kidney disease (CKD) patients for Clinical study of drug metabolism in CKD patients. Background CKD is a significant global health concern, mechanisms of these effects are not well established in characterized by changes in glomerular filtration and tubular secretion leading to impaired elimination of endogenous toxins and reduced renal clearance of drugs and metabolites. These patients are at higher risk for adverse drug outcomes due to frequent medication use and drug-drug interactions. There is increasing evidence suggesting that drug toxicity in renal failure patients may be caused by impaired hepatic drug metabolic capability. Although the underlying humans, there is evidence that this effect may result from accumulation of uremic toxins in CKD patients. The study requires serum samples to be collected from patients with CKD who are undergoing treatment. Scope of Work The contractor shall furnish the necessary personnel, services, materials, and otherwise do all things necessary for, or incident to, the scope of work as described below. I. The contractor shall recruit ten patients for the clinical study based on the criteria stipulated in the “Patient Recruitment Form” and “Research Consent Form”. II.The contractor shall collect one blood sample (10 ml) from each patient before dialysis and a second blood sample (10 ml) after dialysis into EDTA (purple top) tubes. Following coagulation, serum samples will be prepared by the contractor from each blood sample by centrifugation at 600xg for 10 minutes. Serum samples obtained will be stored at -80°C prior to shipment. Reporting Requirements and Deliverable Items The contractor shall deliver samples to Principal Investigator via a courier service or Federal Express. Prior to shipment of samples, the contractor shall contact the Principal Investigator by telephone or email stating that samples are ready for shipment and give an estimated time and date for delivery. Samples from each patient will be shipped individually in foam containers with sufficient dry ice to maintain an internal temperature of < -80°C during shipment. Duration of Project 1 year, to start 10/1/2009 and close 10/1/2010.. FOB: Destination DELIVERY SCHEDULE: 30 days after award DELIVERY LOCATION: FDA/CDER White Oak Campus, Bldg 64 10903 New Hampshire Avenue Silver Spring, MD 20993 EVALUATION AND AWARD: The Government intends to evaluate proposals however; the Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The award will be made to the offeror whose proposal conforms to the terms and conditions of the solicitation under a Firm Fixed Price Purchase Order. Technical Requirements: The technical evaluation for this solicitation will be the contractor’s ability to meet all requirements listed in the Scope of Work. Evaluation for Award: The award will be made to the party whose quote offers the best value to the government, technical and price. The Government may award this purchase order to other than the lowest priced technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor “Meeting or Exceeding the Technical Requirements”; 2) Price and 3) Past Performance. Meeting the Technical Requirements is significantly more important than price and past performance. The FDA intends to make an award immediately after the response of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to: william.lee@fda.hhs.gov no later than September 1, 2009, 4:30 p.m. EST. No phone calls will be accepted. QUOTATIONS DUE: All quotations are due, via email to: william.lee@fda.hhs.gov, no later than September 11, 2009, 4:30 p.m. EST. 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 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. FAR 52.217-9.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/1062247/listing.html)
- Record
- SN01931055-W 20090829/090828085258-d240de16bf6b791e601994e771c61cde (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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