SOLICITATION NOTICE
35 -- Analysis of Heparin Analytical Data
- Notice Date
- 4/14/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- 09-222-SOL-00023
- Archive Date
- 5/19/2009
- Point of Contact
- Julia A Savage, Phone: 303-236-3037
- E-Mail Address
-
julia.savage@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Contracting Office Address Department of Health and Human Services, Office of Acquisition Grants Services, Bldg 20, Denver Federal Center, Denver CO 80225-0087 Description The Food and Drug Administration is soliciting for Multivariate Analysis of Heparin Analytical Data. (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals/bids are being requested and a written solicitation will not be issued. This action is full and open competition. (ii) The solicitation number is 09-222-SOL-00023. This solicitation is issued as a Request for Quote (RFQ). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-31, March 19, 2009. (iv) This is a firm fixed price requirement. All responsible sources may submit a quote which shall be considered. The associated North American Industry Classification System (NAICS) Code is 541712. (v) Description of Work: -Division of Pharmaceutical Analysis (DPA) has analytical data for over 150 heparin sodium API samples from different suppliers with varying levels of OSCS and dermatan sulfate. The heparin NMR spectra, while having many consistent features, have a high degree of variability due to the heterogeneous nature of the carbohydrate. These data generated during the heparin crisis will be used to determine if sophisticated modeling methods can be used to discriminate between authentic and contaminated materials. Data will be supplied by DPA as *.fid files/folders. -Initially, NMR data will be used to develop a multivariate mathematical model for characterizing heparin sodium, including heparin containing naturally occurring impurities such as dermatan sulfate (DS). The model will be internally validated to determine is robustness and ability to distinguish heparin with DS levels <1% from those samples having DS levels >1%. After the model is determined to be sound, it will further challenged with heparin containing the contaminant OSCS to determine its capability and sensitivity to detecting this known contaminant. The model will then be challenged by spectra from heparin sodium samples containing other oversulfated glucosaminoglycans that are prepared or purchased by DPA. Additional analytical data from other laboratories or other methods (NIR and Raman spectra, CE, enzyme digestion) will be added to the model to improve its discrimination capability. Contractor will be expected to convert files as needed for forms useable by the developed model. -Deliverables—This project will determine if pattern recognition models are capable of discriminating low levels of OSCS and other contaminants in heparin sodium. Offeror must provide all sorfware to convert files, create model and run model. Specific deliverables include: (1) Model discriminating heparin with different DS levels utilizing the entire NMR spectrum for heparin API from data generated at DPA. Model must discriminate heparin with <1% DS from heparin with >1%. Data from up to 150 samples will be provided by DPA to generate the model, due one month after receipt of order..(2) Demonstration of the model to discriminate heparin contaminated with OSCS. Data from up to 50 contaminated samples will be provided by DPA to challenge the model. Due one month after receipt of order. (3) Demonstration of the model to discriminate heparin contaminated with other GAGs and/or oversulfated GAGs. Data from up to 50 contaminated samples will be provided by DPA to challenge the model. Due two months after receipt of order. (4) Interim report detailing model development and model limitation based on DPA NMR data. Due three months after receipt of order.(5) Expansion of the model using NMR data submitted to the agency from pharmaceutical firms and/or using other analytical techniques such as CE or HPLC. Up to 400 additional data sets may be provided from DPA (data set equals one NIR spectrum, one HPLC chromatograph, or one NMR*.fid file) due four months after receipt of order.(6) Final report and demonstration detailing model development and limitations based on all data provided to vendor, due five months after receipt of order(7) At least one draft manuscript suitable for publication in a peer reviewed journal detailing the model development and performance, due six months after receipt of order. (vi) Technical Evaluation: Offerors will be evaluated based on the completeness and throughness of their proposal as evidenced by its content and clarity. The following factors, listed indescending order of importance, shall be used to evaluate offers: Technical Approach Past Performance Organizational Experience Feasibility of Completion -Offerors proposals shall be limited to not more than 10 typewritten pages which should include any resume submittals. Proposals submitted shall demonstrate each factor referenced above. Technical acceptability will be determined by review of information submitted which must provide information in sufficient detail to show understanding of the requirement. - Past Performance information shall include recent and relevant performance information for three (3) actions for the same or similar service including contract/purchase order numbers, points of contact with telephone number and brief description of services provided. -The government will award a contract resulting from this solicitation to the responsible offeror whose order, conforming to the solicitation, will be the most advantageous to the government, price and other factors considered. Technical and past performance when combined are of equal importance to price. The Contractor will not release any data or results provided by DPA or generated by the study conducted under this project without the approval of the Project Officer. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to finish required representations, or reject the terms and conditions of the solicitation, may be excluded from consideration. FOB Point Destination, with services on-site. Contract type: Commercial Item-Firm Fixed Price. Simplified procurement procedures will be utilized. (vi) The period of performance: Delivery is required 180 days after receipt of order (ARO). FOB Point of Delivery for Services and Supplies provided will be the Food and Drug Administration, 1114 Market St. Room 1002, ST Louis, MO 63101 (vii) The provision at FAR 52.212-1 Instructions to Offerors- Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. (viii) The government is not responsible for locating or securing any information, which is not identified in the submission. To ensure sufficient information is available, vendors must furnish as part of their proposal all descriptive material (such as cuts, illustration, drawings, or other information) necessary for the government to determine whether the product meets their requirements. (ix) Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Items with its offer. (x) The clause at 52.212-4, Contract Terms and Conditions- Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. (xi) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes of Executive Orders-Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-37, 52.225-1, 52.225-3, 52.225-13, and 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov. CCR Requirement-Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. (xii) A standard commercial warranty on parts and workmanship is required. (xiii) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. (xiv) Applicable Numbered Note(s) 1. (xv) Offers are due in person, by mail or fax on or before May 4, 2009, by 15:00 hours (Mountain Standard Time-Local Prevailing Time in Denver, CO), at Food and Drug Administration OC/OSS/OFFAS, Attn: Julia Savage, Blg 20, Denver Federal Center, POB 25087, Denver, CO 80225. ph (303) 236-3037, fax (303) 236-3100, email: Julia.Savage@fda.hhs.gov. (xvi) For information regarding this solicitation, please contact Julia Savage @ (303) 236-3037, FAX (303) 236-3100, email Julia.savage@fda.hhs.gov. Point of Contact Julia Savage, Admin Spec, Phone (303) 236-3037, Fax (303) 236-3100, Email julia.savage@fda.hhs.gov – Priscella Sullivan, Contracting Officer, Phone (214) 253-5274, Email priscella.sullivan@fda.hhs.gov Location of demonstration of models to be determined by DPA. Location will be: Place of Performance Food & Drug Administration 1114 Market St. Room 1002 St. Louis, MO 63101 Or the FDA White Oak facility in Silver Spring, Maryland.
- Web Link
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- Place of Performance
- Address: Food and Drug Administration, 1114 Market St. Room 1002, St. Louis, Missouri, 63101, United States
- Zip Code: 63101
- Zip Code: 63101
- Record
- SN01792527-W 20090416/090414221716-3a5545ee9e7723db4c27869b5bb0cd72 (fbodaily.com)
- Source
-
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