SOLICITATION NOTICE
B -- Statistical Evaluation of Design, Conduct and Analysis
- Notice Date
- 5/18/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-06-00216
- Response Due
- 5/30/2006
- Archive Date
- 6/14/2006
- Small Business Set-Aside
- Total Small Business
- Description
- For req 1017579 Statistical Evaluation of Design, Conduct and Analysis of Pre-clinical and Clinical Studies This is a combined synopsis/solicitation for commercial service prepared in accordance with the format in FAR 12.603 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 FDA-SOL-06-00216, and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2001-27. The North American Industry Classification (NAICS) Code is 541690.This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The government intends to award the requirement to a small business set aside (FAR 13 and FAR 19). This contract is intended to provide additional statistical expertise to supplement current staff. The contractor is to conduct comprehensive statistical review of premarket submissions from manufacturers including independent analysis of submitted data, and provide backup support for statistical consultation/analysis activities in the Division of Biostatistics (OSB), Center for Devices and Radiological Health (CDRH). Background: The Division of Biostatistics in the FDA?s Center for Devices and Radiological Health provides statistical expertise in the evaluation of materials and documents submitted to and generated by the Center to assure statistical validity and consistency. This contract is intended to provide additional statistical expertise to supplement current staff. Scope of Work: Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel and services, and otherwise do all things necessary for or incident to the performance of the work as described below: 1. Conduct comprehensive statistical review of premarket submissions from manufacturers. This includes reviewing study protocols to determine whether data collected are (or will be) scientifically and statistically valid; evaluating manufacturer?s data to determine whether claims made are supported by valid statistical analyses; identifying deficiencies in the submissions and providing written reviews and specific language for regulatory letters that conveys statistical concerns and requests to non-statisticians. This activity includes collaboration with Center clinicians, scientists and engineers. 2. Perform, when appropriate, statistical analyses of submitted data to validate analytical results and answer specific questions arising during statistical review. 3. Provide backup support for statistical consultation/analysis activities in the Division. Deliverables: Written statistical reviews of individual submissions. Quarterly summary reports providing status of submissions and progress on projects. Monthly reports showing time expended on reviews and projects. Period of Performance: One year. ( anticipated dates Sep 1, 2006 to Aug 31, 2007) Payment schedule: Payment will be made in monthly installments based on level of effort (hours worked). Qualifications: Advanced degree in Statistics or Biostatistics. Experience or training in laboratory or clinical trial design and analysis. Ability to communicate clearly orally and in writing. Clearance to see confidential and proprietary information. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions for Commercials Items, applies to this acquisition. The addenda to the clause reads as follows: The offeror must include in their quotations: qualifications; demonstration of communication skills; clearance status, applicable experience; the hourly price, estimated average hours per week based on task complexity, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items applies to this acquisition. The clauses are available in full text at http://www.arnet.gov/far. Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications ? Commercial Items with the offer. Evaluation Criteria will be based on the qualifications and requirements as stated above. The government will award a contract to the offeror whose offer conforms to this solicitation and will provide the government with the best value. The government reserves the right to make an award without discussion. Interested vendors capable of furnishing the government with the service 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. The quotation must reference the Solicitation number FDA-SOL-06-00216.
- Place of Performance
- Address: Center for Devices and Radiological Health Division of Biostatics, Rockville, MD
- Zip Code: 20850
- Country: United States
- Zip Code: 20850
- Record
- SN01052777-W 20060520/060519133758 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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