SOLICITATION NOTICE
B -- Statistical Evaluation of Design, Conduct and Analysis of Pre-Clinical and Clinical Studies
- Notice Date
- 4/28/2005
- 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
- 12699705
- Response Due
- 5/9/2005
- Archive Date
- 5/24/2005
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items/services 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 acquisition is issued as a Request for quote (RFQ). (ii) The solicitation number is 12699705. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 97-27. (iv) The associated North America Industry Classification System (NAICS) Code is 541690. (v) The Government's intention is to award the requirement as a small business set aside. (vi) Statistical Evaluation of Design, Conduct and Analysis Of Pre-Clinical and Clinical Studies 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 other wise 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 - 16 hours per week. Evaluation Criteria (100 pts total) ~ 1. Advanced degree in Statistics or Biostatistics (15 pts). 2. Experience or training in laboratory and clinical trial design and analysis (40 pts). 3. Ability to communicate clearly orally and in writing (15 pts). 4. Clearance to see confidential and proprietary information (15 pts). 5. Experience in evaluating safety and effectiveness data for diagnostic and therapeutic medical devices (15 pts). (vii)The period of performance is (1) one year from date of award. (viii) The provision at FAR 52.212-1, Instructions to Offerors - Commercial Items applies to this solicitation. The following agenda have been attached to this provision: None. (ix) The provision at FAR 52.212-2, Evaluation - Commercial Items is applicable to this solicitation. The government will award a contract to the offeror whose offer conforms to this solicitation and will be most advantageous to the government, price and other factors considered. The government reserves the right to make an award without discussions. (x) Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items. (xi) The clause at FAR 52.212-4 applies to this acquisition. The following agenda have been attached to the clause: None. (xii) Clauses and provisions are incorporated by reference and apply to this acquisition. (xiii) A standard commercial warranty on parts and workmanship is required. Clauses and provisions can be obtained at http://www.arnet.gov. (xv) See numbered note 1. (xvi) Offers are due either in person or by fax on May 9, 2005 by 1200 hours (EST), at Food and Drug Administration, 5630 Fishers Lane Rockville, MD 20857. (xvii) For information regarding this solicitation, please contact Chrissy Davidson (301) 827-7185, FAX (301) 827-7106, e-mail cdavidson@oc.fda.gov.
- Place of Performance
- Address: Center for Devices and Radiological Health, Division of Biostatistics, OSB, 1350 Piccard Drive, Rockville, MD
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN00797263-W 20050430/050428211729 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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