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FBO DAILY ISSUE OF MAY 29, 2003 FBO #0546
SOLICITATION NOTICE

R -- Statistical Evaluation

Notice Date
5/27/2003
 
Notice Type
Solicitation Notice
 
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857
 
ZIP Code
20857
 
Solicitation Number
Reference-Number-175549
 
Response Due
6/6/2003
 
Archive Date
6/21/2003
 
Point of Contact
Dee Gibson, Contract Specialist, Phone (301) 827-7177, Fax (301) 827-7103, - Dee Gibson, Contract Specialist, Phone (301) 827-7177, Fax (301) 827-7103,
 
E-Mail Address
dgibson@oc.fda.gov, dgibson@oc.fda.gov
 
Small Business Set-Aside
Very Small Business
 
Description
This is a combined synopsis/solicitation for service prepared in accordance with the format in FAR subpart 12.6 Streamlined Procedures for evaluation and solicitation for commercial items as supplemented with additional information included in this notice. This announcement constitutes the only solicitation a written solicitation document will not be issued. This solicitation is a Request for Quotation (RFQ) number 175549. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 01-13. The associated North American Industrial Classification System (NAICS) Code for this procurement is 541690. The Standard Industrial Classification (SIC) Code is 0781. This acquisition is restricted to small business only. The Food and Drug Administration (FDA) intends to negotiate a sole source acquisition with John Dawson of Bethesda Maryland for statistical evaluation services. The contractor will be tasked with conducting comprehensive statistical review of premarket submissions from manufacturers, including independent analysis of submitted data as needed, backup support for statistical consultation and analysis activities in the Division of Biostatistics, Center for Devices and Radiological Health. 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 in the scope of work. Scope of work includes 1. Conduct comprehensive statistical review of premarket submissions from manufacturers. This shall include 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. These activities include 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 and analysis activities in the Division. Deliverables shall be written statistical reviews of individual submissions. Quarterly summary reports providing status of submissions and progress on projects. Monthly reports showing time expanded on reviews and projects. Qualifications include an advanced degree in Statistics or Biostatistics, experience or training in laboratory or clinical trial design and analysis, the ability to communicate clearly and in writing as well as a clearance to see confidential and proprietary information. The period of performance will be nine months from the day the contract is awarded. Mr. Dawson is the only known source for this requirement because he has unique experience in reviewing premarket medical device applications for the Food and Drug Administration. He has also served on the staff of The Center for Devices and Radiological Health. This experience provides him with the unique knowledge of agency policies, and philosophies and a thorough understanding of the FDA organization. Interested persons may identify their capability to perform the requirement by submitting a quote. This notice of intent is not a request for quotes however, all quotes received by June 6, 2003 will be considered. Simplified Acquisition Procedures will be used for this requirement. Evaluation/Award will be based on the acceptable quote that offers the best value to the government. Offerors will include resumes that state accomplishments in this area. The following provision & clauses apply to this acquisition: 52.212-1, Instructions to Offerors-Commercial Items; and 52.212-3 Offeror Representations and Certifications-Commercial Items. The following clauses apply to this acquisition: 52.212-4, Contract Terms and Conditions-Commercial Items. All offerors must submit the following: 1) a quotation; 2) Resume; and 3) Two (2) copies of the most recent fee schedule. Submission must be received by 3:00p.m. local time on June 6, 2003. No questions will be accepted after 5:00 pm June 2, 2003. Fax and e-mail quotes will be accepted. FAR clauses and provision can be accessed at www.arnet.gov/far. All sources must submit along with their written quotes a nine-digit numeric DUNS number that is assigned by Dun & Bradstreet. To apply for Duns number please call 1-800-333-0505.
 
Place of Performance
Address: Food and Drug Administration, Piccard Drive, Rockville, MD
Zip Code: 20850
 
Record
SN00332681-W 20030529/030527213252 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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