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FBO DAILY ISSUE OF JANUARY 11, 2002 FBO #0040
PRESOLICITATION NOTICE

R -- Statistical Review of Medical Device Premarket Submissions

Notice Date

1/9/2002
 

Notice Type

Presolicitation 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-175506
 

Response Due

2/23/2002
 

Archive Date

3/10/2002
 

Point of Contact

Ida Cofield, Contract Specialist, Phone (301) 827-7156, Fax (301) 827-7151,
 

E-Mail Address

icofield@oc.fda.gov
 

Description

This is a combined synopsis /solicitation for commercial items or 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 and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ No.175506). The solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The Standard Industrial Classification (SIC) Code for this acquisition is 7389 and the NAICS Code is 561990. The Food and Drug Administration (FDA) intends to issue a purchase order for the following service: 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; (1) conduct comprehensive statistical review of medical device 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 of Biostatistics, Office of Surveillance, Center for Devices and Radiological Health. The Deliverables will consist of (1) Written statistical reviews of individual submissions. (2) Quarterly summary reports providing status of submissions and progress on projects. (3) Monthly reports showing time expended on reviews and projects. The Period of Performance shall be one year from date of award. The Payment schedule will be made in monthly installments based on level of effort (hours worked) and acceptance of work by the Government. The Qualifications are (1) Advanced degree in Statistics or Biostatistics. (2) Experience for training in laboratory or clinical trial design and analysis. (3) Ability to communicate clearly orally and in writing. (4) Security clearance to see confidential and proprietary information. The FDA will perform the security clearance. The following FAR Clauses shall apply to this solicitation: 52.212-1 Instructions to Offerors Commercial, 52.212-4 Contract Terms and Conditions Electronic Funds Transfer. All responsible sources that can provide and meet the above requirement shall submit written quotations by mail or fax 301/827-7039. Evaluation/Award will be issued to the offeror whose proposal offers the best value to the government and contractors ability to provide evidence of successfully completing at least three projects of a similar or greater scope with verified references. Quotes submitted in response to this solicitation shall be submitted by January 23, 2002, 4:00 P.M Eastern Standard time to the above referenced address or fax 301/827-7039. FAR provisions can be found at the following website: http://www.arnet.gov
 

Place of Performance

Address: Food and Drug Administration, Center for Devices and Radiological Health, Division of Biostatistics, OSB, Room 110W, 1350 Piccard Drive, Rockville, Maryland,

Zip Code: 20850

Country: U.S.A.
 

Record

SN20020111/00012821-020110090110 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(will not be valid after Archive Date)

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