Subscription to Market Share information on Medical Devices

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.



The solicitation, FDA-SOL-09-1056386, is issued as a Request for Proposal (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 05-35. The acquisition is set-aside for Small Business. The associated NAICS code is 541910 and small business size standard is $ 7.0 Millions.



The primary purpose of this contract is to request Market Share Information on Medical Devices.



(1) Specifications or other minimum requirements-

This request is for Market Share Reports on Medical Devices. Reports should provide information on all types of medical devices (cardiovascular, dental, orthopedic, radiologic, in vitro diagnostic, ophthalmic, ENT, plastic surgery, general surgery, urology, ob/gyn, gastroenterology, renal, neurological, general hospital, physical medicine, anesthesia and respiratory devices.



The information should include manufacturers and brand names, brand specific market share information trended over time, description of devices, analysis of disease prevalence, upcoming innovation, current development status, device risks and benefits, information on related clinical trials, and company profiles.



The data should be provided in databases or text/table reports. Reports should be updated approximately every 2 yrs.



(2) Quantities

FDA requests a one year full agency access subscription to the market share information. Each report should be comprehensive, approximately 300 pages of description, tables and analysis. FDA will need more than 20 reports per year.



(3) Performance dates, including a deliverables schedule and option periods;

The information should be available on the purchase date and continue to be available for one year. We would also like the option to extend the contract on a yearly basis for 4 additional years.



(4) Time and place of performance of services;

The reports should be available on line, both as requested and as available.



(5) Quality

The data contained in the market share reports should be current (less than 2 yrs old) and comprehensive. The research should be extensive and include data from clinicians, researchers and industry insiders.



Period of Performance: One (1) Year with Four (4) Option Year

Base Year September 01, 2009 August 30, 2010

Option Year One (1) September 01, 2010 August 30, 2011

Option Year Two (2) September 01, 2011 August 30, 2012

Option Year Three (3) September 01, 2012 August 30, 2013

Option Year Four (4) September 01, 2013 August 30, 2014



Location: 10903 New Hampshire Avenue, Building WO66, Silver Spring, MD 20993



Evaluation Criteria

Award will be made to the offeror who is deemed most responsive, whose proposal conforms to all requirements, and is judged to represent the best value. To conduct a best value assessment, FDA will evaluate the offerors proposal submission based on Technical Elements, Price as described below. As this is a best-value selection, the government may make tradeoffs in the factors below to arrive at a best value decision.



Technical Approach:

The Offeror shall, through a detailed technical proposal, be able to thoroughly explain the product the Government is seeking to obtain through this requirement. The Offeror, through its proposal, shall explain how it intends to provide the requested services within the given time frame and in the most efficient and cost- productive manner. The reports should provide information on all types of medical devices (cardiovascular, dental, orthopedic, radiologic, in vitro diagnostic, ophthalmic, ENT, plastic surgery, general surgery, urology, ob/gyn, gastroenterology, renal, neurological, general hospital, physical medicine, anesthesia and respiratory devices. The Offeror must also show in its proposal the efforts required by the Government in order for the contractor to complete this task. Offerors must demonstrate that their share of savings reflects the risks involved and market conditions.

Price:

FDA will evaluate the offeror's submission/proposal on their ability to provide support at a reasonable and realistic price (to include any discounts offered).

OFFEROR MUST COMPLETE AND SUBMIT WITH ITS QUOTE, FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (JUL 2009), WHICH ARE AVAILABLE ELECTRONICALLY AT: http://www.arnet.gov/far/current/html/52_212_213.html. The clause at FAR 52.212-4 (Mar. 2009), Contract Terms and Conditions Commercial Items and FAR 52.212-5 (Jun. 2009), Contract Terms and Conditions required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. The additional FAR clauses cited in the clause are applicable to the acquisition: (1) 52.203-6 Restrictions on Subcontractor Sales to the Government, with Alternate I (Sep. 2006), (2) 52.219-8, Utilization of Small Business Concerns (May 2004), (3) 52.219-14, Limitations on Subcontracting (DEC 1996), (4) 52.222-21 Prohibition of Segregated Facilities (FEB 1999), (5) 52.222-26 Equal Opportunity (MAR 2007), (6) 52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006), (7) 52.222-36 Affirmative Action for Workers and Disabilities (JUN 1998), (8) 52.222-37 Employment Reports on Special Disabled Veterans, Veterans on the Vietnam Era, and Other Eligible Veterans (Sept 2006) (9) 52.222-19 Child Labor-Cooperation with Authorities and Remedies (Feb 2008) (10) 52.225-13 Restrictions on Certain Foreign Purchases (June 2008) (11) 52.232-33 Payment by Electronic Funds Transfer (Oct 2003). (12) 52.204-7 Central Contractor Registration (Apr 2008). (13) 52.217-7 Option for Increased QuantitySeparately Priced Line Item (Mar 1989) (14) 52.217-8 Option to Extend Services (Nov 1999). (15) 52.217-9 Option to Extend the Term of the Contract (Mar 2000)..



Technical Proposal shall be no more than 25 pages. Award will be made to the offeror providing best value to the Government in consideration of cost and technical proposal. The Contract Specialist must receive any questions no later than August 05, 2009. An original and 3 copy of the offerors cost and technical proposal shall be received on or before 3:00 P.M. local time, August 14, 2009 at Food and Drug Administration 5630 Fishers Lane Rockville, MD 20857. For information regarding this solicitation, please contact Jeankite Joseph, at 301-827-5095, Fax 301-827-7106, or email: jeankite.joseph@fda.hhhs.gov