PRESOL | R | Post-Approval Studies Workshop

FBO DAILY ISSUE OF JUNE 15, 2008 FBO #2393
SOLICITATION NOTICE

R -- Post-Approval Studies Workshop

Notice Date: 6/13/2008
Notice Type: Presolicitation
NAICS: 611430 — Professional and Management Development Training
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: 1043450-45-2605
Archive Date: 7/12/2008
Point of Contact: Jeankite Joseph,, Phone: 301-827-5095, Gwen Y Hubbard,, Phone: (301) 827-7172
E-Mail Address: jeankite.joseph@fda.hhs.gov, gwendolyn.hubbard@fda.hhs.gov
Small Business Set-Aside: N/A
Description: 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; quotes are being requested and a written solicitation will not be issued. The Food and Drug Administration is soliciting for Post-Approval Studies Methodology Workshop and Post-Approval Studies Implementation Workshop. This procurement is a firm fixed price requirement - reference number, 1043450 – 45 – 2605. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 05-25. The associated NAICS code is 611430 and small business size standard is $ 6.5 Millions. Project Purpose: The goal of this specific workshop is to increase CDRH ability to make scientifically sound decisions by designing high quality studies that will answer important post-market questions and be executed efficiently and to facilitate a comprehensive discussion on challenges and opportunities in the conduct of post-approval studies. In order to achieve that goal, the workshop must bring experts from the relevant fields (medical device manufacturers, academia, third party researchers and regulatory experts) together to discuss these issues. Scope of Work: Provide professional services to organize, recruit non-CDRH participants, host, facilitate, and document the workshop. Tasks for the workshop: 1.The length of workshop will be two days. The dates will be determined by the contractor in consultation with the Project Officer. 2.Working with the Project Officer, the contractor will identify invitees, sent out invitations letters. 3.At least two weeks prior to the workshop, participants of the workshop will be sent background material to review. One copy of the background materials will be provided to the contractor by the Project Officer. 4.The contractor will set up an appropriate meeting space. 5.The contractor will provide and set up the required audiovisual and printed agendas. 6.Workshop will begin in the morning with presentations covering the background materials. The contractor will facilitate all sessions allowing for the dialogue and exchanges of ideas and comments. In the evening the contractor will prepare synopsis of day’s events. The second morning the contractor will present a list of action items, followed by discussions by all attendees. 7.The contractor will deliver a report (Microsoft Word format) to the Project Officer within one month of the workshop. The contractor will have the option of including their own recommendations. 8.The contractor will send to each participant and post on its website an FDA-approved electronic report of the workshop. Any further publication will be jointly agreed to by the Project Officer and contractor. Period of Performance: September 15, 2008 through August 31, 2009 OFFEROR MUST COMPLETE AND SUBMIT WITH ITS QUOTE, FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS – COMMERCIAL ITEMS (June 2008), WHICH ARE AVAILABLE ELECTRONICALLY AT: http://www.arnet.gov/far/current/html/52_212_213.html. The clause at FAR 52.212-4 (Feb 2007), Contract Terms and Conditions – Commercial Items and FAR 52.212-5 (June 2008), 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 (JUL 1995), (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). 52.204-7 Central Contractor Registration (Apr 2008). Award will be made to the offeror providing the lowest price system that meets all technical specifications and the best value to the Government. The quote shall be received on or before 4:00 P.M. local time, 27 June, 2008 at the Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, HFA-500, 5630 Fishers Lane Rockville, MD 20857, Attention: Jeankite Joseph. For information regarding this solicitation, please contact Jeankite Joseph, at 301-827-5095, Fax 301-827-7106, or email: jeankite.joseph@fda.hhhs.gov
Web Link: FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=c210b725ef9258d1e2a39a906898e59f&tab=core&_cview=1)
Place of Performance: Address: 1350 Piccard Drive, Rockville, Maryland, 20850, United States; Zip Code: 20850
Record: SN01593491-W 20080615/080613220534-c210b725ef9258d1e2a39a906898e59f (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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R -- Post-Approval Studies Workshop