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FBO DAILY ISSUE OF JUNE 26, 2004 FBO #0943
SOLICITATION NOTICE

A -- OFF-SITE NON-PERSONAL SERVICE CONTRACT TO PROVIDE SUPPORT FOR CLINICAL RESEARCH STUDY CIP#S-04-123

Notice Date

6/24/2004
 

Notice Type

Solicitation Notice
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1 38400 Bob Wilson Drive, San Diego, CA, 92134-5000
 

ZIP Code

92134-5000
 

Solicitation Number

N00259-04-T-0038
 

Response Due

6/29/2004
 

Archive Date

7/14/2004
 

Point of Contact

Domingo Custodio, Contract Specialist, Phone 619-532-8106, Fax 619-532-5596, - Frank Aspuria, Supervisory Contract Specialist, Phone 619-532-8093, Fax 619-532-5596,
 

E-Mail Address

dbcustodio@nmcsd.med.navy.mil, fcaspuria@nmcsd.med.navy.mil
 

Small Business Set-Aside

Total Small Disadvantage Business
 

Description

The proposed contract action is for supplies or services for which the Naval Medical Center San Diego intends to solicit with only one source under the authority of FAR 6.302. Interested contractors/persons may identify their interest and capability to respond to the requirement or submit quotations. This notice of intent is not a request for competitive quotations. However, all quotes received by June 29, 2004, 3:00 pm., Pacific Standard time, will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number, N00259-04-T-0038 is issued as a request for quotation (RFQ). The North American Industry Classification System (NAICS) Code for this acquisition is 325412, Size: 750. This procurement is a small purchase, small business set-aside solicitation. Clin 0001. Off-Site Non-Personal Service Contract to provide support for clinical research study CIP# S-04-123 ?A Prospective Study Assessing the Efficacy of Nutritional Supplement N-Acetyl-Cysteine in the Treatment of Acute Acoustic Trauma? including packaging, labeling, and shipping study kits to specified study site locations. Also will provide the study active drug, N-Acetylcysteine (NAC) for a total of 21,600 capsules or 90 doses for 240 kits IAW the Statement of Work for the period of 01 July 2004 through 30 June 2005. QTY: 1, Unit of Issue: LO @ $ ______ = $ ______. STATEMENT OF WORK: THE CONTRACTOR SHALL PERFORM THE FOLLOWING SERVICES: -Interface with study clinical research organization manager: Duke research Clinical Research Institute (DCRI) for study drug preparation. -Must provide study drug packaging and shipment. -Must provide study drug requirements as directed from the Principal Investigator and DCRI. -Has already provided consulting services and sucessfully assisted the US Navy to initiate other drug trial investigations (protocol CIP S-03-082) -Assistance in FDA filing for study drug as needed. -Must provide study drug N-acetyl-L-cysteine (NAC) as follows: Provide 240 Drug Study Participation Kit construction. Provide 90 Doses for 240 Subjects (21,600 capsules). Must package, label, and ship to specified locations as detailed by DCRI Must follow-up with DCRI for confirmation of delivery QUALIFICATIONS; -Contractor must have unique pharmacokinetic knowledge and experience, especially with the study drug. Must have contacts and preferred pricing on sourcing target compound. Shall provide target compounds from the manufacturer that qualifies under Good Manufacturing Practices (GMP). Must have uniquerelationships with manufacturers of taget compounds and products. Must have unique and exceptional experience in clinical trial organization and trail execution. Must have a history of delivery of high quality products and exceptional service on multiple levels to NMCSD. Must be registered with the Duns and Bradstreet and with the Central Contractor Registry (CCR). SECURITY: No security clearance is needed for contractor PLACE OF PERFORMANCE: As per protocol. INSPECTION AND ACCEPTANCE: Work is reviewed by GPOC for precision of system performance, completeness of work, and for applicability to ONR and DOD Spatial Orientation Center?s (DSOC?s) research objectives. Government Point of Contact (GPOC) will be Dr. Ronald Jackson (619) 532-9840. The solicitation document and incorporated provisions and clauses are those in effect through FAC 2001-24. This acquisition incorporates the following FAR clauses: 52.212-1 Instruction to Offerors-Commercial Item (JAN 2004) 52.212-3 Offeror Representations and Certification--Commercial Items , JAN 2004 52.212-4 Contract Terms and Conditions--Commercial Items OCT 2003 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items, JAN 2004 52.222-3 Convict Labor , JUN 2003 52.222-19 Child Labor -- Cooperation with Authorities and Remedies JAN 2004 52.222-21 Prohibition Of Segregated Facilities FEB 1999 52.222-26 Equal Opportunity, APR 2002 52.222-35 Equal Opportunity For Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans DEC 2001 52.222-36 Affirmative Action For Workers With Disabilities JUN 1998 52.222-37 Employment Reports On Special Disabled Veterans, Veterans Of The Vietnam Era, and Other Eligible Veterans DEC 2001 52.252-2 Clauses Incorporated By Reference FEB 1998 252.204-7004 Alt A Required Central Contractor Registration Alternate A, NOV 2003 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items DEC 2003 252.225-7002 Qualifying Country Sources As Subcontractors APR 2003 252.232-7003 Electronic Submission of Payment Requests DEC 2003 52.212-2, Evaluation ? Commercial Items (JAN 2004), the following factors shall be used to evaluate offers: 1) Past performance 2) Fully qualified clinical research technicians based on SOW ) Price. Past performance and qualified clinical research technicians qualifications based on SOW when combined has more importance than cost or price. Prior to Contract Award, the government reserves the right to review the resumes of contractor employees performing under the contract solely for the purpose of ascertaining their qualifications relative to the personnel qualifications terms of the contract. Accordingly, the contractor shall furnish such resumes and all professional requirements as stated in the Statement of Work (SOW) to the Contract Specialist along with their quote. All responsible sources may submit a quote which shall be considered. All interested bidders must submit quotation to Domingo B. Custodio, Naval Medical Center San Diego, Material Management Dept., Acquisitions Division, 34800 Bob Wilson Drive, San Diego, CA 92134, or by FAX (619) 532-5596 or by e-mail to dbcustodio@nmcsd.med.navy.mil.
 

Place of Performance

Address: NAVAL MEDICAL CENTER, 34800 BOB WILSON DRIVE, SAN DIEGO, CA,

Zip Code: 92134

Country: USA
 

Record

SN00609720-W 20040626/040624212459 (fbodaily.com)
 

Source

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

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