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FBO DAILY ISSUE OF AUGUST 04, 2006 FBO #1712
SOLICITATION NOTICE

66 -- Base Spray View and MDx systems

Notice Date
8/2/2006
 
Notice Type
Solicitation Notice
 
NAICS
541710 — Research and Development in the Physical, Engineering, and Life Sciences
 
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Field Finance and Acquisition Services, Jefferson Laboratories, Attn: Division of Contracts and Acquisitions, HFT-322 3900 NCTR Road, Jefferson, AR, 72079-9502
 
ZIP Code
72079-9502
 
Solicitation Number
FDA-SOL-06-00297
 
Response Due
8/17/2006
 
Description
(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, in conjunction with FAR 13.5, and 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. (ii) The solicitation number is FDA-SOL-06-00297. This solicitation is issued as a Request for Proposal (RFP). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-11, July 5, 2006. (iv) This is a firm fixed price requirement. The associated North American Industry Classification System (NAICS) Code is 541710 Research and Development in the Physical, Engineering, and Life Sciences, Small Business Size Standard 500 Employees. (v) The Food and Drugs is soliciting for an: a. Integrated sheet laser-high speed CCD camera system to perform automated, non-impaction spray pattern and plume geometry measurements of nasal and oral (pMDI) inhalation products; b. Electric actuation system capable of independently controlling velocity, acceleration and stroke length for nasal and oral (pMDI) spray to be used either as an integrated part of item or as a stand alone unit. An acceptable product will consist of either one actuator for each inhalation product type (nasal spray or pMDI) or a single unit capable of actuating both product types. c. Integrated software to control actuator(s) and data acquisition system (item 1), collect and store data in easily retrievable form and analyze data per FDA Nasal BA/BE Guidance. d. Installation and training for a through c. Scheduled items include: Image Therm Engineering Base Spray View System and MDx standalone actuation system ?OR EQUAL? to be used either as an integrated actuator in the Spray VIEW NOSP or as a standalone unit and to perform spray pattern and plume geometry measurements of nasal and oral sprays description as follows: Base Spray VIEW System to perform spray Pattern and plume geometry measurements of Nasal and oral sprays. 1. 2200-NA Spray VIEW NOSP Hardware 1 Each 2. 2200-E Spray VIEW NOSP Encompass Software ? Includes downloadable version released bug fixes and patches 1 Each 3. 22200-IQOQ-E Spray VIEW NOSP System - Installation & Operational Qualification 1 Each 4. 2200-TS1 Spray VIEW NOSP Hardware/ Software Technical Call-In support, 1 year term. Includes telephone and web-based diagnostics for remote troubleshooting for trained users. 1 Each MDx standalone actuation system to be Used either as an integrated actuator in The Spray VIEW NOSP or as a standalone Unit. 5. 1300-NA MDx Hardware 1 Each 6. 1300-E MDx Encompass Software- Includes downloadable version released bug fixes and patches. 1 Each 7. 1300-IQOQ-E MDx Acquisition System ? Installation & Operational Qualification 1 Each 8. 1300-TS1 MDx Hardware/Software Technical Call-In Support, 1 year term. Includes telephone and web-based diagnostics for remote troubleshooting for trained users. 1 Each Software 9. 6000-DB Encompass Database Server Software ? Includes downloadable Version released bug fixes and patches 1 Each 10. 6000-UL-1U Encompass Software Single User License 2 Each 11. 7000-TR Training ? Hands on training on hardware and software usage, system operation, and safety. 3 Each FOB Point Destination, with services on-site. Provide a new Base Spray VIEW System to perform spray pattern and plume geometry measurements of nasal and oral sprays; MDx standalone actuation system to be used either as an integrated actuator in the Spray VIEW NOSP or as a standalone unit; Support Software, Training as listed in items 1 through 11 above to the FDA CDER, Division of Pharmaceutical Analysis in St. Louis, Missouri. An official authorized to bid the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. (vi) Contract type: Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized. (vii) FOB Point Destination. To be delivered 90 days or less after receipt of order (ARO). FOB Point of Delivery for Services and Supplies provided will be the FDA CDER, Division of Pharmaceutical Analysis located at 1114 Market Street, St. Louis, Missouri 63101-2045. (viii) The provision at FAR 52.212-1 Instructions to Offerors ? Commercial Items applies to this solicitation. The following agenda have been attached to this provision: None. (ix) The provision at FAR 52.212-2 Evaluation ? Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the item offered to meet the Government requirement; (ii) past performance (see FAR 15.304); (iii) price. Technical and past performance, when combined, are equal when compared to price. The technical evaluation will be determination as to whether the proposed contractor is capable of completing the work. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure sufficient information is available, vendors must furnish as part of their proposal all descriptive material (such as cuts, illustration, drawings, or other information) necessary for the government to determine whether the product meets the technical requirements. If the vendor proposes to modify a product so as to make it conform to the requirement of this solicitation the vendor shall include a clear description of such proposed modifications and clearly mark any descriptive materials to show modifications. Past performance will be evaluated based on information provided by the offeror as to actual sales of the proposed products to industry or government agencies. Past performance will consider the ability of the items to meet technical specifications as advertised by the offeror, past record of meeting delivery schedules and service/maintenance reputation. The government will award a contract to the offeror whose offer conforms to this solicitation and will be most advantageous to the government, price and other factors considered. The government reserves the right to make an award without discussions. (x) Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications ? Commercial Items with its offer. (xi) The clause at 52.212-4, Contract Terms and Conditions ? Commercial Items, applies to this acquisition. The following agenda have been attached to the clause: None. (xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders ? Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52,222-35, 52.222-36, 52.222-37, 52.222-39, 52.225-3, 52.225-13, and 52.232-33, 52.232-34. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov. CCR Requirement - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. (xiii) A standard commercial warranty on parts and workmanship is required. (xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. (xvi) Offers are due either in person or by fax on or before August 17, 2006 by 1400 hours (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas), at Food and Drug Administration/OC/OSS/OFFAS 3900 NCTR Road, Jefferson, AR 72079-9502. (xvii) For information regarding this solicitation, please contact Barbara Arnold @ (870) 543-7483, FAX (870) 543-7990, email Barnold@fda.hhs.gov.
 
Place of Performance
Address: 1114 Market Street, St Louis, MO 63101,
Zip Code: 63101-2045
Country: UNITED STATES
 
Record
SN01104002-W 20060804/060802220354 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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