SOLICITATION NOTICE
66 -- UV VIS Pharmaceutical System
- Notice Date
- 7/29/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- 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
- FDA-SOL-09-1060743
- Archive Date
- 8/22/2009
- Point of Contact
- Brendan McCarthy, Phone: 3018274680, Jody L. O'Kash,
- E-Mail Address
-
Brendan.McCarthy@fda.hhs.gov, Jody.O'Kash@fda.hhs.gov
(Brendan.McCarthy@fda.hhs.gov, Jody.O'Kash@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The Food and Drug Administration is soliciting for a Distek Dissolution Apparatus with UV-Vis Pharmaceutical System on a brand name or equal basis, pursuant to FAR 12 and 13. This solicitation is set aside exclusively for small business. The system and software must have the following unique characteristics: 1. Spectrophotometer must be equipped with Chemstation general purpose and advanced UV-Vis Spectrophotometer software which are necessary for the qualitative analysis in Color Additives and the quantitative analysis in Aflatoxin. 2. The software should have the capabilites to change operation levels between manager level and operator level. The manager level must be password protected to have developed methods stored secured for ISO 17025. 3. Equipment must have a wavelength scan range of 190nm - 1100nm, wavelength accuracy of <±0.5 nm, in particular <±0.2 nm at 486.0 and 656.1 nm, and wavelength reproducibility of <±0.02 nm for ten consecutive scans. 4. Must have a Pentium based PC with a minimum of 128 MB RAM, 8x CD-ROM drive, Microsoft Windows NT 4.0, monitor and color printer. 5. Must have a security program that supports the requirements for electronic records and signatures that will be compliant with 21 CFR Part 11 6. Multi cell Transport Based Sampling System. 7. Dissolution Testing Software. 8. UV VIS Sampling System w/one dissolution bath. OP PV test of discrete subsystem performance specifications with documented test results. 9. 500ml Sample Probe. 10. 900ml Sample Probe. 11. OQ PV Standards Kit (1) and (2) for UV Vis. 12. Cell Passivating and Cleaning Fluid 1000ml. 13. Basket Adapter for Evolution Style Basket Serialized 14. Vessel cover clear acrylic w/3 probe holes and large center hole for easy basket access. Includes center cap and O-Ring. 15. Filter in-line for water bath. 16. Filter disks 45 micron 1000 PK HDPE. 17. Basket 40 Mesh Evolution Serialized. 18. Dissolution system IQ for one bath. 19. Caffeine Sample Solution. The government will be evaluating all quotes on a lowest price, technically acceptable basis. All vendors submitting quotes should provide documentation that demonstrates that their product/products meets the necessary technical requirements specified in the solicitation. Business proposals should clearly state the overall cost to the government and state how long the quote is valid. All technical proposals should NOT contain pricing information. (i) 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 the only solicitation; proposals/bids are being requested and a written solicitation will not be issued. This action is set aside 100% for small businesses. Only offers from small businesses will be accepted. (ii) The solicitation number is FDA-SOL-09-1060743. This solicitation is issued as a Request for Quote (RFQ). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-26, June 12, 2008. (iv) This is a firm fixed price requirement. All responsible sources may submit a quote which shall be considered. The associated North American Industry Classification System (NAICS) Code is 334516. (v) An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to finish required representations, or reject the terms and conditions of the solicitation, may be excluded from consideration. FOB Point Destination, with services on-site. Contract type: Commercial Item-Firm Fixed Price. Simplified procurement procedures will be utilized. (vi) The period of performance: Delivery is required 45 days after receipt of order (ARO). FOB Point of Delivery for Services and Supplies provided will be the Food and Drug Administration, 5630 Fishers Lane, Rockville, Md 20857. (vii) The provision at FAR 52.212-1 Instructions to Offerors- Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. (viii) The government is not responsible for locating or securing any information, which is not identified in the submission. 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 their requirements. (ix) Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Items with its offer. (x) The clause at 52.212-4, Contract Terms and Conditions- Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. (xi) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes of Executive Orders-Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-37, 52.225-1, 52.225-3, 52.225-13, and 52.232-33. 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. (xii) A standard commercial warranty on parts and workmanship is required. (xiii) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. (xiv) Applicable Numbered Note(s) 1. (xv) Offers are due in person, by mail, fax or email on or before August 3, 2009, by 4:30p (Eastern Standard Time), at Food and Drug Administration OC/OAGS, Attn: Brendan McCarthy(Office 2009), 5630 Fishers Lane, Rockville, Md. 20857 - ph (301) 827-4680; fax (301) 827-7039, email: brendan.mccarthy@fda.hhs.gov. The contracting officer is Brendan McCarthy. E-mail: brendan.mccarthy@fda.hhs.gov; phone: (301) 827-4680. (xvi) For information regarding this solicitation, please contact either Mr. Brendan McCarthy or Ms. Jody O'Kash. Place of Performance: Food and Drug Administration 158-15 Liberty Avenue Jamaica, New York 11433 United States Primary Point of Contact.: Brendan McCarthy, Contracting Specialist brendan.mccarthy@fda.hhs.gov Phone: (301) 827-4680 Fax: (301) 827-7039 Secondary Point of Contact: Jody O'Kash, jody.o'kash@fda.hhs.gov Phone: (301) 827-5094 Fax: (301) 827-7039
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-09-1060743/listing.html)
- Place of Performance
- Address: Jamaica, New York, United States
- Record
- SN01892454-W 20090731/090730002143-2a173573a495d071eacfe6ecbac3d59d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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