MODIFICATION
66 -- Environmental Stabiity Chamber
- Notice Date
- 6/28/2011
- Notice Type
- Modification/Amendment
- NAICS
- 423490
— Other Professional Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 11-223-SOL-00097
- Archive Date
- 7/16/2011
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The Food and Drug Administration intends to award a Purchase Order for the supplies listed below. The requirement will be awarded using Simplified Acquisition Procedures in accordance with FAR Part 13.106. 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 are being requested and a written solicitation will not be issued. The solicitation number is 11-223-SOL-00097. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-52, May 31, 2011. This is a 100% small business set-aside. The associated North American Industry Classification System (NAICS) Code is 423490 - Other Professional Equipment and Supplies Merchant Wholesalers; Small Business Size Standard is 100 employees. The Food and Drug Administration (FDA) is soliciting for a Floor Model Stability Chamber for stressing the Shelf Life Extension Program's finished drug product samples at 50°C and 75% RH. The Office of Regulatory Affairs (ORA) has indicated that Scientific Apparatus Services, Inc. BC5600-ICHX system to include the following specifications and features will meet their needs. However, "or equal" quotes will be accepted and evaluated from all interested parties. The system shall be equivalent to the salient characteristics described herein. System Specifications: Model BC5600-ICHX: External dimensions: 56" wide x 34 ¾" deep x 78 ¼" tall. Capacity: 56 cubic feet. Doors: Two double pane Tempered Glass Doors. Six Stainless Steel wire Shelves. Stainless Steel Interior & Exterior Temperature range: 20ºC 60ºC Temperature control: ±0.3ºC Temperature uniformity: ±0.7ºC Humidity range: 50% to 90% RH Humidity control: ±1% Humidity uniformity: ±3% System Features: BioLogicTM color touch screen control interface featuring Ethernet, USB serial communication and web thin client for remote web-based monitoring and control: multi-level password protected access, integrated secure dataloggin 7-day, 10" 2-pen circular paper chart recorder, calibratable with digital display. Precision 3-wire ±0.01% Band 5 wirewound glass-coated platinum 100 ohm RTD temperature sensors. Sensor to come with NIST certification. Self-powered ultrasonic humidifier with independent fan control and distribution plenum to provide superior humidity control and uniformity throughout chamber. Resistive heat for responsive temperature control. Rear wall plenum and high-speed commutated fan motor for positive airflow throughout chamber. One (1) ¾" diameter instrument port. Set of four (4) casters. Qualification package includes: IQ, OQ, and PQ Protocols, as well as preliminary 24 hour temperature and humidity mapping report and sensor verification. Validation protocols to be executed by others. Preliminary mapping report is informal only and is not intended to satisfy chamber mapping requirements as part of the validation process. 115 Volt on 15 amp breaker. Includes inside delivery, installation (Start up and single point calibration, including Hooking unit up to water, electric and drain), and on-site training. Three year warranty on all parts; 2 scheduled MP visits per year for three years. Guaranteed validate-able to FDA/ICH standards. Quotes must include prices for product inclusive of shipping charges. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized. Delivery Address FDA/ORA Philadelphia District Laboratory US Customs House, Room 104 200 Chestnut St Philadelphia, PA 10106 Period of Performance Delivery shall be 60 days or less after receipt of order (ARO). Invoice Submission Invoices shall be submitted in accordance with the following clauses that are incorporated into this contract: 52.232-25, Prompt Payment (OCT 2003), and 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003). The contractor shall submit one (1) original copy of each invoice to the address or email address specified below: Food and Drug Administration Office of Acquisitions and Grants Services Attn: Regina Williams 3900 NCTR Road, HFT-320 Jefferson, Arkansas 72079 Regina.Williams@fda.hhs.gov To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: 1. Name and address of the Contractor 2. Invoice date and invoice number 3. Purchase order number 4. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of supplies delivered 5. Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading 6. Terms of any discount for prompt payment offered 7. Name and address of official to whom payment is to be sent (Must be the same as that in the purchase order or in a proper notice of assignment) 8. Name, title, and phone number of person to notify in event of defective invoice 9. Taxpayer identification number 10. Electronic Funds Transfer (EFT) banking information 11. Name and telephone number of the FDA COR referenced on the purchase order 12. Any other information or documentation required by the purchase order Questions relating to when payment will be received should be directed to the FDA payment office at 870-543-7446. 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. 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 the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: a. Technical capability of the supplies/services offered to meet the Government's minimum requirement to include the depth of warranty and maintenance. b. Price. In determining the best value to the Government, technical capability is more important than price, though price remains a significant factor and must be reasonable and affordable. Technical capability will be determined by review of information submitted by the small business offeror which must provide a description in sufficient detail to show that the product offered meets or exceeds the government's requirement/specifications and that warranty terms and annual maintenance plans provide extensive support and depth of coverage. The Government will evaluate the technical capability factor as to whether the offer meets or exceeds the minimum specifications. The government reserves the right to make an award without discussions. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. The offer shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (o) of this provision. 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. 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: 52.219-6; 52.222-3; 52.222-19; 52.222-21; 52.222-26; 52.222-36; 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 The following additional provisions and/or clauses apply: 52.204-7. 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. The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/vfhhsara.htm. 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Oct 2009) 352.223-70 Safety and Health (Jan 2006) 352.231-70 Pricing of Adjustments (Jan 2001) 352.242-71 Tobacco-Free Facilities (Jan 2006) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the FedBizOpps website for any released amendments to the solicitation. Offerors that fail to furnish required representations, or reject the terms and conditions of the solicitation, may be excluded from consideration. Question Deadline: All questions shall be submitted via email (regina.williams@fda.hhs.gov) on or before June 27, 2011 by 1:00 pm (Central Standard Time). RFQ Due Date: Offers are due in person, by postal mail, or via email on or before July 1, 2011 by 1:00 p.m. (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas), at the Food and Drug Administration/OAGS, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. The offer must reference solicitation number 11-223-SOL-00097.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/11-223-SOL-00097/listing.html)
- Place of Performance
- Address: FDA/ORA, Philadelphia District Laboratory, US Customs House, Room 104, 200 Chestnut St, Philadelphia, Pennsylvania, 10106, United States
- Zip Code: 10106
- Zip Code: 10106
- Record
- SN02484675-W 20110630/110628235133-d6e2b807a57884bd1d0d684945a58d98 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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