SOLICITATION NOTICE
66 -- ELISpot Reader
- Notice Date
- 6/10/2011
- 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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 11-223-SOL-00116
- Archive Date
- 7/5/2011
- 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-00116. This is a 100% small business set-aside. 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) 2005-50, May 16, 2011. The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Introduction The following scope outlines the need for the purchase of an ELISpot reader capable of high sensitivity and accuracy to determine T-cell proliferation as a surrogate marker for the immunogenicity of therapeutic proteins. Generally the signals expected from the foreign peptides in the bioassays are relatively small. Thus the technology requires a machine with both high sensitivity and accuracy to avoid getting either false positive or false negative signals. Background The Center for Biologics Evaluation and Research (CBER) has initiated a new project on the pharmacogenetics of immunogenicity. Our hypothesis is that identical therapeutic proteins may elicit different immunogenic responses in individual patients. Sequence mismatch between the endogenous (albeit nonfunctional) protein and the infused protein and the HLA Class II repertoire of the patient may contribute to these differences in response. The purpose of the ELISpot reader is to determine if the mismatched peptides can stimulate T-cells from the patients own blood (i.e. with the same HLA Class II repertoire). To accurately test this hypothesis which is central to the project CBER requires a reader that is both sensitive and accurate. Scope To test the hypothesis that regions of a therapeutic protein that the patient is not immuno-tolerized to can initiate a T-cell immune response. Based on SNPs found in patients from different ethnic backgrounds determine whether some populations are more likely to elicit an immune response. To determine if some sequences of the recombinant protein (vis-à-vis SNPs) may be safer than others. Technical Requirements Item #1: ELISpot Reader, qty one (1) each. Instrument must be capable of counting ELISpots in 24 well format with a high (2048x1536) pixel resolution. Software must provide for auto centering as well as provide an audit trail. Instrument must be of modular design to allow easy upgrade to fluorescence. Instrument must have a statistics module and generate qualification reports. Provide inside delivery, installation, on-site training, and one year warranty. Optional Items: Three (3) one year options for service maintenance agreement.. Item #2: Option Yr 1 - Service/Maintenance Agreement after initial warranty. Item #3: Option Yr 2 - Service/Maintenance Agreement after expiration of option year 1. Item #4: Option Yr 3 - Service/Maintenance Agreement after expiration of option year 2. Contract type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized. Delivery Address: DH/OBRR/CBER N29 RM311 HFM-340 8800 Rockville Pike Bethesda MD 20892 Period of Performance Delivery shall be 30 days after receipt of award. 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 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. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. 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: 52.203-6; 52.219-6; 52.219-8; 52.219-14; 52.222-3; 52.222-19; 52.222-21; 52.222-26; 52.222-35; 52.222-36; 52.2222-37; 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. 52.217-5 Evaluation of Options (July 1990) 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within anytime prior to expiration of the initial one year warranty for Option Year 1; anytime prior to expiration of the Option Year 1 Service and Maintenance Agreement for Option Year 2; anytime prior to expiration of the Option Year 2 Service and Maintenance Agreement for Option Year 3; Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. 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) 352.242-71 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 14, 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 June 20, 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-00116.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/11-223-SOL-00116/listing.html)
- Place of Performance
- Address: DH/OBRR/CBER, N29 RM 311 HFM-340, 8800 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02470508-W 20110612/110611000011-c5cb80f4207c51bd2cc24cb78405a6aa (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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