Added: Jun 26, 2008 9:57 am
Modified: Jul 09, 2008 1:53 pm
Track Changes
This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in 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. This requirement is being issued in conjunction with FAR 13.5 Simplified Acquisition Procedures, as applicable. The solicitation number is FDA-SOL-08-00780. This solicitation is issued as a Request for Proposal (RFP).
The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-26.
The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees.
The Food and Drug Administration, National Center for Toxicological Research, Division of Personalized Nutrition and Medicine is developing a strategy and methodology to improve healthcare for individuals. As a part of this plan, the government needs instruments and methodologies for genetic analyses of an individual s ancestry (through genotyping) and capability of analyzing modifications of DNA (epigenomics) which have been implicated in short term and long term health. The proposed system shall be a complete SNP genotyping and gene expression solution for such studies. The system to include components to perform High-Plex Genotyping (whole genome genotyping). The supported system assays/applications to include:
Custom content genotyping
Standard content genotyping
Standard panels for human linkage
Standard panels for mouse linkage
Standard panels for MHC analysis
Standard panels for cancer analysis
Mixed content genotyping
SNP Genotyping Assay Multiplex Level
96- or 384- to 1536-SNP loci multiplexing level from sample preparation to readout using custom genotyping 6,000 to > 655,000 loci in a single reaction using custom genotyping
Call rate routinely > 99%
Reproducibility routinely > 99.7%
Multiplex range
96, 384-1,536 loci assayed in a single reaction
The Gene Expression system shall have the following capabilities:
Supported Assays/Applications
6, 8, or 12 samples per BeadChip for Whole-Genome Expression
16 samples per BeadChip for custom assays
Custom content gene expression
Standard content gene expression
IVT-based gene expression assay
Gene expression profiling from formalin-fixed, paraffin-embedded (FFPE) samples
Gene expression profiling from laser-capture microdissected (LCM) samples
Minimum Sample Input Requirements
50ng total RNA per sample
Array Feature Redundancy
Average 30-fold (minimum of 3-fold) redundancy for every feature type on each array (15-fold for HumanHT-12)
Array Quality Control
Manufacturer quality control for 100% of the features on 100% of arrays (99.99% for HumanHT-12 v3)
Gene Expression Assay: Gene-Specific Probes
Specific 50mer probes designed for each gene, synthesized, and attached to 3-micron beads
Limit of Detection at 99% confidence
0.15 pM
Precision
< 1.3-fold
Dynamic range for two-fold detection
~3 logs
Specificity
< 1:250K
On-site installation and training to be included as part of the proposal.
The system shall meet the following requirements:
1. The system should be a high through-put platform that is a complete SNP genotyping and gene expression solution featuring microarrays configured for standard, custom and whole-genome genotyping applications along with standard, custom and whole-genome focused arrays for gene expression. In addition, it also can be upgraded to perform epigenetic analysis.
2. System requires 250 nanograms or less amount of DNA for genotyping assays
3. The system capable of high specificity of hybridization by allowing ~60 nucleotides or longer as a probe.
4. Custom genotyping on large sample batches should be performed for less than $0.10 per genotyping (including kits and reagents).
5. Scanner resolution of 0.53 micron true spatial resolution with dual-channel collection.
6. Laser excitation 532nm and 658nm and emission spectrum 550-600nm and 677-697nm.
Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized.
FOB Point destination. To be delivered 75 days or less after receipt of order (ARO). Point of Delivery for Services and Supplies will be the FDA/NCTR located at 3900 NCTR Road, Jefferson, AR 72079-9502. Payment terms net 30 days.
Standard commercial warranty is required.
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:
(i) Technical capability of the items offered to meet the Government s requirement.
(ii) Past Performance
(iii) Price.
Technical and past performance, when combined, are significantly more important when compared to price.
Technical acceptability 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 the Government's requirement.
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 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 product and/or service meets the technical requirements. Offerors 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 make an award without discussions.
The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. Offerors shall complete and return a copy of the provision at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items with their offer. If the end product(s) offered is other than domestic end product(s) as defined in the clause entitled "Buy American Act-Supplies," the offeror shall so state and shall list the country of origin.
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.
The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6, 52.219-4, 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, 52.222-50, 52.225-1, 52.225-13, and 52.232-33. The following additional provisions and/or clauses apply: 52.204-7. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov/far/
One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements.
CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system 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 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 internet site for the release of an amendment to the combined synopsis/solicitation (if any).
An official authorized to bind 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.
All responsible sources may submit an offer, which if timely received, shall be considered. The proposal must be submitted on form SF1449 which is attached to this solicitation. The offer must reference solicitation number FDA-SOL-08-00780. The Offers are due in person, by postal mail, fax or email to the point of contact listed below on or before July 10, 2008 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OSS/OFFAS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502.
For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.
