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FBO DAILY ISSUE OF AUGUST 30, 2008 FBO #2469
SOLICITATION NOTICE

70 -- Use of Gene Expression Biomarkers in Preclinical Toxicolgy Studies

Notice Date

8/28/2008
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

334111 — Electronic Computer 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-08-1043888
 

Archive Date

9/20/2008
 

Point of Contact

Cheryl Francine Frazier,, Phone: 301-827-7182, Jody L. O'Kash,, Phone: 301-827-5094
 

E-Mail Address

cheryl.frazier@fda.hhs.gov, Jody.O'Kash@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

(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. (ii) The solicitation number is FDA-SOL-08-1043888. (iii)This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-26. (iv)The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 a small business size standard of 500 employees. (v) The DHHS FDA Office of Acquisitions and Grants Services requires the following items, Brand Name or Equal, to the following: Description of item: Affymetrix GeneChip Scanner CGCS3000 7G System: Description of requirement: WORK STATEMENT: SPECIFICATIONS: 4.1 The instrumentation must include all pieces of specialized, fully integrated equipment necessary for conducting whole genome microarray assays that are not general laboratory equipment and that are all compatible with the same format of high-density microarray. The integrated instrumentation needs to include a microarray scanner, fluidics station, hybridization oven, and computer workstation with operating system software. 4.2 The instrumentation must be compatible with high density microarrays for gene expression analysis of tissues from laboratory animal species routinely used for preclinical toxicology studies, including the rat, mouse, pig, and dog. 4.3 The instrumentation must be compatible with high density microarrays available from commercial sources. 4.4. The microarray scanner must include a solid-state laser that can produce high resolution fluorescence scans at submicron level pixel resolution or a detection system with equivalent resolution. The fluidics station must automatically process multiple microarrays at a time, with precision delivery of washing and staining solutions. The hybridization oven must process at least 20 arrays at a time, with a precision of 0.5°C at the calibration set point and an operating range from 30 to 60°C. The computer workstation must be preloaded with (1) operating system software for the scanner and fluidics station, (2) annotations for all commercially available versions of the manufacturer’s microarrays, (3) software for microarray quality control analysis, and (4) software for different signal extraction algorithms. The order must include installation, training, instruction manuals, and one-year warranty. Training in use of software and equipment for up to 5 people at a government site. (1) Vendors are expected to submit literature supporting their data quality based on results in "transparent, peer-reviewed comparisons involving multiple laboratories and platforms, such as those conducted by the MicroArray Quality Consortium and published in Nature Biotechnology 24, 1151-1161 (2006). The required level of technical consistency could be demonstrated by coefficient of variations of 7.5% or less of quantitative signal values between intrasite and intersite replicates. The required level of accuracy could be demonstrated by good correlation (r2 ≥ 0.90) of log2 ratios with data generated using polymerase chain reaction technology such as TaqMan." 4.5. The equipment must generate data comparable to the quality of data that we have previously generated on Affymetrix microarrays for on-going division programs on cardiac and skeletal muscle toxicity. The data must be comparable because these studies cannot be repeated without prohibitive cost to the agency (estimated at over $25,000) due to the expensive nature of the consumables (enzymatic labeling kits and microarrays). (1) For vendors that meet all the requirements / specifications set forth in the statement of work, systems will be ranked on the demonstrated level of technical consistency and accuracy in transparent, peer-reviewed comparisons involving multiple laboratories and platforms, such as those conducted by the MicroArray Quality Consortium and published in Nature Biotechnology 24, 1151-1161 (2006). The measurements to be reported are the coefficients of variation of quantitative signal values between intrasite and intersite replicates and the Pearson correlation coefficients (for log2 ratios) with data generated using polymerase chain reaction technology such as TaqMan. Selection between vendors that demonstrate equivalent levels of technical consistency will be based on the system cost. 4.6. The equipment must meet projected program needs by possessing the capacity to conduct genotyping assays or high density gene mapping of single nucleotide polymorphisms (SNPs), or be upgradable to that capacity. 4.7. The instrumentation for expression analysis must not require the filtering and monitoring of laboratory air for ozone levels in order to achieve optimal performance because that would require costly modifications to our current laboratory structure. Contract Type: Commercial Item- Firm Fixed Price. FOB Point destination. FOB Point of Delivery for supplies will be at FDA, located 10903 New Hampshire Avenue, Silver Spring, MD. 20903. Payment terms net 30 days. 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: 1. 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/service offered meets the Government's requirement 2. Price. Technical Capability and Price are of equal importance. 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 -- Restrictions on Subcontractor Sales to the Government.(Sept 2006) 52.219-8 -- Utilization of Small Business Concerns. (May 2004) 52.222-19 -- Child Labor—Cooperation with Authorities and Remedies. (Feb 2008) 52.222-21 -- Prohibition of Segregated Facilities. (Feb 1999) 52.222-26 -- Equal Opportunity. (Mar 2007) 52.222-35 -- Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans. (Sept 2006) 52.222-36 -- Affirmative Action for Workers With Disabilities. (Jun 1998) 52.222-37 -- Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans. (Sept 2006) 52.222-39 – Notification of Employee Rights Concerning Payment of Union Dues or Fees. (Dec 2004) 52.222-50 -- Combating Trafficking in Persons. (Aug 2007) 52.225-13 -- Restrictions on Certain Foreign Purchases. (Jun 2008) 52.232-33 -- Payment by Electronic Funds Transfer--Central Contractor Registration. (Oct 2003) Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov/far/. The contractor shall forward invoices to the DHHS/FDA/Accounting Operations Branch, 12345 Parklawn Drive, HFA -720, Rockville, MD. 20857, Customer Service 301-827-3742 or 866-807-3742. 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. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). 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 shall be considered. The offer must reference solicitation number FDA-SOL-08-1043888. The Offers are due in person, by postal mail, fax or email to the point of contact listed before 5:00 pm (1700) EST on September 5, 2008. at the Food and Drug Administration, OC/OAGS, Attn: Cheryl Frazier, 5630 Fishers Lane, Room 2130, Rockville, Maryland 208 rm. 2130, Rockville, Maryland. 20857.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=b4771d4a32ce4a85911ee4ff37bdb20e&tab=core&_cview=1)
 

Place of Performance

Address: Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20903, United States

Zip Code: 20903
 

Record

SN01654903-W 20080830/080828223901-b4771d4a32ce4a85911ee4ff37bdb20e (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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