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The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-57 dated March 15, 2012.
The associated North American Industry Classification System (NAICS) Code is- 325413- In-Vitro Diagnostic Substance Manufacturing; Small Business Size Standard is 500 employees and is issued as full and open competition.
The U.S. Food and Drug Administration (FDA), the National Center for Toxicological Research (NCTR) requires DNA Methylation Microarrays, Labeling and Hybridization Reagents.
The Center for Functional Genomics within NCTR requires rat DNA methylation microarrays and reagents for high quality and sensitive detection of DNA methylation changes to meet the research projects and protocols needs of the Center. The project is for genetic and epigenetic mechanisms for sex differences in the kidney of a rat model system: developing safety biomarkers for FDA regulated products. This study requires that data obtained by microarrays be of highest quality to determine DNA methylation changes in the kidney of a rat model over the 2 year period to assist the FDA in evaluating drug research. Various sex differences in renal disease, renal disease progression, and susceptibility to acute renal failure following surgery have been noted, including age of onset and severity. There is an urgent and unmet need for mechanistic insight to understand and address these sex differences in clinical renal injury and any potential interaction of age with sex. Understanding these differences will aid in the development of biomarkers and therapeutic interventions, as well as identify potential safety issues. Sex- and age-associated differences in gene expression patterns, as well as expression regulatory elements such as microRNA and DNA methylation, will be examined in the kidney in both sexes throughout the life cycle in the rat model system. The arrays with enzyme labeling hybridization reagents, array processing and accessories must meet the following requirements:
• The DNA methylation microarrays must contain at least 385,000 unique probes in order to provide comprehensive coverage throughout the rat genome.
• These DNA methylation microarrays must have high sensitivity and specificity in order to readily detect as low as two methylated CpGs in a 500 base pair (bp) fragment.
• The DNA methylation array reagents must allow low sample input of 10 ng (nanogram) or less genomic DNA per labeling reaction without amplification bias.
• The microarray reagents must utilize a dye source for direct labeling method and hybridization for optimal microarray performance.
• These arrays must be compatible with the Government's existing G2505C Agilent microarray scanner and the Government's long-term experience with the glass-slide based microarray format. The slides must fit a 1"x3" glass slide format for fluorescent image scanning with barcode labels.
• The manufacturer must provide quality kits for the conduct of these experiments and, in addition, provide detailed experimental protocols.
Rat DNA methylation microarrays for 90 samples with accompanying enzyme labeling and hybridization reagents and array processing accessories.
FOB Point Destination. To be delivered 50 calendar days or less after receipt of order (ARO) FOB Point of Delivery for Services and Supplies will be the FDA/NCTR located at 3900 NCTR Road, Jefferson, AR 72079. Payment terms net 30 days after government acceptance.
Schedule of Items:
1. Rat DNA methylation microarrays (1 x 3 inch glass slides in a kit) with accompanying enzyme labeling and hybridization reagents and array processing accessories. Quantity 90. Unit Price $________, Total Price $____________
Contract clauses-
The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (FEB 2012), applies to this acquisition. The following addenda have been attached to the clause.
The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/
52.204-4 Printed or Copied Double-Sided on Recycled Paper.(MAY 2011)
52.204-7 Central Contractor Registration. (FEB 2012)
The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.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
352.231-71 Pricing of Adjustments JAN 2001
352.242-71 Tobacco-Free Facilities JAN 2006
The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.
The COR for this order is: to be completed at time of award.
The COR is responsible for:
(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;
(2) Interpreting the statement of work and any other technical performance requirements;
(3) Performing technical evaluation as required;
(4) Performing technical inspections and acceptances required by this contract; and
(5) Assisting in the resolution of technical problems encountered during performance.
The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:
(1) Direct or negotiate any changes in the statement of work;
(2) Modify or extend the period of performance;
(3) change the delivery schedule;
(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or
(5) Otherwise change any terms and conditions of this contract.
Invoice Submission
The contractor shall submit one (1) original copy of each invoice to the address specified below:
FDA/OC/OA/OFO/OFS
Attn: division of payment services
3900 NCTR road, HFT-324
Building 50, 6th floor suite 616
Jefferson, AR 72079
Fax 870-543-7224
An electronic invoice can be emailed to the following address:
[email protected]
Invoices submitted under this contract must comply with the requirements set forth in far clauses 52.232-25 (prompt payment) and 52.232-33 (payment by electronic funds transfer - central contractor registration) and/or other applicable far clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:
(i) Name and address of the contractor;
(ii) Invoice date and invoice number;
(iii) Purchase order/award number;
(iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;
(vi) Terms of any discount for prompt payment offered;
(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)
(viii) Name, title, and phone number of person to notify in event of defective invoice;
(ix) Taxpayer identification number (tin);
(x) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;
(xi) name and telephone number of the FDA contracting officer technical representative (COR) or other program center/office point of contact, as referenced on the purchase order; and
(xii) Any other information or documentation required by the purchase order/award.
An electronic invoice is acceptable if submitted in adobe acrobat (pdf) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.
Questions regarding invoice payments should be directed to the FDA payment office at a telephone number provided above.
Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042.
The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (MAR 2012) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6 alt I, 204-10, 209-6, 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, 52.222-40, 52.223-15, 52.223-16, 52.223-18, 52.225-5, 52.225-13, and 52.232-33.
Solicitation provisions
Contract Type: Commercial Item-Firm Fixed Price.
The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been attached to this provision:
Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012.
The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) 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 quotes:
(i) Technical capability of the items/services offered to meet or exceed the Government's requirement.
(ii) Price.
Technical is significantly more important when compared to price in determining the best value to the government; however price remains a significant factor and must be affordable.
Technical capability will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered items and components meet the technical requirements identified above. Offerors shall specifically address the specifications stated above as well as technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror.
The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Include the firms DUNS number with quote.
(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 government reserves the right to make an award without discussions.
The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (MAR 2012), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov.
CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system before an award could be made. 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).
Offerors that fail to complete the 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 offer must reference solicitation number 1100668. The offers are due in person, by postal mail or email to the point of contact listed below on or before April 2, 2012 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, 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 [email protected].