SOLICITATION NOTICE
A -- OpenArray Multiplex Testing
- Notice Date
- 7/18/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- 1104392
- Archive Date
- 8/15/2012
- Point of Contact
- Marcia O Park, Phone: (870) 543-7405
- E-Mail Address
-
marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Part 13 and the format in FAR Part 13.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number is 1104392, and is being issued as a Request for Quotations. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-58, dated May 18, 2012. The associated North American Industry Classification System Code is 541711 Research and Development in Biotechnology with a small business size standard of 500 employees. This acquisition is not set aside for small businesses. Objective: The Food and Drug Adminstration's Division of Emerging and Transfusion Transmitted Diseases of the Office of Blood Research and Review (FDA/DETTD/OBRR) requires a contractor assemble an OpenArray platform that will process as many as 60 nucleic acid specimens simultaneously with an input sample extracted from blood of approximately a microliter. The Open Array must be capable of as many as 56 real time fluorescent amplification reactions for the purpose of detecting pathogens that may contaminate blood in each specimen. Background Nucleic acid detection of pathogens in blood products to increase the safety of transfusion has proven to be the most sensitive and efficient method. However, with the number of pathogens recommended by the FDA for testing in blood donations and the constant threat of newly emerging pathogens, the number of individual tests performed on each product unit is becoming burdensome and delays the process of fresh blood products reaching the patients in urgent need. To solve this problem, multiplex Nucleic Acid Tests (NATs) have been developed. To date the highest number of pathogens that can be assayed in one multiplex test licensed for blood screening is three, HIV, HCV, and HBV. One commercial test can assay five targets some of which come from the same pathogen. New technology must be developed that can achieve higher levels of multiplicity. Under a previous contract, Life Technologies Corp. successfully assembled and tested, an initial custom Blood Pathogen Detection Open Array that was able to correctly identify, HIV, HCV, HBV, WNV, Trypansoma cruzi, Leishmania, Plasamodium, E. coli, and Yersinia enterocolitica, in pathogen spiked blood or plasma specimens with a sensitivity and specificity comparable to commercially available individual NCT assays for these pathogens. Under a subsequent contract, Life Technologies, Corp. successfully assembled and tested in collaboration with the FDA/DETTD/OBRR an expanded Blood Pathogen Detection OpenArray. With this device much more discriminating tests and an expanded list of agents were detected in plasma such as HIV-1: four clades: Group O, Group M: subtypes 1, 2, 3, and 4, Influenza Virus: H1N1 and H5N1 and Chikungunya Virus. The OpenArray was also expanded for greater discrimination and additional pathogens found in whole blood such as Leishmania major, L. donovani, L infantum, L tropica, L Mexicana and L. braziliensis, Plasmodium falciparum, P. vivax. Babesia microti, Trypanosoma cruzi, and Gram Negative Bacteria. Tasks and deliverables under this requirement are: 1. Phase 1 (1 month) will consist of optimizing a detailed experimental plan in consultation with scientists at CBER and ordering assembly of sufficient Blood Pathogen OpenaArrays. These OpenArrays will have the same primers and probes that were optimized in the previous contract with Life Technologies. 2. Phase 2 (2 months) will consist of testing 60 pathogen nucleic samples derived from clinical specimens. These samples will be delivered on the schedule: 20 beginning of the 2nd month, 20 beginning of the 3rd month, 20 at the end of 3 ½ months. 3. Phase 3 (1.5 months) will consist of analyzing the results and preparing them for publication or other combination of pathogen testing mutually agreed upon between the contractor and the COR. 4. Reporting requirements: The Contractor shall report to the COR weekly by email with informal reports of progress. At the end of each phase (1 month, 3 months and 4.5 months) the contractor will email a written report to the COR that includes tables of quantitative results and protocols that clearly explain how the results were obtained and participate in a telephone consultation of the reported results. Once during the course of the contract a teleconference meeting will be scheduled between the contractor scientists and CBER personnel. This meeting is for planning and final discussion of the research performed The total Period of Performance for the order resulting from this Request for Quotations shall be four and ½ months from date of Award. The price quoted shall be in a lump sum amount for the entire project. The purchase order resulting from this Request for Quotations will be firm fixed price. The provision at 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition with no addenda. The provision at 52.212-3, Offeror Representations and Certifications - Commercial Items, applies to this acquisition. The 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. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition with the following addenda: 352.202-1 Definitions (JAN 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) This solicitation incorporates one or more FAR and HHSAR Clauses and Provisions by reference, with the same force and effect as if they were given in full text. The full text may be access electronically at this/these addresses(es): http://www.acquisition.gov and http://dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html. 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 Contractor shall comply with the additional following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive Orders applicable to acquisitions of commercial items: a. 52.222-50 Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)) 52.233-3 Protest After Award (AUG 1996) (31 U.S.C. 3553). 52.233-4 Applicable Law for Breach of Contract Claim (OCT 2004)(Pub. L. 108-77, 109-78). b. 52.204-10 Reporting Executive Compensation and First Tier Subcontracting Awards (FEB 2012) 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (DEC 2010) (31 U.S.C. 6101 note). 52.222-3 Convict Labor (JUN 2003) (E.O. 11755) 52.222-19 Child Labor - Cooperation with Authorities and Remedies (MAR 2012)(E.O. 13126) 52.222-21 Prohibition of Segregated Facilities (FEB 1999) 52.222-26 Equal Opportunity (MAR 2007) (E.O. 11246) 52.222-36 Affirmative Action for Workers with Disabilities (OCT 2010)(29 U.S.C. 793) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (EO 13513) 52.225.13 Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) 52.232-33 Payment by Electronic Funds Transfer - Central Contractor Registration (OCT 2003) (31 U.S.C. 3332) Evaluation of Offers: Technical Qualifications and Approach: Contractor shall demonstrate in their response that they are capable of providing the work required and demonstrate recent experience with a custom Blood Pathogen Detection Open Array System. The Contractor shall also demonstrate their plan to fulfill the tasks and deliverables required by this project. Past Performance: Contractor shall provide information for the same or similar types of projects performed in the last three years. Information provided shall include contact name, number, and size of project. Price Technical and Past performance when combined are more important than price. Offerors that fail to complete the required Representations and Certifications, or reject the terms and conditions of this 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 1104392. The RFQ is due in person, by postal mail, fax or email to the point of contact listed below in Jefferson, AR, 72079-9502, no later than 1:00 PM Central Daylight Time Tuesday, July 31, 2012. Any questions regarding this notice shall be submitted to Marcia Park by email to Marcia.park@fda.hhs.gov no later than 1:00 PM CDT. July 26, 2012. For information regarding this Request for Quotations, please contact Marcia Park at 870/543-7405 voice, 870/543-7990 Fax or email to Marcia.park@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1104392/listing.html)
- Place of Performance
- Address: 8800 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02807427-W 20120720/120718235841-120bd742ec7c1e7739ae0cc94d396ae2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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