SOLICITATION NOTICE
A -- Efficacy of High Intensity Narrow Spectrum Light for Bacterial Inactivation Phase II
- Notice Date
- 6/19/2012
- 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
- 1104347
- Archive Date
- 7/24/2012
- 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 1104347, 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 is a notice of intent to negotiate with only one source, The University of Strathclyde Viz Royal College of Science and Technology. Objective: The Food and Drug Administration's (FDA) Center for Biolologics Evaluation and Review (CBER) Division of Hematology (DH) Laboratory of Cellular Biology, has a requirement for Phase II research in investigation of the efficacy of High Intensity Narrow Spectrum (HINS)-light for bacterial inactivation in platelet and plasma bags. Background Microbial contamination of therapeutic cells and tissues is a major safety concern in transfusion medicine. Several solvent extraction and photo-inactivation methods for pathogen reduction (PR) have been under evaluation to reduce the burden of both viruses and bacteria in blood and blood components The current physico-chemical methods produce photo-adducts and other breakdown products that lead to neo-antigenicities of the PR-treated blood products in addition to damaging the products. Adverse reactions (AEs) in patients due to these altered products were only identified in clinical trials at advanced stages. The transfusion medicine field is therefore in critical need of novel proof-of-concept ideas for pathogen reduction in order to facilitate the manufacturing of safer products to the end users. There is need for novel PR technologies, which are different from the current ones that confer a reduced toxicity and/or contamination risk. Recently High Intensity Narrow Spectrum (HINS)-light has been demonstrated to reduce or eliminate bacterial burden in the environment. Since this light is in the visible spectrum, it is anticipated that AEs associated with UV-spectrum of light-based photo-inactivation methods for blood and blood components can be avoided. The Contractor (University of Strathclyde) holds a patent for the work completed under Phase I under which a prototype machine and laboratory protocols were developed that demonstrate efficient control of specific bacteria in the environment. Tasks and deliverables under this requirement are: 1. Investigate the effect of 405 nm HINS-light for decontamination of low level contamination of bacteria within plasma and platelet blood components. Blood components shall be artificially seeded with problematic pathogens and the bactericidal effect of a range of light intensities and doses (applied as high-intensity light over short time periods or low-intensity light over longer time periods) will be explored. A range of methods for detecting low level contamination within plasma and platelet blood components, including the Platelet PGD test and Most Probable Number (MPN) test, will be assess for determining levels of contamination in the blood products pre- and post- treatment. This task is to be completed within 90 days of award of order. 2. Investigate the effect of 405 nm HINS-light on the immunological and physiological status of plasma and platelet components. This will be done through in vitro and in vivo animal studies. The intensities and doses of HINS-light to be used for exposure will be based on the levels required for adequate decontamination of the blood components. A range of exposure parameters will be tested to identify treatments that permit adequate decontamination whist being non-detrimental to the blood components. This deliverable will involve supply of a 405 nm HINS-light test system and appropriate expertise to the FDA for exposure of blood components. This task is to be completed within 180 days of award of order. 3. Based on the treatment levels identified in the aforementioned deliverables, treatment of plasma and platelet transfusion bags will be carried out to determine whether HINS-light can provide appropriate disinfection of the blood components contained within blood bags, whilst not affecting the quality of the blood components. Assessment of a range of optical and mechanical parameters including depth of light penetration and the typical storage conditions of the different blood components will be carried out in order to optimize the treatment conditions of the plasma and platelet bags. This task is to be completed within 270 days of award of order. 4. Preparation of a report to FDA/CBER on results of confirmatory findings, and preparation of a paper for publication in a peer-reviewed scientific journal. This task is to be completed within 364 days of award of order. The total Period of Performance for the order resulting from this Request for Quotations shall be One Year from date of Award. The price quoted shall be in a lump sum amount for the entire Phase II 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 Evaluation of offers: Lowest Cost 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 no addenda. 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). 52.222-19 Child Labor - Cooperation with Authorities and Remedies (MAR 2012)(E.O. 13126) 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) Full Text of clauses and provisions may be obtained by accessing www.acquisition.gov. An official authorized to bind the offeror must sign the terms and conditions of offer. 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 1104347. 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 9, 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 3, 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/1104347/listing.html)
- Place of Performance
- Address: University of Strathclyde Viz Royal College of Science and Technology, 16 Richmond Street, Glasgow, Non-U.S., United States
- Record
- SN02780128-W 20120621/120619235734-c1f06e313ce47fc2c63f7b688e417c0c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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