SOLICITATION NOTICE
B -- MINIATURIZED LAB-ON-A CHIP DEVICE (BIOCHIP) FOR PERFORMING IMMUNOASSAY
- Notice Date
- 4/1/2015
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Morgantown), 1095 Willowdale Road, Morgantown, West Virginia, 26505
- ZIP Code
- 26505
- Solicitation Number
- 000HCCGC-2015-81828
- Archive Date
- 5/15/2015
- Point of Contact
- Rebecca S Mullenax, Phone: 304-285-5880
- E-Mail Address
-
rmullenax@cdc.gov
(rmullenax@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Sole Source FBO Notice for Procurement Request 000HCCGC-2015-81828 Title: Miniaturized Lab-on-a chip Device (Biochip) for Performing Immunoassay The Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH), Division of Applied Research and Technology (Dart) intents to award a sole source firm fixed price purchase order to The University of Cincinnati, 2600 Clifton Ave, Cincinnati, Ohio 45220-2872 for Miniaturized Lab-on-a-chip Device (Biochip) for Performing Immunoassay. This includes three option years if funds are available. STATEMENT OF WORK Miniaturized Lab-on-a-chip Device (Biochip) For Performing Immunoassay Background and Motivation: Workers are routinely exposed to airborne respirable silica. Exposures can be especially high in work environments that involve mining, hydraulic fracturing or fracking, and construction. Respirable silica exposure is considered a significant occupational health problem in the United States. According to the National Institute for Occupational Safety and Health (NIOSH) surveillance data, there has been an increase in the incidence of black lung disease over the last 10 years, possibly due to exposure to silica. Approximately four hundred thousand workers were employed in the US oil and gas extraction industry in 2010 based on a Quarterly Census of Employment and Wages Report. Recent NIOSH field studies identified overexposure to airborne silica as a health hazard. In addition, at least two hundred thousand workers have the potential to be exposed to silica generated during mining and construction operations. Exposure to airborne respirable silica remains an important occupational hazard in many workplaces. While existing, laboratory-based enzyme-linked immunosorbent assay methods for monitoring exposure of workers are sensitive and useful for diagnosis of diseases, conventional immunosorbent assay methods usually take several hours to several days for completion, and they require extensive sample preparation and trained personnel. In addition, the existing laboratory methods and instruments are bulky and expensive, and they are not field-portable. New methods are required that can provide data quickly and accurately. To address these critical needs, low-cost, rapid, field-portable biochip devices to detect biomarkers of pulmonary effects from inhalation exposure to silica are being developed by the Principal Investigator. Portable biochip devices have the potential to overcome drawbacks of the existing methods and revolutionize biomonitoring of occupational and environmental exposures to toxic aerosols, which will significantly improve our ability to assess and mitigate the exposure risks. Project Objectives: The purpose of this service procurement is to support ongoing research activities on the NIOSH FY15 National Occupational Research Agenda (NORA) project (#939039G) entitled ‘Biochip Device for Early Detection of Health Effects from Silica Aerosol Exposure'. The overall goal of this project is to develop a low-cost, rapid, field-portable biochip device, capable of detecting biomarkers of pulmonary effects due to inhalation exposure to silica. The low-cost, miniaturized biochip employs an enzyme-linked immunosorbent assay with chemiluminescence detection and is produced using microfabrication technology. The PI is currently working on the development of a prototype biochip. This contract will support the ongoing development. Scope of Work: This task will support ongoing device development research, under a multi-year NORA project, by the NIOSH Principal Investigator (PI). Low-cost, rapid, field-portable biochip devices are being developed for detection of health effects in workers exposed to silica aerosols. Specialized facilities and technical support from a qualified contractor are required to accomplish the project objectives. The contract investigator will provide: • A qualified Research Assistant (RA) to support this research. Qualified candidates should either possess an advanced degree (M.S. or Ph.D.) in a relevant technical field (e.g., engineering, chemistry) or must be enrolled in a graduate degree program in a related discipline. At the discretion of the PI, junior-level staff in a relevant technical field may be needed for shorter-term project support. • The Research Assistant should be capable of working independently with direction from the contract investigator. Periodic progress reports and frequent on-site and off-site discussions with NIOSH PI are expected. • The contract investigator will maintain regular contact with the NIOSH PI via e-mail or conference calls during the course of the project. • NIOSH will take the lead in preparing and submitting scientific publications based on work conducted under this contract. CDC authorship guidelines will be followed. The contract investigator will work collaboratively with the NIOSH personnel in the analyses, interpretation of results, and the publication of manuscripts in scientific journals. Tasks and Timeline The overall development of biochip devices involves efforts in three areas: i) Design and fabrication of miniaturized lab-on-a-chip devices, ii) Evaluation and calibration of the developed biochips, using commercially available assay reagents, and iii) Evaluation and testing of overall performance of the biosensor (biochip and analyzer) using blood or serum from exposed animals. The contractor will collaborate with the NIOSH PI to address the above-mentioned research needs via a base year and three option years contract. Base Year: Design and fabrication of Biochip Device 1. Investigate several biochip design and fabrication methods, including microfabrication techniques (e.g., injection molding and replaceable mold disk) that are very well suited for rapid mass‐production, for performing immunoassay of a target protein biomarker (T1) 2. Design and fabrication of protein immunoassay protocols and biochips, and evaluation of the biochips (T2) 3. Prepare abstracts or manuscript(s) for conference. (T3) Option Year 1 - if funds are available: Design, fabrication and evaluation of Biochip Device 4. Design and fabrication of protein immunoassay protocols and biochips, and evaluation of the biochips (T4) 5. Support development of approaches to evaluate the developed biochip for a target analyte (T5) 6. Conduct data analyses, and prepare manuscript(s) for publication. (T3) Option Year 2 - if funds are available: Evaluation and testing of the developed biochips 7. Evaluate overall performance of the biosensor (biochip and the analyzer) (T6) 8. Support calibration and laboratory testing of the developed biochip (T7) 9. Prepare journal manuscript(s) for publication. (T3) Option Year 3 - if funds are available: Evaluation and testing of the developed biochips 10. Evaluate overall performance of the biosensor (biochip and the analyzer) (T8) 11. Prepare journal manuscript(s) for publication. (T3) Timeline Tasks Base year, 2015 Option year 1, 2016 Option year 2, 2017 Option year 3, 2018 Q1* Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 T1 T2 T4 T5 T6 T7 T8 T3 * Quarters after award contract date. Tasks may be delivered earlier than the due date. Deliverables Schedule: Base Year Item Deliverable Delivery schedule Recipient 1 Data documentation, generic data reporting pertaining to tasks described above Upon request by NIOSH PI NIOSH PI 2 Progress report Quarterly or upon request by NIOSH PI NIOSH PI 3 Biochip devices 11 months after the contract award date NIOSH PI 4 Final Report * 11 months after the contract award date NIOSH PI (1copy) Contract Office (1 copy) *This deliverable is due to the NIOSH PI within 11 months after the contract award date. The NIOSH PI will provide comments on the report within 2 weeks. The contractor shall make revisions based on the comments provided and submit the revised report to the NIOSH PI within 2 weeks after receipt of the comments. Option Year 1 Item Deliverable Delivery schedule Recipient 1 Data documentation, generic data reporting pertaining to tasks described above Upon request by NIOSH PI NIOSH PI 2 Quarterly Progress report Quarterly NIOSH PI 3 Biochip devices 11 months after the contract award date NIOSH PI 4 Final Report 11 months after the contract award date NIOSH PI (1copy) Contract Office (1 copy) Option Year 2 Item Deliverable Delivery schedule Recipient 1 Data documentation, generic data reporting pertaining to tasks described above Upon request by NIOSH PI NIOSH PI 2 Quarterly Progress report Quarterly NIOSH PI 3 Final Report 11 months after the contract award date NIOSH PI (1copy) Contract Office (1 copy) Option Year 3 Item Deliverable Delivery schedule Recipient 1 Data documentation, generic data reporting pertaining to tasks described above Upon request by NIOSH PI NIOSH PI 2 Quarterly Progress report Quarterly NIOSH PI 3 Final Report 11 months after the contract award date NIOSH PI (1 copy) Contract Office (1 copy) Payment Schedule Payment is authorized after the final report is accepted by NIOSH. Period of Performance Base year: May 1, 2015 - April 30, 2016 Option year 1: May 1, 2016 - April 30, 2017 Option year 2: May 1, 2017 - April 30, 2018 Option year 3: May 1, 2018 - April 30, 2019 This contract action is for a product for which the government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 10 U.S.C 2304(c) (1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. The notice of intent is not a request for competitive quotations; however, all quotations/responses received within (15) days of the issuance of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be e-mailed to purchasing agent Rebecca Mullenax at rmullenax@cdc.gov by COB on April 15, 2015. FAR Reference: FAR 5.207 - Preparation and transmittal of synopses under (c) (15), (c) (16) (i) and (c) (16) (ii).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/MNIOSH/000HCCGC-2015-81828/listing.html)
- Place of Performance
- Address: CINCINNATI, Ohio, 45226, United States
- Zip Code: 45226
- Zip Code: 45226
- Record
- SN03686017-W 20150403/150401235307-d151690754a1298afcf7178b95366f3e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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