SOLICITATION NOTICE
66 -- CE/ETL Medical Laser System
- Notice Date
- 3/6/2017
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- N02RC72532-57
- Point of Contact
- Reyes Rodriguez, Phone: 240-276-5442
- E-Mail Address
-
reyes.rodriguez@nih.gov
(reyes.rodriguez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Molecular Imaging Program (MIP) plans to procure on a sole source basis one brand name Modulight Medical Laser System from Modulight, Inc. Hermiankatu 22, FI-33720 Tampere Finland. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 334516 and the business size standard is 500 employees. Only one award will be made as a result of this pre-solicitation. This will be awarded as a firm fixed price type contract. The estimated delivery date shall be 12 weeks ARO. It has been determined there are no opportunities to acquire green products or services for this procurement. The Molecular Imaging Program (MIP) conducts research in designing, developing and testing new novel targeted imaging agents for the detection and characterization of cancer. These imaging agents include tissue-specific MRI, PET, radionuclide, and optical probes. MIP is focused on the clinical translation of targeted imaging agents for cancer imaging. As part of its pre-clinical research, the Molecular Imaging Program has recently developed a new cancer therapy, near infrared photoimmunotherapy, (NIR-PIT) that can selectively kill cancer cells expressing target molecules on the cell membrane. The first-in-human phase 1 trial of NIR-PIT in patients with inoperable head and neck cancer targeting epidermal growth factor receptor was approved by the US FDA, and is underway as of June 2015. MIP has recently discovered that NIR-PIT not only kills cancer cells, but can also initiate immunity against cancer using dendritic cells in the local environment of the tumor. Moreover, by selectively eliminating foxp3+ negative regulatory T-cells with PIT there are opportunities to further enhance immunity against tumor cells. The phase 1 trial of NIR-PIT patients uses a multi-channel laser system from Modulight and the MIP would like to duplicate the study in animals using the same equipment. The pre-clinical section of the MIP wants to perform more in depth studies with the laser and determine the effect of the PIT on animal tissue and the amount of light exposed to the tissues. Contractor Requirements must include: • Commercially available ML7710 medical laser system. • Capable of a minimum of 6 individually controlled fiber outputs with SMA-905 connector and fiber sensors. • Integrated dose calibration unit. • Green pilot beam. • Automatic power and dose control. • Foot pedal switch. • Certified in CE and ETL in US and Europe. • Platform device must comply with IEC 60601 and FDA CDRH 21CFR1040.10 requirements. • Touch screen. • Certified to operate 400-2000nm and 0-15W. • Safety interlocks. • Turnkey delivery. • Design complies with IEC 60601 and FDA CDRH 21CFR1040.10 requirements and regulation. • A minimum 12-month warranty shall be provided • All quotes must include equipment and shipping/handling estimates. The MIP is currently using the same model in the phase 1 human clinical trials for head and neck cancer. The NCI are requesting to purchase the same laser system model to simulate the clinical trials in animals. For the pre-clinical studies with animals, the MIP needs an n=6 per group at 690nm wavelength. Because this instrument has 6 individual outputs, this will allow all 6 animals required per group to be studied at one time. The NCI and MIP are not aware of other laser systems with the capability of multiple channels. Therefore, Modulight is the only known source to NCI that can meet the Government requirements at this time. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 4 PM EST, on March 13, 2017. All responses and questions must be in writing and faxed to 240-276-5399 or emailed to Reyes Rodriguez, Contracting Officer via electronic mail at reyes.rodriguez@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02RC72532-57 on all correspondence. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Bethesda, MD 20892, UNITED STATES.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/N02RC72532-57/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04424180-W 20170308/170306234503-95c93c6b13356369a33c8d9dbedfe0f4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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