Procurement of Two (2) Modulight Medical Laser Systems, Model ML7710i, or Equivalent

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Molecular Imaging Branch (MIB) conducts research in designing, developing, and testing new novel targeted imaging agents for the detection and characterization of cancer. MIB requires two additional lasers due to the increase in personnel and the study requirements of MIB.

This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice, and shall be processed in accordance with FAR Part 13 - Simplified Acquisition Procedures. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation, 75N91021Q00184, is issued as a request for quote (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2021-05 (07-12-2021), simplified acquisition procedures for commercial items.

The North American Industry Classification System code is 334516 and the business size standard is 1,000 employees.

THIS IS A TOTAL SMALL BUSINESS SET-ASIDE.

1.0 BRAND NAME OR EQUAL

This requirement is for the procurement of the brand name or equivalent instrument described in section 4.0. The Federal Acquisition Regulation (FAR) provision FAR 52.211-6, Brand Name or Equal (AUG 1999) is applicable to this requirement.

2.0 BACKGROUND

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Molecular Imaging Branch (MIB) 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 magnetic resonance imaging (MRI), positron emission tomography (PET), radionuclide, and optical probes. MIB is focused on the clinical translation of targeted imaging agents for cancer imaging. In 2017, the MIB purchased a Modulight medical laser system for pre-clinical studies in order to perform more in depth studies with the laser and determine the effect of PIT (photoimmunotherapy) on animal tissue and the amount of light exposed to the tissues. This is the same laser used for first-in-human phase 1 trial of NIR-PIT in patients with inoperable head and neck cancer targeting epidermal growth factor receptor. MIB requires two additional lasers due to the increase in personnel and the study requirements of MIB.

3.0 TYPE OF ORDER

This is a Firm-Fixed-Price Purchase Order.

4.0 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required:

Both instruments shall:

• Be compatible with the Government-owned Modulight Medical Laser System Model ML7710-PDT.
• Have internet connectivity via ethernet to allow for remote software updates. 
• Shall be capable of a minimum of 6 individually controlled fiber outputs with SMA-905 connector and fiber sensors to study a minimum of 6 animals at one time
• Shall have the ability to operate via frontal diffuser fibers, cylindrical fibers and patch cord fibers in order to replicate a clinical setting and make the light adjustment easier.
• Each output shall operate between 400-700nm to irradiate the correct fluorescence.
• Shall have a foot pedal switch to operate it hands free
• Shall have touch screen monitor to be easier to operate the laser
• Shall be turnkey delivery – no installation shall be necessary
• Shall have ability to calibrate consistent light dose for consistency between animals
• Shall have the capability of connecting to the internet to perform remote operations such as software update
• Shall have real-time treatment monitoring capability to observe the results in real time and make the necessary adjustments

The following configurations are required for the Two (2) Modulight Medical Laser Systems, model ML7710i or equivalent:

Configuration 1 

• 5 channels at 690 nm (2W) and 2 channels at 405 nm (500-600 mW) with individually controllable fiber outputs (400 um, NA=0.22) via SMA-905 connector and fiber sensors.

Configuration 2 

• 6 channels at 690 nm (2W) with individually controlled fiber outputs (400um, NA=0.22) via SMA-905 connector and fiber sensors.

4.1 DELIVERY / INSTALLATION

Delivery shall be within 12 weeks of the Purchase Order award. The Contractor shall coordinate delivery and tracking information with the NCI Technical Point of Contact (TPOC), TBD at award, with tracking information to anticipate delivery to the best extent possible. All shipping/handling (including FOB) and delivery/installation fees shall be included in the quote.

Upon delivery, the Contractor shall notify the TPOC to schedule installation and training identified in section 4.2 below. The installation date and time shall occur within 2 weeks after delivery. Installation shall be performed by, or under the direct supervision of, an Original Equipment Manufacturer (OEM) certified operator.

The instrument shall be delivered and installed at the following location:
NIH, NCI, Molecular Imaging Branch
9000 Rockville Pike
Bldg 10, Room B3B69
Bethesda, MD 20892

The TPOC for delivery, installation, and training is below:
TBD at award
Phone: TBD at award
Email: TBD at award

4.2 TRAINING

On the date of installation, training shall be provided on-site for at least 11 users of the equipment. Due to the fluidity of the COVID-19 pandemic, if travel restrictions prevent on-site training, a temporary remote training shall be provided until on-site training can occur. All training expenses, including materials and/or travel expenses, shall be included in the quoted price.

4.3 WARRANTY

The Contractor shall warrant that any instruments, equipment, components, or other supplies (“Supplies”) procured by this purchase are free of defects in design, material, or manufacture for a period of at least 12-months from date of installation.

The Contractor shall warrant that all consumables or expendable parts are free of defects in design, material, or manufacture for a period of at least 90 calendar days from date of acceptance by the Government.

Supplies which are repaired or replaced shall be warranted for the remainder of the initial warranty period or for 90-days – whichever is greater.

5.0 SUBMISSION INSTRUCTIONS/EVALUATION

QUESTIONS

Questions must be submitted electronically via email to Contracting Officer, Adam Hernandez, at adam.hernandez@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 3:00 PM EST, Wednesday, July 28, 2021 (07/28/2021). Please be advised that the Government reserves the right to transmit any questions and answers of a common interest to all prospective Contractors.

QUOTATIONS

Quotations must be submitted electronically via email to Contracting Officer, Adam Hernandez, at adam.hernandez@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 3:00 PM EST, Monday, August 02, 2021 (08/02/2021).

Reference 75N91021Q00184 on all correspondence.

5.1 BASIS FOR AWARD & EVALUATION

The purchase order will be awarded to the firm that submits the Lowest Price Technically Acceptable (LPTA) quotation. A technically acceptable quote is one in which the quoter(s) complies with the Statement of Need (SON) and does not take exception, nor object to any of the terms of the RFQ. Quotes that are not technically acceptable will not be considered for award. Award will be made on an all or none basis. If you are providing an “equal” product, you must submit additional documentation that highlights and describes how your offering is equal in accordance with FAR Clause 52.211-6.

Evaluation and award will be conducted in accordance with the requirements of FAR 13.106. The technical evaluation will be a determination based on information furnished by the Contractor. The Government is not responsible for locating or securing any information which is not identified in the quotation. The Government intends to evaluate quotations and make a single award. Quotations should contain the quoter’s best terms from a price and technical standpoint. However, the Government reserves the right to request quote revisions that seek additional price discounts, provide revisions to the technical quote, or clarify aspects of the quote. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all quoters. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received.

5.2 GENERAL INSTRUCTIONS

This Request for Quotation (RFQ) does not commit the Government to pay any cost for preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. By submitting a quote in response to this solicitation, it is understood that your firm’s quote shall become a part of the official contract file.

The Vendor’s quote must stipulate that it is predicated upon all the terms and conditions of this RFQ and signed by an official authorized to bind your organization. In addition, it must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt thereof by the Government.

Quotes shall be submitted with a completed copy of FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment, located in Section 8.0 attached to this RFQ.

5.3 Price Quote:

The price quotation must contain all information necessary to allow for a comprehensive evaluation of the prices quoted. The quote must also contain the following information:

a. Federal Tax Identification Number (TIN);
b. Data Universal Numbering System (DUNS) Number;
c. Business Size (e.g., small or large)

SPECIAL DELIVERY INSTRUCTIONS DUE TO COVID-19

Due to the current COVID-19 pandemic, please pay close attention to the following delivery instructions and ensure that sufficient information is included in the quote to be considered for an award. Please be aware that due to the fluidity of the existing pandemic, instructions may be updated as needed after award.

• All quotes must include confirmation that equipment is or will be available for delivery by the due date indicated in Section 4.1.
• Quoters must confirm:
  • Willingness to store or hold equipment until NCI is ready to accept the equipment at no additional cost.
  • The equipment will not be sold to another company in the event NCI is not ready to accept delivery due to unanticipated changes related to COVID-19.
  • Training as identified in Section 4.2 may be made available and provided to required staff at different times and dates at no additional cost.
• Communicate and follow instructions from the NCI TPOC to coordinate delivery, installation, and training. The delivery address and TPOC’s information will be provided at time of award and must be included as part of the order/shipping label.