FDA_17-223-SOL-1176433_Sources_Sought_Notification.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the National Center for Toxicological Research (NCTR)/Office of Regulatory Affairs (ORA) in order to determine if there are existing small business sources capable of providing a Ultrasound System with 4 (1-year Post- Warranty Maintenance Option periods).

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees, and believe that your firm would be able to provide the FDA with the services described below, please submit an email to Yolanda.peer@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The FDA/NCTR/ORA Nanotechnology Facility is in need of a high-resolution ultrasound system with 4 (1-year Post-Warranty Maintenance Option periods) for measuring 3D volumes of tumors and other organs in small animals with high accuracy and reproducibility to compare differences in efficacy of drugs.

Technical Requirements for the Ultrasound System:

• Shall be capable of imaging and shall include instrumentation hardware (portable cart, ultrasound unit), at least a 17 inch monitor for visualization, integrated user friendly software for data analysis and measurements and a hard drive to store data.

• The hardware shall include a bench for small animal handling and adjustable X, Y, and Z positioning system for accurate measurements, a power supply kit, and should support animal welfare needs by providing a heated platform while the animal is under anesthesia.

Shall have a real-time monitoring unit for respiration, temperature, ECG, heart rate and blood pressure.

• Shall include animal anesthesia system for administering anesthesia such as isoflurane, an induction chamber and associated flow meters to maintain anesthesia and oxygen.

• Shall be capable of attaching (plug and play) different transducers based on imaging requirements. Transducers shall have varying sensitivity and resolution based on what is being imaged for different sizes and application.

• Shall provide high-frequency linear array transducer operating at or above 40 MHz with an axial resolution of 40 micrometers or better to image and measure tumor sizes of up to 14 mm in diameter.

• For any future upgrades, the offeror shall be able to provide another transducer at or above 20 MHz frequency to image tumors with 20 mm diameter with a minimum resolution of 80 micrometers.

• Shall be compatible or designed specifically for small animals (mouse, rat, and rabbit).

• Shall allow for accurate measurements of tumor volumes (3D) beyond that of traditional caliper measurements (0.1 mm) and micrometer with high image resolution to monitor subtle differences in therapeutic efficacy.

• Shall include software for measuring cardiovascular function (4D), blood flow visualization and quantitation.

• Shall have multiple imaging modes including, but not limited to, color doppler, non-linear contrast, 3D, and 4D.

• The ultrasound software shall support zooming functions, videography, annotation of images, and the ability to generate reports. The data should be exportable to other generic format (for example: .gif, .bmp, .tiff, .avi, and MP4). The offeror should provide free software upgrades at least within the first three years after installation.

• Shall have all necessary user friendly software and hardware to conduct the experiments and analysis of the data.

Installation and Training for the Ultrasound System:

• Shall be installed by a representative from the company contracted and shall include at least 2 days of on-site training for familiarization of the system, optimization of basic imaging functions and software analysis training.

• The contractor shall include all parts, travel and labor to complete installation and training.

Installation and training shall be performed during normal business hours (Monday thru Friday, 8 am to 4:30 pm, CT, excluding federal holidays).

Warranty

• The system shall be warranted for parts and labor for a minimum of 12 months from date of installation. All warranty and maintenance work shall be performed on-site at NCTR.

Deliverables

• The Ultrasound system shall come with all hardware, computer, monitor, and software for small animal imaging, visualization, measurements and data analysis. The computer hardware should have Ethernet, and USB port(s) and other appropriate connections for smooth overall function.

• All components and/or equipment shall be newly manufactured, not used/refurbished or used for previous demonstration.

Minimum Performance Requirements for four (4) 1-year Maintenance Option Periods:

• The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

• The Maintenance and Repair activities shall be performed following the Original Equipment

Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• The Contractor shall include unlimited software and firmware updates during the coverage period(s).

• The Contractor shall include unlimited technical support Monday through Friday (excluding

Federal Holidays) 8:00AM – 5:00PM Central Time.

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Anticipated Date of Award: 1/30/2017

Option Year 1: 01/30/2018 thru 01/29/2019 Option Year 2: 01/30/2019 thru 01/29/2020 Option Year 3: 01/30/2020 thru 01/29/2021 Option Year 4: 01/30/2021 thru 01/29/2022

Place of Delivery Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079

Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product and service. Though the target audience is small business manufacturers or small businesses capable of providing service from another small business manufacturer or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address.

Provide this same information again if responding to provide a product and service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent.

• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before November 18, 2016 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Peer, 3900 NCTR Road, HFT‐320, Bldg.

50, Rm 420 Jefferson, AR 72079‐9502 or email yolanda.peer@fda.hhs.gov. Reference: FDA_17-

223-SOL-1176433.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.