FDA_21-223-SOL-1238536 SSN_Final.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 Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing an InVivo Imaging System.

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 supplies/services described below, please submit an email to Yolanda.rankin@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/CBER has a need for a multi-species in vivo imaging system that combines micro-CT with optical imaging. The system will be useful to facilitate non-invasive monitoring of disease progression, cell trafficking, cancer invasion and metastasis and gene expression patterns in living animals in both 2D and 3D. CBER intends to get an easy-to-operate device and make it available to numerous laboratories at White Oak that utilize laboratory animals in scientific studies. In addition, micro-CT capability will enhance CBER’s veterinary diagnostic program for clinical cases. In vivo imaging is non-invasive visualization and quantitative evaluation of living organisms for research and/or diagnostic purposes. In vivo imaging systems are used to monitor disease progression, bio-distribution of cell therapy and cell tracking, and gene expression patterns in living animals.

Minimum Technical Requirements for an InVivo Imaging System:

• The device shall be capable of imaging all of the small animal species housed and used in our animal program, which include, but are not limited to mice, rats, guinea pigs, gerbils, voles, hamsters, rabbits, and ferrets.

• Shall include thermoelectrically-cooled digital camera for high-sensitivity in vivo imaging of fluorescence and bioluminescence.

• Shall include custom lens with at least 4 magnification settings.

• Shall include high throughput (5 mice) with 23 cm field of view.

• Shall include high resolution (to 20 microns) with at least 23 cm field of view.

• Should have at least multiple high efficiency filters spanning 430 -850 nm.

• Shall support spectral unmixing applications.

• Shall be ideal for distinguishing multiple bioluminescent and fluorescent reporters.

• Shall include a reflection- mode and transmission-mode illumination that can be switched

• Shall allow for 3D diffuse tomographic reconstruction for both fluorescence and bioluminescence.

• Shall have the ability to import and automatically co-register CT or MRI images yielding a functional and anatomical context for scientific data NIST traceable absolute calibrations.

The CT/MRI system should have a safety lock mechanism.

• Shall include inlet and outlet ports for gas anesthesia or built in anesthesia chamber.

• Shall include Class I Laser Product.

• Shall include scanning laser for alignment and surface topography

• Shall include a camera controller-water chiller re-circulator that has a regulation temperature within an appropriate range to keep the animal normo-thermic while it is under anesthesia.

• Shall include a high-performance acquisition computer (min specs 2.8 GHz, 16 GB Ram, RW CD, 80 GB HD) and 20-inch, high-resolution flat screen monitor

• Shall include one acquisition copy and four analysis copies of a compatible imaging software, both Spectrum and Multimodality components including shuttle kit.

• Shall include an operation manual.

• Power Requirements shall be around 100-120 V, 50/60 Hz 20A.

• Dimensions of the Imaging Chamber shall be close to: Width 43 cm, Depth 50 cm, Height 60 cm, System Space Requirements shall be close to: Width 203 cm, Depth 163 cm, Height 214 cm. and allow imaging of four or more mice simultaneously or one larger animal

• Should be relatively easy to operate by animal care technicians and other staff.

• Shall include rapid start-up time and calibration when machine is turned on the beginning of the day.

• Shall include rodent anesthesia system with induction chamber which allows delivery of isoflurane via 4 ports to run 2 instruments simultaneously.

• Shall use isoflurane gas # two fixed 500 cc/min (1.0 LPM) circuits and two adjustable (0-4 LPM) circuits

• Shall include anesthesia gas connections for two (2) instruments and the induction chamber allowing operation simultaneously

• Shall include a dedicated vacuum pump with adjustable flowmeters to monitor and direct flow to specific ports as required.

• Shall include a isoflurane vaporizer, as well as limit gas escaping into the surrounding laboratory environment.

• Includes ability to connect to house waste gas scavenging or includes isoflurane-absorbing disposable charcoal filters to absorb excess gas.

• Shall include an induction chamber that is appropriate to accommodate rats with ease and the large enough to anesthetize up to five adult mice or two rats simultaneously.

• Shall include an induction chamber that is clear and include a sliding lid. Shall include a dedicated exhaust blower which directs the flow of excess anesthesia gas

• Induction chamber shall include a warranty of at least 12 months.

• Installation shall be included.

• Shall include Micro Computed Tomography imaging system that is completely shielded to prevent release of radiation, with high resolution (2.3 micrometer voxel size), high-speed (scans as fast as 3.9 seconds), low-dose imaging for longitudinal in vivo studies, four Field

Of Views (FOVs) – 18, 36, 72, and 86 mm, multispecies imaging capabilities for /mouse/rat/guinea pig/rabbit), two-phase retrospective respiratory and cardiac gating and seamlessly co-registration of functional optical signals (from in vivo imaging system or fluorescence tomography system) with Micro Computed Tomography imaging data.

• Shall include Micro Computed Tomography accessory kit and beds for positioning of guinea pigs, other rodents and small rabbits.

• Shall include 12 month warranty for Micro Computed Tomography imaging system.

• Shall include a set of advanced image processing, visualization and analysis software tools that provides access to a breadth of essential post-processing functions critical for innovative research such as Analyze Advanced uCT Analysis Software or an equivalent product.

• Shall include IWB-60 Workbench, 60" with 1000lb Capacity.

• Shall include Syringe Injection System.

• Shall include Standard Rat Manifold.

• Shall include one Bone Mineral Density (BMD) phantom with a 32mm diameter and one BMD phantom with a 4.5mm diameter.

• Shall include Micro Computed Tomography Analysis Software.

Installation, Training and Warranty Requirements

• The system and its associated accessories shall include onsite installation, qualification operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

• The FDA shall have the right to exercise optional periods to continue the maintenance and service contract beyond the warranty period, which will include software updates during the service agreement period, phone support, onsite visits for diagnosis of problem and repairs inclusive of all parts, labor, and travel expenses, unless authorized. The contract will include exercisable service contracts for 4 years.

Minimum Performance Requirements for the 4 (1-year Post Warranty 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 Eastern Time.

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

Estimated Delivery Date: 120 days after award

Delivery Location:

Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Building 52/72 Silver Spring, MD 20993

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Though the target audience is small business vendors or small businesses capable of supplying a U.S.

service of a small business vendor 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 service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments 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.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• 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.

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before February 15, 2021 by 13:00 hours (Central Time in Dallas, Texas) at email: yolanda.rankin@fda.hhs.gov. Reference: FDA_21-223-SOL-1238536.

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.