75F40123SSN118306 Amended.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.

Note this SSN has been amended from its original. Changes are highlighted by a bold line in the left margin and by bold print in the text. Erroneous language has been crossed through.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER), Division of Veterinary Services (CBER/DVS) White Oak Consolidated Animal Program (WOCAP) in order to determine if there are existing small business sources capable of providing various Individually Ventilated Cages (IVC) caging equipment and rodent racks which will be used to support increasing approved lab animal bio-hazard levels 2 and 3 research studies for the Food and Drug Administration (FDA) laboratory animal care and use program animal caging for housing rats to support biosafety level 2 studies as well as a Biosafety cabinet which is compatible with the cages, able to accommodate the size and height of cages while providing adequate air flow.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 332999 – All Other Miscellaneous Fabricated Metal Product Manufacturing, with a Small Business Size Standard of 750 employees, and you believe that your firm would be able to provide the FDA with the products described below, please submit an email to suzanne.martella@fda.hhs.gov. Other than small business concerns are also encouraged to submit capability statements. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Technical Specifications:

Three (3) Individually Ventilated Cages (IVCs), 30-Cage Bio Containment Unit (BCU) rat rack system and cage components:

1. Single face IVC, 30 cage BCU ventilated rack with 6 columns and 5 rows

2. Must be a fully sealed individual cage rack system

3. System must have rack and cage bio-sensory capability

4. Must have ECOFLO 20-hour back-up battery unit mailto:suzanne.martella@fda.hhs.gov

5. Must have ECOFLO redundancy touchscreen blower motor

6. Must have clear polysulfone high temperature cages and rack cage locks

7. Must have 3”x 5”3" vertical polysulfone cage cardholder

8. Must have cage fit/check test station assembly unit

9. Must have cage level cage top extract filtration

10. Must have touch screen display with real-time differential Pressure Readings

11. Shall have energy efficient exhaust rack motors

12. Blower/exhaust rack motor unit must mount on top of rack system

13. Rack unit must have dual HEPA filtration of (99.995%) capability

14. Rack and caging components must be Fully autoclavable

15. Rack system shall have an audible alarm when blower unit is experiencing a problem

Two (2) IVC, ferret 10 cage ventilated system and caging components compatible with current caging (1800 NexGen system)

1. Cage must be able to be placed inside biosafety cabinet with window sash closed,

2. Cage height must not exceed 12.5 inches with cage and filter top completely assembled

3. Rack system and caging must be off the shelf, not be non-custom-made equipment

4. Cage components must withstand temperature of 300 degrees Fahrenheit

5. Cage must be constructed of polysulfone clear material for visibility of animal(s)

6. Cage must have internal feeder device that connects to rear of cage

7. Rack must have top mounted supply and exhaust HEPA filtration units

8. Caging system must be suitable for biosafety levels 2 and 3 animal housing

Caging:

16. 64 full caging setups to include: cage bottoms with stainless steel grommets for automatic water, filtertops, cage card holders, stainless steel feeder hoppers and 64 water bottles with caps.

17. Cages shall be in the following dimensions:

• Floor area = 288 square inches

• Overall dimensions (W x D x H) = 18.82” x 15.866” x 15.90”

18. Cage height must allow for rats to sit up. The cage shall be two levels with varying heights (up to 14½”) giving a more enriched environment by allowing the rat to explore and display natural behavioral traits like climbing, stretching, playing and exploring. The combination of levels also provides an area for animals to shelter. Both levels provide 7½” of head height meeting the “Guide’s” standards.

19. Cage shall be high temps and withstand at least 250o F autoclave temperature.

20. Cage shall be able to be run at positive and negative air pressure and controlled by the user.

21. Cage shall allow for water lixit as well as have two external self-centering depressions for water bottles, with no need to pull out the cages from the rack to perform the bottle change.

Racks:

1. Two (2) Stainless Steel racks, single sided, with Avidity auto watering system manifold.

2. Two (2) Microbiological filters (0.2-micron pore size), supply and exhaust self-closing valve for air ventilation. The filter retainers are to feature a silicon gasket or the like, to ensure air tightness

3. Rack shall be made with AISI 304 stainless steel rack structure with cage plastic runners, and visual indicators for each cage to ensure cage is properly docked in cage slot. The plastic runners are snapped onto the tubular rack frame with no screws needed, thus reducing the total weight of the rack, and keeping it neat and clean with no parts protruding. Heavy duty, fully autoclavable fiberglass reinforced nylon castors - maintenance-free, two (2) with brakes and two (2) without for optimal guidance. Shall have free standing supply and exhaust HEPA filtration system.

4. Motors for racks shall be HEPA-filtered air which can deliver up to 80 air changes per hour to each individually ventilated cage by an air handling unit equipped with an H14 HEPA filter for both supply and exhaust.

5. Motors for racks shall have temperature, humidity, and negative/positive mode air flow sensors.

6. Motors for racks shall have Dispersed Oil Particulate (DOP) test certification for HEPA filters, both supply and exhaust.

7. Easy access to the pre-filters, with no tools needed for changing filters for motors.

Biosafety Cabinet (BSC):

1. One (1) Biosafety cabinet (BSC) with all components needed to be fully operational upon receipt.

2. The BSC shall be compatible with the aforementioned cages and able to accommodate the size and height of cages while providing adequate air flow.

3. BSC shall have high-efficiency air filters.

4. BSC shall have electronic adjustable hydraulic stand to adjust to the user’s height.

5. BSC shall have electronic automatic adjustable airflow control and LED dimmer light to include red LED light.

6. BSC shall use innovative ventilation system featuring energy saving blowers (ECM Technology), reduced noise and vibration, lower heat load emissions and energy costs.

7. Automatic window sash opening for cages by control panel or foot pedal switch to achieve two different heights.

8. Prearranged for decontamination with H2O2 sterilization cycle.

9. Possibility to work in two different configurations: class II biosafety cabinet (BSC) and changing station (CS).

Delivery: Expected delivery and installation of the equipment is within five (5) months of contract award.

Place of Delivery The equipment shall be delivered to the Center for Biologics Evaluation and Research (CBER) at the following address:

US FDA/CBER

10903 New Hampshire Ave Silver Spring, MD 20993

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/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, Unique Entity ID (SAM) 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/service offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/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 Unique Entity ID (SAM) number and size status) if not the respondent.

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

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

• The offeror’s estimated historical on-site response time for the brand name and model of product in this 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 applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the product/service is available on.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Though this is not a request for quote, informational pricing for the equipment/service is required for both the purchase and if a lease option is also available.

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 to be submitted by email only to the point of contact listed below on or before 08:00 am (Central Time in Jefferson AR) on June 22, 2023 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40123SSN118306.

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 or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

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).

mailto:suzanne.martella@fda.hhs.gov

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.