75F40124Q00361_SSN.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 Drug Evaluation and Research (CDER) in order to determine if there are existing small business sources capable of providing “Brand Name” operational parts and consumables for two currently owned Nova BioProfile Flex 2 instruments (Serial Numbers T26817050C (FLEX2+CDV+OSM48+ESM) and

T26A200050C (FLEX2+CDV+OSM48+EOLS).

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/CDER requires “Brand Name” operational parts and consumables for two currently owned Nova BioProfile Flex 2 instruments compatible with a NOVA BioProfile Flex 2 (Serial Number: T26817050C) due to the continuing work on Process Analytical Technology and optimizing integration and automated sampling of analyzers to bioreactor systems. One Nova BioProfile Flex 2 has been integrated with the current microbioreactor system and allows for automated sampling and nutrient analysis for 48 vessels on a specified schedule, facilitating the collection of crucial data about cell culture processes that would otherwise take the entire workday to be collected manually. The second Nova BioProfile Flex 2 is integrated to an automated sampling system to sample from our currently owned 5L glass bioreactors.

Minimum Requirements for the “Brand Name” operational parts and consumables:

Shall be delivered within 7 days of Award

QUANTITY DESCRIPTION

5 57510 Bioprofile flex 2 pH/gas microsensor card LV

57526 BioProfile FLEX 2 pH/Gas MicroSensor™ Card HV (425 samples or 21 days)

5 57512 Bioprofile flex 2 chemistry microsensor card LV

57528 BioProfile FLEX 2 Chemistry MicroSensor™ Card HV (550 samples or 14 days)

5 58102 BioProfile FLEX 2 pH/Gas Calibrator Cartridge MV

1 54507 BioProfile FLEX 2 pH/Gas Calibrator Cartridge HV

7 58101 BioProfile FLEX 2 Chemistry Calibrator and Reagent Cartridges MV

1 53937 BioProfile FLEX 2 Chemistry Calibrator and Reagent Cartridges HV

5 55297 Bioprofile flex 2 CDV reagent cartridges

1 59859 OSM48 Micro tubes BioProfile FLEX2 500/box

4 56073 Bioprofile flex 2 pH/gas auto QC cartridge

6 57035 Bioprofile flex 2 chemistry auto QC cartridge

1 55281 Bioprofile flex 2 chemistry module tubing harness

1 55283 Bioprofile flex 2 pH/gas module tubing harness

1 60608 FLEX2 pH/Gas Shutdown Cartridge

1 60610 FLEX2 Chemistry Module Shutdown Cartridge

1 60611 FLEX2 CDV Module Shutdown Cartridge

1 60612 FLEX2 ESM Shutdown Cartridge

1 60613 FLEX2 pH/Gas Auto QC Shutdown Cartridge

5 56227 Bioprofile flex 2 ESM reagent cartridge

1 59209 Bioprofile flex 2 ESM external tubing set n/a Shipping & Handling Charges

Shall be delivered within 90-120 Days of Award

QUANTITY DESCRIPTION

5 57510 Bioprofile flex 2 pH/gas microsensor card LV

57526 BioProfile FLEX 2 pH/Gas MicroSensor™ Card HV (425 samples or 21 days)

5 57512 Bioprofile flex 2 chemistry microsensor card LV

57528 BioProfile FLEX 2 Chemistry MicroSensor™ Card HV (550 samples or 14 days)

5 58102 BioProfile FLEX 2 pH/Gas Calibrator Cartridge MV

1 54507 BioProfile FLEX 2 pH/Gas Calibrator Cartridge HV

7 58101 BioProfile FLEX 2 Chemistry Calibrator and Reagent Cartridges MV

1 53937 BioProfile FLEX 2 Chemistry Calibrator and Reagent Cartridges HV

5 55297 Bioprofile flex 2 CDV reagent cartridges

1 59859 OSM48 Micro tubes BioProfile FLEX2 500/box

4 56073 Bioprofile flex 2 pH/gas auto QC cartridge

6 57035 Bioprofile flex 2 chemistry auto QC cartridge

1 55281 Bioprofile flex 2 chemistry module tubing harness

1 55283 Bioprofile flex 2 pH/gas module tubing harness

1 60608 FLEX2 pH/Gas Shutdown Cartridge

1 60610 FLEX2 Chemistry Module Shutdown Cartridge

1 60611 FLEX2 CDV Module Shutdown Cartridge

1 60612 FLEX2 ESM Shutdown Cartridge

1 60613 FLEX2 pH/Gas Auto QC Shutdown Cartridge

Shall be delivered within 180-210 Days of Award

5 57510 Bioprofile flex 2 pH/gas microsensor card LV

57526 BioProfile FLEX 2 pH/Gas MicroSensor™ Card HV (425 samples or 21 days)

5 57512 Bioprofile flex 2 chemistry microsensor card LV

57528 BioProfile FLEX 2 Chemistry MicroSensor™ Card HV (550 samples or 14 days)

5 58102 BioProfile FLEX 2 pH/Gas Calibrator Cartridge MV

1 54507 BioProfile FLEX 2 pH/Gas Calibrator Cartridge HV

7 58101 BioProfile FLEX 2 Chemistry Calibrator and Reagent Cartridges MV

1 53937 BioProfile FLEX 2 Chemistry Calibrator and Reagent Cartridges HV

5 55297 Bioprofile flex 2 CDV reagent cartridges

1 59859 OSM48 Micro tubes BioProfile FLEX2 500/box

4 56073 Bioprofile flex 2 pH/gas auto QC cartridge

6 57035 Bioprofile flex 2 chemistry auto QC cartridge

1 55281 Bioprofile flex 2 chemistry module tubing harness

1 55283 Bioprofile flex 2 pH/gas module tubing harness

1 60608 FLEX2 pH/Gas Shutdown Cartridge

1 60610 FLEX2 Chemistry Module Shutdown Cartridge

1 60611 FLEX2 CDV Module Shutdown Cartridge

Shall be delivered within 270-300 Days of Award

5 57510 Bioprofile flex 2 pH/gas microsensor card LV

57526 BioProfile FLEX 2 pH/Gas MicroSensor™ Card HV (425 samples or 21 days)

5 57512 Bioprofile flex 2 chemistry microsensor card LV

57528 BioProfile FLEX 2 Chemistry MicroSensor™ Card HV (550 samples or 14 days)

5 58102 BioProfile FLEX 2 pH/Gas Calibrator Cartridge MV

1 54507 BioProfile FLEX 2 pH/Gas Calibrator Cartridge HV

7 58101 BioProfile FLEX 2 Chemistry Calibrator and Reagent Cartridges MV

1 53937 BioProfile FLEX 2 Chemistry Calibrator and Reagent Cartridges HV

5 55297 Bioprofile flex 2 CDV reagent cartridges

1 59859 OSM48 Micro tubes BioProfile FLEX2 500/box

4 56073 Bioprofile flex 2 pH/gas auto QC cartridge

6 57035 Bioprofile flex 2 chemistry auto QC cartridge

1 55281 Bioprofile flex 2 chemistry module tubing harness

1 55283 Bioprofile flex 2 pH/gas module tubing harness

1 60608 FLEX2 pH/Gas Shutdown Cartridge

1 60610 FLEX2 Chemistry Module Shutdown Cartridge

1 60611 FLEX2 CDV Module Shutdown Cartridge

5 56227 Bioprofile flex 2 ESM reagent cartridge

Estimated Delivery Date: 7 to 300 days after award

Delivery Location:

Food and Drug Administration Center for Drug Evaluation and Research 10903 New Hampshire Ave Bldg. 72 RM 2232 Silver Spring, MD 20903

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 UEI 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.

• The offeror shall advise if the product and/or service is on a Best-in-Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• 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.

• 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.

• 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 July 5, 2024, by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov. Reference: 75F40124Q00361.

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 sam.gov. 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.