Sources Sought HFP-2025-129641.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Solid Phase Extraction HLB Cartridges, 60 mg, 3 mL with DEC Caps

HFP-2025-129641

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Office of Regulatory Testing and Surveillance (ORTS), Arkansas Human and Animal Food Laboratory (ARHAFL) Chemotherapeutic workgroup.

The FDA ORTS ARHAFL Chemotherapeutic workgroup is the primary laboratory for the chloramphenicol and nitrofurans in aquaculture species shrimp, frog, crab, crawfish, mussel, barramundi, croaker, and cobia. The laboratory analyzes more than six thousand (6000) subsamples each year. The automated solid phase extraction system (ASPEC) HLB cartridges are consumables used on the Gilson GX-274 system at Arkansas Laboratory (ARHAFL).

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required service/product. Other Than Small Business (OTSB) concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is – 334516 - Analytical Laboratory Instrument Manufacturing. The applicable Small Business Size Standard is 1,000 employees.

Statement of Work See below.

Alternative Solutions Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

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

Response Instructions Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Section 1: Respondent Overview

- Business name, SAM Unique Entity ID 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.

• Section 2: Descriptive Information

- 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, ISO certifications, descriptive material, literature, brochures, and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• Section 3: Past Performance

- Three (3) years of past performance service information, if not the manufacturer of the equipment identified herein, where the respondent has provided same or substantially similar service solutions on the same or near-same brand name equipment.

- For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 SAM Unique Entity ID number and size status) if not the respondent.

• Section 4: Capabilities and Delivery

- The offeror’s capability to meet the delivery requirements within the time specified above.

- Offeror shall provide estimated historical on-site response time from the initial call for service until a service technician was on-site for the brand name and model of instrument in this solicitation or a standard target time for onsite performance from initiation of service call.

- If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

- If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

- Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein.

Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards.

The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

- Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

- If a large business, identify the subcontracting opportunities that would 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; and

- Though this is not a request for quote, informational pricing is encouraged for both the purchase of the instrument and a lease of the instrument.

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before August 17, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov.

Reference HFP-2025-129641

Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/policy/accessibility http://www.itic.org/policy/accessibility

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).

Statement of Work

Solid Phase Extraction HLB Cartridges, 60 mg, 3 mL with DEC Caps

HFP-2025-129641

1. Background

The Food and Drug Administration (FDA), Office of Regulatory Testing and Surveillance (ORTS), Arkansas Human and Animal Food Laboratory (ARHAFL) Chemotherapeutic workgroup is the primary laboratory for the chloramphenicol and nitrofurans in aquaculture species shrimp, frog, crab, crawfish, mussel, barramundi, croaker, and cobia. The laboratory analyzes more than six thousand (6000) subsamples each year. The automated solid phase extraction system (ASPEC) HLB cartridges are consumables used on the Gilson GX-274 system at Arkansas Laboratory (ARHAFL).

2. Purpose/Scope The ARHAFL Chemotherapeutic workgroup is the servicing laboratory for the FDA’s antibiotics in aquaculture program. ARHAFL needs seven thousand (7,000) cartridges for the program’s routine sample analyses. The cartridges must be validated to use them on regulatory samples.

3. Salient Characteristics The cartridges used on the Gilson GX-274 system are assembled consumables. The salient characteristics of the required cartridges are as follows:

a. Each cartridge is used only once.

b. The current compliance program requires each received sample to include the analysis of six (6) composites or twelve (12) subsamples.

c. With quality control included, it takes between eighteen (18) and twenty-four (24) cartridges per sample.

d. ARHAFL needs seven thousand (7,000) cartridges for the analysis of the routine program work.

e. The cartridges must have a particle size restriction of between 25.0 – 35.0 µm.

f. The validation of the method requires the use of a 3cc X 60 mg HLB cartridge.

g. These cartridges must be manufactured by the original equipment manufacturer

(OEM) or be certified by the OEM as being compatible with the Gilson GX-274.

4. Service Specifications

The product must be delivered in accordance with the Section 6 table below, and in proper condition in a timely manner.

5. Records and Reports Each cartridge lot received from the vendor must have a Certificate of Analysis to be provided by the vendor to the Government.

6. Deliverables The cartridges should be received consistent with the timeframes listed below.

Period Deliverable Quantity Delivery Date

Base Period Oasis HLB 3cc Vac Cartridge, 60mg Sorbent per cartridge, 30um, 500/pk 14 Award plus fifteen

(15) calendar days

Option Period 1 Oasis HLB 3cc Vac Cartridge, 60mg Sorbent per cartridge, 30um, 500/pk 14

Option Period 1 exercise plus fifteen

(15) calendar days

Option Period 2 Oasis HLB 3cc Vac Cartridge, 60mg Sorbent per cartridge, 30um, 500/pk 14

Option Period 2 exercise plus fifteen

(15) calendar days

Option Period 3 Oasis HLB 3cc Vac Cartridge, 60mg Sorbent per cartridge, 30um, 500/pk 14

Option Period 3 exercise plus fifteen

(15) calendar days

Option Period 4 Oasis HLB 3cc Vac Cartridge, 60mg Sorbent per cartridge, 30um, 500/pk 14

Option Period 4 exercise plus fifteen

(15) calendar days

7. Government-Furnished Property, Material, Equipment, or Information

(GFP, GFM, GFE, or GFI) N/A

8. Contractor Provided Special Material Requirements

9. Security

10. Travel

11. Shipping Destination:

Arkansas Human and Animal Feed Laboratory U.S. Food and Drug Administration 3900 NCTR Rd., Bldg. 26 Jefferson, AR 72079

12. Period of Performance Base Period: 09/01/2025 – 08/31/2026 Option Year 1: 09/01/2026 – 08/31/2027 Option Year 2: 09/01/2027 – 08/31/2028 Option Year 3: 09/01/2028 – 08/31/2029 Option Year 4: 09/01/2029 – 08/31/2030

13. Holidays and Government Closures The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

• New Year’s Day

• Martin Luther King Day

• President’s Day

• Memorial Day

• Juneteenth Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veteran’s Day

• Thanksgiving Day

• Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

14. Contract Administration Technical Point of Contact (POC):

• To be provided at time of award.