Sources_Sought_Mixed_Custom_Standards.docx

SOURCES SOUGHT NOTICE: Mixed Custom Standards – Custom Multi-Component Veterinary Drug Analytical Reference Standards NAICS / Size Standard: 325998 – All Other Miscellaneous Chemical Product and Preparation Manufacturing (Size Standard: 500 employees) PSC: 6810 – Chemicals] | Place of Delivery: FDA Denver Laboratory, 6th Avenue & Kipling St, Bldg. 20, Door W10, Denver, Colorado 80225 Responses due: 8/7/2026 Noon ET by email to David Seid - David.Seid@FDA.HHS.Gov.

1.0 PURPOSE AND DISCLAIMER

THIS IS A SOURCES SOUGHT NOTICE ONLY, issued for market research under RFO Part 10. It is not a solicitation and does not commit the Government to issue one. The Government will not pay any costs incurred in responding. Responses will not be returned and respondents will not be notified of results. Not responding does not preclude participation in any future solicitation, which, if issued, will be posted to SAM.gov.

This notice has two purposes: (1) to identify sources of any business size capable of supplying domestic end products meeting this requirement, in support of the Government's obligations under the Buy American statute and RFO Part 25; and (2) to determine whether capable small business concerns, whether as manufacturer, OEM, authorized distributor, or reseller, exist in sufficient number to support a set-aside under RFO Part 19. Responses will inform the acquisition strategy, including the set-aside decision and any domestic availability determination, and may be summarized in market research documentation posted publicly with a proposed nonavailability waiver, if applicable. Do not submit proprietary pricing; mark any confidential business information clearly.

2.0 DESCRIPTION OF REQUIREMENT

The Food and Drug Administration (FDA) Denver Human and Animal Food Laboratory (DENHAFL) requires custom-prepared, multi-component analytical reference standard solutions for use in the regulatory analysis of veterinary drug residues in aquaculture, dairy, and game-meat products. The standards support initial calibration verification (ICV) and continuing calibration verification (CCV) in screening and confirmatory liquid chromatography–mass spectrometry (LC-MS) methods.

Salient characteristics. Each reference material must be produced and verified by a producer accredited and certified to ISO 17034 and must be accompanied by, or provide online access to, a certificate of analysis stating at minimum the component name, lot number, CAS number, uncertainty, expiration/retest date, preparation solvent, certified value, method of value assignment (e.g., GC/MS, HPLC), and the ISO 17034 seal or certificate number. Standards must be dissolved in LC-MS–grade solvents and sealed in 1 mL glass ampules, grouped by drug class into the specific multi-component mixtures and target concentrations specified by the Government (drug classes include NSAIDs, macrolides, amphenicols, avermectins, nitroimidazoles, quinolones, fluoroquinolones, and sulfonamides). Each mixture must be supplied in two separate lots — Lot A designated for ICV use and Lot B designated for CCV use — and must carry a minimum expiration or retest date of 12 months from the date of shipment. Concentrations derived from salt, hydrate, or multi-component neat forms must be calculated and reported as specified (e.g., free-base or free-acid equivalent, anhydrous equivalent, or named active-component equivalents such as Abamectin B1a, Ivermectin B1a, and Emamectin B1a).

Estimated quantities. Fifteen (15) distinct multi-component standard mixtures, each delivered as two lots (Lot A/ICV and Lot B/CCV) of five (5) 1 mL ampules per lot — approximately 30 deliverable line items and 150 total ampules. Standards with a certified shelf life shorter than 12 months must be replaced at no additional cost, with replacements shipped before expiration or approximately 165 calendar days after the first shipment.

Delivery timeframe and location. Delivery is required on or about December 1, 2026, to the FDA Denver Laboratory, 6th Avenue & Kipling St, Bldg. 20, Door W10, Denver, Colorado 80225, Monday–Friday, 8:00 AM–4:00 PM (excluding Federal holidays), using priority shipping with appropriate protective packaging on cold packs or dry ice. The anticipated period of performance is one (1) year from the date of contract award.

Applicable standards and compatibility constraints. All reference materials must be prepared and verified in accordance with ISO 17034. Standards must be prepared at the specified target concentrations and must maintain the relative concentration ratios within each mixture; where compounds are chemically incompatible, unstable, or otherwise unsuitable for combination, the affected materials must be separated into individual mixtures or standalone standards while maintaining the specified target concentrations to the maximum extent practicable. Where an ISO 17034 reference material is not commercially available, limited exclusions may be requested with supporting documentation and technical justification, subject to Government review and approval.

3.0 INSTRUCTIONS TO RESPONDENTS

Responses shall be submitted by email to the point of contact identified in the SAM.gov posting no later than the response due date, with subject line “Sources Sought Response – HFP-2026-135452 - [COMPANY NAME].” A complete response consists of:

(a) The Vendor Response Form (Attachment 1), completed and returned in its NATIVE MICROSOFT EXCEL (.xlsx) FORMAT. Do not convert the form to PDF, scan it, or alter its structure. Name the file: HFP-2026-135452_CompanyName.xlsx; and

(b) A capability statement not exceeding five (5) pages in PDF format providing narrative elaboration and supporting documentation as applicable (product literature, specification sheets, letters of supply or authorized distribution).

The Company Information fields in Section 4.0 and the questions in Sections 5.0 and 6.0 below are reproduced in the Vendor Response Form. The Government intends to consolidate and analyze market data directly from the returned forms; responses submitted without the completed form in native Excel format may not be fully considered in the Government’s analysis. Telephone inquiries will not be accepted.

4.0 COMPANY INFORMATION (provide all of the following)

4.1. Company Name / Address:

4.2. UEI / CAGE Code:

4.3. Point of Contact (Name, Phone, Email):

4.4. Active SAM.gov Registration (Yes/No):

4.5. Business Size under the stated NAICS (Small / Other than Small):

4.6. Socioeconomic Categories (all that apply): 8(a); HUBZone; SDVOSB; VOSB; WOSB; EDWOSB; SDB; None

4.7. Existing Contract Vehicles (FSS/MAS, GWAC, IDIQ/BPA):

5.0 SMALL BUSINESS CAPABILITY QUESTIONS

5.1. Identify your role for the required items: OEM, manufacturer, authorized distributor or dealer, reseller, or other (describe). If a distributor or reseller, identify the manufacturer(s) of the end items you would supply and provide evidence of authorized distribution, if available.

5.2. If you are a small business that is not the manufacturer of the end item, state whether you can supply end items manufactured by a small business concern in the United States, consistent with the nonmanufacturer rule (13 CFR 121.406), and identify that manufacturer if known. If you would supply the product of an other than small or foreign manufacturer, state this clearly.

5.3. Describe your capability and capacity to fulfill the full scope of this requirement, including the quantities and delivery timeframes in Section 2.0, and identify any portion you could not fulfill. Include relevant experience (up to three recent contracts or commercial sales) and any applicable quality or regulatory certifications. Federal experience is not required.

5.4. Describe any teaming, joint venture, or subcontracting arrangements you anticipate.

6.0 DOMESTIC MANUFACTURE AND AVAILABILITY QUESTIONS

All respondents shall answer, regardless of business size.

6.1. Identify the country (or countries) in which the offered end item is manufactured and the operations performed at each location.

6.2. If manufactured in the United States, state whether the item meets the domestic content threshold in effect under RFO 25.101 as of the anticipated award date, or the approximate domestic content percentage you can certify to. State whether the item is a commercially available off-the-shelf (COTS) item and whether it consists wholly or predominantly of iron or steel.

6.3. Identify the country of origin of any critical components or components for which no domestic source is known to you.

6.4. If you can supply a domestic end product, describe production capacity against the Section 2.0 quantities (sustainable output, available inventory, lead times). If you can satisfy the requirement only in part (insufficient quantity) or with deviations from the salient characteristics (insufficient quality), describe the shortfall specifically.

6.5. If you do not currently manufacture a domestic end product meeting this requirement, state whether and under what conditions you could establish or expand domestic production (estimated timeline, minimum quantities, or other commitments required).

6.6. Identify any alternative or substitute items manufactured in the United States that could satisfy the Section 2.0 characteristics, including items made by other firms, and any other known domestic manufacturers or supply chain constraints relevant to domestic availability.

6.7. If the offered item is not a domestic end product, identify its country of origin and, if known, whether it is a designated country end product under the Trade Agreements Act.