Sources_Sought_DLS_Instrument_FDA.docx

SOURCES SOUGHT NOTICE: Dynamic Light Scattering (DLS) Instrument for Nanoparticle Characterization NAICS / Size Standard: 334516 – Analytical Laboratory Instrument Manufacturing / 1,000 employees | PSC: 6630 – Chemical Analysis Instruments | Place of Delivery: U.S. Food and Drug Administration, Human Foods Program, 5001 Campus Drive, College Park, MD 20740 Responses due: 7/31/2026 Noon ET by email to 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 U.S. Food and Drug Administration (FDA), Human Foods Program, Office of Chemistry and Toxicology, Division of Analytical Chemistry, requires one (1) Dynamic Light Scattering (DLS) instrument system to measure particle size, particle size distribution, zeta potential, electrophoretic mobility, concentration, refractive index, sedimentation, transmittance, molecular weight, and microrheology of dispersed particles and molecules. The instrument will characterize nano-sized (approximately 1–1000 nm) particles in color and food additives and will support broader analysis of food products that may contain engineered or incidental nanomaterials, including the detection and characterization of microplastics and nanoplastics in food matrices.

Estimated quantities:

- One (1) DLS particle size and zeta-potential analyzer (base instrument).

- One (1) automated titration accessory (autotitrator) compatible with the analyzer.

- One (1) on-site installation and familiarization training event (one day; up to four operators).

- One (1) standard three (3)-year warranty.

Minimum salient characteristics (all values below are minimum requirements; the instrument shall meet or exceed each. Equivalent capabilities that differ from these minimums must be justified by the offeror and are subject to Government evaluation):

- Measurement of particle size, particle size distribution, zeta potential, electrophoretic mobility, concentration, refractive index, sedimentation, transmittance, molecular weight, and microrheology of dispersed particles and molecules.

- Solid-state laser source of up to 50 mW at 671 nm with a high-sensitivity avalanche photodiode (APD) detector, and automatic adjustment of scattering volume to optimize measurement of high-concentration samples.

- Size and molecular-weight measurement by DLS/SLS at a 173° back-scatter detection angle, with 90° and 12° DLS/SLS measurements also available, and a correlation algorithm to reject spurious results.

- Zeta-potential analysis using phase analysis light scattering (PALS) for measuring zeta-potential distributions and for high-conductivity media, with condensation control via external nitrogen or dry air.

- Temperature range of -15 °C to 120 °C, controlled to ±0.1 °C.

- Minimum sample volume of 3 µL.

- Particle size range of 0.3 nm to 15 µm.

- Zeta-potential range greater than ±500 mV (for particles 2 nm to 110 µm).

- Maximum sample conductivity of 260 mS/cm.

- Molecular-mass range of 342 Da to 20 MDa.

- Concentration range of 1 × 10^8 to 1 × 10^12 particles/mL.

- Refractive-index range of 1.2 to 1.6.

- Sedimentation size range of 1 µm to 50 µm.

- Unlimited-seat license for the instrument operating and data-processing software.

- Autotitrator accessory equipped with three high-precision titration pumps (precision of 0.28 µL) and a magnetic stirrer, operating in combination with the particle size and zeta-potential analyzer for automatic acid–base titration and determination of the isoelectric point (IEP).

Delivery, installation, and set-up: The vendor is responsible for delivery, installation, and set-up at the FDA Human Foods Program facility, 5001 Campus Drive, College Park, MD 20740 (delivery hours 10:00 AM–4:00 PM, Monday–Friday). The instrument shall be delivered and installed within sixty (60) days of award. Upon installation, the vendor shall demonstrate that the instrument meets all manufacturer performance specifications; the instrument will not be accepted until those specifications have been met. On-site familiarization training for up to four operators shall be provided within thirty (30) days after installation and FDA acceptance, scheduled through the program's project officer, and shall address proper operation, routine user maintenance, applicable safety practices, troubleshooting, method setup and optimization, and provision of training manuals to participants.

Warranty and service: The instrument shall include a standard three (3)-year warranty for laboratory instruments, effective after installation. Service and installation shall be performed by service engineers trained and certified by the original manufacturer, with access to the manufacturer's current technical developments, repair procedures, application updates, diagnostic software, and preventive-maintenance procedures.

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 – HPF-2026-134655 - FDA.” 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: HPF-2026-134655 - FDA_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.