Sources Source Notice.pdf

Sources Source Notice (SSN)

REQUIRING ACTIVITY:

March 30, 2024

Food and Drug Administration, (FDA)

CONTRACTING

ACTIVITY:

Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Programs (DAP), Facilities Support Branch (FSB)

1. DESCRIPTION OF

SERVICES:

Procurement of: CFSAN-2024-121654 400MHZ NMR Spectrometer Food Screening System, under Solicitation: FDA-RFQ- CFSAN-2024-121654.

2. ESTIMATED COST

(INCLUDING

OPTIONS):

$350,000.00 for a Period of Performance: 07/05/2024 THRU 07/04/2025

The U. S. Food & Drug Administration has a requirement for the procurement of: CFSAN-2024- 121654 400MHZ NMR Spectrometer Food Screening System, under Solicitation: FDA-RFQ-

CFSAN-2024-121654.

The associated NAICS Code is: 334516-Analytical Laboratory Instrument Manufacturing.

Offerors must have an active registration in www.SAM.gov, with completed representations and certifications.

Introduction This Sources Sought Notice (SSN) is a market research tool to determine the availability and technical capability of small businesses (including the following subsets: Small Disadvantaged Businesses, HUBZone Firms, Certified 8(a), Service-Disabled Veteran-Owned Small Businesses and Woman Owned Small Business) to provide the required products and/or services.

Disclaimer This SSN is for informational purposes only. This is not a request for proposals. It does not constitute a solicitation and shall not be construed as a commitment by the Government. Responses in any form are not offers and the Government is under no obligation to issue a solicitation or award a contract as a result of this announcement. No funds are available to pay for the preparation of responses to this announcement. Any information submitted by respondents to this technical description is strictly voluntary.

Program Background

ORS/DAC/SMSB requires an integrated 400MHz NMR system with all parts, software and licenses to prepare samples and produce and test spectra against the Bruker food Screener database.

The integrated NMR sample-preparation/spectrometer/database- analysis system creates a powerful method of differentiation food samples based on origin, adulteration, quality and contamination. The system will allow for the testing and validation of NMR methods involving honey, olive oil, fruit juices, and wines. It will also allow for further development of methods involving these and other foods. The system will also support other areas of research in the center including screening for chemical contaminants such as per-and polyfluorinated alkyl substances

(PFAS).

Purpose The objective of this requirement is to purchase a 400MHz NMR spectrometer and sample preparation and analysis system for analysis with the Bruker Food Screener database. This is critical to support the Agency’s mission in the development and validation of analytical methods for the detection of adulteration and chemical contamination in FDA regulated products.

This is new requirement to purchase an integrated NMR food screening system for the Office of Regulatory Science (ORS), Division of Analytical Chemistry (DAC), Spectroscopy and Mass Spectrometry Branch (SMSB).

Required Capabilities Vendors shall have the ability to meet the technical and hardware requirements. The Government reserves the right to select the system that will offer the best value, including considering features that may enhance the value of the instrument, such as additional software, training, and extension of warranty periods. Price or cost shall be considered only after the technical requirements, hardware, functional and operational specifications have been evaluated.

Additional Information The Contractor shall at a minimum, provide an instrument that meets the following technical requirements:

A 400MHz NMR spectrometer and food screening system. The instrument shall be capable of operating as a regular 400MHz NMR instrument with all components needed for acquiring spectra of sufficient sensitivity and resolution for comparison to the food Screener database. This includes the following:

a. A 400MHz superconducting magnet with specifications of a Bruker Ascend, equivalent or better. Magnet shall be shielded and include cryogen transfer lines.

and parts for maintaining and filling cryogens. Shall include inertial dampening for the magnet to ensure spectra are of sufficient analytical quality for the food Screener database.

b. A spectrometer console with specific parts, including amplifiers, control boards, shim controls, pulsed gradient components, capable of interfacing with and carrying out the required experiments for producing spectra suitable for analysis against and submission to the food Screener database as well as those required for the deuterium SNIF-NMR methods. Shall be of quality and specifications of a Bruker Avance NEO, equivalent or better with shim capabilities of a Bruker BOSS III equivalent or better.

c. A proton-observe probe with a broad-band X-channel with sufficient SNR and resolution for all food Screener applications. Shall be fully integrated with preamplifiers and console. Must have automated tune and match capabilities and a 5G/A*cm z-axis gradient coil. A Bruker PA3163_BI/H_OZ probe, equivalent or better.

d. Also including a 10mm deuterium-observe probe with fluorine lock capabilities with the required components to be fully integrated with the spectrometer console. Shall have automated tune and match capabilities. A Bruker PA1054_DX/HD_OZ probe, equivalent or better.

e. Must include food Screener database access, including at least 600 analyses against the database.

f. Software and workstations necessary for the operation of the NMR instrument and the processing and preparation of spectra for use with the food Screener database.

g. All components needed for the preparation of samples for analysis by the food Screener methods, including sample spinners (compatible with automated sample changer), buffers, standard solutions, vials, device and parts for pH control, specialized tubes, SOPs and any needed training for analyzing samples including honey, wine, juice, olive oil, and research samples.

h. An automated sample changing system fully integrated with the probes, console, and software of the NMR spectrometer that will allow unsupervised analysis of 60 or more samples with barcode tracking of samples.

The contract vehicle is anticipated: Firm Fixed Price, Single award.

Eligibility The applicable NAICS Code for this requirement is 334516-Analytical Laboratory Instrument Manufacturing.

Submission Details

Interested small businesses are requested to submit a capabilities statement. Interested businesses should submit a brief capabilities statement package that shall address, at a minimum, the following items:

1.) What type of work has their company performed in the past in support of the same or similar requirements? This should include the contract number, organization supported, indication of whether as a prime or subcontractor, contract value, Government point of contact, and a brief description of how the referenced contract relates to the items/services described in this SSN.

2.) What specific technical skills does their company possess which ensure capability to provide the requested items/services?

3) Note that under a Small-Business Set-Aside, in accordance with FAR 52.219-14, the small business prime must perform at least 50% of the work themselves in terms of the cost of performance. Vendors shall thus provide an explanation of their company's ability to perform at least 50% of the tasks/terms/services requested.

4.) Respondents to this notice shall also indicate whether they qualify as a Small, Small Disadvantaged, Women-Owned, HUBZone, or Service-Disabled Veteran-Owned Small Business Concern.

In order for the Government to make a determination for a small business set-aside, two or more qualified and capable small businesses must submit responses that demonstrate their qualifications and ability to provide the requested items/services.

To assist the Government in making the subject determination regarding the level of participation by small business in any subsequent procurement that may result from this Sources Sought, Vendors are also encouraged to provide information regarding plans to use joint venturing (JV) or partnering to meet each of the requirements’ areas contained herein. This includes responses from qualified and capable Small Businesses, Small Disadvantaged Businesses, Service Disabled- Veteran Owned Small Businesses, Women-owned Small Businesses, HUBZone Small Businesses, and 8(a) companies.

Vendors shall provide information on how they will envision their company's areas of expertise and those of any proposed JV/partner, combined to meet the specific requirements contained in this announcement.

Responses to this SSN shall be electronically submitted to Emmanuel.mbah@fda.hhs.gov. The deadline for response to this request is 04/07/2024 (12: 00pm) Eastern Standard Time.

mailto:Emmanuel.mbah@fda.hhs.gov

Proprietary information and trade secrets, if any, SHALL be clearly marked on all materials. All information received that is marked Proprietary will be handled accordingly. Be advised that all submissions become Government property and will not be returned.

No phone calls will be accepted. The Government is not committed nor obligated to pay for the information provided, and no basis for claims against the Government shall arise because of a response to these SSN, nor is the Government obligated to issue a solicitation/award from this

SSN.

Emmanuel T. Mbah.

Contracting Officer/Contract Specialist