Sources Source Notice.pdf

Sources Source Notice (SSN)

REQUIRING ACTIVITY:

May 8, 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: CDER-2024-123664 DM BNE- Agilent LCMSD iQ Mass Selective Detector-Brand Name or Equal, under Solicitation: CDER-2024-123664 DM BNE.

2. ESTIMATED COST

(INCLUDING

OPTIONS):

$91,968.33 for a Period of Performance: 09/30/2024 THRU 09/29/2025

The U. S. Food & Drug Administration has a requirement for the procurement of: CDER-2024- 123664 DM BNE- Agilent LCMSD iQ Mass Selective Detector-Brand Name or Equal, under Solicitation: CDER-2024-123664 DM BNE.

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

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Division of Product Quality Research (DPQR) has played an important regulatory role in three QPQ core research areas “Advanced Characterization of Complex Mixtures and Biologics”, “Physicochemical Characterization of Complex Dosage Forms and Formulations” and “Manufacturing Science and Innovation (Continuous Manufacturing)”. The research studies feature advanced separation, characterization and detection of complex drug substance and related impurities to ensure the quality of pharmaceutical products. To expand the analytical capacity in support of the increasing need for characterizing drug impurities, the Division of Product Quality Research (DPQR) is requesting an LC/MSD iQ Mass Selective Detector that must directly interface with the existing Agilent liquid chromatography (1290 Infinity II) system. This compact benchtop mass detector must be controlled by Agilent liquid chromatography (Agilent OpenLab CDS 2.4 or higher) operating system software for qualitative and quantitative analysis of API and impurities by enhancing sensitivity beyond standard LC UV and refractive index detectors. The mass spectrometer detector must provide mass spectral information to confirm the mass to charge ratio of analytes, drug substance and impurities.

Purpose To purchase Agilent LC/MSD iQ Mass Selective Detector that directly interfaces with the existing Agilent liquid chromatography (1290 Infinity II) system to provide mass spectral information and enhance the sensitivity. The objective is to expand the analytical capability of existing ion chromatography system.

Required Capabilities The major components of the requested instrument are as follows: The system shall have the following characteristics:

5.2. Specification/Salient Characteristics: The Contractor shall provide items that meet the following technical requirements:

Requirements

The mass detector shall meet the following criteria:

1) Shall have a mass-to-charge-ratio (m/z) range from 2 u to 1,450 u

2) Shall have scanning speed of up to 10,400 u/s and fast (25 ms) polarity switching

3) Shall have Mass Resolution (Autotune) Full width at half maximum Unit resolution (0.7 u (Da))

4) Shall have SIM sensitivity of 1 pg of reserpine injected on column with signal-to-noise ratio (S/N), RMS >40:1 (ESI Positive, quantifying the m/z 609 ion); SIM sensitivity of 1 pg of chloramphenicol injected on column with S/N, RMS >40:1 (ESI Negative, quantifying the m/z 321 ion)

5) Shall have Mass Stability (Drift) Over 12 hours ≤0.1 u (Da) or 100 ppm, whichever is larger

6) Shall have Mass Accuracy ±0.13 Da over full mass range

7) Shall have minimum SIM Dwell Time 1 msec

8) Shall have Maximum SIM Transitions 500 SIM ions per time segment

9) Shall have Dynamic Range >6 × 106 (electronic)

Additional Information In addition, the Vendor will cover all costs associated with the following:

i. Full system software and peripheral installation (if applicable).

ii. On-site hardware and software training.

iii. The Factory Acceptance Tests (FAT) shall be included. The FAT protocols should be discussed prior to the evaluation. Preferably, the test is performed at the installation site (DPQR lab).

iv. Shall have a warranty, including parts and labor, for at least one year.

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 05/20/2024 (12: 00pm) Eastern Standard Time.

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 mailto:Emmanuel.mbah@fda.hhs.gov response to these SSN, nor is the Government obligated to issue a solicitation/award from this

SSN.

Emmanuel T. Mbah.

Contracting Officer/Contract Specialist