75F40124Q00360_SSN.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Drug Evaluation and Research (CDER) in order to determine if there are existing small business sources capable of providing a Gas Chromatography-Mass Spectrometry (GC-MS) and Headspace Autosampler with 4 (1-year Post-Warranty Maintenance Option periods).

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The FDA/CDER/Office of Testing and Research St. Louis (OTR-STL) has a need for a Gas Chromatography-Mass Spectrometry (GC-MS) and Headspace Autosampler with 4 (1-year Post-Warranty Maintenance Option periods). One of OTR’s goals is to anticipate the need for methods of characterization of both drug and over-the-counter (OTC) products, while providing the FDA and industry with validated methods using instrumentation that is widely available. The previous work demonstrates that GC-MS is capable of helping us fulfill our goals across a variety of demanding projects, while our anticipated work encourages us to invest in the capability and uptime of our GC-MS instrumentation.

Minimum Technical Requirements for a Gas Chromatography-Mass Spectrometry (GC-MS) and Headspace Autosampler with 4 (1-year Post-Warranty Maintenance Option periods):

Headspace Sampler Minimum Requirements:

• Shall be capable of analyzing vials with at least 10 mL size.

• Shall include an autosampler that can be sequenced with at least 60 vials.

• Shall include a headspace autosampler or included autosampler unit must be capable of including SPME (solid phase microextraction) in sequenced routines.

Headspace Specifications:

• Shall include an ideal autosampler that will provide both headspace and liquid injections without reconfiguration of the instrument.

GC Minimum Requirements:

• Shall include operational oven temperatures of up 450 °C.

• Shall include oven ramp rates capable of at least 90 °C per minute.

GC Specifications:

• Shall be able to be upgraded with different headspace/liquid/and solid phase microextraction autosampler interfaces.

MS Minimum Requirements:

• The mass range shall be 1.2 –1100 amu (u).

• The resolution shall be ≤ 1.0 amu over the entire mass range.

• The quadrupole analyzer shall support fast scanning at 20,000 u/sec.

• The acquisition rate for SIM mode shall allow for more than 240 scans/sec.

• The acquisition rate for Full Scan mode shall allow for more than 97 scans/sec written to disk when scanning over a range of 125 u.

• The quadrupole rods shall be assembled in an open configuration.

• The ion source shall be compatible with electron ionization (EI) and chemical ionization (CI) operation.

MS Specifications:

• To ensure uptime, the system shall be designed with replaceable filaments and quick source cleaning.

Instrument Control Minimum Requirements:

• Shall have an audit-ready regulatory compliant tuning environment.

• Instrument methods shall allow in-sequence tuning.

• Shall have the ability to acquire data in centroid, profile, or nominal modes.

• Shall have the following scan modes: Full Scan (FS), single ion monitoring (SIM), alternating

Full Scan/SIM (simultaneous within a single injection), and Timed SIM acquisition (t-SIM).

• Shall be delivered with an automated SIM method development tool and shall allow timed SIM analysis mode.

• Shall have the ability to alternate between Full Scan MS and SIM target analysis on successive scan.

• In Full Scan/SIM mode, the instrument control shall acquire all data into a single file with the ability to be parsed into separate views by the data system.

• The instrument tuning shall include a diagnostic tool in case of failures.

• The instrument tuning shall include customizable sensitivity threshold.

• Shall include Installation and Operational Qualifications (IQ/OQ).

Optional: Trade In

• An option for instrument trade in may be considered for pricing incentive. An older Agilent QQQ GC-MS instrument is available to be traded in given the ability of the bidder to offer incentive to pricing of the contract. The specific instrument is a 7000 series triple quad mass spec with gas chromatograph.

• Model and serial numbers are provided below:

GC: 7890A, Model: G3440A, Serial #US12371014, FDA# 5144585 MSD: 7000, Model: G7001B, Serial #US12376901, FDA# 5144299 In Service Date: 9/21/2012

• The condition of the trade in instrument is “as is”. The instrument was in working condition prior to being removed from service and can be made functional again with appropriate installation.

• Trade-in credit must be itemized in offeror’s proposal. The government reserves the right to reject trade-in offer if credit is below fair market value. Rejected trade-in offer will not be considered towards final price evaluation.

Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• Installation and plumbing of instrument, autosampler, mass spectrometer, computer controller, software, and any other needed accessories should be included. Installation and operational qualifications must be met before the installation is considered complete.

• Instrument Detection Limit (IDL) is an accurate indication of true sensitivity (minimum detectable quantity) than signal-to-noise (S/N), particularly when background noise levels are very low, as with MS/MS measurements when only standard is injected. IDL verification is a more extensive (eight consecutive injections versus one, in the case of S/N) and reliable test that is performed at installation to ensure proper system qualification.

• Manufacturer and instrument specific Installation Qualification and Operational Qualification (IQ/OQ) shall be provided with the response to ensure nominal specifications are appropriate.

• The offeror shall provide Initial Instrument Training/Familiarization.

• The offeror shall provide installation and operational qualifications (IQ/OQ).

• The offeror shall install the equipment and provide all labor, travel, kits and tools, etc, to install the equipment at the address provided below, to include inside delivery.

• The offeror shall provide training for proper operation of the instrument.

• The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Minimum Performance Requirements for 4 (1-year Post Warranty Maintenance Option Period):

• The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

• The Maintenance and Repair activities shall be performed following the Original Equipment

Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• The Contractor shall include unlimited software and firmware updates during the coverage period(s).

• The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time.

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Estimated Delivery Date: 60 days after award

Option Year 1: 09/18/2025 thru 09/17/2026 Option Year 2: 09/18/2026 thru 09/17/2027 Option Year 3: 09/18/2027 thru 09/17/2028 Option Year 4: 09/18/2028 thru 09/17/2029

Delivery Location:

Food and Drug Administration Office of Testing and Research St. Louis 645 S. Newstead Avenue St. Louis, Missouri 63110

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Though the target audience is small business vendors or small businesses capable of supplying a U.S.

service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, DUNS 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.

Provide this same information again if responding to provide a service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client 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 UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

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

• The offeror shall advise if the product and/or service is on a Best-in-Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide if subcontracting opportunities 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.

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

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before July 9, 2024 by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov. Reference: 75F40124Q00360.

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.