FDA-SSN-123037.pdf

Malvern Panalytical Mastersizer 3000 Optical System Preventative Maintenance & Repair Services

Sources Sought Notice

FDA‐SSN-123037

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the National Center for Toxicological Research (NCTR), in order to determine if there are existing small business sources capable of providing Malvern Panalytical Mastersizer 3000 Optical System Preventative Maintenance & Repair Services. Other than small business concerns are also encouraged to submit capability statements.

The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The appropriate NAICS code for the acquisition is 811210 – Electronic and Precision Equipment Repair and Maintenance; Small Business Size standards – $34 MIL.

Background:

The Food and Drug Administration (FDA) makes regulatory assessments of products that either contain nanomaterial or otherwise involve the application of nanotechnology. The FDA Nanotechnology Core Facility (Nanocore) utilizes multiple types of equipment for the separation and detection of nanomaterials used in various experiments. The Malvern MASTERSIZER 3000 (Serial Number: MAL1174886/MAZ3100-MAL1174985) Optical System is integral to these determinations and is one of the “core” equipment in the Nanotechnology Core Facility, NCTR/Nanocore that is supporting: (a) the nanotechnology needs of National Center for Toxicological Research (NCTR) and the Office of Regulatory Affairs/ Arkansas Regional Laboratory (ORA/ARL), which are co-located on the Jefferson Laboratories Campus, (b) the FDA centers located away from the Jefferson Laboratory Campus, and (c) studies conducted under the National Toxicology Program.

The instrument requires a yearly maintenance contract to ensure reliability for the support of ongoing research. It is covered under a maintenance & repair services contract through August 18, 2024.

Minimum Performance Requirements:

Shall include:

1. All components cited in the Malvern Panalytical Mastersizer 3000 Optical System, serial number: MAL1174886/MAZ3100-MAL1174985).

2. Repair of both hardware and software. (Product Catalog Approval Request #RN00012407).

3. Unlimited on-site service visits for instrument repair. The vendor shall be able to guarantee that a service engineer will be able to work on-site within five (5) business days of notifications.

4. All maintenance/repair pricing inclusive of labor, travel, replacement parts, components, subassemblies, consumables, etc. for system.

5. Software and firmware updates and notifications, as required by the OEM.

6. Performance by trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

7. Trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

8. Access by the system operator personnel to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

9. One (1) schedule preventive maintenance (PM) visit per year which includes a full system diagnostic and critical parts exchange to keep the instrument in optimum working condition.

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 by email 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 Contracting Officer's Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Anticipated Performance:

Base Year: 08/19/2024 - 08/18/2025 Option Year 1: 08/19/2025 - 08/18/2026 Option Year 2: 08/19/2026 - 08/18/2027 Option Year 3: 08/19/2027 - 08/18/2028 Option Year 4: 08/19/2028 - 08/18/2029

Pace of Performance:

U. S. FDA – National Center for Toxicological Research (NCTR) TPOC: To be provided upon award 3900 NCTR Rd.

Bldg. 26, Rm. B332 Jefferson, AR 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly engaged in the sale of same or substantially similar product/service. 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:

1. Business name and bio, SAM UEI 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.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum technical/performance requirements identified above, to include descriptive material, literature, brochures, and other information.

3. Past Performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar instrument solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, 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 company (to include the firm’s SAM Unique Entity Identifier (UEI) number and size status) if not the respondent.

4. 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.

5. If applicable, identification of Best in Class (BIC) contract information or other Government Wide or HHS Wide Contracts that the equipment/service is available on.

6. If a large business, provide if subcontracting opportunities exist for small business concerns.

7. Standard commercial warranty.

8. 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.

9. Though this is not a request for quote, informational pricing is being requested.

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

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 24, 2024, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA‐SSN‐123037.

Notice of Intent:

Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole‐source acquisition procedures.

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.