FDA-SSN-122751.pdf

Ultraviolet Visible (UV-Vis) Spectrophotometer System or Equal Sources Sought Notice

FDA‐SSN-122751

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 a UV-Vis Spectrophotometer or Equal. 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 334516 – Analytical Laboratory Instrument Manufacturing; Small Business Size standards – 1,000 employees.

Background:

The National Center for Toxicological Research (NCTR) requires a UV-Vis Spectrophotometer system complete with components, supporting hardware, and software tailored for nanomaterial characterization.

The Food and Drug Administration (FDA) conducts regulatory assessments on products containing nanomaterials or utilizing nanotechnology. The FDA Nanotechnology Core (Nanocore) Facility serves the nanotechnology requirements of the National Center for Toxicological Research (NCTR) and the Office of Regulatory Affairs/Arkansas Regional Laboratory (ORA/ARL), both situated on the Jefferson Laboratories Campus. Additionally, the facility aids studies conducted under the National Toxicology Program and other FDA Centers. Nanocore engages in research focused on characterizing nanomaterials and assessing their biological effects to support regulatory decision-making. Furthermore, Nanocore collaborates with stakeholders to develop consensus standards.

This requirement is as Brand Name or Equal configuration:

1. PerkinElmer, Lambda 365+ PC Version, part # N4100022 or equal, 1 – Each

2. PerkinElmer, NA Power Cord 14AWG 2M 125V 15A, part # 09991420 or equal, 1 - Each

3. PerkinElmer, KIT - UVWINLAB V7.4 STD SOFTWARE, part # L6100127 or equal, 1 -

Each

4. PerkinElmer, PC- DELL XE4 SSD WIN10 IOT LTSC, part # 09406562 or equal, 1 - Each

5. PerkinElmer, 24inch monitor - Dell (ADC), part # 09406426 or equal, 1 - Each

6. PerkinElmer, Micro-Cell Holder, part # N4100206 or equal, 1 – Each

7. PerkinElmer, PELTIER MULTICELL HOLDER WITH REF HE, part # N4100222or equal, 1 – Each

8. PerkinElmer, Peltier Temperature Controller, No Cell, part # N4100040 or equal, 1 - Each

9. PerkinElmer, Gold Plan 1PM LAMBDA 365+ PC VERSION, part # UVSN4100022PAU1 or equal, 48 - months

*The requirement includes a Trade-In: Lambda 45 Perkin Elmer (S/N- 503S09080501; FDA Property # 4003027) and PTP 1x1 Peltier system (S/N- 1004082) Perkin Elmer. Trade-in System is offered in “as is” condition. Contractor shall assume all costs for packaging and shipping of the trade-in equipment.

Minimum Technical Requirements:

A. Ultraviolet Visible (UV-Vis) Spectrophotometer System shall:

1. Include all parts and components essential for collecting spectrum in the ultra-violet and visible region (≤190 nm and ≥1100 nm).

2. Have true dual beam optics to deliver high wavelength range for spectral data collection.

3. Have a wavelength accuracy of ≤ ± 0.1 nm for Deuterium lamp lines and ≤ ± 0.3 nm for the complete wavelength rage of ≤190 nm and ≥1100 nm.

4. Provide a wavelength accuracy (using a holmium oxide solution per NIST 2034) of ± 0.5 nm.

5. Have linearity up to four absorption units (± 4A).

6. Include all the accessories required to measure spectra for various types of samples including solid, liquid, powder, paste, and thin film samples.

7. Have capability to vary bandwidth from ≤1 nm to ≥20 nm and scan speed from ≤10 nm/min to ≥10000 nm/min.

8. Include a minimum of 8 multi cell-changer that can be controlled by software.

9. Accompany Peltier unit to control temperature in the range of ≤ 10 ᴼC and ≥ 90 ᴼC with an accuracy of ± 0.1 ᴼC, and capable of stirring with ability to control stirring rate.

10. The multi-cell changer shall be auto aligned by the instrument software to optimize the sample position for the best results for a wide range of applications.

11. Have the capability of adding variable path lengths.

12. Include one set of extra UV and Vis light sources as spare components.

13. Include a PC, computer monitor, stand-alone analysis software compatible with WIN 10 for method set-up and data analysis.

14. Have the capability of kinetic measurements with accompanying software that takes measurements based on a set schedule.

15. The software shall have the capability to export and save the data in both ASCII and spectral format.

16. The graphics shall be user friendly with zooming, auto-scale and auto-range option.

17. Include all hardware, monitor, and software for the analytical measurements and data analysis. The computer hardware should have internet, and USB port(s) and other appropriate connections for smooth overall function. This equipment will not be on the FDA network.

18. All components and/or equipment newly manufactured, not used/refurbished or used for previous demonstration.

19. Installation by a contracted representative from the company and shall include software familiarization of the system, optimization of basic functions for sample analysis and software analysis training.

20. Include warranty and service from the date of installation: at least 1 year, parts and labor.

21. Include four (4) option years of Post Warranty Preventative Maintenance.

The system shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, software, and that otherwise required to meet these specifications, the FDA’s stated need and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

B. Post Warranty Preventative Maintenance and Repair Services shall include:

1. The Ultraviolet Visible (UV-Vis) Spectrophotometer System.

2. One (1) scheduled on-site planned preventive maintenance visit per year. The consumables required for PM visit shall be included in the contract.

3. Unlimited on-site corrective maintenance and repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

4. Maintenance and repair activities performance by the service engineers who are trained and certified by the original manufacturer, and the service provider should follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

5. Unlimited software and firmware updates during the entire coverage period(s).

6. Unlimited technical support (via phone and email) on software and hardware related issues and trouble-shooting capabilities, Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Central Time.

7. All maintenance and repair pricing encompassing costs for labor, travel, replacement parts, components, subassemblies, and any other necessary expenses related to the system.

Deliverables: 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 Delivery/Performance:

FOB Destination. Shipping, handling in-side delivery, installation, and training shall be not later than 120 calendar days after receipt of contract award. The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery, installation, and offered warranty period of the systems. If/when Option Year 1 is exercised, the periods of performance for all options will be firmed via bilateral modification.

Place of Delivery/Performance:

U. S. FDA – NCTR

3900 NCTR Road Bldg. 25 Jefferson, AR 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing Ultraviolet Visible (UV-Vis) Spectrophotometer System or Equal. 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 21, 2024, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA‐SSN‐122751.

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.