FDA_21-223-SOL-1237645_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 National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing a Preventive Maintenance agreement for the following: Zeiss Merlin (Serial Number: MRL 40-6054), Zeiss Merlin (Serial Number: MRL 40-4265) and Gatan 3View (Serial Number: 3V033M SBFSEM) (Base + 4 1-year Maintenance Option periods).

If your firm is considered a small business source under North American Industry Classification System (NAICS) 811219 – Other Electronic and Precision Equipment Repair and Maintenance;

with a Small Business Size Standard of $22 Million, 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/NCTR has a need for a Preventive Maintenance Agreement the following:

Zeiss Merlin (Serial Number: MRL 40-6054), Zeiss Merlin (Serial Number: MRL 40-4265) and Gatan 3View (Serial Number: 3V033M SBFSEM). A single maintenance agreement is required to cover the two (2) Zeiss Merlin scanning electron microscopes and a Gatan 3View serial block face imaging device. NCTR is responsible for helping conduct scientific research and seeking to increase and improve scientific knowledge of the toxicological and pharmacological impacts and effects of agency regulated materials on human health. For this purpose, FDA/NCTR maintain an electron microscope (EM) core facility available FDA-wide for research purposes. This EM core includes two scanning electron microscopes (SEMs), one with a 3View serial block face attachment. The SEMs are two (2) Zeiss Merlin Field Emission Gun Scanning Electron Microscopes. The first Zeiss Merlin (Serial Number: MRL 40-6054), is a shared resource between the NCTR and the ORA. This instrument is regularly used by both centers to conduct research relevant to the mission of each center. The second Zeiss Merlin (Serial Number: MRL 40-4265) has a Gatan 3View2 serial block face sectioning device paired with it making it a Serial Block Face Scanning Electron Microscopy (SBFSEM). The Gatan 3View2 device is used to serially section through specially prepared and embedded biological research tissues from experimental animals in order to reconstruct these tissues digitally in 3D. These 3D reconstructions are used to elucidate structural impacts of treatment with FDA regulated materials on biological tissues. In addition, the SBFSEM system is used for NCTR research to determine the distribution of nanotechnology within tissue and to study the impact of drug treatment on organs and tissues by allowing the FDA to investigate 3D tissue morphology.

NCTR has a requirement to combine both scanning electron microscopes and the Gatan 3View onto a single service/maintenance contract that will ensure complete repair following unexpected failures caused by wear; age of parts, or normal circumstances beyond the control of the user (power outages). The equipment is currently under coverage until September 11, 2021.

Minimum Performance Requirements or Base and 4 (1-year option periods):

• The Contractor shall provide one (1) schedule preventive (PM) visit per year for each instrument.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs and initiate repairs within a reasonable period of time which fits within the contractor’s queue of service to preceding customers. This time is not to exceed 30 days.

• The Contractor shall provide a 24 hour response time with a proposed action plan indicating a timetable for required repair.

• The Contractor shall provide a contract that becomes effective on Sept. 12, 2021, continuing coverages from the previous contracts on both instruments.

• The Maintenance agreement shall include, a yearly field emission gun (FEG) tip change.

• The Contractor shall include coverage for both Zeiss Merlin (Serial Number: MRL 40-4265) and the Gatan 3View serial sectioning device (Serial Number: 3V033M SBFSEM) as a single line item within the contract.

• The Maintenance agreement shall include repairs to Zeiss Merlin (Serial Number: MRL 40- 6054), Zeiss Merlin (Serial Number: MRL 40-4265), and the Gatan 3View serial sectioning device (Serial Number: 3V033M SBFSEM)and repairs shall render each instrument or component, operational and within the operating specifications of the instrument when originally accepted by the government.

• The Contractor shall maintain the instrument in its original setting for its optimum operations.

• 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 priority access to software and firmware updates during the coverage period(s) and provide on-site application and training..

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

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

Period of Performance: Base + 4 (1-year Maintenance Option periods)

Base Year: 09/12/2021 – 09/11/2022 Option Year 1: 09/12/2022 – 09/11/2023 Option Year 2: 09/12/2023 – 09/11/2024 Option Year 3: 09/12/2024 – 09/11/2025 Option Year 4: 09/12/2025 – 09/11/2026

Place of Performance:

Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079

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 sale of same or substantially similar 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 DUNS number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the 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.

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

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before January 4, 2021 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: FDA_21-223-SOL-1237645.

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 FedBizOpps. 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.