75F40124Q00363_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 source sought announcement on behalf of the Center for Devices and Radiological Health (CDRH) in order to determine if there are existing small business sources capable of providing a Preventive Maintenance and Calibration Service Agreement for three (3) Instron mechanical testing machines (System IDs: 4465C11343J; 68F100B27316, and E3000R3703) with 4 (1-year Option periods).

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 811210 – Other Electronic and Precision Equipment Repair and Maintenance; with a Small Business Size Standard of $30 Million and believe that your firm would be able to provide the FDA with the 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 the minimum performance requirements.

Background: The FDA/CDRH/Office of Science and Engineering Laboratories, Division of Applied Mechanics (FDA/CDRH/OSEL/DAM) currently owns the following equipment: three (3) Instron mechanical testing machines (System IDs: 4465C11343J; 68F100B27316, and E3000R3703) and is in need of a Preventive Maintenance and Calibration Service agreement with 4 (1-year Maintenance option periods). The equipment is currently under coverage until September 27, 2024.

Minimum Performance Requirements:

• The Contractor shall provide one (1) schedule on-site preventive maintenance (PM) visit per year that includes repairs, replacement of parts and access to technical support on an as needed basis.

• 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 NIST calibration 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 provide access to the Original Equipment Manufacturer (OEM) technical developments, repair procedure bulletins, hardware and software application updates and revisions.

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

• The Contractor shall include unlimited technical support (via telephone or email) 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 for system.

• The contractor be a skilled service technician with at least 10 years of experience servicing

INSTRON Systems load frames.

• The contractor and/or contracting agency be accredited per ISO/IEC 17025.

• All calibration equipment shall be traceable to NIST.

• The contractor and/or contracting agency provide technical support via phone and email in the event the FDA system users have questions or problems regarding the INSTRON Systems load frames.

• All work shall be performed on site (FDA White Oak, MD campus)

• The calibration and maintenance of 1 INSTRON Systems load frame (System ID:

4465C11343J) to include:

Preventative Maintenance Speed & Displacement Calibration Technical support

Specifications that apply to a, b, and c On-site calibration shall be performed by an Instron trained technician/engineer

• Calibration shall be completed in a manner which adheres to the specifications outlined in the most current ANSI/CDSL Z540-1, ISO 10012-1, ISO 9001, and ISO/IEC 17025

• The force-measuring system shall be calibrated for the forces indicated using equipment calibrated within the requirements of ASTM E4-21

• The calibration equipment used shall be traceable to NIST

• Speed digital readout (mm/min) shall be capable of being measured within ± 0.5% of reading

• Speed shall be calibrated at 1 and 100 mm/min

• The speed setting system shall be verified for the speeds indicated using equipment calibrated within the requirements of ASTM E2658-15

• The displacement-measuring system shall be verified for the displacements indicated using equipment calibrated within the requirements of ASTM E2309/E2309M-20

• Displacement shall be calibrated between 25 to 250 mm in Tension and -25 mm to -250 mm in Compression

Load Cell Calibrations:

5kN Load Cell: 2525-805 S/N 0178 1kN Load Cell: 2525-806 S/N 0129 100 N Load Cell: 2525-807 S/N 0118 10 Load Cell: 2525-808 S/N 58239 500N Load Cell: 2525-816 S/N 70818 50 Load Cell: 2525-817 S/N 65423

• The calibration and maintenance of one INSTRON Systems load frame system (System Name: Table Top Electropuls; Model Number: E3000; system ID: E3000R3703) Preventative maintenance Stroke Calibration (tension & compression) Technical Support

• On-site calibration shall be performed by an Instron trained technician/engineer

• Calibration shall be done in a manner which adheres to the specifications outlined in the most current ANSI/CDSL Z540-1, ISO 10012-1, ISO 9001, and ISO/IEC 17025 calibrated within the requirements of ASTM E4-21.

• Displacement digital readout (mm) shall be capable of being measured within ± 1% full travel in tension and compression

• Displacement shall be calibrated between 3 to 30 mm in Tension and -3 mm to -30 mm in

Compression

• Capable of measuring and controlling forces in tension and compression

• Calibration range shall be 0.5% to 99.5% of full force range

• Relative uncertainty measurements shall be less than 0.5% in tension and compression

• Force digital readout (N) shall be within ± 1% accuracy, 1% repeatability, and zero return tolerance

Load Cell Calibrations:

5 kN Load Cell: 2527-103 S/N 68436 1 kN Load Cell: 2527-130/1004 S/N 107120 250 N Load Cell: 2527-131 S/N 100438 12 Sites Stent System (part # CP105870-Q01; E3000 Accessory) 25N Load Cell Calibration:

A102626-1005 S/N 73661 A102626-1005 S/N 73657 A102626-1005 S/N 73651 A102626-1005 S/N 73691 A102626-1005 S/N 73660 A102626-1005 S/N 73687 A102626-1005 S/N 73676 A102626-1005 S/N 73643 A102626-1005 S/N 73684 A102626-1005 S/N 73636 A102626-1005 S/N 73668 A102626-1005 S/N 73674 A102626-1005 S/N 73646

• Calibration shall be performed per ASTM E4

• Calibration shall be done in a manner which adheres to the specifications outlined in

ANSI/CDSL Z540-1, ISO 10012-1, ISO 9001, and ISO/IEC 17025

• Calibration range shall be 0.5% to 99.5% of full force range

• Force digital readout (N) shall be within ± 0.5% accuracy, 0.5% repeatability, and zero return tolerance

• The calibration and maintenance of one INSTRON Systems load frame system (System ID:

68F100B27316) Preventative maintenance Stroke Calibration (tension & compression) Technical Support Specifications that apply to a, b, and c

• Calibration shall be done in a manner which adheres to the specifications outlined in the calibrated within the requirements of ASTM E4-21

• Speed digital readout (in/min) shall be capable of being measured within ± 0.5% of reading

• Speed shall be calibrated at 0.05 in/min to 5 in/min

• The speed setting system shall be verified for the speeds indicated using equipment calibrated within the requirements of ASTM E2658-15

• The displacement-measuring system shall be verified for the displacements indicated using equipment calibrated within the requirements of ASTM E2309/E2309M-20

• Displacement digital readout (mm) shall be capable of being measured within ± 0.5% full travel in tension and compression

• Displacement shall be calibrated between 0 and 10 inches

• Calibration range should be 0.5% to 99.5% of full force range

• Force digital readout (N) shall be within ± 1% accuracy, 1% repeatability, and zero return tolerance

Load Cell Calibrations:

• 100 kN Load Cell: 2580-100KN S/N 164123

• The strain-measuring system has been verified for the strains indicated using equipment calibrated within the requirements of ASTM E83-23.

• LVDT (Extensometer ID: 2601-043/LVDT23010501) shall be verified and calibrated between -3 mm and -30 mm in compression Extensometer (ID: 2630-109/167576) shall be calibrated between 0.05 in and 0.5 in Extensometer (ID:2630-110/170310) shall be calibrated between 0.1 in and 1 in AVE 2.0 Video Extensometer: 2663-901/AVE18030601

• Calibration shall be performed per ASTM E83-23

• Calibration shall be done in a manner which adheres to the specifications outlined in the

• Relative uncertainty of measurements shall be less than 0.5%

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

Base Year: 9/28/2024 to 9/27/2025

Option Year 1: 9/28/2025 to 9/27/2026 Option Year 2: 9/28/2026 to 9/27/2027 Option Year 3: 9/28/2027 to 9/27/2028 Option Year 4: 9/28/2028 to 9/27/2029

Place of Performance:

Food and Drug Administration Center for Devices and Radiological Health 10903 New Hampshire Avenue Building 62 Silver Spring, MD 20993

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, 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.

• 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 ANY 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 via email to the point of contact listed below on or before July 8, 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: 75F40124Q00363.

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.