FDA_SOL_1224635 Amendment 0001.pdf

FDA Solicitation No.: FDA_SOL_1224635 Amendment No.: 0001 Date: March 26, 2020

The purpose of this amendment is as follows:

1. To revise the minimum technical requirements beginning at the bottom of page 4 and continuing on page 5 of the solicitation;

2. Extend the deadline and acceptable format for proposals as shown on page 26.

Note: New text is underlined. Revised text is italicized.

1. The Minimum Technical Requirements beginning on page 4 and ending on page 5 have been revised as follows:

Minimum Technical Requirements are as follows for preventive maintenance and repair service for Waters Acquity I-Class SM-FTN sample manager, S/N: D13USM890G and Waters Acquity I-Class BSM binary solvent manager, S/N: H13BUR581M:

*One (1) planned on-site preventive maintenance visit for routine certification and calibration per contract year;

*Unlimited on-site corrective/remedial maintenance/repair visits which includes parts, labor, and travel;

*response time within 4 business days after receipt of service call if issue cannot be corrected remotely within 8 hours from call for service;

*Access by the FDA Technical Representative (TR) and 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;

* Software, firmware, and application updates as required by the OEM;

*Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern Time;

*All maintenance activities shall be performed by formally trained and certified technicians and/or engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.;

*All preventive maintenance and repair service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Minimum Technical Requirements are as follows for preventive maintenance service for Waters Xevo TQ-S quantitative mass spectrometer system, S/N: WAA1011:

*One (1) planned on-site preventive maintenance visit for routine certification and calibration per contract year;

*Access by the FDA Technical Representative (TR) and 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;

*Software, firmware, and application updates as required by the OEM;

*Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 9:00 AM - 5:00 PM Eastern Time;

*All maintenance activities shall be performed by formally trained and certified technicians and/or engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.;

*Pricing for Preventive Maintenance (PM) kits ONLY shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

2. The deadline for proposals and acceptable format of submission beginning on page 30 and ending on page 31 are revised as follows:

Respondents are responsible for electronic delivery by e-mail of their complete proposal, all amendments to the solicitation, and any additional documents before 2:00 pm (Central Time - Local Prevailing Time in Jefferson, Arkansas) on April 2, 2020 to Tim Walbert at the following e-mail address:

timothy.walbert@fda.hhs.gov

END OF AMENDMENT NO.: 0001

mailto:timothy.walbert@fda.hhs.gov mailto:timothy.walbert@fda.hhs.gov