FDA-NOISS1192705.pdf

U.S. Food & Drug Administration Scientific Support Branch 5630 Fishers Lane, Room 2059 Rockville, MD 20857

240.402.7609 www.fda.gov

March 19, 2018

Notice of Intent

FDA-NOISS1192705

Title: Service Agreement for the Maintenance of a JSM-6701F SEM Microscope System (Serial

#:SM17310051)

The Food and Drug Administration intends to award a Sole Source firm-fixed price purchase order for a base and four (4) option years to JEOL USA, INC. at 11 Dearborn Road Peabody, Massachusetts 01961 for $192,868.60. In accordance with FAR part 6.302-1, the contractor is the only responsible source who can provide the required services as no other source has been identified who can provide the services and repairs needed to satisfy the agencies requirements. The JEOL USA JSM-6701F Scanning Electron Microscope System (Serial #:SM17310051) uses specified warranty-specific, guaranteed replacements parts which are only manufactured by JEOL USA, Inc. and can only be purchased through JEOL USA, Inc. Additionally, JEOL USA, Inc. is the sole service provider of the JSM- 6701F SEM system. JEOL does not have authorized technicians through any another company that can be utilized to install these warranty parts or to perform the service work. The functional and operational knowledge to repair and service the SEM is proprietary to JEOL USA, Inc.

The Food, Drug, and Cosmetic act, decrees that the FDA will perform research on the identification, and characterization of microbial pathogens, microbial virulence factors, and microbial interactions, which lead to pathological anomalies associated with foodborne disease so that the agency can provide protection and enhancement of public health.

This scanning electron microscope system is used by Office of Foods’ scientists and is housed in a shared user, core instrument facility located at CFSAN, MOD1 8301 MuirKirk Road, Laurel, MD

20708.

Through collaborative efforts by the Divisions of Virulence Assessment (DVA), Toxicology and

Molecular Biology in response to a critical need for instruments capable of studying the ultrastructure of mammalian and microbial specimens with special emphasis on pathological consequences were made available to other CFSAN scientists and those located in the newly established Office of Foods. The Principal Investigator has the authority and responsibility to maintain the facility and associated equipment in full operating condition and to minimize down time to meet the work load.

The North American Industrial Classification System (NAICS) Code is 811219 Other Electronic and

Precision Equipment Repair and Maintenance http://www.fda.gov/

5630 Fishers Lane, Room 2059

The instrument to be covered under this service agreement is a A JEOL USA, Inc. JSM-6701F SEM system (Serial #:SM17310051). The system includes: JUS-FEGBB, Battery Backup-96621 a S-

71520MSC 3axis motor stage controller 358436, JU2009760 WATER RECIRCULATOR, WATER

COOLED RO75CGN2SK9 (SN:HB20261) and a JUS-PCSEM-WS-XP computer workstation.

Requirements for the service agreement include:

All warranty-specific, guaranteed parts, labor, travel, and expenses necessary for calibrating the equipment and to maintain the equipment at full operating capacity.

All major warranty-specific, guaranteed non-consumable parts and their installation.

A 30-Day Labor, 90-Day Parts Warranty, to repairs performed during the last 90 days of the term of this agreement. In the event the Government elects not to renew or extend the terms of this agreement.

JEOL’s Gold plan for the 6701F SEM: unlimited emergency visits during regular business hours to meet published performance specifications for service other than operator function, damage by third party, acts of nature, etc., unlimited technical telephone support, and guaranteed response times two preventative maintenance checks per year at regular scheduled intervals.

Timely and professional maintenance and repair of the equipment due to the complexity of the equipment and the agency's mission involving the test results of the utilization of the equipment.

Emergency repair/service for the warranty-specific parts, upon government request and at no additional cost to the Government, is being satisfied by one of three ways:

1) Dispatching a Service representative to the government facility for the repair or service.

2) Part being removed by a service representative, replaced with a loaner part, and service at their facility then returned to the Government facility, and installed by a service representative.

3) Shipping guaranteed replacement parts with the appropriate installation instructions to the Government for installation by the Government representative.

5630 Fishers Lane, Room 2059

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the

Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to JEOL USA, INC. within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 11:00 a.m. EST on 3/23/18. Please email responses to Priscilla Harrison at Priscilla.Harrison@fda.hhs.gov.