The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns. The Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small businesses.

The Food and Drug Administration (FDA) is conducting a market survey to assess the availability of small business firms as defined by NAICS code 334516 that has the capability to provide a C-Arm Combination Radiographic Fluoroscope and a C-Arm Mobile Fluoroscope and preventative maintenance. This notification is for market research purposes and does not constitute a commitment, implied or otherwise, that a procurement will be accomplished.

FDA welcomes responses from all interested parties. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted of FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this sources sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

Brand Name or Equal:

This is a BRAND NAME OR EQUAL acquisition; in accordance with FAR
52.211-6, to be considered for award, offers of equal products must meet the
salient physical, functional, or performance characteristics provided in the statement of requirements. In order to be considered an "equal" solution, any alternative solution proposed must be able to perform in strict accordance with the salient operational and technical features described below.

Background

The Food and Drug Administration (FDA), Winchester Engineering and Analytical Center (WEAC) require a Combination Radiographic Fluoroscope Instrument and a C-Arm Mobile Fluoroscope instrument to test, analyze, and conduct field testing for the diagnostic x-ray systems. The government requires a Combination Radiographic Fluoroscope and C-Arm Mobile Fluoroscope instrument, each instrument with one year manufactured warranty and preventative maintenance service agreement for one (1) 12 month option period.

Specific Tasks and Deliverables:

Item 1: Quantity = 1

The Combination Radiographic Fluoroscope Instrument shall "meet or exceed" the following salient characteristics/specifications:

• Tiltable table
• 9 or 12 in image intensifier
• Max kVp 120 kV
• Max tube current 125 mA
• Large and small focal spot
• Inherent filtration 1mm Al eq
• Added filtration 3 mm Al + 0.1 mm Cu
• Automatic shutters
• SID of at least 45 cm
• Carbon fbber grid 60 lines/cm ratio of 1:10 @100 cm SID
• Spot film capability

Radiographic System salient characteristics:

• Large and small focal spots
• Bucky grid (ratio to be determined)
• 150 KvP
• 300 mA (or greater)

The C-Arm Mobile Fluoroscope Instrument shall "meet or exceed" the following salient characteristics/specifications:

• 9 or 12 in image intensifier
• Max kVp 120 kV
• Max tube current 125 mA
• Large and small focal spot
• Inherent filtration 1mm Al eq
• Added filtration 3 mm Al + 0.1 mm Cu
• Automatic shutters
• SID of at least 45 cm
• Carbon fbber grid 60 lines/cm ratio of 1:10 @100 cm SID

Training:

The contractor must provide a three (3) day on-site training for 4 analysts at the delivery location
listed below. The training must include, but not limited to manual (paper or digital) of the equipment and basic functions, operation of the Combination Radiographic Fluoroscope and C-Arm Mobile Fluoroscope instrument, hardware and software integration, generating reports, basic interpretation, overview of the equipment, the functionality of the equipment, tuning and calibration. Training shall be scheduled no later than one (1) week after installation and successful qualification of the instrument. Training shall not be conducted no later than three (3) weeks after completed installation.

Technical /Support Services:

The contractor must provide one year manufacture warranty for all parts, labor, and service for a
12 month (one year) period after complete delivery, installation, and training at no additional cost to the government. The contractor shall provide full service support for the installed equipment,
including but not limited to labor, parts, travel on-site support, telephone support, retesting and
re-qualification of the unit, software updates and enhancements. The contractor must provide continuous online and telephone support for the instrument. The support services shall include, but not limited to trouble shooting, equipment maintenance and repair, and provide responses to operator questions. The contractor shall provide a three (3) day response time for all on-site service and repairs. All service reports shall be provided to the government point of contact within 5 business days of completion of the repair or service.

Preventative Maintenance:

The annual on-site preventative maintenance/service agreement shall include but not limited to the support of qualification services (IQ/OQ), calibration service, cleaning of the instrument,
software and hardware updates, technical/support services (see above), replacement of parts, labor, and travel in support of the instrument at the location. The preventative maintenance
service will be listed as option periods on the contract. The preventative maintenance (PM) service will be for one (1) 12 month option period after the 12 month (one year) manufacture warranty is expunged. The contractor shall provide a services report to the government point of
contact after completion of the annual PM services.

Delivery Timeframe

90 days after receipt of award

Delivery Location

Food and Drug Administration
Winchester Engineering & Analytical Center (WEAC)
109 Holton Street
Winchester, MA 01890
POC: TBA

*Complete address and Point of contract shall be listed at the time of award.

Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see (PART 8) between the hours of 8:30 a.m. and 4:30 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. The Contractor shall provide the FDA with one (1) week's scheduling notice prior to setup of the laboratory instrument and component parts.

General Instructions

Contractors that believe they possess the ability to provide the required equipment must submit documentation of their ability to meet each of the characteristics listed above to the Contracting Officer (i.e. brochure, information on equipment that meets specifications, etc.) The capability statement must also include the organization name, type of business, DUNS number, point of contact name/telephone number/email address, and applicable NAICS code.

Capability statements that do not provide sufficient information for assessment will be considered non-responsive. When submitting the information, please reference the solicitation number FDA-14-1128422/1128371-SS.

Responses must be submitted via email to Tiffany Williamson at [email protected] by 12:00 pm on August 4, 2014.