The U.S. Food and Drug Administration (FDA), is conducting market research to support the Office of Regulatory Affairs (ORA) requirement for a Post Column Derivatization Unit with four (4) 1-year Post-Warranty Maintenance Option Periods.

The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than small businesses. In addition, the FDA is seeking business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer. The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees.

Background: The Denver laboratory currently performs animal feed samples for monensin. The laboratory frequently turns away garlic and cruciferous vegetable sulfite samples because they interfere with the official method. However, sulfite in these types of samples is easily determined using a post column derivatization unit.

Specifications:

POST COLUMN DERIVATIZATION SYSTEM SPECIFICATIONS
• Electrical: 100-120 V, 50/60 Hz, 1.7 A, 200 W or 200-240 V, 50/60 Hz, 0.8 A, 200 W
• Mains voltage ± 10 % of nominal
• Installation (over voltage) category II, pollution degree 2
• Indoor use only
• Environmental: Altitude up to 6000 ft
• Ambient Temperature 15 °- 25 °C
• Relative humidity up to 80 % at 31 °C
REAGENT PUMPS
• True pulse-free syringe pump
• Single piece ceramic barrel
• Completely inert flow path
• Maximum operating pressure 500 psi
• Programmable flow rate
• Flow range: 50 μL to 1500 μL/minute
• Refill cycle of 60 seconds
• Automatic piston wash
• Automatic reagent flush cycle
• No check valves
CONTROL
• Computer controlled
• Windows PC with 2000, NT, XP
• USB connection or network
REACTOR
• Heated reactor for temperature from 5 °C above ambient to 130 °C
• Easy replacement reactor coil cartridges
• Range of reactor dwell volumes; 0.1 mL to 3 mL
• Reaction coil withstands up to 42 bar (600 psi) inlet pressure at 130 °C
• Thermal safety switch limits temperature to
150 °C to prevent damage
• Fast response
SAFEGUARDS
• In-line check valve: Prevents reagent back flow into the column when HPLC pressure drops
• Post-column system over pressure: A pre-calibrated relief valve opens at 35 bar (500 psi) to prevent rupture of the post-column reactor tubing in the event of down-stream blockage
• Back-pressure regulator: Applies 7 bar (100 psi) to the detector flow cell outlet (waste) to prevent detector noise and precipitation due to out-gassing or boiling
COLUMN HEATER AND REACTOR CONTROLLER
• Heater accepts up to 6 or 8 mm OD (0.25 or 0.31 inch) x 50-250 mm in length (column and guard)
• Programmable temperature gradient
• Power cooling capability
• Temperature holds within ± 0.4 °C from the set point. Can be set with 1 °C resolution from
5 °C above ambient to 75 °C
• Easy column access
INSTRUMENT PACKAGE AND FLOW PATH
• Advanced fluidics valve management system
• Easy access to internal components
• Standard fittings
• Post-column pressure relief valve
• Side panels easily removed for service access
• Integrated reagent reservoir tray
• Corrosion proof pan and panels
DISPLAY
• Backlit LCD
• Real time temperature and pressure display
• Simple system control interface
GAS PRESSURE MANIFOLD AND REGULATOR
• Panel mount manifold
• Regulator maintains 0.3 bar (3-5 psi) on reagent
reservoirs with 3-5 bar (45-75 psi) source pressure
• Safety pressure relief valve opens at 1 bar (14 psi)
• Manifold has two 1/4-28 tubing connections
• Gas lines with anti-syphon valves
PRESSURIZED REAGENT RESERVOIR
• One liter capacity (2 and 5 L reservoirs available)
• Maintained under inert gas pressure to inhibit
oxidation of oxygen sensitive reagents
• Valve built into reservoir cap permits sparging
during reagent preparation
• Reagent reservoirs fitted with 3.1 mm (1/8")
OD, oxygen-impermeable SARAN tubing for
oxygen-sensitive reagents

WARRANTY:

• All labor must be covered during warranty period.
• All parts must be covered during warranty period.
• The warranty must not have any situational limitations.
• Travel charges must be included during warranty period.
• Remote trouble shooting and support must be provided during warranty period.
• An official company warranty statement must be included with the bid and must also be stated in the operator's manual.
Initial Qualification (IQ)/Operational Qualification(OQ)/Performance Qualification(PQ) Services:

The Vendor will provide initial qualification, operational qualification, and performance qualification for all provided components.

Post-Warranty Maintenance (Four (4) 1-Year Option Periods):

• On-Site Preventive Maintenance, inclusive of all labor, travel, and parts, components, subassemblies, etc.

• Unlimited Technical Support and Trouble Shooting Assistance (generally accomplished by phone, email, live-chat Interface, etc. within 24-48 hours from initial contact)

• Unlimited On-Site Corrective Maintenance/Repairs (On-Site repairs are only necessary in instances where problems cannot be resolved remotely after 2-3 days of trying)

• Unlimited Software Updates and Firmware Updates

• Preventive and Corrective Maintenance performed by OEM-certified technicians, following OEM specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc.

Place of Performance
US Food and Drug Administration
Denver Laboratory (DEN-LAB)
Denver Federal Center
6th and Kipling
Building 20
Denver CO 80225

Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in the manufacturing and/or sale of same or substantially similar items. Though the target audience is small business manufacturers or small businesses capable of supplying U.S. made product of another small business manufacturer 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 is responding
to provide a product manufactured by another firm].

Past performance information for the manufacture and/or sale of same or
substantially similar items to include date of sale, description (should also
include drawings and photos), 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 items the responding firm is regularly engaged in manufacturing and/or
selling.

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 in person, by postal mail or email to the point of contact listed below on or before
July 2, 2013 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Peer, 3900 NCTR Road, HFT‐320, Bldg 50, Rm 420 Jefferson, AR 72079‐9502 or email [email protected]. Reference: FDA_13-223-SOL-112066.

Notice of Intent
Responses to this sources sought announcement will assist the Government in
determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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 instrument(s) and service plans is encouraged.