News Column

Sources Sought Notice - Ion Chromatography System

May 23, 2014



Notice Type: Sources Sought Notice

Posted Date: 22-MAY-14

Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 3900 NCTR Road, HFT-320 Bldg 50 | Rm 421 Jefferson AR 72079

Subject: Ion Chromatography System

Classification Code: 66 - Instruments & laboratory equipment

Solicitation Number: 1133720

Contact: Crystal G. McCoskey, Phone 8705437267, Email crystal.mccoskey@fda.hhs.gov

Setaside: N/AN/A

Place of Performance (address): Jefferson, AR

Place of Performance (zipcode): 71665

Place of Performance Country: US

Description: Department of Health and Human Services

Food and Drug Administration

Office of Acquisitions and Grants Services

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research's (NCTR), Nanotechnology Core Facility (NanoCore) requirement for one (1) ion chromatography system to include shipping, installation, testing, on-site operator training and up to four (4) 1- year option periods for post-warranty maintenance.

This is a sources sought 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.

REQUIREMENTS:

Statement of Need:

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Nanotechnology Core Facility (NanoCore) has a requirement for one (1) ion chromatography system to include shipping, installation, set-up, testing, on-site operator training and up to four (4) 1- year option periods for post-warranty maintenance, to separate and measure the anion concentration within liposomes. The concentration of the anion component is a critical element and can impact the stability and rate of release of the therapeutic substance; therefore, suppressed conductivity detection to measure the internal anion content in liposomal formulations is important for the research conducted on the system. This technique has been found to be the most accurate way to measure the internal anion content of liposomal nanoparticles because it does not disrupt the nanoparticle structure and has been published as follows:

Wang, S.H.; Raptis, E.; Yeh, J.; Ion chromatography for the determination of sulfate in STEALTH(R) liposomes. J. Chromatography A, 2004. 1039: p. 51-58.

Specifications:

The ion chromatography system shall be delivered with all necessary supplies, equipment, components, tubing, fittings, test solutions, adapters, software, accessories, etc. required to seamlessly install, set-up, test and train; Contractor is responsible for a turnkey solution.

The components and equipment shall be a newly manufactured, not be used, refurbished, or previously used for demonstration.

The entire system shall be warranted for parts and labor for a minimum of 1 year from date of acceptance.

All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system.

Minimum specifications:

* The system shall allow for the separation and detection of anion or cations. * The system shall include a column and guard column for the separation of anions, with the target anion being sulfate. * The system shall include appropriate regents and chemical to demonstrate the separation and detection of anions, such as sulfate. * The system shall include a minimum of a single channel pump with a flow rate of 0.0 mL to 5.0 mL. * The system shall include a conductivity detector. * The system shall include an autosampler for the sample injection. The autosampler shall allow injection volume of at least 10 uL to 100 uL. The autosampler shall include temperature control from at least 4 - 20 degrees Celsius. * The system shall allow for temperature control of the column compartment from at least 10 - 40 degrees Celsius. * The system shall include a suppressor module for anion analysis. * The system shall include a tray or organizer to hold any reagent bottles or chemicals. * The system shall include a complete workstation for instrument control, data acquisition, and data analysis, including computer and monitor. * The system shall have an automated eluent generator.

Installation, Set-Up, Testing and Training Requirements

The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for at least four (4) attendees. Such familiarization shall include system operations, calibration, optimization, and basic operational maintenance procedures. Additionally, the Contractor shall provide training on theory, operations, software, maintenance, and troubleshooting for one (1) attendee at the Contractor's training facility.

Post-Warranty Service Requirements: * Shall include at least one (1) planned, onsite preventative maintenance visit per contract year. * Shall include unlimited technical support within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) and unlimited corrective/remedial maintenance visits within three (3) business days of call for service, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Standard Time (CST). * Shall include unlimited software and firmware updates. * All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc. * All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

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 COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Delivery Address (FOB Destination)

US Food and Drug Administration 3900 NCTR Road, Bldg 85 Jefferson, AR 72079

Installation, set-up, on-site training and post-warranty maintenance shall be conducted at:

US Food and Drug Administration 3900 NCTR Road, Bldg 26 Jefferson, AR 72079

Period of Performance

Delivery, to include installation, set-up, testing and on-site training, required within 60 days of award with up to four (4) 1-year option periods for post-warranty maintenance.

Responses to this sources sought shall unequivocally demonstrate that respondent is regularly engaged in the manufacture and/or sale of same or substantially similar items. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a 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, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [Provide this same information again for the manufacturer/producer if responding to provide a product manufactured by another firm.]

* Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items, which are or have been used with same or similar equipment for same or similar purposes, to include date of sale, description (should also include technical literature and specifications), dollar value, client name, client address, client point of 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 respondent is not the manufacturer/producer;

* Descriptive literature, brochures, specifications, 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 requirement;

* If a large business, identify any existing subcontracting opportunities for small business concerns;

* Although this is not a request for quote, informational pricing is encouraged;

* The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Parties 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 June 2, 2014 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT-320, Jefferson, AR 72079-9502, or email crystal.mccoskey@fda.hhs.gov. Reference #1133720 in all correspondence with the point of contact listed above.

Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open 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 combined synopsis/solicitation (No. 1133720) may be published via 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).

Link/URL: https://www.fbo.gov/spg/HHS/FDA/NCTR/1133720/listing.html


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