SOURCES SOUGHT
66 -- Ultra-High Performance Liquid Chromatography (UHPLC) Mass Spectrometer System
- Notice Date
- 5/17/2016
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1167114
- Archive Date
- 6/15/2016
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 (NCTR) requirement for an Ultra-high performance liquid chromatography (UHPLC) Mass Spectrometer system. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. The FDA/NCTR has a requirement for an Ultra-high performance liquid chromatography (UHPLC) Mass Spectrometer system. The UHPLC/PDA/MS system will be used to provide analytical chemistry support to CTP Projects, including formulation and dose certification or verification of test articles for various dose routes, including oral, injection or inhalation exposures, and certification of exposure concentrations via measurement of filters or air samples. Performance requirements General specifications: The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. 1.Ultra-high performance liquid chromatography (UHPLC) System. This system shall support very fast analytical run times to accommodate "next day" turnaround time for sample analysis. Thus, the UHPLC system shall meet the following specifications: (a) shall be able to support binary pump maximum operating pressures of at least 18,000 PSI under a flow of at least 1 mL/min, have a total delay volume under 100 μL, (b)Shall be able to inject 10 μL samples with an accuracy of at least ±0.2 μL with an injection linearity over 0.999 and a carryover under 0.004%. A flow-through needle design is preferable to reduce carryover. (c)The system shall include a temperature-controlled column compartment and autosampler to increase sample stability. (d)The autosampler shall be able to accommodate at least two 96-well plates, two plates capable of housing 48 standard autosampler vials, or a combination of one 96-well plate and one plate capable of housing 48 standard autosampler vials. This will enable samples to be assayed from a number of existing or future protocols. (e) The UHPLC-/MS system shall include a diode array detector capable of operating in the UV and visible (at least 190-500 nm) and affording a scan rate at least 80 Hz. The system shall be equipped with a high sensitivity analytical cell with an optical path of at least 25 mm and a volume not exceeding 2500 nL. (f)An automated electronic means of tracking each column usage and operational parameters (eg. number of injections, maximum pressure attained in the column) to enable proper maintenance of the UHPLC columns utilized in the system. (g)The recording of instrument diagnostic data, such as pump flow, pressure levels, column and autosampler temperatures, etc.) and environmental parameters (eg. room temperature) are desirable in order to better enable Good Laboratory Practice (GLP) record maintenance and troubleshooting. 2.Mass Detector. This component of the system needs to support the analysis of compounds at more sensitive levels (making use of the selectivity of mass analysis) and should meet the following specificaitons: (h)The mass detector will provide complementing qualitative data for compounds detected with the Photodiode array (PDA), provide quantitation for compounds with low UV response, plus provide better detection limits for compounds. (i)The mass detector will provide for both positive and negative ion capabilities and have dual off-axis ion guides for elimination of neutral noise with better sensitivity and robustness. (j)The mass range of the mass detector shall be up to 1250 amu and enable both single ion recording and full mass scan capabilities. (k)The mass detector will utilize a turbomolecular pump and rotary vane vacuum backing pump. (l)The mass detector shall be controllable by the same software that runs the HPLC system. 3.Chromatography/Data System. The computer and software shall meet the following specifications: (m) Chromatography software control shall be provided by a full 32-bit Windows operating system. (n) Data system will prevent the accidental loss or overwriting of raw data and results files, facilitating the use of the system for GLP applications. (o)Report generation will be customizable to improve preparation of study-specific reports. Quoted instruments shall be compatible with existing system reports and methods. The current reports and methods make use of a Waters Acquity H-Class UPLC System, configured with PDA and Waters Empower Software. Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation and operator familiarization training for each system. The contractor shall provide a minimum of one (1) day of on-site training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA's stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year. Post-Warranty Preventative Maintenance Agreement shall, at a minimum, include the following -Minimum of one (1) planned preventative maintenance visit per contract period. -Unlimited phone and email support during the contractor's normal operating hours. -Preventative maintenance shall include all labor, travel, and parts (except consumables); -Unlimited corrective maintenance, service and repairs shall include all labor, travel, and parts (except consumables); Provide service response time with quote. -Pricing shall be inclusive of all labor, travel, replacement parts, components, subassemblies, etc. -Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. -Access by the FDA Contracting Officer's Representative (COR), 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. -System software and firmware updates required for reliability improvements and correction of any defects; -Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation date is within 90 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. 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, 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 if responding to provide a product manufactured by another firm); •Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. •Information on available service/maintenance plans. •Three (3) years of past performance information for the manufacture and/or sale and maintenance support in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, 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 not the respondent. •If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. •Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. •If a large business, identify the subcontracting opportunities that would exist for small business concerns; •Standard commercial warranty and payment terms; and •Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. 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. Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before May 31, 2016 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1167114. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1167114/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Record
- SN04119031-W 20160519/160517234432-7aa5d14a602e92d10cf86fe4a73d9a14 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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