SOURCES SOUGHT
66 -- Matrix-Assisted Laser Desorption/Ionization Time of Flight (MALDI-TOF) Mass Spectrometer (MS) System.
- Notice Date
- 3/4/2013
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1115058
- Archive Date
- 4/6/2013
- Point of Contact
- Sondea R Blair, Phone: 8705437469
- E-Mail Address
-
sondea.blair@fda.hhs.gov
(sondea.blair@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 Center for Biologics Research and Evaluation (CBER) requirement for a Matrix-Assisted Laser Desorption/Ionization Time of Flight (MALDI-TOF) Mass Spectrometer (MS) System. This sources sought notice is being issued to determine if small business manufacturers or small businesses capable of supplying a U.S. made product that satisfies our requirement of another small business manufacturer exist. The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Background: The FDA's Facility for Biotechnology Resources (FBR) within the Center for Biologics and Evaluation Research (CBER) requires an MALDI-TOF Mass Spectrometer System with a post warranty preventive maintenance plan, to facilitate the accurate determination of the molecular masses of synthesized ologonucleotides and peptides. The FBR within CBER provides an array of services, including the synthesis of oligonucleotides and peptides for scientists at CBER and the Center for Drug Evaluation and Research (CDER). These oligonucleotides and peptides are utilized to carry out research ranging from gene amplification, DNA sequencing, studies of protein-protein interactions, and vaccine development. The syntheses of oligonucleotides and peptides in the facility are under very stringent quality control (QC). One of the QC methods is the determination of a product molecular weight which provides an important assessment regarding whether the synthesis process works as expected and whether the product is as expected. This request is for the purchase, inside delivery, clean-up, installation, training, and post warranty preventive maintenance plan, of a MALDI-TOF Mass Spectrometer System. Requirements: Mass Spectrometer -The instrument shall be operated with both positive and negative (i.e., bipolar) ion modes. -The mass range shall be between 100Da and 500 kDa -The instrument ion source shall be 20 kV -The instrument's laser rate shall be ~5KHz and equipped with 2 GHz digitizer, allowing acquisition of up to 100 spectra/second. -The resolution power for Adrenocorticoptropic Hormone, (ACTH) molecular weight (mw) =2,465 Da shall be >6,000 with signal to noise (S/N) >10 at 1 attomole/ul. -For analytes between 1,000 and 3,000 Da, the resolution shall be >2m (where m is the mass). -The system shall be inclusive of an Uninterrupted Power Source (UPS) for supporting instrument operation in the event of power failure. -The Computer associated with the MS instrument shall have an operating system comparable to Windows 7, 64-bit OS, no less than 8GB memory and 8GB RAM, and include a monitor of no less than 24 inches. Installation -The vendor shall demonstrate upon installation that the items meet all performance specifications, including the mass spectrometer sensitivity specification. The instrument shall not be accepted until the aforementioned performance specifications have been met. Training -The contractor shall provide on-site operator training/familiarization for both the HPLC and mass spectrometer. -Familiarization of the system shall include the system operations, calibration, optimization, and basic preventive maintenance procedures. -The contractor shall include additional training for mass spectrometer operation for at least three (3) operators at the contractors' training facility. Minimum Required Warranty and Preventive Maintenance: -36-month Warranty on entire system (Mass Spectrometer, pumps, and computer/software) inclusive of parts, labor, calibration, and travel expense. -Warranty to commensurate upon receipt, installation, and FDA acknowledgment of acceptability. -The vendor shall perform one additional system installation and validation upon request for the probable relocation of the equipment at a later date (estimated 12-16 months after purchase). Relocation, installation and validation of equipment shall be provided at no charge during the warranty period or during the option year preventive maintenance period. Qty: 1 System Required Option Year One Preventive Maintenance Agreement Period of Performance: 12-month period to commensurate upon expiration of initial 36-month warranty. Requirements: -Minimum of one scheduled preventive maintenance visit annually on mass spectrometer, inclusive of calibration services, parts, travel, and labor expense -On-site engineering support within 5-business days of request (M-F 8:00-5:00PM EST) inclusive of parts, travel, and labor expense. -Service to be conducted by OEM certified technicians with trouble-shooting capabilities based on the complete knowledge of the entire instrument. -OEM certified technicians shall have access to the manufacturers latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. -Only certified replacement parts shall be used -Service shall include immediate access to technical applications, application support, and technical assistance from senior engineers capable if providing high-level expertise via telephone and email during normal business hours (M-F 8:00 - 5:00PM EST). -Immediate access to improvements and new procedures provided by the manufacturer. -The vendor shall perform one additional system installation and validation upon request for the probable relocation of the equipment at a later date (estimated 12-16 months after purchase). Relocation, installation and validation of equipment shall be provided at no charge during the warranty period or during the option year preventive maintenance period. Option Year Two Preventive Maintenance Agreement Period of Performance: 12-month period to commensurate upon completion of option year one preventive maintenance agreement. Option Year Three Preventive Maintenance Agreement Period of Performance: 12-month period to commensurate upon completion of option year two preventive maintenance agreement. Option Year Four Preventive Maintenance Agreement Period of Performance: 12-month period to commensurate upon completion of option year three preventive maintenance agreement. The offeror may provide information on multiple types of service agreements plans available and pricing of each. Place of Performance Work shall be formed on-site at the location of the instrument: US Food and Drug Administration FBR/CBER Bldg 204, Room 29 29 Lincoln Drive Bethesda, MD 20892 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 March 22, 2013 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, HFT-320, Bldg 50, Rm 421 Jefferson, AR 72079-9502 or email sondea.blair@fda.hhs.gov. Reference FDA 1115058. 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. All price quotes shall be F.O.B. destination (Inside Delivery) inclusive of shipping and handling expense.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1115058/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, FBR/CBER, 29 Lincoln Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03003382-W 20130306/130305114953-5eb3905bf8bdf002c17341fbdebb58fb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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