SOLICITATION NOTICE
66 -- Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometer System
- Notice Date
- 4/15/2013
- Notice Type
- Combined Synopsis/Solicitation
- 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
- FDA_13-223-SOL-00058
- Archive Date
- 5/18/2013
- 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
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6 as applicable and in conjunction with FAR part 13.5, and supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is FDA_13-223-SOL-00058. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66 dated April 01, 2013. The associated North American Industry Classification System (NAICS) Code is- 334516 Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This acquisition is set-aside 100% for small business concerns. The FDA's Facility for Biotechnology Resources (FBR) within the Center for Biologics and Evaluation Research (CBER) requires a Matrix-Assisted Laser Desorption/Ionization Time of Flight (MALDI-TOF) Mass Spectrometer (MS) System with a post warranty preventive maintenance plan, to facilitate the accurate determination of the molecular masses of synthesized ologonucleotides and peptides. Background: 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. Minimum 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: One (1) System Price: _______________ Post-Warranty Service Agreement The service agreement shall include, at a minimum, the following: •Minimum of one (1) Preventative Maintenance visit per contract year; •Unlimited on-site preventative maintenance, services, and repairs; •Unlimited Priority Telephone and Email Support; •Peak performance maintenance kits; •Software updates; •Preventative maintenance, services, and repairs performed by an trained and certified technician; •Preventative maintenance, services, and repairs inclusive of all labor, travel, and new certified replacement parts, components, subassemblies, etc. (except consumables); •Phone support available from 8am to 5pm Eastern Time, Monday through Friday; Post Warranty Period of Performance: Option Period 1: 12-month period to commensurate upon the completion of the base 12-month warranty. Option Period 1 Price:___________ Option Period 2: 12-month period to commensurate upon the completion of the option period 1 preventive maintenance agreement. Option Period 2 Price:___________ Option Period 3: 12-month period to commensurate upon the completion of the option period 2 preventive maintenance agreement. Option Period 3 Price:___________ Option Period 4: 12-month period to commensurate upon the completion of the option period 3 preventive maintenance agreement. Option Period 4 Price:___________ Contract Type: Commercial Item-Firm Fixed Price Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Pricing: Offerors shall provide pricing, clearly delineating the applicable performance period, using the attached format for each period of performance. Prices shall be firm-fixed-price and shall not be subject to any further economic price increase beyond the initial price offered. Options: The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). FOB Point Destination FOB Point of Delivery for Installation Services and Supplies will be the Center for Biologics and Evaluation Research located in Bethesda, Maryland. Place of Performance: US Food and Drug Administration Center for Biologics and Evaluation Research (CBER) 29 Lincoln Drive, Room 204, Bldg 29 Bethesda, MD 20892 Period of Performance: Delivery, installation, training, and Government acceptance to occur within 120-days after receipt of award. Contract Clauses: The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (FEB 2012), applies to this acquisition. The following addenda have been attached to the clause: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Other Terms and Conditions: Maintenance and Repair All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications. 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. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper. (MAY 2011) FAR Clause 52.204-7 Central Contractor Registration. (DEC 2012) FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a)... within 1 day of contract expiration;.... at least 15 days before the contract expires... (c)...shall not exceed 4 years. The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.202-1 Definitions JAN 2006 352.203-70 Anti-Lobbying JAN 2006 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations JAN 2010 352.223-70 Safety and Health JAN 2006 352.231-71 Pricing of Adjustments JAN 2001 352.242-71 Tobacco-Free Facilitates JAN 2006 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) Modify or extend the period of performance; (3) change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contracting Specialist for this order is: Sondea Blair 3900 NCTR Rd HFT-320, Room 421 Jefferson, AR. 72079 Phone: (870) 543-7469 Email: sondea.blair@fda.hhs.gov The COR is responsible for: (1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract; and (5) Assisting in the resolution of technical problems encountered during performance. The COR for this order is: shall be completed at time of award. Invoice Submission Payment terms net 15 days after government acceptance of the supplies/services. Invoices shall be submitted to the attention of the designated Contract Specialist identified above and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. An original and two (2) copies shall be submitted to: FDA/OC/OA/OFO/OFS Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor, Suite 616 Jefferson, AR 72079 Phone: (870) 543-7446 Fax 870-543-7224 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked as: Courtesy Copy Only: To be completed at time of award. Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above. Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (JAN 2013) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6, 52.204-10, 52.209-6, 52.219-6, 52.219-8, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-51, 52.222-54, 52.223-18, 52.225-3 Alt III, 52.225-13, and 52.232-33. Solicitation Provisions The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been attached to this provision: Addendum to Paragraph (b)(8) Representations and Certifications - In addition to completing the representations and certifications at FAR 52.212-3(b), the Contractors quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48. Note: This solicitation is being issued under the premise that the Contractor will certify that the combination of equipment/service it proposes to fulfill this requirement is exempt form the Service Contract Act per the conditions set forth in FAR 52.222-48 and FAR 22.1003-4(c). If this is the case and the Contractor certifies exemption under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41 and 52.222-43 shall be included in the resulting award as well as the Wage Determination WD 05-2035 (Rev.-13): http://www.wdol.gov/wdol/scafiles/std/05-2035.txt?v=13 Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (i) Technical capability of the items/services offered to meet or exceed the Government's requirement (ii) Past Performance (iii) Price When combined, technical and past performance are more important than price in determining the best value to the government. Technical Acceptability Technical acceptability will be determined by review of information submitted by the quoter who must provide sufficient descriptive literature that unequivocally demonstrates that offered services meet the technical requirements as stated herein. Past Performance: Contractor should provide references to at least two previous projects where similar or same systems were sold and installed. For each project, please include a thorough description of the project, the customer name, telephone number, email address of someone who has knowledge of the project and would be available to answer any follow-up questions the Government may have. The government is not responsible for locating or securing any information, which is not identified in the proposal, however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Include the firm's DUNS number with quote. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The government reserves the right to make an award without discussions. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit an offer, which if timely received, shall be considered. The quote shall reference solicitation number 13-223-SOL-00058. Quotes are due in person, by postal mail or email to the point of contact listed below on or before 03 May, 2013 by 9:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA|OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, HFT-320, Room 421, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Sondea Blair at (870) 543-7469 or email sondea.blair@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_13-223-SOL-00058/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, Center for Biologics and Evaluation Research (CBER), 29 Lincoln Drive, Room 204, Bldg 29, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03036817-W 20130417/130415234646-ccad071676797a782d150418283b4633 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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