SOURCES SOUGHT
J -- SBSS No. FDA-SOL-13 Maintenance Services for a Beckman Coulter PA800 Plus Capillary Electrophoresis Pharmaceutical Analysis System
- Notice Date
- 4/26/2013
- Notice Type
- Sources Sought
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- 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-SOL-1114109
- Archive Date
- 5/22/2013
- Point of Contact
- Daniel Gregory Laidlaw Feldman, Phone: 301-827-0359
- E-Mail Address
-
daniel.g.feldman@fda.hhs.gov
(daniel.g.feldman@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTE: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition (811219, Other Electronic and Precision Equipment Repair and Maintenance, Size Standard: $19 million). Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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). BACKGROUND The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) requires service maintenance on a Beckman Coulter PA800 Plus Capillary Electrophoresis Pharmaceutical Analysis system (PA800 Plus) due to its on-going work with capillary electrophoresis. Capillary electrophoresis is an emerging analytical choice for a number of analyses performed on protein therapeutics to characterize and compare proteins. The PA800 Plus is a standard system that is required to develop a method to analyze proteins with minimal perturbations and under near native conditions. Beckman Coulter is the sole manufacturer of this system and has proprietary rights on the instrument hardware and software. System Description: The PA800 Plus provides analysts with robust and easy-to-use characterization, integrating quantitative, qualitative, and automated solutions for protein purity, charge isoform distribution and glycan analysis. The PA800 Plus includes: • A high-resolution separation module • A high-sensitivity UV, PDA solid-state laser-induced fluorescence detection devise • Sample storage temperature control • A high-speed system 32 Karat controller (version 9.0 and specific PA800 Plus software) • Validated applications for SDS-MW, IgG, Capillary Isoelectric Focusing (cIEF), and glycan analysis The PA800 Plus includes the following applications that yield reproducible and quantitative results at a turn-key level: • High resolution SDS-CE separation for protein purity and IgG purity analysis • cIEF for charge heterogeneity analysis • Carbohydrate profiling for assessment of glycoprotein microheterogeneity • Dedicated specialized software for routine users from set-up through results • Modular UV, photodiode array and laser-induced fluorescence detectors that can be easily interchanged for the choice of application The system is located at CDER's facilities at the National Institutes of Health (NIH) Building 29A, Room 3B16, 29 Lincoln Drive, Bethesda, MD 20892. PURPOSE/OBJECTIVE The purpose of this requirement is to provide preventive maintenance, technical support, and troubleshooting assistance services for a Beckman Coulter PA800 Plus Capillary Electrophoresis Pharmaceutical Analysis system. PROJECT REQUIREMENTS To meet the purpose and objective of this requirement, the Contractor shall perform the following comprehensive preventive maintenance, technical support, and troubleshooting assistance services to the PA800 Plus on-site at CDER's facilities in Bethesda, MD (NIH Building 29A, Room 3B16, 29 Lincoln Drive, Bethesda, MD 20892), unless otherwise indicated: • Preventive maintenance, which shall include inspection, cleaning, and making any necessary repairs or adjustments to meet original equipment manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc., where applicable, including installation of a laser module upgrade kit. Preventive maintenance shall include installation of engineering modifications, including hardware design modifications. The Contractor shall perform annual preventive maintenance at an appropriate time determined by the FDA's Technical Point of Contact (TPOC). • Unlimited emergency technical support and troubleshooting assistance throughout the period of performance of the order, including applications assistance, operator training and retraining, field rotor inspections, rotor car seminars, and software and other computer assistance. At the direction of the FDA TPOC, these services may be provided off-site, such as telephonically, when such support is most practical and effective. The Contractor shall respond to the FDA's technical support and troubleshooting requests within 24 hours of the FDA's initial request to the Contactor for assistance. The Contractor may be permitted to respond initially to the FDA's inquiries for assistance by phone, email, or live-chat interface. All preventive maintenance, technical support, and troubleshooting assistance services shall be performed by OEM trained and certified service engineers following OEM specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc., where applicable. For all on-site maintenance, the Contractor's personnel are required to report to the security guards at the NIH Building 29A, 29 Lincoln Drive, Bethesda, MD 20892, who will contact the TPOC or his or her designated FDA employee. The Contractor's personnel must be escorted by the TPOC or his or her designated FDA employee at all times while working on-site under this order. ANTICIPATED PERIOD OF PERFORMANCE The FDA anticipates a base period of one year with four one year options. For each option period, the Contractor shall perform the same tasks and produce the same deliverables as delineated in the base period. The FDA anticipates an award date on or around June 3, 2013 with maintenance expected to be performed shortly after award. OTHER IMPORTANT CONSIDERATIONS Qualifications: The Contractor shall propose and provide technicians with documented evidence that they have the knowledge, skills, and abilities to perform the above described preventive maintenance, technical support, and troubleshooting assistance services on the Beckman Coulter PA800 Plus Capillary Electrophoresis Pharmaceutical Analysis system. The Contractor shall provide OEM trained and certified service engineers for all preventive maintenance, technical support, and troubleshooting assistance services, unless otherwise authorized by the FDA TPOC. Place and Time of Performance: The Contractor shall perform all on-site maintenance service at CDER's facilities located at the NIH Building 29A, 29 Lincoln Drive, Bethesda, MD 20892 during normal business hours, unless otherwise indicated by the FDA's TPOC. Pricing and Payment: This requirement is anticipated to be a firm-fixed-price order, inclusive of all costs, including labor, travel, replacement parts, and components with firm-fixed-price payment upon completion of the base and each option period, if the FDA decides to exercise the particular option. However, the firm-fixed-price excludes consumables, such as reagents, rotors, needle cartridges and blocks, sample and reagent cups, racks, trays, cuvettes and reservoirs, lamps, electrodes, membranes, printer ribbons and paper, cassettes, labels, tube adapters, reagent pickup tubes, stylets, syringe tips, slides, pipettes, ups systems, and line conditioners. Payment for items excluded from the firm-fixed-prices will be paid through modification to this order or another payment mechanism, such as a purchase card. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement electronically to Dan Feldman at daniel.g.feldman@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement shall be no more than five pages, excluding a cover page and table of contents, and shall include examples of successfully completing similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses shall also include company information to determine eligibility, including their contact information, DUNS number and size and business type (e.g. 8(a), HUBZone, etc.) based on the applicable NAICS code for the proposed acquisition (811219, Other Electronic and Precision Equipment Repair and Maintenance, Size Standard: $19 million). Potential offerors have until 8:00 am ET, Tuesday, May 7, 2013 to respond to the FDA.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1114109/listing.html)
- Place of Performance
- Address: National Institutes of Health (NIH) Building 29A, Room 3B16, 29 Lincoln Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03046682-W 20130428/130426234224-a04b66e9b129f23368516bbd9a2f5658 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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