SOURCES SOUGHT
J -- Service Agreement for PA800 Plus System - Sources Sought Notice PDF
- Notice Date
- 12/30/2014
- 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
- HHS-FDA-CDER-SS-14-189
- Archive Date
- 1/29/2015
- Point of Contact
- Christopher R. McGucken, Phone: 2404027599
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice, PDF Format. This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. BACKGROUND The U.S. Food and Drug Administration's Center for Drug Evaluation and Evaluation (CDER) requires service maintenance on a PA800 Plus due to its on-going work with capillary electrophoresis. Capillary electrophoresis has become a standard analytical tool used by protein manufacturers to develop a method to analyze proteins with minimal perturbations and under near native conditions. System Description: The PA800 Plus allows 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 and a solid-state laser-induced fluorescence detection device (488nm wavelength). •Sample storage temperature control. •A high-speed system 32 Karat controller running Windows 7 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: • 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. CONTRACTOR REQUIREMENTS To meet the purpose and objective of this requirement, the Contractor shall provide documentation demonstrating the capability to provide the following comprehensive preventive and corrective maintenance, including technical support, and troubleshooting assistance services, for one (1) PA800 Plus [Serial # A746030829] and one (1) Laser [Serial # A47385AH0912130001] on-site at CDER's facilities in Silver Spring, MD. • Comprehensive 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 TPOC. • Unlimited emergency corrective maintenance, 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 and corrective maintenance, including 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, unless otherwise authorized by the TPOC. The Contractor shall perform all on-site maintenance service during the hours of 9:00 am to 5:00 pm ET, Monday through Friday, unless otherwise indicated by the TPOC.Capability statements must demonstrate the minimum requirements outlined above. Please address each in the order listed above. Please provide the follow Business information: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought 8. Current Government Wide Agency Contracts (GWACs) 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be limited to 10 pages. Responses must be received not later than 3:00PM Eastern Time, January 14th, 2015. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Christopher.McGucken@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/HHS-FDA-CDER-SS-14-189/listing.html)
- Place of Performance
- Address: Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03606209-W 20150101/141230234033-5170f59d2106c6da2d3f4942650123bc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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