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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 30, 2015 FBO #4967
SOURCES SOUGHT

66 -- “Malvern Nano Nanosight LMLO

Notice Date

6/28/2015
 

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

Requisition_(1152448)
 

Archive Date

7/21/2015
 

Point of Contact

Emmanuel T. Mbah,
 

E-Mail Address

Emmanuel.mbah@fda.hhs.gov
(Emmanuel.mbah@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Market Research Purposes Only: Not a Request for Proposal Or Solicitation Subject: Requisition -1152448: "Malvern Nano Nanosight LMLO" Particle Characterization System" including Camera Adaptor Standard Laser Fluorescence Filter PC Package Software Latex Standard. The U. S Food & Drug Administration, Office of Acquisitions and Grants Services has a requirement for the purchase of a "Malvern Nano Nanosight LMLO" Particle Characterization System" including Camera Adaptor Standard Laser Fluorescence Filter PC Package Software Latex Standard. This is a sources sought notice to determine the availability and capability of small business manufacturers or small businesses capable of providing a Multi-Channel Adaptive Optics Lens, with 16 Actuators. The associated NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing. Background: Part of the mission statement of FDN Division of Pharmaceutical Analysis is to help ensure the safety and efficacy of human drugs used in the United States and to provide a strong analytical science base to support complex FDA investigations and enforcement actions concerning the quality and authenticity of human drugs. An environmental testing chamber is the key equipment to perform the stability studies by accurately controlling the ambient temperature and humidity of the testing product. Specific requirements are as follows: The requested instrument must meet the following salient characteristics and specifications: Performance Requirements: Partial Size Detection Capability: i) At a minimum, the Partial Size Detection Capability must be: 10nm to 2000nm. ii) At a minimum, the instrument must be able to detect an Ebola pseudotype virus particle: 80nm diameter, 800nm in length. iii) At a minimum, the instrument must be able to detect particles within concentration of 107 - 109 particles per mL. Microscope: i) At a minimum, the instrument must contain the optimally designed microscope to be used only in conjunction with the mounted NanoSight LM10 device. ii) At a minimum, the instrument must use a laser light source to illuminate Nano-Scale particles within a 0.3ml sample. iii) The instrument must have enhanced near perfect black background, so particles appear individually as point-scatterers moving under Brownian motion. Software: i) At a minimum, the software must contain NTA Analytical Software for real-time nanoparticle visualization, analysis, counting and sizing and displayed data output and have dimensions of: 16.5W x 7.9D x 10.2H inches. ii) At a minimum, the system requires room for a laptop/desktop and approximately 0.4 x 0.4m of bench space. iii) At a minimum, the instrument must not be more than these dimensions after installation to keep lab space unobstructed. Electrical: 11OV- 220V. Operation Conditions: i) At a minimum, the instrument must have a wavelength capability of 405nm (violet), 488nm (blue), 532nm (green) or 642nm (red). ii) At a minimum, the instrument must have temperature control within the range of soc below ambient to 55°C. iii) At a minimum, the instrument must have a manual stage and focus. iv) iii) At a minimum, the instrument must have a sCMOS Camera and Super High Sensitivity Scientific CMOS device that can extend the range below 30nm, for the measurement of size of dispersed particles and molecules in solution. Environmental Testing Chamber: a) At a minimum, the Environmental Testing Chambers must be able to control both temperature and humidity: i) Temperature Range: No more than -40°C on low end, and no less than 150°C on high end. ii) Humidity Range: No more than I 0% RH on low end, and no less than 95% RH on high end. iii) Control & Stability: ±1.5°C and ±4% RH at steady state conditions after stabilization Interior. Iv) Dimensions: No less than 20" in width, 20" in depth, and 20" in height Exterior Dimensions: b) The instrument must be able to be delivered through a 40-inch wide door. c) Work Space must: Not be less than 8 cubic feet. d) Water Supply must be: Five (or more) gallon reservoir with water recovery recirculating system. c) Window is required. d) Site start-up and training is required. IT. Trade and Service Criteria i) The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of the instrument is intended to be greater than ten years at full performance. COER must be able to reasonable expect service and technical support from the vendor during its lifecycle. ii) The instrument must be warranted for parts and labor for 12 months from the date of installation. Software updates shall be furnished at no additional cost during the warranty period. iii) Technical support must be furnished at no additional cost during the warranty period. iv) The vendor shall provide a copy and pricing for any available extended warranties and service contracts. v) The vendor must also be capable of servicing the instrument through the extended warranty or service contract. This information shall not obligate COER to purchase an extended warranty. Other Considerations. i) The requested equipment shall be delivered, installed and calibrated within 2 months from date of contract award. ii) Delivery Location: Food and Drug Administration (FDA) Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center For Devices and Radiological Health (CDRH), 10903 New Hampshire Avenue, Building WO62, Room 2210, Silver Spring, MD 20993. Responses to this sources sought notice shall unequivocally demonstrate that the respondent is regularly engaged in the manufacture and/or sale of same or substantially similar items. 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 and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [Provide this same information again if responding to provide a product manufactured by another firm.] • Three (3) years of 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 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; • 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 requirement; • If a large business, identify the subcontracting opportunities that would exist for small business concerns; and • Though this is not a request for quote, informational pricing is encouraged. 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. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties 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 July 06, 2015 by 12:00 P. M ET) at the Food and Drug Administration, Attn: Emmanuel T. Mbah, 5630 Fishers Lane, Room 2142, Rockville, MD 20857 or email Emmanuel.mbah@fda.hhs.gov. Reference: 1120158. 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 businesses, made available to full and open competition or procured through sole-source acquisition procedures. 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. 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/DCASC/Requisition_(1152448)/listing.html)
 

Place of Performance

Address: Food and Drug Administration (FDA), Division of Applied Mechanics, Office of Science and Engineering Laboratories Center For Devices and Radiological Health (CDRH), 10903 New Hampshire Avenue, Building WO62, Room 2210, Silver Spring, MD 20993, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN03778851-W 20150630/150628233231-3469f1821b227f71694ea95e9f85d5f0 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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