Loren Data's SAM Daily™

FBO DAILY ISSUE OF JUNE 09, 2012 FBO #3850
SOURCES SOUGHT

66 -- Automatic Magnetic Cell Separator System

Notice Date

6/7/2012
 

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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 

ZIP Code

72079
 

Solicitation Number

FDA1104410
 

Archive Date

6/22/2012
 

Point of Contact

Nicholas E Sartain, Phone: 870-543-7370
 

E-Mail Address

nick.sartain@fda.hhs.gov
(nick.sartain@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 Evaluation and Research (CBER) requirement for a magnetic cell separator system. The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The government is seeking capability statements from manufacturing businesses capable of meeting the performance requirements. The U.S. Food and Drug Administration (FDA), Laboratory for Emerging Pathogens (LEP), within the Center for Biologics Evaluation and Research (CBER) requires an automatic magnetic cell separator with post-warranty service/maintenance options inclusive of all parts, labor and travel for the entire system. The Laboratory of Emerging Pathogens (LEP) performs FDA mission-oriented research in bioterrorism agents. Congress mandated the FDA to develop a counter terrorism program to address licensing of products to counter the threat of biological release of bioterrorism agents. To evaluate immune responses against bioterrorism pathogens, LEP needs to separate pure sub-populations of cells from heterogeneous populations. Due to the number of cell sub-populations needed to perform the FDA research (along with the need for reproducibility of results), LEP requires the use of an automated cell separator based on attachment of cells to magnetic beads. This technology has incredibly less impact on a cell than the larger, non bead separators currently on the market and positive and negative selection of cells without affecting cell viability is paramount. It is also necessary to isolate populations of leukocytes from whole blood without affecting the function of the cell. For this reason, the automatic cell separator based on magnetic beads is required to conduct experimentation in molecular biology, immunology, vaccine development, and diagnostics of bioterrorism agents. Due to space limitations within the lab, the system has to have a small profile and great flexibility to accommodate different formats such as large and small separation columns, and input volumes of 0.1 to 50 ml. The system must also perform cell separations in 3-10 minutes to maintain cell viability. Performance Requirements • Cell separator must be fully automated • Footprint must be no larger than 24in X 15in due to space constraints. • Automatic Magnetic cell separation must use bead technology • Must have the ability to bind 2x108 to 4x109 total cells. • System must be equipped with preprogrammed isolation protocols. • Integrated high resolution screen and computer must be included. • Must have a separation time of no greater than 10 minutes in order to maintain cell viability. • Input volume must be 0.1 to 50 ml. • Must have automated system cleaning. • System must be capable of 99% depletion of cells. • System must be capable of isolating cells at a frequency of up to 10-8 cells in heterogeneous cell populations. 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 OEM trained and certified technician; • Preventative maintenance, services, and repairs include all labor, travel, and new OEM factory-certified replacement parts, components, subassemblies, etc. (except consumables); • Phone support available from 8am to 5pm Eastern Time, Monday through Friday; • Priority scheduling for requests for service within 24 hrs; and 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: 8800 Rockville Pike Bethesda, MD 20892 The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Firms believing they can meet the requirements to the above specifications are encouraged to respond electronically with no less than the following information: • Business name, 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; • Sufficient descriptive literature that unequivocally demonstrates that offered products and services meet or exceed above specifications. • At a minimum provide the following: All descriptive material necessary for the government to determine whether the product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Indicate whether the organization is the manufacturer of the items or authorized reseller. If reseller, include the manufacturer's name, address and DUNS number. Include information on the instruments: a. Ability to perform automated magnetic cell separation. b. Diameter of magnetic bead used for separation c. The ability to bind cells d. Time needed to complete cell separation e. Ability to isolate cells in heterogeneous cell populations f. Percentage of successful depletion of unwanted cell types g. Negative and positive cell isolation • 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. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, provide if subcontracting opportunities exist for small business concerns. • Though this is not a request for quote, informational pricing must be submitted for the instrument and service plans. The government is not responsible for locating or securing any information, not identified in the response. The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. 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 June 21, 2012 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1104410. 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).
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1104410/listing.html)
 

Place of Performance

Address: 8800 Rockville Pike, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN02768876-W 20120609/120607235128-242c5ef5c89363e131586c229d28a538 (fbodaily.com)
 

Source

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

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