SOURCES SOUGHT
66 -- Human Primary Bronchial Cells
- Notice Date
- 7/2/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1152525
- Archive Date
- 7/25/2015
- 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 National Center for Toxicological Research (NCTR) requirement for Human Primary Bronchial Cells. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-541711- Research and Development in Biotechnology; Small Business Size Standard is 500 employees. The Division of Genetic and Molecular Toxicology (DGMT) has a need for human primary bronchial epithelial cells. The in vitro air-liquid-interface (ALI) airway tissues used in NCTR protocol E7549.01 are derived from human primary bronchial epithelial cells that are at the very early passage- passage one. Such differentiated airway tissues are used as the in vitro models for testing the toxicity of airway toxicants. The protocol is a CTP-funded NCTR protocol designed to develop in vitro testing platforms consisting of in vitro ALI airway tissue model and human disease-related toxicity endpoints. Establishing ALI tissue models of high quality is paramount to the success of this project. Some commercial tissue banks usually over-expand the primary cells. Such over-expansion decreases the percentage of the progenitor cells, which are the only cell type that possess the ability to differentiate. Furthermore, some commercial vendors supply cells at 0.5 million/ampule, causing over-stress on the progenitor cells at the expansion phase. These limitations, in combination, lead to heterogeneous differentiation of the airway tissue models. The heterogeneous nature of airway tissue models greatly affects the power and consistency of detecting responses to airway toxicant exposures. Therefore, DGMT requires the cells supplied at earlier passages with a larger starting number to ensure the quality and robustness of the study. Minimum Technical Requirement: 1. The primary cells are pre-tested for their ability to differentiate into air-liquid-interface tissue models; 2. The primary cells are supplied at Passage 1 or lower to ensure higher percentage of the progenitor cells; 3. Two million cells per ampule supplied, which shall yield at least 1 million cells at the recovery; 4. Primary cells collected from a large number of donors with different demographic background and disease conditions. This is particularly advantageous for studying population-based responses. 5. Medium shall be pre-tested for consistency to induce differentiation of human primary bronchial epithelial cells. The Government will provide shipping labels for cell delivery. Cells will be shipped 5 ampules at a time; different donors may be requested for each shipment. Delivery: 3900 NCTR Road Jefferson, AR 72079 Period of Performance Delivery shall occur within 200 calendars days from date of award. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. 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, 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 (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/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. • Information on available service/maintenance plans. • Three (3) years of past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, 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. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. • 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, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. 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. Interested Parties shall 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 10, 2015 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1152525. 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/FDA1152525/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03785318-W 20150704/150702235525-51f6045255da6f64e4cfb9f32e371591 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |