SOURCES SOUGHT
B -- hepatotoxicity flux study for regorafenib
- Notice Date
- 3/3/2016
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA-1163199
- Archive Date
- 3/26/2016
- 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 a hepatotoxicity flux study for regorafenib. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. 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-541690- Other Scientific and Technical Consulting Services; Small Business Size Standard is $15.0 million. A. Background The FDA approved and indicated that regorafenib has to be marketed with a black box warning for hepatotoxicity (Weng et al 2015 Toxicology327:10-21 ). Since regorafenib uncouples oxidative phosphorylation a contract is needed to establish its toxicity using the 13C-glucose tracer fate association study approach, developed and published using the usnic acid toxicity marker profile by the FDA-NCTR (Sonko et al. Food and Chemical Toxicology 2011 49: 2968-2974, ). B. Performance requirements The Contract shall provide a flux study with control (vehicle), low, medium, and high regorafenib doses at three drug dosing time points (24-hour glucose tracer incubation for each drug dose) after dosing with 4 replicates for a total of48 studies that would have cells and media. The Contractor shall generate the [U-13C6]-D-glucose isobolome in regorafenib treated tumor cells. The Contractor shall use 13C metabolic markers in order to differentiate between cycling versus branching (noncycling) tricarboxylic acid (TCA) cycle functions, as well as compromised deuterium depleting hydrogen exchange aldoseketose transformation processes in liver cells. This approach will determine precise mitochondrial toxicity markers in the liver with a translational edge regarding regorafenib. The Contractor shall provide consultation on the data and analysis of the study as necessary to assist the FDA research in assessing the analysis. C. Deliverables to government. 1. Collection of data and analysis of flux study with control (vehicle), low, medium, and high regorafenib doses at three drug dosing time points with 24-hour glucose tracer incubation for each drug dose. After dosing with 4 replicates a total of 48 flux studies in cells and media will be sent for flux and data analysis. The flux surrogates of the [U-13C6]-D-glucose will be used to measure 13C labeling in all biologically significant, measurable products of glycolysis, the TCA cycle, glycogen synthesis, single carbon pathways, fatty acid synthesis and breakdown, gluconeogenesis and the reverse processes in regorafenib treated tumor cells and media. These 13C labeled substrates that are measured are referred the isobolome. Dose and time regression analysis of the isobolome will reveal energy pathway changes related to regorafenib. 2. Contractor shall provide sample analyses, data compilation, project management, master data interface and explain the biological meaning of their analysis to NCTR PIs. Period of performance: Flux surrogates of all samples shall be analyzed within 3 months of receiving samples. Data analysis and biological interpretation shall be provided within 6 months of initial sample delivery. Government will provide the samples within 2 months of contract award. FOB Point Destination. All items/services shall include shipping and handling to the destination identified herein. 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 businesses 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 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. • Experience with providing data analysis for scientific publications • Three (3) years of past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar service solutions. 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 March 11, 2016 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 FDA-1163199. 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/FDA-1163199/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN04038860-W 20160305/160303235752-ef1b1ca8bb3c848f2208519f78a273b2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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