SOURCES SOUGHT
B -- ADME and Toxicity Studies for target compound
- Notice Date
- 5/28/2015
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-2015-372
- Archive Date
- 6/20/2015
- Point of Contact
- Samantha A. Kelly, Phone: 3014028855
- E-Mail Address
-
samantha.kelly2@nih.gov
(samantha.kelly2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE TEMPLATE 1.Solicitation Number:HHS-NIH-NIDA-SSSA-SBSS-2015-372 2.Title: ADME and Toxicity Studies for target compound 3.NAICS Code: 541380- Testing Laboratories 4.Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Center for Advancing Translational Sciences (NCATS) requires Absorbtion, Distribution, Metabolism, & Excretion (ADME) and Toxicity studies for one compound. ADME assesses the effects of a drug or drug-like compound against a variety of assays, designed to analyze how a drug is distributed and processed within the human body. Early ADME assays are critical to determine the effect and potential side effects of drug-like compounds in the human body. Metabolite profiling gives insight into the potential degradation pathways. Toxicity is related to ADME, in that a drug that is too toxic may not be administered to humans, even if it is effective. Purpose and Objectives: The purpose of this acquisition is to procure ADME and Toxicity studies for one compound. Features/Requirements: Specifically, the NCATS DPI Chemistry Technology group requires the following: Comprehensive ADME profiling, including a.Cytochrome P450 induction b.Cytochrome P450 Inhibition i.Across 7 isoforms ii.With Determination of IC50 values c.Hepatocyte stability for both human and mouse d.Microsomal metabolic stability in both human and mouse e.Plasma protein binding f.Blood binding for both human and mouse g.Determination of LogP h.Determination of aquous pKa i.Determination of thermodynamic solubility j.Determination of bidirectional Caco 2 permeability k.Determination of MDR1 MDCK permeability Comprehensive Mebolite profiling, including a.Initial metabolite profiling of any metabolites of the target compound b.The ability to do follow-up assays to determine the exact structures of any metabolites Comprehensive Toxicity Screeening a.hERG channel inhibition b.Ames testing, with and without S9 c.Mitochondrial toxicity d.Phospholipidosis and Steatosis e.Lysosomal Trapping. Anticipated period of performance: Results are to be delivered within eight (8) weeks after receipt of award. Capability statement /information sought. Contractors that believe they possess the ability to provide the requirement should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The response should directly and specifically state in the, capabilities statement, which project requirements you can supply. Contractors must also provide their Company Name, DUNS Number, Physical Address, Point of Contact, and Size and Type of Business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses (capability statements) sent in response to this Small Business Sources Sought Notice must be submitted electronically (via e-mail) to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Samantha Kelly, Contract Specialist at e-mail address Samantha.Kelly2@nih.gov The response must be received on or before June 5, 2015 at 12:00PM, eastern time. "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 presolicitation synopsis and solicitation may be published in Federal Business Opportunities. 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)."
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