SOLICITATION NOTICE
B -- Development of Liver Toxicity Knowledge Base
- Notice Date
- 8/22/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- 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
- 1104096
- Archive Date
- 9/19/2012
- Point of Contact
- Howard Nesmith, Phone: 870-543-7459
- E-Mail Address
-
howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement herein under Simplified Acquisition Procedures. The solicitation number is 1104096. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-60, July 26, 2012. The associated North American Industry Classification System (NAICS) Code is- 541380 - Testing Laboratories; Size standards $12 million. This combined synopsis/solicitation is set-aside for Small Business. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 1:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on September 4, 2012 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below. When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time. For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov. The Food and Drug Administration is soliciting quotes for the Development of Liver Toxicity Knowledge Base (LTKB) to empower the FDA Review Process as defined in the below Statement of Work (SOW). Statement of Work (SOW) Title: Development of Liver Toxicity Knowledge Base (LTKB) to empower the U.S. Food and Drug Administration (FDA) Review Process 1. Background A significant amount of drugs are withdrawn from the market and fail during clinical trial stage of development due to liver toxicity. Drug-induced liver injury (DILI) has become one of the most important concerns in the drug development and approval process. There is a need to develop content-rich resources (i.e., knowledge base) to improve FDA's basic understanding of liver toxicity at the mechanistic level and facilitate the efficient development of novel biomarkers and tools for utilization by research, industry and regulatory groups, a focus of this project. Specifically, the project is drug-specific with aim to identify potential risk factors distinguishing drugs in DILI. It is anticipated that the project will provide a wealth of focused knowledge and data mining tools for hepatotoxicity in the form of networks between chemicals (and drugs), molecular signatures, liver specific biomarkers, genes/proteins functions, pathways and liver diseases (and pathology). The project contains three components (1) collecting diverse data (e.g., DILI mechanisms, drug metabolism, histopathology, therapeutic use, targets, side effects, etc) associated with individual drugs; (2) applying systems biology and network pharmacology approaches to integrate these data for DILI assessment and prediction; and (3) verifying the results using both conventional and high-throughput molecular biomarker assays for selected drugs to develop novel biomarkers. The Scope of Work below will fulfill the goal of the third component of this project. 2. Scope Specifically, the work accomplished under this contract will develop potential biomarkers to predict severe DILI and propose an early hepatotoxicity screening scheme for pharmaceutical industries' drug development. 3. Objectives The objectives of this project are two-fold: 1) To evaluate the severe DILI prediction potential of in vitro human hepatocyte assayed with 4 end points. 2) To develop a dose-response relationship of tested drugs for a quantitative measure of drug toxicity and rank order the severe DILI drugs. This research supports FDA/NCTR Strategic Plan (2011-2015) Goal 1 "Advance scientific approaches and tools necessary to support public health" and will specifically implement Objective 1.1 "Integrated safety assessment" and 1.2 "Advance emerging science through the development and application of new tools and approaches" by conducting in vitro toxicological assessment to identify biomarkers, quantifying toxicities and establish dose-response information for chemicals of interest. 4. Tasks and Deliverables A. The responsibilities Following the industry's good practice1, the contractor shall produce validation reports and Standard Operating Procedures (SOPs) with 12 reference drugs on the assays proposed, to maintain the raw data generated from the assays for auditing and to communicate any obstacles and problems for the completion of this contract. B. The deliverables - Cryopreserved human hepatocytes from 10 donors with 85% viability. - Raw data generated from 4 assays performed on pooled hepatocytes with 7 concentrations, two time points and technical triplicates on initial 100 drugs. The results will be repeated once to see the inter-run variabilities. - Quality RNA samples (1 ug of RNA per sample, and RIN (RNA Integrity Number) > 8 and the 28S/18S ratio > 0.9) produced from 24 Government-selected drugs enough for next-generation sequencing. 5. Government-Furnished Property FDA will provide the stock solution of testing drugs with identities blinded. Upon key break with data analysis done, FDA will share the results with the identities and annotated information of the tested drugs. 6. Place of Performance Work is to be performed at the contractor site. 7. Period of Performance The period of performance will be 90 calendar days from date of award with an option for an additional 100 drugs which may be exercised at any time within 180 calendar days of award. 1. C. T. Viswanathan et al Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays Pharmaceutical Research Vol. 24, No. 10, October 2007 Base Requirement, One (1) Job @ $____________________ Option Requirement (see FAR 52.217-7), One (1) Job @ $____________________ Total, Base & Option $____________________ GSA Contract Number (if applicable): ________________________ DUNS or DDUNS+4: _____________________ FOB Destination - U.S. Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Rd., Jefferson, AR 72079. Contract Type - Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The government will award the purchase order to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government on a best value (tradeoff) evaluation basis, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical acceptability of the services offered to meet the Government's requirement. (ii) Past Performance. (iii) Price. Technical acceptability and past performance are significantly more important when compared to price in determining the best value to the government; however, price remains a significant factor. Technical acceptability will be determined by review of the technical approach proposed to meet the requirements of the SOW. Past Performance will be determined by review of recent (within the past 3 years) and relevant cryopreserved human primary hepatocytes and in vitro toxicity screening and biomarker development past performance and information submitted by the quoter. The Government reserves the right to look to other sources of information (e.g., the Past Performance Information Retrieval System (PPIRS), etc.) to support past performance evaluations. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, 52.209-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.223-18, 52.225-3, 52.225-13, and 52.232-33. The clause at 52.217-7, Option for Increased Quantity-Separately Priced Line Item. (Mar 1989) "...180 Calendar Days of award..." Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1104096/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Rd., Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02850928-W 20120824/120823001333-a26335a91786dc56acdcf4bd82362f95 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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