SOLICITATION NOTICE
B -- Computational Toxicology Research Study
- Notice Date
- 7/28/2004
- Notice Type
- Solicitation Notice
- Contracting Office
- RTP Procurement Operations Division (D143-01) Research Triangle Park, NC 27711
- ZIP Code
- 27711
- Solicitation Number
- PR-NC-04-10674
- Response Due
- 8/24/2004
- Archive Date
- 9/23/2004
- Point of Contact
- JENNIFER B. HILL, Contract Specialist, Phone: 919-541-3083, E-Mail: hill.jennifer@epa.gov; LENORA HILLIARD, Placement Contracting Officer, Phone: 919-541-4392, E-Mail: HILLIARD.LENORA@EPA.GOV
- E-Mail Address
-
Email your questions to JENNIFER B. HILL
(hill.jennifer@epa.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL SERVICES PREPARED IN ACCORDANCE WITH THE 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 solicitation number is PR-NC-04-10674, and the solicitation is being issued as a 100% small business set-aside competition Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 01-24. The associated North American Industry Classification System (NAICS) Code 541990, which has a size standard of $6.0 million to qualify as a small business, is applicable. A firm, fixed-price contract is anticipated to result from the award of this solicitation. In seeking to apply concepts embedded in the Computational Toxicology Framework, this procurement is designed to: (1) evaluate the predictiveness of a toxicogenomic screening platform for identifying toxicity pathways; (2) provide analysis of the key toxicity pathways for five chemicals of interest to the regulatory programs of EPA; and (3) contrast the toxicity pathways, or lack therefore, amongst the five. The resulting data and reports will also be used as educational materials to staff in the Office of Pesticide Programs in order to provide training on toxicogenomic data using directly relevant compounds. The period of performance will be 8 months from the date of award. The contractor shall conduct the protocol, or an approximation agreed upon by the EPA, as described below as a blinded study (i.e., unaware of the actual identities of the test chemicals) in order to assess their potential toxicity; to identify the likely pathologies that will be induced; to compare and contrast toxicities of the chemicals, and to provide information on the similarity of the test agents with toxicities of known chemicals in a reference database which shall contain a minimum of 100 chemicals. Data shall be provided for a total of five chemicals selected by the Agency. The study is to be conducted in 10-11 week old male Sprague-Dawley rats, and the dosing vehicle for all chemicals shall be 15% Alkamuls EL-620 (Rhodia Inc., West Point GA) at a dosing volume of 5 ml per kg body weight. The study shall not be conducted under General Laboratory Practices (GLP) conditions, and the EPA will supply the chemicals to the contractor. Verification of the dosing concentrations and dosing solution stability are not required. The study shall be conducted in two phases: a dose range finding study, and a main study. In the dose range finding study, three animals per group per chemical shall be exposed to a low, middle and high level by oral gavage for 14 days in order to establish the dose level that shall be optimal for the definitive study. EPA will supply sufficient toxicity information on the individual chemicals to allow the contractor to select the three dose levels in the range finding study. The contractor shall be responsible for selecting the dose level of the definitive study based on this information and knowledge of similar studies comprised in the reference database. The dose range finding animals shall be allowed a 7 day acclimation period prior to dosing, at which time they shall be randomly assigned to one of the 16 groups (15 chemical treatment groups plus a concurrent control); body weights are to be recorded at the beginning of the dosing period, and at necropsy (24 hours after the 14th dose). Prior to sacrifice, 350 :l of serum from all animals shall be collected, frozen on dry ice, and shipped to the EPA laboratory in Research Triangle Park, NC. There shall be a full necropsy of all animals. The liver weight shall be recorded, and a standard clinical chemistry panel shall be conducted. Livers shall be fixed in neutral buffered formalin (NBF) for possible later histopathological examination. In the main study design, the single dose of each chemical identified in the dose range finding study shall be used, with group sizes of fifteen animals per chemical. Five animals from each group shall be examined at 6 hr and 24 hrs post dose for each animal; while the remaining five animals per group shall be maintained and dosed daily at the same level for 13 additional days. For additional details on the study see EPA Website http://www.epa.gov/oam/rtp_cmd. Upon completion of the gene expression study and analysis using the reference database and bioinformatic approaches, the contractor shall provide a report on the likely toxicities pathways and toxicities for each of the test chemicals. Contractor shall also provide spreadsheets of expression data suitable for independent analysis and study by the EPA. To fulfill the Quality Assurance requirements for this contract, the Contractor shall provide, prior to award, a Quality Management Plan (QMP), which describes the quality system in terms of organizational structure, functional responsibilities of management and staff, line of authority, and required interfaces for planning, implementing and assessing all quality assurance activities. In addition, within 30 days of award, the Contractor shall provide a Quality Assurance Project Plan (QAPP), which comprehensively describes the necessary QA, QC and other technical activities to ensure that the results of the work performed satisfy the stated performance criteria. QA guidance documents can be found on the internet at http://www.epa.gov/quality1/qatools.html. The R-2 document discusses the Quality Management Plan, and the R-5 document discusses the QA Project Plan. Work on this contract shall not begin until the EPA has approved these documents. The EPA reserves the right to conduct one on-site Technical Systems Review of the Contractor during the term of the contract. Within 8 months from the date of the award, the Contractor shall provide reports describing the toxicogenomic profiles elicited by each of the chemicals, including the bioinformatic analyses indicating the likely toxicity pathways invoked and the predicted target organ pathologies. Where possible, the predictions for the chemicals shall be compared and contrasted based on groupings of the chemicals provided by the Agency after completion of the in life phase of the study. CONFIDENTIALITY AGREEMENT: The contractor shall provide Reports solely to the Agency. The Reports, including the results of the study and the gene expression data generated from test chemicals, shall be the property of the Agency. The Reports shall contain confidential and proprietary information of the Contractor. Such information shall include description of the Contractor's models, methods, study designs for compounds not provided by Customer, identities or characteristics of such other compounds, bioinformatic tools, algorithms, and software as well as information and data excerpted from the Contractor's reference database. The Reports shall also contain a complete list of submodel predictions, which the Contractor may consider to be proprietary and confidential commercial information. The following FAR provisions apply to this solicitation: 52-212-1, Instructions to Offerors-Commercial Items; 52.212-2, Evaluation-Commercial Items. Evaluation criteria to be included in paragraph (a) of provision 52.212-2 are as follows: I.)Technical Capabilities: 1)Demonstrate technical approach to accomplish the statement of work to include: a.)Number and diversity of chemicals contained in reference database. b.)Demonstrated ability to incorporate diverse biological and toxicological information into predicting algorithm. c.)Extent to which inclusion of predictive parameters can be included in open peer-reviewed publication. d.)Bioinformatic approach to generation of predicted toxicity profile. e.)Demonstrated ability to report on similarities and differences of measured responses across a series of related chemicals. f.)Demonstrated ability to map measured genomic responses across diverse analytical platforms and gene chip designs. 2)Demonstrate adequacy of the Quality Assurance Management Plan. 3)Past Performance - Submit a list of 3 customers for whom like or similar services have been performed within the past 2 years. Include specific points of contact and phone numbers. Past Performance will be evaluated on a) quality of service; b) timeliness of performance; and c) overall customer satisfaction. II.)Price. Award will be made to the offeror whose offer is determined the best overall value to the government, price and other factors considered. For the purpose of this best value evaluation of technically acceptable proposals, technical capabilities and past performance, when combined, are significantly more important than price. All offerors are to include with their offer a completed copy of provision 52.212-3, Offeror Representations and Certifications-Commercial Items. The following FAR clauses apply to this acquisition: 52.212-4, Contract Terms and Conditions-Commercial Items; 52.227-14, Rights In Data-General, Alt III, 52.227-17 Rights in Data-Special Works; 52.246-11, Higher Level Contract Quality Requirement, 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items and the following additional FAR clauses which are cited in Clause 52.212-5: 52.203-6 Restrictions on Subcontractor Sales to the Government, Alt I; 52.219-6, Notice of Total Small Business Set-Aside; 52.219-8, Utilization of Small Business Concerns; 52.219-14, Limitations on Subcontracting; 52.222-3, Convict Labor; 52.222-21, Prohibition of Segregated Facilities; 52.222-26, Equal Opportunity, 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36 Affirmative Action for Handicapped Workers; 52.222-37, Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era; 52-232-33, Payment by Electronic Funds Transfer. The completed Representations and Certifications should be included with the price proposal. All technical questions are to be forwarded via email to the Contracting Officer at the following email address: hill.jennifer@epa.gov. Offerors should review the Statement of Work and other information posted with this Request for Proposal on EPA's website at the following address: http://www.epa.gov/oam/rtp_cmd. Scroll down to the REQUEST FOR PROPOSAL section and click on the solicitation. Scroll down below that section to COMMERCIAL BUY CLAUSES AND FORMS which are provided for your convenience. Please submit four copies of the technical proposal and two copies of the price proposal to Jennifer B. Hill, Contracting Officer, U.S. Environmental Protection Agency, RTP Procurement Operations Division (D143-01), Research Triangle Park, NC 27711 if using US Post Office. Courier delivery address is U.S. Environmental Protection Agency, Attn: Jennifer B. Hill, RTP Procurement Operations Division (D143-01), 4930 Page Road, Durham, NC 27703. All offers are due by August 24, 2004, 12:00 p.m., EDT. No telephonic or faxed requests will be honored.
- Web Link
-
The Environmental Protection Agency
(http://www.epa.gov/oam/solicit)
- Record
- SN00632410-W 20040730/040728212858 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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