SOLICITATION NOTICE
A -- Competitive Binding Assay
- Notice Date
- 7/7/2005
- Notice Type
- Solicitation Notice
- Contracting Office
- RTP Procurement Operations Division (D143-01) Research Triangle Park, NC 27711
- ZIP Code
- 27711
- Solicitation Number
- PR-NC-05-10467
- Response Due
- 7/22/2005
- Archive Date
- 8/21/2005
- Small Business Set-Aside
- N/A
- Description
- THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR 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. This solicitation is for FULL AND OPEN COMPETITION. The North American Industry Classification System (NAICS) Code is 541710-Chemical Research and Development Laboratories or Services The solicitation number is PR-NC-05-10467, and the solicitation is being issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-04. A firm, fixed-price contract is anticipated to result from the award of this solicitation. This procurement is for Development of a Standardized Approach for Evaluating Environmental Chemicals with Low Solubility (Highly Non-polar) in the Estrogen Receptor (ER) Competitive Binding Assay. STATEMENT OF WORK: Background and Purpose: The U.S. EPA is currently implementing an Endocrine Disruptor Screening Program (EDSP) that is designed to detect chemicals that alter the estrogen, androgen, and thyroid systems in human, fish and wildlife (http://www.epa.gov/scipoly/oscpendo/index.htm). To date, the U.S. EPA has implemented the program on three fronts: (1) Establishing procedural rules and policy for program implementation; (2) Developing a strategy for how to prioritize chemicals for screening and testing; and (3) Developing protocols to conduct specific assays, evaluating their effectiveness, and ensuring that the assay can be performed reliably and consistently in different laboratories. The project proposed under this contract will support the latter of these three activities by developing a standardized approach for evaluating environmental chemicals with low solubility in the estrogen receptor (ER) competitive binding assay. An ER competitive binding assay using rat uterine cytosol is currently undergoing evaluation for use in the Tier I Screening Battery of the Agency?s EDSP. http://www.epa.gov/scipoly/oscpendo/assayvalidation/status.htm. To date, under the direction of the Office of Science Coordination and Policy (OSCP), an optimized protocol for this assay has been developed and pre-validation studies demonstrating its potential use for detecting environmental chemicals that can bind to the ER have been completed. It is apparent from the previous studies that a standardized approach for evaluating environmental chemicals with low solubility should be included in the final protocol. The incorporation of these methods is critical to ensure that the structurally diverse group of chemicals that will likely be tested using this protocol will be properly evaluated. Thus, the purpose of this contract is to (1) Identify the limit concentrations for at least two chemical solvents (ethanol and DMSO) for the ER Competitive Binding Assay undergoing validation for the Agency?s EDSP; (2) Develop a tiered approach for determining the best solvent and the limit of solubility any given test chemical; (3) Compare ER binding affinity for a set of test chemicals using ethanol and DMSO as solvent; and (4) Demonstrate the utility of the standardized approach for a set of structurally diverse chemicals with low solubility and low binding affinity. Data from these studies will be submitted to the OSCP for use while preparing the working protocol for the final validation studies for the ER Competitive Binding Assay. Contractor Requirements: Contractor Requirements-The contractor shall conduct the experiments using the protocol for ER Competitive Binding Assay (rat uterine cytosol) that is currently undergoing validation for the U.S. EPA?s EDSP. The general protocol for this assay is available at: http://iccvam.niehs.nih.gov/methods/endodocs/final/erbndbrd/erbndall.pdf (Appendix B5, 1-14), but a final protocol will be distributed at the time of contract award. The Scope of Work shall be completed through multiple tasks, and written deliverables (electronic and hard copy) documenting the findings. Completion and approval of each task shall be required before proceeding to the next task. Problems or technical difficulties shall be reported immediately to the U.S. EPA technical point of contact. Government Responsibilities: EPA shall provide the contractor with the test chemicals for Task IV only. Chemicals (approximately 15) shall be distributed at least 1 month prior to the scheduled start of Task IV. Upon receipt of the results from each task, EPA shall examine the data and provide feedback to the Contractor within 30 days. Reporting Requirements: The contractor shall file a report within 30 days after the completion of each task. However, if the contractor has specific technical questions/issues, unaudited reports/data may be submitted earlier to obtain feedback from EPA. The report shall consist of a hard copy and an electronic version of the data, graphs, analyses, and conclusions. Formats for electronic data shall be submitted in a lotus or excel spreadsheet suitable for further data analyses. Graphs shall be submitted as PRISM, Lotus Freelance, Powerpoint, and pdf files. The time frame for each task is as follows: Tasks I and II (2 months); Task III (2 months); and Task IV (6 months). Quality Assurance (QA): Quality Assurance Documentation shall be submitted to the U.S. EPA Project Officer within 60 days after the effective date of the contract. A hybrid version of the Quality Management Plan and the Quality Assurance Plan (see EPA website) may be submitted to meet this requirement. No work involving direct measurements or data generation, compilation of data from literature or electronic media shall be initiated under this project until the EPA Project Officer has approved the quality assurance documentation. Additional QA guidance documents can be found on the internet at http://es.epa.gov/ncer/guidance/qa.html. Delivery Schedule: Tasks I and II (within 2 months after the effective date of the order), Task III (within 2 months after the completion and acceptance of Task 1), and Task IV (within 6 months after the completion and acceptance of Task III). All final reports and data shall be due with the completion of Task IV. Equipment: The contractor shall provide all necessary equipment for the project. EPA shall provide the selected chemicals for Task IV in accordance with "Government Responsibilities" found in previous section. Security: Although the research to be conducted under this award is not considered to be of a sensitive nature, it is expected that data safeguards shall be incorporated under the study design. Place of Performance: The submitted proposal shall indicate where the studies are to be conducted, and the U.S. EPA reserves the right to conduct periodic site visits and QA audits at the research organization. Period of Performance: The period of performance shall be 10 months from the effective date of the award. Task I: Identify the limit concentration for at least two chemical solvents (ethanol and DMSO) for the ER Competitive Binding Assay. It is known that high concentrations of solvents such as ethanol can coagulate protein and destroy the ability of a receptor to bind and retain ligand. Thus, the maximum concentration of each solvent that can be used under any specific set of assay conditions should be identified in order to prevent interference (e.g., reduction) with maximal ER binding. Using the same protocol currently undergoing evaluation by the U.S. EPA?s EDSP, carefully demonstrate the limit concentration for each solvent (e.g, using increasing concentrations of ethanol or DMSO, determine the maximal concentration of solvent for which no inhibition of ER binding is detected). (Note: The general protocol for this assay is available at: http://iccvam.niehs.nih.gov/methods/endodocs/final/erbndbrd/erbndall.pdf (Appendix B5, 1-14), but a final protocol will be distributed at the time of contract award.). Full ER competitive binding curves shall be conducted in two runs for each solvent (with two replicates for each solvent concentration ranging from 0, 0.01, 0.1, 1.0, 5, 10, and 15% solvent per total volume in each assay tube). The report shall include all raw data, graphs of competitive binding curves, the limit concentration for each solvent. In addition, electronic copies of all data and graphs should be submitted. Data shall be submitted to the U.S. EPA technical point of contact. Task II: Develop a tiered approach for determining the best solvent and the limit of solubility for any test chemical. It shall be noted that the chemicals that will be tested using the ER competitive binding assay will encompass a broad group of structurally diverse chemicals. The solubility characteristics of a particular test chemical, ranging from polar to highly non-polar, will limit the maximal concentration of the chemical that can be tested in the assay. The objective of this task shall be to develop a tiered approach for (1) determining the best solvent (Note: Order of solvents tested should be water, ethanol, and then DMSO as specified by ICCVAM?s Expert Panel Report (Section 2.1.3) http://iccvam.niehs.nih.gov/methods/endodocs/edfinrpt/edfinrpt.pdf ) for any given test chemical, and (2) identifying the maximum concentration of the test chemical that can be used in the assay without disrupting ER binding kinetics. An example of a tiered approach developed for the NTP, NICEATM, ICCVAM, NIEHS?s In Vitro Cytotoxicity Validation Study may be found at the following web site: http://iccvam.niehs.nih.gov/methods/invidocs/phIIIprot/solphIII.pdf. However, it is anticipated that the approach for the ER Competitive Binding Assay will also include preliminary information of the physical properties of the test chemical (e.g., partition coefficients, hydrophobicity, solubility, etc.), as well as indicators that a chemical is precipitating out after being added to the assay tube/buffer (e.g., U-shaped curves with increasing chemical concentration; solubility test using light scattering technique and Nepheloskan instrument). The report for this task shall include a flow chart demonstrating the approach for (1) determining the best solvent as evidenced by allowing the highest limit concentration of the test chemical (but not to exceed 1mM); and (2) determining the maximum concentration of test chemical that can be used in the assay without chemical precipitation following addition to the assay tube and an overnight incubation at 4 C. Task III: Compare ER binding affinity for a set of test chemicals in ethanol and DMSO. The objective of this task shall be to determine whether or not the IC50 for a test chemical is likely to change significantly when different solvents are used. ER competitive binding curves and IC50s shall be compared for a set of 5 ? 8 test chemicals when ethanol and DMSO are used as the solvent (Note: EPA shall select the chemicals to be used in this task). The chemicals selected for this task shall have known ER binding affinities (ranging from high to low). Duplicate curves (2 runs) shall be conducted for each test chemical with each solvent; test chemical concentrations will range from .1nM ? 1 mM (in duplicates). The report shall include all raw data, graphs of competitive binding curves, and the comparison of IC50s. In addition, electronic copies of all data and graphs shall be submitted. Task IV: Demonstrate the utility of the standardized approach (developed in Task II) using a set of structurally diverse chemicals. This task shall include a set of 15 chemicals that will be distributed by the U.S. EPA to the contractor. Competitive binding assays with full concentration curves shall be conducted in two runs with duplicates at each concentration for each chemical using the best solvent. For this task, some of the chemicals will have limited solubility in ethanol (e.g., limit concentration will range from 1 -10 uM), but inhibit binding 10 - 40% at the limit dose (determined from previous testing). For these chemicals, DMSO shall be tested to determine if a higher limit concentration can be obtained. If so, then a Ki experiment will be conducted for those chemicals at the limit dose using the alternate solvent. General methods for the Ki experiments are reported in Laws et al., 1996. (Toxicology. 112(3):173-82), but a final protocol shall be distributed by the U.S. EPA at the time of contract award. The report shall include all raw data, graphs of competitive binding curves, Ki experiments, and the comparison of IC50s. In addition, electronic copies of all data and graphs shall be submitted. SPECIAL INSTRUCTIONS: Chemicals for task III shall be purchased by the contractor at an estimated cost of $100 or less per chemical. Proposal Instructions and Evaluation Criteria: The Government intends to award a single contract to the responsible offeror whose technically acceptable proposal offers the ?Best Value? to the Government. ?Best Value? will be determined based on (1) technical capability, (2) past performance and (3) price. For this requirement, criterion (1)technical capability is significantly more important than all other factors, past performance and price . This procurement will be awarded based on the following ?best value? criteria: (1)Technical Capability: Demonstrated Approach and Knowledge. The offeror shall submit a detailed technical approach that demonstrates the ability to perform the requirements outlined in Tasks I - IV. Examples of data from the contractor?s laboratory (e.g., show actual data and graphs for scatchards for estrogen receptor binding assays, competitive binding and/or Ki data from competitive binding assays; data to demonstrate intra- and inter-laboratory variation, publications, etc.) shall be submitted to demonstrate technical knowledge in estrogen receptor biochemistry and binding assays. It is suggested that the complete technical proposal not exceed 15 pages in length. (2) Past Performance: Demonstrated successful past performance of the offeror and any major subcontractors as evidenced by information gathered concerning (1) previous history of successful conduct of research under contract; and/or (2) the successful completion of similar scale projects within time and cost estimates. Include the following information for each contract and subcontract listed: (a) name of contracting agency, (b) contract number, (c) contract title, (d) brief description of contract or subcontract and relevance to this requirement, (e) total contract value, (f) contract type, (g) period of performance, (h) contracting officer and telephone number, (i) program manager/project officer and telephone number. (3)Price- The pricing proposal shall include sufficient information to enable the Contracting Officer to perform a price analysis in accordance with FAR 15.404-1 (b). NOTE: 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 provisions apply to this solicitation: 52.212-1, Instructions to Offerors--Commercial Items. The following FAR clauses apply to this acquisition: 52.212-4, Contract Terms and Conditions-Commercial Items. The following additional FAR clauses which are cited in clauses 52.212-5 are applicable to the acquisition: 52.222-26, Equal Opportunity; 52.222-35, Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era; 52.222-36, Affirmative Action for Handicapped Workers; 52.222-37, Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era; 52,225-1, Buy American Act, 52.225-3, Buy American Act--North American Free Trade Agreement, 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. In accordance with FAR 52.204-7(b)(1)Central Contractor Registration, all prospective awardees shall be registered in the CCR database prior to award, during performance, and through final payment of any contract or purchasing agreement resulting from this solicitation. Offerors should review any other information posted with this Request for Quotation on EPA's website at the following address: http://www.epa.gov/oam/rtp_cmd. Arrow down to the REQUEST FOR QUOTATION section and click on the solicitation. Please submit two copies of the technical and price proposal to U.S. Environmental Protection Agency, RTP Procurement Operations Division (E105-02), Attn: Robin S. Harris, Contract Specialist, 4930 Page Road, Durham, NC 27703. All offers are due by July 22, 2005, 12:00 p.m. (noon), ET. No telephonic or faxed requests will be honored. E-mail proposals are acceptable and should be e-mailed to: harris.robin@epa.gov
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