MODIFICATION
A -- PROVIDE A REPORT FROM TOXICOLOGICAL STUDIES OF FUELS/FUEL ADDITIVES (ALCOHOL AND ETHERS) TO BE USED IN US EPA HEALTH ASSESSMENTS
- Notice Date
- 7/5/2006
- Notice Type
- Modification
- Contracting Office
- Environmental Protection Agency, Acquisition Management Branch, 26 W Martin Luther King, Cincinnati, OH 45268
- ZIP Code
- 45268
- Solicitation Number
- RFQ-OH-06-00164
- Response Due
- 7/12/2006
- Archive Date
- 8/12/2006
- Description
- NAICS Code: 541710 Amendment #1 NOTE: This requirement can result in the award of multiple purchase orders to obtain the data required in the Statement of Work. Technical Questions Question #1: It is unclear from the Statement of Work whether the EPA's intent for this requirement is asking for a contractor to submit explicit data reports for fuel/fuel additive toxicology studies already completed, or identify one facility that will provide a single detailed report from possibly several studies conducted in various laboratories. In the latter case, it would be assumed that the raw data might be sent to the lab for report preparation. Could this be clarified Answer: The EPA's intent with this requirement was to leave open the possibility that the Government might purchase data from more than one contractor (see note above). One contractor would not provide their data to another contractor. Question #2: The statement "successful offerors shall retain possession of their data and the right to publish reports referring to such data" suggests that multiple contractors could submit detailed reports to the EPA? Answer: See note and answer #1. Question #3: However, the descriptions of Task 2, subtasks 1-7 suggest data is being acquired, if not from internal sources, then outside sources, for evaluation? Answer: Task 2 refers to the contractor's own study and the data derived from the study. Subtask 5 may be confusing because it should have the verb "describe" inserted after "shall". As the Statement of Work indicates, the EPA does not intend to purchase information "that has already been fully reported in accessible publications." However, the EPA is looking for unpublished ancillary information from or about a previously reported study. The EPA is especially interested in data from studies that have not been published even in partial form. The EPA does NOT intend to have sources submit their data to another contractor or to have one contractor obtain data from other sources. However, we reserve the right to use a "third party" contractor to conduct analyses of data that we have procured through this process. This is a combined synopsis/request for quote (RFQ) for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. The identifying RFQ number is RFQ-OH-06-00164. The RFQ and incorporated provisions/clauses are those in effect through Federal Acquisition Circular 05-09. A firm fixed price purchase order is anticipated to result from the award of this RFQ. The NAICS code is 541710 and the size standard is 500 employees. STATEMENT OF WORK Title: Provide data from toxicological studies of fuels/fuel additives (alcohols and ethers) to be used in EPA health assessments. Program Office: ORD/NCEA-RTP Period of Performance: 12 months from date of award Estimated Hours/Level of Effort: 2,930 hours BACKGROUND: Various alcohols and ethers have been used or considered as fuels and fuel additives (F/FAs) in an attempt to formulate "cleaner" gasoline in an effort to reduce levels of carbon monoxide, ozone, and toxic air pollutants. Although the purpose of these F/FAs is to reduce air pollution levels, such chemicals need to be evaluated for their own potential toxicity under certain conditions. Thus, the U.S. Environmental Protection Agency (U.S. EPA) is interested in compiling health effects information on F/FAs such as DIPE (di-isopropyl ether), ETBE (ethyl tertiary butyl ether), EtOH (ethanol), MeOH (methanol), MTBE (methyl tertiary butyl ether), TAME (tertiary amyl methyl ether), and TBA (tert butanol). Health assessments of some of these chemicals (MTBE, ETBE, EtOH, MeOH) are underway for the U.S. EPA's IRIS (Integrated Risk Information System) program, and Section 1506 of the Energy Policy Act of 2005 further reinforces the need to evaluate such F/FAs. The number of published toxicological studies of F/FA chemicals varies widely. For example, ethanol has been investigated extensively whereas DIPE has not. Even a well-studied substance such as ethanol may have been investigated primarily by one route (ingestion) whereas other routes (e.g., inhalation) may be more relevant to F/FA use and likely exposure pathways. Under Section 211(b) of the Clean Air Act, the U.S. EPA has exercised its authority to require manufacturers of several of the above-named F/FAs to conduct toxicological testing of mixtures of these respective alcohols or ethers with baseline gasoline, using the inhalation route of exposure. Although the U.S. EPA's authority to require such testing under CAA 211(b) is limited to the inhalation route, other routes, especially ingestion, are also of importance in attempting to understand the broad environmental and health implications of these F/FAs. Peer-reviewed, published reports of health studies are preferred for use in U.S. EPA health assessments, but such reports may not provide as much information as desired or necessary for modeling and other analyses used in health assessments. For example, data on effects in individual animals may be needed for analytic purposes, but published reports often do not include this level of detail. Unpublished data may also be used in assessments so long as the data are available in a manner that can be subjected to peer review in the context of the assessment's preparation. There is reason to think that researchers and research organizations in the scientific community have detailed data from studies that could be useful for U.S. EPA assessments of F/FAs. In some cases, these data may have been the subject of published reports, but in other cases the data may come from studies that have not yet been reported in the published literature. In the latter instance, studies may be in various stages of completion. This requirement is not intended to fund the initiation of new experimental studies, nor is it intended to obtain information that has already been fully reported in accessible publications. Rather, this requirement seeks to obtain unpublished data from existing studies that have been completed, at a minimum, experimental exposures and collection of "raw" effects data. For example, tissues from selected target organs may have been collected from laboratory animals exposed to F/FA chemicals in toxicological experiments. Under this requirement, pathological evaluations of tissues could be conducted, along with statistical analyses of the data. Ancillary data on individual experimental animals, including food and water consumption, body weights, time until death, and similar information, would also be required. Potential offerors should indicate the nature and extent of data available, including the specific chemical(s) and route(s) of exposure; the chemical concentrations administered; the number, gender, age and species of animals for each exposed and control group; detailed descriptions of the endpoints examined and/or quantified (e.g., tumor sites, number and classification of tumors); the statistical analyses completed or planned; the relationship of the data to any previously published report(s) on the same chemical from the laboratory in question; and any other information, including provisions for quality control/assurance, that would help the U.S. EPA determine the utility of the data for health assessment purposes. Successful offerors shall retain possession of their data and the right to publish reports referring to such data. Procurement or consideration of an offeror's data shall not imply an endorsement of the study by the U.S. EPA. Tasks Task 1: After award of a purchase order, the contractor shall be required to develop a Joint Quality Management/Quality Assurance Project Plan (JQM/QAPP), specifying how the data will be compiled, evaluated, statistically analyzed, reported, and transferred in electronic format. The QAPP shall address at a minimum the topics listed in the QA attachment The QAPP shall be submitted to the US EPA Project Officer for approval within four (4) weeks of receiving award of the purchase order. The intent of the JQM/QAPP is to ensure that the data, data analysis, and reporting of the results are of acceptable quality and support reconstruction of the conduct of the study by outside review. The requirements in QA attachments, "EPA Requirements for Quality Management Plans" (http://www.epa.gov/quality/qs-docs/r2-final.pdf) and "EPA Requirements for Quality Assurance Project Plans" (http://www.epa.gov/quality/qs-docs/r5-final.pdf) shall be followed. Task 2: The contractor shall prepare a report that includes a detailed description of the experimental methods (including information on the dose regimen for chemical administered, the experimental subjects, the endpoints measured), QA procedures (see Subtasks 1-8 below), data handling procedures, statistical analyses, and results, along with a narrative description and discussion of the results. This information is expected to be more detailed than typically provided in journal articles or similar publications of comparable experimental studies. The report shall be accompanied by the complete dataset in an acceptable electronic format (e.g., Excel, Lotus 123) as an appendix to the report. The dataset shall include identifiers for individual animals, their respective experimental condition/group, food consumption (if available) and body weight data, qualitative and quantitative data on toxicological endpoints measured (e.g., number and type of tumors), time of death, and any other available relevant information. Subtasks 1-7 1. The contractor shall describe all procedures and methods that will be used in the data collection effort and how they will be documented. The contract shall also indicate whether the data collection will be carried out in a certified environment, such as a GLP accredited lab, and under generally accepted, citable protocols, including those dealing with the humane care of experimental animals. 2. The contractor shall identify how study records (e.g., methods, data, supporting documentation) are maintained (including where and how this documentation and the data record will be provided to the U.S. EPA). 3. The contractor shall provide application of the statistical method, including: a) method executions and any applicable analysis/visualization techniques; (b) anticipated data portability and/or data storage requirements; 4. The contractor shall provide statistical method integrity: (a) verification that the correct version of the method and correct input/output files are used during method evaluation and analysis of results (b) archiving method results and periodic review of archives for obsolescence. 5. The contractor shall input and output data characteristics and requirements: (a) sources of original data; (b) criteria for data acceptance or rejection for the purpose of the current project; (c) any modifications to the original data necessitated by the current project; (d) data input/output; (e) data format conventions, conversion issues, maintenance, and archiving. 6. The contractor shall provide procedures for recording data and supporting information, noting that the intent is to provide a data record that, in conjunction with the methods section, supports an independent review and the ability to reconstruct the conduct of the study as well as to evaluate the conclusions in the report based on the study data and study record. 7. The contractor shall include other applicable procedures designed to ensure the quality of the study, the transparency and integrity of the study record, and the ability to reconstruct the study based on the report and accompanying record that will be provided to the USEPA. Reporting Requirements The contractor shall have up to 11 months from the date of award to prepare and submit a draft report to the USEPA for review and approval. The draft report shall include the complete dataset as an appendix to the report. The final report, including the complete dataset in electronic format, shall reflect any changes made in response to the U.S. EPA's review of the draft report and shall be submitted to the U.S. EPA within 3 weeks of the U.S. EPA's review or within 12 months of date of award of the contract, whichever is later. The draft and final report and appended dataset shall be provided in acceptable electronic formats such as Word or WordPerfect for the textual report and Excel or Lotus 123 for the dataset. Schedule and Deliverables Joint Quality Management/Quality Assurance Project Plan (JQM/QAPP) 4 weeks after award Draft Report 11 months after award Final Report 3 weeks after receipt of U.S. EPA review of draft report, or 12 months after award, whichever is later The Government anticipates award, using simplified acquisition procedures, for a Purchase Order resulting from this RFQ. The following clauses apply to this request for quote: FAR 52.212-1, Instructions to Offerors-Commercial Items; FAR 52.212-3, Offeror Representations & Certifications-Commercial Items, shall be completed by offeror and submitted with quote, unless the offeror's registered with CCR; FAR 52.212-4, Contract terms & Conditions-Commercial Items; The following FAR clauses in paragraph (b) of FAR clause 52.212-5, Contract Terms & Conditions Required to Implement Statutes or Executive Orders-Commercial Items will apply, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-13. Payment by Electronic Funds Transfer-Central Contractor Registration; all clauses can be found at: http://farsite.hill.af.mil/VFFARA.HTM. In addition, the following US EPA EPAAR clause is applicable to this RFQ: EPAAR 1552.233-70, Notice of Filing Requirements for Agency Protests, and 1552.211-79, Compliance with EPA Policies for Information Resource Management. These EPAAR clauses are available at http://www.epa.gov/oam/ptod/epaar.pdf. FAR 52.212-2 Evaluation-Commercial Items, and the specific evaluation criteria is as follows: Technical Evaluation Criteria A. The Government will award a purchase order resulting from this RFQ to the responsible offeror whose quote conforming to the RFQ will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers: technical approach/acceptability of toxicity information and datasets, past performance, and price. The following requirements will be evaluated on a Best Value basis. Offerors shall provide information to demonstrate/substantiate that its quote meets the statement of work. Offerors shall: 1. Demonstrate in its quote the technical approach/acceptability of indicating how toxicity information is relevant to fuels and fuel additives that are in use or may be of regulatory/programmatic interest to the EPA, as stated in the Statement of Work. A quote shall clearly indicate the extent of data being offered (i.e.: types and number of endpoints evaluated, ancillary information on experimental subjects, and other information) as indicated in the Statement of Work. A quote shall also provide information on QA procedures followed in generating this type of data, along with any information which reflects the quality of the data (i.e.: measures of statistical power, features of study design, qualifications of professional staff, etc). 2. Provide demonstrated performance during the last three years on contracts/purchase orders which are similar to this requirement. The Government will consider the following areas under past performance: (1) quality of products or service, (2) cost control, (3) timeliness of performance, (4) business relations. The offeror shall provide reference information for at least three projects completed or currently ongoing, which are similar to this requirement. The name, phone number, and e-mail address for the customer=s primary technical contact point (project officer) shall be provided 3. Provide a fixed price quote in accordance with the Specifications identified. B. Responses to the above factors shall be evaluated on the following scale: Superior: Exceeds the Government's minimum requirements. Acceptable: Meets the minimum requirements of the specifications Unacceptable: Does not meet all requirements of the specifications. C. After the responses have been evaluated against the factors above, an order is expected to be placed with the offeror that represents the Best Value to the government. Price may not be the determining factor. Offers shall submit 1 copy of their quotation that references RFQ-OH-06-00164, no later than July 12, 2006 at 3:00 PM (EST) to Scott A. Fogle, at fogle.scott@epa.gov or via fax at 513 487-2107. Technical questions or comments may also be directed to Scott A. Fogle, at 513 487-2049, or at fogle.scott@epa.gov. The last day for technical questions is July 03, 2006.
- Record
- SN01083096-W 20060707/060705225651 (fbodaily.com)
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