SOLICITATION NOTICE
B -- Statistical Analysis
- Notice Date
- 10/10/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- RTP Procurement Operations Division (D143-01) Research Triangle Park, NC 27711
- ZIP Code
- 27711
- Solicitation Number
- PR-NC-08-10002
- Response Due
- 10/26/2007
- Archive Date
- 11/25/2007
- Point of Contact
- JENNIFER B. HILL, Contract Specialist, Phone: 919-541-3083, E-Mail: hill.jennifer@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-08-10002, and the solicitation is being issued as a 100% small business set-aside competition Request for Quotation (RFQ)using FAR Part 13 Simplified Acquisition Procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-20. The associated North American Industry Classification System (NAICS) Code 541712, which has a size standard of 500 employees to qualify as a small business, is applicable. A firm fixed-price contract is anticipated to result from the award of this solicitation. This procurement is to support chemical mixture research in the Neurotoxicology Division, NHEERL/ORD, US EPA. Work shall involve testing the additivity of complex mixtures of pyrethroid insecticides. The contractor shall analyze sets of data to determine whether there is evidence of dose addition. The end product shall be a statistical evaluation of the following null hypothesis: Responses of the combined treatment with specific pesticides can be predicted based on dose-addition. This shall involve a statistical model that compares the theoretical results and the empirical results. The fixed-ratio ray experimental design used in the analysis of these mixtures shall be based on published scientific literature (Casey et al., 2004; Gennings et al., 2004; Wolansky et al., 2005). Endpoints will include behavioral data, as specified below. Analysis services shall be submitted as delivery orders. A ?study? is defined for a single endpoint as a set of single chemical dose-response curves and a corresponding mixture dose-response. A maximum of 8 studies shall be submitted within 6 months of award of this contract, and an additional 6 months for data analysis will be allowed. QUALITY ASSURANCE REQUIREMENTS. 1. The contractor is required to submit a pre-award Quality Management Plan consistent with the specifications contained in document EPA/QAR-2 EPA Requirements for Quality Management Plans. No award may be made until and unless the conditions of that plan are approved by the Quality Assurance Manager and the Project Officer. EPA/QAR-2 can be downloaded from EPA?s Quality Staff Home Page (http://www.epa.gov/quality) under ?Documents?. 2. The contractor is required to submit a Quality Assurance Project Plan consistent with the conditions of document EPA/QAR-5 EPA Requirements for Quality Assurance Project Plans. The QAPP must be submitted and approved by the QAM and the Project Officer prior to work beginning on the project. EPA/QAR-5 can be downloaded from EPA?s Quality Staff Home Page (http://www.epa.gov/quality under ?Documents?. REQUIRED SERVICES. The contractor shall provide analytical services to the EPA in accordance with the Specific Description of Services, Attachment A. Services shall be performed in accordance with this contract and the instructions as stated in the Description of Services. TIME OF COMPLETION. The period of performance will be 12 months from date of award. All data shall be submitted within 6 months of award of the contract. Six months from the time of receipt of the complete dataset for each project (see Specific Description of Services) will be allowed for analyses. KEY PERSONNEL. The contractor shall designate a Study Manager upon award of this contract, and provide contact information (telephone, email, postal address) to the Contracting Officer. The Study Manager shall coordinate communications between EPA and the contractor, supply necessary forms, and oversee execution of the performance for the Contractor. The EPA administrative Project Officer, Edie Coates, will be responsible for coordinating interactions with the Contractor. Other EPA key personnel will be Drs. Kevin Crofton and Tim Shafer in the Neurotoxicology Division. PUBLICATION AND OWNERSHIP OF DATA. EPA reserves the right to publish in the open, peer-reviewed scientific literature, any and all of the data collected, including output from all data analyses, in the performance of this contract. Tests and methods developed and validated by Contractor shall supply sufficient experimental detail regarding analysis methods to enable its publication in this literature. DELIVERABLES. The contractor shall provide a report with the information listed below. The report shall be of quality to be publishable in the peer-reviewed literature. Three separate reports shall be provided. Each report will include descriptions of: 1) the statistical models used to analyze the data; 2) the procedures used to ensure quality of the statistical work; 3) the results shall including: a. list of all parameters for the single-chemical models, b. list of parameters for the additivity and mixture models, including tests of significance for deviations from dose-additivity, c. calculation of ED30s, plus 95% confidence limits, for the additivity and mixture models; 4) graphical representations of the results; 5) a descriptive text, including any relevant statistical equations, that explains the design for experimentally testing additivity of a complex mixture of pyrethroids, and corresponding bibliography when applicable; 6) Conclusions based on the statistical analyses; 7) The contractor shall provide electronic files that document, validate and explain all the procedures applied to reach a final decision on testing the default hypothesis of dose-addition and construct the formal report. The electronic format for storing these electronic files (i.e., CD or DVD) will contain copies of the original files for all graphical (single-compound and mixture dose-response curves or plots) or schematic (e.g., mathematical expressions) representations prepared using user-friendly formats (preferable Excel or SigmaPlot for graphical plots, and Word, Word Perfect or PowerPoint for text, mathematical expressions, tables, diagrams, or any schematics). ATTACHMENT A - SPECIFIC DESCRIPTION OF SERVICES. The contractor shall provide analytical services for each study, described below for each of three projects. Each service, or study, shall constitute a separate deliverable. Studies. There shall be three projects based on the endpoint examined: motor activity, cellular activity, and ion flux. A deliverable shall include the analyses of each project, i.e., three final products. 1. Motor Activity: A total of 5 pyrethroids will be included in this mixture. Dose-response data will then be collected for two mixtures, using each of these endpoints. The mixing ratio will be defined by: A) relative potencies of the individual chemicals, and B) relative human exposure to the individual chemicals based on EPA projections of food, water, and air exposures. For the motor activity endpoint, the dose-response data has already been analyzed and relative potencies were previously determined (see Wolansky et al., 2006). These values may be re-calculated under this contract if required. 2. Cellular Activity: Up to 11 pyrethroids will be included in this mixture. Each pyrethroid will be tested individually to define the concentration-response characteristics on cellular activity. Concentration-response data will then be collected for one mixture. The mixing ratio will be defined by relative human exposure to the individual chemicals based on EPA projections of food, water, and air exposures. 3. Ion Flux: Up to 11 pyrethroids will be included in this mixture. Each pyrethroid will be tested individually to define the concentration-response characteristics on ion flux. Concentration-response data will then be collected for one mixture. The mixing ratio will be defined by relative human exposure to the individual chemicals based on EPA projections of food, water, and air exposures. Total, 3 studies to be analyzed. Statistical Basis of Analysis. The data shall be analyzed by the dose-additivity models previously described, the so-called ?single chemicals required method? (Casey et al., 2004; Gennings et al., 1997, 2002, 2003a,b, 2004; Meadows et al., 2003). Specifically, single-chemical data shall be used, under an assumption of dose-additivity, to predict the response of a fixed-ratio mixture. A nonlinear threshold model will be fit to the mixture data in terms of total dose along the specified fixed-ratio of the chemicals. An overall test of additivity shall be performed by comparing the two models. The contractor may elect, based on the professional judgments of the contractor, to examine the data by other advanced statistical techniques. 1. Definition of Additivity: a. The single chemical dose-response data will be used to estimate an additivity model. b. The additivity model used shall be based on the definition of additivity (i.e., zero interaction) given by Berenbaum (e.g., 1985) and is based on the classical isobolograms for the combination of two chemicals (e.g., Loewe and Muischnek, 1926; Loewe, 1953). 2. Preliminary study of the relationship between the mean and variance. a. Throughout the analysis of these data, a quasi-likelihood estimation method shall be used which is based on assumptions of the model for the mean as a function of dose and the relationship between the variance and the mean. b. Graphs of the sample variances versus sample means shall be used to illustrate the form of this relationship. 3. Estimation of the Additivity Model. a. The method of maximum quasi-likelihood shall be used to estimate model parameters. b. The adequacy of the fit of the additivity model to the single chemical data will be assessed through a goodness-of-fit test and will be assessed graphically, i.e., the observed and model predicted responses for each single chemical shall be provided. c. The estimated additivity model will be used to predict the mean response along the fixed mixing ratio of the chemicals in terms of total dose. A plot of the predicted response under additivity along the mixture ray in terms of total dose also shall be provided. d. An overall test for departure of the experimental data from the predicted additivity model shall be provided. e. Individual data point predictions will include both the predicted value and the 95% prediction interval for the estimate. f. In addition, a table of parameter estimates, standard errors, and p values will be included in the analysis report. 4. Estimation of the Mixture Model. a. A nonlinear threshold model will be fit to the mixture data. b. A plot of the observed and model predicted responses in terms of total dose shall be provided. Included in this graph will be the predicted curve under the assumption of additivity. c. Adequacy of the model fit shall be conducted graphically. d. A table of estimated model parameters, standard errors, and p values will be included in the analysis report. e. Using additivity models as described in Gennings et al (2002), prediction intervals will be produced under additivity at each mixture group and shall be included in the analysis report. 5. Test of additivity. a. Comparison of the mixture model to the additivity model along the fixed-ratio ray will be statistically conducted based on suitable statistical methods. A 5% significance level will be used. b. The results of the test shall be provided in the analysis report. c. If departure from additivity is detected, the suitability of the data for estimation of an interaction threshold shall be determined. d. If appropriate, the interaction threshold shall be estimated and reported. 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: The Government intends to award a single contract to the responsible offeror whose technically acceptable quotation represents the best overall value to the Government based on the evaluation of the technical criteria, past performance, and price. Only those offerors submitting technically acceptable quotations shall be considered for award. 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. The following is a description of each evaluation criterion, including information which must be included with the response: I. Technical Capabilities. 1) Provide a copy of the Quality Management Plan in accordance with the Statement of Work. 2) The contractor shall have demonstrated experience in using single-chemical dose-response data to predict the expected dose-additive response of mixtures of those chemicals at specified total dose levels and specified relative proportions of the chemicals in the mixture. The definition of dose additivity shall be the same as that used by Berenbaum (Pharmacological Reviews, Vol. 1989, 41:93-141). Experience shall be demonstrated by publication in peer-reviewed scientific journals. Publication in statistical or toxicological journals is preferred, but not an absolute requirement. 3) To assure competency of the contractor, and that the methods used are analogous to earlier research in this area, the contractor will be required to analyzed specific datasets and demonstrate the same results as before. Raw data is available via published literature (Crofton et al., 2004; Wolansky et al., 2005), and the analyses and outcomes must be submitted with the proposal showing that the offeror arrived at the same conclusions. 4) Ability to meet time line for the project. II. Past Performance: Submit a list of 3 customers for whom like analyses have been performed. Include specific points of contact and phone numbers. Past Performance will be evaluated on 1) quality of service; 2) timeliness of performance (ability of adhere to deadlines); and 3) overall customer satisfaction. III. Price. The government will make award to the responsible offeror(s) whose offer conforms to the solicitation and is the best value to the government. All offerors are to include with their offers 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; 52.227-17, Rights in Data--Special Works; 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: 52.219-6, Notice of Total Small Business Set-Aside; 52.219-28, Post Award Small Business Program Representation; 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; 52.222-50, Combating Trafficking in Persons; 52.225-13 Restrictions on Certain Foreign Purchases; 52-232-33, Payment by Electronic Funds Transfer-Central Contractor Registration. 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 Quotation on EPA's website at the following address: http://www.epa.gov/oam/rtp_cmd. Click on the CURRENT SOLICITATIONS section and click on the solicitation for viewing applicable documents. Near the top of the page COMMERCIAL BUY CLAUSES AND FORMS sections are provided for your convenience. Please submit two copies each of the technical proposal and 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 the US Postal Service. Courier delivery address is U.S. Environmental Protection Agency, Attn: Jennifer B. Hill, RTP Procurement Operations Division (D143-01), 4930 Old Page Road, Durham, NC 27703. All offers are due by October 26, 2007, 12:00 p.m., ET. No telephonic or faxed requests will be honored.
- Web Link
-
The Environmental Protection Agency
(http://www.epa.gov/oam/solam.htm)
- Record
- SN01431873-W 20071012/071010230110 (fbodaily.com)
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