SOLICITATION NOTICE
R -- Statistical Analytical Services
- Notice Date
- 8/23/2005
- Notice Type
- Solicitation Notice
- Contracting Office
- RTP Procurement Operations Division (D143-01) Research Triangle Park, NC 27711
- ZIP Code
- 27711
- Solicitation Number
- PR-NC-05-10472
- Response Due
- 9/6/2005
- Archive Date
- 10/6/2005
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FEDERAL ACQUISITION REGULATION (FAR) SUBPART 12.6 "SOLICITATION FOR COMMERCIAL ITEMS", AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION. QUOTES ARE BEING REQUESTED AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. This solicitation is for Statistical Analysis and is a SMALL BUSINESS SET-ASIDE. The North American Industry Classification System (NAICS) Code is 541990-All Other Professional, Scientific and Technical Services. The small business size standard is $6,000,000. The solicitation number is PR-NC-05-10472, 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 05-05. A firm, fixed-price contract is anticipated to result from the award of this solicitation. STATEMENT OF WORK. DESCRIPTION OF PROJECT. This procurement is to support chemical mixture research in the Neurotoxicology Division, NHEERL/ORD, US EPA. Work will involve analyses of datasets of : 1) a mixture of 7 carbamate pesticides, and 2) a mixture of 11 pyrethroid pesticides. 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 will be based on methodology developed in EPA assistance agreements which are now available in the scientific literature (Casey et al., 2004; Gennings et al., 2004). Endpoints shall include biochemical measures and behavioral data, as specified below. 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. QUALITY ASSURANCE REQUIREMENTS. 1. The contractor shall submit a pre-award Quality Management Plan consistent with the specifications contained in document EPA/QAR-2 EPA Requirements for Quality Management Plans. The Quality Assurance Manager must be approved prior to award. EPA/QAR-2 can be downloaded from EPA?s Quality Staff Home Page (http://www.epa.gov/quality) under ?Documents?. 2. The contractor shall also submit a Quality Assurance Project Plan consistent with the conditions of document EPA/QAR-5 EPA - Requirements for Quality Assurance Project Plans (QAPP). The QAPP shall be submitted and approved by the EPA 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 all necessary personnel, facilities and equipment for analytical services in accordance with the Statement of Work and Description of Services. PERIOD OF PERFORMANCE. Total contract period of performance is 12 months. KEY PERSONNEL. The contractor shall designate a Project Manager who shall be responsible for overseeing the overall project. 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 course of this agreement. Tests and methods developed and validated by Contractor shall supply sufficient experimental detail regarding analysis methods to enable its publication in this literature. No other analyses of these data will be released in any publication or presentation in any forum without prior review and written approval of the EPA Project Officer, either during the contract period or anytime thereafter. DELIVERY PRODUCTS. The contractor shall submit two separate reports with the information listed below. The report shall be of quality to be published in the peer-reviewed literature. Each report shall 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 including a) list of 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) tests of significance between the two ratios (i.e., do the mixing ratios alter the results), d) calculation of ED10s and ED30s (values predicted to produce 10% and 30% decreases, respectively), plus 95% confidence limits, for the single chemical curves, and the additivity and mixture models; 4) conclusions based on the statistical analyses; 5) graphical representations of the results. The carbamate report shall include analyses of the brain and blood cholinesterase activity and total activity counts in two mixing ratios. The pyrethroid report shall include analyses of the total activity counts in two dosing procedures. SPECIFIC DESCRIPTION OF SERVICES The contractor shall provide analytical services for each study, described below for each of two major projects. Each service, or study, will constitute a separate task. STUDIES. There will be two major projects based on the type of pesticides examined: carbamates and pyrethroids. A task shalll include the analyses of each project, i.e., two final products. 1. Carbamates. A total of 7 carbamates will be included in this mixture. Each carbamate shall be tested individually to define the dose-response characteristics on: A) brain cholinesterase (ChE) inhibition; B) red blood cell (RBC) ChE inhibition; and C) motor activity. Dose-response data shall then be collected for two mixtures, using each of these endpoints. The mixing ratio of the two mixtures 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. Thus, 3 endpoints x 2 mixing ratios = 6 studies 2. Pyrethroids. A total of 11 pyrethroids will be included in this mixture. Each pyrethroid shall be tested individually to define the dose-response characteristics on motor activity. Dose-response data shall then be collected for two mixtures. The mixing ratio of the two mixtures will be the same, however, the time of testing will differ as follows: A) all pesticides given concurrently, and B) pesticides given in a staggered manner before testing. The mixing ratio will be defined by relative human exposure to the individual chemicals based on EPA projections of food, water, and air exposures. Dose shall be calculated either as delivered dose or administered dose, but not both. Thus, 1 endpoint x 2 mixture dose-responses = 2 studies. Total, 8 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 will be used, under an assumption of dose-additivity, to predict the response of a fixed-ratio mixture. A nonlinear threshold model shall 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 to examine the data by other advanced statistical techniques. 1. Definition of Additivity. The single chemical dose-response data shall be used to estimate an additivity model. The additivity model used will 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. Throughout the analysis of these data, a quasi-likelihood estimation method will 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. Graphs of the sample variances versus sample means will be used to illustrate the form of this relationship. 3. Estimation of the Additivity Model. The method of maximum quasi-likelihood shall be used to estimate model parameters. 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 will be provided. 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 will be provided. An overall test for departure of the experimental data from the predicted additivity model will be provided. Individual data point predictions will include both the predicted value and the 95% prediction interval for the estimate. 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 nonlinear threshold model shall be fit to the mixture data. A plot of the observed and model predicted responses in terms of total dose will be provided. Included in this graph will be the predicted curve under the assumption of additivity. Adequacy of the model fit will be conducted graphically. A table of estimated model parameters, standard errors, and p values will be included in the analysis report. 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. Comparison of the mixture model to the additivity model along the fixed-ratio ray shall be statistically conducted based on suitable statistical methods. A 5% significance level shall be used. The results of the test shall be provided in the analysis report. If departure from additivity is detected, the suitability of the data for estimation of an interaction threshold will be determined. If appropriate, the interaction threshold shall be estimated and reported. References. Berenbaum, M.C. The expected effect of a combination of agents: The general solution Journal Theoretical Biology, 114: 413-431, 1985. Casey M, Gennings C, Carter, Jr. WH, Moser VC, and Simmons JE. Detecting interaction(s) and assessing the impact of component subsets in a chemical mixture using fixed-ratio mixture ray designs. J. Agr. Biol. Environ. Statistics 9:339-361, 2004. Gennings, C., Carter, W.H., Jr., Campain, J.A., Bae, D., Yang, R.S.H. (2002) Statistical Analysis of Interactive Cytotoxicity in Human Epidermal Keratinocytes Following Exposure to a Mixture of four Metals, Journal of Agricultural, Biological, and Environmental Statistics, 7(1), 58-73. Gennings, C., Carter, W.H., Jr., Casey, M., Moser, V.C., Carchman, R., Simmons, J.E. (2004). Analysis of functional effects of a mixture of five pesticides using a ray design, Environ. Toxicol. Pharmacol. 18:115-125. Gennings, C., Carter, W.H., Jr., Carchman, R., Charles, G., Gollapudi, B., Carney, E. (2003b). Analysis of fixed ratios of chemical mixtures developed from a comparison to an indirect additivity surface determined by single chemical dose-response models, Environmetrics, under internal review. Gennings, C., Schwartz, P., Carter, W.H., Jr., Simmons, J.E.(1997). Detection of departures from additivity in mixtures of many chemicals with a threshold model, Journal of Agricultural, Biological, and Environmental Statistics, 2:198-211. ----- (2000). ERRATUM: Detection of Departures from Additivity in Mixtures of Many Chemicals with a Threshold Model, Journal of Agricultural, Biological, and Environmental Statistics, 5, 257-259. Loewe, S. and Muischnek, H. (1926) Uber kombinationswirkunger. I. Mitteilung: Hiltsmittel der fragstellung. Naunyn-Schmiedebergs. Arch. Pharmacol 114, 313-326. Loewe, S. (1953) The problem of synergism and antagonism of combined drugs. Arzneimittle forshung 3, 285-290. Meadows, S.L., Gennings, C., Carter, W.H., Jr., Bae, D.-S. (2002) Experimental Designs for Mixtures of Chemicals along Fixed Ratio Rays. Environmental Health Perspectives 110(6):979-983. 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, 52.227-14, Rights in Data - General, 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 the Statement of Work, Evaluation Criteria and 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 CURRENT SOLICITATIONS section and click on the solicitation. Please submit one copy 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 September 6, 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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