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A--Statistical Analyses and Expert Consultation, RFQ-RT-12-00085

Solicitation Number: RFQ-RT-12-00085
Agency: Environmental Protection Agency
Office: Office of Acquisition Management (OAM)
Location: RTP Procurement Operations Division (RTPPOD)
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Combined Synopsis/Solicitation
Added: Jun 12, 2012 10:06 am
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. QUOTATIONS ARE BEING REQUESTED AND A WRITTEN SOLICITATION WILL NOT BE ISSUED. This solicitation number is RFQ-RT-12-000085 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 05-41. The associated North American Industry Classification System (NAICS) Code 541690 ? Other Scientific and Technical Consulting Services, which has a size standard of $14.0 million to qualify as a small business, is applicable. This procurement is for analyses and expert consultation. The Government intends to award a firm fixed-price contract for a 12 month period of performance. DESCRIPTION OF PROJECT: The contractor shall provide statistical analyses and expert consultation and evaluation of current methodologies that will enhance the usefulness of statistical analysis of single chemical and mixtures data. These analyses and evaluations shall be conducted for the United States Environmental Protection Agency (U.S. EPA), National Health and Environmental Effects Research Laboratory (NHEERL), Research Triangle Park, NC 27711. A major concern with regard to exposure to multiple chemicals from both a risk assessment and an environmental protection perspective is accurate assessment of the risk posed by exposure to chemical mixtures. The chemicals in a mixture may be additive (either dose-additive or response-additive) or the chemicals may interact in such a way to cause toxicity either greater or less than expected based on dose-additive or response-additive models. The majority of assessments of the additivity of mixtures are of defined mixtures with the expected effect of the mixture determined from single chemical data and an expectation of additivity. The purpose of this requirement is to obtain the analysis of single chemical and mixtures data and for evaluation of factors that may influence the ability to detect departure from additivity. Over the past 5-10 years, multiple methods for analysis of mixtures data have been published. The majority have been either for a) prediction, under an as sumption of dose-additivity, of the expected effect of a defined mixture from single-chemical dose-response curves or for b) estimation, under an assumption of dose addition and use of either relative potency factors (RPFs) or toxicity equivalent factors (TEFs) whether the estimated effect of the mixture exceeds an acceptable level of health risk. However, there has been essentially no consideration of factors that may determine the ability to detect deviations from additivity or how varied expression of dose might affect RPF or TEFs. SPECIFIC ELEMENTS OF THE STATEMENT OF WORK: The contractor shall analyze single chemical and mixture data sets for consistency with dose additivity and identify factors that influence the ability to detect deviations from additivity and examine their impact. The contractor shall focus on methods and techniques for prediction, under an assumption of either dose-additivity or response-additivity or another defined expectation of additivity, of the expected effect of a defined mixture from single-chemical dose-response curves or estimation of whether the expected effect of the mixture exceeds an acceptable level of health risk. The smallest number of chemicals in the mixture is two and the expected largest number of chemicals is seven to ten chemicals. Factors for possible consideration include whether the experimental design has sufficient statistical power to detect departure from additivity in the low dose/low response region, how the severity or degree of departure from ad ditivity affects the ability to detect deviations from the default additivity assumption, how expressions of dosage affect the conclusion of additivity or nonadditivity, how the degree of variability in the single chemical dose response curves affects the ability to detect departure from additivity, and how the fit of the curves to both the single chemical and the mixture data affect the ability to detect departure from additivity. Consideration of impact of dose expression may include consideration of RPF and TEF risk assessment methodologies. Possible factors for consideration include: the number of chemicals in the mixture; how the dose is expressed; the mixing ratio of the constituent chemicals in the mixture; the placement of the single chemical dose levels on the single chemical dose-response curves relative to the placement of the mixture dose levels; the variability contained in each single-chemical dose-response curve; inclusion of mixture data in the addit ivity model; the variability in the single-chemical dose-response curves; the fit of the single chemical-dose response curves; and, the number of dose groups and the (n) per dose group for both the single chemicals and the chemical mixtures. Upon completion of the analysis, the contractor shall prepare a draft a final report with the results of the analysis of up to three data sets identifying, examining and discussing key factors that affect the predictive nature of such models. The draft report shall consider factors that affect the risk assessment application of the methods as well as factors that affect the ability to detect departure from additivity in experimental data sets. Upon EPA review and comments of the draft report the contractor shall submit the final report prior to the expiration date of the purchase order. All data sets will be supplied by the U.S. upon award of purchase order. Attachment 1 provides examples of the data to be supplied to the contractor. US EPA RESPONSIBILITIES: 1. The U.S. EPA will inform the contractor of any data sets to be transmitted at least 5 business days in advance of transmittal. Data sets will be supplied to the contractor by the U.S. EPA as either Excel or SAS files. The data files, along with a description of the code names used, will be sent to the contractor by e-mail. 2. The U.S. EPA will review and approve the draft report and draft quality assurance project plan within 10 days of receipt or request revisions. If modifications to the draft reports are required, the U.S. EPA will provide comments and recommendations via teleconference between EPA and the contractor, followed up by a written summary; 3.The U.S EPA will provide the contractor with listings of known, published methods for analysis of mixtures data upon award of purchase order. The U.S. EPA will provide the contractor with either hard copies or PDF files of published methodologies and key references upon purchase order award. DATA USE BY THE CONTRACTOR: Any data sets that are conveyed to the contractor are to be used by the contractor solely and exclusively for the purposes of this contract effort. Any other uses of the data are expressly forbidden. The contractor is not to publish, present or make known any of the data or of the results of the analyses done under this contract except by prior written approval of the EPA. Any such request shall be granted or denied based solely on the interests of EPA. DELIVERABLES: The Contractor shall submit the following deliverables: Within 10 business days of award of the contract a draft quality assurance project plan specific to performance of the elements of the Statement of Work to the EPA. Three (3) interim progress reports submitted at the end of each quarter. The draft final report summarizing the body of work as a total useable unit shall be delivered to the U.S. EPA in draft form a minimum of 4 weeks prior to the end of the contract period. Final rep ort incorporating all EPA comments of the draft report. This report shall be submitted prior to expiration date of purchase order. The contractor shall prepare the progress reports and the final report in a commonly available word processing program, Microsoft Word. The reports shall be supplied to EPA in electronic format. Other word processing programs shall be used only after consultation with and approval by EPA. The progress reports shall report on the work done in that quarter designed to work toward achievement of the final report. The final report shall include an executive summary. The final report shall also include a detailed description of any methods used; the results of any analyses conducted, including confidence intervals, statistical significance, multiple comparisons (as appropriate); for any data analyses conducted, summary statistics of the data generated from the final program used to analyze the data shall be provided with the summary statistics con sisting of sample means, sample standard deviations and sample size for each dose group and the programs used for analysis. Portions of the interim and final reports are expected to be provided in the form of draft or accepted/published peer-reviewed journal articles. Within 10 business days of receipt of a draft report, the U.S. EPA will either accept the report as written or provide written comments requesting revisions. The final report shall be provided in both electronic form and a paper copy mailed to the Contracting Officer Representative. The program(s) used to analyze the data shall be provided in an appendix to both the draft and the final report. PERIOD OF PERFORMANCE: The period of performance shall be 12 months from the date of contract award. The following FAR provisions apply to this solicitation: 52.212 1, Instructions to Offerors Commercial Items, FAR 52.212-2, Evaluation ? Commercial items. Evaluation criteria to be included in paragraph (a) of provi sion 52.212-2 are as follows: 1.TECHNICAL CRITERIA: Demonstrated technical approach to performing the requirements of the Statement of Work. Specifically, the offerors should provide details regarding their technical approach with the types of analyses outlined in the Statement of work.. 2. QUALIFICATIONS OF PERSONNEL: The offeror shall provide specific, relevant experience and availability for the personnel in accordance with the SOW. Offerors will be evaluated on the adequacy of the types of personnel who will form the team, their experience and their educational background as it relates to the SOW. 3. PAST PERFORMANCE: Submit a list of 3 customers for whom like or similar analyses have been performed within the past 2 years. Include specific points of contact, phone numbers and e-mail addresses. Past performance will be evaluated on 1) quality of product or service; 2) timeliness of performance (ability to adhere to deadlines); and overall customer satisfaction. 4. Pric e: The Government intends to award a single contract to the responsible offeror whose technically acceptable proposal offers the 'Best Value' to the Government price and other factors considered. For this requirement, 'best value' will be determined based on technical approach, qualifications of personnel, past performance and price. For this requirement, technical approach, qualifications of personnel, past performance are significantly more important than price. All offerors are to complete the On-line Representations and Certifications at 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. All offerors are to include with their offers a completed copy of provision 52.212-3, Offeror Representations and Certifications ?Commercial It ems. 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: 52.219-6 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 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; 52.222-50 Combating Trafficking in Persons; 52.225-13 Restrictions on Certain Foreign Purchases; 52.232 33, Payment by Electronic Fund Transfer-Central Contractor Registration; 52.222-41 Service Contract Act of 1965, As Amended; 52.222-42 Statement of Equivalent Rates for Federal hires. Any applicable wage determina tion(s) will be made a part of the resultant contract. All technical questions are to be forwarded to the Contracting Specialist at the following email address: Technical questions are due by June 20, 2012. Offerors should review the Statement of Work and other information posted with this Request for Quotation on EPA's website at the following address: Arrow down to the CURRENT SOLICITATIONS section and click on the solicitation. ALL FURTHER INFORMATION RELATED TO THIS SOLICITATION WILL BE LOCATED AT THE EPA WEBSITE. Please submit two copies each of the technical and price proposal (including pricing sheet) to U.S. Environmental Protection Agency, RTP Procurement Operations Division, Attn: Jeffery Clodfelter (E105-02), 4930 Old Page Road, Durham, NC 27703. All offers are due by July 2, 2012, 12:00 p.m. (noon), ET. No telephonic or faxed requests will be honored. E-mail proposals are acceptable and should be e-m ailed to:
RTPPODUS Environmental Protection Agency109 T.W. Alexander DriveMail Code: E105-02Research Triangle ParkNC27709USA
Jeffery Clodfelter