SOLICITATION NOTICE
B -- Physiologically Based Pharmacokinetic (PBPK) Modeling of Environmental Contaminants
- Notice Date
- 4/20/2018
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02RC82557-73
- Point of Contact
- Ronette P. Collins, Phone: 2402765745, Kimesha Leake, Phone: 2402765669
- E-Mail Address
-
ronette.collins@nih.gov, kimesha.leake@nih.gov
(ronette.collins@nih.gov, kimesha.leake@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E132, Bethesda, MD 20892, UNITED STATES Description The National Cancer Institute (NCI), Center for Cancer Research (CCR), National Toxicology Program (NTP) plans to procure on a sole source basis the creation of Physiologically based pharmacokinetic (PBPK) models from data derived from studies of the fate and biological effects of environmental chemicals in humans and rodents from Biosimulation Consulting, 2915 Ogletown Road #1182, Newark, DE 19713 USA The purpose of this acquisition is to complete unfinished PBPK models and to establish PBPK models for additional chemicals of interest using the same methods and techniques. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 and the business size standard is 500 employees. Only one (1) award will be made as a result of this solicitation. It has been determined there are no opportunities to acquire green products or services for this procurement. The Center for Cancer Research (CCR) at the National Cancer Institute (NCI) investigates the pharmacokinetics and pharmacodynamics of potential environmental toxicants. These studies are conducted in rodents with the ultimate goal of providing data for extrapolation to assess risk of exposure to humans. Mathematical modeling of these data using PBPK methods can be used for extrapolation of results between doses, routes of exposure, and species. Further, applying this approach to data analysis may result in a reduction in animal numbers through predictive study design. The project will support epidemiologists and the National Institute of Environmental Health Sciences (NIEHS) for modeling chemical contaminant data derived from blood samples collected during the Anniston Community Health Survey. The goal of the project is to build a PBPK model to predict the fate of the contaminants in the populations identified in the Anniston Community Health Survey (Anniston Project) in humaand rodents. The goal is to publish a report (manuscript) describing the major pharmacokinetic of persistent organic pollutants identify during biomonitoring. This description would help to understand the relation between internal dose of the majors persistent organic pollutants (POPs) and the health effects observed, and to support the human risk assessment for health in the Anniston project The Contractor shall have the requisite knowledge, skills, and abilities to create PBPK models from data collected from human derived samples (data will be shared from CDC/ATSDR), provided from the laboratories of co-investigators, or derived from the literature. These models will be used to support toxicological evaluations and risk assessments of these chemicals. The Contractor will model chemical data from animal- or human-derived samples (data will be shared from CDC/ATSDR) using PBPK models already developed or a modified PBPK model for this specific modeling tasks. The contractor will work with Dr. Birnbaum and the epidemiologists of Anniston project to limit the objectives of this modeling. The Contractor shall perform the following tasks: Project Management Plan The Contractor shall develop an overall project plan for the Scope of the project. The Project Management Plan shall describe the development and implementation of the requirements under this contract and detail the timing and mode of key operations. Task 1: Generation of multiple PBPK models for individual chemicals, based on different exposure scenarios (e.g. male and/or female rats and/or mice). The Contractor shall initially develop a PBPK model for hexabromocyclododecane (HBCDD/HBCD) for the naïve rodent. PBPK models may be requested to support observations of a specific mechanism of action, target tissue, route of exposure or excretion, or metabolic pathway. When requested, the Contractor shall extend a model to include embryonic and fetal compartments as well as assess different exposure timelines. Further, the Contractor may be requested to convert rodent PBPK models to human PBPK models. Task 2: To develop PBPK models from data derived from studies of the fate and biological effects of environmental chemicals in humans (Anniston Community Health Survey). This task will support epidemiologists and the NIEHS for modeling chemical contaminant data derived from blood samples collected during the Anniston Community Health Survey. The present goal of the project is to build a PBPK model to predict the fate of the contaminants in the populations identified in the Anniston Community Health Survey (Anniston Project). The Contractor will model chemical data from human derived samples (data will be shared from CDC/ATSDR) using PBPK models already developed or a modified PBPK model for this specific modeling tasks. This is a firm fixed price purchase order. The period of performance shall be for 12 months from time of award All work shall be performed at the Contractor's facility. The Contractor shall submit all required report(s)/deliverables in accordance with the following schedule: DELIVERABLES and DESCRIPTION DUE DATE 1. The Contractor shall provide monthly progress reports of the work by email to the COR. A final report, which may consist of a manuscript suitable for submission to a peer-reviewed journal, shall be due at completion of the Hexabromocyclododecane model. The Contractor may be requested to combine some models into a single final report for publication purposes. Monthly reporting from initiation of contract, final report due 12 months from the date of award. 2. The Contractor shall provide monthly progress reports of the work by email to the COR. A final report, which may consist of a manuscript suitable for submission to a peer-reviewed journal, shall be due at completion of the Anniston model. The Contractor may be requested to combine some models into a single final report for publication purposes. 12 months from the date of completion of task 1. 3. A complete listing of following additional information: procedures used; description of the experimental design; methods used for statistical analyses of data; anything unusual about the data or models, any deviation from these procedures, and any other relevant information. 12 months from the date of award. BioSimulation Consulting, Inc has the capability and capacity to complete unfinished PBPK models initiated under the previous contract at the greatest efficiency in terms of time and cost to the U.S. Government. Other contractors would be expected to recreate previous achievements. Based on past performance, BioSimulation Consulting, Inc continuity is needed to complete unfinished PBPK models. BioSimulation Consulting work is of high standard and their expertise, methods, and techniques are required to ensure an acceptable level of comparison between previous and future models developed by BioSimulation Consulting, Inc for the CCR. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 4:00 PM EST, on May 4, 2018. All responses and questions must be in writing and emailed to Ronette Collins, Contract Specialist via electronic mail at ronette.collins@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: N02RC82557-73 on all correspondence.
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- SN04896352-W 20180422/180420230634-792c981dae9145d8bb828b067f7fdd6f (fbodaily.com)
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