SOLICITATION NOTICE
R -- Workshop
- Notice Date
- 2/15/2008
- Notice Type
- Solicitation Notice
- Contracting Office
- Environmental Protection Agency, Program Contract Service Center, 1200 Pennsylvania Avenue, Nw, Washington, DC 20460
- ZIP Code
- 20460
- Solicitation Number
- RFQ-DC-08-00093
- Response Due
- 3/1/2008
- Archive Date
- 4/1/2008
- Point of Contact
- Point of Contact, Thomas Martinez, Purchasing Agent, Phone (202) 564-1418
- E-Mail Address
-
Email your questions to U.S. Environmental Protection Agency
(martinez.thomas@epa.gov)
- Description
- NAICS Code: 541990 NAICS code 541990: The U.S. Environmental Protection Agency (EPA) plans to negotiate on a sole source basis with Dr. Tracey Woodruff of the University of California, San Francisco. Negotiations shall be conducted pursuant to the authority of 41 U.S.C. 253 (c)(1), which allows for negotiations without full and open competition if there is only one responsible source. Project Identification: Workshop(S) on Applications of Mechanistic Information in Human Health Risk Assessment BACKGROUND Among the major challenges in risk assessment is to incorporate scientific advances and mechanistic information regarding the relationship between exposures to environmental contaminants and adverse health outcomes. Mechanistic information can inform issues such as the relative human sensitivity to effects observed in laboratory animals, and the variability of response within the human population. Several collaborative groups have developed frameworks for analyzing and utilizing information about a chemical?s mode of action (MOA) in human health risk assessment of environmental carcinogens and toxicants, including the International Programme on Chemical Safety, International Life Sciences Institute and US Environmental Protection Agency. A recent critical review of these MOA frameworks identified several gaps and opportunities for progress (Guyton et al., J. Tox Environ Health, Part B, 11: 1-16, 2008). These include addressing known causes of human disease and the potential for chemical effects to act additively with these as well as endogenous background processes. Another area for improvement is to consider multiple MOAs over the same dose range, or of varying MOAs resulting from exposure at different life stages. Instead of considering each MOA and outcome individually, the contribution of multiple metabolites, modes, and toxicity pathways to the overall toxicological profile could be addressed. This would facilitate the application of toxicogenomic data covering multiple genes, molecular targets, and toxicity pathways in the risk assessment process. In keeping with this view, a recent NAS panel highlighted areas such as identifying toxicity pathways and exploring simultaneous alteration of multiple pathways as among the key considerations for future toxicity testing strategies. Finally, the attendant quantitative implications?particularly how to address toxicodynamic differences across species?also deserve further consideration. The overall goal of this project is to address these issues in the context of recent scientific advances regarding human disease mechanisms. The project aims to promote interdisciplinary dialogue among scientists from academic, government (federal/state) and public/private organizations regarding the application of emerging science in decision making. Specifically, the project shall entail developing synthesis and reviews of scientific literature, convening a workshop to evaluate case studies of how new information can be concretely incorporated into hazard and dose-response assessments, and developing recommendations on new approaches to be incorporated in hazard and risk assessment frameworks. A central theme of this project is the application of evolving mechanistic information in human health risk assessment decisions. Recent evidence to be examined in this context includes the multiple toxicity pathways controlling response to exposures, the windows of susceptibility, and the complex interactions that can result from multiple exposures common within the population. Specific topics to be covered include: background diseases, exposures, and processes; multiple mechanisms of toxicity for environmental agents-- and how they might interact with each other and background processes and can be used to identify susceptible subpopulation; consideration of mechanisms contributing to human disease (e.g., leukemia), and the likelihood that the necessary causative factors associated with environmental agents already exist within human population subgroups; associated quantitative considerations (including how to address toxicodynamic differences across and within species, quantitative approaches to use of biomarkers/markers of adversity, etc). SOLE SOURCE JUSTIFICATION Dr. Tracey Woodruff is solely qualified to perform the work described in this project, based on her special expertise and experience in the project area. Her expertise in reproductive health as well as environmental policy will be especially valuable to this effort. In addition, no one with her qualifications is available to perform the work during the time frame specified. Dr. Woodruff serves as the Director of the Program on Reproductive Health and the Environment in the Department of Obstetrics, Gynecology and Reproductive Sciences at UCSF. Prior to joining UCSF, Dr. Woodruff served as a Senior Scientist in the National Center for Environmental Economics, Office of Policy, Economics and Innovation at US EPA. She received numerous US EPA awards for her exceptional service and dedication to improving public health, including two Gold Medals, a Silver Medal as well as two Bronze medals. Among the numerous projects on which she had a leading role was the development of US EPA?s 2005 Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens. This guidance document addresses general issues pertaining to cancer risks associated with early-life exposures and presents comparative analyses of risks associated with early-life and adult exposures. In addition, it provides specific guidance on adjusting risk estimates using for carcinogens with a mutagenic MOA. Because the current project will consider issues pertinent to the evaluation of risk based on MOA considerations, her expertise in this area will be particularly valuable. In addition, her past experience directly related to the current work includes serving as the co-organizing director of the 2007 UCSF/CHE Summit on Environmental Challenges to Reproductive Health and Fertility, and co-organizing a 2007 meeting entitled Moving Upstream: A Workshop on Evaluating Adverse Upstream Endpoints for Improved Decision Making and Risk Assessment. Dr. Woodruff has authored 45 peer-reviewed publications in her areas of expertise. For further information about Dr. Woodruff?s expertise and accomplishments, please see the attached CV. STATEMENT OF WORK The contractor shall conduct the following Tasks in accomplishing the objectives of this contract. As detailed below, Tasks include proposal and Workplan development, planning committee activities facilitation, pre-workshop planning and logistical arrangements, travel arrangements, on-site meeting support and meeting documentation. Task 1. Establish Communication Within one week of award, the contractor shall convene a conference call with the Technical Project Officer (Contractor?s Officer Representative, COR) to clarify outstanding questions and confirm the schedule and specific tasks for the contract. The contractor shall also provide monthly (or more frequently, as needed) verbal status updates to the COR throughout the conduct of the contract. The contractor shall initiate additional communication with the COR should developments arise that will affect the conduct or schedule of this contract. Task 2. Provide a Workplan Within two weeks of the initial conference call with the COR, the contractor shall provide a Workplan that describes in detail the tasks and schedule to be conducted under this Contract. This shall include a schedule for all activities specified under Tasks 3-8. Task 3. Facilitate Planning Committee Activities Working with the US EPA COR and US EPA staff, the contractor shall facilitate selection of a planning committee to develop a program appropriate to address the subject of the workshop. The workshop process shall entail: The planning committee shall choose from one to three different types of toxicological pathways that shall be developed into case studies for the workshop. Possibilities include thyroid disruption; immunosuppression; anti-androgen related toxicities; and pathways that could lead to childhood leukemia. Selected pathways shall be well-characterized and attributed to a number of different chemicals, thus providing the ability to address multiple chemicals with a particular case study. In addition, sufficient information should be available to develop quantitative relationships between exposures and different metrics of outcomes. The planning committee shall develop an outline of the issues to be addressed in each of the case studies. The case studies shall focus on one or more representative chemicals with sufficient scientific information to illustrate key concepts. The case studies shall synthesize the relevant science with specific examples of how the scientific information can be used in hazard and risk assessment considering the key areas listed above. A group of scientists along with a representative from the planning committee shall be selected to develop each case study. Each case study shall be developed into a working paper. The working papers shall be discussed at a workshop. The workshop shall attempt to synthesize the findings and develop specific suggestions from the case studies and approaches for incorporating information in dose-response analysis. The workshop format shall be determined by the US EPA in consultation with the contractor, but is anticipated to include one and a half days of presentations and panel discussions, with on focus on finalizing 2-3 case studies that explore the attendant issues. Task 4. Pre-Meeting Support The contractor shall issue the invitations, coordinate schedules of potential attendees, determine their participation and provide US EPA with a final list of participants for approval of the US EPA COR. A web-based (or suitable alternative) mechanism for registering participants, and email distribution list of registered participants, shall be established. It shall be the contractor's responsibility to coordinate all speakers' participation and deliverables. As part of the pre-meeting planning activities, the contractor shall work with US EPA staff to develop or collect pre-meeting and registration materials (i.e., agenda, background papers, logistical information, etc) and shall make these available (e.g., via a website) to confirmed attendees prior to the workshop. In addition, the contractor shall prepare materials to be distributed on-site (name badges, final agenda, logistical information, pen, paper, etc.) The contractor shall also reserve hotel rooms and provide logistical information for out-of-town attendees. The contractor shall arrange for a block of sleeping rooms to be reserved for two nights: the night prior to the meeting and the first night of the meeting. The contractor shall make all logistical arrangements for the workshop. Specifically, activities under this task include (but are not limited to): The contractor shall arrange for all facilities and required materials and equipment necessary for conduct of the workshop. This shall include arranging for all necessary audio equipment, including but not limited to recorder, table microphones, podium microphones, lavalier microphones, and floor microphones. Finally, the contractor shall prepare signs to be displayed at the meeting site and table tents to be dispersed at the meeting room(s), as well as name badges for all attendees. As necessary, the contractor shall arrange for phone lines that are connected to the audio system for attendees via teleconference. The contractor shall reimburse invited participants (maximum of 10) for their expenses (airline, rail and/or private vehicle) including per diem and local travel, if applicable. No federal government employees are eligible to receive any funds obliged by US EPA. Task 5. On-Site Meeting Support The contractor shall coordinate with on-site technical audiovisual support. One or two administrative support staff shall also be provided to assist with dispersal of on-site meeting materials (agenda, logistical information, etc). The contractor shall also record the proceedings of the workshop to assist in preparation of a written summary of the major outcomes (Task 9). Task 6. Publication of Findings Proceedings of the workshop and recommendations for improved concepts and approaches to hazard and risk assessment shall be published in the peer-reviewed literature. This may include publication of the case studies in addition to a summary manuscript highlighting the key findings and recommendations. The Contractor shall facilitate development of any publications resulting from the workshop, including revision and finalization of the manuscript in accordance with the journal review process as well as payment of page charges, as appropriate. Schedule of Deliverables Task 1 Planning teleconference Within 1 week of award Update teleconferences Monthly or more frequently thereafter Task 2 Workplan Within 4 weeks of planning teleconference Tasks 3-5 Planning committee coordination Per Workplan Pre-meeting and on-site support activities Per Workplan Distribution of pre-meeting materials Prior to workshop On-site meeting support Per Workplan Task 6 Draft manuscript(s) Within 6 months of workshop Final manuscript(s) Within 1 year of workshop This notice of intent is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to the requirement by submitting documentation, to martinez.thomas@epa.gov, phone number (202)564-1418, which establishes that their specifications meet EPA's requirement. Documentation must be received within fifteen (15) days after the date of publication of this synopsis to be considered by EPA. A determination not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
- Record
- SN01510585-W 20080217/080215231335 (fbodaily.com)
- Source
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