ADP Contracts Placement Service Center (3803R), 401 M Street, S.W., Washington, DC 20460-0001

B -- EXPERT PANEL REVIEW OF VINYL CHLORIDE SOL PR-DC-98-2H9X04 POC Valoree S. Lilley, lilley.valoree@epamail.epa.gov E-MAIL: click here to contact the contracting officer, lilley.valoree@epamail.epa.gov. The U.S. EPA intends to issue a sole source purchase order to Syracuse Research Corporation under FAR Part 13 Simplified Acquisition Procedures. The SIC code for this requirement is 8748. SCOPE OF WORK: The contractor shall provide support to the U.S. Environmental Protection Agency (EPA) in organizing and conducting an Expert panel Second Review of the document "Toxicological Review of Vinyl chloride, accompanying Cancer and Noncancer Summaries and Appendices". The panel shall consist of experts in several key disciplines (including 2 in cancer toxicology/risk assessment, one in developmental/reproductive toxicology/risk assessment, 3 in pharmacokinetic modeling/risk assessment, and one epidemiologist. These experts shall include a subsection of the original panel as well as new members required to obtain a sufficient number with the required expertise as well as a range of affiliations and viewpoints. The output of the meeting will be a report that conveys the independent scientific judgement of the panel members about the technical adequacy of the risk assessment, the reasonableness of the analysis and conclusions, including the addition of uncertainty factors in quantitating cancer risk. Specific questions shall be developed by EPA for the contractor to include in a charge to the peer reviewers. Also included in the report will be an interpretation, rationale and evaluation of the strengths and weaknesses of the conclusions, and uncertainties regarding the alterations to the document since the last peer review. The report shall include a succinct statement describing the major conclusions and recommendations to assist the EPA to modify the current text in the document.TASKS -- The contractor shall conduct the following tasks in accomplishing the objective of the work assignment:Task 1 -- Contractor selection of facility and panelists, and preparation for panel meeting 1. The contractor shall search, identify and arrange for a hotel and/or conference facility for a one-day meeting in during February, 1999, in the Washington, D.C. metropolitan area that meets Federal offsite meeting requirements. Audiovisual equipment or any other equipment needed to conduct and record the minutes of the meeting shall be the responsibility of the contractor. Estimated attendance for the one day meeting is expected to be 35, including 7 panelists and 25-30 observers. A single table for the participants in the front of a theater room style for the observers is preferred. The contractor will reserve a block of seven (7) overnight rooms for the Expert Panel participants the night before. The contractor shall obtain PO approval before entering into an agreement with the hotel for audiovisual, or computer equipment and any other conference so named.2. The contractor shall select 7 panelists, including some that participated in the original panel review of the June, 1997 Vinyl Chloride Toxicological Assessment. The panelists shall include two with expertise in cancer toxicology/risk assessment, one with expertise in reproductive/developmental toxicology, three with expertise in pharmacokinetic modeling/risk assessment, and one with expertise in epidemiology. The contractor shall select members of the original panel based upon required expertise and availability and one or more new panel members to fulfill the requirements. The contractor shall provide a resume of any proposed new panel members to the Project Officer (PO), who will review their qualifications for approval as new members. The contractor shall provide travel, per diem and associated expenses to the chosen Expert Panel Members.3. The contractor shall designate one of the panelists to serve as the Expert Panel Chairperson. This individual should be broadly knowledgeable on the subject and have demonstrated ability in leading a scientific group. Unless directed by the PO, none of the selected experts will be EPA employees.4. The contractor shall develop with EPA and the Expert Panel Chairperson a draft agenda and prepare for the meeting, and resolve any issues concerning purpose, scope, format, attendance, or logistics.Task 2 -- Panel member preparation and participation 1. Panel Chair -- The Panel Chair shall review relevant pre-meeting materials, hold a conference call with the panelists to focus the discussion for the meeting, submit his/her pre-meeting comments to the contractor in electronic format, and prepare an introductory presentation for the meeting. He/she shall attend the meeting, and contribute to the preparation of a post-panel report. Specific duties are listed below: A. The Chair shall prepare an opening panel presentation (approximately 15 to 20 minutes) that states the charge to the panel, expected products, and highlights topics and issues raised. B. The Chair shall attend and lead the one day Expert Panel discussion meeting. The Chair shall also make a verbal presentation to all attendees at the end of the session summarizing the content of the panel discussion. The Chair shall also work with the panelists and the contractor to prepare a written summary of the content of the panel discussions that will specify areas of the documents "Toxicological Review and IRIS Summary of Vinyl Chloride in Support of Summary Information on the Integrated Risk Information System" that would require modification to reflect the specific advice offered by the panelists. C. After the Panel meeting, the Chair shall review and approve the preparation of the draft report assembled by the contractor. 2. Other Expert Panelists -- The other panelists shall review portions of the documents "Toxicological Review and IRIS Summary of Vinyl Chloride in Support of Summary Information on the Integrated Risk Information System", where changes have been made since the June 1997 panel meeting and where the charge asks for comment or affirmation, and submit his/her meeting comments to the Chair and contractor in electronic format. He/she shall attend the panel meeting and contribute to the preparation of the draft and final post-meeting report. Specific duties are listed below: A. Atthe Panel meeting, in accordance with the agenda prepared by the contractor and Chair, panelists shall lead discussions of issues in her/his area of expertise. Each expert shall be responsible for summarizing comments in his/her areas of expertise on the agenda, and help to write a draft summary of the meeting during the afternoon of the meeting. B. After the Panel meeting, each expert shall participate in the preparation and review of the draft and final Expert Panel report outlining recommendations and modifications that the Panel believes should be included in the document "Toxicological Review and IRIS Summary of Vinyl Chloride In Support of Summary Information on the Integrated Risk Information System" and assembled by the contractor.Task 3 -- Provide premeeting mailing and preparations 1. The contractor shall send letters of invitation to each expert and the invited observers, and shall prepare and send attendance confirmation cards to be returned to the contractor. The contractor shall provide confirmed participants with any premeeting materials designated by EPA, and logistical information on the meeting including arrangements for hotel accommodations, airport and local transportation, other associated expenses. 2. The contractor shall establish a procedure for observers to call in and register for attendance at the meeting. There may be as many as 30 observers. The contractor shall prepare signs to be displayed at the meeting site and placecards to be placed on the table in the meeting room. 3. The contractor shall prepare name tags and placecards for all Panel members at the meeting, and name tags only for observers. 4. The contractor shall set in the agenda a 30-minute time period for public comments and to ask questions at the end of the meeting. 5. Copies of all mailings shall be sent to the PO. Task 4 -- Contractor prepares meeting report 1. The contractor shall prepare and submit a draft Expert Panel report using premeeting materials and written comments by the panel members within thirty days of the close of the meeting, or as agreed. This draft report shall incorporate preliminary review and comments by the panel members. The draft report shall also address specific questions in the charge to the panel, which shall include, recommendations regarding the suitability of using adjustment and uncertainty factors to account for childrens risk and possible risk from tumors at sites other than the liver. The statement shall include a recommendation for either retention of the present approach or employment of a different approach and justifiable reasoning for approving the present approach or recommending another one. The contractor shall exercise technical and editorial quality control. 2. The contractor shall send ten copies of the draft Expert Panel report to the PO and additional copies to the panelists for review and comment.3. The PO will provide written comments on the draft Expert Panel Report to the contractor who shall discuss the comments received from the panelists on the draft report with the PO before finalizing the Expert Panel report. 4. The final report shall be delivered to the PO within 15 days of receiving PO comments. If EPA's comments result in significant additional work on the report, the contractor shall have an additional 15 days to develop the changes and provide for review by the Panel before finalization. After the Expert Panel report has been finalized, the contractor shall mail 10 copies to the PO. In addition, the contractor shall supply the PO with an electronic copy of the report in WP 8.0. (Reproduction services shall not exceed Agency and GPO limitations). Posted 02/09/99 (W-SN296554). (0040)

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