Document XR36M5R5VbMBK1765XQ4p1OeR

Applied Health Sciences, Inc. Post Office Box 2078 San Mateo, California 94401 Otto Wong, SeD. Fellow of American College of Epidemiology Associate Editor ofAnnals ofEpidemiology Adjunct Professor of Epidemiology University of North Texas Medical Center, Fort Worth, USA Adjunct Professor of Community & Family Medicine Chinese University of Hong Kong, Hong Kong, China Honorary Professor of Community Medicine University of Hong Kong, Hong Kong, China Visiting Professor of Occupational Epidemiology Fudan University Medical Center, Shanghai, China Editorial Board, Regulatory Toxicology & Pharmacology USA Telephone: 1 (650) 347-7898 Facsimile: 1 (650) 344-6887 Email: OttoWong@aol.com 12 May 2007 Bruce M. Jarnot, Ph.D., DABT Senior Toxicologist Regulatory and Scientific Affairs American Petroleum Institute 1220 L Street, NW Washington, DC 20005 Re: Revised timeline and additional budget for the completion of the case-control study Dear Bruce: I am writing to follow-up our recent discussions of revising the timeline and budget estimate for the completion of the case-control study of AML and NHL. As a result of the new timeline of deliverables from Cinpathogen, both the timeline and the budget for the case-control study will be significantly affected, and both need to be revised. I have been asked, for the purpose of projecting a new timeline and estimating additional budget for the casecontrol study, to assume that AML case accrual will end by June 2007 and that for NHL patients by December 2007. Your email dated 10 May 2007 further indicates that we will receive from Cinpathogen a comprehensive test dataset by the end of September 2007 and the final dataset with complete diagnostic, exposure and questionnaire information ready for analysis by the end of August 2008. Based on these newly projected dates of deliverables, I have revised the timeline for the completion of the case-control study (see below). I am being slightly optimistic and project that we may be able to complete our analysis and report within four months after we receive the final dataset. However, I must emphasize that I am being optimistic. The actual date of completion of the case-control study will depend heavily on the date of delivery and the status of the final dataset, but for planning purposes I will set the end of 2008 as our goal. SHELL-MCCLURG-062012 Revised timeline for the case-control study Tasks Test dataset to AHS* Exploration of test dataset QA/QC of test dataset End of patient accrual* Development of analytical programs/plans Final diagnoses of all patients completed* Interviews of all patients completed* Questionnaire data entry completed* Exposure assessment completed* Final dataset ready for analysis to AHS* Final QA/QC and data editing Statistical!epidemiological analysis Preparation of draft report Consultations with SRP members Preparation of final report Date September 2007 October-November 2007 November-December 2007 December 2007 December 2007-May 2008 March 2008 March/April 2008 May 2008 July 2008 August 2008 September-October 2008 September-November 2008 September-November 2008 September-December 2008 December 2008 * activities not under AHS control. As indicated in the timeline above, some of our most important tasks can be carried out in 2008 only after patient accrual has been completed, diagnoses have been finalized and exposure classifications have been assigned. In projecting the above timeline, we assume that we will receive a final dataset with complete information ready for analysis by August 2008. Any delay in receiving the final dataset or any unanticipated additional preparation or processing of the final dataset will have an impact on the projected timeline. At this moment, there is no budget for the case-control study at all for 2008. (Please refer to the contract amendment signed between American Petroleum Institute and Applied Health Sciences in November 2006, Contract No. 2004-101153, Amendment No. 1.) Additional funding will be needed. Attached is a spreadsheet detailing the additional budget needed to complete the casecontrol study. Again, the budget estimate is based on the assumptions and timeline outlined above. Any changes in our assumptions will likely affect the budget. Additional amounts needed by year (2007 and 2008) are itemized and justified in the attached budget (dated 2007-05-12). We are requesting the following additional amounts by year: Year 2007 Year 2008 Total $184,695 $703,505 $888,200 These amounts are needed in addition to those already approved in the November 2006 amendment (Contract No. 2004-101153, Amendment No. 1.). 2 SHELL-MCCLURG-062013 I am assuming that I will continue to be assisted by Professor Fu's group in connection with the case-control study, particularly with my QA/QC activities in Shanghai. Professor Fu's graduate assistants are also assisting me in a literature review of occupational and non-occupational risk factors of subtypes of AML and NHL. I anticipate that Professor Fu's group will also participate in analysis and report preparation. For the past years, Professor Fu had a separate contract with API to assist me in these activities. If Professor Fu's contract is not renewed, then we need to explore other appropriate alternatives. Please note that I have reserved both time and budget for interacting with members of the SRP in the last quarter of 2008. I anticipate that I will seek advice and suggestions in both analysis and report preparation from SRP members in the final months of the study. By the same token, API should budget separately some time for the SRP members to interact with me. If you have questions, please let me know. I::Z; Otto Wong, Sc.D. Chief Epidemiologist Enclosure: AHS additional budget for 2007 & 2008 3 SHELL-MCCLURG-062014 Applied Health Sciences, Inc. Case-control Study of AML and NHL Additional Budget Estimate for 2007 and 2008 2007-05-12 Rationale and assumptions We will receive a comprehensive test dataset by the end of September 2007 and the final dataset ready for analysis by the end of August 2008. We will perform the following tasks in September-December 2008: final QAlQC, data editing, statistical analysis, presentations, discussion with SRP and report writing. In addition, based on our recent experience, we need to increase our efforts of QAlQC, database testing and auditing, and monitoring of patient interviews in 2007. For 2007, we have also added two additional trips to Shanghai (to the three already approved, with a new total of five trips). Labor Category Chief Epidemiologist (PI) Biostatistician Statistical programmer Research/Administration assistant Consulting industrial hygienist Total labor in 2006 dollars Approved 2006 hourly rates $355 $175 $150 $115 $250 Hours 160 100 80 40 20 Year 2007 Amount $56,800 $17,500 $12,000 $4,600 $5,000 $95,900 Meetings/working tril2s (time & eXl2enses) Trips to Shanghai (10 days each) Tri~s in USA {3 days each} Total for meetings/working trips in 2006 dollars Approved 2006 unit costs $39,000 $11,600 Year 2007 No. Amount 2 $78,000 0 $0 $78,000 Miscellaneous expenses (copying, domestic & international calls, mail) in 2006 dollars $2,000 Total additional budget in 2006 dollars (labor, trips & miscellaneous expenses) $175,900 Hours 700 400 400 160 80 Year 2008 Amount $248,500 $70,000 $60,000 $18,400 $20,000 $416,900 Year 2008 No. Amount 5 $195,000 2 $23,200 $218,200 $3,000 $638,100 Hours 860 500 480 200 100 Total Amount $305,300 $87,500 $72,000 $23,000 $25,000 $512,800 Total No. Amount 7 $273,000 2 $23,200 $296,200 $5,000 $814,000 Yearly budget estimates with a 5% annual adjustment Total additional budget by year (with 5% annual adjustment) Budget already approved (Contract No. 2004-101153, Amendment No.1) TOTAL REVISED BUDGET Year 2007 $184,695 $456,475 $641,170 Year 2008 $703,505 $0 $703,505 Total $888,200 $456,475 $1,344,675 SHELL-MCCLURG-062015