Document KJYBjjDd8EoerDgJmNQ5e5mJQ

Benzene - API Benzene Study Summary Exhibit B Exhibit B as referred to in Benzene Consortium Write-Up Overall Approved Budget Example only. To be verified by API Approved Original Cost Estimate Revised Cost Estimate Item (Jan. 2001) (Dec. 2001) AHSciences Case-Control Study $1,595,000 $2,283,095 DP & ME Studies (UCHSC) $13,665,017 $15,258,017 Irons(T & E) $1,253,428 $1,253,428 Fudan University $165,700 $190,555 Total Research Costs $16,679,145 $18,985,095 Scientific Review Panel $648,000 Ethics Review Panel $216,000 External Pathology & Cytogenetics (J) Workgroups(Cost in UC I cost) m Total Panel Costs r r API Seed Monies s:I Outside Counsel () Public Affairs $450,000 $500,000 $1,000,000 $130,000 $994,000 $0 $500,000 $1,000,000 () QAlQC Activities r C Misc. ? ;a $190,855 $225,000 $0 G) oI c..n Benzene Study Summary c..n -.....J o (J) Unapproved Changes API not approved (June o (17) 343,845 470,445 (96,264) (24,000) (J) I (130,000) m r r o s:I $100,576 (399,424) () $960,600 (39,400) () $100,000 (125,000) r C $0 o ;a G) oI c..n Benzene Study Summary c..n -.....J o -.....J GRAND TOTAL Notes by API Notes!Assumptions: Miscellaneous Costs Subtotal API Overhead (5%) $1,690,855 $18,820,000 $941,000 $19,761,000 $1,725,000 $21,704,095 $1,085,205 $22,789,300 - The total research costs have changed as a result of the protocol review process and changes in the - Panel costs assume that there will be only one face-to-face meeting for each panel each year. - Miscellaneous costs for outside counsel and media relations are based solely on assumptions. - QAlQC costs are based on an assumption of $45,000 per year for 5 years. (J) I m r r sI : () () r C ;a G) oI c..n Benzene Study Summary c..n -.....J o ex> $1,161,176 $21,704,280 $1,085,019 $22,789,299 (186) (1 ) (J) I m r r sI : () () r C ;a G) oI c..n Benzene Study Summary c..n -.....J o <D Year 2001 2002 2003 2004 2005 2006 2007 Original Budget Jan. 2001 (w/o inflation adj. (Table 1) Applied Health Sciences: Shanghai Health Study Budget Inflation Adjustment 5% annually (Table 2) Original Budget WI Inflation Exhibit B Additional Budget for Exposure Assessment (includes 5% inflation adj.) (Table 3) Approved Cost Total AHS Payments to Date AHS Balance as of June 2003 84,025 0 84,025 $0 $84,025 128,852 326,175 16,308 342,483 $93,030 $435,513 435,406 288,900 29,612 318,512 $113,999 $432,511 120,508 266,400 41,991 308,391 $84,970 $393,361 290,125 62,524 352,649 $89,218 $441,867 305,175 84,314 389,489 $60,496 $449,985 34,200 11,631 45,831 $0 $45,831 Total -- 1,595,000 $ 246,380 $ 1,795,549 $441,713 $~,283,Q93 (J) I m r r sI : () () r C ;a G) I 0c..n AHS Project Summary c..n -.....J .....lo. 0 684,766 $1,598,327 Task Activity Applied Health Sciences: TASK TIMELINE (Milestones) Exhibit B Project year Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Specifi c tasks S1 Finalization of research protocol S2 Development, translation and pre-test of questionnaire S3 Development of database, data linkage and data security S4 Enrollment of study subjects (AML & NHL patients and controls) S5 Interviews of study subjects S6 Acquisition of employment records of study subjects S7 Data entry and data management S8 Data audit S9 Acquisition of exposure data from Shanghai CDC and factories S10 Exposure assessment of individual study subjects S11 Data analysis S12 Presentation of results to Scientific Committee and sponsors in USA S13 Presentation of results to SMU, Shanghai CDC & others in China S14 Preparation of draft report S15 Finalization of report and response to comments S16 Preparation of manuscripts for journal publication S17 Presentations of study at two international conferences X X X XX X XX XX X XX XX X XX XX X XX XX X XX X X XX X X XX X X X X X X X (J) I Genera m r I tasks r s:I G1 Working with Chinese investigators in Shanghai XX X XX () G2 Meetings with the Scientific & Ethics Committees in USA XX X XX () r G3 Communication with the Scientific Committee C G4 Communication with the Ethics Committee ;a G5 Project management G) XX X XX XX X XX XX X XX I 0c..n Milestones c..n -.....J --lo. --lo. Numbe r of meetin gs and working trips Number of periodic meetings and working trips in Shanghai Number of periodic meetings in USA Meeting in USA to present study results Meeting in China to present study results Presentations at two international conferences 43 3 33 33 2 22 1 1 2 (1-302002) (J) I m r r sI : () () r C ;a G) oI c..n c..n -.....J .....lo. I'V Milestones Applied Health Sciences: 2001 Original Budget W/out Inflation Adjustment: Explanation of Costs - Labor for regular activities Project (time) year Hourly rate Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Hour Hour Category in 2001 $ s Amount Hours Amount Hours Amount Hours Amount s Amount Hours Amount Chief Epidemiologist (PI) $280 380 $106,400 350 $98,000 300 $84,000 300 $84,000 400 $112,000 100 $28,000 Biostatistician $140 140 $19,600 120 $16,800 120 $16,800 120 $16,800 200 $28,000 20 $2,800 Statistical programmer $120 120 $14,400 120 $14,400 120 $14,400 120 $14,400 200 $24,000 Research assistant $90 100 $9,000 100 $9,000 100 $9,000 100 $9,000 150 $13,500 20 $1,800 Administrative assistant $90 80 $7,200 80 $7,200 80 $7,200 80 $7,200 120 $10,800 Consulting industrial hygienist Consulting hematologist Consulting pathologist Total labor for regular activities $200 120 $24,000 $250 20 $5,000 $250 20 $5,000 120 $24,000 20 $5,000 20 $5,000 100 $20,000 20 $5,000 20 $5,000 100 $20,000 100 $20,000 20 $5,000 20 $5,000 20 $5,000 20 $5,000 $190,600 $179,400 $161,400 $161,400 $218,300 $32,600 Meetings/working trigs (time & exgenses) Unit cost in 2001 $ Year 1 No. Amount Year 2 No. Amount Year 3 No. Amount Year 4 Year 5 No. Amount No. Amount Year 6 No. Amount Meetings in China (8 days @) $26,000 Meetings in USA (3 days @) $12,000 4 $104,000 3 $36,000 3 $78,000 3 $36,000 3 $78,000 2 $24,000 3 $78,000 2 $24,000 4 $104,000 3 $36,000 $12,000 Meeting in Europe (4 days @) $20,000 $20,000 (J) Total for meetings/meeting I m trips r r s:I Other direct exgenses () () r C ;a Fee for IRB members $140,000 $114,000 $102,000 $102,000 $140,000 $32,000 Year 1 Amount $2,500 Year 2 Amount Year 3 Amount Year 4 Amount Year 5 Amount Year 6 Amount G) I 0c..n Table1 c..n -.....J .....lo. c..> Domestic long-distance calls (in 2001 $) International calls (in 2001 $) Copying (in 2001 $) Postage and express mail (in 2001 $) Total for other expenses (in 2001 $) GRAND TOTAL (in 2001 $) TOTAL BUDGET FOR 6 YEARS (I N 2001 $) $1,200 $1,000 $500 $300 $5,500 $336,100 $1,200 $1,000 $500 $300 $3,000 $296,400 $1,200 $1,000 $500 $300 $3,000 $266,400 $1,200 $1,000 $500 $300 $3,000 $266,400 $1,200 $1,000 $500 $300 $3,000 $361,300 $1,500 $1,200 $800 $300 $3,800 $68,400 $1,595,000 (J) I m r r sI : () () r C ;a G) oI c..n Table1 c..n -.....J .....lo. ..j:::o. Project year 2001 Original Budget: With Inflation Adjustment - Exhibit B Total by Total for project year Amount by quarter Calendar quarter Adjusted by 5% calendar year (in 2001 $) (in 2001 $) annual increase Year 1 $336,100 $84,025 $84,025 $84,025 $84,025 4th Q, 2001 1st Q, 2002 2nd Q, 2002 3rd Q, 2002 $84,025 $88,226 $88,226 $88,226 Total for 2001 = $84,025 $348,704 $12,604 Year 2 $296,400 $74,100 $74,100 $74,100 $74,100 4th Q, 2002 1st Q, 2003 2nd Q, 2003 3rd Q, 2003 $77,805 $81,695 $81,695 $81,695 Total for 2002 = $342,484 $322,891 $26,491 Year 3 $266,400 $66,600 $66,600 $66,600 $66,600 4th Q, 2003 1st Q, 2004 2nd Q, 2004 3rd Q, 2004 $73,427 $77,098 $77,098 $77,098 Total for 2003 = $318,512 $304,720 $38,320 Year 4 $266,400 $66,600 $66,600 $66,600 $66,600 4th Q, 2004 1st Q, 2005 2nd Q, 2005 3rd Q, 2005 $77,098 $80,953 $80,953 $80,953 Total for 2004 = $308,391 $319,956 $53,556 Year 5 $361,300 $90,325 4th Q, 2005 $109,791 Total for 2005 = $352,649 (J) I $90,325 1st Q, 2006 $115,280 m $90,325 2nd Q, 2006 $115,280 $455,631 r r $90,325 3rd Q, 2006 $115,280 $94,331 s:I () () Year 6 $68,400 $34,200 $34,200 4th Q, 2006 1st Q, 2007 $43,649 $45,831 Total for 2006 = $389,489 Total for 2007 = $45,831 r C ;a G) I 0c..n Table 2 c..n -.....J .....lo. c..n C\I Q) :c0o f- -(ij o f- SHELL-MCCLURG-055716 Scientific Review Panel Budget Increase by Category: With Inflation Adjustment Exhib Labor by category Hourly rate Year 1 Year 2 Year 3 Year 4 Year 5 Category in 2001 $ Hours Amount Hours Amount Hours Amount Hours Amount Hours Amount Chief Epidemiologist (PI) $280 80 $22,400 40 $11,200 40 $11,200 40 $11,200 40 $11,200 Statistical programmer $120 20 $2,400 20 $2,400 20 $2,400 20 $2,400 20 $2,400 Research assistant $90 20 $1,800 20 $1,800 20 $1,800 20 $1,800 20 $1,800 Consulting industrial hygienist $200 120 $24,000 120 $24,000 100 $20,000 100 $20,000 100 $20,000 Total labor for regular activities (2001 $) $50,600 $39,400 $35,400 $35,400 $35,400 Meetings/working tri~s (time & ex~enses) Meetings in China (8 days @) Meetings in USA (3 days @) Total for meetings/working trips (2001 $) Total in 2001 $ (labor and trips) Unit cost in 2001 $ $26,000 $12,000 Year 1 No. Amount 1 $26,000 1 $12,000 $38,000 $88,600 Year 2 No. Amount 2 $52,000 1 $12,000 $64,000 $103,400 Year 3 No. Amount 1 $26,000 1 $12,000 $38,000 $73,400 Year 4 No. Amount 1 $26,000 1 $12,000 $38,000 $73,400 Year 5 No. Amount $12,000 $12,000 $47,400 (J) Yearly budget estimates with a 5% I annual adjustment m r r Budget by calendar year s:I Total (with 5% annual adjustment) () () r C ;a G) oI c..n c..n -.....J .....lo. -.....J 4,430 Year 2002 $93,030 10,599 Year 2003 $113,999 11,570 Year 2004 $84,970 15,818 Year 2005 $89,218 13,096 Year 2006 $60,496 Table 3 UB Total Hours Amount 240 $67,200 100 $12,000 100 $9,000 540 $108,000 $980 $196,200 Total No. Amount 5 $130,000 5 $60,000 10 $190,000 $386,200 (J) I m r 55,512 r Total s:I $441,712 () () r C ;a G) I 0 c..n c..n -.....J Table 3 .....lo. ex> Labor (time) Category Physician epidemiologist (FU) Graduate research assistant 1 Graduate research assistant 2 Questionaire coordinator Senior industrial hygenist1 Senior industrial hygenist2 Senior occupational physican Project coordinator General assistant Total for labor Table 3. ANLL and NHL Case-control Studies Budget Estimate forFudan University Medical Center July 2,2002 Annual salary* in 2001 US$ $16,900 $6,240 $6,240 $6,240 $2,930 $2,930 $7,050 $9,500 $5,700 Year 1 Time Amount 20% $3,380 50% $3,120 50% $3,120 100% $6,240 100% $2,930 100% $2,930 100% $7,050 100% $9,500 100% $5,700 $43,970 Year 2 Time Amount 0 $2,535 $3,120 $3,120 $6,240 $2,930 $2,930 100% $7,050 100% $9,500 100% $5,700 $43,125 Year 3 Time Amount 15% $2,535 50% $3,120 50% $3,120 100% $6,240 100% $2,930 100% $2,930 100% $7,050 100% $9,500 100% $5,700 $43,125 Year 4 Time Amount 15% $2,535 50% $3,120 50% $3,120 100% $6,240 100% $2,930 100% $2,930 100% $7,050 100% $9,500 100% $5,700 $43,125 Year 5 Time Amount 25% $4,225 50% $3,120 50% $3,120 100% $6,240 100% $2,930 100% $2,930 100% $7,050 100% $9,500 100% $5,700 $44,815 [* includes salary, bonus and benefits.] Expenses Unit cost Year 1 Year 2 Year 3 Year 4 Year 5 in 2001 US$ No. Amount No. Amount No. Amount No. Amount No. Amount Shanghai CDC activities # $3,000 $1,800 $1,800 $1,800 $1,500 Fee for Shanghai CDC staff $6,000 $6,000 $6,000 $6,000 $3,000 Shanghai IPHS activities # $5,000 $3,000 $3,000 $3,000 $2,500 Fee for Shanghl IPHS staff $9,000 $9,000 $9,000 $9,000 $4,500 Fee for local IPHS staff $13,200 $13,200 $13,200 $13,200 $6,600 Fee for AML patients $30 60 $1,800 120 $3,600 120 $3,600 120 $3,600 60 $1,800 Fee for NHL patients $30 60 $1,800 120 $3,600 120 $3,600 120 $3,600 60 $1,800 (J) Fee for controls I Hospital coordinators(AML) m r Hospital coordinators(NHL) r Hospital coordinators(Controls) s:I Traning cost () Long transportation and travel () r Copying cost C Copy machine ;a $30 240 $7,200 480 $14,400 480 $14,400 480 $14,400 240 $7,200 $30 60 $1,800 120 $3,600 120 $3,600 120 $3,600 60 $1,800 $30 60 $1,800 120 $3,600 120 $3,600 120 $3,600 60 $1,800 $30 240 $7,200 480 $14,400 480 $14,400 480 $14,400 240 $3,600 $200 $100 $100 $100 $100 $1,000 $1,000 $1,000 $1,000 $1,000 $200 $200 $200 $200 $200 $10,000 G) I 0 c..n c..n -.....J --lo. <D Year 6 Time Amount 6-Year Total 10% $1,690 $16,901 $15,600 $15,600 $15,600 $14,650 $14,650 $35,254 $47,500 $28,500 $1,690 $219,850 Table 3. ANLL and NHL Case-control Studies Budget Estimate forFudan University Medical Center Year 6 No. Amount 6-Year Total $9,900 $27,000 $16,500 $40,500 $59,400 $14,820 $14,820 (J) $57,600 I $14,400 m r $14,400 r $54,000 sI : () $5,000 () r $100 $1,100 C $10,000 ;a G) oI c..n c..n -.....J oI'V July 2,2002 Table 3. ANLL and NHL Case-control Studies Budget Estimate forFudan University Medical Center July 2,2002 Comupters Printer Office facilities Pliot study Communications Total expenses $1,200 $1,000 $60 [# includes transporation,co mmunication, training and other related activities happening in the project] 4 $4,800 1 $1,000 $300 100 $6,000 $500 $81,800 $300 $500 $78,300 $300 $500 $78,300 $300 $500 $78,300 $300 $500 $38,200 [* be shared with UCSHC] SUB TOTAL (IN 2001 US$) Overhead Charges (15%) $125,770 $18,866 $121,425 $18,214 $121,425 $18,214 $121,425 $18,214 $83,015 $12,452 GRAND TOTALS (IN 2001 US$) $144,636 $139,639 $139,639 $139,639 $95,467 Quarterly Break-outs (J) I m r r sI : () () r C ;a G) I 0c..n c..n -.....J I'V --lo. 4 2001 1 2002 2 2002 3 2002 4 2002 1 2003 2 2003 3 2003 4 2003 1 2004 2 2004 3 2004 4 2004 1 2005 $36,159 $36,159 $36,159 $36,159 $34,910 $34,910 $34,910 $34,910 $34,910 $34,910 $34,910 $34,910 $34,910 $34,910 2001 2002 2003 2004 $36,159 $143,386 $139,639 $139,639 $100 $200 $400 $4,800 $1,000 $1,600 $6,000 $2,700 $355,300 Table 3. ANLL and NHL Case-control Studies Budget Estimate forFudan University Medical Center $2,090 $314 $2,404 $575,150 $86,273 $661,423 (J) I m r r sI : () () r C ;a G) oI c..n c..n -.....J I'V I'V July 2,2002 Table 3. ANLL and NHL Case-control Studies Budget Estimate forFudan University Medical Center 2 2005 3 2005 4 2005 1 2006 2 2006 3 2006 4 2006 $34,910 $34,910 $23,867 2005 $23,867 $23,867 $23,867 $2,404 2006 Total $128,596 $74,004 $661,423 July 2,2002 (J) I m r r sI : () () r C ;a G) oI c..n c..n -.....J I'V c..>