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PRICE SCHEDULE
ASEPTIC PROCESSING FACILITY (APF) CERTIFICATION AND TESTING PROGRAM FOR THE NATIONAL INSTITUTES OF HEALTH (NIH), CLINICAL CENTER (CC), OFFICE OF RESEARCH SUPPORT AND COMPLIANCE (ORSC)
| INDEFINITE DELIVERY-INDEFINITE QUANTITY (IDIQ) PRICE SCHEDULE | | | | |
| POSITION | HOURS | RATE (HOURLY) | # OF PERSONNEL | ANNUAL COST |
| Prime Project Manager | 1880 | $ - 0 | 1 | $0.00 |
| Support Staff | 1880 | $ - 0 | 2 | $0.00 |
| TOTAL ANNUAL COST OF PERSONNEL | | | | $0.00 |
| CURRENT APFs - CALIBRATION AND REQUALIFICATION | | | | | | | |
| SUBCONTRACTORS - VALUES GIVEN IN MAN HOURS/DOLLARS | | | | | | | |
| AREA | # OF CONTROLLED TEMPERATURE UNITS | # OF COMMON PROCESS EQUIPMENT FOR CALIBRATION | QUALIFICATION/CALIBRATION HOURS | | | | |
| | | | ANNUAL EQUIPMENT REQUALIFICATION | PERFORM CTU AND COMMON EQUIPMENT CALIBRATIONS | TOTAL | RATE ($) | ANNUAL COST |
| I-IVAU | 12 | 6 | 32 | 36 | 68.00 | $ - 0 | $0.00 |
| 2J | 43 | 23 | 114.7 | 132 | 246.67 | $ - 0 | $0.00 |
| 3T | 33 | 24 | 88.0 | 114 | 202.00 | $ - 0 | $0.00 |
| 1B42 | 8 | 3 | 21.3 | 22 | 43.33 | $ - 0 | $0.00 |
| cGMP Trailer 1 | 9 | 2 | 24.0 | 22 | 46.00 | $ - 0 | $0.00 |
| PET Radiopharm | 15 | 11 | 40.0 | 52 | 92.00 | $ - 0 | $0.00 |
| Pharm | | | | | | | |
| 3-1741 | 2 | 0 | 5.3 | 4 | 9.33 | $ - 0 | $0.00 | |
| CRC TIL | 17 | 6 | 45.3 | 46 | 91.33 | $ - 0 | $0.00 |
| Sterility Lab | 15 | 3 | 40.0 | 36 | 76.00 | $ - 0 | $0.00 |
| CCE PACT (QC) Lab | 11 | 2 | 29.3 | 26 | 55.33 | $ - 0 | $0.00 |
| DTM Bloodbank | | | | | | | |
| (AD HOC ONLY) | 52 | 32 | 138.7 | 168 | 306.67 | $ - 0 | AD HOC | |
| NCI QC | 15 | 5 | 40.0 | 40 | 80.00 | $ - 0 | $0.00 |
| TOTAL ANNUAL COST OF QUALIFICATION/CALIBRATION HOURS | | | | | | | $0.00 |
| FUTURE APFs CALIBRATION AND REQUALIFICATION | # OF CONTROLLED TEMPERATURE UNITS | # OF COMMON PROCESS EQUIPMENT FOR CALIBRATION | ANNUAL EQUIPMENT REQUALIFICATION | PERFORM CTU AND COMMON EQUIP CALIBRATIONS | TOTAL | RATE ($) | HOURS | ANNUAL COST | END OF CQV | 1ST CALIBRATION DUE | 1ST REQUALIFICATION DUE | 2021 COST | 2022 COST | 2023 COST | 2024 COST (CALIBRATION) | 2024 (REQUALIFICATION) | 2025 Cost (CALIBRATION) | 2025 (REQUALIFICATION) | 2026 (CALIBRATION) | 2026 (REQUALIFICATION) |
| E-IVAU | 11 | 0 | 0.0 | 22.0 | 22.0 | $ - 0 | 8 | $ - 0 | 4/30/20 | 3/30/21 | 4/1/23 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| TIL (modular) | 39 | 14 | 0.0 | 106 | 106.00 | $ - 0 | 8 | $ - 0 | 10/30/20 | 9/30/21 | 10/1/23 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| Sterility Lab | 8 | 1 | 0.0 | 18 | 18.00 | $ - 0 | 8 | $ - 0 | 12/30/20 | 11/30/21 | 12/1/23 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| Terrace Modules | 21 | 16 | 0.0 | 74 | 74.00 | $ - 0 | 8 | $ - 0 | 12/30/20 | 11/30/21 | 12/1/23 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| 12E | 116 | 49 | 0.0 | 330 | 330.00 | $ - 0 | 8 | $ - 0 | 10/30/21 | 9/30/22 | 10/1/24 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| P-IVAU | 43 | 0 | 0.0 | 86 | 86.00 | $ - 0 | 8 | $ - 0 | 12/30/21 | 11/30/22 | 12/1/24 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| 29B | 0 | 0 | 0.0 | 0 | 0.00 | $ - 0 | 8 | $ - 0 | 12/30/21 | 11/30/22 | 12/1/24 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| Radio pharmacy | 5 | 7 | 0.0 | 24 | 24.00 | $ - 0 | 8 | $ - 0 | 2/28/22 | 1/30/23 | 2/1/25 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
TOTALS 475 618.67 1358 1976.67 $ - 0 $ - 0 $ - 0 $ - 0 $ - 0 $ - 0 $ - 0 $ - 0 $ - 0
| CURRENT ROOM AND PEC RECERTIFICATION | | | | | | | | | | | |
| AREA | # OF ISO ROOMS | # OF CNC ROOMS | # OF PECS | ROOM CERTIFICATION HOURS + DOCUMENTATION | PEC CERTIFICATION HOURS + DOCUMENTATION | AVS (PHARMACY) | AVS DOCUMENTATION REVIEW | TOTAL HOURS | ANNUAL HOURS (TOTAL X 2) | RATE ($) | ANNUAL COST |
| I-IVAU | 10 | 11 | 5 | 55.65 | 17.5 | 20 | 60 | 153.15 | 306.3 | $ - 0 | $ - 0 |
| 2J | 17 | 3 | 10 | 53 | 35 | | | 88 | 176 | $ - 0 | $ - 0 |
| 3T | 14 | 3 | 15 | 45.05 | 52.5 | | | 97.55 | 195.1 | $ - 0 | $ - 0 |
| 1B42 | 3 | 0 | 4 | 7.95 | 14 | | | 21.95 | 43.9 | $ - 0 | $ - 0 |
| GMP Trailer 1 | 2 | 1 | 1 | 7.95 | 3.5 | | | 11.45 | 22.9 | $ - 0 | $ - 0 |
| Pet Radiopharmacy | 3 | 1 | 3 | 10.6 | 10.5 | | | 21.1 | 42.2 | $ - 0 | $ - 0 |
| Pharmacy 3-1741 | 0 | 0 | 1 | 0 | 3.5 | | | 3.5 | 7 | $ - 0 | $ - 0 |
| CRC TIL | 2 | 0 | 7 | 5.3 | 24.5 | | | 29.8 | 59.6 | $ - 0 | $ - 0 |
| TOTALS | | | | | | | | | | | $ - 0 |
| FUTURE ROOM AND PEC CERTIFICATIONS | # OF ISO ROOMS | # OF CNC HEPA ROOMS | # OF PECs | ROOM CERTIFICATION HOURS + DOCUMENTATION | PEC CERTIFICATION HOURS + DOCUMENTATION | AVS (PHARMACY) | AVS DOCUMENTATION REVIEW | TOTAL HOURS | RATE ($) | HOURS | END OF CQV | 1ST CERTIFICATION DUE | 2021 COST | 2022 COST | 2023 COST | 2024 COST | 2025 COST | 2026 COST |
| E-IVAU | 6 | 3 | 4 | 23.85 | 14 | 16 | 30 | 83.85 | $ - 0 | 2 | 4/30/21 | 9/30/21 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| TIL Lab | 10 | 4 | 10 | 37.1 | 35 | 0 | 0 | 72.1 | $ - 0 | 2 | 10/30/21 | 3/30/22 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| Sterility Lab | 5 | 0 | 5 | 13.25 | 17.5 | 0 | 0 | 30.75 | $ - 0 | 2 | 12/30/21 | 5/30/22 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| Terrace Modules | 15 | 3 | 4 | 47.7 | 14 | 0 | 0 | 61.7 | $ - 0 | 2 | 12/30/21 | 5/30/22 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| P-IVAU | 29 | 5 | 12 | 90.1 | 42 | 48 | 60 | 240.1 | $ - 0 | 2 | 10/30/22 | 3/30/23 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| 12E | 24 | 10 | 16 | 90.1 | 56 | 0 | 0 | 146.1 | $ - 0 | 2 | 12/30/22 | 5/30/23 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| 29B | 2 | 2 | 1 | 10.6 | 3.5 | 0 | 0 | 14.1 | $ - 0 | 2 | 12/30/22 | 5/30/23 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| Radio pharmacy | 6 | 3 | 3 | 23.85 | 10.5 | 0 | 0 | 34.35 | $ - 0 | 2 | 2/28/23 | 7/30/23 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| TOTALS | | | | | | | | | | | | | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | $ - 0 |
| BASE PERIOD | MAY 01, 2021 TO APRIL 30, 2022 | |
| CONTRACT LINE ITEM NUMBER (CLIN) | DESCRIPTION OF SUPPLIES/SERVICES | TOTAL ESTIMATE |
| 0001 | Personnel | $ - 0 |
| 0002 | Current APFs (Calibration and Requalification) | $ - 0 |
| 0003 | Future APF (Calibration and Requalification) | $ - 0 |
| 0004 | Current APF (Room and PEC Certification | $ - 0 |
| 0005 | Future APF (Room and PEC Certification) | $ - 0 |
| TOTALS | | $ - 0 |
| BASE PERIOD (TOTAL AGGREGATE VALUE) | | $ - 0 |
| OPTION PERIOD #1 | MAY 01, 2022 TO APRIL 30, 2023 | |
| CONTRACT LINE ITEM NUMBER (CLIN) | DESCRIPTION OF SUPPLIES/SERVICES | TOTAL ESTIMATE |
| 1001 | Personnel | $ - 0 |
| 1002 | Current APFs (Calibration and Requalification) | $ - 0 |
| 1003 | Future APF (Calibration and Requalification) | $ - 0 |
| 1004 | Current APF (Room and PEC Certification | $ - 0 |
| 1005 | Future APF (Room and PEC Certification) | $ - 0 |
| TOTALS | | $ - 0 |
| OPTION PERIOD #1 (TOTAL AGGREGATE VALUE) | | $ - 0 |
| OPTION PERIOD #2 | MAY 01, 2023 TO APRIL 30, 2024 | |
| CONTRACT LINE ITEM NUMBER (CLIN) | DESCRIPTION OF SUPPLIES/SERVICES | TOTAL ESTIMATE |
| 2001 | Personnel | $ - 0 |
| 2002 | Current APFs (Calibration and Requalification) | $ - 0 |
| 2003 | Future APF (Calibration and Requalification) | $ - 0 |
| 2004 | Current APF (Room and PEC Certification | $ - 0 |
| 2005 | Future APF (Room and PEC Certification) | $ - 0 |
| TOTALS | | $ - 0 |
| OPTION PERIOD #2 (TOTAL AGGREGATE VALUE) | | $ - 0 |
| OPTION PERIOD #3 | MAY 01, 2024 TO APRIL 30, 2025 | |
| CONTRACT LINE ITEM NUMBER (CLIN) | DESCRIPTION OF SUPPLIES/SERVICES | TOTAL ESTIMATE |
| 3001 | Personnel | $ - 0 |
| 3002 | Current APFs (Calibration and Requalification) | $ - 0 |
| 3003 | Future APF (Calibration and Requalification) | $ - 0 |
| 3004 | Current APF (Room and PEC Certification | $ - 0 |
| 3005 | Future APF (Room and PEC Certification) | $ - 0 |
| TOTALS | | $ - 0 |
| OPTION PERIOD #3 (TOTAL AGGREGATE VALUE) | | $ - 0 |
| OPTION PERIOD #4 | MAY 01, 2025 TO APRIL 30, 2026 | |
| CONTRACT LINE ITEM NUMBER (CLIN) | DESCRIPTION OF SUPPLIES/SERVICES | TOTAL ESTIMATE |
| 4001 | Personnel | $ - 0 |
| 4002 | Current APFs (Calibration and Requalification) | $ - 0 |
| 4003 | Future APF (Calibration and Requalification) | $ - 0 |
| 4004 | Current APF (Room and PEC Certification | $ - 0 |
| 4005 | Future APF (Room and PEC Certification) | $ - 0 |
| TOTALS | | $ - 0 |
| OPTION PERIOD #4 (TOTAL AGGREGATE VALUE) | | $ - 0 |
TOTAL AGGREGATE CONTRACT VALUE $ - 0