| Form Name | Type of Respondent | Number of Respondents1 | Number of Responses per Respondent2 | Number of Respondents x Number of Responses | Average Burden Per Response (in hours)3 |
Total Annual Burden Hour - Corrected | Hourly Wage Rate | Total Cost - Corrected | Total Cost - Corrected |
| CTSU IRB/Regulatory Approval Transmittal Form (Attachment A01) | Health Care Practitioner | 2,444 | 12 | 29,328 | 2/60 | 978 | $46.52 | $45,496.56 | $45,496.56 |
| CTSU IRB Certification Form (Attachment A02) | Health Care Practitioner | 2,444 | 12 | 29,328 | 10/60 | 4,888 | $46.52 | $227,389.76 | $227,389.76 |
| Withdrawal from Protocol Participation Form (Attachment A03) | Health Care Practitioner | 279 | 1 | 279 | 10/60 | 47 | $46.52 | $2,186.44 | $2,186.44 |
| Site Addition Form (Attachment A04) | Health Care Practitioner | 80 | 12 | 960 | 10/60 | 160 | $46.52 | $7,443.20 | $7,443.20 |
| CTSU Request for Clinical Brochure (Attachment A06) | Health Care Practitioner | 360 | 1 | 360 | 10/60 | 60 | $46.52 | $2,791.20 | $2,791.20 |
| CTSU Supply Request Form (Attachment A07) | Health Care Practitioner | 90 | 12 | 1,080 | 10/60 | 180 | $46.52 | $8,373.60 | $8,373.60 |
| RTOG-0834 CTSU Data Transmittal Form (Attachment A10) | Health Care Practitioner | 30 | 2 | 60 | 5/60 | 5 | $46.52 | $232.60 | $232.60 |
| CTSU Patient Enrollment Transmittal Form (Attachment A15) | Health Care Practitioner | 12 | 12 | 144 | 10/60 | 24 | $46.52 | $1,116.48 | $1,116.48 |
| CTSU Transfer Form (Attachment A16) | Health Care Practitioner | 360 | 2 | 720 | 10/60 | 120 | $46.52 | $5,582.40 | $5,582.40 |
| CTSU OPEN Rave Request Form (Attachment A18) | Health Care Practitioner | 30 | 21 | 630 | 10/60 | 105 | $46.52 | $4,884.60 | $4,884.60 |
| CTSU LPO Form Creation (Attachment A19) | Health Care Practitioner | 5 | 2 | 10 | 2 | 20 | $46.52 | $930.40 | $930.40 |
| CTSU DTL Site Form Creation (Attachment A20) | Health Care Practitioner | 400 | 10 | 4,000 | 30/60 | 2,000 | $46.52 | $93,040.00 | $93,040.00 |
| CTSU DTL Electronic Signature Form (Attachment A21) | Health Care Practitioner | 400 | 10 | 4,000 | 10/60 | 667 | $46.52 | $31,028.84 | $31,028.84 |
| CTSU CLASS Course Setup Form (Attachment A22) | Health Care Practitioner | 10 | 2 | 20 | 20/60 | 7 | $46.52 | $325.64 | $325.64 |
| CTSU LPO Approval for Early Closure Form (Attachment A23) | Health Care Practitioner | 2,444 | 6 | 14,664 | 20/60 | 4,888 | $46.52 | $227,389.76 | $227,389.76 |
| International DTL Signing (Attachment A24) | Health Care Practitioner | 29 | 1 | 29 | 10/60 | 5 | $114.76 | $573.80 | $573.80 |
| NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B01) | Participants | 50 | 1 | 50 | 15/60 | 13 | $46.52 | $604.76 | $604.76 |
| NCI CIRB Signatory Enrollment Form (Attachment B02) | Participants | 50 | 1 | 50 | 15/60 | 13 | $46.52 | $604.76 | $604.76 |
| CIRB Board Member Application (Attachment B03) | Board Member | 100 | 1 | 100 | 30/60 | 50 | $46.52 | $2,326.00 | $2,326.00 |
| CIRB Member COI Screening Worksheet (Attachment B08) | Board Members | 100 | 1 | 100 | 15/60 | 25 | $114.76 | $2,869.00 | $2,869.00 |
| CIRB COI Screening for CIRB meetings (Attachment B09) | Board Members | 72 | 1 | 72 | 15/60 | 18 | $114.76 | $2,065.68 | $2,065.68 |
| CIRB IR Application (Attachment B10) | Health Care Practitioner | 80 | 1 | 80 | 1 | 80 | $46.52 | $3,721.60 | $3,721.60 |
| CIRB IR Application for Exempt Studies (Attachment B11) | Health Care Practitioner | 4 | 1 | 4 | 30/60 | 2 | $46.52 | $93.04 | $93.04 |
| CIRB Amendment Review Application (Attachment B12) | Health Care Practitioner | 400 | 1 | 400 | 15/60 | 100 | $46.52 | $4,652.00 | $4,652.00 |
| CIRB Ancillary Studies Application (Attachment B13) | Health Care Practitioner | 1 | 1 | 1 | 1 | 1 | $46.52 | $46.52 | $46.52 |
| CIRB Continuing Review Application (Attachment B14) | Health Care Practitioner | 400 | 1 | 400 | 15/60 | 100 | $46.52 | $4,652.00 | $4,652.00 |
| Adult IR of Cooperative Group Protocol (Attachment B15) | Board Members | 65 | 1 | 65 | 3 | 195 | $114.76 | $22,378.20 | $22,378.20 |
| Pediatric IR of Cooperative Group Protocol (Attachment B16) | Board Members | 15 | 1 | 15 | 3 | 45 | $114.76 | $5,164.20 | $5,164.20 |
| Adult Continuing Review of Cooperative Group Protocol (Attachment B17) | Board Members | 275 | 1 | 275 | 1 | 275 | $114.76 | $31,559.00 | $31,559.00 |
| Adult Amendment of Cooperative Group Protocol (Attachment B19) | Board Members | 40 | 1 | 40 | 2 | 80 | $114.76 | $9,180.80 | $9,180.80 |
| Pediatric Amendment of Cooperative Group Protocol (Attachment B20) | Board Members | 25 | 1 | 25 | 2 | 50 | $114.76 | $5,738.00 | $5,738.00 |
| Pharmacist's Review of a Cooperative Group Study (Attachment B21) | Board Members | 50 | 1 | 50 | 2 | 100 | $114.76 | $11,476.00 | $11,476.00 |
| Adult Expedited Amendment Review (Attachment B23) | Board Members | 348 | 1 | 348 | 30/60 | 174 | $114.76 | $19,968.24 | $19,968.24 |
| Pediatric Expedited Amendment Review (Attachment B24) | Board Members | 140 | 1 | 140 | 30/60 | 70 | $114.76 | $8,033.20 | $8,033.20 |
| Adult Expedited Continuing Review (Attachment B25) | Board Members | 140 | 1 | 140 | 30/60 | 70 | $114.76 | $8,033.20 | $8,033.20 |
| Pediatric Expedited Continuing Review (Attachment B26) | Board Members | 36 | 1 | 36 | 30/60 | 18 | $114.76 | $2,065.68 | $2,065.68 |
| Adult Cooperative Group Response to CIRB Review (Attachment B27) | Health Care Practitioner | 30 | 1 | 30 | 1 | 30 | $46.52 | $1,395.60 | $1,395.60 |
| Pediatric Cooperative Group Response to CIRB Review (Attachment B28) | Health Care Practitioner | 5 | 1 | 5 | 1 | 5 | $46.52 | $232.60 | $232.60 |
| Adult Expedited Study Chair Response to Required Modifications (Attachment B29) | Board Members | 40 | 1 | 40 | 30/60 | 20 | $114.76 | $2,295.20 | $2,295.20 |
| Reviewer Worksheet- Determination of UP or SCN (Attachment B31) | Board Members | 400 | 1 | 400 | 10/60 | 67 | $114.76 | $7,688.92 | $7,688.92 |
| Reviewer Worksheet -CIRB Statistical Reviewer Form (Attachment B32) | Board Members | 100 | 1 | 100 | 15/60 | 25 | $114.76 | $2,869.00 | $2,869.00 |
| CIRB Application for Translated Documents (Attachment B33) | Health Care Practitioner | 100 | 1 | 100 | 30/60 | 50 | $46.52 | $2,326.00 | $2,326.00 |
| Reviewer Worksheet of Translated Documents (Attachment B34) | Board Members | 100 | 1 | 100 | 15/60 | 25 | $114.76 | $2,869.00 | $2,869.00 |
| Reviewer Worksheet of Recruitment Material (Attachment B35) | Board Members | 20 | 1 | 20 | 15/60 | 5 | $114.76 | $573.80 | $573.80 |
| Reviewer Worksheet Expedited Study Closure Review (Attachment B36) | Board Members | 20 | 1 | 20 | 15/60 | 5 | $114.76 | $573.80 | $573.80 |
| Reviewer Worksheet of Expedited IR (Attachment B38) | Board Members | 5 | 1 | 5 | 30/60 | 3 | $114.76 | $344.28 | $344.28 |
| Annual Signatory Institution Worksheet About Local Context (Attachment B40) | Health Care Practitioner | 400 | 1 | 400 | 40/60 | 267 | $46.52 | $12,420.84 | $12,420.84 |
| Annual Principal Investigator Worksheet About Local Context (Attachment B41) | Health Care Practitioner | 1,800 | 1 | 1,800 | 20/60 | 600 | $114.76 | $68,856.00 | $68,856.00 |
| Study-Specific Worksheet About Local Context (Attachment B42) | Health Care Practitioner | 4,800 | 1 | 4,800 | 15/60 | 1,200 | $46.52 | $55,824.00 | $55,824.00 |
| Study Closure or Transfer of Study Review Responsibility (Attachment B43) | Health Care Practitioner | 1,680 | 1 | 1,680 | 15/60 | 420 | $46.52 | $19,538.40 | $19,538.40 |
| Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attachment B44) | Health Care Practitioner | 360 | 1 | 360 | 20/60 | 120 | $46.52 | $5,582.40 | $5,582.40 |
| Change of Signatory Institution PI Form (Attachment B45) | Health Care Practitioner | 120 | 1 | 120 | 20/60 | 40 | $46.52 | $1,860.80 | $1,860.80 |
| Request Waiver of Assent Form (Attachment B46) | Health Care Practitioner | 35 | 1 | 35 | 20/60 | 12 | $46.52 | $558.24 | $558.24 |
| CIRB Waiver of Consent Request Supplemental Form (Attachment B47) | Health Care Practitioner | 20 | 1 | 20 | 15/60 | 5 | $46.52 | $232.60 | $232.60 |
| Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48) | Board Members | 20 | 1 | 20 | 1 | 20 | $46.52 | $930.40 | $930.40 |
| Notification of Incarcerated Participant Form (B49) | Health Care Practitioner | 20 | 1 | 20 | 20/60 | 7 | $46.52 | $325.64 | $325.64 |
| Final Video Submission Posting Form (Attachment B50) | Health Care Practitioner | 80 | 1 | 80 | 15/60 | 20 | $46.52 | $930.40 | $930.40 |
| Unanticipated Problem or Serious or Continuing Noncompliance Application (Attachment B52) | Health Care Practitioner | 20 | 1 | 20 | 30/60 | 10 | $46.52 | $465.20 | $465.20 |
| CIRB Customer Satisfaction Survey (Attachment C04) | Participants | 600 | 1 | 600 | 15/60 | 150 | $46.52 | $6,978.00 | $6,978.00 |
| Follow-up Survey (Communication Audit) (Attachment C05) | Participants/Board Members | 300 | 1 | 300 | 15/60 | 75 | $46.52 | $3,489.00 | $3,489.00 |
| CIRB Board Member Annual Assessment Survey (Attachment C07) | Board Members | 60 | 1 | 60 | 15/60 | 15 | $114.76 | $1,721.40 | $1,721.40 |
| PIO Customer Satisfaction Survey (Attachment C08) | Health Care Practitioner | 60 | 1 | 60 | 5/60 | 5 | $46.52 | $232.60 | $232.60 |
| Audit Scheduling Form (Attachment D01) | Health Care Practitioner | 229 | 5 | 1,145 | 21/60 | 401 | $46.52 | $18,654.52 | $18,654.52 |
| Preliminary Audit Finding Form (Attachment D02) | Health Care Practitioner | 229 | 5 | 1,145 | 10/60 | 191 | $46.52 | $8,885.32 | $8,885.32 |
| Audit Maintenance Form (Attachment D03) | Health Care Practitioner | 158 | 5 | 790 | 9/60 | 119 | $46.52 | $5,535.88 | $5,535.88 |
| Final Audit Finding Report Form (Attachment D04) | Health Care Practitioner | 110 | 11 | 1,210 | 18 18/60 | 22,143 | $46.52 | $1,030,092.36 | $1,030,092.36 |
| Follow-up Form (Attachment D05) | Health Care Practitioner | 44 | 7 | 308 | 27/60 | 139 | $46.52 | $6,466.28 | $6,466.28 |
| Roster Maintenance Form (Attachment D06) | Health Care Practitioner | 7 | 1 | 7 | 18/60 | 2 | $46.52 | $93.04 | $93.04 |
| Final Report and CAPA Request Form (Attachment D07) | Health Care Practitioner | 3 | 9 | 27 | 30 | 810 | $46.52 | $37,681.20 | $37,681.20 |
| NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) | Physician | 26,500 | 1 | 26,500 | 15/60 | 6,625 | $114.76 | $760,285.00 | $760,285.00 |
| NCI/DCTD/CTE Biosketch (Attachment E02) | Physician; Health Care Practitioner | 48,000 | 1 | 48,000 | 2 | 96,000 | $73.81 | $7,085,760.00 | $7,085,760.00 |
| NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03) | Physician; Health Care Practitioner | 48,000 | 1 | 48,000 | 15/60 | 12,000 | $73.81 | $885,720.00 | $885,720.00 |
| NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04) | Physician | 24,000 | 1 | 24,000 | 10/60 | 4,000 | $114.76 | $459,040.00 | $459,040.00 |
| Non-IND/Non-Treatment Registration Form (Attachment E05) | Physician | 1,000 | 1 | 1,000 | 1 | 1,000 | $114.76 | $114,760.00 | $114,760.00 |
| International Investigator Statement (Attachment E06) | Physician | 2,100 | 1 | 2,100 | 15/60 | 525 | $114.76 | $60,249.00 | $60,249.00 |
| Basic Study Information Form (Attachment F01) | Health Care Practitioner | 140 | 1 | 140 | 20/60 | 47 | $46.52 | $2,186.44 | $2,186.44 |
| ANNUALIZED TOTALS | 173,523 | 214 | 253,570 | 162,836 | 11,480,540.32 | 11,480,540.32 | |||
| Years Requested6 = | |||||||||
| Totals Over the Course of 3 Years = | 34,441,621 | ||||||||
| Notes: | |||||||||
| Bold outline of blocks within C, D, or E categories should match Table 12-1 - Estimated Annualized Burden Hours | |||||||||
| Bold outline of blocks within H & K categories should match Table 12-2 - Annualized Costs to Respondents | |||||||||
| Use Column D totals when there is only 1 response per respondent | |||||||||
| Use Column E totals when there is more than 1 response per respondent | |||||||||
| Staff | Grade/Step | Salary | % of Effort | Fringe (if applicable) | Total Cost to Gov't | |||||
| Federal Oversight | ||||||||||
| Associate Branch Chief, CTOIB | 14/10 | $181,216.00 | 50.000% | $90,608.00 | ||||||
| Chief, CTOIB | 15/10 | $191,900.00 | 50.000% | $95,950.00 | ||||||
| Head CIRB | 14/10 | $181,216.00 | 5.000% | $9,060.80 | ||||||
| Nurse Consultant, DCP CIRB Liaison | 14/10 | $181,216.00 | 5.000% | $9,060.80 | ||||||
| CTMB, Branch Chief | 15/10 | $191,900.00 | 25.000% | $47,975.00 | ||||||
| PMB, Branch Chief | 15/10 | $191,900.00 | 5.000% | $9,595.00 | ||||||
| Contractor Cost | $1,400,000.00 | |||||||||
| Travel | $0.00 | |||||||||
| Other | $0.00 | |||||||||
| Total Cost | $1,662,249.60 | |||||||||
| Salary Table 2024-DCB For the Locality Pay Area of Washington-Baltimore-Arlington, DC-MD-VA-WV-PA Effective January 2024 |
||||||||||
| Annual Rates by Grade and Step | ||||||||||
| Grade | Step 1 | Step 2 | Step 3 | Step 4 | Step 5 | Step 6 | Step 7 | Step 8 | Step 9 | Step 10 |
| 1 | $ 29,299 | $ 30,282 | $ 31,255 | $ 32,226 | $ 33,198 | $ 33,767 | $ 34,732 | $ 35,703 | $ 35,742 | $ 36,649 |
| 2 | 32,945 | 33,728 | 34,820 | 35,742 | 36,145 | 37,209 | 38,272 | 39,336 | 40,399 | 41,463 |
| 3 | 35,947 | 37,145 | 38,343 | 39,541 | 40,739 | 41,937 | 43,135 | 44,333 | 45,531 | 46,729 |
| 4 | 40,351 | 41,696 | 43,040 | 44,385 | 45,730 | 47,074 | 48,419 | 49,763 | 51,108 | 52,452 |
| 5 | 45,146 | 46,650 | 48,155 | 49,659 | 51,164 | 52,668 | 54,173 | 55,677 | 57,182 | 58,686 |
| 6 | 50,326 | 52,003 | 53,681 | 55,359 | 57,037 | 58,714 | 60,392 | 62,070 | 63,748 | 65,425 |
| 7 | 55,924 | 57,788 | 59,653 | 61,517 | 63,381 | 65,245 | 67,110 | 68,974 | 70,838 | 72,703 |
| 8 | 61,933 | 63,997 | 66,061 | 68,125 | 70,189 | 72,254 | 74,318 | 76,382 | 78,446 | 80,510 |
| 9 | 68,405 | 70,685 | 72,965 | 75,245 | 77,525 | 79,805 | 82,085 | 84,366 | 86,646 | 88,926 |
| 10 | 75,329 | 77,840 | 80,350 | 82,861 | 85,372 | 87,882 | 90,393 | 92,904 | 95,414 | 97,925 |
| 11 | 82,764 | 85,522 | 88,281 | 91,039 | 93,798 | 96,556 | 99,315 | 102,073 | 104,832 | 107,590 |
| 12 | 99,200 | 102,506 | 105,812 | 109,119 | 112,425 | 115,731 | 119,037 | 122,343 | 125,650 | 128,956 |
| 13 | 117,962 | 121,894 | 125,827 | 129,759 | 133,692 | 137,624 | 141,557 | 145,489 | 149,422 | 153,354 |
| 14 | 139,395 | 144,042 | 148,689 | 153,336 | 157,982 | 162,629 | 167,276 | 171,923 | 176,570 | 181,216 |
| 15 | 163,964 | 169,429 | 174,894 | 180,359 | 185,824 | 191,289 | 191,900 | 191,900 | 191,900 | 191,900 |
| File Type | application/vnd.openxmlformats-officedocument.spreadsheetml.sheet |
| File Modified | 0000-00-00 |
| File Created | 0000-00-00 |