78 FR 223 pgs. 69426-69428 - Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
Type: NOTICEVolume: 78Number: 223Pages: 69426 - 69428
Pages: 69426, 69427FR document: [FR Doc. 2013-27556 Filed 11-18-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: National Institutes of Health
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
SUMMARY:
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2013, Vol. 78, P. 52204 and allowed 60-days for public comment. There were no public comments received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
FOR FURTHER INFORMATION:
To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: CAPT Michael Montello, Pharm. D., MBA, Cancer Therapy Evaluation Program, Operations and Informatics Branch, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number 240-276-6080 or Email your request, including your address to: mike.montello@nih.gov . Formal requests for additional plans and instruments must be requested in writing.
Proposed Collection: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 0925-0625, Expiration Date 1/31/2014, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) provides a centralized approach to human subject protection and provides a cost efficient approach avoiding duplication of effort at each institution. The CIRB provides the services of a fully constituted IRB and provides a comprehensive and efficient mechanism to meet regulatory requirements pertaining to human subject protections including: initial reviews, continuing reviews, review of amendments, and adverse events. The Initiative consists of three central IRBs: Adult CIRB-late phase emphasis, Adult CIRB-early phase emphasis, and Pediatric CIRB. CIRB membership includes oncology physicians, surgeons, nurses, patient advocates, ethicists, statisticians, pharmacists, attorneys and other health professionals. The benefits of the CIRB Initiative reaches research participants, investigators and research staff, Institutional Review Boards (IRB), and Institutions. Benefits include: study participants having dedicated review of NCI-sponsored trials for participant protections, access to more trials more quickly and access to trials for rare diseases, accrual to trials begin more rapidly, ease of opening trials, elimination of need to submit study materials to local IRBs, and elimination of the need for a full board review. The benefits to the National Clinical Trials Network and Experimental Therapy-Clinical Trials Network include a cost efficient approach that avoids duplication of efforts at each institution. A variety of information collection tools are needed to support NCI's CIRB activities which include: worksheets, forms and a survey that is provided to all customers contacting the CIRB helpdesk.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,199.
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| Form name | Type of respondents | Number of respondents | Frequency of responses per respondent | Average burden per response (in hours) | Total annual burden hours |
|---|---|---|---|---|---|
| CIRB Customer Satisfaction Survey | Participants/Board Members | 1,500 | 1 | 10/60 | 250 |
| Request for 30 Day Website Access Form | Participants | 25 | 1 | 10/60 | 4 |
| Authorization Agreement and Division of Responsibilities between the NCI CIRB and Signatory Institution | Participants | 340 | 1 | 30/60 | 170 |
| NCI CIRB Signatory Enrollment Form | Participants | 40 | 1 | 4 | 160 |
| IRB Staff at Signatory Institution's IRB | Participants | 25 | 1 | 10/60 | 4 |
| Investigator at Signatory Institution | Participants | 65 | 1 | 10/60 | 11 |
| Research Staff at Signatory Institution | Participants | 65 | 1 | 10/60 | 11 |
| Investigator at Affiliate Institution with an IRB | Participants | 25 | 1 | 10/60 | 4 |
| Research Staff at Affiliate Institution with an IRB | Participants | 25 | 1 | 10/60 | 4 |
| Investigator at Affiliate Institution without an IRB | Participants | 25 | 1 | 10/60 | 4 |
| Research Staff at Affiliate Institution without an IRB | Participants | 25 | 1 | 10/60 | 4 |
| Institutional Contact for Signatory Institution | Participants | 65 | 1 | 10/60 | 11 |
| IRB at Signatory Institution | Participants | 25 | 1 | 10/60 | 4 |
| Component Institution at Signatory Institution | Participants | 65 | 1 | 10/60 | 11 |
| IRB at Affiliate Institution | Participants | 25 | 1 | 10/60 | 4 |
| Affiliate Institution without an IRB | Participants | 25 | 1 | 10/60 | 4 |
| Facilitated Review Acceptance Form | Participants | 300 | 1 | 10/60 | 50 |
| Study Review Responsibility Transfer Form | Participants | 80 | 1 | 10/60 | 13 |
| Annual Signatory Institution Worksheet About Local Context | Participants | 120 | 1 | 20/60 | 40 |
| Annual Principal Investigator Worksheet About Local Context | Participants | 120 | 1 | 20/60 | 40 |
| Study-Specific Worksheet About Local Context | Participants | 220 | 1 | 20/60 | 73 |
| Study Closure or Transfer of Study Review Responsibility Form | Participants | 120 | 1 | 10/60 | 20 |
| Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form | Participants | 120 | 1 | 15/60 | 30 |
| Add or Remove Signatory and/or Component Institution Personnel | Participants | 120 | 1 | 10/60 | 20 |
| Add or Remove Affiliate Institution Personnel | Participants | 120 | 1 | 10/60 | 20 |
| Add or Remove Component Institution | Participants | 120 | 1 | 10/60 | 20 |
| Add or Remove Affiliate Institution | Participants | 120 | 1 | 10/60 | 20 |
| One Time Study Roll Over Worksheet | Participants | 120 | 1 | 10/60 | 20 |
| Change of Signatory Institution PI Form | Participants | 120 | 1 | 10/60 | 20 |
| CIRB Board Member Biographical Sketch Form | Board Members | 25 | 1 | 15/60 | 6.25 |
| CIRB Board Member Contact Information Form | Board Members | 25 | 1 | 10/60 | 4 |
| CIRB Board Member W-9 | Board Members | 25 | 1 | 15/60 | 6 |
| CIRB Board Member Non-Disclosure Agreement (NDA) | Board Members | 25 | 1 | 10/60 | 4 |
| CIRB Direct Deposit Form | Board Members | 25 | 1 | 15/60 | 6 |
| NCI Adult/Pediatric CIRB Application for Treatment Studies | Participants | 25 | 1 | 2 | 50 |
| NCI Adult/Pediatric CIRB Application for Ancillary Studies | Participants | 10 | 1 | 2 | 20 |
| NCI Adult/Pediatric CIRB Application for Continuing Review | Participants | 80 | 1 | 1 | 80 |
| Summary of CIRB Application Revisions | Participants | 20 | 1 | 30/60 | 10 |
| Locally-Developed Material Submission Form | Participants | 15 | 1 | 15/60 | 4 |
| Application Request to Review Translated Documents | Participants | 15 | 1 | 15/60 | 4 |
| Adult Initial Review of Cooperative Group Protocol | Board Members | 15 | 1 | 4 | 60 |
| Pediatric Initial Review of Cooperative Group Protocol | Board Members | 15 | 1 | 4 | 60 |
| Adult Continuing Review of Cooperative Group Protocol | Board Members | 130 | 1 | 1 | 130 |
| Pediatric Continuing Review of Cooperative Group Protocol | Board Members | 70 | 1 | 1 | 70 |
| Adult Amendment of Cooperative Group Protocol | Board Members | 10 | 1 | 2 | 20 |
| Pediatric Amendment of Cooperative Group Protocol | Board Members | 10 | 1 | 2 | 20 |
| Adult Cooperative Group Response to CIRB Review | Participants | 15 | 1 | 1 | 15 |
| Pediatric Cooperative Group Response to CIRB Review | Participants | 10 | 1 | 1 | 10 |
| Adult Pharmacist's Review of a Cooperative Group Study | Board Members | 10 | 1 | 2 | 20 |
| Pediatric Pharmacist's Review of a Cooperative Group Study | Board Members | 20 | 1 | 2 | 40 |
| CIRB Statistical Reviewer Form | Board Members | 30 | 1 | 30/60 | 15 |
| Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) | Board Members | 40 | 1 | 10/60 | 7 |
| Adult Expedited Amendment Review | Board Members | 350 | 1 | 30/60 | 175 |
| Ped Expedited Amendment Review | Board Members | 150 | 1 | 30/60 | 75 |
| Adult Expedited Continuing Review | Board Members | 120 | 1 | 30/60 | 60 |
| Ped Expedited Continuing Review | Board Members | 70 | 1 | 30/60 | 35 |
| Adult Expedited Study Closure | Board Members | 20 | 1 | 20/60 | 7 |
| Ped Expedited Study Closure | Board Members | 20 | 1 | 20/60 | 7 |
| Adult Expedited Study Chair Response to Required Mod | Board Members | 350 | 1 | 15/60 | 88 |
| Ped Expedited Study Chair Response to Required Mod | Board Members | 150 | 1 | 15/60 | 38 |
| Reviewer Worksheet of Translated Documents | Board Members | 15 | 1 | 15/60 | 4 |
| Reviewer Advertisement Checklist | Board Members | 10 | 1 | 20/60 | 3 |
Dated: November 7, 2013.
Vivian Horovitch-Kelley,
Program Analyst, National Institutes of Health.
[FR Doc. 2013-27556 Filed 11-18-13; 8:45 am]
BILLING CODE 4140-01-P