Proposed Collection; 60-day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

Federal Register, Volume 78 Issue 163 (Thursday, August 22, 2013)

Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)

Notices

Pages 52204-52206

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2013-20415

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, 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.

Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

Proposed Collection: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 0925-0625, 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.

Page 52205

Estimates of Annual Burden Hours

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Frequency of Average burden

Form name Type of respondents Number of responses per per response Total annual

respondents respondent (in hours) burden hours

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CIRB Customer Satisfaction Survey.............. Participants/Board Members............. 1500 1 10/60 250

Request for 30 Day Web site Access Form........ Participants........................... 25 1 10/60 4

Authorization Agreement and Division of Participants........................... 340 1 30/60 170

Responsibilities between the NCI CIRB and

Signatory Institution.

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 Participants........................... 25 1 10/60 4

IRB.

Research Staff at Affiliate Institution with an Participants........................... 25 1 10/60 4

IRB.

Investigator at Affiliate Institution without Participants........................... 25 1 10/60 4

an IRB.

Research Staff at Affiliate Institution without Participants........................... 25 1 10/60 4

an IRB.

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 Participants........................... 120 1 20/60 40

Local Context.

Annual Principal Investigator Worksheet About Participants........................... 120 1 20/60 40

Local Context.

Study-Specific Worksheet About Local Context... Participants........................... 220 1 20/60 73

Study Closure or Transfer of Study Review Participants........................... 120 1 10/60 20

Responsibility Form.

Potential Unanticipated Problem or Serious or Participants........................... 120 1 15/60 30

Continuing Noncompliance Reporting Form.

Add or Remove Signatory and/or Component Participants........................... 120 1 10/60 20

Institution Personnel.

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 Board Members.......................... 25 1 10/60 4

(NDA).

CIRB Direct Deposit Form....................... Board Members.......................... 25 1 15/60 6

NCI Adult/Pediatric CIRB Application for Participants........................... 25 1 2 50

Treatment Studies.

NCI Adult/Pediatric CIRB Application for Participants........................... 10 1 2 20

Ancillary Studies.

NCI Adult/Pediatric CIRB Application for Participants........................... 80 1 1 80

Continuing Review.

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 Participants........................... 15 1 15/60 4

Documents.

Adult Initial Review of Cooperative Group Board Members.......................... 15 1 4 60

Protocol.

Pediatric Initial Review of Cooperative Group Board Members.......................... 15 1 4 60

Protocol.

Adult Continuing Review of Cooperative Group Board Members.......................... 130 1 1 130

Protocol.

Pediatric Continuing Review of Cooperative Board Members.......................... 70 1 1 70

Group Protocol.

Adult Amendment of Cooperative Group Protocol.. Board Members.......................... 10 1 2 20

Pediatric Amendment of Cooperative Group Board Members.......................... 10 1 2 20

Protocol.

Adult Cooperative Group Response to CIRB Review Participants........................... 15 1 1 15

Pediatric Cooperative Group Response to CIRB Participants........................... 10 1 1 10

Review.

Adult Pharmacist's Review of a Cooperative Board Members.......................... 10 1 2 20

Group Study.

Pediatric Pharmacist's Review of a Cooperative Board Members.......................... 20 1 2 40

Group Study.

CIRB Statistical Reviewer Form................. Board Members.......................... 30 1 30/60 15

Determination of Unanticipated Problem (UP) and/ Board Members.......................... 40 1 10/60 7

or Serious or Continuing Noncompliance (SCN).

Adult Expedited Amendment Review............... Board Members.......................... 350 1 30/60 175

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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 Board Members.......................... 350 1 15/60 88

Required Mod.

Ped Expedited Study Chair Response to Required Board Members.......................... 150 1 15/60 38

Mod.

Reviewer Worksheet of Translated Documents..... Board Members.......................... 15 1 15/60 4

Reviewer Advertisement Checklist............... Board Members.......................... 10 1 20/60 3

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Dated: August 15, 2013.

Vivian Horovitch-Kelley,

Program Analyst, National Institutes of Health.

FR Doc. 2013-20415 Filed 8-21-13; 8:45 am

BILLING CODE 4140-01-P