NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

Forms and Documents

Document	Type	Status	Availability
Form 2b Authorization Agreement and Division of Responsibilities b/w NCI CIRB and Signatory Institution (Attach 2B)	Form and Instruction	New	Available
Form 29 Adult Pharmacist's Review of a Cooperative Group Study (Attach 6I)	Form and Instruction	New	Repair queued
Form 29 Reviewer Advertisement Checklist (Attach 6V)	Form and Instruction	New	Repair queued
Form 28 Reviewer Worksheet of Translated Documents (Attach 6U)	Form and Instruction	New	Available
Form 27 Ped Expedited Study Chair Response to Required Mod (Attach 6T)	Form and Instruction	New	Available
Form 26 Adult Expedited Study Chair Response to Required Mod (Attach 6S)	Form and Instruction	New	Available
Form 25 Ped Expedited Study Closure (Attach 6R)	Form and Instruction	New	Available
Form 24 Adult Expedited Study Closure (Attach 6Q)	Form and Instruction	New	Repair queued
Form 23 Ped Expedited Continuing Review (Attach 6P)	Form and Instruction	New	Repair queued
Form 22 Adult Expedited Continuing Review (Attach 6O)	Form and Instruction	New	Repair queued
Form 21 Ped Expedited Amendment Review (Attach 6N)	Form and Instruction	New	Repair queued
Form 21 Adult Expedited Amendment Review (Attach 6M)	Form and Instruction	New	Available
Form 20 Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) (Attach 6L)	Form and Instruction	New	Repair queued
Form 18 Application Request to Review Translated Documents (Attach 5F)	Form and Instruction	New	Available
Form 17 Locally-Developed Material Submission Form (Attach 5E)	Form and Instruction	New	Repair queued
Form 16 Change of Signatory Institution PI Form (Attach 2ZB)	Form and Instruction	New	Repair queued
Form 15 One Time Study Roll Over Worksheet (Attach 2ZA)	Form and Instruction	New	Repair queued
Form 14 Add or Remove Affiliate Institution (Attach 2Z)	Form and Instruction	New	Repair queued
Form 13 Add or Remove Component Institution (Attach 2Y)	Form and Instruction	New	Repair queued
Form 2x Add or Remove Affiliate Institution Personnel (Attach 2X)	Form and Instruction	New	Repair queued
Form 11 Add or Remove Signatory and /or Component Institution Personnel (Attach 2W)	Form and Instruction	New	Repair queued
Form 10 Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach 2V)	Form and Instruction	New	Available
Form 9 Study Closure or Transfer of Study Review Responsibility Form (Attach 2U)	Form and Instruction	New	Repair queued
Form 8 Study-Specific Worksheet About Local Context (Atttach 2T)	Form and Instruction	New	Repair queued
Form 7 Annual Principal Investigator Worksheet About Local Context (Attach 2S)	Form and Instruction	New	Repair queued
Form 3 Investigator at Affiliate Institution without IRB (Attach 2I)	Form and Instruction	New	Repair queued
Form 2r Annual Institutional Worksheet About Local Context (Attach 2R)	Form and Instruction	New	Repair queued
Form 5 Institutional Contact for Signatory Institution (Attach 2K)	Form and Instruction	New	Repair queued
Form 4 Research Staff at Affiliated Institution without an IRB (Attach 2J)	Form and Instruction	New	Repair queued
Form 35 CIRB SAE Reviewer Worksheet (Attach 6K)	Form and Instruction	Removed	Repair queued
Form 6k CIRB Statistical Reviewer Form (Attach 6K)	Form and Instruction	Modified	Repair queued
Form 2 Pediatric Pharmacist's Review of a Cooperative Group Study (Attach 6J)	Form and Instruction	Modified	Repair queued
Form 6d Pediatric Continuing Review of Cooperative Group Protocol (Attach 6D)	Form and Instruction	Modified	Repair queued
Form 6c Adult Continuing Review of Cooperative Group Protocol (Attach 6C)	Form and Instruction	Modified	Available
Form 6f Pediatric Amendment of Cooperative Group Protocol (Attach 6F)	Form and Instruction	Modified	Available
Form 6e Adult Amendment of Cooperative Group Protocol (Attach 6E)	Form and Instruction	Modified	Repair queued
Form 6h Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6H)	Form and Instruction	Modified	Available
Form 6g Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6G)	Form and Instruction	Modified	Repair queued
Form 6b Pediatric Initial Review of Cooperative Group Protocol (Attach 6B)	Form and Instruction	Modified	Repair queued
Form 6a Adult Initial Review of Cooperative Group Protocol (Attach 6A)	Form and Instruction	Modified	Repair queued
Form 5c Adult/Pediatric CIRB Application for Continuing Review (Attach 5C)	Form and Instruction	Modified	Available
Form 5d Summary of CIRB Application Revisions (Attach 5D)	Form and Instruction	Modified	Repair queued
Form 22 Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5B )	Form and Instruction	Modified	Repair queued
Form 21 NCI Pediatric CIRB Application (Attach 5B)	Form and Instruction	Removed	Repair queued
Form 5a NCI Adult CIRB Application and Adult-Peds Treatment Studies (Attach 5A)	Form and Instruction	Modified	Repair queued
Form 3e CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E)	Form and Instruction	Modified	Repair queued
Form 4 Direct Deposit Form (Attach 4)	Form and Instruction	Modified	Repair queued
Form 3d CIRB New Board Member W-9 (Attach 3D)	Form and Instruction	Modified	Repair queued
Form 3c CIRB New Board Member Contact Information Form (Attach 3C)	Form and Instruction	Modified	Repair queued
Form 3b CIRB New Board Member Biographical Sketch Form (Attach 3B)	Form and Instruction	Modified	Repair queued
Form 2q Study Review Responsibility Transfer Form (Attach 2Q)	Form and Instruction	Modified	Repair queued
Form 2p Facilitated Review Acceptance Form (FRAF) (Attach 2P)	Form and Instruction	Modified	Repair queued
Form 2a Request for 30-Day Access Form (Attach 2A)	Form and Instruction	Modified	Repair queued
Form 2o Institution Affiliate Institution without an IRB (Attach 2O)	Form and Instruction	Modified	Available
Form 2n IRB at Affiliate Institution (Attach 2N)	Form and Instruction	Modified	Repair queued
Form 2m Component Institution at Signatory Institution (Attach 2M)	Form and Instruction	Modified	Repair queued
Form 2l IRB at Signatory Institution (Attach 2L)	Form and Instruction	Modified	Repair queued
Form 2h Research Staff at Affiliate Institution (Attach 2H)	Form and Instruction	Modified	Repair queued
Form 2g Investigator at Affiliate Institution (Attach 2G)	Form and Instruction	Modified	Repair queued
Form 2f Research Staff at Signatory Institution (Attach 2F)	Form and Instruction	Modified	Repair queued
Form 2e Investigator at Signatory Institution (Attach 2E)	Form and Instruction	Modified	Repair queued
Form 2d IRB Staff at Signatory Institution's IRB (Attach 2D)	Form and Instruction	Modified	Repair queued
Form 2c NCI CIRB Institution Enrollment Worksheet (Attach 2C)	Form and Instruction	Modified	Repair queued
Form 1 CIRB Helpdesk Survey (Attach 1B)	Form and Instruction	Modified	Repair queued
SSB_CIRB_11-13-2013.docx	Supporting Statement B	Uploaded 2013-11-13	Repair queued
3J Template Letter_CanQual&COI.doc	Supplementary Document	Uploaded 2013-11-18	Repair queued
3K-M Template Letters_Notice&Thanks.doc	Supplementary Document	Uploaded 2013-11-18	Available
3H-I Template Letters-CanInterest.doc	Supplementary Document	Uploaded 2013-11-18	Repair queued
3G - CIRB_New BMO_PrivacyPolicy.doc	Supplementary Document	Uploaded 2013-11-18	Repair queued
3F - CIRB_New BMO_OrientSteps.doc	Supplementary Document	Uploaded 2013-11-18	Available
3A - CIRB_New BMO_WelcomeLet.doc	Supplementary Document	Uploaded 2013-11-18	Repair queued
9_CIRB_PIA.pdf	Supplementary Document	Uploaded 2013-11-18	Repair queued
1A_Email Invite.pdf	Supplementary Document	Uploaded 2013-11-18	Repair queued
Cover Memo_11-7-2013.docx	Supplementary Document	Uploaded 2013-11-18	Available
3N-Q Internal Operations.doc	Supplementary Document	Uploaded 2013-11-07	Repair queued
8_OHSR Determination_CIRB.pdf	Supplementary Document	Uploaded 2013-11-07	Repair queued
7_Privacy Act Memo.docm	Supplementary Document	Uploaded 2013-11-07	Repair queued
1A_Survey Email.pdf	Supplementary Document	Uploaded 2013-11-13	Repair queued
SSA_CIRB_11-18-2013.docx	Supporting Statement A	Uploaded 2013-11-18	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
209457	Authorization Agreement and Division of Responsibilities b/w NCI CIRB and Signatory Institution (Attach 2B)	Form and Instruction	New
209456	Adult Pharmacist's Review of a Cooperative Group Study (Attach 6I)	Form and Instruction	New
209455	Reviewer Advertisement Checklist (Attach 6V)	Form and Instruction	New
209454	Reviewer Worksheet of Translated Documents (Attach 6U)	Form and Instruction	New
209453	Ped Expedited Study Chair Response to Required Mod (Attach 6T)	Form and Instruction	New
209452	Adult Expedited Study Chair Response to Required Mod (Attach 6S)	Form and Instruction	New
209451	Ped Expedited Study Closure (Attach 6R)	Form and Instruction	New
209450	Adult Expedited Study Closure (Attach 6Q)	Form and Instruction	New
209449	Ped Expedited Continuing Review (Attach 6P)	Form and Instruction	New
209448	Adult Expedited Continuing Review (Attach 6O)	Form and Instruction	New
209447	Ped Expedited Amendment Review (Attach 6N)	Form and Instruction	New
209446	Adult Expedited Amendment Review (Attach 6M)	Form and Instruction	New
209445	Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) (Attach 6L)	Form and Instruction	New
209444	Application Request to Review Translated Documents (Attach 5F)	Form and Instruction	New
209443	Locally-Developed Material Submission Form (Attach 5E)	Form and Instruction	New
209442	Change of Signatory Institution PI Form (Attach 2ZB)	Form and Instruction	New
209441	One Time Study Roll Over Worksheet (Attach 2ZA)	Form and Instruction	New
209440	Add or Remove Affiliate Institution (Attach 2Z)	Form and Instruction	New
209439	Add or Remove Component Institution (Attach 2Y)	Form and Instruction	New
209438	Add or Remove Affiliate Institution Personnel (Attach 2X)	Form and Instruction	New
209437	Add or Remove Signatory and /or Component Institution Personnel (Attach 2W)	Form and Instruction	New
209436	Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach 2V)	Form and Instruction	New
209435	Study Closure or Transfer of Study Review Responsibility Form (Attach 2U)	Form and Instruction	New
209434	Study-Specific Worksheet About Local Context (Atttach 2T)	Form and Instruction	New
209433	Annual Principal Investigator Worksheet About Local Context (Attach 2S)	Form and Instruction	New
209432	Investigator at Affiliate Institution without IRB (Attach 2I)	Form and Instruction	New
209431	Annual Institutional Worksheet About Local Context (Attach 2R)	Form and Instruction	New
209430	Institutional Contact for Signatory Institution (Attach 2K)	Form and Instruction	New
209429	Research Staff at Affiliated Institution without an IRB (Attach 2J)	Form and Instruction	New
195558	CIRB SAE Reviewer Worksheet (Attach 6K)	Form and Instruction	Removed
195557	CIRB Statistical Reviewer Form (Attach 6K)	Form and Instruction	Modified
195556	Pediatric Pharmacist's Review of a Cooperative Group Study (Attach 6J)	Form and Instruction	Modified
195555	Pediatric Continuing Review of Cooperative Group Protocol (Attach 6D)	Form and Instruction	Modified
195554	Adult Continuing Review of Cooperative Group Protocol (Attach 6C)	Form and Instruction	Modified
195553	Pediatric Amendment of Cooperative Group Protocol (Attach 6F)	Form and Instruction	Modified
195552	Adult Amendment of Cooperative Group Protocol (Attach 6E)	Form and Instruction	Modified
195551	Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6H)	Form and Instruction	Modified
195550	Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6G)	Form and Instruction	Modified
195549	Pediatric Initial Review of Cooperative Group Protocol (Attach 6B)	Form and Instruction	Modified
195548	Adult Initial Review of Cooperative Group Protocol (Attach 6A)	Form and Instruction	Modified
195547	Adult/Pediatric CIRB Application for Continuing Review (Attach 5C)	Form and Instruction	Modified
195546	Summary of CIRB Application Revisions (Attach 5D)	Form and Instruction	Modified
195545	Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5B )	Form and Instruction	Modified
195544	NCI Pediatric CIRB Application (Attach 5B)	Form and Instruction	Removed
195543	NCI Adult CIRB Application and Adult-Peds Treatment Studies (Attach 5A)	Form and Instruction	Modified
195542	CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E)	Form and Instruction	Modified
195541	Direct Deposit Form (Attach 4)	Form and Instruction	Modified
195540	CIRB New Board Member W-9 (Attach 3D)	Form and Instruction	Modified
195539	CIRB New Board Member Contact Information Form (Attach 3C)	Form and Instruction	Modified
195538	CIRB New Board Member Biographical Sketch Form (Attach 3B)	Form and Instruction	Modified
195537	Study Review Responsibility Transfer Form (Attach 2Q)	Form and Instruction	Modified
195536	Facilitated Review Acceptance Form (FRAF) (Attach 2P)	Form and Instruction	Modified
195535	Request for 30-Day Access Form (Attach 2A)	Form and Instruction	Modified
195534	Institution Affiliate Institution without an IRB (Attach 2O)	Form and Instruction	Modified
195533	IRB at Affiliate Institution (Attach 2N)	Form and Instruction	Modified
195532	Component Institution at Signatory Institution (Attach 2M)	Form and Instruction	Modified
195531	IRB at Signatory Institution (Attach 2L)	Form and Instruction	Modified
195530	Research Staff at Affiliate Institution (Attach 2H)	Form and Instruction	Modified
195529	Investigator at Affiliate Institution (Attach 2G)	Form and Instruction	Modified
195528	Research Staff at Signatory Institution (Attach 2F)	Form and Instruction	Modified
195527	Investigator at Signatory Institution (Attach 2E)	Form and Instruction	Modified
195526	IRB Staff at Signatory Institution's IRB (Attach 2D)	Form and Instruction	Modified
195525	NCI CIRB Institution Enrollment Worksheet (Attach 2C)	Form and Instruction	Modified
195524	CIRB Helpdesk Survey (Attach 1B)	Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0625	ICR Reference No: 201311-0925-004
Status: Historical Active	Previous ICR Reference No: 201106-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 20880
Title: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/26/2013
	Date Received in OIRA: 11/22/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	36 Months From Approved	01/31/2014
Responses	6,085	0	5,044
Time Burden (Hours)	2,199	0	2,210
Cost Burden (Dollars)	0	0	0

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Abstract: 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 to support NCI's CIRB activities which include: worksheets, forms and a survey that is provided to all customers contacting the CIRB helpdesk.

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Authorizing Statute(s): US Code: 42 USC 411 (285a) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 52204	08/22/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 69426	11/19/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 62

IC Title	Form No.	Form Name
CIRB Helpdesk Survey (Attach 1B)	1	Survey (Attachment 1B)
NCI CIRB Institution Enrollment Worksheet (Attach 2C)	2c	NCI CIRB Signatory
Adult Continuing Review of Cooperative Group Protocol (Attach 6C)	6c	Adult Continuing Review of Cooperative Group Protocol
Pediatric Continuing Review of Cooperative Group Protocol (Attach 6D)	6d	Pediatric Continuing Review of Cooperative Group Protocol
Adult/Pediatric CIRB Application for Continuing Review (Attach 5C)	5c	NCI Adult/Pediatric CIRB Application for Continuing Review
Adult Initial Review of Cooperative Group Protocol (Attach 6A)	6a	Adult Initial Review of Cooperative Group Protocol
Pediatric Initial Review of Cooperative Group Protocol (Attach 6B)	6b	Pediatric Initial Review of Cooperative Group Protocol
Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6G)	6g	Adult Cooperative Group Response to CIRB Review
Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6H)	6h	Pediatric Cooperative Group Response to CIRB Review
Adult Amendment of Cooperative Group Protocol (Attach 6E)	6e	Adult Amendment of Cooperative Group Protocol
Pediatric Amendment of Cooperative Group Protocol (Attach 6F)	6f	Pediatric Amendment of Cooperative Group Protocol
Ped Expedited Study Closure (Attach 6R)	25	Ped Expedited Study Closure (Attach 6R)
Adult Expedited Study Chair Response to Required Mod (Attach 6S)	26	Adult Expedited Study Chair Response to Required Mod (Attach 6S)
Ped Expedited Study Chair Response to Required Mod (Attach 6T)	27	Ped Expedited Study Chair Response to Required Mod (Attach 6T)
Reviewer Worksheet of Translated Documents (Attach 6U)	28	Reviewer Worksheet of Translated Documents
Reviewer Advertisement Checklist (Attach 6V)	29	Reviewer Advertisement Checklist (Attach 6V)
Adult Pharmacist's Review of a Cooperative Group Study (Attach 6I)	29	Adult Pharmacist's Review of a Cooperative Group Study
Authorization Agreement and Division of Responsibilities b/w NCI CIRB and Signatory Institution (Attach 2B)	2b	Authorization Agreement and Division of Responsibilities between CIRB and Signatory Institution
NCI Pediatric CIRB Application (Attach 5B)	21, 21a, 21a	NCI Pediatric CIRB Application ,   NCI Pediatric CIRB Application ,   NCI Pediatric CIRB Application
CIRB SAE Reviewer Worksheet (Attach 6K)	35	CIRB SAE Reviewer Worksheet
Study Closure or Transfer of Study Review Responsibility Form (Attach 2U)	9	Study Closure or Transfer of Study Review Responsibility Form
Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach 2V)	10	Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form
Add or Remove Signatory and /or Component Institution Personnel (Attach 2W)	11	Add or Remove Signatory and /or Component Institution Personnel
Add or Remove Affiliate Institution Personnel (Attach 2X)	2x	Add or Remove Affiliate Institution Personnel
Add or Remove Component Institution (Attach 2Y)	13	Add or Remove Component Institution
Add or Remove Affiliate Institution (Attach 2Z)	14	Add or Remove Affiliate Institution
One Time Study Roll Over Worksheet (Attach 2ZA)	15	One Time Study Roll Over Worksheet
Change of Signatory Institution PI Form (Attach 2ZB)	16	Change of Signatory Institution PI Form
Ped Expedited Continuing Review (Attach 6P)	23	Ped Expedited Continuing Review
Adult Expedited Study Closure (Attach 6Q)	24	Adult Expedited Study Closure (Attach 6Q)
Locally-Developed Material Submission Form (Attach 5E)	17	Locally-Developed Material Submission Form
Application Request to Review Translated Documents (Attach 5F)	18	Application Request to Review Translated Documents
Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) (Attach 6L)	20	Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN)
Adult Expedited Amendment Review (Attach 6M)	21	Adult Expedited Amendment Review
Ped Expedited Amendment Review (Attach 6N)	21	Ped Expedited Amendment Review
Adult Expedited Continuing Review (Attach 6O)	22	Adult Expedited Continuing Review
IRB Staff at Signatory Institution's IRB (Attach 2D)	2d	IRB Staff at Signatory Institution's IRB
Investigator at Signatory Institution (Attach 2E)	2e	Investigator at Signatory Institution
Research Staff at Signatory Institution (Attach 2F)	2f	Research Staff at Signatory Institution
Investigator at Affiliate Institution (Attach 2G)	2g	Investigator at Affiliate Institution with an IRB
Research Staff at Affiliate Institution (Attach 2H)	2h	Research Staff at Affiliate Institution with an IRB
IRB at Signatory Institution (Attach 2L)	2l	IRB at Signatory Institution
Component Institution at Signatory Institution (Attach 2M)	2m	Component Institution at Signatory Institution
IRB at Affiliate Institution (Attach 2N)	2n	IRB at Affiliate Institution
Institution Affiliate Institution without an IRB (Attach 2O)	2o	Affiliate Institution without an IRB
Request for 30-Day Access Form (Attach 2A)	2a	Request for 30 Day Website Access Form
Facilitated Review Acceptance Form (FRAF) (Attach 2P)	2p	Facilitated Review Acceptance Form
Study Review Responsibility Transfer Form (Attach 2Q)	2q	Study Review Responsibility Transfer Form
CIRB New Board Member Biographical Sketch Form (Attach 3B)	3b	CIRB Board Member Biographical Sketch Form
CIRB New Board Member Contact Information Form (Attach 3C)	3c	CIRB Board Member Contact Information Form
CIRB New Board Member W-9 (Attach 3D)	3d	CIRB Board Member W-9
Direct Deposit Form (Attach 4)	4	CIRB Direct Deposit Form
CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E)	3e	CIRB Board Member Non-Disclosure Agreement (NDA)
NCI Adult CIRB Application and Adult-Peds Treatment Studies (Attach 5A)	5a	NCI Adult/Pediatric CIRB Application for Treatment Studies
Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5B )	22	Adult/Pediatric CIRB Application - Ancillary Studies
Summary of CIRB Application Revisions (Attach 5D)	5d	Summary of CIRB Application Revisions
Pediatric Pharmacist's Review of a Cooperative Group Study (Attach 6J)	2	Pediatric Pharmacist's Review of a Cooperative Group Study
CIRB Statistical Reviewer Form (Attach 6K)	6k	CIRB Statistical Reviewer Form
Research Staff at Affiliated Institution without an IRB (Attach 2J)	4	Researcg Staff at Affiliate Institution without an IRB
Institutional Contact for Signatory Institution (Attach 2K)	5	Institutional Contact for Signatory Institution
Annual Institutional Worksheet About Local Context (Attach 2R)	2r	Annual Institution Worksheet About Local Context
Investigator at Affiliate Institution without IRB (Attach 2I)	3	Investigator at Affiliate Institution without IRB
Annual Principal Investigator Worksheet About Local Context (Attach 2S)	7	Annual Principal Investigator Worksheet ABout Local Context
Study-Specific Worksheet About Local Context (Atttach 2T)	8	Study-Specific Work sheet About Local Context

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	6,085	5,044	0	1,041	0	0
Annual Time Burden (Hours)	2,199	2,210	0	-11	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

Short Statement: This is a request for a program change (i.e., considered a revision) that is the result of an agency's decision to make changes to the previously approved information collections. Initially, NCI CIRB review was conducted via a "facilitated review" process that streamlined local IRB review of adult and pediatric national multi-center cancer treatment trials. In 2012, the NCI conducted a pilot program to change the model for the NCI CIRBs to that of an independent model, which was well accepted. This pilot study was a generic sub-study under a separate OMB #: 0925-0046-16. This independent model is now the NCI CIRB operating model and all current members of the NCI CIRB will be transitioned over to the new model during 2013. Although there is an increase in the number of forms due in part to the new model and adding of a new board and the number of respondents (from 5,044 to 6,085 respondents; an increase of 1,181 respondents), the total burden has actually decreased by 121 hours (from 2,210 hours to 2,199 hours).

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Annual Cost to Federal Government: $239,771

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 11/22/2013

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