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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 2b Authorization Agreement and Division of Responsibilities between CIRB and Signatory Institution	Form and Instruction	New	Available
Form 29 Adult Pharmacist's Review of a Cooperative Group Study	Form and Instruction	New	Available
Form 29 Reviewer Advertisement Checklist (Attach 6V)	Form and Instruction	New	Available
Form 28 Reviewer Worksheet of Translated Documents	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	Available
Form 23 Ped Expedited Continuing Review	Form and Instruction	New	Available
Form 22 Adult Expedited Continuing Review	Form and Instruction	New	Available
Form 21 Ped Expedited Amendment Review	Form and Instruction	New	Available
Form 21 Adult Expedited Amendment Review	Form and Instruction	New	Available
Form 20 Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN)	Form and Instruction	New	Available
Form 18 Application Request to Review Translated Documents	Form and Instruction	New	Available
Form 17 Locally-Developed Material Submission Form	Form and Instruction	New	Available
Form 16 Change of Signatory Institution PI Form	Form and Instruction	New	Available
Form 15 One Time Study Roll Over Worksheet	Form and Instruction	New	Repair queued
Form 14 Add or Remove Affiliate Institution	Form and Instruction	New	Repair queued
Form 13 Add or Remove Component Institution	Form and Instruction	New	Available
Form 2x Add or Remove Affiliate Institution Personnel	Form and Instruction	New	Repair queued
Form 11 Add or Remove Signatory and /or Component Institution Personnel	Form and Instruction	New	Available
Form 10 Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form	Form and Instruction	New	Available
Form 9 Study Closure or Transfer of Study Review Responsibility Form	Form and Instruction	New	Available
Form 8 Study-Specific Work sheet About Local Context	Form and Instruction	New	Available
Form 7 Annual Principal Investigator Worksheet ABout Local Context	Form and Instruction	New	Available
Form 3 Investigator at Affiliate Institution without IRB	Form and Instruction	New	Available
Form 2r Annual Institution Worksheet About Local Context	Form and Instruction	New	Available
Form 5 Institutional Contact for Signatory Institution	Form and Instruction	New	Repair queued
Form 4 Researcg Staff at Affiliate Institution without an IRB	Form and Instruction	New	Repair queued
Form 35 CIRB SAE Reviewer Worksheet	Form and Instruction	Removed	Available
Form 6k CIRB Statistical Reviewer Form	Form and Instruction	Modified	Available
Form 2 Pediatric Pharmacist's Review of a Cooperative Group Study	Form and Instruction	Modified	Repair queued
Form 6d Pediatric Continuing Review of Cooperative Group Protocol	Form and Instruction	Modified	Available
Form 6c Adult Continuing Review of Cooperative Group Protocol	Form and Instruction	Modified	Available
Form 6f Pediatric Amendment of Cooperative Group Protocol	Form and Instruction	Modified	Available
Form 6e Adult Amendment of Cooperative Group Protocol	Form and Instruction	Modified	Available
Form 6h Pediatric Cooperative Group Response to CIRB Review	Form and Instruction	Modified	Available
Form 6g Adult Cooperative Group Response to CIRB Review	Form and Instruction	Modified	Available
Form 6b Pediatric Initial Review of Cooperative Group Protocol	Form and Instruction	Modified	Available
Form 6a Adult Initial Review of Cooperative Group Protocol	Form and Instruction	Modified	Repair queued
Form 5c NCI Adult/Pediatric CIRB Application for Continuing Review	Form and Instruction	Modified	Available
Form 5d Summary of CIRB Application Revisions	Form and Instruction	Modified	Available
Form 22 Adult/Pediatric CIRB Application - Ancillary Studies	Form and Instruction	Modified	Available
Form 21a NCI Pediatric CIRB Application	Form and Instruction	Removed	Available
Form 21a NCI Pediatric CIRB Application	Form and Instruction	Removed	Available
Form 21 NCI Pediatric CIRB Application	Form and Instruction	Removed	Available
Form 5a NCI Adult/Pediatric CIRB Application for Treatment Studies	Form and Instruction	Modified	Repair queued
Form 3e CIRB Board Member Non-Disclosure Agreement (NDA)	Form and Instruction	Modified	Available
Form 4 CIRB Direct Deposit Form	Form and Instruction	Modified	Available
Form 3d CIRB Board Member W-9	Form and Instruction	Modified	Available
Form 3c CIRB Board Member Contact Information Form	Form and Instruction	Modified	Available
Form 3b CIRB Board Member Biographical Sketch Form	Form and Instruction	Modified	Available
Form 2q Study Review Responsibility Transfer Form	Form and Instruction	Modified	Available
Form 2p Facilitated Review Acceptance Form	Form and Instruction	Modified	Available
Form 2a Request for 30 Day Website Access Form	Form and Instruction	Modified	Available
Form 2o Affiliate Institution without an IRB	Form and Instruction	Modified	Available
Form 2n IRB at Affiliate Institution	Form and Instruction	Modified	Repair queued
Form 2m Component Institution at Signatory Institution	Form and Instruction	Modified	Available
Form 2l IRB at Signatory Institution	Form and Instruction	Modified	Available
Form 2h Research Staff at Affiliate Institution with an IRB	Form and Instruction	Modified	Available
Form 2g Investigator at Affiliate Institution with an IRB	Form and Instruction	Modified	Repair queued
Form 2f Research Staff at Signatory Institution	Form and Instruction	Modified	Available
Form 2e Investigator at Signatory Institution	Form and Instruction	Modified	Available
Form 2d IRB Staff at Signatory Institution's IRB	Form and Instruction	Modified	Available
Form 2c NCI CIRB Signatory	Form and Instruction	Modified	Available
Form 1 Survey (Attachment 1B)	Form and Instruction	Modified	Available
SSB_CIRB_11-13-2013.docx	Supporting Statement B	Uploaded 2013-11-13	Available
3J Template Letter_CanQual&COI.doc	Supplementary Document	Uploaded 2013-11-18	Available
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	Available
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	Available
9_CIRB_PIA.pdf	Supplementary Document	Uploaded 2013-11-18	Available
1A_Email Invite.pdf	Supplementary Document	Uploaded 2013-11-18	Available
Cover Memo_11-7-2013.docx	Supplementary Document	Uploaded 2013-11-18	Available
3N-Q Internal Operations.doc	Supplementary Document	Uploaded 2013-11-07	Available
8_OHSR Determination_CIRB.pdf	Supplementary Document	Uploaded 2013-11-07	Available
7_Privacy Act Memo.docm	Supplementary Document	Uploaded 2013-11-07	Repair queued
1A_Survey Email.pdf	Supplementary Document	Uploaded 2013-11-13	Available
SSA_CIRB_11-18-2013.docx	Supporting Statement A	Uploaded 2013-11-18	Available

IC Document Collections

Information collection document groups

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

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
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/22/2013
Terms of Clearance:

table that charts list comparision

	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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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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