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 REV	Form and Instruction	Modified	Available
Form 6I Adult Pharmacist's Review of a Cooperative Group Study REV	Form and Instruction	Modified	Available
Form 6V Reviewer Advertisement Checklist REV	Form and Instruction	Modified	Available
Form 6U Reviewer Worksheet of Translated Documents REV	Form and Instruction	Modified	Available
Form 6T Ped Expedited Study Chair Response to Required Mod REV	Form and Instruction	Modified	Available
Form 6S Adult Expedited Study Chair Response to Required Mod REV	Form and Instruction	Modified	Available
Form 6R Ped Expedited Study Closure REV	Form and Instruction	Modified	Available
Form 6Q Adult Expedited Study Closure REV	Form and Instruction	Modified	Available
Form 6P Ped Expedited Continuing Review REV	Form and Instruction	Modified	Available
Form 6O Adult Expedited Continuing Review REV	Form and Instruction	Modified	Available
Form 6N Ped Expedited Amendment Review REV	Form and Instruction	Modified	Available
Form 6M Adult Expedited Amendment Review REV	Form and Instruction	Modified	Available
Form 6L Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) REV	Form and Instruction	Modified	Available
Form 18 Application for Translation Review	Form and Instruction	Modified	Available
Form 5E Locally-Developed Material Submission Form REV	Form and Instruction	Modified	Available
Form 2ZB Change of Signatory Institution PI Form REV	Form and Instruction	Modified	Available
Form 2ZA One Time Study Roll Over Worksheet REV	Form and Instruction	Modified	Available
Form 2Z Add or Remove Affiliate Institution REV	Form and Instruction	Modified	Available
Form 2Y Add or Remove Component Institution REV	Form and Instruction	Modified	Source copy available
Form 2X Add or Remove Affiliate Institution Personnel REV	Form and Instruction	Modified	Available
Form 2W Add or Remove Signatory and /or Component Institution Personnel REV	Form and Instruction	Modified	Available
Form 2V Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form REV	Form and Instruction	Modified	Available
Form 2U Study Closure or Transfer of Study Review Responsibility Form REV	Form and Instruction	Modified	Available
Form 2T Study-Specific Work sheet About Local Context REV	Form and Instruction	Modified	Available
Form 2S Annual Principal Investigator Worksheet ABout Local Context REV	Form and Instruction	Modified	Available
Form 2I Investigator at Affiliate Institution without IRB REV	Form and Instruction	Modified	Available
Form 2R Annual Institution Worksheet About Local Context REV	Form and Instruction	Modified	Available
Form 2K Institutional Contact for Signatory Institution REV	Form and Instruction	Modified	Available
Form 2J Research Staff at Affiliate Institution without an IRB REV	Form and Instruction	Modified	Available
Form 6K CIRB Statistical Reviewer Form REV	Form and Instruction	Modified	Available
Form 6J Pediatric Pharmacist's Review of a Cooperative Group Study REV	Form and Instruction	Modified	Available
Form 6D Pediatric Continuing Review of Cooperative Group Protocol REV	Form and Instruction	Modified	Available
Form 6C Adult Continuing Review of Cooperative Group Protocol REV	Form and Instruction	Modified	Available
Form 6F Pediatric Amendment of Cooperative Group Protocol REV	Form and Instruction	Modified	Available
Form 6E Adult Amendment of Cooperative Group Protocol REV	Form and Instruction	Modified	Available
Form 6H Pediatric Cooperative Group Response to CIRB Review REV	Form and Instruction	Modified	Available
Form 6G Adult Cooperative Group Response to CIRB Review REV	Form and Instruction	Modified	Available
Form 6B Pediatric Initial Review of Cooperative Group Protocol REV	Form and Instruction	Modified	Available
Form 6A Adult Initial Review of Cooperative Group Protocol REV	Form and Instruction	Modified	Available
Form 5C NCI Adult/Pediatric CIRB Application for Continuing Review REV	Form and Instruction	Modified	Available
Form 5D Summary of CIRB Application Revisions REV	Form and Instruction	Modified	Available
Form 5B Adult/Pediatric CIRB Application - Ancillary Studies REV	Form and Instruction	Modified	Available
Form 5A NCI Adult/Pediatric CIRB Application for Treatment Studies REV	Form and Instruction	Modified	Available
Form 3E CIRB Board Member Non-Disclosure Agreement (NDA) REV	Form and Instruction	Modified	Available
Form 4 CIRB Direct Deposit Form REV	Form and Instruction	Modified	Available
Form 3D CIRB Board Member W-9 REV	Form and Instruction	Modified	Available
Form 3C CIRB Board Member Contact Information Form REV	Form and Instruction	Modified	Available
Form 3B CIRB Board Member Biographical Sketch Form REV	Form and Instruction	Modified	Available
Form 2Q Study Review Responsibility Transfer Form REV	Form and Instruction	Modified	Available
Form 2P Facilitated Review Acceptance Form REV	Form and Instruction	Modified	Available
Form 2A Request for 30 Day Website Access Form REV	Form and Instruction	Modified	Available
Form 2O Affiliate Institution without an IRB REV	Form and Instruction	Modified	Available
Form 2N IRB at Affiliate Institution	Form and Instruction	Modified	Available
Form 2M Component Institution at Signatory Institution REV	Form and Instruction	Modified	Available
Form 2L IRB at Signatory Institution	Form and Instruction	Modified	Repair queued
Form 2H Research Staff at Affiliate Institution with an IRB REV	Form and Instruction	Modified	Available
Form 2G Investigator at Affiliate Institution with an IRB REV	Form and Instruction	Modified	Available
Form 2F Research Staff at Signatory Institution REV	Form and Instruction	Modified	Available
Form 2E Personnel Signatory Institution REV	Form and Instruction	Modified	Available
Form 2D IRB Staff at Signatory Institution's IRB REV	Form and Instruction	Modified	Available
Form 2C NCI IRB Enrollment Form REV	Form and Instruction	Modified	Available
Form 1 Survey (Attachment 1B)	Form and Instruction	Modified	Available
Change Request Memo_1-24-2014.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2014-01-24	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	Modified	Authorization Agreement and Division of Responsibilities between CIRB and Signatory Institution REV
209456	Adult Pharmacist's Review of a Cooperative Group Study (Attach 6I)	Form and Instruction	Modified	Adult Pharmacist's Review of a Cooperative Group Study REV
209455	Reviewer Advertisement Checklist (Attach 6V)	Form and Instruction	Modified	Reviewer Advertisement Checklist REV
209454	Reviewer Worksheet of Translated Documents (Attach 6U)	Form and Instruction	Modified	Reviewer Worksheet of Translated Documents REV
209453	Ped Expedited Study Chair Response to Required Mod (Attach 6T)	Form and Instruction	Modified	Ped Expedited Study Chair Response to Required Mod REV
209452	Adult Expedited Study Chair Response to Required Mod (Attach 6S)	Form and Instruction	Modified	Adult Expedited Study Chair Response to Required Mod REV
209451	Ped Expedited Study Closure (Attach 6R)	Form and Instruction	Modified	Ped Expedited Study Closure REV
209450	Adult Expedited Study Closure (Attach 6Q)	Form and Instruction	Modified	Adult Expedited Study Closure REV
209449	Ped Expedited Continuing Review (Attach 6P)	Form and Instruction	Modified	Ped Expedited Continuing Review REV
209448	Adult Expedited Continuing Review (Attach 6O)	Form and Instruction	Modified	Adult Expedited Continuing Review REV
209447	Ped Expedited Amendment Review (Attach 6N)	Form and Instruction	Modified	Ped Expedited Amendment Review REV
209446	Adult Expedited Amendment Review (Attach 6M)	Form and Instruction	Modified	Adult Expedited Amendment Review REV
209445	Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) (Attach 6L)	Form and Instruction	Modified	Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) REV
209444	Application Request to Review Translated Documents (Attach 5F)	Form and Instruction	Modified	Application for Translation Review
209443	Locally-Developed Material Submission Form (Attach 5E)	Form and Instruction	Modified	Locally-Developed Material Submission Form REV
209442	Change of Signatory Institution PI Form (Attach 2ZB)	Form and Instruction	Modified	Change of Signatory Institution PI Form REV
209441	One Time Study Roll Over Worksheet (Attach 2ZA)	Form and Instruction	Modified	One Time Study Roll Over Worksheet REV
209440	Add or Remove Affiliate Institution (Attach 2Z)	Form and Instruction	Modified	Add or Remove Affiliate Institution REV
209439	Add or Remove Component Institution (Attach 2Y)	Form and Instruction	Modified	Add or Remove Component Institution REV
209438	Add or Remove Affiliate Institution Personnel (Attach 2X)	Form and Instruction	Modified	Add or Remove Affiliate Institution Personnel REV
209437	Add or Remove Signatory and /or Component Institution Personnel (Attach 2W)	Form and Instruction	Modified	Add or Remove Signatory and /or Component Institution Personnel REV
209436	Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach 2V)	Form and Instruction	Modified	Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form REV
209435	Study Closure or Transfer of Study Review Responsibility Form (Attach 2U)	Form and Instruction	Modified	Study Closure or Transfer of Study Review Responsibility Form REV
209434	Study-Specific Worksheet About Local Context (Atttach 2T)	Form and Instruction	Modified	Study-Specific Work sheet About Local Context REV
209433	Annual Principal Investigator Worksheet About Local Context (Attach 2S)	Form and Instruction	Modified	Annual Principal Investigator Worksheet ABout Local Context REV
209432	Investigator at Affiliate Institution without IRB (Attach 2I)	Form and Instruction	Modified	Investigator at Affiliate Institution without IRB REV
209431	Annual Institutional Worksheet About Local Context (Attach 2R)	Form and Instruction	Modified	Annual Institution Worksheet About Local Context REV
209430	Institutional Contact for Signatory Institution (Attach 2K)	Form and Instruction	Modified	Institutional Contact for Signatory Institution REV
209429	Research Staff at Affiliated Institution without an IRB (Attach 2J)	Form and Instruction	Modified	Research Staff at Affiliate Institution without an IRB REV
195557	CIRB Statistical Reviewer Form (Attach 6K)	Form and Instruction	Modified	CIRB Statistical Reviewer Form REV
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 REV
195555	Pediatric Continuing Review of Cooperative Group Protocol (Attach 6D)	Form and Instruction	Modified	Pediatric Continuing Review of Cooperative Group Protocol REV
195554	Adult Continuing Review of Cooperative Group Protocol (Attach 6C)	Form and Instruction	Modified	Adult Continuing Review of Cooperative Group Protocol REV
195553	Pediatric Amendment of Cooperative Group Protocol (Attach 6F)	Form and Instruction	Modified	Pediatric Amendment of Cooperative Group Protocol REV
195552	Adult Amendment of Cooperative Group Protocol (Attach 6E)	Form and Instruction	Modified	Adult Amendment of Cooperative Group Protocol REV
195551	Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6H)	Form and Instruction	Modified	Pediatric Cooperative Group Response to CIRB Review REV
195550	Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6G)	Form and Instruction	Modified	Adult Cooperative Group Response to CIRB Review REV
195549	Pediatric Initial Review of Cooperative Group Protocol (Attach 6B)	Form and Instruction	Modified	Pediatric Initial Review of Cooperative Group Protocol REV
195548	Adult Initial Review of Cooperative Group Protocol (Attach 6A)	Form and Instruction	Modified	Adult Initial Review of Cooperative Group Protocol REV
195547	Adult/Pediatric CIRB Application for Continuing Review (Attach 5C)	Form and Instruction	Modified	NCI Adult/Pediatric CIRB Application for Continuing Review REV
195546	Summary of CIRB Application Revisions (Attach 5D)	Form and Instruction	Modified	Summary of CIRB Application Revisions REV
195545	Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5B )	Form and Instruction	Modified	Adult/Pediatric CIRB Application - Ancillary Studies REV
195543	NCI Adult CIRB Application and Adult-Peds Treatment Studies (Attach 5A)	Form and Instruction	Modified	NCI Adult/Pediatric CIRB Application for Treatment Studies REV
195542	CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E)	Form and Instruction	Modified	CIRB Board Member Non-Disclosure Agreement (NDA) REV
195541	Direct Deposit Form (Attach 4)	Form and Instruction	Modified	CIRB Direct Deposit Form REV
195540	CIRB New Board Member W-9 (Attach 3D)	Form and Instruction	Modified	CIRB Board Member W-9 REV
195539	CIRB New Board Member Contact Information Form (Attach 3C)	Form and Instruction	Modified	CIRB Board Member Contact Information Form REV
195538	CIRB New Board Member Biographical Sketch Form (Attach 3B)	Form and Instruction	Modified	CIRB Board Member Biographical Sketch Form REV
195537	Study Review Responsibility Transfer Form (Attach 2Q)	Form and Instruction	Modified	Study Review Responsibility Transfer Form REV
195536	Facilitated Review Acceptance Form (FRAF) (Attach 2P)	Form and Instruction	Modified	Facilitated Review Acceptance Form REV
195535	Request for 30-Day Access Form (Attach 2A)	Form and Instruction	Modified	Request for 30 Day Website Access Form REV
195534	Institution Affiliate Institution without an IRB (Attach 2O)	Form and Instruction	Modified	Affiliate Institution without an IRB REV
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 REV
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 REV
195529	Investigator at Affiliate Institution (Attach 2G)	Form and Instruction	Modified	Investigator at Affiliate Institution with an IRB REV
195528	Research Staff at Signatory Institution (Attach 2F)	Form and Instruction	Modified	Research Staff at Signatory Institution REV
195527	Investigator at Signatory Institution (Attach 2E)	Form and Instruction	Modified	Personnel Signatory Institution REV
195526	IRB Staff at Signatory Institution's IRB (Attach 2D)	Form and Instruction	Modified	IRB Staff at Signatory Institution's IRB REV
195525	NCI CIRB Institution Enrollment Worksheet (Attach 2C)	Form and Instruction	Modified	NCI IRB Enrollment Form REV
195524	CIRB Helpdesk Survey (Attach 1B)	Form and Instruction	Modified	Survey (Attachment 1B)

ICR Details

OMB Control No: 0925-0625	ICR Reference No: 201402-0925-001
Status: Historical Active	Previous ICR Reference No: 201311-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No: 21346
Title: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/20/2014
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/14/2014
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	12/31/2016	12/31/2016
Responses	6,085	0	6,085
Time Burden (Hours)	2,199	0	2,199
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

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)	2Z	Add or Remove Affiliate Institution REV
Add or Remove Affiliate Institution Personnel (Attach 2X)	2X	Add or Remove Affiliate Institution Personnel REV
Add or Remove Component Institution (Attach 2Y)	2Y	Add or Remove Component Institution REV
Add or Remove Signatory and /or Component Institution Personnel (Attach 2W)	2W	Add or Remove Signatory and /or Component Institution Personnel REV
Adult Amendment of Cooperative Group Protocol (Attach 6E)	6E	Adult Amendment of Cooperative Group Protocol REV
Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6G)	6G	Adult Cooperative Group Response to CIRB Review REV
Adult Continuing Review of Cooperative Group Protocol (Attach 6C)	6C	Adult Continuing Review of Cooperative Group Protocol REV
Adult Expedited Amendment Review (Attach 6M)	6M	Adult Expedited Amendment Review REV
Adult Expedited Continuing Review (Attach 6O)	6O	Adult Expedited Continuing Review REV
Adult Expedited Study Chair Response to Required Mod (Attach 6S)	6S	Adult Expedited Study Chair Response to Required Mod REV
Adult Expedited Study Closure (Attach 6Q)	6Q	Adult Expedited Study Closure REV
Adult Initial Review of Cooperative Group Protocol (Attach 6A)	6A	Adult Initial Review of Cooperative Group Protocol REV
Adult Pharmacist's Review of a Cooperative Group Study (Attach 6I)	6I	Adult Pharmacist's Review of a Cooperative Group Study REV
Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5B )	5B	Adult/Pediatric CIRB Application - Ancillary Studies REV
Adult/Pediatric CIRB Application for Continuing Review (Attach 5C)	5C	NCI Adult/Pediatric CIRB Application for Continuing Review REV
Annual Institutional Worksheet About Local Context (Attach 2R)	2R	Annual Institution Worksheet About Local Context REV
Annual Principal Investigator Worksheet About Local Context (Attach 2S)	2S	Annual Principal Investigator Worksheet ABout Local Context REV
Application Request to Review Translated Documents (Attach 5F)	18	Application for Translation Review
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 REV
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 REV
CIRB New Board Member Contact Information Form (Attach 3C)	3C	CIRB Board Member Contact Information Form REV
CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E)	3E	CIRB Board Member Non-Disclosure Agreement (NDA) REV
CIRB New Board Member W-9 (Attach 3D)	3D	CIRB Board Member W-9 REV
CIRB Statistical Reviewer Form (Attach 6K)	6K	CIRB Statistical Reviewer Form REV
Change of Signatory Institution PI Form (Attach 2ZB)	2ZB	Change of Signatory Institution PI Form REV
Component Institution at Signatory Institution (Attach 2M)	2M	Component Institution at Signatory Institution REV
Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) (Attach 6L)	6L	Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) REV
Direct Deposit Form (Attach 4)	4	CIRB Direct Deposit Form REV
Facilitated Review Acceptance Form (FRAF) (Attach 2P)	2P	Facilitated Review Acceptance Form REV
IRB Staff at Signatory Institution's IRB (Attach 2D)	2D	IRB Staff at Signatory Institution's IRB REV
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 REV
Institutional Contact for Signatory Institution (Attach 2K)	2K	Institutional Contact for Signatory Institution REV
Investigator at Affiliate Institution (Attach 2G)	2G	Investigator at Affiliate Institution with an IRB REV
Investigator at Affiliate Institution without IRB (Attach 2I)	2I	Investigator at Affiliate Institution without IRB REV
Investigator at Signatory Institution (Attach 2E)	2E	Personnel Signatory Institution REV
Locally-Developed Material Submission Form (Attach 5E)	5E	Locally-Developed Material Submission Form REV
NCI Adult CIRB Application and Adult-Peds Treatment Studies (Attach 5A)	5A	NCI Adult/Pediatric CIRB Application for Treatment Studies REV
NCI CIRB Institution Enrollment Worksheet (Attach 2C)	2C	NCI IRB Enrollment Form REV
One Time Study Roll Over Worksheet (Attach 2ZA)	2ZA	One Time Study Roll Over Worksheet REV
Ped Expedited Amendment Review (Attach 6N)	6N	Ped Expedited Amendment Review REV
Ped Expedited Continuing Review (Attach 6P)	6P	Ped Expedited Continuing Review REV
Ped Expedited Study Chair Response to Required Mod (Attach 6T)	6T	Ped Expedited Study Chair Response to Required Mod REV
Ped Expedited Study Closure (Attach 6R)	6R	Ped Expedited Study Closure REV
Pediatric Amendment of Cooperative Group Protocol (Attach 6F)	6F	Pediatric Amendment of Cooperative Group Protocol REV
Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6H)	6H	Pediatric Cooperative Group Response to CIRB Review REV
Pediatric Continuing Review of Cooperative Group Protocol (Attach 6D)	6D	Pediatric Continuing Review of Cooperative Group Protocol REV
Pediatric Initial Review of Cooperative Group Protocol (Attach 6B)	6B	Pediatric Initial Review of Cooperative Group Protocol REV
Pediatric Pharmacist's Review of a Cooperative Group Study (Attach 6J)	6J	Pediatric Pharmacist's Review of a Cooperative Group Study REV
Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach 2V)	2V	Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form REV
Request for 30-Day Access Form (Attach 2A)	2A	Request for 30 Day Website Access Form REV
Research Staff at Affiliate Institution (Attach 2H)	2H	Research Staff at Affiliate Institution with an IRB REV
Research Staff at Affiliated Institution without an IRB (Attach 2J)	2J	Research Staff at Affiliate Institution without an IRB REV
Research Staff at Signatory Institution (Attach 2F)	2F	Research Staff at Signatory Institution REV
Reviewer Advertisement Checklist (Attach 6V)	6V	Reviewer Advertisement Checklist REV
Reviewer Worksheet of Translated Documents (Attach 6U)	6U	Reviewer Worksheet of Translated Documents REV
Study Closure or Transfer of Study Review Responsibility Form (Attach 2U)	2U	Study Closure or Transfer of Study Review Responsibility Form REV
Study Review Responsibility Transfer Form (Attach 2Q)	2Q	Study Review Responsibility Transfer Form REV
Study-Specific Worksheet About Local Context (Atttach 2T)	2T	Study-Specific Work sheet About Local Context REV
Summary of CIRB Application Revisions (Attach 5D)	5D	Summary of CIRB Application Revisions REV

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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	6,085	0	0	0	0
Annual Time Burden (Hours)	2,199	2,199	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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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: 02/14/2014

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