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OMB Control No: 0925-0753	ICR Reference No: 202012-0925-003
Status: Historical Active	Previous ICR Reference No: 201908-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: CTEP Branch Support Contracts Forms and Surveys (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: 05/14/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/16/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2024	36 Months From Approved	07/31/2021
Responses	235,670	0	207,989
Time Burden (Hours)	151,792	0	112,838
Cost Burden (Dollars)	0	0	0

Abstract: This is a revised information collection for OMB control number #0925-0753, expiration 7/31/2021 for three years. The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) fund an extensive national program of cancer research, sponsoring clinical trials in cancer prevention, symptom management and treatment for qualified clinical investigators. As part of this effort, CTEP implements programs to register clinical site investigators and clinical site staff, and to oversee the conduct of research at the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and processes for initiating and managing clinical trials is termed the Clinical Oncology Research Enterprise (CORE) and represents an integrated set of information systems and processes which support investigator registration, trial oversight, patient enrollment, and clinical data collection. The information collected is required to ensure compliance with applicable federal regulations governing the conduct of human subjects research (45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational New Drug (IND) holder (FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53).

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

Citations for New Statutory Requirements: None

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

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 63561	10/08/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 9524	02/16/2021
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	235,670	207,989	27,681
Annual Time Burden (Hours)	151,792	112,838	38,954
Annual Cost Burden (Dollars)	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: Miscellaneous Actions

Short Statement: This revision removes several forms and surveys and adds new forms for the CIRB. The burden from the previously approved submission was 112,798 hours and with these changes, it has increased to 151,792 hours. The net change is an increase of 38,994 hours. The increase in total burden hours is driven by an increase in the number of respondents for the PMB forms (E01 – E04). From the 2018 submission, the total burden hours for PMB forms was 78,333 hours. For the current submission the total burden hours for PMB forms is 118,625. The addition of new CIRB forms increased burden for the CIRB forms by 32 hours annually, and the removal of several CTSU forms and surveys decreased the overall burden by 740 hours annually.

Annual Cost to Federal Government: $1,529,246

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. Yes

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? No

Agency Contact: Tawanda Abdelmouti 240 276-5530 ta401@nih.gov

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