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View ICR - OIRA Conclusion

OMB Control No: 0925-0613	ICR Reference No: 202409-0925-001
Status: Active	Previous ICR Reference No: 202111-0925-005
Agency/Subagency: HHS/NIH	Agency Tracking No: 18857
Title: Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials in Cancer Treatment (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: 11/08/2024
	Date Received in OIRA: 09/30/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2027	36 Months From Approved	01/31/2025
Responses	100,000	0	78,100
Time Burden (Hours)	4,166	0	4,831
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	100,000	78,100	24,000	-2,100
Annual Time Burden (Hours)	4,166	4,831	-140	-525
Annual Cost Burden (Dollars)	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 revision removes the International Investigator Statement (IIS) form as it was transitioned to the CTEP Branch and Support Contracts Forms and Surveys (OMB#0925-0753) submission, thereby reducing the burden hours by 665 hours annually. The eDARF will be completed online using the AURORA inventory management system, ultimately replacing the DARF and DARF-Oral. Full use of the eDARF will be implemented over the next 12 months, and the burden is based upon a total percentage of the burden for maintaining agent records.

Annual Cost to Federal Government: $28,273

Does this IC contain surveys, censuses, or employ statistical methods? No

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: Mikia Currie 3014350941

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