View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0925-0613	ICR Reference No: 202111-0925-005
Status: Historical Active	Previous ICR Reference No: 201901-0925-002
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: 01/18/2022
	Date Received in OIRA: 11/29/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2025	36 Months From Approved	03/31/2022
Responses	78,100	0	45,504
Time Burden (Hours)	4,831	0	3,033
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	78,100	45,504	32,596
Annual Time Burden (Hours)	4,831	3,033	1,798
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 involves a request for an additional 778 burden hours from the 2019 submission due to the phasing in of two new forms, the eDARF and the IIS. The eDARF will be completed online using the AURORA inventory management system, and will ultimately replace the DARF and DARF-Oral. Full use of the eDARF will be implemented over the next 24-months and the burden is based upon a total percentage of burden for maintaining agent records. The IIS requirement is for non-U.S. investigators who can no longer sign the Form FDA 1572 as part of their RCR registration. The form is completed annually. The Form FDA 1572 and other forms that are part of the RCR registration process are covered under the CTEP Branch and Support Contracts Forms and Surveys (OMB No. 0925-0753, exp. 5/31/2024).

Annual Cost to Federal Government: $23,782

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

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