View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0925-0613	ICR Reference No: 201901-0925-002
Status: Historical Active	Previous ICR Reference No: 201602-0925-006
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: 03/14/2019
	Date Received in OIRA: 02/01/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved	03/31/2019
Responses	45,504	0	119,457
Time Burden (Hours)	3,033	0	14,649
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	45,504	119,457	-73,953
Annual Time Burden (Hours)	3,033	14,649	-11,616
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: The investigator registration process underwent a technology change from paper data collection to electronic data collection. The use of the electronic forms for investigator registration information collection were approved under the CTEP Branch and Support Contracts Forms and Surveys submission (OMB No. 0925-0753) with an expiration date of 7/31/2021. Therefore, removing the investigator registration forms from this submission has decreased the total burden by 11,142 hours. In addition, this submission requests a reduction of 474 fewer burden hours than the 2016 submission because there is a year to year variation in the number of active studies (and subsequently the number of patients enrolled in those studies).

Annual Cost to Federal Government: $23,524

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? Uncollected

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

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