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View ICR - OIRA Conclusion

OMB Control No: 0990-0263	ICR Reference No: 202404-0990-001
Status: Active	Previous ICR Reference No: 202012-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/06/2024
	Date Received in OIRA: 06/26/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	09/30/2024
Responses	26,000	0	28,000
Time Burden (Hours)	13,000	0	14,000
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	26,000	28,000	-2,000
Annual Time Burden (Hours)	13,000	14,000	-1,000
Annual Cost Burden (Dollars)	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: The burden calculation has been adjusted to account for changes to the overall number of institutions that hold an active Federalwide assurance (FWA) with the Office for Human Research Protections (OHRP). The estimate of the number of respondents is based on the current number of institutions with an active OHRP-approved FWA; 12,700 (as of 12/31/2023), and projecting that the number may increase to 13,000. We estimate that there will be an average of 2 certifications per institution annually (13,000 x 2 = 26,000) and that each form, including certification or declaration of exemption and assurance information, will require 30 minutes to complete, accounting for the estimated 13,000 response burden hours. This represents a 1,000 hour decrease in annual burden hours compared to the previously approved burden. The decrease is because there are 1,000 fewer institutions with an active OHRP-approved FWA compared to the prior approved information collection request.

Annual Cost to Federal Government: $467,000

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. No

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. 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? No

Agency Contact: Sherette Funn-Coleman

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