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View ICR - OIRA Conclusion

OMB Control No: 0915-0310	ICR Reference No: 202309-0915-005
Status: Historical Active	Previous ICR Reference No: 202302-0915-002
Agency/Subagency: HHS/HSA	Agency Tracking No: 21065
Title: Stem Cell Therapeutic Outcomes Database
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/22/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/20/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2025	08/31/2025	08/31/2025
Responses	75,101	0	75,101
Time Burden (Hours)	75,101	0	75,101
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	75,101	75,101
Annual Time Burden (Hours)	75,101	75,101
Annual Cost Burden (Dollars)	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: This is a revised collection of information with an estimated reduction to the overall hour burden inventory to 75,106 due to improvements in burden estimation. As noted in Table 1, the total number of responses is less than previous calculations because of improvements in estimation. The number of responses in any given year is a function of three values: the number of transplants in the year of interest, the number of transplants in previous years, and expected patient survival between the time of transplant and any follow-up activity. Previous estimates assumed all years had the same number of transplants. This improved estimate includes accurate transplant counts from prior years, which are often less that the year of interest.

Annual Cost to Federal Government: $4,730,240

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? Yes

Agency Contact: Laura Cooper 301 443-2126 lcooper@hrsa.gov