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OMB Control No: 0990-0473	ICR Reference No: 202609-0990-002
Status: Received in OIRA	Previous ICR Reference No: 202303-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Subpart C Research Certification Form
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 09/16/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	85	65
Time Burden (Hours)	85	65
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	85	65	35	-15
Annual Time Burden (Hours)	85	65	35	-15
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: No

Burden Reduction Due to:

Short Statement: The burden calculation has been adjusted to account for the number of institutions that submitted for certifications, average responses per institution annually, and the time required to complete a certification. We estimate that an average of forty institutions will submit certifications: thirty-five of the institutions will submit two certifications (35 x 2= 70); five of the forty institutions will submit three certifications (5 x 3= 15); and that each certification will require 1 hour to complete, accounting for the estimated 85 response burden hours. This represents an increase in annual burden hours of 20 hours compared to the previously approved burden. The change accounts for agency adjustments based on data on the number of institutions that submitted certifications.

Annual Cost to Federal Government: $137,701

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: Natalie Klein 301 284-2272 natalie.klein@hhs.gov

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