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OMB Control No: 0915-0184	ICR Reference No: 202512-0915-001
Status: Received in OIRA	Previous ICR Reference No: 202502-0915-003
Agency/Subagency: HHS/HSA	Agency Tracking No: 21566
Title: Organ Procurement and Transplantation Network Application Form
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 12/10/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2026
Responses	1,699	858
Time Burden (Hours)	3,546	5,610
Cost Burden (Dollars)	0	0

Abstract: This is a request to revise the current Organ Procurement and Transplantation Network (OPTN) data collection associated with institutional (including transplant hospital, organ procurement organization, and transplant histocompatibility laboratory) and non-institutional (medical/scientific and public organization, business and individual) applications to meet or sustain requirements for OPTN membership. This request include adding two new data collection forms (Hope Act Variance Request and Kidney Paired Donation Pilot Program or KPDPP contact update form), three standalone forms (Primary Program Administrator, Primary Data Coordinator, and Additional Surgeon and Physician) for revised data collection, and a revision of organ-specific applications found in the Certificate of Assessment and Program Coverage Plan Membership Application (COA/PCP). The likely respondents are new and existing transplant hospitals, organ procurement organization, histocompatibility laboratories, medical/scientific organization, public organization, business and individual members.

Authorizing Statute(s): US Code: 42 USC 1138 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies
US Code: 42 USC 273 Name of Law: National Organ Transplant Act of 1984

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 40606	08/20/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 57077	12/09/2025
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	1,699	858	841
Annual Time Burden (Hours)	3,546	5,610	-2,064
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: Estimates are based on the number of OPTN members in each membership category (i.e., transplant center, OPO, histocompatibility laboratory) as of December 2, 2024, form submission volumes from January 1, 2023, to December 31, 2023, and average burden per response estimated by either a survey of OPTN members or consultation with OPTN committees. This is the most current and reliable dataset available at this time for estimating burden. In addition, one new form as added. Note: Although the "OPTN Membership Application Surgeon or Physician Log" shows up as a "new form" it was included in prior packages with the Membership Application forms (forms 1-10). We included it as a separate form here to make sure the IC list aligned with the burden table.

Annual Cost to Federal Government: $600,530

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

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