Process Data for Organ Procurement and Transplantation Network

Forms and Documents

Document Name	Status
Form 3 Ventilated Patient Form Form	New
Privacy Act Statement - 0906-NEW - HSB - OPTN Process - New - 05292025.docx Supplementary Document	2025-07-01
06232025 - Supporting Statement A - 0906-NEW - HSB - OPTN Process - New - OPAE Edits - Clean.docx Supporting Statement A	2025-07-01

IC Document Collections

IC ID	Document Title	Status
276085	Ventilated Patient Form Form	New
276084	Pre-Waitlist Transplant Evaluation Form Instruction	New
276083	Pre-Waitlist Transplant Referral Form Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202507-0906-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: Process Data for Organ Procurement and Transplantation Network
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/02/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	620,560	0
Time Burden (Hours)	246,686	0
Cost Burden (Dollars)	0	0

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Abstract: Section 372 of the Public Health Service Act requires that the Secretary of HHS, by awards, provide for the establishment and operation of the Organ Procurement and Transplantation Network (OPTN), which, under oversight of the Health Resources and Services Administration (HRSA), operates the U.S. organ procurement and transplantation system. The Secretary/HRSA may direct the collection of data in accordance with the regulatory authority in 42 CFR 121.11 of the OPTN Final Rule. HRSA, in alignment with the Paperwork Reduction Act of 1995, submits data elements for collection to OMB for official federal approval. HRSA is submitting this new data collection, separate from OMB No. 0915-0157, since it includes new forms developed in response to an HHS Secretarial Data Directive that are not in use by OPTN. HRSA believes that separating these data collections will minimize confusion, increase clarity among OPTN members and stakeholders, and enable more direct feedback on the new forms. Both data collections include time-sensitive, life-critical data on transplant candidates and potential organ donor patients, the organ matching process, histocompatibility results, organ labeling and packaging, as well as pre- and post-transplantation data on recipients and donors. The OPTN collects these specific data elements from transplant centers.

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Authorizing Statute(s): US Code: 42 USC 274(b)(2)(I), Sec 372(b)(2)(I) Name of Law: PHS Act
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 87592	11/04/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 28754	07/01/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Pre-Waitlist Transplant Evaluation Form	2	Pre-Waitlist Transplant Evaluation Form
Pre-Waitlist Transplant Referral Form	1	Pre-Waitlist Transplant Referral Form
Ventilated Patient Form	3	Ventilated Patient Form

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	620,560	0	0	620,560	0	0
Annual Time Burden (Hours)	246,686	0	0	246,686	0	0
Annual Cost Burden (Dollars)	0	0	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: This is a new collection

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Annual Cost to Federal Government: $519,606

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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/02/2025

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