OPTN Ventilated Patient Forms

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 Ventilated Patient Form	Form	Modified	Available
Form 1 Ventilated Patient Form	Form	Modified	Available
04292026 - VPF - Non-Substantive Change Memo Request.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2026-04-29	Available
04292026 - VPF - Non-Substantive Change Memo Request.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2026-04-29	Available
04292026 - Ventilated Patient Form (VPF) – Data Dictionary.xlsx	Supplementary Document	Uploaded 2026-04-29	Available
04292026 - Ventilated Patient Form (VPF) – Data Dictionary.xlsx	Supplementary Document	Uploaded 2026-04-29	Available
Appendix A - Comment Analysis - OPTN Process Data - VPF 0906-NEW_11.20.2025.docx	Supplementary Document	Uploaded 2025-12-01	Available
Appendix A - Comment Analysis - OPTN Process Data - VPF 0906-NEW_11.20.2025.docx	Supplementary Document	Uploaded 2025-12-01	Available
Privacy Act Statement - 0906-NEW - HSB - OPTN Process - New - 05292025.docx	Supplementary Document	Uploaded 2025-07-01	Repair queued
Privacy Act Statement - 0906-NEW - HSB - OPTN Process - New - 05292025.docx	Supplementary Document	Uploaded 2025-07-01	Available
Supporting Statement A - OPTN Process Data - VPF - 0906-NEW-12.1.2025.docx	Supporting Statement A	Uploaded 2025-12-01	Available
Supporting Statement A - OPTN Process Data - VPF - 0906-NEW-12.1.2025.docx	Supporting Statement A	Uploaded 2025-12-01	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
276085	Ventilated Patient Form	Form	Modified	Ventilated Patient Form
276085	Ventilated Patient Form	Form	Modified	Ventilated Patient Form
276085	Ventilated Patient Form	Instruction	Modified

ICR Details

OMB Control No: 0906-0112	ICR Reference No: 202604-0906-002
Status: Active	Previous ICR Reference No: 202507-0906-001
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: OPTN Ventilated Patient Forms
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: 05/11/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/30/2026
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2028	12/31/2028	12/31/2028
Responses	105,095	0	105,095
Time Burden (Hours)	38,885	0	38,885
Cost Burden (Dollars)	0	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: 1

table that charts list of burden

IC Title	Form No.	Form Name
Ventilated Patient Form	1	Ventilated Patient Form

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	105,095	105,095	0	0	0	0
Annual Time Burden (Hours)	38,885	38,885	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	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:

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Annual Cost to Federal Government: $1,277,103

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: 04/30/2026

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