OPTN Ventilated Patient Forms

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 Ventilated Patient Form	Form	New	Available
Form 3 Ventilated Patient Form	Form	New	Available
Appendix A - Comment Analysis - OPTN Process Data - VPF 0906-NEW_11.20.2025.docx	Supplementary Document	Uploaded 2025-12-01	Available
Comment 89_Jones OPTN Board 07312025.pdf	Public Comments	Uploaded 2025-08-07	Available
HRSA UW OTD Comment on Data Collection.pdf	Public Comments	Uploaded 2025-08-01	Available
PC_202507-0906-001_073125_095223_1.pdf	Public Comments	Uploaded 2025-07-31	Available
Mid-America Transplant Process Data for OPTN Public Comment 7.31.25.pdf	Public Comments	Uploaded 2025-07-31	Available
PC_202507-0906-001_073125_023558_1.pdf	Public Comments	Uploaded 2025-07-31	Available
ESTAR Executive Team_HRSA_Proposed Collection_Public Comment_Final.pdf	Public Comments	Uploaded 2025-07-31	Available
PC_202507-0906-001_073125_120140_1.pdf	Public Comments	Uploaded 2025-07-31	Available
PC_202507-0906-001_073125_120349_1.pdf	Public Comments	Uploaded 2025-07-31	Available
HRSA_Response_WIUW_7.31.25.pdf	Public Comments	Uploaded 2025-07-31	Available
PC_202507-0906-001_073125_104525_1.pdf	Public Comments	Uploaded 2025-07-31	Available
PC_202507-0906-001_073125_103227_1.pdf	Public Comments	Uploaded 2025-07-31	Available
2025 Information Collection Request HRSA _ GLDP Comments FINAL 7_29_25.pdf	Public Comments	Uploaded 2025-07-31	Repair queued
PC_202507-0906-001_073125_091531_1.pdf	Public Comments	Uploaded 2025-07-31	Repair queued
25.7.31 Process Data for Organ Procurement and Transplantation Network_Comments.pdf	Public Comments	Uploaded 2025-07-30	Available
2025-07-28_OPTN Data Collection Comment_Final.pdf	Public Comments	Uploaded 2025-07-29	Available
PC_202507-0906-001_072925_011821_1.pdf	Public Comments	Uploaded 2025-07-29	Available
07292025_Process Data for OPTN_Mayo Clinic Comment.pdf	Public Comments	Uploaded 2025-07-29	Repair queued
PC_202507-0906-001_072925_110951_1.pdf	Public Comments	Uploaded 2025-07-29	Repair queued
2025 Information Collection Request HRSA _ GLDP Comments FINAL 7_29_25.pdf	Public Comments	Uploaded 2025-07-29	Available
PC_202507-0906-001_072925_091419_1.pdf	Public Comments	Uploaded 2025-07-29	Repair queued
PC_202507-0906-001_072925_084527_1.pdf	Public Comments	Uploaded 2025-07-29	Repair queued
FINAL AOPO Response to HRSA Data Collection Request 072425.pdf	Public Comments	Uploaded 2025-07-24	Available
Baylor Scott & White Health HRSA OPTN Process Data Collection Request Comment Letter.pdf	Public Comments	Uploaded 2025-07-23	Available
PC_202507-0906-001_072225_035042_1.pdf	Public Comments	Uploaded 2025-07-22	Available
PC_202507-0906-001_071825_103355_1.pdf	Public Comments	Uploaded 2025-07-18	Available
PC_202507-0906-001_071625_112459_1.pdf	Public Comments	Uploaded 2025-07-16	Repair queued
PC_202507-0906-001_071525_073014_1.pdf	Public Comments	Uploaded 2025-07-15	Available
Comment 67_Powell_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 66_Wright_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 65_Mason Franciscan Health_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 65_Mason Franciscan Health Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 64_Benson_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 63_St. Josephs_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 62_Kennedy_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 61_Lo_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 60_Bearden_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 59_Dokus_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 58_UW OTD_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 58_UW OTD Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 57_LifeShare Network_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 57_LifeShare Network Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 56_DCI Donor Services_1.3.25.docx	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 56_DCI Donor Services Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 55_Flores_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 54_Gift of Life_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 54_Gift of Life Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 49_Baylor St. Lukes_1.3.25.pdf	Public Comments	Uploaded 2024-11-12	Repair queued
Comment 49_Baylor St. Lukes Transmittal_1.3.25.pdf	Public Comments	Uploaded 2024-11-12	Repair queued
Comment 53_LifeLink Foundation_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 53_LifeLink Foundation Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 52_Kayler_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 51_ASN_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 51_ASN Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 50_Mohsenin_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 48_AOPO_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 48_AOPO Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 47_McNatt_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 46_Ohio River Valley Transplant Coalition_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 46_Ohio River Valley Transplant Coalition Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 45_Sullivan_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 44_King_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 43_AST_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 43_AST Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 42_UCHealth Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 42_UCHealth_1.3.25.docx	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 41_Epic_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 41_Epic Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 40_ESTAR Addendum_1.10.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 40_ESTAR Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 40_ESTAR_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 39_Cope_1.3.25.pdf	Public Comments	Uploaded 2024-11-11	Repair queued
Comment 38_Banon_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 37_Southeastern Kidney Transplant Coalition Transmittal_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 37_Southeastern Kidney Transplant Coalition_1.3.25.pdf	Public Comments	Uploaded 2025-01-03	Repair queued
Comment 36_Transplants_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 35_Inova Comment_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 35_Inova Transmittal_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 34_ASTS Transmittal_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 34_ASTS_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 33_Lewis_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 32_Tankersley_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Available
Comment 31_Preczewski_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 31_Perlman_1.2.25 (Support).pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 30_Advocate Health Transmittal_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 30_Advocate Health_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 29_Boston Childrens_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 28_Boston Childrens Transmittal_1.2.25.pdf	Public Comments	Uploaded 2025-01-02	Repair queued
Comment 27_Urtel_1.1.25.pdf	Public Comments	Uploaded 2025-01-01	Repair queued
Comment 26_Sharp_1.1.25.pdf	Public Comments	Uploaded 2025-01-01	Repair queued
Comment 25_Nordstrom_1.1.25.pdf	Public Comments	Uploaded 2025-01-01	Available
Comment 24_Goudie_12.31.24.pdf	Public Comments	Uploaded 2024-12-31	Available
Comment 23_UW Health_12.31.24.pdf	Public Comments	Uploaded 2024-12-31	Repair queued
Comment 23_UW Health Transmittal_12.31.24.pdf	Public Comments	Uploaded 2024-12-31	Repair queued
Comment 22_Parchuri_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 21_Plummer_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 20_Hellberg_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 19_Campbell_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 18_Post Monterosso_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 17_Vanderbilt Transmittal_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 17_Vanderbilt_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 16_Segal_12.30.24.pdf	Public Comments	Uploaded 2024-12-30	Repair queued
Comment 15_UNC Health_12.28.24.docx	Public Comments	Uploaded 2024-12-28	Repair queued
Comment 15_UNC Health Transmittal_12.28.24.pdf	Public Comments	Uploaded 2024-12-28	Repair queued
Comment 14_BSWH_12.27.24.pdf	Public Comments	Uploaded 2024-12-27	Repair queued
Comment 14_BSWH Transmittal_12.27.24.pdf	Public Comments	Uploaded 2024-12-27	Repair queued
Comment 13_Alvarez_12.23.24.pdf	Public Comments	Uploaded 2025-01-07	Repair queued
Comment 12_Dickinson_12.23.24.pdf	Public Comments	Uploaded 2024-12-23	Repair queued
Comment 11_ASPN_12.23.24.pdf	Public Comments	Uploaded 2024-12-23	Repair queued
Comment 11_ASPN Transmittal_12.23.24.pdf	Public Comments	Uploaded 2024-12-23	Repair queued
Comment 10_Kidney Foundation Transmittal_12.20.24.pdf	Public Comments	Uploaded 2024-12-20	Repair queued
Comment 10_Kidney Foundation_12.20.24.pdf	Public Comments	Uploaded 2024-12-20	Repair queued
Comment 9_Hodges_12.17.24.pdf	Public Comments	Uploaded 2024-12-17	Repair queued
Comment 8_Davis_12.17.24.pdf	Public Comments	Uploaded 2024-12-17	Repair queued
Comment 7_UNOS 12.18.24.pdf	Public Comments	Uploaded 2024-12-18	Repair queued
Comment 7_UNOS_Transmittal 12.18.24.pdf	Public Comments	Uploaded 2024-12-18	Available
Comment 6_Lease 12.3.24.pdf	Public Comments	Uploaded 2024-12-03	Repair queued
Comment 5_Giles 12.2.24.pdf	Public Comments	Uploaded 2024-12-02	Available
Comment 5_Giles_Transmittal 12.2.24.pdf	Public Comments	Uploaded 2024-12-02	Repair queued
Comment 4_Bourgeois_11.12.24.pdf	Public Comments	Uploaded 2024-11-12	Repair queued
Comment 3_Cope_11.11.24_kidney-referral-evaluation-registration-form (3).xlsx	Public Comments	Uploaded 2024-11-11	Repair queued
Comment 3_Cope_11.11.24.pdf	Public Comments	Uploaded 2024-11-11	Repair queued
Comment 2_Oliver_11.6.24.pdf	Public Comments	Uploaded 2024-11-06	Available
Comment 1_Cyr_11.6.24.pdf	Public Comments	Uploaded 2024-11-06	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	Repair queued
Supporting Statement A - OPTN Process Data - VPF - 0906-NEW-12.1.2025.docx	Supporting Statement A	Uploaded 2025-12-01	Available
06232025 - Supporting Statement A - 0906-NEW - HSB - OPTN Process - New - OPAE Edits - Clean.docx	Supporting Statement A	Uploaded 2025-07-01	Repair queued

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0906-0112	ICR Reference No: 202507-0906-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: OPTN Ventilated Patient Forms
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/05/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/02/2025
Terms of Clearance: Prior to the re-submission of this information collection request (ICR), the agency will submit a non-substantive change request to upload the data dictionary. Other instruments (i.e., Pre-Waitlist Transplant Referral and Evaluation Forms) will be submitted under a discrete OMB Control Number.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2028	36 Months From Approved
Responses	105,095	0	0
Time Burden (Hours)	38,885	0	0
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	0	0	105,095	0	0
Annual Time Burden (Hours)	38,885	0	0	38,885	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: $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: 07/02/2025

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