View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0906-0112
ICR Reference No:
202507-0906-001
Status:
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.
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
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.
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
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:
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
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Ventilated Patient Form
1
Ventilated Patient Form
ICR Summary 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
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
Agency Contact:
Laura Cooper 301 443-2126 lcooper@hrsa.gov
Common Form ICR:
No
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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