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View ICR - OIRA Conclusion
OMB Control No:
0915-0184
ICR Reference No:
202502-0915-003
Status:
Active
Previous ICR Reference No:
202410-0915-001
Agency/Subagency:
HHS/HSA
Agency Tracking No:
21566
Title:
Organ Procurement and Transplantation Network Application Form
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:
04/18/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/28/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2025
12/31/2025
12/31/2025
Responses
858
0
858
Time Burden (Hours)
5,610
0
5,610
Cost Burden (Dollars)
0
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:
87 FR 52389
08/25/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 68713
11/16/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
21
IC Title
Form No.
Form Name
Additional Surgeon and Physician Request Form
20S (Revised 03.25), 20
Additional Surgeon and Physician Request Form
,
Additional Surgeon and Physician Request Form
HOPE Act Variance Request Form
21T (03.25 Version), 21
Hope Act Variance Request Form
,
Hope Act Variance Request Form
Kidney Paired Donation Pilot Program (KPDPP) contact update Form
23U (03.25 Version), 23
Kidney Paired Donation Pilot Program (KPDPP) contact update Form
,
Kidney Paired Donation Pilot Program (KPDPP) Contact Update Form
OPTN Business Membership Application
16O (03.25 version), 16
OPTN Membership_Business Form
,
OPTN Business Membership Application
OPTN Individual Membership Application
17P (03.25 version), 17
OPTN Membership_Individual Form
,
OPTN Individual Membership Application
OPTN Medical Scientific Membership Application
14M (03.25 Version), 14
Membership_MedicalScientific Form.docx
,
OPTN MedicalScientific Membership Application
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application
9, 9, 9V (03.25 version), 9H (03.25 version), 9 , 9 B
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log
,
09_OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs CLEAN 10072024
,
09_OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs REDLINE 10072024
,
OPTN Membership Application Surgeon or Physician Log
,
OPTN Membership Application for VCA Transplant Programs
OPTN Membership Application Islet Transplant Program
8, 8, 8V (03.25 version), 8G (03.25 version), 8, 8 B
OPTN Membership Application for Islet Transplant Programs CLEAN
,
OPTN Membership Application_Surgeon or Physician Log
,
08_OPTN Membership Application for Islet Transplant Programs CLEAN 10072024
,
08_OPTN Membership Application for Islet Transplant Programs REDLINE 10072024
,
OPTN Membership Application Surgeon or Physician Log
,
OPTN Membership Application for Islet Transplant Programs
OPTN Membership Application for Heart Transplant Program
6, 6, 6, 6E (03.25 version), 6V (03.25 version), 6 B
OPTN Membership Application_Surgeon or Physician Log
,
OPTN Membership Application for Heart Transplant Programs
,
06_OPTN Membership Application for Heart Transplant Programs CLEAN 10072024
,
06_OPTN Membership Application for Heart Transplant Programs REDLINE 10072024
,
OPTN Membership Application for Heart Transplant Programs
,
OPTN Membership Application Surgeon or Physician Log
OPTN Membership Application for Histocompatibility Labs
12K (03.25 Version), 12
OPTN Membership Application for Histocompatibility Laboratories
,
OPTN Membership Histocompatibility Laboratory Application
OPTN Membership Application for Intestine Transplant Programs
10, 10, 10V (03.25 version), 10I (03.25 version), 10, 10 B
OPTN Membership Application for Intestine Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log
,
10_OPTN Membership Application for Intestine Transplant Programs CLEAN 10072024
,
10_OPTN Membership Application for Intestine Transplant Programs REDLINE 10072024
,
OPTN Membership Application Surgeon or Physician Log
,
OPTN Membership Application for Intestine Transplant Programs
OPTN Membership Application for Kidney Transplant Programs
3, 3, 3B (03.25 version), 3V (03.25 version), 3 B, 3
OPTN Membership Application_Surgeon or Physician Log.docx
,
OPTN Membership Application for Kidney Transplant Programs
,
03_OPTN Membership Application for Kidney Transplant Programs CLEAN 10072024
,
03_OPTN Membership Application for Kidney Transplant Programs REDLINE 10072024
,
OPTN Membership Application for Kidney Transplant Programs
,
OPTN Membership Application Surgeon or Physician Log
OPTN Membership Application for Liver Transplant Progrms
4 B, 4, 4C (03.25 version), 4V (03.25 version), 4, 4
OPTN Membership Application_Surgeon or Physician Log
,
OPTN Membership Application for Liver Transplant Programs
,
04_OPTN Membership Application for Liver Transplant Programs CLEAN 10072024
,
04_OPTN Membership Application for Liver Transplant Programs REDLINE 10072024
,
OPTN Membership Application for Liver Transplant Programs
,
OPTN Membership Application Surgeon or Physician Log
OPTN Membership Application for Lung Transplant Program
7, 7, 7, 7V (03.25 version), 7F (03.25 version), 7 B
OPTN Membership Application_Surgeon or Physician Log
,
OPTN Membership Application for Lung Transplant Programs
,
07_OPTN Membership Application for Lung Transplant Programs CLEAN 10072024
,
07_OPTN Membership Application for Lung Transplant Programs REDLINE 10072024
,
OPTN Membership Application Surgeon or Physician Log
,
OPTN Membership Application for Lung Transplant Programs
OPTN Membership Application for OPOs
11J (03.25 Version), 11
Membership_OPO Form.docx
,
OPTN Membership Application for Organ Procurement Organizations
OPTN Membership Application for Pancreas Transplant Programs
5D (03.25 version), 5V (03.25 version), 5, 5, 5, 5 B
OPTN Membership Application_Surgeon or Physician Log
,
OPTN Membership Application for Pancreas Transplant Programs
,
05_OPTN Membership Application for Pancreas Transplant Programs CLEAN 10072024
,
05_OPTN Membership Application for Pancreas Transplant Programs REDLINE 10072024
,
OPTN Membership Application for Pancreas Transplant Programs
,
OPTN Membership Application Surgeon or Physician Log
OPTN Membership Application for Transplant Hospitals and Programs
1, 1, 1A (03.25 version), 1V (03.25 version), 1
OPTN Membership Application for Transplant Hospitals and Programs.docx
,
01_OPTN Membership Application for Transplant Hospitals and Programs CLEAN 10072024
,
01_OPTN Membership Application for Transplant Hospitals and Programs REDLINE 10072024
,
OPTN Membership Application for Transplant Hospitals and Programs
,
OPTN Membership Application Surgeon or Physician Log
OPTN Public Organization Membership Application
15N (03.25 Version), 15
Membership_PublicOrg Form.docx
,
OPTN Public Organization Membership Application
OPTN Representative Form
13L (03.25 Version), 13
OPTN Membership_Representative Form.docx
,
OPTN Representative Form
Primary Data Coordinator Form
19R (03.25 version), 19
Primary Data Coordinator
,
Primary Data Coordinator Form
Primary Program Administrator Form
18Q (03.25 version), 18
Primary Program Administrator Form
,
Primary Program Administrator 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
858
858
0
0
0
0
Annual Time Burden (Hours)
5,610
5,610
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:
Annual Cost to Federal Government:
$347,361
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.
No
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.
No
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:
03/28/2025