Organ Procurement and Transplantation Network Application Form

ICR 202310-0915-002

OMB: 0915-0184

Federal Form Document

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Justification for No Material/Nonsubstantive Change
2023-10-13
Supporting Statement A
2022-11-18
IC Document Collections
IC ID
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Status
257000 Unchanged
256999 Unchanged
256998 Unchanged
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ICR Details
0915-0184 202310-0915-002
Received in OIRA 202211-0915-001
HHS/HSA 21566
Organ Procurement and Transplantation Network Application Form
No material or nonsubstantive change to a currently approved collection   No
Regular 10/13/2023
  Requested Previously Approved
12/31/2025 12/31/2025
858 858
5,610 5,610
0 0

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.

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
  
None

Not associated with rulemaking

  87 FR 52389 08/25/2022
87 FR 68713 11/16/2022
No

21
IC Title Form No. Form Name
Additional Surgeon and Physician Request Form 20 Additional Surgeon and Physician Request Form
HOPE Act Variance Request Form 21 Hope Act Variance Request Form
Kidney Paired Donation Pilot Program (KPDPP) contact update Form 23 Kidney Paired Donation Pilot Program (KPDPP) contact update Form
OPTN Business Membership Application 16 OPTN Membership_Business Form
OPTN Individual Membership Application 17 OPTN Membership_Individual Form
OPTN Medical Scientific Membership Application 14 Membership_MedicalScientific Form.docx
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application 9 , 9 B OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs ,   OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application Islet Transplant Program 8, 8 B OPTN Membership Application for Islet Transplant Programs CLEAN ,   OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Heart Transplant Program 6 B, 6 OPTN Membership Application_Surgeon or Physician Log ,   OPTN Membership Application for Heart Transplant Programs
OPTN Membership Application for Histocompatibility Labs 12 OPTN Membership Application for Histocompatibility Laboratories
OPTN Membership Application for Intestine Transplant Programs 10, 10 B OPTN Membership Application for Intestine Transplant Programs ,   OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Kidney Transplant Programs 3 B, 3 OPTN Membership Application_Surgeon or Physician Log.docx ,   OPTN Membership Application for Kidney Transplant Programs
OPTN Membership Application for Liver Transplant Progrms 4 B, 4 OPTN Membership Application_Surgeon or Physician Log ,   OPTN Membership Application for Liver Transplant Programs
OPTN Membership Application for Lung Transplant Program 7 B, 7 OPTN Membership Application_Surgeon or Physician Log ,   OPTN Membership Application for Lung Transplant Programs
OPTN Membership Application for OPOs 11 Membership_OPO Form.docx
OPTN Membership Application for Pancreas Transplant Programs 5, 5 B OPTN Membership Application_Surgeon or Physician Log ,   OPTN Membership Application for Pancreas Transplant Programs
OPTN Membership Application for Transplant Hospitals and Programs 1 OPTN Membership Application for Transplant Hospitals and Programs.docx
OPTN Public Organization Membership Application 15 Membership_PublicOrg Form.docx
OPTN Representative Form 13 OPTN Membership_Representative Form.docx
Primary Data Coordinator Form 19 Primary Data Coordinator
Primary Program Administrator Form 18 Primary Program Administrator Form

  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 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
No
No
Note: The burden table on the Supporting Statement are slightly different than the 30 Day FRN due to a rounding issue. The The burden estimates are derived from Burden Surveys sent out by the OPTN Contractor to the OPTN members who have participated in this data collection activity. The survey is sent to 5-9 members per form. The survey results are collected from the respondents and the Average Burden is calculated. Changes to the burden hours from the last approval are due to agency discretion (i.e., changes in the estimated burden). Changes to the forms are proposed to make application requirements even clearer and organized, and thus less cumbersome for applicants to complete. Proposed revisions include changes to wording to make questions more consistent with the language of the OPTN bylaws. In addition, the applications have been revised so that the sequence of questions is parallel to that of the bylaws. Using the bylaws as a baseline, the revamped applications have been constructed in parallel order of the bylaws so that an applicant can have the application and bylaws side-by-side for easy reference. More detail is provided in the supporting statement.

$347,361
No
    No
    No
No
No
No
No
Laura Cooper 301 443-2126 lcooper@hrsa.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/13/2023


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