Information Collection Request

Organ Procurement and Transplantation Network Application Form

ICR 202106-0915-002 · OMB 0915-0184 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form 17 OPTN Individual Membership Application Form and Instruction Unchanged Repair queued
Form 16 OPTN Business Membership Application Form and Instruction Unchanged Repair queued
Form 15 OPTN Public Organization Membership Application Form and Instruction Unchanged Repair queued
Form 14 OPTN Medical Scientific Membership Application Form and Instruction Unchanged Repair queued
Form 13 OPTN Representative Form Form and Instruction Unchanged Missing upstream
Form 12 OPTN Membership Application for Histocompatibility Labs Form and Instruction Unchanged Repair queued
Form 11 OPTN Membership Application for OPOs Form and Instruction Unchanged Repair queued
Form 10 OPTN Membership Application for Intestine Transplant Programs Form and Instruction Unchanged Repair queued
Form 2 OPTN Certificate of Assessment and Program Coverage Plan Membership Application Form and Instruction Unchanged Available
Form 9 OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application Form and Instruction Unchanged Repair queued
Form 8 OPTN Membership Application Islet Transplant Program Form and Instruction Unchanged Repair queued
Form 7 OPTN Membership Application for Lung Transplant Program Form and Instruction Unchanged Repair queued
Form 6 OPTN Membership Application for Heart Transplant Program Form and Instruction Unchanged Repair queued
Form 5 OPTN Membership Application for Pancreas Transplant Programs Form and Instruction Unchanged Repair queued
Form 4 OPTN Membership Application for Liver Transplant Progrms Form and Instruction Unchanged Repair queued
Form 3 OPTN Membership Application for Kidney Transplant Programs Form and Instruction Unchanged Repair queued
Form 1 OPTN Membership Application for Transplant Hospitals Form and Instruction Unchanged Repair queued
05272021 - OPTN Membership Application for Heart Transplant Programs - REDLINE.docx Supplementary Document Uploaded 2021-06-02 Repair queued
05272021 - OPTN Membership Application for Heart Transplant Programs - CLEAN.docx Supplementary Document Uploaded 2021-06-02 Repair queued
FINAL Change Memo - OPTN Membership Forms - 0915-0184.docx Justification for No Material/Nonsubstantive Change Uploaded 2021-06-02 Repair queued
FINAL Supporting Statement - 0915-0184.docx Supporting Statement A Uploaded 2020-06-26 Repair queued
60-Day OPTN FRN OMB No. 0915-0184.Published.pdf Supplementary Document Uploaded 2020-06-26 Repair queued
Names_Crosswalk.xlsx Supplementary Document Uploaded 2020-06-26 Repair queued
05.19.2020 Summary of Changes - OPTN 0915-0184.docx Supplementary Document Uploaded 2020-06-26 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
226701 OPTN Individual Membership Application Form and Instruction Unchanged
226700 OPTN Business Membership Application Form and Instruction Unchanged
226699 OPTN Public Organization Membership Application Form and Instruction Unchanged
226698 OPTN Medical Scientific Membership Application Form and Instruction Unchanged
226695 OPTN Representative Form Form and Instruction Unchanged
226694 OPTN Membership Application for Histocompatibility Labs Form and Instruction Unchanged
226693 OPTN Membership Application for OPOs Form and Instruction Unchanged
226692 OPTN Membership Application for Intestine Transplant Programs Form and Instruction Unchanged
226689 OPTN Certificate of Assessment and Program Coverage Plan Membership Application Form and Instruction Unchanged
226687 OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application Form and Instruction Unchanged
226686 OPTN Membership Application Islet Transplant Program Form and Instruction Unchanged
226685 OPTN Membership Application for Lung Transplant Program Form and Instruction Unchanged
226684 OPTN Membership Application for Heart Transplant Program Form and Instruction Unchanged
226683 OPTN Membership Application for Pancreas Transplant Programs Form and Instruction Unchanged
226682 OPTN Membership Application for Liver Transplant Progrms Form and Instruction Unchanged
226681 OPTN Membership Application for Kidney Transplant Programs Form and Instruction Unchanged
226680 OPTN Membership Application for Transplant Hospitals Form and Instruction Unchanged
ICR Details
0915-0184 202106-0915-002
Received in OIRA 202006-0915-007
HHS/HSA 21566
Organ Procurement and Transplantation Network Application Form
No material or nonsubstantive change to a currently approved collection   No
Regular 06/02/2021
  Requested Previously Approved
08/31/2023 08/31/2023
1,661 1,661
4,755 4,755
0 0

This is a request for OMB approval for revisions of the application documents used to collect information for determining if the interested party is compliant with membership requirements contained in the final rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN), (42 CFR part 121) ‘‘the OPTN final rule.’’ Respondents include: hospitals seeking to perform organ transplants, non-profit organizations seeking to become an organ procurement organization, and medical laboratories seeking to become an OPTN-approved histocompatibility laboratory.

US Code: 42 USC 273 Name of Law: National Organ Transplant Act of 1984
   US Code: 42 USC 1138 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies
  
None

Not associated with rulemaking

  85 FR 8300 02/13/2020
85 FR 38380 06/26/2020
No

17
IC Title Form No. Form Name
OPTN Business Membership Application 16 Membership_Business Form.docx
OPTN Certificate of Assessment and Program Coverage Plan Membership Application 2 Membership_CertificateAssessment_ProgramCoverage Form.docx
OPTN Individual Membership Application 17 Membership_Individual Form.docx
OPTN Medical Scientific Membership Application 14 Membership_MedicalScientific Form.docx
OPTN Membership Application Islet Transplant Program 8, 8B Membership_Pancreas Islet Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application 9B, 9 Membership_VCA Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Heart Transplant Program 6, 6B Membership_Heart Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Histocompatibility Labs 12 Membership_HistoLab Form.docx
OPTN Membership Application for Intestine Transplant Programs 10, 10B Membership_Intestine Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Kidney Transplant Programs 3 , 3B Membership_Kidney_LDKidney Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Liver Transplant Progrms 4, 4B Membership_Liver_LDLiver Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Lung Transplant Program 7B, 7 Membership_Lung Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for OPOs 11 Membership_OPO Form.docx
OPTN Membership Application for Pancreas Transplant Programs 5B, 5 Membership_Pancreas Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Transplant Hospitals 1 Membership_Transplant Hospital_General Form.docx
OPTN Public Organization Membership Application 15 Membership_PublicOrg Form.docx
OPTN Representative Form 13 Membership_Representative Form.docx

  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 1,661 1,661 0 0 0 0
Annual Time Burden (Hours) 4,755 4,755 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Burden decrease due to less forms and less average burden per response; burden increase due to an increase in respondents.

$345,000
No
    No
    No
No
No
No
No
Elyana Bowman 301 443-3983 [email protected]

  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.
06/02/2021