Data System for Organ Procurement and Transplantation Network

ICR 202202-0915-002

OMB: 0915-0157

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-02-15
IC Document Collections
IC ID
Document
Title
Status
6389 Modified
251650 New
251649 New
251648 New
251647 New
251645 New
251644 New
251643 New
251642 New
251641 New
251640 New
226455 Modified
226454 Modified
226453 Modified
226452 Modified
226451 Modified
226449 Modified
226448 Modified
226447 Modified
226446 Modified
226445 Modified
226443 Modified
226442 Modified
226441 Modified
226440 Modified
226439 Modified
226438 Modified
226431 Modified
226430 Modified
226428 Modified
226426 Modified
226425 Modified
226424 Modified
226422 Modified
226418 Modified
226417 Modified
226416 Modified
226415 Modified
214131 Modified
214130 Modified
214128 Modified
214127 Modified
214126 Modified
214124 Modified
181750 Modified
181749 Modified
181748 Modified
181745 Modified
181742 Modified
181741 Modified
181740 Modified
181739 Modified
181738 Modified
181737 Modified
181736 Modified
181733 Modified
181732 Modified
181731 Modified
181730 Modified
181729 Modified
181728 Modified
181727 Modified
ICR Details
0915-0157 202202-0915-002
Received in OIRA 202006-0915-008
HHS/HSA
Data System for Organ Procurement and Transplantation Network
Revision of a currently approved collection   No
Regular 02/17/2022
  Requested Previously Approved
36 Months From Approved 08/31/2023
604,519 567,472
430,267 425,929
0 0

These forms, which collect data on donors and potential transplant recipients, and the information gathered from the forms, are needed to enable the OPTN to operate a computerized matching system to facilitate matching organs from donors to those who are in need of organs based on medical criteria. In addition, the OPTN shares this data with the Scientific Registry of Transplant Recipients (SRTR) to enable the SRTR to provide statistical and analytic support for the OPTN Board of Directors and committees, HRSA, and the Department of Health and Human Services (HHS) Advisory Committee on Organ Transplantation (ACOT). Respondents include transplant hospitals, organ procurement organizations, and histocompatibility laboratories.

US Code: 42 USC 274(b)(2)(I), Sec 372(b)(2)(I) Name of Law: PHS Act
  
None

Not associated with rulemaking

  86 FR 48743 08/31/2021
87 FR 1151 01/10/2022
Yes

62
IC Title Form No. Form Name
Deceased Donor Registration (DDR) 1 Deceased Donor Registration_Form.xlsx
Disease Transmission Event 58 Disease Transmission Event_Form.xlsx
Donor Histocompatibility Form 4 Donor Histocompatibility_Form.xlsx
Heart Follow Up (6 months) 8 Heart Transplant Recipient Follow Up 6 Month_Form.xlsx
Heart Post-Transplant Malignancy Form 11 Heart Post Transplant Malignancy_Form.xlsx
Heart Recepient Registration 7 Heart Transplant Recipient Registration_Form_clean.xlsx
Heart Transplant Candidate Registration (TCR) 6 Heart Transplant Candidate Registration_Form.xlsx
Heart Transplant Recipient Follow Up 1-5 Year 9 Heart Transplant Recipient Follow Up 1_5 Year _Form.xlsx
Heart Transplant Recipient Follow Up Post 5 Year 10 Heart Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Heart/Lung Post Transplant Malignancy (PTM) Form 23 Heart/Lung Post Transplant Malignancy_Form.xlsx
Heart/Lung Recipient Registration 19 Heart/Lung Transplant Recipient Registration_Form_clean.xlsx
Heart/Lung Transplant Candidate Registration (TCR) 18 Heart/Lung Transplant Candidate Registration_Form_clean.xlsx
Heart/Lung Transplant Recipient Follow Up 1-5 Year (TRF) 21 Heart/Lung Transplant Recipient Follow Up 1_5 Year_Form_clean.xlsx
Heart/Lung Transplant Recipient Follow Up 6 Month (TRF) 20 Heart/Lung Transplant Recipient Follow Up 6 Month_Form.xlsx
Heart/Lung Transplant Recipient Follow Up Post 5 Year (TRF) 22 Heart/Lung Transplant Recipient Follow Up Post 5 Year_Form_clean.xlsx
Intestine Post Transplant Malignancy (PTM) Form 34 Intestine Post Transplant Malignancy_Form.xlsx
Intestine Transplant Candidate Registration (TCR) 30 Intestine Transplant Candidate Registration_Form.xlsx
Intestine Transplant Recipient Follow Up 6 Month -5 Year (TRF) 32 Intestine Transplant Recipient Follow Up 6 Month_5 Year_Form.xlsx
Intestine Transplant Recipient Follow Up Post 5 Year (TRF) 33 Liver Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Intestine Transplant Recipient Registration (TRR) 31 Intestine Transplant Recipient Registration_Form_clean.xlsx
Kidney Paired Donation Candidate Registration 55 Kidney Paired Donation Candidate Registration_Form.xlsx
Kidney Paired Donation Donor Registration 56 Kidney Paired Donation Donor Registration_Form.xlsx
Kidney Paired Donation Match Offer Management 57 Kidney Paired Donation Match Offer Management_Form.xlsx
Kidney Post Transplant Malignancy (PTM) Form 39 Kidney Post Transplant Malignancy_Form.xlsx
Kidney Transplant Candidate Registration (TCR) 35 Kidney Transplant Candidate Registration_Form.xlsx
Kidney Transplant Recipient Follow Up 6 Month -5 Year (TRF) 37 Kidney Transplant Recipient Follow Up 6 Month_5 Year_Form.xlsx
Kidney Transplant Recipient Follow Up Post 5 Year (TRF) 38 Kidney Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Kidney Transplant Recipient Registration (TRR) 36 Kidney Transplant Recipient Registration_Form_clean.xlsx
Kidney/Pancreas Post Transplant Malignancy (PTM) Form 49 Kidney/Pancreas Post Transplant Malignancy_Form.xlsx
Kidney/Pancreas Transplant Candidate Registration (TCR) 45 Kidney/Pancreas Transplant Candidate Registration_Form.xlsx
Kidney/Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) 47 Kidney/Pancreas Transplant Recipient Follow Up 6 Month_5 Year_Form.xlsx
Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) 48 Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Kidney/Pancreas Transplant Recipient Registration (TRR) 46 Kidney/Pancreas Transplant Recipient Registration_Form_clean.xlsx
Liver Post Transplant Malignancy (PTM) Form 29 Liver Post Transplant Malignancy_Form.xlsx
Liver Recipient Explant Pathology Form 28 Liver Explant Pathology_clean.xlsx
Liver Transplant Candidate Registration (TCR) 24 Liver Transplant Candidate Registration_Form.xlsx
Liver Transplant Recipient Follow Up 6 Month -5 Year (TRF) 26 Liver Transplant Recipient Follow Up 6 Month_5 Year_Form.xlsx
Liver Transplant Recipient Follow Up Post 5 Year (TRF) 27 Liver Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Liver Transplant Recipient Registration (TRR) 25 Liver Transplant Recipient Registration_Form_clean.xlsx
Living Donor Event 59 Living Donor Event_Form.xlsx
Living Donor Follow-up (LDF) 3 Living Donor Follow Up_Form.xlsx
Living Donor Registration (LDR) 2 Living Donor Registration_Form.xlsx
Lung - Post Transplant Malignancy (PTM) Form 17 Lung Post Transplant Malignancy_Form.xlsx
Lung Transplant Candidate Registration (TCR) 12 Lung Transplant Candidate Registration_Form_clean.xlsx
Lung Transplant Recipient Follow Up 1-5 Year (TRF) 15 Lung Transplant Recipient Follow Up 1_5 Year_Form_clean.xlsx
Lung Transplant Recipient Follow Up 6 Month (TRF) 14 Lung Transplant Recipient Follow Up 6 Month_Form.xlsx
Lung Transplant Recipient Follow Up Post 5 Year (TRF) 16 Lung Transplant Recipient Follow Up Post 5 Year_Form_clean.xlsx
Lung Transplant Recipient Registration (TRR) 13 Lung Transplant Recipient Registration_Form_clean.xlsx
Organ Labeling and Packaging System 53 Organ Labeling and Packaging_Form.xlsx
Organ Tracking and Validating System 54 Organ Tracking and Validating_Form.xlsx
Pancreas Post Transplant Malignancy (PTM) Form 44 Pancreas Post Transplant Malignancy_Form.xlsx
Pancreas Transplant Candidate Registration (TCR) 40 Pancreas Transplant Candidate Registration_Form.xlsx
Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) 42 Pancreas Transplant Recipient Follow Up 6 Month_5 Year_Form.xlsx
Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) 43 Pancreas Transplant Recipient Follow Up Post 5 Year_ Form.xlsx
Pancreas Transplant Recipient Registration (TRR) 41 Pancreas Transplant Recipient Registration_Form_clean.xlsx
Potential Disease Transmission Report 61 Potential Disease Transmission Report_Form.xlsx
Recipient Histocompatibility Form 5 Recipient Histocompatibility_Form.xlsx
Request to Unlock Form 62 Request to Unlock Form_Form.xlsx
Safety Situation 60 Safety Situation_Form.xlsx
VCA Transplant Candidate Registration (TCR) 50 VCA Transplant Candidate Registration_Form.xlsx
VCA Transplant Recipient Follow Up (TRF) 52 VCA Transplant Recipient Follow Up_Form.xlsx
VCA Transplant Recipient Registration (TRR) 51 VCA Transplant Recipient Registration_Form_clean.xlsx

  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 604,519 567,472 0 37,047 0 0
Annual Time Burden (Hours) 430,267 425,929 0 4,338 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Using Information Technology
This increase in burden is a result of adding 10 new forms to the existing Information Collection. A burden reduction is a result of rounding down burden on a few ICRs.

$718,569
No
    Yes
    Yes
No
No
No
No
Elyana Bowman 301 443-3983 enadjem@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.
02/17/2022


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