Data System for Organ Procurement and Transplantation Network

Forms and Documents

Document Name	Status
Supporting Statement A 0157 Rev.docx Supporting Statement A	2022-02-15

IC Document Collections

IC ID	Document Title	Status
6389	Deceased Donor Registration (DDR) Instruction	Modified
251650	Request to Unlock Form Instruction	New
251649	Potential Disease Transmission Report Instruction	New
251648	Safety Situation Instruction	New
251647	Living Donor Event Instruction	New
251645	Disease Transmission Event Instruction	New
251644	Kidney Paired Donation Match Offer Management Instruction	New
251643	Kidney Paired Donation Donor Registration Instruction	New
251642	Kidney Paired Donation Candidate Registration Instruction	New
251641	Organ Tracking and Validating System Instruction	New
251640	Organ Labeling and Packaging System Instruction	New
226455	VCA Transplant Recipient Follow Up (TRF) Instruction	Modified
226454	VCA Transplant Recipient Registration (TRR) Instruction	Modified
226453	Kidney/Pancreas Post Transplant Malignancy (PTM) Form Instruction	Modified
226452	Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226451	Kidney/Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
226449	Kidney/Pancreas Transplant Recipient Registration (TRR) Instruction	Modified
226448	Pancreas Post Transplant Malignancy (PTM) Form Instruction	Modified
226447	Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226446	Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
226445	Pancreas Transplant Recipient Registration (TRR) Instruction	Modified
226443	Kidney Post Transplant Malignancy (PTM) Form Instruction	Modified
226442	Kidney Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226441	Intestine Post Transplant Malignancy (PTM) Form Instruction	Modified
226440	Intestine Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226439	Liver Post Transplant Malignancy (PTM) Form Instruction	Modified
226438	Liver Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226431	Heart/Lung Post Transplant Malignancy (PTM) Form Instruction	Modified
226430	Lung - Post Transplant Malignancy (PTM) Form Instruction	Modified
226428	Lung Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
226426	Lung Transplant Recipient Follow Up 1-5 Year (TRF) Instruction	Modified
226425	Lung Transplant Recipient Follow Up 6 Month (TRF) Instruction	Modified
226424	Lung Transplant Recipient Registration (TRR) Instruction	Modified
226422	Heart Post-Transplant Malignancy Form Instruction	Modified
226418	Heart Transplant Recipient Follow Up Post 5 Year Instruction	Modified
226417	Heart Transplant Recipient Follow Up 1-5 Year Instruction	Modified
226416	Heart Follow Up (6 months) Instruction	Modified
226415	Heart Recepient Registration Instruction	Modified
214131	VCA Transplant Candidate Registration (TCR) Instruction	Modified
214130	Liver Recipient Explant Pathology Form Instruction	Modified
214128	Heart/Lung Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Modified
214127	Heart/Lung Transplant Recipient Follow Up 1-5 Year (TRF) Instruction	Modified
214126	Heart/Lung Transplant Recipient Follow Up 6 Month (TRF) Instruction	Modified
214124	Heart/Lung Recipient Registration Instruction	Modified
181750	Intestine Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
181749	Intestine Transplant Recipient Registration (TRR) Instruction	Modified
181748	Intestine Transplant Candidate Registration (TCR) Instruction	Modified
181745	Pancreas Transplant Candidate Registration (TCR) Instruction	Modified
181742	Kidney/Pancreas Transplant Candidate Registration (TCR) Instruction	Modified
181741	Liver Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
181740	Liver Transplant Recipient Registration (TRR) Instruction	Modified
181739	Liver Transplant Candidate Registration (TCR) Instruction	Modified
181738	Kidney Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Modified
181737	Kidney Transplant Recipient Registration (TRR) Instruction	Modified
181736	Kidney Transplant Candidate Registration (TCR) Instruction	Modified
181733	Heart/Lung Transplant Candidate Registration (TCR) Instruction	Modified
181732	Lung Transplant Candidate Registration (TCR) Instruction	Modified
181731	Heart Transplant Candidate Registration (TCR) Instruction	Modified
181730	Recipient Histocompatibility Form Instruction	Modified
181729	Donor Histocompatibility Form Instruction	Modified
181728	Living Donor Follow-up (LDF) Instruction	Modified
181727	Living Donor Registration (LDR) Instruction	Modified

ICR Details

OMB Control No: 0915-0157	ICR Reference No: 202202-0915-002
Status: Received in OIRA	Previous ICR Reference No: 202006-0915-008
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Data System for Organ Procurement and Transplantation Network
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/17/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2023
Responses	604,519	567,472
Time Burden (Hours)	430,267	425,929
Cost Burden (Dollars)	0	0

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Abstract: 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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 48743	08/31/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 1151	01/10/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 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

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ICR Summary of Burden

	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

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: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: 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.

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Annual Cost to Federal Government: $718,569

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

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Common Form ICR:  No

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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: 02/17/2022

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