Data System for Organ Procurement and Transplantation Network

Forms and Documents

Document Name	Status
01572019 Change Memo -OPTN DDR-Strongyloides.docx Justification for No Material/Nonsubstantive Change	2019-05-23
2019 Change Memo-OPTN DDR - ATTACHMENT.docx Justification for No Material/Nonsubstantive Change	2019-05-23
0157Change Memo - Lung Data Form-2019.docx Justification for No Material/Nonsubstantive Change	2019-05-23
0157Change Memo - Lung Data Form - ATTACHMENT.docx Justification for No Material/Nonsubstantive Change	2019-05-23
Supporting StatementOPTN Forms OMB No. 0915-0157.docx Supporting Statement A	2017-04-17

IC Document Collections

IC ID	Document Title	Status
6389	Deceased Donor Registration (DDR) Instruction	Unchanged
226455	VCA Transplant Recipient Follow Up (TRF) Instruction	Unchanged
226454	VCA Transplant Recipient Registration (TRR) Instruction	Unchanged
226453	Kidney/Pancreas Post Transplant Malignancy (PTM) Form Instruction	Unchanged
226452	Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Unchanged
226451	Kidney/Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Unchanged
226449	Kidney/Pancreas Transplant Recipient Registration (TRR) Instruction	Unchanged
226448	Pancreas Post Transplant Malignancy (PTM) Form Instruction	Unchanged
226447	Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Unchanged
226446	Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Unchanged
226445	Pancreas Transplant Recipient Registration (TRR) Instruction	Unchanged
226443	Kidney Post Transplant Malignancy (PTM) Form Instruction	Unchanged
226442	Kidney Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Unchanged
226441	Intestine Post Transplant Malignancy (PTM) Form Instruction	Unchanged
226440	Intestine Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Unchanged
226439	Liver Post Transplant Malignancy (PTM) Form Instruction	Unchanged
226438	Liver Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Unchanged
226431	Heart/Lung Post Transplant Malignancy (PTM) Form Instruction	Unchanged
226430	Lung - Post Transplant Malignancy (PTM) Form Instruction	Unchanged
226428	Lung Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Unchanged
226426	Lung Transplant Recipient Follow Up 1-5 Year (TRF) Instruction	Unchanged
226425	Lung Transplant Recipient Follow Up 6 Month (TRF) Instruction	Unchanged
226424	Lung Transplant Recipient Registration (TRR) Instruction	Unchanged
226422	Heart Post-Transplant Malignancy Form Instruction	Unchanged
226418	Heart Transplant Recipient Follow Up Post 5 Year Instruction	Unchanged
226417	Heart Transplant Recipient Follow Up 1-5 Year Instruction	Unchanged
226416	Heart Follow Up (6 months) Instruction	Unchanged
226415	Heart Recepient Registration Instruction	Unchanged
214131	VCA Transplant Candidate Registration (TCR) Instruction	Unchanged
214130	Liver Recipient Explant Pathology Form Instruction	Unchanged
214128	Heart/Lung Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	Unchanged
214127	Heart/Lung Transplant Recipient Follow Up 1-5 Year (TRF) Instruction	Unchanged
214126	Heart/Lung Transplant Recipient Follow Up 6 Month (TRF) Instruction	Unchanged
214124	Heart/Lung Recipient Registration Instruction	Unchanged
181750	Intestine Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Unchanged
181749	Intestine Transplant Recipient Registration (TRR) Instruction	Unchanged
181748	Intestine Transplant Candidate Registration (TCR) Instruction	Unchanged
181745	Pancreas Transplant Candidate Registration (TCR) Instruction	Unchanged
181742	Kidney/Pancreas Transplant Candidate Registration (TCR) Instruction	Unchanged
181741	Liver Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Unchanged
181740	Liver Transplant Recipient Registration (TRR) Instruction	Unchanged
181739	Liver Transplant Candidate Registration (TCR) Instruction	Unchanged
181738	Kidney Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	Unchanged
181737	Kidney Transplant Recipient Registration (TRR) Instruction	Unchanged
181736	Kidney Transplant Candidate Registration (TCR) Instruction	Unchanged
181733	Heart/Lung Transplant Candidate Registration (TCR) Instruction	Unchanged
181732	Lung Transplant Candidate Registration (TCR) Instruction	Unchanged
181731	Heart Transplant Candidate Registration (TCR) Instruction	Unchanged
181730	Recipient Histocompatibility Form Instruction	Unchanged
181729	Donor Histocompatibility Form Instruction	Unchanged
181728	Living Donor Follow-up (LDF) Instruction	Unchanged
181727	Living Donor Registration (LDR) Instruction	Unchanged

ICR Details

OMB Control No: 0915-0157	ICR Reference No: 201905-0915-005
Status: Historical Active	Previous ICR Reference No: 201704-0915-007
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Data System for Organ Procurement and Transplantation Network
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: 05/31/2019
	Date Received in OIRA: 05/23/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	07/31/2020	07/31/2020
Responses	488,980	0	488,980
Time Burden (Hours)	370,279	0	370,279
Cost Burden (Dollars)	0	0	0

---

Abstract: Data for the OPTN data system are collected from transplant hospitals, organ procurement organizations, and tissue-typing laboratories. The information is used to indicate the disease severity of transplant candidates, to monitor compliance of member organizations with OPTN rules and requirements, and to report periodically on the clinical and scientific status of organ donation and transplantation in this country.

---

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

---

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:
	81 FR 13378	03/14/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 18001	04/14/2017
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 52

IC Title	Form No.	Form Name
Liver Transplant Candidate Registration (TCR)	24	Liver Transplant Candidate Registration_Form.xlsx
Liver Transplant Recipient Registration (TRR)	25	Liver Transplant Recipient 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
Kidney/Pancreas Transplant Candidate Registration (TCR)	45	Kidney_Pancreas Transplant Candidate Registration_Form.xlsx
Pancreas Transplant Candidate Registration (TCR)	40	Pancreas Transplant Candidate Registration_Form.xlsx
Intestine Transplant Candidate Registration (TCR)	30	Intestine Transplant Candidate Registration_Form.xlsx
Intestine Transplant Recipient Registration (TRR)	31	Intestine Transplant Recipient Registration_Form.xlsx
Heart/Lung Recipient Registration	19	Heart_Lung Transplant Recipient Registration_Form.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 1-5 Year (TRF)	21	Heart_Lung Transplant Recipient Follow Up 1-5 Year_Form.xlsx
Heart/Lung Transplant Recipient Follow Up Post 5 Year (TRF)	22	Heart_Lung Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Intestine Transplant Recipient Follow Up 6 Month -5 Year (TRF)	32	Intestine Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Lung Transplant Recipient Registration (TRR)	13	Lung Transplant Recipient Registration_Form.xlsx
Lung Transplant Recipient Follow Up 1-5 Year (TRF)	15	Heart_Lung Transplant Recipient Follow Up 1-5 Year_Instructions.docx
Heart Post-Transplant Malignancy Form	11	Post Transplant Malignancy Form_All Organs.xlsx
Recipient Histocompatibility Form	5	Recipient Histocompatibility_Form.xlsx
Heart Transplant Recipient Follow Up Post 5 Year	10	Heart Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Heart Recepient Registration	7	Heart Transplant Recipient Registration_Form.xlsx
Lung Transplant Recipient Follow Up 6 Month (TRF)	14	Liver Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Lung - Post Transplant Malignancy (PTM) Form	17	Post Transplant Malignancy Form_All Organs.xlsx
Deceased Donor Registration (DDR)	1	UPDATED -Copy of Copy of Deceased Donor Registration Form-Jan2017.xlsx
Living Donor Registration (LDR)	2	Living Donor Registration Form.xlsx
Living Donor Follow-up (LDF)	3	Living Donor Follow Up Form.xlsx
Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year (TRF)	48	Kidney_Pancreas Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Pancreas Transplant Recipient Follow Up Post 5 Year (TRF)	43	Pancreas Transplant Recipient Follow Up Post 5 Year_Form.xlsx
VCA Transplant Recipient Registration (TRR)	51	Vascular Composite Allograft Transplant Recipient Registration_Form.xlsx
Lung Transplant Recipient Follow Up Post 5 Year (TRF)	16	Lung Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Kidney Post Transplant Malignancy (PTM) Form	39	Post Transplant Malignancy Form_All Organs.xlsx
Heart Transplant Recipient Follow Up 1-5 Year	9	Heart Transplant Recipient Follow Up 1-5 Year_Form.xlsx
Donor Histocompatibility Form	4	Donor Histocompatibility _Form.xlsx
Heart Transplant Candidate Registration (TCR)	6	Heart Transplant Candidate Registration_Form.xlsx
Lung Transplant Candidate Registration (TCR)	12	Lung Transplant Candidate Registration_Form.xlsx
Heart/Lung Transplant Candidate Registration (TCR)	18	Heart_Lung Transplant Candidate Registration_Form.xlsx
Kidney Transplant Candidate Registration (TCR)	35	Kidney Transplant Candidate Registration_Form.xlsx
Kidney Transplant Recipient Registration (TRR)	36	Kidney Transplant Recipient 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
Liver Recipient Explant Pathology Form	28	Liver Recipient Explant Pathology_Form.xlsx
Heart/Lung Post Transplant Malignancy (PTM) Form	23	Post Transplant Malignancy Form_All Organs.xlsx
Liver Transplant Recipient Follow Up Post 5 Year (TRF)	27	Liver Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Liver Post Transplant Malignancy (PTM) Form	29	Post Transplant Malignancy Form_All Organs.xlsx
Intestine Transplant Recipient Follow Up Post 5 Year (TRF)	33	Intestine Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Intestine Post Transplant Malignancy (PTM) Form	34	Post Transplant Malignancy Form_All Organs.xlsx
Kidney Transplant Recipient Follow Up Post 5 Year (TRF)	38	Kidney Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Pancreas Transplant Recipient Registration (TRR)	41	Pancreas Transplant Recipient 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 Post Transplant Malignancy (PTM) Form	44	Post Transplant Malignancy Form_All Organs.xlsx
Kidney/Pancreas Transplant Recipient Registration (TRR)	46	Kidney_Pancreas Transplant Recipient 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 Post Transplant Malignancy (PTM) Form	49	Post Transplant Malignancy Form_All Organs.xlsx
VCA Transplant Recipient Follow Up (TRF)	52	Vascular Composite Allograft Transplant Recipient Follow Up_Form.xlsx
VCA Transplant Candidate Registration (TCR)	50	Vascular Composite Allograft (VCA) Transplant Candidate Registration_Form.xlsx
Heart Follow Up (6 months)	8	Heart Transplant Recipient Follow Up 6 Month_Form.xlsx

---

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	488,980	488,980	0	0	0	0
Annual Time Burden (Hours)	370,279	370,279	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: Burdens in ROCIS may differ from SSA as ROCIS automatically rounds up. Currently, there are a total of 370,274.9 burden hours in the OMB inventory. The total burden hours has decreased from the previous total burden of 373,729 by 3,454.1 hours. The decreased total burden may be attributable to the increase in the use of data import/export capabilities by OPTN members. This has lessened the manual data entry burden on OPTN member staff. Although the contractor submitted the entire form packet for review, the current submission only requires modifications to 16 forms. The changes in burden referenced in above table include all forms.

---

Annual Cost to Federal Government: $212,524

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? Uncollected

---

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: 05/23/2019

---