Data System for Organ Procurement and Transplantation Network

Forms and Documents

Document Name	Status
Form 39 Kidney Post Transplant Malignancy (PTM) Form Form	New
Form 11 Post-Transplant Malignancy Form Form and Instruction	Removed
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	Modified
226455	VCA Transplant Recipient Follow Up (TRF) Instruction	New
226454	VCA Transplant Recipient Registration (TRR) Instruction	New
226453	Kidney/Pancreas Post Transplant Malignancy (PTM) Form Instruction	New
226452	Kidney/Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	New
226451	Kidney/Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	New
226449	Kidney/Pancreas Transplant Recipient Registration (TRR) Instruction	New
226448	Pancreas Post Transplant Malignancy (PTM) Form Instruction	New
226447	Pancreas Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	New
226446	Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF) Instruction	New
226445	Pancreas Transplant Recipient Registration (TRR) Instruction	New
226443	Kidney Post Transplant Malignancy (PTM) Form Form	New
226442	Kidney Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	New
226441	Intestine Post Transplant Malignancy (PTM) Form Instruction	New
226440	Intestine Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	New
226439	Liver Post Transplant Malignancy (PTM) Form Instruction	New
226438	Liver Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	New
226431	Heart/Lung Post Transplant Malignancy (PTM) Form Instruction	New
226430	Lung - Post Transplant Malignancy (PTM) Form Instruction	New
226428	Lung Transplant Recipient Follow Up Post 5 Year (TRF) Instruction	New
226426	Lung Transplant Recipient Follow Up 1-5 Year (TRF) Instruction	New
226425	Lung Transplant Recipient Follow Up 6 Month (TRF) Instruction	New
226424	Lung Transplant Recipient Registration (TRR) Instruction	New
226422	Heart Post-Transplant Malignancy Form Instruction	New
226418	Heart Transplant Recipient Follow Up Post 5 Year Instruction	New
226417	Heart Transplant Recipient Follow Up 1-5 Year Instruction	New
226416	Heart Follow Up (6 months) Instruction	New
226415	Heart Recepient Registration Instruction	New
214131	VCA Transplant Candidate Registration (TCR) Instruction	Modified
214130	Liver Recipient Explant Pathology Form Instruction	Modified
214129	Post-Transplant Malignancy Form Form and Instruction	Removed
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: 201704-0915-007
Status: Historical Active	Previous ICR Reference No: 201411-0915-004
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/19/2017
	Date Received in OIRA: 04/21/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved	02/28/2018
Responses	488,980	0	472,418
Time Burden (Hours)	370,279	0	373,729
Cost Burden (Dollars)	0	0	0

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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.

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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:
	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

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

IC Title	Form No.	Form Name
Pancreas Transplant Recipient Follow Up Post 5 Year (TRF)	43	Pancreas Transplant Recipient Follow Up Post 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
VCA Transplant Recipient Registration (TRR)	51	Vascular Composite Allograft Transplant Recipient Registration_Form.xlsx
Heart Recepient Registration	7	Heart 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
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
Post-Transplant Malignancy Form	11	Post-Transplant Malignancy Form
Heart Post-Transplant Malignancy Form	11	Post Transplant Malignancy Form_All Organs.xlsx
Recipient Histocompatibility Form	5	Recipient Histocompatibility_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
Heart Transplant Recipient Follow Up Post 5 Year	10	Heart Transplant Recipient Follow Up Post 5 Year_Form.xlsx
Lung Transplant Recipient Follow Up 6 Month (TRF)	14	Liver Transplant Recipient Follow Up 6 Month-5 Year_Form.xlsx
Liver Transplant Candidate Registration (TCR)	24	Liver Transplant Candidate Registration_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 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
Intestine Transplant Recipient Follow Up 6 Month -5 Year (TRF)	32	Intestine Transplant Recipient Follow Up 6 Month-5 Year_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
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
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
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

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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	472,418	0	24,450	-7,888	0
Annual Time Burden (Hours)	370,279	373,729	0	2,857	-6,307	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: Cutting Redundancy

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.

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Annual Cost to Federal Government: $212,524

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

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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: 04/21/2017

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