Organ Procurement and Transplantation Network Application Form

Forms and Documents

Document Name	Status
Form 23 Kidney Paired Donation Pilot Program (KPDPP) contact update Form Form and Instruction	Unchanged
Form 21 HOPE Act Variance Request Form Form and Instruction	Unchanged
Form 20 Additional Surgeon and Physician Request Form Form and Instruction	Unchanged
Form 19 Primary Data Coordinator Form Form and Instruction	Unchanged
Form 18 Primary Program Administrator Form Form and Instruction	Unchanged
Form 17 OPTN Individual Membership Application Form and Instruction	Unchanged
Form 16 OPTN Business Membership Application Form and Instruction	Unchanged
Form 15 OPTN Public Organization Membership Application Form and Instruction	Unchanged
Form 14 OPTN Medical Scientific Membership Application Form and Instruction	Unchanged
Form 13 OPTN Representative Form Form and Instruction	Unchanged
Form 12 OPTN Membership Application for Histocompatibility Labs Form and Instruction	Modified
Form 11 OPTN Membership Application for OPOs Form and Instruction	Unchanged
Form 10 OPTN Membership Application for Intestine Transplant Programs Form and Instruction	Unchanged
Form 9 OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application Form and Instruction	Unchanged
Form 8 OPTN Membership Application Islet Transplant Program Form and Instruction	Unchanged
Form 7 B OPTN Membership Application for Lung Transplant Program Form and Instruction	Modified
Form 6 B OPTN Membership Application for Heart Transplant Program Form and Instruction	Modified
Form 5 B OPTN Membership Application for Pancreas Transplant Programs Form and Instruction	Modified
Form 4 B OPTN Membership Application for Liver Transplant Progrms Form and Instruction	Modified
Form 3 B OPTN Membership Application for Kidney Transplant Programs Form and Instruction	Modified
Form 1 OPTN Membership Application for Transplant Hospitals and Programs Form and Instruction	Unchanged
10062023 - Change Memo - 091820235005 - CLEAN.docx Justification for No Material/Nonsubstantive Change	2023-10-13
10252022 - Supporting Statement - OMB 0915-0184.docx Supporting Statement A	2022-11-18

IC Document Collections

IC ID	Document Title	Status
257000	Kidney Paired Donation Pilot Program (KPDPP) contact update Form Form and Instruction	Unchanged
256999	HOPE Act Variance Request Form Form and Instruction	Unchanged
256998	Additional Surgeon and Physician Request Form Form and Instruction	Unchanged
256997	Primary Data Coordinator Form Form and Instruction	Unchanged
256996	Primary Program Administrator Form Form and Instruction	Unchanged
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	Modified
226693	OPTN Membership Application for OPOs Form and Instruction	Unchanged
226692	OPTN Membership Application for Intestine Transplant Programs 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	Modified
226684	OPTN Membership Application for Heart Transplant Program Form and Instruction	Modified
226683	OPTN Membership Application for Pancreas Transplant Programs Form and Instruction	Modified
226682	OPTN Membership Application for Liver Transplant Progrms Form and Instruction	Modified
226681	OPTN Membership Application for Kidney Transplant Programs Form and Instruction	Modified
226680	OPTN Membership Application for Transplant Hospitals and Programs Form and Instruction	Unchanged

ICR Details

OMB Control No: 0915-0184	ICR Reference No: 202310-0915-002
Status: Received in OIRA	Previous ICR Reference No: 202211-0915-001
Agency/Subagency: HHS/HSA	Agency Tracking No: 21566
Title: Organ Procurement and Transplantation Network Application Form
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/13/2023

	Requested	Previously Approved
Expiration Date	12/31/2025	12/31/2025
Responses	858	858
Time Burden (Hours)	5,610	5,610
Cost Burden (Dollars)	0	0

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Abstract: This is a request to revise the current Organ Procurement and Transplantation Network (OPTN) data collection associated with institutional (including transplant hospital, organ procurement organization, and transplant histocompatibility laboratory) and non-institutional (medical/scientific and public organization, business and individual) applications to meet or sustain requirements for OPTN membership. This request include adding two new data collection forms (Hope Act Variance Request and Kidney Paired Donation Pilot Program or KPDPP contact update form), three standalone forms (Primary Program Administrator, Primary Data Coordinator, and Additional Surgeon and Physician) for revised data collection, and a revision of organ-specific applications found in the Certificate of Assessment and Program Coverage Plan Membership Application (COA/PCP). The likely respondents are new and existing transplant hospitals, organ procurement organization, histocompatibility laboratories, medical/scientific organization, public organization, business and individual members.

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Authorizing Statute(s): US Code: 42 USC 1138 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies
   US Code: 42 USC 273 Name of Law: National Organ Transplant Act of 1984
  

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:
	87 FR 52389	08/25/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 68713	11/16/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 21

IC Title	Form No.	Form Name
Additional Surgeon and Physician Request Form	20	Additional Surgeon and Physician Request Form
HOPE Act Variance Request Form	21	Hope Act Variance Request Form
Kidney Paired Donation Pilot Program (KPDPP) contact update Form	23	Kidney Paired Donation Pilot Program (KPDPP) contact update Form
OPTN Business Membership Application	16	OPTN Membership_Business Form
OPTN Individual Membership Application	17	OPTN Membership_Individual Form
OPTN Medical Scientific Membership Application	14	Membership_MedicalScientific Form.docx
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application	9 , 9 B	OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs ,   OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application Islet Transplant Program	8, 8 B	OPTN Membership Application for Islet Transplant Programs CLEAN ,   OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Heart Transplant Program	6 B, 6	OPTN Membership Application_Surgeon or Physician Log ,   OPTN Membership Application for Heart Transplant Programs
OPTN Membership Application for Histocompatibility Labs	12	OPTN Membership Application for Histocompatibility Laboratories
OPTN Membership Application for Intestine Transplant Programs	10, 10 B	OPTN Membership Application for Intestine Transplant Programs ,   OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Kidney Transplant Programs	3 B, 3	OPTN Membership Application_Surgeon or Physician Log.docx ,   OPTN Membership Application for Kidney Transplant Programs
OPTN Membership Application for Liver Transplant Progrms	4 B, 4	OPTN Membership Application_Surgeon or Physician Log ,   OPTN Membership Application for Liver Transplant Programs
OPTN Membership Application for Lung Transplant Program	7 B, 7	OPTN Membership Application_Surgeon or Physician Log ,   OPTN Membership Application for Lung Transplant Programs
OPTN Membership Application for OPOs	11	Membership_OPO Form.docx
OPTN Membership Application for Pancreas Transplant Programs	5, 5 B	OPTN Membership Application_Surgeon or Physician Log ,   OPTN Membership Application for Pancreas Transplant Programs
OPTN Membership Application for Transplant Hospitals and Programs	1	OPTN Membership Application for Transplant Hospitals and Programs.docx
OPTN Public Organization Membership Application	15	Membership_PublicOrg Form.docx
OPTN Representative Form	13	OPTN Membership_Representative Form.docx
Primary Data Coordinator Form	19	Primary Data Coordinator
Primary Program Administrator Form	18	Primary Program Administrator Form

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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	858	858	0	0	0	0
Annual Time Burden (Hours)	5,610	5,610	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: Note: The burden table on the Supporting Statement are slightly different than the 30 Day FRN due to a rounding issue. The The burden estimates are derived from Burden Surveys sent out by the OPTN Contractor to the OPTN members who have participated in this data collection activity. The survey is sent to 5-9 members per form. The survey results are collected from the respondents and the Average Burden is calculated. Changes to the burden hours from the last approval are due to agency discretion (i.e., changes in the estimated burden). Changes to the forms are proposed to make application requirements even clearer and organized, and thus less cumbersome for applicants to complete. Proposed revisions include changes to wording to make questions more consistent with the language of the OPTN bylaws. In addition, the applications have been revised so that the sequence of questions is parallel to that of the bylaws. Using the bylaws as a baseline, the revamped applications have been constructed in parallel order of the bylaws so that an applicant can have the application and bylaws side-by-side for easy reference. More detail is provided in the supporting statement.

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Annual Cost to Federal Government: $347,361

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? 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: 10/13/2023

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