Organ Procurement and Transplantation Network Application Form

Forms and Documents

Document Name	Status
Form D Organ Procurement and Transplantation Network Application Form and Instruction	Modified
Form H OPTN Non-Institutional Application Form and Instruction	Modified
Form E OPTN Personnel Change Application Form and Instruction	Modified
Summary of Changes.docx Supplementary Document	2014-03-11
Supporting Statement A.docx Supporting Statement A	2014-04-29

IC Document Collections

IC ID	Document Title	Status
6410	Organ Procurement and Transplantation Network Application Form and Instruction	Modified
183035	OPTN Appeal for Designation	Removed
183034	OPTN Designated Transplant Program Requirements	Removed
183033	OPTN Transplant to Prevent Organ Wastage	Removed
183032	OPTN Reasons for Refusal	Removed
183031	OPTN criteria reporting and disclosure	Removed
183030	OPTN Appeal for Membership	Removed
183029	OPTN Non-Institutional Application Form and Instruction	Modified
183028	OPTN Personnel Change Application Form and Instruction	Modified

ICR Details

OMB Control No: 0915-0184	ICR Reference No: 201403-0915-002
Status: Historical Active	Previous ICR Reference No: 201102-0915-005
Agency/Subagency: HHS/HSA	Agency Tracking No: 21566
Title: Organ Procurement and Transplantation Network Application Form
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/16/2014
	Date Received in OIRA: 03/17/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved	05/31/2014
Responses	1,547	0	36,868
Time Burden (Hours)	6,006	0	23,503
Cost Burden (Dollars)	0	0	0

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Abstract: The final rule of the Organ Procurement and Transplantation Network (OPTN) established the final policies governing the OPTN. This ICR contains application requirements outlined in the rule regarding application procedures and policies of the OPTN and membership, designation, and transplant program requirements. This submission contains burden associated with the final rule for application for membership in the OPTN and requirements for membership, including compliance with OPTN policies and bylaws.

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Authorizing Statute(s): US Code: 42 USC 273 Name of Law: National Organ Transplant Act
   US Code: 42 USC 1138 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies
   US Code: 42 USC 274 Name of Law: Organ Procurement and Transplantation Network
  

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:
	78 FR 69695	11/20/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 11798	03/03/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Organ Procurement and Transplantation Network Application	D, C, A1, B1, A2, B3, B4, B5, B6, B7, B8, B9	Histocompatibility Laboratory Membership Application ,   Application for Organ Procurement (OPO) Membership ,   A1 ,   B1 ,   A2 ,   B3 ,   B4 ,   B5 ,   B6 ,   B7 ,   B8 ,   B9
OPTN Personnel Change Application	E, F, G	Personnel Change Application (Transplant Program) ,   Change in Key Personnel Application - Histocompatibility Laboratory ,   Application for Approval for Change in Key Personnel - OPO
OPTN Non-Institutional Application	H, I, J, K	Application for Medical/Scientific Organization Membership ,   Application for Public Organization Membership ,   Application for Business Membership ,   Application for Individual Membership
OPTN Appeal for Membership
OPTN criteria reporting and disclosure
OPTN Reasons for Refusal
OPTN Transplant to Prevent Organ Wastage
OPTN Designated Transplant Program Requirements
OPTN Appeal for Designation

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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	1,547	36,868	0	-36,404	1,083	0
Annual Time Burden (Hours)	6,006	23,503	0	-17,497	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: Changing Forms

Short Statement: This renewal request is made with revisions to the expiring documents. The paperwork burden is decreasing. The application forms were revised to make them more respondent friendly. Specifically, the revised application is rewritten in plain language and asks only for information relevant to current membership requirements. It is estimated that the number of respondents will increase significantly. First, there will be more individual forms to fill out. However, each individual form will be shorter and easier to complete - therefore, the burden will not be increased. In addition, some membership application activities are being formalized with the development of two new data collection forms: o F Change in Histocompatibility Lab Director; and o G Change in OPO Key Personnel Although two new data forms have been developed, membership obligations have always required that this information be formally reported to the OPTN; as such, the new forms referenced above will not create a new burden for OPTN members.

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Annual Cost to Federal Government: $0

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: 03/17/2014

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