Organ Procurement and Transplantation Network

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 15 B2_NewLDL_only_Cover_instructions	Form	Modified	Available
Form 14 E_Lab_Independent_app	Form	Modified	Available
Form 13 A12_Lab_section_part_6	Form	Modified	Available
Form 11 A10_OPO_Inhouse	Form	Modified	Available
Form 10 A9_PI_App	Form	Modified	Available
Form 9 A8_HL_App	Form	Modified	Available
Form 8 C_OPO_App	Form	Modified	Available
Form 7 A7_LU_App	Form	Modified	Available
Form 6 A6_HR_App	Form	Modified	Available
Form 5 A5_PA_app	Form	Modified	Available
Form 3 A3_KI_LDK_Combined_app	Form	Modified	Available
Form 2 A2_part_1_2_General_facility	Form	Modified	Available
Form 4 A4_LI_LDL_combined_app	Form	Modified	Repair queued
Form 1 A1_Full_App_Cover_Instructions	Form and Instruction	Modified	Available
Form 0 Organ Procurement and Transplantation Network Application	Form	Modified	Available
Form 0 Organ Procurement and Transplantation Network Application	Form	Modified	Available
Form 4 Individual_member_app	Form and Instruction	Modified	Available
Form 3 Public_organ_app	Form and Instruction	Modified	Available
Form 1 Business_Member_app	Form and Instruction	Modified	Available
Form 2 G_medical_scientific_app	Form and Instruction	Modified	Available
Form 1 F_Cover_Instructions_Personnel	Form and Instruction	Modified	Available
Draft Summary Statement UPDATED 2_8_2011.docx	Supporting Statement A	Uploaded 2011-02-11	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6410	Organ Procurement and Transplantation Network Application	Form	Modified	B2_NewLDL_only_Cover_instructions
6410	Organ Procurement and Transplantation Network Application	Form	Modified	E_Lab_Independent_app
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A12_Lab_section_part_6
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A10_OPO_Inhouse
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A9_PI_App
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A8_HL_App
6410	Organ Procurement and Transplantation Network Application	Form	Modified	C_OPO_App
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A7_LU_App
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A6_HR_App
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A5_PA_app
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A3_KI_LDK_Combined_app
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A2_part_1_2_General_facility
6410	Organ Procurement and Transplantation Network Application	Form	Modified	A4_LI_LDL_combined_app
6410	Organ Procurement and Transplantation Network Application	Form and Instruction	Modified	A1_Full_App_Cover_Instructions
6410	Organ Procurement and Transplantation Network Application	Form	Modified	0
6410	Organ Procurement and Transplantation Network Application	Form	Modified	0
6410	Organ Procurement and Transplantation Network Application	Instruction	Modified
183035	OPTN Appeal for Designation		Modified
183034	OPTN Designated Transplant Program Requirements		Modified
183033	OPTN Transplant to Prevent Organ Wastage		Modified
183032	OPTN Reasons for Refusal		Modified
183031	OPTN criteria reporting and disclosure		Modified
183030	OPTN Appeal for Membership		Modified
183029	OPTN Non-Institutional Application	Form and Instruction	Modified	Individual_member_app
183029	OPTN Non-Institutional Application	Form and Instruction	Modified	Public_organ_app
183029	OPTN Non-Institutional Application	Form and Instruction	Modified	Business_Member_app
183029	OPTN Non-Institutional Application	Form and Instruction	Modified	G_medical_scientific_app
183028	OPTN Personnel Change Application	Form and Instruction	Modified	F_Cover_Instructions_Personnel

ICR Details

OMB Control No: 0915-0184	ICR Reference No: 201102-0915-005
Status: Historical Active	Previous ICR Reference No: 200712-0915-001
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: 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: 04/25/2011
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/24/2011
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	36 Months From Approved	04/30/2011
Responses	36,868	0	36,788
Time Burden (Hours)	23,503	0	23,503
Cost Burden (Dollars)	0	0	41,446

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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:
	75 FR 63187	10/14/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 9584	02/18/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

table that charts list of burden

IC Title	Form No.	Form Name
OPTN Appeal for Designation
OPTN Appeal for Membership
OPTN Designated Transplant Program Requirements
OPTN Non-Institutional Application	2, 1, 3, 4	G_medical_scientific_app ,   Business_Member_app ,   Public_organ_app ,   Individual_member_app
OPTN Personnel Change Application	1	F_Cover_Instructions_Personnel
OPTN Reasons for Refusal
OPTN Transplant to Prevent Organ Wastage
OPTN criteria reporting and disclosure
Organ Procurement and Transplantation Network Application	0, 0, 1, 4, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15	0 ,   0 ,   A1_Full_App_Cover_Instructions ,   A4_LI_LDL_combined_app ,   A2_part_1_2_General_facility ,   A3_KI_LDK_Combined_app ,   A5_PA_app ,   A6_HR_App ,   A7_LU_App ,   C_OPO_App ,   A8_HL_App ,   A9_PI_App ,   A10_OPO_Inhouse ,   A12_Lab_section_part_6 ,   E_Lab_Independent_app ,   B2_NewLDL_only_Cover_instructions

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ICR Summary of Burden

table that charts list 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	36,868	36,788	0	0	80	0
Annual Time Burden (Hours)	23,503	23,503	0	0	0	0
Annual Cost Burden (Dollars)	0	41,446	0	0	-41,446	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:

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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: 02/24/2011

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