Organ Procurement and Transplantation Network Application Form

ICR 201906-0915-004

OMB: 0915-0184

Federal Form Document

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Justification for No Material/Nonsubstantive Change
2019-06-04
Justification for No Material/Nonsubstantive Change
2019-06-04
Justification for No Material/Nonsubstantive Change
2019-06-04
Justification for No Material/Nonsubstantive Change
2019-06-04
Justification for No Material/Nonsubstantive Change
2019-06-04
Justification for No Material/Nonsubstantive Change
2019-06-04
Supplementary Document
2018-02-27
Supporting Statement A
2017-05-03
IC Document Collections
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226701 Unchanged
226700 Unchanged
226699 Unchanged
226698 Unchanged
226697 Unchanged
226696 Unchanged
226695 Unchanged
226694 Unchanged
226693 Unchanged
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226680 Unchanged
ICR Details
0915-0184 201906-0915-004
Historical Active 201802-0915-002
HHS/HSA 21566
Organ Procurement and Transplantation Network Application Form
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 06/05/2019
Retrieve Notice of Action (NOA) 06/05/2019
  Inventory as of this Action Requested Previously Approved
07/31/2020 07/31/2020 07/31/2020
1,868 0 1,868
7,020 0 7,020
0 0 0

A question regarding designated intestine transplant programs was inadvertently omitted from the OPTN membership application forms approved by the Office of Management and Budget during July 2017. Specifically, the omitted question is used to collect information to demonstrate compliance with the intestine transplant program “primary transplant physician” training and experience requirements in the OPTN bylaws.

US Code: 42 USC 274 Name of Law: Organ Procurement and Transplantation Network
   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
  
None

Not associated with rulemaking

  81 FR 89115 12/09/2016
82 FR 22145 05/12/2017
No

22
IC Title Form No. Form Name
B Intestine Designated Program Application B17 B17 Intestine_HRSA.doc
D Histocompatibility Lab Application D D_HistoLab_New_Clean_HRSA.doc
I Public Org Application I I_PublicOrg_Clean_HRSA.doc
B Heart (HR) Designated Program Application B6 B6_HR Heart_Clean.doc
B Living Donor (LD) Recovery Program Application B9 B9_LD NewLivingDonorRecoveries_Clean.doc
B VCA Upper Limb Designated Program Application B11 B VCA_Upper Limb_Updated.doc
C OPO New Application C C_OPO_New_final_Clean_HRSA.doc
E Personnel Change Cover Application F F_HistoLab_PersonnelChange_Clean_HRSA.doc
F Change in Histocompatibility Lab Director F F_HistoLab_PersonnelChange_Clean_HRSA.doc
G Change in OPO Key Personnel G G_OPO_DirectorChange_final_clean_HRSA.doc
H Medical Scientific Org Application H H_MedicalScientific_Clean_HRSA.doc
J Business Member Application j J_Business_Clean_HRSA.doc
K Individual Member Application K K_Individual_Clean_HRSA.doc
B VCA Abdominal Wall Designated Program Application B12, B13, B14, B15 B12 VCA_AW_Kidney_Updated.doc ,   B13 VCA_AW_Liver_Updated.doc ,   B14 _VCA_AW_Pancreas_Updated.doc ,   B15 VCA_AW_Intestine_Updated.doc
B VCA Other Designated Program Application B16 c, B16 a, B16 b B16 a VCA_Other_Updated.doc ,   B16 b VCA_Other_NewTransplantProgram_Cover_HRSA.doc_.doc ,   B16 c VCA_Other_PersonnelChange_Cover_HRSA.doc_.doc
B Kidney (KI) Designated Program Application B3 B3_Kidney_LDKidney_Clean.doc
B Liver (LI) Designated Program Application B4 B4_L1 Liver_LDLiver_Clean.doc
B Pancreas (PA) Designated Program Application B5 B5_PA Pancreas_Clean.doc
A New Transplant Hospital Program Application - General B2, A2, B1, A1 A1_NewTransplantHospital_Cover_HRSA.doc ,   A2_NewTransplant_General_Clean.doc ,   B1_NewTransplantProgram_Cover_Clean_HRSA.doc ,   B2 VCA_NewTransplantProgram_Cover_HRSA.doc
B Lung (LU) Designated Program Application B7 B7_LU Lung_Clean.doc
B Islet (PI) Designated Program Application B8 B8_PI PancreasIslet_Clean.doc
B VCA Head and Neck Designated Program Application B10 B VCA_Head and Neck_Updated.doc

  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 1,868 1,868 0 0 0 0
Annual Time Burden (Hours) 7,020 7,020 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The estimated burden for the revised collection increased from 6,006 to 7,016. This increase is due to the additions and revisions to selected forms and the addition of new forms around VCA transplants. However, each individual form will be shorter and easier to complete, leading to a decrease in burden in some instruments. ROCIS doesn't allow for 0 respondents or burden, so the respondents had to be increased to 1 in order to be entered. This caused the total respondents to increase by 1 and the total burden by 4 hours. Form C "OPO New Applications" has 0 for respondents as there are no new respondents, thus no form to respond to.

$345,000
No
    No
    No
No
No
No
Uncollected
Elyana Bowman 301 443-3983 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/05/2019


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