Organ Procurement and Transplantation Network Application Form

ICR 201705-0915-002

OMB: 0915-0184

Federal Form Document

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Supporting Statement A
2017-05-03
IC Document Collections
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6410 Removed
226701 New
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226698 New
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ICR Details
0915-0184 201705-0915-002
Historical Active 201403-0915-002
HHS/HSA 21566
Organ Procurement and Transplantation Network Application Form
Revision of a currently approved collection   No
Regular
Approved without change 07/19/2017
Retrieve Notice of Action (NOA) 05/12/2017
  Inventory as of this Action Requested Previously Approved
07/31/2020 36 Months From Approved 07/31/2017
1,868 0 1,547
7,020 0 6,006
0 0 0

The OPTN recommends changes to existing OMB approved forms, as well as the addition of 5 new forms for capturing new VCA and Intestine designated transplant program applications. This is a request for OMB approval for additions and revisions to the information collection activities for the application and membership requirements. This packet contains the membership application documents used to collect information required for membership in the OPTN. These materials are needed in the format submitted to allow for verification that applicants meet OPTN obligations or to document that an application does not qualify for OPTN membership. Respondents include hospitals interested in providing transplant services, histocompatibility laboratories, organ procurement organizations, individuals and organizations that wish to participate in the OPTN.

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
   US Code: 42 USC 273 Name of Law: National Organ Transplant Act
  
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 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
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
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
Organ Procurement and Transplantation Network Application C, A1, B1, A2, B3, D, B4, B5, B6, B7, B8, B9 B5 ,   B6 ,   B7 ,   B8 ,   B9 ,   A2 ,   B3 ,   B4 ,   Histocompatibility Laboratory Membership Application ,   Application for Organ Procurement (OPO) Membership ,   A1 ,   B1
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
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
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
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

  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 1,547 0 321 0 0
Annual Time Burden (Hours) 7,020 6,006 0 1,014 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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
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.
05/12/2017


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