View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0915-0184
ICR Reference No:
201705-0915-002
Status:
Historical Active
Previous ICR Reference No:
201403-0915-002
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 without change
Conclusion Date:
07/19/2017
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/12/2017
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2020
36 Months From Approved
07/31/2017
Responses
1,868
0
1,547
Time Burden (Hours)
7,020
0
6,006
Cost Burden (Dollars)
0
0
0
Abstract:
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.
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 274
Name of Law: Organ Procurement and Transplantation Network
US Code:
42 USC 273
Name of Law: National Organ Transplant Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
81 FR 89115
12/09/2016
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 22145
05/12/2017
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
22
IC Title
Form No.
Form Name
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 Heart (HR) Designated Program Application
B6
B6_HR Heart_Clean.doc
B Intestine Designated Program Application
B17
B17 Intestine_HRSA.doc
B Islet (PI) Designated Program Application
B8
B8_PI PancreasIslet_Clean.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 Living Donor (LD) Recovery Program Application
B9
B9_LD NewLivingDonorRecoveries_Clean.doc
B Lung (LU) Designated Program Application
B7
B7_LU Lung_Clean.doc
B Pancreas (PA) Designated Program Application
B5
B5_PA Pancreas_Clean.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 Head and Neck Designated Program Application
B10
B VCA_Head and Neck_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 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
D Histocompatibility Lab Application
D
D_HistoLab_New_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
I Public Org Application
I
I_PublicOrg_Clean_HRSA.doc
J Business Member Application
j
J_Business_Clean_HRSA.doc
K Individual Member Application
K
K_Individual_Clean_HRSA.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
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
Organ Procurement and Transplantation Network Application
C, A1, B1, A2, B3, D, 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
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
1,868
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
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:
Miscellaneous Actions
Short Statement:
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.
Annual Cost to Federal Government:
$345,000
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
Agency Contact:
Elyana Bowman 301 443-3983 enadjem@hrsa.gov
Common Form ICR:
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:
(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:
05/12/2017