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:
201906-0915-004
Status:
Historical Active
Previous ICR Reference No:
201802-0915-002
Agency/Subagency:
HHS/HSA
Agency Tracking No:
21566
Title:
Organ Procurement and Transplantation Network Application Form
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/05/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/05/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2020
07/31/2020
07/31/2020
Responses
1,868
0
1,868
Time Burden (Hours)
7,020
0
7,020
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
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
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
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
1,868
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
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:
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
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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:
06/05/2019