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:
202211-0915-001
Status:
Historical Active
Previous ICR Reference No:
202106-0915-002
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:
12/30/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/28/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2025
36 Months From Approved
08/31/2023
Responses
858
0
1,661
Time Burden (Hours)
5,610
0
4,755
Cost Burden (Dollars)
0
0
0
Abstract:
This is a request to revise the current Organ Procurement and Transplantation Network (OPTN) data collection associated with institutional (including transplant hospital, organ procurement organization, and transplant histocompatibility laboratory) and non-institutional (medical/scientific and public organization, business and individual) applications to meet or sustain requirements for OPTN membership. This request include adding two new data collection forms (Hope Act Variance Request and Kidney Paired Donation Pilot Program or KPDPP contact update form), three standalone forms (Primary Program Administrator, Primary Data Coordinator, and Additional Surgeon and Physician) for revised data collection, and a revision of organ-specific applications found in the Certificate of Assessment and Program Coverage Plan Membership Application (COA/PCP). The likely respondents are new and existing transplant hospitals, organ procurement organization, histocompatibility laboratories, medical/scientific organization, public organization, business and individual members.
Authorizing Statute(s):
US Code:
42 USC 273
Name of Law: National Organ Transplant Act of 1984
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:
87 FR 52389
08/25/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 68713
11/16/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
21
IC Title
Form No.
Form Name
Additional Surgeon and Physician Request Form
20
Additional Surgeon and Physician Request Form
HOPE Act Variance Request Form
21
Hope Act Variance Request Form
Kidney Paired Donation Pilot Program (KPDPP) contact update Form
23
Kidney Paired Donation Pilot Program (KPDPP) contact update Form
OPTN Business Membership Application
16
OPTN Membership_Business Form
OPTN Certificate of Assessment and Program Coverage Plan Membership Application
2
Membership_CertificateAssessment_ProgramCoverage Form.docx
OPTN Individual Membership Application
17
OPTN Membership_Individual Form
OPTN Medical Scientific Membership Application
14
Membership_MedicalScientific Form.docx
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application
9 , 9 B
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application Islet Transplant Program
8, 8 B
OPTN Membership Application for Islet Transplant Programs CLEAN
,
OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Heart Transplant Program
6, 6 B
OPTN Membership Application for Heart Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Histocompatibility Labs
12
OPTN Membership Application for Histocompatibility Laboratories
OPTN Membership Application for Intestine Transplant Programs
10, 10 B
OPTN Membership Application for Intestine Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Kidney Transplant Programs
3 B, 3
OPTN Membership Application for Kidney Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log.docx
OPTN Membership Application for Liver Transplant Progrms
4, 4 B
OPTN Membership Application for Liver Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Lung Transplant Program
7, 7 B
OPTN Membership Application for Lung Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for OPOs
11
Membership_OPO Form.docx
OPTN Membership Application for Pancreas Transplant Programs
5, 5 B
OPTN Membership Application for Pancreas Transplant Programs
,
OPTN Membership Application_Surgeon or Physician Log
OPTN Membership Application for Transplant Hospitals and Programs
1
OPTN Membership Application for Transplant Hospitals and Programs.docx
OPTN Public Organization Membership Application
15
Membership_PublicOrg Form.docx
OPTN Representative Form
13
OPTN Membership_Representative Form.docx
Primary Data Coordinator Form
19
Primary Data Coordinator
Primary Program Administrator Form
18
Primary Program Administrator Form
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
858
1,661
0
-803
0
0
Annual Time Burden (Hours)
5,610
4,755
0
855
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:
Changing Forms
Short Statement:
Note: The burden table on the Supporting Statement are slightly different than the 30 Day FRN due to a rounding issue. The The burden estimates are derived from Burden Surveys sent out by the OPTN Contractor to the OPTN members who have participated in this data collection activity. The survey is sent to 5-9 members per form. The survey results are collected from the respondents and the Average Burden is calculated. Changes to the burden hours from the last approval are due to agency discretion (i.e., changes in the estimated burden). Changes to the forms are proposed to make application requirements even clearer and organized, and thus less cumbersome for applicants to complete. Proposed revisions include changes to wording to make questions more consistent with the language of the OPTN bylaws. In addition, the applications have been revised so that the sequence of questions is parallel to that of the bylaws. Using the bylaws as a baseline, the revamped applications have been constructed in parallel order of the bylaws so that an applicant can have the application and bylaws side-by-side for easy reference. More detail is provided in the supporting statement.
Annual Cost to Federal Government:
$347,361
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?
No
Agency Contact:
Laura Cooper 301 443-2126 lcooper@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:
11/28/2022