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:
202006-0915-007
Status:
Historical Active
Previous ICR Reference No:
201906-0915-004
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:
08/20/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/29/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2023
36 Months From Approved
08/31/2020
Responses
1,661
0
1,868
Time Burden (Hours)
4,755
0
7,020
Cost Burden (Dollars)
0
0
0
Abstract:
This is a request for OMB approval for revisions of the application documents used to collect information for determining if the interested party is compliant with membership requirements contained in the final rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN), (42 CFR part 121) ββthe OPTN final rule.ββ Respondents include: hospitals seeking to perform organ transplants, non-profit organizations seeking to become an organ procurement organization, and medical laboratories seeking to become an OPTN-approved histocompatibility laboratory.
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:
85 FR 8300
02/13/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 38380
06/26/2020
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
17
IC Title
Form No.
Form Name
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
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
OPTN Business Membership Application
16
Membership_Business Form.docx
OPTN Certificate of Assessment and Program Coverage Plan Membership Application
2
Membership_CertificateAssessment_ProgramCoverage Form.docx
OPTN Individual Membership Application
17
Membership_Individual Form.docx
OPTN Medical Scientific Membership Application
14
Membership_MedicalScientific Form.docx
OPTN Membership Application Islet Transplant Program
8, 8B
Membership_Pancreas Islet Form.docx
,
Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Program Application
9, 9B
Membership_VCA Form.docx
,
Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Heart Transplant Program
6B, 6
Membership_Heart Form.docx
,
Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Histocompatibility Labs
12
Membership_HistoLab Form.docx
OPTN Membership Application for Intestine Transplant Programs
10, 10B
Membership_Intestine Form.docx
,
Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Kidney Transplant Programs
3B, 3
Membership_Kidney_LDKidney Form.docx
,
Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Liver Transplant Progrms
4, 4B
Membership_Liver_LDLiver Form.docx
,
Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Lung Transplant Program
7B, 7
Membership_Lung Form.docx
,
Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for OPOs
11
Membership_OPO Form.docx
OPTN Membership Application for Pancreas Transplant Programs
5, 5B
Membership_Pancreas Form.docx
,
Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Transplant Hospitals
1
Membership_Transplant Hospital_General Form.docx
OPTN Public Organization Membership Application
15
Membership_PublicOrg Form.docx
OPTN Representative Form
13
Membership_Representative Form.docx
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
1,661
1,868
0
-207
0
0
Annual Time Burden (Hours)
4,755
7,020
0
-2,265
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:
Burden decrease due to less forms and less average burden per response; burden increase due to an increase in respondents.
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?
No
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:
06/29/2020