Organ Procurement and Transplantation Network Application Form

ICR 202006-0915-007

OMB: 0915-0184

Federal Form Document

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Supporting Statement A
2020-06-26
Supplementary Document
2020-06-26
Supplementary Document
2020-06-26
Supplementary Document
2020-06-26
IC Document Collections
IC ID
Document
Title
Status
226701 Modified
226700 Modified
226699 Modified
226698 Modified
226697 Removed
226696 Removed
226695 Modified
226694 Modified
226693 Modified
226692 Modified
226691 Removed
226690 Removed
226689 Modified
226688 Removed
226687 Modified
226686 Modified
226685 Modified
226684 Modified
226683 Modified
226682 Modified
226681 Modified
226680 Modified
ICR Details
0915-0184 202006-0915-007
Active 201906-0915-004
HHS/HSA 21566
Organ Procurement and Transplantation Network Application Form
Revision of a currently approved collection   No
Regular
Approved without change 08/20/2020
Retrieve Notice of Action (NOA) 06/29/2020
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved 08/31/2020
1,661 0 1,868
4,755 0 7,020
0 0 0

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) ‘‘the OPTN final rule.’’ 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.

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
  
None

Not associated with rulemaking

  85 FR 8300 02/13/2020
85 FR 38380 06/26/2020
No

17
IC Title Form No. Form Name
OPTN Certificate of Assessment and Program Coverage Plan Membership Application 2 Membership_CertificateAssessment_ProgramCoverage Form.docx
G Change in OPO Key Personnel G G_OPO_DirectorChange_final_clean_HRSA.doc
F Change in Histocompatibility Lab Director F F_HistoLab_PersonnelChange_Clean_HRSA.doc
OPTN Membership Application for OPOs 11 Membership_OPO Form.docx
OPTN Representative Form 13 Membership_Representative Form.docx
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
OPTN Membership Application for Intestine Transplant Programs 10, 10B Membership_Intestine Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Histocompatibility Labs 12 Membership_HistoLab Form.docx
OPTN Public Organization Membership Application 15 Membership_PublicOrg Form.docx
OPTN Membership Application for Heart Transplant Program 6B, 6 Membership_Heart 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 Medical Scientific Membership Application 14 Membership_MedicalScientific Form.docx
OPTN Business Membership Application 16 Membership_Business Form.docx
OPTN Individual Membership Application 17 Membership_Individual Form.docx
OPTN Membership Application for Kidney Transplant Programs 3 , 3B Membership_Kidney_LDKidney Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application for Liver Transplant Progrms 4B, 4 Membership_Liver_LDLiver Form.docx ,   Membership_SurgeonOrPhysicianLog 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 Membership Application for Lung Transplant Program 7B, 7 Membership_Lung Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
OPTN Membership Application Islet Transplant Program 8, 8B Membership_Pancreas Islet Form.docx ,   Membership_SurgeonOrPhysicianLog Form.docx
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

  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
Yes
Miscellaneous Actions
Yes
Changing Forms
Burden decrease due to less forms and less average burden per response; burden increase due to an increase in respondents.

$345,000
No
    No
    No
No
No
No
No
Elyana Bowman 301 443-3983 enadjem@hrsa.gov

  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.
06/29/2020


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