Summry of Changes

High Level Summary of Revisions to

OPTN Membership Application forms (0915-0184)

HRSA is submitting this summary of revisions to forms in the OPTN Membership Application ICR package (0915-0184) rather than submitting individual redlines of forms. The revisions are proposed to make OPTN membership application requirements more clear 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 (Bylaws). The Bylaws outline membership requirements for organizations and individuals to participate the in U.S. transplant network.  In addition, the applications have been revised so that the sequence of questions is parallel to that of the Bylaws so that an applicant can have the application and Bylaws side-by-side for easy reference.

In addition, the 2020 OPTN Membership Application revisions will coincide with the introduction of a web based tool that will assist users to fill out the application forms and submit them electronically. Approval signatures required for application submission will also be captured electronically using a web based application tool.

Given these changes, the overall burden has decreased significantly from an estimated 7,020 total burden hours in 2017 to 4,755 hours in this current proposed revision package, although some forms have been combined into one more comprehensive form resulting in increased burden hours for a particular form.

Other changes include the following:

• The “Membership – Surgeon or Physician transplant log,” previously included in other forms, is now a separate form that will be attached to each application. This new separate form will provide applicants with all requirements for a log per OPTN Bylaws for each organ and pathway.

• Also within the applications, what were formerly known as “checkboxes”—fillable tables that were not really checkboxes at all—were removed and real checkboxes were put in to reduce the burden to applicants. The “narrative” section was replaced by checkbox “attestations,” which will serve the same purpose: understanding relevant and recent surgeon and physician applicant experience. The previous membership applications had several places for the applicants to sign; the new application requests only one signature from each individual member applicant involved.

• Previous application attachments for key personnel and living donor components have been streamlined into one form for each respective organ application.

• Pediatric Bylaw Requirements—where applicable—were also given their own sections in the organ applications.

• The Certificate of Assessment (formerly known as Certificate of Investigation) and the Primary Coverage Plan Checklist were pulled out of the previous organ specific applications and given their own, separate form.

• VCA Transplant program applications, which were previously submitted as separate applications based on the type of VCA body part transplanted, is now one single application with sections for each VCA organ type.

• Personnel changes for Organ Procurement Organizations (OPOs) and Histocompatibility Laboratories have also been combined with organization applications, so that OPO and lab applicants will be able to use one respective application for new and personnel changes.

The table below provides more detail regarding the difference in the 2017 ICR package and the current 2020 package, and demonstrates which forms have been combined. Again, the overall purpose of these modifications is to make OPTN application requirements more clear and organized, more user-friendly, and less burdensome.

Current Cycle File HRSA SWIFT File Names: Expiring 7/31/2020	New HRSA File Names	60 Days FRN Supporting Statement Names and Draft 30 Days FRN	Notes
A1_NewTransplantHospital_Cover	Membership_Transplant Hospital_General	OPTN Membership Application for Transplant Hospitals
A2_NewTransplant_General
B1_NewTransplantProgram_Cover_Clean_HRSA	N/A	N/A	No longer needed. Information is captured in new Kidney, Liver, Pancreas, Pancreas Islet, Heart, Lung and Intestine
B3_Kidney_LDKidney	Membership_Kidney_LDKidney	OPTN Membership Application for Kidney Transplant Programs
B4_Liver_LDLiver	Membership_Liver_LDLiver	OPTN Membership Application for Liver Transplant Programs
B5_Pancreas	Membership_Pancreas	OPTN Membership Application for Pancreas Transplant Programs
B6_Heart	Membership_Heart	OPTN Membership Application for Heart Transplant Programs
B7_Lung	Membership_Lung	OPTN Membership Application for Lung Transplant Programs
B8_PancreasIslet	Membership_PancreasIslet	OPTN Membership Application for Islet Transplant Programs
B9_NewLiving Donor Recoveries	N/A	N/A	No longer needed. Information is captured in new Kidney and Liver Applications
C_OPO_New	Membership_OPO	OPTN Membership Application for Organ Procurement Organizations (OPOs)	New Form will serve as new program and key personnel change request
G_OPO_DirectorChange
D_HistoLab_New	Membership_HistoLab	OPTN Membership Application for Histocompatibility Laboratories	New Form will serve as new program and key personnel change request
F_HistoLab_PersonnelChange
E_PersonnelChange_Cover	N/A	N/A	No longer needed: Members will use relevant portions of their respective organ applications to apply for a key personnel change
H_MedicalScientific	Membership_MedicalScientific	OPTN Medical/Scientific Membership Application
I_PublicOrg	Membership_PublicOrg	OPTN Public Organization Membership Application
J_Business	Membership_Business	OPTN Business Membership Application
K_Individual	Membership_Individual	OPTN Individual Membership Application
L_Intestine	Membership_Intestine	OPTN Membership Application for Intestine Transplant Programs
M1_VCA_NewTransplantProgram
M2_VCA_AW_Intestine
M3_VCA_AW_Kidney
M4_VCA_AW_Liver
M5_VCA_AW_Pancreas
M6_VCA_Head and Neck	Membership_VCA	OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs	All requests for VCA have been combined into one form
M7_VCA_Upper Limb
N1_VCA_Other_NewTransplantProgram
N2_VCA_Other_PersonnelChange_Cover
N3_VCA_Other
O_VCA_PersonnelChange_Cover
	Membership_SurgeonOrPhysicianLog	OPTN Membership Application Surgeon or Physician Log	New Independent Form. Information was previously collected within organ application. This form will accompany every application and must be filled out as part of membership application
	Membership_CertificateAssessment_ProgramCoveragePlan	OPTN Certificate of Assessment and Program Coverage Plan Membership Application	New Independent Form. Information was previously collected within organ application. This form will accompany every application and must be filled out as part of membership application
	Membership_Representative	OPTN Representative Form	New Form. Information is routinely collected from member
Total Forms = 30	Total Forms = 18

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