The final rule of the Organ Procurement and Transplantation Network (OPTN) established the final policies governing the OPTN. This ICR contains application requirements outlined in the rule regarding application procedures and policies of the OPTN and membership, designation, and transplant program requirements. This submission contains burden associated with the final rule for application for membership in the OPTN and requirements for membership, including compliance with OPTN policies and bylaws.
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
US Code:
42 USC 274
Name of Law: Organ Procurement and Transplantation Network
This renewal request is made with revisions to the expiring documents.
The paperwork burden is decreasing. The application forms were revised to make them more respondent friendly. Specifically, the revised application is rewritten in plain language and asks only for information relevant to current membership requirements.
It is estimated that the number of respondents will increase significantly. First, there will be more individual forms to fill out. However, each individual form will be shorter and easier to complete - therefore, the burden will not be increased. In addition, some membership application activities are being formalized with the development of two new data collection forms:
o F Change in Histocompatibility Lab Director; and
o G Change in OPO Key Personnel
Although two new data forms have been developed, membership obligations have always required that this information be formally reported to the OPTN; as such, the new forms referenced above will not create a new burden for OPTN members.
$0
No
No
No
No
No
Uncollected
Jodi Duckhorn 301 443-1984
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.
Form D Organ Procurement and Transplantation Network Application
Summary of Changes.docx
Organ Procurement and Transplantation Network Application