The OPTN recommends changes to existing OMB approved forms, as well as the addition of 5 new forms for capturing new VCA and Intestine designated transplant program applications. This is a request for OMB approval for additions and revisions to the information collection activities for the application and membership requirements. This packet contains the membership application documents used to collect information required for membership in the OPTN. These materials are needed in the format submitted to allow for verification that applicants meet OPTN obligations or to document that an application does not qualify for OPTN membership. Respondents include hospitals interested in providing transplant services, histocompatibility laboratories, organ procurement organizations, individuals and organizations that wish to participate in the OPTN.
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
US Code:
42 USC 273
Name of Law: National Organ Transplant Act
The estimated burden for the revised collection increased from 6,006 to 7,016. This increase is due to the additions and revisions to selected forms and the addition of new forms around VCA transplants.
However, each individual form will be shorter and easier to complete, leading to a decrease in burden in some instruments.
ROCIS doesn't allow for 0 respondents or burden, so the respondents had to be increased to 1 in order to be entered. This caused the total respondents to increase by 1 and the total burden by 4 hours. Form C "OPO New Applications" has 0 for respondents as there are no new respondents, thus no form to respond to.
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.