Organ Procurement and
Transplantation Network Application Form
No
material or nonsubstantive change to a currently approved
collection
No
Regular
10/13/2023
Requested
Previously Approved
12/31/2025
12/31/2025
858
858
5,610
5,610
0
0
This is a request to revise the
current Organ Procurement and Transplantation Network (OPTN) data
collection associated with institutional (including transplant
hospital, organ procurement organization, and transplant
histocompatibility laboratory) and non-institutional
(medical/scientific and public organization, business and
individual) applications to meet or sustain requirements for OPTN
membership. This request include adding two new data collection
forms (Hope Act Variance Request and Kidney Paired Donation Pilot
Program or KPDPP contact update form), three standalone forms
(Primary Program Administrator, Primary Data Coordinator, and
Additional Surgeon and Physician) for revised data collection, and
a revision of organ-specific applications found in the Certificate
of Assessment and Program Coverage Plan Membership Application
(COA/PCP). The likely respondents are new and existing transplant
hospitals, organ procurement organization, histocompatibility
laboratories, medical/scientific organization, public organization,
business and individual members.
US Code:
42
USC 1138 Name of Law: Hospital Protocols for Organ Procurement
and Standards for Organ Procurement Agencies
US Code: 42
USC 273 Name of Law: National Organ Transplant Act of 1984
Note: The burden table on the
Supporting Statement are slightly different than the 30 Day FRN due
to a rounding issue. The The burden estimates are derived from
Burden Surveys sent out by the OPTN Contractor to the OPTN members
who have participated in this data collection activity. The survey
is sent to 5-9 members per form. The survey results are collected
from the respondents and the Average Burden is calculated. Changes
to the burden hours from the last approval are due to agency
discretion (i.e., changes in the estimated burden). Changes to the
forms are proposed to make application requirements even clearer
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. In addition,
the applications have been revised so that the sequence of
questions is parallel to that of the bylaws. Using the bylaws as a
baseline, the revamped applications have been constructed in
parallel order of the bylaws so that an applicant can have the
application and bylaws side-by-side for easy reference. More detail
is provided in the supporting statement.
$347,361
No
No
No
No
No
No
No
Laura Cooper 301 443-2126
lcooper@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.