Notice2025-15830
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Membership Forms for Organ Procurement and Transplantation Network OMB No. 0915-0184-Revision
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 20, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Full Text
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<title>Federal Register, Volume 90 Issue 159 (Wednesday, August 20, 2025)</title>
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[Federal Register Volume 90, Number 159 (Wednesday, August 20, 2025)]
[Notices]
[Pages 40606-40608]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15830]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: Membership
Forms for Organ Procurement and Transplantation Network OMB No. 0915-
0184--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than October
20, 2025.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#186879687d6a6f776a7358706a6b79367f776e"><span class="__cf_email__" data-cfemail="e797869782959088958ca78f959486c9808891">[email protected]</span></a> or by mail to the
HRSA Information Collection Clearance Officer, Room 14NWH04, 5600
Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email <a href="/cdn-cgi/l/email-protection#2c5c4d5c495e5b435e476c445e5f4d024b435a"><span class="__cf_email__" data-cfemail="4c3c2d3c293e3b233e270c243e3f2d622b233a">[email protected]</span></a> or call Samantha Miller,
the HRSA Information Collection Clearance Officer at (301) 443-9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
[[Page 40607]]
information, please include the ICR title for reference.
Information Collection Request Title: Membership Forms for Organ
Procurement and Transplantation Network, OMB No. 0915-0184--Revision.
Abstract: The purpose of this ICR is to renew and revise membership
application materials for the Organ Procurement and Transplantation
Network (OPTN). Membership in the OPTN is determined by submission of
application materials to the OPTN demonstrating that the applicant
meets all required criteria for membership and will agree to comply
with all applicable provisions of the National Organ Transplant Act, as
amended, 42 U.S.C. 273, et seq., the OPTN final rule, 42 CFR part 121,
OPTN Policies, and OPTN Management and Membership Policies. Section
1138 of the Social Security Act, as amended, 42 U.S.C. 1320b-8,
requires that hospitals in which transplants are performed by members
of the OPTN abide by the rules and requirements of, the OPTN (that have
been approved by the Secretary of HHS) as a condition of participation
in Medicare and Medicaid.
Need and Proposed Use of the Information: The application materials
are needed to ensure that all members and prospective members of the
OPTN submit evidence that they meet the required qualifications for
membership. These materials provide the OPTN with the information
necessary to confirm and demonstrate that applicants meet OPTN
membership application requirements and create a record of the
application review process and resulting actions for consideration by
the Secretary of HHS in the event an applicant subsequently appeals a
membership rejection by the OPTN.
Transplant hospitals, organ procurement organizations, transplant
histocompatibility laboratories, medical/scientific and public
organizations, business organizations, and individuals complete the
appropriate application materials to meet or sustain requirements for
OPTN membership. The revisions include the addition of a new data
collection form for Information Security Contact Management, a required
role for accessing the OPTN Computer System; additional updates to
align the membership applications for histocompatibility laboratories
and businesses with new requirements, as well as non-substantive
changes to the existing OMB data collection forms to improve clarity
and efficiency for both members and OPTN.
Likely Respondents: New and existing transplant hospitals, organ
procurement organizations, histocompatibility laboratories, medical/
scientific organizations, public organizations, businesses, and
individual members.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
The estimated burden hours for this collection decreased by 2,091
hours from the currently approved ICR package. The decrease in burden
can be attributed to members becoming more familiar with the revised
2022 application forms and from consultation with the appropriate OPTN
committees to estimate the burden. Specifically, OPTN based its burden
hour estimates on input from a representative sample of potential
respondents. Accordingly, the estimates were developed through
consultation with the Transplant Administrator, Histocompatibility,
Organ Procurement Organization, and Vascularized Composite Allograft
committees. These committees reviewed the forms and instructions and
determined the estimates through consensus during their meetings. In
preparation for these discussions, some committee members also sought
input from subject matter experts within their respective
organizations.
Total Estimated Annualized Burden Hours:
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Number of Number of Average burden
Form Form name respondents responses per Total per response Total burden
\1\ respondent responses \2\ (in hours) hours \3\
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1......................................... OPTN Membership Application 250 0.14 35 12.17 426
for Transplant Hospitals
and Programs.
2......................................... OPTN Membership Application 235 0.34 80 6.85 548
for Kidney Transplant
Programs.
3......................................... OPTN Membership Application 144 0.46 66 5.79 382
for Liver Transplant
Programs.
4......................................... OPTN Membership Application 135 0.22 30 5.79 174
for Pancreas Transplant
Programs.
5......................................... OPTN Membership Application 155 0.25 39 16.82 656
for Heart Transplant
Programs.
6......................................... OPTN Membership Application 81 0.20 16 5.79 93
for Lung Transplant
Programs.
7......................................... OPTN Membership Application 22 0.09 2 8 16
for Islet Transplant
Programs.
8......................................... OPTN Membership Application 48 0.27 13 23.79 309
for Vascularized Composite
Allograft Transplant
Programs.
9......................................... OPTN Membership Application 19 0.16 3 11 33
for Intestine Transplant
Programs.
10........................................ OPTN Membership Application 138 0.22 30 3.7 111
for Histocompatibility
Laboratories.
11........................................ OPTN Membership Application 55 0.18 10 18.33 183
for Organ Procurement
Organizations.
[[Page 40608]]
12........................................ OPTN Medical/Scientific 11 0.18 2 1.42 3
Membership Application.
13........................................ OPTN Public Organization 10 0.40 4 2 8
Membership Application.
14........................................ OPTN Business Membership 19 0.47 9 1.61 14
Application.
15........................................ OPTN Individual Membership 16 0.625 10 1.53 15
Application.
16........................................ OPTN Representative Form.... 499 0.27 135 0.43 58
17........................................ Primary Data Coordinator 1,032 0.09 93 0.43 40
Form.
18........................................ Primary Program 839 0.12 101 0.45 45
Administrator Form.
19........................................ Additional Surgeon and 839 0.37 310 0.84 260
Physician Request Form.
20........................................ HOPE Act Variance Request 56 0.02 1 0.50 1
Form.
21........................................ Kidney Paired Donation Pilot 160 0.18 29 0.56 16
Program contact update form.
22........................................ OPTN Membership Application 0 0 0 0 0
Surgeon or Physician Log
\4\.
23........................................ Information Security Contact 462 1.46 675 0.19 128
Management Form \5\.
5,225 1,693 3,519
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1. The numbers of respondents were updated with OPTN membership data as of December 2, 2024, and reflect the number of current OPTN members.
2. The numbers of total responses were calculated with data from December 1, 2023, through December 31, 2023. ``Total Responses'' are rounded to the
nearest whole number.
3. ``Total Burden Hours'' are rounded to the nearest whole number.
4. The OPTN Membership Application Surgeon or Physician Log is an optional form. The information can also be submitted by the OPTN member using a
different format. The burden of completing the application is included in the organ-specific application form.
5. The Information Security Contact Management Form is new, added to the Membership ICR in 2025.
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-15830 Filed 8-19-25; 8:45 am]
BILLING CODE 4165-15-P
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