Notice2025-22330
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; 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
December 9, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Full Text
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<title>Federal Register, Volume 90 Issue 234 (Tuesday, December 9, 2025)</title>
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[Federal Register Volume 90, Number 234 (Tuesday, December 9, 2025)]
[Notices]
[Pages 57077-57079]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22330]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; 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 Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30-day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than January 8,
2026.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the HRSA
Information Collection Clearance Officer at <a href="/cdn-cgi/l/email-protection#84f4e5f4e1f6f3ebf6efc4ecf6f7e5aae3ebf2"><span class="__cf_email__" data-cfemail="5e2e3f2e3b2c29312c351e362c2d3f70393128">[email protected]</span></a> or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
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 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 OPTN abide
by the rules and requirements of OPTN (that have been approved by the
Secretary of HHS) as a condition of participation in Medicare and
Medicaid.
A 60-day Federal Register notice was published in the Federal
Register on August 20, 2025, Vol. 90, No. 159; pp. 40606-40608. HRSA
received one comment from the President of the Association of Organ
Procurement Organizations. The commenter expressed support for the
necessity and utility of the proposed information collection, noting
that it provides critical information to assess whether applicants meet
OPTN membership requirements. The commenter also sought clarification
on whether a written agreement is required between an Organ Procurement
Organization (OPO) and its laboratory when the two entities operate
under separate Centers for Medicare & Medicaid Services Certification
Numbers.
HRSA Response: Laboratories are required to maintain written
agreements with each OPO they serve, unless clinical urgency prevents
such an agreement. These agreements delineate the respective
responsibilities and expected procedures of the OPO and the laboratory
to ensure compliance with OPTN membership standards and support the
integrity of the organ procurement process. This requirement is
outlined in OPTN Bylaw C.2.D (OPO Affiliation), which specifies the
elements that must be included in OPO-laboratory agreements.
Need and Proposed Use of the Information: The application materials
are needed to ensure that all members and prospective members of OPTN
submit evidence that they meet the required qualifications for
membership. These materials provide 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 OPTN.
Transplant hospitals, OPOs, 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 and public organizations, businesses, and individual
members.
[[Page 57078]]
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 2,062
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,
OPO, 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 No. Form name respondents responses per Total per response Total burden
\1\ respondent responses \2\ (in hours) hours
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1............ OPTN Membership 250 0.14 35 12.17 425.95
Application for
Transplant
Hospitals and
Programs.
2............ OPTN Membership 235 0.34 80 6.85 548.00
Application for
Kidney
Transplant
Programs.
3............ OPTN Membership 144 0.46 67 5.79 387.93
Application for
Liver Transplant
Programs.
4............ OPTN Membership 135 0.22 30 5.79 173.70
Application for
Pancreas
Transplant
Programs.
5............ OPTN Membership 155 0.25 39 16.82 655.98
Application for
Heart Transplant
Programs.
6............ OPTN Membership 81 0.2 17 5.79 98.43
Application for
Lung Transplant
Programs.
7............ OPTN Membership 22 0.09 2 8 16.00
Application for
Islet Transplant
Programs.
8............ OPTN Membership 48 0.27 13 23.79 309.27
Application for
Vascularized
Composite
Allograft
Transplant
Programs.
9............ OPTN Membership 19 0.16 4 11 44.00
Application for
Intestine
Transplant
Programs.
10........... OPTN Membership 138 0.22 31 3.7 114.70
Application for
Histocompatibili
ty Laboratories.
11........... OPTN Membership 55 0.18 10 18.33 183.30
Application for
Organ
Procurement
Organizations.
12........... OPTN Medical/ 11 0.18 2 1.42 2.84
Scientific
Membership
Application.
13........... OPTN Public 10 0.4 4 2 8.00
Organization
Membership
Application.
14........... OPTN Business 19 0.47 9 1.61 14.49
Membership
Application.
15........... OPTN Individual 16 0.625 10 1.53 15.30
Membership
Application.
16........... OPTN 499 0.27 135 0.43 58.05
Representative
Form.
17........... Primary Data 1,032 0.09 93 0.43 39.99
Coordinator Form.
18........... Primary Program 839 0.12 101 0.45 45.45
Administrator
Form.
19........... Additional 839 0.37 311 0.84 261.24
Surgeon and
Physician
Request Form.
20........... HOPE Act Variance 56 0.02 2 0.5 1.00
Request Form.
21........... Kidney Paired 160 0.18 29 0.56 16.24
Donation Pilot
Program contact
update form.
22........... OPTN Membership 0 0 0 0 0.00
Application
Surgeon or
Physician Log
\3\.
23........... Information 462 1.46 675 0.19 128.25
Security Contact
Management Form
\4\.
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Total = 23 5,225 .............. 1,699 .............. 3,548
forms.
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Notes:
\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 January 1, 2023, through December 31, 2023.
``Total Responses'' are rounded to the nearest whole number.
\3\ 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. Please note that if a form has 0.00 under average number of responses,
this is an indicator that there were no submissions in calendar year 2023.
\4\ The Information Security Contact Management Form is new, added to the Membership ICR in 2025.
[[Page 57079]]
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-22330 Filed 12-8-25; 8:45 am]
BILLING CODE 4165-15-P
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