Agency Information Collection Activities: Submission to OMB for Review and Approval: Public Comment Request; Organ Procurement and Transplantation Network Board of Directors and Committee Member Applications and Forms

Issuing agencies

Abstract

In compliance with the Paperwork Reduction Act of 1995, HRSA 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.

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<title>Federal Register, Volume 91 Issue 206 (Tuesday, October 27, 2026)</title>
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[Federal Register Volume 91, Number 206 (Tuesday, October 27, 2026)]
[Notices]
[Pages 67589-67592]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21857]


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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; Organ Procurement and 
Transplantation Network Board of Directors and Committee Member 
Applications and Forms

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA 
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 October 
27, 2026.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent

[[Page 67590]]

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 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#522233223720253d2039123a2021337c353d24"><span class="__cf_email__" data-cfemail="a0d0c1d0c5d2d7cfd2cbe0c8d2d3c18ec7cfd6">[email&#160;protected]</span></a> or call 
(301) 443-9094.

SUPPLEMENTARY INFORMATION: Information Collection Request Title: Organ 
Procurement and Transplantation Network Board of Directors and 
Committee Member Applications and Forms, OMB No. 0906-New.
    Abstract: The Organ Procurement and Transplantation Network (OPTN) 
is a public-private partnership that links professionals involved in 
the U.S. donation, procurement, and transplantation system. The OPTN 
focuses on promoting long, healthy, and productive lives for people 
with organ failure. The OPTN also aims to increase opportunities for 
transplants, optimize organ use, enhance efficiency, and prioritize 
patient care. The OPTN Board of Directors (BOD) is authorized by 
section 372 of the National Organ Transplant Act of 1984 (NOTA) (see 42 
U.S.C. 274(b)(1)(B)), and the operation composition of the OPTN BOD are 
further codified in federal regulation under the regulations 
implementing NOTA (see 42 CFR 121.3(a)). These regulations also provide 
that the OPTN BOD shall ``establish committees as are necessary to 
perform the duties of the OPTN'' and describe the composition of these 
committees (see 42 CFR 121.3(a)(4)). As part of the ongoing OPTN 
Modernization Initiative (<a href="https://www.hrsa.gov/optn-modernization/learn-more-about-modernization">https://www.hrsa.gov/optn-modernization/learn-more-about-modernization</a>), HRSA seeks OMB approval of 
applications to be completed by candidates interested in volunteering 
to serve on the OPTN BOD and/or on the committees that support the BOD. 
Members of the OPTN BOD and committees do not receive payment for this 
work. HRSA also seeks approval of conflict-of-interest (COI), code of 
conduct, confidentiality, and attestation forms to be completed by the 
selected/confirmed members of the OPTN BOD, committees, and review 
boards on an annual, tri-annual, or ad hoc basis. The OPTN BOD consists 
of 35 members who serve 2 to 3-year terms and are supported by 21 
committees with a total of approximately 419 members with the same term 
limits. Select members of the BOD also serve on committee(s) as 
Visiting Board Members. In addition, there are ad hoc committees or BOD 
workgroups that may be established to work on time-limited issues, and 
these members (approximately 20 a year) would fill out the annual COI 
form as well. Given some committee turnover, there are approximately 
505 committee and BOD members filling out the annual COI form, code of 
conduct form, confidentiality form, and attestation form every year. In 
addition, approximately 841 members of OPTN Review Boards will fill out 
the annual COI form, confidentiality agreements, and code of conduct 
forms.
    A 60-day Notice was published in the Federal Register on August 6, 
2026, Vol. 91, No. 150, FR pp. 50861. HRSA received comments from one 
entity, the Association of Organ Procurement Organizations. The 
commenter recognized the important role of volunteers within the OPTN 
and provided recommendations intended to clarify and improve the 
proposed Board of Directors and Committee Volunteer Interest Forms and 
the COI disclosure forms. The commenter recommended revisions to the 
forms related to questions concerning applicant disciplinary history, 
Organ Procurement Organization (OPO) roles and transplant programs, 
living and deceased donor experience, social media information, prior 
OPTN volunteer service, financial interests, and the frequency of 
recurring COI disclosures.
    On Form 1, the commenter asked for the justification for requesting 
social media handles and expressed concern that they would be used to 
screen out applicants with divergent views.
    HRSA Response: HRSA removed an optional open-ended question 
regarding social media handles.
    On Form 1, the commenter expressed concern that a question asking 
about an applicant's employer facing regulatory discipline could 
require an applicant to disclose confidential information.
    HRSA Response: HRSA revised the question concerning criminal, 
ethics, or regulatory disciplinary matters. The revised question no 
longer requests information concerning disciplinary matters involving 
an applicant's employer and separates the remaining inquiry into two 
yes/no questions addressing prior actions and currently pending matters 
regarding the applicant and not the employer.
    On Form 1, the commenter also asked, for clarification purposes, to 
list ``organ donor'' as ``living donor'' and allowing for OPO 
experience to be marked as OPO-administrative versus OPO-clinical.
    HRSA Response: HRSA revised Form 1 and accepted both changes.
    On Form 1, the commenter expressed concern that questions asking 
patient and family members about their advocacy and outreach experience 
may discourage people from applying if they lack this experience.
    HRSA Response: Regarding the comment that the questions may 
discourage applicants who lack outreach or advocacy experience, the 
form also asks for other background experience in areas such as 
finance, governance, and ethics. The nominating committee considers all 
applicants, and inclusive language will be included in outreach 
materials for these roles.
    On Forms 1 and 2, the commenter suggested some questions did not 
appear to apply to the procurement side because they only mentioned 
transplantation experience.
    HRSA Response: On Forms 1 and 2, HRSA broadened ``transplant'' 
language throughout to ``transplant, donation, or procurement'' in 
order to be more inclusive to applicants on the donation or procurement 
side.
    Based on feedback from leadership of the OPTN Board of Directors, 
on Forms 1 and 2, HRSA added two employment-related questions regarding 
the applicant's current employment status and whether the applicant's 
employer is aware of the application. These questions require only 
selection from predefined response options and are expected to require 
negligible time to complete.
    On Form 3, the commenter suggested the financial question in the 
COI form was overly broad and should be more limited.
    HRSA Response: HRSA clarified in the COI form (the annual COI form 
as well as the tri-annual COI form) that financial conflicts should 
exclude salary from current employers and exclude investments in 
broadly diversified funds. However, HRSA is not adopting the proposed 5 
percent threshold. The question intentionally reaches the broader 
concept of an individual's or family member's ``ownership or beneficial 
interest.'' A 5 percent threshold could exclude financial interests 
that might still create an actual, potential, or perceived COI in the 
OPTN context.
    On Form 3, the commenter expressed concern that disclosing 
information in the COI form could be used to screen applicants with 
diverse views from serving.
    HRSA Response: HRSA appreciates the commenter's concern. As noted 
in the instructions, answering ``Yes'' to any question does not 
automatically

[[Page 67591]]

preclude an individual from serving. Rather, the information provided 
is used to assist in assessing the relevant circumstances.
    On Form 3 and Form 4, the commenter suggested an annual filing with 
reminders to file any changes in the interim as they occur rather than 
the tri-annual cadence between annual filings.
    HRSA Response: The OPTN has members fill out the form proactively 
with updates on a tri-annual basis to ensure the most recent COI 
information is collected to uphold the strongest governance standards. 
However, volunteers are also asked to submit updates every time a 
change takes place between filings, so COI information is up to date 
ahead of every meeting.
    Need and Proposed Use of the Information: HRSA and the OPTN 
anticipate collecting committee and BOD applications on an annual basis 
for committee and board openings. Resumes are requested and required 
for Board applicants and requested but not required for committee 
applicants. To ensure applicants to the OPTN BOD and committees have 
the appropriate expertise, the proposed applications will collect 
information including candidates' professional background, expertise, 
experience in organ donation and transplantation, and areas of 
interest. The OPTN and its Nominating Committee, with HRSA oversight, 
will evaluate the applications to analyze qualifications and support a 
structured nomination and selection process. The application 
information will help ensure the OPTN governance bodies are composed of 
individuals with the necessary knowledge, skills, and perspectives to 
effectively oversee and support the nation's organ donation and 
transplantation system.
    In addition, annual COI disclosures will be collected from BOD, 
committee members, and will be used to review board members upon their 
election/selection or annual anniversary. The BOD and Membership and 
Professional Standards Committee members will also submit COI updates 
on a tri-annual basis as well as fill out an ad hoc COI form when 
needed. HRSA and the OPTN will use information collected via the 
selected BOD and committee members' COI forms to routinely identify, 
monitor, prevent, and address actual, potential or appearances of COI 
relating to the operation of the OPTN. HRSA will use this information 
to strengthen oversight and accountability within the OPTN to enhance 
trust and confidence among stakeholders and the public. Without access 
to this information, HRSA and the OPTN would be less able to prevent 
potential conflicts of interest, which could jeopardize the 
independence and objectivity of the OPTN BOD and committees that inform 
national organ procurement and transplantation policy. Upon committee 
election or appointment and volunteer orientation, BOD and committee 
members will complete and submit an attestation form, confidentiality 
agreement, as well as the code of conduct. The code of conduct and 
confidentiality agreement, and attestation are collected to ensure that 
OPTN BOD and committee members annually acknowledge their obligations 
to act in the best interests of the OPTN, comply with applicable 
ethical and conduct requirements, protect confidential information, and 
uphold the standards necessary to maintain good standing and public 
trust in OPTN governance.
    Likely Respondents: Respondents completing the application forms 
will be individuals who express interest in serving in volunteer 
governance or committee roles within the OPTN. This includes a broad 
and diverse group of stakeholders involved in or connected to organ 
donation and transplantation, such as transplant professionals (e.g., 
physicians, surgeons, coordinators, administrators), OPO personnel, 
histocompatibility experts, researchers, patients, living donors, 
family members, caregivers, and members of the public with relevant 
expertise (e.g., ethics, finance, governance, public policy, or 
operations). Respondents may be employed or unaffiliated individuals 
and will represent a wide range of professional disciplines, lived 
experiences, and geographic regions across the United States, helping 
to support a more dynamic and representative governance process. 
Respondents completing the COI forms, code of conduct, confidentiality, 
and attestation forms will be individuals who have been elected or 
appointed to committee, review board, and BOD positions for the OPTN.
    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.
    HRSA calculated estimated burden hours based on internal testing 
for completing each form. The estimated total annual burden for this 
information collection is 2,110.84 hours across all respondents on an 
annual basis, including for both tri-annual and annual responses. HRSA 
made minor revisions to several forms, and in the annual and tri-annual 
conflict-of-interest forms consolidated eight conflict questions down 
to two. In addition, since two questions were added to the application 
forms, the time increased slightly for the committee application but 
remained the same for the board application as two questions were 
removed. HRSA also increased the total volume of respondents by adding 
841 review board member volunteers to receive the COI, confidentiality, 
and code of conduct forms annually. Thus, the total number of responses 
increased from the 60-day FRN to the 30-day FRN from 5,160 to 7,683, 
and the total burden hours increased from 1,870.39 to 2,110.84.

                                     Total Estimated Annualized Burden Hours
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                                                                                          Average
                                               Number of      Number of       Total      burden per     Total
     Form No.              Form name          respondents   responses per   responses     response      burden
                                                             respondent                  (in hours)     hours
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1................  OPTN Board of Directors            304               1          304         1.50       456.00
                    Volunteer Interest Form
                    * \+\.
2................  OPTN Committee Interest            838               1          838         1.27     1,064.26
                    Form * \+\.
3................  OPTN Annual Conflict-of-         1,346               1        1,346         0.13       174.98
                    Interest Disclosure
                    Questionnaire \+\.
4................  OPTN Conflict-of-                   74               3          222         0.08        17.76
                    Interest Disclosure:
                    Tri-Annual Update \+\.

[[Page 67592]]

 
5................  OPTN Ad hoc Conflict-of-            74              24        1,776         0.08       142.08
                    Interest Disclosure
                    Questionnaire ** \+\.
6................  OPTN Attestation Form...           505               1          505         0.08        40.40
7................  OPTN Code of Conduct             1,346               1        1,346         0.08       107.68
                    Form.
8................  OPTN Volunteer                   1,346               1        1,346         0.08       107.68
                    Confidentiality
                    Agreement \+\.
                                            --------------------------------------------------------------------
                      Total................         5,833  ..............        7,683  ...........     2,110.84
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* Estimated responses per year, every 2-to-3 years.
** Board members submit ad hoc conflict-of-interest forms prior to each monthly meeting, and before any ad hoc
  Board Meeting or Executive Board meeting with specific institution-based discussion.
\+\ Form name has been updated since the publication of the 60-day Federal Register Notice.


Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2026-21857 Filed 10-26-26; 8:45 am]
BILLING CODE 4165-15-P


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