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) ( see42 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 ( see42 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 ( www.hrsa.gov/​optn-modernization/​learn-more-about-modernization), 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 ( printed 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.

91 FR 67589