SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the ICR title for reference.

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 ( printed page 50862) public-private partnership that links professionals involved in the donation, procurement, and transplantation system in the United States. 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 the National Organ Transplant Act of 1984 ( see42 U.S.C. 27(b)(1)(B)), and the operation composition of the OPTN BOD are further codified in federal regulation under the regulations implementing the National Organ Transplant Act ( 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 and committees 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 20 of these members would fill out the annual COI form as well, as other members already receive the form as per their other OPTN committee roles. Given some committee turnover, there are approximately 505 committee and BOD members filling out the annual COI form and attestation form every year.

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 and committee members upon their election/selection or annual anniversary. The BOD and Membership and Professional Standards Committee members will also submit COI updates on a triannual 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, 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), organ procurement organization 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 and attestation forms will be individuals who have been elected or appointed to committee 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 in the applications, COI, and attestation forms. 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 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. ( printed page 50863)

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.

91 FR 50861