Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Part 121</CFR> <RIN>RIN 0937-AA13</RIN> <SUBJECT>Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Office of the Assistant Secretary for Health (OASH) and Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Notice of proposed rulemaking. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Health and Human Services (HHS) proposes to amend the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove clinical research and institutional review board (IRB) requirements (“research and IRB requirements”) for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. As allowed by the HIV Organ Policy Equity (HOPE) Act, the Secretary of HHS proposes to determine that participation in such clinical research should no longer be a requirement for transplantation of HIV positive kidneys and livers from donors with HIV to recipients with HIV. This proposed rule serves as publication of the Secretary's proposed determination and proposes to amend the regulations to reflect this determination. Consistent with NOTA and current regulatory requirements, the Secretary's proposed determination and the proposed corresponding regulatory revision, if finalized, will necessitate that the Organ Procurement and Transplantation Network (OPTN) adopt and use standards of quality concerning kidneys and livers from donors with HIV, as directed by the Secretary, consistent with NOTA and in a way that ensures the revised requirements for transplantation of such organs will not reduce the safety of organ transplantation. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments on this notice of proposed rulemaking should be received no later than October 15, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may send comments, identified by Document ID HRSA-2024-0001, to the Federal eRulemaking Portal: <E T="03">https://www.regulations.gov.</E> For detailed instructions on sending comments and additional information on the rulemaking process, see the “Public Participation” heading of the <E T="02">SUPPLEMENTARY INFORMATION</E> section of this document. In accordance with 5 U.S.C. 553(b)(4), a summary of this rulemaking may be found in the docket for this rulemaking at <E T="03">www.regulations.gov</E> [Document ID HRSA-2024-0001]. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Frank Holloman, Director, Division of Transplantation, Health Systems Bureau, HRSA, 5600 Fishers Lane, Room 08W63, Rockville, MD 20857; by email at <E T="03">donation@hrsa.gov;</E> or by telephone (301) 443-7577. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Public Participation</HD> All interested parties are invited to participate in this rulemaking by submitting written comments and supportive data that should be considered. HHS also invites comments that relate to the economic, legal, environmental, or federalism effects that might result from this proposed rule. Comments that will provide the most assistance to HHS in finalizing the rule will reference a specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authority that supports such recommended change. <E T="03">Instructions:</E> If you submit a comment, you must include the agency name and the Document ID HRSA-2024-0001 for this rulemaking. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at <E T="03">https://www.regulations.gov,</E> and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary public comment submission you make to HHS. HHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of <E T="03">https://www.regulations.gov.</E> <E T="03">Docket:</E> For access to the docket and to read background documents or comments received, go to <E T="03">https://regulations.gov,</E> referencing Document ID HRSA-2024-0001. You may also sign up for email alerts on the online docket to be notified when comments are posted or a final rule is published. <HD SOURCE="HD1">II. Background and Purpose</HD> <HD SOURCE="HD2">A. HHS Oversight of Organ Allocation and Transplantation</HD> Within HHS, HRSA is responsible for overseeing the operation of the nation's OPTN, including assisting in the equitable allocation of donor organs for transplantation. 42 U.S.C. 274(b)(2)(D). The allocation of organs is guided by the OPTN in accordance with NOTA and with the HHS regulations governing the operation of the OPTN in 42 Code of Federal Regulations (CFR) part 121. The OPTN is also charged with developing policies on many subjects related to organ donation and transplantation, which include establishing standards of quality pertaining to organs procured for use in transplantation. 42 U.S.C. 274(b)(2)(E). In addition to ensuring the efficient and effective allocation of donor organs through the OPTN, HHS supports efforts to increase the number of transplants performed in the United States. <HD SOURCE="HD2">B. HOPE Act Requirements and Implementation</HD> In 1988, NOTA was amended to prohibit the transplantation of organs from donors with HIV, referring to HIV as the etiologic agent for acquired immunodeficiency virus or AIDS. Until 1997, a total of 32 kidney transplants were performed in recipients with HIV, all with organs from donors without HIV. <SU>1</SU> <FTREF/> Advances in antiretroviral therapies (ART) have now made it possible for individuals with HIV to live longer and with fewer complications from the virus. Following the success of pioneering transplants occurring outside the United States of organs from donors with HIV to recipients with HIV, <SU>2</SU> <FTREF/> interest in developing specialized HIV transplant programs grew domestically. <SU>3</SU> <FTREF/> <FTNT> <SU>1</SU>  Werbel WA, Durand CM. Solid Organ Transplantation in HIV-Infected Recipients: History, Progress, and Frontiers. Curr HIV/AIDS Rep. 2019 Jun;16(3):191-203. </FTNT> <FTNT> <SU>2</SU>  Muller E, Barday Z, Mendelson M, Kahn D. HIV-Positive to HIV-Positive Kidney Transplantation—Results at 3 to 5 Years. New England Journal of Medicine. 2015 Feb 12;372(7):613-620. </FTNT> <FTNT> <SU>3</SU>  Botha J, Fabian J, Etheredge H, Conradie F, Tiemessen CT. HIV and Solid Organ Transplantation: Where Are we Now. Curr HIV/AIDS Rep. 2019 Oct;16(5):404-413. </FTNT> The enactment of the HOPE Act in 2013, Public Law 113-51, amended NOTA to eliminate the prohibition in the United States on transplantation of organs from persons with HIV, allowing transplantation of these organs if certain requirements are satisfied. Under the HOPE Act, organs from donors with HIV may be transplanted only in recipients living with HIV prior to receiving such an organ. 42 U.S.C. 274(b)(3)(A). Further, the HOPE Act requires that transplants of HIV-positive organs occur only in recipients with HIV who are participating in IRB-approved research protocols that adhere to certain criteria, standards, and regulations. 42 U.S.C. 274(b)(3)(B)(i). However, the Secretary may lift the research and IRB requirements if the Secretary has determined that participation in such clinical research, as a requirement for such transplants, is no longer warranted. 42 U.S.C. 274(b)(3)(B)(ii). The HOPE Act outlines the process by which the Secretary may make such a determination under 42 U.S.C. 274(b)(3)(B)(ii). Specifically, the Secretary must routinely review the results of clinical research, in conjunction with the OPTN, to determine whether the results warrant revision of the OPTN standards of quality regarding organs from donors with HIV. If the Secretary determines that those standards of quality should be revised, the Secretary must direct the OPTN to revise the standards. 42 U.S.C. 274f-5(c)(2). The Secretary is also required to revise the regulatory provision implementing the HOPE Act, 42 CFR 121.6, upon determining that revisions to the OPTN standards of quality are warranted. 42 U.S.C. 274f-5(c)(3). HRSA published a final rule implementing the HOPE Act on May 8, 2015. 80 FR 26464. <SU>4</SU> <FTREF/> The 2015 rule amended 42 CFR 121.6 to permit transplants of organs from donors with HIV in accordance with the HOPE Act requirements. <FTNT> <SU>4</SU>   <E T="04">Federal Register</E> . Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act. 2015 May:80 FR 26464. <E T="03">https://www.federalregister.gov/documents/2015/05/08/2015-11048/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-act.</E> </FTNT> The HOPE Act also directs the Secretary to develop and publish criteria for the conduct of research relating to transplantation of organs from donors with HIV into persons who are living with HIV before receiving an HIV-positive organ. 42 U.S.C. 274f-5(a). Subsequent to publication of the 2015 rule implementing the HOPE Act, NIH published the <E T="03">Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV,</E> on November 25, 2015. 80 FR 73785. <SU>5</SU> <FTREF/> The NIH Research Criteria wer ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 78k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━