Background

FCIC serves America's agricultural producers through effective, market-based risk management tools to strengthen the economic stability of agricultural producers and rural communities. FCIC is committed to increasing the availability and effectiveness of Federal crop insurance as a risk management tool. Approved Insurance Providers (AIPs) sell and service Federal crop insurance policies in every state through a public-private partnership. FCIC reinsures the AIPs who share the risks associated with catastrophic losses due to major weather events. FCIC's vision is to secure the future of agriculture by providing world class risk management tools to rural America.

Federal crop insurance policies typically consist of the Basic Provisions, the Crop Provisions, the Special Provisions, the Commodity Exchange Price Provisions, if applicable, other applicable endorsements or options, the actuarial documents for the insured agricultural commodity, the Catastrophic Risk Protection Endorsement, if applicable, and the applicable regulations published in 7 CFR chapter IV. Throughout this rule, the terms “Crop Provisions,” “Special Provisions,” and “policy” are used as defined in the Common Crop Insurance Policy (CCIP) Basic Provisions in 7 CFR 457.8. Additional information and definitions related to Federal crop insurance policies are in 7 CFR 457.8.

FCIC is amending the following regulations:

• Area Risk Protection Insurance Basic Provisions (7 CFR part 407);

• Common Crop Insurance Policy Basic Provisions (7 CFR 457.8);

• Small grain crop insurance provisions (7 CFR 457.101);

• Prune crop insurance provisions (7 CFR 457.133);

• Green pea crop insurance provisions (7 CFR 457.137);

• Northern potato crop insurance provisions (7 CFR 457.142);

• Central and Southern potato crop insurance provisions (7 CFR 457.147);

• Dry bean crop insurance provisions (7 CFR 457.150);

• Processing sweet corn crop insurance provisions (7 CFR 457.154); and

• Blueberry crop insurance provisions (7 CFR 457.166).

The changes to the crop insurance policies resulting from the amendments in this rule are applicable for the 2025 and succeeding crop years for crops with a contract change date on or after November 30, 2024. For all other crops, the changes to the crop insurance policies resulting from the amendments in this rule are applicable for the 2026 and succeeding crop years.

The Small Grain Crop Provisions previously offered actual production history (APH) coverage to buckwheat and flax; and offered yield protection (YP), revenue protection (RP), and revenue protection with harvest price exclusion (RP-HPE) to barley, oats, rye, and wheat. In this Final Rule, FCIC is expanding revenue protection (RP and RP-HPE) to flax, matching available coverage for barley, oats, rye, and wheat.

The current APH coverage for flax is now converted to YP. For producers who wish to maintain yield coverage, the only difference in coverage is the price guarantee matches the projected price offered for revenue protection (established approximately two weeks prior to the sales closing date), instead of a price election established by the Risk Management Agency (RMA) (established prior to the contract change date).

With the availability of revenue protection for flax, the terms “price election” and “production guarantee” are no longer applicable. Instead, the terms “projected price,” “yield protection guarantee,” and “revenue protection guarantee” are applicable. These changes appear in the following sections of the Small Grain Crop Provisions: 3(a) and (b), 9(c), and 11(b) and (c).

FCIC is revising section 3(a) to remove the references to flax. This provision previously stated that revenue protection is not available for flax or buckwheat. FCIC is removing flax from the list of crops because revenue coverage is now available for flax. FCIC is also revising section 3(b) to add references to flax. These provisions previously stated that revenue protection is available for barley, oats, rye, and wheat. FCIC is adding flax to the list of crops in the two places where the list occurs.

FCIC is revising section 9(c)(2)(i) to remove the reference to flax and revise section 9(c)(2)(ii) to add a reference to flax. When a crop does not have yield or revenue protection available, the price used for determining coverage and any indemnity payments, including replanting payments, is called the price election. For crops for which yield and revenue protection are available, this price is called the projected price. In section 9(c)(2)(i), the provision previously stated that the replanting payment for flax will be determined by using the price election. Under this rule, revenue and yield protection plans of insurance are now available for flax; therefore, the price used is the projected price. FCIC is revising section 9(c)(2)(i) to remove the reference to flax. Section 9(c)(2)(ii) contains provisions applicable to the projected price. FCIC is revising section 9(c)(2)(ii) to include flax, as the projected price will now be used.

For crops for which yield and revenue protection are available, the applicable terms for insurance coverage are yield protection guarantee and revenue protection guarantee. For crops for which yield and revenue protection are not available, the applicable term is production guarantee. FCIC is revising sections 11(b)(1)(i), (ii), and (iii). These sections refer to “yield protection guarantee,” “production guarantee,” and “revenue protection guarantee,” respectively. The references to flax in section 11(b)(1)(ii), which addresses production guarantee, were removed and added to sections 11(b)(1)(i) and (iii), which address yield protection guarantee and revenue protection guarantee.

FCIC is also revising section 11(b)(3)(i) to add a reference to flax and revising section 11(b)(3)(ii) to remove the reference to flax. This change is consistent with the change in section 9(c)(2). Section 11(b)(3)(i) refers to computations using the projected price; section 11(b)(3)(ii) refers to computations using the price election. Flax was removed from section 11(b)(3)(ii) and added to section 11(b)(3)(i) to align with the proper terms for crops for which revenue protection is available.

Section 11(c)(1)(i) explains what is included in appraised production. Previously, flax was contained in a list of crops with buckwheat. Those two crops had similar coverage and used the same crop insurance terminology under the Small Grain Crop Provisions when revenue coverage was not yet available for flax. Now, flax has been removed from the list of crops containing buckwheat and added to the list of crops containing barley, oats, rye, and wheat in two places because allowing revenue coverage for flax makes coverage and crop insurance terminology for that crop consistent with coverage and terminology for barley, oats, rye, and wheat.

FCIC is combining written agreement deadlines to reduce confusion and administrative complexity when a producer requests a written agreement based on multiple criteria. Previously, the written agreement deadline to add an insurable practice or type was the acreage reporting date for new requests and the sales closing date for renewal requests; however, the deadline to add an insurable dry bean type that is not on the actuarial documents was the sales closing date. This created extra paperwork and confusion in instances where a producer wanted to insure a new dry bean type and under a practice that is not currently available in the county. FCIC is combining the deadline for all written agreements to match all other insurance policies with this type of request, so that for the first year of coverage, the deadline is the acreage reporting date and for subsequent years of coverage, the deadline is the sales closing date.

The CCIP Basic Provisions allow enterprise units (EU) by organic farming practice, beginning with the June 30, 2024, contract change date. Unlike major row crops, optional units (OUs) by organic farming practice were not available for most specialty and perennial crops due to language in the Crop Provisions (CP) that superseded the standard OU definition in the CCIP Basic Provisions. In this rule, FCIC is removing limitations on OUs by organic farming practice and making clarifications and edits for consistency with the EU and OU choices provisions in the CCIP Basic Provisions in the following Crop Provisions:

• Green pea crop insurance provisions (7 CFR 457.137); and

• Processing sweet corn crop insurance provisions (7 CFR 457.154).

These changes are responsive to organic growers and the Climate Smart Initiative.

FCIC is making the following corrections and clarifications in the Small Grain Crop Provisions (7 CFR 457.101):

• Updating the effective crop year of the Crop Provisions;

• Removing the hyphen in the phrase “initially-planted” in section 2(b) for consistency with the defined phrase in the Crop Provisions;

• Making plain language clarifications in sections 5, 6, and 7;

• Combining the two introductory paragraphs in section 8 into one introductory paragraph;

• Replacing the word “and” with “or” in sections 11(d)(2)(i)(A) and 11(d)(2)(ii). Section 11(d) contains six subparagraphs for deficiencies in quality for the small grain crop. The list of deficiencies in quality varies by crop. In four of the six subparagraphs, the last item in the list is preceded by “or,” while in the other two paragraphs, the last item is preceded by “and.” FCIC is changing the word “and” to “or” for consistency among subparagraphs; and

• Replacing the word “flaxseed” with “flax” in section 11(d)(2)(E). This is the only instance of “flaxseed,” whereas “flax” is used elsewhere.

FCIC is making the following clarifications and corrections in the Green pea crop insurance provision (7 CFR 457.137):

• Updating the effective crop year of the Crop Provisions;

• Removing the paragraph immediately preceding section 1, which refers to the order of priority if a conflict exists among the policy provisions. This same provision is contained in the Basic Provisions. Therefore, the appearance here is duplicative and should be removed. FCIC is clarifying which Basic Provisions apply by replacing the aforementioned paragraph with an introductory sentence preceding the Crop Provisions;

• Removing all instances of the phrase “the provisions of,” “the provisions contained in,” and “contained” where a policy reference follows;

• Revising the definition of “good farming practices” to clarify that the definition in the Crop Provisions expands upon the definition contained in the Basic Provisions because good farming practices include the cultural practices required by the processor contract;

• Revising the definition of “practical to replant” to clarify that the definition in the Crop Provisions does not replace, but rather expands upon the definition in the Basic Provisions, and remove duplicative criteria that are already included in the definition in the Basic Provisions;

• Revising the definition of “processor contract” to replace the phrase “a written agreement” with the phrase “a written contract.” The phrase “written agreement” is a specifically defined term in the Basic Provisions and is not applicable to a processor contract for green peas. This change is necessary to minimize confusion between a written contract and a written agreement, which is a document that alters designated terms of a policy as authorized under these Basic Provisions, the Crop Provisions, or the Special Provisions for the insured crop;

• Removing the phrase “for determining indemnities” from the section heading for section 3. The section heading will now read “Insurance Guarantees, Coverage, Levels, and Prices.” The new section heading is more accurate because insurance guarantees, coverage levels, and prices are not exclusively used for determining indemnities. This change is also for consistency with section headings of the same name in other Crop Provisions;

• Replacing the reference to Special Provisions with actuarial documents in section 3(a), since the price election information referred to in this section is displayed in the actuarial documents;

• Replacing abbreviated months (“Feb” and “Mar”) with the full spelling for the months (“February” and “March”) in the cancellation and termination date table, in section 5;

• Adding a hyphen to the adjective compound “15-day” as it describes a “15-day period” in section 11(c); and

• Updating prices in the settlement of claim examples to be more reflective of current crop prices and potential indemnities, in section 12.

FCIC is making the following clarifications and corrections in the Processing sweet corn crop insurance provisions (7 CFR 457.154):

• Updating the effective crop year of the Crop Provisions;

• Clarifying which Basic Provisions apply by adding an introductory sentence preceding the Crop Provisions; and

• Adding a hyphen to the adjective compound “15-day” as it describes a “15-day period” in section 11(c).

In addition, the Common Crop Insurance Regulations in 7 CFR part 457 were revised by a final rule with request for comments published in the Federal Register on June 27, 2024 (89 FR 53822-53847). Changes were made in that rule to the Area Risk Protection Insurance Basic Provisions (7 CFR part 407), Common Crop Insurance Policy (Common Crop Insurance Policy (CCIP) Basic Provisions (7 CFR 457.8), the General Administrative Regulations in subpart J of part 400 (7 CFR 400.98), and 18 Crop Provisions. In reviewing the changes made, FCIC found some incorrect references, missing words, missing parentheses, incorrect paragraph designations, and an extra word. This rule will also make these corrections in the following provisions:

• Area Risk Protection Insurance Basic Provisions (7 CFR part 407);

• Common Crop Insurance Policy Basic Provisions (7 CFR 457.8);

• Prune crop insurance provisions (7 CFR 457.133);

• Northern potato crop insurance provisions (7 CFR 457.142);

• Central and Southern potato crop insurance provisions (7 CFR 457.147); and

• Blueberry crop insurance provisions (7 CFR 457.166).

The Administrative Procedure Act (APA, 5 U.S.C. 553) provides that the notice and comment and 30-day delay in the effective date provisions do not apply when the rule involves specified actions, including matters relating to contracts. This rule governs contracts for crop insurance policies and therefore falls within that exemption.

This rule is exempt from the regulatory analysis requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996.

Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, (also known as the Congressional Review Act) requires a delay of the effective date of 60 days after publication to allow for Congressional review. The Office of Information and Regulatory Affairs has determined that this rule does not meet the criteria in 5 U.S.C. 804(2). Therefore, this final rule is effective on November 30, 2024. Although not required by APA or any other law, FCIC has chosen to request comments on this rule.

Executive Order 12866, “Regulatory Planning and Review,” was amended by and Executive Order 13563, “Improving Regulation and Regulatory Review,” and Executive Order 14094, “Modernizing Regulatory Review.” Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The requirements in Executive Orders 12866 and 13563 for the analysis of costs and benefits apply to rules that are determined to be significant.

The Office of Management and Budget (OMB) has designated this rule as not significant under Executive Order 12866, “Regulatory Planning and Review,” and therefore, OMB has not reviewed this rule and analysis of the costs and benefits is not required under either Executive Order 12866 or 13563.

Executive Order 12866, as supplemented by Executive Order 13563, requires each agency to write all rules in plain language. Executive Order 14094 requires Federal agencies to increase and improve public participation in the regulatory process. The Executive order's objective is to improve public trust in the regulatory process by reducing the risk or appearance of unequal or unfair influence in regulatory development. Under Executive Order 14904, agencies must, to the extent they can under law, seek out, assist with, and include your input in the regulatory process. We welcome comments from public (State, local, Tribal, and territorial) and private sector regulated entities; members of underserved communities; consumers; workers and labor organizations; businesses; and program beneficiaries, among others. In addition to your substantive comments on this rule, we invite your comments on how to make the rule easier to understand. For example:

• Are the requirements in the rule clearly stated? Are the scope and intent of the rule clear?

• Does the rule contain technical language or jargon that is not clear?

• Is the material logically organized?

• Would changing the grouping or order of sections or adding headings make the rule easier to understand?

• Could we improve clarity by adding tables, lists, or diagrams?

• Would more, but shorter, sections be better? Are there specific sections that are too long or confusing?

• What else could we do to make the rule easier to understand?

The environmental impacts of this final rule have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and because USDA will be making the payments to producers, the USDA regulation for compliance with NEPA (7 CFR part 1b). As specified in 7 CFR 1b.4(b)(4), FCIC is categorically excluded from the preparation of an Environmental Analysis or Environmental Impact Statement unless the FCIC Manager (agency head) determines that an action may have a significant environmental effect. The FCIC Manager has determined this rule will not have a significant environmental effect. Therefore, FCIC will not prepare an environmental assessment or environmental impact statement for this action and this rule serves as documentation of the programmatic environmental compliance decision.

This rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” This rule will not preempt State or local laws, regulations, or policies unless they represent an irreconcilable conflict with this rule. Before any judicial actions may be brought regarding the provisions of this rule, the administrative appeal provisions of 7 CFR part 11 are to be exhausted. For good farming practice determinations, the administrative appeal provisions under 7 CFR part 11 do not apply.

This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

RMA has assessed the impact of this rule on Indian Tribes and determined that this rule does not, to our knowledge, have Tribal implications that require Tribal consultation under E.O. 13175. The regulation changes do not have Tribal implications that preempt Tribal law and are not expected have a substantial direct effect on one or more Indian Tribes. If a Tribe requests consultation, RMA will work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified in this rule are not expressly mandated by Congress.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L. 104-4) requires Federal agencies to assess the effects of their regulatory actions of State, local, and Tribal governments or the private sector. Agencies generally must prepare a written statement, including cost benefits analysis, for proposed and final rules with Federal mandates that may result in expenditures of $100 million or more in any 1 year for State, local or Tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates, as defined in Title II of UMRA, for State, local, and Tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

The title and number of the Assistance Listing, to which this rule applies is No. 10.450—Crop Insurance.

In accordance with the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, subchapter I), the rule does not change the information collection approved by OMB under control numbers 0563-0053 and 0563-0083.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Individuals who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA TARGET Center at (202) 720-2600 (voice and text telephone (TTY)) or dial 711 for Telecommunications Relay Service (both voice and text telephone users can initiate this call from any telephone). Additionally, program information may be made available in languages other than English. To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by: (1) mail to: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email: program.intake@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

For the reasons discussed above, FCIC amends 7 CFR parts 407 and 457, effective for the 2025 and succeeding crop years for crops with a contract change date on or after November 30, 2024, and for the 2026 and succeeding crop years for all other crops, as follows:

On December 14, 2004, FSIS issued a final rule establishing January 1, 2008, as the uniform compliance date for new meat and poultry labeling regulations issued between January 1, 2005, and December 31, 2006 (69 FR 74405). The 2004 final rule also provided that the Agency would set uniform compliance dates for new labeling regulations in 2-year increments and periodically issue final rules announcing and requesting comments on those dates. Consistent with the 2004 final rule, the Agency has since published nine rules establishing the uniform compliance dates of January 1, 2010, January 1, 2012, January 1, 2014, January 1, 2016, January 1, 2018, January 1, 2020, January 1, 2022, January 1, 2024, and January 1, 2026 (72 FR 9651, 73 FR 75564, 75 FR 71344, 77 FR 76824, 79 FR 71007, 81 FR 91670, 83 FR 63052, 85 FR 81339, and 87 FR 77707).

The new uniform compliance date will apply only to final FSIS regulations that require changes in the labeling of meat and poultry products and that are published after January 1, 2025, and before December 31, 2026. For each final rule that requires changes in labeling, FSIS will specifically identify January 1, 2028, as the compliance date. All meat and poultry food products that are subject to labeling regulations issued between January 1, 2025, and December 31, 2026, will be required to comply with these regulations on products introduced into commerce on or after January 1, 2028. If any food labeling regulation involves special circumstances that justify a compliance date other than January 1, 2028, the Agency will determine an appropriate compliance date and will publish that compliance date in the rulemaking.

Two-year increments increase industry's ability to make orderly adjustments to new labeling requirements without exposing consumers to outdated labels. This approach allows meat and poultry producers to plan for the use of label inventories and to develop new labeling materials that meet the new requirements. It also serves to reduce the economic impact of changing labels on both producers and consumers.

In the March 5, 2007, final rule, FSIS received only four comments on the announced uniform compliance dates, all in support. In the March 5, 2007, final rule, FSIS determined that further rulemaking for uniform compliance dates for labeling requirements is unnecessary (72 FR 9651). The Agency received no comments on the 2007 final rule, the comments FSIS received on the 2012 final rule were outside the scope (77 FR 76824), and FSIS received no comments on the 2014 final rule (79 FR 71007) or the 2016 final rule (81 FR 91670). The Agency received four comments on the 2018 final rule (83 FR 63052), all in support. The Agency received four comments on the 2020 final rule (85 FR 81339); one was outside the scope of the rulemaking and three were in support of the rule. The Agency received two comments on the 2022 final rule (87 FR 77707); one was in support of the rule, and one requested a 90-day extension because of potential supply chain issues for self-adhesive label materials. Because the commenter did not provide any additional information to support their claim about supply shortages and no other members of industry expressed concerns about a shortage, FSIS did not change the uniform compliance date.

Consistent with its statement in 2007, FSIS finds that further rulemaking on this matter is unnecessary. However, FSIS is providing an opportunity for comment on the uniform compliance date established in this final rule.

Executive Orders (E.O.) 12866 (as amended by E.O. 14094) and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated as a “non-significant” regulatory action under section 3(f) of E.O. 12866. Accordingly, the final rule has not been reviewed by the Office of Management and Budget (OMB) under E.O. 12866.

This rule does not have a significant economic impact on a substantial number of small entities; consequently, a regulatory flexibility analysis is not required (5 U.S.C. 601-612).

FSIS has reviewed this rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and has determined that there is no new information collection related to this final rule. Under this final rule, the Agency is establishing January 1, 2028, as the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2025, and December 31, 2026. The relevant information collection or record keeping requirements are covered under OMB approval number 0583-0092, Marking, Labeling, and Packaging.

FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, et seq. ) by, among other things, promoting the use of the internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes.

This final action has been reviewed under E.O. 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this action will be preempted; (2) no retroactive effect will be given to this action; and (3) no administrative proceedings will be required before parties may file suit in court challenging this rule. However, parties may be required to exhaust their administrative remedies before challenging in court any specific agency action that is the subject of an appeal pursuant to this action.

This rule has been reviewed in accordance with the requirements of E.O. 13175, “Consultation and Coordination with Indian Tribal Governments.” E.O. 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

FSIS has assessed the impact of this action on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a tribe requests consultation, FSIS will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: https://www.fsis.usda.gov/federal-register.

FSIS will also announce and provide a link to it through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Mission Areas, agencies, staff offices, employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information ( e.g., Braille, large print, audiotape, American Sign Language) should contact the responsible Mission Area, agency, or staff office; the USDA TARGET Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service at (800) 877-8339.

To file a program discrimination complaint, a complainant should complete a Form AD-3027, USDA Program Discrimination Complaint Form, which can be obtained online at https://www.usda.gov/forms/electronic-forms, from any USDA office, by calling (866) 632-9992, or by writing a letter addressed to USDA. The letter must contain the complainant's name, address, telephone number, and a written description of the alleged discriminatory action in sufficient detail to inform the Assistant Secretary for Civil Rights about the nature and date of an alleged civil rights violation. The completed AD-3027 form or letter must be submitted to USDA by:

(1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410;

(2) Fax: (833) 256-1665 or (202) 690-7442; or

(3) Email: program.intake@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2023-21-06, Amendment 39-22578 (88 FR 76114, November 6, 2023; corrected December 7, 2023 (88 FR 85093)) (AD 2023-21-06). AD 2023-21-06 applied to certain serial-numbered Embraer Model EMB-505 airplanes. AD 2023-21-06 was prompted by an MCAI originated by ANAC, which is the aviation authority for Brazil. ANAC issued ANAC AD 2023-05-03, effective June 2, 2023 (ANAC AD 2023-05-03) to correct an unsafe condition.

AD 2023-21-06 required installing structural reinforcements on certain monuments and replacing certain floor support rivets. The FAA issued AD 2023-21-06 to address certain monuments (the right-hand refreshment center and left-hand forward cabinet) that might not withstand the loads expected for specific emergency landing conditions, which may cause the detachment of mass items and result in injuries to the airplane occupants.

Since the FAA issued AD 2023-21-06, ANAC superseded ANAC AD 2023-05-03 and issued ANAC AD 2023-05-03R01, effective March 8, 2024 (ANAC AD 2023-05-03R01) for certain serial-numbered Embraer Model EMB-505 airplanes. ANAC AD 2023-05-03R01 stated it was issued to incorporate Embraer Service Bulletin SB505-25-0046, Revision 02, dated February 19, 2024, which updates effectivity information, compliance information, and part number information.

ANAC superseded ANAC AD 2023-05-03R01 and issued ANAC AD 2023-05-03R02, effective May 17, 2024 (ANAC AD 2023-05-03R02) (also referred to as the MCAI) for certain serial-numbered Embraer Model EMB-505 airplanes. The MCAI states it was issued to incorporate Embraer Service Bulletin SB505-25-0046, Revision 03, dated May 6, 2024 (actual date May 7, 2024), which includes additional actions for certain airplane groups that had complied with the requirements of ANAC AD 2023-05-03R01 but had not yet installed part number 506-66837-001 and updates the effectivity information, compliance information, and part number information.

The NPRM published in the Federal Register on August 16, 2024 (89 FR 66642). The NPRM was prompted by ANAC AD 2023-05-03R02. In the NPRM, the FAA proposed to require installing structural reinforcements on monuments and replacing fasteners on the floor support, as specified in ANAC AD 2023-05-03R02.

The FAA is issuing this AD to address certain monuments that might not withstand the loads expected for specific emergency landing conditions, which may cause the detachment of mass items and result in injuries to the airplane occupants.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2024-2020.

The FAA received no comments on the NPRM or on the determination of the costs.

These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.

The FAA reviewed ANAC AD 2023-05-03R02, which specifies procedures for installing structural reinforcements on certain monuments and replacing certain fasteners on the floor support.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in ADDRESSES .

The material specified in ANAC AD 2023-05-03R02 allows the use of alternative or similar parts in place of the ones specified in the kits, provided these alternative or similar parts are approved by Embraer, but this AD requires approval from either the Manager, International Validation Branch, FAA; ANAC; or ANAC's authorized Designee. If approved by the ANAC Designee, the approval must include the Designee's authorized signature.

The FAA estimates that this AD affects 208 airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs for the additional work that operators would be required to do for compliance with this AD if they completed the actions in the original version of Embraer Service Bulletin SB505-25-0046, dated March 31, 2021; Service Bulletin SB505-25-0046, Revision 01, dated May 8, 2023; or Service Bulletin SB505-25-0046, Revision 02, dated February 19, 2024. The agency has no way of determining the number of airplanes that might need these actions:

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA has determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency, for good cause, finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard was notified of this event on October 30, 2024, and must establish this safety zone by December 7, 2024, to protect personnel, vessels, and the marine environment from potential hazards created by the fireworks display, and therefore lack sufficient time to provide a reasonable comment period and then a period to consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because prompt action is needed to respond to the potential safety hazards associated with fireworks launched from a barge in the waters of the Laguna Madre.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port, Sector Corpus Christi (COTP) has determined that potential hazards associated with the fireworks display, occurring from 9:30 p.m. through 11:59 p.m. on December 7, 2024, will be a safety concern for anyone within the waters of the Laguna Madre area within a 700-yard radius of the barge from which the display will be launched. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks display occurs in the Laguna Madre.

This rule establishes a temporary safety zone from 9:30 p.m. to 11:59 p.m. on the night of December 7, 2024. The safety zone will encompass all navigable waters of the Laguna Madre and is defined by a 700-yard radius from the launch platform. The regulated area encompasses a 700-yard radius of the following point: 26°06′02.1″ N, 97°10′17.7″ W. The fireworks display will take place in waters of the Laguna Madre. No vessel or person is permitted to enter the temporary safety zone during the effective period without obtaining permission from the COTP or a designated representative, who may be contacted on Channel 16 VHF-FM (156.8 MHz) or by telephone at 361-939-0450. The Coast Guard will issue Broadcast Notices to Mariners and Safety Marine Information Broadcasts.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, and duration of the safety zone. The temporary safety zone will be enforced for the short period of two and a half hours, on the night of December 7, 2024, when vessel traffic is normally low. The zone is limited to a 700-yard radius from the launching position in the navigable waters of the Laguna Madre. The rule does not completely restrict the traffic within a waterway and allows mariners to request permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, and Environmental Planning, COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f) and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of a temporary safety zone for navigable waters of the Laguna Madre in a zone defined by a 700-yard radius around the fireworks barge, located at the following point: 26°06′02.1″ N, 97°10′17.7″ W. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce the safety zone in 33 CFR 165.801, Table 4, Line 11, for the Rockport Tropical Christmas Festival Fireworks Display Show from 8 p.m. through 8:45 p.m. on December 6, 2024, with a rain date set for December 7, 2024, from 8 p.m. through 8:45 p.m. This action is being taken to provide for the safety of persons, vessels, and the marine environment on navigable waterways during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801, specifies the location of the safety zone for the Rockport Tropical Christmas Festival Fireworks Display Show, which encompasses portions of Little Bay in Rockport, TX. As reflected in § 165.23 and § 165.801(a), if you are the operator of a vessel in the regulated area you must comply with directions from the Captain of the Port Sector Corpus Christi (COTP) or any designated representative. Persons or vessels desiring to enter the zone must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16 or by telephone at (361) 939-0450.

If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

In addition to this notice of enforcement in the Federal Register , the COTP or a designated representative will inform the public through Broadcast Notice to Mariners (BNM) and Marine Safety Information Broadcasts (MSIBs) at least 24 hours in advance of each enforcement.

Section 115 of the Copyright Act, title 17 of the United States Code, creates a statutory license for making and distributing phonorecords of nondramatic musical works. On December 16, 2022, the Copyright Royalty Judges (Judges) adopted final regulations governing the rates and terms of copyright royalty payments under that license for the license period 2024-2027 for making and distributing phonorecords of nondramatic musical works. See 87 FR 76942.

Pursuant to those regulations, at least 25 days before January 1 of each year, the Judges shall publish in the Federal Register notice of a cost of living adjustment (COLA) applicable to the royalty fees for making and distributing physical phonorecords and Permanent Downloads. See 37 CFR 385.11.

The adjustment in the royalty fee shall be based on a calculation of the percentage increase in the Consumer Price Index for All Urban Consumers (CPI-U) published in November 2022 (298.012)  1 (“base rate”) according to the following formulas: for the per-work rate, (1 + (Cy−298.012  2 )/298.012) × 12¢, rounded to the nearest tenth of a cent; for the per-minute rate, (1 + (Cy−298.012)/298.012) × 2.31¢, rounded to the nearest hundredth of a cent; where Cy is the CPI-U published by the Secretary of Labor before December 1 of the preceding year. 37 CFR 385.11(a)(2). The CPI-U published by the Secretary of Labor from the most recent index published before December 1, 2024, is 315.664. 3 Applying the formulas in 37 CFR 385.11(a)(2) results in an increase in the rates for 2025.

The adjusted rates for 2025 are 12.7 cents for the per-work rate and 2.45 cents for the per-minute rate.

In consideration of the foregoing, the Judges amend part 385 of title 37 of the Code of Federal Regulations as follows:

This final rule describes new prices and product features for competitive products, by class of mail, established by the Governors of the United States Postal Service®. New prices are available under Docket Number CP2025-1 on the Postal Regulatory Commission PRC website at http://www.prc.gov, and on the Postal Explorer® website at http://pe.usps.com.

The Postal Service will revise Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), to reflect changes to certain prices and mailing standards for the following competitive products:

• Priority Mail Express®.

• Priority Mail®.

• USPS Ground Advantage®.

• Parcel Select®.

• Extra Services.

• Return Services.

• Mailer Services.

• Recipient Services.

• Other.

Competitive product prices and changes are identified by product as follows:

Overall, Priority Mail Express prices will increase 3.2 percent. Priority Mail Express will continue to offer zoned and Flat Rate, Retail and Commercial pricing.

Retail prices will increase an average of 3.2 percent. The Flat Rate Envelope price will increase to $31.40, the Legal Flat Rate Envelope will increase to $31.65, and the Padded Flat Rate Envelope will increase to $32.25.

Commercial prices will increase an average of 3.2 percent.

Overall, Priority Mail prices will increase 3.2 percent. Priority Mail will continue to offer zoned and Flat Rate, Retail and Commercial pricing.

Retail prices will increase an average of 3.2 percent. The Flat Rate Envelope price will increase to $10.10, the Legal Flat Rate Envelope will increase to $10.40, and the Padded Flat Rate Envelope will increase to $10.85. The Small Flat Rate Box price will increase to $10.65, and the Medium Flat Rate Boxes will increase to $19.15. The Large Flat Rate Box will increase to $26.30 and the APO/FPO/DPO Large Flat Rate Box will increase to $25.05.

Commercial prices will increase an average of 3.2 percent.

Overall, USPS Ground Advantage prices will increase 3.9 percent.

USPS Ground Advantage—Retail prices will increase 4.9 percent.

USPS Ground Advantage—Commercial prices will increase 3.2 percent.

The prices for Parcel Select Destination Entry will increase an average of 9.2 percent.

The prices for USPS Connect® Local will increase 5.4 percent.

Adult Signature Required and Adult Signature Restricted Delivery service prices are decreasing 10.2 and 10.4 percent respectively. The price for Adult Signature Required will decrease to $8.40 and Adult Signature Restricted Delivery will decrease to $8.65.

There are no structural changes to USPS Returns Service.

The Pickup on Demand® service fee will remain the same.

The USPS Tracking Plus® service prices will increase on average between 11.1 and 152.5 percent.

The USPS Label Delivery Service TM prices will increase 24.0 percent to $1.55.

The competitive Post Office Box TM service prices will increase an average of 5.7 percent within the updated price ranges.

Premium Forwarding Service® (PFS®) prices will increase between 2.5 and 6.1 percent depending on the specific price element. The enrollment fee paid at the retail counter for PFS-Residential will increase to $26.85 and the PFS-Residential, PFS-Commercial, and PFS-Local enrollment fee paid online will increase to $24.70 per application. The price of the weekly shipment charge for PFS-Residential and per container charge for PFS-Local will increase to $27.80.

The USPS Package Intercept® fee will increase 4.9 percent to $18.35.

Address Enhancement Service competitive product prices will increase between 8.4 and 9.1 percent.

To encompass all the compliance qualities included under the current IMpb Noncompliance Fee, the Postal Service is renaming the IMpb Noncompliance Fee the Package Quality Noncompliance Fee.

The Postal Service is requiring mailers to add a supplemental GS1-DataMatrix (2D) Intelligent Mail matrix barcode (IMmb) to domestic shipping labels to improve package visibility. The placement of the IMmb will be in the address block to the left of the delivery address. Optionally, a mailer may place a second IMmb in the lower right corner of the shipping label. The Postal Service recommends using the second IMmb on all labels. The addition of the IMmb barcode will provide the Postal Service with a greater opportunity for the package to be scanned providing customers with better visibility of their packages.

The Postal Service will also update Publication 52, Hazardous, Restricted, and Perishable, Matter, for consistency in barcode application.

The Postal Service is implementing a Live Animal and Perishable Handling fee. This fee will be assessed on all live animals and perishables ( e.g. fruit, meat), entered at retail and commercial Priority Mail Express, Priority Mail, and USPS Ground Advantage prices. The Live Animal and Perishable Handling fee is nonrefundable once the piece is entered in the network.

The Live Animal and Perishable Handling fee is in addition to the current Live Animal Transportation fee provided in the Notice 123—Price List, when applicable.

The Postal Service will also update Publication 52, Hazardous, Restricted, and Perishable, Matter, to provide detailed information on the fee requirement.

The Postal Service is revising the current requirement to include the hazardous materials icon (“H”) in lieu of the service icon on a shipping address label when mailing eligible hazardous materials. Items containing mailable hazardous materials addressed to an APO/FPO/DPO, the USPS territories and possessions, and the Freely Associated States, are excluded from the requirement to include the hazardous materials icon in lieu of the service icon on a shipping address label.

The Postal Service is increasing the overweight and oversize item fee to $200.00, to continue to deter nonmailable volumes from being entered in the network.

The Postal Service provides additional resources to assist customers with this price change for competitive products. These tools include price lists, downloadable price files, and Federal Register Notices, which may be found on the Postal Explorer® website at http://pe.usps.com.

The Postal Service adopts the described changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

Accordingly, the Postal Service amends Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations as follows (see 39 CFR part 111.1):

On September 12, 2024, HHS published a notice of proposed rulemaking (NPRM) in the Federal Register (89 FR 74174) proposing both that the Secretary of HHS determine that participation in clinical research should no longer be required for transplantation of kidneys and livers from donors with HIV to recipients with HIV, and that the HHS regulations at 42 CFR part 121 implementing the HOPE Act be amended consistent with this proposed determination. The NPRM provided for a 30-day comment period, and HHS received 56 comments raising a variety of issues. HHS has carefully considered all comments in developing this rule, as outlined in section III, below, and presents a summary of all significant comments and Departmental responses.

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 CFR part 121. The OPTN is also charged with developing policies on many subjects related to organ donation, procurement, and transplantation, which include establishing standards of quality pertaining to organs procured for use in transplantation. 42 U.S.C. 274(b)(2)(E).

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 scientific 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. 1 The 2015 rule amended 42 CFR 121.6 to permit transplants of organs from donors with HIV in accordance with the HOPE Act requirements.

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, the National Institutes of Health (NIH) published the Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV, on November 25, 2015. 80 FR 73785. 2

In general, the NIH Research Criteria include safeguards designed to protect both donors and recipients, as well as healthcare providers at Organ Procurement Organizations (OPOs) and transplant centers. Specifically, and in addition to the requirements in established OPTN transplant policies, donors with HIV must not have evidence of opportunistic infections and recipients must have a stable CD4+ T-cell count and established HIV suppression and control on effective antiretroviral therapy (ART). The study team must describe the anticipated effective HIV treatment plan and ART regimen for patients receiving an organ with a potentially different HIV strain. Antiretroviral drugs suppress viral replication; however, HIV may develop resistance to a specific drug necessitating a different medication regimen to maintain effectiveness. Transplant hospitals conducting HOPE Act operations are required to have expertise in transplants provided to recipients with HIV. OPOs are required to have procedures in place to address working with families of deceased donors who lived with HIV and a biohazard plan to address viral exposure and potential transmission. Finally, the Research Criteria establish uniform outcome measures that must be incorporated in the research design so that data on HOPE Act transplants can be analyzed consistently and data collection is harmonized to inform future implementation of the HOPE Act.

Publication of both the final rule implementing the HOPE Act and the NIH Research Criteria necessitated that the OPTN update its standards of quality for HIV-positive organ transplants and coordinate related OPTN policies. On November 21, 2015, the OPTN published an open variance (an experimental policy that tests methods of improving organ allocation) providing standards for transplant hospitals conducting HOPE Act transplants. 3 The OPTN expanded the variance in 2019 to include all solid organs, 4 and extended the variance through January 2026, to provide for the gathering of data and subsequent evaluation of the outcomes of HOPE Act transplants. 5

The Secretary, in conjunction with the OPTN, reviewed the results of scientific research to determine whether the results warrant revision to the OPTN standards of quality with respect to organs from donors with HIV and the safety of transplanting an organ from a donor with a particular strain of HIV into a recipient with a different strain of HIV. 42 U.S.C. 274f-5(c)(1). This review allowed the Secretary to determine if the safety and efficacy of HOPE Act transplants are comparable to non-HOPE Act transplants and, if warranted, to further determine whether such transplants should be conducted outside of a research setting.

In 2018, the OPTN initiated a review of research results and data relevant to HOPE Act transplants, forming a working group for this purpose. 6 The OPTN's assessment as to whether revision is warranted for the OPTN standards of quality applicable to HOPE Act transplants was based primarily on (1) the review of studies demonstrating the safety and outcomes of organ transplantation in recipients with HIV and (2) a recognition that the removal of the general research and IRB requirements for HOPE Act transplants could expand access to organ transplantation for all patients regardless of their HIV status. In this context, safety is measured by accidental or inadvertent transmission of HIV in the performance of HOPE Act transplants. (Of note, there were no recorded accidental or inadvertent transmission events in the data reviewed by the OPTN.) Outcomes are determined primarily by transplant recipient or graft survival, compared to non-HOPE Act transplants or transplant recipients without HIV. Measures ( e.g., CD4+ T-cell counts, ART resistance, and detectable HIV viral loads) or variables such as opportunistic infections, HIV superinfection, malignancy, rejection, or graft failure may also factor into comparative outcomes in the short and long term.

The OPTN used three primary sources of data to assess HOPE Act transplants, each of which contributed to the recommendation the OPTN provided to the Secretary: (1) the research results of two pilot studies evaluating HOPE Act kidney transplants and liver transplants, and the progress of two ongoing NIH-funded clinical trials evaluating HOPE Act kidney transplants and liver transplants, (2) the research results of an older clinical trial analyzing safety and efficacy of kidney transplants in a small cohort of transplant recipients with HIV, and (3) OPTN data on the outcomes of all HOPE Act transplants.

A multicenter pilot study was launched in 2016 to determine safety and efficacy of HOPE Act kidney transplants. The HOPE In Action Consortium of 14 transplant centers conducting HOPE Act kidney transplants found no major differences between HOPE Act transplants of a kidney from a donor with HIV to a recipient with HIV and non-HOPE Act kidney transplants from a donor without HIV to a recipient with HIV. 7 Rates of opportunistic infections and infections requiring hospitalization post-transplant did not differ significantly across the study arms. Rejection was common for the study participants in the first year after transplant, occurring in 50 percent of recipients who received a kidney from a donor with HIV and 29 percent of recipients who received a kidney from a donor without HIV, but this result was not statistically significant. The insignificance of the result is due, in part, to the relatively small sample size. This finding is consistent with the earlier clinical trial of kidney transplantation in recipients with HIV, discussed in the next subsection of this preamble, which also found higher rejection rates in HIV allografts. The pilot study investigators noted that despite rejection rates, 1-year renal function was excellent for both study populations. Limitations of the pilot study include study size (75 transplants), which investigators attributed to the lower number of HOPE Act transplants conducted than the projected potential. In general, the study authors concluded that there is a survival benefit of transplantation for kidneys from donors with HIV to recipients with HIV, and that the availability of HOPE Act kidney transplants has the potential to mitigate disparities for a vulnerable population that faces lower access to transplant and higher waitlist mortality. The investigators further concluded that the observed trend toward higher rejection, albeit not statistically significant, for transplanted organs from donors with HIV merited further investigation.

A separate pilot study conducted by HOPE In Action Consortium participants compared HOPE Act transplants of a liver from a donor with HIV to a recipient with HIV and non-HOPE Act liver transplants from a donor without HIV to a recipient with HIV, and found that there were no differences in one-year graft survival, rejections, HIV breakthrough or severe adverse events. While the recipients of HOPE Act liver transplants presented with more opportunistic infections, infectious hospitalizations, and cancer, compared to non-HOPE Act liver transplants, the investigators determined that these findings warrant further investigation and perhaps consideration of additional donor and recipient infection and malignancy monitoring. In general, the investigators concluded that the transplant outcomes were more favorable compared to historical data on liver transplantation in recipients with HIV, who are known to experience higher rates of opportunistic infections and other complications. In addition, it was noted that co-infections are more common among both donors and recipients with HIV and confound the results. (Results of non-HOPE Act transplants have confirmed that recipients with both HIV and a co-infection have lower survival rates. Therefore, the presence of co-infections could independently impact survival and other variables measured by studies on HOPE Act transplants.) This pilot study was the first multicenter prospective study reporting results of U.S. transplants of livers from donors with HIV to recipients with HIV and comparing outcomes according to donor HIV status in order to assess attributable risk. The investigators recognized as a limitation that the pilot study was relatively small (45 transplants), and noted that increases among HOPE Act liver transplant recipients in mortality, cytomegalovirus (CMV) viremia, infectious hospitalizations, and cancer, were observed. However, they note that these results should be considered in light of the relatively high rate of mortality for recipients awaiting liver transplant. For these patients, the benefit of undergoing a HOPE Act liver transplant may outweigh the risks of living with HIV and end stage liver disease. 8

The OPTN further considered the progress of an NIH-funded study on HOPE Act kidney transplants that was ongoing at the time of the OPTN's analysis. The NIH-funded U01 HOPE Act kidney transplant clinical trial was designed to analyze rejection and long-term outcomes of kidney transplantation for recipients with HIV. While the study was subsequently expanded, at the time of the OPTN's consideration the study was designed to compare outcomes of 100 HOPE Act kidney transplant recipients to 100 kidney transplant recipients with HIV who received an HIV-negative organ at 15 transplant centers, adding to the cohort accrued from the pilot studies discussed in the immediately preceding section of this preamble. 9 The results from this clinical trial were published in October 2024 and are described in section 3, “Additional Research Results Published Subsequent to Issuance of the NPRM,” below. Of note, these investigators were awarded an expansion grant to evaluate longer-term outcomes in HOPE Act kidney transplants.

Similarly, the OPTN considered the progress of an ongoing U01 HOPE Act liver transplant clinical trial designed to compare outcomes between HOPE Act transplants and non-HOPE Act transplants of livers from donors without HIV. The study has enrolled 40 individuals in each group over 3 years at 16 transplant centers, 10 reaching target enrollment, and now is in the phase of patient follow-up. The final results are not yet published.

Prior to the initiation of the pilot studies and clinical trials discussed previously, a clinical trial examined outcomes of 150 kidney transplants in recipients with HIV conducted between November 2003 and June 2009. The investigators found both recipient and graft survival rates were high with no important increases in complications associated with HIV. 11 As noted in the description of the findings of the HOPE Act kidney transplant pilot study described in the immediately preceding subsection of this preamble, the investigators observed what they described as “unexpectedly higher” rejection rates in the transplant recipients with HIV participating in the study, compared with kidney transplant recipients who are not living with HIV. This higher rejection rate was blunted in transplant recipients that received anti-T-cell antibody medication at the time of transplantation. Studies of non-HOPE Act transplants have confirmed that such immunosuppressive regimens can reduce the risk of rejection for kidney transplant recipients with HIV. 12

Data from HOPE Act transplants is compiled by the OPTN on a quarterly basis, including waitlist registrations and counts of HOPE Act transplants, and is routinely reviewed. Prior to issuing its recommendation to the Secretary, the OPTN reviewed data on over 300 patients included in the HOPE Act research variance for which no case was halted, paused, or substantially amended to address safety concerns.

Based on the assessment of the above-described research results and data, in 2021 the OPTN recommended to the Secretary that the research and IRB requirements of the HOPE Act be removed for all organs. 13 The OPTN specifically noted that in its review of the data safety monitoring review board (DSMB) reports from five years of HOPE Act transplants, with over 300 persons with HIV receiving HOPE Act transplants, no DSMB identified patient safety concerns in HOPE Act research. Further, there have been no reports made to the OPTN of safety issues regarding HOPE Act transplants among OPO, hospital, or transplant center personnel or in patients, in donor hospitals, or transplant hospitals. The OPTN noted that it was the opinion of the OPTN Safety Review Group that the research and IRB requirements for HOPE Act transplants present a barrier to fully realizing the potential of organ transplantation from donors with HIV to recipients with HIV, as the research and IRB requirements limit access to such transplants. 14 15

Prior to publication of the NPRM, the Secretary further considered additional research published providing more evidence for the safety of organ transplantation from donors with HIV to recipients with HIV. In general, this research demonstrates that the safety and outcomes of kidney and liver HOPE Act transplants are well established, with over 517 HOPE Act kidney and liver transplants conducted to date.

One prospective study published in 2022, examined 92 HOPE Act donors contributing 177 organs, which included 131 kidneys and 46 livers, to understand the characteristics of donors with HIV in terms of clinical, immunologic, and virologic profiles to ensure the safety of transplantation. Of these donors, 58 were donors with HIV and 34 were donors without HIV. For those donors with known HIV infection, 90 percent received ART treatment. The study concluded that although drug resistant mutations (DRMs) were common, DRMs that could compromise the effectiveness of certain ART were rare, reassuring the safety of using organs from donors with HIV in recipients with HIV. Further, the study also found that there were no major differences in comorbidities between recipient groups that received an organ from a donor with HIV compared to those that received an organ from a donor without HIV. 16

In a March 2024 analysis of the impact of the HOPE Act on access to kidney transplantation for recipients with HIV, the authors found 70 percent of HOPE Act recipients received a kidney transplant during the 4.5 year study period versus 43 percent of non-HOPE Act transplant candidates at the same center. 17 Furthermore, those who received transplants in HOPE Act trials had shorter estimated wait times (median 10.3 months versus 60.8 months), and after adjusting for relevant allocation factors including time on dialysis, kidney transplantation was 3.3-fold higher for those who received an organ from a donor with HIV. 18 These findings suggest that the availability of kidneys from donors with HIV increases access to transplantation among people with HIV. Given that people with HIV who are living with end stage renal disease (ESRD) have higher mortality than people with ESRD who are not also living with HIV, 19 in HHS's view, this data illustrates the benefit of HOPE Act kidney transplants for this vulnerable population.

The HOPE in Action Consortium also has published information on the positive outcomes of living HOPE Act kidney donors. In a case series of three transplants, investigators reported that two of the three donors developed adverse events, but findings suggested these were medically managed and that HIV RNA copies and CD4+ T-cell counts were stable at two to four years post-transplant. 20

There is significantly less data on non-kidney and non-liver HOPE Act transplants. Since 2019, when the OPTN's HOPE Act policy was expanded to include all solid organs, only three heart transplant programs have received approval to perform HOPE Act transplants. To date, just three heart transplants have been conducted, including one heart-kidney transplant. 21 22 No HOPE Act transplants have been recorded among recipients in need of other organs. The lack of data makes it difficult to assess the safety and outcomes of HOPE Act transplants other than kidney and liver HOPE Act transplants.

Since publication of the NPRM, results from a new, groundbreaking study were published in October 2024. 23 In the largest prospective, observational, multicenter study to date, researchers compared transplantation of kidneys at 26 U.S. centers from deceased donors with HIV and donors without HIV to recipients with HIV. The study enrolled 408 transplantation candidates, of whom 198 received a kidney from a deceased donor; 99 received a kidney from a donor with HIV and 99 from a donor without HIV. This study was larger than the HOPE Act pilot study, described above, and was designed to assess whether kidney transplantation from donors with HIV to recipients with HIV would be noninferior to transplantation from donors without HIV. The study further assessed safety and post-transplantation complications.

The primary outcome assessed was a safety outcome (a composite of death from any cause, graft loss, serious adverse event, HIV breakthrough infection, persistent failure of HIV treatment, or opportunistic infection) for noninferiority (margin for the upper bound of the 95% confidence interval, 3.00). Researchers found an adjusted hazard ratio of 1.00 for the primary composite outcome, demonstrating noninferiority of kidney transplantation from donors with HIV as compared to kidney transplantation from donors without HIV.

Secondary outcomes included overall survival, survival without graft loss, rejection, infection, cancer, and HIV superinfection. The following secondary outcomes were similar whether the donor had HIV or not: overall survival at 1 year (94% vs. 95%) and 3 years (85% vs. 87%), survival without graft loss at 1 year (93% vs. 90%) and 3 years (84% vs. 81%), and rejection at 1 year (13% vs. 21%) and 3 years (21% vs. 24%).

The incidence of serious adverse events, infections, and cancer was similar in all groups studied. Of note, the incidence of HIV breakthrough infection was approximately three times higher among HOPE Act transplants (incidence rate ratio, 3.14; 95% CI, 1.02 to 9.63), which the researchers attributed to non-adherence to antiretroviral therapy. In all participants with HIV breakthrough infection, viral suppression was regained. A single case of potential HIV superinfection or dual infection occurred among the 58 recipients in this group, without HIV breakthrough infection or clinical consequences.

Among the acknowledged limitations of this study are the lack of true randomization, which the authors note was not possible due to the U.S. national organ allocation process. The authors further note that study participants were equally eligible for a kidney from a donor with or a donor without HIV, and that study group assignment was determined according to whichever organ was available first. The study group whose donors did not have HIV served as a control group and included 27 donors who were treated as having HIV during allocation but did not; in the authors' estimation, recipients of kidneys from these donors represent an ideal counterfactual control group. Immunosuppression and prophylaxis were heterogeneous; however, these factors were balanced between the two groups and reflect real-world practice, which the authors assert increases the generalizability of the study results.

This study is an important addition to the evidence base for HOPE Act kidney transplants in that the finding that kidney transplantation from donors with HIV was noninferior to kidney transplantation from donors without HIV with respect to the primary safety outcome, and that the incidence of serious adverse events, infections, surgical or vascular complications, and cancer was similar in the two groups, supporting the safety of HOPE Act kidney transplants.

The Secretary also considered the HHS Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) recommendation that the Secretary eliminate research and IRB requirements for all HOPE Act transplants. The ACBTSA working group developing this recommendation considered the OPTN recommendation and the results of relevant scientific research. While the ACBTSA working group proposed that the full committee recommend that the Secretary eliminate research and IRB requirements for all HOPE Act transplants, the working group expressed concern about the elimination of research and IRB requirements for non-kidney and non-liver HOPE Act transplants, 24 and whether there was sufficient data collected on other organs to justify a full adoption of the OPTN's recommendation.

The ACBTSA subsequently recommended that the Secretary act to lift the statutory research and IRB requirements for all HOPE Act transplants and at the same time recommended that the Secretary direct the OPTN to adopt, for HOPE Act transplants of organs other than kidneys and livers, organ-specific policies imposing additional requirements for the conduct of these transplants, including collecting safety and outcomes data for transplant candidates and recipients of such transplants through an IRB-approved research protocol.

These recommendations were later approved by the HHS Blood, Organ, and Tissue Senior Executive Council (BOTSEC), an advisory forum for senior leadership from HHS entities involved in blood, organ, and tissue safety and availability.

Upon review of the OPTN, ACBTSA and BOTSEC recommendations, and in consideration of the results of relevant scientific research, the Secretary proposed to determine that the research and IRB requirements for kidney and liver HOPE Act transplants are no longer warranted. The NPRM incorporated this approach, publishing the Secretary's proposed determination for comment, and proposing regulatory changes to exempt HOPE Act kidney and liver transplants from research and IRB requirements. In an effort to avoid the use of stigmatizing language, the NPRM further proposed wording changes to references to persons, donors, and recipients with HIV, and organs from individuals with HIV.

HHS received 56 comments from individuals and organizations involved in healthcare, organ transplantation, HIV advocacy, health equity, LGTBQIA+ health, and HOPE Act clinical research. The comments received expressed overwhelming support for the finalization of this rule. A total of 55 of the 56 commenters expressed support for the proposed rule. One commenter did not support the proposed rule. Additional consideration was given to comments that were expressed by multiple individuals and entities. HHS has considered all of the comments, and, in response to comments regarding the use of non-stigmatizing language, made changes to the final rule as suggested by commenters.

Themes identified in many comments include that the proposed rule, if finalized, could reduce morbidity and mortality for people with HIV, reduce barriers to organ transplantation, increase organ utilization, reduce wait times for people on organ transplant wait lists, and reduce stigma and discrimination associated with HIV. One commenter indicated that, given that only 31 of the 250 transplant centers in the U.S. currently participate in HOPE Act clinical trials, access to these vital transplants is geographically limited: the proposed rule would encourage more transplant centers to offer HOPE Act transplants, enabling more equitable access to life-saving care for people with HIV across the country and helping to generate additional clinical data to enhance understanding and inform best practices in transplant care for people with HIV. In addition, numerous commenters noted that research has sufficiently demonstrated that HOPE Act kidney and liver transplants are both safe and effective.

The NPRM specifically invited public comment on the future Secretarial direction to the OPTN to revise the standards of quality concerning kidneys and livers from donors with HIV. Some commenters provided specific suggestions for the Secretary's direction, and other comments received appear relevant to HHS's consideration as to the content of the direction to the OPTN. These comments are noted below in both the subheading discussing the comments specifically provided on the content of the direction to the OPTN, and the subheadings relating to the subject matter of the comment. HHS has considered these comments in the development of the Secretary's direction to the OPTN, which is provided in section V, “Implementation Considerations,” below.

Multiple commenters also provided specific suggestions for the content of the revised NIH Research Criteria, and other comments received appear relevant to the content of the Research Criteria. These comments are noted below in both the subheading discussing the comments specifically provided on the Research Criteria, as well as in the subheadings relating to the subject matter of the comment when the commenter did not specifically reference the Research Criteria. All comments relating to the content of the revised Research Criteria were provided to NIH for consideration in the development of the revised Research Criteria.

Detailed descriptions of comments on specific aspects of the NPRM preamble and the proposed regulation, and HHS's responses to these comments, are provided below.

Several commenters suggested that the Secretary should consider in this rule, or in a future rulemaking, the removal of research and IRB requirements for all HOPE Act organ transplants instead of removing research and IRB requirements only for kidney and liver transplants. Some of these commenters referenced the October 2021 letter from the OPTN to the Secretary providing that the OPTN had not identified any patient safety concerns involving HOPE Act transplants and that no research protocols applicable to HOPE Act transplants had been stopped, paused, or substantially altered due to patient safety concerns. 25 Many of these comments suggested that the available data was sufficient to prove the safety and efficacy of HOPE Act transplantation for all organ transplants, not only kidney and liver transplants. Others suggested that HHS should continue supporting research on HOPE Act transplants with the goal of generating sufficient evidence to make the case for a future Secretarial determination and rulemaking process that would remove the research and IRB requirements for all HOPE Act transplants.

HHS response: In the process leading up to the development of the NPRM, the Secretary considered whether to eliminate research and IRB requirements for all HOPE Act transplants. As a part of this process, the Secretary considered the October 2021 communication from the OPTN referenced by commenters, recommendations of advisory bodies, and research results and outcomes data on HOPE Act transplants. The vast majority of this data was generated from kidney and liver transplants, and, as discussed in the NPRM preamble, the Secretary notes the limited evidence demonstrating safety and efficacy of non-kidney and non-liver HOPE Act transplants. In order to lift the research and IRB requirements for HOPE Act transplants, the HOPE Act requires that the Secretary must determine that participation in clinical research is no longer warranted. 42 U.S.C. 274(b)(3)(B)(ii). In the absence of research results and robust outcomes data relevant to HOPE Act transplants of organs other than kidneys and livers, the Secretary does not have sufficient information about transplants of organs other than kidneys and livers on which to base the statutorily required determination. For this reason, the NPRM proposal to lift the research and IRB requirements only for HOPE Act kidney and liver transplants is incorporated in this final rule. As required by the HOPE Act, the Secretary will periodically review the results of additional scientific research relevant to transplants of organs other than kidneys and livers, and will reevaluate in the future whether the evidence is robust enough to demonstrate that other types of HOPE Act transplants need not be conducted in the research context. HHS makes no changes to the regulatory proposal in response to these comments.

Many commenters expressed support for the proposed revisions to the regulatory language used when referencing people, donors, and recipients with HIV. In general, commenters suggested that the proposed changes are more respectful, reflect a person-centered approach, and help to combat stigma associated with HIV. Others noted that these wording changes help to create a more inclusive healthcare environment.

One commenter requested that the proposed modification to 42 CFR 121.6 regarding references to donor organs be changed from “donor organ(s) with HIV” to “organ(s) from donors with HIV.” The commenter stated that, in their view, the term “organs from donors with HIV” is accurate and precise, stigma-reducing, and reflects a person-first approach in describing these donated organs.

HHS response: HHS appreciates this feedback, and includes the regulatory revisions in this final rule as proposed with regard to references to people, donors, and recipients with HIV. Further, HHS concurs with the suggested revision provided by the commenter with respect to the references to donor organs, and has incorporated this suggested revision and other similar revisions in the final rule at 42 CFR 121.6(b)(1)(ii)(B) introductory text, (b)(1)(ii)(B)( 1 ) and ( 2 ), and (b)(2).

Multiple commenters expressed support for efforts to monitor outcomes of HOPE Act transplants, both for patient safety and to develop evidence for the safety and efficacy of HOPE Act transplants.

Commenters addressing patient safety indicated that while the proposed rule may streamline the transplant process and increase the availability of organs, patient safety must be the top priority and rigorous safety standards must continue to apply. Several commenters noted that areas needing further attention, such as monitoring for rejection, malignancy, and infection, do not overshadow the overall favorable outcomes for HOPE Act kidney and liver transplants. Commenters emphasized the importance of continued monitoring of outcomes for these transplants by the OPTN, and that transparency and public communication of these outcomes are critical to maintaining trust and ensuring the ongoing success of HOPE Act transplant programs. Commenters indicated that application of the NIH Research Criteria has provided essential protections with regard to outcomes monitoring for HOPE Act kidney and liver transplants, and urged continued monitoring of HOPE Act transplants to ensure these protections are maintained.

Other commenters expressed that data monitoring could help HOPE Act transplant recipients and HOPE Act living donors who may need to be monitored for the development of chronic or end-stage conditions. For example, one commenter noted that living kidney donors “are already at higher risk of kidney disease and will now only have one kidney.”

Commenters addressing evidence development noted that monitoring and evaluation of HOPE Act transplants may help develop evidence that will inform future policy, including a potential future implementation of the HOPE Act to remove research and IRB requirements for all HOPE Act organ transplants.

Several commenters indicated that current data monitoring requirements applicable to all organ transplants are sufficient. One commenter indicated that there is no reason to continue monitoring HOPE Act kidney and liver transplant outcomes above and beyond the baseline safety and outcomes monitoring for all organ transplants in the United States. One commenter indicated that the OPTN structure and outcome data collected are sufficient in their current state to provide oversight for all organs. Another commenter indicated comfort with appropriate oversight and data management by the organizations designated to oversee transplant services on a national level, which could include comprehensive reporting systems to track outcomes and address any issues promptly. The commenter further expressed an expectation that this information be made available to the public is a transparent manner.

HHS response: HHS notes that the final rule does not affect existing data monitoring or evaluation requirements for HOPE Act transplants, as these are determined by OPTN policy and the NIH Research Criteria. HHS agrees that patient safety remains a paramount concern and that appropriate safety standards apply to protect organ donors and transplant recipients. Further, HHS expects to utilize data on HOPE Act transplant outcomes in its ongoing evaluation of the HOPE Act. These comments were provided to the NIH working group for consideration in the development of revisions to the Research Criteria. Further, HHS considered these comments in developing the Secretary's direction to the OPTN to revise the OPTN standards of quality embodied in OPTN policy regarding organs from donors with HIV. HHS makes no changes to the regulatory proposal in response to these comments.

Several commenters provided suggestions for transplant centers that are seeking to participate in HOPE Act transplants. One commenter requested that HHS evaluate all outstanding requests by transplant centers to participate in HOPE Act transplants, and approve qualifying transplant centers as soon as possible to both expand access to care and to generate additional data on the HOPE Act transplants they perform. The commenter further requested that HHS explore providing grants designed to build the capacity at transplant centers such that more transplant centers will be able to meet the minimum requirements necessary to become HOPE Act transplant centers.

HHS response: Thank you for these suggestions. While no changes have been made to the regulatory proposal in response to these comments, HHS will consider these suggestions in the Department's ongoing approach to implementation of the HOPE Act.

Some commenters expressed the desire that, if HHS finalizes the proposed rule, that HHS take steps to prioritize ethical considerations relevant to the autonomy of donors and recipients. In particular, commenters asked that transplant centers maintain meaningful processes to provide patients with the opportunity to provide informed consent, and that transplant candidates with HIV retain the option to elect a non-HOPE Act transplant instead of a HOPE Act transplant.

HHS response: This rule does not affect existing OPTN policies that require that informed consent is obtained from all transplant candidates, including HOPE Act transplant candidates, 26 or the informed consent policies or practices at hospitals providing clinical care to potential organ donors, OPOs, or individual transplant centers. HHS supports retaining the existing approach in OPTN policy that requires informed consent.

Further, existing OPTN policies do not prohibit transplant candidates eligible for a HOPE Act transplant to choose a non-HOPE Act transplant. 27 There are no revisions made in this rule that would force a transplant candidate to receive an organ from a donor with HIV. HHS supports retaining the existing approach in OPTN policy that permits transplant candidates eligible for a HOPE Act kidney or liver transplant to choose a non-HOPE Act kidney or liver transplant.

HHS considered these comments in developing the Secretary's direction to the OPTN to revise the OPTN standards of quality embodied in OPTN policy regarding organs from donors with HIV, as provided below in this preamble in the discussion of implementation considerations. HHS makes no changes to the regulatory proposal in response to these comments.

Commenters expressed the desire for additional educational efforts regarding HOPE Act transplantation. Some commenters suggested that HRSA collaborate with the OPTN and work with OPOs to ensure that transplant centers are making compassionate efforts to seek authorization from potential kidney donors with HIV. Commenters further suggested that HRSA partner with the Centers for Medicare & Medicaid Services (CMS) to ensure that donor hospitals recognize every opportunity for organ donation for patients with an HIV-positive diagnosis and make referrals to the local OPO for an organ donation evaluation as mandated by the CMS Conditions of Participation. Other commenters asked for educational efforts aimed at people with HIV, healthcare professionals, students of health sciences, transplant centers, OPOs, and the public at large to increase awareness of the HOPE Act and opportunities to elect organ donation regardless of HIV status.

HHS response: HHS is supportive of any and all efforts to increase awareness and education about HOPE Act transplants, opportunities for persons with HIV to participate as organ donors, and transplant candidates with HIV to receive a HOPE Act transplant. While HHS is not making any revisions to the regulatory proposal in response to these comments, HHS will consider additional educational efforts along the lines of those suggested by the commenters.

Several commenters provided specific suggestions for the content and development of the revised NIH Research Criteria:

• Commenters requested the elimination of the current requirement that a transplant team perform at least five transplants within a four-year period between any donor and a recipient with HIV for all organs, as, in the commenters' estimation, this requirement is not necessary for organs from donors with HIV to be used safely.

• Commenters suggested that each transplant team should include infectious disease specialists with expertise in HIV care.

• One commenter requested the elimination of the biopsy requirement.

• One commenter noted that, in revising the Research Criteria, NIH should both maintain the strong patient safety record for HOPE Act transplants, while actively seeking to reduce burdens that may be slowing the establishment of non-kidney and non-liver HOPE Act transplant programs.

• One commenter requested that NIH include people with HIV, HIV researchers, physicians, and healthcare providers in the process of developing revised Research Criteria, and indicated that these individuals can provide invaluable insights that can only come from lived experience.

HHS response: HHS appreciates these suggestions, and agrees that these comments are relevant to the content of the NIH Research Criteria. These comments were provided to the NIH working group for consideration in the development of revisions to the Research Criteria. HHS makes no changes to the regulatory proposal in response to these comments.

While multiple commenters provided suggestions that appear relevant to the Secretary's future direction to the OPTN to revise the standards of quality concerning kidneys and livers from donors with HIV, only a few commenters specifically referenced the content of the Secretarial direction and provided recommendations. One commenter indicated that they defer to health care professionals as to the content of such direction, and further urged HHS to make sure that the final OPTN policies do not create additional barriers or lead to unintended consequences that make it more difficult for individuals to access these organs. One commenter requested that the direction to the OPTN require intensive and multi-disciplinary counseling and discussions to be conducted with the solid organ recipient, with ongoing care before, during, and after the transplant, to ensure that solid organ recipients understand the complexities of the transplant procedure while also receiving the emotional and physical care they need throughout the entirety of the process. The commenter further noted the opportunity for the OPTN to define transplant program collaboration on a more formal basis, recommending that the structure of the transplant team include nephrologists and/or hepatologists, infectious diseases experts, and transplant pharmacy members, and that requirements be instituted for providing counseling or any specific transplant training recommendations for infectious disease experts.

The commenters who provided views and suggestions that are relevant to the Secretary's direction to the OPTN, while not specifically referencing the content of the Secretary's direction, generally indicated that the current requirements applicable to all organ transplants are sufficient to appropriately ensure the safety of HOPE Act kidney and liver transplants conducted outside of the research context. One commenter indicated that there is no reason to impose special monitoring requirements for HOPE Act kidney and liver transplant outcomes, as appropriately protective standards are already included in the baseline safety and outcomes monitoring for all organ transplants in the United States. One commenter indicated that the OPTN structure and outcome data collected are sufficient in their current state to provide appropriate oversight for all organ transplants, regardless of whether the transplant involves organs from donors with HIV to recipients with HIV. Another commenter indicated comfort with appropriate oversight and data management by the organizations designated to oversee transplant services on a national level, indicating that such oversight may include stringent medical protocols, regular follow-ups, and comprehensive reporting systems to track outcomes and address any issues promptly. The commenter further expressed an expectation that safety and outcomes information be made available to the public is a transparent manner.

One commenter noted that HHS stated in the NPRM that scientific evidence demonstrates that transplants of kidneys and livers from donors with HIV to recipients with HIV are safe and effective. Given this view, the commenter opined that the current clinical standards of care for non-HOPE Act organ transplants are sufficient to apply to transplants of all kidneys and livers, of any HIV serostatus. The commenter further expressed that additional scrutiny of transplants of kidneys and livers from donors with HIV to recipients with HIV could be viewed as discrimination against recipients with HIV who are willing to accept offers of an organ from a donor with HIV, and infringes on patient autonomy. The commenter noted that the OPTN already is responsible for safety and outcomes monitoring for transplants that involve donors or recipients with viruses other than HIV, including cytomegalovirus, Epstein-Barr virus, hepatitis B and C viruses, and severe acute respiratory syndrome coronavirus 2.

HHS response: HHS appreciates all of the comments and suggestions regarding the content of the Secretary's direction to the OPTN. HHS has carefully considered these comments in developing the Secretary's direction to the OPTN to revise the OPTN standards of quality embodied in OPTN policy regarding organs from donors with HIV. As discussed below in section V, “Implementation Considerations,” through publication of this final rule, the Secretary directs the OPTN to adopt and use standards of quality with respect to kidneys and livers from donors with HIV to ensure that HOPE Act kidney and liver transplants are subject to OPTN policies that, from the OPTN's expertise, will not reduce the safety of HOPE Act kidney and liver transplants, provide appropriate oversight for these transplants, and require sufficient data collection and outcomes monitoring.

Many comments positively noted the health equity component of the proposed rule and the potential impact to populations that are disproportionately impacted by HIV and end-stage chronic diseases. Several commenters requested that HHS consider the insights and experiences of HOPE Act patients in this and future rulemaking efforts.

HHS response: We agree. HHS supports efforts to better address health equity in organ transplantation and believes this rule will help to increase access to care among populations that are disadvantaged. HHS also is supportive of efforts to incorporate patient experience into policy, and we have received, and considered, comments from HOPE Act patients during this rulemaking process, including a comment from a self-identified living donor of a kidney used in a HOPE Act transplant. HHS makes no changes to the regulatory proposal in response to these comments.

Several commenters suggested changes to clinical care standards for HOPE Act transplant patients. One commenter requested that the Department encourage transplant centers to incorporate syndemic care approaches to address the complex needs of people with HIV. Syndemic care aims to provide more holistic service delivery to prevention and care, including by addressing the social determinants of health that allow for health conditions to cluster and interact. Several commenters requested that additional safety protocols be developed for transplant centers, such as post-operative care guidelines for HOPE Act transplant recipients.

HHS response: HHS is supportive of efforts to incorporate syndemic care approaches within the organ transplantation domain. Regarding the establishment of additional safety protocols for transplant centers, currently safety protocols beyond those included in the NIH Research Criteria are determined by individual transplant centers. These comments were provided to the NIH working group for consideration in the development of revisions to the Research Criteria. Further, HHS considered these comments in developing the Secretary's direction to the OPTN to revise the OPTN standards of quality embodied in OPTN policy regarding organs from donors with HIV, as provided below in the discussion of implementation considerations. HHS makes no changes to the regulatory proposal in response to these comments.

Several commenters requested that HHS consider the unique challenges of patients who are Black, Indigenous, and people of color and patients living in rural areas. A commenter indicated that post-transplant care is essential for positive patient outcomes and factors such as implicit bias in medical settings, socioeconomic disparities, and geographic limitations frequently hinder equitable access to post-transplant care, especially for people experiencing both geographic isolation and medical racism. Long travel distances to transplant centers and lacking local healthcare options can impede consistent follow-up care and medication compliance.

HHS response: HHS is supportive of efforts to improve health equity in organ transplantation and believes this rule will contribute to improving access to care for patients who are Black, Indigenous, and people of color and patients living in rural areas by allowing HOPE Act kidney and liver transplants to be conducted at any transplant center in the United States. HHS makes no changes to the regulatory proposal in response to this comment.

One commenter noted his opposition to lengthy sobriety requirements for liver transplant candidates.

HHS response: Currently, sobriety requirements for transplant candidates are determined by individual transplant centers. This comment was provided to the NIH working group for consideration in the development of revisions to the Research Criteria. Further, HHS considered this comment in developing the Secretary's direction to the OPTN to revise the OPTN standards of quality embodied in OPTN policy regarding organs from donors with HIV, as provided below in this preamble in the discussion of implementation considerations. HHS makes no changes to the regulatory proposal in response to this comment.

Multiple commenters expressed support for additional research evaluating the safety and efficacy of HOPE Act transplants. One commenter suggested that the experience of HOPE Act transplant patients should help inform the direction of future research on HOPE Act transplants.

HHS response: HHS is supportive of additional research evaluating the safety and efficacy of HOPE Act transplants, and considering patient experiences in informing the direction of future research. While no changes are made to the regulatory proposal in response to these comments, HHS will consider these comments in further efforts to implement the HOPE Act.

Some commenters provided comments or made suggestions that are beyond the scope of the proposed rule.

One commenter requested that HHS establish a program to provide technical assistance to state, local, and tribal health departments with the goal of adopting policies to prevent health information from being used in a criminal, civil, or immigration legal proceeding.

One commenter noted that none of the other comments provided on the NPRM highlight that there will be a conflict between a majority of expressly prohibitive or potentially permissive State laws and expressly permissive Federal law when this proposed rule is finalized. The commenter indicated that State laws that are silent on or prohibitive of organ transplantation between people diagnosed with HIV can and do preclude performance of HOPE Act transplants within a given jurisdiction regardless of permissive Federal laws, and despite Congress and Federal regulators having the authority to preempt state and local health laws.

Multiple commenters noted that State criminal laws that prohibit persons with HIV for donating or attempting to donate organs, blood, tissue, and other bodily fluids are a legal barrier to implementation of the HOPE Act.

HHS response: As these comments are not within the scope of the proposed rule, these comments have not altered HHS's proposed approach to lifting the research and IRB requirements for HOPE Act kidney and liver transplants.

One commenter opposed the proposed rule, suggesting that organs from donors with HIV are not the same as organs from donors without HIV, and expressing concern regarding the transmission of HIV through organ transplantation to recipients without HIV.

HHS response: HHS notes that there have been no reported cases of inadvertent HIV transmission resulting from HOPE Act transplants. Further, under the requirements of the HOPE Act, transplantation of organs from donors with HIV to recipients without HIV is prohibited. HHS makes no changes to the regulatory proposal in response to this comment.

The Secretary has reviewed the recommendations of the OPTN, the ACBTSA, and the BOTSEC on implementation of the HOPE Act, the results of research on HOPE Act transplants conducted to date as well as results of other relevant research on organ transplants in recipients with HIV, and public comment received on the NPRM. Pursuant to his authority under the HOPE Act, 42 U.S.C. 274(b)(3)(B)(ii), and consistent with the implementing regulations at 42 CFR 121.6, the Secretary determines that participation in clinical research, and therefore adherence to research and IRB requirements, as a requirement for transplants of kidneys and livers from persons with HIV, is no longer warranted. Through publication of this final rule, the Secretary is lifting the statutory research and IRB requirements for such transplants.

HHS anticipates that the Secretary's determination and publication of this final rule will increase access to kidney and liver transplants by allowing more transplant centers to perform HOPE Act kidney and liver transplants. Currently, only a limited number of centers can perform HOPE Act transplants, because there are specific requirements stipulated by the NIH Research Criteria for such transplant centers. These requirements include expertise in HIV infection management, minimum organ-specific transplant team experience of five transplants of organs from donors without HIV to recipients with HIV over four years and an independent advocate for both recipients with HIV and prospective living donors with HIV. The requirements for centers conducting HOPE Act transplants have been subject to critique and have been viewed by some as a barrier to participation in HOPE Act transplant programs, which may impact equity and access to organ transplantation throughout the United States. 28 By eliminating the requirement that HOPE Act kidney and liver transplants are conducted in the research context, HHS expects that a larger number of transplant centers will be able to conduct such transplants. This rule will enable more transplant centers to transplant kidneys and livers donated by both living and deceased donors with HIV, in recipients with HIV, thereby expanding opportunities for people with HIV and end-stage diseases.

Further, HHS expects this rule will expand access to organ transplantation for all patients, regardless of their HIV status. When eligible for transplant, a person with HIV is added to the waiting list. That patient may elect to receive an organ from a donor with HIV, as a HOPE Act transplant, should it become available, or may choose to wait for an organ from a donor who did not have HIV. If the patient with HIV chooses the HOPE Act transplant, this will allow another patient on the waiting list to receive the next available organ from a donor who does not have HIV, which would reduce the time spent waiting for a transplant. Of note, patients who do not have HIV will not be offered an organ from a donor who has HIV, as such transplants are not allowed under Federal law.

As of February 16, 2024, more than 103,000 men, women, and children were on the national organ transplant waiting list. 29 Every 10 minutes another person is added to the waiting list, and nearly 20 people die every day while waiting for a transplant. 30 HHS expects that the Secretary's determination and publication of this rule will improve access to kidney and liver transplants both by increasing the number of kidneys and livers available for transplant, and by allowing more transplant centers to perform HOPE Act kidney and liver transplants. This anticipated positive result is consistent with the Department's commitment to reducing the number of persons on the organ transplant waiting list.

The HOPE Act provides the Secretary with the discretion to determine what research criteria should apply to HOPE Act transplants. 42 U.S.C. 274f-5(a). NIH, in consultation with HRSA and the OPTN, and including the input of other relevant Federal stakeholders, formed a working group to develop revised NIH Research Criteria. The NIH Research Criteria, as originally drafted, include a strong focus on HOPE Act kidney and liver transplants, as these are the most common types of HOPE Act transplants: as this rule removes HOPE Act kidney and liver transplants from the research context, it is necessary that the revised NIH Research Criteria appropriately address non-kidney and non-liver HOPE Act transplantation.

Further, HHS recognizes the revised NIH Research Criteria should reflect advances in research in the time since HOPE Act transplants began, including the current needs of various entities involved in non-kidney and non-liver HOPE Act transplants in consideration of input from transplant centers, transplant surgeons, OPOs, HIV clinicians, donors, recipients, HIV advocates, the OPTN, and individuals affected by the HOPE Act.

HHS has considered the comments submitted in response to the NPRM that are relevant to the revised NIH Research Criteria, as summarized in the discussion of public comment in section III, supra. These comments have been provided to NIH for consideration in developing the revised NIH Research Criteria. HHS will publish updated Research Criteria in the Federal Register for public comment.

As part of the implementation of the Secretary's determination that participation in clinical research as a requirement for transplants of kidneys and livers from persons with HIV is no longer warranted, the Secretary must direct the OPTN to update its policies to clarify that HOPE Act kidney and liver transplants may be conducted in a way consistent with the statutory requirements at 42 U.S.C. 274, and that ensures the revisions to the policies will not reduce the safety of organ transplantation. 42 U.S.C. 274f-5(c)(2); 42 CFR 121.6(b)(3).

In the NPRM preceding publication of this final rule, HHS specifically sought public comment on the nature and content of the Secretary's direction to the OPTN, including the level of specificity in the direction and the extent of the OPTN's discretion in developing the revised policies; what factors should be considered in assessing whether the revised policies are consistent with 42 U.S.C. 274; and what factors should be considered in assessing whether the revisions to the OPTN policies will not reduce the safety of organ transplantation. HHS further welcomed comment on any other aspects relating to the Secretary's direction to the OPTN to revise its standards of quality as required by the HOPE Act.

As described in the discussion of public comment in section III, supra, HHS received multiple comments relating to HHS's consideration as to the direction to the OPTN. The vast majority of commenters agreed that scientific evidence clearly demonstrates that HOPE Act kidney and liver transplants are safe and effective. Many of those commenters indicated that the current requirements applicable to all organ transplants are sufficient to appropriately ensure the continued safety of HOPE Act kidney and liver transplants conducted outside of the research context. HHS has carefully considered all comments received in the development of the Secretary's direction to the OPTN.

Through publication of this final rule, the Secretary directs the OPTN to adopt and use standards of quality with respect to kidneys and livers from donors with HIV to ensure that HOPE Act kidney and liver transplants are subject to OPTN policies that are consistent with 42 U.S.C. 274, and from the OPTN's expertise, will not reduce the safety of HOPE Act kidney and liver transplants, provide appropriate oversight for these transplants, and require sufficient data collection and outcomes monitoring.

In consideration of the public comments received, HHS notes that it may be appropriate for the OPTN to determine that current OPTN policies that are generally applicable to kidney and liver transplants provide appropriate safety and oversight standards for HOPE Act kidney and liver transplants. Alternatively, the OPTN may choose to revise OPTN policies to provide additional standards for HOPE Act kidney and liver transplants.

This rule provides the Secretary's determination that that participation in clinical research as a requirement for transplants of kidneys and livers from persons with HIV is no longer warranted; revises 42 CFR 121.6 to reflect the removal of the statutory research and IRB requirements for HOPE Act kidney and liver transplants; and directs the OPTN to revise its standards of quality with respect to kidneys and livers from donors with HIV consistent with 42 U.S.C. 274 and in a way that ensures the changes will not reduce the safety of organ transplantation policies as required by the HOPE Act. The final implementation step is for the OPTN to adopt and use standards of quality as directed by the Secretary to reflect that HOPE Act kidney and liver transplants no longer are subject to research and IRB requirements.

As was stated in the NPRM, HHS expects that the OPTN will solicit public comment on a proposed revision to relevant OPTN policies, and update the OPTN policies containing standards of quality with respect to kidneys and livers from donors with HIV, within 15 months from the publication of this final rule. As publication of this final rule has obviated current OPTN policies requiring HOPE Act kidney and liver transplants to be conducted in accordance with research and IRB requirements, HHS encourages the OPTN to act expeditiously to revise these policies. This will allow transplant centers that had not previously been performing HOPE Act kidney and liver transplants in the research context to begin performing HOPE Act kidney and liver transplants in accordance with the revised OPTN policies.

Consistent with the Secretary's determination under the HOPE Act, this rule revises 42 CFR 121.6 to reflect the removal of the statutory research and IRB requirements for kidney and liver HOPE Act transplants. Section 121.6(b)(1)(ii)(B) provides that participation in clinical research is no longer warranted for the following categories of transplants:

• Transplant of a kidney from a donor with HIV; and

• Transplant of a liver from a donor with HIV.

In implementation, this means that HOPE Act kidney and liver transplants will no longer be required to be conducted as research, and instead will be conducted in accordance with OPTN policies applicable to HOPE Act kidney and liver transplants. As noted above, the OPTN may decide that OPTN policies that generally apply to kidney and liver transplants are appropriate to apply to HOPE Act kidney and liver transplants, or may create different policies for HOPE Act kidney and liver transplants.

HHS is aware that previous language used in enacting and implementing the HOPE Act contained vocabulary and phrases that some people find stigmatizing—namely, references to “infected with HIV” when the regulatory language encompasses both living and deceased donors with HIV, or recipients with HIV. For the references to both living and deceased donors with HIV, HHS revises all current references in 42 CFR 121.6(b) from “individuals infected with human immunodeficiency virus (HIV)” and “individuals infected with HIV” to “donors with HIV” or, when discussing organs donated, “organs from donors with HIV” and specifically “kidneys from donors with HIV” and “livers from donors with HIV.” Further, HHS revises the current reference in 42 CFR 121.6(b)(1)(i) describing the allowable recipients of HOPE Act transplants from individuals who are “infected with HIV before receiving such organ(s)” to instead refer to individuals who are “living with HIV before receiving such organ(s).” This is consistent with the Centers for Disease Control and Prevention's (CDC) Stigma Language Guide. 31 These changed regulatory references are to avoid stigmatizing language, and do not change the groups of people referenced in 42 CFR 121.6.

HHS finds that there is good cause for this rule to be effective upon publication in accordance with 5 U.S.C. 553(d)(3) of the Administrative Procedure Act and 5 U.S.C. 808(2) of the Congressional Review Act.

The waiting list for kidney transplant in the U.S. currently exceeds 88,700 candidates. 32 The 2022 OPTN/U.S. Scientific Registry of Transplant Recipients (SRTR) Annual Data Report indicated that over the course of a year more than 4,400 adults died while waiting for a kidney transplant, and an additional 4,500 persons were removed from the waiting list because they became too sick to receive a transplant. 33 Most transplant candidates wait years for a kidney transplant, often requiring dialysis or other interventions.

In addition, thousands of Americans suffer from conditions requiring liver transplant. As of November 8, 2024, 13,170 candidates were added to the waiting list in 2024. 34 In 2022, more than 1,031 liver patients died while awaiting transplant, according to the OPTN/SRTR Annual Data Report. 35

HHS expects that this final rule will have the effect of decreasing the time all candidates for kidney and liver transplants spend on the waiting list, regardless of their HIV status. As described in section IV, above, a transplant candidate with HIV may choose to receive a HOPE Act kidney or liver transplant if an organ from a donor with HIV becomes available, or may choose to wait for an organ from a donor without HIV. Research has demonstrated that candidates with HIV who accept a HOPE Act kidney transplant spend significantly less time awaiting transplant than candidates on the waiting list for an kidney from a donor without HIV. A 2023 study found that median wait time for a HOPE Act kidney transplant was 10.8 months compared to 60.8 months—a 3.3-fold higher rate of transplant compared to non-HOPE Act transplants. 36 When candidates with HIV choose a HOPE Act transplant, this data suggests that this will decrease the time they spent on the waiting list. Additionally, this will have the effect of allowing a candidate further down the waiting list to receive the next available organ from a donor who does not have HIV, both reducing the time that candidate spends waiting for a transplant and decreasing the time all other candidates spend on the waiting list.

Moreover, HHS expects that this final rule also will increase access to organ transplantation. Thirty-one transplant centers are qualified to perform HOPE Act kidney and liver transplants as research in conformance with the requirements of the NIH Research Criteria, while 250 transplant centers operate nationwide. As, pursuant to this rule, HOPE Act kidney and liver transplants no longer need to be conducted as research, it can be reasonably expected that more transplant centers than in the past will be able to offer HOPE Act kidney and liver transplants to appropriate candidates on the transplant center's waiting list. It also is reasonable to expect that if a greater number of transplant centers will be able to offer HOPE Act transplants, this will allow more candidates with HIV on the waiting list to receive HOPE Act kidney and liver transplants.

Lastly, HHS believes that a delayed effective date is unnecessary to afford affected parties a reasonable time to adjust practices in accordance with this rule. From the economic analysis of impacts, provided below in section IX, this final rule will have a minimal direct impact on affected entities with regard to preparing for implementation. The direct effect of this final rule on transplant centers is considered to be limited to the time spent by transplant centers to read and understand the final rule, educate their staff on the content of this final rule, and review and update internal policies. This rule does not impose obligations on transplant centers, and rather increases available flexibilities in that transplant centers are no longer required to conduct HOPE Act kidney and liver transplants in the research context. Further, as described above in section V(B), the final implementation step for HOPE Act kidney and liver transplants to begin occurring outside of the research context is for the OPTN to revise its policies to reflect that HOPE Act kidney and liver transplants no longer are subject to research and IRB requirements. HHS is encouraging the OPTN to act expeditiously to revise these policies, and it is likely that transplant centers will educate their staff and review and update internal policies relevant to the content of this final rule after the OPTN has published its revised policies for HOPE Act kidney and liver transplants. Transplant centers do not have any obligations stemming from this rule until the OPTN revises its policies. In light of this context, a delayed effective date for this rule is unnecessary for implementation purposes.

Given that, and the expected positive effects on time candidates spend on the waiting list and the increase in access to HOPE Act transplants resulting from this rule, pursuant to 5 U.S.C. 553(d)(3) and 5 U.S.C. 808(2) HHS finds that there is good cause for this rule to be effective upon publication.

This rule does not impose any additional information collection burden under the Paperwork Reduction Act and does not contain any information collection requirements beyond those already imposed by current regulations, which have been approved by the Office of Management and Budget (OMB). The current data collection requirements in the OPTN final rule approved by OMB under the Paperwork Reduction Act of 1995 are assigned control numbers OMB No. 0915-0157 (for organ donors, candidates, and recipients) and OMB No. 0915-0184 (for OPTN membership application data).

We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 14094, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review Act (5 U.S.C. 801, Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866, section 3(f)(1) (as amended by Executive Order 14094), if they have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities. The regulatory impact analysis indicates, and OIRA has determined, that the final rule is a significant regulatory action under Executive Order 12866, section 3(f)(1), and that it meets the criteria set forth in 5 U.S.C. 804(2) under the Congressional Review Act.

The Regulatory Flexibility Act (RFA) requires agencies to consider the impact of their regulatory proposals on small entities. Because the impacts on kidney and liver transplants are small relative to the number of transplants performed annually, and because the economic impacts on affected small entities are small relative to the average payroll of firms in the smallest enterprise size category, HHS certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (UMRA) generally requires that each agency conduct a cost-benefit analysis; identify and consider a reasonable number of regulatory alternatives; and select the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the final rule before promulgating any proposed or final rule that includes a Federal mandate that may result in expenditures of more than $100 million (adjusted for inflation) in at least one year by State, local, and tribal governments, in the aggregate, or by the private sector. Each agency issuing a final rule with relevant effects over that threshold must also seek input from State, local, and tribal governments. The current threshold after adjustment for inflation using the Implicit Price Deflator for the Gross Domestic Product is $183 million, reported in 2023 dollars. The final rule will not result in an unfunded mandate in any year that meets or exceeds this amount.

The final rule removes the current research and IRB requirements for the transplantation of kidneys and livers from donors with HIV. We have assessed the likely impacts of the final rule, and report in the regulatory impact analysis (RIA) several sources of monetized, quantified, and unquantified benefits, costs, or transfers. Most of the monetized or quantified impacts relate to the incremental increases in the number of kidney and liver transplants that will be performed annually as a result of the final rule.

We report monetized benefits from increases in life expectancy for both kidney and liver transplant recipients; and for kidney transplant recipients, we also report monetized benefits from quality-of-life improvements and time savings from fewer kidney dialysis visits. We also anticipate quality-of-life improvements for liver transplant recipients, and quantify the number of people affected who might experience those benefits. We also identify several sources of unquantified benefits, which could potentially be quantified through additional research or data, including time savings for caregivers, and cost savings for transplant centers from removing the research and institutional review board requirements. We also identify difficult-to-quantify benefits associated with revising vocabulary and phrases that some people find stigmatizing through adoption of language that is intended be respectful of people living with HIV, and living and deceased donors with HIV. These changes may result in people living with HIV experiencing more inclusive interactions when accessing healthcare, generating additional benefits beyond the increases in life expectancy and improvements in quality of life from improved access to liver and kidney transplantation.

We report monetized costs from increases in medical expenditures associated with organ transplantation; for kidney transplants, we report net costs that account for reductions in medical expenditures associated with kidney dialysis. We report this shift in expenditures from kidney dialysis to kidney transplantation as a monetized transfer. We also monetize the opportunity costs of the time spent by transplant centers reading and understanding the final rule, reviewing policies and procedures, and training staff.

Table 1 summarizes our estimates of the benefits, costs, and transfers of the final rule, annualizing impacts over a 10-year analytic time horizon covering 2025 through 2034 using a 2 percent real discount rate, and reporting all monetary estimates in constant 2023 dollars. Annualized benefits range from $381 million to $858 million, with a primary estimate of $612 million; costs range from $73 million to $92 million, with a primary estimate of $83 million; and transfers range from $24 million to $37 million, with a primary estimate of $30 million. Table 1 also reports our estimates of the annualized net benefits of the final rule, which range from $301 million to $772 million, with a primary estimate of $530 million. The RIA concludes that the monetized net benefits, combined with the quantified, but non-monetized, and unquantified impacts, indicate that the final rule is highly likely to generate net benefits to society. This finding is further supported through additional quantitative assessments of uncertainty and sensitivity analyses contained in the RIA. The full RIA is available in the docket for this final rule at https://www.regulations.gov/docket/HRSA-2024-0001/document.

Accordingly, by the authority vested in me as the Secretary of Health and Human Services, and for the reasons set forth in the preamble, 42 CFR part 121 is amended as follows:

Table of Contents I. Public Participation A. Submitting Comments B. Viewing Comments and Documents C. Privacy Act II. Table of Abbreviations III. Executive Summary IV. Background and Purpose A. Background and History B. Authority C. Basis and Scope of Regulatory Action D. Severability V. Discussion of Elements of the Interim Final Rule VI. Good Cause for Issuing This IFR VII. Collection of Information Requirements VIII. Regulatory Impact Analysis A. Economic Analysis B. Regulatory Flexibility Analysis C. Unfunded Mandates Reform Act D. Executive Order 13132: Federalism E. Executive Order 12988: Civil Justice Reform IX. Assessment of Federal Regulation and Policies on Families I. Public Participation

ORR encourages all interested parties to participate in this rulemaking by submitting written comments, views, and data on any or all aspects of this interim final rule. ORR also invites comments that relate to the economic, environmental, or federalism effects that might result from this interim final rule. ORR will review all comments received, but ORR will only post comments that address the topic of the interim final rule. All comments ORR posts to https://www.regulations.gov will include any personal or commercial information you provide.

Comments that will provide the most assistance to ORR will reference a specific portion of the interim final rule, explain the reason for any recommended change, and include data, information, or authority that support such recommended change. If you submit comments, please indicate the specific section of this document to which each comment applies and provide a reason for each suggestion or recommendation. You may submit your comments and materials online or by email, but please use only one of these means. If you submit a comment online via https://www.regulations.gov, it will be considered received when it is received at the Docket Management Facility.

Instructions: To submit your comments online, go to https://www.regulations.gov and insert “XXXX-XXXX-XXXX” in the “Search” box. Click on the “Comment Now!” box and input your comment in the text box provided. Click the “Continue” box, and if you are satisfied with your comment, follow the prompts to submit it.

For additional information, please read the “Privacy and Security Notice” that is available via the link in the footer of https://www.regulations.gov.

ORR will consider all comments and materials received during the comment period and may change this rule based on your comments.

Docket: To view posted comments, as well as documents mentioned in this preamble as being available in the docket, go to https://www.regulations.gov and insert “XXXX-XXXX-XXXX” in the “Search” box. Click on the “Open Docket Folder,” and you can click on “View Comment” or “View All” under the “Comments” section of the page. Individuals without internet access can make alternate arrangements for viewing comments and documents related to this rulemaking by contacting ORR through the FOR FURTHER INFORMATION CONTACT section above. You may sign up for email alerts on the online docket to be notified when comments are posted, or a final rule is published.

As stated in the Submitting Comments section above, please be aware that anyone can search the electronic form of comments received into any dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.).

This interim final rule provides standards and processes for the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), to apply when it conducts investigations into allegations of child abuse and neglect that occur in certain care provider facilities funded by ORR to provide residential and other services for unaccompanied children;  1 describes a process for appeal and review of substantiated allegations; and establishes an ORR Central Registry to list individuals with certain findings of child abuse and neglect that have been substantiated and sustained after exhausting the appeal and review process. This rule describes how and in what circumstances ORR may conduct investigations, and impose certain consequences with respect to sustained allegations of child abuse and neglect by care provider facility staff, contractors or sub-grantees of the care provider facility, care provider facility volunteers, and other individuals with access to unaccompanied children in ORR care through contracts or grants with ORR. Specifically, the investigations and required consequences described in this rule shall apply in two circumstances: (1) where the State or local authority that would otherwise be responsible for such investigations will not investigate allegations arising at ORR care provider facilities that care for or propose to care for unaccompanied children; and (2) at ORR emergency or influx facilities (EIFs).

Child abuse and neglect can have devastating lifelong mental and physical effects on an individual. ORR is committed to preventing and mitigating child abuse and neglect in its care provider facilities and seeks to ensure the safety, well-being, and security of all unaccompanied children in its care.

On March 1, 2003, section 462 of the Homeland Security Act of 2002 (HSA) transferred responsibilities for the care and placement of unaccompanied children from the Commissioner of the former Immigration and Naturalization Service to the Director of ORR. Since that time, ORR has provided for the day-to-day care of over 700,000 unaccompanied children in ORR care provider facilities that are currently administered through a nationwide network of providers (funded via cooperative agreements or contracts, or sub-awards thereof). 2

As further detailed below in section IV.B., ORR oversees its care provider facilities through its Unaccompanied Children Bureau  3 pursuant to its responsibilities under the HSA, 4 the Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA), 5 the Unaccompanied Children (UC) Program Foundational Rule, 6 the Flores Settlement Agreement (FSA) as relevant, 7 8 and ORR's regulatory Standards To Prevent, Detect, and Respond to Sexual Abuse and Sexual Harassment Involving Unaccompanied Children interim final rule (PSA IFR). 9

Consistent with the HSA and TVPRA, ORR is responsible for the care, custody, and placement of unaccompanied children who are in Federal custody by reason of their immigration status. 10 Any department or agency of the Federal government that has an unaccompanied child from a non-contiguous country in its custody is required to transfer custody of such child to HHS. 11 Typically, ORR places unaccompanied children in care provider facilities it funds to provide these children with residential and other services, until the children can be safely released to qualified and vetted sponsors (individuals or entities to whom ORR releases unaccompanied children out of ORR custody, in accordance with ORR's sponsor suitability assessment process and release procedures), 12 are repatriated to their home country, obtain legal status, or otherwise no longer meet the statutory definition of an unaccompanied child ( e.g., turn 18 years old). In accordance with the UC Program Foundational Rule (and consistent with the FSA), ORR makes reasonable efforts to place unaccompanied children in State-licensed facilities in those geographical areas where the majority of children are apprehended  13 —except in cases of emergency or influx, when ORR may utilize EIFs. 14 EIFs are Federally contracted facilities that ORR may need to stand up quickly to accommodate placements for children that exceed its standard capacity. Consistent with ORR's UC Program Foundational Rule (and the FSA), EIFs are not required to be State-licensed. 15

As of the publication date of this rulemaking, ORR has built a network of nearly 300 care provider facilities in 27 States, funded through cooperative agreements and grants between ORR and the care provider facilities. As discussed below, a significant number of ORR care provider facilities are in Texas, which has decided to no longer conduct investigations of reported abuse and neglect arising at ORR-funded care provider facilities housing unaccompanied children.

In addition, as of the publication date of this rulemaking, ORR oversees three influx care facilities, funded through contracts, that currently have no children in care but are ready to commence or resume operations within certain timeframes if needed. 16 ORR does not currently have formal written agreements with the relevant State or local authorities to investigate reports of child abuse and neglect at these facilities. If such agreements are executed, ORR may in its discretion elect not to exercise its investigative authority and instead rely on the relevant State or local authorities (consistent with its approach to sexual abuse as described at 45 CFR part 411). 17 Nevertheless, even in these circumstances, ORR retains statutory authority to conduct investigations at EIFs, and in these situations could do so consistent with this rule. If ORR were to conduct its own investigation concurrently with a State or local authority's investigation, ORR would cooperate with such authority and ORR's investigation would not conflict with such investigation. Further, ORR would conduct its investigation in such a manner as to minimize potential trauma to the alleged victim ( e.g., by not interviewing a child where the State or local authority has already interviewed the child for the same information).

To ensure that reports of child abuse and neglect at Texas care provider facilities and EIFs (as relevant) do not go uninvestigated, and pursuant to ORR's statutory responsibilities, on June 12, 2024, ORR established a Division of Unaccompanied Child Protection Investigations (DCPI) to, among other things, receive reports of alleged abuse or neglect involving unaccompanied children in ORR custody and investigate those claims where it has jurisdiction. 18 DCPI began conducting investigations of alleged child abuse and neglect in ORR-funded care provider facilities in Texas as of July 2024. This interim final rule describes the procedures DCPI uses when it performs child welfare investigations of alleged child abuse and neglect at ORR care provider facilities; and establishes employment consequences for care provider facility staff and volunteers based on ORR investigation dispositions, including relevant due process protections for alleged perpetrators of abuse and neglect.

ORR's statutory authority enables it to perform investigations of alleged child abuse and neglect occurring at its care provider facilities, and to establish disciplinary consequences, including employment consequences, for individuals it determines to have perpetrated abuse or neglect. The HSA transferred to the Director of ORR functions under the immigration laws of the United States with respect to the care of unaccompanied children that were vested by statute in, or performed by, the Commissioner of the Immigration and Naturalization Service. Pursuant to such transfer, the ORR Director is “responsible for,” among other things, “ensuring that the interests of the child are considered in decisions and actions relating to the care and custody of an [unaccompanied child],”  19 “implementing policies with respect to the care and placement of [unaccompanied children],”  20 and “identifying a sufficient number of qualified individuals, entities, and facilities to house [unaccompanied children].”  21 In addition, the HSA makes the ORR Director responsible for “overseeing the infrastructure and personnel of facilities in which [unaccompanied children] reside,”  22 and “conducting investigations and inspections of facilities and other entities in which [unaccompanied children] reside, including regular follow-up visits to such facilities, placements, and other entities, to assess the continued suitability of such placements.”  23

Necessarily, a fundamental aspect of ensuring that there are qualified individuals, entities, and care provider facilities to care for and house unaccompanied children is ensuring that care provider facility staff, contractors, or sub-grantees of the care provider facility, along with care provider facility volunteers and other individuals who have access to children in ORR care through contracts or grants with ORR, do not engage in abuse or neglect of children in ORR care; that such individuals who are alleged to have engaged in such abuse or neglect are reported and identified; that allegations of child abuse or neglect against such individuals are properly and thoroughly investigated; and that if the allegations are found to be substantiated and are sustained pursuant to an appeal and review process, actions are taken to ensure that such individuals are prohibited from working or volunteering in any way on ORR-funded grants or contracts and do not have contact with children in ORR custody. Thus, the rule described here is a crucial aspect of implementing ORR's statutory mandates under the HSA, which expressly delegates authority to the ORR Director to administer the UC Bureau.

Pursuant to these authorities, this rule describes the circumstances in which ORR will investigate allegations of child abuse and neglect; the procedures for such investigations; and steps ORR may take in response to findings that individuals who work or volunteer at ORR-funded care provider facilities have perpetrated abuse or neglect against children in its custody, including due process requirements that would apply to such steps.

In addition to the HSA, ORR's Interim Final Rule regarding the Prevention of Sexual Abuse  24 (PSA IFR), which ORR promulgated in 2014 pursuant to the Violence Against Women Reauthorization Act of 2013 (VAWA), 25 describes requirements concerning sexual abuse of unaccompanied children in ORR custody. Though the PSA IFR specifically applies to the prevention of sexual abuse of unaccompanied children, it describes requirements that inform this IFR regarding the prevention of abuse and neglect, including requirements for staff background checks; suspension of staff, contractors, and volunteers suspected of perpetrating sexual abuse or sexual harassment from all duties that would involve or allow access to unaccompanied children pending the outcome of an investigation; and requirements for restricting the employment of care provider facility staff against whom allegations of child abuse or neglect have been substantiated. 26

The standards in the PSA IFR also require care provider facilities to refer allegations of sexual abuse and sexual harassment to proper investigating authorities ( i.e., State and local law enforcement, child protective services, and licensing authorities), and to remain informed of ongoing investigations and fully cooperate with outside investigators as necessary. 27 ORR notes that nothing in this rule is intended to replace or prohibit investigations of sexual abuse and sexual harassment under other civil rights laws. The PSA IFR also states that ORR will refer allegations to the Department of Justice or other investigating authority for further investigation where such reporting is in accordance with its policies and procedures and any memoranda of understanding. 28

At the time the PSA IFR was published, ORR assumed that all States or localities would maintain their historic practices of investigating alleged child abuse and neglect in ORR State-licensed care provider facilities. Accordingly, the PSA IFR only contemplates scenarios where a State or local authority is the investigating authority for allegations of sexual abuse and harassment occurring at ORR care provider facilities. This rule describes a new system of ORR investigations and actions to be taken based on investigation findings, which ORR would apply, as needed, at care provider facilities as described at § 412.100(c).

Finally, the Victims of Child Abuse Act (VCAA) and its implementing regulations  29 impose reporting requirements on ORR-contracted facilities ( e.g., EIFs). Under the VCAA, child abuse (as defined in the Act) occurring at Federally-operated or contracted facilities must be reported to local law enforcement or child protective services agencies with jurisdiction to investigate reports of child abuse or to protect child abuse victims in the land area or facility in question, “provided that such agencies, if non-federal, enter into formal written agreements to do so. . . .”  30 If there is no such formal written agreement, the Federal Bureau of Investigation (FBI) is the agency designated to receive such reports. 31 However, ORR is advised that the FBI's jurisdiction is limited to Federal crimes ( i.e., the FBI cannot investigate conduct that does not rise to the level of a Federal crime)—and many child abuse and neglect allegations that nonetheless warrant investigation do not constitute Federal crimes. Upon receipt of such reports of child abuse, agencies designated under the VCAA—which can include other federal agencies or non-federal agencies that are designated pursuant to a formal written agreement—may conduct investigations of the alleged abuse and neglect. This IFR does not conflict with any agency duties under the VCAA. If ORR executes formal written agreements with relevant local authorities to investigate child abuse and neglect at EIFs, it reserves discretion under its statutory authorities to conduct its own investigations as well. In such cases, ORR intends under this rule that any ORR investigation will not conflict with investigations performed by other authorities in connection with the VCAA.

For years, ORR has relied on States or localities both to license its care provider facilities and to investigate any allegations of child abuse and neglect. 32 Since 2021, however, three States—Texas, Florida, and South Carolina—have ceased licensing childcare facilities that serve or propose to serve unaccompanied children under grant or contract with ORR. As of publication of this rule, Florida and South Carolina continue to provide for State-based investigations of alleged child abuse and neglect in ORR-funded care provider facilities. 33 In contrast, in connection with the State's decision to end licensing of care provider facilities housing unaccompanied children, the Texas State agency that would otherwise be responsible for such investigations no longer conducts them at ORR care provider facilities (except foster care providers).

Pursuant to a proclamation by Texas's Governor Abbott, 34 on July 13, 2021, the Texas Health and Human Services Commission (HHSC) issued an emergency rule temporarily exempting Texas's childcare facilities that shelter unaccompanied children in Federal custody from Texas's licensing requirement. 35 The exemption went through a series of renewals until, on July 22, 2022, Texas amended the emergency rule to make the licensure exemption ongoing. 36

ORR understands that, pursuant to this change in Texas law, neither Texas HHSC nor the Texas Department of Family and Protective Services (DFPS) currently conducts child abuse and neglect investigations in facilities that house unaccompanied children due to their lack of jurisdiction over license-exempt childcare facilities. Because DFPS is not investigating, substantiating, or sustaining these allegations pursuant to administrative reviews as appropriate, DFPS does not list potential sustained perpetrators in the Texas child abuse and neglect registry, 37 and thus such perpetrators will not be identified as having committed abuse or neglect in a background check by an ORR-funded or other provider. State and local law enforcement continue to investigate reported child abuse and neglect that rises to the level of a crime, but in many instances, actions involving abuse or neglect constitute civil violations, but not criminal violations. Depending on circumstances, this may include physical abuse, verbal/emotional abuse, and sexual harassment.

As discussed above, ORR has historically relied on State and local authorities to investigate allegations of child abuse and neglect arising at its care provider facilities. However, a significant gap in investigative capacity has resulted from Texas's decision to cease DFPS investigations at ORR care provider facilities. ORR was unable to immediately fill this gap by conducting its own investigations because such investigations necessitate the use of skilled and trained investigators, and historically ORR had not played this role.

However, ORR took immediate and ongoing steps after determining that Texas planned to cease its investigations into alleged child abuse and neglect at ORR-funded care provider facilities housing unaccompanied children. Soon after it became clear that Texas DFPS was not going to resume its long-standing child welfare and investigative functions when it extended its emergency declaration in 2022, ORR began examining the operational feasibility, capacity, and expertise that would be required to permanently absorb the investigative responsibilities once performed by Texas DFPS. Such an endeavor represented an unexpected and significant expansion of ORR's operations, as ORR had successfully relied on relevant state child welfare entities to fulfill that role for years up to this point. ORR's work over the past two years has included, but not been strictly limited to: communicating with Texas state officials to confirm their position regarding investigations into alleged child abuse and neglect at ORR care providers and attempt to reach a resolution with the state directly; consulting with other federal agencies to evaluate available options to address the lack of investigations and seek feedback on ORR's proposed approach; researching and planning how ORR would develop the necessary expertise and capacity to conduct investigations; developing policies and procedures to inform how investigations are conducted; obtaining administrative approval for new agency positions; creating of new comprehensive technical systems for recording and tracking investigations; and, eventually, the hiring, onboarding, and training of qualified investigative staff.

In addition, while engaged in these efforts, ORR directed its care provider facilities in Texas to continue reporting abuse and neglect allegations to State child welfare agencies, State licensing agencies, State and local law enforcement, and where appropriate, the HHS Office of the Inspector General and the FBI. ORR also established a framework, utilizing its child welfare team or CWT (later becoming known as the ORR Prevention of Child Abuse and Neglect or PCAN Team) for conducting in-depth reviews of care provider facility responses to each individual allegation of abuse and neglect. In these reviews, ORR staff receive and review documentation concerning the allegation, assess whether proper interventions and reporting requirements under ORR policies and procedures were followed, and make recommendations for appropriate follow-up actions regarding the alleged victim's medical and mental health needs.

While ORR's in-depth reviews have played an important role in filling some of the investigations-related gaps like ensuring compliance with reporting requirements and following up on appropriate interventions for staff and children, there remained a need for a separate entity other than the care provider facilities themselves—that would ensure independent oversight and response—to investigate allegations of abuse and neglect that do not constitute criminal violations. Accordingly, pursuant to its statutory responsibilities to oversee the personnel and infrastructure of care provider facilities and to conduct investigations (see discussion under section IV.B. Authority), ORR established the Division of Unaccompanied Child Protection Investigations (DCPI) in June 2024. 38 DCPI began conducting investigations of alleged child abuse and neglect at care provider facilities in Texas in July 2024.

However, investigations without more do not fully fill the gap left by Texas DFPS's decision not to investigate allegations of child abuse and neglect, including by substantiating and sustaining such allegations so that perpetrators may be identified and precluded from working with unaccompanied children in ORR's care. The statutory provisions authorizing ORR to establish its investigative division do not specify the particular procedures ORR should follow in conducting investigations and taking action to protect children from individuals with pending or sustained allegations of sexual abuse or neglect. Thus, ORR has determined that in order to fully address the protection of children in its custody, consistent with its statutory responsibility, it is important to establish a mechanism to ensure that individuals with sustained Tier I allegations (as defined in this rule) investigated by DCPI are terminated from employment in ORR-funded programs, prevented from having contact with children in ORR programs, and barred from employment in any ORR-funded program in the future. To accomplish this goal with appropriate due process protections, ORR has adopted this rule.

In addition, this rulemaking provides needed clarity with respect to investigations of child abuse and neglect at EIFs. Responsibility for investigating allegations of child abuse and neglect at EIFs is unique to each EIF based on a number of factors, including the willingness of States or local authorities to investigate child abuse and neglect at care provider facilities housing unaccompanied children or enter into a formal written agreement with ORR to do so; the unique size, capacity, and scope of EIFs; and the urgent timelines under which EIFs may be activated. Because EIFs are activated in times of influx, which arise based on unpredictable migration patterns, there may not be sufficient time to establish formal written agreements with local authorities to conduct child abuse and neglect investigations when ORR activates such facilities. For example, referrals of unaccompanied children to ORR increased dramatically from Federal fiscal year (FFY) 2020 (15,381 children) to FFY 2021 (122,731 children), continued to increase in FFY 2022 (128,904 children), but then decreased in FFY 2023 (118,938 children). 39 ORR believes, as a result, that it is appropriate to include EIFs within the scope of this rule—to ensure that reports of child abuse and neglect arising at EIFs are consistently investigated and that ORR may take actions to protect unaccompanied children from those with pending or sustained allegations. 40

ORR prefers that State and local authorities exercise their long-standing authority under State and local laws and regulations to investigate allegations of child abuse and neglect and will continue to seek to establish agreements with States and local authorities to investigate child abuse and neglect at EIFs. However, as noted above, as of the date of publication, ORR does not currently have written agreements with State or local authorities to conduct child welfare investigations at EIFs, and as noted above, FBI investigations are limited to allegations that potentially rise to the level of Federal crimes. Further, with DCPI investigations of alleged child abuse and neglect underway, there is also a need to maintain an ORR central registry to document substantiated abuse and neglect findings based on its own investigations. As in States that do not to provide an investigative infrastructure for ORR-funded facilities housing unaccompanied children, both investigations and the maintenance of a central registry are required at EIFs—particularly where no State or local investigative infrastructure is available ( e.g., pursuant to a formal written agreement with ORR).

ORR notes that any ORR investigations into allegations of child abuse and neglect at EIFs under this rule would be separate from any other investigations that may occur by other authorities, whether pursuant to the VCAA or otherwise, and will not conflict with investigations by those other authorities.

This IFR describes the circumstances in which ORR will investigate and substantiate child abuse and neglect allegations. It also delineates further steps ORR may take upon conducting such investigations to protect unaccompanied children, such as ensuring that certain individuals against whom allegations of child abuse and neglect have been substantiated and upheld after an appeal and review process are prevented from working or volunteering in any way on ORR-funded grants or contracts, and that alleged perpetrators with pending allegations do not have continued access to children. As discussed below at section VI, considering ORR's recent establishment of the DCPI, there is good cause to issue an IFR both to describe the nature and scope of ORR investigations, and critically, to establish required consequences for certain investigative findings, with appropriate due process protections.

This IFR:

• Describes the responsibilities of ORR to conduct investigations into allegations of child abuse and neglect of unaccompanied children at (1) care provider facilities located in States where the State agency responsible for investigating child abuse and neglect allegations will not investigate such allegations in ORR-funded care provider facilities, and at (2) EIFs;

• Defines the applicable burden of proof as a preponderance of the evidence and describes the investigation disposition types as substantiated-Tier I; substantiated-Tier II; not substantiated; unfounded; or administratively closed;

• Describes notification requirements of the findings of investigations;

• Describes an appeal and review process for individuals with substantiated allegations of child abuse and neglect at ORR care provider facilities in States that will not investigate allegations of abuse or neglect in facilities housing unaccompanied children and at emergency or influx facilities;

• Creates an ORR Central Registry, and associated processes and sanctions, for individuals with sustained Tier I allegations of child abuse and neglect at EIFs and at ORR care provider facilities in States that will not investigate allegations of abuse or neglect in facilities housing unaccompanied children; and

• Describes requirements for care provider facilities to cooperate with investigations.

The different parts of this interim final rule address distinct aspects of investigations of child abuse and neglect. These include: the investigation of allegations of child abuse and neglect occurring at care provider facilities that do not conduct their own investigations, and investigations at EIFs (§ 412.100); interventions and discipline, including an ORR Central Registry of perpetrators relating to certain sustained allegations (§ 412.101); the appeal and review process (§ 412.102); and obligations of care provider facilities (§ 412.103) in cooperating with investigations. To the extent any section or subsection of the rule is declared invalid by a court, ORR intends for all remaining sections and subsections to remain in effect, as they would continue to function sensibly. As an illustration, ORR expects that if a court were to invalidate § 412.100(c)(2), which makes the requirements of § 412.100 relating to investigations into allegations of child abuse and neglect applicable to EIFs, the standards, requirements, and procedures under § 412.100 would continue to be applicable to care provider facilities housing unaccompanied children in States where the State agency responsible for investigating child abuse and neglect allegations will not investigate such allegations in ORR-funded care provider facilities, as provided in § 412.100(c)(1). Likewise, ORR expects that if a court were to declare that the ORR Central Registry as defined at § 412.001 and described at § 412.101(a) is invalid, the requirements of § 412.100 relating to investigations into allegations of child abuse and neglect at certain facilities, and the obligations of care facilities delineated at § 412.103 will remain in effect.

ORR, in § 412.001, is codifying the definitions of terms that apply to this part. Many terms used in this rule are defined in other authorities, including statutes and ORR regulations, and this rule uses these terms consistently with those definitions. For example, this rule uses the term “unaccompanied child” consistently with the definition provided in the UC Program Foundational Rule, at 45 CFR 410.1001 (which is further consistent with the definition of “unaccompanied alien child” found in the Homeland Security Act (HSA), at 6 U.S.C. 279(g)(2)). Below, ORR further explains its rationale for certain definitions applied in this rule.

The definition of “administrative closure” describes when ORR determines it will not make a finding regarding an allegation of child abuse or neglect. Administrative closure does not imply that ORR would have found an allegation of abuse or neglect to be substantiated or not substantiated. ORR may assign an intake report for administrative closure if ORR determines it is not appropriate for investigation. Reasons for administrative closure before an investigation may include, but are not limited to, lack of jurisdiction to conduct an investigation of the allegation ( e.g., if the alleged abuse or neglect occurred in a State where the State agency responsible for investigating child abuse and neglect continues to investigate such reports of unaccompanied children in ORR care); transfer of the report to another jurisdiction or agency; an allegation not rising to the level of child abuse or neglect; duplication of an existing report; or an allegation is otherwise outside the scope of this rule, as described at § 412.100(c). ORR may also make a disposition of administrative closure after investigation. Reasons for administrative closure after an investigation may include, but are not limited to, inability to contact the child; insufficient information to proceed with the investigation; or transfer to another jurisdiction or agency. If ORR administratively closes an intake report or investigation, it may consider further investigation related to the initial allegation if new information becomes available.

The definition of “alleged perpetrator” means a person who is alleged to have abused or neglected a child within the scope of this part as described at § 412.100(a) and (c). The term encompasses individuals who are identified in an intake report, and subject to an investigation under this part, but does not include individuals who have been subject to an investigation which resulted in a not substantiated allegation, unfounded allegation, or administrative closure. Per the definition of child abuse and neglect set out at § 412.001, alleged perpetrators can include individuals who observed, permitted, or otherwise allowed a child to be mistreated and knowingly failed to act to protect the child. Alleged perpetrators do not become sustained perpetrators until all appropriate investigative steps have been completed and they have exhausted all administrative remedies, including waiving their right to appeal, as applicable and as specified in § 412.102(c).

The definition of “child abuse and neglect” in this IFR is based on ORR's review of Federal laws, consultation with the Administration on Children, Youth, and Families, including the Children's Bureau, and on its experience operating the UC Bureau. For example, ORR intends that this definition capture the types of behaviors identified at 22 U.S.C. 7102, 34 U.S.C. 20341, and 42 U.S.C. 5106g, Note § 3, to the extent they describe behaviors and situations that are relevant to unaccompanied children for purposes of this rule. At the same time, the definition of “child abuse and neglect” and related definitions ( e.g., medical neglect, verbal or emotional abuse) in this rule provide additional granularity relevant to the UC Bureau. The definitions of sexual abuse and sexual harassment used in this rule are the same as the PSA IFR at 45 CFR 411.6. ORR developed other related definitions to appropriately capture incidents and circumstances that raise child welfare concerns, and also reflect how abuse or neglect has historically been identified within the UC Bureau ( e.g., based on historical significant incident reporting to ORR, input from subject matter experts in child welfare including ORR's CWT, Prevention of Sexual Abuse Team, Division of Health for Unaccompanied Children, Federal field specialists, and Data Analytics and Information Management team). For example, this IFR provides separate definitions distinguishing neglect and medical neglect, and child abuse from child neglect, in contrast to 34 U.S.C. 20341, which groups these concepts together. Having separate definitions in this rule also enables ORR to have accurate data on specific kinds of abuse or neglect that may occur with respect to children in its care.

The definition of “inappropriate sexual behavior” refers to inappropriate sexual, derogatory, or offensive conduct that does not rise to the level of sexual abuse or sexual harassment. ORR intends that this term, which is also used in current ORR policies, capture conduct that falls outside of other relevant definitions, but still merits reporting and response.

The definition of “medical neglect” draws in part from ORR's review of other Federal authorities. For example, it is meant to include concerns described in the definition of “negligent treatment” from 34 U.S.C. 20341(c)(7), and the definition of “neglect” from 42 CFR 483.5. ORR found that these authorities described the types of issues from which it seeks to protect unaccompanied children in its custody, and, to that extent, these authorities informed the definition of “medical neglect” in this rule. ORR is providing a separate definition for medical neglect, distinct from other forms of neglect, based on its experience operating the UC Bureau, including knowledge of the forms of neglect historically reported within the context of the UC Bureau, and the importance of having sufficient granularity in data reporting and monitoring to appropriately capture and address the types of incidents and circumstances that raise child welfare concerns.

“Multidisciplinary team” is defined as a group of individuals comprised of ORR staff, including subject matter experts. Multidisciplinary teams provide input to ORR's Child Welfare Investigators by assessing reported allegations of child abuse and neglect at care provider facilities and making recommendations regarding physical and behavioral healthcare needs of unaccompanied children potentially impacted by child abuse and neglect at these facilities. Notably, the multidisciplinary team may include, but is not limited to, child welfare experts, forensic interviewers, mental health practitioners, child development and disability practitioners, pediatricians and other medical experts as needed, policy advisors, Federal program analysts, Federal program management staff, or other subject matter experts. The multidisciplinary team will also focus on the physical and behavioral healthcare needs of unaccompanied children potentially impacted by, and during the course of, the investigation of child abuse or neglect. Importantly, this team is different from, and in addition to, the ORR Child Welfare Investigator. The ORR Child Welfare Investigator sits within the DCPI, which will have the option to consult with the separate multidisciplinary team as necessary and appropriate. ORR believes that this collaborative approach to the investigation will lead to a coordinated response, representing a variety of fields and disciplines to support unaccompanied children while also ensuring a more efficient and thorough investigation.

The definition of “not substantiated allegation” means a disposition that there is not a preponderance of the evidence establishing that the alleged perpetrator committed child abuse or neglect (as defined in this section), but there is at least some evidence that the unaccompanied child was harmed or placed at risk of harm, whether or not by the alleged perpetrator. This term does not include administratively closed allegations. ORR notes that this definition differs from its definition of “unsubstantiated allegation” under the PSA IFR at 45 CFR 411.5 (“an allegation that was investigated and the investigation produced insufficient evidence to make a final determination as to whether or not the event occurred”). This investigation disposition, as well as the other defined dispositions, are further described in § 412.100.

The definition of “physical abuse” in this IFR aligns with the types of behaviors identified at 34 U.S.C. 20341 and described at 42 U.S.C. 5106g, Note § 3, to the extent that those provisions describe behaviors and situations that are relevant to unaccompanied children for the purposes of this rule. Further, the definition of “physical abuse” provided in this rule includes specific non-exhaustive examples, based on ORR's experience operating the UC Bureau and the forms of physical abuse historically reported, as well as feedback from care provider facilities that definitions with greater specificity better support effective reporting and monitoring.

The definition of “preponderance of the evidence” describes the burden of proof used to substantiate allegations of child abuse and neglect. ORR notes that this definition is based on 42 CFR 93.219, and that this definition means something is more likely than not to be true.

The definition of “sexual abuse,” has the same meaning as that term is defined in 45 CFR 411.6.

The definition of “sexual harassment,” has the same meaning as that term is defined in 45 CFR 411.6. ORR notes that this definition indicates that prohibited conduct “includes” repeated actions; however, the definition is not intended to be exhaustive, and a single instance may constitute sexual harassment.

The definition of “sub-grantee” is based on the definition of the term “subrecipient” from 45 CFR 75.2. ORR is using the term sub-grantee instead of subrecipient for consistency with existing ORR policies and guidance.

The definition of “substantiated allegation-Tier I” means a disposition that there is a preponderance of the evidence establishing that the alleged perpetrator committed child abuse or neglect, and the investigation indicates one or more automatic Tier I substantiating circumstances have been found pursuant to § 412.100(e)(7) or substantiation at Tier I is warranted based on consideration of aggravating and mitigating factors pursuant to § 412.100(e)(8). ORR notes that this definition differs from its definition of “substantiated allegation” under the PSA IFR at 45 CFR 411.5 (“an allegation that was investigated and determined to have occurred”) to incorporate that ORR, as the investigating entity, is using the preponderance of evidence standard to establish a disposition of “substantiated” and to incorporate the consideration of automatic Tier I substantiating circumstances, aggravating factors, and mitigating factors.

The definition of “substantiated allegation-Tier II” means a disposition that there is a preponderance of the evidence establishing that the alleged perpetrator committed child abuse or neglect, and that based on consideration of aggravating and mitigating factors pursuant to § 412.100(e)(8), the evidence does not warrant a finding of “Substantiated Allegation-Tier I.” ORR notes that this definition differs from its definition of “substantiated allegation” under the PSA IFR at 45 CFR 411.5 (“an allegation that was investigated and determined to have occurred”) to incorporate that ORR, as the investigating entity, is using the preponderance of the evidence standard to establish a disposition of “substantiated” and to incorporate the consideration of whether a disposition of substantiated allegation-Tier I is warranted, including in consideration of the aggravating and mitigating factors.

The definition of “substantiated perpetrator” means a person against whom an allegation of child abuse or neglect has been substantiated by ORR at Tier I or Tier II, but who has not exhausted the applicable appeal and review process for such allegations. Substantiated perpetrators at both Tier I and Tier II may appeal the disposition made by ORR to an Administrative Law Judge (ALJ) of the HHS Departmental Appeals Board (DAB) pursuant to § 412.102(c) and subsequently to the HHS Assistant Secretary for Children and Families pursuant to § 412.102(e).

The definition of “sustained allegation” means an allegation that was substantiated by ORR at Tier I or Tier II and that was upheld pursuant to the appeal and review process described in this rule or for which an appeal and review process was dismissed, including when the substantiated perpetrator waives their right to appeal by failing to make a timely request or by waiving those rights as specified in § 412.102(c).

The definition of “sustained perpetrator” means a substantiated perpetrator at Tier I or Tier II whose child abuse or neglect finding was upheld in the appeal and review process or whose appeal and review process was dismissed, including due to the sustained perpetrator's waiver of their right to appeal by failing to timely request appeal, or by otherwise waiving those rights as specified at § 412.102(c). Tier I Sustained perpetrators shall be prohibited from working in any way in connection with ORR-funded grants or contracts, including working or volunteering at any ORR care provider facility; may not have access to or contact with any unaccompanied child in ORR custody; will be added to the ORR Central Registry; and will be referred to appropriate law enforcement agencies. Information concerning Tier II sustained perpetrators will be recorded and maintained in agency records.

The definition of “unfounded allegation” means a disposition that there is not a preponderance of the evidence establishing that the alleged perpetrator committed child abuse or neglect, and the evidence indicates that the unaccompanied child was not harmed or placed at risk of harm. ORR notes that this definition differs from its definition of “unfounded allegation” under 45 CFR 411.5 (“an allegation that was investigated and determined not to have occurred”) to incorporate that ORR, as the investigating entity, is using the preponderance of evidence standard to establish a disposition of “unfounded allegation.” ORR also notes that records regarding unfounded allegations are maintained and disposed of in accordance with the applicable federal records management requirements.

The definition of “verbal or emotional abuse” aligns with the definition of “mental injury” at 34 U.S.C. 20341 and described at 42 U.S.C. 5106g, Note § 3, to the extent that those authorities describe behaviors and situations that are relevant to unaccompanied children for the purposes of this rule. The definition also includes specific non-exhaustive examples, based on ORR's experience operating the UC Bureau and the forms of verbal and emotional abuse historically reported, as well as feedback from care provider facilities that definitions with greater specificity will better support effective reporting and monitoring.

ORR describes the purpose of this IFR at § 412.100(a). This rule establishes the standards, requirements, and procedures for investigations by ORR of allegations of child abuse and neglect of unaccompanied children in ORR custody alleged to have been committed by care provider facility staff, contractors or sub-grantees of the care provider facility, care provider facility volunteers, or other individuals who have access to children in ORR care through contracts or grants with ORR, subject to § 412.100(c). ORR may also investigate individuals including those who are affiliated with legal service providers, child advocates, or other contractors engaged by ORR or the relevant care provider facility, to the extent allegations of abuse or neglect concern unaccompanied children who were in ORR custody at the time of the alleged incident. ORR believes these regulations will reduce the risk of child abuse and neglect of unaccompanied children in ORR care.

Section 412.100(b) provides that the provisions of this part are separate and severable from one another and that if any provision is stayed or determined to be invalid in a final judgment by a court of law, the remaining provisions shall continue in effect. This provision is meant to be consistent with the discussion of severability provided in the preamble at section IV.D.

Section 412.100(c) states that this rule applies in two circumstances. First, it applies to care provider facilities located in States where the State agency otherwise responsible for investigating child abuse and neglect allegations will not, as a matter of policy, investigate allegations of abuse or neglect concerning unaccompanied children at ORR-funded care provider facilities. 41 Second, this rule applies to EIFs. ORR notes this regulation implements ORR's statutory authority to conduct investigations and inspections of care provider facilities and other entities in which unaccompanied children reside while in ORR custody, regardless of the alleged perpetrator's particular role or job at the care provider facility— i.e., regardless of whether they are employed directly by the care provider facility, are employed by a contractor or sub-grantee of the care provider facility, are caring for unaccompanied children through a cooperative agreement with ORR, or are volunteers at a care provider facility. Finally, this regulation provides ORR the authority to investigate any allegations of child abuse and neglect that occurred during a child's stay at an ORR care provider facility, even if the allegation is reported after the unaccompanied child has been released from ORR care and custody. In the event that a child is transferred to another care provider facility, ORR will continue to investigate any allegations of child abuse and neglect that occurred at the care provider facility for which the allegation was submitted.

ORR believes that it is critical to ensure that allegations of child abuse and neglect are reported to ORR. For example, ORR's existing policies and procedures require care provider facilities to report all allegations of child abuse and neglect of an unaccompanied child in ORR custody to ORR and to Federal, State, and local authorities in accordance with any applicable Federal, State, and local reporting and licensing laws. 42 Further, 45 CFR 411.61 requires care provider facilities to report to ORR any allegation, suspicion, knowledge, or information regarding an incident of sexual abuse or sexual harassment occurring in ORR care, along with any retaliatory actions resulting from reporting such incidents. The UC Program Foundational Rule requires at 45 CFR 410.1303(g) that all care provider facilities report to ORR any emergency incident, significant incident, or program-level event, in accordance with any applicable Federal, State, and local reporting laws. These existing requirements apply to all ORR care provider facilities. The requirements outlined in this rule at § 412.100(d) further provide that any person may report an allegation of child abuse and neglect to ORR directly, to the care provider facility, or to a designated entity or office that is not part of the care provider facility. To ensure clarity and consistency, ORR believes it is important to outline these additional reporting requirements for care provider facilities subject to this rule.

ORR believes that ensuring individuals can report allegations of child abuse and neglect without fear of retaliation is key to ensuring that such reports are made. Therefore, under § 412.100(d), care provider facilities to which this part applies must have written policies and procedures that allow children, care provider facility staff, contractors or sub-grantees of the care provider facility, care provider facility volunteers, families of unaccompanied children, legal service providers, child advocates, attorneys of record, and any other persons to report allegations of child abuse and neglect to ORR directly, to the care provider facility, or to a designated entity or office that is not part of the care provider facility. Under § 412.100(d), the written policies and procedures must minimally address three topics. First, under § 412.100(d)(1), the care provider facilities' policies and procedures must at minimum provide unaccompanied children and other individuals with methods for reporting and inform them of how they can report an allegation of child abuse and neglect to a designated entity or office that is not part of the care provider facility. Such entity or office must be able to receive allegations of child abuse and neglect and to immediately forward them to ORR, allowing unaccompanied children to remain anonymous upon request. Second, under § 412.100(d)(2), all the methods of reporting must be accessible to all unaccompanied children including those with disabilities and those with limited English proficiency. This can include, for example, ensuring unaccompanied children are aware of, and are able to call, ORR's National Call Center. 43 In order to be accessible to unaccompanied children with disabilities, the method of reporting must provide effective communication consistent with section 504 of the Rehabilitation Act of 1973. In addition, ORR notes that the requirements for language access for unaccompanied children with disabilities under the UC Program Foundational Rule must also be met, at 45 CFR 410.1306 and 45 CFR 410.1311 respectively. Third, under § 412.100(d)(3), the care provider facility policies and procedures must include protections to prevent retaliation against unaccompanied children and others who report allegations of child abuse and neglect.

At § 412.100(e), ORR is establishing requirements for the screening and intake of reports of allegations of child abuse and neglect, conducting investigations, assigning dispositions to the allegations, and documenting investigations. When receiving reports of allegations of child abuse and neglect and conducting investigations, ORR must ensure the health and safety of unaccompanied children while making every effort to reduce further trauma to the alleged victim(s).

ORR is requiring at § 412.100(e)(1), that when it receives a report of alleged child abuse or neglect, ORR must generate an intake report and determine whether the report includes an allegation that, if found to be true, would meet the definition of child abuse and neglect in this part and is consistent with § 412.100(a) and (c). If so, ORR will assign the intake report for investigation. If not, ORR will assign the intake report for administrative closure. ORR will assign an intake report for investigation where the allegation meets the requirements of § 412.100(a) and (c); but ORR may in its discretion elect not to investigate an allegation at an EIF if it has a formal written agreement with the relevant State or local authority to perform such investigations. ORR may administratively close an intake report when it determines it is not appropriate for an investigation, which may include circumstances such as those described in the definition of administrative closure in § 412.001. ORR notes that it will assign an intake report for investigation in accordance with the requirements at § 412.100(e) even if the child is no longer in ORR care, as long as the alleged abuse or neglect occurred while the child was in ORR care. This could include, for example, instances in which an unaccompanied child reports an allegation of abuse or neglect to ORR after they have been released, or if the child has been transferred to another care provider facility. In the event that a child has been transferred to a new care provider facility in a State that conducts investigations, ORR will continue its investigation in the State in which the alleged child abuse or neglect occurred, as the alleged perpetrator may still pose a risk to other children in the care provider facility from which the child was transferred. ORR will document and assess the report to determine the timeline for assigning the report for investigation based on the level of risk of harm to the alleged victim and assign different response times based on the level of risk of harm. ORR will document and maintain a record of every allegation received at care provider facilities that fall under this IFR, whether it is ultimately assigned for investigation and a disposition rendered or assigned for administrative closure. ORR's decision and rationale about whether to classify the allegation as an intake report and assign it for investigation (or for administrative closure) will also be documented.

After an intake report is assigned for investigation, under § 412.100(e)(2), ORR shall assign an ORR Child Welfare Investigator to make a prompt and thorough investigation of the report to obtain sufficient information to determine whether the allegation is substantiated based on a preponderance of the evidence. The preponderance of the evidence standard for ORR investigations shall be applied in determining whether the alleged perpetrator committed child abuse or neglect. As such, the investigation prescribed in this section relates to the underlying allegation of abuse or neglect to a child, in addition to focusing on the individual perpetrator(s) involved. ORR will communicate its disposition to the alleged perpetrator, consistent with the requirements set forth at § 412.100(g), specifying whether the investigation determined that the alleged perpetrator committed abuse or neglect as defined in this rule. ORR emphasizes that this child-centered approach comports with common child welfare best practices seen across State systems.

ORR is requiring, at § 412.100(e)(3), that ORR shall provide notification that an allegation of child abuse and neglect will be investigated by ORR. This notification shall be provided to the alleged perpetrator; care provider facility; alleged victim; alleged victim's attorney of record (if the child has an attorney of record); and the alleged victim's parent(s), legal guardian(s), or sponsor(s) (as appropriate), unless ORR has evidence showing the parents, legal guardians, or sponsors should not be notified. If the alleged victim is 14 years old or older and ORR has determined that the alleged victim is able to make an independent decision, the alleged victim can affirmatively consent to disclosure. ORR notes that this notification requirement to the alleged victim, their attorney of record, and their parents, legal guardians, or sponsors is consistent with ORR's existing subregulatory notification policies and the PSA IFR requirements at 45 CFR 411.61(e) that are specific to sexual abuse and sexual harassment. To be clear, ORR also notes that the requirements of 45 CFR 411.61(f) continue to apply with respect to allegations of sexual abuse and harassment.

ORR is requiring, at § 412.100(e)(4), that the care provider facility must take immediate responsive measures to protect child welfare when notified that an investigation has been initiated, confirm the actions to ORR, and notify the alleged perpetrator, as appropriate. Such responsive measures may extend throughout the pendency of an investigation, and during the pendency of appeal and review processes, as necessary and applicable. ORR believes that this requirement is necessary to protect the safety and well-being of the unaccompanied children in ORR's care and custody until the allegation is either found to be not substantiated, unfounded, or is administratively closed. Additionally, ORR notes that care provider facility actions must be consistent with 45 CFR 411.66, which requires that any ORR and care provider facility staff, contractors, and volunteers suspected of perpetrating sexual abuse or sexual harassment must be suspended from all duties that would involve or allow access to unaccompanied children pending the outcome of an investigation.

At § 412.100(e)(5), ORR is establishing minimum standards that ORR shall follow when investigating allegations of child abuse and neglect. ORR investigations under this rule are not intended to replace investigations that may be performed by other relevant authorities, including State law enforcement or other Federal agencies, or entities designated under the VCAA to receive reports of child abuse. Accordingly, to the extent possible and appropriate, ORR is requiring at § 412.100(e)(5)(i) that it coordinate with any local or State law enforcement or other Federal agencies during its investigation. ORR may pause or resume an investigation at its discretion, with input from law enforcement partners or other relevant investigatory bodies, as necessary. Such coordination and cooperation with outside investigations is consistent with similar principles described in the PSA IFR. 44

Additionally, under § 412.100(e)(5)(ii), ORR shall establish, as necessary, a multidisciplinary team comprised of ORR staff, which may include, but is not limited to, child welfare experts, forensic interviewers, mental health practitioners, child development and disability practitioners, pediatricians and other medical experts as needed, policy advisors, Federal program analysts, Federal program management staff, and subject matter experts to collaborate with the ORR Child Welfare Investigator. Although the ORR Child Welfare Investigator is responsible for rendering a final disposition based on their investigation, the multidisciplinary team will engage a range of ORR staff who are subject matter experts to provide input and an assessment of the reported allegation of child abuse or neglect to assist the ORR Child Welfare Investigator's investigation. The multidisciplinary team will also focus on the physical and behavioral healthcare needs of unaccompanied children potentially impacted by, and during the course of, the investigation of child abuse or neglect. This team is different from, and in addition to, the ORR Child Welfare Investigator and the DCPI will have the option to consult with the separate multidisciplinary team as necessary and appropriate. ORR believes that this collaborative approach to the investigation will lead to a coordinated response, representing a variety of fields and disciplines to support unaccompanied children while also ensuring a more efficient and thorough investigation.

Under § 412.100(e)(5)(iii), the Child Welfare Investigator is required to complete certain minimum actions during an investigation. The Investigator should demonstrate that they have thoroughly investigated the allegation to obtain sufficient information for ORR to make a disposition. Under § 412.100(e)(5)(iii)(A), ORR is requiring that upon receipt of the intake report, the ORR Child Welfare Investigator must review the intake report and the care provider facility's records on the alleged victim and alleged perpetrator, conduct a background check on the alleged perpetrator, interview the person who reported the allegation if this person was not interviewed during intake, immediately request preservation of any potential video and documentary evidence, and as needed, establish a plan for thoroughly investigating the allegation. ORR already requires background checks of care provider facility staff, contractors, and volunteers prior to hiring or before such individuals may have contact with unaccompanied children;  45 but the intent of this requirement is to ensure that ORR has an updated background check regarding the alleged perpetrator. This may include an FBI fingerprint check of national and State criminal history repositories, a National Sex Offender Public website check, state child abuse and neglect registry checks, or other public records checks. Further, ORR recognizes the importance of avoiding the loss of any video and documentary evidence and therefore requires the ORR Child Welfare Investigator to immediately seek preservation of that evidence. At § 412.100(e)(5)(iii)(B), ORR is requiring the ORR Child Welfare Investigator to visit the care provider facility, as appropriate, to conduct a walkthrough of the facility and review video and documentary evidence. The intent of this requirement is to ensure the Investigator is able to review any video and documentary evidence in a timely way and record any observations that may be relevant to the investigation. Visits to the care provider facility may be unannounced, and the ORR Child Welfare Investigator may visit a care provider facility as often as necessary to complete an investigation.

Under § 412.100(e)(5)(iii)(C), ORR is requiring the ORR Child Welfare Investigator to make reasonable efforts to interview all individuals who have information relevant to the report of child abuse or neglect, including, but not limited to, the alleged perpetrator, care provider facility staff, the alleged victim, sponsor(s), and the parent(s) or legal guardian(s) (as appropriate) of the alleged victim, and any other potential witnesses. ORR recognizes the importance of conducting investigations in a way that minimizes the number of times individual children, including the alleged victim and those who may have relevant information, are interviewed, so as to mitigate potential trauma during the investigation process and to promote reliability of the information collected. This includes taking into consideration when law enforcement or other Federal entities are conducting an investigation of the same allegation in alignment with § 412.100(e)(5)(i). ORR recognizes that some children, however, may require multiple interviews in order to feel more comfortable discussing allegations of child abuse and neglect, remember details, or overcome feelings of shame or guilt. 46

Care provider facility staff will not be compelled to address questions about allegations regarding either themselves or other staff, under threat of disciplinary actions. ORR will not use threat of discharge to force an employee to be interviewed.

ORR notes that there may be circumstances where the ORR Child Welfare Investigator may not be able to interview all individuals who have information relevant to the report of child abuse or neglect. For example, the ORR Child Welfare Investigator may be unable to locate the individual after making reasonable efforts or the individual is unable to be interviewed due to the individual's parent, legal guardian, sponsor, or attorney representing the individual, refusing to permit the interview. ORR also notes that there may be situations in which it would not be appropriate for the parent, legal guardian, or sponsor to be interviewed ( e.g., when a child 14 years old or older has not consented to disclosure). Additionally, the ORR Child Welfare Investigator may not be able to interview an alleged perpetrator if the perpetrator was arrested or is under investigation by a law enforcement agency and the interview would interfere with the investigation; or the alleged perpetrator is detained and the jail, prison, or other detention facility where the alleged perpetrator is detained will not permit the interview.

At § 412.100(e)(5)(iii)(D), ORR is requiring the ORR Child Welfare Investigator ensure that interviews conducted as part of the investigation are accessible for all unaccompanied children, including those with disabilities and those with limited English proficiency and are properly documented either in writing or by audio or video recording. In order to be accessible for unaccompanied children with disabilities, the interviews must provide effective communication consistent with section 504 of the Rehabilitation Act of 1973. In addition, ORR notes that the requirements for language access and the requirements for unaccompanied children with disabilities under the UC Program Foundational Rule must also be met, at 45 CFR 410.1306 and 45 CFR 410.1311 respectively.

At § 412.100(e)(5)(iii)(F), ORR is requiring that the ORR Child Welfare Investigator review any available evidence in DCPI's records relating to past conduct of an alleged perpetrator, except allegations that resulted in a finding of unfounded or administrative closure. ORR's intent in taking these steps is to ensure that it captures situations that reveal patterns of behavior warranting further scrutiny but protects the rights of the individual as relates to prior unfounded or administratively closed allegations.

At § 412.100(e)(5)(iii)(F), ORR is requiring the ORR Child Welfare Investigator to gather relevant information as part of the investigation, including documents and audio or video evidence.

Lastly, at § 412.100(e)(5)(iii)(G), ORR is requiring the ORR Child Welfare Investigator to assess any imminent or ongoing risk of child abuse or neglect to the unaccompanied children at the care provider facility and, as appropriate, request that the care provider facility implement a plan to mitigate the risk and ensure the safety of the children. ORR's intent, in addition to investigating the underlying allegation, is also to assess any imminent or ongoing risks to children at the care provider facility following an allegation and to ensure the care provider facility implements safeguards to mitigate any such risks and ensure the safety of the children. The ORR Child Welfare Investigator is responsible for identifying any immediate risks to child welfare during the initial care provider facility visit following an allegation. This is not the same as determining whether the allegation occurred, which is done through the described investigation process, but rather to gain additional insight on how the allegation may have occurred. As appropriate, the ORR Child Welfare Investigator may request that the care provider facility implement a plan to mitigate the risk of child abuse or neglect to ensure safety of the unaccompanied children in ORR care at the care provider facility.

ORR is establishing at § 412.100(e)(6), that once the ORR Child Welfare Investigator's investigation is complete, ORR has the authority to render a disposition based on a preponderance of the evidence for each allegation. Possible dispositions include substantiated allegation-Tier I; substantiated allegation-Tier II; not substantiated allegation; unfounded; or administrative closure. If ORR determines the allegation is not substantiated, unfounded, or administratively closed, it may nevertheless consider further future investigation of the allegation if new information becomes available. ORR based its disposition types and definitions, including the relevant factors in § 412.100(e)(7) and (8), on a variety of existing State domestic child welfare systems and established best practices that balance children's needs and safety, the nuances that can exist in each allegation, and the due process rights of alleged perpetrators.

ORR notes that the first step in determining the disposition of an investigation is establishing whether child abuse or neglect, as defined under § 412.001, occurred based on the available information. If ORR finds, based on a preponderance of the evidence, that child abuse or neglect occurred, the allegation is considered substantiated as defined in § 412.001. ORR will determine whether each substantiated allegation is considered a substantiated allegation-Tier I or substantiated allegation-Tier II as to the substantiated perpetrator, based on the circumstances described at § 412.100(e)(7) and § 412.100(e)(8). ORR will make every reasonable effort to determine the perpetrator(s) responsible for each substantiated allegation of child abuse or neglect, and what role any other individuals involved in the abuse or neglect had, even if they did not perpetrate the act. An individual against whom an allegation of child abuse or neglect has been substantiated by ORR at Tier I or Tier II is considered a substantiated perpetrator, as defined in § 412.001. Under § 412.001, a substantiated perpetrator at Tier I or Tier II may appeal ORR's disposition pursuant to the established appeals process in § 412.102(d).

ORR distinguishes an “unfounded” disposition from a “not substantiated” disposition based on whether there was evidence indicating that a child was harmed or placed at risk of harm. ORR believes that distinguishing these two categories in this way allows for a more child-centric approach to conducting investigations and rendering dispositions by ensuring that any situation in which a child is harmed or placed at risk of harm is specifically documented as such. While there are other existing mechanisms, including ORR's Significant Incident Reporting and monitoring systems, that may capture this information, these mechanisms do not specifically document ORR investigation dispositions.

By distinguishing “unfounded” and “not substantiated” dispositions, ORR will be able to better monitor and track individuals, grantees, and contractors who may have repeated instances of allegations against them. Even where alleged child abuse and neglect is ultimately not substantiated, ORR believes documenting “not substantiated” is important for child welfare because over time such findings may reveal patterns of conduct requiring further scrutiny or action by ORR. Notably, ORR is also requiring at § 412.100(e)(5)(iii)(F) that any available evidence of past conduct in DCPI's records relating to the same alleged perpetrator be reviewed as part of the Child Welfare Investigator's investigative process, except for allegations that resulted in a finding of unfounded or administrative closure.

Under § 412.100(e)(7), a disposition of substantiated allegation-Tier I is automatically required where the allegation is (1) substantiated by a preponderance of the evidence, and (2) where certain enumerated factors are present. The factors warranting an automatic Tier I substantiated allegation are: (i) death or near death of a child as a result of child abuse or neglect; (ii) subjecting or exposing a child to sexual abuse or sexual harassment; (iii) inflicting an injury or creating a condition requiring a child to be hospitalized or to receive significant medical attention; (iv) repeated instances of physical abuse committed by the individual against any unaccompanied child in ORR care; (v) failure to take reasonable action to protect a child from sexual abuse or repeated instances of physical abuse under circumstances where the individual knew or should have known that such abuse was occurring; and (vi) depriving a child of necessary care ( e.g., food, shelter, healthcare, supervision) which either caused serious harm or created a substantial risk of serious harm. ORR notes that “individual” in this case means the care provider facility staff, contractors or sub-grantees of the care provider facility, care provider facility volunteers, or other individuals who have access to children in ORR care through contracts or grants with ORR. Under § 410.100(e)(7)(iv), when repeated instances of physical abuse are committed by the individual, the finding of substantiated allegation-Tier I could apply to the first incident reported if evidence is found which indicates a pattern of abusive behavior, injuries to a child, or harm. Additionally, under § 410.100(e)(7)(v), the condition of an individual failing to take reasonable action to protect a child from sexual abuse or repeated instances of physical abuse would be met, for example, when another individual is aware of the abuse, and fails to take any action to stop it, and thus allows the perpetrator's abusive behavior to continue. Under § 410.100(e)(7)(vi), the condition of depriving a child of necessary care which either caused serious harm or a substantial risk of harm includes cases of willful abandonment, deprivation of food, withholding of vital healthcare, forced isolation, and other acts or omissions of similar severity.

If no automatic Tier I substantiating circumstances, as described at § 412.100(e)(7), are present, § 412.100(e)(8) enumerates aggravating and mitigating factors which will be considered in determining if child abuse or neglect should be substantiated at Tier I or II. In the absence of automatic Tier I substantiating circumstances, where ORR finds under a preponderance of the evidence that child abuse or neglect occurred, ORR will make a determination as to whether the allegation should be substantiated as Tier I or Tier II by weighing aggravating and mitigating factors together. Consideration of aggravating and mitigating factors will be based on the totality of the circumstances and in the interest of protecting child welfare. ORR again notes that the “individual” means the care provider facility staff, contractors or sub-grantees of the care provider facility, care provider facility volunteers, or other individuals who have access to children in ORR care through contracts or grants with ORR. Aggravating factors include any of the following under § 412.100(e)(8)(i): (A) violations of ORR behavior management requirements pursuant to the UC Program Foundational Rule at 45 CFR 410.1304; (B) failure to comply with clearly established care provider facility policies, corrective action plans, or agreed-upon conditions; (C) the tender age, delayed developmental status or other vulnerability of the child; (D) any significant or lasting physical, psychological, or emotional harm to the child; (E) an attempt to inflict any significant or lasting physical, psychological, or emotional harm to the child; and (F) evidence suggesting a repetition or pattern of abuse or neglect, including multiple instances in which child abuse or neglect was substantiated at Tier I or Tier II, or not substantiated allegations if they demonstrate a pattern of abuse or neglect.

Under § 412.100(e)(8)(i)(A), violations of ORR behavior management requirements  47 include, for example, the use of prone physical restraints, chemical restraints, or peer restraints for any reason in any care provider facility setting, especially considering the age and particular vulnerability of the child. ORR notes the factor under § 412.100(e)(8)(i)(C) includes tender age as defined in ORR's Policy Guide which means children 12 years of age or younger. It also includes the alleged victim's vulnerable status (including history of trauma), particularly if the child is under the age of five; the child's developmental stage; the child's individualized needs, the child's disabilities, if any; and other vulnerabilities of the child. ORR's consideration of an attempt to inflict any significant or lasting physical, psychological, or emotional harm on the child under § 412.100(e)(8)(i)(E) will include whether there was an attempt to harm the child, even if the child does not appear to have suffered actual harm. Finally, to understand whether there is a repetition or pattern of child abuse or neglect under § 412.100(e)(8)(i)(F), ORR will consider whether there have been multiple Tier I or Tier II allegations that have been sustained pursuant to this IFR, or determined to have occurred by other relevant authorities that indicate such a pattern. ORR will also consider whether there is evidence to indicate prior occurrences or ongoing incidents of child abuse or neglect even if it is the first incident investigated by ORR.

Under § 412.100(e)(8)(ii), mitigating factors shall be weighed together with any existing aggravating factors. ORR again notes that the “individual” means the care provider facility staff, contractors or sub-grantees of the care provider facility, volunteers, or other individuals who have access to children in ORR care through contracts or grants with ORR. Mitigating factors include any of the following: (A) remedial actions taken by the individual before the investigation was concluded; (B) extraordinary, situational, or temporary stressors that caused the individual to act in an uncharacteristically abusive or neglectful manner; (C) the isolated or aberrational nature of the child abuse or neglect; and (D) the limited, minor, or negligible physical, psychological, or emotional impact of the abuse or neglect on the child. Under § 412.100(e)(8)(ii)(C), ORR will consider the isolated nature of the child abuse or neglect and that there is no evidence of a pattern. If a subsequent report yields additional evidence of a historical pattern or behavior, however, this mitigating factor would be eliminated.

Under § 412.100(f), records created, and information gathered or obtained during the course of an investigation are for internal purposes only, will not be shared or made public unless otherwise required or authorized by law, and may not be disclosed without prior ORR approval. All records will be maintained in an appropriate recordkeeping system with protections for the privacy and security of the individuals identified in the records. This provision refers to the entire record gathered during the course of an investigation under this part, in contrast to § 412.101(d), which states ORR will refer names and other identifying information of sustained perpetrators to relevant State and local authorities and to relevant law enforcement agencies in the State in which the child abuse and neglect occurred. This provides ORR with discretion to disclose records, for example, to Federal, State, or local government authorities, or any agents of such authorities, that have a need for such information in order to carry out their responsibilities under law to protect children from child abuse and neglect. The provision also provides ORR with discretion to share relevant information with the HHS Office of the Inspector General (OIG) for purposes of conducting investigations in accordance with the Inspector General Act (IG Act) of 1978. 48 ORR notes that § 412.100(f) applies to all records and information gathered, whether they pertain to an alleged perpetrator, an unaccompanied child who is an alleged victim or any other unaccompanied child, an individual making an allegation to ORR, or any other individual associated with an allegation, intake report, or investigation under this part. Safeguarding and maintaining the confidentiality of an unaccompanied child's case file records is critical to carrying out ORR's responsibilities under the HSA and the TVPRA. 49 Additionally, requiring confidentiality is critical for promoting compliance with the requirement to report allegations of child abuse and neglect at § 412.100(d). 50

ORR is establishing requirements pertaining to notification of dispositions at § 412.100(g). At § 412.100(g)(1), ORR must notify the alleged perpetrator of the disposition of an investigation in writing within five days of making the disposition. ORR must also notify in writing the alleged victim and their parent(s), legal guardian(s) (as appropriate), or sponsor(s), of the disposition within five days of making a disposition.

Under § 412.100(g)(2), if the disposition is substantiated at Tier I, the notification must state: (i) the substantiated perpetrator will be considered a sustained perpetrator at Tier I and their name and other relevant information will be placed on the ORR Central Registry (unless they seek an appeal of the disposition pursuant to § 412.102) and that once identified in the Central Registry, they will be prohibited from working or volunteering in any way on ORR-funded grants or contracts, and may not have access to or contact with any unaccompanied child in ORR custody; (ii) the reasons for the Tier I substantiated perpetrator's placement on the ORR Central Registry in terms sufficient to put the perpetrator on notice of the conduct or incident(s) upon which it is based; (iii) the substantiated perpetrator may appeal ORR's disposition pursuant to § 412.102, but that if the Tier I substantiated perpetrator either fails to request such appeal in a timely manner, or upon conclusion of the appeal and subsequent review, if any, the disposition is upheld, the perpetrator will be added to the ORR Central Registry and the disposition will be reported to Federal, State, and local authorities as appropriate (such as notifying the State in which the allegation occurred when an allegation is sustained); and (iv) ORR's procedures for making the disposition. ORR believes these requirements are a key part in ensuring a Tier I substantiated perpetrator has adequate notification that they will be placed on the ORR Central Registry, the consequences of being placed on the Registry, and of the ability to request an appeal and subsequent review.

Under § 412.100(g)(3), if the disposition is a Tier II substantiated allegation, the notification must inform the Tier II substantiated perpetrator that they may appeal ORR's disposition pursuant to § 412.102, but that if the Tier II substantiated perpetrator either fails to request such appeal in a timely manner, or upon the conclusion of the appeal and subsequent review, if any, the disposition is upheld, the Tier II substantiated perpetrator will be designated as a Tier II sustained perpetrator and ORR's disposition will be retained in ORR records. ORR may use these records for determining patterns of abuse and neglect and for informing future safety planning at care provider facilities. A Tier II sustained perpetrator will not be placed on the ORR Central Registry.

Under § 412.101, ORR is establishing mechanisms for interventions and discipline related to substantiated and sustained allegations of child abuse and neglect as determined by ORR under § 412.100. These intervention and discipline mechanisms include maintenance by ORR of a ORR Central Registry of individuals with Tier I sustained allegations of child abuse and neglect; prohibitions on hiring, employing, or permitting as volunteers individuals who are listed in the ORR Central Registry; required disciplinary sanctions by ORR care provider facilities; and provisions for ORR referrals of substantiated allegations of child abuse and neglect to other government and law enforcement agencies. ORR believes that these enforcement mechanisms and requirements are crucial to carrying out the purpose of this part, as specified and described under § 412.100(a) and (c) above.

Section 412.101(a) describes an ORR Central Registry to list Tier I sustained perpetrators under this rule. Under § 412.101(a)(1), for purposes consistent with § 412.100(a) and (c), ORR will create and maintain an ORR Central Registry of Tier I sustained perpetrators, including names and other identifying information, and details regarding the sustained allegations. Under § 412.101(a)(2), subject to legal requirements regarding disclosure of information ( e.g., under Freedom of Information Act (FOIA), the Privacy Act, or the IG Act), the ORR Central Registry will not be public-facing, nor available to persons outside of ORR, since its purpose is to inform employment decisions by ORR care provider facilities, home study providers, and post-release service providers by providing the names and other identifying information of Tier I sustained perpetrators, and for ORR to use as part of the screening process by care provider facilities as described in § 412.101(b).

Section 412.101(b) sets out certain working and volunteering prohibitions for individuals listed in the ORR Central Registry, as well as requirements for checking the ORR Central Registry. ORR is requiring at § 412.101(b)(1) that the individuals listed in the ORR Central Registry shall be prohibited from working or volunteering in any way on ORR-funded grants or contracts, and may not have access to or contact with any unaccompanied child in ORR custody, unless ORR removes such individual from the Central Registry ( e.g., circumstances contemplated under § 412.102(c)(2)(ii), addressing temporary removal of an individual from the Central Registry while an appeal is pending; § 412.102(e), addressing possible reversal of a DAB finding by second-level review, carried out by the Assistant Secretary for ACF). ORR-funded grants or contracts where individuals listed in the ORR Central Registry will be prohibited from working or volunteering may cover, for example, other care provider facilities, ORR home study and post-release service providers, or other ORR-funded services that may include access to unaccompanied children. At § 412.101(b)(2), ORR is requiring that, as part of the screening process for hiring decisions for staff, contractors or sub-grantees, or for screening volunteers, all care provider facilities, home study providers, and post-release service providers, whether or not located in States that investigate child abuse and neglect allegations at ORR care provider facilities, must check with ORR to confirm that an applicant is not listed in the ORR Central Registry.

At § 412.101(b)(3), ORR sets out the requirement that all care provider facilities, home study providers, and post-release service providers, whether or not located in States that investigate child abuse and neglect allegations at ORR care provider facilities, must also check all of their personnel against the ORR Central Registry at least once annually. Checking applicants and current personnel against the ORR Central Registry is an especially important child safety measure for care provider facilities located in States that do not investigate allegations of child abuse and neglect, and thus whose registries will not include individuals alleged, or found through investigation, to have perpetrated abuse or neglect at ORR care provider facilities. ORR notes that the requirements at § 412.101(b) are supplementary to those in the PSA IFR at 45 CFR 411.16 and 45 CFR 411.81.

Under § 412.101(c), care provider facilities must implement appropriate disciplinary or remedial measures where they or ORR find care provider facility staff, contractors or sub-grantees of the care provider facility, or care provider facility volunteers engaged in conduct that does not rise to the level of a Tier I substantiated allegation, as defined at § 412.001, but nevertheless raises child welfare concerns.

ORR believes that it is important to share information regarding sustained perpetrators with relevant State and local authorities such that they can take additional action as necessary to protect children in their jurisdictions in accordance with their legal obligations. This information sharing does not mean that information on the registry is public facing, such as other public criminal records databases. Rather, ORR will only share information directly with relevant entities and in accordance with applicable State and Federal information sharing, privacy, and due process protections. Accordingly, under § 412.101(d)(1), ORR will refer names and other identifying information of Tier I sustained perpetrators to relevant State and local authorities ( e.g., child protective services) and to relevant law enforcement agencies in the State in which the sustained allegation of child abuse and neglect occurred. This requirement comports with existing requirements in the PSA IFR that all terminations for violations of ORR or care provider facility policies and procedures regarding sexual abuse and sexual harassment, or resignations by staff who would have been terminated if not for their resignation, must be reported to law enforcement agencies and to any relevant State or local licensing bodies. 51 Additionally, if requested by a relevant State or local authority or relevant law enforcement agency, including an authority or agency outside of the State in which the Tier I sustained allegation occurred, ORR will confirm whether a particular individual is on the ORR Central Registry. Furthermore, under § 412.101(d)(2), ORR will provide the names and other identifying information of Tier I sustained perpetrators to the Federal Bureau of Investigation, and HHS Office of the Inspector General (OIG), consistent with any applicable agreements. Finally, § 412.101(d)(3) requires that neither ORR nor care provider facilities shall interfere with another State, local, or Federal authority or agency's investigation into allegations of child abuse and neglect.

ORR is establishing guidelines and requirements regarding the availability of an appeal and review process of dispositions made by ORR at § 412.102.

Under § 412.102(a), a substantiated perpetrator, whether at Tier I or Tier II, may appeal the disposition made by ORR to an Administrative Law Judge (ALJ) in the HHS Departmental Appeals Board (DAB) pursuant to § 412.102(c).

ORR is requiring, at § 412.102(b), that ORR shall notify substantiated perpetrators at Tier I or Tier II of their opportunity for an appeal. As stated above, all alleged perpetrators receive notice of the allegations against them pursuant to § 412.100(e)(3). Under § 412.102(b)(1), after completing an investigation and upon substantiation of any relevant allegations, ORR will send a written notice to the substantiated perpetrator at Tier I or Tier II, in accordance with § 412.100(g). The notice will state that the relevant allegations have been substantiated and that the Tier I substantiated perpetrator will be placed on the ORR Central Registry unless they appeal the disposition by ORR and that the Tier II substantiated perpetrator's information will be retained as a Tier II sustained perpetrator in agency records. Under § 412.102(b)(2), the written notice shall: (i) clearly describe the basis for ORR's disposition that substantiates the relevant allegations at Tier I or Tier II and shall explain the Tier I or Tier II substantiated perpetrator's right to appeal the disposition and the steps required to initiate the appeal; (ii) inform the substantiated perpetrator that they may appeal the disposition before an ALJ; (iii) provide the substantiated perpetrator at Tier I or Tier II and their attorney, if any, with written information and instructions describing the appeal process; and (iv) inform the substantiated perpetrator at Tier I or Tier II that if they do not appeal within 30 days of receiving the notice, the DAB will consider the substantiated perpetrator to have waived their opportunity for an appeal and any subsequent review. A Tier I substantiated perpetrator will be identified on the ORR Central Registry as a Tier I sustained perpetrator. A Tier II substantiated perpetrator's information will be retained as a Tier II sustained perpetrator in agency records.

At § 412.102(c), ORR is establishing a process for substantiated perpetrators at Tier I or Tier II to appeal of ORR's disposition. Under § 412.102(c)(1)(i), and as further elaborated at § 412.102(c)(2), if the substantiated perpetrator elects to appeal ORR's disposition that a child abuse or neglect allegation is substantiated at Tier I or Tier II, they must file a written notice of appeal with the DAB within 30 days of receipt of the written notice of ORR's disposition. Under § 412.102(c)(1)(ii), within 30 days of receiving this written notice of appeal, ORR will provide all evidence it used in making its disposition to the DAB. Under § 412.102(c)(1)(iii), within 30 days of receiving this written notice of appeal, ORR will provide to the substantiated perpetrator at Tier I or Tier II, and their attorney, if any, all information used in making its disposition, except any information that ORR determines: (A) would compromise the safety and well-being of a child, the reporter, or any other person; (B) would reveal the identity of a child who furnished information with the understanding that their identity would be held in confidence; (C) would reveal the identity of any other alleged perpetrator(s) involved in the same case who has an unfounded disposition (to protect the privacy of the alleged perpetrator with an unfounded disposition); or (D) is otherwise prohibited by State or Federal law or regulation. In the case of information being withheld, the substantiated perpetrator at Tier I or Tier II will be advised of the general nature of the information and the reasons that it is being withheld. Neither the substantiated perpetrator at Tier I or Tier II nor the care provider facility are required to provide information unless they would like the ALJ to consider such information as part of the hearing or record review, and they will not be compelled to provide it.

Dismissal of appeals is covered in § 412.102(c)(2). Under § 412.102(c)(2)(i), the ALJ may dismiss an appeal when the ALJ determines that the substantiated perpetrator waived appeal by not submitting the notice of appeal in a timely manner ( i.e., an appeal within 30 days of receiving written notice of ORR's disposition) and failed to demonstrate good cause for the untimely request, withdraws the appeal, abandons the appeal, or does not have a right to ALJ review (including, but not limited to, situations where the case does not involve a Tier I or Tier II substantiated allegation). If the appeal is dismissed, the Tier I substantiated perpetrator will be placed on the ORR Central Registry as a Tier I sustained perpetrator or ORR will retain the information regarding the Tier II substantiated perpetrator as a Tier II sustained perpetrator in agency records, as applicable. Notwithstanding such a dismissal, under § 412.102(c)(2)(ii) the DAB may in its discretion temporarily remove the designation of sustained perpetrator at Tier I or Tier II, which would result in ORR removing the individual who was designated as a Tier I sustained perpetrator from the ORR Central Registry, in situations where, for example, the ALJ determines that the sustained perpetrator at Tier I or Tier II has established good cause for exceeding the appeal timeframe. This rule contemplates that good cause may be established, for example, where a serious medical condition prevented timely filing of the notice of appeal.

The appeal and review processes are described in § 412.102(d) and (e). Under § 412.102(d)(1), when a substantiated perpetrator at Tier I or Tier II appeals, ORR must transmit all of the evidence upon which ORR's disposition was based to the ALJ. Under § 412.102(d)(2), the evidentiary record must contain all documents and other materials, such as video or audio recordings, that were used by ORR in making its disposition. The ALJ may remand the case to ORR if the ALJ determines that the evidentiary record is insufficiently complete to determine whether ORR's disposition is supported by a preponderance of the evidence. Under § 412.102(d)(3), the substantiated perpetrator at Tier I or Tier II may be represented by an attorney. As described in § 412.102(d)(4), the substantiated perpetrator shall have the burden to show that, considering the totality of the evidence, there is not a preponderance of the evidence to support the substantiated allegation at Tier I or Tier II, and to dispute whether any automatic Tier I substantiating circumstances described at § 412.100(e)(7) existed (if applicable) or whether aggravating factors or mitigating factors described at § 412.100(e)(8) existed (if applicable). Both ORR and the substantiated perpetrator may present the testimony of witnesses, documents, factual data, arguments, or other submissions of proof. The testimony of care provider facility staff shall be voluntary and failure to provide such testimony will not subject the care provider staff member to disciplinary action. Under § 412.102(d)(5), if the substantiated perpetrator appeals and the appeal is not dismissed by the ALJ pursuant to § 412.102(d)(7), ORR must notify the alleged victim and the alleged victim's parent(s), legal guardian(s) (as appropriate), or sponsor(s) that an appeal of ORR's disposition will be conducted by an ALJ. The alleged victim, other child witness(es), and family members of the alleged victim shall not be required to testify. Refusal to testify shall have no bearing on a determination as to whether the alleged abuse or neglect did or did not take place.

Under § 412.102(d)(6), both parties (ORR and the substantiated perpetrator) may cross examine witnesses and ask questions during a live hearing, as well as request additional information, either during a live hearing or pursuant to a record review. In order to mitigate the potential for re-traumatization of an alleged victim while still providing a substantiated perpetrator with the opportunity to respond to the allegations, a substantiated perpetrator may not personally cross examine the alleged victim. The parties will be given an opportunity to file briefs or other written statements of fact or law. Under § 412.102(d)(7), the ALJ must conduct a fair and impartial hearing under a de novo standard of review to determine whether the substantiated perpetrator met their burden of proving that, considering the totality of the evidence, there is not a preponderance of the evidence to support the substantiated allegation. The ALJ will issue a written decision upholding, modifying, or reversing the ORR's disposition. Under § 412.102(d)(8), the ALJ shall serve a copy of the decision upon the parties and the Assistant Secretary for ACF. The ALJ's decision shall provide the substantiated perpetrator at Tier I or Tier II and their attorney, if any, with instructions for filing a request for review with the Assistant Secretary for ACF. The ALJ also shall provide a copy of the decision to the alleged victim, and, as appropriate, the alleged victim's parent(s), legal guardian(s), or sponsor(s). The complete record upon which the decision is based shall be made available to the Assistant Secretary.

This rule provides another level of review under § 412.102(e). This subsection provides that the Assistant Secretary for ACF may review the ALJ's determination, either sua sponte or upon a request by the substantiated perpetrator. Under § 412.102(e)(1), a substantiated perpetrator at Tier I or Tier II may request review of the ALJ's decision within 30 days of receipt of the ALJ's decision, by filing a request for review with Office of the Assistant Secretary for ACF. Under § 412.102(e)(2), the Assistant Secretary has discretion, within 30 days after receiving a timely request for review of an ALJ's decision under § 412.102(e)(1), to review the ALJ's decision and to dismiss a request for review based on untimeliness or other procedural defects, or to affirm, modify, or reverse the ALJ's decision with regard to dismissal or ORR's disposition of the allegation. A review by the Assistant Secretary will determine whether the ALJ's decision was based on a material error of law or fact.

Section 412.102(e)(3) provides that if the Assistant Secretary affirms the ALJ's decision, or does not modify or reverse the ALJ's decision, within 30 days after receiving a timely review request under § 412.102(e)(1), then the ALJ's decision becomes the final decision of the Assistant Secretary and is binding on both parties (ORR and the substantiated perpetrator). Likewise, under § 412.102(e)(4), if the Assistant Secretary modifies or reverses the ALJ's decision pursuant to § 412.102(e)(2), then the Assistant Secretary's decision is final and binding.

Under § 412.102(e)(5), if at the end of the 30-day period in § 412.102(e)(1), no timely request for review has been made, the Assistant Secretary has 30 days from that point to exercise discretion to review the ALJ's decision. If the Assistant Secretary does not modify or reverse the ALJ's decision, then the ALJ's decision becomes the final decision of the Assistant Secretary and is binding on both parties. The intent of § 412.102(e)(5) is to make clear that the Assistant Secretary has discretion to review the ALJ's decision regardless of whether a timely request for review is made.

Under § 412.102(e)(6), the Office of the Assistant Secretary for ACF shall notify the parties of the Assistant Secretary's final decision. The Office of the Assistant Secretary also shall provide a copy of the final decision to the alleged victim and the alleged victim's parent(s), legal guardian(s) (as appropriate), or sponsor(s), based on review of the ALJ's previous decision, under § 412.102(e).

To ensure that ORR can obtain sufficient information to make fair, accurate, and impartial decisions regarding allegations of child abuse and neglect, at § 412.103, ORR is establishing obligations with which care provider facilities must comply during investigations.

Under § 412.103(a)(1) through (3), during any investigation of child abuse and neglect by ORR, a care provider facility must permit ORR: (1) to have unrestricted access to the premises, any physical property on the premises, buildings, staff, and children in the physical custody of the care provider facility; (2) to conduct interviews with children residing at the care provider facility, and without care provider facility staff, contractors or sub-grantees of the care provider facility, or care provider facility volunteers, present; and (3) to observe the activities of care provider facility staff, contractors or sub-grantees of the care provider facility, care provider facility volunteers, or other individuals who have access to children in ORR care through contracts or grants with ORR. Under § 412.103(a)(4), care provider facilities must promptly preserve any potential video or documentary evidence. ORR notes that this requirement is aligned with the requirement at § 412.100(e)(5)(iii)(A), which states that upon receiving an intake report, the ORR Child Welfare Investigator must immediately request preservation of any potential video and documentary evidence. Additionally, under § 412.103(a)(5), care provider facilities must promptly provide and facilitate access to, upon request, all files, records, reports, data, video recordings, and other information, including copies of any such documents, requested by ORR either prior to or during the investigation. Care provider facilities subject to this rule must also promptly provide access to and contact information for staff, contractors, or sub-grantees of the care provider facility, its volunteers, or other individuals who have access to children in ORR care (§ 412.103(a)(6)); submit complete and accurate responses to any written questions in a timely manner (§ 412.103(a)(7)); and fully cooperate with ORR (§ 412.103(a)(8)). Finally, under § 412.103(a)(9) care provider facilities are required to fully cooperate with any investigation of the same allegation by other State, local, and Federal authorities, and relevant law enforcement agencies.

Further, in alignment with existing ORR policy and 45 CFR 411.67, ORR is requiring at § 412.103(b) that care provider facility staff, contractors or sub-grantees of the care provider facility, and care provider facility volunteers must not retaliate against any person who in good faith reports or participates in an investigation of child abuse or neglect.

Under § 412.103(c), a care provider facility's obstruction, interference, delay of, or failure to permit or cooperate with any investigation under this part, including failure to protect unaccompanied children from retaliation pursuant to § 412.103(b), may result in ORR taking monitoring and enforcement measures. Such measures may include remote monitoring of the care provider facility ( i.e., monitoring that does not occur on-site); on-site monitoring of the care provider facility; monitoring of the corporate offices to review internal policies and reporting structures, as well as supervisory responses to events ( e.g., mitigation or future preventative measures); limiting or stopping new placements of unaccompanied children at the care provider facility; removing all children in ORR care and custody from the care provider facility and placing them into other care provider facilities; issuing corrective actions; terminating the contract or cooperative agreement with the care provider facility; or imposing other such remedies for noncompliance applicable to HHS grant recipients and contractors. ORR notes that the cooperation of care provider facilities is critical in investigations of child abuse and neglect, and that enforcement measures such as those described are appropriate to help ensure that ORR can obtain the information necessary to determine whether allegations are substantiated.

Under § 412.103(d), ORR requires care provider facilities, during the course of an investigation, to provide unaccompanied children confidential access to attorneys of record and other legal service providers, as well as their families and legal guardians, in a manner consistent with requirements established at 45 CFR 411.55 (as applicable) as well as 45 CFR 410.1309. Care provider facilities must provide unaccompanied children with access to their child advocates, in a manner consistent with the requirements of the TVPRA at 8 U.S.C. 1232(c)(6) and 45 CFR 410.1308. Finally, care provider facilities must also provide unaccompanied children access to health services (including specialists and mental health practitioners), individual counseling sessions, and crisis intervention (including access to outside victim services and rape crisis centers where appropriate) to most appropriately address unaccompanied children's needs, in a manner consistent with requirements established at 45 CFR 410.1302(c)(5), 45 CFR 410.1307, 45 CFR 410.1311, and 45 CFR 411.21 (as applicable).

When engaging in rulemaking, ORR ordinarily publishes a notice of proposed rulemaking (NPRM) in the Federal Register and invites public comment on the proposed rule. However, under the Administrative Procedure Act, 5 U.S.C. 553(b), an NPRM is not required when an agency, for good cause, finds that notice and public comment is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the agency's reasons in the rule issued. With respect to this rulemaking, delaying implementation of the provisions of this regulation until a public notice and comment process is complete would risk serious and imminent harm to unaccompanied children in Texas care provider facilities (and in the future at EIFs, which ORR may need to open on short notice, before it can execute formal written agreements describing child welfare investigations of child abuse and neglect with relevant local authorities), and thus would be impracticable. As such, ORR believes that it has good cause to issue this rulemaking as an Interim Final Rule (IFR) rather than issuing an NPRM.

ORR has determined that this rulemaking is imminently necessary because ORR must have the ability to establish employment consequences at relevant care provider facilities for sustained perpetrators of abuse and neglect in order to fulfill its statutory responsibilities. 52 Critically, as mentioned earlier, ORR began taking immediate action soon after it became clear that Texas DFPS was not going to resume its historical child welfare and investigative functions when it extended its emergency declaration in 2022. Subsequently, ORR began consulting with other federal agencies, developing the necessary expertise and capacity to conduct investigations, drafting policies and procedures to inform how investigations are conducted, obtaining administrative approval for new agency positions, creating new comprehensive technical systems for recording and tracking investigations, and hiring, onboarding, and training qualified investigative staff. Most pertinently, as discussed at section IV.A, ORR's recently established Division of Unaccompanied Child Protective Investigations (DCPI) began its investigations of allegations of child abuse and neglect in ORR-funded care provider facilities in Texas as of July 2024.

In addition to investigating allegations of abuse and neglect at care provider facilities located in States that do not conduct investigations, and at EIFs, ORR needs to be able to direct its care provider facilities to prohibit individuals from working or volunteering on ORR-funded grants or contracts when there has been a sustained allegation of abuse or neglect at Tier I (as defined in this rule), and to ensure that perpetrators with such sustained allegations do not have access to or contact with children in ORR custody. To that end, this rulemaking establishes an ORR Central Registry listing Tier I sustained perpetrators, as described in this rule. Further, this rule establishes that Tier I sustained perpetrators listed on the ORR Central Registry are prohibited from working or volunteering in any way on ORR-funded grants or contracts, so as to prohibit them from having access to or contact with any unaccompanied child in ORR custody. Because such requirements potentially implicate alleged perpetrators' ability to work in their chosen profession (if the allegation is sustained at Tier I), ORR believes that substantive rulemaking is required to codify appeal and review procedures with appropriate due process protections for alleged perpetrators ( e.g., notice and an opportunity to be heard).

There is good cause to issue this rulemaking as an IFR because requiring notice and comment before implementing these provisions would risk serious and imminent harm to unaccompanied children. For example, even if DCPI concludes through an investigation that an individual perpetrated child abuse or neglect, without an ORR Central Registry, such a perpetrator could potentially pass a background check and be re-hired at any time at another ORR care provider facility, which would undermine the very purpose of the rule—to protect children from such perpetrators. As noted above, ORR understands that creation of the Central Registry requires rulemaking because adequate due process procedures need to be established in consideration of the employment interests at stake. In other words, ORR's DCPI can now investigate, substantiate, and sustain allegations of abuse and neglect of unaccompanied children in its custody against alleged perpetrators in accordance with existing statutory authority, but requiring notice and comment before this rule goes into effect would prevent ORR from using that critical information in the ORR Central Registry to keep children safe in the near and long term. Until ORR is able to begin operating the ORR Central Registry, unaccompanied children are at elevated risk of abuse or neglect—a risk that ORR seeks to prevent by using this IFR to prohibit the hiring of Tier I sustained perpetrators of child abuse and neglect.

As discussed above, as of July 2024, ORR began investigative activities in relation to reported child abuse and neglect at care provider facilities in Texas. As a result, there is an urgent need to have the provisions of this rule in place to protect child welfare while also providing appropriate due process protections for alleged perpetrators of child abuse and neglect. Notice and comment rulemaking would prevent ORR from taking swift and appropriate action when it identifies an imminent threat to child safety and would allow perpetrators of child abuse and neglect to evade ORR's efforts, pursuant to statutory responsibilities, to protect unaccompanied children in its custody. Notice and comment rulemaking would increase the risk of serious potential harm to unaccompanied children—which ORR seeks to address through this IFR by prohibiting employment of individuals on the ORR Central Registry.

ORR has therefore found good cause in the specific circumstances presented here—where ORR has recently established a new Division to conduct child welfare investigations at EIFs and in States that do not do so given that there is an immediate and ongoing risk to unaccompanied children in such States without the protections described in this rule. This rulemaking is urgently required now to establish required employment consequences for individuals found by ORR investigations to have perpetrated child abuse or neglect, and ORR has not delayed responding to the urgent need to establish such consequences because DCPI began initiating investigations as of July 2024.

Therefore, HHS finds good cause to waive the notice of proposed rulemaking and to issue this final rule on an interim basis. Finally, HHS is providing a 60-day public comment period and will carefully consider public comments received and may update the final rule, as appropriate. ORR plans to finalize the rule within one year of implementation.

Under the Paperwork Reduction Act of 1995 (PRA), HHS is required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a control number assigned by OMB.

This interim final rule with comment requires information collections for which HHS plans to seek OMB approval at a later date. The information collection requirements associated with this interim final rule will not take effect until approved by OMB. HHS will issue future Federal Register notices to seek comments on its information collections within one month following finalization, as required by the PRA, 53 and will include a system of records notice related to the requirements in this rule.

To estimate the costs associated with the information collection activities described in this interim final rule, ORR utilizes median hourly wage rates in accordance with the Bureau of Labor Statistics' (BLS) most recent update in April 2024 for Education and Childcare Administrators. 54 The median hourly wage rate is calculated to be $26.10 with fringe benefits at 100 percent, for a total hourly wage rate of $52.20 ($26.10 + $26.10).

Section 412.100(d) requires that care provider facility staff, contractors, sub-grantees, volunteers, and all ORR staff must report allegations of child abuse and neglect by care provider facility staff, contractors or sub-grantees of the care provider facility, care provider facility volunteers, or other individuals who have access to children in ORR care through contracts or grants with ORR in accordance with ORR policies and procedures to ORR, and to Federal, State, and local authorities in accordance with any applicable Federal, State, and local reporting and licensing laws. Because this reporting requirement would not require additional reporting above and beyond existing ORR policy, this requirement will not result in additional burden for care provider facilities.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866, as amended by Executive Order 14094, defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $200 million or more (adjusted every 3 years for changes in gross domestic product), or adversely affecting in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impact of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the Executive Order. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. While there are some costs associated with these regulations, they do not exceed the monetary threshold for significance as defined under section 3(f)(1) of E.O. 12866, as amended. However, the regulation is significant and has been reviewed by OMB.

As previously discussed, ORR has developed the child abuse and neglect investigation requirements for ORR care provider facilities with the intention of keeping the best interests of unaccompanied children at the forefront. Because the requirements in this IFR are in line with existing ORR policy, ORR anticipates that care provider facilities will need to make only minimal updates to their staffing, training, and/or policy in order to meet the requirements. Specifically, ORR anticipates that care provider facilities will need to make updates to meet requirements under § 412.101(c) and § 412.103. Typically, ORR care provider facilities spend up to approximately 5 hours to cooperate with a State-led investigation of alleged child abuse or neglect, which can vary widely depending on the circumstances of the specific allegation. ORR expects that its Texas care provider facilities will spend the same amount of time cooperating with investigations conducted by ORR. Because ACF lacks the ability to account for the specific details of every care provider facility and their ability to meet the requirements, ORR is only able to estimate costs associated with other remedies in general, rather than specific to each care provider facility.

To estimate the economic impacts associated with the policies promulgated in this interim final rule, ACF uses wage rate and annual salary data provided by BLS for Childcare Workers and First-Line Supervisors working in the Child Care Services industry. 55   56 The median hourly wage rate for childcare workers is calculated to be $14.60. Assuming benefits and indirect costs of labor equal 100 percent of the hourly wage, the corresponding fully loaded cost of labor for childcare workers is $29.20 per hour. Additionally, the mean hourly wage rate for First-Line Supervisors working in the Child Care Services industry is calculated to be $22.45. Note that we do not use the median wage rate because BLS only provides mean wage rates for specific industries. Assuming benefits and indirect costs of labor equal 100 percent of the hourly wage, the corresponding fully loaded cost of labor for childcare supervisors is $44.90 per hour. ORR assumes that it will take between 0.25 and 0.5 hours at a cost between $7.30 ($29.20 × 0.25 hours) and $14.60 ($29.20 × 0.5 hours) for each childcare worker to receive the relevant policy update training and between $11.23 ($44.90 × 0.25 hours) and $22.45 ($44.90 × 0.5 hours) for each childcare supervisor to administer the training. This training would include administrative guidance related to how investigations will be conducted and due process under the interim final rule. ORR also assumes that it will take approximately 1 hour at a cost of $44.90 ($44.90 × 1 hour) for each childcare supervisor to update relevant policies.

In § 412.100(a) through (g) ORR discusses the establishment and operation of its investigations into alleged child abuse and neglect. Currently, based on FY 2024 levels of wages, benefits, and indirect labor costs, ORR estimates 24 full-time staff will be required at a cost of approximately $209,000 per staff member for a total of approximately $5 million ($209,000 × 24 staff) per year. The ORR Child Welfare Investigators will receive allegations of child abuse and neglect as intake reports, assess the allegation to determine whether it meets applicable requirements and definitions, conduct all necessary interviews, review and preserve all relevant evidence, implement any necessary safety plans, coordinate with the multidisciplinary team as needed, and render a disposition. ORR expects no new costs or burdens on care provider facilities to cooperate with ORR's investigations.

ORR also notes that all care provider facilities discussed in this interim final rule are ACF grantees and the costs of maintaining compliance with the requirements are allowable costs to grant awards under the Basic Considerations for cost provisions at 45 CFR 403 through 405, in that the costs are reasonable, necessary, ordinary, treated consistently, and are allocable to the award. Additional costs associated with the policies discussed in this interim final rule that were not budgeted, and cannot be absorbed within existing budgets, would be allowable for the grant recipient to submit a request for supplemental funds to cover the costs.

The Secretary certifies under 5 U.S.C. 605(b), as enacted by the Regulatory Flexibility Act (Pub. L. 96-354), that this rule will not result in a significant impact on a substantial number of small entities. This rule primarily affects the operations of the Federal Government and requires that ORR care provider facilities within the scope of this rule cooperate with Federal investigations of child abuse and neglect. As of publication of this rule, 66 of 284 (23 percent) ORR care provider facilities are located in Texas and would be impacted by the requirements in this interim final rule. While the affected percentage of small entities exceeds the threshold of 5 percent for this subcategory of care provider facilities within the U.S., ORR believes the burden associated with the requirements in this interim final rule are equal to or negligibly greater than the burden imposed by any State-based requirements to which the affected care provider facilities would otherwise be subjected. While this rule primarily affects the Federal Government, ORR assumes all of these care provider facilities qualify as small businesses as defined by the Small Business Administration (SBA), and ORR has therefore attempted to ensure the economic impact on individual care provider facilities is kept to a minimum.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires ORR to prepare a written statement, which includes estimates of anticipated impacts, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $177 million, using the most current (2022) Implicit Price Deflator for the Gross Domestic Product. This interim final rule would not likely result in unfunded expenditures that meet or exceed this amount.

This interim final rule would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. This interim final rule would implement ORR's explicit statutory authority to investigate child abuse and neglect allegations in ORR care provider facilities, and would enable it to make findings relevant to its responsibility for the care of unaccompanied children. In codifying these practices, ORR was mindful of its obligations to meet the requirements of Federal statutes while also minimizing conflicts between State law and Federal interests. At the same time, ORR is also mindful that its fundamental obligations are to ensure that it implements its statutory responsibilities pursuant to both the HSA and TVPRA, to protect the safety of unaccompanied children while in ORR care.

Typically, ORR enters into cooperative agreements or contracts with non-profit and private organizations to provide shelter and care for unaccompanied children in a care provider facility licensed by the appropriate State or local licensing authority if the State licensing agency provides for licensing of care provider facilities that provide services to unaccompanied children. This regulation allows ORR to investigate allegations of child abuse and neglect only in instances where a State will not investigate allegations of child abuse and neglect in ORR care provider facilities, and at EIFs. ORR has designed its policies and regulations, as well as the terms of its cooperative agreements and contracts with the unaccompanied children care provider facilities, to complement applicable State and local licensing rules, not to supplant or replace the requirements. Because the applicability of this regulation is limited precisely to circumstances where a State does not investigate child abuse and neglect at ORR care provider facilities, and EIFs, it does not implicate federalism concerns or impose substantial direct compliance costs on State or local governments. Further, this regulation does not preempt State laws and regulations because it applies specifically where States have explicitly abdicated their investigatory responsibility in ORR care provider facilities housing unaccompanied children, and at EIFs where States may not have authority to conduct investigations. Where State or local authorities enter into formal written agreements with ORR to conduct investigations, ORR may still, pursuant to its statutory authority, carry out its own investigations, but any potential ORR investigation under this rule would not interfere with the State or local authority's investigation.

Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this interim final rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

Notwithstanding the determination that the formal consultation process described in Executive Order 13132 is not required for this rule, ORR welcomes any comments from representatives of State and local juvenile or family residential facilities—among other individuals and groups—during this rulemaking.

This interim final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

Section 654 of the Treasury and General Government Appropriations Act of 1999 requires Federal agencies to determine whether a policy or regulation may affect family well-being. If the agency's determination is affirmative, then the agency must prepare an impact assessment addressing criteria specified in the law. This regulation will not have an impact on family well-being as defined in this legislation, which asks agencies to assess policies with respect to whether the policy: strengthens or erodes family stability and the authority and rights of parents in the education, nurture, and supervision of their children; helps the family perform its functions; and increases or decreases disposable income.

For the reasons set forth in the preamble, the ORR adds 45 CFR part 412 to read as follows:

NMFS manages the Pacific sardine fishery in the U.S. exclusive economic zone (EEZ) off the Pacific coast ( i.e., off the U.S. West Coast states of California, Oregon, and Washington) in accordance with the CPS FMP. The CPS FMP and its implementing regulations require NMFS to set annual reference points and management measures for the Pacific sardine fishery based on the annual specification framework and control rules in the FMP. These control rules include the harvest guideline (HG) control rule, which, in conjunction with the OFL and ABC control rules in the FMP, are used to set required reference points, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (MSA) (16 U.S.C. 1801 et seq. ). Additionally, the CPS FMP requires additional management measures, intended to restrict harvest, for the Pacific sardine fishery, such as catch restrictions.

NMFS publishes annual specifications in the Federal Register to establish these annual reference points ( e.g., the OFL, ABC, and ACL) and management measures for each Pacific sardine fishing year. NMFS published proposed specifications and management measures on June 21, 2024 (89 FR 52005). Additionally, in response to a court order, and to avoid a lapse in regulations, NMFS published an interim final rule (89 FR 62668; August 1, 2024) that was effective July 29, 2024, and is in place until replaced by these 2024-2025 final specifications.

Based on the 2024 benchmark stock assessment for Pacific sardine, the associated estimated age 1+ biomass of 58,614 mt, the control rule formulas in the FMP, and recent related Court orders, NMFS is implementing, as proposed, an OFL of 8,312 mt, an ABC of 6,005 mt, an ACL of 6,005 mt, and an ACT of 5,500 mt.

The CPS FMP includes a prohibition of the primary directed fishery when the biomass is at or below 150,000 mt. The Pacific sardine primary directed fishery is therefore closed, and Pacific sardine catch during the 2024-2025 fishing season is prohibited unless it is harvested as part of the live bait, tribal, or minor directed fisheries, as incidental catch in other fisheries, or as part of exempted fishing permit (EFP) activities.

The 2024-2025 fishing year specifications can be found in table 1, and management measures are listed after table 1.

The following are the additional management measures and in-season accountability measures for the 2024-2025 Pacific sardine fishing year:

(1) If landings in the live bait fishery reach 3,000 mt of Pacific sardine, then a per-trip limit of 1 mt of Pacific sardine applies to the live bait fishery;

(2) An incidental per-landing limit of 30 percent (by weight) of Pacific sardine applies to other CPS primary directed fisheries ( e.g., Pacific mackerel);

(3) If the ACT of 5,500 mt is attained, then a per-trip limit of 1 mt of Pacific sardine applies to all CPS fisheries ( i.e., (1) and (2) will no longer apply); and

(4) An incidental per-landing allowance of 2 mt of Pacific sardine applies to non-CPS fisheries until the ACL is reached.

In addition to the management measures and in-season accountability measures listed in the previous paragraphs, Pacific sardine catch in the minor directed fishery for finfish remains limited to 1 mt per trip per day, and 1 trip per day by any vessel, per regulations at 50 CFR 660.511(d)(2).

At the April 2024 Pacific Fisheries Management Council (Council) meeting, the Council's Scientific and Statistical Committee (SSC) reviewed a Stock Assessment Review (STAR) panel report on the Southwest Fisheries Science Center's 2024 benchmark stock assessment, and also reviewed the benchmark stock assessment itself, titled “Assessment of the Pacific sardine resource ( Sardinops sagax ) in 2024 for U.S. management in 2024-2025.” The SSC concluded that the 2024 benchmark assessment for Pacific sardine is the best scientific information available for the management of Pacific sardine. During their review, the SSC noted major improvements in methodology from the 2020 benchmark assessment, including an updated habitat model for assigning fishery catch and survey biomass to the northern and southern subpopulations of Pacific sardine. However, the SSC applied a category 2d sigma uncertainty buffer which, compared to a category 1, equates to a larger allowance for scientific uncertainty, and therefore a lower ABC and a decreased risk of overfishing. During the discussion of the appropriate category, the SSC discussed potential uncertainty in the relationship between sardine productivity and ocean temperatures recently used to calculate the E MSY parameter of the OFL and ABC control rules, as well as uncertainty in the strength of the 2023 year-class represented in the stock assessment, along with other uncertainties in the data used in the assessment.

The CPS FMP control rules, as they apply to annual reference points, use the following formulas:

Biomass. The estimated stock biomass of Pacific sardine ages 1 and older, in metric tons.

E MSY . The exploitation rate for deterministic equilibrium maximum sustainable yield. Since 2014, based on annual recommendations by the Pacific Fishery Management Council's SSC, the E MSY for Pacific sardine has most recently been based on a temperature-recruitment relationship based on a running 3-year average of the California Cooperative Oceanic Fisheries Investigations (CalCOFI) temperature index.

DISTRIBUTION. The average portion of the Pacific sardine biomass estimated to be in the U.S. EEZ off the Pacific coast. DISTRIBUTION is currently defined in the CPS FMP as 87 percent and is based on the average historical larval distribution obtained from scientific cruises and the distribution of the resource according to the logbooks of aerial fish-spotters.

BUFFER. The percentage reduction of the OFL as determined by the SSC's evaluation of scientific uncertainty (sigma) and the Council's risk policy (P*).

During the 2019-2020 fishing year, the estimated biomass of sardine dropped below its minimum stock size threshold of 50,000 mt, which triggered an overfished determination process. NMFS accordingly declared the stock overfished on June 26, 2019 and notified the Council on July 9, 2019. NMFS worked with the Council to develop a rebuilding plan for Pacific sardine to implement within two years and finalized it on June 24, 2021 (86 FR 33142). The rebuilding plan maintained the status quo management for Pacific sardine, which includes a complete closure of the primary sardine fishery. Oceana, an environmental non-governmental organization, challenged this rebuilding plan and later included a challenge to the 2023-2024 annual specifications (“2023 Final Rule”; 88 FR 41040), in an action filed in the United States District Court for the Northern District of California: Oceana, Inc., v. Raimondo, et al., No. 5:21-cv-05407-VKD (N.D. Cal., filed July 14, 2021). In its rulings on the challenges, the Court partially vacated the rebuilding plan and held that NMFS failed to demonstrate that it relied on best available science to set the overfishing limits in using the CalCOFI temperature index to determine E MSY for the 2023 Final Rule.

The Court partially vacated the rebuilding plan on June 28, 2024. Accordingly, NMFS cannot rely on the vacated components of the rebuilding plan to guide these annual specifications. The harvest control rules in place before Amendment 18 to the CPS FMP implemented the now partially-vacated rebuilding plan are still applicable. None of the provisions of Amendment 18, whether vacated or not, changed the previously applicable harvest control rules.

NMFS considered the recent order from the Court in making a determination that the harvest specifications and management measures in this action would prevent overfishing, rebuild the stock, and are supported by the best scientific information available. As they have in previous years, the SSC recommended an OFL and ABC for the 2024-2025 fishing year that were calculated, in part, by using an E MSY based on a relationship with CalCOFI temperatures as best scientific information available for preventing overfishing. The CPS FMP does not mandate that E MSY be based on this relationship. Under the MSA, the SSC provides scientific advice for NMFS' consideration in fishery management decisions, including ABC and preventing overfishing. Per National Standard 2 at 50 CFR 600.315(a)(2), scientific information that is used to inform decision making should include an evaluation of its uncertainty and management decisions should recognize the risks, such as those to overfishing, associated with the sources of uncertainty. The SSC discussed the potential uncertainty surrounding the use of the CalCOFI-based E MSY when considering their choice of the appropriate sigma for the ABC. NMFS has determined that the use of a Category 2 sigma, as recommended by the SSC, appropriately accounts for any scientific uncertainty and gaps in scientific information that may exist, including any surrounding E MSY , in the information used to calculate the recommended reference points.

In making the determination to approve the OFL and ABC recommended by the Council, NMFS took into account the fact that the SSC recommended that the analysis and assumptions surrounding a CalCOFI based E MSY be revisited. This was one of several scientific recommendations made by the SSC in April 2024. Other recommendations included a potential reconsideration of the need for the precaution provided by the DISTRIBUTION term, noting that a substantial proportion of the U.S. catch in recent years is inferred to be from the southern subpopulation of Pacific sardine and that there has been a decline in the assumed catch of northern subpopulation by Mexico, as well as endorsement of the eight high-priority research recommendations for future sardine stock assessments in the 2024 sardine STAR panel report. All of these recommendations are typical of the scientific process to inform fishery management decisions such as determining an appropriate OFL and ABC to prevent overfishing and achieve optimum yield in the fishery.

NMFS also examined recent and past years' CalCOFI temperatures in relation to this year's calculated CalCOFI-based E MSY . The calculated value for this year is 0.163 and represents the lowest E MSY in 10 years, and falls in the lower range of expected values. The decline in E MSY this year compared to the last 3 years is the result of a high temperature record year in 2020 falling out of the running 3-year average temperature used to calculate E MSY . This effect was also observed between 2014 and 2017 when a very large marine heatwave off the Pacific coast caused unprecedented disruptions in the ocean environment, resulting in high CalCOFI temperatures. The highest CalCOFI temperature in 40 years was recorded in 2015. Such events increase the running 3-year average temperature used to calculate E MSY . To reduce the risk of potentially excessive E MSY values, the SSC recommended in 2014 that a CalCOFI-based E MSY be restricted to a maximum of 0.25 (for reference, this equated to a temperature of 16.16 °C when the median temperature was 15.90 °C). This cap on E MSY was applied to calculations of the reference points for the 2016-2017 and 2018-2019 fishing years.

Although the Court found that NMFS' rationale for exclusively using CalCOFI data to determine E MSY in order to set the 2023-2024 specifications was inadequate, it explicitly declined to prohibit NMFS from employing the CalCOFI-based E MSY in setting catch limits, and stated that the agency must reassess the rebuilding plan and determine how to meet the requirements of the MSA in view of the Court's order. In light of the Court's finding prior to the issuance of the 2024-2025 harvest specifications, and as part of a robust decision-making process, NMFS considered whether there was alternative scientific information, per 50 CFR 600.315(a)(2), that would warrant disapproving the Council's recommendation.

Although E MSY is lower this year than any E MSY used in the last 10 years, NMFS acknowledges there is still scientific uncertainty surrounding the predictive efficacy of the CalCOFI temperature index. However, as explained in both the proposed rule and this final rule, this uncertainty was considered by the SSC and the Council when recommending a 2,307 mt reduction from the OFL to the ABC ( i.e., OFL is 8,312 mt but ABC and ACL are both 6,005 mt). Importantly, as discussed in the proposed rule and in the paragraphs that follow, in addition to accounting for any scientific uncertainty surrounding CalCOFI, NMFS also considered the only available alternative to its use, which resulted in a higher value than the CalCOFI-based E MSY , and determined the lower value was appropriate to use in setting this year's specifications.

Currently, there are no other formulaic relationships between Pacific sardine recruitment and an environmental variable on which to base E MSY . However, past analyses have calculated a stochastic (referenced as “static” in proposed rule) E MSY of 0.18 when the effects of temperature on productivity are ignored. 1 This value for E MSY was recommended by the SSC and utilized by NMFS as best scientific information available for management in 2012-2014 as an alternative to the default option of applying the temperature-stock relationship due to uncertainty surrounding the relationship at that time. 2 During the Council's April 2023 Pacific sardine harvest specification process, the SSC specifically compared this stochastic value to the CalCOFI-based 2023-2024 E MSY of 0.22 in its discussion of an appropriate OFL buffer: “There was no support among SSC members for a category 1 designation, but there was some discussion of the merits of a category 2 versus a category 3 assessment. Although uncertainty in E MSY would argue for increased uncertainty in the OFL, it was noted that the `nondynamic' harvest rate (estimated to maximize long-term yield in stochastic simulations), of 0.18, is not very different from 0.22 based on current SSTs, and that other CPS stocks have rates that are higher still (Pacific mackerel E MSY is ~0.3).”  3

NMFS considers this modeled stochastic E MSY of 0.18 as the only available alternative that could have been considered in making OFL determinations for Pacific sardine without the use of the CalCOFI temperature index. However, the Council's SSC recommended to the Council an OFL that utilized the CalCOFI-based E MSY as the best scientific information available. In making the decision to approve the OFL and ABC in this action, NMFS considered the stochastic E MSY of 0.18. NMFS concluded that, at this time, it cannot make a determination that the stochastic E MSY of 0.18 represents a better alternative to the CalCOFI-based E MSY value the SSC recommended as the best scientific information available for determining this year's OFL. Since 2000, when the CPS FMP was adopted and harvest control rules were established for Pacific sardine, it has been determined that making efforts to include environmental information into the management of Pacific sardine is the preferred approach. And although the relatively recent running 3-year average CalCOFI temperatures have resulted in higher values than in previous years, likely as a result of anomalous, although becoming more frequent, oceanographic events, that may appear to contradict the original concept of the environmental E MSY, this year's temperature and resulting E MSY align with the concept as they are both in the lower range of values during a time of relatively low sardine recruitment. NMFS will continue, as it has each year, to evaluate whether the use of the CalCOFI-based E MSY is the best scientific information available for future annual specifications.

As noted in the proposed rule, the Council's recommended OFL, calculated using an E MSY of 0.163, is a lower OFL and therefore more precautionary than an OFL would have been based on the stochastic E MSY of 0.18. Additionally, it has been previously suggested that one approach to set a precautionary proxy fishing mortality rate for small pelagic fish such as Pacific sardine is to use a value that equates to one half of the species natural mortality rate. 4 Based on the estimates of natural mortality from the 2024 Pacific sardine stock assessment, this formula would produce an E MSY in the range of 0.25-0.30. By contrast, the E MSY utilized to calculate the OFL implemented through this action is only 0.163. For these reasons, NMFS has determined that the reference points recommended by the Council are based on the best scientific information available and, therefore, NMFS has determined to implement them through this action.

Although this action implements an ACL equal to the ABC at 6,005 mt, as envisioned by the FMP, NMFS has determined that as a result of the closure of the directed fishery and additional management measures, landings of the northern subpopulation of Pacific sardine will remain very low and total U.S. sardine landings are highly unlikely to exceed 2,200 mt, similar to what has occurred since the 2015-2016 fishing year, when the directed fishery was closed (see table 2).

All sources of catch, including any EFP set-asides, the live bait fishery, and other minimal sources of harvest, such as incidental catch in CPS and non-CPS fisheries and minor directed fishing, will be accounted for against the ACT and ACL. Any Pacific sardine harvested between July 1, 2024, and the effective date of this final rule will count toward the 2024-2025 ACT and ACL.

At the April 2024 Council meeting, the Council recommended apportioning 670 mt of the ACL for two EFP proposals to support stock assessments for Pacific sardine. NMFS published a notice of receipt of EFP applications on June 26, 2024 (89 FR 53396). The comment period closed on July 26, 2024, and NMFS received no comments. NMFS is deciding whether to issue the EFPs during the promulgation of this final rule. The NMFS West Coast Regional Administrator will publish a notice in the Federal Register to announce when catch reaches the incidental limits, as well as any changes to allowable incidental catch percentages or trip limits. Additionally, to ensure that the regulated community is informed of any closure, NMFS will make announcements through other means available, including emails to fishermen, processors, and state fishery management agencies.

On June 21, 2024, NMFS published a proposed rule for this action and solicited public comments through July 8, 2024 (89 FR 52005). NMFS received two public comment letters relevant to this action, one from the California Wetfish Producer's Association (CWPA) and one from the non-governmental conservation organization Oceana. After considering the public comments, NMFS made no changes from the proposed rule. The comment from CWPA supported this action. The comment letter from Oceana included multiple comments, some of which are beyond the scope of this action. Additionally, some of the comments and requests provided by Oceana were the subject of recent litigation. The U.S. District Court (N.D. Cal.) has ruled in this case, and NMFS notes that it must complete the remand of the Pacific sardine rebuilding plan by June 1, 2025 ( Oceana, Inc., v. Raimondo, et al. ). NMFS summarizes and responds to those comments from Oceana below.

Comment 1: Oceana states that the E MSY used to set the OFL, ABC, and ACL fails to prevent overfishing and is inconsistent with the best available science on sardine productivity. Oceana states that in NMFS' rationale for continuing to use the CalCOFI index for E MSY , NMFS incorrectly asserts that the identified flaws in the CalCOFI index are due to uncertainty.

Response: NMFS has determined that the OFL and ABC implemented through this action will prevent overfishing and are supported by the best scientific information available. NMFS notes that this issue was the subject of recent court orders: on April 22, 2024, the Court issued an order stating that NMFS failed to demonstrate that it had relied on the best available science in setting the 2023-2024 OFL for Pacific sardine using an exclusively CalCOFI-derived E MSY . As stated in this rule, NMFS took into account the Court's finding on this matter and has determined that reference points established by this action, specifically the OFL and ABC, will prevent overfishing, support the rebuilding of the stock, and are supported by the best scientific information available. In an attempt to address the Court's concern for these 2024-2025 harvest specifications, NMFS expressly considered what available information exists that would necessitate that NMFS disapprove the Council's recommended OFL. As stated above, NMFS considered the only alternative E MSY value previously analyzed and used by the Council's SSC and NMFS, which was 18 percent. The use of the 18 percent E MSY was previously supported by analyses conducted by Hurtado-Ferro and Punt (2013) developed to evaluate the performance of alternative candidate OFL and HG control rule variants. That analysis used a Pacific sardine specific model to calculate an E MSY to examine constant exploitation rate harvest control rules ( i.e., an E MSY that does not account for an environmental effect), and is also the E MSY value that was used to project the population in the rebuilding analysis for Pacific sardine.

For this year, the alternative of an 18 percent E MSY would be higher than the CalCOFI-based E MSY value, and would therefore result in a higher OFL than the OFL recommended by the SSC. As described in this rule, the CalCOFI-based E MSY is among the lowest values produced by the CalCOFI (sea surface) temperature index in the past 10 years. The literature cited by the commenter (Zwolinski and Demer, 2019) re-evaluated the correlation between the sea surface temperature E MSY values and recruitment success of the northern subpopulation of Pacific sardine over a specific period of years and suggested that the relationship was no longer statistically valid. However, the same journal article that called into question the validity of the CalCOFI temperature index in predicting the productivity of Pacific sardine stated that “. . . even a marginally statistically significant environment-dependent recruitment model may be useful. For example, if required by the HCR, it could be used to predict recruitment in the management year and forecast the stock biomass into the following year more precisely than a model without environmental influence.”  5 While NMFS will continue to evaluate E MSY , it has determined that use of the CalCOFI temperature index is the best scientific information available in setting the 2024-2025 Pacific sardine harvest specifications.

Comment 2: Oceana argues that the stochastic E MSY value of 18 percent is outdated and incorrect and that NMFS fails to analyze other available alternatives for setting the E MSY value for the 2024-2025 specifications. Oceana suggests using an E MSY value of 5 percent from Alternative 3 in Amendment 18 to the CPS FMP to set the OFL. Oceana states that NMFS could alternatively also readily produce an E MSY from the 2024 stock assessment, as it did in the 2022 northern anchovy stock assessment, and use it to calculate the 2024-2025 annual catch specifications.

Response: As stated previously in this rule, in light of the Court's finding that NMFS' rationale for using the CalCOFI based E MSY in the 2023-2024 specifications was inadequate, NMFS re-examined and reviewed the relevant information available to make a determination on approving the OFL and ABC implemented through this action. While Oceana states that the CalCOFI-based E MSY and the stochastic 18 percent E MSY are not consistent with the best scientific information available on sardine productivity, the comment did not offer alternative best scientific information available and NMFS has determined that none exists. Oceana suggests that NMFS consider a 5 percent E MSY ; however, NMFS could not, through this action, implement an OFL utilizing a 5 percent E MSY and additionally has no evidence that this would represent best scientific information available. NMFS recognizes that a harvest rate of 5 percent was considered as part of alternative 3 for Amendment 18, and this could remain a potential alternative under any future rebuilding plan; however, NMFS has determined it does not represent the best scientific information available for use as an E MSY to calculate this year's OFL. NMFS has no basis to consider a 5 percent E MSY as alternative best scientific information available. Unlike the stochastic 18 percent described above, 5 percent is not a result of modeling work explicitly designed to calculate E MSY . The 5 percent value under alternative 3 represented a harvest level between status quo management and zero U.S. harvest, which was analyzed as a policy option to explore the differences in potential rebuilding timelines as a result of reduced harvest levels. Absent any support for an E MSY of 5 percent as a basis for calculating the OFL, NMFS could not determine that it was the best scientific information available.

In addition, Oceana's suggestion that NMFS could “readily” produce an updated E MSY from the 2024 stock assessment as was done for the central subpopulation of northern anchovy (CSNA) is misleading, because the 2024 sardine stock assessment did not produce an E MSY that could be considered in this rulemaking. The management of Pacific sardine has never utilized an E MSY derived from a stock assessment model. No such E MSY is available because it has not been produced by scientists and peer reviewed, and thus an E MSY derived from a stock assessment model would not be the best scientific information available as required under the MSA. Calculating E MSY for CPS stocks from a stock assessment requires scientists to run multiple data analyses, including reassessments to address potential issues, and these results would then need to be packaged and written up. This is not a straightforward process that could be accomplished and appropriately reviewed in the time available to complete this rulemaking.

The complications of this process are highlighted by the CSNA E MSY development. The most appropriate way to calculate the CSNA E MSY was discussed at multiple meetings, including the STAR panel meeting for the 2022 CSNA assessment as well as a full SSC meeting. These discussions included scientifically technical deliberations on the parameters of the stock assessment that influence the E MSY calculation. Ultimately the SSC recommended an E MSY value resulting from the stock assessment model; however, at the time the SSC noted that uncertainty in that value remained: “The SSC endorses the E MSY value (labeled F MSY in the assessment) of 0.493 estimated within the assessment, where E is expressed as annual total catch divided by summary age-1+ biomass, while noting that the value of E MSY remains a major uncertainty.” During the 2024 Pacific sardine stock assessment process an E MSY was not developed. Furthermore, any sort of E MSY from the assessment model for Pacific sardine would likely carry similar uncertainties as those associated with the CSNA value that would require a thorough review and would not be reliable for the 2024-25 specifications.

Comment 3: Oceana states that the proposed ACL would not allow rebuilding within the legally required timeline because it represents a harvest rate and overall catch level that NMFS's rebuilding analysis showed will not rebuild the Pacific sardine population. Oceana states that in contrast, NMFS's rebuilding analysis showed that a constant catch of 2,200 metric tons or a 5 percent harvest rate would rebuild the population.

Response: NMFS acknowledges that the Court's order vacated parts of the rebuilding plan that must be addressed by June 1, 2025, including that the plan failed to rebuild the stock within the statutory timeframe under the MSA. The Court has provided NMFS until June 1, 2025 to develop a new rebuilding plan that will specify a time period for rebuilding Pacific sardine that will be as short as possible, taking into account the status and biology of any overfished stocks of fish, the needs of fishing communities, recommendations by international organizations in which the United States participates, and the interaction of the overfished stock of fish within the marine ecosystem. The rebuilding plan will also include conservation and management measures consistent with achieving rebuilding within the specified time period. It is not required by the Court's order to implement this rebuilding plan in this rule.

Comment 4: Oceana states that given the uncertainties, evidence of previous overfishing, and the need to rebuild, Oceana recommended NMFS use a lower P-star parameter than the 0.4 recommended by the Council. Noting that P-star represents the risk of overfishing.

Response: The choice of P-star is only one factor in creating a buffer between the OFL and ABC to help ensure overfishing is prevented. The other factor used for Pacific sardine is the sigma value recommended by the SSC. This sigma value is intended to capture scientific uncertainty in the OFL estimate. The Council's P-star choice is then intended to capture other factors, such as management uncertainty, in preventing overfishing. There is extremely limited management uncertainty associated with tracking catch levels against the applicable catch reference points for Pacific sardine. NMFS is readily able to track fishing mortality across the various sectors in season to ensure landings do not exceed the ACL or ABC. NMFS therefore has determined that the ABC has been appropriately reduced from the OFL to prevent overfishing.

Comment 5: Oceana states that given the stock remains near the 50,000 mt minimum stock size threshold, the proposed incidental harvest rate of 30 percent is excessive.

Response: The CPS FMP dictates that if the estimated biomass is below 50,000 mt, then the incidental harvest rate is restricted to 20 percent landing by weight. The 2024 estimated biomass is 58,614 mt. Under the CPS FMP, at this value, the incidental rate could be up to 45 percent; therefore, 30 percent is in line with the allowances of the CPS FMP. Additionally, during the 2018-2019 fishing year, the last year that the stock's biomass was more than 50,000 mt, the incidental harvest allowance was 40 percent, and the incidental fishery harvested 272 mt. The following year, the incidental harvest allowance was restricted to 20 percent, and the incidental fishery harvested 249 mt. Increasing the incidental harvest allowance doesn't necessarily change the amount of Pacific sardine catch, but allows more flexibility for vessels to reduce unwanted discards when the catch ratio of sardine to other CPS is greater than 20 percent.

Pursuant to section 304(b)(1)(A) of the MSA, the NMFS Assistant Administrator has determined that this final rule is consistent with the CPS FMP, other provisions of the MSA, and other applicable law.

This final rule is exempt from review under Executive Order 12866 because it is a routine rule that would implement regulations for less than 1 year.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities for the purposes of the Regulatory Flexibility Act. The factual basis for the certification was published in the proposed rule (89 FR 52005, June 21, 2024) and is not repeated here. As a result, a final regulatory flexibility analysis was not required and none was prepared.

Pursuant to Executive Order 13175, this proposed rule was developed after meaningful consultation and collaboration with the Council's tribal representative, who has agreed with the provisions that apply to tribal vessels.

This action does not contain a collection-of-information requirement for purposes of the Paperwork Reduction Act. There are no relevant Federal rules that may duplicate, overlap, or conflict with the proposed action.