This Committee meeting is available to the public through the registration link above. Any interested members of the public may attend this meeting. An open comment period will be provided to allow members of the public to make oral comments as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email svillanueva@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Sarah Villanueva at svillanueva@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at (434) 515-0204.

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Committee meetings are available to the public through the videoconference link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Closed captions will be provided for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Angelica Trevino, Support Services Specialists, at atrevino@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Kayla Fajota (DFO) at kfajota@usccr.gov.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via www.facadatabase.gov under the Commission on Civil Rights, Alaska Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at atrevino@usccr.gov.

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on April 23, 2025. 1 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. 2 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The products covered by this investigation are certain monomers and oligomers from Taiwan. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the Preamble to Commerce's regulations, 3 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). 4 No interested party commented on the scope of the investigation as it appeared in the Initiation Notice. Therefore, Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice.

Commerce is conducting this investigation in accordance with section 731 of the Act. Pursuant to section 776(a) of the Act, Commerce has preliminarily relied upon facts otherwise available for Eternal Materials Co., Ltd. (Eternal Materials), Qualipoly Chemical Corporation (Qualipoly), and Synth-Edge Advanced Material Co., Ltd. (Synth-Edge), the mandatory respondents in this investigation, because each failed to submit the necessary information to calculate an antidumping margin in this investigation. Furthermore, pursuant to sections 776(a) and (b) of the Act, Commerce has preliminarily relied upon facts otherwise available, with adverse inferences for Eternal Materials, Qualipoly, and Synth-Edge. For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

In accordance with section 733(e) of the Act and 19 CFR 351.206, Commerce preliminarily finds that critical circumstances exist for Eternal Materials, Qualipoly, Synth-Edge, and all-other companies not selected for individual examination. For a full description of the methodology and results of Commerce's critical circumstances analysis, see the Preliminary Decision Memorandum.

Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that, in the preliminary determination, Commerce shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act.

In this investigation, Commerce preliminary assigned a rate based entirely on facts available under section 776 of the Act to the three mandatory respondents. Consequently, pursuant to section 735(c)(5)(B) of the Act, Commerce's normal practice under these circumstances has been to calculate the all-others rate as a simple average of the alleged dumping margin(s) from the petition. 5

On December 13, 2024, Commerce published the Preliminary Results in the Federal Register and invited interested parties to comment. 1 On May 16, 2025, Commerce extended the deadline for the final results of this administrative review. 2 The deadline for these final results is now September 5, 2025. For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 3

The product covered by this Order is aluminum foil. 4 For a complete description of the scope of the Order, see the Issues and Decision Memorandum.

Commerce addressed all issues raised in interested parties' case and rebuttal briefs in the Issues and Decision Memorandum. A list of the issues raised by parties, to which Commerce responded in the Issues and Decision Memorandum, is provided as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Commerce conducted this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we find that there is a subsidy, i.e., a government-provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific. 5 For a complete description of the methodology underlying all of Commerce's conclusions, including our reliance on facts otherwise available, including adverse facts available (AFA), pursuant to sections 776(a) and (b) of the Act, see the Issues and Decision Memorandum.

Based on a review of the record and comments received from interested parties regarding our Preliminary Results and Post-Preliminary Analysis, 6 and for the reasons explained in the Issues and Decision Memorandum, we made one modification to our upstream subsidy analysis for these final results of review.

We determine that the following net countervailable subsidy rate exists for the period January 1, 2022, through December 31, 2022:

Commerce intends to disclose its calculations and analysis performed for these final results of review within five days after the date of publication of this notice in the Federal Register in accordance with 19 CFR 351.224(b).

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries of subject merchandise in accordance with the final results of this review, for the above-listed companies at the applicable ad valorem assessment rates listed. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

In accordance with section 751(a)(2)(C) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown for the companies subject to this review for shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review. For all non-reviewed companies, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposits, when imposed, shall remain in effect until further notice.

This notice also serves as a final reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.

These final results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5).

The following items included in the tentative agenda will be discussed:

SEDAR 91 U.S. Caribbean Spiny Lobster St. Croix Assessment Report- Adyan Ríos, Caribbean Branch SEFSC, NOAA Fisheries

The order of business may be adjusted as necessary to accommodate the completion of agenda items. The meeting will begin on September 23, 2025, at 12:30 p.m. AST, and will end on September 25, 2025, at 5 p.m., AST. Other than the start time, interested parties should be aware that discussions may start earlier or later than indicated, at the discretion of the Chair. In addition, the meeting may be completed prior to the date established in this notice.

For Any Additional Information On This Public Virtual Meeting, Please Contact Dr. Graciela García-Moliner, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 403-8337.

Authority: 16 U.S.C. 1801 et seq.

The Council will begin the meeting with introductions and announcements by Acting Council Chair Daniel Salerno, followed by the swearing-in of new and reappointed Council members and the election of officers for the 2025-2026 term.

The Council will then receive reports from the Council Chair and Executive Director, the Greater Atlantic Regional Fisheries Office (GARFO), NOAA General Counsel, the Northeast Fisheries Science Center (NEFSC), the Mid-Atlantic Fishery Management Council (MAFMC), the Atlantic States Marine Fisheries Commission (ASMFC), the U.S. Coast Guard, NOAA Enforcement, and the Highly Migratory Species Advisory Panel.

Following reports, Council staff will present recommendations under Executive Order 14276, Restoring American Seafood Competitiveness, for Council approval. The Council will then take final action on an omnibus Management Flexibility Action addressing specification frequency, rollover provisions, in-season adjustment authority, and related measures.

After the lunch break, the Council will receive a report from the Northeast Trawl Advisory Panel (NTAP) on its July 2025 meeting and updates on the Regional Industry-Based Trawl Survey (RIBTS) pilot project. The Scientific and Statistical Committee (SSC), chaired by Dr. Conor McManus, will present overfishing limit (OFL) and acceptable biological catch (ABC) recommendations for northern and southern monkfish and the skate complex, as well as scallop specification process recommendations.

The Council will then hear from the Monkfish and Skate Committees and take final action on Framework 17 to set monkfish specifications for 2026-2028 and defaults for 2029-2030, along with final action on skate specifications for 2026-2027 and defaults for 2028-2030. The meeting will adjourn at 5 p.m.

At 6 p.m., the Council will host a public outreach session at the Beauport Hotel to foster informal discussion among Council members, staff, industry participants, and members of the public.

The second day will begin with a presentation from the NEFSC Cooperative Research Branch, followed by the Scallop Committee report on Framework Adjustment 40, survey updates, the Scallop Strategic Plan, and the Limited Access General Category Individual Fishing Quota Program Review.

Next, the Groundfish Committee will report on Amendment 25, including Council final action to incorporate four cod stock units into the Northeast Multispecies Fishery Management Plan, and provide an update on Framework 72.

After a Council photo and lunch break, the Habitat Committee will present final action on an Essential Fish Habitat (EFH) framework revising EFH designations for Atlantic herring, Atlantic cod, skates, and monkfish. The Climate and Ecosystem Steering Committee will provide updates on process mapping, Inflation Reduction A-funded projects, and regional climate and ecosystem initiatives.

The day will conclude with an open public comment period for issues not listed on the agenda.

The Council will begin with a report from the On-Demand Gear Conflict Working Group, including final action on an omnibus framework to revise gear-marking regulations for the use of fixed gear without persistent buoy lines in New England and Mid-Atlantic fisheries. The Council also will review and approve the Working Group's final report under its Terms of Reference.

The Council will then hold an initial discussion of 2026 Council priorities, followed by planning updates from the Executive Director. The meeting will conclude with any other business and adjourn at noon.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Executive Director Cate O'Keefe (see ADDRESSES ) at least 5 days prior to the meeting date.

On February 25, 2025, the Council on Environmental Quality (CEQ) published an interim final rule that removed all iterations of its National Environmental Policy Act (NEPA) implementing regulations (as required by Executive Order (E.O.) 14154, Unleashing American Energy ), effective April 11, 2025.

The EIS complies with guidance for implementing NEPA in effect at the time of the preparation of the EIAMD System on Guam EIS: Section 102(2)(C) of NEPA of 1969, Sections 4321 et seq. of Title 42 United States Code (U.S.C.); CEQ regulations; MDA's NEPA Implementing Procedures (79 Federal Register 46410); USAF's Environmental Impact Analysis Process (32 Code of Federal Regulations (CFR) part 989); USA's NEPA Implementing Procedures (32 CFR part 651); USN's Procedures for Implementing NEPA (32 CFR part 775); and Chief of Naval Operations Instruction 5090.1E, Environmental Readiness Program; and Chief of Naval Operations Manual M-5090.1, Environmental Readiness Program Manual; and FAA NEPA implementing policies (FAA Order 1050.1F, Environmental Impacts: Policies and Procedures ).

The MDA and USA are issuing this ROD to select the Proposed Action, as described in the EIAMD System on Guam Final EIS. This action will allow them to construct and implement the EIAMD system capability, along with its associated mission support facilities and infrastructure requirements, on Guam. The other option, the No Action Alternative, would be not to construct and implement the EIAMD system capability, along with the associated mission support facilities and infrastructure requirements, on Guam; this would not meet the purpose of or need for the Proposed Action. The MDA and USA will request the FAA establish or modify existing restricted airspace on Guam, as described in the EIAMD System on Guam Final EIS, to address the High Intensity Radiated Fields hazard introduced by the operation of the EIAMD system.

The FAA is a cooperating agency for the EIS because it is assigned responsibilities pursuant to 49 U.S.C. 40101 for civil aviation and regulation of air commerce in the interests of aviation safety and efficiency. The MDA and USA will request that the FAA, as a cooperating agency, consider and adopt, in whole or in part, the EIS as the required NEPA documentation to support FAA decisions on the establishment and configuration of special use airspace. The FAA will publish a separate public notification as part of its rulemaking process and issue a separate ROD for the EIS in accordance with FAA Joint Order 7400.2R, Procedures for Handling Airspace Matters.

The selected action will construct, deploy, and operate and maintain a comprehensive, persistent, 360-degree EIAMD system to defend the entirety of Guam against the rapidly evolving threats of advanced cruise, ballistic, and hypersonic missile attacks from regional adversaries. The proposed EIAMD system includes a combination of MDA, USA, and USN components that have been integrated for air and missile defense and positioned on 16 sites on DoD lands across Guam. Site preparation could begin late in calendar year 2025. Following construction, testing, and final system check, the EIAMD system would become operational.

Guam is a key strategic location for sustaining and maintaining U.S. influence, deterring adversaries, responding to crises, and maintaining a free and open Indo-Pacific. Within the context of homeland defense, an attack on Guam would be considered a direct attack on the U.S. and would be met with an appropriate response. The Commander of U.S. Indo-Pacific Command has identified the need for a comprehensive, persistent, 360-degree layered Integrated Air and Missile Defense capability on Guam to address the rapid evolution of missile threats from regional adversaries. The U.S. Congress codified this requirement in the Fiscal Year (FY)22 and FY23 National Defense Authorization Acts. This defensive architecture must be adaptable to expand capability and capacity as the threat evolves. The purpose of the Proposed Action is to provide an enhanced integrated air and missile defense system to defend the entirety of Guam against rapidly evolving threats of advanced cruise, ballistic, and hypersonic missile attacks from regional adversaries as soon as possible.

The NEPA process includes a robust public participation component. The MDA initiated a 60-day formal public scoping period by publishing a Notice of Intent to prepare an EIS in the Federal Register on May 5, 2023. The public comment period was extended to 105 days to account for impacts from Typhoon Mawar, which struck Guam on May 24, 2023. Three public scoping meetings were held on Guam on August 2, 3, and 4, 2023. The MDA received 136 comments during the scoping period, which closed on August 18, 2023. The Draft EIS was released for a 75-day public review and comment period from October 25, 2024, through January 8, 2025, with a Notice of Availability published in the Federal Register on October 25 and 28, 2024. Two public meetings were held on Guam on November 14 and 15, 2024. The MDA received 72 comment letters during the public comment period, which closed on January 8, 2025. A Notice of Availability for the EIAMD System on Guam Final EIS was published in the Federal Register on July 25, 2025. This ROD concludes the NEPA process.

Although current U.S. forces are capable of defending Guam against regional ballistic missile threats, regional threats to Guam continue to increase and advance technologically. Guam's geographical location in the Pacific, topography, existing DoD lands, and critical infrastructure the island the only reasonable location capable of accommodating the unique 360-degree EIAMD system performance requirements. System components need to be distributed at locations throughout Guam to provide the performance required to defend against threats. As such, alternatives analyzed in the EIAMD System on Guam EIS consist of the Proposed Action and the No Action Alternative.

Under the No Action Alternative, the EIAMD system would not be established on Guam. By implementing the No Action Alternative, defensive capabilities would not expand to provide enhanced defense capability for Guam against the rapidly evolving threats of potential missile attacks from regional adversaries. The No Action Alternative serves as the baseline against which the Proposed Action is compared.

The Proposed Action is to implement an EIAMD system capability by constructing, deploying, and operating and maintaining a comprehensive, persistent, 360-degree EIAMD system for air and missile defense positioned on 16 sites on DoD properties on Guam. Of the proposed 16 sites, which include mission support sites, 8 are on Naval Base Guam (NBG) (including the NBG Munitions Site [NMS]), 6 are on Andersen Air Force Base (AAFB), and 2 are on Marine Corps Base Camp Blaz (MCBCB). Two sites (MCBCB South and NBG Nimitz Hill) would have Explosive Safety Quantity Distance arcs that encroach on non-DoD land, potentially requiring real estate actions on those properties. Additionally, one site (NMS Northeast) would require a road easement across Government of Guam lands to access the EIAMD system site on DoD property. In addition, the Proposed Action would include modifications and restrictions to existing airspace.

The EIAMD System on Guam Final EIS includes an analysis of potential impacts of the Proposed Action and No Action Alternative on the following resource areas; airspace management, health and safety, cultural resources, terrestrial biological resources, socioeconomics, protection of children and environmental justice, land use and recreational resources, transportation, visual quality, utilities, air quality, greenhouse gases, 1 noise, water resources, and geological and soil resources.

The discussion below summarizes only those resource areas expected to have significant impacts as a result of implementation of the Proposed Action. Based on the analysis presented in the Final EIS, all other resource areas were determined to have less than significant impacts.

Site Preparation and Construction: Implementation of the Proposed Action would result in removal of limestone forest (biologically important habitat for native wildlife and federal Endangered Species Act (ESA)-listed species) across nine sites. Implementation of mitigation measures would reduce expected impacts on terrestrial biological resources on Guam but impacts from the loss of limestone forest would remain major, long term, and significant with implementation of the Proposed Action.

There would be significant impacts from the removal of approximately 5,459 individuals of the federal ESA-listed threatened plant Cycas micronesica at five locations. Implementation of mitigation measures would reduce impacts from the implementation of the Proposed Action. Due to the ongoing population decline of Cycas micronesica on Guam, combined with the additional loss of approximately 5,459 individuals, the impacts on Cycas micronesica would remain major, long term, and significant.

There would be significant impacts on the ESA-listed threatened Mariana fruit bat due to loss of 235 acres of limestone forest habitat. Given this loss of foraging and roosting habitat and the critically low numbers of fruit bats on Guam, the loss would be a major, direct, long-term, and significant impact on Mariana fruit bats but mitigable to less than significant with implementation of the mitigation measures ( e.g., improving foraging and roosting habitat through the establishment of habitat enhancement sites [HESs]).

Site Preparation and Construction: Construction of the Proposed Action would require an average of 400 construction workers annually, and span over 10 years, with approximately 240 workers (60 percent) expected to be in-migrant laborers originating off Guam. Construction contractors may house in-migrant workers in suitable temporary workforce housing facilities or be required to find accommodations within the local housing market. The 2020 Guam Housing and Needs Study identified a need for an additional 9,908 housing units between 2020 and 2025 to meet community demand. In-migrant workers accommodated within the local housing market would further impact housing availability on Guam. Impacts on housing associated with the influx of in-migrant workers, although temporary, would have direct and indirect long-term, major, and significant impacts on the availability of housing on Guam.

Operations and Maintenance: Because the overall availability of housing on Guam is low, EIAMD system personnel arriving from other locations would serve on a rotational basis until adequate community support facilities are available. DoD recognizes the need for additional Life Support Facilities on Guam, including housing, to support the additional mission requirements. DoD is reviewing these needs holistically and plans to address the EIAMD system housing needs before the arrival of dependents in 2031. In the interim, for the Proposed Action, the USA plans to phase the deployment of EIAMD system personnel arriving on Guam. All EIAMD system personnel and dependents (except for civilian personnel and DoD contractors) arriving prior to 2031 will be housed in military housing units located on military installations as available. This phased approach would minimize the initial need for housing for EIAMD system personnel and limit the impact on Guam's housing market.

Beginning in 2031, approximately 2,300 permanent military and civilian personnel and their dependents, and 44 contractors supporting the EIAMD system, would reside on Guam. An estimated 20 percent (469 individuals) would require off-base housing. The projected housing requirement to support these personnel and their dependents is 324 units, which is approximately 18.8 percent of the currently available rental units on Guam that meet military housing standards. The local housing market and military housing may have sufficient capacity to meet the number of units required for operations personnel and their dependents arriving in 2031. The extent of impacts on housing, however, would depend on the availability of military housing, both the number of units and the timing of the construction of new units with the arrival of personnel, to support multiple DoD projects on Guam. Considering the limited availability of housing and the unmet community demand for housing units on Guam, impacts on housing are expected to be long term, major, and significant.

Given the increase in population associated with the Proposed Action, impacts on medical and health care services were determined to be long term and significant based on Guam's status as a Medically Underserved Area and the likelihood that the 2,300 permanent personnel and their dependents arriving on the island in 2031 would require access to local medical services, increasing the demand on a system that is already significantly overburdened. The DoD is also looking at medical services holistically and plans to address these needs prior to the arrival of dependents in 2031; military personnel associated with the Proposed Action would receive general health services at the military treatment facilities, which would minimize impacts on Guam.

Site Preparation and Construction: Site preparation and construction would result in significant short-term impacts on traffic at six intersections.

Operations and Maintenance: When compared to the 2035 baseline traffic conditions (conditions after completion of construction), 13 intersections are currently operating at level of service (LOS) F but would have an increase of at least 50 additional vehicles during peak AM/PM hours as a result of the Proposed Action. Therefore, impacts from operations and maintenance would be long term, major, and significant.

Pursuant to E.O. 14154, the CEQ issued guidance, “Implementation of the National Environmental Policy Act,” dated February 19, 2025, directing federal agencies to establish or update their NEPA implementing procedures by February 19, 2026, consistent with NEPA as amended by the Fiscal Responsibility Act of 2023 (Pub. L. 118-5). With respect to cumulative impacts considerations, the CEQ guidance provides: “Effects: Federal agencies should analyze the reasonably foreseeable effects of the proposed action consistent with section 102 of NEPA, which does not employ the term `cumulative effects;' NEPA instead requires consideration of `reasonably foreseeable' effects, regardless of whether or not those effects might be characterized as `cumulative.'” Because of the regulations in effect at the time of the preparation of the EIS, the Final EIS supporting this ROD continues to provide an analysis of cumulative effects, however, the decision in this ROD must only consider those effects resulting from the reasonably foreseeable impacts of the Proposed Action. This approach is consistent with the May 29, 2025, decision by the U.S. Supreme Court in Seven County Infrastructure Coalition v. Eagle County, Colorado, 605 U.S. ___; 145 S. Ct. 1497; 221 L. Ed. 2d 820 (2025). Further explanation of the cumulative effects can be found in Chapter 4 (Cumulative Impacts) of the Final EIS.

Cumulative impacts for all resources, except terrestrial biological resources, socioeconomics (specifically, housing, medical services, and Government of Guam that provide infrastructure support on the island), and transportation, were determined to be less than significant.

• There would be significant, adverse, cumulative impacts on terrestrial biological resources due to the removal of limestone forest and the removal of approximately 5,459 individuals of the Federal ESA-listed plant species Cycas micronesica.

• Any additional demand on the local housing market as a result of the increase in EIAMD system personnel on Guam would result in a significant cumulative impact. In addition, given that Guam is designated as a Medically Underserved Area and Government of Guam services related to infrastructure support are already strained, any additional demands on these services are also considered significant cumulative impacts.

• Significant cumulative impacts would occur at 6 transportation roadway intersections from site preparation and construction and at 13 transportation roadway intersections associated with operations and maintenance when impacts of the selected action are combined with those of other actions. Implementation of the Proposed Action would generate increased traffic due to other ongoing projects on Guam.

The MDA and USA have consulted and coordinated with appropriate agencies and representatives, including the U.S. Fish and Wildlife Service (USFWS), Guam State Historic Preservation Office (SHPO), and Bureau of Statistics and Plans (BSP), during planning and development of the EIS. A summary of the results from each consultation and coordination process is included below:

• Federal Endangered Species Act (ESA). In accordance with the USFWS under Section 7 of the Federal ESA, the MDA and USA received a Biological Opinion (BO) on July 9, 2025 and the associated terms and conditions are addressed in this ROD. Species addressed in the BO include Mariana fruit bat, Mariana common moorhen, Mariana swiftlet, Guam kingfisher, Guam rail, Mariana crow, Mariana eight-spot butterfly, and eight plant species: Bulbophyllum guamense, Cycas micronesica, Dendrobium guamense, Eugenia bryanii, Heritiera longipetiolata, Phyllanthus saffordii, Tabernaemontana rotensis, and Tuberolabium guamense. The USFWS estimates the Proposed Action will potentially result in the incidental take of Mariana fruit bat in the form of harassment due to nighttime construction and ungulate control activities. Further, the USFWS estimates that incidental take in the form of capture and collection and mortality of Mariana eight-spot butterfly due to the development of the AAFB Munitions Storage Area (MSA) site. The USFWS determined the Proposed Action including the estimated anticipated take is likely to adversely affect, but is not likely to jeopardize the continued existence of, the Mariana fruit bat, Mariana eight-spot butterfly, Bulbophyllum guamense, Cycas micronesica, Dendrobium guamense, Eugenia bryanii, Heritiera longipetiolata, Phyllanthus saffordii, Tabernaemontana rotensis, Tuberolabium guamense, or the three extirpated species, the Guam kingfisher, Mariana crow, or Guam rail. The USFWS concurred with the determination the Proposed Action may affect but is unlikely to adversely affect Guam tree snail, humped tree snail, fragile tree snail, Mariana common moorhen and Mariana swiftlet. The MDA and USA commit to all the conservation measures, best management practices, the reasonable and associated terms, prudent measure, and terms and conditions in the BO.

• National Historic Preservation Act (NHPA). The MDA and USA are required to comply with Section 106 of the NHPA for the EIAMD undertaking. Joint Region Marianas (JRM), MDA, and USA, through consultations with the Guam SHPO, have determined the Programmatic Agreement among the Commander, Navy Region Marianas (CNRM); the Advisory Council on Historic Preservation; and the Guam SHPO regarding Navy Undertakings on the Island of Guam, November 20, 2008, applies to the Proposed Action and thus fulfills the federal agency obligations under Section 106. The 2008 Programmatic Agreement applies to all undertakings initiated within the USN's area of responsibility, regardless of whether they are initiated, funded, or carried out by CNRM (now JRM) or by another command or lessee of the USN. AAFB, MCBCB, NMS, and NBG are currently under USN joint command. The 2008 Programmatic Agreement provides alternate, streamlined procedures for completing the Section 106 process for agreed-upon undertakings. Any adverse effects on historic properties in the study area will be mitigated in accordance with the 2008 Programmatic Agreement.

• Coastal Zone Management Act (CZMA). The MDA and USA completed the CZMA federal consistency process for the Proposed Action on Guam. JRM submitted the Coastal Consistency Determination to BSP on March 11, 2025. JRM received conditional concurrence from BSP that the Proposed Action is consistent to the maximum extent practicable with the enforceable policies of Guam's Coastal Management Program (GCMP) on May 8, 2025. The Proposed Action was updated as part of the Final EIS to clarify it will be implemented consistent with the enforceable policies of the GCMP to the maximum extent practicable, satisfying the conditions in the BSP's conditional concurrence. Thus, the Proposed Action, as described in the Final EIS, is fully consistent with GCMP's enforceable policies to the maximum extent practicable.

The MDA and USA will take all practicable means to avoid or minimize environmental harm while still fulfilling the need for the 360-degree defense of Guam. Mitigation measures are summarized below. The MDA and USA will use a mitigation monitoring database to track the implementation of mitigation measures identified in the EIS.

The following is a general summary of the mitigation measures that will be implemented commensurate with impacts to minimize impacts on terrestrial biological resources. A detailed list of the conservation and mitigation measures, best management practices, the reasonable and prudent measures, and associated terms and conditions included in the incidental take statement are included in the USFWS BO (see Appendix E [Agency Coordination, Consultation, and Correspondence]).

• Establish Habitat Enhancement Sites (HESs)

○ Several potential HESs have been identified in northern Guam on AAFB and in southern Guam on NMS that could be used to compensate for impacts associated with the Proposed Action. The location and size of these HESs will be commensurate with the amount of limestone forest and savanna complex removed under the Proposed Action. The number, size, and location of potential HESs will be finalized in conjunction with ongoing coordination with JRM and the installation site approval process.

○ Habitat enhancement activities will include the following:

Installation of ungulate exclusion fences around the HESs;

Removal of ungulates ( i.e., trapping, snaring, and shooting) with the goal of eradication within the fenced areas;

Invasive plant removal; and

Propagation, planting, and establishment of dominant and rare species characteristic of native limestone forest and savanna complex habitats.

○ Prior to any site preparation at the AAFB MSA site, ungulate exclusion fencing would be installed commensurate with the amount of limestone forest removal associated with the AAFB MSA site.

• Pre-Construction Surveys, General ESA-Listed Plant Salvage and Transplantation

○ If pre-construction surveys identify an ESA-listed plant as present in the construction area, one of the following will occur:

1. Salvageable ESA-listed plants will be directly transplanted into HESs. Transplantation will occur after fencing and ungulate removal is complete (see CM-3) and the site is reasonably likely to support the transplants; or

2. If individuals cannot be directly transplanted, then propagules will be salvaged or collected, and such material housed in a native plant nursery until they are ready for transplant into the HESs.

3. If there is an insufficient number of propagules or whole plants from within the project footprint to collect or salvage, then propagule collection from other sources outside the project footprint will be conducted to provide seedlings to meet transplanting/outplanting establishment targets. Transplantation/outplanting timing will be site specific for each EIAMD system site.

• Mariana Eight-Spot Butterfly Host Plant Outplanting at HESs

○ The DoD will plant Mariana eight-spot butterfly host plants within the HESs. The number of host plants established within the HESs will be commensurate with the number of individuals removed with the implementation of the Proposed Action.

The MDA and USA recognize potential impacts on transportation associated with implementation of the Proposed Action. To minimize these impacts, any mitigation measures would be coordinated with the Guam Department of Public Works for the most appropriate solution. Mitigations would be implemented where practical and feasible, and applicable permits would be obtained. These solutions would also be coordinated with stakeholders prior to implementation. Any such mitigations would only be accomplished if duly authorized and funded by Federal legislation.

Based on the findings of the EIAMD System on Guam Final EIS, the No Action Alternative would be the environmentally preferred alternative because the significant, adverse, cumulative impacts from the Proposed Action would not occur. However, under the No Action Alternative, defensive capabilities would not be expanded to provide enhanced defense capability for Guam, nor would it satisfy the purpose of or need for the Proposed Action.

On August 15, 2025, the Governor and Lieutenant Governor of Guam submitted a letter to the MDA Director responding to the EIAMD System on Guam Final EIS on behalf of the people of Guam and the Government of Guam. The letter indicates the Final EIS does not sufficiently address cumulative impacts on Guam's infrastructure, public services, economy, and natural and cultural resources, noting two reports issued in 2025 by the U.S. Government Accountability Office (GAO-25-108187 and GAO-25-107453). While neither of these GAO reports were specifically addressed in the Final EIS, we reviewed the reports and determined they provide no new information or data and the reports' conclusions were based significantly upon the same available information and data analyzed in the EIS. In fact, both reports make reference to MDA resources, including in one report, the EIAMD System on Guam Draft EIS. We have determined the August 15, 2025, letter from the Governor and Lieutenant Governor of Guam does not provide new data or information that would necessitate supplementing the Final EIS before a decision may be made. Further, the conclusions and recommendations made in the letter were taken into consideration before this decision was made.

No other comments were received after the EIAMD System on Guam Final EIS was published that need be addressed before a decision may be made.

In accordance with NEPA, we have considered the information contained within the EIAMD System on Guam Final EIS, comments from the public, input from regulatory agencies, EIAMD system capabilities including system performance and operation effectiveness, the analysis of the missile threat to Guam, and other relevant factors in deciding whether to implement the EIAMD system on Guam. We have decided to select the Proposed Action over the No Action Alternative. Although the No Action Alternative would have fewer environmental impacts, it would not support the purpose and need of a 360-degree defense of Guam. While this decision reflects the intent of the MDA and the USA to proceed with the Proposed Action, not all of the Proposed Action is immediately funded. In accordance with the BO, site-specific mitigations, which are yet to be authorized and funded, would only be accomplished should the portion of the Proposed Action necessitating mitigation proceed. No subsequent decision is required to proceed with the mitigations described in the Biological Opinion or the construction, deployment, operations, and maintenance of any of the sites described in the Final EIS.

1. Authority. The Sabine Pass to Galveston Bay, Texas Coastal Storm Risk Management and Ecosystem Restoration (S2G) study described in the Final Integrated Feasibility Report and Environmental Impact Statement (FIFR-EIS) was conducted under the “Coastal Texas Protection and Restoration Study” authority, Senate resolution dated June 23, 2004, in accordance with Section 110 of the Rivers and Harbors Act of 1962. The FIFR-EIS was completed in May 2017 and the Chief of Engineers Report was signed December 7, 2017. The ROD was signed by the Assistant Secretary of the Army, Civil Works on October 2, 2018. Construction was authorized under section 1401(3)(3) of the Water Resources Development Act of 2018 (Pub. L. 115-270) and the project received appropriations to construct under the Bipartisan Budget Act of 2018 (Pub. L. 115-123). The lead agency for this action is the USACE and the non-federal sponsor is the Gulf Coast Protection District (GCPD).

2. Background. The purpose of the proposed action is to provide coastal storm risk management by addressing storm surge threats through protecting critical infrastructure and people, reducing structural damage, lessening financial and social burdens following storm events, and increasing the counties' ability to respond to natural hazards and build resiliency to long-term impacts associated with sea level rise and land subsidence. Orange County, TX (project area) has sustained several major historical surge events in the past 120 years that have resulted in significant impacts on infrastructure and residents, coastal shorelines, marshes, and forested wetlands prompting the need to reduce coastal storm risks.

The USACE prepared the S2G FIFR-EIS to document the feasibility of reducing coastal storm risks and included identification of a Recommended Plan that proposed a new approximately 26.7-mile-long levee and floodwall system along the edge of the Sabine and Neches River floodplains in Orange County, and to raise or reconstruct 11.6 miles and 18.2 miles of existing levees and floodwalls for Port Arthur and Freeport vicinities, respectively. The S2G Recommended Plan was divided into three distinct project areas: Port Arthur, Freeport, and Orange County as separable elements (projects) for the Preconstruction, Engineering, and Design (PED) and construction phases. The projects are in various stages of design and construction. The Orange County Project has moved from the feasibility phase to PED, which involves completing detailed engineering, design, and technical studies needed to begin construction. In response to new information resulting from additional technical studies, stakeholder engagement, and collection of site-specific data, alternatives that would modify the Recommended Plan for the Orange County Project are being considered.

Following the National Environmental Policy Act of 1969 (NEPA, Pub. L. 91-190) as amended, and Department of Defense NEPA implementing procedures, the USACE determined that a Draft Supplemental Environmental Impact Statement (SEIS) would be prepared because the agency (i) made substantial changes to the proposed action that are relevant to environmental concerns and (ii) there are substantial new circumstances or information about the significance of the adverse effects that bear on the proposed action or its effects.

In the S2G FIFR-EIS, the Orange County Project was estimated to result in the direct and indirect loss of 69.5 acres of forested wetlands and 2,340.2 acres of estuarine marsh, of which would be offset through restoration of 453 acres of estuarine marsh and preservation of 559.5 acres of forested wetlands. The impacts expected to be evaluated in the SEIS include additional short- and long-term effects to existing aquatic and terrestrial habitats, fish and wildlife including federally protected species and their habitat, water quality, noise, protected lands, recreation features, and viewshed. Compensatory mitigation is expected to be required to address impacts to aquatic habitats and federally protected species. Additional details related to these effects and other relevant data collection will be described in the Draft SEIS.

3. Alternatives. The Draft SEIS will compare the Recommended Plan, as described in the Chief's Report and FIFR-EIS for the Orange County Project and proposed alternative alignments and system changes identified during PED. More specifically, analyses in PED have resulted in recommendations to increase the height of levees and floodwalls, modify the lengths of these features, increase the number of pump stations, include interior drainage channels, and shift the alignment to be closer to the Sabine River. The Draft SEIS will evaluate reasonably foreseeable effects of the proposed design changes in the Recommended Plan including potential adverse and beneficial impacts to the human and natural environments that balance the interests of coastal storm risk management and environmental impacts. The USACE requests comments on alternatives or effects and relevant information, studies, or analyses with respect to the proposed action (NEPA § 107(c); 42 U.S.C. 4336a(c)).

4. Public Participation. Scoping completed prior to and after publication of this NOI will be used to develop the Draft SEIS. The scoping comment period begins with publication of this notice and ends on October 9, 2025. All substantive comments received during the scoping period may be used to identify or modify alternatives, or to supplement or improve analyses, not previously considered that should be evaluated in the Draft SEIS. Additional comments received outside of the scoping period will be considered prior to the Draft SEIS public review period, to the extent possible.

One public scoping meeting is scheduled for September 17, 2025. A Public Notice was published for the scoping meeting on the Galveston District website, the Legal Notices section of the Orange Leader and Beaumont Enterprise, and the S2G Orange County Project website. Public news releases included the scoping period timeframe, public meeting date, time, location, and where to send comments. The news releases were also distributed to the local stakeholders and known interested parties.

5. Coordination. The USACE will serve as the lead federal agency in the preparation of the Draft SEIS. Federal and state agencies have been invited to participate throughout the study process as Cooperating or Participating Agencies. The following agencies have accepted: Environmental Protection Agency, National Marine Fisheries Service, Texas Commission of Environmental Quality, Texas Parks and Wildlife Department, Texas General Land Office, and Texas Water Development Board. Further coordination with environmental agencies will be conducted under the Fish and Wildlife Coordination Act, the Endangered Species Act, the Clean Water Act, the Coastal Zone Management Act, the National Historic Preservation Act, and the Magnuson-Stevens Fishery Conservation and Management Act.

6. Schedule. The USACE currently estimates that the Draft SEIS will be available for public review and comment in or around mid- to late-2026. At that time, the USACE will provide a 45-day public review period for individuals and agencies to review and comment. The USACE will notify all interested agencies, organizations, and individuals of the availability of the draft document at that time. A Final SEIS and Record of Decision are expected in mid- to late-2027.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Student Assistance General Provisions—Student Right to Know (SRK).

OMB Control Number: 1845-0004.

Type of Review: Extension without change to a currently approved ICR.

Respondents/Affected Public: Private Sector; State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 31,971.

Total Estimated Number of Annual Burden Hours: 24,016.

Abstract: Section 485 of the Higher Education Act of 1965, as amended (HEA) authorizes the administration of the Student Right-to-Know (SRK) regulations. These regulations are in 34 CFR 668.41 and 668.45 and relate to the retention, placement and post-graduate study by students at an institution.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Migrant Student Information Exchange (MSIX) Minimum Data Elements.

OMB Control Number: 1810-0683.

Type of Review: A revision of a currently approved ICR.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 343,880.

Total Estimated Number of Annual Burden Hours: 391,338.

Abstract: The Migrant Information Exchange (MSIX) is a nationwide electronic records exchange mechanism mandated under Title I, Part C of the Elementary and Secondary Education Act of 1965 (ESEA), as amended. MSIX and its minimum data elements (MDEs) are authorized under ESEA section 1308(b). As a condition of receiving a grant of funds under Title I, Part C, each State educational agency (SEA) is required to collect, maintain, and submit minimum health and education- related data to MSIX within established timeframes. Regulations for the MSIX issued by the U.S. Department of Education (the Department) have been in effect since June 9, 2016 (34 CFR 200.85).

As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might further reduce the information collection burden for small business concerns with fewer than 25 employees.

OMB Control Number: 3060-0953.

Title: Section 95.2309, Frequency Coordination/Coordinator, Wireless Medical Telemetry Service.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit and Not-for-profit institutions.

Number of Respondents and Responses: 3,000 respondents; 3,000 responses.

Estimated Time per Response: 2-5 hours.

Frequency of Response: On occasion and one-time reporting requirements, third party disclosure requirement and recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority is contained in 47 U.S.C. 4(i), 302, 303(b), (c), (e), (f), (r), and 307.

Total Annual Burden: 15,000 hours.

Total Annual Cost: $750,000.

Needs and Uses: The Commission will submit this information collection to OMB as an extension after this 60-day comment period to obtain the full three-year clearance from them.

The Commission allocated spectrum and set stringent regulations for a “Wireless Medical Telemetry Service,” ensuring that critical medical equipment operates free from interference. Medical telemetry equipment is essential in hospitals and healthcare facilities, transmitting vital patient data—such as pulse and respiration rates—directly to nearby receivers. This technology not only enhances patient mobility but also significantly improves their comfort. It is crucial for advancing healthcare delivery.

The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

OMB Control Number: 3060-0430.

Title: Section 1.1206, Permit-but-Disclose Proceedings.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Individuals or households; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, local, or tribal governments.

Number of Respondent and Responses: 11,500 respondents; 34,500 responses.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Required to obtain benefits. Statutory authority for this collection of information is contained in sections 4(i) and (j), 303(r), and 409 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i) and (j), 303(r), and 409.

Estimated Time per Response: 0.75 hours (45 minutes).

Total Annual Burden: 25,875 hours.

Total Annual Costs: No cost.

Needs and Uses: The Commission's rules, under 47 CFR 1.1206, require that a public record be made of ex parte presentations ( i.e., written presentations not served on all parties to the proceeding or oral presentations as to which all parties have not been given notice and an opportunity to be present) to decision-making personnel in “permit-but-disclose” proceedings, such as notice-and-comment rulemakings and declaratory ruling proceedings.

On February 2, 2011, the FCC released a Report and Order and Further Notice of Proposed Rulemaking, GC Docket Number 10-43, FCC 11-11, which amended and reformed the Commission's rules on ex parte presentations (47 CFR 1.1206(b)(2)) made in the course of Commission rulemakings and other permit-but-disclose proceedings. The modifications to the existing rules adopted in this Report and Order require that parties file more descriptive summaries of their ex parte contacts, ensure that other parties and the public have an adequate opportunity to review and respond to information submitted ex parte, and improve the FCC's oversight and enforcement of the ex parte rules. The modified ex parte rules that contain information collection requirements which OMB approved on December 6, 2011, are as follows: (1) Ex parte notices will be required for all oral ex parte presentations in permit-but-disclose proceedings, not just for those presentations that involve new information or arguments not already in the record; (2) If an oral ex parte presentation is limited to material already in the written record, the notice must contain either a succinct summary of the matters discussed or a citation to the page or paragraph number in the party's written submission(s) where the matters discussed can be found; (3) Notices for all ex parte presentations must include the name of the person(s) who made the ex parte presentation as well as a list of all persons attending or otherwise participating in the meeting at which the presentation was made; (4) Notices of ex parte presentations made outside the Sunshine period must be filed within two business days of the presentation; (5) The Sunshine period will begin on the day (including business days, weekends, and holidays) after issuance of the Sunshine notice, rather than when the Sunshine Agenda is issued (as the current rules provide); (6) If an ex parte presentation is made on the day the Sunshine notice is released, an ex parte notice must be submitted by the next business day, and any reply would be due by the following business day. If a permissible ex parte presentation is made during the Sunshine period (under an exception to the Sunshine period prohibition), the ex parte notice is due by the end of the same day on which the presentation was made, and any reply would need to be filed by the next business day. Any reply must be in writing and limited to the issues raised in the ex parte notice to which the reply is directed; (7) Commissioners and agency staff may continue to request ex parte presentations during the Sunshine period, but these presentations should be limited to the specific information required by the Commission; (8) Ex parte notices must be submitted electronically in machine-readable format. PDF images created by scanning a paper document may not be submitted, except in cases in which a word-processing version of the document is not available. Confidential information may continue to be submitted by paper filing, but a redacted version must be filed electronically at the same time the paper filing is submitted. An exception to the electronic filing requirement will be made in cases in which the filing party claims hardship. The basis for the hardship claim must be substantiated in the ex parte filing; (9) To facilitate stricter enforcement of the ex parte rules, the Enforcement Bureau is authorized to levy forfeitures for ex parte rule violations; (10) Copies of electronically filed ex parte notices must also be sent electronically to all staff and Commissioners present at the ex parte meeting so as to enable them to review the notices for accuracy and completeness. Filers may be asked to submit corrections or further information as necessary for compliance with the rules; and (11) Parties making permissible ex parte presentations in restricted proceedings must conform and clarify rule changes when filing an ex parte notice with the Commission.

The information is used by parties to permit-but-disclose proceedings, including interested members of the public, to respond to the arguments made and data offered in the ex parte presentations. The responses may then be used by the Commission in its decision-making.

The availability of the ex parte materials ensures that the Commission's decisional processes are fair, impartial, and comport with the concept of due process in that all interested parties can know of and respond to the arguments made to the decision-making officials.

Title: Duties of Furnishers of Information to Consumer Reporting Agencies.

OMB Control Number: 3084-0144.

Type of Review: Extension without change of a currently approved collection.

Affected Public: Private Sector: Businesses and other for-profit entities.

Estimated Annual Burden Hours: 15,423 hours.

Estimated Annual Labor Costs: $942,021.

Estimated Annual Non-Labor Costs: $0.

Abstract: The Dodd-Frank Act  1 transferred most of the FTC's rulemaking authority for the furnisher provisions of the Fair Credit Reporting Act (“FCRA”)  2 to the CFPB. The FTC, however, retains rulemaking authority for motor vehicle dealers that are predominantly engaged in the sale and servicing of motor vehicles, the leasing and servicing of motor vehicles, or both. 3 In addition, the FTC retains its authority to enforce the furnisher provisions of the FCRA and rules issued under those provisions. Accordingly, the FTC and CFPB have overlapping enforcement authority for many entities subject to CFPB's Regulation V (subpart E), and the FTC has sole enforcement authority for the motor vehicle dealers subject to the FTC rule.

Under § 660.3 of the FTC's Information Furnishers Rule  4 and § 1022.42 of the CFPB Rule, 5 furnishers must establish and implement reasonable written policies and procedures regarding the accuracy and integrity of the information relating to consumers that they furnish to a consumer reporting agency (“CRA”) for inclusion in a consumer report. 6 Section 660.4 of the FTC Rule and § 1022.43 of the CFPB Rule require that entities which furnish information about consumers to a CRA respond to direct disputes from consumers. These provisions also require that a furnisher notify consumers by mail or other means (if authorized by the consumer) within five business days after making a determination that a dispute is frivolous or irrelevant (“F/I dispute”).

Request for Comment: On May 16, 2025, the Commission sought comment on the information collection requirements associated with the Information Furnishers Rule. 90 FR 21032. No relevant comments addressing the Rule's information collections were received. Pursuant to the OMB regulations, 5 CFR part 1320, the FTC is providing this second opportunity for public comment while seeking OMB approval to renew clearance for the Rule's information collection requirements.

Your comment—including your name and your state—will be placed on the public record of this proceeding. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns devices, manufacturing processes, or customer names.

The Horseracing Integrity and Safety Act of 2020  1 recognizes a self-regulatory nonprofit organization, the Horseracing Integrity and Safety Authority (“HISA” or “the Authority”), which is charged with developing proposed rules on a variety of subjects. Those proposed rules and proposed rule modifications take effect only if approved by the Federal Trade Commission (“FTC” or the “Commission”). 2 The proposed rules and rule modifications must be published in the Federal Register for public comment. 3 Thereafter, the Commission has 60 days from the date of publication to approve or disapprove the proposed rule or rule modification. 4

Pursuant to section 3053(a) of the Act and Commission Rule 1.142, notice is hereby given that, on September 27, 2023, the Authority filed with the Commission a proposed Enforcement Rule modification and supporting documentation as described in Items I, II, III and IX below, which Items have been prepared by the Authority. This revised submission was filed on July 7, 2025, to reflect updated proposed modifications to the rules since September 27, 2023. The Office of the Secretary of the Commission determined that the filing complied with the Commission's rule governing such submissions. 5 The Commission is publishing this document to solicit comments on the proposed rule modification from interested persons.

The Horseracing Integrity and Safety Act of 2020 (“Act”) recognizes that the establishment of a national set of uniform standards for racetrack safety and medication control will enhance the safety and integrity of horseracing. On December 20, 2021, the Authority filed with the Commission the Rule 8000 Series, which establishes penalties and adjudicatory procedures for the enforcement of rules promulgated by the Authority. The Rule 8000 Series was published in the Federal Register on January 26, 2022, 6 and approved by the Commission by Order dated March 25, 2022. 7 The Authority filed a proposed rule modification to the Rule 8000 Series on June 5, 2022. The modification was published in the Federal Register on July 26, 2022, 8 and approved by the Commission by Order dated September 23, 2022. 9 The Authority filed a proposed rule modification to Rule 8400 on May 31, 2023. The modification was published in the Federal Register on July 28, 2023. 10 The modification was approved by the Commission by Order dated September 26, 2023. 11

The Authority now proposes modifications to several provisions in the Rule 8000 Series. The modifications are outlined in detail in Item II of this document, but in general terms, the more significant proposed modifications are as follows. Rule 8100 would be modified to clarify that it is a violation of Rule 8100 to cause a Covered Horse to compete in a Covered Horserace with the knowledge that it is ineligible to compete pursuant to the rules of the Authority. Rule 8200 would be amended to clarify the penalties that apply to various violations of the Rule 2000 Series, to direct the purse be redistributed after a Covered Horse is disqualified from a Covered Horserace, and to authorize an automatic suspension for failure to pay a fine or to repay a purse. Rules 8310, 8320, and 8330 would be modified to state with precision the rule violations that are subject to adjudication under the Rule 8000 series, and the procedures under which the adjudications shall be conducted. Rule 8320 would be amended to separate the procedures for riding crop violations from those for violation of the rules in the Rule 2000 Series pertaining to prohibited aspects of Shock Wave therapy and prohibited use of electrical and mechanical devices. Rule 8320 also would be amended to permit appeals of riding crop violations to the Internal Adjudication Panel pursuant to Rule 2285. Rule 8340 would be amended to specify that the procedures in the rule concerning initial hearings are applicable to proceedings to suspend or revoke accreditation under Rule 2116. The procedural rules for appeals in Rule 8350(a) would be modified to provide consistency with modifications of the Rule 2000 Series that went into effect on July 8, 2024. Rule 8360 would be modified to clarify procedural details concerning the suspension and revocation of Racetrack accreditation. Rule 8400 would be modified to include standards to guide the Authority in the issuance of subpoenas. The Rule 8000 Series would further be modified to include a new Rule 8410, which allows the Authority to review and act upon information or evidence submitted to the Authority from any source concerning possible rule violations. A new rule 8420 is proposed to require the Authority to seek and obtain the approval of the Commission before initiating civil actions under 15 U.S.C. 3054(j). Finally, several modifications are proposed to make minor clarifying changes to the language of several rules for greater precision throughout the Rule 8000 Series.

This submission is also made to comply with the Commission's March 27, 2023, Order that directed “the Authority to review all of its existing rules (Racetrack Safety, Assessment Methodology, Enforcement, Registration, and [Anti-Doping and Medication Control (`ADMC')] and submit any proposed rule modifications to the Commission by September 27, 2023.” The Authority reviewed all its existing rules, and this submission was originally filed on September 27, 2023, in accordance with the March 27, 2023, Order. This revised submission is now filed to reflect updated proposed modifications to the rules since September 27, 2023. The modifications are limited in scope and build upon or alter the details of a disciplinary and procedural framework already in place. The reason for proposing the rule modification is to enhance the Rule 8000 Series Enforcement Rules in a manner that is consistent with 15 U.S.C. 3057(d). An effective enforcement system builds public confidence in the sport by ensuring that Covered Horseraces are conducted in a fair and transparent manner. The proposed rule modification takes into account the unique character of horseracing, including the various types of violations that arise and the range of penalties that are imposed in horseracing. Covered Persons, Covered Horseraces, and Covered Horses will be affected by the proposed rule modification in similar ways. Covered Persons who participate in horseracing will benefit from the enhanced enforcement of the rules, the running of horseraces in a fair and transparent manner, and the deterrence of violations that the Rule 8000 Series achieves. Covered Persons will have confidence that the rules are being applied fairly and evenly to all racing participants. Covered Horseraces will also benefit from the enhanced standards of integrity that effective enforcement of the rules will make possible. The safety and well-being of Covered Horses, always a primary concern to the Authority, will also be safeguarded by the modifications to the Rule 8000 Series that help to ensure the rules of the Authority pertaining to the safety and welfare of Covered Horses are consistently and effectively enforced.

On August 28, 2023, HISA representatives shared a draft of the Rule 8000 Series modifications with the following interested stakeholders for input: Racing Officials Accreditation Program; Racing Medication and Testing Consortium (Scientific Advisory Committee); National Thoroughbred Racing Association; The Jockey Club; The Jockeys' Guild; Thoroughbred Racing Association; Arapahoe Park; Rillito Downs; Thoroughbred Owners of California; California Horse Racing Board; Kentucky Racing Commission; Delaware Racing Commission; Maryland Racing Commission; National Horsemen's Benevolent and Protective Association; Thoroughbred Horsemen's Association; Thoroughbred Owners and Breeders Association; Kentucky Thoroughbred Association; American Association of Equine Practitioners; American Veterinary Medical Association; Stronach Racing Group (five thoroughbred racetracks); Churchill Downs (six thoroughbred racetracks); Breeders' Cup; Keeneland; Del Mar; and the Racing Operations Committee. Additionally, on August 28, 2023, a draft of the proposed modifications was made available to the public for review and comment on the HISA website at https://hisaus.org/. Attached to this document is Exhibit A, which includes copies of all comments received concerning the rule modification proposal. 12

The modifications have been crafted in the most precise manner possible to resolve the specific issues that are outlined in Item II for each modification. In some instances, as noted below, commenters proposed revisions and alternatives that were adopted in drafting the proposed rule modification. A summary of the substance of the comments received by the Authority is included in the discussion of the proposed rule modification that relates to the particular comment. The Authority incorporates by reference into this modification the existing standards  13 set forth in the Notice of Filing of Proposed Rule that originally established the Rule 8000 Series and that was submitted to the Commission in the original filing of the Rule 8000 Series on December 20, 2021. Similarly, the Authority incorporates by reference additional standards submitted as Exhibit A  14 to the Authority's Proposed Rule Modification Submission of the Rule 8000 Series on June 5, 2022.

With the review, input, and ultimate approval of the Authority's Board of Directors, the proposed rule modification to the Rule 8000 Series modifies and enhances the penalties and adjudication procedures for the enforcement of rules promulgated by the Authority. HISA submits herewith the proposed rule modification for Commission approval.

The Horseracing Integrity and Safety Act of 2020, 15 U.S.C. 3051 through 3060.

The modifications in the proposed Rule 8000 Series would not make significant substantive changes to the rules. The majority of the modifications are provisions concerning the procedures applicable to existing rules, changes made to conform to the Rule 2000 modifications that went into effect on July 8, 2024, and stylistic changes that enhance the clarity of the rules.

Rule 8100 sets forth a series of violations that are subject to disciplinary action under the Rule 8000 Series. A new paragraph (k) would be added to establish a new violation for “Entering a Covered Horse or causing a Covered Horse to compete in a Covered Horserace prior to registering the Covered Horse with the Authority in accordance with the Rule 9000 Series.” This violation is included to enforce the requirement in Rule 9000(h) that Responsible Persons must register Covered Horses before running them in Covered Horseraces. Covered Horses must be registered to be eligible to be entered or to run in Covered Horseraces. Additionally, new paragraph (l) would be added to clarify that it is a violation for “[c]ausing a Covered Horse to compete in a Covered Horserace with the knowledge that, at the time of the Covered Horserace, the Covered Horse is ineligible to compete pursuant to the rules of the Authority.” Under Rule 2240(a), Covered Horses are not eligible to compete in a Covered Horserace if they are placed on the Veterinarians' List. Similarly, under Rules 3229(a)(1) and 3339(a)(1), Covered Horses are not eligible to compete in a Covered Horserace if they are serving a period of Ineligibility for an Anti-Doping Rule Violation or a Controlled Medication Rule Violation. The new paragraph (l) would penalize running a Covered Horse that is ineligible to compete. The rule would include a requirement that, in order to impose a penalty, the Authority must show that a Covered Person acted with knowledge that the horse was ineligible. 15 These modifications will be of particular benefit to Covered Horses and the running of Covered Horseraces, because it will ensure the horses are subject to veterinary supervision and other forms of oversight by the Authority, and bolster the integrity and safety of the sport.

Rule 8200(b) establishes a schedule of sanctions that may be imposed upon a Covered Person by the Authority for violations of specified Authority rules as described in paragraph 8200(a). Rule 8200(b)(1) specifies various rule violations by rule number, and also lists the penalty provisions applicable to those violations. The rule would be modified to make clear that these penalties are to be imposed in lieu of the penalties listed under Rule 8200(b)(2) through (12). An additional modification would be made to include the following clause: “provided, however, for any violation involving a Covered Horse that participates in a Covered Horserace in violation of Rule 2271(a)(11) or 2271(a)(12), the Covered Horse shall be disqualified, the purse forfeited, and the Responsible Person shall be subject to the penalty schedule established in Rule 2271(b).” This clause clarifies the penalties for racing violations of Rule 2271(a)(11) and Rule 2271(a)(12).

A modification would be made to Rule 8200(b)(2)(ii). The current rule authorizes a fine of up to $100,000.00 for any violation that “due to its nature, chronicity, or severity poses an actual or potential threat of harm to the safety, health, and welfare of Covered Persons, Covered Horses, or the integrity of Covered Horseraces” (emphasis added). The word “and” would be deleted and replaced with “or.” This will clarify that the rule is invoked when a threat of harm is posed to any one of the elements of “safety, health, or welfare of Covered Persons or Covered Horses, or to the integrity of Covered Horseraces”; it is not necessary that the threat of harm jeopardizes safety, health, and welfare in combination with one another. The rule modification will provide clear direction in the imposition of appropriate fines as a penalty for harmful or dangerous behavior.

Rule 8200(b)(9) permits the Authority to deny purse money or require the forfeiture of purse money, disqualify a Covered Horse, or make changes to the order of finish in Covered Horseraces. The rule would be modified to add an additional sentence, which states: “If a Covered Horse is disqualified, the purse shall be redistributed in accordance with the revised order of finish.” This sentence would be added to make clear that after revising the order of finish, the stewards (who in most instances are the body imposing the sanction) must redistribute the purse according to the revised order of finish. This modification is proposed because some stewards have questioned whether purse redistribution is a duty of the stewards in those cases in which an Authority rule is violated that necessitates a disqualification. The rule would be modified to state explicitly the purse redistribution requirement.

A modification of Rule 8200 is proposed to include a new paragraph (e), which states: “(e) Failure by a Covered Person to pay any fine by the prescribed deadline that is imposed by the Authority, or by any official or body authorized to adjudicate violations under the Rule 2000 or 8000 Series, shall subject the Covered Person to automatic suspension by the Authority, absent a showing to the Authority by the Covered Person of exceptional circumstances that resulted in the failure to pay the fine.” This rule would penalize the failure to pay fines imposed by the Authority. Non-payment permits the Authority to automatically suspend the registration of a Covered Person, absent a showing of exceptional circumstances that resulted in the failure to pay the fine. This rule is similar to a common practice of various State racing commissions, in which licensure is temporarily suspended as a penalty for overdue fines until the fines are repaid. A similar provision would be included in a new paragraph (f) in Rule 8200, which imposes an automatic suspension for failure to repay a purse.

Rule 8310 would be amended to include Rule 2116 (concerning the suspension or revocation of accreditation) within the class of violations to be adjudicated under the Rule 8300 Series. This modification is necessary to conform to provisions in Rule 2116 concerning the suspension or revocation of accreditation that took effect on July 8, 2024.

Rule 8320(a) would be modified as follows, with additions underlined and deleted language marked with a strikethrough:

This modification is proposed at the suggestion of a commenter to distinguish violations of the riding crop rules from rules concerning the use of Shock Wave Therapy and of all other electrical and mechanical devices. 16 The citation to Rule 2271(b) in Rule 8320(a)(i) would be changed to Rule 2271(a)(2) to conform to Rule 2000 Series modifications of the rule number that took effect on July 8, 2024.

Rule 8320(a)(3) would be modified to permit the appeal of riding crop violations to the Internal Adjudication Panel pursuant to Rule 2285. Rule 2285 creates an intermediate appeal process specific to violations of the riding crop rules. The modification to Rule 8320(a)(3) is necessary to specify that these appeals are adjudicated under the procedures set forth in Rule 2285 rather than under Rule 8320(b).

Rules 8320(b)(1) and 8320(b)(2) would be further amended to add Rule 2286 and the Rule 8000 Series to the body of procedures applicable to Rule 2200 violations adjudicated by the Internal Adjudication Panel and the Arbitral Body. Similarly, Rules 8330(a) and 8330(b) would be amended to add the Rule 8000 Series to the body of procedures applicable to Rule 8100 violations adjudicated by Internal Panel and the Arbitral Body. Both modifications include language stating that the Rule 8000 Series procedures are controlling in any instances of conflict between the Rule 7000 and Rule 8000 Series. These modifications are proposed to ensure that the appropriate procedures are applied to the various types of rule violation cases arising under the Rule 2200 Series and the Rule 8100 Series. Rule 2286 specifies that the procedures set forth in Rule 8340(c) through (j) are applicable to Rule 2200 Series violation cases; Rules 8320(b)(1) and (b)(2) would correspondingly be modified to include Rule 2286 proceedings among those to be adjudicated by the Internal Adjudication Panel or the Arbitral Body, to conform to Rule 2286. Similarly, the reference to the Rule 8000 procedures in Rule 8320(b)(1) and (b)(2) is included because Rule 2286 requires the use of the procedures established in Rule 8340(c) through (j).

Rule 8340(a) would be amended to specify that the procedures for initial hearings under the rule are applicable to proceedings concerning the suspension or revocation of Racetrack accreditation under Rule 2116. Accreditation cases will therefore be heard first by a panel of three Board members, whose decision is then appealable to the full Board. The panel adjudication process is well-suited to the potentially complex nature of Racetrack accreditation violations and issues.

Rule 8350, “Appeal to the Board,” states in paragraphs (a) and (b) the basic rule of appeal, that decisions rendered by the Racetrack Safety Committee, the stewards, the Internal Adjudication Panel, an independent Arbitral Body, or an initial Board hearing panel may be appealed on the record to the full Board. Rule 8350(a) would be modified to include the following introductory clause: “Except as set forth in Rule 2285 concerning intermediate appeals for violations of Rules 2280 and 2281, and in Rule 2287 concerning appeals taken in the course of adjudicating the provisional suspension of registration, any . . . [.]” Similar clauses excepting Rule 2116, Rule 2117, and Rule 2287 would be included in Rule 8350(b).

The modification in Rule 8350(a) (excepting intermediate appeals for violations of Rules 2280 and 2281 under Rule 2285) is proposed to conform to Rule 2285. Rule 2285, which went into effect on July 8, 2024, establishes a level of intermediate appeal of rulings issued to jockeys by the stewards for violations of the riding crop provisions in Rules 2280 and 2281. Rule 2285 provides that the appeals shall be heard initially by a three-member appeal panel appointed from the pool of adjudicators who constitute the Internal Adjudication Panel as established under the Rule 7000 Series. Under Rule 2285, any decision rendered by the three-member appeal panel is then appealable to the Board of the Authority. The modification to Rule 8350(a) excepting intermediate appeals under Rule 2285 is proposed to make clear that decisions rendered by the stewards under Rules 2280 and 2281 are not appealed directly to the Board under Rule 8350, but instead are first appealed to the three-member appeal panel established in Rule 2285.

Rule 8350(a) would be further modified to exempt from its procedures those appeals taken in the course of adjudicating the provisional suspension of registration under Rule 2287. Similarly, Rule 8350(b) would be modified to exempt appeals taken in the course of adjudicating the provisional suspension of accreditation under Rule 2117 and the provisional suspension of registration under Rule 2287. These changes are proposed because Rules 2117 and 2287 establish comprehensive procedures to be applied in their respective provisional suspension proceedings, and the modifications to Rule 8350(a) and (b) make clear that the Rule 8350 procedures do not apply to those proceedings. Rule 2116 would be excepted from Rule 8350(b) because appeals of suspension or revocation of Racetrack accreditation are covered by Rule 8360.

Rule 8360 would be modified to clarify various procedural details concerning the appeal of the suspension and revocation of Racetrack accreditation. Rule 8360 currently provides that the appeal procedures in the rule apply to the appeal of Board Panel decisions to the full Board, and that the Board's review of a decision shall take the form of a de novo hearing or review. Rule 8360(a)(1) would be modified to specify that a de novo hearing shall be conducted under the appeal procedures set forth in Rule 8340(c) through (h). The rule would be further modified to state that its procedures do not apply to proceedings concerning the provisional suspension of accreditation under Rule 2117, since Rule 2117 establishes procedures specific to the provisional suspension context. These modifications to Rule 8360 would enhance the orderly adjudication of Racetrack accreditation proceedings.

Rule 8400(a) would be modified as follows:

The replacement of the word “and” with “or” would make clear that care, training, and racing are independent of one another as activities that render items and locations subject to access by the Authority. An item or location does not have to be used in the care, treatment, training, and racing of a Covered Horse in order to be subject to the provisions of Rule 8400(a)(i) and (ii).

In several provisions of the current Rule 8400, reference is made to both the Commission and the Authority as exercising various powers prescribed by the rules. Proposed amendments to the rule would delete the reference to the Commission. The Commission's investigatory powers and enforcement authority are set forth in various statutes, e.g., sections 9 and 20 of the Federal Trade Commission Act, 15 U.S.C. 49, 57b-1. 17 There is therefore no reason to reference the Commission in the Rule 8400 Series.

Rule 8400(e) would be modified to require the Authority to request and obtain the approval of the Commission before issuing a subpoena under 15 U.S.C. 3054(h), with the proviso that the request will be deemed approved if the Commission does not act upon the request within 20 days of receipt of the request. The modification is proposed to enhance the Commission's oversight of, and power to constrain, the Authority in the exercise of its subpoena power.

Rule 8400 also would be modified to establish a set of standards by which subpoenas are issued. The standards are set forth in a new paragraph (f), which states:

The rule would guide the Authority's discretion in considering whether to request Commission approval to issue a subpoena. The proposed rule sets forth three relevant considerations as specified in paragraphs (f)(1) through (3). These considerations will ensure that subpoenas will be used as an investigatory tool only when truly necessary, and not as a matter of routine in cases concerning the violation of Authority rules. The rules are patterned after and congruent with nearly identical provisions in Rule 5730(e) of the Anti-Doping and Medication Control Rules.

Rule 8410 is a new provision that would establish procedures by which the Authority may review matters concerning alleged violations of one or more rules in the Rule 2200 Series or the Rule 8100 Series. Proposed Rule 8410, to a certain degree, parallels rules pertaining to objections and protests that are common to the regulations of many State racing commissions. The rule would authorize the Authority on its own initiative to review evidence or information that is submitted from any source. The proposed rule states that evidence or information pertaining to the running of a Covered Horserace should be submitted within 72 hours after the race. The proposed rule provides that the Authority is not required to act on the evidence or information if the Authority deems it lacking in credibility. Conversely, if the information or evidence indicates that there is a reasonable probability that the rules of the Authority have been violated or have not been enforced, the proposed rule directs the Authority to conduct an investigation. The Authority also would be empowered to submit the matter for a hearing or to issue a Notice of Suspected or Actual Violation. The new provisions would create a procedure by which to review, for example, complaints made by racing participants alleging that other racing participants or their horses are non-compliant with the rules of the Authority.

A new Rule 8420 would be established to require the Authority to request and obtain the approval of the Commission before initiating any civil action pursuant to 15 U.S.C. 3054(j). The Authority's request would be deemed approved if the Commission does not act upon the request within 20 days of receipt. The rule would ensure that civil actions contemplated by the Authority are subject to the approval of the Commission prior to initiation of the civil action by the Authority. The proposed rule thus enhances the oversight of the Commission over the Authority.

In several provisions of the rules, the term “National Stewards Panel” would be replaced by the term “Internal Adjudication Panel,” as defined in the Rule 1000 Series and as referred to in the Rule 3000 and Rule 7000 Series. 18 The Internal Adjudication Panel is a body of adjudicators (many of whom are current or former stewards) who are assigned to preside over cases involving controlled medication violations. The name “National Stewards Panel” has sometimes been confused with references in the Authority's rules to “the stewards,” who preside over Covered Horseraces taking place at Racetracks. To avoid confusion, the language would be modified to remove any reference to the word “stewards.”  19

Two commenters suggested that the Authority calculate time without regard to Saturdays, Sundays, and holidays, which under Rule 8011 cannot be the last day of a specified period of time. 20 The commenters noted racing is routinely conducted on Saturdays, Sundays, and holidays, and there is no reason to make exceptions for these days as opposed to traditional business workdays. The Authority believes the exemptions for weekends and holidays are still appropriate, as many participants in horseracing do not organize their routine activities around weekend and holiday racing.

A commenter submitted this note concerning the proposed rule modification in Rule 8100(k): “Given the combination of reduction in the annual number of starters and the growing trend of greater time between close of entry and start, horses with regulatory restrictions that would otherwise prohibit a start should be given time to relieve such conditions prior to the day of the race. Thus, entries of all horses could be taken with any regulatory restriction cleared by the day of the race. Horses failing to satisfy regulatory restrictions at a time certain on the day of the race could be subject to scratch.”  21 The Authority took this comment into consideration and separated registration (in proposed Rule 8100(k)) from other regulatory activities (in proposed Rule 8100(l)) for greater clarity.

In accordance with the Commission's March 27, 2023 Order, the Authority's submission in support of the proposed rule modification discusses each of the suggestions made by commenters on the Federal Register publication from the original Enforcement Rule submission, where the Authority, in its February 21, 2022, letter to the Commission (the “February 21, 2022, Letter”  22 ), committed to further consider the suggestions. 23 The Authority's response to each of the suggestions is set out below.

The Authority agreed with the commenter that an additional rule was necessary setting forth the manner in which time is to be calculated. The Authority therefore proposed a modification to the Rule 8000 Series to include Rule 8011, “Calculation of Time.” This change was approved by the Commission on September 23, 2022. 24

The Authority is aware its jurisdiction must be precisely and carefully defined to avoid overreach. The Authority proposed, and the Commission approved, modifications to several provisions in Rule 8400 pertaining to search and seizure in response to concerns about its jurisdiction. 25 The Authority disagrees that the term “racing matter” is overbroad, however, and notes similar language is commonly used in the regulations of State racing commissions. 26

The Authority agreed with the underlying idea of the comment and recognized that additional language should be added to guide the discretion of the stewards and other disciplinary bodies in Rule 8200(b). The Authority therefore proposed, and the Commission approved, a modification to Rule 8200(b) to require that any fine be imposed “in proportion to the nature, chronicity and severity of the violation.”  27 This permits the decisionmaker to consider the circumstances of each particular violation, including mitigating circumstances.

The Authority notes that Rule 8100 sets forth a series of precisely defined violations, and further violations are specifically identified in the Rule 2000 Series Racetrack Safety rules. The Authority does not agree that the rules are confusing, but regularly provides assistance to Covered Persons who have questions about the rules and compliance issues.

The Authority recognized that additional language should be added to guide the discretion of the stewards and other disciplinary bodies in Rule 8200(b). The Authority therefore proposed, and the Commission approved, a modification to Rule 8200(b) to require that any fine be imposed “in proportion to the nature, chronicity and severity of the violation.”  28

The Authority agreed that these terms were problematic. The Authority proposed, and the Commission approved, a modification to Rule 8200(b)(6) to remove the “association” provision entirely, and to replace it with a narrower provision that permits the Authority to bar a penalized Covered Person from access to any location under the jurisdiction of the Authority. 29

The Authority declines to adopt this commenter's suggestion. The concept of censure is well-known as a pronouncement in which a body formally expresses its disapproval of an individual's actions.

The current rule permits the Authority to require a response in 7 days, and the Authority believes that this comports with due process. The rule also, however, permits the Authority to grant a longer period to respond based upon the seriousness of the violation, the imminence of risk, or other factors. The Authority declines to expand upon the details of accomplishing service. Email is commonly accepted as a means of service, and the Rule 9000 Series requires a Covered Person to provide and maintain contact information.

The Authority agreed with this commenter's suggestion and proposed a modification to Rule 8200(d)(1)(iii) to state that additional time to respond may be granted for reasons unrelated to the seriousness of the violation and imminence of risk. 30 This modification was approved by the Commission. 31

In response to these commenters and other comments concerning the penalty schedule set forth in Rule 8200(b), the Authority proposed, and the Commission approved, a modification to the rule to make clear that fines may be imposed in amounts lower than $50,000.00 for second violations  32 and removed a rule that prohibited association between Covered Persons in favor of a rule permitting the Authority to bar a penalized Covered Person from access to any location under the jurisdiction of the Authority. 33 Rule 8200(b) was modified to require that any fine be imposed “in proportion to the nature, chronicity and severity of the violation.”  34 These changes were made to ensure that the penalty structure is applied consistently and in a manner appropriate to the circumstances of the violation.

The Authority considered this comment but declines the request to include a specific list of factors guiding the discretion of the Racetrack Safety Committee. The Racetrack Safety Committee is mindful that there are numerous types of violations that might be brought before it under Rule 8320(b). The rule specifies that in referring the case, the Racetrack Safety Committee may consider the “seriousness of the alleged violation and the facts of the case[.]” Per the Rules of the 7000 Series, the Arbitral Body and the Internal Adjudication Panel are guided by an elaborate set of procedures suitable for complex cases, and the stewards are the obvious preference for adjudication of violations more directly related to race day activities and the running of the race.

The Authority has carefully considered the comments relating to the rule and believes that the rule adequately specifies the roles of attorneys and witnesses. The hearing process rules are intended to provide some flexibility of application as appropriate to particular cases. The rules are similar in many respects to State laws and regulations pertaining to adjudicative proceedings.

The Authority believes that the current 10-day period for filing an appeal is appropriate, not overly burdensome, and has been easily complied with by Covered Persons who have filed appeals since the Program Effective Date of July 1, 2022.

Since this comment was submitted in 2022, the Authority has proposed, and the Commission approved, a modification to Rule 8400(a) to more precisely define the extent and reach of the Authority's right of access to various types of records and physical locations. 35 The modification was prompted in part by the points and suggestions made by the commenters.

Since this comment concerning Rule 8400 was received in 2022, the Authority proposed, and the Commission approved, a modification to Rule 8400(a) to define more precisely the categories of physical items subject to seizure by the Authority, though the Authority did not specifically reference Shock Wave machines, goading instruments or TCO2 devices. 36

The changes advanced in the proposed Enforcement Rule modification are intended to enhance the Rule 8000 Series in a manner that is consistent with the Act. The proposed rules are carefully tailored to the unique character of horseracing and to the organizational structure of the Authority.

This rule is proposed by the Authority for approval or disapproval by the Commission under 15 U.S.C. 3053(c)(1).

If approved by the Commission, this proposed rule modification would be effective 30 days following the date of the Commission's order approving the modification.

Members of the public are invited to comment on the Authority's proposed rule modification. The Commission requests that factual data on which the comments are based be submitted with the comments. The supporting documentation referred to in the Authority's filing is available for public inspection on the docket for this matter at https://www.regulations.gov.

The Commission seeks comments that address the decisional criteria provided by the Act. The Act gives the Commission two criteria against which to measure proposed rules and rule modifications: “The Commission shall approve a proposed rule or modification if the Commission finds that the proposed rule or modification is consistent with—(A) this chapter; and (B) applicable rules approved by the Commission.”  37 In other words, the Commission will evaluate the proposed rule for its consistency with the specific requirements, factors, standards, or considerations in the text of the Act as well as the Commission's rules.

Although the Commission evaluates the Authority's proposed rule for its consistency with the Act and the Commission's rules, the Commission may consider broader questions—about the health and safety of horses and jockeys, the integrity of horseraces and wagering on horseraces, and the administration of the Authority itself—in another context: “The Commission . . . may abrogate, add to, and modify the rules of the Authority promulgated in accordance with [the Act] as the Commission finds necessary or appropriate to ensure the fair administration of the Authority, to conform the rules of the Authority to requirements of [the Act] and applicable rules approved by the Commission, or otherwise in furtherance of the purposes of [the Act].”  38 The Commission may exercise this rulemaking power on its own initiative or in response to a petition from a member from the public. If members of the public wish to provide comments to the Commission about its use of the rulemaking power, they are encouraged to submit a petition requesting that the Commission issue a rule addressing the subject of interest. The petition must meet all the criteria established in the Rules of Practice (part 1, subpart D);  39 if it does, the petition will be published in the Federal Register for public comment. In particular, the petition for a rulemaking must “identify the problem the requested action is intended to address and explain why the requested action is necessary to address the problem.”  40

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before September 23, 2025. Write “HISA Enforcement Rule Modification” on your comment. Your comment—including your name and your State—will be placed on the public record of this proceeding, including the https://www.regulations.gov website.

Postal mail addressed to the Commission is subject to delay because of heightened security screening. We strongly encourage you to submit your comments online. To ensure the Commission considers your online comment, you must file it at https://www.regulations.gov by following the instructions on the web-based form.

If you file your comment on paper, write “HISA Enforcement Rule Modification” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Mail Stop H-144 (Annex H), Washington, DC 20580. If possible, please submit your paper comment to the Commission by overnight service.

Because your comment will be placed on the public record, you are solely responsible for making sure your comment does not include any sensitive or confidential information. In particular, your comment should not contain sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other State identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential”—as provided in section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including, in particular, competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted publicly at https://www.regulations.gov —as legally required by FTC Rule 4.9(b), 16 CFR 4.9(b)—we cannot redact or remove your comment, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

Visit the FTC website to read this document and any news release describing it. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments it receives on or before September 23, 2025. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/siteinformation/privacypolicy.

Written communications and summaries or transcripts of oral communications respecting the merits of this proceeding, from any outside party to any Commissioner or Commissioner's advisor, will be placed on the public record. See 16 CFR 1.26(b)(5).

The following language reflects the Enforcement Rule with the proposed modifications incorporated. A redline version that shows every way in which the previously approved Enforcement Rule would be modified by the proposed rule modification is available as Exhibit B on the docket at https://www.regulations.gov.

In calculating any period of time prescribed in the Rule 8000 Series, time shall be calculated in calendar days. If the last day of a specified period of time falls on a Saturday, Sunday, or holiday, then the last day of the period shall be considered to be the next working day immediately following the Saturday, Sunday, or holiday.

Violations under this Rule shall include:

(a) Failure to cooperate with the Authority or an agent of the Authority during any investigation;

(b) Failure to respond truthfully, to the best of a Covered Person's knowledge, to a question of the Authority or an agent of the Authority with respect to any matter under the jurisdiction of the Authority;

(c) Tampering or attempted tampering with the application of the safety, performance, or anti-doping and medication control rules or process adopted by the Authority, including:

(1) Intentional interference, or an attempt to interfere, with an official or agent of the Authority;

(2) Procurement or the provision of knowingly false information to the Authority or agent of the Authority; and

(3) The intimidation of, or an attempt to intimidate, a potential witness;

(d) Assisting, encouraging, aiding, abetting, conspiring, covering up, or any other type of intentional complicity involving a racetrack safety violation or the violation of a period of suspension or ineligibility;

(e) Threatening or seeking to intimidate a person with the intent of discouraging the person from the good faith reporting to the Authority, an agent of the Authority, or the Commission, of information that relates to:

(1) A suspected or alleged violation of a rule in the Rule 2200 Series; or

(2) A suspected or alleged noncompliance with a rule in the Rule 2200 Series;

(f) Failure to comply with a written order or ruling of the Authority or an agent of the Authority pertaining to a racing matter or investigation;

(g) Failure to register with the Authority, failure of a Responsible Person to register a Covered Horse, making a knowingly false statement or omission of information in an application for registration with the Authority, or failure to advise the Authority of material changes in the application information as required by the rules of the Authority;

(h) Perpetrating or attempting to perpetrate a fraud or misrepresentation in connection with the care or racing of a Covered Horse;

(i) Failure to remit fees as required under 15 U.S.C. 3052(f)(3);

(j) Failure by a Racetrack to collect equitable allocation amounts among Covered Persons in conformity with the funding provisions of 15 U.S.C. 3052(f)(3) and any rules pertaining thereto;

(k) Entering a Covered Horse or causing a Covered Horse to compete in a Covered Horserace prior to registering the Covered Horse with the Authority in accordance with the Rule 9000 Series; and

(l) Causing a Covered Horse to compete in a Covered Horserace with the knowledge that, at the time of the Covered Horserace, the Covered Horse is ineligible to compete pursuant to the rules of the Authority.

(a) Application. This Schedule shall apply to any Covered Person's violation of, or failure to comply with, the Act or rules promulgated by the Authority, except for:

(1) Anti-doping and medication control rule violations as established in the Rule 3000 Series; and

(2) Racing rules and State laws or regulations not pre-empted by 15 U.S.C. 3054(b).

(b) Imposition of Sanction. The Board of the Authority, the Racetrack Safety Committee, the stewards, any steward or body of stewards selected from the Internal Adjudication Panel, or an Arbitral Body, after any hearing required to be conducted in accordance with the Rule 7000 Series or Rule 8000 Series and upon finding a violation or failure to comply with the rules of the Authority (with the exceptions identified in paragraph (a)), may impose one or more of the following sanctions on a Covered Person for each violation of the rules of the Authority, in proportion to the nature, chronicity, and severity of the violation:

(1) For a violation of Rule 2271(a)(2) or 2272 relating to the use of Shock Wave Therapy, a violation of Rule 2271(a)(11) or 2271(a)(12) relating to permitting a Covered Horse to perform a Workout or participate in a Covered Horserace after treatment with an intra-articular injection, a violation of Rule 2273 relating to the use of other electrical or mechanical devices, or a violation of Rule 2280 relating to the use of the riding crop, impose the penalties set forth in Rules 2271(b), 2272, 2274, 2282, and 2283, in lieu of the penalties set forth in Rule 8200(b)(2) through (12); provided, however, for any violation involving a Covered Horse that participates in a Covered Horserace in violation of Rule 2271(a)(11) or 2271(a)(12), the Covered Horse shall be disqualified, the purse forfeited, and the Responsible Person shall be subject to the penalty schedule established in Rule 2271(b);

(2) Impose a fine upon a Covered Person in the following amounts:

(i) Up to $50,000.00 for a first violation; or

(ii) Up to $100,000.00 for a second violation of the same or similar nature to a prior violation, or any violation that due to its nature, chronicity, or severity poses an actual or potential threat of harm to the safety, health, or welfare of Covered Persons or Covered Horses, or to the integrity of Covered Horseraces;

(3) Deny or suspend the registration of a Covered Person for a definite period, a probationary period, or a period contingent on the performance of a particular act;

(4) Revoke the registration of a Covered Person subject to reapplication at a specified date;

(5) Impose a lifetime ban from registration with the Authority;

(6) Deny a Covered Person or a Covered Horse access to any location under the jurisdiction of the Authority during the period of a suspension;

(7) Impose a temporary or permanent cease and desist order against a Covered Person;

(8) Require a Covered Person, as a condition of participation in horseracing, to take any remedial or other action that is consistent with the safety, welfare, and integrity of Covered Horses, Covered Persons, and Covered Horseraces;

(9) Deny purse money or require the forfeiture of purse money, disqualify a Covered Horse, or make changes to the order of finish in Covered Horseraces as consistent with the safety, welfare, and integrity of Covered Horses, Covered Persons, and Covered Horseraces. If a Covered Horse is disqualified, the purse shall be redistributed in accordance with the revised order of finish;

(10) Censure a Covered Person;

(11) Prohibit a Racetrack from conducting any Covered Horserace; or

(12) Impose any other sanction as a condition of participation in horseracing as deemed appropriate in keeping with the seriousness of the violation and the facts of the case, and that is consistent with the safety, welfare, and integrity of Covered Horses, Covered Persons, and Covered Horseraces.

(c) Consent Decrees. The Board of the Authority shall have the discretion to enter into a consent decree or other similar agreement with a Covered Person as necessary to promote the safety, welfare, and integrity of Covered Horses, Covered Persons, and Covered Horseraces.

(d) Notice of Suspected or Actual Violation.

(1) The Authority, the Racetrack Safety Committee, or one or more stewards may issue a Notice of Suspected or Actual Violation to a Covered Person in any case in which the issuing body has reason to believe that the Covered Person has violated or has failed to comply with any rule of the Authority. The notice shall:

(i) Identify the provision or provisions which the Covered Person is believed to have violated;

(ii) Specify with reasonable particularity the factual basis of the issuing body's belief that the provision has been violated; and

(iii) Provide the Covered Person at least 7 days to respond, or a longer period as deemed appropriate and specified in the Notice based upon:

(A) The seriousness of the violation;

(B) The imminence of risk to Covered Persons, Covered Horses, Covered Horseraces, or the public; or

(C) Any other relevant factor.

(2) Upon receipt of the Notice of Suspected or Actual Violation, the Covered Person shall respond in writing to the issuing body within the time period specified in the notice. The Covered Person shall include in the response:

(i) A statement by the Covered Person admitting the violation or explaining the reasons why the Covered Person believes that a violation has not occurred;

(ii) All relevant details concerning the circumstances of the suspected or actual violation, including the results of any investigation undertaken by the Covered Person of the circumstances, and identification of any persons responsible for the circumstances; and

(iii) A detailed explanation of any remedial plan the Covered Person proposes to undertake to cure the suspected or actual violation and the date of the expected completion of the remedial plan.

(3) Upon receipt of the written response of the Covered Person, the issuing body may accept any proposed remedial plan, subject to any reasonable modifications the issuing body deems necessary, or it may initiate disciplinary proceedings in conformity with the provisions of Rule 8300. If the issuing body determines that no violation has occurred, the issuing body shall so inform the Covered Person and no further action shall be taken.

(e) Failure by a Covered Person to pay any fine by the prescribed deadline that is imposed by the Authority, or by any official or body authorized to adjudicate violations under the Rule 2000 or 8000 Series, shall subject the Covered Person to automatic suspension by the Authority, absent a showing to the Authority by the Covered Person of exceptional circumstances that resulted in the failure to pay the fine.

(f) Failure by a Covered Person to repay a purse as ordered by the Authority, or by any official or body authorized to adjudicate violations under the Rule 2000 or Rule 8000 Series, shall subject the Covered Person to automatic suspension by the Authority, absent a showing to the Authority by the Covered Person of exceptional circumstances that resulted in the failure to repay the purse.

An alleged violation or failure to comply with the provisions of the Rule 2200 Series or Rule 8100, and any matter involving the suspension or revocation of accreditation pursuant to Rule 2116 shall be adjudicated in accordance with this Rule 8300 Series, except that:

(a) An alleged violation of the anti-doping and medication control rule provisions in the Rule 3000 Series shall be adjudicated in accordance with the procedures set forth therein; and

(b) This rule shall not apply to the adjudication of violations arising under State laws, racing rules, and regulations not preempted under 15 U.S.C. 3054(b).

(a) Violations of the Rule 2200 Series shall be adjudicated as follows.

(1) The stewards shall adjudicate all alleged violations of Rule 2271(a)(2) or 2272 relating to the use of Shock Wave Therapy, and Rule 2273 relating to the use of other electrical or mechanical devices.

(2) The stewards shall adjudicate all alleged violations of Rules 2280 through 2283 relating to riding crops.

(3) The stewards shall apply the hearing procedures of the State jurisdiction in which the violation is alleged to have occurred. Provided, however, that in any State that has not entered into an agreement with the Authority under which the State stewards serve in an adjudicatory capacity under the Rule 8000 Series and enforce the Rule 2200 Series, a hearing may be conducted by one or more stewards, notwithstanding any State rule to the contrary. All testimony at a stewards' hearing shall be given under oath, and a record of the hearing shall be kept by use of an audio recorder, video recording, or court reporter's transcript. Any ruling finding a violation relating to the use of the riding crop under Rules 2280 and 2281 may be appealed under the procedures described in Rule 2285. All other rulings by the stewards finding a violation may be appealed to the Board of the Authority under the procedures described in Rule 8350. An appeal shall be filed in writing within 10 days of the issuance of the ruling by the stewards.

(b) With regard to any matter involving an alleged violation of a rule in the Rule 2200 Series other than those set forth in paragraph (a) above, the Racetrack Safety Committee may, at its discretion and taking into account the seriousness of the alleged violation and the facts of the case:

(1) Refer the matter to one or more members of the Internal Adjudication Panel for adjudication in conformity with the procedures established in Rule 2286, the Rule 7000 Series, and the Rule 8000 Series. Where there is any inconsistency between the provisions of the Rule 7000 and Rule 8000 Series, the provisions of the Rule 8000 Series shall be controlling;

(2) Refer the matter to an Arbitral Body for adjudication in conformity with the procedures established in Rule 2286, the Rule 7000 Series, and the Rule 8000 Series. Where there is any inconsistency between the provisions of the Rule 7000 and Rule 8000 Series, the provisions of the Rule 8000 Series shall be controlling;

(3) Refer the matter to the stewards for adjudication in accordance with the hearing procedures of the applicable State jurisdiction. Provided, however, that in any State that has not entered into an agreement with the Authority under which the State stewards serve in an adjudicatory capacity under the Rule 8000 Series and enforce the Rule 2200 Series, a hearing may be conducted by one or more stewards, notwithstanding any State rule to the contrary; or

(4) Conduct a hearing upon the matter itself, under the procedures set forth in Rule 8340.

With regard to any matter involving an alleged violation of any provision of Rule 8100, the Board of the Authority may, at its discretion and taking into account the seriousness of the violation and the facts of the case:

(a) Refer the matter to one or more members of the Internal Adjudication Panel for adjudication in conformity with the procedures established in the Rule 7000 Series and the Rule 8000 Series. Where there is any inconsistency between the provisions of the Rule 7000 and Rule 8000 Series, the provisions of the Rule 8000 Series shall be controlling;

(b) Refer the matter to an Arbitral Body for adjudication in conformity with the procedures established in the Rule 7000 Series and the Rule 8000 Series. Where there is any inconsistency between the provisions of the Rule 7000 and Rule 8000 Series, the provisions of the Rule 8000 Series shall be controlling;

(c) Refer the matter to the stewards for adjudication in accordance with the hearing procedures of the applicable State jurisdiction. Provided, however, that in any State that has not entered into an agreement with the Authority under which the State stewards shall serve in an adjudicatory capacity under the Rule 8000 Series and enforce the Rule 2200 Series, a hearing may be conducted by one or more stewards, notwithstanding any State rule to the contrary; or

(d) Conduct a hearing upon the matter itself, under the procedures set forth in Rule 8340.

(a) An initial hearing before the Board, including a proceeding under Rule 2116, shall be conducted by a panel of three Board members. The Board chair shall appoint the panel members and shall also designate one of them as the chair of the panel. At the discretion of the panel of the Board, an initial hearing may be conducted in person or by means of an audio-visual teleconferencing system or by telephone.

(b) An initial hearing before the Racetrack Safety Committee shall be heard by a quorum of the Racetrack Safety Committee. The Racetrack Safety Committee Chair shall act as the chair of the hearing panel unless the Chair is unavailable, in which case the Racetrack Safety Committee Chair shall designate a member of the quorum to act as the chair of the panel. At the discretion of the Racetrack Safety Committee, an initial hearing may be conducted in person or by means of an audio-visual teleconferencing system or by telephone.

(c) The Covered Person charged with an alleged violation is entitled to notice of a hearing before the Board panel or the Racetrack Safety Committee, and shall be informed not less than 20 days prior to the hearing of:

(1) The time, place, and nature of the hearing;

(2) The legal authority and jurisdiction under which the hearing is to be held;

(3) A description of the rule or rules allegedly violated, specifying by number the rule or rules allegedly violated; and

(4) A statement of the factual basis of the alleged violation(s) in sufficient detail to provide adequate opportunity to prepare for the hearing.

(d) At any time prior to, during, or after the hearing, the Board panel or the Racetrack Safety Committee in its discretion may require the submission of written briefs or other information as will assist in the hearing of the matter.

(e) All testimony in proceedings before the Board panel or the Racetrack Safety Committee shall be given under oath, and a record of the proceedings shall be kept in stenographic or recorded form.

(f) The burden of proof shall be on the party alleging the violation to show, by a preponderance of the evidence, that the Covered Person has violated or failed to comply with, or is responsible for a violation of, a provision of the Authority's rules.

(g) The Board panel or the Racetrack Safety Committee shall allow a full presentation of evidence and shall not be bound by the technical rules of evidence. However, the Board panel or the Racetrack Safety Committee may disallow evidence that is irrelevant or unduly repetitive of other evidence. The Board panel or the Racetrack Safety Committee shall have the authority to determine, in its sole discretion, the weight and credibility of any evidence or testimony. The Board panel or the Racetrack Safety Committee may admit hearsay evidence if it determines the evidence is of a type that is commonly relied on by reasonably prudent people. Any applicable rule of privilege shall apply in hearings before the Board panel or the Racetrack Safety Committee.

(h) A party shall be entitled to present its case or defense by oral or documentary evidence, to be represented by counsel at the party's expense, to submit rebuttal evidence, and to conduct such limited cross-examination as may be required for a full and true disclosure of the facts.

(i) Presiding Officer for the Conduct of the Hearing. The Board panel or the Racetrack Safety Committee may appoint a presiding officer to assist in regulating the orderly conduct of and presentation of evidence at the hearing. The Board panel or the Racetrack Safety Committee may assign to the presiding officer any or all of the following powers, in any manner that the Board panel or the Racetrack Safety Committee determines is most appropriate based upon the nature and complexity of the subject matter of the hearing. The presiding officer may be granted the power to:

(1) Rule upon requests, including all requests for adjournments;

(2) Set the time and place of hearing, recesses, and adjournments;

(3) Administer oaths and affirmations;

(4) Summon and examine witnesses, including the authority to direct a party to appear and to testify;

(5) Order that opening and closing statements be made;

(6) Admit or exclude evidence;

(7) Allow oral argument;

(8) Issue orders limiting the scope and length of cross-examination, the length of briefs, and similar matters;

(9) Order the parties to appear for a prehearing conference to consider matters that may simplify the issues or expedite the proceeding; and

(10) Perform all acts and take all measures necessary for the maintenance of order and the efficient conduct of the hearing.

(j) Presiding Officer for the Submission of a Hearing Report. The Board panel or the Racetrack Safety Committee may direct a presiding officer to issue in writing a hearing report at the conclusion of the hearing and to submit it to the Board panel or the Racetrack Safety Committee and all parties. A copy of the record of the hearing shall accompany the hearing report. The hearing report shall set forth findings of fact, conclusions of law, and a recommended disposition. If the presiding officer finds that imposition of a penalty under Rule 8200 is warranted, the recommended penalty shall be set forth in specific detail, including the length of any suspension and the amount of any fine. If so directed by the Board panel or the Racetrack Safety Committee, the presiding officer shall establish a schedule for the filing by the parties of:

(1) Briefs to be considered by the presiding officer prior to the presiding officer's preparation of the hearing report; and

(2) Exceptions to the presiding officer's hearing report after the hearing report has been delivered to the parties. The exceptions may include, for consideration and adoption by the Board panel or the Racetrack Safety Committee, the particular findings of fact, conclusions of law, and recommendations for disposition with which the party disagrees and the reasons for such disagreement, any general comments by the party on the suitability of the hearing report, and the party's alternative proposed findings of fact, conclusions of law, and recommendations for disposition. A party shall send a copy of its exceptions to all other parties or their attorneys and to the presiding officer.

(k) Review by the Board panel or the Racetrack Safety Committee. Upon receipt of the record of the hearing, and of any hearing report and exceptions thereto submitted pursuant to paragraph (j), the Board panel or the Racetrack Safety Committee shall review the record and submissions. The period for review shall not exceed 20 days unless extended by the Board panel or the Racetrack Safety Committee upon notice to all parties.

(l) Written Decision. Within 30 days of the close of the review period, the Board panel or the Racetrack Safety Committee shall issue to all parties a written decision setting forth findings of fact, conclusions of law, and the disposition of the matter including any penalty imposed. If a hearing report has been received, the Board panel and the Racetrack Safety Committee shall have discretion to adopt, modify, or reject any or all of the hearing report including, but not limited to, the appropriate disposition of the proceeding and any penalty recommended.

(a) Except as set forth in Rule 2285 concerning intermediate appeals for violations of Rules 2280 and 2281, and in Rule 2287 concerning appeals taken in the course of adjudicating the provisional suspension of registration, any decision rendered by the Racetrack Safety Committee, the stewards, the Internal Adjudication Panel, or an Arbitral Body may be appealed on the record to the Board. The decision may be appealed by a party to the decision, or the decision may be reviewed upon the Board's own initiative and at its discretion.

(b) Except as set forth in Rule 2116 concerning appeals taken in the course of adjudicating the suspension or revocation of accreditation, in Rule 2117 concerning appeals taken in the course of adjudicating the provisional suspension of accreditation, and in Rule 2287 concerning appeals taken in the course of adjudicating the provisional suspension of registration, any decision rendered by an initial Board hearing panel may be appealed on the record to the Board, to be reviewed by a quorum of the Board which shall not include the Board members who were on the panel in the initial hearing. The decision may be appealed by a party to the decision, or the decision may be reviewed upon the Board's own initiative and at its discretion.

(c) An appeal shall not automatically stay the decision. A party may request the Board to stay the decision. A stay may be issued by the Board, or by any official or body of the Authority to whom the Board delegates the authority to review requests for stay, for good cause shown.

(d) A party to the decision must file with the Board a written request for any appeal within 10 days of receiving a written order. The appeal request shall contain the following information:

(1) The name, address, and telephone number, if any, of the appellant;

(2) A description of the objections to the decision;

(3) A statement of the relief sought; and

(4) Whether the appellant requests a hearing.

(e) The Board may in its discretion review a decision based solely upon written submissions scheduled for filing with such timing and response requirements as the Board may require. Alternatively, or in addition to written submissions, the Board may set a date, time, and place for a hearing. Notice shall be given to all parties in writing and shall set out the date, time, and place of the hearing, and shall be served personally or sent by electronic or U.S. mail to the last known address of the appellant. If the appellant objects to the date of the hearing, the appellant may obtain a continuance, but the continuance shall not automatically stay imposition of a sanction or prolong a stay issued by the Board. At the discretion of the Board, the hearing may be conducted in person or by means of an audio-visual videoconferencing system or by telephone.

(f) Upon review of the decision that is the subject of the appeal, the Board shall uphold the decision unless it is clearly erroneous or not supported by the evidence or applicable law.

(g) Upon completing its review, the Board may:

(1) Accept the decision;

(2) Reject or modify the decision, in whole or in part;

(3) Remand the matter, in whole or in part, to the stewards, the Racetrack Safety Committee, the Internal Adjudication Panel, or an Arbitral Body, as the case may be, for further proceedings as appropriate; or

(4) Conduct further proceedings on the matter as appropriate, including but not limited to requiring the submission of written briefs or, in extraordinary circumstances and at the Board's discretion, the taking of additional testimony before the Board under oath.

(h) The Board may appoint a presiding officer to assist in regulating the orderly conduct of, and presentation of evidence at, a hearing in accordance with Rule 8340(i). The Board may also direct a presiding officer to issue in writing a hearing report at the conclusion of the hearing in accordance with Rule 8340(j).

(i) The Board shall issue its written decision based on the record, any further proceedings, testimony, or hearing report and exceptions thereto submitted in accordance with Rule 8340(j), and any additional submissions or testimony under Rule 8350(g)(4). If a hearing report and exceptions have been submitted, the Board's written decision shall, in accordance with Rule 8340(l), include findings of fact, conclusions of law, and the disposition of the matter including any penalty imposed. The Board shall not be bound by the timing provisions in Rules 8340(k) and 8340(l) relating to the period for review and the issuance by the Board of its written decision. A copy of the Board's decision shall be served upon all parties by first class mail, electronic mail, or personal service.

(j) The decision of the Board shall be the final decision of the Authority.

(a) Except as set forth in Rule 2117 concerning appeals taken in the course of adjudicating the provisional suspension of accreditation, any decision issued by a Board panel denying, suspending, or revoking Racetrack accreditation may:

(1) Be appealed within 10 days by the Racetrack to the Board of the Authority for a de novo hearing reviewing the Board panel's decision, to be conducted under the procedures set forth in Rule 8340(c) through (h); or

(2) Be reviewed by the Board of the Authority on its own initiative.

(b) The Board panel's order suspending or revoking accreditation shall be stayed automatically pending the de novo hearing and review of the decision by the Board of the Authority.

(c) At its discretion, the Board of the Authority may request and consider any additional information from any source that may assist in the review.

(d) The Racetrack may request to make a presentation before the Board of the Authority concerning racetrack safety and any remedial efforts proposed to be undertaken by the Racetrack. At its discretion, the Board of the Authority may permit the Racetrack to make such presentation.

(e) In conducting its initial review under Rule 8340 or the de novo hearing on appeal, the Board of the Authority may consider all factors that it deems appropriate, including but not limited to:

(1) The extent and magnitude of any deficiencies in racetrack operations conducted at the Racetrack;

(2) The threat posed by the deficiencies to the safety and integrity of horseracing conducted at the Racetrack;

(3) The adequacy of the efforts the Racetrack proposes to undertake or has undertaken to remedy all deficiencies at the Racetrack;

(4) The likelihood and timeframe within which compliance can be achieved by the Racetrack, given the resources available to the Racetrack and the past record of the Racetrack in achieving and maintaining compliance with the rules of the Authority; and

(5) Any other factors the Board of the Authority deems relevant to its review.

(f) Upon completing its initial review under Rule 8340, or upon concluding the de novo hearing on appeal, the Board of the Authority may take one or more of the following actions:

(1) Order that the Racetrack's accreditation be denied, suspended, or revoked, upon a vote in favor of denial, suspension, or revocation by two-thirds of a quorum of the members of the Board of the Authority;

(2) Reinstate accreditation subject to any requirements the Board of the Authority deems necessary to ensure that horseracing will be conducted in a manner consistent with racetrack safety and integrity. The Board of the Authority may also impose a fine upon reinstatement in an amount not to exceed $50,000.00. The Board of the Authority may require the Racetrack to report at prescribed intervals on the status of racetrack safety operations and remedial efforts to improve safety pursuant to the Authority's racetrack safety rules; or

(3) Prohibit a Racetrack from conducting any Covered Horserace.

Any decision rendered by the Board of the Authority under Rule 8350 or under Rule 8360 shall constitute a final civil sanction subject to appeal and review in accordance with the provisions of 15 U.S.C. 3058.

As used in this Rule, “public disclosure” means the dissemination or distribution of information by the Authority to the general public.

(a) This Rule shall apply to an alleged violation of any provision of the Act, the Rule 2000 Series, the Rule 8000 Series, or the Rule 9000 Series. It shall not apply to:

(1) An alleged violation of the anti-doping and medication control rule provisions in the Rule 3000 Series; or

(2) An alleged violation arising under State laws, racing rules, and regulations not preempted under 15 U.S.C. 3054(b).

(b) After notice of a violation of any provision in the Rule 2200 Series, the Rule 8000 Series, or the Rule 9000 Series has been provided to a Covered Person by the Authority or any official or body authorized to adjudicate violations under the Rule 8000 Series, the Authority shall publicly disclose the following information relating to the alleged violation:

(1) The identity of any Covered Person who is the subject of the alleged violation;

(2) The identity of any applicable horse; and

(3) The rule violated and, where appropriate, the basis of the asserted violation.

(c) Information as described in paragraph (b) concerning a violation of the Rule 2100 Series shall be disclosed in accordance with this Rule by the Authority either upon issuance of a Notice of Suspected or Actual Violation, or at any time thereafter, as deemed appropriate by the Authority.

(d) If at any time information pertaining to an alleged violation is publicly disclosed by the Covered Person charged with the violation or any employee or agent of the Covered Person, the Authority may comment on the information publicly disclosed by the Covered Person.

(e) The Authority need not disclose to the public any information if such public disclosure might compromise an ongoing investigation or proceeding. When the Authority determines that an ongoing investigation or proceeding will no longer be compromised by public disclosure, the Authority shall at such time make any public disclosure required under this Rule.

(f) Notwithstanding any provision to the contrary in the rules of the Authority, the Authority may make public disclosure of any relevant information at any time, including prior to delivery of notice of a violation, if the Authority determines that such disclosure:

(1) Concerns a violation or circumstance that poses a serious and imminent risk of harm to Covered Persons, Covered Horses, or the public; or

(2) Is otherwise in the best interest of horseracing conducted at Covered Horseraces.

(g) The Authority shall publicly disclose the resolution of an alleged violation no later than 20 days after the earliest of:

(1) The imposition of a final civil sanction;

(2) A resolution between the Authority and the Covered Person; or

(3) The dismissal of the allegation or a finding of no violation by the Authority.

(h) Public disclosure under paragraphs (g)(1) and (g)(2) shall include the following:

(1) The name of the Covered Person who committed the violation and any Covered Horse affected by the violation;

(2) The Rule violated;

(3) The sanction imposed;

(4) The order or other ruling issued in the matter; and

(5) The results of any appellate decisions concerning the violation.

(i) Public disclosure shall not be required under this Rule if the Covered Person alleged to have committed a violation is a minor. Public disclosure concerning a case involving a minor shall be at the discretion of the Authority and in proportion to the facts and circumstances of the case.

(j) Publication shall be accomplished at a minimum by placing the required information on the Authority's website or publishing it through other means.

(k) Pursuant to 15 U.S.C. 3054, this Rule shall preempt any provision of State law or regulation, including those pertaining to data practices and privacy laws.

(a) The Authority or its designees:

(1) Shall have free access to:

(i) With regard to Covered Persons, books, records, offices, Racetrack facilities, and other places of business of Covered Persons that are used in the care, treatment, training, or racing of Covered Horses; and

(ii) With regard to any person who owns a Covered Horse or performs services on a Covered Horse, books, records, offices, facilities, and other places of business that are used in the care, treatment, training, or racing of Covered Horses.

(2) May seize:

(i) Any medication, drug, substance, or injectable in violation or suspected violation of any provision of 15 U.S.C. 3151 through 3160 or the rules of the Authority; and

(ii) Intravenous tubing, syringes, needles, nasogastric tubes, container bags, vials, electrical devices, riding crops not in compliance with Rule 2281, and similar items that may be evidence of a violation or suspected violation of any provision of 15 U.S.C. 3151 through 3160 or the rules of the Authority.

(b) After the conclusion of any proceedings relating to the alleged violation, the Authority or its designees shall return any seized property if its possession by a Covered Person is not specifically prohibited by the Act or the rules of the Authority.

(c) A Covered Person shall:

(1) Cooperate with the Authority or its designees during any investigation; and

(2) Respond truthfully to the best of the Covered Person's knowledge if questioned by the Authority or its designees about a racing matter.

(d) A Covered Person or any officer, employee, or agent of a Covered Person shall not hinder a person who is conducting an investigation under, or attempting to enforce or administer any provision of, 15 U.S.C. 3151 through 3160 or the rules of the Authority.

(e) The Authority may issue subpoenas for the attendance of witnesses in proceedings within their jurisdiction, and for the production of documents, records, papers, books, supplies, devices, equipment, and all other instrumentalities related to matters within the jurisdiction of the Authority. The Authority shall request and obtain the approval of the Commission before issuing a subpoena pursuant to 15 U.S.C. 3054(h). If the Commission does not act upon the request within 20 days of receipt, the Authority's request to issue a subpoena pursuant to 15 U.S.C. 3054(h) shall be deemed approved by the Commission.

(f) The following considerations shall be taken into account by the Authority in determining whether a subpoena shall be issued:

(1) The availability of, and likelihood of success in using, alternative methods for obtaining the information in a timely manner;

(2) The indispensability of the information to the success of an investigation or establishing a violation; and

(3) The need to protect against the destruction of records or information or to preserve testimony that may be necessary to investigate and prosecute violations of the rules of the Authority.

(g) Failure to comply with a subpoena or with the other provisions of this Rule may be penalized by the imposition of one or more penalties set forth in Rule 8200.

(h) The Authority may administer oaths to witnesses and require witnesses to testify under oath in matters within the jurisdiction of the Authority.

(a) The Authority may on its own initiative review any evidence or information submitted from any source which establishes a reasonable probability that one or more rules of the Authority in the Rule 2200 Series or the Rule 8100 Series have been violated or have not been enforced. If the evidence or information pertains to the running of a Covered Horserace, the evidence or information should be submitted to the Authority within 72 hours after the Covered Horserace. If the Authority deems the evidence or information submitted to be lacking in credibility, the Authority is not obligated to take further action. The Authority's decision whether to take further action is not subject to appeal.

(b) If the Authority determines there is a reasonable probability that the rules of the Authority have been violated or have not been enforced, the Authority shall conduct an investigation of the matter. The Authority may in its discretion:

(1) Assign the matter for a hearing pursuant to Rule 8320(b) or Rule 8330; or

(2) Issue a Notice of Suspected or Actual Violation pursuant to Rule 8200(d).

The Authority shall request and obtain the approval of the Commission before initiating any civil action pursuant to 15 U.S.C. 3054(j). If the Commission does not act upon the request within 20 days of receipt, the Authority's request to initiate a civil action pursuant to 15 U.S.C. 3054(j) shall be deemed approved by the Commission.

Title: OGE Form 201 Request an Individual's Ethics Documents.

Agency Form Number: OGE Form 201.

OMB Contro Number: 3209-0002.

Type of Information Collection: Extension with modifications of a currently approved collection.

Type of Review Request: Regular.

Respondents: Individuals requesting access to executive branch public financial disclosure reports and other covered records.

Estimated Annual Number of Respondents: 12,461.

Estimated Time per Response: 10 minutes.

Estimated Total Annual Burden: 2,077 hours.

Abstract: The OGE Form 201 collects information from, and provides certain information to, persons who seek access to OGE Form 278 Public Financial Disclosure Reports, including OGE Form 278-T Periodic Transaction Reports, and other covered records. The form reflects the requirements of the Ethics in Government Act, subsequent amendments pursuant to the STOCK Act, and OGE's implementing regulations that must be met by a person before access can be granted. These requirements include the address of the requester, as well as any other person on whose behalf a record is sought, and acknowledgement that the applicant is aware of the prohibited uses of executive branch public disclosure financial reports. See 5 U.S.C. 13107(b) and (c) and 13122(b)(1) and 5 CFR 2634.603(c) and (f). Executive branch departments and agencies are encouraged to utilize the OGE Form 201 for individuals seeking access to public financial disclosure reports and other covered documents. OGE permits departments and agencies to use or develop their own forms as long as the forms collect and provide all of the required information.

OGE currently has OMB approval for six versions of the form: OGE's online application (English, Arabic, Chinese, French, and Spanish), and a PDF version in English.

OGE is proposing two changes to both English language versions of the form. First, OGE proposes updating the language of its Privacy Act Statement. Second, OGE proposes replacing the outdated Ethics in Government Act citation with the current citation.

OGE is also proposing additional changes only to the English language PDF version of the form, as summarized below:

• Adding text to the Supplemental Information section, page 3 (section 5a), and page 5 (above the large text box) to inform requesters of general retention periods that may impact availability of documents they are requesting.

• Modifying the text in several places to improve accuracy, clarity, consistency, and align with plain language principles.

To view a pdf draft containing the proposed changes, visit https://www.oge.gov/web/OGE.nsf/0/7CBE89A1496B40E785258CEC00555DC2/$FILE/OGE%20Form%20201%20Renewal_Draft_website.pdf.

To register to attend the virtual public meeting on October 6, 2025 from 2:00-3:00 p.m. Eastern Time, visit https://events.gcc.teams.microsoft.com/event/2a12717b-0338-4df7-af40-342375b8dd51@c0abca44-0182-40a9-8010-01ec94254f77.

Request for Comments: Agency and public comment is invited specifically on the need for and practical utility of this information collection, the accuracy of OGE's burden estimate, the enhancement of quality, utility and clarity of the information collected, and the minimization of burden (including the use of information technology). Comments received in response to this notice will be summarized for and included with the OGE request for extension of OMB paperwork approval. The comments will also become a matter of public record.

Specifically, OGE seeks public comment on the following:

• What problems do you have using the form?

• Are there sections of the form or instructions that are unclear?

• Is there information provided that is confusing?

• What additional information would be helpful?

Authority: 44 U.S.C. 3506(c)(2)(A); 5 U.S.C. 13107(b) and (c); 5 U.S.C. 13122(b)(1); 5 CFR 2634.603(c) and (f).

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products (OMB Control No. 0920-0210, Exp. 1/31/2026)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Cigarette smoking is the leading preventable cause of premature death and disability in our nation. Each year more than 480,000 deaths occur as the result of cigarette smoking-related diseases. Since 1986, as required by the Comprehensive Smoking Education Act (CSEA) of 1984, which amended the Federal Cigarette Labeling and Advertising Act (FCLAA), 15 U.S.C. 1335a, CDC has collected information about the ingredients used in cigarette products. HHS has delegated responsibility for implementing the required information collection to CDC. Respondents are commercial cigarette manufacturers, packagers, or importers (or their representatives), who are required by FCLAA to submit ingredient reports to HHS on an annual basis.

Respondents are not required to submit specific forms; however, they are required to submit a list of all ingredients used in their products. CDC requires the ingredient report to be submitted by chemical name and Chemical Abstract Service (CAS) Registration Number, consistent with accepted reporting practices for other companies currently required to report ingredients added to other consumer products. The information collected is subject to strict confidentiality provisions.

Ingredient reports are due annually on March 31. Upon receipt and verification of the annual ingredient report, CDC issues a Certificate of Compliance to the respondent. As deemed appropriate by the Secretary of HHS, HHS is authorized to use the information to report to Congress the health effects of ingredients, research activities related to the health effects of ingredients, and other information that the Secretary determines to be of public interest.

The total estimated annualized burden hours are 358. OMB approval is requested for three years. There are no costs to respondents other than their time.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the U.S. (OMB Control No. 0920-0338, Exp. 1/31/2026)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Smokeless tobacco products (SLT) are associated with many health problems. Using smokeless tobacco can lead to nicotine addiction; causes cancer of the mouth, esophagus, and pancreas; is associated with diseases of the mouth; can increase risks for early delivery and stillbirth when used during pregnancy; can cause nicotine poisoning in children; and may increase the risk for death from heart disease and stroke.

As required by the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA, 15 U.S.C. 4401 et seq., Pub. L. 99-252), CDC collects a list of ingredients added to tobacco in the manufacture of smokeless tobacco products and a specification of the quantity of nicotine contained in each product. Respondents are not required to submit specific forms; however, they are required to meet reporting guidelines and to submit the ingredient report by chemical name and Chemical Abstract Service (CAS) Registration Number, consistent with accepted reporting practices for other companies that are required to report ingredients added to other consumer products, and to report on the quantity of nicotine contained in each smokeless tobacco product as specified in previous Federal Register Notices. Respondents may submit the required information to CDC through a designated representative. The information collection is subject to strict confidentiality provisions.

Ingredient and nicotine analysis reports for new SLT products are due at the time of first importation. Thereafter, ingredient reports are due annually on March 31. Following receipt of the annual nicotine and ingredient report, CDC issues a Certificate of Compliance to the respondent. As deemed appropriate by the Secretary of HHS, HHS is authorized to use the information to report to Congress the health effects of ingredients, research activities related to the health effects of ingredients, and other information that the Secretary determines to be of public interest.

The total estimated annualized burden hours are 18,843. OMB approval is requested for three years. There are no costs to respondents other than their time.

Description: The SCIP provides federal funding to state courts to assess their child welfare and judicial practices and develop and implement improvement plans. States use funds in a variety of ways, including improving legal representation and hearing quality, enhancing the engagement of families in court proceedings, and supporting child welfare and court partnerships. The proposed collection is a continuation of the current collection and comprised of two instruments: a strategic plan and self-assessment. The self-assessment reflects what the state has done in the prior year focusing on its progress and status within the change management cycle. The strategic plan looks forward to those interventions and actions the state plans to undertake to address needs or buttress strengths they have discovered in their assessment activities. These two instruments serve as an application for annual SCIP funding as well as a source for data which are shared back with SCIP grantees to support their community learning and peer connections, to inform technical assistance, and support any reporting to Congress and others. Regarding updates to the self-assessment and strategic plan, a minor change was made early in 2025 to the self-assessment in response to Executive Orders, amounting to one optional topical box and a few drop-down categories being removed. Additionally, at this time, the following minor changes are proposed to the currently approved version of the self-assessment. These do not impact estimated time to respond.

• Brief questions were added on IV-E funding, self-assessment point of contact or publishing information, and additional collaborative partners.

• Dropdown categories have been added to reduce burden and improve data where `other' was too often selected.

• Some questions about technical assistance states participated in were removed because alternative data sources were found that reduced burden.

No changes are proposed to the strategic plan.

The next application will be due June 30, 2026.

Respondents: We anticipate the highest state court of every state, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands to respond. All 53 jurisdictions currently participate in the program. One response from each jurisdiction is anticipated.

Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

In addition, the Children's Bureau (CB) would specifically like to highlight:

(e) Regarding IV-E legal representation funding, in addition to asking an open-ended question about this topic in the Self-Assessment, would additional data elements around type of attorneys funded ( e.g., agency, kin) or type of cases ( e.g., only in foster care, in other civil matters) be useful? These data are not needed for SCIP application approval by CB but could be compiled and shared back with grantees to support peer learning and connections. From your cost/benefit vantage, would this be worth including? And;

(f) Under section II of the Self-Assessment, for the optional project areas, each has a box on any training associated with the projects that includes more granular information such as the number of attendees, mode of delivery, and evaluation. This level of detail was formerly useful for CB in reviewing for grant compliance when there were three separate SCIP grants, one of which was for training. With the statutory merger of the SCIP grants, this level of detail is no longer needed for CB for grant compliance. These data can still be organized to share back with grantees to support peer learning and connections. From your cost/benefit vantage, would this be worth keeping or should we remove that level of detail? Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Authority: 42 U.S.C. 629h.

Description: TVAP and Aspire are funded by the Office on Trafficking in Persons to provide time-limited comprehensive case management services to individuals who have experienced severe forms of human trafficking, including adults (TVAP) and children (Aspire). The programs also aim to (1) develop and maintain a nationwide network of providers to conduct human trafficking outreach and provide direct services and community referrals, and (2) establish local regional presence within each of the 10 ACF geographic regions to coordinate project activities and direct services. The purpose of the proposed information collection activity is to document and examine the goals of TVAP and Aspire following redesign in 2022, how the programs are structured and administered, how partnerships are developed and maintained, how clients reach the programs, how comprehensive case management services are provided, and factors that affect program implementation.

The proposed information collection activities include:

1. Semi-structured virtual interviews focused in three of the ACF geographic regions with:

a. Subrecipient service providers who provide case management services to TVAP and/or Aspire clients. Interviews will include questions about client referral and enrollment, case management service provision, support received from TVAP/Aspire leadership, interactions with community partners and/or government systems, and perceptions of the programs.

b. Other service providers who serve people referred from TVAP and/or Aspire but are not formal subrecipient partners. Interviews will include questions about providers' relationship to the programs, referral pathways through TVAP/Aspire, assistance provided to these clients, interactions with various groups related to TVAP/Aspire, and perceptions of the programs.

c. Local government system ( e.g., law enforcement, child welfare) personnel who interact with TVAP/Aspire program staff, subrecipients, and/or clients. Interviews will include questions about their interactions with and perceptions of TVAP/Aspire.

d. Clients, i.e., people who have been enrolled in and received assistance through TVAP and/or Aspire beginning in Fiscal Year (FY) 2023. Respondents must be at least 18 years old at the time of the interview. Interviews will include questions about how they learned about the programs, services they received, what was helpful, and what could be improved.

2. A web-based survey of all providers that have participated as a TVAP and/or Aspire subrecipient beginning in FY 2023. The survey will include questions about organizational characteristics, client enrollment and services provision, and perceptions of program implementation, including challenges, strengths, and successes.

Respondents: TVAP and Aspire subrecipient service providers, other service providers (non-subrecipients) who receive TVAP and/or Aspire referrals, local government system personnel ( e.g., law enforcement, child welfare professionals), and TVAP and/or Aspire clients (individuals who have been enrolled into the programs).

Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Statutory Authority: Public Law 106-386 section 107 [22 U.S.C. 7105]

In the Federal Register of June 2, 2025 (90 FR 23339), FDA published a notice with a 30-day period to provide comments on the draft guidance for industry entitled, “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.” Interested persons were originally given until August 1, 2025, to submit comments to the docket. The Agency is reopening the comment period for the draft guidance until October 9, 2025. The Agency is planning to host a webinar on September 11, 2025, to present an overview of the draft guidance, explain the current scientific thinking behind the draft guidance, and highlight the main areas that differ from FDA's current guidance on selected topics. The Agency believes that an additional 30 days will allow adequate time for interested persons to submit comments after the webinar.

FDA is announcing the availability of a final guidance for industry entitled “Classification Categories for Certain Supplements Under BsUFA III.” This guidance provides recommendations for applicants and FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements (hereafter “supplements”) submitted to approved applications under section 351(k) of the PHS Act (42 U.S.C. 262(k)). These classification categories pertain to supplements for biosimilar and interchangeable biosimilar products seeking the following:

• To update prescribing information and, if applicable, FDA-approved patient labeling ( e.g., Patient Package Insert, Medication Guide, Instructions for Use) with safety information that has been updated in the reference product labeling and is applicable to one or more indications for which the biosimilar or interchangeable biosimilar product is licensed.

• To receive licensure for an additional indication.

• To remove an approved indication.

• To receive an initial determination of interchangeability.

Supplements to approved applications under section 351(k) of the PHS Act that do not meet the criteria under Categories A through F are outside the scope of this guidance.

This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. Section I.A. of the commitment letter associated with the BsUFA III sets forth these supplement classification categories and their associated review performance goals. The full text of the proposed BsUFA III Commitment Letter can be found on the Agency's web page “BsUFA III: Fiscal Years 2023-2027,” available at https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027 .

This guidance finalizes the draft guidance entitled “Classification Categories for Certain Supplements Under BsUFA III” issued on August 11, 2023 (88 FR 54626). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include clarification that the guidance does not include recommendations for manufacturing-only supplements or for all supplements for safety-related updates to the labeling, clarification that applicants can request reconsideration of classification category with appropriate justification, and clarification that a pediatric assessment or amended initial pediatric study plan may be included in a Category D supplement. In addition, editorial changes were made to improve clarity.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Classification Categories for Certain Supplements Under BsUFA III.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information pertaining to the Biosimilar User Fee Program and for the submission of biologics license applications under section 351(k) of the PHS Act regarding biosimilar product applications, interchangeable biosimilar product applications, and supplemental applications have been approved under OMB control number 0910-0718. The collections of information in 21 CFR 201.56 and 201.57 for the submission of labeling have been approved under OMB control number 0910-0572. The collections of information pertaining to Medication Guides for prescription human drug and biological products have been approved under OMB control number 0910-0393. The collections of information in 21 CFR part 601 for the submission of biologics license applications, supplemental applications, and Form FDA 356h have been approved under OMB control number 0910-0338.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov .

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection supports the Food and Drug Administration (FDA, us, or we) regulations and guidance. Tobacco products are generally governed by chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (sections 900 through 921) (21 U.S.C. 387 through 21 U.S.C. 387u).

Section 905 of the FD&C Act requires the annual registration of any “establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products.” Section 905 of the FD&C Act requires this registration be completed by December 31 of each year. The Secretary of Health and Human Services (Secretary) has delegated to the FDA Commissioner the responsibility for administering the FD&C Act, including section 905. Section 905 of the FD&C Act requires owners or operators of each establishment to register: (1) their name; (2) places of business; (3) a list of all tobacco products which are manufactured by that person; (4) a copy of all labeling and a reference to the authority for the marketing of any tobacco product subject to a tobacco product standard under section 907 of the FD&C Act (21 U.S.C. 387g) or to premarket review under section 910 of the FD&C Act (21 U.S.C. 387j); (5) a copy of all consumer information and other labeling; (6) a representative sampling of advertisements; (7) upon request made by the Secretary for good cause, a copy of all advertisements for a particular tobacco product; and (8) upon request made by the Secretary, if the registrant has determined that a tobacco product contained in the product list is not subject to a tobacco product standard established under section 907 of the FD&C Act, a brief statement of the basis upon which the registrant made such determination.

FDA collects the information submitted pursuant to section 905 of the FD&C Act through the Tobacco Registration and Product Listing Module Next Generation (TRLM NG) electronic portal, and through paper forms; Form FDA 3741, “Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments,” available at www.fda.gov/media/77915/download, and Form FDA 3741a, “Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments,” available at www.fda.gov/media/99863/download, for those individuals who are unable to submit online through TRLM NG. TRLM NG is designed to streamline the data entry process for registration and product listing. FDA strongly encourages electronic submission through TRLM NG, available at www.fda.gov/tobacco-products/manufacturing/tobacco-registration-and-listing-module-next-generation-trlm-ng-instructions, to facilitate efficiency and timeliness of data submission and management.

FDA has published a guidance for industry titled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments” (March 2023; www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf ). This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA.

At this time, FDA is proposing several updates to the information submitted pursuant to section 905 of the FD&C Act through Form FDA 3741, Form FDA 3741a, and the corresponding information submitted electronically through TRLM NG. The updates include: (1) merging the contents of Form FDA 3741a into Form FDA 3741 to create an updated and comprehensive Form FDA 3741, “Registration and Product Listing of Tobacco Product Manufacturing Establishments”; (2) restructuring and developing sections of the updated Form FDA 3741 for ease of navigation and data input; (3) updating terminology of the updated Form FDA 3741 for clarity; (4) updating instructions of the updated Form FDA 3741 for clarity; and (5) aligning tobacco product categories and subcategories of the updated Form FDA 3741 to be consistent with other FDA tobacco forms. Since the publication of the 60-day Federal Register notice, the following changes have been applied to the updated Form FDA 3741: (1) material file data elements have been added and are captured in TRLM NG; and (2) product listing updates can be entered directly in TRLM NG and relevant data elements have been added to Form FDA 3741 in case of paper submissions. Finally, as discussed in the 60-day Federal Register notice, FDA is proposing to add Form FDA 3741b, a new product listing spreadsheet, to this information collection. FDA anticipates the new Form FDA 3741b will streamline product listing submissions and subsequent FDA review. Since the publication of the 60-day Federal Register notice, the following changes have been applied to the product listing spreadsheet (Form FDA 3741b): (1) removal of the “Material Files” tab, which will now be captured through TRLM NG user interface as part of Form FDA 3741; (2) restriction of form usage to initial product list submissions only, as this form will be used exclusively for initial submissions; (3) addition of “Universal Product Code” field to improve data quality and traceability; (4) removal of multiple data elements regarding manufacturer information, product marketing, and product status fields from the spreadsheet, which will be incorporated into Form FDA 3741 and TRLM NG for improved efficiency.

Although these proposed updates will increase the overall length of the updated and comprehensive Form FDA 3741 and the corresponding information submitted electronically through TRLM NG, FDA anticipates these updates will streamline the navigation and completion of Form FDA 3741, reduce redundancies, increase overall user efficiency and ultimately enable industry to more accurately convey the required registration and listing information to FDA as required by section 905 of the FD&C Act. Both current versions of Form FDA 3741, “Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments”; and Form FDA 3741a, “Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments”, will be discontinued upon implementation of the updated and comprehensive Form FDA 3741, “Registration and Product Listing of Tobacco Product Manufacturing Establishments”.

Section 904(a)(1) of the FD&C Act requires that each tobacco product manufacturer or importer submit “a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand” by December 22, 2009. This section applies only to those tobacco products manufactured and distributed before June 22, 2009, and which are still manufactured as of the date of the ingredient listing submission.

Section 904(c) of the FD&C Act requires that a tobacco product manufacturer: (1) provide all information required under section 904(a) of the FD&C Act to FDA “at least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product not on the market on the date of enactment”; (2) advise FDA in writing at least 90 days prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive, except for those additives that have been designated by FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use; and (3) advise FDA in writing at least 60 days of such action of eliminating or decreasing an existing additive, or adding or increasing an additive that has been designated by FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.

FDA collects the information submitted pursuant to section 904(a)(1) and 904(c) of the FD&C Act through an electronic portal, and through a paper form (Form FDA 3742, “Listing of Ingredients in Tobacco Products” available at www.fda.gov/media/77661/download ) for those individuals who choose not to use the electronic portal.

In addition to the development of the electronic portal and paper form, FDA published a guidance titled “Listing of Ingredients in Tobacco Products” (March 2023; www.fda.gov/regulatory-information/search-fda-guidance-documents/listing-ingredients-tobacco-products ). This guidance is intended to assist persons making tobacco product ingredient listing submissions. FDA also provides a technical guide, embedded hints, and a web tutorial to the electronic portal, available at www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions. The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product  1 2 to be subject to Chapter 9 of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to all products that meet the definition of tobacco product in the law (except for accessories of newly regulated tobacco products), including electronic nicotine delivery systems, cigars, hookah tobacco, pipe tobacco, nicotine gels, and dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future (81 FR 28974 at 28976) (“the final deeming rule”).

In the Federal Register of January 17, 2025 (90 FR 5909), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Since publication of the 60-day Federal Register notice, we have revised our estimates to consolidate like activities, and the estimated annual reporting burden for establishment registration and product listing based on updated center data. We believe this is a more accurate picture of what our annualized burden would be. FDA has based these estimates on experience with this information collection, information we have available from interactions with industry, registration and listing reports, and TRLM NG.

FDA estimates that the updated Form FDA 3741 will be available and required to be used by tobacco product manufacturers in Spring 2026. As mentioned previously in this notice, this new form will replace both the current Form FDA 3741 and Form 3741a, which is scheduled to be discontinued in Spring 2026. To capture this consolidation accurately in the burden table, we have combined like activities from the 60-day Federal Register notice and averaged the burden over the 3-year approved information collection request (ICR) period for a more comprehensive burden table.

Based on updated data, we have revised our estimate for sections 905(b), 905(c), 905(d), 905(h), or 905(i) of the FD&C Act. Based on FDA's experience with current establishment registration and product listing information submitted to the agency, FDA has lowered the estimated annual respondents for (1) initial tobacco product establishment registration and listing (via Form FDA 3741) from 200 to 37 respondents, and (2) renewal of tobacco product establishment and listing (via Form FDA 3741) from 2,572 to 900 respondents.

The agency estimates that up to 37 new establishments will each submit one initial establishment registration and product listing via the current Form FDA 3741. The agency retains the hours per response estimate of 1.60 hours (or 96 minutes) for the initial tobacco product establishment registration and listing via the current Form FDA 3741, which FDA estimates manufacturers will need to use through the first year of the 3-year ICR approval period. Once the updated Form FDA 3741 is released, FDA estimates its completion to take 1.67 hours (100 minutes) for an initial registration of a tobacco product establishment and material file submission. As shown in Table 1, averaged across the 3-year ICR period, FDA estimates an average annual burden of 1.65 hours (99 minutes) for a total of 61 burden hours (across the 37 annual respondents). FDA estimates up to 37 establishments will each submit 1 initial product listing spreadsheet each year using the new Form FDA 3741b, which is expected to take 0.33 hours (20 minutes), for a total of 12 burden hours. Averaged across the 3-year ICR approval period, FDA estimates an average annual hours per response of 0.22 hours (8 average total hours) because, as noted above, the agency estimates that tobacco product manufacturers will not start using this new form until Year 2 of the 3-year ICR approval period.

Based on updated data, FDA estimates that the annual number of respondents for establishment registration and product listing renewals required under FD&C Act section 905 (Form FDA 3741) will decrease from 2,572 to 900. FDA retains the hours per response estimate of 10 minutes (0.17 hours) for the registration renewal via the current Form FDA 3741, which FDA estimates manufacturers will need to use through the first year of the 3-year ICR approval period. For Years 2 and 3, FDA estimates that the updated Form FDA 3741 will take 20 minutes (0.33 hours) for registration renewal. The renewal time increases with the updated Form FDA 3741 because the consolidated registration renewal process now encompasses establishment registration, product listing updates, and material file updates. Averaged across the 3-year ICR period, FDA estimates an average annual burden of 0.28 hours (17 minutes) for a total of 252 burden hours (across the 900 annual respondents).

FDA estimates that the submission of ingredient listings required by section 904(a)(1) of the FD&C Act for each establishment will take 2 hours initially. Ingredients may be submitted electronically through the CTP Portal Next Generation or if unable to submit ingredients electronically then by mail using Form FDA 3742. FDA estimates that 16 establishments will initially submit one report annually at 2 hours per report, for a total of 32 hours.

Based on FDA's experience and the number of new products authorized to be introduced or delivered for introduction into interstate commerce submitted over the past 3 years, FDA estimates that 37 establishments will each submit 10 reports (one every 6 months). FDA also estimates that the confirmation or updating of product (ingredient) listing information required by section 904(c) of the FD&C Act is expected to take 0.40 hour (24 minutes) for a total 148 burden hours. FDA estimates that obtaining a D-U-N-S number will take 30 minutes. FDA assumes that all new establishment facilities that will be required to initially register under section 905 of the FD&C Act would obtain a D-U-N-S number. FDA estimates that up to 37 establishments that would need to obtain this number each year. The total industry burden to obtain a D-U-N-S number is 19 hours.

Our estimated burden for the information collection reflects an overall decrease of 442 hours and a decrease of 1,861 annual responses. We attribute this adjustment to the proposed revisions to this information collection to add the updated and comprehensive Form FDA 3741, “Registration and Product Listing of Tobacco Product Manufacturing Establishments” and add Form FDA 3741b, “Tobacco Product List Spreadsheet”.

FDA is announcing the availability of a final guidance for industry entitled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” This final guidance describes the Agency's recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under section 351(a) of the PHS Act (42 U.S.C. 262(a)). Additionally, this final guidance is intended to provide recommendations to sponsors on the scientific and technical information for the CMC portion of a marketing application for a proposed product submitted under section 351(k) of the PHS Act. Although the 351(k) pathway applies generally to biological products, this final guidance focuses on therapeutic protein products.

Section 351(k) of the PHS Act (42 U.S.C. 262(k)) provides an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product and sets forth the requirements for an application for a proposed biosimilar product and an application for a proposed interchangeable biosimilar product. Under this abbreviated licensure pathway, FDA will license a proposed biological product submitted under section 351(k) of the PHS Act if, among other things, FDA determines that the information submitted in the application is sufficient to show that the biological product is biosimilar to the reference product.

This guidance finalizes the draft guidance entitled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” issued on May 22, 2019 (84 FR 23569). FDA considered comments received on the draft guidance as the guidance was finalized. Comments submitted to the docket of the draft guidance addressed a range of issues, including clarifying questions on reference product lots and on the analyses of the comparative analytical data. FDA provided additional information and clarifying edits in response to comments as appropriate. In addition, editorial changes were made to improve clarity.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information related to the submission of: (1) An investigational new drug application under 21 CFR part 312 have been approved under OMB control number 0910-0014; (2) a new drug application, under 21 CFR part 314 have been approved under OMB control number 0910-0001; (3) a biologics license application (BLA) under 21 CFR part 601 have been approved under OMB control number 0910-0338; and (4) a BLA under section 351(k), under 21 CFR part 601 have been approved under OMB control number 0910-0718. The collections of information regarding current good manufacturing processes for drug products and biological products under 21 CFR part 211 and 21 CFR parts 600, 601, and 610 have been approved under OMB control numbers 0910-0139 and 0910-0338.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

FDA is announcing the availability of a guidance for industry entitled “E6(R3) Good Clinical Practice.” The guidance was prepared under the auspices of ICH. ICH seeks to achieve greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

By harmonizing the regulatory requirements in regions around the world, ICH guidelines enhance global drug development, improve manufacturing standards, and increase the availability of medications. For example, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, and standardized marketing application submissions.

The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. ICH membership continues to expand to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ).

ICH works by engaging global regulatory and industry experts in a detailed, science-based, and consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.

As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

In the Federal Register of June 7, 2023 (88 FR 37257), FDA published a notice announcing the availability of a draft guidance entitled “E6(R3) Good Clinical Practice.” The notice gave interested persons an opportunity to submit comments by September 5, 2023.

After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in December 2024.

This guidance finalizes the draft guidance issued on June 7, 2023. The guidance offers modernized and agile recommendations for designing and conducting trials efficiently, safely, and innovatively. In response to public comments, the guidance clarifies that technology and design elements are likely to evolve and that the principles of E6(R3) are developed to remain relevant as such advances occur. The guidance stresses proportionality and a focus on the risk to participants and the reliability of the results. Furthermore, the guidance adds clarity to enable different modalities of informed consent (including remote and eConsent) as well as refining language on consent and assent. The guidance also clarifies the responsibilities of the investigators and sponsors regarding delegating clinical trial conduct responsibilities to service providers to reflect the practical application of E6(R3). Lastly, the guidance significantly streamlines and adds clarity to the section on data governance and simplifies the table in appendix C by providing clarity on the considerations for determining what records are considered essential.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “E6(R3) Good Clinical Practice.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

FDA considered the applicability of Executive Order 14192, per OMB guidance in M-25-20, and finds this action to be deregulatory in nature.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information found in 21 CFR part 312 for investigational new drug applications have been approved under OMB control number 0910-0014. The collections of information under 21 CFR part 312.145 pertaining to good clinical practice have been approved under OMB control number 0910-0843. The collections of information found in 21 CFR parts 50 and 56 pertaining to protection of human subjects, institutional review boards and informed consent have been approved under OMB control number 0910-0130. The collections of information found in 21 CFR part 314 relating to the review of new drug applications have been approved under OMB control number 0910-0001. The collections of information found in 21 CFR part 601 relating to the review of biologic licensing applications have been approved under OMB control number 0910-0338. The collections of information found in 21 CFR part 11 pertaining to electronic records and electronic signatures have been approved under OMB control number 0910-0303. The collections of information found in 21 CFR parts 210 and 211 pertaining to current good manufacturing practice have been approved under OMB control number 0910-0139.

Persons with access to the internet may obtain the guidance at https:// www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

I. Background

The purpose of the Rental Housing Finance Survey (RHFS) is to provide a current and continuous measure of the financial, mortgage and property characteristics of single-family and multifamily rental housing properties in the United States. The survey provides information on the financing of rental housing properties with emphasis on new originations for purchase, refinancing, and loan terms associated with these originations. In addition, the survey includes information on property characteristics, such as number of units, amenities available, rental income, operating costs, and capital expenditure information. The RHFS presents a full picture of the financing of rental housing, which is much more fragmented than the market for owner-occupied mortgages that is well documented by the private sector and supported by HUD, the Government Sponsored Enterprises, Fannie Mae and Freddie Mac, the Department of Veterans' Affairs, the U.S. Department of Agriculture's Rural Housing Service, and banks. The RHFS is the only data source with detailed information on the mortgage financing of multifamily rental properties with two or more units. RHFS data, tables, and documentation can be found here: https://www.census.gov/programs-surveys/rhfs.html .

HUD is soliciting information from the public on uses of RHFS data and other comments or concerns about the RHFS. HUD welcomes all comments relevant to the RHFS. HUD is particularly interested in receiving input from interested parties, including government policy makers, academic researchers, and RHFS data users, on the questions outlined below.

1. What important data in the RHFS does the public use to analyze current rental housing finance characteristics and/or forecast future rental housing finance characteristics?

2. What concerns are there related to reducing the scope of, or eliminating entirely, the RHFS?

3. Is there any current RHFS content that is no longer relevant or has limited usefulness? Is there content that should be added to the RHFS?

4. Are there private sector data sources that provide comparable information to the RHFS?

5. Are there other concerns about content that is included or missing in the RHFS?

Section 224 of the National Housing Act (12 U.S.C. 1715o) provides that debentures issued under the Act with respect to an insured loan or mortgage (except for debentures issued pursuant to Section 221(g)(4) of the Act) will bear interest at the rate in effect on the date the commitment to insure the loan or mortgage was issued, or the date the loan or mortgage was endorsed (or initially endorsed if there are two or more endorsements) for insurance, whichever rate is higher. This provision is implemented in HUD's regulations at 24 CFR 203.405, 203.479, 207.259(e)(6), and 220.830. These regulatory provisions state that the applicable rates of interest will be published twice each year as a notice in the Federal Register .

Section 224 further provides that the interest rate on these debentures will be set from time to time by the Secretary of HUD, with the approval of the Secretary of the Treasury, in an amount not in excess of the annual interest rate determined by the Secretary of the Treasury pursuant to a statutory formula based on the average yield of all outstanding marketable Treasury obligations of maturities of 15 or more years.

The Secretary of the Treasury (1) has determined, in accordance with the provisions of Section 224, that the statutory maximum interest rate for the period beginning July 1, 2025, is 4 5/8 percent; and (2) has approved the establishment of the debenture interest rate by the Secretary of HUD at 4 5/8 percent for the 6-month period beginning July 1, 2025. This interest rate will be the rate borne by debentures issued with respect to any insured loan or mortgage (except for debentures issued pursuant to Section 221(g)(4)) with insurance commitment or endorsement date (as applicable) within the next 6 months of 2025).

For convenience of reference, HUD is publishing the following chart of debenture interest rates applicable to mortgages committed or endorsed since January 1, 1980: