FAA proposes to revise part 61 of title 14 of the Code of Federal Regulations (14 CFR) to except certain military pilot trainees from the requirement to have an FAA third-class medical certificate if they have an up-to-date U.S. military pilot medical examination authorizing pilot flight status. FAA's proposal, if adopted, would provide military pilot trainees with the same regulatory relief currently afforded to U.S. military pilots, codify existing FAA exemptions that support the U.S. Air Force's use of civilian flight schools for initial pilot training, and extend the deregulatory benefits of those exemptions to all branches of the U.S. Armed Forces.

FAA also proposes to introduce definitions for military pilot medical examination and military pilot trainee to ensure the proposed exception applies only to military pilot trainees who received a U.S. military pilot medical examination of equivalent or greater stringency to that for an FAA third-class medical certificate and who are currently receiving pilot training in civil aircraft as part of a military flight training program. This relief would extend to U.S. military pilot trainees and to foreign military pilot trainees sponsored by the U.S. Armed Forces who also meet U.S. military pilot medical examination requirements.

FAA's authority to issue rules on aviation safety is found in title 49 of the United States Code (U.S.C.). Subtitle I, section 106 describes, in part, the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of FAA's authority.

Specifically, this rulemaking is issued under the authority described in subtitle VII, part A, subpart III, sections 44701-44703. Under section 44701, FAA is charged with prescribing regulations and minimum standards for cybersecurity and other practices, methods, and procedures the Administrator finds necessary for safety in air commerce. Under sections 44702 and 44703, FAA is also authorized to issue airman certificates, including airman medical certificates, when the Administrator finds, after investigation, the individual is qualified for, and physically able to perform the duties related to the position to be authorized by the certificate. This proposed rule is within the scope of those authorities because it would allow individuals who have already been issued medical authorization by the U.S. military for qualification as a U.S. military pilot trainee to engage in civil flight operations without needing to obtain an FAA third-class medical certificate.

The United States Air Force (USAF) Air Education and Training Command (AETC) has taken steps to increase flight training capacity by leveraging civilian pilot schools to train military pilot trainees. Under this model, academic institutions provide civilian training programs at pilot schools to supplement USAF military pilot schools. Military pilot trainees graduate from these FAA-certificated pilot schools  1 with an FAA-issued private pilot certificate with an airplane category, multiengine land class rating, and an instrument-airplane rating. The USAF AETC uses this civilian training approach to meet the annual demands for new military pilots reliably, while enhancing flexibility and scalability.

In addition to training U.S. military pilot trainees, 2 USAF and other branches of the U.S. Armed Forces partner with military organizations of other allied countries to train non-U.S. military pilots. These foreign military pilot trainees are members of U.S.-allied military organizations who also receive U.S. Armed Forces-sponsored training at part 141 pilot schools. This flight training is conducted under agreements between the U.S. and foreign governments, and the foreign military pilot trainees are cleared by both the trainee's military organization and the branch of the U.S. Armed Forces sponsoring the training to meet eligibility requirements for security, medical fitness, and aptitude.

Under current FAA regulations, applicants for an FAA pilot certificate or rating, including military pilot trainees, are generally required to have an FAA third-class airman medical certificate to conduct solo flights and take practical tests in civil aircraft. 3 Therefore, a prospective student of a part 141 pilot school must have at least an FAA third-class medical certificate to be eligible to conduct the solo flights and practical tests required under the pilot school's FAA-approved curriculum leading to the issuance of a private pilot certificate or applicable instrument or class rating.

In 2009, as part of an amendment to part 61 (2009 final rule), FAA revised §§ 61.3(c) and 61.23(b) to relieve military pilots engaged in civil flight operations from the requirement to have an FAA third-class airman medical certificate if they already have an up-to-date military medical examination for pilot status. 4 This change was made because FAA determined the medical examinations provided by a U.S. Armed Forces medical facility to military pilots equal or exceed the content and quality of a third-class medical examination required by FAA. 5 The 2009 final rule, however, did not extend this equivalency to individuals who have not been authorized for military pilot status, such as military pilot trainees.

On October 18, 2018, the USAF Air Force Security Assistance Training (AFSAT) Squadron petitioned FAA for an exemption from the third-class airman medical certificate requirements to allow International Military Students (IMS)  6 conducting civil flight training sponsored by the Department of Defense (DoD)  7 to use their military medical authorizations in lieu of an FAA-issued third-class medical certificate. AFSAT sought this relief to coordinate IMS training in civil aircraft in the United States better and minimize delays resulting from trainees applying for third-class medical certificates after arriving in the U.S. and prior to beginning training. Noting that IMS trainees receive the same level of military medical examination as U.S. Armed Forces pilot trainees, FAA provided the relief AFSAT sought in Grant of Exemption No. 18245, issued on June 6, 2019. 8

On May 15, 2025, USAF AETC likewise petitioned FAA for relief from the FAA third-class medical certificate requirement for the training of USAF pilot trainees at part 141 pilot schools. In its evaluation of that petition, FAA referenced the AETC assertion that “all USAF student pilots must meet and maintain USAF IFC I [Initial Flying Class I] standards, which are more stringent than USAF Initial Flying Class II (IFC II) standards that are the basis for the § 61.23(b)(11) military pilot carve out.” Based on this determination, and the fact that the circumstances presented in the AETC petition for exemption were similar in all material respects to the previously issued USAF AFSAT grant of exemption, FAA granted Exemption No. 23890 to USAF  9 AETC on May 30, 2025. 10

FAA proposes to provide military pilot trainees with the same regulatory relief currently afforded to U.S. military pilots, to codify in 14 CFR part 61 the burden-relieving exemptions already extended to the U.S. Air Force, and to extend that regulatory relief to all branches of the U.S. Armed Forces. This proposal would apply to military pilot trainees sponsored by the U.S. Air Force, U.S. Army, U.S. Marine Corps, U.S. Navy, U.S. Space Force, U.S. Coast Guard, and National Guard and Reserve units. FAA recognizes the requirement to have an FAA-issued third-class airman medical certificate is unnecessary for those military pilot trainees who have already undergone extensive medical examination through their branch of the U.S. Armed Forces. This proposed rule would remove the administrative burden on the U.S. Armed Forces of the time and expense associated with ensuring military pilot trainees meet the FAA third-class medical certificate requirement. This proposed rule would also reduce the volume of third-class medical certificate applications requiring FAA consideration.

The proposed rule is only intended to apply to military pilot trainees who have received a U.S. military medical examination and are actively receiving flight training under the sponsorship of a branch of the U.S. Armed Forces. While the proposed relief is intended to relieve military pilot trainees from the burden of obtaining an FAA third-class medical certificate to engage in civil pilot training, the relief proposed is not limited to flight training conducted under part 61 or part 141 only. Consistent with the relief presently granted to military pilots, the proposed relief would allow military pilot trainees to act as pilot in command of an aircraft without holding an FAA medical certificate if the flight does not require higher than a third-class medical certificate. For example, a military pilot trainee who obtained his or her private pilot certificate may act as the pilot in command of a recreational flight not associated with the civil pilot training program without holding an FAA medical certificate. This proposed relief would continue as long as that person met the definition of military pilot trainee or became a U.S. military pilot (and, as further discussed in this preamble, has an up-to-date U.S. military pilot medical examination).

FAA proposes to define military pilot trainee and military pilot medical examination to ensure the exception will only apply in situations where excepting the pilot trainee from the requirements of §§ 61.3(c) and 61.23(a)(3) does not result in a reduction in safety within the National Airspace System (NAS). FAA invites comments on this limited scope of the proposed rule.

Currently, § 61.3(c)(2)(xii) provides an exception to the requirement that a required pilot flightcrew member have an FAA third-class medical certificate if that person is a pilot of the U.S. Armed Forces, has an up-to-date U.S. military medical examination, and holds military pilot flight status. Further, § 61.23(b)(11) provides that a military pilot of the U.S. Armed Forces is not required to hold an FAA third class medical certificate when the pilot can show evidence of an up-to-date medical examination authorizing pilot flight status issued by the U.S. Armed Forces, the flight does not require higher than a third-class medical certificate, and the flight conducted is a domestic flight operation within U.S. airspace. As discussed in the preamble to the 2009 final rule, FAA has found that the military medical standards met by pilot applicants—many who will conduct complex military exercises or combat operations—are, by nature and of necessity, more stringent and, therefore, exceed the minimum 14 CFR part 67 third-class medical standards. 11 Current regulations, however, do not provide a similar exception from the requirement to hold an FAA third-class medical certificate for military pilot trainees, despite the fact that they meet the same or higher military medical standards. Thus, military pilot trainees are required to obtain an FAA third-class medical certificate in addition to their U.S. military medical examination to undertake flight training in civil aircraft.

The issue arising for both U.S. Armed Forces pilot trainees and U.S. Armed Forces-sponsored foreign military pilot trainees is that a military pilot trainee is not a military pilot who is authorized for full military pilot flight status and is therefore not eligible for the exception currently provided in § 61.23(b)(11). This distinction was not intentional; FAA recognizes, as discussed in the existing exemptions and in this proposed rule, the U.S. military's medical requirements for military pilot trainees who will operate in the air meet or exceed the level of safety provided by an FAA third-class medical certificate, where required by FAA. Likewise, in Exemption No. 18245, FAA noted that “International Military Students receive the same DoD Class 1 flight physical that all DoD pilots receive prior to any civilian or military flight training.”  12 When U.S. and foreign military pilot trainees undergo and demonstrate to the U.S. military that they meet or exceed requirements of the same medical examination used to qualify military pilots for general pilot flight status, it follows that they are meeting or exceeding the level of safety established by part 67 third-class medical standards. 13

Accordingly, FAA proposes to extend the medical certificate relief for military pilots in §§ 61.3(c)(2)(xii) and 61.23(b)(11) to include both U.S. military pilot trainees and foreign military pilot trainees sponsored by the U.S. Armed Forces who can show evidence of an up-to-date U.S. military pilot medical examination authorizing pilot flight status issued by the U.S. Armed Forces.

FAA airman medical certification ensures that only those pilots who are physically and mentally fit will be authorized to operate aircraft, enhancing aviation safety by mitigating the risk of medical factors as a cause of aircraft accidents. To ensure that the proposed exception from the requirements of §§ 61.3 and 61.23 would only apply where it results in an equivalent level of safety, the rule proposes to add two definitions to § 61.1. First, FAA proposes to define military pilot trainee as “a member of the U.S. Armed Forces, or of a foreign military, who is receiving pilot training sponsored by a branch of the U.S. Armed Forces.” Second, FAA proposes to define military pilot medical examination as “a medical examination conducted by a branch of the U.S. Armed Forces for the purpose of establishing medical eligibility for a military pilot or military pilot trainee to perform military pilot duties onboard military aircraft.”

In defining military pilot trainee, FAA seeks to ensure only military personnel who are actively receiving U.S. military-sponsored pilot training would be excepted from the third-class medical certificate requirement. Military pilot trainees who are voluntarily or involuntarily separated from the training program would no longer qualify for relief under this proposed rule, regardless of whether the military medical examination is still valid. This proposed limitation would be consistent with the scope of the current regulations, which apply to military pilots only if they are authorized for pilot flight status. Further, in some cases, recipients of military pilot medical examinations may receive waivers for certain medical conditions that would otherwise be disqualifying. FAA notes the standards associated with waivers granted under military pilot medical examinations are predicated on access to and interaction with military flight surgeons who are ultimately responsible for ensuring military pilots and military pilot trainees are medically qualified to engage in flight operations. Military pilots and military pilot trainees may receive waivers for conditions on the basis that those individuals are under the care of a military flight surgeon who may actively monitor a specific medical condition and proactively ground the pilot if the condition changes in a way that would make further flight operations unsafe. Individuals who are not engaged in flight training may no longer have access to this medical oversight and could potentially pose a safety risk to the NAS.

FAA also proposes a definition for military pilot medical examination. FAA proposes this definition to account for the U.S. Armed Forces conducting military medical examinations for roles other than military pilots or those that would involve attending civil pilot schools as military pilot trainees. The medical examinations required for these positions vary among branches of the U.S. Armed Forces and by role and may not meet or exceed the level of safety established by FAA third-class medical certificate standards in all cases. Therefore, only U.S. Armed Forces medical examinations intended for military pilots who will operate in the air onboard military aircraft and will perform military pilot duties would meet the requirement for a U.S. military medical examination and would except those military pilots or military pilot trainees from the requirement to have an FAA third-class medical certificate.

Accordingly, FAA proposes to define military pilot medical examination in § 61.1 for purposes of part 61 as a medical examination conducted by a branch of the U.S. Armed Forces for the purpose of establishing medical eligibility for a military pilot or military pilot trainee performing military pilot duties onboard military aircraft. This proposed definition differentiates the military pilot medical examinations required to perform in-flight pilot duties recognized by FAA as meeting or exceeding the level of safety established by an FAA third-class medical certificate from other U.S. Armed Forces medical examinations. The U.S. Armed Forces have the option to require other personnel to meet the same medical examination requirements used to qualify military pilots or military pilot trainees, and in doing so, would then bring those military personnel under the exception proposed in this rule while those personnel also meet the proposed definition of pilot trainee.

The proposed definition would clarify that these exceptions do not apply to military medical examinations that only authorize remote piloting flight status. The 2009 final rule did not contemplate the use of remote pilots by the U.S. Armed Forces, and FAA did not evaluate whether military medical examinations conducted for military remote pilots meet or exceed the level of safety established by an FAA third-class medical certificate.

FAA invites comments on whether remote pilots or non-pilot flightcrew members who receive military pilot medical examinations should be granted additional relief from holding an FAA third-class medical certificate under this proposed rule. Further, FAA seeks comment on whether military personnel who receive military medical examinations intended for roles other than pilot flightcrew members should be extended relief from holding an FAA third-class medical certificate.

Executive Order (E.O.) 12866 (“Regulatory Planning and Review”) and E.O. 13563 (“Improving Regulation and Regulatory Review”) require agencies to regulate in the “most cost-effective manner,” to make a “reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.” The Office of Management and Budget has determined this proposed rule is not a significant regulatory action as defined in section 3(f) of Executive Order 12866.

This proposed rule would provide time savings for U.S. military pilot trainees and U.S. Armed Forces-sponsored foreign military pilot trainees by removing the requirement that these pilot trainees hold an FAA third-class medical certificate when receiving training conducted under part 61 or under part 141.

Based on information provided by the U.S. Air Force about pilot trainees exempted from holding an FAA third-class medical certificate in the past seven years, FAA estimates 1,850 U.S. Armed Forces military pilot trainees  14 and 150 U.S. Armed Forces-sponsored foreign military pilot trainees would be affected each year, for a total of 2,000 military pilot trainees. FAA assumes, for the purposes of this analysis, these U.S. and foreign military pilot trainees operate under exemptions that expire in year two of the rule. 15 If this rule is not finalized as proposed, by year two, these pilot trainees would be required to obtain an FAA third-class medical certificate. This proposed rule would eliminate that requirement. The U.S. Air Force has identified a further 450 trainees who are not eligible under the current regulatory framework but could be eligible under the proposed rule. Thus, cost savings would be realized in year two of the analysis of this proposed rule.

The 2019 NPRM “Removal of Check Pilot Medical Certificate Requirement”  16 found the cost for an applicant to apply for a medical certificate is $437  17 per certificate. The U.S. Armed Forces currently bear this cost, which this proposed rule would avert. The 2022 rule “Medical Certification Standards for Commercial Balloon Operations”  18 found the cost to review an application, if the applicant meets the standards for a third-class medical certificate under subpart D of 14 CFR part 67, is $36  19 per certificate. These cost savings sum to $946,000  20 per year and would be realized starting in 2027 (year 2 of this analysis). FAA invites comment on these assumptions and figures.

Because military pilot trainees undergo rigorous medical examinations, FAA assumes no applicants require a special issuance of an FAA third-class medical certificate. To date, few, if any, military pilot trainees have required a special issuance. Therefore, FAA assumes there would be no cost savings related to the special issuance of FAA third-class medical certificates from this proposed change.

This proposed rule would impose no new costs and would result in cost savings for the U.S. Armed Forces from eliminating the requirement for military pilot trainees to obtain FAA third-class medical certificates and for FAA to review those certificate applications. FAA estimates this proposed rule would result in cost savings of $2.9 million over five years ($730,373 annualized) at a seven percent discount rate, or $3.4 million over five years ($745,452 annualized) at a three percent discount rate.

The Regulatory Flexibility Act (RFA) of 1980, (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), and the Small Business Jobs Act of 2010 (Pub. L. 111-240), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

This proposed rule does not add any new costs to regulated entities, and has only modest cost savings. Furthermore, all regulated entities are not considered small entities by the Small Business Administration. If an agency determines a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under section 605(b) of the RFA. Therefore, as provided in section 605(b) and based on the foregoing, the head of FAA certifies this proposed rule would not result in a significant economic impact on a substantial number of small entities.

FAA welcomes comments on this certification.

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, they be the basis for U.S. standards.

FAA has assessed the potential effect of this proposed rule and has determined it ensures the safety of the American public and does not exclude imports that meet this objective. As a result, FAA does not consider this proposed rule as creating an unnecessary obstacle to foreign commerce.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or Tribal government or the private sector to incur direct costs without the Federal Government having first provided the funds to pay those costs. FAA determined the proposed rule would not result in the expenditure of $193,000,000 or more ($100,000,000 adjusted for inflation using the most current Implicit Price Deflator for the Gross Domestic Product) by State, local, or Tribal governments, in the aggregate, or the private sector, in any one year.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that FAA consider the impact of paperwork and other information collection burdens imposed on the public. Information collection 2120-0034, Medical Standards and Certification, is the information collection associated with the requirements to obtain an FAA medical certificate. FAA collects this medical information only when an individual initially applies for or renews an FAA medical certificate. Because the military pilot trainees who are the subject of this proposed rule generally have not applied for an FAA third-class medical certificate as part of their military duties because of the exemptions granted to the U.S. Air Force, FAA does not believe there will be any reduction in the burdens associated with this information collection.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. FAA has determined there are no ICAO Standards and Recommended Practices that correspond to these regulations.

FAA has analyzed the environmental impacts of this proposed rule pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq. ). FAA has determined this rule is categorically excluded pursuant to Paragraph B-2.6(f) of Appendix B to FAA Order 1050.1G, FAA National Environmental Policy Act Implementing Procedures. 21 Categorical exclusions are categories of actions the agency has determined normally do not significantly affect the quality of the human environment and therefore do not require either an environmental assessment (EA) or an environmental impact statement (EIS). 22 In analyzing the applicability of a categorical exclusion, the agency must also consider whether extraordinary circumstances are present that would warrant the preparation of an EA or EIS. 23 This rulemaking, which proposes to remove the requirement for U.S. military pilot trainees and foreign military pilot trainees sponsored by the U.S. Armed Forces to hold FAA third-class airman medical certificates, is categorically excluded pursuant to Paragraph B-2.6(f) of FAA Order 1050.1G: “Regulations, standards, and exemptions (excluding those that if implemented may cause a significant impact on the human environment).” FAA does not anticipate any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.

FAA has analyzed this NPRM under the principles and criteria of Executive Order 13132, Federalism. FAA has determined this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, will not have federalism implications.

FAA analyzed this NPRM under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use. FAA has determined it is not a “significant energy action” under the Executive order and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Executive Order 13609, Promoting International Regulatory Cooperation, promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609 and has determined this action will have no effect on international regulatory cooperation.

This proposed rule, if finalized as proposed, is expected to be an Executive Order 14192 deregulatory action.

FAA invites interested persons to participate in this proposed rulemaking by submitting written comments, data, or views. FAA also invites comments relating to economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.

FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rule. Before acting on this proposal, FAA will consider all comments it receives on or before the closing date for comments. FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. FAA may change this proposal in light of the comments it receives.

Privacy: In accordance with 5 U.S.C. 553(c), FAA solicits comments from the public to inform its rulemaking process better. FAA posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to the person in the FOR FURTHER INFORMATION CONTACT section of this document. Any commentary that FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

A copy of this NPRM, all comments received, any final rule, and all background material may be viewed online at www.regulations.gov using the docket number listed above. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of the Federal Register's website at www.federalregister.gov and the Government Publishing Office's website at www.govinfo.gov. A copy may also be found at FAA's Regulations and Policies website at www.faa.gov/regulations_policies.

Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Commenters must identify the docket or notice number of this rulemaking.

All documents FAA considered in developing this NPRM, including economic analyses and technical reports, may be accessed in the electronic docket for this rulemaking.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the internet, visit www.faa.gov/regulations_policies/rulemaking/sbre_act/.

For the reasons discussed in the preamble, FAA proposes to amend chapter I of title 14, Code of Federal Regulations as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace extending upward from 700 feet above the surface at Ranch at Double Gates Airport, Coleman, TX, to support IFR operations at this airport.

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.

The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it received on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.

Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov as described in the system of records notice (DOT/ALL-14FDMS), which can be reviewed at www.dot.gov/privacy.

An electronic copy of this document may be downloaded through the internet at www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at w ww.fa a .gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address, phone number, and hours of operation). An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

Class E airspace is published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11K, dated August 4, 2025, and effective September 15, 2025. These updates would be published subsequently in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11K, which lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points, is publicly available as listed in the ADDRESSES section of this document.

The FAA is proposing an amendment to 14 CFR part 71 that would establish Class E airspace extending upward from 700 feet above the surface within a 7.2-mile radius of Ranch at Double Gates Airport, Coleman, TX.

This action is the result of instrument procedures being developed for this airport to support IFR operations.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Order 2100.6B, “Policies and Procedures for Rulemakings” (March 10, 2025); and (3) is expected to result in, at most, de minimis costs from compliance with applicable operating requirements or minor flight rerouting for operators choosing to navigate around the controlled airspace. Since these proposed amendments are routine and the expected impact to operators is de minimis, the FAA certifies that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1G, “FAA National Environmental Policy Act Implementing Procedures” prior to any FAA final regulatory action.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace extending upward from 700 feet above the surface at Mason District Hospital Heliport, Havana, IL, to support IFR operations at this airport.

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.

The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it received on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.

Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov as described in the system of records notice (DOT/ALL-14FDMS), which can be reviewed at www.dot.gov/privacy.

An electronic copy of this document may be downloaded through the internet at www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address, phone number, and hours of operation). An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

Class E airspace is published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11K, dated August 4, 2025, and effective September 15, 2025. These updates would be published subsequently in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11K, which lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points, is publicly available as listed in the ADDRESSES section of this document.

The FAA is proposing an amendment to 14 CFR part 71 that would establish Class E airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Mason District Hospital Heliport, Havana, IL.

This action is the result of instrument procedures being developed for this airport to support IFR operations.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Order 2100.6B, “Policies and Procedures for Rulemakings” (March 10, 2025); and (3) is expected to result in, at most, de minimis costs from compliance with applicable operating requirements or minor flight rerouting for operators choosing to navigate around the controlled airspace. Since these proposed amendments are routine and the expected impact to operators is de minimis, the FAA certifies that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1G, “FAA National Environmental Policy Act Implementing Procedures” prior to any FAA final regulatory action.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of the safety and effectiveness of the device; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act).

Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, and for which there is sufficient information to establish special controls to provide such assurance, including the issuance of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions FDA (the Agency or we) deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act).

Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act).

Devices that were not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, (generally referred to as “postamendments devices”) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require approval of a premarket approval application (PMA) unless, and until: (1) FDA reclassifies the device into class I or II, or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807, subpart E, of the regulations (21 CFR part 807, subpart E).

A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA, acting by administrative order, can reclassify the device into class I or II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide a reasonable assurance of the safety and effectiveness of the device for its intended use. 1

FDA relies upon “valid scientific evidence,” as stated in section 513(a)(3) of the FD&C Act and defined in 21 CFR 860.7(c)(2), in the classification process to determine the level of regulation for devices. 2 In general, to be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA (see section 520(c) of the FD&C Act). Section 520(h)(4) of the FD&C Act provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of the device, but it does not include descriptions of methods of manufacture and product composition and other trade secrets.

In accordance with section 513(f)(3) of the FD&C Act, FDA is issuing this proposed order to reclassify DBT systems intended to generate digital cross-sectional x-ray images of the breast that can be used for the screening and diagnosis of breast cancer for prescription use only (product code OTE), 3 which are postamendments class III devices, into class II (special controls), subject to premarket notification, because FDA believes the standard in section 513(a)(1)(B) of the FD&C Act is met as general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls, which, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of these devices. 4

Based on the PMA data available to FDA in accordance with section 520(h)(4) of the FD&C Act, 5 6 associated Panel deliberations, published peer-reviewed literature, and data available to the Agency demonstrating a lack of significant postmarket safety signals, FDA believes there is sufficient information to reclassify these devices from class III (premarket approval) into class II (special controls). Therefore, FDA is proposing to establish a new device classification regulation, “Digital Breast Tomosynthesis System” and classify this device type into class II along with the special controls that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.

Under the FD&C Act, premarket notification (510(k)) submissions are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt from 510(k) requirements under section 510(m) of the FD&C Act. 7 FDA has not made this determination for DBT systems, and therefore, FDA is not proposing that this class II device type be exempt from the 510(k) requirements. If this proposed order is finalized, persons who intend to market a DBT system must submit to FDA a premarket notification under section 510(k) of the FD&C Act and receive clearance prior to marketing the device.

In accordance with section 513(f)(1) of the FD&C Act, DBT systems are automatically classified into class III because they were not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, have not been reclassified into class I or II, and have not been found substantially equivalent to a device placed in commercial distribution after May 28, 1976, which was subsequently classified or reclassified into class II or class I. Therefore, these devices are subject to the PMA requirements under section 515 of the FD&C Act (21 U.S.C. 360e).

The proposed reclassification applies to DBT systems that are prescription use devices (product code OTE) intended to generate digital cross-sectional x-ray images of the breast that can be used for the screening and diagnosis of breast cancer. As discussed further below, FDA approved the first DBT system on February 11, 2011(Refs. 1 and 2). Since the first approval order for a DBT system, FDA has reviewed and approved 3 additional original PMAs (P130020 (Ref. 3), P140011 (Ref. 4), P160031 (Ref. 5)) and 26 PMA supplements, including 1 panel-track supplement (P080003/S001 (Ref. 6)), under product code OTE. In accordance with the “six-year rule” described in section 520(h)(4) of the FD&C Act (21 U.S.C. 360j(h)(4)), FDA considered data contained in each of the original PMAs as well as the panel-track supplement  8 as part of the evidence being relied upon  9 to support the proposed reclassification from class III to II.

While the DBT systems that are the subject of the four original PMAs have unique attributes in certain respects ( e.g., angular span), FDA has determined that these DBT systems have sufficiently similar purposes, design considerations, functions, and other features related to safety and effectiveness such that the information and data reviewed and analysis conducted by FDA was analogous across all applications available to the Agency. As such, and to avoid redundancy, the summaries below are intended to provide examples that are representative of the PMA information and data that was reviewed and considered by FDA across the applications in proposing to reclassify DBT systems from class III (premarket approval) into class II (special controls).

On January 22, 2008, FDA filed an original PMA (P080003 (Ref. 1)) for the Selenia Dimensions 3D system from Hologic, Inc. The Radiological Devices Panel (the “Panel”) met on September 24, 2010, and deliberated on the Selenia Dimensions 3D system PMA (Ref. 2) and the Panel's consensus was that the benefits of the device outweighed the risks for the proposed indications. On February 11, 2011, FDA approved the original PMA for the Selenia Dimensions 3D system, the first DBT system to obtain premarket approval (Ref. 1). The Selenia Dimensions 3D system is intended for use in the same clinical applications as full field digital mammography (FFDM). The system can be used to generate both a two-dimensional (2D) FFDM image set and a three-dimensional (3D) DBT image set and the screening examination is intended to consist of a 2D FFDM image set plus a 3D DBT image set.

On October 22, 2012, FDA filed a panel-track supplement to the original PMA (P080003/S001 (Ref. 6)) seeking to expand the indications for use for the Selenia Dimensions 3D system with C-View Software Module to include the capability to generate synthesized 2D views as an alternative to 2D FFDM views to be reviewed along with DBT images, thereby reducing the cumulative radiation exposure for a screening exam. The Panel met again on October 24, 2012 (Ref. 7), to review the panel-track PMA supplement, and the consensus of the Panel (with no Panel members abstaining) was that the benefits outweigh the risks of the Selenia Dimensions 3D System with C-View Software Module (synthetic 2D or s2D) for the proposed indications for use. The single dissent from one Panel member was due to concerns with the generalizability of the clinical study results in support of the proposed indication for use given the study design and specific study exclusions (patients with large breasts, implants, or tissue markers). As further elaborated in section VI, which discusses the use and adoption of this technology since these approvals, FDA believes that the concerns expressed by the dissenting Panel member have been addressed as a result of the significant amount of subsequently generated data demonstrating the safety and effectiveness of DBT systems with the capability to generate synthetic 2D images.

Based on a search of FDA's Medical Device Recalls database using product code OTE, as of July 21, 2026 FDA has received no Class III recalls, five Class II recalls, and no Class I recalls  10 for DBT systems. Of the Class II recalls, one was due to potential errors in image reconstruction in cases where breasts with a thickness greater than 90 mm covered nearly the entire detector surface, one was due to the potential that unexpected movement by the c-arm might cause blunt trauma should the tube arm impinge upon an individual, one was due to a software issue that may impact image quality when the device is used in certain modalities, one was due to an unapproved slabbing software function enabled for use, and one was due to systems developing loose, missing, or broken internal bolts over time. No injuries have been reported as a result of these recalls. Based on a search of FDA's Manufacturer and User Facility Device Experience (MAUDE) database using product code OTE, as of July 21, 2026 FDA has received 968 Medical Device Reports (MDRs). While this represents a notable volume of reports, the majority of the MDRs reported indicated no known impact or consequence to patient, no patient involvement, and/or no clinical signs, symptoms, or conditions. Moreover, the majority of MDRs documented straightforward resolutions to identified problems, such as replacing a part or tightening loose hardware. About 1 percent of these MDRs reported serious injury attributed to the use of the device, but not necessarily caused by the device ( e.g., a technologist operating the device slipped and twisted an ankle). FDA's analysis of these MDRs, in conjunction with the identified risks to health, demonstrates that the reported adverse events align with known risk categories and can be effectively addressed with special controls to provide a reasonable assurance of the safety and effectiveness of DBT systems.

DBT systems are postamendments devices classified into class III under section 513(f)(1) of the FD&C Act. DBT systems are prescription devices that are intended to generate digital cross-sectional x-ray images of the breast that can be used for the screening and diagnosis of breast cancer. DBT systems may include various components, such as acquisition hardware, x-ray tube, x-ray generator, breast compression system and software, digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment support devices, and other components. The device acquires 2D projection images by moving the tube head in a specific limited angular arc over the stationary compressed breast capturing multiple images at multiple angles during a short scan. These individual images are then reconstructed into a series of thin slices that can be displayed on a workstation. DBT systems enable generating 2D and 3D images, separately or combined under a single compression. Additionally, 2D images or slabs may be synthesized from the 3D images for viewing along with the original images.

In addition, DBT is considered a mammographic modality under the Mammography Quality Standards Act (MQSA) (Pub. L. 102-539), and facilities that perform mammography using DBT systems are subject to MQSA requirements. 11 The MQSA regulations define a mammographic modality as “a technology [. . .] for radiography of the breast.”  12

In accordance with section 513(f)(3) of the FD&C Act and 21 CFR part 860, subpart C, FDA is proposing to reclassify DBT systems, which are postamendments devices, from class III into class II, subject to premarket notification (510(k)) requirements under section 510(k) of the FD&C Act. FDA believes that there is sufficient data and information available to the Agency through the data and information provided in original PMAs and one panel-track supplement that may be considered under section 520(h)(4) of the FD&C Act (Refs. 1 and 3 to 6), associated Panel deliberations (Refs. 2 and 7), published peer-reviewed literature (Refs. 8 to 10), FDA's MAUDE database, and the Medical Device Recalls database to establish special controls. More specifically, in evaluating these data sources, FDA has identified the risks to health for inclusion in the overall risk assessment of DBT systems and is proposing special controls that include mitigation measures for each of the risks to health identified in section V. FDA believes that these special controls, together with general controls, would effectively mitigate the risks to health identified in section V and are necessary to provide a reasonable assurance of safety and effectiveness of these devices. The Agency does not believe that the general controls applicable to the devices are sufficient to effectively mitigate the risks to health identified for these devices, and therefore, does not believe that the general controls applicable to the devices are sufficient to provide reasonable assurance of the safety and effectiveness of these devices.

FDA is proposing to revise 21 CFR part 892 to create a new device classification regulation with the name “Digital Breast Tomosynthesis System.” DBT systems are intended for the generation of digital cross-sectional x-ray images of the breast that can be used for the screening and diagnosis of breast cancer. Under this proposed order, if finalized, DBT systems will be identified as intended for prescription use. Prescription use devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and § 801.5 (21 CFR 801.5), if the conditions of § 801.109 are met.

Under the FD&C Act, 510(k) submissions are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt from 510(k) requirements under section 510(m) of the FD&C Act. 13 FDA has not made this determination for DBT systems, and therefore, FDA is not proposing this class II device type be exempt from 510(k) requirements. If this proposed order is finalized, persons who intend to market a DBT system will need to submit to FDA a 510(k) and receive clearance prior to marketing the device.

This proposed order does not apply to FFDM systems, which FDA has previously classified under 21 CFR 892.1715. FFDM systems are in class II (special controls)  14 under their respective classification regulation, in addition to general controls. Further, this proposed order does not apply to other cross-sectional mammographic x-ray systems, such as Dedicated Breast Computed Tomography System, 15 which remains a class III device.

This proposed order, if finalized, will decrease regulatory burden on industry, as manufacturers will no longer have to submit a PMA for these types of devices but can instead submit a 510(k) to the Agency for review prior to marketing their device. The 510(k) pathway is less burdensome and generally more cost-effective for industry and FDA than the PMA pathway, the most stringent type of device marketing application required by FDA. A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately may provide more timely patient access for these types of devices. FDA expects that the reclassification of these devices would enable more manufacturers to develop these types of devices such that patients would benefit from increased access to appropriately safe and effective devices.

Additionally, manufacturers may wish to use predetermined change control plans (PCCPs) to implement future modifications to their devices without needing to submit a new 510(k) for each significant change or modification  16 while continuing to provide a reasonable assurance of device safety and effectiveness. 17 FDA reviews a PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. When used appropriately, PCCPs authorized by FDA are expected to be least burdensome for manufacturers and FDA. 18

After consideration of FDA's accumulated experience with these devices from review of the data and information provided in each DBT system original PMA and a panel-track supplement that may be considered under section 520(h)(4) of the FD&C Act (Refs. 1 and 3 to 6), associated Panel deliberations (Refs. 2 and 7), published peer-reviewed literature (Refs. 8 to 10), FDA's MAUDE database, and the Medical Device Recalls database, FDA has identified the following probable risks to health associated with a DBT system:

(1) Corrupted or non-diagnostic images. Incorrect or delayed diagnosis and treatment, as well as repeated x-ray radiation exposure could occur if the images are corrupted or otherwise not sufficient for diagnostic purposes.

(2) Failure to interpret the images correctly. If a user cannot interpret the images correctly due to poor image quality, false positive or false negative diagnoses may result. False negative results could result in complications, including incorrect or delayed diagnosis of cancer and treatment; false positive results may result in complications, such as incorrect management of the patient with possible adverse effects, and unnecessary additional imaging and/or invasive procedures, such as biopsy or unnecessary x-ray radiation exposure, as well as patient anxiety.

(3) Inadequate breast coverage. Incorrect or delayed diagnosis and treatment, as well as repeated x-ray radiation exposure could result from an incomplete image that does not include all areas of the breast.

(4) Inappropriate breast compression. When the breast is compressed with too much, or not enough, force and/or is not positioned properly, patient motion, reduced image quality, reduced lesion conspicuity, and inappropriate radiation exposure may result. Consequently, incorrect or delayed diagnosis and treatment, as well as repeated x-ray radiation exposure may occur.

(5) Device failure or malfunction. The absence or delay of device output, or incorrect device output, leading to inaccurate patient assessment and incorrect or delayed diagnosis and treatment, as well as repeated x-ray radiation exposure, could result from a device failure or malfunction. Additionally, electrical, thermal, or mechanical injury may occur if, while in operation, the device discharges electricity that could shock the user or patient; electrical discharges or exposure to device-generated heat may cause thermal injury or discomfort; and moving parts may cause mechanical injury.

(6) Use error or improper use of the device. Use of the device with inappropriate image acquisition parameters, or to process images acquired with incompatible imaging hardware or with incompatible software, could result in incorrect or delayed diagnosis and treatment, as well as repeated x-ray radiation exposure.

(7) Excessive x-ray exposure. Acute health effects such as erythema (skin reddening) and epilation (hair loss) can result from excessive x-ray exposure.

(8) Interference with other devices. The device or nearby devices could fail to function as intended due to interference caused by components of the device. Individuals with electrically powered implants could experience an adverse interaction with the device due to electromagnetic interference or radiofrequency interference.

(9) Adverse tissue reaction. A patient could experience skin irritation and/or allergic reaction associated with the use and operation of the device via the use of non-biocompatible materials in patient-contacting components of the device.

(10) Infection. If validated methods and instructions for reprocessing ( i.e., cleaning or disinfecting between uses, as necessary) of any reusable components as provided in the labeling are not followed, the device may introduce pathogenic organisms to patients which may result in infection.

The safety and effectiveness of this device type have become well established since the initial approval of the first DBT system in 2011. FDA believes that DBT systems (product code OTE) should be reclassified from class III (premarket approval) into class II (special controls) on the basis that special controls, in addition to general controls, can be established to mitigate the risks to health identified in section V and there is sufficient information to establish special controls, which, in addition to general controls, would provide a reasonable assurance of the safety and effectiveness of these devices. The proposed special controls are identified by FDA in section VII of this proposed order.

Taking into account the available evidence and the nature and known incidence of the risks to health of the devices, FDA, on its own initiative, is proposing to reclassify these postamendments class III devices into class II. FDA's reasons for reclassification are based on the scientific and clinical information available. As noted earlier, the safety and effectiveness of this device type have become well established since the initial approval of the first DBT system in 2011. The Agency has gained considerable experience with DBT in the last decade and has considered and analyzed the data from four original PMAs and one PMA panel-track supplement for DBT systems available to FDA in accordance with section 520(h)(4) of the FD&C Act. Further, there have been many advancements in the field in terms of clinical research and adoption of DBT systems as well as the development of standards, including recognized consensus standards and guidelines (Refs. 11 to 17), which serve as important factors in shaping the Agency's knowledge and confidence about this technology. 19 As such, the nature of the associated risks to health is known, and special controls can be established to sufficiently mitigate these risks.

As reported in the medical literature, clinical studies evaluating millions of women have been performed to analyze the performance of DBT systems (Refs. 8 to 10). One of the largest systematic meta-analysis studies to date (Ref. 8) recently compared the performance of (a) FFDM, (b) DBT alone, (c) combined use of DBT and FFDM, and (d) combined use of DBT and s2D. This meta-analysis analyzed 42 published studies covering 2,606,269 patients with 13,003 cases of breast cancer. The key metrics studied were cancer detection rate (CDR), invasive cancer detection rate (iCDR), recall rate, and positive predictive value (PPV1). Findings suggested that combined DBT and FFDM (6.36/1000) and combined DBT and s2D (7.40/1000) had significantly higher CDRs than FFDM alone (4.68/1000). DBT alone (5.20/1000) was not significantly different from FFDM alone. Combined DBT and FFDM (4.53/1000) and combined DBT and s2D (5.68/1000) had significantly higher iCDRs than FFDM alone (3.42/1000). DBT alone (3.68/1000) was not significantly different from FFDM alone. The recall rate was lowest in combined DBT and s2D (42.3/1000) compared to FFDM alone (78.8/1000). No significant difference was observed for DBT alone (82.4/1000) or combined DBT and FFDM (64.6/1000) compared to FFDM alone. Positive predictive value (PPV1) was observed to be highest in combined DBT and s2D (16.0%) and combined DBT and FFDM (10.0%), compared to FFDM alone (7.0%). DBT alone (7.0%) showed no improvement over FFDM alone.

This meta-analysis concluded that DBT combined with FFDM or s2D improves cancer detection and reduces recall rates. Furthermore, the data showed that s2D with DBT is preferred over combined DBT and FFDM because it maintains diagnostic performance while reducing radiation dose and costs. The meta-analysis demonstrates that DBT systems perform at least as effectively as FFDM systems across all key performance metrics—CDR, iCDR, recall rate, and positive predictive value—with no statistically significant differences observed.

FFDM systems with similar performance characteristics and similar risks to health as DBT systems are currently regulated as class II devices with special controls and have been without any significant safety signals since 2010. FDA believes this further supports the reclassification of DBT systems into class II and specifically supports a determination that there is sufficient information to establish special controls that, in addition to general controls, will provide a reasonable assurance of safety and effectiveness. The additional finding that DBT combined with s2D provides superior performance to FFDM alone further supports that DBT systems, when subject to appropriate special controls, will continue to provide appropriately safe and effective breast cancer screening. The extensive evidence base—encompassing more than 2.6 million patients across 42 studies—provides sufficient data to support the proposed reclassification of DBT systems.

Further, FDA publishes the most commonly requested national statistics regarding the MQSA program at a recurring cadence. 20 Based on the statistics as of July 8, 2026, out of the 9,107 certified facilities in the United States, 94 percent have DBT units, and 95 percent of the accredited digital 2D units within those facilities are also accredited DBT units. As noted in section II, there remains an absence of any major safety issues in postmarket data despite wide adoption, which increases FDA's confidence that special controls, in addition to general controls, are sufficient to ensure the safety and effectiveness of DBT systems.

The MQSA regulations established specific quality control (QC) testing methodologies for every mammography system in the United States. A number of national and international professional associations, in addition to DBT system manufacturers, have now developed QC manuals that provide uniform test procedures, performance criteria, and minimum test frequencies that may be useful to manufacturers and users of DBT systems in evaluating and maintaining the performance of the device (Refs. 16 and 17). FDA's experience with the utility of these QC manuals in evaluating and maintaining the performance of the device provides additional confidence that special controls can be established to provide a reasonable assurance of safety and effectiveness of these devices.

There has also been significant development in the methods and tools used for assessing performance of DBT systems since the first DBT system was approved by FDA in 2011. The increasing availability and confidence in such evaluation methods and tools support FDA's determination that special controls, in addition to general controls, are sufficient to provide a reasonable assurance of the safety and effectiveness of DBT systems. Image quality measurements are essential for evaluating whether DBT systems are adequately safe and effective. There is now a rich body of scientific literature describing testing methods for objectively assessing the image quality of DBT systems for both the physical testing (Refs. 18 and 19), as well as in silico testing (Refs. 20 to 23). Multiple workshops and special sessions have been held at scientific conferences throughout the world to discuss these methods to evaluate parameters of safety and effectiveness.

In November 2018 FDA held a symposium titled “Objective Assessment of Digital Breast Tomosynthesis Image Quality Using Anthropomorphic Phantoms.” During this one-day technical symposium, scientists from FDA and other institutions discussed different approaches for assessing the image quality of DBT systems. The focus was on objective, task-based performance assessment of DBT systems using anthropomorphic phantoms and use of human and model observer studies. Example applications of the methodologies discussed were described and have since been published in the literature (Refs. 18 to 20).

One prevailing theme that has come from these studies, workshops, and special sessions, and from FDA's symposium is that depending on system characteristics and modifications, these task-based performance studies using anthropomorphic phantoms with structured background may serve as an alternative to clinical studies (Refs.18 to 23). Such methods have been used in lieu of clinical studies in the scientific evaluation of these devices to support their safety and effectiveness, which has increased FDA's confidence in developing the special controls identified in this proposed order.

Based on our review of the information described in this proposed order, FDA has determined that special controls, in addition to general controls, are necessary to provide a reasonable assurance of safety and effectiveness for DBT systems and that sufficient information exists to establish such special controls. Therefore, FDA, on its own initiative, is proposing to reclassify DBT systems from class III (premarket approval) into class II (special controls), subject to premarket notification (510(k)) requirements.

FDA believes that DBT systems can be reclassified into class II with the establishment of special controls. The Agency believes that the following proposed special controls, together with general controls, would provide reasonable assurance of the safety and effectiveness of DBT systems intended to generate digital cross-sectional x-ray images of the breast that can be used for the screening and diagnosis of breast cancer for prescription use only. Table 1 demonstrates how FDA believes the proposed special controls would mitigate each of the risks to health identified in section V. 21

• The risk of corrupted or non-diagnostic images can be mitigated by special controls that require performance testing, including (1) bench testing to demonstrate the imaging characteristics of the DBT system and (2) objective task-based assessment of diagnostic accuracy of the DBT system conducted using human subjects, structured physical phantoms, in silico methodologies, or a combination of these approaches, as appropriate based on a detailed description of the system hardware and software, as well as appropriate software verification, validation, and hazard analysis. This risk can be further mitigated by special controls that require clinical image evaluation. 22 Furthermore, informing intended users in the labeling of a summary of performance testing results and clinical image evaluation can mitigate this risk.

○ Examples of bench tests that may be used to demonstrate the imaging characteristics of a DBT system and mitigate this risk to health include (see Refs. 11 to 13 for more detail on recognized consensus standard methods for performing these tests):

Spatial Resolution,

Noise Analysis,

Signal-to-Noise Ratio transfer—Detective Quantum Efficiency (DQE),

Detector Lag,

Automatic Exposure Control (AEC) Performance,

Geometric Distortion,

Missed tissue at top and bottom of reconstructed DBT volume,

Missed tissue at chest wall side in reconstructed DBT volume,

Testing of Alignment and Collimation, and

Radiation Dosimetry.

○ Objective task-based assessment of diagnostic accuracy can be conducted through one or more of the following methodologies to mitigate this risk to health:

Reader study with human subjects, defined as a study in which readers review and interpret patient images acquired from a DBT system for a specified task, and task performance of the readers is measured to evaluate the effectiveness of the DBT system.

Observer study with structured physical phantoms, defined as an objective task-based assessment of performance for the DBT system using structured phantoms similar to published methods described in the literature (Refs. 18 and 19).

In silico Trials (IST) also referred to as Virtual Clinical Trials (VCT), defined as a study to provide estimates of the performance of a DBT system based on computational modeling in a virtual population for a clinical task of interest and within a specific context of use (Refs. 20 to 24).

• The risk of failure to interpret the images correctly due to poor image quality (the risk of false positive and false negative results) can be mitigated by special controls that require demonstrating the performance characteristics of the device across a representative range of settings in screening and diagnosis of breast cancer. The device can be evaluated using performance testing, which includes bench testing and objective task-based assessment of diagnostic accuracy of the DBT system, as previously described, to mitigate the risk to health of “corrupted or non-diagnostic images.” This risk can be further mitigated by special controls that require clinical image evaluation. Informing intended users in the labeling of a description of the qualifications and/or clinical training needed for the safe use of the device and a summary of performance testing results and clinical image evaluation can further mitigate this risk.

• The risk of inadequate breast coverage can be mitigated by special controls that require some elements of performance testing, specifically bench testing  23 to demonstrate the imaging characteristics of the DBT system as well as clinical image evaluation. This risk can be further mitigated with a description of the qualifications and/or clinical training needed for the safe use of the device and a summary of performance testing and clinical image evaluation in the labeling.

• The risk of inappropriate breast compression can be mitigated by special controls that require some elements of performance testing, specifically bench testing  24 to demonstrate the imaging characteristics of the DBT system, and software verification, validation, and hazard analysis, and clinical image evaluation. This risk can be further mitigated with a description of the qualifications and/or clinical training needed for the safe use of the device and a summary of performance testing and clinical image evaluation in the labeling.

• The risk of device failure or malfunction can be mitigated by special controls that require some elements of performance testing, specifically bench testing, to demonstrate the imaging characteristics of the DBT system, appropriate software verification, validation, and hazard analysis, and electrical safety/electromagnetic compatibility (EMC) testing. Additionally, this risk can be further mitigated with quality control testing recommendations in the labeling.

• The risk of use error or improper device use can be mitigated by special controls that require appropriate software verification, validation, and hazard analysis as well as a detailed description of the device and its outputs and a description of the qualifications and/or clinical training needed for the safe use of the device in the labeling.

• The risk of excessive x-ray radiation exposure can be mitigated by special controls that require some elements of performance testing, specifically bench testing  25 to demonstrate the imaging characteristics of the DBT system as well as appropriate software verification, validation, and hazard analysis and electrical safety/EMC testing. This risk can be further mitigated with a description of the qualifications and/or clinical training needed for the safe use of the device in the labeling.

• The risk of device failure to function as intended due to interference with other devices due to radiofrequency or electromagnetic interference can be mitigated by special controls requiring testing that demonstrates EMC.

• The risk of adverse tissue reaction for patient-contacting components can be mitigated by special controls requiring that components of the device that may contact the patient be demonstrated to be biocompatible.

• The risk of infection from patient-contacting devices can be mitigated by special controls that require labeling that includes validated instructions for cleaning and disinfecting equipment surfaces that contact the patient.

If this proposed order is finalized, DBT systems will be reclassified into class II (special controls) and will be subject to premarket notification requirements under section 510(k) of the FD&C Act. As discussed in this proposed order, the intent is for the reclassification to be codified in the new classification regulation 21 CFR 892.1717. If finalized, DBT systems will be required to comply with the particular mitigation measures set forth in the special controls. In addition, FDA is proposing that these devices be for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and § 801.5, as long as the conditions of § 801.109 are met. Adherence to the proposed special controls, in addition to the general controls, is necessary to provide a reasonable assurance of the safety and effectiveness of the devices.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

While this proposed order contains no new collections 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 in 21 CFR part 820 (Quality Management System Regulation) have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 807, subpart E (Premarket Notification Procedures) have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 801 (Device Labeling) have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 814, subparts A through E (Premarket Approval (PMA) of Medical Devices) have been approved under OMB control number 0910-0231.

FDA proposes that any final order based on this proposed order become effective 30 days after its date of publication in the Federal Register .

Under section 513(f)(3) of the FD&C Act, FDA may issue final orders to reclassify devices. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as newly codified orders. Therefore, under section 513(f)(3) of the FD&C Act, in the proposed order, we are proposing to codify digital breast tomosynthesis system in the new 21 CFR 892.1717, under which DBT systems would be reclassified from class III into class II.

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA has verified the website addresses as of the date this document publishes in the Federal Register , websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 892 be amended as follows:

On January 14, 2026, HUD issued a notice of proposed rulemaking, HUD's Implementation of the Fair Housing Act's Disparate Impact Standard, 91 FR 1475 (HUD's 2026 proposed rule). HUD's 2026 proposed rule would remove HUD's disparate-impact regulations at 24 CFR part 100 subpart G, consisting of § 100.500, and make a corresponding technical revision to 24 CFR 100.5(b).

HUD's regulations at 24 CFR part 1 (HUD's Title VI regulations) implement nondiscrimination requirements under Title VI of the Civil Rights Act of 1964. Public Law 88-352, 78 Stat. 252 (Title VI). Section 601 of Title VI prohibits any person in the United States, on the ground of race, color, or national origin, from being excluded from participation in, being denied the benefits of, or being subjected to discrimination under any program or activity receiving Federal financial assistance. 42 U.S.C. 2000d. Section 602 of Title VI directs Federal departments and agencies that provide Federal financial assistance to any program or activity, by way of grant, loan, or contract other than a contract of insurance or guaranty, to implement section 601 by, among other things, issuing rules and regulations. 42 U.S.C. 2000d-1. HUD provides Federal financial assistance of the types described by Title VI; therefore, Title VI's nondiscrimination prohibition applies to certain programs and activities for which Federal financial assistance is administered by HUD. See 24 CFR 1.1-1.3.

HUD's Title VI regulations implement the prohibition against discrimination on the basis of race, color, or national origin, which includes exclusion from participation in, denial of benefits of, or discrimination under any HUD program or activity to which 24 CFR part 1 applies. 24 CFR 1.4(a); see also 24 CFR 1.3. HUD's Title VI regulations were last substantively amended in 1973, consistent with uniform amendments adopted by Federal agencies at that time. 38 FR 17949 (July 5, 1973). HUD and DOJ collaborated on this rulemaking, and both agencies reviewed public comments provided in response to HUD's proposed rule for that rulemaking. Id. Since then, HUD has made minor or technical amendments to sections in 24 CFR part 1 through other rulemakings to remove outdated regulations and reduce regulatory burden, 1 to update nomenclature in response to statutory changes, 2 and to remove obsolete provisions on nondiscrimination hearing procedures and instead cross-reference updated and consolidated procedures in 24 CFR part 180. 3

On December 10, 2025, DOJ issued a final rule, Rescinding Portions of Department of Justice Title VI Regulations To Conform More Closely With the Statutory Text and To Implement Executive Order 14281, 90 FR 57141 (DOJ's 2025 final rule), which amended DOJ's Title VI regulations to remove disparate-impact liability consistent with changes directed by Executive Order 14281. See id. at 57141-45. HUD agrees with and adopts the rationale provided in DOJ's rule. HUD's Title VI regulations that are the subject of this proposed rulemaking closely follow DOJ's rule.

HUD's regulation at 24 CFR 1.4, entitled “Discrimination Prohibited,” contains several provisions that go beyond the statute and the Constitution by prohibiting conduct or activities causing an unintentional disparate impact. And in some instances, these provisions may encourage or even require unlawful discrimination labeled as “affirmative action.” Section 1.4(b)(2)(i) is the general disparate-impact prohibition, which states that a “recipient . . . may not . . . utilize criteria or methods of administration which have the effect of subjecting persons to discrimination because of their race, color, or national origin.” Beyond that general prohibition, § 1.4(b)(3) addresses a Federal-funding recipient's selection of the site or location of facilities and includes two references to “effect” that extend to conduct with an unintentional disparate impact. Section 1.4(b)(6) concerns the use of “affirmative action” and provides that funding recipients may (and sometimes must) use race, color, or national origin to overcome unintentional disparate “effects,” but does not expressly specify that the funding recipient must narrowly tailor such use nor that this use must serve a compelling governmental interest, as is required to satisfy strict scrutiny. Finally, § 1.4(c) addresses prohibited discriminatory employment practices and extends beyond intentional discrimination to conduct that “tends” to have a discriminatory effect.

There are serious statutory and constitutional concerns associated with § 1.4's prohibition on discrimination because that prohibition encompasses disparate-impact liability. HUD also has serious policy concerns with its current disparate-impact regulations because they create confusion, undermine public confidence in the nation's civil rights laws and the rule of law, and produce burdensome litigation and compliance costs.

There are serious concerns as to whether Title VI authorizes the disparate-impact provisions of the current regulations. As the Supreme Court has made clear, Title VI prohibits “only intentional discrimination” and “permits” facially neutral policies that result in disparate outcomes when there is no discriminatory intent. Alexander v. Sandoval, 532 U.S. 275, 280, 286 n.6 (2001). That is the “single, best meaning” of Title VI. See Loper Bright Enters. v. Raimondo, 603 U.S. 369, 400 (2024). Sandoval calls into serious doubt the legality of HUD's “disparate-impact regulations.” See 532 U.S. at 281-82, 284-85 (noting that DOJ's then-existing regulations, which HUD's current regulations mirror, were in “considerable tension” with the Supreme Court's Title VI precedents); see also id. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”).

Although Sandoval resolved only the question of private enforceability of Title VI, subsequent cases such as Loper Bright have made clear that HUD cannot extend Title VI beyond its best meaning. See 603 U.S. at 412-13 (holding that “courts must . . . ensur[e] that [an] agency acts within” its statutory authority). And even in the absence of Supreme Court precedent, HUD would have concluded that the best reading of Title VI is that it prohibits only intentional discrimination.

Title VI authorizes agencies to promulgate regulations “to effectuate” the statute's prohibition of intentional discrimination. 42 U.S.C. 2000d-1. The current prohibition of conduct having an unintentional disparate impact reaches a vastly broader scope than the statute itself. This scope is too broad to be considered a simple prophylactic measure aimed at preventing intentional discrimination. See Sandoval, 532 U.S. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”). Thus, the disparate-impact regulations do not “effectuate” Title VI. 42 U.S.C. 2000d-1.

There are also serious concerns about whether HUD's Title VI regulations pass constitutional muster under the Equal Protection Clause. As the Supreme Court recently held in Students for Fair Admissions, Inc. v. President & Fellows of Harvard College, “the Equal Protection Clause . . . applies without regard to any differences of race, of color, or of nationality—it is universal in its application” and the “guarantee of equal protection cannot mean one thing when applied to one individual and something else when applied to a person of another color.” 600 U.S. 206 (2023) ( SFFA ) (internal quotation marks omitted) (first quoting Yick Wo v. Hopkins, 118 U.S. 356, 369 (1886); and then quoting Regents of Univ. of California v. Bakke, 438 U.S. 265, 289-90 (1978) (Powell, J.)). Despite the promises of the Equal Protection Clause, a funding recipient's risk of disparate-impact liability under HUD's Title VI regulations is triggered by unintentional disparate outcomes, which the recipient may not even know about without investigation. To evaluate and avoid this risk, the funding recipient must incur investigatory costs, such as conducting an impact analysis, and is coerced to proactively consider race, color, and national origin, and potentially use it to change the unintended disparate outcomes.

In short, disparate-impact liability encourages and, in some cases, requires covered entities to engage in the intentional use of race and racial balancing to eliminate those disparate outcomes by treating certain racial groups differently from others—the exact conduct the Equal Protection Clause forbids. See id. The serious constitutional concerns raised by these perverse incentives further confirm that the best reading of Title VI is that it prohibits only intentional discrimination and does not authorize HUD to impose disparate-impact liability under that statute. See Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568, 575 (1988) (“[W]here an otherwise acceptable construction of a statute would raise serious constitutional problems, the Court will construe the statute to avoid such problems unless such construction is plainly contrary to the intent of Congress.” (citing NLRB v. Catholic Bishop of Chi., 440 U.S. 490, 499-501, 504 (1979)).

This encouraged or coerced use of race, color, or national origin violates the Equal Protection Clause unless it survives review under the “daunting” strict-scrutiny standard. SFFA, 600 U.S. at 206; see also Free Speech Coal., Inc. v. Paxton, 145 S. Ct. 2291, 2310 (2025) (“Strict scrutiny—which requires a restriction to be the least restrictive means of achieving a compelling governmental interest—is `the most demanding test known to constitutional law.' ” (quoting City of Boerne v. Flores, 521 U.S. 507, 534 (1997))). The use of race, color, or national origin necessitated by the disparate-impact provisions runs into serious issues with the requirement of narrow tailoring to achieve a compelling interest. SFFA, 600 U.S. at 206-07.

Similarly, the “affirmative action” provision authorizes and sometimes requires the intentional use of race without requiring that this intentional use be narrowly tailored to serve a recognized compelling interest. Instead, it encourages intentional racial balancing “to overcome the effects of” unintended racial disparities. 24 CFR 1.4(b)(6). Thus, for substantially the same reasons as above, the “affirmative action” provision raises serious constitutional concerns.

As summarized above, there are serious statutory and constitutional concerns with HUD's disparate-impact regulations under Title VI. But even if the regulations were legal, HUD finds that eliminating the potential constitutional concerns addressed above would independently justify the amendment of the regulations. Cf. U.S. Tel. Ass'n v. FCC, 188 F.3d 521, 528 (D.C. Cir. 1999) (concluding it was not “arbitrary and capricious” to adopt a certain policy in order to “avoid[ ] raising a non-trivial constitutional question”). And even if the regulations did not raise serious constitutional concerns, HUD finds that eliminating the costs and confusion caused by the mismatch between the statute and the Title VI disparate-impact regulations would independently justify the repeal of the regulations.

HUD also has serious policy concerns with the imposition of disparate-impact liability. Although HUD expresses its policy concerns with disparate-impact liability independent of Executive Order 14281, that Order sets forth many valid policy concerns with disparate-impact liability. As noted in section 1 of the Order, “[o]n a practical level, disparate-impact liability has hindered businesses from making hiring and other employment decisions based on merit and skill, their needs, or the needs of their customers because of the specter that such a process might lead to disparate outcomes, and thus disparate-impact lawsuits. This has made it difficult, and in some cases impossible, for employers to use bona fide job-oriented evaluations when recruiting, which prevents job seekers from being paired with jobs to which their skills are most suited—in other words, it deprives them of opportunities for success.” 90 FR at 17537. Moreover, the legal concerns identified above have caused uncertainty and confusion for Federal-funding recipients as to whether and when they need to comply with the disparate-impact regulations and when they can or must consider race, color, and national origin. As explained above, Sandoval casts substantial doubt on the validity of the disparate-impact regulations that many Federal departments and agencies, including HUD, have promulgated pursuant to Title VI. 532 U.S. at 280-82.

Additionally in practice, disparate-impact liability may lead covered entities to engage in racial balancing even as Title VI forbids intentional racial discrimination. This tension tends to create confusion as well as undermine public confidence in the nation's civil rights laws and in the rule of law itself, as the law seems to both forbid and require the same conduct.

These problems are amplified by the arbitrary nature of the racial and ethnic categories typically used to measure disparate effects, which, by virtue of their arbitrariness, typically lack a meaningful connection to a compelling interest. See, e.g., SFFA, 600 U.S. at 216-17 (explaining that the “[racial] categories” utilized by the programs at issue were “themselves imprecise in many ways” and “the use of these opaque racial categories undermine[d], instead of promote[d], [their] goals”). This confusion undermines the law's ability to teach principles of nondiscrimination and is evident in, among other things, many of the grant proposals that HUD awarded funds to in past years.

HUD further notes that Sandoval has also led to a divergence between Title VI enforcement by private plaintiffs and enforcement by Federal departments and agencies. After Sandoval, private plaintiffs can enforce only Title VI's statutory prohibition on intentional discrimination, while HUD could continue to pursue disparate-impact liability. Repealing the disparate-impact regulations would eliminate this incongruent enforcement.

Accordingly, through this supplemental notice of proposed rulemaking, HUD is continuing its fulfillment of directives under Executive Order 14281. As discussed below, HUD's Title VI regulations include provisions that directly implement or allude to discriminatory effects and disparate-impact liability. HUD accordingly proposes to revise or remove those provisions for the reasons set forth above.

HUD is also seeking to make its Title VI regulations consistent with regulatory changes to 24 CFR 100.5 and 100.500 proposed by HUD's 2026 proposed rule. The changes proposed in this supplemental notice of proposed rulemaking would also align with DOJ's 2025 final rule. HUD's Title VI regulations resulted from uniform amendments adopted by Federal agencies and use the same or similar language as DOJ's former Title VI regulations. The proposed changes would revise or remove those provisions and improve consistency between DOJ and HUD regulations that implement Title VI's nondiscrimination requirements. This rule's proposed changes would also further the Administration's regulatory reform efforts by promoting the rule of law through consistency in the Federal government's interpretation of Title VI.

This supplemental notice of proposed rulemaking proposes revisions to 24 CFR 1.4 and reopens the public comment period on HUD's 2026 proposed rule. New comments received during this re-opened period will only be considered if they concern changes proposed in this supplemental notice of proposed rulemaking. For an explanation of HUD's extensive solicitation and review of public comment on prior disparate-impact and discriminatory-effects rulemakings, see HUD's 2026 proposed rule at 91 FR 1476-77. HUD is proposing the following changes to § 1.4:

Section 1.4 implements Title VI's prohibition against intentional discrimination on the grounds of race, color, or national origin, in the participation in, denial of benefits of, or other subjection to discrimination. See also 24 CFR 1.3. Paragraph (b) of § 1.4 describes discriminatory actions specifically prohibited by HUD's Title VI regulations, and existing paragraph (b)(2)(i) incorporates a general prohibition on Federal financial assistance recipients using criteria or methods of administration that have the effect of “subjecting persons to discrimination because of their race, color or national origin,” or “defeating or substantially impairing accomplishment of the objectives of the program or activity as respect to persons of a particular race, color, or national origin.” Because this paragraph incorporates a general prohibition on conduct producing unintended discriminatory effects, HUD is proposing to remove paragraph (b)(2)(i) in its entirety and redesignate existing paragraphs (b)(2)(ii) and (iii) as (b)(2)(i) and (ii).

Paragraph (b)(3) of § 1.4 addresses a Federal-funding recipient's or applicant's selection of the site or location of facilities. It prohibits applicants and recipients from discriminating, through purpose “or effect,” on the grounds of race, color, or national origin in determining the site or location of housing, accommodations, or facilities, or in making related selections. Paragraph (b)(3) also prohibits selections made with the purpose “or effect” of “defeating or substantially impairing the accomplishment of the objectives of the [Title VI]” or 24 CFR part 1. HUD is proposing to remove both instances of the phrase “or effect,” because they extend to unintentional discriminatory effects.

Existing paragraph (b)(6)(i) of § 1.4 requires recipients to take “affirmative action to overcome the effects of prior discrimination” by the recipient against persons on the ground of race, color, or national origin. This provision goes beyond the Equal Protection Clause, which permits, but does not mandate, a government to take narrowly tailored action to remedy the effects of its identified past discrimination. See, e.g., Bakke, 438 U.S. at 307 (Powell, J.). Moreover, even putting aside the mandatory language, this provision does not expressly require narrow tailoring to counter particular past discrimination, but rather simply “affirmative action to overcome the effects of prior discrimination.” 24 CFR 1.4(b)(6)(i). This provision accordingly promotes potentially illegal race, color, and national origin discrimination. Moreover, in some instances, it may even coerce recipients to consider and use race preferences when the recipient may not want to. This is contrary to HUD's goal of promoting and defending a culture of nondiscrimination and is destructive to the public's understanding of and faith in the nation's civil rights laws.

Existing paragraph (b)(6)(ii) requires recipients to take affirmative action even in the absence of prior discrimination to “overcome the effects of conditions” that resulted in limiting the participation of persons of a particular race, color, or national origin in an applicable HUD program. This provision points not to intentional discrimination, but rather to the unintentional “effects of conditions.” It consequently encourages intentional racial classifications, racial preferences, and other race-based actions without requiring the compelling governmental interest and narrow tailoring that the Equal Protection Clause demands. This section is unlawful under the Equal Protection Clause. This rule, therefore, proposes to remove paragraph (b)(6).

Existing paragraph (c)(2) extends the prohibition on discrimination to employment practices of the funding recipient even “[w]here a primary objective of the Federal financial assistance is not to provide employment” if discrimination in the non-funded employment practices “tends, on the ground of race, color, or national origin, to exclude individuals from participation in, to deny them the benefits of, or to subject them to discrimination under any program to which this part 1 applies.” This paragraph prohibits not only intentional discrimination but also conduct that “tends” to have a discriminatory effect.

Moreover, HUD notes that paragraph (c)(2)'s extension to employment practices where the Federal funding's primary objective is not to provide employment conflicts with 42 U.S.C. 2000d-3. That section states that “[n]othing contained in [Title VI] shall be construed to authorize action under [Title VI] by any department or agency with respect to any employment practice of any employer, employment agency, or labor organization except where a primary objective of the Federal financial assistance is to provide employment.” 42 U.S.C. 2000d-3; see also Johnson v. Transp. Agency, Santa Clara Cnty., 480 U.S. 616, 627-28 n.6 (1987) (citing the statutory limitation and noting Congress's intent that Title VI not “impinge” on Title VII, which prohibits discriminatory employment practices).

Because paragraph (c)(2) applies to employment practices that unintentionally produce discriminatory effects and conflicts with the statutory limitation in 42 U.S.C. 2000d-3, HUD is proposing to remove paragraph (c)(2) in its entirety. HUD is proposing to redesignate paragraph (c)(1) as paragraph (c) and to make a technical edit to the last sentence of that paragraph, which cross-references part III of Executive Order 11246, Equal Employment Opportunity, (Sept. 24, 1965). Executive Order 14173, Ending Illegal Discrimination and Restoring Merit-Based Opportunity (Jan. 21, 2025), revoked Executive Order 11246. Therefore, HUD is proposing to revise the last sentence of newly redesignated paragraph (c) to state, “The requirements applicable to construction employment under such program or activity are those specified in or pursuant to Executive Order 14173 or any executive order which supersedes or amends it.” Section 3(b) of Executive Order 14173 specifies new requirements for the Federal contracting process and for Federal contractors and subcontractors.

Under Executive Order 12866, Regulatory Planning and Review, a determination must be made regarding whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget in accordance with the requirements of the order. 58 FR 51735, 51738 (Sep. 30, 1993). This supplemental notice of proposed rulemaking was determined to be a significant regulatory action under section 3(f) of Executive Order 12866, but not economically significant under section 3(f)(1).

Executive Order 13563, Improving Regulation and Regulatory Review directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” 76 FR 3821, 3821 (Jan. 18, 2011). Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. As previously discussed, this supplemental notice of proposed rulemaking removes unnecessary regulations and is consistent with Executive Order 13563.

Data limitations make the costs and benefits of the rule difficult to quantify. Although it does not represent the monetary impact of the rule, HUD issued approximately 4,412 separate grants and 5,393 separate subsidies totaling approximately $170,153,001,187 (approximately $56,530,401,288 in grants and $113,622,599,899 in subsidies) over the past 3 calendar years (CYs) (CY23-CY25). HUD's Title VI-related, active investigations and compliance reviews regarding these funds and their recipients totaled 500 over a 3-year period (CY23-CY25), and HUD's Title VI-related, closed investigations and compliance reviews totaled 585 over those same 3 years (CY23-CY25).

HUD does not track which of its investigations and compliance reviews involve solely allegations of disparate-impact discrimination. For enforcement actions that relate to both intentional discrimination and conduct having an unintentional disparate impact, HUD does not track and cannot reliably quantify the costs attributable to the disparate-impact portions of enforcement actions. That the existence of a disparate impact is sometimes a factor that may be considered in evaluating intentional discrimination further impedes monetizing costs and benefits. Therefore, the overall cost effect on HUD is difficult to quantify. The deregulatory action should decrease HUD's enforcement costs by allowing HUD to focus enforcement procedures and resources on intentional discrimination cases. It should also produce a qualitative benefit by aligning HUD's Title VI regulations with the best reading of Title VI and DOJ's revised Title VI regulations. It should also have the benefit, albeit difficult to quantify, of bringing HUD's conduct in line with the law. Similarly, HUD is unable to quantify how funding recipients will respond to the regulatory changes. However, HUD anticipates that the proposed deregulatory action should result in greater flexibility and lower compliance costs for recipients.

Ultimately, HUD does not envision that this proposed rule will appreciably increase administrative costs or compliance costs for funding recipients who must also adhere to the regulations of another department or agency. This proposed deregulatory action does not create any new obligations for funding recipients. On the contrary, by eliminating disparate-impact liability from the regulation, it eliminates a source of regulatory confusion, narrows the conduct prohibited, and thus lessens the costs of compliance and potential liability. Moreover, recipients who receive funds for the same program or activity from more than one Federal entity already enter into separate contractual assurances with each funding entity. See, e.g., 24 CFR 1.5. These contractual assurances impose varying requirements that each Federal funding source deems necessary. Recipients receiving funds from more than one Federal agency will remain responsible for complying with all applicable assurances and regulatory requirements. And in any event, HUD notes that other agencies are currently amending their regulations to align with the changes made in this rule, so HUD anticipates that there will be little, if any, disparity in federal requirements regarding disparate-impact liability going forward.

Based on the analysis of the practical qualitative costs and benefits noted above, HUD believes that this proposed rule is consistent with the principles of Executive Orders 12866 and 13563, including the requirements that, to the extent permitted by law, HUD adopt a regulation only upon a reasoned determination that its benefits justify its costs.

Pursuant to section 1-202 of Executive Order 12250, DOJ has the responsibility to “review . . . proposed rules . . . of the Executive agencies” implementing nondiscrimination statutes such as Title VI “in order to identify those which are inadequate, unclear or unnecessarily inconsistent.” Additionally, section 1-101 of Executive Order 12250 delegated the President's responsibility to approve Title VI regulations to the Attorney General. See 42 U.S.C. 2000d-1. DOJ has reviewed and approved this proposed rule.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. This supplemental notice of proposed rulemaking would not impose new compliance obligations on small entities. To the extent that it has any economic effect, HUD expects the effect to be deregulatory because the proposal would remove effects-based provisions from HUD's Title VI regulations. As such, there is no change in burden for those involved in a challenged practice. Accordingly, the undersigned certifies that the rule will not have a significant economic impact on a substantial number of small entities.

Executive Order 14192 requires that any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations. This supplemental notice of proposed rulemaking proposes to remove unnecessary existing regulations and will impose no regulatory costs.

Executive Order 13132 prohibits an agency from publishing any rule that has federalism implications if the rule either: (i) imposes substantial direct compliance costs on State and local governments and is not required by statute, or (ii) preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This supplemental notice of proposed rulemaking does not have federalism implications and does not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive Order.

This supplemental notice of proposed rulemaking is a policy document that sets out nondiscrimination standards. Accordingly, under 24 CFR 50.19(c)(3), this rule is categorically excluded from environmental review under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ).

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments, and on the private sector. This supplemental notice of proposed rulemaking does not impose any Federal mandates on any State, local, or Tribal governments, or on the private sector, within the meaning of the UMRA.

Accordingly, for the reasons stated in the preamble, HUD proposes to amend 24 CFR part 1 as follows:

The revisions read as follows:

This is a synopsis of the Commission's Notice of Proposed Rulemaking, MB Docket No. 26-196; RM-12024; DA 26-806, adopted July 31, 2026, and released July 31, 2026. The full text of this document is available online at https://www.fcc.gov/edocs.

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.

Members of the public should note that all ex parte contacts are prohibited from the time a notice of proposed rulemaking is issued to the time the matter is no longer subject to Commission consideration or court review, see 47 CFR 1.1208. There are, however, exceptions to this prohibition, which can be found in § 1.1204(a) of the Commission's rules, 47 CFR 1.1204(a).

See §§ 1.415 and 1.420 of the Commission's rules for information regarding the proper filing procedures for comments, 47 CFR 1.415 and 1.420.

Providing Accountability Through Transparency Act: The Providing Accountability Through Transparency Act, Public Law 118-9, requires each agency, in providing notice of a rulemaking, to post online a brief plain-language summary of the proposed rule. The required summary of this notice of proposed rulemaking is available at https://www.fcc.gov/proposed-rulemakings.

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:

FMCSA organizes this NPRM as follows:

If you submit a comment, please include the docket number for this NPRM (FMCSA-2026-0826), indicate the specific section of this document to which your comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name, mailing address, email address, or telephone number in the body of your document so FMCSA can contact you if there are questions regarding your submission.

To submit your comment online, go to https://www.regulations.gov/docket/FMCSA-2026-0826/document, click on this NPRM, click “Comment,” and type your comment into the text box on the following screen.

If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing.

FMCSA will consider all comments and material received during the comment period.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to the NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission that constitutes CBI as “PROPIN” to indicate it contains proprietary information. FMCSA will treat such marked submissions as confidential under the Freedom of Information Act, and they will not be placed in the public docket of the NPRM. Submissions containing CBI should be sent to Brian Dahlin, Chief, Regulatory Evaluation Division, Office of Policy, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 or via email at brian.g.dahlin@dot.gov. At this time, you need not send a duplicate hardcopy of your electronic CBI submissions to FMCSA headquarters. Any comments FMCSA receives not specifically designated as CBI will be placed in the public docket for this rulemaking.

To view any documents mentioned as being available in the docket, go to https://www.regulations.gov/docket/FMCSA-2026-0826/document, and choose the document to review. To view comments, click this NPRM, then click “Document Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations in room W58-213 of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to inform its regulatory process. DOT posts these comments, including any personal information the commenter provides, to www.regulations.gov as described in the system of records notice DOT/ALL 14 (Federal Docket Management System (FDMS)), which can be reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices. The comments are posted without edits and are searchable by the name of the submitter.

FMCSA proposes to update the FMCSR to reflect that, under current enforcement tolerances, a violation of 49 CFR 391.11(b)(2) is an OOS violation. This rulemaking would make updates to sections 390.5, 390.5T, and 391.11(b)(2) to reflect that noncompliance with ELP requirements will result in a driver being placed OOS, unless the driver's current trip would not involve transportation in the United States outside of the U.S.-Mexico border commercial zones. These changes would align the FMCSR with current enforcement tolerances in the North American Standard Out-of-Service Criteria from CVSA and ensure uniform enforcement. The rulemaking is consistent with an April 19, 2026 revision to the CVSA OOS criteria, which narrows the previous exception for placing drivers OOS for ELP violations in U.S.-Mexico border commercial zones. FMCSA anticipates that the revision would result in annual costs of approximately $14.4 million for motor carriers.

This NPRM is consistent with the concurrent authorities of the Motor Carrier Act of 1935 (49 U.S.C. 31502), as amended, and the Motor Carrier Safety Act of 1984 (49 U.S.C. 31131, et seq. ), as amended. Section 204 of the Motor Carrier Act of 1935 provides that it shall be the duty of the Interstate Commerce Commission (ICC) (now the Secretary of Transportation, after the broad delegation of jurisdiction to the Secretary under the ICC Termination Act of 1995)  1 to regulate common and contract carriers by motor vehicle as provided in that act, and that “to that end the Commission may establish reasonable requirements with respect to . . . qualifications and maximum hours of service of employees, and safety of operation and equipment.” Motor Carrier Act, sec. 204(a)(1)-(2). Section 204 further provides for the establishment of similar regulations with respect to private carriers of property by motor vehicle, if need therefore is found. See Motor Carrier Act, section 204(a)(3). The Department of Transportation Act (Pub. L. 89-670, 80 Stat. 931, Oct. 15, 1966) transferred the ICC's safety authority and regulations to DOT (Section 6(e)(6)(C)), where those functions were assigned to the Federal Highway Administration (FHWA), and now to FMCSA (49 U.S.C. 113(f)). Most of the Motor Carrier Act of 1935 has been repealed, but the previous safety provisions have been retained in 49 U.S.C. 31502(b).

The Motor Carrier Safety Act of 1984 (49 U.S.C. 31131 et seq. ) was intended to recodify the previous ICC and FHWA regulations. Section 206(e) of the 1984 Act provided that, if DOT failed to issue new regulations consistent with the requirements of the statute, “the regulations pertaining to commercial motor vehicle safety which the Secretary issued before such date of enactment and in effect on such date of enactment shall, for purposes of this title, be deemed to be regulations issued by the Secretary under this section” Public Law 95-554, Title II, 98 Stat. 2832, 2834 (Oct. 30, 1984). The provisions listed in Section 206(a) were codified as 49 U.S.C. 31136(a)(1)-(4). Thus, the 1984 Act intended to capture and recodify the detailed regulations on commercial motor vehicle safety that the ICC and FHWA had previously issued, including the requirement for ELP. Congress said that even more clearly in the Senate Report on Title II of the 1984 Act: “It is the intent of the Committee [on Commerce, Science, and Transportation] that nothing in section 6 of the bill [which became Section 206 of the 1984 Act] alter this state of affairs which has developed under existing provisions of law. Rather the Committee intends to reaffirm the scope of DOT's authority to regulate safety in this area.” S. Rep. No. 98-424, at 9 (1984). Pursuant to 49 U.S.C. 31502(b) and 31136(a), FMCSA may prescribe safety of operation requirements for the qualification of drivers operating CMVs in interstate commerce. This rulemaking addresses the qualifications of motor carrier employees, consistent with the safe operation of CMVs.

This NPRM is consistent with the safe operation of CMVs, as provided for in 49 U.S.C. 31136(a)(1), as the proposal would ensure that drivers who cannot meet the minimum qualification requirements are placed out of service. The remaining statutory factors and requirements in section 31136(a), to the extent they are relevant, are also satisfied here. In accordance with section 31136(a)(2), the requirement under 49 CFR 391.11(b)(2) would not impose any responsibilities on CMV drivers that would impair their ability to operate the vehicles safely. This rulemaking does not address medical standards for drivers or possible physical effects caused by driving CMVs (section 31136(a)(3) and (a)(4), respectively). There is no basis to anticipate that this rulemaking would lead to driver coercion (section 31136(a)(5)), as the FMCSRs have required ELP since the 1930s and the rulemaking is codifying current enforcement tolerances.

The FMCSA Administrator is delegated authority under 49 CFR 1.87 to carry out the functions vested in the Secretary by 49 U.S.C. chapters 311 and 315 as they relate to CMV operators, programs, and safety.

On December 23, 1936, as part of its newly-promulgated “Motor Carrier Safety Regulations,” the ICC established an English language requirement for drivers of motor vehicles operated in interstate or foreign commerce by common and contract carriers. The original wording, as contained in paragraph 3 of Part I [Qualification of Drivers] required that, on and after July 1, 1937, “no motor carrier shall drive, or require or permit any person to drive, any motor vehicle operated in interstate or foreign commerce, unless the person so driving possesses the following minimum qualifications: . . . (k) Ability to read and speak the English language, unless the person was engaged in so driving on July 1, 1937 or within one year prior thereto, but in any case ability to understand traffic and warning signs.” 1 Motor Carrier Cases (M.C.C.) 1, at 18-19; later published at 2 FR 144 (Jan. 22, 1937). The preamble to the ICC decision stated that “[i]t is evident that ability to read and speak English is important to any adequate compliance with safety regulations. Cognizance has been taken, however, of the existence in certain areas of numbers of drivers in present service who are unable to read or speak English, but even in these cases the ability at least to understand traffic and warning signs is required” 1 M.C.C. 1, at 7-8.

On May 27, 1939, the ICC made certain changes and additions to the Motor Carrier Safety Regulations, including elimination of the exceptions granted by the original rules for those drivers unable to read and speak English. As stated in that notice, “[t]he intent of the Commission to require such ability of all drivers in this service has been unmistakable since 1937, and the intervening period of more than two years is regarded as sufficient to justify the removal of the exception” (14 M.C.C. 669, at 675). As explained above, while the ICC regulations on ELP have been recodified, the intent of Congress to retain and enforce them is clear.

In accordance with 49 CFR 391.11(a), a person shall not drive a commercial motor vehicle, as defined in section 390.5T, in interstate commerce unless the individual meets the driver qualification requirements in part 391. Under section 391.11(b)(2), the Secretary has determined that one such qualification requirement is that a person must be able to read and speak the English language sufficiently to converse with the general public, to understand highway traffic signs and signals in the English language, to respond to official inquiries, and to make entries on reports and records. Pursuant to the regulation, a driver that cannot do so is therefore not qualified to operate a CMV in interstate commerce. In addition, each State or other entity receiving Federal funds through FMCSA's Motor Carrier Safety Assistance Program, which is currently all States plus DC and all U.S. territories, must adopt and maintain compatible laws, regulations, standards, and orders concerning CMV safety. Generally, the compatible State requirements include applicability of the rules to CMVs operating in intrastate commerce. See Subpart C to 49 CFR part 350. This includes the requirements in section 391.11.

Effective April 1, 2005, CVSA amended its North American Standard Out-of-Service Criteria to include violations of section 391.11(b)(2). CVSA is a non-profit organization, comprising Federal, State, provincial, territorial and local safety officials and industry representatives, that develops inspection, training, and enforcement standards for commercial motor vehicles. The North American Standard Out-of-Service Criteria is a reference guide that sets forth enforcement tolerances developed and maintained by CVSA to assist State inspectors in deciding whether to allow a commercial motor vehicle or driver, found in violation of law, to continue in commerce. It provides a detailed list of violations that the CVSA membership has agreed are sufficiently hazardous to justify restricting further operation by a driver or a commercial motor vehicle and placing them out of service. The list was developed over a period of more than 40 years by Federal, State and Provincial safety professionals, with input from the motor carrier industry, vehicle and equipment manufacturers, researchers, and other interested parties. The North American Standard Out-of-Service Criteria is non-binding guidance to assist Federal and State personnel to determine whether to place a vehicle or driver out-of-service. 2 3 All States participating in the Motor Carrier Safety Assistance Program consider the North American Standard Out-of-Service Criteria during roadside inspections. In accordance with the definition of out-of-service order under section 390.5T, violations may be considered an OOS condition if included within the North American Standard Out-of-Service Criteria.

On October 1, 2014, FMCSA published regulatory guidance titled, “Driver Qualifications; Regulatory Guidance Concerning the Applicability of Language Requirement to Drivers Who Do Not Meet the Hearing Standard” (79 FR 59139). 4 This guidance explained that the English language requirement should not be construed to prohibit operation of a CMV by hearing-impaired drivers who can read and write in the English language but do not speak, for whatever reason, and were granted exemptions  5 from section 391.41(b)(11) by FMCSA. Specifically, the guidance advises that a driver who is granted an exemption from section 391.41(b)(11) is not considered unqualified under the ELP requirement in section 391.11(b)(2) if the driver is capable of reading and writing in the English language. In that circumstance, the hearing-impaired driver satisfies the English language requirement. This guidance remains in effect.

Effective April 1, 2015, CVSA removed section 391.11(b)(2) from its North American Standard Out-of-Service Criteria. On June 15, 2016, FMCSA issued a policy memorandum titled “English Language Proficiency Testing and Enforcement Policy (MC-ECE-2016-006)” to provide guidance to FMCSA personnel conducting safety investigations, audits, and inspections of CMVs and drivers. The policy removed the requirement for FMCSA personnel to place drivers OOS for ELP violations and changed the Agency's standard for determining non-compliance with the ELP requirements of section 391.11(b)(2). Under the 2016 policy, FMCSA personnel were directed to cite drivers for violations of section 391.11(b)(2) but not to place them OOS, consistent with CVSA's change to the enforcement tolerances used by personnel conducting CMV inspections.

On April 28, 2025, the President issued Executive Order (E.O.) 14286, “Enforcing Commonsense Rules of the Road for America's Truck Drivers,”  6 which directed FMCSA to rescind the 2016 guidance document and issue new enforcement guidance to FMCSA personnel, outlining inspection procedures necessary to ensure compliance with the requirements of section 391.11(b)(2). The E.O. directed FMCSA to take all necessary and appropriate actions, consistent with applicable law, to ensure that the North American Standard Out-of-Service Criteria are revised such that a violation of the ELP requirement results in the driver being placed OOS, including by working with the relevant entities responsible for establishing the North American Standard Out-of-Service Criteria.

On May 1, 2025, during a meeting of the CVSA Board of Directors where FMCSA presented on the issue of ELP, CVSA voted to incorporate violations of section 391.11(b)(2) into the North American Standard Out-of-Service Criteria, effective June 25, 2025. 7 On May 20, 2025, FMCSA issued policy memorandum “English Language Proficiency Under § 391.11(b)(2) (MC-SEE-2025-0001)” 8 (May 2025 policy memo) to rescind the 2016 policy and provide guidance to FMCSA enforcement personnel providing oversight of part 391 in conducting North American Standard Driver and Vehicle Inspections who need to evaluate whether drivers can satisfy the ELP qualification requirements in section 391.11(b)(2). 9 The May 2025 policy memo also provides enforcement guidance for discovered violations of section 391.11(b)(2). The updates to the North American Standard Out-of-Service Criteria that became effective on June 25, 2025 established violations of section 391.11(b)(2) as an OOS violation and incorporated the inspection procedures from the May 2025 policy memo, which was applicable only to Federal personnel. 10

On May 22, 2025 and May 28, 2025, FMCSA trained approximately 650 staff members—including inspectors, auditors, investigators, and headquarters personnel—on internal enforcement policy MC-SEE-2025-0001 via webinar. The training included information on the policy's background, the key provisions, procedures for effectuating the policy, and the updated SafeSpect violation codes. On June 25, 2025, FMCSA provided a similar webinar to state MCSAP personnel.

On October 25, 2025, CVSA submitted a petition for rulemaking requesting that FMCSA amend the FMCSR by requiring that noncompliance with the ELP requirements in section 391.11(b)(2) result in a driver being placed OOS. 11 CVSA stated that noncompliance with ELP requirements in section 391.11(b)(2) has already been added to the North American Standard Out-of-Service Criteria, and updating the FMCSR would be consistent with that action and the objectives of E.O. 14286. CVSA provided some recommended revisions to sections 390.5T and 391.11(b)(2) to accomplish this. The Agency grants that petition and proposes to incorporate the recommended changes, as discussed below.

On April 16, 2026, FMCSA issued a policy memorandum, titled “English Language Proficiency Under § 391.11(b)(2) (MC-SEE-2026-0002)”  12 (April 2026 policy memo), to update the guidance in the May 2025 policy memo. The April 2026 policy memo clarified that FMCSA enforcement personnel conducting inspections within a U.S.-Mexico border commercial zone must determine the scope of the driver's current trip before determining whether to issue an OOS order when citing a violation of 49 CFR 391.11(b)(2). If the driver's current trip (as evidenced by bills of lading, dispatch records, equipment interchange receipts, driver statements, or other related shipping documents) involves transportation in the United States that would take the driver outside of the U.S.-Mexico border commercial zones, the driver shall be placed OOS for a violation of section 391.11(b)(2). If the driver's current trip does not involve transportation in the United States that would take the driver outside of the U.S.-Mexico border commercial zones (even if the cargo itself is ultimately destined outside of a border commercial zone via a different driver), the driver shall not be placed OOS for a violation of section 391.11(b)(2). As with the May 2025 policy memo, the April 2026 policy memo applies to FMCSA enforcement personnel only.

On April 16, 2026, FMCSA also published a guidance document titled, “English Language Proficiency Roadside Enforcement Policy FAQs,”  13 to address four questions regarding the April 2026 policy memo. 14 The FAQs provided clarity on the exception for drivers operating CMVs in the border commercial zones along the U.S.-Mexico border, on how to cite violations under the two-step test, on whether the violation codes were hardcoded in SafeSpect to ensure the correct OOS designation is applied to violation codes, and on language regarding initiating an action to disqualify the driver from operating CMVs in interstate commerce.

On April 19, 2026, CVSA's board of directors voted to revise the North American Standard Out-of-Service Criteria to update the entry for violations of section 391.11(b)(2) by replacing the reference to the May 2025 policy memo with a reference to “current FMCSA enforcement guidance.”  15 This change ensures that the latest FMCSA enforcement guidance for violations of section 391.11(b)(2), which is now the April 2026 memo, is incorporated into the North American Standard Out-of-Service Criteria. This incorporation by CVSA makes FMCSA's April 2026 policy applicable to State inspectors as well and thereby provides uniform enforcement by Federal and State authorities.

FMCSA proposes to revise the FMCSR to reflect the current practice of placing drivers OOS for violations of the ELP requirements in section 391.11(b)(2), except when the driver's current trip would not involve transportation in the United States that would take the driver outside of the U.S.-Mexico border commercial zones. As discussed in the background section above, the North American Standard Out-of-Service Criteria currently require drivers in violation of section 391.11(b)(2) to be placed out of service.

CVSA, through its petition for rulemaking, requested revisions to sections 390.5T and 391.11(b)(2) to reflect that noncompliance with ELP requirements will result in a driver being placed OOS. CVSA requested that section 391.11(b)(2) be added to the list of regulatory requirements listed in the definition for out-of-service order in section 390.5T. Additionally, CVSA requested a new paragraph (c) be added to section 391.11 stating that a driver in violation of paragraph (b)(2) must be placed out of service immediately. FMCSA agrees with CVSA that the changes recommended in their petition are consistent with CVSA's enforcement tolerances in the North American Out-of-Service Criteria, FMCSA's updated enforcement policy in the April 2026 policy memo, and E.O. 14286.

The Agency is proposing to add the language recommended by CVSA in its petition, with two slight differences. First, FMCSA also proposes to update the definition of out-of-service order in the suspended section 390.5 to ensure consistency with section 390.5T. 16 This ensures that the changes made to the definition in section 390.5T would remain in effect if the suspension of section 390.5 is lifted in the future. In addition, the Agency proposes additional language at the end of CVSA's recommended language in section 391.11(c).

The addition to section 391.11(c) would incorporate the limited exception from being placed OOS for ELP for drivers whose current trip would not involve transportation in the United States outside of the U.S.-Mexico border commercial zones. Specifically, the exception for U.S.-Mexico border commercial zones in the North American Out-of-Service Criteria, provides that enforcement personnel should cite drivers whose current trip would not involve transportation in the United States outside of the U.S.-Mexico border commercial zones for ELP violations during inspections in such zones but should not take follow-on actions of placing the driver OOS or initiating an action to disqualify the driver. This exception would not apply when there is evidence that the driver intends to operate, or has been operating, a CMV in the United States outside the border commercial zones. This would close a safety loophole to ensure uniform enforcement, regardless of where the inspection takes place. Non-compliant drivers who would not be placed OOS under this exception (because they did not operate or intend to operate in the United States outside of a border commercial zone) would still be cited for violating the ELP requirements in section 391.11(b)(2). FMCSA notes that under this proposed rule, a driver not placed OOS for an ELP violation under the exception could still be placed OOS if he or she commits a violation, other than under section 391.11(b)(2), that warrants being placed OOS.

Upon publication of a final rule, FMCSA will hold training for FMCSA and State partner enforcement personnel similar to the ones held in May and June 2025. This training will cover the limited exception from the paragraph above, as well as any other provisions in a final rule that may differ from prior enforcement practices.

The proposed revisions to sections 390.5, 390.5T, and 391.11 would ensure that the FMCSR are consistent with the enforcement tolerances in the North American Standard Out-of-Service Criteria. In addition, the MCSAP program requires States to adopt State laws or regulations compatible with the FMCSR as a condition of MCSAP grant eligibility. By codifying the OOS condition in the FMCSR, States will be required to adopt a compatible requirement into their State law regardless of any future revisions to the North American Standard Out-of-Service Criteria. This would ensure uniform enforcement of ELP violations beyond State use of the North American Standard Out-of-Service Criteria. This rulemaking would merely codify enforcement tolerances consistent with an April 19, 2026 revision to the North American Standard Out-of-Service Criteria, which narrows the previous exception for placing drivers OOS for ELP violations in U.S.-Mexico border commercial zones.

Motor carriers and drivers are subject to the laws and regulations of the countries where they operate, unless an international agreement states otherwise. Drivers and carriers should be aware of the regulatory differences between nations. Canada- and Mexico-domiciled drivers operating CMVs in the United States have been subject to the ELP rules since they were implemented in the 1930s, regardless of whether those drivers' native language is not English. However, CMV drivers operating in the commercial zones along the U.S.-Mexico international border are not currently subject to being placed OOS for violating ELP requirements when their current trip would not involve transportation in the United States that would take the driver outside of the U.S.-Mexico border commercial zones. Those drivers would not be impacted by this rulemaking.

The proposed rule is consistent with established international agreements, including the United States-Mexico-Canada Agreement (USMCA) and the predecessor North American Free Trade Agreement (NAFTA) as well as agreements providing for the reciprocal recognition of commercial driver's licenses between the United States, Canada, and Mexico. The ELP requirement, like other operating qualification standards, applies equally to all commercial vehicle drivers operating in the United States regardless of nationality. Non-discriminatory, safety-based operating standards, like ELP requirements, and the enforcement tolerances set forth in this proposed rule are permissible under the USMCA framework.

This section-by-section analysis describes the proposed changes in numerical order.

FMCSA proposes to revise the definition of out-of-service order in sections 390.5 and 390.5T to include section 391.11(b)(2).

FMCSA proposes to add a new paragraph (c)(1), which would state that drivers violating paragraph (b)(2) of this section would be placed OOS. FMCSA would also add a new paragraph (c)(2), which would state that drivers would not be placed OOS if operating in the commercial zones, as designated in 49 CFR part 372, subpart B, along the U.S.-Mexico international border, unless there is evidence that the person has operated or intends to operate a CMV in the United States beyond the boundaries of the commercial zones.

FMCSA has considered the impact of this proposed rule under E.O. 12866 (58 FR 51735, Oct. 4, 1993) and DOT Rulemaking Procedures (49 CFR part 5, subpart B). The Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB) determined that this proposed rule is a significant regulatory action under section 3(f) of E.O. 12866 and has reviewed it under that E.O.

The proposed rulemaking does not create new requirements or obligations for regulated entities but would codify and align with current enforcement tolerances in the North American Standard Out-of-Service Criteria and E.O. 14286. The rulemaking is necessary to ensure uniform enforcement by aligning the FMCSR with the current enforcement tolerances in the North American Standard Out-of-Service Criteria. This proposed rule would incorporate the limited exception from OOS violations for drivers whose current trip would not involve transportation in the United States outside of the U.S.-Mexico border commercial zones and would amount to a slight clarification and narrowing of the previous exception in the North American Standard Out-of-Service Criteria, which had incorporated FMCSA's May 2025 internal enforcement policy, for inspections performed of drivers “operating [CMVs] in the border commercial zones along the U.S.-Mexico border.” The May 2025 policy memo, which was incorporated by CVSA and effective on June 25, 2025, stated that enforcement personnel should cite drivers for ELP violations during inspections in such zones but should not take follow-on actions of placing the driver OOS or initiating an action to disqualify the driver. The proposed rule clarifies that this exception should not be applied where there is evidence that the driver intends to operate, or has been operating, a CMV in interstate commerce outside the U.S.-Mexico border commercial zones as part of their current trip. This would ensure uniform enforcement, regardless of where the inspection takes place.

Under the regulatory baseline, the enforcement tolerances in the North American Standard Out-of-Service Criteria, effective June 25, 2025, which incorporated the May 2025 policy memo, would remain in effect. The Agency has had requirements for ELP dating back to 1936. This proposed rule would not change the ELP requirements set forth in section 391.11(b)(2). Further, the proposal would not impact existing tools at the Agency's discretion regarding letters of disqualification and civil penalty actions. These tools have been in place for over 40 years and would continue to be available to FMCSA if this proposed rule is finalized. This regulatory analysis of the proposed rule does, however, consider the cost of non-compliance with the existing ELP requirements with regards to violations identified during roadside inspections under certain circumstances. While the April 2026 memo and the update to the North American Standard Out-of-Service Criteria have already gone into effect, DOT has determined that it is appropriate to consider the costs and benefits of this policy change since it is roughly contemporaneous with this rulemaking.

Between January 2025 and June 24, 2025, 7,812 ELP violations were issued across the United States, with 33 of those resulting in OOS orders. 17 Between June 25, 2025 and March 19, 2026, there were 60,399 ELP violations issued, with 19,045 of those resulting in OOS orders. 18 The change to CVSA's enforcement tolerances in the summer of 2025 resulted in an increase in ELP violations and OOS orders. The 19,045 ELP violations that resulted in OOS orders all occurred outside of border commercial zones, while the remaining 44,354 ELP violations that occurred in border commercial zones did not result in OOS orders.

Though FMCSA believes the recent increase in ELP violations and OOS orders tied to the 2025 change in enforcement tolerances would continue under the baseline, the proposed rule would also clarify that OOS orders should be issued for ELP violations issued within the U.S.-Mexico border commercial zones if the driver's current trip involves transportation in the United States outside of the border commercial zones. Inspection documentation collected from June 25, 2025 through March 19, 2026 did not definitively capture the number of ELP violations that would fall into this category. It did capture the origin and destination of the cargo and the operating authority of the carrier for which the driver was working. This provides FMCSA with two different proxies for whether the driver had left or intended to leave the border commercial zone. For example, if cargo originated in Mexico and is bound for a commercial zone, FMCSA assumed that the driver was not planning to leave the commercial zone. In this case, under the proposal, the driver would have received an ELP violation, but would not have received an OOS order, which is the same result as under the June 2025 enforcement tolerances. However, if the cargo originated in a border commercial zone and was destined for a U.S. location outside the commercial zones, FMCSA assumed that the driver was planning to leave the commercial zones and would have received an OOS order under the proposal. Analyzing all 41,563 violations that were issued in the commercial zones between June 25, 2025 and March 19, 2026, FMCSA estimated that 83.5 percent would have only received ELP violations, and 16 percent would also have received an OOS order (in addition to the underlying ELP violation). Approximately 0.5 percent of the violations did not include either origin or destination information. Extrapolating to an entire year, FMCSA estimates that there would be approximately 56,575 ELP violations within the border commercial zones and that approximately 9,052 (16 percent) would be issued as OOS orders. FMCSA recognizes that origin and destination information from the inspection documentation may be specific to the cargo, and not necessarily the driver ( e.g., where the driver's destination as reflected on a dispatch order differs from the final destination of the cargo as listed on a waybill), but nevertheless believes it to be a reasonable estimate of the number of drivers who would be affected by the proposed rule. 19