Modernizing Medical Standards for Non-Insulin Dependent Diabetes Mellitus Cases

Modernizing Medical Standards for Non-Insulin Dependent Diabetes Mellitus Cases

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Overview of Proposed Rule

Under current regulations in 14 CFR part 67, an applicant for medical certification who has an established medical history or clinical diagnosis of diabetes mellitus (commonly referred to as diabetes) that requires insulin or any other hypoglycemic drug for control has a specifically disqualifying medical condition. These applicants must go through the FAA Authorization for Special Issuance of a Medical Certificate (hereafter referred to as "SI" process) under § 67.401, Special issuance of medical certificates. FAA proposes to amend §§ 67.113(a), 67.213(a), and 67.313(a), which provide the general medical standards for a first-class, second-class, or third-class airman medical certificate, to remove the phrase "or any other hypoglycemic drug" from these sections, thereby allowing persons with diabetes that can be controlled through the use of non-insulin medications who meet all other applicable medical qualifications to receive a medical certificate without having to go through the SI process.

Non-insulin dependent diabetes mellitus (NIDDM) is routinely managed by primary care physicians today using a variety of treatments that may include one or a combination of oral or injectable medication(s). The availability of numerous new diabetes medication classes and other non-insulin treatments has substantially improved disease management. Diabetes is now more effectively controlled, resulting in a reduction in severe complications, including cardiovascular events, hypoglycemia, and other adverse outcomes. This level of disease management did not exist when the current regulatory language was adopted in 1959 and through the many ensuing years.

This rulemaking would allow medical certificate applicants with NIDDM to be evaluated by an Aviation Medical Examiner (AME) instead of being deferred to FAA for consideration of an SI from the Federal Air Surgeon.

B. Summary of the Costs and Benefits

The proposed rule would replace the existing NIDDM certification process, which requires application deferral and FAA review for an SI, with a more efficient process under the general medical standards for applicants with NIDDM. The proposed rule would reduce NIDDM medical certification wait times and FAA processing time, resulting in cost savings to both industry and FAA. Processing all NIDDM cases via the SI process places a burden on applicants and FAA. Reducing time, steps, and number of people required to issue medical certificates in new or recertification cases would provide relief to airmen whose NIDDM is well controlled with approved treatments. Applicant wait times and FAA backlogs would lessen, assuming current resources remain available.

FAA estimates industry cost savings over five years, providing both low and high-case scenarios, based on cost savings per applicant and the estimated total number of applicants during that timeframe. In the low-case scenario, FAA estimates the proposed rule would save industry $39.70 million ($34.78 million at a seven percent discount rate, $37.43 million at a three percent discount rate) in labor hours during the period of analysis. In the high-case scenario, FAA estimates the proposed rule would save industry $80.19 million ($70.24 million at a seven percent discount rate, $75.60 million at a three percent discount rate) in labor hours during the period of analysis.

II. Authority for This Rulemaking

FAA's authority to issue rules on aviation safety is found in title 49 of the United States Code (49 U.S.C.). 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 issued under the authority described in subtitle VII, part A, subpart III, sections 44701, 44702, and 44703. Under section 44701, FAA is charged with prescribing regulations and minimum standards for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. Pursuant to 49 U.S.C. 44701(a)(5), the Administrator is required to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for cybersecurity and other, methods, and procedures the Administrator finds necessary for safety in air commerce and national security. Under sections 44702 and 44703, the Administrator may issue medical certificates to individuals who are 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 amend the regulations pertaining to airman medical standards and certification to allow applicants with NIDDM potentially to be issued unrestricted medical certificates after ensuring the individuals are qualified and physically able to perform the duties related to their medical certificate, but without the need to go through the SI process.

III. Background

A. Overview of Medical Certificate Process

FAA issues a medical certificate to an applicant who has met specific medical standards required to qualify for, or otherwise perform the duties related to, the applicant's position. There are three classes of medical certificates, each with different requirements and privileges with respect to pilots: first-class medical certificates are required for most airline transport pilots;  ⁽¹⁾ second-class medical certificates are required for most commercial pilots;  ^(2 3) and third-class medical certificates are required for private pilots, student pilots, and recreational pilots, as well as flight instructors and examiners under certain circumstances. ⁽⁴⁾ The duration of each class of medical certificate is determined by the age of the applicant on the date of the medical examination and the type of operation being conducted, as set forth in § 61.23(d).

The regulations governing medical standards and certification are contained in 14 CFR part 67, Medical standards and certification. Subparts B, C, and D of part 67 detail the medical eligibility requirements of first-, second-, and third-class medical certificates, respectively. These eligibility requirements include specific standards for vision, hearing, psychological, neurologic, and cardiovascular symptoms, including listing disqualifying conditions for each medical category. Sections 67.113, 67.213, and 67.313 provide the general medical standards that apply to other, unspecified medical conditions, and detail disqualifying conditions that do not fit into the other categories, including diabetes mellitus.

To obtain a medical certificate, an applicant without a specifically disqualifying medical condition described in subparts B, C, and D of part 67 (for first-class, second-class, and third-class medical certificates, respectively) must undergo a medical examination conducted by an FAA-authorized AME. An applicant who is found to meet the appropriate medical standards, based on the medical examination and an evaluation of the applicant's history and condition, is entitled to a medical certificate.

For applicants who are unable to meet the medical standards, such as those with a disqualifying condition like diabetes mellitus, the regulations provide for the ability to grant issuance of a certificate under § 67.401. ⁽⁵⁾ Section 67.401, Special issuance of medical certificates, details the ability of the Federal Air Surgeon to grant an Authorization for Special Issuance of a Medical Certificate or a Statement of Demonstrated Ability (SODA)  ⁽⁶⁾ to applicants who do not meet the provisions of subparts B, C, or D of part 67 if the person shows to the satisfaction of the Federal Air Surgeon that the duties authorized by the class of medical certificate applied for can be performed without endangering public safety.

B. Regulatory History of Diabetes Medical Standards

In 1959, the Federal Aviation Agency  ⁽⁷⁾ promulgated the standard to disqualify applicants for medical certificates who have an established history or clinical diagnosis of diabetes mellitus requiring insulin or other hypoglycemic drug for control. ⁽⁸⁾ For years after the standard was adopted, FAA did not provide any exemption or special issuances from the diabetes standard. FAA policy was that a medical history or diagnosis of diabetes was disqualifying for all classes of medical certification because of concerns about unpredictable hypoglycemia and the risk it posed to aviation safety.

Since then, however, FAA has incrementally updated the special issuance medical certification protocol for applicants with diabetes. In 1982, FAA published a final rule on special issuance of airman medical certificates. ⁽⁹⁾ In the discussion of that final rule, FAA explained that it would continue its existing policy of denying medical certification to individuals with diabetes, regardless of whether the condition was controlled with insulin or other hypoglycemic medications. FAA indicated, however, that if future medical advances should make certification possible, FAA would consider those factors in its review of medical standards.

Shortly after the 1982 final rule, FAA initiated a contract with the American Medical Association (AMA) to assist in a review of the medical standards for airmen and FAA's medical certification practices and procedures. The AMA presented its report (AMA report) on March 26, 1986, and FAA invited the public to comment in its announcement of that report. ⁽¹⁰⁾

In the late 1980s, FAA began to grant special issuance of medical certificates to individuals who controlled their diabetes with diet and oral hypoglycemic drugs. In 1994, FAA issued an NPRM  ⁽¹¹⁾ to revise a number of the medical standards in part 67 substantially based largely on the findings of the AMA report. In the discussion of that NPRM, FAA noted that "(t)he AMA report recommended that persons whose diabetes is adequately controlled with oral hypoglycemic drugs and who show evidence of stability and freedom from adverse effects be considered for medical certification with proper medical monitoring." In the final rule issued in 1996, ⁽¹²⁾ while no changes were made to the text of the diabetes standards, FAA formally adopted a policy of no longer categorically denying medical certification applications of persons with diabetes requiring oral hypoglycemic drugs. ⁽¹³⁾ Instead, as adopted in the final rule and continued under current regulations and procedures, applicants with NIDDM are issued medical certificates through the SI process.

IV. Discussion of the Proposed Rule

A. Removal of NIDDM as a Disqualifying Medical Condition

FAA proposes to no longer classify NIDDM as a specifically disqualifying medical condition under part 67. The proposed amendment would remove the phrase "or any other hypoglycemic drug" from §§ 67.113(a), 67.213(a), and 67.313(a). If finalized as proposed, this change would allow applicants with NIDDM to be potentially issued first-, second-, and third-class medical certificates by AMEs at the time of the medical examination, as opposed to deferral to FAA for the SI process required under current regulations.

Because NIDDM would no longer be a specifically disqualifying condition, NIDDM applicants would be evaluated under the general medical standards contained in paragraphs (b) and (c) of §§ 67.113, 67.213, and 67.313. Under these provisions, an NIDDM applicant may nonetheless be denied a medical certificate, on a case-by-case basis, if the Federal Air Surgeon or designated AME finds that the diabetes or non-insulin hypoglycemic treatment makes, or may reasonably be expected to make, the applicant unable to perform the duties or exercise the privileges of the airman certificate held or for which application has been sought safely.

Under the proposed amendment, §§ 67.113(a), 67.213(a), and 67.313(a) would continue to disqualify applicants with insulin-treated diabetes mellitus (ITDM) from receiving an unrestricted medical certificate at the time of examination. Applicants with ITDM would still be required to go through the SI process, and individual circumstances would determine what requirements the Federal Air Surgeon would put in place in terms of regular testing and monitoring, and the duration of any authorization issued.

B. Aviation Safety Impact

FAA conducted an analysis of fatal accidents involving airmen using non-insulin diabetes medications from 2008-2025. Data sources included the FAA ToxDB databases, which include both MANTRA and ToxFlo. ⁽¹⁴⁾ Fifty-one cases were found where non-insulin diabetes medications were reported. The Office of Aerospace Medicine examined the available records, including autopsy, toxicology, accident, and National Transportation Safety Board determinations, to determine the possibility of diabetes-related incapacitation in the accident. Of these, it was deemed improbable that diabetes, diabetes complications, or diabetes medications contributed to the accident in 50 cases. One case remains under investigation and, therefore, FAA could not make determinations on this case at this time.

Advancements in medical science have significantly reduced the risk associated with diabetic complications in those with NIDDM. Population-level data from the United States reveal dramatic improvements in complication rates among adults with diabetes between 1990 and 2010, with acute myocardial infarction rates declining by approximately two-thirds, and substantial reductions in stroke, lower extremity amputation, and death from hyperglycemic crisis. ⁽¹⁵⁾ The Steno-2 study demonstrated that multifactorial intervention targeting glycemic control, blood pressure, and lipids reduced both microvascular and macrovascular complications more effectively than glucose-lowering alone, which has become the cornerstone of modern diabetes management. ⁽¹⁶⁾ In addition, newer glucose-lowering agents have produced a paradigm shift in preventing cardiovascular and renal complications. Sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists reduce mortality and major cardiovascular events compared to usual care. ⁽¹⁷⁾ SGLT2 inhibitors specifically reduce progression to chronic kidney disease, heart failure hospitalizations, and severe hypoglycemia, while GLP-1 receptor agonists demonstrate particular efficacy in reducing stroke and achieving weight loss. ⁽¹⁸⁾

In addition to the risk reductions associated with medical advancements, the current SI process required for those with NIDDM presents a significant burden to medical professionals within FAA's Office of Aerospace Medicine who must devote time and resources to reviewing these lower-risk cases at the expense of more complex and potentially higher-risk cases. If this rule is finalized as proposed, FAA medical staff would be able to focus on these higher-risk cases and provide more expeditious review, reducing overall risk in the national airspace.

C. Medical Evaluation of NIDDM Cases

If this rule is finalized as proposed, NIDDM cases would be evaluated by an AME under paragraphs (b) and (c) of §§ 67.113, 67.213, and 67.313, the general medical standards, instead of by FAA medical personnel under the SI process. The applicant must have no other organic, functional, or structural disease or limitation nor any medication or treatment that the AME finds-based on the applicant's case history and appropriate, qualified medical judgment relating to the condition or treatment-makes, or may reasonably be expected to make, the applicant unable to perform the duties safely or exercise the privileges of the airman certificate sought. As such, while NIDDM would no longer be disqualifying specifically, an applicant with NIDDM must still undergo medical evaluation for the condition to ensure the applicant can safely perform his or her airman duties.

If this rule is finalized as proposed, FAA would notify the public and its AMEs of the regulatory change. Applicants currently pending review by FAA could choose to remain in the review process for their currently pending application or return to their AME and reinitiate the medical certificate application process.

Applicants with NIDDM would continue to provide their medical case history of NIDDM for evaluation, typically to include a clinical progress note, status report, or similar documentation from their treating physician, as well as an acceptable Hemoglobin A1C (A1C) test. NIDDM cases would be evaluated on a case-by-case basis by an AME to determine an applicant's medical qualification. The AME would consider multiple factors, such as the stability of the applicant's diabetes mellitus, any recommendations made by the treating physician, and the types of medication or treatment being used. Notwithstanding the proposed rule, in higher-risk NIDDM cases, the AME may still defer the applicant to FAA medical personnel for further evaluation and, if the applicant is ultimately determined to be medically fit, issuance of an unrestricted or limited medical certificate using the established SI process. Deferral to FAA would be appropriate, for example, in NIDDM cases involving recent episodes of clinical hypoglycemia requiring intervention, medication side effects that could potentially interfere with the performance of airman duties, evidence of any diabetes-induced end organ disease, or high A1C levels.

D. Cost Savings and Burden Reduction

Cost savings are expected upon finalization of this proposal. FAA estimates that allowing AMEs to evaluate applicants with controlled NIDDM using the general medical standards in paragraphs (b) and (c) of §§ 67.113, 67.213, and 67.313 would potentially enable them to issue medical certificates at the time of the applicant medical exam in roughly 3,000 cases annually. Therefore, about 3,000 applicants would receive their medical certificates much more quickly each year because their cases would avoid the current time-consuming AME-deferral to FAA. The proposed change would also allow an estimated 1,200 total cases currently followed under SI to be transitioned, so that AMEs-rather than FAA-would be able to handle recertification. As of September 2025, 1,300 initial applications are in the specific FAA Medical Appeals queue for review. Of these, 300 would potentially qualify for AME-issuance under the general medical standards that would be allowed if this rule is finalized as proposed. Approximately 50 percent of these cases are applicants for first- or second-class medical certificates. For the recertification cases currently awaiting the same FAA review, approximately 1,200 applicants (about 75 percent are applying for a first- or second-class medical certificate) would potentially qualify for AME issuance rather than FAA review under the proposed change.

V. Regulatory Notices and Analyses

A. Regulatory Impact Analysis (RIA)

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 (OMB) has determined this proposed rule is not a significant regulatory action as defined in section (3)(f) of E.O. 12866. In conducting this analysis, FAA has determined the proposed rule has benefits that justify its costs.

1. Baseline and Population

The existing regulatory framework and practices for prospective applicants with NIDDM constitute the baseline for this analysis. Current airmen with NIDDM or those with NIDDM seeking a medical certification would be impacted. In addition, all applicants with deferred medical applications under review for SI would have faster processing times. FAA uses a five-year period of analysis for the proposed rule. Five years encompasses the longest period a medical certification remains valid before needing re-certification. ⁽¹⁹⁾ Therefore, the analysis period encompasses at least one cycle of initial and recurrent costs for all active pilots initially certificated under an SI within or prior to year zero. ⁽²⁰⁾

FAA used internal data and airman growth rates to estimate the number of initial and recurrent medical certifications for affected airmen with NIDDM and all deferred applicants throughout the five-year period of analysis. FAA estimated the number of certifications and the share of certifications by class of medical certificate using internal data, and FAA estimated the annual growth rate in first-, second-, and third-class pilot medical certifications using the growth in active pilot certificates from 2015 to 2024. ⁽²¹⁾ Table 1 displays FAA's growth rate and certification assumptions by pilot class.

Using growth rate and historical certification data, FAA estimates there would be 44,176 unrestricted NIDDM certifications (7,595 initial and 36,581 recurrent) and 169,085 Authorizations for SI (49,967 initial and 119,118 recurrent) in the analysis period. The estimated initial and recurrent NIDDM certifications include only applicants with NIDDM who would be issued an unrestricted medical certificate after FAA examination under the proposed rule. All applicants with NIDDM who would not receive an unrestricted medical certificate after FAA review are estimated within Authorization for SI projections. Table 2 displays the estimated initial and recurrent unrestricted NIDDM certifications, and Table 3 displays the initial and recurrent SI Authorizations throughout the analysis period. ⁽²²⁾

2. Costs

FAA does not anticipate any new costs from the proposed rule's changes to the NIDDM medical certification. To receive a medical certificate, a prospective applicant with NIDDM currently provides (1) a "Diabetes or Hyperglycemia on Oral Medications Status Report" or a clinical progress note from their treating physician and (2) an A1C test performed no more than 90 days prior to their AME exam. ⁽²³⁾ For recertifications, applicants with NIDDM provide (1) an Authorization for SI granted by FAA and (2) a "Diabetes or Hyperglycemia on Oral Medications Status Report" or a current status report (including an A1C test) from their

treating physician. ⁽²⁴⁾ FAA anticipates the proposed process would not impose any new cost burdens to applicants with NIDDM relative to the existing application process. Applicants would provide the same or similar documentation to their AME for review.

FAA does not anticipate any additional risk from streamlining the NIDDM medical certification process. In an analysis of 51 fatal accidents from 2008 to 2025 in which the use of NIDDM medications was identified, FAA deemed it improbable that diabetes, diabetes complications, or diabetes medications contributed to the accident in 50 cases. One case remains under investigation. In addition, advancements in medical technology have reduced the risk associated with diabetic complications in those with NIDDM. Under the proposed rule, applicants with NIDDM would be evaluated by an AME for stability and control similar to what is currently performed for such deferred applications. The proposed process does not incur an additional cost to initial or recurrent medical certification for applicants with NIDDM, and FAA does not anticipate new safety risks from the streamlining of the NIDDM certification process.

i. Industry Cost Savings

Transitioning a portion of medical certification applications from the special issuance process to the proposed process would reduce initial certification delays for airmen with NIDDM and airmen requiring an SI Authorization. FAA estimates initial applications deferred for an SI Authorization currently take an average of 64 days for FAA to process. ⁽²⁵⁾ Pilots cannot perform flight duties during this processing time, resulting in a cost to both pilots and industry in lost labor hours. The proposed rule's process would significantly reduce processing delays for pilots with NIDDM. FAA would also receive fewer deferred applications, leading to faster processing for all deferred applicants.

FAA estimates the reduction in lost flight hours from processing delays to estimate pilots' and industry cost savings because of the proposed rule. Using Bureau of Labor Statistics data, FAA estimates the fully-loaded hourly wage of a pilot holding a first-class medical certificate is $108.85, and the fully-loaded hourly wage of a pilot holding a second-class medical certificate is $58.93. ⁽²⁶⁾ To estimate the lost labor hours recovered for both initial applicants with NIDDM who would be eligible for an unrestricted medical certificate and all deferred initial applicants because of the proposed rule, FAA estimates the per-applicant reduction in medical certification delays. FAA assumes that a pilot with NIDDM who would be eligible for an unrestricted medical certificate under the proposed rule will see a 64-day (2.10 month) reduction in certification delays. For all deferred initial applicants, FAA estimates the reduction in delays based upon the reduction in total deferred application backlogs. Based upon internal FAA data, 15.2 percent of the current deferred applicant backlog would transition to the proposed rule's NIDDM unrestricted medical certification process. A 15.2 percent reduction in the 64-day certification delay would result in a 10-day (0.33 month) reduction in processing delays for all other applicants in FAA's deferred backlog.

Reducing these processing delays would shorten a pilot's grounded time and, therefore, recover flight hours for pilots with NIDDM who would be eligible for an unrestricted medical certificate and all deferred applicants. FAA estimates the average pilot holding a first- or second-class medical certificate flies 75 hours monthly based upon BLS's estimation of monthly flight hours for airline pilots. ⁽²⁷⁾ FAA anticipates that, while a pilot is grounded because of a deferred application, a pilot could take on additional non-flying labor activities to offset lost labor hours. Based upon this inference, FAA created a low-case and high-case estimation of the number of flight hours reclaimed. In the low-case scenario, FAA assumes that half of a pilot's lost flight hours are replaced with additional non-flying labor hours when grounded. In the high-case scenario, FAA assumes that none of a pilot's lost flight hours are replaced with additional non-flying labor hours when grounded. FAA requests comment on how certification delays impact pilot labor hours, including what labor activities pilots undertake while grounded and the low-case and high-case labor hour assumptions. Table 4 displays the low-case and high-case labor hour scenarios.

FAA uses these estimated delay reductions, pilot wages, and monthly flight hours to estimate the cost savings per application in both the low-case and high-case scenario. Table 5 displays the calculations used to estimate per-applicant cost savings in both scenarios.

FAA estimates the industry low-case and high-case cost savings from per-applicant cost savings and total number of estimated applicants throughout the period of analysis. In the low-case scenario, FAA estimates the proposed rule would save industry $38.87 million ($34.05 million at a seven percent discount rate, $36.64 million at a three percent discount rate) in labor hours during the period of analysis. In the high-case scenario, FAA estimates the proposed rule would save industry $79.36 million ($69.51 million at a seven percent discount rate, $74.81 million at a three percent discount rate) in labor hours during the period of analysis. Table 6 displays the estimated low-case industry cost savings, and Table 7 displays the high-case industry cost savings.

ii. FAA Cost Savings

FAA estimates the proposed certification process would reduce FAA labor hours spent processing NIDDM applications. Currently, an AME must defer all initial and recurrent NIDDM applications. These applications then go to an FAA Legal Instruments Examiner for processing. FAA estimates it takes 15 minutes for a Legal Instruments Examiner to process an NIDDM application. In approximately 10 percent of NIDDM applications, the Legal Instruments Examiner defers the application to an FAA Physician who spends an additional 15 minutes processing that NIDDM application for authorization of a special issuance. Based upon the fully-loaded hourly wage for Legal Instruments Examiners and Physicians, ⁽²⁸⁾ FAA estimates NIDDM applications incur an $18.91 processing cost. Table 8 displays the wage and labor hours used to calculate the per-unit processing cost.

Through the proposed rule's certification process, FAA would avoid all Legal Instruments Examiner and Physician processing costs for NIDDM applications issued an unrestricted medical certificate. FAA estimates the proposed rule would save the Agency $835,366 ($730,488 at a seven percent discount rate, $786,906 at a three percent discount rate) in labor hours throughout the period of analysis. Table 9 displays the estimated FAA cost savings.

iii. Unquantified Cost Savings

FAA did not quantify the cost savings from reduced third-class medical certificate processing delays or from non-pilot second-class medical certificate processing delays. Private, student, and recreational pilots must generally have a third-class medical certificate. As with pilots holding or applying for first- and second-class medical certificates, pilots holding or applying for third-class medical certificates would receive their NIDDM medical certification and deferred application review faster, resulting in reclaimed flight hours. Pilots with a third-class medical certificate could experience cost savings from private, student, or recreational operations. However, private, student, and recreational activities are difficult to quantify and monetize. FAA requests comment on the proposed rule's cost savings impact on affected pilots applying for a third-class medical certificate. The impacts of the proposed rule were not quantified for flight engineers, flight navigators, and certain air traffic control tower operators due to the small size of these populations. Although this can provide a cost saving, FAA has not quantified the cost savings for pilots with third-class medical certificates or for non-pilots with second-class medical certificates from faster processing under the proposed rule.

3. Benefits

FAA has not quantified the estimated benefit of an increase in NIDDM pilot applications. The proposed rule may entice more prospective applicants with NIDDM to acquire a pilot certificate through the simplified medical certification process under the general medical standards. An increase in the number of prospective pilots would be a benefit to both prospective pilots and to air carriers seeking to hire new pilots. An influx of pilots would allow air carriers to expand service opportunities and offerings, while prospective pilots themselves could gain benefits through the salary and benefits of a pilot career. However, FAA has not quantified the number of prospective pilots who would acquire a certificate because of the proposed rule. FAA requests comment on the quantitative and qualitative impacts the proposed rule would have on certificate applications received from prospective pilots with NIDDM.

4. Summary

The proposed rule would replace the existing medical certification process, which requires deferral and review for authorization of a special issuance, with a more efficient certification process for airmen with NIDDM. The revised process would provide cost savings for both FAA and industry by reducing FAA processing time for unrestricted NIDDM pilot medical certifications and eliminating delays for pilots with NIDDM to receive their medical certifications. It would also decrease the processing time for deferred applications by reducing the total deferred application backlog. Table 10 below provides a summary of the annual and total cost savings to both industry operators and FAA.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) of 1980, (Pub. L. 96-354) (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.

FAA used the definition of small entities in the RFA for this analysis. The RFA defines small entities as small businesses, small governmental jurisdictions, or small organizations. In 5 U.S.C. 601(3), the RFA defines "small business" to have the same meaning as "small business concern" under section 3 of the Small Business Act. The Small Business Act authorizes the Small Business Administration (SBA) to define "small business" by issuing regulations. SBA (2023) has established size standards for various types of economic activities, or industries under the North American Industry Classification System (NAICS). These size standards generally define small businesses based on the number of employees or annual receipts.

There are ten affected NAICS codes for air transportation services based on the type of activity conducted. Table 11 shows the SBA size standards for these transportation activities. Note that the SBA definition of a small business applies to the parent company and all affiliates as a single entity.

To identify small entities impacted by the proposed rule, FAA analyzed data from various sources, including company annual reports and the Bureau of Transportation Statistics. Of the 4,840 total entities identified, FAA concludes the majority are small. The small entities include approximately 32 of 56 part 121 operators (NAICS codes 481111 and 481112), the majority of the 525 part 141 flight schools, and the majority of the 45 part 142 training centers (NAICS code 611512). Although the proposed rule also impacts four air traffic control (NAICS code 488111) entities, FAA estimates only one is a small business. The remaining affected entities are either part 135, part 91, or part 137 operators (NAICS codes 481211, 481219, 487990, 115112, 541370, and 488190). There were approximately 1,750 part 135 operators, 900 part 91 operators, and 1,560 part 137 (crop dusting) operators at the time of this proposed rule. FAA infers that most of these 4,210 operators are small. Therefore, FAA has determined that this proposed rule would impact a substantial number of small entities.

Although a substantial number of small entities would be affected by the proposed rule, it would not have a significant impact. Affected entities, including small entities, would experience cost savings from a more streamlined certification process for some applicants with NIDDM. Therefore, FAA certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

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, that they be the basis for U.S. standards.

FAA has assessed the potential effect of this proposed rule and 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.

D. Unfunded Mandates Assessment

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 $187,000,000 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.

E. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires FAA to consider the impact of paperwork and other information collection burdens imposed on the public. Although the process of applying for an FAA medical certificate does involve an information collection, the proposed rule will not affect that process for individual applicants.

All applicants for an FAA medical certificate are currently required to complete a form 8500-8 using the FAA MedXPress system. ⁽²⁹⁾ The applicant's submitted information is made available to the selected AME at the time of the required medical examination. The proposed rule would only remove the need to request an SI and would have no impact on the requirement for applicants to complete form 8500-8, and there would be no change in individual information collection burden as a result of this proposed rule.

F. International Compatibility

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. ICAO publishes medical standards regarding diabetes in Annex 1, Personnel Licensing. These standards are less strict than current FAA regulatory requirements. Adjustments to existing differences filed with ICAO would be needed to reflect the proposed change, once implemented. The proposed change would bring FAA closer into alignment with ICAO standards and will provide a path to manage the risk associated with issuing medical certificates to airmen with non-insulin-dependent diabetes into the future, as medical technologies affecting diagnosis and treatment continue to evolve.

G. Environmental Analysis

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. ⁽³⁰⁾ 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 environmental impact statement (EIS). ⁽³¹⁾ 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. ⁽³²⁾ This rulemaking, which proposes to amend FAA regulations regarding the issuance of medical certificates to applicants with NIDDM, 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.

VI. Executive Order Determinations

A. Executive Order 13132, Federalism

FAA has analyzed this proposed rule under the principles and criteria of E.O. 13132, Federalism. FAA has determined this action would 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, would not have federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy Supply, Distribution, or Use

FAA analyzed this proposed rule under E.O. 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use. FAA has determined it would not be a "significant energy action" under the Executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.

C. Executive Order 13609, Promoting International Regulatory Cooperation

E.O. 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 E.O. 13609 and has determined that no action is required under this E.O., and that the proposed rule would bring FAA into closer alignment with ICAO.

D. Executive Order 14192, Unleashing Prosperity Through Deregulation

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

VII. Additional Information

A. Comments Invited

FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. FAA also invites comments relating to the 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.

B. Confidential Business Information

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 which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

C. Electronic Access and Filing

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 proposed rule, including economic analyses and technical reports, may be accessed in the electronic docket for this rulemaking.

D. Small Business Regulatory Enforcement Fairness Act

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/.

The Proposed Amendment

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

PART 67-MEDICAL STANDARDS AND CERTIFICATION

* * * * *

(a) No established medical history or clinical diagnosis of diabetes mellitus that requires insulin for control.

* * * * *

* * * * *

(a) No established medical history or clinical diagnosis of diabetes mellitus that requires insulin for control.

* * * * *

* * * * *

(a) No established medical history or clinical diagnosis of diabetes mellitus that requires insulin for control.

* * * * *

[FR Doc. 2026-18162 Filed 9-3-26; 8:45 am]

BILLING CODE 4910-13-P

⁽¹⁾  Specifically, a first-class medical certificate is required when exercising pilot-in-command privileges of an airline transport pilot (ATP) certificate; when exercising second-in-command privileges of an ATP certificate in a flag or supplemental operation under 14 CFR part 121 that requires three or more pilots; or when serving as a required pilot in a part 121 operation if the pilot is 60 years or older. See § 61.23(a)(1).

⁽²⁾  Specifically, a person must hold at least a second-class medical certificate: when exercising second-in-command privileges of an ATP certificate in part 121 operations other than in a flag or supplemental operation that requires three or more pilots; when exercising the privileges of a commercial pilot certificate in an aircraft other than a balloon or glider; or when exercising the privileges of a commercial pilot certificate with a balloon class rating, except if the person is providing flight training in a balloon in accordance with § 61.133(a)(2)(ii). See § 61.23(a)(2).

⁽³⁾  In addition to pilots, FAA notes that flight engineers, flight navigators, and certain air traffic control tower operators are required to obtain a second-class medical certificate pursuant to 14 CFR 63.31(c), 63.51(c), and 65.31(c), respectively. The changes proposed in this rule would apply equally to medical certificates issued to flight engineers, flight navigators, and certain air traffic control tower operators as they would to pilots.

⁽⁴⁾  Specifically a person must hold at least a third-class medical certificate: when exercising the privileges of a private pilot certificate, recreational pilot certificate, or student pilot certificate, except when operating under the conditions and limitations of BasicMed; when exercising the privileges of a flight instructor certificate and acting as the pilot in command or as a required flightcrew member, except when operating under the conditions and limitations of BasicMed; when taking a practical test in an aircraft for a recreational pilot, private pilot, commercial pilot, or airline transport pilot certificate, or for a flight instructor certificate, except when operating under the conditions and limitations of BasicMed; or when performing the duties as an Examiner in an aircraft when administering a practical test or proficiency check for an airman certificate, rating, or authorization, except when meeting the requirements to operate under the conditions and limitations of BasicMed. See § 61.23(a)(3).

⁽⁵⁾ See §§ 67.115, 67.215, and 67.315.

⁽⁶⁾  The primary difference between an SI and a SODA is that an SI is valid for a period set by the Federal Air Surgeon based on the conditions of the SI while a SODA has no expiration date. SODAs are generally issued to an applicant whose disqualifying condition is static or nonprogressive and who has been found capable of performing airman duties without endangering public safety.

⁽⁷⁾  From its inception in 1958 through 1967, FAA was known as the Federal Aviation Agency.

⁽⁸⁾ Amendment of Medical Standards, 24 FR 7309 (Sep. 11, 1959).

⁽⁹⁾ Special Issuance of Airman Medical Certificates and Revision of Cardiovascular and Alcoholism Standards final rule, 47 FR 16298 (Apr. 15, 1982).

⁽¹⁰⁾ Review of Medical Standards and Certification Procedures; Availability of Report and Request for Comments notice, 51 FR 19040 (May 23, 1986).

⁽¹¹⁾ Revision of Airman Medical Standards and Certification Procedures and Duration of Medical Certificates NPRM, 59 FR 53226 (Oct. 21, 1994).

⁽¹²⁾ Revision of Airman Medical Standards and Certification Procedures and Duration of Medical Certificates final rule, 61 FR 11238 (Mar. 19, 1996).

⁽¹³⁾  In 1996, FAA issued a policy statement regarding the issuance of third-class airmen medical certificates to applicants with insulin-treated diabetes mellitus (ITDM) ( Special Issuance of Third-Class Airman Medical Certificates to Insulin-Treated Diabetic Airman Applicants, 61 FR 59282, Nov. 21, 1996). In that policy statement, FAA determined selected individuals with ITDM could be considered for special issuance of a third-class airman medical certificate under certain conditions and monitoring protocols. In 2019, FAA announced that it would also issue first and second-class certificates to pilots with ITDM under the special issuance process ( Special-Issuance Medical Certification: Diabetes Protocol for Applicants Seeking to Exercise Airline Transport, Commercial, or Private Pilot Privileges, 84 FR 60137, Nov. 7, 2019). This proposed rule would only extend to applicants with NIDDM, and applicants with ITDM would continue to be required to utilize the special issuance process.

⁽¹⁴⁾  The FAA ToxDB databases are internal data sources used by FAA as part of its accident investigation responsibilities and are not available to the public. More information can be found at https://www.transportation.gov/individuals/privacy/toxicology-database-toxdb.

⁽¹⁵⁾  Gregg, E.W., et al., Changes in diabetes-related complications in the United States, 1990-2010, N Engl J Med., 370(16): 1514-23 (Apr. 17, 2014).

⁽¹⁶⁾  Ahmad, E., et al., Type 2 diabetes, Lancet, 400(10365): 1803-1820 (Nov. 19, 2022).

⁽¹⁷⁾  Drake, T., et al., Newer Pharmacologic Treatments in Adults With Type 2 Diabetes: A Systematic Review and Network Meta-analysis for the American College of Physicians, Ann Intern Med., 177(5): 618-632 (May 2024).

⁽¹⁸⁾  Management of Type 2 Diabetes Mellitus Work Group, VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF TYPE 2 DIABETES MELLITUS (2023), Available at: https://www.healthquality.va.gov/HEALTHQUALITY/guidelines/CD/diabetes/VADOD-Diabetes-CPG_Final_508.pdf (last accessed Sep. 1, 2026).

⁽¹⁹⁾ See § 61.23(d).

⁽²⁰⁾  FAA notes that, while flight engineers, flight navigators, and certain air traffic control tower operators are required to obtain at least a second-class medical certificate, FAA considered only pilots for this analysis because the volume of non-pilot certificates is small and would not significantly impact the proposed rule's analysis. In 2024, for example, 0.8 percent of new second-class medical certificates issued were for non-pilot positions (See: U.S. Civil Airmen Statistics, Table 17, available at: https://www.faa.gov/media/90441.

⁽²¹⁾ 2024 Active Civil Airmen Statistics, FAA (2025), available at: https://www.faa.gov/data_research/aviation_data_statistics/civil_airmen_statistics.

⁽²²⁾  Pilots are not impacted by the same deferred certification process upon recertification, and the recertification process does not impact pilot cost savings. However, FAA will experience cost savings when reviewing pilot recertifications, regardless of pilot class. Therefore, FAA estimated the number of recertifications but did not separate these recertifications by pilot class.

⁽²³⁾ Guide for Aviation Medical Examiners: Protocol for Diabetes Mellitus Treated with Any Medication Other Than Insulin, FAA (2025), available at: https://www.faa.gov/ame_guide/dec_cons/disease_prot/diabetes_med.

⁽²⁴⁾ Guide for Aviation Medical Examiners: Special Issuances AME Assisted-All Classes-Diabetes Mellitus-Type II, Medication Controlled (Not Insulin), FAA (2025), https://www.faa.gov/ame_guide/special_iss/all_classes/diabetes.

⁽²⁵⁾  Special Issuance recertifications can be processed by an AME, resulting in zero grounding time. However, FAA Legal Instruments Examiners and Physicians still review and verify recertifications.

⁽²⁶⁾  Based upon Bureau of Labor Statistics (BLS) data, a pilot with an airline transport pilot certificate and a first-class medical certificate has a median salary of $226,600 annually; a pilot holding a commercial certificate and a second-class medical certificate has a median salary of $122,670 annually; and both pilot classes work approximately 2,700 labor hours annually (900 flight hours and 1,800 non-flight hours) (See: Airline and Commercial Pilots, BLS OOH (2025), available at: https://www.bls.gov/ooh/transportation-and-material-moving/airline-and-commercial-pilots.htm ). BLS also estimated the fringe benefit factor for a private industry worker is 1.297 (See: Employer Costs for Employee Compensation, BLS (June 2024), available at: https://www.bls.gov/news.release/archives/ecec_09102024.pdf ). FAA multiplied the median salaries by the fringe benefit factor and divided the fully-loaded salaries by 2,700 labor hours.

⁽²⁷⁾ Airline and Commercial Pilots, BLS OOH (2025), available at: https://www.bls.gov/ooh/transportation-and-material-moving/airline-and-commercial-pilots.htm.

⁽²⁸⁾  To estimate the fully-loaded labor hours of a Legal Instruments Examiners and Physicians, FAA used the average salary of an FAA employee located in the "rest of the U.S." locality (an H-band salary for Examiners and an M-band salary for Physicians) (See: Pay & Benefits, FAA (2025), available at: https://www.faa.gov/jobs/working_here/benefits ) and multiplied that salary by a fringe benefit cost factor of 1.3625. A fringe benefit factor estimates the additional monetary benefits, such as healthcare and retirement benefits (See: OMB Memo M-08-13 ). Lastly, FAA estimated the hourly wage for by dividing the annual salary by 2,080 annual labor hours.

⁽²⁹⁾  This information collection has been approved by the OMB under OMB Control Number 2120-0036.

⁽³⁰⁾  90 FR 29615 (Jul. 3, 2025).

⁽³¹⁾ See DOT Order 5610.1D § 9.

⁽³²⁾  Id. § 9(b).