National Oceanic and Atmospheric Administration
Ocean Energy Management Bureau
Drug Enforcement Administration
Copyright Office, Library of Congress
Federal Aviation Administration
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Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective February 5, 2026. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 5, 2026.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, visit
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Rune Duke, Manager (Acting), Standards Section, Flight Procedures and Airspace Group, Aviation Safety, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., STB Annex, Bldg. 26, Room 217, Oklahoma City, OK 73099. Telephone (405) 954-1139.
This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective February 5, 2026. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 5, 2026.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30. 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Rune Duke, Manager (Acting), Standards Section, Flight Procedures and Airspace Group, Aviation Safety, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., STB Annex, Bldg. 26, Room 217, Oklahoma City, OK 73099. Telephone (405) 954-1139.
This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA Forms are 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this 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 Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Drug Enforcement Administration, Department of Justice.
Final rule.
The “Protecting Patient Access to Emergency Medications Act of 2017,” (the Act) which became law on November 17, 2017, amended the Controlled Substances Act (CSA) to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration is publishing this final rule to conform its regulations to the statutory amendments of the CSA and to otherwise implement its requirements. This final rule adopts, with minor modifications, the notice of proposed rulemaking published on October 5, 2020.
This rule is effective March 9, 2026.
Heather E. Achbach, Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 776-3882.
On November 17, 2017, the “Protecting Patient Access to Emergency Medications Act of 2017,” Public Law 115-83 (131 Stat. 1267) (the Act), became law.
The Act amended a section of the CSA, 21 U.S.C. 823, by adding a new subsection, 21 U.S.C. 823(k). This new subsection alters a number of CSA requirements “[f]or the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services.” 21 U.S.C. 823(k)(1). The Act also specifically authorizes the Attorney General (and thus the Administrator of the Drug Enforcement Administration (DEA) by delegation)
The purposes of this final rule are two-fold. First, this final rule codifies, in DEA regulations, the statutory amendments made by the Act, conforming DEA's implementing regulations to statutory amendments of the CSA that have already taken effect. Second, this final rule makes limited additional changes that are authorized by the CSA, as amended by the Act, and to further implement the Act and effectuate its purposes.
When an individual experiences a medical emergency, the entry into the healthcare system may not start with the care of a physician within a traditional clinical setting, but instead with the intervention of emergency medical services (EMS) personnel affiliated with a local EMS agency at the incident site. EMS personnel, who provide emergency medical services by ground, air, or otherwise, respond to 60 million calls in 2024. EMS involves the evaluation and management of patients with acute traumatic and medical conditions in a prehospital environment,
The delivery of emergency medical care is primarily a local function; and, accordingly, a wide variety of organizational structures are utilized across the nation. EMS programs may be a part of the local municipal government, hospital, or independent government agency, or may be contracted by local government with a private entity. Each State has a State EMS licensing office that is responsible for the overall planning, coordination, and regulation of the State EMS system, as well as licensing or certifying EMS providers and ambulances.
The Act established uniform EMS agency requirements for the administration of controlled substances while ensuring adequate safeguards against theft and diversion. The Act added a new subsection to the CSA, 21 U.S.C. 823(k). The new 21 U.S.C. 823(k) makes several notable changes to the CSA.
First, the Act creates a new registration category under the CSA for EMS agencies, directing the Attorney General (and thus the Administrator of DEA by delegation) to register such an agency under the CSA if the agency submits an application demonstrating that it is authorized to conduct emergency medical services under the laws of each State in which the agency practices. 21 U.S.C. 823(k)(1)(A). Pursuant to 21 U.S.C. 823(k)(1)(B), the Act authorizes the Attorney General to deny the application of an EMS agency if registering it is inconsistent with other requirements of 21 U.S.C. 823(k) or with the public interest based on the factors of 21 U.S.C. 823(g).
Second, the Act directs the Attorney General (and thus the Administrator) to allow a registered EMS agency to obtain a single registration for each State in which the EMS agency administers controlled substances, rather than requiring the agency to obtain a separate registration for each location at which it operates within that State. 21 U.S.C. 823(k)(2). The Act also provides that a hospital-based emergency medical services agency registered under 21 U.S.C. 823(g) may use the registration of the hospital to administer controlled substances under 21 U.S.C. 823(k), without requiring the agency to acquire a separate registration. 21 U.S.C. 823(k)(3).
Third, subject to certain restrictions, the Act authorizes EMS professionals of a registered EMS agency to administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional while providing emergency medical services. 21 U.S.C. 823(k)(4). EMS professionals are only allowed to make such administrations if authorized by State law and pursuant to standing or verbal orders that satisfy a number of statutory conditions.
Fourth, the Act provides a variety of requirements for how registered EMS agencies must deliver controlled substances from registered to unregistered locations, store controlled substances, restock EMS vehicles at a hospital, maintain records, and otherwise conduct their operations. 21 U.S.C. 823(k)(5)-(10).
Fifth, the Act specifically authorizes the Attorney General (and thus the Administrator) to issue regulations regarding the delivery and storage of controlled substances by EMS agencies.
DEA published a notice of proposed rulemaking (NPRM) in the
DEA received eighty-one comments in response to the publication of the NPRM. The commenters included EMS medical directors, physicians, medical associations, and members of the general public. DEA thanks all commenters for their comments and appreciates the input received during the rulemaking process. While the majority of the commenters expressed support for various provisions in the proposed rule, some commenters offered only partial support for the rule—agreeing with the general purpose of the rule, but disagreeing with particular provisions. Several commenters also disagreed with the proposed changes entirely, and two comments were entirely outside the scope of the rule. These comments and suggested changes to the rule, along with DEA's responses, are further described below.
In the proposed rule, DEA sought to fulfill this purpose by limiting designated locations to “stationhouses” and defining stationhouses as enclosed structures housing EMS agency vehicles within the State of the emergency medical services agency's registration, and which are actively and primarily being used for emergency response. By limiting designated locations to those clearly being used by EMS personnel to house and resupply EMS vehicles, the proposed rule sought to reduce the opportunities for controlled substances to be stolen by non-EMS personnel or mislaid. Through such limitations, the proposed rule also sought to ensure that designated locations would be readily identifiable to DEA investigators.
Commenters, however, have identified several situations in which EMS agency facilities may be used clearly and primarily for official EMS purposes—generally fulfilling purposes of the proposed rule's limitations—but not actually “house” associated EMS vehicles. Such purposes include but are not limited to the storage of medical supplies, controlled substances, and equipment; staff training and education; and administrative functions essential to EMS operations. The commenters were concerned with defining a “stationhouse” strictly as a brick-and-mortar structure that houses EMS vehicles. The commenters expressed concern that a narrow definition could inadvertently limit the operational flexibility of EMS agencies, particularly in scenarios where EMS operations are conducted from multiple locations.
In response to these concerns, in this final rule, DEA is amending the definition of “stationhouse” by removing the requirement that a stationhouse must house an EMS vehicle, removing the phrase “for emergency response,” and adding the phrase “at its premises” to accommodate locations where EMS vehicles are not housed or stored indoors. These revisions aim to acknowledge the unique operational demands of EMS agencies and ensure that this rule supports the efficient and effective delivery of emergency medical services. Specifically, the definition of stationhouse is revised to mean an enclosed structure within a State where the emergency medical services agency is registered, which may house EMS vehicles at its premises, and which is actively and primarily being used by that emergency medical services agency. DEA acknowledges the concerns raised about the limitations of the stationhouse definition and recognizes that it is important for EMS agencies to have the flexibility they need to effectively serve their communities. DEA's revised definition of stationhouse addresses the concerns raised and supports how EMS agencies treat patients and provides greater flexibility for EMS agencies to operate.
In response to the commenters' concern that EMS agency facilities may at times be used primarily for various operational EMS purposes, but not actually “house” associated EMS vehicles, DEA removed the requirement that a stationhouse must house an EMS vehicle from the stationhouse definition. DEA also removed the phrase “for emergency response” from the stationhouse definition in response to the comments received. DEA removed this phrase because in addition to housing EMS vehicles, stationhouses may also be used for various non-emergency EMS activities such as the storage of medical supplies, controlled substances, and equipment; staff training and education; and administrative functions essential to EMS operations. These regulatory changes provide EMS agencies with greater flexibility in fulfilling the operational activities involved in managing emergency medical services and response efforts. For this reason, DEA is removing the requirement that a stationhouse must house an EMS vehicle and removed the phrase “for emergency response” from the stationhouse definition. Thus, an EMS agency may house an EMS vehicle at a stationhouse, however it is not required. Additionally, although DEA has removed the phrase “for emergency response,” DEA is retaining the requirement that a stationhouse must actively and primarily be used by the emergency medical services agency. This would preclude, for example, an apartment or residence from being designated as a stationhouse.
Further, the addition of the phrase “at its premises” to accommodate locations where EMS vehicles are not housed or stored indoors, allows flexibility for an EMS agency to house a vehicle outside of an enclosed registered or designated location. The primary goal for this regulatory change is to provide EMS agencies with the necessary flexibility to effectively serve the public. EMS agencies play a critical role in responding to emergencies and providing life-saving medical care. However, the housing of EMS vehicles inside of a structure posed challenges for EMS agencies, particularly those with larger vehicles and limited space. By allowing EMS vehicles to be housed at the premises of an enclosed structure, but not necessarily within the structure itself, the regulatory changes ensure that agencies can maintain their vehicles in a manner that best suits their operational needs. While an EMS vehicle may be parked outside of a stationhouse, for security purposes, if it stores controlled substances it must be locked, with the controlled substances stored in a securely locked, substantially constructed cabinet or safe that cannot be readily removed.
While emphasizing the need for flexibility, DEA remains diligent in its commitment to preventing diversion and misuse of controlled substances. As such, for security purposes and diversion safeguards, an enclosed structure is necessary to securely store controlled substances at a stationhouse or designated location, if those controlled substances are being stored in the stationhouse or designated location, but not in an EMS vehicle. An enclosed structure is also required to maintain records, ensuring that these items are protected against unauthorized access and potential diversion. The regulatory changes are designed to create a balance between flexibility and diversion safeguards. For instance, although EMS vehicles may now be housed or stored at the premises of an enclosed structure, safeguards are in place to ensure the security of controlled substances. Specifically, EMS vehicles storing controlled substances must be locked when parked outside of an enclosed registered or designated location, with the controlled substances stored in a securely locked, substantially constructed cabinet or safe that cannot be readily removed. This measure mitigates the risk of diversion by ensuring that controlled substances are inaccessible to unauthorized individuals.
The regulatory changes are also driven by a commitment to public health and safety. DEA recognizes that EMS agencies often operate in dynamic and unpredictable environments where rapid emergency response is essential. By providing EMS agencies with greater flexibility in how they house their vehicles, the regulatory changes enable them to respond more effectively to emergencies, potentially saving lives in the process. This public health benefit must be weighed against the risk of diversion, and the regulatory changes are designed to strike an appropriate balance between these considerations.
Additionally, DEA is issuing this final rule to amend its regulations to make them consistent with the changes made to the CSA by the Act and to otherwise implement the Act's requirements. DEA recognizes that EMS agencies may at times need to utilize multiple locations as a regular part of their distribution networks. This final rule does not prevent them from doing so. For this reason and to be consistent with the requirements established by the Act, DEA will allow a single registration in each State where the agency operates.
The final rule incorporates changes to provide flexibility for EMS agencies driven by the comments received. Except when EMS personnel are carrying controlled substances on their person or in a jump bag as set forth in § 1301.80(d), a registered EMS agency must store controlled substances in a storage component that is identified as a securely locked, substantially constructed cabinet or safe that cannot be readily removed; which is located at a secured location specified in § 1301.80(a)(1) through (4); or an automated dispensing machine as defined in § 1300.01. In addition, an emergency medical services vehicle storing controlled substances must be locked when parked outside of an enclosed registered or designated location, or when it is actively in use, but unattended during non-emergency stops. An emergency medical services vehicle storing controlled substances does not need to be locked only if it is parked within an enclosed registered or designated location, it is at the scene of an emergency, or emergency services personnel are in attendance. Personnel are considered to be in attendance when personnel are physically present and able to monitor the vehicle; such as when the vehicle is traveling to or from the scene of an emergency, or it is at public displays or educational events. The presence of EMS personnel monitoring the vehicle mitigates the risk of diversion by ensuring that controlled substances are inaccessible to unauthorized individuals.
DEA recognizes the different and unique circumstances of EMS agencies and the practical issues presented in an emergency response. In response to the comments related to carrying controlled substances in a jump bag, DEA revised § 1301.80, adding new section (d). Controlled substances are not considered “stored” when they are being dispensed during an emergency response, or when EMS personnel are preparing them to be dispensed to respond to a particular emergency. Thus, this new provision allows EMS personnel to carry (as opposed to store) controlled substances on their person or in a jump bag as long as they are currently engaged in responding to an emergency. The goal is to allow personnel to have immediate and ready access to controlled substances to prepare for and provide emergency services during their active duties. The controlled substances must be returned to a storage component as described in § 1301.80(c)(1), either inside of the emergency medical services vehicle or at the registered or designated location, when emergency medical services agency personnel are not currently engaged in responding to an emergency, for example at the end of the shift and when the EMS vehicle is actively in use but on call and unattended (
Except when emergency medical services personnel are carrying controlled substances on their person or in a jump bag as set forth in (d), a registered emergency medical services agency must store controlled substances in a storage component that is identified as: (1) a securely locked, substantially constructed cabinet or safe that cannot be readily removed; which is located at a secured location specified in § 1301.80(a)(1) through (4); or (2) an automated dispensing machine as defined in § 1300.01; which is located at a secured location specified in 1301.80(a)(1) and (2); installed and operated by the emergency medical services agency; not used to directly dispense controlled substances to an ultimate user; and is in compliance with the requirements of State law.
For purposes of this rule, as described in the definition for actively in use, “on call” means that the EMS vehicle and its personnel are ready and available to respond, but may not be responding to an emergency at that precise moment. Examples of “on call” would include providing standby medical coverage for public events; participating in educational events; or parking and leaving the vehicle unattended, such as when EMS personnel stop for lunch or a break.
The requirement that an EMS agency use a substantially constructed cabinet or safe to store controlled substances on an EMS vehicle parallels the security requirements for other registrants.
Additionally, many commenters suggested that getting the medical director to initial every time a controlled substance is administered would create an undue burden on the EMS system and the medical professionals overseeing them. The commenters further noted that the law already requires that there be an existing protocol or verbal order in place providing the paramedic permission to administer the medication. Therefore, the commenters stated that physically or electronically tracking down the medical professional giving the order is impractical and problematic.
One important point of clarification: proposed § 1304.27(a) stated that the records of registered EMS agencies would be required to include “initials” of the person who administered the controlled substance, of the medical director or authorizing medical professional issuing the standing or verbal order, and of the person who disposed of a controlled substance (if applicable) and of the witness to the disposal. The proposed rule, however, did not specify whether the relevant individual had to personally write or input their initials, or whether records merely had to reflect those initials, even if written or entered by someone else.
The commenters objecting to this requirement generally based their objections on the understanding that the medical director or authorizing medical professional issuing the standing or verbal order must personally initial each record. That is, they do not necessarily object to the requirement that the records identify the medical director or authorizing medical professional issuing the relevant standing or verbal order, but they do object to the additional burden that asking such directors or professionals to personally initial each record would place on EMS agency operations or to the incompatibility of this approach with their recordkeeping systems.
DEA, however, did not intend in proposed § 1304.27(a) to require that the person who administered the substance, the medical director or authorizing medical professional who issued the standing or verbal order, the person who disposed of the substance (if applicable), or the witness to the disposal (if applicable) personally initial each record. It is enough for DEA's purposes that the records clearly and accurately reflect their identities to allow DEA to discern under whose authority the controlled substance was administered. In many situations, the best way to ensure that these records are accurately maintained may be for the EMS agency to have individuals personally initial these records themselves. But, as commenters highlight, there are situations in which this is practically difficult, and thus DEA is not requiring such personal initialing.
Accordingly, to further clarify that personal initialing is
DEA also does not believe records need to specifically reference the full name of the medical director or authorizing medical professional that issued that order for that particular patient. If the goal is to create efficiency, then writing the full name of the medical director or authorizing medical professional would create additional work and time for EMS personnel, and initials should generally suffice to identify the relevant individual. For this reason, while a registrant could satisfy this provision by writing out a full name, DEA also will maintain the option that EMS agencies only record these individuals' last name or initials.
Similarly, commenters stated that the Patient Care Record (PCR) should be sufficient as it has the required additional record requirement with the name of the medical director who issued the standing order or the provider who gave a verbal order. Multiple commenters stated that EMS providers are already required to complete PCRs on all patient encounters and include all the information that is being proposed by this regulation and that therefore having a separate recordkeeping system to meet DEA's recordkeeping requirement is overly burdensome and redundant.
Contrary to the commenter's suggestions, the recordkeeping provisions of this rule does not impose any additional requirements on EMS agencies other than what they are currently required to do. The recordkeeping requirements outlined in this rule codify existing practices. EMS agencies are required to record the details of any administration, disposal, acquisition, distribution, or delivery of controlled substances and make these records readily retrievable. DEA believes that EMS agencies are already collecting and storing these records as a normal course of their business operations.
As explained in the regulatory analyses section below, DEA conducted an analysis of the statutory and regulatory changes of this rule and concluded that benefits of the rule are expected to be generated by reducing regulatory uncertainty among EMS agencies and personnel regarding the administration, transfer, and disposal of controlled substances. Furthermore, DEA believes that because EMS agencies are already collecting and storing these records as a normal course of their business operations, fulfilling the requirements of § 1304.27(a) should not create substantial additional burden.
For maintenance of standing orders, the Act (in 21 U.S.C. 823(k)(13)(M)) and proposed 21 CFR 1300.06(b)(13) already require that a standing order be a “written medical protocol” containing a determination by the medical director. To satisfy this requirement, an EMS agency already will have to retain a copy of the standing order that indicates the medical director's authorization. EMS agencies are required to maintain complete and accurate records of patient care, including any orders or protocols used in treatment. Retaining a copy of standing orders ensures compliance with established standards of care. No more is necessary.
NAEMSP members' suggestions regarding quality assurance or improvement programs and internal audits provide potentially useful ideas for how EMS agencies may ensure the integrity of their controlled substance dispensing and maintain effective controls against diversion. And DEA agrees that medical directors are responsible for monitoring the dispensing of controlled substances by EMS personnel to ensure that their orders are not being abused to divert controlled substances. DEA has concluded, however, that EMS agencies can accomplish this in a number of ways, and that specifically requiring the recommended programs and audits is beyond the scope of these regulations.
DEA is aware that NEMSIS provides a framework for collecting, storing, and sharing standardized EMS data from States nationwide. DEA must ensure its ability to investigate registrants' dispensing of controlled substances as appropriate. DEA may consider the efficacy of NEMSIS-compliant patient care reporting software to fulfill the recordkeeping requirement to ensure compliance with standing and verbal orders in the administration of controlled substances.
Thus, DEA cannot remove the requirement of recordkeeping here, especially given the increased potential for diversion from EMS vehicles operating in the field, as opposed to in a secure environment, and where unregistered EMS personnel are relying on the authority of others to administer controlled substances. That said, DEA considers all relevant circumstances when assessing the severity of recordkeeping violations by registrants and recognizes that some EMS agencies may have occasional difficulty fully complying with the requirements of § 1304.27. Given the importance of these requirements, however, DEA concludes that such difficulties are not a sufficient reason to eliminate them.
Likewise, the Act directly ties DEA's registration of an EMS agency to such State licensing, directing DEA to register an EMS agency if the agency demonstrates that “it is authorized to conduct [emergency medical services] under the laws of each State in which the agency practices” and the registration is not inconsistent with the Act or the public interest. 21 U.S.C. 823(k)(1). DEA thus relies on State licensing bodies to determine that EMS agencies are qualified to perform emergency medical services. State authority to conduct these activities only confers rights and privileges within the issuing State; consequently, a DEA registration based on a State license cannot itself authorize controlled substance dispensing outside of the State. This aspect of the CSA and DEA regulations also helps to ensure that each State retains the primary authority to regulate the practice of medicine within its borders.
The Act, however, as codified at 21 U.S.C. 823(k)(11)(C), specifically authorizes DEA to issue regulations allowing hospitals and EMS agencies to deliver controlled substances to one another during shortages, public health emergencies, or mass casualty events. This rule does so in 21 CFR 1307.15 and makes written approval from the SAC for the area or DEA Headquarters a condition of this allowance.
This approval requirement serves two primary purposes. First, as noted, the Act only authorized this allowance in limited circumstances: shortages, public health emergencies, and mass casualty events. Requiring SAC or Headquarters approval allows DEA to keep this allowance appropriately limited to the circumstances specified in the Act.
Second, as explained above, generally restricting distribution to registered distributors enables DEA to better monitor distribution and prevent diversion—because DEA is aware which registrants will be distributing controlled substances. Requiring written approval fulfills a similar purpose: hospitals and EMS agencies will be informing DEA that they are also going to be engaged in temporary distributing, thereby better enabling DEA to monitor that distributing and prevent diversion.
To the degree that there is any confusion about how to contact Headquarters or the relevant SAC, contact information is available on the DEA Diversion Control Division's website,
Further, although the existence of a mass casualty incident is also relevant to whether controlled substances may be administered pursuant to a verbal order, see 21 U.S.C. 823(k)(4)(B), 21 CFR 1306.07, Headquarters or SAC approval is not required before a medical director or authorizing medical professional may issue such a mass casualty incident verbal order. Headquarters or SAC confirmation of a mass casualty is only necessary to make deliveries pursuant to 21 CFR 1307.15.
Finally, DEA acknowledges that restocking EMS vehicles with controlled substances is a concern for some commenters, particularly regarding the time constraints EMS personnel face after emergency responses. Under § 1307.14(a) of this final rule, a registered EMS agency may receive controlled substances from a hospital for purposes of restocking an EMS vehicle following an emergency response, and without being subject to the requirements of § 1305.03 of this chapter, provided all of the following criteria are met: (1) the registered or designated location of the agency operating the vehicle maintains the record of such receipt in accordance with § 1304.27(b) of this chapter; (2) the hospital maintains a record of such delivery to the agency in accordance with § 1304.22(c) of this chapter; and (3) if the vehicle is primarily situated at a designated location of an emergency medical services agency, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the controlled substances.
The specific reasons commenters gave for why the proposed rule would allegedly hinder the ability of EMS
Some commenters were concerned that the definition of “stationhouse” would not apply to some structures used in rural or urban settings because the structures did not house EMS vehicles. Other commenters noted that EMS vehicles operating in rural environments far from their registered location may have difficulty getting a medical director to personally initial records or returning to the hospital at which they are registered to restock.
In this final rule, as discussed above, DEA is amending the definition of “stationhouse” to provide clarity by removing the requirement that a stationhouse must house an EMS vehicle, removing the phrase “for emergency response,” and adding the phrase “at its premises” to accommodate locations where EMS vehicles are not housed or stored indoors. These revisions aim to acknowledge the unique operational demands of EMS agencies and ensure that this rule supports the efficient and effective delivery of emergency medical services. DEA acknowledges the concerns raised about the limitations of the stationhouse definition and recognizes that it is important for EMS agencies to have the flexibility they need to effectively serve their communities.
The addition of the phrase “at its premises” is intended to accommodate locations where EMS vehicles are not housed or stored indoors and allows flexibility for an EMS agency to house a vehicle outside of an enclosed registered or designated location. However, an EMS vehicle may be parked outside of a stationhouse, but for security purposes, if it stores controlled substances, it must be locked with the controlled substances stored in a securely locked cabinet or safe. The primary goal for this regulatory change is to provide EMS agencies with the necessary flexibility to effectively serve the public. EMS agencies play a critical role in responding to emergencies and providing life-saving medical care. However, the housing of EMS vehicles inside of a structure posed challenges for EMS agencies, particularly those with larger vehicles and limited space. By allowing EMS vehicles to be housed at the premises of an enclosed structure, but not necessarily within the structure itself, the regulatory changes ensure that agencies can maintain their vehicles in a manner that best suits their operational needs.
The final rule will also allow EMS agencies to administer controlled substances via standing or verbal orders from the medical director, thereby eliminating the requirement to personally initial records.
With respect to commenters' request for more flexible security requirements, the goal of this final rule is to provide flexibility for EMS agencies to operate. DEA recognizes the different and unique circumstances of EMS agencies and the practical issues presented in an emergency response. In response to the commenters' concern about flexible security requirements, this final rule will allow EMS personnel to carry controlled substances on their person or in a jump bag while responding to an emergency to have immediate and ready access to controlled substances while providing emergency services. The final rule also recognizes the critical need for EMS personnel to have swift and easy access to controlled substances during emergencies by allowing EMS personnel to carry controlled substances on their person or in a jump bag during emergencies. This provision ensures immediate access to necessary medications, enhancing the ability to provide rapid and effective care. It maintains strict security protocols to prevent diversion and supports the overall goal of improving patient outcomes in emergency situations. While the rule allows for portability, it maintains strict security measures. Controlled substances must be returned to a storage component consistent with the requirements of 21 CFR 1301.80(c) when EMS personnel are not currently engaged in responding to an emergency. This ensures compliance with regulatory requirements and minimizes the risk of diversion.
Additionally, the Regulatory Flexibility Act (RFA) requires agencies to analyze options for regulatory relief of small entities unless it can certify that the rule will not have a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. DEA evaluated the impact of this rule on small entities, such as the small rural or urban EMS agencies, and concluded that the final rule will not have a significant impact on small entities as a whole.
DEA appreciates all comments that were received during the comment period. DEA received two comments which were outside of the scope of this rule. These comments did not mention content related to actual changes of the proposed regulatory text. An anonymous commenter made a general complaint about alleged evidence of voter fraud and a State representative's alleged deceptive voter registration. This comment was clearly outside the scope of the rulemaking and therefore not addressed. Another commenter sought clarification of certain provisions within State legislation regarding EMS agencies, which is also outside the scope of this rule.
The purposes and functions of this rule were discussed in the NPRM. The Act amended the CSA to add regulatory provisions pertaining to the handling of controlled substances by EMS professionals, and the majority of the provisions of this final rule merely reiterate those statutory requirements. The remainder of this rule includes changes to the registration, security, recordkeeping, inventory, and administering requirements for EMS agencies, which are discussed below.
Consistent with the Act, DEA is implementing regulations to explicitly include EMS agencies handling controlled substances as registrants under the CSA
In this manner, DEA is bringing its regulations into conformity with the Act's amendments to the CSA. In particular, 21 CFR 1300.06 adds 21 U.S.C. 823(k)(13)'s new definitions of relevant terms to DEA regulations. Section 1301.12 is being amended to reflect the statutory amendments of sections 823(k)(2) and 823(k)(5), and § 1301.13 is being amended to bring it into conformity with section 823(k)(1). Section 1301.20(a) is adapted directly from the statutory amendment, specifically from section 823(k)(1)-(3). The provisions of § 1301.80(a) add provisions from section 823(k)(6). Section 1304.03(j) is taken from section 823(k)(9)(A). Section 1306.07(g) adds the provisions of sections 823(k)(4) and 823(k)(10)(D) to DEA regulations, while § 1307.14 adds those of section 823(k)(8).
Not all of the proposed amendments to DEA regulations, however, directly codify the Act's statutory amendments in DEA regulations. Some of the changes—specifically, §§ 1301.20(b), 1301.80(b), 1304.03(i), 1304.04, 1304.27, 1306.07(h), and 1307.15—implement the purposes of the Act more broadly, consistent with the Administrator's authority to promulgate regulations under 21 U.S.C. 821, 21 U.S.C. 823(k)(11), and 21 U.S.C. 871(b).
The regulatory text in this final rule is identical to that in the proposed rule aside from the following changes:
• The definition for “actively in use” and “on call” were added to 21 CFR 1300.06. The definition of “actively in use” was added to provide clarity under 21 U.S.C. 823(k)(6)(C)(ii) as to when an EMS vehicle used by an agency may store controlled substances. This definition would include instances when an EMS vehicle is responding to an emergency, is transporting patients, or is on call. “On call” means that personnel are ready and available to respond, but may not be responding to an emergency at that precise moment. EMS vehicles and personnel are considered “on call” when they are prepared to respond to emergencies, even if they are not actively engaged in an emergency call. This includes periods when the vehicle is on standby for the next call, which may include waiting in designated standby areas, maintaining readiness for deployment. Examples of “on call” also include, but are not limited to, participating in public safety or educational events, and parking and leaving the vehicle unattended, during lunch or a break, for example. The aim is to delineate when an EMS vehicle is considered engaging in an emergency response or waiting for the next call.
• In 21 CFR 1300.06, DEA is amending the definition of “stationhouse” to provide clarity by removing the requirement that a stationhouse must house an EMS vehicle, removing the phrase “for emergency response,” and adding the phrase “at its premises” to accommodate locations where EMS vehicles are not housed or stored indoors. “At the premises” specifically refers to the stationhouse premises, where EMS vehicles are parked outside of a stationhouse. This includes areas directly associated with the stationhouse where EMS activities are conducted. DEA also removed the phrase “for emergency response” from the stationhouse definition because stationhouses may also be used for various non-emergency EMS activities such as the storage of medical supplies, controlled substances, and equipment; staff training and education; and administrative functions essential to EMS operations. These revisions aim to acknowledge the unique operational demands of EMS agencies and ensure that this rule supports the efficient and effective delivery of emergency medical services. Specifically, the definition of stationhouse is revised to mean an enclosed structure within a State where the emergency medical services agency is registered and may house EMS vehicles at its premises and is actively and primarily being used by that emergency medical services agency.
• The provisions outlined in § 1301.80(b) specify when an EMS vehicle storing controlled substances must be locked. An emergency medical services vehicle storing controlled substances must be locked when parked outside of an enclosed registered or designated location, or when it is actively in use and left unattended during non-emergency stops. An emergency medical services vehicle storing controlled substances does not need to be locked if: (1) It is parked within an enclosed registered or designated location; (2) It is at the scene of an emergency; or (3) Emergency services personnel are in attendance. If an EMS vehicle is not at a registered or designated location of the agency, or traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency, the Act and § 1301.80(a) require that it must be “actively in use” in order to store controlled substances.
• § 1301.80(d) will allow EMS personnel to carry (as opposed to store) controlled substances on their person or in a jump bag that remains in their possession at all times while responding to an emergency. When EMS personnel are not responding to an emergency, the controlled substances must be returned to a storage component consistent with the requirements of 21 CFR 1301.80(c), including at the end of the shift and when personnel stop for breaks and meals. This allows EMS personnel to have immediate and ready access to controlled substances in the context of preparing for and providing emergency services. If an EMS vehicle is not at a registered or designated location of the agency, or traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency, then the Act and § 1301.80(a) require that it must be “actively in use” in order to store controlled substances.
• In § 1304.27, the requirement that EMS agency records reflect certain individuals' “initials” has been changed to allow agencies to instead record a “last name or initials.”
• The amendments to 21 CFR 1301.13(e) have been updated to reflect the increased registration and reregistration fees for controlled substance dispensers from $731 to $888 for a three-year registration period. On July 24, 2020, DEA published a final rule, 85 FR 44710, to adjust registration and reregistration fees, in which registration and reregistration fees for dispensing or instructing business activities in § 1301.13(e) were adjusted to $888 for a three-year registration period.
The Act contains a provision, 21 U.S.C. 823(k)(13), defining the terms used throughout its other provisions. In order to conform to the Act, DEA is adding these new definitions to its regulations as part of a new section, 21 CFR 1300.06. This includes defining the terms “actively in use,” “authorizing medical professional,” “designated location,” “emergency medical services,” “emergency medical services agency,” “emergency medical services professional,” “emergency medical services vehicle,” “hospital-based,” “medical director,” “medical oversight,” “on call,” “registered emergency medical services agency,” “registered location,” “specific State authority,” “standing order,” “stationhouse,” and “verbal order.”
The definition of “actively in use” was added to provide clarity under 21 U.S.C. 823(k)(6)(C)(ii) as to when an EMS vehicle used by an agency may store controlled substances. This definition would include instances when an EMS vehicle is responding to an emergency, is transporting patients, or is on call. The aim is to delineate when an EMS vehicle is considered engaging in an emergency response or waiting for the next call. “On call” means that the emergency medical services vehicle and its personnel are ready and available to respond, but may not be responding to an emergency at that precise moment. EMS vehicles and personnel are considered “on call” when they are prepared to respond to emergencies, even if they are not actively engaged in an emergency call. This includes periods when the vehicle is on standby for the next call, which may include waiting in designated standby areas, maintaining readiness for deployment. Examples of on call also include participating in public safety/educational events, going to lunch, and parking and leaving the vehicle unattended during a break.
Additionally, the Act contains provisions that allows DEA to issue regulations specifying, with regard to the delivery of controlled substances under 21 U.S.C. 823(k)(5), the types of locations that may be designated. 21 U.S.C. 823(k)(11)(A)(i). In order to conform with the Act, DEA has identified this type of location as a “stationhouse” and is adding the definition of a “stationhouse” to its regulations as part of 21 CFR 1300.06. As discussed above, the definition of “stationhouse” in this final rule differs slightly from that in the proposed rule. In this final rule, the definition of “stationhouse” is being amended to provide clarity by removing the requirement that a stationhouse must house an EMS vehicle, removing the term “for emergency response,” and adding the phrase “at its premises” to accommodate locations where EMS vehicles are not housed or stored indoors. These revisions aim to acknowledge the unique operational demands of EMS agencies and ensure that this rule supports the efficient and effective delivery of emergency medical services. In response to the commenters concern that EMS agencies may at times be used primarily for various operational EMS purposes, but not actually “house” associated EMS vehicles, DEA removed the requirement that a stationhouse must house an EMS vehicle from the stationhouse definition. DEA also removed the phrase “for emergency response” from the stationhouse definition in response to the comments received. In addition to housing EMS vehicles, stationhouses may also be used for various EMS activities such as the storage of medical supplies, controlled substances, and equipment; staff training and education; and administrative functions essential to EMS operations.
Further, the addition of the phrase “at its premises” to accommodate locations where EMS vehicles are not housed or stored indoors, allows flexibility for an EMS agency to house a vehicle outside of an enclosed registered or designated location. However, an EMS vehicle may be parked outside of a stationhouse, but for security purposes, if it stores controlled substances, it must be locked. The primary goal for this regulatory change is to provide EMS agencies with the necessary flexibility to effectively serve the public. “At the premises” specifically refers to the stationhouse premises, where EMS vehicles are parked outside of a stationhouse. This includes areas directly associated with the stationhouse where EMS activities are conducted. Examples of permissible locations at the stationhouse premises may include, but are not limited to: nearby docks (secure docking areas used for EMS boats or watercraft, part of the stationhouse premises); airplane hangars (enclosed, secure hangars within the stationhouse premises used for EMS aircraft); or garages and parking areas (designated parking spaces within the stationhouse premises where EMS vehicles are parked and secured). EMS vehicles containing controlled substances must be locked, unless responding to an emergency, at the scene of an emergency, or EMS personnel are in attendance.
Pursuant to 21 CFR 1301.12(a), controlled substances may only be delivered to and distributed or dispensed from a DEA registered location. In addition, under the CSA and DEA regulations, a separate registration is generally required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person. 21 U.S.C. 822(e); 21 CFR 1301.12(a).
Until the passage of the Act, the CSA and its implementing regulations did not directly mention EMS. Historically, DEA has not specifically registered EMS agencies to procure or dispense controlled substances. Instead, generally, EMS vehicles have obtained controlled substances for dispensing pursuant to a physician's instructions by operating under the registration of a hospital through one of two options.
Under the first option, an EMS vehicle owned and operated by a hospital handles controlled substances under the hospital's registration.
The Act authorized the Attorney General (and thus, by delegation, the Administrator) to register EMS agencies, which allowed for a new registration category for EMS professionals to administer controlled substances in schedule II-V to patients receiving emergency medical services. 21 U.S.C. 823(k)(1). The Act thereby effectively amends the CSA to add a new category of registrant—an EMS agency—and to require DEA to grant registrations to those agencies if certain conditions are met. Thus, in conformity with the Act, DEA is amending 21 CFR 1301.13 and adding 21 CFR 1301.20 to provide for the registration of EMS agencies.
As part of this regulatory change, DEA is adding § 1301.20(a) to its regulations, which describes the registration requirements for EMS agencies registered under § 1301.13. The registration requirements of § 1301.20(a) are taken directly from the Act, 21 U.S.C. 823(k)(1)-(3).
DEA recommends three options to allow EMS agencies to transition their registrations, in accordance with the Act. The three options for EMS agencies to transition are: (1) transition immediately on the effective date established by DEA; (2) transition at the expiration of their current registration; or (3) transition three to six months prior to their renewal date. DEA recommends that registrants contact their local DEA field office to complete this transition.
To lessen the burden for EMS agencies with several stationhouses in a single State, the Act allows EMS agencies to choose the option of a single registration in each State where the EMS agency operates, 21 U.S.C. 823(k)(2), and DEA is amending its regulations accordingly through provisions of § 1301.20(a)(1). This rule would allow EMS registrants to consolidate multiple registrations into a single registration for each State in which they currently operate. EMS agencies that operate EMS facilities in multiple States must still have a separate registration in each State where the agency operates. In addition, under the Act and § 1301.20(a)(2) of this regulation, hospital-based EMS agencies are allowed to operate under the registration of a hospital to administer controlled substances without being separately registered pursuant to 21 U.S.C. 823(k)(3).
Many EMS agencies currently utilize what is sometimes termed the “hub-and-spoke” model where the agency has a main or central location and several stationhouses managed by the main location. The stationhouses are strategically placed throughout a geographical area to provide timely responses to the emergency medical needs of the residents of the area. Under DEA's current registration regulations, if only the main location is registered with DEA, the employees of each of the separate (unregistered) stationhouses are not allowed to acquire or store controlled substances at the unregistered stationhouse.
The Act amended the CSA to authorize EMS agencies to designate specific unregistered locations where controlled substances will be delivered and stored, but requires registered EMS agencies to provide notice of these locations to the Attorney General at least 30 days before delivery. 21 U.S.C. 823(k)(5). A registered EMS agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency (1) designates the unregistered location for such delivery; and (2) notifies DEA at least 30 days prior to first delivering controlled substances to the unregistered location.
DEA is bringing its regulations into conformity with the Act by adding 21 CFR 1301.20(b). Under this regulatory framework, controlled substances must be delivered to the registered location of the EMS agency or the hospital if the EMS agency operates under the hospital's DEA registration. EMS agencies may then distribute these substances to designated unregistered locations, provided they designate the unregistered location for such delivery and notify DEA at least 30 days prior to first delivering controlled substances to the designated unregistered location. Direct deliveries from distributors to designated unregistered locations are not permitted under DEA regulations. This process ensures secure management of the diversion of controlled substances while accommodating the operational needs of EMS agencies. Consistent with the Attorney General's authority under 21 U.S.C. 823(k)(11)(A)(ii) to prescribe how EMS agencies provide notice of designated locations, this regulation requires notification of the name and physical address of the designated location through DEA's website,
The Act also authorizes the Attorney General to issue regulations specifying the types of locations that may be designated by an EMS agency. 21 U.S.C. 823(k)(11)(A)(i). Pursuant to this authority, DEA is including a provision in § 1301.20(b) that allows an EMS agency to label stationhouses as the type of location that will be considered a “designated location” of the EMS agency. A registered EMS agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency designates the unregistered location as a stationhouse for such delivery; and notifies the Administration at least 30 days prior to the first delivery of controlled substances to the unregistered location. The delivery of controlled substances by a registered emergency medical services agency pursuant to this section shall not be treated as distribution. Thus, for example, a location that serves primarily as a residence does not meet the definition of a stationhouse and may not be selected as a “designated location” by an EMS agency that is registered with DEA. In contrast, a building that is actively serving primarily to house the equipment of an EMS agency, such as a county fire and rescue department that is a part of the EMS agency, for example, would qualify as a stationhouse under this rule (and thus may be selected as a “designated location” by an EMS agency that is registered with DEA) regardless of whether the location is also used for other purposes. The final rule, however, does not include a requirement (as did the proposed rule) that the stationhouse
As discussed above, the provisions of § 1301.20(b) outline the process by which a stationhouse is “designated” under an existing EMS agency registration. This notification must occur at least 30 days prior to the first delivery of controlled substances to the unregistered designated location of the agency. Unless an objection is raised by DEA, an unregistered location automatically becomes a designated location of the agency 30 days after notification of the designated location is made to DEA.
Additionally, § 1301.80(a) codifies in DEA regulations the Act's list of the locations where a registered EMS agency may store controlled substances.
Both the Act and section 1300.06 define an emergency services vehicle as an ambulance, fire apparatus, supervisor truck, or other vehicle used by an EMS agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations.
Furthermore, in accordance with new section 1301.80(d), registered EMS agency personnel may carry controlled substances on their person or in a jump bag instead of storing the controlled substances in a safe when responding to an emergency. The controlled substances must be returned to a storage component as described § 1301.80(c), either inside of the EMS vehicle or at the registered or designated location, when EMS personnel are not responding to an emergency or the EMS vehicle is actively in use.
The transportation of controlled substances for administration to EMS patients presents unique recordkeeping concerns. Concerning non-practitioners that transport controlled substances (
EMS agencies are typically the last registrants to possess controlled substances prior to administering to a patient at the scene of an emergency. As such, the two-registrant integrity system does not exist beyond the transfer to an EMS agency, in the traditional sense of registrant recordkeeping. Therefore, DEA is implementing recordkeeping regulations for EMS agencies to incorporate the Act's CSA amendments regarding recordkeeping, and to ensure an accurate accounting of the controlled substances outside the two-registrant integrity system.
DEA is implementing § 1304.03(i) to require EMS agencies to maintain records of the EMS personnel whose State license or certification gives them the ability to administer controlled substances, in compliance with their State laws. Because States have differing requirements for the ability to handle controlled substances, maintaining records of employees authorized to handle controlled substances will help DEA identify the source of any diversion occurring at EMS agencies.
Section 1304.03(i) is not based directly on the text of the Act, but instead on DEA's general authority under the CSA to prevent diversion of controlled substances by requiring registrants to maintain records.
Following an emergency response where controlled substances were administered, EMS personnel may not have enough time to return to their stationhouse to restock their EMS vehicle with controlled substances. Depending on the circumstances, the stationhouse may be a considerable distance from the hospital where the EMS personnel brought a patient, or the volume of emergencies may be so great that the ambulance does not have time to return to the stationhouse. Rural EMS systems in the United States may face transport distances of 20 to 100 miles to the nearest hospital.
Under § 1304.04(a), controlled substance records for all DEA registrants are required to be maintained for at least two years from the date of such inventory or records. Under this rule, DEA requires maintenance of records of deliveries of controlled substances between all locations of the agency. Following the Act, 21 U.S.C. 823(k)(9)(B)(ii), DEA also establishes in § 1304.04(a)(5) the requirement that records be maintained, whether electronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of.
Because EMS agencies have a unique registration that differs from other types of registrants, DEA is also adding a new section to its regulations that describes the recordkeeping requirements applicable to EMS agencies. Consistent with the Act's amendments to the CSA, 21 U.S.C. 823(k)(9), § 1304.27(a) requires an EMS agency to maintain records for each controlled substance administered or disposed of in the course of providing emergency medical services. Under the provisions of § 1304.27(a), any EMS personnel who disposes of or administers controlled substances to a patient in the course of providing emergency medical care must record the name of the controlled substance(s) and detailed information about the circumstances surrounding the administration of the controlled substance(s) (
DEA provides in § 1304.27(b)(3) that an EMS agency must maintain records of controlled substances delivered between registered and designated locations of the agency (except agencies restocking at the hospital under which the EMS agency is operating, because the hospital is required to keep records of such restocking). These records, for example, should include the name of the controlled substance(s), finished form, number of units in the commercial container, date delivered, and the address of the EMS agency location where the controlled substances were delivered. In the event of theft or loss of controlled substances, registrants must report such occurrence in accordance with the existing theft and loss reporting requirements of 21 CFR part 1304.
Finally, under 21 U.S.C. 823(k)(8)(c) of the Act, designated locations of an EMS agency must notify the registered location of their EMS agency within 72 hours of receiving controlled substances from a hospital for the purpose of restocking an EMS vehicle following an emergency response. The provisions in § 1304.27(c) codify this requirement in DEA regulations. However, EMS agencies that operate under a hospital-based registration and receive restock of controlled substances from the hospital under which the agency is operating are exempt from these requirements. In this specific instance, under § 1307.14(a)(2), hospitals would already have a record of the controlled substances that the hospital delivered to the EMS agency operating under that hospital's registration. As such, it would be duplicative to require that EMS agency to obtain a receipt of those controlled substances because the EMS agency would be reporting receipt of the controlled substances back to the hospital that issued the controlled substances in the first place.
Every DEA registrant must follow certain security requirements to prevent the theft or loss of controlled substances, and the Act authorizes the Attorney General to issue regulations specifying the manner in which controlled substances must be stored by EMS agencies. 21 U.S.C. 823(k)(11)(B). Pursuant to this authorization, DEA will implement physical security requirements for EMS agencies similar to those already established for practitioners in § 1301.75.
Pursuant to its authorization under the Act to issue regulations regarding EMS agencies' storage of controlled substances, DEA is adding § 1301.80 to address additional security concerns for EMS agencies. First, although designated locations of EMS agencies are not individually registered, they are allowed to store controlled substances in secured locations. The provisions of § 1301.80(a)(1) through (4) specify the secured locations within an EMS agency where controlled substances may be stored, and implement the Act's allowance in 21 U.S.C. 823(k)(6) of storage at EMS registered locations, at designated locations, inside of EMS vehicles stationed at registered or designated locations, and inside of EMS vehicles that are actively in use by the agency.
Pursuant to § 1301.80(a)(1) through (4), an EMS agency may store controlled substances at a registered location of the agency; a designated location of the agency 30 days following notification to DEA in accordance with § 1301.20; in an emergency medical services vehicle situated at a registered location or designated location of the agency; or in an emergency medical services vehicle used by the agency that is traveling from, or returning to, a registered location or designated location of the agency while responding to an emergency, or when the emergency medical services vehicle is actively in use.
DEA's final rule provides a framework to effectively minimize the risk of diversion while maintaining their readiness to respond to emergencies and to ensure the security of controlled substances in EMS vehicles, when parked outside stationhouses and designated locations. As outlined in § 1301.80, EMS vehicles must be equipped with secure locking mechanisms for cabinets if they are to store controlled substances. These locks are designed to prevent unauthorized access, even when vehicles are parked outside stationhouses. Further, § 1301.80(c)(1) mandates that controlled substances must be stored in a securely locked, substantially constructed cabinet if not being carried in a jump bag or on the person of EMS personnel when responding to an emergency, whether within the vehicle or at a registered or designated location. Alternatively, under § 1301.80(c)(2), controlled substances may also be stored in an automated dispensing machine at a registered or designated location. This ensures secure storage at all times, in order to minimize the risk of diversion.
The provision outlined in § 1301.80(b) specifies when an EMS vehicle storing controlled substances must be locked.
Under § 1301.80(b), an EMS vehicle storing controlled substances is not required to be locked when EMS personnel are in attendance, although the controlled substances must themselves still be stored in a securely locked, substantially constructed cabinet or safe that cannot be readily removed. “In attendance” refers to the presence of authorized EMS personnel who are responsible for the security and control of the EMS vehicle and its contents, particularly controlled substances. “In attendance” could also encompass having the EMS personnel physically present within the immediate vicinity of the EMS vehicle, which allows for effective supervision and immediate response to any security threats or emergencies. Examples of “in attendance” include, but are not limited to, being at an emergency scene, on standby at events, or when transporting patients. Being “in attendance” at an EMS vehicle plays a critical role in deterring diversion of controlled substances by ensuring continuous supervision and immediate response capabilities, thereby ensuring the secure handling of controlled substances. When EMS personnel are “in attendance,” they can continuously monitor the vehicle, which discourages unauthorized access.
By comparison, an EMS vehicle storing controlled substances must be locked whenever the EMS vehicle is unattended, meaning there are no EMS personnel in attendance, with the controlled substances stored in a securely locked, substantially constructed cabinet or safe that cannot be readily removed. This includes when the EMS vehicle is parked at a stationhouse, hospital, or any other location. Additionally, an EMS vehicle storing controlled substances must be locked when the vehicle is actively in use but is not at an emergency scene and is parked in a public or unsecured area, such as when EMS personnel are on call and stop for lunch, or leave the vehicle unattended, such as during a break. Requiring EMS vehicles storing controlled substances to be locked, with the controlled substances stored in a separately locked cabinet or safe that is substantially constructed and cannot be readily removed, mitigates the risk of diversion by ensuring that controlled substances are inaccessible to unauthorized individuals.
In addition, DEA is adding § 1301.80(c) to allow several options by which EMS agencies may store controlled substances. This change is not taken directly from the Act's statutory amendments to the CSA, but instead implements the Act's authorization to the Attorney General to “specify . . . the manner in which [controlled] substances must be stored at registered and designated locations, including in EMS vehicles.” 21 U.S.C. 823(k)(11)(B).
The first option in § 1301.80(c)(1) will allow for an EMS agency to store controlled substances in a securely locked, substantially constructed cabinet or safe that cannot be readily removed. This storage component must be located at a secured location, as stated in § 1301.80(a). Such cabinets or safes can be used in either vehicles or buildings meeting the requirements of a secure location. Premises that are set aside for housing outdoor EMS vehicles are required to securely lock the EMS vehicle and the controlled substances must be stored in a securely locked cabinet or safe. If an EMS vehicle is used to store controlled substances, it must have a secure cabinet or safe. The controlled substances cannot be stored in a vehicle that is locked, without putting them in a safe.
The second option in § 1301.80(c)(2) will allow an EMS agency to store controlled substances in an automated dispensing system (ADS) machine, under specific conditions. An ADS is “a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transactions in information.” 21 CFR 1300.01. Currently, DEA regulations permit retail pharmacies to install and operate ADS machines at long-term care facilities as a way of preventing the accumulation of surplus controlled substances at those facilities.
The conditions in § 1301.80(c)(2) under which an EMS agency could use an ADS machine to store controlled substances include the following: (1) the ADS machine must be located at an EMS agency registered location or designated location; (2) the EMS agency cannot permit any entity other than the registered EMS agency to install and operate the ADS machine; (3) the ADS machine cannot be used to directly dispense controlled substances to an ultimate user; and (4) EMS agency must operate the ADS machine in compliance with requirements of State law. It is necessary that access to the ADS machine be limited to employees of the EMS agency in order to account for and monitor dissemination of controlled substances. Unlike a safe or cabinet, an ADS machine cannot be used to provide secure storage on an EMS vehicle.
In sum, the provisions of § 1301.80(c)(1)-(2) will provide alternative options for short-term or long-term storage of controlled substances that are actively being transported or stored in a fixed location.
The provisions set forth in § 1301.80(d) will allow EMS personnel to carry controlled substances on their person or in a jump bag when responding to an emergency, instead of storing the controlled substances in a safe during an emergency response. The controlled substances must be returned to a storage component as described in § 1301.80(c)(1), either inside of the EMS vehicle or at the registered or designated location, when EMS personnel are not currently engaged in responding to an emergency.
EMS personnel will have immediate and ready access to controlled substances in the context of preparing for and providing emergency services during active duty. This would eliminate the need to return to the EMS vehicle to get controlled substances from a locked safe during an emergency response. Thus, the provisions of § 1301.80(d) provide options for carrying controlled substances in a jump bag or on EMS personnel's person in preparation for or during an emergency response.
The Act allows for controlled substances to be delivered between a registered location and a designated location of an EMS agency. 21 U.S.C. 823(k)(5). Also, pursuant to its authorization to issue regulations regarding the delivery of controlled substances under 21 U.S.C. 823(k)(11), DEA maintains that medical directors determine who accepts deliveries of controlled substances because medical directors provide oversight for EMS agencies. This rule will require that the delivery of controlled substances at a registered or designated location be accepted by a medical director of the agency or a person designated in writing by the medical director. For record keeping purposes of the delivery of controlled substances, § 1304.27(b)(3) will require the medical director of the agency or designated person accepting the controlled substances to provide their signature, title, date received, quantity, and any additional information required. These regulations specify the requirements that will be set forth regarding the delivery of controlled substances for emergency medical services.
As codified at 21 U.S.C. 823(k)(11)(C), the Act also authorizes DEA to issue regulations allowing hospitals and EMS agencies to deliver controlled substances to one another during shortages, public health emergencies, or mass casualty events—rather than relying on distributors or hospital restocking. This rule does so in 21 CFR 1307.15 and makes written approval from the SAC for the area or DEA Headquarters a condition of this allowance.
DEA is adding § 1306.07(g), which implements 21 U.S.C. 823(k)(4) in the DEA regulations, allowing EMS professionals of registered EMS agencies to administer controlled substances outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services.
Many agencies have given their EMS personnel the autonomy to administer controlled substances in the event of an emergency by establishing what is commonly known as a standing order. The Act defines a standing order as a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services. 21 U.S.C. 823(k)(13)(M). The provisions of § 1300.06 incorporate this definition into DEA regulations.
The Act and § 1306.07(g) allow standing orders to be used by EMS professionals. Under both the Act and the proposed regulation, such EMS professionals must be authorized by their individual State to administer controlled substances.
In the absence of standing orders, EMS personnel may receive a verbal order. Under the Act and § 1300.06, a verbal order is an oral directive through any method of communication including by radio or telephone, directly to an EMS professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.
Under the Act and § 1306.07(g), an EMS professional may administer directly a controlled substance in schedules II-V outside of the presence of a practitioner in the course of providing emergency medical services if the administration is authorized by State law and is pursuant to a verbal order that is issued in accordance with the policy of the agency. Such authorization must be provided by a medical director or authorizing medical professional in response to a request by the EMS professional with respect to a specific patient, either in the case of a mass casualty incident, or to ensure the proper care and treatment of a specific patient.
As explained above, DEA is issuing this final rule to amend its regulations in order to make them consistent with the changes made to the CSA by the “Protecting Patient Access to Emergency Medications Act of 2017,” and to otherwise implement the Act's requirements. DEA conducted an analysis of the statutory and regulatory changes of this rule, the results of which are discussed below.
DEA has determined that this rulemaking is a “significant regulatory action” under section 3(f) of Executive Order (E.O.) 12866, Regulatory Planning and Review, but is not a section 3(f)(1) significant action. Accordingly, this rule has been submitted to the Office of
This rule is a deregulatory action for the purposes of E.O. 14192. This rule is an enabling rule because it allows EMS agencies to consolidate many registrations in the same State under a single registration, and EMS personnel to administer controlled substances in schedules II-V pursuant to a standing or verbal order, which was previously not authorized.
On July 24, 2020, DEA published a final rule to adjust registration and reregistration fees, effective October 1, 2020.
DEA expects the annual economic impact of this final rule to range from a decrease of $555,888 to an increase of $1,010,544 in registration fees paid to DEA depending on the number of registrations that can be consolidated and the number of new separate registrations that will be needed as a result of this rule. Detailed analysis is provided below. Fees paid to DEA pertaining to registrations are considered transfer payments and not costs.
Annual changes in labor burden costs as a result of this rule are expected to range from a decrease of $19,594 to an increase of $64,636.
DEA analyzed the impact of the following provisions of the rule: allowing EMS agencies to register under the CSA with a single registration for each State in which an agency operates, along with the security and recordkeeping requirements for such a registrant; allowing EMS personnel to administer controlled substances in schedules II-V outside the presence of a medical director or authorizing medical professional when authorized in the State and pursuant to a standing or verbal order; and allowing EMS agencies and hospitals to transfer controlled substances between each other in order to restock EMS vehicles or to deliver controlled substances in the event of shortages, public health emergencies, or mass casualty events. Additionally, this rule is incorporating into regulation several new terms defined in the Act.
Benefits of the rule are expected to be generated by reducing regulatory uncertainty among EMS agencies and personnel regarding the administration, transfer, and disposal of controlled substances, and these benefits will be discussed qualitatively. By allowing EMS registrants to consolidate multiple registrations into a single registration for each State in which they currently operate, there will be a resulting reduction in transfer payments for current registrants. This rule may also result in an increase in transfer payments for EMS agencies that are currently not separately registered. The expected net change in transfer payments is quantified below. There are also labor burden costs associated with obtaining a DEA registration for any EMS agencies that must become separately registered after this rule is promulgated. These costs or cost savings are discussed and quantified below. DEA expects the recordkeeping and security requirements of this final rule to have no impact, as they are codifications of existing practice among EMS agencies. Finally, the newly defined terms being incorporated into regulation by this rule will have no impact on regulated entities.
While this rule is allowing for a new registration category for EMS agencies that handle controlled substances, many EMS agencies have already obtained separate DEA registrations as “Mid-level Practitioner—Ambulance Service” (MLP-AS).
Similarly, of the 2,108 fee-exempt registrations, 411 can be consolidated into an agency's existing registration in the same State, reducing the labor-related paperwork burden for these agencies, as they no longer need to complete multiple registration renewal applications for the same State every three years. Combining the 411 fee-exempt registrations with the 395 fee-paying registrations results in a total of 806 registration renewal applications that are eliminated. The resulting annual cost savings generated from this reduction in labor burden is $3,026.
DEA assumes that all other EMS agencies not registered as MLP-AS currently operate under the registration of another DEA registrant in one of two ways: a DEA registered practitioner, typically a licensed physician, serves as the medical director of the EMS agency; or for EMS agencies operated by hospitals, the agency will utilize that hospital's registration. In the latter case,
Accurately measuring how many EMS agencies fall into the two aforementioned categories is not possible using DEA registration data because DEA has not historically collected data on how many practitioners hold multiple registrations for the purposes of serving as the medical director of an EMS agency. Therefore, DEA chose to estimate how many new registrations will be required by considering the entire range of possible scenarios and calculated the outcome if either 0 percent, 50 percent, or 100 percent of EMS agencies will receive a transferred practitioner registration from their medical director. While DEA cannot accurately assess the likelihood of each of these scenarios given the lack of available data, DEA considers the 50 percent scenario to be a reasonable estimate because it is the mid-point of the upper and lower bounds.
In order to calculate the range of impacted entities, DEA must first estimate the total population of EMS agencies active in the United States. Because DEA registration data are insufficient for these purposes, DEA used the latest data available from the National Highway Traffic Safety Administration's (NHTSA) Office of EMS. According to an NHTSA research note published in 2014,
DEA then analyzed its registration database to match current MLP-AS registrants with the corresponding EMS organizational types defined in the NHTSA research note.
It is reasonable to assume that a portion of these estimated EMS agencies not separately registered operate multiple locations in the same State. The NHTSA research note states that EMS agencies are “licensed in each State to provide service to a specific location or service area. EMS service areas can be very large, as in a geopolitical boundary, such as a county, city or municipality, or as small as the local service area of a single EMS agency station.” This definition suggests that the 21,283 total EMS agencies estimated by NHTSA includes EMS agencies operating multiple stations in the same State. Because only one registration is required for multiple “agencies,” as defined by NHTSA, DEA must adjust its calculation of the number of EMS agencies not separately registered to account for this.
In order to estimate how many EMS agencies not separately registered operate at more than one location in a State, DEA used the existing MLP-AS registrant category as a model. It is reasonable to assume that the characteristics of the population of EMS agencies registered as MLP-AS are broadly representative of the characteristics of the population of EMS agencies that are not separately registered. As discussed previously, the fee-paying MLP-AS registrant category contains 1,413 registrations that can be consolidated into 1,018 registrations. Similarly, the fee-exempt category contains 2,108 registrations that can be consolidated into 1,697 registrations. DEA used these figures to calculate a State-level “agency-to-location” ratio of 0.72 for fee-paying registrants,
As discussed previously, DEA's methodology for estimating the number of new EMS agency registrations must account for situations in which a practitioner is currently using a single DEA registration to serve as the medical director of multiple EMS agency locations. Because DEA does not have the ability to identify how many EMS agencies are currently operating in this manner, DEA chose to calculate a range of between 0 percent and 100 percent of EMS agencies that may have a DEA registration transferred from a practitioner. If 100 percent of the estimated 3,809 fee-paying EMS agencies not separately registered are currently operating under a practitioner registration that will be transferred from their medical director, there will be no increase in fees (transfer payments) from these future registrants to DEA. If 0 percent of these 3,809 fee-paying EMS agencies operate under a practitioner registration that can be transferred from their medical director, there will be an increase in fees (transfer payments) of $1,127,464 to DEA on an annual basis.
Similarly, if 100 percent of the estimated 1,483
For the respective 0 percent, 50 percent, and 100 percent scenarios for the estimated annual change in transfer payments, DEA calculated the net present values at a 7 percent discount rate and a 3 percent discount rate over 12 years, or three registration cycles. The results of this analysis are summarized below in Table 2.
As detailed previously, of the estimated 4,827 fee-paying EMS agency locations and 10,807 fee-exempt EMS agency locations not separately registered, only 3,809 and 9,110 (a total of 12,919) will require separate registrations after the promulgation of this rule, respectively. If 100 percent of these 12,919 EMS agencies will have an existing practitioner registration transferred from their medical director, there will be a decrease in labor burden
However, if 0 percent of these 12,919 EMS agencies will have an existing practitioner registration transferred from their medical director, there will be a one-time increase in labor burden of $272,830
Finally, under the 50 percent scenario, there would be a one-time increase in labor burden of $136,426
Table 3 summarizes the estimated net change in labor burden cost for both scenarios as a result of this rule.
Because some EMS agencies are currently registered under the practitioner business activity as MLP-AS, this rule adopts similar physical security controls for EMS agencies as practitioners. EMS agencies will be authorized to store controlled substances at EMS registered locations and designated locations inside of a securely locked, substantially constructed cabinet or safe that cannot be readily removed or an automated dispensing system; inside EMS vehicles stationed at registered or designated locations; inside locked EMS vehicles stationed at registered or designated unenclosed locations; and inside EMS vehicles that are actively in use by the agency. DEA expects currently unregistered EMS agencies to be operating in a similar manner as registered MLP-AS, and such EMS agencies are already in compliance with the minimum physical security requirements outlined above. Therefore, DEA expects the physical security requirements of this rule to be a codification of existing practice that will impose no costs.
The recordkeeping provisions of this rule require EMS agencies to record the details of any administration, disposal, acquisition, distribution, or delivery of controlled substances and make these records readily retrievable. DEA believes that EMS agencies are already collecting and storing these records as a normal course of their business operations, and therefore these recordkeeping requirements will have no economic impact on EMS registrants. Designated EMS locations with vehicles that restock controlled substances at a hospital after an emergency event or receive controlled substances from another designated location must also notify the registered location of the EMS agency within 72 hours. Because designated EMS locations have 72 hours to notify registered locations, and because designated and registered locations are likely to communicate on a more frequent basis during their normal course of business, DEA does not expect these events to require any additional communication between designated and registered locations. Therefore, this provision will also have no economic impact on EMS registrants.
Prior to the CSA amendments of the “Protecting Patient Access to Emergency Medications Act of 2017,” the CSA did not explicitly explain exactly how its rules governing the administration, disposal, delivery, acquisition, and
With the Act, and this rule codifying the resulting CSA amendments into DEA regulation, EMS registrants have clear rules that direct their behavior regarding controlled substances. DEA expects there to be benefits resulting from this reduction in regulatory uncertainty, especially the explicit authorization of standing and verbal orders, by allowing EMS vehicles to restock their supply of controlled substances at hospitals following an emergency, and by allowing EMS vehicles and hospitals to transfer controlled substances between each other in the event of a shortage, public health emergency, or mass casualty event. DEA does not have a method to quantify the impact of these reductions in regulatory uncertainty; however, DEA believes the regulatory clarity provided by this rule will result in a benefit to EMS agencies, EMS professionals, and the public.
The provisions of this regulation meet the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to eliminate ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of E.O. 13175. It does not have direct effects on one or more Indian tribes via Indian Health Services.
Executive Order 14294 specifies that all notices of proposed rulemaking (NPRMs) and final rules published in the
The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.
The RFA requires agencies to analyze options for regulatory relief of small entities unless it can certify that the rule will not have a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. DEA evaluated the impact of this rule on small entities, and discussions of its findings are below.
As discussed in the above economic analysis of the rule, because DEA is not able to identify how many EMS agencies currently operate under the practitioner registration of their medical director, DEA chose to assess the impact of this rule by considering the full range of possible scenarios. Thus, DEA considered the impact of the rule if 0 percent, 50 percent, or 100 percent of EMS agencies receive an existing DEA registration from a practitioner. For the purposes of this analysis, DEA conservatively assumes that 0 percent of EMS agencies will have a DEA registration transferred from a practitioner because this is the scenario with the largest possible economic impact on affected entities, including small entities.
There are three types of EMS agencies that are affected by this rule: hospital-based, private, and governmental. Of these types, some agencies currently hold their own DEA registrations while others operate under the registration of another DEA registrant. As detailed previously, DEA estimated that 3,809 private EMS agencies and 9,110 governmental EMS agencies are currently not separately registered with DEA, while 1,018 private EMS agencies and 1,697 governmental EMS agencies are currently registered with DEA. Additionally, there are an estimated total of 1,236 hospital entities
These three types of entities are affected by at least one of the following four quantifiable impacts of the rule: registration fees, recordkeeping and security requirements, the labor burden of obtaining a DEA registration, and the labor burden of renewing a DEA registration. Only the 4,827 private EMS agencies are affected by registration fees. Governmental EMS agencies are fee-exempt and hospital-based agencies can continue to operate under their hospital's registration. All three types of entities, whether separately registered or not, are affected by the security and recordkeeping requirements of the rule. However, there is no impact because these entities are expected to already be in compliance with these requirements. Both the estimated 3,809 private agencies and 9,110 governmental agencies not separately registered must incur the labor burden of registering and renewing their registration with DEA every three years. Hospital-based agencies already incur this labor burden and this rule will have no further impact on these entities. The following table summarizes the estimated impact of the provisions of the rule for each type of EMS agency.
DEA
While this rule affects a substantial number of small entities, because the economic impact for the smallest entities is not significant, the final rule will not have a significant impact on small entities as a whole. In summary, DEA's evaluation of economic impact by size category indicates that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities.
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501
Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
OMB approved Information Collection 1117-0060:
For each EMS professional employed by a registered EMS agency, the agency is required to maintain documents, as required by the State in which the professional practices, which describe the conditions and extent of the professional's authorization to dispense or administer controlled substances and must make such documents available for inspection and copying by authorized employees of the Administration.
EMS agencies are also required to maintain records of all controlled substances received, administered, or otherwise disposed of. Such records must be maintained, whether electronically or otherwise, at each registered and designated location of the agency where such controlled substances are received, administered, or otherwise disposed of.
For each dose of controlled substances administered or disposed of in the course of providing emergency medical services, these records must include: (1) the name of the substance; (2) the finished form of the substance;
For controlled substances acquired from or distributed to another registrant, the records must include: (1) the name of the substance; (2) the finished form of the substance; (3) the number of units or volume of finished form in each commercial container; (4) the number of units or volume of finished form and commercial containers transferred; (5) the date of the transfer; (6) name, address, and registration number of the person to or from whom the substance was transferred; and (7) the name and title of the person in receipt of the transferred substance.
For deliveries of controlled substances between a designated location and a registered location—except hospital-based agencies restocking at the hospital under which the agency is operating—the records must include: (1) the name of the substance; (2) the finished form of the substance; (3) the number of units or volume of finished form in each commercial container; (4) the number of units or volume of finished form and commercial containers transferred; (5) the date of the transfer; (6) the name and address of the designated location to which the substance is delivered; and (7) the name and title of the person in receipt of the transferred substance.
For destruction of a controlled substance (
Additionally, designated locations of EMS agencies must notify their registered locations within 72 hours of any receipt of controlled substances in the following circumstances: (1) an EMS vehicle primarily situated at the designated location acquires controlled substances from a hospital while restocking following an emergency response; or (2) a designated location receives controlled substances from another designated location of the same EMS agency.
DEA does not have a good basis to estimate the number of respondents and burden related to this collection of information, because there is no available data regarding the administration, receipt, delivery, acquisition or distribution, and disposal of controlled substances specific to the operation of EMS agencies. Therefore, DEA submits the following estimated number of respondents and burden associated with this collection of information and will update this estimate with data when the collection is renewed:
Figures are rounded.
2.
OMB approved Information Collection 1117-0014:
Under § 1301.13, EMS agencies, if authorized by State law, may register as a new type of business activity. A new “EMS Agency” business activity is added to the application for registration and application for registration renewal forms to allow EMS agencies to obtain a DEA registration that permits EMS agencies to deliver controlled substances to their designated locations without obtaining a separate registration as a Distributor. This registration allows EMS personnel to administer controlled substances outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services. Upon issuance of an EMS agency registration, the EMS agency should use the online system to identify all of the locations it intends to designate under the EMS agencies' DEA registration.
To lessen the burden for EMS agencies with several stationhouses in a single State, DEA allows EMS agencies to choose the option of a single registration in each State where the EMS agency operates. If the agency operates EMS facilities in multiple States, the agency must have a separate registration in each State where the agency operates.
DEA estimates the following number of respondents and burden associated with this collection of information:
Figures are rounded.
The activities described in this information collection are usual and ordinary business activities and no additional cost is anticipated.
If you need additional information, please contact the Regulatory Drafting and Policy Support Section (DPW), Diversion Control Divisions, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 776-2265.
Any additional comments on this collection of information may be sent in writing to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please state that your comments refer to RIN 1117-AB37/Docket No. DEA-377.
Chemicals, Drug traffic control.
Administrative practice and procedure, Drug traffic control, Exports, Imports, Security measures.
Drug traffic control, Reporting and recordkeeping requirements.
Drug traffic control, Prescription drugs.
Drug traffic control.
For the reasons stated in the preamble, the Drug Enforcement Administration is amending 21 CFR parts 1300, 1301, 1304, 1306, and 1307 as follows:
21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).
(a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802).
(b) As used in parts 1301, 1304, 1306, and 1307 of this chapter, the following terms shall have the meanings specified:
(1)
(2)
(i) Who is registered under 21 U.S.C. 823;
(ii) Who is acting within the scope of the registration; and
(iii) Whose scope of practice under a State license or certification includes the ability to provide verbal orders.
(3)
(4)
(5)
(i) Is governmental (including fire-based and hospital-based agencies), non-governmental (including hospital-based agencies), private, or volunteer-based;
(ii) Provides emergency medical services by ground, air, or otherwise; and
(iii) Is authorized by the State in which the organization is providing such services to provide emergency medical care, including the administering of controlled substances, to members of the general public on an emergency basis.
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(i) An emergency medical services agency that is registered under 21 U.S.C. 823(k); or
(ii) A hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection 823(g).
(13)
(14)
(15)
(16)
(17)
21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965.
(b) * * *
(5) A designated location that a registered emergency medical services agency has identified to the Administration at least 30 days prior to first delivering controlled substances to that unregistered location.
The revision and addition read as follows:
(d) At the time a retail pharmacy, hospital/clinic, practitioner, emergency medical services agency or teaching institution is first registered, that business activity shall be assigned to one of twelve groups, which correspond to the months of the year. The expiration date of the registrations of all registrants within any group will be the last day of the month designated for that group. In assigning any of the above business activities to a group, the Administration may select a group the expiration date of which is not less than 28 months nor more than 39 months from the date such business activity was registered. After the initial registration period, the registration expires 36 months from the initial expiration date.
(e) * * *
(1) * * *
(a) An emergency medical services agency shall be issued a registration under § 1301.13 if the agency submits an application demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices, unless the Administration determines that the issuance of such a registration would be inconsistent with the requirements of 21 U.S.C. 823(k) or the public interest based on the factors listed in 21 U.S.C. 823(g).
(1) An agency has the option of requesting a single registration in each State where the agency administers controlled substances in lieu of a separate registration for each location of the agency within a State.
(2) If a hospital where an emergency medical services agency is based is registered under § 1301.13, the agency may use the registration of the hospital to administer controlled substances in accordance with § 1306.07(g) of this chapter, without being separately registered as an emergency medical services agency.
(b) A registered emergency medical services agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency designates the unregistered location as a stationhouse for such delivery; and notifies the Administration at least 30 days prior to the first delivery of controlled substances to the unregistered location. The delivery of controlled substances by a registered emergency medical services agency pursuant to this section shall not be treated as distribution. To notify the Administration, the emergency medical services agency must submit the name and physical address of the designated location online at
(a)
(1) A registered location of the agency;
(2) A designated location of the agency 30 days following notification to DEA in accordance with § 1301.20;
(3) In an emergency medical services vehicle situated at a registered location or designated location of the agency; or
(4) In an emergency medical services vehicle used by the agency that is traveling from, or returning to, a registered location or designated location of the agency while responding to an emergency, or when the emergency medical services vehicle is actively in use by the agency.
(b)
(1) It is parked within an enclosed registered or designated location;
(2) It is at the scene of an emergency; or
(3) Emergency services personnel are in attendance. This includes situations when personnel are physically present and able to monitor the vehicle; such as when the vehicle is traveling to or from the scene of an emergency, or it is at public displays or educational events.
(c)
(1) A securely locked, substantially constructed cabinet or safe that cannot be readily removed; which is located at a secured location specified in paragraphs (a)(1) through (4) of this section; or
(2) An automated dispensing machine as defined in § 1300.01; which is
(i) Located at a secured location specified in paragraphs (a)(1) and (2) of this section;
(ii) Installed and operated by the emergency medical services agency;
(iii) Not used to directly dispense controlled substances to an ultimate user; and is
(iv) In compliance with the requirements of State law.
(d)
21 U.S.C. 821, 823(j), 827, 831, 871(b), 958(e)-(g), and 965, unless otherwise noted.
(i) For each emergency medical services professional employed by a registered emergency services agency,
(j) A registered emergency medical services agency shall maintain records, as described in § 1304.27, of all controlled substances that are received, administered, or otherwise disposed of pursuant to the agency's registration.
(a) Except as provided in paragraphs (a)(1) and (2) of this section, every inventory and other record required to be kept under this part must be kept by the registrant and be available for inspection and copying by authorized employees of the Administration, for at least 2 years from the date of such inventory or record.
(4) Records shall include records of deliveries of controlled substances between all locations of the agency.
(5) Records shall be maintained, whether electronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of.
(a) Each emergency medical services agency registered pursuant to § 1301.20 of this chapter (including a hospital-based emergency medical services agency using a hospital registration under § 1301.20(a)(2) of this chapter) must maintain records for each dose of controlled substances administered or disposed of in the course of providing emergency medical services. The following information shall be included in each record:
(1) Name of the substance;
(2) Finished form of the substance (
(3) Date administered or disposed of;
(4) Identification of the patient (consumer), if applicable;
(5) Amount administered;
(6) Last name or initials of the person who administered the controlled substance;
(7) Last name or initials of the medical director or authorizing medical professional issuing the standing or verbal order;
(8) Whether a standing or verbal order was issued and adopted;
(9) Amount disposed of, if applicable;
(10) Manner disposed of; and
(11) Last name or initials of person who disposed and witness to disposal, if applicable.
(b) For each acquisition of a controlled substance from another registrant, or each distribution of a controlled substance to another registrant, each emergency medical services agency registered pursuant to § 1301.20 of this chapter must maintain records with all of the following information:
(1) For each acquisition of a controlled substance from another registrant:
(i) Name of the substance;
(ii) Finished form of the substance (
(iii) Number of units or volume of finished form in each commercial container;
(iv) Number of commercial containers acquired (
(v) Date of the acquisition;
(vi) Name, address, and registration number of the person from whom the substance was acquired; and
(vii) Name and title of the person acquiring the controlled substance.
(2) For each distribution of a controlled substance to another registrant:
(i) Name of the substance;
(ii) Finished form of the substance (
(iii) Number of units or volume of finished form in each commercial container (
(iv) Number of commercial containers distributed;
(v) Date of the distribution;
(vi) Name, address, and registration number of the person to whom the substance was distributed; and
(vii) Name and title of the person in receipt of the distributed controlled substances.
(3) For each delivery of controlled substances between a designated location and a registered location:
(i) Name of the substance;
(ii) Finished form of the substance (
(iii) Number of units or volume of finished form in each commercial container (
(iv) Number of units or volume of finished form in each commercial container and number of commercial containers delivered (
(v) Date of the delivery;
(vi) Name and address of the designated location to which the substance is delivered; and
(vii) Name and title of the person in receipt of the controlled substances.
(4) For destruction of a controlled substance:
(i) Name of the substance;
(ii) Finished form of the substance (
(iii) Number of units or volume of finished form in each commercial container (
(iv) Number of units or volume of finished form in each commercial container and number of commercial containers destroyed (
(v) Date of the destruction;
(vi) Manner of disposal of the substance, if applicable;
(vii) Name, address, and registration number of the person to whom the substance was distributed, if applicable; and
(viii) Name and title of the person destroying the controlled substance.
(c) A designated location of an emergency medical services agency that receives controlled substances must notify the agency's registered location within 72 hours of receipt of the controlled substances, in the following circumstances:
(1) An emergency medical services vehicle primarily situated at a designated location of the emergency medical services agency acquires controlled substances from a hospital while restocking following an emergency response;
(2) The designated location of the emergency medical services agency receives controlled substances from another designated location of the same agency.
21 U.S.C. 821, 823(k), 829, 831, 871(b), unless otherwise noted.
This part sets forth the process and procedures for dispensing, by way of prescribing and administering controlled substances to ultimate users. The purpose of such procedures is to provide safe and efficient methods for dispensing controlled substances while providing effective controls against diversion.
(e) An emergency medical services professional of a registered emergency medical services agency may administer directly (but not prescribe) controlled substances in schedules II-V outside the physical presence of a medical director or authorizing medical professional while providing emergency medical services if the administration is authorized by law of the State in which it occurs, and is pursuant to:
(1) A standing order that is issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State's authority; or
(2) A verbal order that is:
(i) Issued in accordance with a policy of the agency; and
(ii) Provided by a medical director or an authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient --
(A) In the case of a mass casualty incident; or
(B) To ensure the proper care and treatment of a specific patient.
(f) An emergency medical services agency shall maintain, at a registered location of the agency, a record of the standing or verbal orders issued or adopted in accordance with § 1304.13 of this chapter.
21 U.S.C. 821, 822(d), 823(k), 871(b), unless otherwise noted.
(a) Notwithstanding the definition of registered location in § 1300.06 of this chapter, a registered emergency medical services agency may receive controlled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency response, and without being subject to the requirements of § 1305.03 of this chapter, provided all of the following criteria are met:
(1) The registered or designated location of the agency operating the vehicle maintains the record of such receipt in accordance with § 1304.27(b) of this chapter;
(2) The hospital maintains a record of such delivery to the agency in accordance with § 1304.22(c) of this chapter; and
(3) If the vehicle is primarily situated at a designated location of an emergency medical services agency, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the controlled substances.
(a) Hospitals and emergency medical services agencies' registered locations and designated locations may deliver controlled substances to each other, with written approval from the Special Agent in Charge of DEA for the area or DEA Headquarters, in the event of:
(1) Shortages of such substances;
(2) A public health emergency; or
(3) A mass casualty event.
(b) Reserved.
This document of the Drug Enforcement Administration was signed on January 30, 2026, by Administrator Terrance Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved the information collections associated with the amendments to § 1.8002(b)(2) under OMB Control Number 3060-0918 and the amendments to § 64.6305(h) under OMB Control Number 3060-1285 adopted by the
The amendments to §§ 1.8002(b)(2) and 64.6305(h), published at 91 FR 343 on January 6, 2026, are effective February 5, 2026. The initial compliance date for the annual recertification requirement under § 64.6305(h) is March 1, 2026.
For additional information on this proceeding, contact Merry Wulff, Competition Policy Division, Wireline Competition Bureau, at (202) 418-1084, or email:
This document announces that OMB approved the information collection requirements associated with the amendments to §§ 1.8002(b)(2) and 64.5305(h) on May 27, 2025 and August 11, 2025, respectively. The amendments to these rules were adopted in the
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval for the information collection requirements contained in §§ 1.8002(b)(2) and 64.6305(h) on May 27, 2025, and August
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Numbers are 3060-0918 and 3060-1285.
The foregoing notice is required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13) October 1, 1995, and 44 U.S.C. 3507.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; commercial accountability measure.
NMFS implements an accountability measure (AM) for commercial greater amberjack in the Gulf of America (Gulf) exclusive economic zone (EEZ) for the 2026 fishing year through this temporary rule. NMFS has determined that Gulf greater amberjack landings in 2025 exceeded the commercial annual catch limit (ACL). Therefore, NMFS reduces both the commercial ACL and commercial annual catch target (ACT) for Gulf greater amberjack during the 2026 fishing year. This commercial ACL and ACT reduction is necessary to protect the Gulf greater amberjack resource.
This rule is effective, February 5, 2026, through December 31, 2026.
Kelli O'Donnell, NMFS Southeast Regional Office, telephone: 727-824-5305, or email:
The Gulf reef fish fishery, which includes greater amberjack, is managed under the Fishery Management Plan for the Reef Fish Resources of the Gulf (FMP). The FMP was prepared by the Gulf Fishery Management Council, approved by the Secretary of Commerce, and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All greater amberjack weights described in this temporary rule are in round weight.
The 2026 commercial ACL for Gulf greater amberjack is 101,000 pounds (lb) (45,813 kilograms (kg)), as specified in 50 CFR 622.41(a)(1)(iii). The 2026 commercial quota (equivalent to the commercial ACT) is 93,930 lb (42,606 kg), as specified in 50 CFR 622.39(a)(1)(v). However, NMFS has determined that in 2025, the commercial harvest of greater amberjack exceeded the 2025 commercial ACL of 101,000 lb (45,813 kg) by 8,184 lb (3,712 kg). As described in 50 CFR 622.41(a)(1)(ii), NMFS is required to reduce both the commercial ACL and the commercial ACT for greater amberjack in the year following an overage of the commercial ACL, by the amount of any commercial ACL overage. Consistent with the commercial AM, for the 2026 fishing year, NMFS reduces both the commercial ACL and the commercial ACT by 8,184 lb (3,712 kg), to 92,816 lb (42,101 kg) and 85,746 lb (38,894 kg), respectively.
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 622.41(a)(1)(ii), which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment is unnecessary and contrary to the public interest. Such procedures are unnecessary because the regulations associated with the commercial AM and the commercial ACL and ACT have already been subject to notice and public comment, and all that remains is to notify the public of the updated commercial ACL and ACT for the 2026 fishing year. Prior notice and opportunity for public comment are contrary to the public interest because of the need to implement this action as soon as possible in order to protect the amberjack stock and provide sufficient notice to the industry for the 2026 fishing year.
For the aforementioned reasons, there is also good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness of this action.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by catcher vessels greater than or equal to 60 feet (ft) (18.3 meters (m)) length overall (LOA) using pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the A season allowance of the 2026 Pacific cod total allowable catch (TAC) allocated to catcher vessels greater than or equal to 60 ft (18.3 m) LOA using pot gear in the BSAI.
Effective 1200 hours, Alaska local time (A.l.t.), February 4, 2026, through 1200 hours, A.l.t., September 1, 2026.
Andrew Olson, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared and recommended by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery
The A season allowance of the 2026 Pacific cod TAC allocated to catcher vessels greater than or equal to 60 ft (18.3 m) LOA using pot gear in the BSAI is 5,016 metric tons (mt) as established by the final 2025 and 2026 harvest specifications for groundfish in the BSAI (90 FR 12640, March 18, 2025) and inseason adjustment (90 FR 60025, December 23, 2025).
In accordance with § 679.20(d)(1)(iii), the Regional Administrator, Alaska Region, NMFS has determined that the A season allowance of the 2026 Pacific cod TAC allocated as a directed fishing allowance to catcher vessels greater than or equal to 60 ft (18.3 m) LOA using pot gear in the BSAI will be or has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels greater than or equal to 60 ft (18.3 m) LOA using pot gear in the BSAI to prevent exceeding this sector's A season allowance of Pacific cod TAC.
While this closure is effective, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data on Pacific cod catch in a timely fashion and would delay the closure of directed fishing for Pacific cod by catcher vessels greater than or equal to 60 ft (18.3 m) LOA using pot gear in the A season in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of February 2, 2026.
There is good cause under 5 U.S.C. 553(d)(3) to establish an effective date less than 30 days after date of publication. This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by catcher vessels less than 60 feet (18.3 meters (m)) length overall (LOA) using hook-and-line or pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2026 Pacific cod total allowable catch (TAC) allocated to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI.
Effective 1200 hours, Alaska local time (A.l.t.), February 3, 2026, through 2400 hours, A.l.t., December 31, 2026.
Andrew Olson, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared and recommended by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2026 Pacific cod TAC allocated to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI is 3,272 metric tons as established by the final 2025 and 2026 harvest specifications for groundfish in the BSAI (90 FR 12640, March 18, 2025), inseason adjustment (90 FR 60025, December 23, 2025), and reallocation (90 FR 61069, December 30, 2025).
In accordance with § 679.20(d)(1)(iii), the Regional Administrator, Alaska Region, NMFS has determined that the 2026 Pacific cod TAC allocated as a directed fishing allowance to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI will be or has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI to prevent exceeding this sector's allocation of Pacific cod TAC.
While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data on Pacific cod catch in a timely fashion and would delay the closure of directed fishing for Pacific cod by catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of February 2, 2026.
There is good cause under 5 U.S.C. 553(d)(3) to establish an effective date less than 30 days after date of publication. This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
16 U.S.C. 1801
Federal Communications Commission.
Petition for Reconsideration (Petition) has been filed in the Commission's proceeding by Travis LeBlanc on behalf of SZ DJI Technology Co., Ltd.
Application for Review (AFR) has been filed in the Commission's proceeding by Fan Liang, Zhiyu Liang on behalf of Autel Robotics Co., Ltd.
Oppositions to the Petition and AFR must be filed on or before April 6, 2026. Replies to oppositions to the Petition and AFR must be filed on or before March 9, 2026.
Federal Communications Commission, 45 L Street NE, Washington, DC 20554. You may submit oppositions and replies to oppositions to the Petition identified by new assign docket, ET Docket No. 26-22 and AFR identified by new assign docket, ET Docket No. 26-23, electronically or on paper.
The Office of Engineering and Technology, 202-418-2470, or
This is a summary of the Commission's document, Report No. 3232, released January 29, 2026. The full text of the Petition and AFR can be accessed online via the Commission's Electronic Comment Filing System at:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of proposed fishery management plan amendment; request for comments.
NMFS announces that the Pacific Fishery Management Council (Council) has submitted amendment 37 to the Pacific Coast Groundfish Fishery Management Plan (Groundfish FMP) to the Secretary of Commerce for review. If approved, amendment 37 would define stocks that are in need of conservation and management in the exclusive economic zone (EEZ), consistent with the provisions and guidelines of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Amendment 37 would define stocks for 27 species within the fishery management unit. Amendment 37 is necessary for NMFS to make stock status determinations, which in turn will help prevent overfishing, rebuild overfished stocks, and achieve optimum yield. Amendment 37 is administrative in nature and does not change harvest levels or timing and location of fishing, nor does it revise the goals and objectives or the management frameworks of the Groundfish FMP.
Comments on amendment 37 must be received no later than April 6, 2026.
You may submit comments on this document, identified by NOAA-NMFS-2025-1428, by the following method:
•
Electronic copies of proposed amendment 37 and the draft analysis (the Analysis) prepared for this action may be obtained from
Megan Mackey, Fishery Management Specialist, at 206-526-6140, or
NMFS manages the groundfish fisheries in the exclusive economic zone (EEZ) seaward of Washington, Oregon, and California under the Groundfish FMP. The Council prepared and NMFS implemented the Groundfish FMP under the authority of the Magnuson-Stevens Act, 16 U.S.C. 1801
In 2021, NMFS was unable to make stock status determinations for stocks that were assessed in 2021, because the “stocks” for which the Council was expecting status determinations did not exist in the Groundfish FMP. At that time, the Groundfish FMP contained a list of over 80 species and did not describe whether each species is a single stock within the fishery management unit (FMU) (
Phase 2 was initiated by the Council at the November 2023 Council meeting, and at the June 2025 and September 2025 Council meetings, the Council recommended stock definitions for 27 species of Pacific Coast groundfish managed under the Groundfish FMP that were determined to be in need of conservation and management in the EEZ. Amendment 37 is administrative in nature, and the economic impacts, if any, will come when stock assessments are completed, the status of the stocks are determined by NMFS, and appropriate fishery management actions are taken by the Council.
During the development of amendment 31, the Council was advised by the Scientific and Statistical Committee (SSC) that indications of population structure within a species should be an indicator of whether stock status should be determined at a finer scale than coastwide. Therefore, the Council evaluated a literature review of the best scientific and biological information available for each species, which is appended to the analyses developed for amendment 35 and amendment 37, available on the Council website (see
The analysis pertaining to the amendment 37 species considered a single stock definition alternative for all but four of the species (darkblotched and greenspotted rockfishes, boccacio, and cowcod, as explained below). Generally, species with no known population structure, based on the literature review, or with known single-population structure based on genetic information, were considered under a single stock definition alternative.
The analysis assumed each alternative stock definition considered by the Council was adopted, then applied the Groundfish FMP's harvest specifications framework to each stock to assess some of the biological and fishery management trade-offs that might be expected from implementation of future management actions based on the alternative stock definition. Impacts of these stock definitions are expected to flow from future, subsequent action(s) to set harvest specifications and management measures for the stock(s), but the analysis provided information for the Council to consider in making its decision. The Council considered these tradeoffs when making its final stock definition recommendations for the amendment 37 species at its June and September 2025 meetings.
The Council considered 23 of the 27 amendment 37 species under a single stock definition (arrowtooth flounder, aurora rockfish, bank rockfish, big skate, blackgill rockfish, California scorpionfish, flathead sole, greenstriped rockfish, longnose skate, longspine thornyhead, Pacific cod, Pacific hake, Pacific Ocean perch, Pacific sanddab, redstripe rockfish, rosethorn rockfish, sharpchin rockfish, shortraker rockfish, silvergray rockfish, splitnose rockfish, starry rockfish, stripetail rockfish, and yellowmouth rockfish). Specifically, California scorpionfish and starry rockfish were considered under a California-only stock, due to their known geographic range, whereas the others were considered under a single coastwide stock definition. Except for blackgill rockfish (as discussed below), all of these species have been consistently considered a single population, assessed as a single geographic unit, and have historically had a single overfishing limit (OFL) established under the FMP. At present, genetics, larval dispersal, and/or adult movement data do not support delineating these 23 species on a finer geographic scale than coastwide, or as less than a single California stock for starry rockfish and California scorpionfish, which can be more finely defined based on their known geographic range.
Blackgill rockfish has been assessed north and south of 40°10′ N lat. and is currently managed as a component stock to the slope rockfish complexes north and south of 40°10′ N lat. Under a single coastwide stock definition, this management structure is assumed to continue and is not expected to trigger future allocative actions, increase management burden during the next biennial cycle as compared to 2025-2026, or result in short-term or long-term biological impacts, if status is determined at a coastwide scale. Therefore, the Council recommended and NMFS is proposing to approve a single coastwide stock of arrowtooth flounder, aurora rockfish, bank rockfish, big skate, blackgill rockfish, flathead sole, greenstriped rockfish, longnose skate, longspine thornyhead, Pacific cod, Pacific hake, Pacific Ocean perch, Pacific sanddab, redstripe rockfish, rosethorn rockfish, sharpchin rockfish, shortraker rockfish, silvergray rockfish, splitnose rockfish, stripetail rockfish, and yellowmouth rockfish, and single California-only stocks of California scorpionfish and starry rockfish in the Groundfish FMP, as only a single geographic delineation clearly aligned with past and recent fishery management and policy decisions and with the best scientific information available for these species.
For the four species considered under multiple alternatives, the following narrative provides species-specific information, in alphabetical order by common name, and rationale for the stock definition for each species that
Bocaccio (
Cowcod (
Darkblotched rockfish (
The Council considered darkblotched rockfish under all three alternatives: a single coastwide stock, two separate stocks north and south of 40°10′ N lat., and three stocks (a California stock, an Oregon stock, and a Washington stock). Because a single coastwide geographic delineation aligns well with the best scientific information available, as well as with past and recent fishery management and policy decisions for the species, the Council recommended and NMFS is proposing to approve a single coastwide stock of darkblotched rockfish in the Groundfish FMP.
Greenspotted rockfish (
The Council considered greenspotted rockfish as two separate stocks (a stock north of 34°27′ N lat. and a stock south of 34°27′ N lat.) to account for differences in growth rates and exploitation histories. However, because a single coastwide geographic delineation reflects the range of the species, with little impact to the management burden expected, the Council recommended and NMFS is proposing to approve a single coastwide stock of greenspotted rockfish in the Groundfish FMP.
16 U.S.C. 1801
Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the Colorado Advisory Committee to the Commission will hold a public meeting via Zoom. The purpose of the meeting is to continue reviewing drafts of their report examining campus antisemitism on the Auraria campus in Denver.
Wednesday, February 18, 2026; 3:00 p.m.-4:30 p.m. Mountain Time.
The meeting will be held via Zoom.
Ana Fortes, Designated Federal Officer at
This virtual committee meeting is available to the public through the registration link above. Any interested member of the public may join at the link to listen to this meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the Zoom meeting platform. To request additional accommodations, please email
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Evelyn Bohor,
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the file sharing website: as well as at:
Commission on Civil Rights.
Announcement of meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Maryland Advisory Committee (Committee) to the Commission will hold public meetings via Zoom. The purpose is for the committee to begin the proposal discussion on the chosen topic of artificial intelligence and its application in voting administration.
• Tuesday, February 24, 2026, at 2:00 p.m. ET.
• Tuesday, March 31, 2026, at 2:00 p.m. ET.
•
•
•
•
Brooke Peery, Designated Federal Officer, at
Virtual committee meetings are available to the public through the registration links above. Any interested member of the public may join at the link to listen to the meetings. Open comment periods will be provided to allow members of the public to make a statement as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of the meetings will include a list of persons who are present at the meetings. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the Zoom meeting platform. To request additional accommodations, please email
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following scheduled meetings. Written comments may be emailed to Evelyn Bohor at
Records generated from the meetings may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after meetings. Records of the meetings will be available via the file sharing website:
Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration, Department of Commerce.
Notice of public meeting; opportunity to comment.
The National Oceanic and Atmospheric Administration's (NOAA) Office for Coastal Management will hold a virtual public meeting to solicit input on the performance evaluation of the Georgia Coastal Management Program. NOAA also invites the public to submit written comments.
NOAA will hold a virtual public meeting at 5:30 p.m. Eastern Time (ET) on Wednesday, March 25, 2026. NOAA may close the meeting 10 minutes after the conclusion of public testimony and after responding to any clarifying questions from hearing participants. NOAA will consider all relevant written comments received by Friday, April 3, 2026.
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Michael Migliori, Evaluator, NOAA Office for Coastal Management, by email at
Section 312 of the Coastal Zone Management Act (CZMA) requires NOAA to conduct periodic evaluations of federally approved coastal management programs. The evaluation process includes holding one or more public meetings, considering public comments, and consulting with interested federal, state, and local agencies and members of the public. During the evaluation, NOAA will consider the extent to which the State of Georgia has met the national objectives, adhered to the management program approved by the Secretary of Commerce, and adhered to the terms of financial assistance under the CZMA. When the evaluation is complete, NOAA's Office for Coastal Management will place a notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of incidental harassment authorization.
In accordance with regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to Pacific Gas & Electric (PG&E) for authorization to take marine mammals incidental to construction for a sediment remediation project in San Francisco Bay, California (CA).
This authorization is effective for 1 year from the date of notification by the IHA-holder, not to exceed 1 year from the date of issuance (February 2, 2026).
Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
Kristy Jacobus, Office of Protected Resources, NMFS, (301) 427-8401.
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Among the exceptions is section 101(a)(5)(D) of the MMPA (16 U.S.C. 1361
Specifically, NMFS will issue an IHA if it finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least [practicable] adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to here as “mitigation”). NMFS must also prescribe requirements pertaining to the monitoring and reporting of such takings. The definitions of key terms, such as “take,” “harassment,” and “negligible impact,” can be found in the MMPA and the NMFS' implementing regulations (see 16 U.S.C. 1362; 50 CFR 216.103).
On December 29, 2025, a notice of NMFS' proposal to issue an IHA to PG&E for take of marine mammals incidental to construction for a sediment remediation project in San Francisco Bay, CA was published in the
No comments were received during the public comment period. There are no changes to the specified activity, the species taken, the proposed numbers, type, or methods of take, or the mitigation, monitoring, or reporting measures in the proposed IHA notice. No new information that would change any of the preliminary analyses, conclusions, or determinations in the proposed IHA notice has become available since that notice was published, and therefore, the preliminary analyses, conclusions, and determinations included in the proposed IHA are considered final.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531
Accordingly, consistent with the requirements of section 101(a)(5)(D) of the MMPA, NMFS has issued an IHA to PG&E for authorization to take marine mammals incidental to construction for a sediment remediation project in San Francisco Bay, CA.
10 a.m., Thursday, February 12, 2026.
You may observe this meeting in person at 1501 Farm Credit Drive, McLean, Virginia 22102-5090, or virtually. If you would like to observe, at least 24 hours in advance, visit
This meeting will be open to the public.
The following matters will be considered:
If you need more information or assistance for accessibility reasons, or have questions, contact Ashley Waldron, Secretary to the Board. Telephone: 703-883-4009. TTY: 703-883-4056.
Bureau of Ocean Energy Management, Interior.
Final notice of sale.
On Wednesday, March 11, 2026, the Bureau of Ocean Energy Management (BOEM) will open and publicly announce bids received for blocks offered in the Gulf of America (GOA) Outer Continental Shelf (OCS) Oil and Gas One Big Beautiful Bill Act Lease Sale 2 (Lease Sale BBG2). BOEM is holding this sale pursuant to the One Big Beautiful Bill Act (OBBBA) and in accordance with the Outer Continental Shelf Lands Act (OCSLA), as amended, and its implementing regulations. The Final Notice of Sale (NOS) package for Lease Sale BBG2 contains information essential to potential bidders and comprises this notice, Information to Lessees, and Lease Stipulations. Section 50102 of the OBBBA mandates that the Secretary of the Interior (Secretary) conduct the sale within a specific time period and directs the Secretary to offer the same lease form, lease terms, economic conditions, and stipulations as contained in the Final Notice of Sale entitled, “Gulf of Mexico Outer Continental Shelf Region-Wide Oil and Gas Lease Sale 254” (85 FR 8010, Feb. 12, 2020).
BOEM will hold Lease Sale BBG2 at 9:00 a.m. on Wednesday, March 11, 2026. All times referred to in this document are Central time, unless otherwise specified.
Bids will be accepted, prior to the bid submission deadline, through any parcel delivery service (
Greg Purvis, Gulf of America Region Lease Sale Coordinator, at
• Whole and Partial Blocks withdrawn from leasing by Presidential Withdrawal in the September 8, 2020,
• Whole and Partial Blocks within the boundary of the Flower Garden Banks National Marine Sanctuary (East and West Flower Garden Banks and the Stetson Bank) as of the July 14, 2008,
• Whole and Partial Blocks that are adjacent to or beyond the United States Exclusive Economic Zone in the area known as the northern portion of the Eastern Gap:
• Depth-restricted, segregated block portion(s). The current block meeting this criterion is:
Block 299, Main Pass Area, South and East Addition (as shown on Louisiana Leasing Map LA10A), containing 1,125 acres from the surface of the earth down to a subsea depth of 1,900 feet with respect to the following described portions: SW
• Any blocks in which the status of existing leases is under appeal.
• Any block which received a bid in Lease Sale BBG1.
The final list of blocks available for bid will be posted on BOEM's website at
Each lease is issued pursuant to the OBBBA and OCSLA, 43 U.S.C. 1331
The OBBBA was signed into law on July 4, 2025, and contains statutory requirements to conduct lease sales in the Gulf of America with specific parameters and timing requirements. Section 50102(a)(1) of the OBBBA requires the Secretary to conduct a minimum of 30 offshore lease sales in the Gulf of America Region through 2040, notwithstanding the 2024-2029 Outer Continental Shelf Oil and Gas Leasing Program (or any successor leasing program that does not satisfy the requirements of the OBBBA). This lease sale constitutes the second lease sale required by OBBBA in the Gulf of America. The statute directs the Secretary to hold at least two lease sales in each calendar year from 2026 through 2039 (by March 15 and August 15 of each applicable year), and at least one sale by March 15, 2040. The statute further requires specific Terms and Stipulations that must be used for these sales, stating that the Secretary must “offer the same lease form, lease terms, economic conditions, and stipulations 4 through 9 as contained in the Final Notice of Sale of the Bureau of Ocean Energy Management entitled for the `Gulf of Mexico Outer Continental Shelf Region-Wide Oil and Gas Lease Sale 254' (85 FR 8010 (February 12, 2020)).”
Additionally, the OBBBA requires the Secretary to set royalty rates at not less than 12
BOEM will offer leases that include certain terms and conditions to ensure compliance with the requirements of the OBBBA.
Pursuant to Section 50102(b)(1)(A) of the OBBBA, BOEM will use Form BOEM-2005 (February 2017) to convey leases resulting from this sale. This lease form can be viewed on BOEM's website at
Section 50102(b)(1)(A) of the OBBBA requires that the primary term for leases in water depths less than 800 meters to be the same as those in Lease Sale 254. Additionally, Section 50102(b)(1)(D) requires a primary term of 10 years for leases offered in water depths 800 meters or deeper. The primary terms for this sale are summarized in the following table:
1. The primary term for a lease in water depths of less than 400 meters is 5 years. If the lessee spuds a well targeting hydrocarbons below 25,000 feet TVDSS within the first 5 years of the lease, then the lessee may earn an additional 3 years, resulting in an 8-year primary term. The lessee will earn the 8-year primary term when the well is drilled to a target below 25,000 feet TVDSS; or the lessee may earn the 8-year primary term in cases where the well targets, but does not reach, a depth below 25,000 feet TVDSS due to mechanical or safety reasons that are beyond the lessee's control, and that are supported by sufficient evidence from the lessee. To earn the 8-year primary term, the lessee is required to submit a letter to the BOEM GOA Regional Supervisor, Office of Leasing and Plans, as soon as practicable, but no more than 30 days after completion of the drilling operation, providing the well number, spud date, information demonstrating a target below 25,000 feet TVDSS and whether that target was reached, and if applicable, any safety or mechanical reasons encountered that prevented the well from reaching a depth below 25,000 feet TVDSS. In the letter, the lessee must request confirmation from BOEM that the lessee earned the 8-year primary term. The BOEM GOA Regional Supervisor for Leasing and Plans will confirm in writing, within 30 days of receiving the lessee's letter, whether the lessee has earned the extended primary term and accordingly update BOEM's records. The extended primary term is not effective unless and until the lessee receives confirmation from BOEM. A lessee that has earned the 8-year primary term by spudding a well with a hydrocarbon target below 25,000 feet TVDSS during the standard 5-year primary term of the lease will not be granted a suspension for that same period under the regulations at 30 CFR 250.175 because the lease is not at risk of expiring.
2. The primary term for a lease in water depths ranging from 400 meters to less than 800 meters is 5 years. If the lessee spuds a well within the first 5 years of the lease, the lessee may earn an additional 3 years, resulting in an 8-year primary term. To earn the 8-year primary term, the lessee is required to submit a letter to the BOEM GOA Regional Supervisor, Office of Leasing and Plans, as soon as practicable, but no more than 30 days after spudding a well, providing the well number and spud date, and requesting confirmation from BOEM that the lessee earned the 8-year extended primary term. Within 30 days of receipt of the request, the BOEM GOA Regional Supervisor for Leasing and Plans will provide written confirmation of whether the lessee has earned the extended primary term and accordingly update BOEM's records. The extended primary term is not
3. The primary term for a lease in water depths 800 meters or deeper is 10 years.
Pursuant to Section 50102(b)(1)(A) of the OBBBA, the minimum bonus bids are the same as those used in Lease Sale 254. BOEM will not accept a bonus bid unless it provides for a cash bonus in an amount equal to or exceeding the specified minimum bid, as described below.
• $25 per acre or fraction thereof for blocks in water depths less than 400 meters; and
• $100 per acre or fraction thereof for blocks in water depths 400 meters or deeper.
Pursuant to Section 50102(b)(1)(A) of the OBBBA, rental rates are the same as those used in Lease Sale 254. Annual rental rates, per acre or fraction thereof, are summarized in the following table:
Any lessee with a lease in less than 400 meters water depth who earns an 8-year primary term will pay an escalating rental rate as shown above. The rental rates after the fifth year for blocks in less than 400 meters water depth will become fixed and no longer escalate if another well is spudded targeting hydrocarbons below 25,000 feet TVDSS after the fifth year of the lease, and BOEM concurs that such a well has been spudded. In this case, the rental rate will become fixed at the rental rate in effect during the lease year in which the additional well was spudded.
Pursuant to Section 50102(b)(1)(A) of the OBBBA, the minimum royalty rates are the same as those used in Lease Sale 254:
• $7.00 per acre or fraction thereof per year for blocks in water depths less than 200 meters; and
• $11.00 per acre or fraction thereof per year for blocks in water depths 200 meters or deeper.
The royalty rate is the minimum allowed by Section 50102(b)(1)(C) of the OBBBA:
• 12
Pursuant to Section 50102(b)(1)(A) of the OBBBA, the royalty suspensions offered in this sale are the same as those offered in Lease Sale 254. The Department may issue leases with Royalty Suspension Volumes (RSVs) under 30 CFR part 560, which BOEM administers. The specific details relating to eligibility and implementation of RSVs and other royalty relief programs are found at 30 CFR part 203, which the Bureau of Safety and Environmental Enforcement administers.
Pursuant to 30 CFR part 203, certain leases issued because of this sale may be eligible for RSV incentives on gas produced from ultra-deep wells. Under this program, wells on leases in less than 400 meters water depth and completed to a drilling depth of 20,000 feet TVDSS or deeper receive an RSV of 35 billion cubic feet on the production of natural gas. This RSV incentive is subject to applicable price thresholds set forth in the regulations at 30 CFR part 203. These regulations implement the requirements of the Energy Policy Act of 2005 (Pub. L. 109-58, 119 Stat. 594 (2005)).
Pursuant to Section 50102(b)(1)(A) of the OBBBA, BOEM must use the same lease stipulations 4 through 9 that were provided in the Lease Sale 254 Final NOS. BOEM has updated Stipulations 1, 2, 3, and 10, where applicable, to reflect current conditions in the GOA.
One or more of the stipulations below may be applied to leases issued in this sale. The applicable blocks for each stipulation are identified on the map entitled, “Final Gulf of America Oil and Gas Lease Sale BBG2, March 2026, Stipulations and Deferred Blocks,” which is included in the Final NOS package. The full text of the following stipulations is contained in the “Lease Stipulations” section of the Final NOS package. BOEM has posted the final list of blocks available for bid and the applicable stipulations that apply to those blocks on its website at
Information to Lessees (ITLs) provide detailed information on certain issues pertaining to specific oil and gas lease sales. The full text of the ITLs for this sale is contained in the “Information to Lessees” section of the Final NOS package and covers the following topics:
The maps pertaining to this lease sale can be viewed on BOEM's website at
The sale area is shown on the map entitled, “Final Oil and Gas Sale Area for Sale BBG2.”
The lease terms and economic conditions associated with leases of certain blocks are shown on the map entitled, “Final Gulf of America Oil and Gas Lease Sale BBG2, March 2026, Lease Terms and Economic Conditions.”
The lease stipulations and the blocks to which they apply are shown on the map entitled, “Final Gulf of America Oil and Gas Lease Sale BBG2, March 2026, Stipulations and Deferred Blocks.”
Prior to the bid submission deadline, bids may be submitted through any parcel delivery service (
Instructions on how to submit a bid, secure payment of the advance bonus bid deposit (if applicable), and the information to be included with the bid are as follows:
For each block bid upon, a separate sealed bid must be submitted in a sealed envelope (as described below) and include the following items:
• Total amount of the bid in whole dollars only;
• Sale number;
• Sale date;
• Each bidder's exact name;
• Each bidder's proportionate interest, stated as a percentage, using a maximum of five decimal places (
• Typed name and title, and signature of each bidder's authorized officer. Electronic signatures are acceptable. The typed name, title, and signature must agree exactly with the name and title on file in the BOEM Gulf of America OCS Region Adjudication Section;
• Each bidder's BOEM qualification number;
• Map name and number or OPD name and number;
• Block number; and
• Statement acknowledging that the bidder(s) understands that this bid legally binds the bidder(s) to comply with all applicable regulations, including the requirement to post a deposit in the amount of one-fifth of the bonus bid amount for any tract bid upon and make payment of the balance of the bonus bid and first year's rental upon BOEM's acceptance of high bids.
The information required for each bid is specified in the document “Bid Form” that is available in the Final NOS package, which can be found at
Each bid must be submitted in a separate sealed envelope labeled as follows:
• “Sealed Bid for GOA Region-wide Sale BBG2, not to be opened until 9 a.m. Wednesday, March 11, 2026”;
• Map name and number or OPD name and number;
• Block number for block bid upon;
• Acreage, if the bid is for a block that is split between the Central and Eastern Planning Areas; and
• The exact name and qualification number of the submitting bidder only.
The Final NOS package includes a sample bid envelope for reference.
Please address the envelope containing the sealed bid envelope(s) as follows:
Bidders
Bidders who are not currently an OCS oil and gas lease record title holder or designated operator, or those who have ever defaulted on a one-fifth bonus bid deposit, must guarantee (secure) the payment of the one-fifth bonus bid deposit, by Electronic Funds Transfer (EFT) or otherwise,
• Provide a third-party guarantee;
• Amend a development stage area-wide bond via bond rider;
• Provide a letter of credit; or
• Provide a lump sum payment in advance via EFT.
Please provide, at the time of bid submittal, a confirmation or tracking number for the payment, the name of the company submitting the payment as it appears on the payment, and the date the payment was submitted so that BOEM can confirm payment with the
If providing a third-party guarantee, amending a development stage area-wide bond via bond rider, or providing a letter of credit to secure your one-fifth bonus bid deposit, bidders are urged to file these documents with BOEM well in advance of submitting the bid. This allows processing time and ensures bidders have time to take any necessary curative actions prior to bid submission. For more information on EFT procedures, see Section X, “The Lease Sale.”
The GDIS is composed of five parts:
1. A “Statement” page that includes the company representatives' information and separate lists of blocks bid on that used proprietary data and those blocks bid upon that did not use proprietary data;
2. A “Table” listing the required data about each proprietary survey used (see below);
3. A “Survey Parameter Worksheet” listing acquisition geometry, frequency range, fold coverage and processing methods for each survey (see below);
4. “Maps,” which contain the live trace maps for each proprietary survey and fast-track survey that are identified in the GDIS statement and table; and
5. “Proprietary geophysical and fast-track SEGY”, not submitted previously to BOEM, needs to be submitted along with the GDIS.
Any bidder who used proprietary seismic data not previously submitted to BOEM to evaluate a block in Lease Sale BBG2—or who is a joint bidder on such a bid—must submit all five parts of the GDIS at the time of bid submission. If only speculative seismic data was used, the bidder must submit the GDIS Form and GDIS Table listing all speculative data used for each block. A bidder must submit the GDIS
The bidder and joint bidder must submit the GDIS in a separate and sealed envelope and must identify all proprietary data; reprocessed speculative data, and/or any Controlled Source Electromagnetic surveys, Amplitude Versus Offset (AVO) data, gravity data, and/or magnetic data; or other data or information used as part of the decision to bid or participate in a bid on the block.
The bidder and joint bidder must also include a live trace map (
The GDIS statement must include the name, phone number, and full address for a contact person and an alternate, who are both knowledgeable about the geophysical information and data listed and who are available for 30 days after the sale date. The GDIS statement must also include a list of all blocks bid upon, including those blocks where no proprietary or reprocessed geophysical data and/or proprietary information was used, as a basis for the bidder's decision to bid or to participate as a joint bidder in the bid. All bidders must submit the GDIS statement even if no proprietary geophysical data or information was used in its bid preparation for the block.
Examples of the preferred format of the table and parameter worksheet are included in the Final NOS package, and a blank digital version of the preferred table and Survey Parameter Worksheet can be accessed on the Lease Sale BBG2 website at
• The sale number;
• The bidder's company name;
• The joint bidder's company name (if applicable);
• The company providing proprietary data to BOEM;
• The block area and block number bid upon;
• The owner of the original data set (
• The industry's original name of the survey (
• The BOEM permit number for the survey;
• Whether the data set is a fast-track version; BOEM will request all fast-track data;
• Whether the data is speculative or proprietary;
• The data type (
• The migration algorithm (
• The live proprietary survey coverage (2-D miles 3-D blocks);
• The computer storage size, to the nearest gigabyte, of each seismic data and velocity volume used to evaluate the lease block;
• Who reprocessed the data;
• The date on which the final reprocessing was completed (month and year);
• If the data was previously sent to BOEM, list the sale number and date of the sale for which it was used;
• Whether proprietary or speculative AVO/AVA (PROP/SPEC) was used;
• The date on which the AVO or AVA was sent to BOEM, if it was sent before the sale;
• Whether AVO/AVA is time or depth (PSTM or PSDM);
• Which angled stacks were used (
• Whether the company used Gathers to evaluate the block in question; and
• List of other Geophysical Data methods used to evaluate the bid block (
BOEM will use the computer storage size information to estimate the reproduction costs for each data set, if applicable. BOEM will determine the availability of reimbursement of production costs consistent with 30 CFR 551.13.
BOEM reserves the right to inquire about alternate data sets, perform quality checks, and compare the listed and alternative data sets to determine which data set most closely meets the needs of the fair market value determination process. See the “Example of Preferred Format” that is included in the Final NOS package.
The BOEM GOA Region now requires bidders to submit a completed electronic version of the Survey Parameters Worksheet alongside any Seismic Survey submittal. This worksheet plays a critical role in supporting BOEM's Fair Market Value (FMV) Evaluation Methodology, which
By supplying detailed parameters—such as acquisition geometry, frequency range, fold coverage, and processing methods—bidders provide BOEM with the context necessary to:
• Qualitatively assess the degree of geological understanding obtained from the survey;
• Evaluate the quality and resolution of seismic imaging, which can directly influence the identification of leads and prospects;
• Determine the likelihood of successful hydrocarbon identification, by considering how the data may mitigate or highlight geological risks;
• Identify geophysical phenomena (
• Assess the commercial implications of the survey in supporting new play concepts or de-risking known trends.
Ultimately, the inclusion of this worksheet enhances the transparency and technical rigor behind BOEM's FMV assessments. It ensures that economic evaluations are informed by the best available subsurface data and geological interpretations, helping to safeguard the public interest in OCS resource development.
Bidders are encouraged to complete the worksheet with care and accuracy, as it will directly inform BOEM's ability to fairly and accurately evaluate lease block value based on current geoscientific insight.
Glossary of Terms in order the terms appear in the Seismic Parameter Worksheet:
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• Velocity Anisotropy Used? Type? (HTI, VTI, TTI, other, none). List the type of anisotropy used in the velocity.
• For Sub-Stack Volumes, list class and offset or angle range per volume. (Example, Mid Offset Range: 5000′-7000′ or Mid Angle Range: 24deg-30deg). Use a separate line for each sub-stack volume. Include the angle or offset range.
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• TTI (Tilted Transverse Isotropy) performed (yes, no, unknown). If TTI applied, indicate Yes or No.
• Is Inversion Speculative or Proprietary (Prospect Specific)? Is the Inversion speculative or proprietary?
The GDIS maps are live trace maps (
Pursuant to 30 CFR 551.12 and 556.501, as a condition of the sale, the BOEM GOA RD requests that all bidders and joint bidders submit the proprietary data and fast-track data identified on their GDIS along with their bid and GDIS packet.
This includes any proprietary data or fast-track data that has not been provided previously to BOEM. Commercially available speculative data should not be submitted to BOEM unless specifically requested by BOEM. If the bidder is not sure whether the data has been provided previously, the bidder should send the proprietary or fast-track. BOEM requires all data that are considered proprietary and fast-track to be submitted for the evaluation of the bid blocks.
The proprietary and fast-track data must be submitted to BOEM at the following address: Bureau of Ocean Energy Management, Resource Studies, 1201 Elmwood Park Boulevard MS-266A, New Orleans, Louisiana 70123-2394. Please deliver to Mr. Greg Purvis or Mrs. Renee Bigner, 2nd Floor, immediately.
BOEM recommends that bidders mark the submission's external envelope as “Deliver Immediately to DASPU.” BOEM also recommends that bidders submit the GDIS data and Survey Parameter Worksheet in an internal envelope, or otherwise marked, with the following designation: “Geophysical Data and Information Statement for Oil and Gas Lease Sale BBG2, Company Name, GOA Company Qualification Number, and “Proprietary Data.”
In the event a person supplies any type of data to BOEM, that person must meet the following requirements to qualify for reimbursement:
1. Must be registered with the System for Award Management (SAM), formerly known as the Central Contractor Registration (CCR). CCR usernames will not work in SAM. A new SAM user account is needed to register or update an entity's records. The website for registering is
2. Must be enrolled in the U.S. Treasury's Invoice Processing Platform (IPP) for electronic invoicing; to enroll go to
3. Must have a current Online Representations and Certifications Application at
Bidders should refer to the “Acceptance, Rejection, or Return of Bids” heading under Section X, “The Lease Sale,” regarding a bidder's failure to comply with the requirements of the Final NOS, including any failure to submit information required in the Final NOS package.
BOEM requests that bidders provide this information in the suggested format prior to or at the time of bid submission. The suggested format is included in the Final NOS package. The form must not be enclosed inside the sealed bid envelope.
BOEM may require bidders to submit other documents in accordance with 30 CFR 556.107, 556.401, 556.501, and 556.513.
On November 4, 2025, BOEM published the most recent List of Restricted Joint Bidders in the
All signatories executing documents on behalf of the bidder(s) must execute the same in conformance with the BOEM qualification records. Bidders are advised that BOEM considers the signed bid to be a legally binding obligation on the part of the bidder(s) to comply with all applicable regulations, including the required payment of one-fifth of the bonus bid on all high bids. A statement to this effect is included on each bid form (see the document “Bid Form and Envelope” that is included in the Final NOS package).
BOEM warns bidders against violation of 18 U.S.C. 1860, which prohibits unlawful combination or intimidation of bidders.
Bids may only be withdrawn by written request delivered to BOEM via any parcel delivery service, or in-person prior to the bid submission deadline. Withdrawals will not be accepted via email. The withdrawal request must be on company letterhead and must contain the bidder's name, its BOEM qualification number, the map name and number, and the block number(s) of the bid(s) to be withdrawn. The withdrawal request must be executed by one or more of the representatives named in the BOEM qualification records. The name and title of the authorized signatory must be typed under the signature block on the withdrawal request. The BOEM GOA RD, or the RD's designee, will indicate approval by signing and dating the withdrawal request.
Minimum bonus bid calculations, including rounding, for all blocks are shown in the document “List of Blocks Available for Leasing” that is included in the Final NOS package. The bonus bid amount must be stated in whole dollars. If the acreage of a block contains a decimal figure, then prior to calculating the minimum bonus bid, BOEM will round up to the next whole acre. The appropriate minimum rate per acre will be applied to the whole (rounded up) acreage. The bonus bid amount must be greater than or equal to the minimum bonus bid, as calculated and stated in the Final NOS package.
The Final NOS package includes instructions, samples, and/or the preferred format for the items listed below. BOEM strongly encourages bidders to use the recommended formats. If bidders use another format, they are responsible for including all the information specified for each item in the Final NOS package.
Sealed bids received in response to the Final NOS will be opened at the place, date, and hour specified under the
Each bidder submitting an apparent high bid must submit a bonus bid deposit to ONRR equal to one-fifth of the bonus bid amount for each such bid. A copy of the notification of the high bidder's one-fifth bonus bid amount can be obtained on the BOEM website at
Bidders must submit payment to their financial institution as soon as possible on the day of bid reading and no later than 7:00 p.m. Eastern Time on the day of bid reading. This will help ensure that deposits have time to process through the U.S. Treasury and post to ONRR. ONRR cannot confirm payment until the monies have been moved into settlement status by the U.S. Treasury.
BOEM requires bidders to use EFT procedures for payment of one-fifth bonus bid deposits for Lease Sale BBG2, following the detailed instructions contained on the ONRR Payment Information web page at
The United States reserves the right to withdraw any block from this lease sale before issuance of a written acceptance of a bid for the block.
The United States reserves the right to reject any and all bids, regardless of the amount offered. Furthermore, no bid will be accepted, and no lease for any block will be awarded to any bidder, unless:
1. The bidder has complied with all applicable regulations and requirements of the Final NOS, including those set forth in the documents contained in the Final NOS package;
2. The bid is the highest valid bid; and
3. The amount of the bid has been determined to be adequate by the authorized officer.
Any bid submitted that does not conform to the requirements of the Final NOS, OCSLA, or other applicable statutes or regulations will be rejected and returned to the bidder. The United States Department of Justice and the Federal Trade Commission will review the results of the lease sale for any antitrust issues prior to the acceptance of bids and issuance of leases.
To ensure that the U.S. Government receives fair market value for the conveyance of leases from this sale, BOEM will evaluate high bids in accordance with the bid adequacy procedures that are effective on the date of the sale. This is the second lease sale to use the revised bid adequacy procedures that BOEM finalized in 2024. The bid adequacy procedures are available on BOEM's website at
BOEM requires each bidder who is awarded a lease to complete the following:
1. Execute all copies of the lease (Form BOEM-2005 [February 2017], as amended);
2. Pay by EFT the balance of the bonus bid amount and the first year's rental for each lease issued in accordance with the requirements of 30 CFR 1218.155 and 556.520(a); and
3. Satisfy the bonding requirements of 30 CFR part 556, subpart I, as amended.
ONRR requests that bidders use only one transaction for payment of the balance of the bonus bid amount and the first year's rental. Once ONRR receives such payment, the bidder awarded the lease may not request a refund of the balance of the bonus bid amount or first year's rental payment.
The BOEM GOA RD has the discretion to change any date, time, and/or location specified in the Final NOS package if the RD deems that an emergent event could interfere with a fair and orderly lease sale. Such events could include, but are not limited to, natural disasters (
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission (“Commission”) has determined to review in part a final initial determination (“Final ID”) of the presiding administrative law judge (“ALJ”). The Commission requests written submissions, submissions from the parties, interested government agencies, and other interested persons on the issues of remedy, the public interest, and bonding, under the schedule set forth below.
Joelle Justus, Esq., Office of the General
The Commission instituted this investigation on August 30, 2024, based on a complaint filed by Infineon Technologies Americas Corp. of El Segundo, California, and Infineon Technologies Austria AG of Villach, Austria (collectively, “Complainants” or “Infineon”). 89 FR 70667-68 (Aug. 30, 2024). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain semiconductor devices and products containing the same by reason of infringement of claims 1-4, 6, 9, and 17 of U.S. Patent No. 9,899,481 (“the '481 patent”); claims 1, 2, 8-10, and 13-15 of U.S. Patent No. 8,686,562 (“the '562 patent”); claims 1-4, 8, and 9 of U.S. Patent No. 9,070,755 (“the '755 patent”); and claims 1, 2, and 10 of U.S. Patent No. 8,264,003 (“the '003 patent”).
On November 4, 2024, the Commission determined not to review an initial determination granting Complainants' unopposed motion to amend the complaint and notice of investigation to correct the corporate title of Respondent Innoscience (Suzhou) Technology Co., Ltd. to Innoscience (Suzhou) Technology Holding Co., Ltd.
On December 2, 2025, the ALJ issued the Final ID finding a violation of section 337 by Innoscience with respect to the '481 patent, and no violation with respect to the '755 patent. The Final ID finds,
The ALJ also issued a recommended determination (“RD”) on remedy and bonding. The RD recommends that, if the Commission were to find a violation, it should issue a limited exclusion order as well as and cease and desist orders against the Respondents based on their significant U.S. inventory and significant U.S. operations. The RD further recommends that the Commission issue a bond of one hundred (100) percent.
On December 15, 2025, Innoscience filed a petition for review of the Final ID's finding of violation as to the '481 patent. That same day, Infineon filed a petition for review of the Final ID's finding of no violation as to the '755 patent. The parties filed responses to the petitions on December 23, 2025.
Having reviewed the record of the investigation, including the Final ID, the parties' submissions to the ALJ, the petitions for review, and the responses thereto, the Commission has determined to review the Final ID in part. Specifically, the Commission has determined to review the Final ID's findings as to the '481 patent regarding claim construction of “lateral transistor devices,” infringement, technical and economic prongs of the domestic industry requirement, and validity. The Commission has determined not to review the remainder of the Final ID.
In connection with its review, the Commission requests responses to the following questions. The parties are requested to brief their positions with reference to the applicable law and the existing evidentiary record.
1. With respect to whether claims 1-3 and 6 of the '481 patent are rendered obvious by Nega in combination with Roberts:
a. Have Respondents met their burden to show a reasonable likelihood of success? In answering this question, please address, in addition to any other relevant considerations, Infineon's arguments regarding the complexities of packaging design (including such factors as thermal control and current conductions).
b. If the Commission finds that Respondents have made a
2. Does the record permit a quantitative and qualitative assessment of the significance of complainant's domestic industry investments/expenses that takes into account all non-U.S. activities, including manufacturing, related to the DI products? Examples of such a quantitative assessment include a comparison of domestic with foreign investments; a value-added analysis; or a comparison of domestic investments to total value of, or revenue (U.S., global, or both) from, the DI products. In answering this question, please address the appropriate use of the data in CDX-0005C.25.
The parties are invited to brief only the discrete issues requested above. The parties are not to brief other issues on review, which are adequately presented in the parties' existing filings.
In connection with the final disposition of this investigation, the statute authorizes issuance of,
The statute requires the Commission to consider the effects of that remedy upon the public interest. The public interest factors the Commission will consider include the effect that an exclusion order and cease and desist orders would have on: (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.
In connection with the consideration of the public interest, the Commission requests responses from the parties to the following question:
1. Please identify which, if any, of the '481 patent accused products are subject to the remedial orders in Investigation No. 337-TA-1366.
2. Please identify with supporting facts and data the share of the U.S. market for the '481 patent accused products, and also delineate the market share for any '481 patent accused products that are not subject to the remedial orders in Investigation No. 337-TA-1366. Please also identify with supporting facts and data the share of the U.S. market for the Infineon '481 patent DI products, as well as other suppliers and whether these suppliers have the capability to supply U.S. demand in the event of an exclusion order and/or cease and desist orders.
3. Please explain with supporting facts and data the extent to which competitors' products are reasonable substitutes for the accused products.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission's determination.
In its initial submission, Complainant is also requested to identify the remedy sought and to submit proposed remedial orders for the Commission's consideration. Complainant is further requested to state the date that the '481 patent expires, to provide the HTSUS subheadings under which the accused products are imported, and to supply the identification information for all known importers of the products at issue in this investigation. All initial written submissions, from the parties and/or third parties/interested government agencies, and proposed remedial orders from the parties must be filed no later than close of business on February 17, 2026. All reply submissions must be filed no later than the close of business on February 24, 2026. Opening submissions from the parties are limited to 30 pages. Reply submissions from the parties are limited to 15 pages. All submission from third parties and/or interested government agencies are limited to 10 pages. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above pursuant to 19 CFR 210.4(f). Submissions should refer to the investigation number (Inv. No. 337-TA-1414) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. Any non-party wishing to submit comments containing confidential information must serve those comments on the parties to the investigation pursuant to the applicable Administrative Protective Order. A redacted non-confidential version of the document must also be filed with the Commission and served on any parties to the investigation within two business days of any confidential filing. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS.
The Commission vote for this determination took place on February 2, 2026.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Polaris Inc., Polaris Industries Inc., and Polaris Sales Inc. on February 2, 2026. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain off-road vehicles and components thereof. The complaint names as a respondents: Zhejiang CFMOTO Power Co., Ltd. of China; and CFMOTO Powersports, Inc. of Plymouth, Minnesota. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, members of the public, and interested government agencies are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3883”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of AX Wireless, LLC on February 2, 2026. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain laptops, routers and gateways, and components thereof. The complaint names as a respondents: ASUSTeK Computer Inc. (Taiwan) of Taiwan; ASUS Computer International, Inc. of Fremont, CA; TP-Link Systems Inc. of Irvine, CA; D-Link Corporation of Taiwan; D-Link Systems, Inc. of Irvine, CA; and Ubiquiti Inc. of New York, NY. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, members of the public, and interested government agencies are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3882”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the
By order of the Commission.
U.S. Copyright Office, Library of Congress.
Public notice.
The U.S. Copyright Office is announcing receipt of notices of intent to conduct audits pursuant to the section 115 blanket license.
Rhea Efthimiadis, Assistant to the General Counsel, by email at
The Orrin G. Hatch-Bob Goodlatte Music Modernization Act (“MMA”) substantially amended the compulsory “mechanical” license for reproducing and distributing phonorecords of nondramatic musical works, including by creating a new blanket license administered by a mechanical licensing collective (“MLC”).
On December 26, 2025, the MLC submitted a notice of intent to conduct audits for the following DMPs for the period beginning on January 1, 2022 and ending on December 31, 2024:
1.
2. MedRhythms, Inc.; and
3. Music Health Pty Ltd.
A copy of each notice will be made available on the Office's website at
U.S. Small Business Administration.
Notice.
This is notice of an Economic Injury Disaster Loan (EIDL) declaration for the state of Louisiana dated February 2, 2026.
Issued on February 2, 2026.
Jennifer Talarico, Office of Disaster Recovery and Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given as a result of the Administrator's EIDL declaration, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for economic injury is 214300.
The states which received an EIDL declaration are Arkansas, Louisiana, Mississippi.
February 5, 2026, 12:00 p.m. to 3:00 p.m., Eastern Time.
The meeting will be accessible via conference call and via Zoom Meeting and Screenshare. Any interested person may call (i) 1-929-205-6099 (US Toll) or 1-669-900-6833 (US Toll), Meeting ID: 981 4482 4972, to listen and participate in this meeting. The website to participate via Zoom Meeting and Screenshare is
This meeting will be open to the public.
The Unified Carrier Registration Plan Board of Directors (the “Board”) will continue its work in developing and implementing the Unified Carrier Registration Plan and Agreement. The subject matter of this meeting will include:
The UCR Board Chair will welcome attendees, call the meeting to order, call roll for the Board, confirm the presence of a quorum, and facilitate self-introductions.
The UCR Executive Director will verify publication of the meeting notice on the UCR website and distribution to the UCR contact list via email, followed by subsequent publication of the notice in the
The proposed Agenda will be reviewed. The Board will consider action to adopt.
➢ Board actions taken only in designated areas on the agenda.
Draft Minutes from the December 3, 2025, UCR Board meeting will be reviewed. The Board will consider action to approve.
Draft Minutes from the December 18, 2025, UCR Board meeting will be reviewed. The Board will consider action to approve.
A Federal Motor Carrier Safety Administrator (FMCSA) Representative will introduce to the UCR Plan Board. The FMCSA will provide a report on any relevant agency activity.
The FMCSA Deputy Administrator will ask the Board to evaluate the extent of the Board's statutory oversight requirements and/or responsibilities to ensure that participating states use entitlement revenue in accordance with 49 U.S.C. 14504a(e)(1)(B), and whether the Board's current compliance procedure is adequate. Specifically, participating states are required to use an amount at least equal to the revenue derived from the Unified Carrier Registration Agreement for motor carrier safety programs, enforcement, or the administration of the UCR plan and UCR agreement. The Board may take action on a proposal to require each participating state to demonstrate their use of UCR Plan entitlement revenue in accordance with 49 U.S.C. 14504a(e)(1)(B).
No report.
No report.
The UCR Education and Training Subcommittee Chair will provide an update on key projects and initiatives, including the ongoing development of the learning management program and training modules, awareness and engagement efforts for various stakeholders, and the optimization of the website and newsletter.
The UCR Enforcement Subcommittee Chair and Vice-Chair will provide an update on current and planned initiatives, including efforts to enhance UCR enforcement efficiency, and recognition of states and inspectors.
The UCR Finance Subcommittee Chair and UCR Depository Manager will provide an update on the UCR Plan's 2024 External Financial Audit.
The UCR Finance Subcommittee Chair and UCR Depository Manager will provide an update on UCR finances and related topics.
No report.
The UCR Governance Task Force Chair will provide an update on topics to include the UCR agreement, motor carrier regulatory review requirements and other related governance topics.
The UCR Executive Director will provide a report covering his recent activity for the UCR Plan.
The UCR Chief of Staff will provide a management update covering any additional activity for the Depository, Operations, and Communications.
DSL Transportation Services, Inc. will report on the latest data from the FARs program, Tier 5 and 6 unregistered motor carriers, and other matters.
Seikosoft will provide an update on its recent/new activity related to the UCR's National Registration System.
The UCR Chief Legal Officer will provide a report covering the status of the Petition For Review filed by the Small Business in Transportation Coalition, Inc. in the United States Court of Appeals for the District of Columbia Circuit involving the UCR Plan.
The UCR Board Chair will call for any other business, old or new, from the floor.
The UCR Board Chair will adjourn the meeting.
The agenda will be available no later than 5:00 p.m. Eastern daylight time, January 28, 2026, at:
Elizabeth Leaman, Chair, Unified Carrier Registration Plan Board of Directors, (617) 305-3783,