Animal and Plant Health Inspection Service
Food and Nutrition Administration
National Oceanic and Atmospheric Administration
Defense Acquisition Regulations System
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
Fish and Wildlife Service
Mine Safety and Health Administration
Wage and Hour Division
Federal Aviation Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Comptroller of the Currency
Foreign Assets Control Office
Internal Revenue Service
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Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the non-medicated topical formulation for treatment of erectile dysfunction into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the non-medicated topical formulation for treatment of erectile dysfunction. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
This order is effective July 27, 2026. The classification was applicable on June 9, 2023.
Mark Antonino, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2618, Silver Spring, MD 20993-0002, 240-402-9980,
Upon request, FDA (the Agency or we) has classified the non-medicated topical formulation for treatment of erectile dysfunction into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.
On October 21, 2022, FDA received Futura Medical Developments Limited's request for De Novo classification of the Eroxon device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the
Therefore, on June 9, 2023, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 876.5021.
FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for non-medicated topical formulations for treatment of erectile dysfunction. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) The device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Condom compatibility;
(ii) Temperature profile evaluation; and
(iii) Verification of device specifications.
(3) Performance data must support the shelf life of the device by demonstrating the device meets its specifications over the identified shelf life.
(4) Labeling must include:
(i) Information regarding compatibility with condoms;
(ii) An expiration date;
(iii) A statement that the product is not a contraceptive;
(iv) Information for the correct diagnosis of erectile dysfunction; and
(v) Dosage and frequency of use.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the active noise attenuation system for infant incubators. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
This order is effective July 27, 2026. The classification was applicable on June 16, 2023.
Gang Peng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2424, Silver Spring, MD 20993-0002, 301-348-1960,
Upon request, FDA (the Agency or we) has classified the active noise attenuation system for infant incubators into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.
On July 25, 2022, FDA received Invictus Medical, Inc.'s request for De Novo classification of the Neoasis device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on June 16, 2023, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 880.5405.
FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for active noise attenuation systems for infant incubators. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Non-clinical performance testing under anticipated conditions of use must demonstrate that the device performs as intended, including:
(i) Verification and validation of critical acoustic parameters, including the maximum output of the device;
(ii) Verification and validation of the attenuation performance of the device, including:
(A) Testing with compatible incubator model(s) and dimensions;
(B) Attenuation performance testing simulating different infant locations and orientations within the incubator; and
(C) Testing with relevant noise sources and room configurations.
(2) Software validation, verification, and hazard analysis must be performed.
(3) Electrical safety and electromagnetic compatibility testing must be performed for any electrical components of the device.
(4) The patient- or user-contacting components of the device must be demonstrated to be biocompatible.
(5) Labeling for the device must include:
(i) Instructions for infant placement and the expected attenuation performance of the device;
(ii) Warnings regarding the risks of exposure to the potential maximum output of the device;
(iii) Methods and instructions for cleaning and disinfection; and
(iv) Identification of the incubator(s) that the device is intended to be used with.
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is adopting a final rule to update website and contact information in certain parts of the Code of Federal Regulations (CFR). Additionally, OFAC is amending one CFR Part to update general licenses authorizing payments for legal services from funds originating outside the United States to replace the reporting requirement in the general license with a recordkeeping requirement and correcting typographical errors in two CFR Parts. OFAC is also updating its
This rule is effective July 27, 2026.
OFAC: Assistant Director for Regulatory Affairs, 202-622-4855; or
This document and additional information concerning OFAC are available on OFAC's website:
In this rule, OFAC is updating contact information by removing a phone number or office name or replacing a website address in the following places in 31 CFR chapter V: parts 501, 510, 525, 526, 536, 544, 546, 547, 548, 549, 550, 551, 552, 553, 555, 558, 560, 561, 562, 566, 569, 570, 576, 578, 579, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591, 594, 596, 598, and 599 and appendix A to chapter V. Additionally, OFAC is updating general licenses authorizing payments for legal services from funds originating outside the United States to replace the reporting requirement in the general license with a recordkeeping requirement in part 546. In the Hostages and Wrongful Detention Sanctions Regulations, 31 CFR part 526, OFAC is correcting an erroneous cross-reference in note 1 to § 526.201 to remove the words “part 501 of” from “appendix A to part 501 of this chapter.” Lastly, OFAC is amending parts 553 and 598 to correct typographical errors.
Because the Regulations involve a foreign affairs function, the provisions of E.O. 12866 of September 30, 1993, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), as amended, and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of E.O. 14192 of January 31, 2025, “Unleashing Prosperity Through Deregulation” (90 FR 6065, February 6, 2025) and E.O. 14219 of February 19, 2025, “Ensuring Lawful Governance and Implementing the President's “Department of Government Efficiency” Deregulatory Initiative” (90 FR 10583, February 25, 2025) are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banks, banking, Blocking of assets, Credit, Foreign trade, Hostage-taking, Hostages, Penalties, Reporting and recordkeeping requirements, Sanctions, Securities, Services, Wrongful detention.
For the reasons set forth in the preamble, OFAC amends 31 CFR chapter V as follows:
8 U.S.C. 1189; 18 U.S.C. 2332d, 2339B; 19 U.S.C. 3901-3913; 21 U.S.C. 1901-1908; 22 U.S.C. 287c, 2370(a), 6009, 6032, 7205, 8501-8551; 31 U.S.C. 321(b); 50 U.S.C. 1701-1706, 4301-4341; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note).
(d) * * *
(2) * * * If a submitter can provide evidence of unique and extraordinary circumstances that would not allow the submitter to report electronically, such as lack of access to the internet, the submitter may request to submit reports in an alternative manner by contacting OFAC at
(d) * * * If a submitter can provide evidence of unique and extraordinary circumstances that would not allow the submitter to use ORS, such as lack of access to the internet, the submitter may request to submit reports in an alternative manner by contacting OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
(a) * * *
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 28 U.S.C. 2461 note (Pub. L. 101-410, 104 Stat. 890, as amended); E.O. 14014, 86 FR 9429, 3 CFR, 2021 Comp., p. 514.
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 22 U.S.C. 1741
The revision reads as follows:
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
(a) * * *
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13067, 62 FR 59989, 3 CFR, 1997 Comp., p. 230; E.O. 13400, 71 FR 25483, 3 CFR, 2006 Comp., p. 220; E.O. 14098, 88 FR 29529.
* * * Inquiries regarding any such order should be directed to OFAC at
(b)
(1) The individual or entity from whom the funds originated and the amount of funds received; and
(2) If applicable:
(i) The names of any individuals or entities providing related services to the U.S. person receiving payment in connection with authorized legal services, such as private investigators or expert witnesses;
(ii) A general description of the services provided; and
(iii) The amount of funds paid in connection with such services.
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
(a) * * *
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
(a) * * *
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 22 U.S.C. 287c; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 18 U.S.C. 2339B, 2332d; 22 U.S.C. 2349aa-9, 7201-7211, 8501-8551, 8701-8795; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12613, 52 FR 41940, 3 CFR, 1987 Comp., p. 256; E.O. 12957, 60 FR 14615, 3 CFR, 1995 Comp., p. 332; E.O. 12959, 60 FR 24757, 3 CFR, 1995 Comp., p. 356; E.O. 13059, 62 FR 44531, 3 CFR, 1997 Comp., p. 217; E.O. 13599, 77 FR 6659, 3 CFR, 2012 Comp., p. 215; E.O. 13846, 83 FR 38939, 3 CFR, 2018 Comp., p. 854.
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 8501-8551, 8701-8795; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12957, 60 FR 14615, 3 CFR, 1995 Comp., p. 332; E.O. 13553, 75 FR 60567, 3 CFR, 2010 Comp., p. 253; E.O. 13599, 77 FR 6659, 3 CFR, 2012 Comp., p. 215; E.O. 13846, 83 FR 38939, 3 CFR, 2018 Comp., p. 854; E.O. 13871, 84 FR 20761, 3 CFR, 2019 Comp., p. 309.
3 U.S.C. 301; 18 U.S.C. 2332d; 22 U.S.C. 8501-8551; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12957, 60 FR 14615, 3 CFR, 1995 Comp., p. 332; E.O. 13553, 75 FR 60567, 3 CFR, 2010 Comp., p. 253; E.O. 13871, 84 FR 20761, 3 CFR, 2019 Comp., p. 308.
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 114-102, 129 Stat. 2205 (50 U.S.C. 1701 note); Pub. L. 115-272, 132 Stat. 4144 (50 U.S.C. 1701 note).
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
The revision reads as follows:
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 22 U.S.C. 287c; 31 U.S.C. 321(b); 50 U.S.C. 1601
(a) * * *
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 22 U.S.C. 10101-10103; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 116-145, 134 Stat. 651, as amended (22 U.S.C. 6901 note); Pub. L. 117-78, 135 Stat. 1531 (22 U.S.C. 6901 note); E.O. 13818, 82 FR 60839, 3 CFR, 2017 Comp., p. 399.
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
(a) * * *
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13959, 85 FR 73185, 3 CFR, 2020 Comp., p. 475; E.O. 14032, 86 FR 30145.
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 22 U.S.C. 8901-8910, 8921-8930; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 115-44, 131 Stat. 886 (codified in scattered sections of 22 U.S.C.); E.O. 13660, 79 FR 13493, 3 CFR, 2014 Comp., p. 226; E.O. 13661, 79 FR 15535, 3 CFR, 2014 Comp., p. 229; E.O. 13662, 79 FR 16169, 3 CFR, 2014 Comp., p. 233; E.O. 13685, 79 FR 77357, 3 CFR, 2014 Comp., p. 313., E.O. 13849, 3 CFR, 2018 Comp., p. 875, E.O. 14065, 87 FR 10293, 3 CFR, 2022 Comp., p. 340.
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Public Law 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Public Law 113-278, 128 Stat. 3011 (50 U.S.C. 1701 note); E.O. 13692, 80 FR 12747, 3 CFR, 2015 Comp., p. 276; E.O. 13808, 82 FR 41155, 3 CFR, 2017 Comp., p. 377; E.O. 13827, 83 FR 12469, 3 CFR, 2018 Comp., p. 794; E.O. 13835, 83 FR 24001, 3 CFR, 2018 Comp., p. 817; E.O. 13850, 83 FR 55243, 3 CFR, 2018 Comp., p. 881; E.O. 13857, 84 FR 509, 3 CFR, 2019 Comp., p 251; E.O. 13884, 84 FR 38843, 3 CFR, 2019 Comp., p. 351.
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 22 U.S.C. 287c; 22 U.S.C. 9404-9411; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Public Law 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Public Law 114-102, 129 Stat. 2205, as amended (50 U.S.C. 1701 note); Public Law 115-348, 132 Stat. 5055 (50 U.S.C. 1701 note); E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13268, 67 FR 44751, 3 CFR 2002 Comp., p. 240; E.O. 13284, 68 FR 4075, 3 CFR, 2003 Comp., p. 161; E.O. 13372, 70 FR 8499, 3 CFR, 2006 Comp., p. 159; E.O. 13886, 84 FR 48041, 3 CFR, 2019 Comp., p. 356.
* * * Inquiries regarding any such order should be directed to OFAC at
18 U.S.C. 2332d; 22 U.S.C. 7201-7211; 31 U.S.C. 321(b).
3 U.S.C. 301; 21 U.S.C. 1901-1908; 31 U.S.C. 321(b); Public Law 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note).
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 21 U.S.C. 2301
* * * Inquiries regarding any such order should be directed to OFAC at
3 U.S.C. 301; 8 U.S.C. 1182, 1189; 18 U.S.C. 2339B; 21 U.S.C. 1901-1908; 22 U.S.C. 287c; 31 U.S.C. 321(b); 22 U.S.C. 9201-9255; 22 U.S.C. 10101-10103; 50 U.S.C. App. 1-44; Public Law 110-286, 122 Stat. 2632 (50 U.S.C. 1701 note); Public Law 111-195, 124 Stat. 1312 (22 U.S.C. 8501-8551); Public Law 112-81, 125 Stat. 1298 (22 U.S.C. 8513a); Public Law 112-158, 126 Stat. 1214 (22 U.S.C. 8701-8795); Public Law 112-208, 126 Stat. 1502 (22 U.S.C. 5811 note); Public Law 113-278, 128 Stat. 3011 (50 U.S.C. 1701 note); Public Law 114-102, 129 Stat. 2205 (50 U.S.C. 1701 note); Public Law 114-194, 130 Stat. 674 (50 U.S.C. 1701 note); Public Law 115-44, 131 Stat. 886 (codified in scattered sections of 22 U.S.C.).
In addition to accessing information through OFAC's website, the public may contact OFAC at
Notes: * * *
5. Notices of blocking, designation, identification, and delisting actions are published in the
7. The SDN List incorporates the names of vessels owned by blocked persons, which are themselves blocked. SDN List entries for blocked vessels, which include the notation “(vessel),” are incorporated into the SDN List. Except in limited circumstances, financial institutions are instructed to reject any funds transfer referencing a blocked vessel and must notify OFAC through the OFAC Reporting System, available on OFAC's website,
Federal Communications Commission.
Final rule.
In this document, the Federal Communications Commission (Commission or FCC) adopted a
Svantje Swider, Office of International Affairs, Telecommunications and Analysis Division, at
This is a summary of the Commission's
In this
We adopt a regulatory framework for SLTE owners and operators to execute our duties to protect national security under the Cable Landing License Act and Executive Order 10530. Cable Landing License Act of May 27, 1921, Public Law 8, 67th Cong., ch. 12, § 1, 42 Stat. 8 (1921) (codified as amended at 47 U.S.C. 34-39) (Cable Landing License Act); Executive Order 10530, sec. 5(a). We find it critical to include SLTE owners and operators as licensed entities on submarine cables landing in the United States. First, we find that the Cable Landing License Act and Executive Order 10530 authorize the Commission to regulate entities that own and/or operate SLTE on a submarine cable connecting to the United States. Second, we adopt a blanket license for SLTE owners and operators not otherwise currently licensed under our submarine cable rules. This blanket license approach combined with tailored routine conditions avoids imposing requirements comparable to current cable landing licensee rule requirements prior to the one-time information collection. Third, to protect national security and law enforcement interests, we exclude from the grant of this blanket license any entity that would not be qualified to hold a cable landing license under our presumptive disqualifying conditions. Fourth, we require SLTE owners and operators to adhere to a subset of routine conditions for cable landing licensees, among other requirements, to comply with Commission rules and regulations, file annual Section 43.82 circuit capacity reports, and create, implement, and update cybersecurity and physical security risk management plans. Finally, for situations where submarine cables contain SLTEs that are owned and/or operated by foreign adversary-controlled entities and/or Covered List entities at the time the rules become effective, SLTE owners and operators must file an SLTE Foreign Adversary Annual Report. This annual reporting requirement will structure transparency tools to help the Commission maintain consistent oversight over submarine cable operations, including those SLTEs associated with foreign adversary interests. Our actions today are the initial steps in our application of the submarine cable licensing regime to SLTE owners and operators given the technological advancements in today's modern submarine cable systems. We anticipate conducting the one-time information collection adopted in the
We build on the Commission's submarine cable modernization effort started in the
We adopt certifications and routine conditions that will prohibit the following: (1) the use of principal equipment that is produced (including any major stage of the process through which the device is made, including manufacturing, assembly, design, and development) by foreign adversary-controlled entities in a submarine cable system; (2) the use of third-party service providers that are foreign adversary-controlled entities, entities identified on the Covered List, or entities that can access the submarine cable from a foreign adversary country, and (3) licensees, their customers, and further downstream customers from entering into IRUs and capacity lease arrangements with entities identified on the Covered List, where such arrangement would give such entity (
We take action to streamline and expedite the processing of submarine cable applications while still ensuring the security and integrity of submarine cable systems in partnership with the Committee Members. First, we establish a set of ten national security standards that, if met, will qualify a submarine cable application to be presumptively exempt from referral to the Executive Branch agencies. These national security standards in combination will ensure an applicant adheres to the highest level of protective measures to mitigate national security, law enforcement, foreign policy, and/or trade policy concerns. Second, we exclude from referral to the Executive Branch agencies certain renewal or extension applications where the Commission referred and the Executive Branch agencies reviewed an application previously filed by the applicant within three (3) years of the filing of the renewal or extension application. We find that reducing the number of applications that are referred to the Committee will provide regulatory certainty and reduce delays for applicants while decreasing administrative burdens on the U.S. government by prioritizing the review of applications that present significant national security and law enforcement concerns. Overall, our actions will promote faster submarine cable deployment, reduce administrative and regulatory burden on both the U.S. government and licensees, and yield greater resilience in U.S. submarine cable connectivity.
The rules adopted today are necessary to enhance our national security and to ensure that the United States maintains its leadership position in advanced technology, including artificial intelligence (AI). Carrying the vast majority of transcontinental digital communications, submarine cables serve as the foundational backbone of the global internet. The SLTE is the equipment on both ends of the submarine cable system that converts optical signals to electrical signals and vice versa, thereby connecting undersea transmission with terrestrial transmission of telecommunications traffic. Thus, an entity that owns or operates SLTE is able to affect the operation of the submarine cable system, whether or not it holds an ownership interest in the overall cable system. Therefore, an entity affiliated with a foreign adversary that owns or operates SLTE in the United States introduces a similar risk to national security as if the entity owned the submarine cable itself. Potential vulnerabilities in this type of situation include threats of physical disruption, manipulation of service, overt attacks, as well as interception of unencrypted traffic.
In addition to addressing vulnerabilities associated with SLTE, the
The rules adopted in the
The
As noted above, SLTE plays a critical role in the overall functioning of a cable system as it converts optical signals from submarine cables into electric signals that can be carried by terrestrial networks. The mandatory licensing of all SLTE owners and operators should increase the Commission's ability to monitor the strategic chokepoints where a large volume of traffic passes through, ensuring that foreign adversaries cannot achieve significant access and control of the United States submarine cable network. As the Commission noted in the
The routine conditions adopted in the
The
The requirement that all SLTE owners and operators develop cybersecurity and physical security risk management plans should help to ensure that SLTE owners and operators follow best practices to mitigate risk. We note, however, that to balance our goal of safeguarding critical infrastructure with the goal of reducing administrative burdens, in the
Submarine cables are estimated to carry as much as 99% of intercontinental internet traffic and serve as the backbone to global communications. The international submarine cable network facilitates more than $10 trillion financial transactions globally each day and the volume of data carried by submarine cables is dramatically increasing, including an increasing amount of confidential and sensitive data. Even a temporary, localized disruption to data passing through submarine cables would likely result in very substantial economic losses. Although both the risk of such losses and the quantitative harms of such losses are difficult to measure, on an annual basis, we find that they are likely well in excess of the annual costs that we estimate would be associated with our rules.
We estimate that the actions adopted today will impose costs totaling approximately $39.2 million in the first year and $10.7 million in subsequent years. These costs include one-time and recurring costs that SLTE owners and operators are expected to incur as a result of becoming licensees as well as additional recurring costs that existing and new licensees would incur.
We estimate that there are approximately 3,136 SLTE owners and operators that will be subject to blanket licensing. We conservatively estimate this number by estimating that each of the 98 U.S. licensed cables has 16 fiber pairs, which each require 2 SLTEs (98 × 16 × 2 = 3,136). New SLTE owners and operators that do not qualify for blanket licensing will be required to file as applicants for a cable landing license under the Cable Landing License Act. We estimate that approximately 320 SLTE owners and operators will require a new license each year, and that at most, one-fifth of new SLTE owners and operators would be subject to the character and/or foreign adversary presumptions that would require them to incur the cost of applying for an individual license because they would not qualify for a blanket license. We conservatively estimate the number of new licensees under the blanket license as 320 = 16 fiber pairs per cable × 2 SLTEs per fiber pair × 10 submarine cables, where the number of submarine cables is based on the average annual number of applications during 2022-2024. In the
In addition, all SLTE owners and operators will be subject to routine conditions designed to enhance transparency and security. These include the requirement to file annual circuit capacity reports, which we estimate will cost up to $3 million per year, and the requirement to create, update, and implement a cybersecurity and physical security risk management plan consistent with Section 1.70006(c) of our rules, for a one-time cost of approximately $28.5 million. We estimate a per applicant cost of $972 based on the Commission's estimates of circuit capacity report costs as represented in previous PRA statements. Thus, the $3 million annual cost is based on $972 × 3,136 SLTE owners and operators = $3,048,192, which we round to $3 million. Note that we do not add the 320 new SLTE owners and operators to this estimate because of likely overlap between this and the initial 3,136 figure as well as due to our expectation that other owners and operators may leave the market. International Section 214 Authorizations—47 CFR 63.10-63.25, 1.40001, and 1.40003, OMB Control No. 3060-0686 Paperwork Reduction Act (PRA) Supporting Statement at 10 (Apr. 01, 2024), In the
We estimate a cost of approximately $51,000 per year across all licensees associated with new applicant certifications and notifications required under the adopted rules—such as changes in address or coordinates, intent not to renew, system retirement, and certifications related to foreign adversary ownership or Covered List changes. We estimate that preparation of the notification of intent of non-renewal of license, notification of submarine cable system retirement, certification of change in foreign adversary ownership, certification of change to the Department of Commerce's list of foreign adversaries, and certification of change to the Commission's Covered List will each require 2 hours of work by an attorney and 2 hours of work by support staff. We estimate that the cost of outside legal assistance is $300 per hour and the cost of in-house staff is $40 per hour, making the cost of preparing one notification or certification approximately $680 (($300 × 2 hours) + ($40 × 2 hours) = $680). Assuming 15 filings per type per year (for a total of 75 filings), the annual cost is approximately $51,000 ($680 × 75 filings = $51,000). Our cost data on wages for attorneys are based on the Commission's estimates of labor costs as represented in previous PRA statements. We do not anticipate substantial costs associated with the remaining routine conditions. With respect to the prohibition on cable landing licensees using any equipment in the operation of the submarine cable system that is produced by any entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, we note that the
Finally, the Commission has taken steps to significantly reduce compliance costs for licensees while advancing national security objectives. For example, the
In sum, we estimate that the actions adopted in this
Under this alternative, the Commission would either decline to adopt any new rules governing Submarine Line Terminal Equipment (SLTE) owners and operators and would maintain the existing submarine cable licensing framework without modification or only take limited actions that would not entail licensing of SLTE owners and operators. First, we note that, as discussed in section III.A.1 and III.A.3, the
Failure to modernize the regulatory approach would leave the submarine cable network vulnerable to otherwise avoidable security threats, reduce the Commission's visibility into entities with operational control of critical infrastructure, and allow continued use of foreign-adversary-produced equipment without adequate oversight. Moreover, the limited-or-no-action option would fail to realize potential gains in transparency, national security, and supply-chain integrity. For these reasons, we find that taking no action is not a recommended option and would be inferior to the adopted rules, which meaningfully reduce vulnerabilities while minimizing compliance burdens.
Under this alternative, which we adopt, the Commission sets up a comprehensive framework requiring all SLTE owners and operators to be licensees, subject to a blanket license with exclusions for entities meeting foreign adversary or character disqualifying conditions. These rules subject SLTE owners and operators to a variety of routine conditions, which among other things, include obtaining Section 214 authority to handle telecommunications to or from the United States; the filing of annual circuit capacity reports per Section 43.82; creating, implementing, and updating cybersecurity and physical security risk management plans; and for entities subject to certain foreign adversary criteria, filing SLTE Foreign Adversary Annual Reports.
New and existing licensees will also be subject to certain prohibitions, including on use of “principal equipment” or third party services when, for instance, these are provided by any entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary. We note that the use of third party services is subject to a narrow exemption for wet-segment repair and maintenance to address a relative dearth of specialized cable repair ships available and the reality that problems on the submarine cable systems may occur outside the territorial waters of the United States. New and existing licensees will also be subject to various other routine conditions described in section IV of this Appendix. The adopted rules also streamline application review for lower-risk applicants by establishing ten national security standards that, if met, will qualify a submarine cable application to be presumptively exempt from referral to the Executive Branch agencies.
This alternative would differ from Alternative B, which we adopt, in two respects: (1) by requiring the removal and replacement of covered list equipment, (2) by foregoing the wet segment exemption for third-party service providers.
First, as discussed in section VI of this Appendix, while the
As we note above, the
We find that the changes being adopted in the
Based on the record and economic analysis, Staff find that Alternative B—SLTE Licensing and Targeted National Security Safeguards—offers the greatest net benefit among the three alternatives considered. This combination of rules to bolster national security with respect to our nation's submarine cable systems, coupled with targeted exemptions to limit burdens on licensees recognizes the need to take action to safeguard national security while foregoing actions where the incremental cost may outweigh the incremental benefit.
The rules adopted in this
As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Federal Communications Commission (Commission) incorporated an Initial Regulatory Flexibility Analysis (IRFA) in the
The
In this
No specific comments on the IRFA were made on the record; however, commenters addressed the potential impact of the Commission's proposed rules in the
A commenter raised concerns about small business impacts in response to potential Commission requirements to remove and replace certain equipment in the submarine cable system, and shared observations from previous “rip and replace” requirements in other settings. The commenter also raised concerns about potential impacts to small and medium-sized licensees that would need to determine the entities in their global supply chain that would be prohibited from being used in the “submarine cable infrastructure.” Other commenters raised concerns about the burden on SLTE owners and operators to become licensees or to submit reports; submarine cable licensees to submit certifications and reports; and of customized existing mitigation agreements instead of standardized mitigation.
The Commission responded to the concerns of commenters by not adopting some of the proposals from the
Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel for the Small Business Administration (SBA) Office of Advocacy, and also provide a detailed statement of any change made to the proposed rules as a result of those comments. The Chief Counsel did not file any comments in response to the proposed rules in this proceeding.
The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the adopted rules. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA. The SBA establishes small business size standards that agencies are required to use when promulgating regulations relating to small businesses; agencies may establish alternative size standards for use in such programs, but must consult and obtain approval from SBA before doing so.
Our actions, over time, may affect small entities that are not easily categorized at present. We therefore describe three broad groups of small entities that could be directly affected by our actions. In general, a small business is an independent business having fewer than 500 employees. These types of small businesses represent 99.9% of all businesses in the United States, which translates to 34.75 million businesses. Next, “small organizations” are not-for-profit enterprises that are independently owned and operated and are not dominant in their field. While we do not have data regarding the number of non-profits that meet that criteria, over 99 percent of nonprofits have fewer than 500 employees. Finally, “small governmental jurisdictions” are defined as cities, counties, towns, townships, villages, school districts, or special districts with populations of less than fifty thousand. Based on the 2022 U.S. Census of Governments data, we estimate that at least 48,724 out of 90,835 local government jurisdictions have a population of less than 50,000.
The rules adopted in the
The RFA directs agencies to describe the economic impact of adopted rules on small entities, as well as projected reporting, recordkeeping and other compliance requirements, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record.
This
We estimate that the compliance cost for the new rules is no more than approximately $28.5 million in one-time costs and $10.7 million per year for licensees. This figure includes all additional expected costs that would be incurred as a result of the rules adopted in this
The RFA requires an agency to provide, “a description of the steps the agency has taken to minimize the significant economic impact on small entities . . . including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.”
The Commission has taken steps to significantly reduce compliance costs for licensees while advancing national security objectives. In response to commenter input, we reduced the regulatory burden on the industry by declining to adopt a requirement to
As noted above, commenters highlighted the need to tailor requirements to actual risks, particularly as they relate to prohibiting foreign adversary-affiliated third-party service providers for time-sensitive operations. In response, we adopt an exception for wet-segment repair and maintenance, addressing the primary operational concern and preventing significant cost increases. We also adopt a national security exemption process that will generate cost savings for qualifying applicants and impose no costs on other applicants by avoiding the expense and delay of Executive Branch referral of applications. Those applications that meet the national security standards adopted in the
The Commission will send a copy of the
Communications, Communications common carriers, Communications equipment, internet, Security measures, Reporting and recordkeeping requirements, Telecommunications.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 0 and 1 as follows:
47 U.S.C. 151, 154(i), 154(j), 155, 225, 409, and 1754, unless otherwise noted.
(a) * * *
(16) Authority is delegated to OIA, in consultation with the Public Safety and Homeland Security Bureau, the Committee Members as defined in § 1.70001(l), and other federal agencies, as needed, to adopt necessary policies and procedures to make determinations regarding submarine cable licensing and policy matters, including through clarifications, declaratory rulings, and further guidance.
47 U.S.C. chs. 2, 5, 9, 13; 28 U.S.C. 2461 note; 47 U.S.C. 1754, unless otherwise noted.
(a) * * *
(1) The Commission will generally refer to the Executive Branch agencies applications filed for an international section 214 authorization and submarine cable landing license as well as an application to assign, transfer control of, or modify those authorizations and licenses where the applicant has reportable foreign ownership and petitions for section 310(b) foreign ownership rulings for broadcast, common carrier wireless, and common carrier satellite earth station licenses pursuant to Subpart FF and §§ 63.18 and 63.24 of this chapter, and 1.5000 through 1.5004.
(2) * * *
(v) Applications filed pursuant to § 1.70020 of this chapter where:
(A) The applicant(s) is a cable landing licensee of the submarine cable system
(B) The applicant(s) previously filed an application involving the same submarine cable system that was referred to and reviewed by the Executive Branch agencies within three years of the filing of the renewal or extension application. To the extent there are multiple licensees of the submarine cable system, all of the licensees must have jointly filed a previous application that was reviewed by the Executive Branch agencies within three years of the instant filing;
(C) There is a mitigation agreement on which the cable landing license is conditioned, and the applicant(s) certifies that it is in compliance and will continue to comply with the terms of the mitigation agreement;
(D) There are no new individuals or entities that hold ten percent or greater direct or indirect equity and/or voting interests, or a controlling interest, in any applicant(s) since that prior review by the Executive Branch agencies; and
(E) The applicant(s) is not owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), and certifies that it is not subject to the presumptive disqualifying conditions in §§ 1.70002(c) and
1.70004(a) and (b).
(b) To presumptively qualify for exemption from referral to the Executive Branch agencies, an applicant, or in the case of an application jointly filed by multiple applicants, each joint applicant, must certify that it meets the national security standards set forth below in an application for a cable landing license or modification, assignment, transfer of control, or renewal or extension of a cable landing license:
(1) The applicant must be a licensee and certify that:
(i) It either has a cable landing license that was granted by the Commission after November 27, 2020 and is conditioned on compliance with a mitigation agreement or, starting in 2028, it was granted (within the previous five (5) years) a license that is conditioned on compliance with a mitigation agreement or was granted pursuant to the exemption process as described in § 1.40001(b);
(ii) There are no new individuals or entities that hold 10% or greater direct or indirect equity and/or voting interests, or a controlling interest, in the applicant since the most recent review by the Commission; and
(iii) It is in compliance with the terms of any existing mitigation agreement(s) on which any of its cable landing license(s) is conditioned.
(2) The applicant must certify that:
(i) No entity holding less than 5% direct interest in the submarine cable system is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g);
(ii) The applicant has not entered into and will not enter into an agreement, formal or informal, with entities owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), to secure financing (such as business loans or bonds, debts, lines of credit, debt forgiveness, or in kind contributions or services) related to or affecting the submarine cable system; and
(iii) The applicant has no strategic partnerships nor has entered or will enter into mergers with entities owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), that might affect access to and/or the management or operation of the submarine cable system.
(3) The applicant must certify that:
(i) No senior official of the applicant or the applicant's parent company(ies) meets the definition of “owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary,” as defined in § 1.70001(g), and
(ii) No senior official of the applicant or any of the applicant's parent company(ies) performs or will perform duties with respect to the submarine cable system from a foreign adversary country, as defined in § 1.70001(f).
(iii) For purposes of this paragraph (b)(3), the term “senior official” is defined as a board member or executive-level management, including an individual who performs the duties, or any of the duties, ordinarily performed by a president, vice president, secretary, treasurer, Chief Executive Officer, Chief Technical Officer, Chief Operations Officer, Chief Information Officer, and/or Chief Financial Officer, or other officer.
(iv) Individuals that perform duties indicative of executive-level management may be included for purposes of this certification, and the Commission may seek additional information from an applicant to verify its certification under this national security standard.
(4) The applicant must certify that it will prohibit its customers or any further downstream customers from entering into a new or an extension of an existing arrangement, such as for indefeasible rights of use (IRUs) or leases for capacity on the submarine cable, where such arrangement would give an entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), the ability to install, own, or manage SLTE on the submarine cable.
(i) The applicant must also certify that it will adopt contractual provisions in the arrangements described in this paragraph (b)(4) that prohibit its customers or any further downstream customers from selling, leasing out, sharing, or swapping fiber, spectrum, or capacity to or with an entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g).
(ii) [Reserved]
(5) The applicant must certify that it will:
(i) File with the Commission and the Committee Members, as the term is defined in § 1.70001(l) and used hereafter in this section, a list identifying all of its arrangements described in paragraph (b)(4) of this section and provide copies of all such arrangements within sixty (60) days of commencing service on the submarine cable, consistent with the requirements of § 1.70007(ii)(4), and
(ii) Continue filing the information in paragraph (b)(5)(i) and copies of all such arrangements with the Commission and the Committee Members as part of an annual report, consistent with the requirements of § 1.70007(ii)(4).
(6) The applicant must certify that the submarine cable system will not connect directly or via a branching unit with a submarine cable:
(i) That is owned or operated by an entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), or
(ii) That lands in a foreign adversary country, as defined in § 1.70001(f).
(7) The applicant must certify that it has created and will implement and update an enhanced cybersecurity and physical security risk management plan.
(i) The applicant must affirm, as part of the cybersecurity and physical security risk management certification
(ii) The applicant shall submit this plan to the Commission and the Committee Members at the time of filing the application. The cybersecurity and physical security risk management plans provided under this subsection shall be treated as presumptively confidential.
(8) The applicant must certify that it will:
(i) Report to the Commission and to the Committee Members in writing within seventy-two (72) hours if it learns of information that reasonably indicates unauthorized access to, or disruption or corruption of, a submarine cable system, its management servers, or any service, communications, or information being carried on a submarine cable system, or a significant attempt to gain unauthorized access to such system, service, communications, or information. This includes unauthorized access to, or disruption or corruption of, third-party service providers' (as defined in § 1.70001(d)) systems, SLTE owners' or operators' systems, or IRU holders' systems that could reasonably be expected to harm the physical or logical security of the submarine cable system. Reportable incidents include, but are not limited to, unauthorized physical or logical access to cable facilities, including but not limited to, the cable landing station space or any NOC, as defined in § 1.70001(n); unauthorized access to or disclosure of network management information; cable cuts; data compromise; or unauthorized system modification.
(ii) Submit to the Commission and Committee Members, within fifteen (15) days of learning of the incident a detailed written report describing in greater depth the incident identified in the initial report and its steps to remediate that incident.
(iii) Submit updates to the Commission and the Committee Members, as requested by the Commission, and continue providing supplementary information until the Commission's evaluation is complete.
(iv) For purposes of this § 1.40001, the term “unauthorized” is defined as in a manner without permission or that exceeds authorization. The term “access” is defined consistent with § 1.70001(i).
(9) The applicant must certify that it will implement heightened physical and logical security controls. For purposes of this section, the terms “domestic communications,” “principal equipment,” “Network Operations Center” (or “NOC”), “sensitive U.S. records” are defined consistent with § 1.70001(j), (m), (n), (o). Information provided pursuant to this subsection shall be treated as presumptively confidential. Specifically, the applicant must certify that it will implement heightened physical and logical security controls that:
(i) Meet appropriate physical security standards consistent with the Commission's rules in this paragraph (b)(9), such as taking all practicable measures to physically secure the submarine cable system, including the cable landing station(s), NOC(s), beach manholes and related sites, principal equipment, and Submarine Line Terminal Equipment (SLTEs);
(ii) Not provide any individual or entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), and/or an entity that is identified on the Covered List that the Commission maintains on its website pursuant to the Secure and Trusted Communications Networks Act of 2019 (Secure Networks Act), 47 U.S.C. 1601 through 1609, with physical and/or logical access to the submarine cable system, including but not limited to the cable landing station(s), NOC(s), beach manhole(s) and related sites, principal equipment, and SLTEs;
(iii) Not provide any individual or entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), and/or an entity that is identified on the Covered List with access to sensitive U.S. records and domestic communications;
(iv) Not provide any individual or entity located in a foreign adversary country, as defined in § 1.70001(f), with physical or logical access to the submarine cable system, sensitive U.S. records, or domestic communications;
(v) Adopt personnel screening and vetting measures for individuals whose position could involve securing principal equipment and/or physical and/or logical access to the submarine cable system (including but not limited to the cable landing station(s), NOC(s), beach manholes and related sites, principal equipment, and SLTEs), sensitive U.S. records, and/or domestic communications;
(vi) Adopt a written policy that will include, at a minimum, background investigations, public criminal records checks, or other analogous means to ascertain an individual's trustworthiness, subject to applicable law, conducted at least every five (5) years;
(vii) Ensure adherence to these requirements;
(viii) Report to the Commission and Committee Members the identities of all foreign individuals with physical and/or logical access to the submarine cable system (including but not limited to the cable landing station(s), NOC(s), beach manholes and related sites, principal equipment, and SLTEs), sensitive U.S. records, and/or domestic communications, or who secure principal equipment, within thirty (30) days of the submarine cable commencing service; and report any changes on a quarterly basis, including identifying new personnel with access and personnel who no longer have access;
(ix) Provide the Commission and the Committee Members annually in the report described in paragraph (b)(10)(iii) of this section, with the submission of the names and information on: security officers, foreign participation, security policies, owners and officers, operational requirements, locations of access, principal equipment, third-party service providers (as defined in § 1.70001(d)), foreign persons or entities with access, SLTE owners and controllers, as well as any such information requested by the Commission and/or the Committee Member from the SLTE owners and operators. Authority is delegated to the Office of International Affairs, in coordination with the Public Safety and Homeland Security Bureau and the Committee Members as needed, to determine the information to be submitted and provide further guidance;
(x) Provide advance notification of thirty (30) days to the Commission and the Committee Members and obtain the majority of the Committee Members' non-objection in writing prior to the testing, adding, or use of any sensing capability (such as distributed acoustic, thermal, seismic, or other sensing) on the submarine cable system by any person (
(A) Activities requiring advanced notice include but are not limited to:
(
(
(
(
(B) The advanced notice submitted by the entity or person must include, at a minimum, the following information:
(
(
(
(
(
(xi) Provide updates to its submarine cable system information to the Commission and the Committee Members annually and within thirty (30) days of the change, to include but not limited to:
(A) A network and fiber map or diagram that includes physical and logical topology, including any terrestrial backhaul from the cable landing stations to the SLTE locations or other facilities housing principal equipment of the submarine cable;
(B) Network and telecommunications architecture descriptions and associated descriptions of interconnection points and controlled gateways to the principal equipment; and
(C) Descriptions of interfaces and connections to the submarine cable system for service offload, disaster recovery, or administrative functions.
(10) The applicant must certify that it consents to reporting to, and ongoing monitoring and inspection by, the Commission and the Committee Members throughout the term of the cable landing license to assess its compliance with all applicable routine conditions and national security standards. The applicant must also certify that it consents to:
(i) Monitoring and inspection of the applicant's facilities where principal equipment, as defined in § 1.70001(m), is located or that support the operation of the submarine cable system's connections to or from the United States, including but not limited to the NOC, as defined in § 1.70001(n), by the Commission and/or any other relevant U.S. government agencies, including the Committee Members;
(ii) Allowing the Commission and/or the Committee Members to meet with the applicant's personnel and conduct on-site interviews and to request additional information as necessary, throughout the term of the cable landing license, to verify the implementation of and compliance with all applicable routine conditions and national security standards;
(iii) Providing the Commission and Committee Members with an annual report, and upon request by the Commission, of its compliance with all applicable routine conditions and national security standards throughout the term of the license. The report shall include updated information and identify any changes made in the reporting period to:
(A) The names and contact information of the points of contact (POCs) and security and compliance officers;
(B) Ownership and foreign participation information;
(C) A list of all officers;
(D) The locations of access for the submarine cable;
(E) All third-party service providers, principal equipment, as defined in § 1.70001(m), and foreign persons or entities with access;
(F) The names and contact information of the SLTE owners and/or operators on the submarine cable, as well as any information requested by the Commission and/or the Committee Members from the SLTE owners and/or operators;
(G) All security policies;
(H) Any operational changes and/or expansion plans for the submarine cable;
(I) A summary of any events that occurred during the reporting period that will or reasonably could impact the effectiveness of or compliance with the national security standards; and
(J) A certification that the licensee remains in compliance with all applicable routine conditions and national security standards or, if there were any known acts of noncompliance with the routine conditions and national security standards, a summary of such acts—whether inadvertent or intentional, with a discussion of what steps have been or will be taken to prevent such acts from occurring in the future.
(K) The annual report shall be submitted each year in the relevant license file number(s) in ICFS, or any successor system. A copy of the annual report shall be filed directly with the Committee Members;
(iv) Allowing the Commission and/or the Committee Members to periodically, and no more than biennially, request a third-party audit or assessment of compliance with all applicable routine conditions and national security standards;
(v) Providing the Commission and the Committee Members with the name, title, business address, email address, and telephone number of a designated Security and Compliance Officer, who serves or will serve as the primary point of contact for license and compliance matters. This officer will be responsible for implementing and maintaining the applicant's cybersecurity and physical security risk management plans and ensuring adherence to the Commission's security and compliance requirements for the cable system. The application shall include a summary of the officer's qualifications relevant to cybersecurity, physical security, and regulatory compliance.
(A) The Security and Compliance Officer shall be a U.S. citizen who is eligible for a U.S. government security clearance at the “Secret” level or higher. The Security and Compliance Officer will possess the appropriate senior-level corporate authority, reporting lines, independence, technical skills, and resources required to assess the cybersecurity, physical security, and logical security of submarine cable systems and to ensure compliance with the applicable Commission rules and regulations.
(B) The applicant shall notify the Commission and the Committee within ten (10) days of any change in the designated officer or the officer's contact information. The applicant shall agree to work with the Commission and Committee Members to resolve any national security or law enforcement concerns that the Commission or
(vi) Notifying the Commission and the Committee Members within seventy-two (72) hours of any violation of applicable routine conditions or national security standards, including a description of the violation, an explanation for why it occurred, and a description of any steps taken to remediate the violation.
(c) The Commission will consider any recommendations from the Executive Branch agencies on pending application(s) for an international section 214 authorization or cable landing license(s) or petition(s) for foreign ownership ruling(s) pursuant to §§ 1.5000 through 1.5004 or on existing authorizations or licenses that may affect national security, law enforcement, foreign policy, and/or trade policy as part of its public interest analysis. The Commission will evaluate concerns raised by the Executive Branch agencies and will make an independent decision concerning the pending matter.
(d) In any such referral pursuant to paragraph (a) of this section, or when receiving information pursuant to paragraph (b) of this section or when considering any recommendations pursuant to paragraph (c) of this section, the Commission may disclose to relevant Executive Branch agencies, subject to the provisions of 44 U.S.C. 3510, any information submitted by an applicant, petitioner, licensee, or authorization holder in confidence pursuant to § 0.457 or § 0.459 of this chapter. Notwithstanding the provisions of § 0.442 of this chapter, notice will be provided at the time of disclosure.
(e) As used in this subpart, “reportable foreign ownership” for applications filed pursuant to Subpart FF and §§ 63.18 and 63.24 of this chapter means any foreign owner of the applicant that must be disclosed in the application pursuant to § 63.18(h); and for petitions filed pursuant to §§ 1.5000 through 1.5004, “reportable foreign ownership” means foreign disclosable interest holders pursuant to § 1.5001(e) and (f).
(i)
(1) Read, divert, or otherwise obtain non-public information or technology from or about software, hardware, a system, or a network;
(2) Add, edit, or alter information or technology stored on or by software, hardware, a system, or a network; and
(3) Alter the physical or logical state of software, hardware, a system, or a network (
(j)
(1) Wire Communications, as described in 18 U.S.C. 2510(1), or Electronic Communications (whether stored or not), as described in 18 U.S.C. 2510(12), from one U.S. location to another U.S. location, and
(2) The U.S. portion of a Wire Communication or Electronic Communication (whether stored or not) that originates or terminates in the United States or its territories.
(k)
(1) Any portion of a submarine cable system that is physically located in the United States or its territories, up to and including the SLTE, including (if any) transmission, switching, bridging, and routing equipment, and any associated software (with the exception of commercial-off-the-shelf (COTS) software used for common business functions) used by or on behalf of the licensee(s) to provide, process, direct, control, supervise, or manage Domestic Communications; and
(2) Any “Network Operations Center” or “NOC,” as defined in paragraph (n) of this section.
(l)
(m)
(1) Domestic Communications Infrastructure, as defined in paragraph (k) of this section;
(2) Wet Infrastructure, as defined in paragraph (p) of this section;
(3) Servers, routers, switches, repeaters,
(4) SLTE;
(5) System supervisory equipment (SSE);
(6) Signal modulators and amplifiers;
(7) Power feed equipment (PFE);
(8) Tilt and shape equalizer units (TEQ/SEQ);
(9) Optical distribution frames (ODF);
(10) Branching units (BU);
(11) Optical splitters (OS);
(12) Switches;
(13) Multiplexers;
(14) Optical carrier network (OCx) equipment, as applicable;
(15) Fiber optic cables; and
(16) All equipment (including hardware, software, and firmware) and Network Management Systems used to support, operate, manage, monitor, secure, maintain, analyze, administer, and provision the cable system.
(n)
(o)
(p)
(e) The Commission may disclose to the Committee, Committee Members, and relevant Federal Government agencies information that is submitted pursuant to § 1.40001 and Subpart FF of this chapter. Where such information has been submitted in confidence pursuant to § 0.457 or § 0.459 of this chapter, such information may be shared subject to the provisions of § 0.442 of this chapter with the Committee and with relevant Federal Government agencies for targeted national security purposes where sharing of the information is consistent with an agency's function to protect U.S. national security and/or to protect the security, integrity, and resilience of submarine cable infrastructure. Notwithstanding the provisions of § 0.442(d)(1) of this chapter, notice will be provided at the time of disclosure.
(a)
(1) Any entity that controls a cable landing station in the United States; and
(2) All other entities owning or controlling a five percent (5%) or greater interest in the cable system and using the U.S. points of the cable system.
(b)
(1) The blanket license is subject to the routine conditions in § 1.70007(a)(1) through (3), (d), (m), (n), (gg), and (hh).
(2) [Reserved]
(c)
(1) An entity excluded from the blanket license pursuant to paragraph (c) of this section may file an application seeking to own and/or operate new SLTE on a submarine cable landing in the United States. An application filed by such entity will be subject to the presumptive disqualifying conditions in §§ 1.70002(c) and/or 1.70004(a), which the Commission reserves the discretion to apply on a cable-by-cable basis where warranted.
(2) Authority is delegated to the Office of International Affairs (OIA) to develop, in consultation with the Committee, application forms or provide alternative instructions and guidelines as necessary with regard to those entities subject to paragraph (c) of this section that seek to own and/or operate new SLTE on a submarine cable landing in the United States. OIA shall notify the Committee of any applications submitted pursuant to this paragraph (c)(2).
(e) That no principal equipment, as defined in § 1.70001(m), that is produced (including any major stage of the process through which the device is made, including manufacturing, assembly, design, and development) by any entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), will be used or added, whether by the licensee or any other entity, on the submarine cable system.
(f) That the applicant will not use any third-party service provider, as defined in § 1.70001(d), to provide services relating to the submarine cable system, that is:
(1) An entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g);
(2) An entity identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609; and/or
(3) An entity that can access the submarine cable system from a foreign adversary country, as defined in § 1.70001(f).
(4) This paragraph (f) shall not apply to a licensee that is an entity identified on the Covered List. This paragraph (f) shall not apply where any entity identified in paragraphs (f)(1) through (3) of this section is involved in providing repair and maintenance to the wet segment of a Commission-licensed submarine cable.
(g) That the applicant will not enter into a new arrangement or extend an existing arrangement, such as for Indefeasible Rights of Use (IRUs) or leases for capacity on the submarine cable system, with an entity identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609), where such arrangement would give such entity (
(h) That the applicant will comply with the requirements of § 1.80003(l)(1)(i) of this chapter.
(i) That the applicant will comply with the requirements of § 1.80003(l)(1)(ii) of this chapter.
(j) That the applicant will submit a certification, within sixty (60) days of the release of a public notice by the Commission or the Public Safety and Homeland Security Bureau announcing any new addition of equipment or services to the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609, that:
(1) Acknowledges the addition to the Covered List, irrespective of whether the entity uses such equipment or services in its submarine cable system, and
(2) Includes a brief description of how and the purpose for which such equipment or services are used on the submarine cable system, if applicable.
(k) That the applicant will notify the Commission of any change of address or geographic coordinates concerning
(u) No licensee shall add to its submarine cable system(s) under its respective license(s) equipment or services identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609; except, this part of paragraph (u) shall not apply to a licensee that is identified on the Covered List whose cable landing license was or is granted prior to November 26, 2025.
(1) A licensee whose application for a cable landing license is filed and granted after November 26, 2025, shall not use equipment or services identified on the Covered List on its submarine cable system under the license.
(i) A licensee whose modification application to add a new segment is filed and granted after November 26, 2025, shall not use equipment or services identified on the Covered List on the new segment and the new landing point.
(ii) [Reserved]
(2) [Reserved]
(i) [Reserved]
(ii) [Reserved]
(w) The licensee shall not:
(1) Enter into a new or extension of an existing arrangement for Indefeasible Rights of Use (IRUs) or leases for capacity on submarine cable systems landing in the United States, where such arrangement for IRUs or lease for capacity would give an entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), the ability to install, own, or manage SLTE on a submarine cable landing in the United States, unless so authorized by the Commission.
(i) A licensee may petition the Commission for waiver of the condition; however, any waiver of the condition would be granted only to the extent the licensee demonstrates by clear and convincing evidence that a new or extension of an existing arrangement for IRUs or lease for capacity subject to this subpart would serve the public interest and would present no risks to national security or that the national security benefits of granting the waiver would substantially outweigh any risks.
(ii) [Reserved]
(2) [Reserved]
(u) * * * No principal equipment, as defined in § 1.70001(m), that is produced (including any major stage of the process through which the device is made, including manufacturing, assembly, design, and development) by any entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), shall be added, whether by the licensee or any other entity, to a Commission-licensed submarine cable system.
(2) A licensee whose application for a cable landing license is filed and granted after [effective date of the amendatory instruction 11], shall ensure that no principal equipment, as defined in § 1.70001(m), that is produced (including any major stage of the process through which the device is made, including manufacturing, assembly, design, and development) by any entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), is used or added, whether by the licensee or any other entity, on its licensed submarine cable system.
(i) A licensee whose modification application to add a new segment is filed and granted after [effective date of the amendatory instruction 11], shall ensure that no principal equipment, as defined in § 1.70001(m), that is produced (including any major stage of the process through which the device is made, including manufacturing, assembly, design, and development) by any entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), is used on or added to the new segment(s) and/or landing station(s) of the submarine cable system, whether by the licensee or any other entity.
(ii) [Reserved]
(w) * * *
(2) Enter into a new arrangement or extend an existing arrangement, such as for IRUs or leases for capacity on the licensed submarine cable system, with an entity identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609, where such arrangement would give such entity (
(y) The licensee shall notify the Commission of any change of address or geographic coordinates concerning information provided under § 1.70005(e)(7) and (f), within thirty (30) days of the change. The licensee must submit a specific description of the updated information, including an updated map and geographic data in generally accepted GIS formats or other formats. Authority is delegated to the Office of International Affairs, in coordination with the Office of Economics and Analytics, to determine the specific file formats and data fields which will be collected and to ensure standardization of the information requested from the licensee.
(z) The licensee must notify the Commission, within sixty (60) days prior to the date of the expiration of the cable landing license, if the licensee does not intend to seek renewal or extension of the license. The notification shall be filed under the relevant license file number in the Commission's International Communications Filing System (ICFS), or any successor system. This requirement will be met if a licensee submits an application to renew or extend the license or requests Special Temporary Authority to continue operating the submarine cable system within or earlier than sixty (60) days prior to the date of license expiration.
(aa) The licensee must notify the Commission, within sixty (60) days prior to any retirement of its submarine cable system, of the planned retirement of the submarine cable system. The notification shall be filed under the relevant license file number in the Commission's International Communications Filing System (ICFS), or any successor system.
(bb) The licensee shall comply with the requirements of § 1.80003(l)(1)(i) of this chapter.
(cc) The licensee shall comply with the requirements of § 1.80003(l)(1)(ii) of this chapter.
(dd) The licensee must submit a certification, within sixty (60) days of
(1) Acknowledges the addition to the Covered List, irrespective of whether the entity uses such equipment or services in its submarine cable system, whether or not the licensee uses such equipment or services in its submarine cable system, and
(2) Includes a brief description of how and the purpose for which such equipment or services are used on the submarine cable system, if applicable.
(ee) No licensee shall enter into a new or extension of an existing arrangement with any third-party service provider for the provision of services relating to the submarine cable system that is identified in paragraphs (ee)(1)(i) through (iii) of this section, except as otherwise specified in paragraph (ee)(1)(iv).
(1) A licensee whose application for a cable landing license is filed and granted after [effective date of amendatory instruction 11] shall not use a third-party service provider, as defined in § 1.70001(d), to provide services relating to submarine cable, that is identified in paragraphs (ee)(1)(i) through (iii) of this section, except as otherwise specified in paragraph (ee)(1)(iv).
(i) An entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g);
(ii) An entity identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609; and/or
(iii) An entity that can access the submarine cable system from a foreign adversary country, as defined in § 1.70001(f).
(iv) This paragraph (ee) shall not apply to a licensee that is an entity identified on the Covered List. This paragraph (ee) shall not apply where any entity described in paragraphs (ee)(1)(i) through (iii) of this section is involved in providing repair and maintenance to the wet segment of a Commission-licensed submarine cable.
(2) [Reserved]
(ff) Within thirty (30) days of initiating a service by a third-party service provider that is identified in § 1.70007(ee)(1)(i) through (iii) for the repair and maintenance of the wet segment of the licensed submarine cable, the licensee must file a letter certifying as to the information in paragraphs (ff)(1) through (9) of this section. The letter must be signed by an officer of the licensee and may be filed on a confidential basis. The licensee shall file the letter under the relevant license file number in the Commission's International Communications Filing System (ICFS), or any successor system.
(1) The name and address of the third-party service provider and link to the company website, if available;
(2) The name of the licensed cable system and the segment for which the service was provided;
(3) Identify the location where the service was provided, including if the service was provided at sea or from a certain country or if service was remotely provided;
(4) The start and end date of the repair and/or maintenance service or estimated end date and a description of the service provided, including whether the service was due to an emergency or routine maintenance;
(5) Whether the third-party service provider is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), is an entity identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609, and/or is an entity that can access the submarine cable from a foreign adversary country, as defined in § 1.70001(f);
(6) The country of organization of the third-party service provider;
(7) Identify the foreign adversary country, as defined in § 1.70001(f), from where the entity can access the submarine cable, if applicable;
(8) Whether the ship or vessel was produced in a foreign adversary country, as defined in § 1.70001(f); and
(9) Whether the crew of the ship or vessel at the time that the service was provided consisted of any national of a foreign adversary country, as defined in § 1.70001(f), and the number of crew.
(gg) A licensee subject to § 1.70003 and criteria under § 1.70018 shall submit an SLTE Foreign Adversary Annual Report every year consistent with the requirements under § 1.70018.
(hh) A licensee subject to § 1.70003(b) must create, implement, and update a cybersecurity and physical security risk management plan applicable to its SLTE operations. The cybersecurity and physical security risk management plan shall meet basic requirements consistent with paragraphs (hh)(1) through (3) of this section.
(1) The plan must describe how the entity takes or will take reasonable measures to employ its organizational resources and processes to ensure the confidentiality, integrity, and availability of its systems and services that could affect its provision of communications services through the SLTE portion of the submarine cable system;
(2) The plan must identify the cyber risks that the entity faces, the controls it uses or plans to use to mitigate those risks, and how it ensures that these controls are applied or will be applied effectively to its operations; and
(3) The plan must address both logical and physical access risks, as well as supply chain risks.
(4) The licensee shall submit cybersecurity and physical security risk management plans to the Commission upon request. The Office of International Affairs, in coordination with the Public Safety and Homeland Security Bureau, may request, at their discretion, submission of such cybersecurity and physical security risk management plans and evaluate them for compliance with paragraph (hh) of this section. The cybersecurity and physical security risk management plans provided under this paragraph (hh) shall be treated as presumptively confidential.
(ii) A licensee whose application was exempted from referral to the Executive Branch agencies pursuant to § 1.40001(b), shall comply with the national security standards, as set forth in paragraphs (ii)(1) through (9) of this section, upon which the cable landing license is conditioned. A licensee's failure to comply with these national security standards or resolve compliance concerns shall constitute grounds for revocation and/or termination of the cable landing license.
(1) The licensee shall ensure that:
(i) No entity holding less than 5% direct interest in the submarine cable system is owned by, controlled, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g);
(ii) The licensee has not entered into and will not enter into an agreement, formal or informal, with entities owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), to secure financing (such as business loans or bonds, debts, lines of credit, debt forgiveness, or in kind contributions or services) related to or affecting the submarine cable system; and
(iii) The licensee has no strategic partnerships nor has entered or will enter into mergers with entities owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g),
(2) The licensee shall ensure that:
(i) No senior official of the licensee or the licensee's parent company(ies) meets the definition of “owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary,” as defined in § 1.70001(g), and
(ii) No senior official of the licensee or any of the licensee's parent company(ies) performs or will perform duties with respect to the submarine cable system from a foreign adversary country, as defined in § 1.70001(f).
(iii) For purposes of complying with this paragraph (ii)(2), the licensee shall rely on the definition and terms set forth in § 1.40001(b)(3).
(3) The licensee shall ensure that it will prohibit its customers or any further downstream customers from entering into a new or extension of an existing arrangement, such as for IRUs or leases for capacity on the submarine cable, where such arrangement would give an entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), the ability to install, own, or manage SLTE on the submarine cable.
(i) To meet this national security standard, the licensee shall adopt contractual provisions in the arrangements described in this paragraph (ii)(3) that prohibit its customers or any further downstream customers from selling, leasing out, sharing, or swapping fiber, spectrum, or capacity to or with an entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g).
(ii) [Reserved]
(4) The licensee shall:
(i) File with the Commission and the Committee Members, as the term is defined in § 1.70001(l) and used hereafter in this section, a list identifying all of its arrangements described in paragraph (iii)(3) of this section, including the legal name, Employer Identification Number (EIN) (if available), website, and the physical address of the headquarters of each contracting party and the type and duration of each arrangement, and provide copies of all such arrangements within sixty (60) days of commencing service on the submarine cable. The licensee must also identify in this filing whether or not each contracting entity is “owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary,” as defined in § 1.70001(g), and whether or not each arrangement gives any such entity the ability to install, own, or manage SLTE on a submarine cable landing in the United States.
(ii) Continue filing the information in paragraph (ii)(4)(i) and copies of all such arrangements with the Commission and the Committee Members as part of an annual report required under paragraph (ii)(9)(iii) of this section. The annual report must also identify any such arrangements that ended as of the licensee's most recent annual report and identify which arrangements are new as of the most recent report.
(iii) The information provided under this section shall be treated as presumptively confidential.
(iv) Authority is delegated to OIA to request, at its discretion, submission of any arrangements subject to paragraph (ii)(4) of this section by the licensee(s) and to evaluate them for compliance with the national security standards in this § 1.70007(ii).
(5) The licensee shall ensure that the submarine cable system will not connect directly or via a branching unit with a submarine cable:
(i) That is owned or operated by an entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), or
(ii) That lands in a foreign adversary country, as defined in § 1.70001(f).
(6) The licensee shall ensure that it has created and will implement and update an enhanced cybersecurity and physical security risk management plan consistent with the requirements set out in § 1.40001(b)(7).
(i) OIA, in consultation with the Public Safety and Homeland Security Bureau (PSHSB), may require the licensee, upon request, to submit the cybersecurity and physical security risk management plan to the Commission and Committee Members to assess whether the licensee is in compliance with the national security standard. The cybersecurity and physical security risk management plans provided under this subsection shall be treated as presumptively confidential.
(ii) [Reserved]
(7) The licensee shall ensure that it will:
(i) Report to the Commission and to the Committee Members in writing within seventy-two (72) hours if it learns of information that reasonably indicates unauthorized access to, or disruption or corruption of, a submarine cable system, its management servers, or any service, communications, or information being carried on a submarine cable system, or a significant attempt to gain unauthorized access to such system, service, communications, or information being carried on a submarine cable system, or a significant attempt to gain unauthorized access to such system, service, communications, or information. This includes unauthorized access to, or disruption or corruption of, third-party service providers' (as defined in § 1.70001(d)) systems, SLTE owners' or operators' systems, or IRU holders' systems that could reasonably be expected to harm the physical or logical security of the licensee's submarine cable system. Reportable incidents include, but are not limited to, unauthorized physical or logical access to cable facilities, including but not limited to, the cable landing station space or any NOC, as defined in § 1.70001(n); unauthorized access to or disclosure of network management information; cable cuts; data compromise; or unauthorized system modification.
(ii) Submit to the Commission and Committee Members within fifteen (15) days of learning of the incident a detailed written report describing in greater depth the incident identified in the initial report and its steps to remediate that incident.
(iii) Submit updates to the Commission and the Committee Members, as requested by the Commission, and continue providing supplementary information until the Commission's evaluation is complete.
(iv) Authority is delegated to the Public Safety and Homeland Security Bureau to consult with the Committee Members to determine how licensees will submit the required incident reports, including the reporting submission and review platform and the required reporting fields, and to seek comment and adopt rules relating to such reporting for the purpose of implementing the Commission's requirement.
(v) For purposes of this paragraph (ii)(7), the term “unauthorized” is defined as in a manner without permission or that exceeds authorization. The term “access” is defined consistent with § 1.70001(i).
(8) The licensee shall implement heightened physical and logical security controls. For purposes of this paragraph (ii)(8), the terms “domestic communications,” “principal equipment,” “Network Operations Center” (or “NOC”), “sensitive U.S. records” are defined consistent with § 1.70001(j), (m), (n), (o). Information provided pursuant to this subsection shall be treated as presumptively confidential. Specifically, the licensee
(i) Meet appropriate physical security standards consistent with the Commission's rules in this paragraph (ii)(8), such as taking all practicable measures to physically secure the submarine cable system, including the cable landing station(s), NOC(s), beach manholes and related sites, principal equipment, and SLTEs;
(ii) Not provide any individual or entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), and/or an entity that is identified on the Covered List, that the Commission maintains on its website pursuant to the Secure and Trusted Communications Networks Act of 2019 (Secure Networks Act), 47 U.S.C. 1601 through 1609, with physical and/or logical access to the submarine cable system, including but not limited to the cable landing station(s), NOC(s), beach manhole(s) and related sites, principal equipment, and SLTEs;
(iii) Not provide any individual or entity that is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), and/or an entity that is identified on the Covered List with access to sensitive U.S. records and domestic communications;
(iv) Not provide any individual or entity located in a foreign adversary country, as defined in § 1.70001(f), with physical or logical access to the submarine cable system sensitive U.S. records, or domestic communications;
(v) Adopt personnel screening and vetting measures for individuals whose position could involve securing principal equipment and/or physical and/or logical access to the submarine cable system (including but not limited to: the cable landing station(s), NOC(s), beach manholes and related sites, principal equipment, and SLTEs), sensitive U.S. records, and/or domestic communications;
(vi) Adopt a written policy that will include, at a minimum, background investigations, public criminal records checks, or other analogous means to ascertain an individual's trustworthiness, subject to applicable law, conducted at least every five (5) years;
(vii) Ensure adherence to these requirements;
(viii) Report to the Commission and Committee Members the identities of all foreign individuals with physical and/or logical access to the submarine cable system (including but not limited to the cable landing station(s), NOC(s), beach manholes and related sites, principal equipment, and SLTEs), sensitive U.S. records, and/or domestic communications, or who secure principal equipment, within thirty (30) days of the submarine cable commencing service; and report any changes on a quarterly basis, including identifying new personnel with access and personnel who no longer have access;
(ix) Provide the Commission and the Committee Members annually in the report described in paragraph (ii)(9)(iii) of this section, with the submission of the names and information on: security officers, foreign participation, security policies, owners and officers, operational requirements, locations of access, principal equipment, third-party service providers (as defined in § 1.70001(d)), foreign persons or entities with access, SLTE owners and controllers, as well as any such information requested by the Commission and/or the Committee Member from the SLTE owners and operators. Authority is delegated to the Office of International Affairs, in coordination with the Public Safety and Homeland Security Bureau and the Committee Members as needed, to determine the information to be submitted and provide further guidance;
(x) Provide advance notification of thirty (30) days to the Commission and the Committee Members and obtain the majority of the Committee Members' non-objection in writing prior to the testing, adding, or use of any sensing capability (such as distributed acoustic, thermal, seismic, or other sensing) on the submarine cable system by any person (
(xi) Provide updates to its submarine cable system information to the Commission and the Committee Members annually and within thirty (30) days of the change, to include but not limited to:
(A) A network and fiber map or diagram that includes physical and logical topology, including any terrestrial backhaul from the cable landing stations to the SLTE locations or other facilities housing principal equipment of the submarine cable;
(B) Network and telecommunications architecture descriptions and associated descriptions of interconnection points and controlled gateways to the principal equipment; and
(C) Descriptions of interfaces and connections to the submarine cable system for service offload, disaster recovery, or administrative functions.
(9) The licensee shall ensure that it consents to reporting to, and ongoing monitoring and inspection by, the Commission and the Committee Members throughout the term of the cable landing license to assess its compliance with all applicable routine conditions and national security standards. Authority is delegated to OIA, in consultation with the Committee Members, to, if it deems necessary to ensure compliance, administer audits to ensure compliance with these national security standards, including authority to establish the qualifications and approval of third-party auditors, establish deadlines and submission procedures, and coordinate with other U.S. government agencies as necessary. The licensee shall consent to:
(i) Monitoring and inspection of the licensee's facilities where principal equipment, as defined in § 1.70001(m), is located or that support the operation of the submarine cable system's connections to or from the United States, including but not limited to the NOC, as defined in § 1.70001(n), by the Commission and/or any other relevant U.S. government agencies, including the Committee Members;
(ii) Allowing the Commission and/or the Committee Members to meet with the licensee's personnel and conduct on-site interviews and to request additional information as necessary, throughout the term of the cable landing license, to verify the implementation of and compliance with all applicable routine conditions and national security standards;
(iii) Providing the Commission and Committee Members with an annual report, and upon request by the Commission, of its compliance with all applicable routine conditions and national security standards throughout the term of the license. The report shall include updated information and identify any changes made in the reporting period to:
(A) The names and contact information of the points of contact (POCs), and security and compliance officers;
(B) Ownership and foreign participation information;
(C) A list of all officers;
(D) The locations of access for the submarine cable;
(E) All third-party service providers, principal equipment, as defined in § 1.70001(m), and foreign persons or entities with access;
(F) The names and contact information of the SLTE owners and operators on the submarine cable, as well as any information requested by the Commission and/or the Committee
(G) All security policies;
(H) Any operational changes and/or expansion plans for the submarine cable;
(I) A summary of any events that occurred during the reporting period that will or reasonably could impact the effectiveness of or compliance with the national security standards; and
(J) A certification that the licensee remains in compliance with all applicable routine conditions and national security standards or, if there were any known acts of noncompliance with the routine conditions and national security standards, a summary of such acts—whether inadvertent or intentional, with a discussion of what steps have been or will be taken to prevent such acts from occurring in the future.
(K) The annual report shall be submitted each year in the relevant license file number(s) in ICFS or any successor system. A copy of the report shall be filed directly with the Committee Members;
(iv) Allowing the Commission and/or the Committee Members to periodically, and no more than biennially, request a third-party audit or assessment of compliance with all applicable routine conditions and national security standards;
(v) Providing the Commission and the Committee Members with the name, title, business address, email address, and telephone number of a designated Security and Compliance Officer, who serves or will serve as the primary point of contact for license and compliance matters. This officer will be responsible for implementing and maintaining the licensee's cybersecurity and physical security risk management plans and ensuring adherence to the Commission's security and compliance requirements for the cable system.
(A) The Security and Compliance Officer shall be a U.S. citizen who is eligible for a U.S. government security clearance at the “Secret” level or higher. The Security and Compliance Officer will possess the appropriate senior-level corporate authority, reporting lines, independence, technical skills, and resources required to assess the cybersecurity, physical security, and logical security of submarine cable systems and to ensure compliance with the applicable Commission rules and regulations.
(B) The licensee shall notify the Commission and the Committee within ten (10) days of any change in the designated officer or the officer's contact information. The licensee shall work with the Commission and Committee Members to resolve any national security or law enforcement concerns that the Commission or Committee may raise with respect to the Security and Compliance Officer; and
(vi) Notifying the Commission and the Committee Members within seventy-two (72) hours of any violation of applicable routine conditions or national security standards, including a description of the violation and an explanation for why it occurred, and a description of any steps taken to remediate the violation.
(a) * * *
(2) Certifications set forth under § 1.70006, except for § 1.70006(d) through (f). In addition to the certification set forth in § 1.70006(a), the licensee must certify that no third-party service provider, as defined in § 1.70001(d), will be used to provide services relating to the new segment(s) and/or cable landing station(s) that is an entity identified in § 1.70007(ee)(1)(i) through (iii), except as otherwise specified in § 1.70007(ee).
(i) A licensee seeking a modification of a cable landing license must certify in an application filed after [effective date of the amendatory instruction 12], that no principal equipment, as defined in § 1.70001(m), that is produced (including any major stage of the process through which the device is made, including manufacturing, assembly, design, and development) by any entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), will be used on or added to the new segment(s) and/or landing station(s) of the submarine cable system, whether by the licensee or any other entity.
(ii) A licensee seeking a modification of a cable landing license must certify in the application that it has created, updated, and implemented a cybersecurity and physical security risk management plan, consistent with §§ 1.70006(c) and 1.70007(q).
(b) * * *
(4) Certifications set forth under § 1.70006 for the proposed new licensee, except for § 1.70006(d) through (f);
(b) * * *
(7) The certifications set forth in § 1.70006, except for § 1.70006(d) through (f). A licensee seeking an assignment or transfer of control must certify in the application that it has created, updated, and implemented a cybersecurity and physical security risk management plan, consistent with §§ 1.70006(c) and 1.70007(q). The application must include a certification that the assignee or the transferee and the licensee that is the subject of the transfer of control accepts and will abide by the routine conditions specified in § 1.70007.
(b)
(2) On the date of filing with the Commission, the applicant(s) seeking exemption from referral to the Executive Branch agencies pursuant to § 1.40001(b) shall also send a complete copy of the application, or any major amendments or other material filings regarding the application, electronically to the Committee for the Assessment of Foreign Participation in the United States Telecommunications Services Sector (Committee). The applicant shall certify such service on a service list attached to the application or other
(i) The application will be placed on an informative public notice stating that the applicant has requested an exemption from referral and the application was submitted to the Committee.
(ii) The Committee or any Committee Member may notify the Commission in writing by filing in the relevant file number in the International Communications Filing System (ICFS) within thirty (30) days of the release date of the public notice if it objects to the exemption and requests referral of the application for further review pursuant to Executive Order 13913. Referral may only be requested via a filing in the relevant ICFS file number wherein the Committee or a Committee Member identifies credible and articulable national security, law enforcement, or other concerns specific to the applicant or the cable system, along with an explanation for why Committee referral is requested, and may include filing confidential and/or classified information if appropriate. In extraordinary extenuating circumstances, the Committee may request an additional thirty (30) days to complete its review and notify the Commission if it objects to the exemption and requests referral of the application pursuant to Executive Order 13913. In the case of a lapse of funding impacting any Committee Member's ability to review the information, this thirty (30) day period will be tolled and shall resume once funding is restored and review can continue. The Committee's requests for referral shall not be used to routinely refer all applications that presumptively qualify for the exemption. The Commission shall retain discretion whether or not to refer the application.
(iii) An applicant that seeks an exemption from referral pursuant to § 1.40001(b) shall comply with the requirement to file responses to standard questions pursuant to §§ 1.70005(j)(1) and 63.18(p) if applicable. Such applicant shall not be subject to the time frames and requirements of § 1.40004, unless or until such time the Commission determines that the application should be referred to the Executive Branch agencies.
(b) * * *
(4) * * * ; and/or
(5) That has purchased, rented, leased, or otherwise obtained or utilized equipment and/or services on the Covered List and/or is using such equipment or services in the submarine cable.
(c) * * *
(2) Certifications as set forth under § 1.70006, except for § 1.70006(b), (d) through (f).
(d)
(a)
(b)
(1) That is owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g);
(2) That is identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601 through 1609;
(3) That has purchased, rented, leased, or otherwise obtained or utilized equipment and/or services on the Covered List and/or is using such equipment or services in the submarine cable;
(4) Whose authorization, license, or other Commission approval, whether or not related to the operation of a submarine cable, was denied or revoked and/or terminated or is denied or revoked and/or terminated in the future on national security and law enforcement grounds, as well as the current and future affiliates or subsidiaries of any such entity as defined in § 2.903(c) of this chapter; and/or
(5) The submarine cable system for which the entity is licensed to operate in the United States pursuant to § 1.70003, lands in a foreign adversary country, as defined in § 1.70001(f), or the licensee's SLTE is owned in or operated from a foreign adversary country such that the operation directly or indirectly connects the United States with any foreign country.
(c)
(1) The information of the licensee as required in §§ 1.70005(a) through (d), (g), and 63.18(h);
(2) The location(s) of the SLTE(s) that the licensee owns and/or operates;
(3) Identify and describe whether the SLTE(s) is managed or operated by a third party; and
(4) Identify and describe whether the licensee leases, sells, shares, or swaps fiber, capacity, or spectrum on a Commission-licensed submarine cable system, including the name of each submarine cable system.
(5) Certifications as set forth under § 1.70006(b); and
(6) Certification that the licensee accepts and will abide by the routine conditions in § 1.70007 upon which its cable landing license is conditioned as set forth in § 1.70003.
(d)
(1) A licensee that owns and/or operates SLTE on a submarine cable landing in the United States must submit both the Foreign Adversary Annual Report under § 1.70017 and the SLTE Foreign Adversary Annual Report under this section if it meets any of the criteria set out in § 1.70017(b) and in § 1.70018(b).
(2) [Reserved]
(e)
(b) The application must include the information and certifications required in §§ 1.70002(b) through (c), 1.70004, 1.70005 except as specified herein, and 1.70006, except for 1.70006(d) through (f). A licensee seeking a renewal or extension of a cable landing license must certify in the application that it has created, updated, and implemented a cybersecurity and physical security risk management plan, consistent with §§ 1.70006(c) and 1.70007(q).
Each cable landing licensee shall submit a certification, within sixty (60) days of [effective date of amendatory instruction 18], that no principal equipment, as defined in § 1.70001(m), that is produced (including any major stage of the process through which the device is made, including manufacturing, assembly, design, and development) by any entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g), will be added, whether by the licensee or any other entity, to its licensed submarine cable system.
(a) The certification shall be filed under the relevant license file number(s) in the Commission's International Communications Filing System (ICFS), or any successor system.
(b) For those licensees with multiple cable landing licenses, the licensee will need to certify for each submarine cable system.
(a) Each cable landing licensee shall submit a certification, within sixty (60) days of [effective date of amendatory instruction 19], that it will not enter into a new or extension of an existing arrangement with any third-party service provider, as defined in § 1.70001(d), for the provision of services relating to the submarine cable system that is identified in paragraphs (a)(1) through (3) of this section, except as otherwise specified in paragraph (a)(4):
(1) An entity owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, as defined in § 1.70001(g);
(2) An entity identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609; and/or
(3) An entity that can access the submarine cable system from a foreign adversary country, as defined in § 1.70001(f).
(4) This paragraph (a) shall not apply to a licensee that is an entity identified on the Covered List. This paragraph (a) shall not apply where any entity identified in paragraphs (a)(1) through (3) of this section is involved in providing repair and maintenance to the wet segment of a Commission-licensed submarine cable; provided, the licensee must comply with § 1.70007(ff) as necessary.
(b) The certification shall be filed under the relevant license file number(s) in the Commission's International Communications Filing System (ICFS), or any successor system.
(c) For those licensees with multiple cable landing licenses, the licensee will need to certify for each submarine cable system.
Each cable landing licensee shall submit a certification, within sixty (60) days of [effective date of amendatory instruction 20], that it will not enter into a new arrangement or extend an existing arrangement, such as for Indefeasible Rights of Use (IRUs) or leases for capacity on the licensed submarine cable system, with an entity identified on the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609, where such arrangement would give the entity (
(a) The certification shall be filed under the relevant license file number(s) in the Commission's International Communications Filing System (ICFS), or any successor system.
(b) For those licensees with multiple cable landing licenses, the licensee will need to certify for each submarine cable system.
Each cable landing licensee shall submit a certification, within sixty (60) days of [effective date of amendatory instruction 21], that the licensee will comply with the requirements of § 1.80003(l)(1)(i) and (ii) of this chapter.
(a) The certification shall be filed under the relevant license file number(s) in the Commission's International Communications Filing System (ICFS), or any successor system.
(b) For those licensees with multiple cable landing licenses, the licensee will need to certify for each submarine cable system.
Each cable landing licensee shall certify, within sixty (60) days of [effective date of amendatory instruction 22], that the licensee will submit a certification, within sixty (60) days of the release of a public notice by the Commission or the Public Safety and Homeland Security Bureau announcing any new addition of equipment or services to the Covered List that the Commission maintains on its website pursuant to the Secure Networks Act, 47 U.S.C. 1601-1609, that:
(a) Acknowledges the addition to the Covered List, irrespective of whether the entity uses such equipment or services in its submarine cable system, and
(b) Includes a brief description of how and the purpose for which such equipment or services are used on the submarine cable system, if applicable.
(c) The certification shall be filed under the relevant license file number(s) in the Commission's International Communications Filing System (ICFS), or any successor system.
(d) For those licensees with multiple cable landing licenses, the licensee will need to certify for each submarine cable system.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; inseason adjustment; request for comments.
NMFS announces an inseason action for the Pacific halibut recreational fishery in the International Pacific Halibut Commission's (IPHC) regulatory Area 2A. This action adds fishing dates in August and September in the Columbia River and Washington subareas. These actions are intended to provide additional fishing opportunity for anglers in 2026 and are necessary to achieve the overall recreational fishery allocations for Area 2A established in the Pacific Fishery Management Council's (Council) 2026 Pacific Halibut Catch Sharing Plan and the 2026 IPHC regulations.
Effective July 24, 2026 through September 30, 2026. Comments are requested following this rule's publication, and are due on or before August 11, 2026.
Submit your comments, identified by NOAA-NMFS-2025-1131, by either of the following methods:
•
•
Joshua Lindsay, (213) 392-7410, or
On April 30, 2026, consistent with the 2026 IPHC regulations, NMFS implemented the 2026 recreational (sport) fishery bag limits, fishing dates, and subarea allocations for subareas off the U.S. West Coast in IPHC regulatory Area 2A via a final rule (91 FR 23369). The final rule implementing the 2026 recreational fishery management measures for Area 2A (91 FR 23369, April 30, 2026) opened the coastal Washington and Columbia River subareas on select days of the week from April 30, 2026 through June 30, 2026. The Puget Sound subarea opened 7 days per week from April 1, 2026 through June 30, 2026, pursuant to the 2026 IPHC regulations. The final rule implementing the 2026 recreational fishery management measures for Area 2A (91 FR 23369, April 30, 2026) stated that, if sufficient Washington and Columbia River subarea allocations remain for at least another full day of fishing after June 30, NMFS may take inseason action to reopen the Washington and Columbia River subareas in August, up to 7 days per week, through September. Additionally, Federal regulations provide that inseason modifications to recreational fishing periods, bag limits, size limits, open days per calendar week (fishing dates), and state and subarea allocations may be implemented to allow for annual allocation objectives to be met, so long as such action would not result in exceeding the Area 2A annual recreational allocation (50 CFR 300.63(c)(6)(i)).
In accordance with § 300.63(c), inseason actions are announced in the
After consulting with the Washington Department of Fish and Wildlife (WDFW), the Oregon Department of Fish and Wildlife (ODFW), and other appropriate entities, NMFS has determined that the following actions are necessary to meet the management objective of achieving, but not exceeding, the Area 2A 2026 recreational fishery subarea allocations. These actions are intended to provide opportunity for anglers to achieve the overall Area 2A 2026 recreational fishery allocation. NMFS will continue to monitor the recreational catch estimates for all subareas obtained via state sampling procedures, until NMFS has determined that there is not sufficient allocation for another full day of fishing and the relevant subarea is closed by NMFS, or until there are no more open fishing dates, whichever is earlier.
The Pacific halibut fishery regulations for Area 2A at § 300.63(c)(6) provide NMFS with the authority to modify annual management measures inseason, including fishing periods, following
The Puget Sound subarea recreational fishery opened on April 2, 2026, consistent with IPHC regulations. Through June 30, 2026, anglers in the Puget Sound subarea harvested 46,791 pounds (lb) (21.2 metric tons (mt)) of the 80,512 lb (36.5 mt) allocation, leaving 33,721 lb (15.3 mt) remaining (41.9 percent). Sufficient allocation remains for at least another full day of fishing; therefore, this action opens the Puget Sound subarea 7 days per week from August 8 through September 30, 2026, or until there is not sufficient allocation for another full day of fishing and the area is therefore closed.
The North Coast subarea recreational fishery opened on April 30, 2026. Through June 30, 2026, anglers in the North Coast subarea harvested 58,194 lb (26.4 mt) of the 131,149 lb (59.49 mt) allocation, leaving 72,955 lb (26.4 mt) remaining (55.6 percent). Sufficient allocation remains for at least another full day of fishing; therefore, this action opens the North Coast subarea 7 days per week from August 8 through September 30, 2026, or until there is not sufficient allocation for another full day of fishing and the area is therefore closed.
The South Coast subarea recreational fishery opened on April 30, 2026. Through June 30, 2026, anglers in the South Coast subarea harvested 38,229 lb (17.3 mt) of the 65,857 lb (29.9 mt) allocation, leaving 27,628 lb (12.5 mt) remaining (42.0 percent). Sufficient allocation remains for at least another full day of fishing; therefore, this action opens the South Coast subarea 7 days per week from August 16 through September 30, 2026, or until there is not sufficient allocation for another full day of fishing and the area is therefore closed.
The Columbia River subarea recreational fishery opened on April 30, 2026. Through June 30, 2026, anglers in the Columbia River subarea harvested 11,743 lb (5.3 mt) of the 19,299 lb (8.8 mt) allocation, leaving 7,556 lb (5.3 mt) remaining (39.2 percent). Sufficient allocation remains for at least another full day of fishing; therefore, this action opens the Columbia River subarea 7 days per week from August 16 through September 30, 2026, or until there is not sufficient allocation for another full day of fishing and the area is therefore closed.
NMFS issues this action pursuant to the Northern Pacific Halibut Act of 1982. This action is taken under the regulatory authority at 50 CFR 300.63(c)(6) and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive notice and an opportunity for public comment on this action prior to it being effective, as prior notice and comment would be impracticable and contrary to the public interest. There is good cause to waive prior notice and an opportunity for public comment on this inseason action because the public had an opportunity to comment on the final rule implementing the 2026 recreational fishery in Area 2A. The final rule specifically provided that additional fishing periods may be set through inseason action during the 2026 fishing season, in accordance with § 300.63(c)(6), if an additional fishing period is deemed necessary to attain a subarea's 2026 allocation. WDFW and ODFW provided updated landings data to NMFS on July 6, 2026, showing that through June 30, 2026, an estimated 41.9 percent of the Puget Sound subarea annual allocation, 55.6 percent of the North Coast subarea annual allocation, 42.0 percent of the South Coast subarea annual allocation, and 39.7 percent of the Columbia River subarea annual allocation was remaining. The 2026 Area 2A recreational fishery's final rule (91 FR 23369; April 30, 2026) specifically included a provision that, if after June 30, 2026 sufficient allocation remained for at least another full day of fishing in these subareas, then NMFS may take inseason action to reopen the recreational fishery. NMFS has determined that sufficient allocation remains for at least another full day of fishing in the Columbia River and Washington subareas; therefore, NMFS is taking this inseason action. Because this potential inseason action was part of the rulemaking establishing this year's Area 2A recreational fishery, which included public notice and comment, this action will not be unexpected by the public, which had specific notice and an opportunity to comment on NMFS' intent to implement this inseason action during that rulemaking process.
In addition, this inseason action is necessary to allow for the Area 2A 2026 allocation objectives to be met in accordance with § 300.63(c)(6)(i)(A). Specifically, this inseason action will increase the opportunity for the Area 2A fishery to reach the overall 2026 recreational allocation. The annual recreational fishing season for Pacific halibut in Area 2A is relatively short and occurs primarily during the summer months and in early fall. As the Washington and Columbia River subareas close on September 30, 2026, implementing this action through proposed and final rulemaking would undermine the benefit this action is intended to provide to fishery participants and there is good cause to waive notice and comment rulemaking under 5 U.S.C. 553(b)(B). The regulated public needs sufficient time to plan for additional fishing periods. Thus, it is necessary that this rulemaking be implemented in a timely manner, so that proper planning for additional fishing dates can take place, including time to allow for business and personal decision making by the regulated public and others impacted by this action, which includes recreational charter fishing operations, associated port businesses, and private anglers who do not live near the fishery's coastal access points, among others. Without timely implementation of the additional fishing dates in the Washington and Columbia River subareas, the overall Area 2A recreational fishery allocation for 2026 is unlikely to be harvested this year, which would limit the economic benefits to fishery participants and obstruct the goals of the 2026 Catch Sharing Plan.
To ensure the regulated public is fully aware of this action, notice of the action will be provided to anglers through a telephone hotline, news release, and by the relevant state Fish and Wildlife agencies. NMFS will receive public comments for 15 days after publication of this action, in accordance with 50 CFR 300.63(c)(6)(iv)(B). No aspect of this action is controversial, and changes of this nature were anticipated in the process described in regulations at § 300.63(c), and in the proposed and final rules implementing the 2026 management measures for the Area 2A recreational fishery.
NMFS has also determined that the 30-day delay in the date of effectiveness required by 5 U.S.C. 553(d) does not apply to this inseason action because this action relieves a restriction on the fishery and there is good cause to waive
The 30-day delay in effective date requirement pursuant to 5 U.S.C. 553(d)(1) does not apply to this inseason action because this inseason action relieves a restriction by allowing participants to fish on the additional fishing dates. Waiving the 30-day delay in effectiveness thus provides additional opportunity for recreational fishermen to harvest Pacific halibut and increases the likelihood of full utilization of the 2026 allocations in Area 2A.
Additionally, there is good cause pursuant to 5 U.S.C. 553(d)(3) to establish an effective date less than 30 days after the date of publication of this rule for the reasons discussed above. A delay in effectiveness of this action would constrain fishing opportunity, be inconsistent with the goals of the 2026 Catch Sharing Plan, and potentially limit the economic opportunity intended by this rule to the associated fishing communities. The purpose of the 30-day delay in effectiveness provision of the Administrative Procedure Act is generally to give the regulated community time to adjust to new regulations. This rule does not establish any new or unique regulations, nor otherwise make changes that would require fishery participants to purchase new gear or make other time-consuming adjustments. By contrast, this rule implements routine inseason action. Waiving the 30-day delay in effectiveness will benefit the public because it will provide additional opportunity for recreational Pacific halibut anglers in 2026 and thus increase the likelihood of full utilization of the 2026 allocations in Area 2A. Additionally, NMFS regulations allow the Regional Administrator to modify sport fishing periods, bag limits, size limits, days per calendar week, and subarea allocations in Area 2A, when the action supports allocation objectives being met and such action will not result in exceeding the catch limit for the subarea or for Area 2A. The regulated public is aware of this authority and therefore expects such inseason action throughout the fishing year.
In conclusion, NMFS finds good cause to waive prior notice and an opportunity for public comment for this rule and to find that the 30-day delay in effective date does not apply. NMFS recently received information on the progress of landings in the recreational fisheries in the Washington and Columbia River subareas, which indicate that additional season dates should be implemented to promote the optimal harvest of the subareas' annual allocations. It is therefore in the public's interest that this action not be delayed.
16 U.S.C. 773-773k.
Nuclear Regulatory Commission.
Proposed rule and guidance; request for comment; correction.
The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice published in the
The correction takes effect on July 27, 2026.
Please refer to Docket ID NRC-2025-0975 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
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• Technical Library: The Technical Library, which is located at Two White Flint North, 11545 Rockville Pike, Rockville, Maryland 20852, is open by appointment only. Interested parties may make appointments to examine documents by contacting the NRC Technical Library by email at
You can read a plain language description of the proposed rule at
Daniel Doyle, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-3748, email:
The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Draft Regulatory Guide (DG)-4037, “Preparation of Environmental Reports for Nuclear Power Stations” (Proposed Revision 5 to Regulatory Guide 4.2; ADAMS Accession No. ML25268A122). The DG-4037 was included in the proposed rule, “Modernizing Reactor Licensing, Safety Oversight, and Siting Practices” published in the
Draft Regulatory Guide DG-4037 contains outdated and incorrect information. Accordingly, the NRC is withdrawing DG-4037 from the proposed rule and guidance; request for comment. Stakeholders should disregard DG-4037 when evaluating the “Modernizing Reactor Licensing, Safety Oversight, and Siting Practices” proposed rule. The NRC will consider whether revised or consolidated implementing guidance is warranted in the future.
In Proposed Rule Document 2026-14341, appearing on pages 44650 and 44652 in the issue of Thursday, July 16, 2026, make the following corrections:
On page 44650, in the third column, delete “22. The DG-4037, `Preparation of Environmental Reports for Nuclear Power Stations,' would be Revision 5 to the existing RG 4.2.”
On page 44652, in the Availability of Documents table, delete “DG-4037, `Preparation of Environmental Reports for Nuclear Power Stations,' July 2026” and “ML25268A122.”
The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Proposed rule; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the
Comments must be submitted electronically using
Submit your comments, identified by Docket ID NRC-2025-1667, at
Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are public records; they are publicly displayed exactly as received, and will not be deleted, modified, or redacted. Comments may be submitted anonymously.
Follow the search instructions on
You can read a plain language description of this proposed rule at
Soly Soto Lugo, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7258, email:
Please refer to Docket ID NRC-2025-1667 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
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•
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•
Comments must be submitted electronically using
On May 23, 2025, President Donald J. Trump signed Executive Order (E.O.) 14300, “Ordering the Reform of the Nuclear Regulatory Commission.” Section 5, “Reforming and Modernizing the NRC's Regulations,” requires the NRC to undertake a review and wholesale revision of its regulations and guidance documents as guided by the policies set forth in section 2 of the E.O. This rulemaking addresses section 5 of the E.O., proposing changes pertaining to the packaging and transportation of radioactive material that would yield efficiencies and reduce regulatory burden for licensees and the NRC while maintaining reasonable assurance of adequate protection for public health and safety and the environment.
Transportation of radioactive material in the United States has a strong historical safety record. Since the 1970s, millions of shipments of radioactive material—including medical isotopes, industrial sources, and spent nuclear fuel—have been safely transported worldwide. Overall, the historical safety record demonstrates that the transportation of radioactive material is one of the safest sectors of hazardous materials logistics, with no recorded fatalities or serious injuries attributable to radiation exposure during transport or as a result of a transportation accident.
The NRC's regulations for packaging and transportation of radioactive material are codified in title 10 of the
The NRC's requirements ensure the safe and reliable transport of radioactive material by establishing clear, well-defined design and performance criteria for Type B and fissile material transportation packages. Emerging technologies, such as microreactors, may present unique design, operational, and deployment considerations that warrant the use of different performance criteria. In particular, applications involving considerations that were not addressed in current regulations, such as limited cooling time for the fuel, may benefit from additional regulatory flexibility that continues to ensure reasonable assurance of adequate protection of public health and safety and the environment. This proposed rule seeks to provide such flexibility by allowing the regulatory framework to continue supporting innovation while preserving the safety objectives of 10 CFR part 71. These proposed changes support anticipated future transportation needs for microreactors and other new reactor designs, in line with E.O. 14300, which directs actions to enable safe and increased domestic deployment of new civilian nuclear reactor technologies.
The proposed revisions to 10 CFR part 71 are generally intended to add flexibility to the current regulatory framework and support the future domestic deployment of microreactors and other similar new nuclear technologies. Specifically, the proposed changes would:
1. Provide applicants seeking certification of transportation package designs with greater flexibility by allowing the voluntary use of alternative approaches—such as risk-informed or performance-based methods—to demonstrate compliance with physical testing or analyses requirements specified in the NRC's transportation regulations.
2. Allow increased radiation level limits, under certain conditions, for approval of certain Type B packages, primarily to facilitate the certification of transportation package designs for microreactors, should such designs be submitted to the NRC for review.
3. Streamline requirements and reduce burden on holders of certificates of compliance, while reducing application review timelines.
The NRC is proposing to revise § 71.41 to allow the use of an NRC-endorsed methodology as an alternative to meeting certain prescriptive requirements in 10 CFR part 71. This design certification pathway could, with appropriate justifications, allow a package designer to demonstrate that the transportation package meets or exceeds the current level of safety provided by the 10 CFR part 71 framework. Specifically, the proposed rule introduces a new paragraph, § 71.41(e), that explicitly identifies the availability of an optional framework for evaluating transportation package performance that would allow applicants to demonstrate an equivalent level of safety, as an alternative to meeting the specific physical testing requirements outlined for Type B packages in §§ 71.71, 71.73 and 71.61. The proposed § 71.41(e) would allow for the evaluation of packages through other methods of demonstration acceptable to the Commission, depending on the feature under consideration. These revisions align with the existing regulatory language in § 71.41(a).
Under this alternative approach, applicants would be permitted to reference a previously approved risk methodology or submit a risk-informed methodology for NRC approval in accordance with § 71.1(a) before submitting an application for a certificate of compliance. The methodology would be required to provide a means for demonstrating adequate safety during transportation and be acceptable to the Commission. For example, the NRC has previously endorsed a risk-informed methodology in SECY-24-0062, “Risk-Informed Methodology for a Future Transportable Triso-Based Micro-Reactor Package Application,” for the Project PELE TRISO-based package. Adoption of a similarly acceptable risk-informed approach in future applications may provide applicants with enhanced flexibility and potential cost efficiencies.
The proposed voluntary approach would enable applicants to demonstrate compliance with existing package performance requirements in §§ 71.71, 71.73 and 71.61 by assessing the likelihood and consequences of potential transportation events, thereby meeting the NRC's standard of reasonable assurance of adequate protection. The NRC anticipates that the use of other methods to address package response to normal and accident conditions in applications for package certification may be beneficial, offering an alternative to the current procedures found in § 71.41(c) and (d) for requesting package approval using different approaches. The proposed rule also includes minor changes to § 71.1, “Communications and Records,” to reflect this alternative, and to update the NRC's address with the zip code.
Currently, in accordance with 10 CFR part 71, subpart E, “Package Approval Standards,” package designs must be assessed for compliance with § 71.47, “External radiation standards for all packages.” Microreactor designs, including those for critical applications such as post-natural disaster (
These constraints could hinder the domestic deployment of microreactors for critical applications such as post-natural disaster (
To address these challenges, this proposed rule would amend § 71.47 by adding new language to paragraph (b)(3). The existing external radiation standards in the current regulations would remain in place, but proposed revision to § 71.47(b)(3) would establish an additional, optional external radiation standard for certain package approvals by allowing higher radiation levels for certain packages, such as transportable microreactors under exclusive use controls, as defined in § 71.4. Public radiation exposures for single transportation events under this new proposed limit would fall well within the current annual 10 CFR part 20, “Standards for Protection Against Radiation,” public radiation level limit (1 mSv (100 mrem)). The proposed new paragraph at § 71.47(b)(3) would establish radiation level limits that apply only under the normal transportation conditions under § 71.71.
The proposed limit in the revised § 71.47(b) is 0.5 mSv/h (50 mrem/h) at 2 m from the vehicle surface and would apply to certain approvals of packages for shipment that (1) are made under exclusive use provisions for normal conditions of transportation and (2) do not meet the 0.1 mSv/h (10 mrem/h) radiation level limit at 2 m (6.6 feet (ft)) from the vehicle in accordance with the existing language in § 71.47(b)(3). The proposed limit in the revised paragraph would be applicable to packages with contents which meet the definition of highway route controlled quantity (HRCQ) in 49 CFR 173.403, and which would, therefore, be required to meet applicable regulations of the Federal Motor Carrier Safety Administration (FMCSA). The FMCSA regulations enhance safety by minimizing access to HRCQ shipments from the public.
In developing a basis for the proposed addition of an optional higher radiation level limit in § 71.47(b)(3), the NRC staff, with assistance from the Pacific Northwest National Laboratory (PNNL) of the U.S. Department of Energy, examined potential public and occupational radiation exposures from postulated microreactor transportation scenarios. In the report PNNL-38760, “Microreactor Incident Free Transportation Radiation Dose Assessment,” PNNL evaluated possible future microreactor transportation scenarios and estimated the public and occupational radiation exposures from those transportation scenarios which considered radiation level limits greater than the current limit in § 71.47(b)(3) (
Although the PNNL evaluation is considered bounding for the microreactor transportation scenarios analyzed in the study, it may not bound radiation fields associated with other Type B package contents, such as spent nuclear fuel assemblies or potential future microreactor concepts with differing source term characteristics. Use of the proposed limit in revised § 71.47(b) for package designs or contents that were not evaluated in the PNNL analysis (
Based on the results of the report, the NRC determined that the 0.5 mSv/h (50 mrem/h) at 2 m from the vehicle scenario, with established measures and controls for highway routing, rendered public radiation exposures for single transportation events well within the current annual 10 CFR part 20 public radiation level limit. Licensees consigning an irradiated microreactor to a carrier for transport would be required to comply with § 71.5, and, as appropriate, coordinate with Federal, State, or local inspection authorities along the transportation route of such transport to ensure awareness of the higher radiation levels associated with these packages. At the single inspection estimated radiation dose reported in PNNL-38760 for a 2 m radiation level limit of 0.5 mSv/h (50 mrem/h) (0.586 mSv (58.6 mrem)), a vehicle safety inspector could perform multiple inspections (estimated at 85) in a single year before approaching the occupational dose limit for radiation workers of 50 mSv/y (5,000 mrem/y).
Specifically, the proposed new requirements in § 71.47(b)(3) that must be met for use of the higher radiation level limit are as follows:
1. The package contents meet the definition of highway route controlled quantity specified in 49 CFR 173.403; and
2. The licensee must coordinate in advance with the appropriate Federal, State or local inspection authorities to ensure those authorities are aware of the shipment and are prepared to conduct any required vehicle inspections. Such coordination must ensure that inspection personnel are informed of the radiological conditions and of any applicable controls needed to support inspection activities, including appropriate radiation dosimetry.
The proposed new § 71.47(b)(3) requirements are applicable to packages with contents which meet the definition of HRCQ in 49 CFR 173.403, as provided in proposed § 71.47(b)(3)(i), to ensure that packages with a higher radiation level at 2 m (6.6 ft.) from the vehicle are subject to the requirements of the FMCSA, which would include highway route planning and vehicle safety inspections. These requirements help to reduce the likelihood of a transportation incident and enhance the ability to prevent public access to the package during transportation. Irradiated microreactors will likely contain a quantity of radioactive material greater than 3,000 A
HRCQ shipments are required to have a pre-shipment inspection, in accordance with 49 CFR 385.415. The
In support of inspections of shipments of licensed material involving packages of irradiated material—particularly shipments of a microreactor which may qualify as HRCQ shipments—licensees would benefit by conducting pre-shipment coordination with inspector organizations along the transport route. Such coordination will provide the opportunity for inspection authorities to ensure that properly trained personnel are available to safely conduct inspections in close proximity to the vehicle.
Under this proposed rule, the NRC would certify packages with higher radiation levels (50 mrem/h at 2 m from the vehicle) if approved following its safety review; however, packages approved for these higher radiation levels could exceed the limits currently permitted under DOT transport requirements (49 CFR 173.441). Consequently, a shipper who voluntarily seeks to use this flexibility under NRC requirements for package approval would need to obtain an exception or special permit from DOT requirements.
NRC certification of packages is limited to domestic shipment within the U.S., unless the NRC Certificate of Compliance is revalidated by a foreign Competent Authority against the requirements in the International Atomic Energy Agency's (IAEA) “Regulations for the Safe Transport of Radioactive Material” (SSR-6) for import into a foreign country. Since SSR-6 requirements do not have a similar provision for higher radiation levels for Type B packages, as described in the proposed new requirements in § 71.47(b)(3), use of these requirements will be effectively limited to domestic U.S. shipments.
This proposed rule provides the public and stakeholders with the opportunity to provide feedback on the revised criteria for package certification for this voluntary approach for certification of packages allowing higher radiation levels during domestic shipments. The NRC plans to continue its practice of interagency coordination with Federal agencies, as well as coordination with State, local, and Tribal authorities, on this potential rule change. Consistent with Section VII of the Memorandum of Understanding between NRC and DOT (44 FR 38690; July 2, 1979), the NRC has engaged and intends to continue to engage with DOT to discuss the proposed rule changes and consult on proposed mechanisms to ensure alignment between NRC and DOT requirements.
This proposed rule also seeks to, among other things, streamline requirements, and reduce regulatory burden. The NRC considered removing certain unused provisions related to the air transport of plutonium in §§ 71.64, 71.74, and 71.88. However, the NRC did not remove these requirements because air transportation of plutonium has specific statutory requirements in the second undesignated paragraph in Section 201 of Public Law 94-79 and Section 5062 of Public Law 100-203.
The proposed rule also includes minor revisions to streamline 10 CFR part 71 and reduce regulatory burden. For example, the NRC proposes to revise § 71.45 to adopt the IAEA's SSG-26, Rev. 1, Table IV.1 design load values for lifting and tie-down standards. The NRC reviewed these requirements and determined they provide a level of safety equivalent to the current NRC requirements. The values originated through consensus by international experts and are published within international guidance documents. These consensus values are considered adequate to meet the applicable international transport regulations, and the U.S. actively participated in their development. The proposed change would align U.S. requirements with the internationally endorsed standards that have undergone extensive expert review. This alignment with international guidelines would eliminate discrepancies between U.S. and international requirements and reduce the burden on applicants seeking certification or revalidation of foreign packages.
The proposed rule also includes minor revisions to §§ 71.17 and 71.95 to streamline reporting and submittal processes, as well as removing the definition of spent fuel from § 71.4. The proposed rule also makes a revision to § 71.5 to add a reference to FMCSA regulations in paragraphs (a) and (a)(2)(iv). Specifically, licensees should note that a shipment of an HRCQ of radioactive material is required to meet the applicable requirements in 49 CFR 385, consistent with current practice.
To improve the efficiency of report submittals, the NRC proposes to revise § 71.17(c)(3) to allow for the electronic submission of letters registering the first use of a package. Additionally, paragraph (c) of § 71.95, “Reports,” would be revised to allow notifications and reports to be submitted electronically to the NRC's Document Control Desk or through the NRC's electronic submittal portal. These changes are expected to improve the timeliness of report receipt, thereby enhancing the NRC's ability to respond promptly to safety-related information.
Finally, the NRC proposes to remove the definition of “Spent nuclear fuel or Spent fuel” from 10 CFR part 71. While the definition of these terms appears in § 71.4, the terms “Spent nuclear fuel” or “Spent fuel” do not appear in any of the subsequent regulations in 10 CFR part 71. Further, the requirements of 10 CFR part 71 apply to transportation of irradiated fuel, regardless of cooling time. The removal of this definition furthers harmonization of U.S. regulations with IAEA international radioactive material transport regulations.
The NRC is seeking advice and recommendations from the public on the proposed rule. The NRC is particularly interested in comments and supporting rationale from the public on the following:
A proposed revision to § 71.47(b)(3) would establish an additional, optional external radiation standard for certain package approvals by allowing higher radiation levels for certain packages, such as transportable microreactors, under exclusive use controls. This revision is informed by the technical analysis in the PNNL report (PNNL-38760), which evaluated radiation dose scenarios for microreactor transportation. To help make the rule technology-neutral while also providing the necessary safety basis to meet the optional higher radiation levels, the proposed provision does not specifically reference transportable microreactors, but instead, requires that package contents meet the definition of HRCQ in 49 CFR 173.403. By meeting this definition, shipments would be required to meet applicable regulations of the FMCSA. The FMCSA regulations enhance safety by minimizing access to HRCQ shipments from the public and thus minimizing potential public exposure. This approach is intended to ensure enhanced safety controls while providing flexibility for certain packages
1. If the NRC were to consider an alternative approach, what criteria should guide allowing the optional radiation standard for NRC-approved Type B packages that do not meet the HRCQ definition?
2. Are there certain scenarios where the NRC-approved Type B package contents would not meet the HRCQ definition but could still justify higher allowable radiation levels at 2 meters (6.6 ft) from the vehicle?
a. Please describe the scenario and explain why higher radiation standards would be necessary and appropriate.
b. What requirements would be needed to minimize potential public and occupational exposure in such scenarios?
c. Provide your technical basis for these recommendations.
3. The technical basis for the proposed increased dose rate provisions in § 71.47(b)(3) is informed, in part, by the analysis presented in the PNNL-38760 report. While this report provides a valuable foundation, its scope may be limited by the current lack of detailed information regarding emerging microreactor designs. The report also does not encompass other types of radioactive material, such as nuclear reactor spent fuel, which may be subject to the proposed provisions. Recognizing these limitations and the potential for new data and operational experience to inform future regulatory decisions, the NRC is seeking stakeholder input on the following matter:
a. Should the optional increased dose rate provision in § 71.47(b)(3) be applied broadly to all shipments of radioactive material, or should its use be subject to specific criteria, limitations, or circumstances? Please provide which criteria, limitations, or circumstances and provide your rationale and technical justification for your recommendations, including any supporting data or analysis.
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule, if adopted, will not have a significant economic impact on a substantial number of small entities. This proposed rule would affect a number of “small entities” as defined by the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810). However, as indicated in the draft regulatory analysis section, the proposed amendments, if promulgated, would not have a significant economic impact on the affected small entities.
Any small entity subject to this regulation that determines, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the Commission of this opinion in a comment that indicates—
(a) The licensee's size and how the proposed regulation would impose a significant economic burden on the licensee as compared to the economic burden on a larger licensee;
(b) How the proposed regulations could be modified to take into account the licensee's differing needs or capabilities;
(c) The benefits that would accrue or the detriments that would be avoided if the proposed regulations were modified as suggested by the licensee;
(d) How the proposed regulation, as modified, would more closely equalize the impact of NRC regulations or create more equal access to the benefits of Federal programs as opposed to providing special advantages to any individual or group; and
(e) How the proposed regulation, as modified, would still adequately protect public health and safety and the environment.
Comments should be submitted as indicated under the
The NRC is proposing amendments to 10 CFR part 71 to strengthen and streamline the regulatory framework to better support the future deployment of microreactors and other similar new nuclear technologies. The proposed changes in 10 CFR part 71 would allow applicants requesting certification of a transportation package design to use alternative approaches to demonstrate compliance with certain transportation requirements, which would yield efficiencies and reduce regulatory burden for licensees and the NRC while maintaining reasonable assurance of adequate protection for public health and safety and the environment. The NRC anticipates the changes made in 10 CFR part 71 would strengthen the regulatory framework in support of deployment of microreactors and otherwise support a more technology-neutral regulatory framework. The NRC is proactively developing this proposed rule to account for anticipated advancements in nuclear technology. As a result, the rulemaking approach is intentionally technology neutral.
The proposed changes under § 71.41 include a new paragraph (e). The new language identifies the availability of an optional framework allowing applicants to use an alternative method for evaluating transportation package performance in order to demonstrate an equivalent level of safety for a certification review of a package design, in an application to the NRC, made in accordance with § 71.1(a).
This proposed rule would also amend § 71.47 by new requirements under § 71.47(b)(3). The proposed new requirements address specific design and operational parameters for transportation of certain packages that might exceed currently allowed radiation dose rate limits. The proposed new provision would establish a voluntary external radiation standard for approval of packages for shipments by allowing higher radiation dose rates for exclusive use shipments of certain packages, such as transportable microreactors. Hence, vendors of microreactors would have the option to continue developing transportation packages based on current radiation level limits, or vendors could submit a design, or an amendment to the NRC for design changes, which, if approved, would allow an increase in radiation dose rate at 2 m from the vehicle.
Vendors who choose to maintain the status quo would see no change to their monetary commitment in the construction of their transportable package. However, the NRC's Subject Matter Experts (SMEs) anticipate vendors would change to a design that meets the new acceptable radiation dose level of 50 mrem at 2 m from the vehicle (up from 10 mrem) to take advantage of the flexibility the proposed rule provides in the construction of transportable packages for certain shipments. The NRC anticipates that vendors who change to a design that meets the new, alternative radiation standard would realize a monetary saving due to the additional flexibility in the design afforded by the new radiation standard for certain transportable packages. Although there is no data that can identify how a vendor would design their transportable package under this newly proposed standard, given the numerous design options a vendor may take, the NRC anticipates a transportation package
To illustrate potential savings associated with proposed § 71.47, the NRC has assessed a hypothetical transportation package design that would meet the new radiation standard with reduced package shielding on 5 sides of the package walls that are impacting the 2 m vehicle distance of radiation exposure requirement. Using a shielding material composed of carbon steel (as an example), SMEs have estimated an overall reduction of half inch (moving from a 2-inch plate to a 1.5-inch plate) would have a potential savings of approximately $25,000 dollars per package. In addition, the perceived estimated net average growth rate of microreactors coming on-line over a 40-year period of analysis is 2,102 microreactors.
In addition to the savings based on proposed optional design standards for certain transportation packages, the SMEs also anticipate additional savings from the actual transportation of the package due to the reduction in package weight. Although currently there is no data or logistical premise to measure potential savings, the NRC anticipates a substantial cost-savings due to a reduction in fuel use and wear and tear of the transportation vehicle.
Finally, applicants are not obligated to undertake any activity under these requirements. The NRC anticipates that none of the changes proposed in 10 CFR part 71 will create any added burden to future applicants for package certification. Conversely, the NRC does anticipate the changes to 10 CFR part 71 would create an economic benefit for applicants and certificate holders, since they will now be able to streamline their processes to meet both their operational needs and regulatory obligations. At this time, NRC is limited in quantifying the benefits applicants might incur from the proposed changes since actual data is not available.
The NRC has determined that the backfit rule, which is found in §§ 50.109, 70.76, 72.62, 76.76, and 10 CFR part 52, does not apply to this proposed rule because the proposed amendments do not involve any provisions that would impose backfits as defined in 10 CFR chapter I or affect the issue finality of any approval issued under 10 CFR part 52. There is no backfit provision in 10 CFR part 71.
The backfitting and issue finality provisions under 10 CFR parts 50, 52, 70, 72, and 76 apply to activities directly regulated under those parts of the NRC's regulations and do not apply to activities regulated under other parts that do not include backfitting or issue finality provisions. The exception to this general principle is where the activity regulated under other parts that do not include backfitting or issue finality provisions is an inextricable part of the regulated activity within the scope of backfitting or issue finality. The activity that would be regulated by this proposed rule,
The NRC seeks to minimize potential negative consequences resulting from the cumulative effects of regulation (CER). The NRC believes that the de-regulatory impacts of this rulemaking activity are unlikely to cause implementation challenges for stakeholders. In addition, during the pendency of this rulemaking, the NRC is deprioritizing issuance of regulatory actions that might influence the implementation date for the new rule requirements (
To fully understand any potential CER implications that could result from this rulemaking, the NRC is asking the following questions. Response to these questions is voluntary and any input will be considered during development of the final rule.
1. The NRC is proposing an effective date that will be 30 days after the date of publication of a final rule. Does this
2. Are there unintended consequences related to this rulemaking and how should they be addressed? Please provide a rationale for your response.
3. Please comment on the NRC's cost and benefit estimates in the regulatory analysis that supports this proposed rule. Please comment on how to quantify unquantified portions of this analysis. NRC acknowledges difficulties in developing scenarios involving future advanced technologies that have not yet been commercially realized, and would like to refine these estimates to produce agency's best estimates of potential effects. Please comment on any underlying uncertainties about the proposed changes that would lead to using, or potentially not using, the afforded flexibilities (
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885). The NRC requests comment on this document with respect to the clarity and effectiveness of the language used.
The NRC has prepared this environmental assessment (EA) of the proposed rule amending package certification requirement regulations to determine the significance of the environmental effects of the proposed agency action in accordance with the National Environmental Policy Act of 1969, as amended (NEPA) and NRC's NEPA implementing regulations in 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” As explained below, the NRC has determined that the proposed agency action to modernize NRC's package certification requirement regulations would have no significant effect on the quality of the human environment.
Proposed rule changes would occur in 10 CFR part 71. Conforming changes would be made to guidance in the future consistent with changes to regulations. Table B-1 lists the sections of the regulations being changed and affected guidance.
Conforming changes are administrative actions with no physical environmental effect and provide for the appropriate administrative and regulatory framework for package certification under 10 CFR. An example would be adding a reference to a newly created subsection in an existing regulation. All proposed amendments to NRC regulations in this proposed rule occur within the affected regulation.
Categorical exclusions provide a mechanism to identify Federal actions that normally do not have a significant environmental effect on the human environment and for which neither an EA nor environmental impact statement is normally required. This ensures that resources are not expended on the environmental analysis of proposed actions that do not present the potential for significant environmental effects. The NRC has determined that some of the changes to the regulations identified in this proposed rule meet criteria under § 51.22, “Categorical exclusions.” These proposed rule amendments belong to categories of actions which the Commission, by rule or regulation, has declared to be a categorical exclusion, after first finding that the category of actions within the category do not individually or cumulatively have a significant effect on the human environment. In reviewing the list of regulations in Table B-1, the NRC staff have determined that several of the rule amendments are actions eligible for categorical exclusion examples under § 51.22(a)(1).
Rule amendments with applicable categorical exclusions are presented in Table B-2 below and no further NEPA analysis is required.
The following rulemaking actions meet the criterion for categorical exclusion under § 51.22(c)(2) or § 51.22(c)(3):
The NRC also evaluated rule amendments that have the potential to affect the human environment and determined that the proposed agency action (rulemaking) would not have a significant environmental effect. These rule amendments would clarify NRC regulations, would continue to provide reasonable assurance of adequate protection of public health and safety, and would result in no new or different environmental effects. The following table presents the basis for why these
These proposed rule amendments would modernize existing NRC regulations while ensuring the continued safe, effective, and efficient package certification to provide reasonable assurance of adequate protection of public health and safety and the environment. Table B-3 notes that any of the changes to the 10 CFR part 71 regulations must still provide reasonable assurance of adequate protection of public health and safety. Therefore, the proposed amendments would have no significantly different environmental effects than those resulting from the current regulatory framework.
Implementation of the proposed rule would result in no physical changes to the environment, and, therefore, the NRC has determined that this proposed agency action will not have a significant effect on the quality of the human environment. Proposed rule amendments are administrative in application, involve matters of procedure, clarify reporting requirements, and would provide an equivalent level of safety and security as current NRC regulations.
Since no physical changes would occur in the human environment, the proposed agency action (rulemaking) would not affect any threatened or endangered species or historic properties. Accordingly, the NRC finds that the proposed rulemaking would have no significant environmental impact.
Under the no action alternative (
The NRC is requesting public comments on this draft EA and Finding of No Significant Impact (FONSI). The NRC will consider public comments in
As discussed in Section XI.B, the proposed rule provisions would not have a significant effect on the quality of the human environment. For this reason, the proposed rulemaking would not impact threatened or endangered species or critical habitat, and the NRC has determined that section 7 consultation under the Endangered Species Act of 1973, as amended, is not necessary. The proposed regulatory changes do not involve any ground disturbing activities or visual effects that would adversely affect historic properties. Therefore, the NRC has determined that consultation is not required under section 106 of the National Historic Preservation Act of 1966, as amended.
The NRC has prepared this EA to determine the environmental effects of the proposed agency action (rulemaking). Proposed rule amendments are primarily administrative or procedural in nature and thus would not have any physical environmental effect. As explained in the EA, the NRC has determined the proposed rulemaking would continue to provide reasonable assurance of adequate protection of public health and safety and would result in no new or different environmental effects. Therefore, the NRC concludes that the proposed regulatory changes would not have a significant effect on the quality of the human environment. Based on this conclusion, the NRC has determined there is no need to prepare an environmental impact statement. Accordingly, the NRC finds the proposed agency action would have no significant environmental impact.
This proposed rule contains new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The NRC is seeking public comment on the potential impact of the information collections contained in this proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility? Please explain your response.
2. Is the estimate of the burden of the proposed information collection accurate? Please explain your response.
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? Please explain your response.
4. How can the burden of the proposed information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
A copy of the Office of Management and Budget (OMB) clearance package and proposed rule are available in the “Availability of Documents” section of this document or may be viewed free of charge by contacting the NRC's Public Document Room reference staff at 1-800-397-4209, at 301-415-4737, or by email to
You may submit comments on any aspect of these proposed information collection(s), including suggestions for reducing the burden and on the above issues, by the following methods:
•
Submit comments by August 26, 2026.
The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.
The following are Executive orders that are related to this proposed rule:
The Office of Information and Regulatory Affairs (OIRA) has determined that this proposed rule is a significant regulatory action under section 3(f) of E.O. 12866; though not economically significant under section 3(f)(1). Accordingly, the NRC submitted this proposed rule to OIRA for review. The NRC is required to conduct an economic analysis in accordance with section 6(a)(3)(B) of E.O. 12866. More can be found in Section VI of this document, “Regulatory Analysis.”
The NRC has examined this proposed rule and has determined that it is consistent with the policies and directives outlined in E.O. 14154.
This action is tentatively determined to be a deregulatory action. This proposed rule is a deregulatory action as defined by E.O. 14192. Details on the estimated costs of this proposed rule can be found in Section VI of this document, “Regulatory Analysis.”
E.O. 14270, “Zero-Based Regulatory Budgeting to Unleash American Energy,” requires the NRC to insert a conditional sunset date into all new or amended NRC regulations provided the regulations are (1) promulgated under the Atomic Energy Act of 1954, as amended (AEA), the Energy Reorganization Act of 1974, as amended, or the Nuclear Waste Policy Act of 1982, as amended; (2) not statutorily required; or (3) not part of the NRC's permitting regime. The NRC determined that the regulatory changes proposed in this rule are required because they are necessary for providing reasonable assurance of adequate protection of public health and safety and common defense and security, and would be part of NRC's permitting regime as they apply to package certification requirements. Therefore, the NRC views this rulemaking to be outside the scope of E.O. 14270 and did not insert conditional sunset dates for the regulatory changes in this proposed rule.
This proposed rule includes Federal regulations that, if adopted, would be enforceable by criminal penalty, as authorized by Section 223 of the AEA. Therefore, per Executive Order 14294, those regulations constitute “criminal regulatory offenses.”
For the purposes of Section 223 of the AEA, the NRC is issuing this proposed rule that would amend 10 CFR part 71 under one or more of Sections 161b, 161i, or 161o of the AEA, except as noted in § 71.100(b). The applicability of criminal penalties to regulations in part 71 is set forth in § 71.100. Willful violations of the 10 CFR part 71 regulations, other than those listed in § 71.100(b), would be subject to criminal enforcement.
On September 3, 2025, the NRC held a government-to-government meeting with the Agreement States regarding E.O. 14300. In this meeting, the NRC presented its goals and objectives for future rulemakings to be done in response to the E.O. At the time of the meeting, the proposed rule text was not available. On January 29, 2026, the proposed rule was shared with the Standing Committee for Compatibility.
On the basis of the “Agreement State Program Policy Statement” approved by the Commission on October 2, 2017, and published in the
Compatibility Category B pertains to a limited number of program elements that cross jurisdictional boundaries and should be addressed to ensure uniformity of regulation on a nationwide basis. For Compatibility Category B, the Agreement State program element shall be essentially identical to that of NRC.
Compatibility Category D are those program elements that do not meet any of the criteria of Category A, B, or C, and are not required to be adopted by Agreement States for purposes of compatibility. An Agreement State has the flexibility to adopt and implement program elements within the State's jurisdiction that are not addressed by the NRC or that are not required for compatibility. However, such program elements of an Agreement State relating to agreement material shall (1) not create conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis; (2) not preclude a practice authorized by the AEA and in the national interest; and (3) not preclude the ability of the NRC to evaluate the effectiveness of Agreement State programs for agreement material with respect to protection of public health and safety and the environment.
Compatibility Category NRC are those program elements that address areas of regulation that cannot be relinquished to the Agreement States under the AEA, or provisions of 10 CFR. The NRC maintains regulatory authority over these program elements and the Agreement States must not adopt these NRC program elements. However, an Agreement State may inform its licensees of these NRC requirements through a mechanism under the State's administrative procedure laws, as long as the State adopts these provisions solely for the purposes of notification, and does not exercise any regulatory authority as a result.
The proposed rule is a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among Agreement State and NRC requirements. The compatibility (A, B, C, D, and NRC) and adequacy (H&S) categories are designated in the following table:
Due to the accelerated schedule for this rulemaking, the NRC is not issuing draft guidance for implementation of the proposed requirements at this time.
The NRC will conduct a public meeting on the proposed rule for the purpose of providing stakeholders with the opportunity to ask questions and seek clarification from the NRC staff on the proposed rule.
The NRC will publish a notice of the location, time, and agenda of the meeting in the
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at
Criminal penalties, Hazardous materials transportation, Intergovernmental relations, Nuclear materials, Packaging and containers, Penalties, Radioactive materials, Reporting and recordkeeping requirements.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing to amend 10 CFR part 71.
Atomic Energy Act secs. 53, 57, 62, 63, 81, 161, 182, 183, 223, 234, 1701 (42 U.S.C. 2073, 2077, 2092, 2093, 2111, 2201, 2232, 2233, 2273, 2282, 2297f); Energy Reorganization Act secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act sec. 180 (42 U.S.C. 10175); Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 594 (2005).
Section 71.97 also issued under sec. 301, Pub. L. 96-295, 94 Stat. 789-790.
(a) Except where otherwise specified, all communications, demonstrations of alternative package evaluations, and reports concerning the regulations in this part and applications filed under them should be sent by mail addressed: ATTN: Document Control Desk, Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland, 20852; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's website at
(c) * * *
(3) Submit using an appropriate method listed in § 71.1(a), the licensee's name and license number and the package identification number specified in the package approval before the first use of the package to: ATTN: Document Control Desk, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards.
(e) In accordance with paragraphs (a) and (c) of this section, in lieu of an evaluation of the effects on a package of the tests specified in § 71.71 (“Normal conditions of transport”), and the tests specified in § 71.73 (“Hypothetical accident conditions”), and § 71.61 (“Special requirements for Type B packages containing more than 10
(b) * * *
(1) If there is a system of tie-down devices that is a structural part of the package, the system must be capable of withstanding, without generating stress in any material of the package in excess of its yield strength, a static force applied to the center of gravity of the package having a vertical component of 2 times or, for air transportation, 2.5 times the weight of the package with its contents; a horizontal component along the direction in which the vehicle travels of 5 times the weight of the package with its contents; and a horizontal component in the transverse direction of 1.3 times the weight of the package with its contents.
(b) * * *
(3) 0.1 mSv/h (10 mrem/h) at any point 2 meters (80 in) from the outer lateral surfaces of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed style vehicle, at any point 2 meters (6.6 feet) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle). These radiation standards apply unless the following conditions are met, in which case the limit is 0.5 mSv/h (50 mrem/h):
(i) The package contents meet the definition of highway route controlled quantity specified in 49 CFR 173.403; and
(ii) The licensee coordinates in advance with the appropriate Federal, State or local inspection authorities to ensure those authorities are aware of the shipment and are prepared to conduct any required vehicle inspections. Such coordination must ensure that inspection personnel are informed of the radiological conditions and of any applicable controls needed to support inspection activities, including appropriate radiation dosimetry; and
(c) Each licensee must submit, in accordance with § 71.1, a report required by paragraph (a) or (b) of this section within 60 days of the event or discovery of the event. The licensee must also provide an electronic copy of each report submitted to the NRC to the applicable certificate holder. Reports prepared under other regulations may be submitted to fulfill this requirement if the reports contain all the necessary information, and the appropriate distribution is made. Using an appropriate method listed in § 71.1(a), the licensee must report to: ATTN: Document Control Desk, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards. These reports must include the following:
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-8, 737-9, and 737-8200 airplanes. This proposed AD was prompted by a report that certain passenger seat assemblies were not correctly installed in the seat tracks. This proposed AD would require a detailed inspection of the seat track fittings of each left and right side track-mounted passenger seat assembly for correct installation and applicable on-condition actions. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by September 10, 2026.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For Boeing material identified in this proposed AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; website
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available at
Julie Linn, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3584; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under the
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Julie Linn, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3584; email:
The FAA has received a report indicating that certain track-mounted passenger seat assemblies were not correctly installed in the seat tracks; the aft fitting shear plungers were not correctly lowered and not engaged in the seat tracks. A track-mounted passenger seat assembly that is installed incorrectly can disengage from the seat tracks if there is an increased load, turbulence, or emergency landing. This condition, if not addressed, could result in injury to passengers and crew during an emergency landing or could block the aisle, which could slow evacuation.
The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
The FAA reviewed Boeing Special Attention Requirements Bulletin 737-25-1927 RB, dated December 10, 2025. This material specifies procedures for conducting a detailed inspection of the seat track fittings of each left and right side track-mounted passenger seat assembly for correct installation and applicable on-condition actions. On-condition actions include correctly installing each affected left and right side track-mounted passenger seat assembly. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This proposed AD would require accomplishing the actions specified in the material already described, except for any differences identified as exceptions in the regulatory text of this proposed AD. For information on the procedures and compliance times, see this material at
The FAA estimates that this AD, if adopted as proposed, would affect 453 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the following costs to do any necessary installations that would be required based on the results of the proposed inspection. The agency has no way of determining the number of aircraft that might need these repairs:
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by September 10, 2026.
None.
This AD applies to The Boeing Company Model 737-8, 737-9, and 737-8200 airplanes, certificated in any category, as identified in Boeing Special Attention Requirements Bulletin 737-25-1927 RB, dated December 10, 2025.
Air Transport Association (ATA) of America Code 25, Equipment/furnishings.
This AD was prompted by a report that certain track-mounted passenger seat assemblies were not correctly installed in the seat tracks. The FAA is issuing this AD to address incorrectly installed track-mounted passenger seat assemblies, which could potentially disengage from the seat tracks. The unsafe condition, if not addressed, could result in injury to passengers and crew during an emergency landing or could block the aisle, which could slow evacuation.
Comply with this AD within the compliance times specified, unless already done.
Except as specified by paragraph (h) of this AD: At the applicable times specified in the “Compliance” paragraph of Boeing Special Attention Requirements Bulletin 737-25-1927 RB, dated December 10, 2025, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Special Attention Requirements Bulletin 737-25-1927 RB, dated December 10, 2025.
Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Special Attention Requirements Bulletin 737-25-1927 RB, dated December 10, 2025, refer to the original issue date of Requirements Bulletin 737-25-1927 RB, this AD requires using the effective date of this AD.
(1) The Manager, AIR-520, Continued Operational Safety Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the Continued Operational Safety Branch, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to:
(2) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, AIR-520, Continued Operational Safety Branch, FAA, to make those findings. To be approved, the repair method,
(1) For more information about this AD, contact Julie Linn, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3584; email:
(2) Material identified in this AD that is not incorporated by reference is available at the address specified in paragraph (k)(3) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Special Attention Requirements Bulletin 737-25-1927 RB, dated December 10, 2025.
(ii) [Reserved].
(3) For Boeing material identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; website
(4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2024-22-01, which applies to certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. AD 2024-22-01 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. Since the FAA issued AD 2024-22-01, the FAA has determined that new or more restrictive airworthiness limitations are necessary. This proposed AD would continue to require certain actions in AD 2024-22-01 and would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by September 10, 2026.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For Transport Canada material identified in this proposed AD, contact Transport Canada, Transport Canada National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-3639; email
• For Airbus Canada Limited Partnership material identified in this proposed AD, contact Airbus Canada Limited Partnership, 13100 Henri-Fabre Boulevard, Mirabel, Québec J7N 3C6, Canada; telephone: 450-476-7676; email:
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
Frank Carreras, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3539; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under the
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each
The FAA issued AD 2024-22-01, Amendment 39-22872 (89 FR 93157, November 26, 2024) (AD 2024-22-01), for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. AD 2024-22-01 was prompted by an MCAI originated by Transport Canada, which is the is the aviation authority for Canada. Transport Canada issued AD CF-2023-69, dated October 5, 2023 (Transport Canada AD CF-2023-69), to correct an unsafe condition.
AD 2024-22-01 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA issued AD 2024-22-01 to address reduced structural integrity of the airplane or reduced controllability of the airplane.
Since the FAA issued AD 2024-22-01, Transport Canada superseded Transport Canada AD CF-2023-69 and issued Transport Canada AD CF-2025-67, dated December 11, 2025 (Transport Canada AD CF-2025-67) (also referred to as the MCAI), for all Model BD-500-1A10 and BD-500-1A11 airplanes. However, airplanes on which the information specified in Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue No. 019.01, dated August 28, 2025, or later revisions of Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, approved by Transport Canada, has been incorporated into the existing maintenance or inspection program, as applicable, are not included in the applicability of this proposed AD; those airplanes must comply with the airworthiness limitations specified as part of the approved type design and referenced on the type certificate data sheet. The MCAI states that new or more restrictive airworthiness limitations have been developed.
The FAA is proposing this AD to address the unsafe condition on these products. You may examine the MCAI in the AD docket at
Transport Canada AD CF-2025-67 specifies new or more restrictive airworthiness limitations, which include certification maintenance requirements (CMRs), structural inspections, safe life limits, and Critical Design Configuration Control Limitations (CDCCLs). The airworthiness limitations also include Additional Mandatory Maintenance Tasks (AMMTs), which are applicable to U.S. operators in lieu of the candidate CMRs (CCMRs).
This proposed AD would also require Transport Canada AD CF-2023-69, dated October 5, 2023 (Transport Canada AD CF-2023-69), which the Director of the Federal Register approved for incorporation by reference as of December 31, 2024 (89 FR 93157, November 26, 2024).
This proposed AD would also require Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue 011.00, dated June 18, 2020, which the Director of the Federal Register approved for incorporation by reference as of March 30, 2021 (86 FR 10799, February 23, 2021).
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI and material referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would retain certain requirements of AD 2024-22-01. This proposed AD would also require revising the existing maintenance or inspection program, as applicable, to incorporate additional new or more restrictive airworthiness limitations, which are specified in Transport Canada AD CF-2025-67 already described, as proposed for incorporation by reference. Any differences with Transport Canada AD CF-2025-67 are identified as exceptions in the regulatory text of this proposed AD. See “Differences Between This Proposed AD and the MCAI” for a discussion of the general differences included in this AD.
This proposed AD would require revisions to certain operator maintenance documents to include new actions (
Although Transport Canada AD CF-2025-67 refers to Airbus Canada Limited Partnership A220 (
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to retain the Incorporation by Reference (IBR) of Transport Canada AD CF-2023-69 and incorporate Transport Canada AD CF-2025-67 by reference in the FAA final rule. This proposed AD
The FAA's process of incorporating by reference MCAI ADs as the primary source of information for compliance with corresponding FAA ADs has been limited to certain MCAI ADs (primarily those with service bulletins as the primary source of information for accomplishing the actions required by the FAA AD). However, the FAA is now expanding the process to include MCAI ADs that require a change to airworthiness limitation documents, such as airworthiness limitation sections.
For these ADs that incorporate by reference an MCAI AD that changes airworthiness limitations, the FAA requirements are unchanged. Operators must revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in the new airworthiness limitation document. The airworthiness limitations must be followed according to 14 CFR 91.403(c) and 91.409(e).
The previous format of the airworthiness limitation ADs included a paragraph that specified that no alternative actions (
The FAA estimates that this AD, if adopted as proposed, would affect 184 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the total cost per operator for the retained actions from AD 2024-22-01 to be $7,650 (90 work-hours × $85 per work-hour).
The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the average total cost per operator for the new proposed actions to be $7,650 (90 work-hours × $85 per work-hour).
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by September 10, 2026.
This AD replaces AD 2024-22-01, Amendment 39-22872 (89 FR 93157, November 26, 2024) (AD 2024-22-01).
This AD applies to Airbus Canada Limited Partnership (Type Certificate previously held by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.) Model BD-500-1A10 and BD-500-1A11 airplanes, certificated in any category, except for airplanes on which the information specified in Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue No. 019.01, dated August 28, 2025, or later revisions of Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, approved by Transport Canada, has been incorporated into the existing maintenance or inspection program, as applicable.
Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks.
This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address reduced structural integrity of the airplane and reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2024-22-01, with a new terminating action. For airplanes with an original airworthiness certificate or original export certificate of airworthiness issued on or before June 18, 2020: Within 90 days after March 30, 2021 (the effective date of AD 2021-04-05, Amendment 39-21426 (86 FR 10799, February 23, 2021)), revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in Section 03, “Candidate CMR Limitations—General,” of Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue 011.00, dated June 18, 2020. The initial compliance time for doing the tasks is at the time specified in Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue 011.00, dated June 18, 2020, or within 90 days after March 30, 2021, whichever occurs later. Accomplishing the revision of the existing maintenance or inspection program required by paragraph (l) of this AD terminates the requirements of this paragraph.
This paragraph restates the requirements of paragraph (h) of AD 2024-22-01 with a new exception. Except as required by paragraph (l) of this AD, after the existing maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (
This paragraph restates the requirements of paragraph (k) of AD 2024-22-01, with a new terminating action. For airplanes with an original airworthiness certificate or original export certificate of airworthiness issued on or before August 17, 2023: Except as specified in paragraph (j) of this AD, comply with all required actions and compliance times specified in, and in accordance with, Transport Canada AD CF-2023-69, dated October 5, 2023 (Transport Canada AD CF-2023-69). Accomplishing the revision of the existing maintenance or inspection program required by paragraph (l) of this AD terminates the requirements of this paragraph.
This paragraph restates the exceptions specified in paragraph (l) of AD 2024-22-01, with no changes.
(1) Where Transport Canada AD CF-2023-69 refers to its effective date, this AD requires using December 31, 2024, (the effective date of AD 2024-22-01).
(2) Where paragraph A. of Transport Canada AD CF-2023-69 specifies to “amend the TC-approved maintenance schedule,” this AD requires replacing that text with “revise the existing maintenance or inspection program, as applicable.”
(3) Where paragraph A. of Transport Canada AD CF-2023-69 specifies incorporating Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue 017.01, dated August 17, 2023, for this AD, incorporating the information specified in Section 03, “Candidate CMR Limitations—General” of Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue 017.01, dated August 17, 2023, is not required.
(4) The initial compliance time for doing the tasks specified in paragraph A. of Transport Canada AD CF-2023-69 is at the applicable “thresholds” as incorporated by the requirements of paragraph A. of Transport Canada AD CF-2023-69, or within 90 days after December 31, 2024, (the effective date of AD 2024-22-01), whichever occurs later.
(5) This AD does not adopt paragraph B. of Transport Canada AD CF-2023-69.
This paragraph restates the provisions specified in paragraph (m) of AD 2024-22-01, with a new exception. Except as required by paragraph (l) of this AD, after the existing maintenance or inspection program has been revised as required by paragraph (i) of this AD, no alternative actions (
Except as specified in paragraph (m) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, Transport Canada AD CF-2025-67, dated December 11, 2025 (Transport Canada AD CF-2025-67). Accomplishing the revision of the existing maintenance or inspection program required by this paragraph terminates the requirements of paragraphs (g) and (i) of this AD.
(1) Where the “Corrective Actions” section of Transport Canada AD CF-2025-67 specifies to “Within the thresholds and repeat intervals identified within the tasks, or discard time, as applicable, complete the new or more restrictive limitations contained in ACLP BD-500-1A10 and BD-500-1A11 AWL, BD500-3AB48-11400-02, Issue No. 019.00, dated 17 April 2025”, this AD requires replacing that text with “Revise the existing maintenance or inspection program, as applicable, by incorporating the information specified in Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue No. 019.01, dated August 28, 2025”. The compliance time for revising the maintenance or inspection program, as applicable, is within 30 days after the effective date of this AD.
(2) The initial compliance time for doing the tasks specified in Issue No. 019.01 of the material referenced in paragraph (m)(1) of this AD is at the applicable thresholds, limitations, and life limits as specified in Issue No. 019.01 of the material referenced in paragraph (m)(1) of this AD, or within 30 days after the effective date of this AD, whichever occurs later.
After the existing maintenance or inspection program has been revised as required by paragraph (l) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(i) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
(ii) AMOCs approved previously for AD 2024-22-01 are approved as AMOCs for the corresponding provisions of paragraph (g) of this AD.
(iii) AMOCs approved previously for AD 2024-22-01 are approved as AMOCs for the corresponding provisions of paragraph (i) of this AD, except AMOCs that allow issues earlier than Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue 017.01, dated August 17, 2023.
(2)
For more information about this AD, contact Frank Carreras, Aviation Safety Engineer, FAA, 2200 South 216th St., Des
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following material was approved for IBR on August 31, 2026.
(i) Transport Canada AD CF-2025-67, dated December 11, 2025.
(ii) [Reserved]
(4) The following material was approved for IBR on December 31, 2024 (89 FR 93157, November 26, 2024).
(i) Transport Canada AD CF-2023-69, dated October 5, 2023.
(ii) [Reserved]
(5) The following service information was approved for IBR on March 30, 2021 (86 FR 10799, February 23, 2021).
(i) Airbus Canada Limited Partnership A220 Airworthiness Limitations, BD500-3AB48-11400-02, Issue 011.00, dated June 18, 2020.
(ii) [Reserved]
(6) For Transport Canada material identified in this AD, contact Transport Canada, Transport Canada National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-3639; email
(7) For Airbus Canada Limited Partnership material identified in this AD, contact Airbus Canada Limited Partnership, 13100 Henri-Fabre Boulevard, Mirabel, Québec J7N 3C6, Canada; telephone: 450-476-7676; email:
(8) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(9) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission or FCC) adopted a Second Further Notice of Proposed Rulemaking (
Comments are due on or before August 26, 2026; reply comments are due on or before September 25, 2026.
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS).
•
•
• Filings can be sent by hand or messenger delivery, by commercial courier, or by the U.S. Postal Service. All filings must be addressed to the Secretary, Federal Communications Commission.
• Hand-delivered or messenger-delivered paper filings for the Commission's Secretary are accepted between 8:00 a.m. and 4:00 p.m. by the FCC's mailing contractor at 9050 Junction Drive, Annapolis Junction, MD 20701. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.
• Commercial courier deliveries (any deliveries not by the U.S. Postal Service) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• Filings sent by U.S. Postal Service First-Class Mail, Priority Mail, and Priority Mail Express must be sent to 45 L Street NE, Washington, DC 20554.
•
Svantje Swider, Office of International Affairs, Telecommunication and Analysis Division, at
This is a summary of the Commission's Second Further Notice of Proposed Rulemaking (
In this
In the
In the
Our actions in the
In this
We seek comment on the routine conditions that we should consider to improve our oversight of SLTE owners and operators given the evolving national security risks posed by foreign adversaries. While we conduct and complete the one-time collection time adopted in the
With respect to SLTE, we also seek comment on whether to consider consistent or differing routine conditions for the aforementioned licensees that (1) own and/or operate SLTE on their licensed submarine cable, or (2) owns an SLTE and either owns or leases the underlying fiber, capacity, or spectrum, or leases the SLTE and the underlying fiber, capacity, or spectrum to another entity. To the extent we consider any routine conditions, are there any timing or compliance considerations that we should also consider for these licensees and any owners and/or operators of SLTE? What, if any, would be the impact on small entities in the market that we should consider?
Should the Commission adopt any other routine conditions? Should the Commission also adopt as routine conditions for all cable landing licensees, including SLTE owners and operators, any or all of the national security standards that we apply in this
Should the Commission adopt a mechanism for existing licensees to opt-in to the ten national security standards in lieu of existing NSAs? For example, should the Commission allow existing licensees that can comply with the ten national security standards to opt-in to those ten national security standards in lieu of their existing NSA by filing a petition with the Commission, and if granted, their existing NSA shall be deemed terminated?
We also seek comment on whether an applicant with reportable foreign ownership that seeks exemption from referral should be exempt from the requirement to submit responses to the Standard Questions. In this
Through the
The Commission has also prepared an Initial Regulatory Flexibility Analysis (IRFA) concerning the potential impact of rule and policy change proposals on small entities in the
As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Federal Communications Commission (Commission) has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the policies and rules proposed in the
In this
The proposed action is authorized pursuant to Sections 1, 4(i), 4(j), 201-255, 303(r), 403, and 413 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), 201-255, 303(r), 403, and 413, and the Cable Landing License Act, 47 U.S.C. 34-39, and Executive Order No. 10530, section 5(a), (May 12, 1954) reprinted as amended in 3 U.S.C. 301.
The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the adopted rules. 5 U.S.C. 604. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.”
Rules adopted in response to the
The RFA directs agencies to describe the economic impact of proposed rules on small entities, as well as projected reporting, recordkeeping and other compliance requirements, including an estimate of the classes of small entities which will be subject to the requirements and the type of professional skills necessary for preparation of the report or record. 5 U.S.C. 603(b)(4). As described in the
The RFA directs agencies to provide a description of any significant alternatives to the proposed rules that would accomplish the stated objectives of applicable statutes, and minimize any significant economic impact on small entities.
As described in the
Animal and Plant Health Inspection Service, USDA.
Notice of availability.
We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with the interstate movement of fresh turmeric rhizomes (
We will consider all comments that we receive on or before September 25, 2026.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Dr. Derek A. Woller, Senior Regulatory Policy Specialist, Pest Exclusion and Import Permits, Import Regulations and Manuals, Regulatory Coordination and Compliance, PPQ, APHIS, 1400 Independence SW, Washington, DC 20250; (480) 490-6454;
Under the regulations in “Subpart A-Regulated Articles From Hawaii and the Territories” (7 CFR 318.13-1 through 318.13-17, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) prohibits or restricts the movement in interstate commerce of any plant or plant product from Hawaii and the Territories to prevent plant pests or noxious weeds from being introduced into or disseminated within the United States.
Section 318.13-4 contains a performance-based process for authorizing the interstate movement of certain fruits and vegetables from Hawaii and the Territories that, based on the findings of a pest risk analysis, can be safely moved interstate subject to one or more of the five designated phytosanitary measures listed in paragraph (b) of that section.
APHIS received a request from the government of Puerto Rico to allow the interstate movement of fresh rhizomes of turmeric (
Therefore, in accordance with § 318.13-4(c), we are announcing the availability of our pest risk assessment and RMD for public review and comment. Those documents, as well as a description of the economic considerations associated with the interstate movement of fresh turmeric rhizomes from Puerto Rico, may be viewed on the
After reviewing any comments we receive, we will announce our decision regarding the interstate movement status of fresh turmeric rhizomes from Puerto Rico in a subsequent notice. If the overall conclusions of our analysis and the Administrator's determination of risk remain unchanged following our consideration of the comments, then we will authorize the interstate movement of fresh turmeric rhizomes for consumption from Puerto Rico into the continental United States subject to the requirements specified in the RMD.
Food and Nutrition Administration (FNA), Agriculture (USDA).
Notice.
This notice announces the annual adjustments to the national average payment rates for meals and snacks served in child care centers, outside-school-hours care centers, at-risk afterschool care centers, and adult day care centers; the food service payment rates for meals and snacks served in day care homes; and the administrative reimbursement rates for sponsoring organizations of day care homes, to reflect changes in the Consumer Price Index. Further adjustments are made to these rates to reflect the higher costs of providing meals in Alaska, Guam, Hawaii, Puerto Rico, and Virgin Islands. The adjustments contained in this notice are made on an annual basis each July, as required by the laws and regulations governing the Child and Adult Care Food Program.
These rates are in effect from July 1, 2026, through June 30, 2027.
Penny Burke, Branch Chief, Program Monitoring and Operational Support Division, Child Nutrition Programs, FNA USDA, 1400 Independence Avenue SW, Washington, DC 20250, 720-822-8597.
Pursuant to sections 4, 11, and 17 of the Richard B. Russell National School Lunch Act (42 U.S.C. 1753, 1759a, and 1766), section 4 of the Child Nutrition Act of 1966 (42 U.S.C. 1773) and 7 CFR 226.4, 226.12, and 226.13 of the Program regulations, notice is hereby given of the new payment rates for institutions participating in the Child and Adult Care Food Program. As provided for under the law, all rates in the Child and Adult Care Food Program must be revised annually, on July 1, to reflect changes in the Consumer Price Index (CPI), published by the Bureau of Labor Statistics of the United States Department of Labor, for the most recent 12-month period. These rates are in effect during the period of July 1, 2026, through June 30, 2027.
The following national average payment factors and food service payment rates for meals and snacks are in effect from July 1, 2026, through June 30, 2027. All amounts are expressed in dollars or fractions thereof. Due to a higher cost of living, the reimbursements for Alaska, Guam, Hawaii, Puerto Rico, and Virgin Islands are higher than those for all other States. The District of Columbia uses the figures specified for the contiguous States. These rates do not include the value of USDA Foods or cash-in-lieu of USDA Foods, which institutions receive as additional assistance for each lunch or supper served to participants under the Program. A notice announcing the value of USDA Foods and cash-in-lieu of USDA Foods is published separately in the
Adjustments to the national average payment rates for all meals served under the Child and Adult Care Food Program are rounded down to the nearest whole cent.
The changes in the national average payment rates for centers reflect a 3.54 percent increase during the 12-month period from May 2025 to May 2026 (from 381.228 in May 2025, as previously published in the
Payments for breakfasts served are:
Payments for lunch or supper served are:
Payments for snack served are:
The changes in the food service payment rates for day care homes reflect a 2.74 percent increase during the 12-month period from May 2025 to May 2026 (from 312.491 in May 2025, as previously published in the
Payments for breakfast served are:
Payments for lunch and supper served are:
Payments for snack served are:
The changes in the administrative reimbursement rates for sponsoring organizations of day care homes reflect a 4.25 percent increase during the 12-month period, May 2025 to May 2026 (from 321.465 in May 2025, as previously published in the
Monthly administrative payments to sponsors for each sponsored day care home are:
The following chart illustrates the national average payment factors and food service payment rates for meals and snacks in effect from July 1, 2026, through June 30, 2027.
This action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612) and thus is exempt from the provisions of that Act. This notice has been determined to be exempt under Executive Order 12866.
Child and Adult Care Food Program is listed in the Catalog of Federal Domestic Assistance under No. 10.558 and is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR 415.3-415.6).
This notice imposes no new reporting or recordkeeping provisions that are subject to OMB review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3518).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that ABR, Inc. Environmental Research and Services, P.O. Box 80410, Fairbanks, AK 99708 (Responsible Party: Adrian Gall, Ph.D.), has applied in due form for a permit to conduct research on 4 pinniped species and 10 cetacean species.
Written comments must be received on or before August 26, 2026.
The application and related documents are available for review upon written request via email to
Written comments on this application should be submitted via email to
Those individuals requesting a public hearing should submit a written request via email to
Amy Hapeman or Sara Young, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant proposes to evaluate the seasonal and annual distribution and abundance of marine mammals in the vicinity of a proposed barge site in the Tuxedni Bay and Tuxedni Channel, western Cook Inlet, Alaska. Target species include: endangered beluga (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of hybrid meeting open to the public offering both in-person and virtual options for participation.
The Gulf Fishery Management Council (Council) will hold a four-day meeting to consider actions affecting the Gulf of America fisheries in the exclusive economic zone (EEZ).
The meeting will convene Monday, August 24, 2026 through Thursday, August 27, 2026. Daily schedule: Monday through Wednesday from 8:30 a.m. to 5 p.m., CDT and Thursday from 8:30 a.m. to 3:15 p.m., CDT.
The meeting will take place at the Golden Nugget Hotel and Casino, located at 151 Beach Boulevard, Biloxi, MS 39530. If you prefer to “listen in,” you may access the log-on information by visiting our website at
Dr. Carrie Simmons, Executive Director, Gulf Fishery Management Council; telephone: (813) 348-1630.
The meeting will begin with the induction of reappointed Council members, followed by the Administrative/Budget Committee's review and discussion of the Final 2026 Funded Budget and Activities, the future funding cycle, timing of funding releases, and Council planning.
The Shrimp Committee will review the July 2026 Scientific and Statistical Committee (SSC) Meeting Summary and Recommendations and receive a status update from the Working Group to Address Interactions and Bycatch of Protected Resources in Shrimp Trawls.
The Gulf Southeast Data Assessment and Review (SEDAR) Committee will receive the July 2026 SEDAR Steering Committee Summary Report. The Ecosystem Committee will review the contractor report, Identification of Stakeholder-Driven Fishery Ecosystem Issues. The Data Collection Committee will review and discuss Final Action for the Generic Amendment: Modifications to the Gulf For-hire Data Collection Program and receive a presentation on the Marine Recreational Information Program (MRIP)-Fishing Effort Survey (FES) Pilot Study Results.
The meeting will begin with a litigation update, followed by the Reef Fish Committee's review of draft options for Reef Fish Amendment 64: Delegate Federal For-hire Red Snapper Management to Gulf States and for Management Flexibility for the Federal For-hire component of the Red Snapper fishery.
The committee will also review a draft of Modifications to Red Snapper Private Recreational Post-Season Accountability Measures and the July 2026 SSC Meeting Summary and Recommendations.
Following lunch, the committee will review draft Reef Fish Amendment 59A: Permit Requirements in Individual Fishing Quota (IFQ) Programs and discuss decision points for Red Snapper Catch Limits and Allocations.
The committee will review Public Hearing draft—Reef Fish Amendment 55/Snapper Grouper Amendment 44: Mutton Snapper and Yellowtail Snapper Management Measures and Discuss any Exempted Fishing Permits.
The Reef Fish Committee will reconvene to receive an overview titled “Understanding Catch Per Unit Effort from Fishery-Independent and Fishery-Dependent Indices of Relative Abundance,” followed by presentations on the Gulf Fishery-Independent Survey of Habitat and Ecosystem Resources (G-FISHER) Composite Video Index and the Red Grouper Commercial Catch Per Unit Effort (CPUE) Index.
The Sustainable Fisheries Committee will discuss the Five-Year Standardized Bycatch Reporting methodology.
At approximately 11:15 a.m., CDT the Council will convene with the Call to Order, Announcements and Introductions, Adoption of the Agenda, and Approval of Minutes.
The Council will receive updates from supporting agencies, including the South Atlantic Council Liaison, Mississippi Law Enforcement, NOAA Office of Law Enforcement (OLE), Gulf States Marine Fisheries Commission, U.S. Coast Guard, U.S. Fish and Wildlife Service, and the Department of State.
The Council will receive a presentation Celebrating 50 Years of Magnuson-Steven Fishery Conservation and Management Act in the Gulf, followed by public testimony beginning at 2 p.m.-5 p.m., CDT for public comment on Final Action-Generic Amendment: Modifications to Gulf For-hire Data Collection Program and Exempted Fishing Permits; and any Open Testimony on other Fishery Issues or Concerns.
The Council will receive reports from the Administrative/Budget, Shrimp, Gulf SEDAR, Ecosystem, Data Collection, Sustainable Fisheries, and Reef Fish Committees.
The Council will also receive an update on documents transmitted for Rule Making, discuss Council Planning and Primary Activities, and consider any other business.
The meeting will conclude with the election of the Council Chair and Vice-Chair for the 2026-2027 term.
This meeting will be conducted in a hybrid format, with both in-person and virtual participation options available. Members of the public may register to listen to the meeting via webinar by visiting
The timing and order of agenda items are subject to change to accommodate the needs of the Council. The most current agenda and all meeting materials will be posted on the Council's website as they become available.
Although non-emergency issues not included in this notice may come before the Council for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal Council action. Formal action will be limited to those issues specifically identified in this notice and any issues arising after publication that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids or accommodations should be directed to Kathy Pereira at (813) 348-1630 at least 15 days prior to the meeting.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public hybrid meeting.
The Caribbean Fishery Management Council (CFMC) will hold the 190th public hybrid meeting to address the items contained in the tentative agenda included in the
The 190th CFMC public hybrid meeting will be held on August 11, 2026, from 9 a.m. to 5 p.m., and on August 12, 2026, from 9 a.m. to 5:15 p.m., AST. A closed meeting will be held on August 11, 2026, from 5:15 p.m. to 5:45 p.m., AST. The meeting will be held at the Courtyard by Marriott Isla Verde Beach Resort, 7012 Boca de Cangrejos Avenue, Carolina, Puerto Rico 00979.
You may join the 190th CFMC public hybrid meeting via Zoom, from a computer, tablet or smartphone by entering the following address:
In case there are problems, and we cannot reconnect via Zoom, the meeting will continue using GoToMeeting.
You can join the meeting from your computer, tablet, or smartphone.
Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 398-3717.
The following items included in the tentative agenda will be discussed:
(1): Other than starting time and dates of the meetings, the established times for addressing items on the agenda may be adjusted as necessary to accommodate the timely completion of discussion relevant to the agenda items. To further accommodate discussion and completion of all items on the agenda, the meeting may be extended from, or completed prior to the date established in this notice. Changes in the agenda will be posted to the CFMC website, Facebook, Twitter and Instagram as practicable.
(2): Financial disclosure forms are available for inspection at this meeting, as per 50 CFR part 601.
The order of business may be adjusted as necessary to accommodate the completion of agenda items. The meeting will begin on August 11, 2026, at 9 a.m. AST, and will end on August 12, 2026, at 5:15 p.m. AST. Other than the start time on the first day of the meeting, interested parties should be aware that discussions may start earlier or later than indicated in the agenda, at the discretion of the Chair.
Simultaneous interpretation will be provided.
For simultaneous interpretation English-Spanish-English follow your Zoom screen instructions. You will be asked which language you prefer when you join the meeting.
For any additional information on this public virtual meeting, please contact Diana Martino, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone: (787) 226-8849.
National Marine Fisheries Service (NMFS), National Oceanic and
Notice; request for comments.
The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit (EFP) application contains all of the required information and warrants further consideration. The EFP would allow federally permitted fishing vessels to fish outside fishery regulations in support of exempted fishing activities proposed by Coonamessett Farm Foundation (CFF). Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed EFPs.
Comments must be received on or before August 11, 2026.
You may submit written comments by email:
Ashley Trudeau, Fishery Resource Management Specialist,
The applicant, CFF, has submitted a complete application for an EFP to conduct commercial fishing activities that the regulations would otherwise restrict. This EFP would exempt participating vessels from the following Federal regulations:
CFF requests an EFP for a project funded by the National Fish and Wildlife Foundation Electronic Monitoring and Reporting Grant Program that aims to evaluate the benefits and challenges of EM systems in the Atlantic sea scallop fishery as a tool to modernize data collection, improve management efficiencies, and augment the IFS observer program. Through a pilot program begun in 2024, EM systems have been installed on six limited access commercial sea scallop fishing vessels. The project has successfully trialed EM for observing and documenting fishing effort and behaviors with over 500 DAS and over 5,000 hauls reviewed. However, it remains unclear whether EM systems can be utilized to provide incentives for fishing vessels to augment their installation and maintenance costs.
Each vessel is outfitted with two cameras positioned on fixed structures that have an unobstructed view of the entire deck. Cameras are activated at the start of a trip by winch-mounted sensors that are either triggered by a spike in winch pressure (employed on 3 vessels) or by 10 full rotations of the winch (employed on 3 vessels). Each EM system also contains a Global Positioning System unit with a sampling interval of 10 seconds. During every trip, sensor and still-image video would be exported via Starlink from the system during the first five winch activations and during the last five winch
As an additional confirmation of fishing activity, participating vessels will be asked to record haul-level catch information on an electronic logbook (eLog). CFF will monitor vessel activity and ensure eLogs are submitted within 5 days after a vessel returns from a trip. CFF has an existing agreement in place with NOAA's Greater Atlantic Regional Fisheries Office to access eVTR for these six vessels biannually. These records include all relevant variables, such as sail dates, number of tows, fishing area, gear type, catch, discards, and port. In addition to eLogs, CFF would use eVTR records to confirm fishing activity.
Through a Community Projects Award, CFF has developed a novel fish measuring and identification system with Acbotics Research, LLC, designed for use offshore on commercial fishing vessels. CFF would use this fishboard and a paired scale to enable participating fishermen to collect length and weight data for scallops and priority bycatch species following the IFS sampling protocol during one trip per year. For multiday trips, this protocol includes observation of at least 50 percent of hauls during a trip, measuring and weighing scallops from one basket during the first haul of each watch, measuring and weighing priority bycatch species, and opportunistically monitoring for scallop diseases. A CFF scientist will join one fishing trip with a minimum duration of seven DAS on each vessel. On these trips, they would train the captain and at least one crew member on fishboard use, data collection, and system maintenance.
This EFP would authorize two regulatory exemptions as incentives for participation in this developing EM program. The first exemption would allow an alternative calculation method for DAS used per trip; rather than beginning and ending the trip's DAS upon crossing the demarcation line, the start of DAS accounting for a trip would be based on the time at which a vessel's dredge(s) first enter the ocean, and the end of DAS for a trip will be determined based on the time at which a vessel's dredge(s) last leave the ocean before returning to port. By removing transit time between port departure and first dredge deployment and between final dredge deployment and port arrival, DAS would be used only while on the fishing grounds, and not during transit time. In the previous two years of piloting the EM system, the six participating vessels took 36 trips where the trip length could be calculated by both DAS estimation methods. By the typical DAS calculation method (days between outgoing and return crossing of the VMS demarcation line), these trips used 259.75 DAS. If DAS had been calculated using the alternative method (days between start of first haul and end of final haul), the trips would have used 217.3 DAS, a difference of 42.45 DAS. This equates to an average of 1.18 fewer DAS being used for each of the 36 trips. Under this EFP, CFF expects participating vessels to take 24 trips during each year of the 2-year project. If each trip uses approximately 1.18 fewer DAS under the alternative calculation method, this could result in a total difference of 28.32 DAS that participating vessels could apply to other scallop trips. For fishing year 2026, NMFS allocated 11,023 DAS to the commercial fleet. This EFP could potentially result in an approximately 0.26-percent increase to maximum fleetwide DAS use for the year.
The second exemption would allow participating vessels continuous transit through Scallop Rotational Areas, which are closed during the project duration. Vessels would not be permitted to fish in these Areas and would be required to stow their gear. Allowing transit of closed areas would additionally allow vessels to take more direct routes to fishing grounds, reducing fuel expenditures and potentially DAS used. These incentives would allow vessels to recoup EM system installation and maintenance costs and incentivize further participation in this developing EM program. The applicant expects that participating vessels would primarily transit the Nantucket Lightship-North and -South Access areas.
If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.
Defense Acquisition Regulations System; Department of Defense (DoD).
Notice and request for comments regarding a proposed extension of an approved information collection requirement.
In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of DoD's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use under Control Number 0750-0002 through October 31, 2026. DoD proposes that OMB approve an extension of the information collection requirement, to expire three years after the approval date.
DoD will consider all comments received by September 25, 2026.
You may submit comments, identified by OMB Control Number 0750-0002, using either of the following methods:
•
•
Comments received generally will be posted without change to
Heather Kitchens, at 571-296-7152.
This requirement supports implementation of section 1656(b) of the National Defense Authorization Act for Fiscal Year 2018. Section 1656 prohibits DoD from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service to carry out the nuclear deterrence mission and homeland defense mission that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as a part of any system.
This requirement is implemented in the Defense Federal Acquisition Regulation Supplement (DFARS) through the solicitation provision at 252.204-7017, Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services—Representation, and the contract clause at 252.204-2018, Prohibition on Acquisition of Covered Defense Telecommunications Equipment or Services.
This clearance covers the following requirements:
• DFARS 252.204-7017 requires that if an offeror provides an affirmative representation under the solicitation provision at 252.204-7016, Covered Defense Telecommunications Equipment or Services—Representation, that offeror is required to represent whether it will or will not provide under the contract covered defense telecommunications equipment or services.
• DFARS 252.204-7018 requires contractors to report covered telecommunications equipment, systems, and services identified during performance of a contract.
The license for the Lovejoy Dam Project No. 9649 was issued for a period ending June 30, 2026.
Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 9649 is issued to the Lovejoy Tool Company Inc. for a period effective July 1, 2026, through June 30, 2027, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.
If issuance of a new license (or other disposition) does not take place on or
If the project is not subject to section 15 of the FPA, notice is hereby given that the Lovejoy Tool Company Inc. is authorized to continue operation of the Lovejoy Dam Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding. eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Maynard Hydro filed its request to use the Traditional Licensing Process on April 21, 2026, and provided public notice of its request on April 19, 2026. In a letter dated July 22, 2026, the Director of the Division of Hydropower Licensing approved Maynard Hydro's request to use the Traditional Licensing Process.
k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and/or the National Marine Fisheries Service (NMFS) under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR, Part 402; and NMFS under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the Arkansas State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. With this notice, we are designating Maynard Hydro as the Commission's non-federal representative for carrying out informal consultation, pursuant to section 7 of the Endangered Species Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act; and consultation pursuant to section 106 of the National Historic Preservation Act.
m. Maynard Hydro filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD may be viewed on the Commission's website (
o. You may register online at
p. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The license for the Gilman Dam Project No. 9650 was issued for a period ending June 30, 2026.
Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 9650 is issued to Factory Falls, Inc. for a period effective July 1, 2026, through June 30, 2027, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.
If issuance of a new license (or other disposition) does not take place on or before June 30, 2027, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that Factory Falls, Inc. is authorized to continue operation of the Gilman Dam Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Kram Hydro 3 filed its request to use the Traditional Licensing Process on April 22, 2026, and provided public notice of its request on April 19, 2026.
k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and/or the National Marine Fisheries Service (NMFS) under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR, Part 402; and NMFS under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the Arkansas State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. With this notice, we are designating Kram Hydro 3 as the Commission's non-federal representative for carrying out informal consultation, pursuant to section 7 of the Endangered Species Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act; and consultation pursuant to section 106 of the National Historic Preservation Act.
m. Kram Hydro 3 filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD may be viewed on the Commission's website (
o. You may register online at
p. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202)502-6595 or
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental document that will discuss the environmental impacts of the Tupelo Trail Project (Project) involving the installation, replacement, modification, and operation of compressor station facilities by Southeast Supply Header, LLC (SESH) in George and Jefferson Davis Counties, Mississippi, and Richland Parish, Louisiana. The Commission will use this environmental document in its decision-making process to determine whether the project is in the public convenience and necessity.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies regarding the project. As part of the National Environmental Policy Act (NEPA) review process, the Commission takes into account concerns the public may have about proposals and the environmental impacts that could result from its action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. This gathering of public input is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the environmental document on the important environmental issues. Additional information about the Commission's NEPA process is described below in the
By this notice, the Commission requests public comments on the scope of issues to address in the environmental document. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5:00 p.m. Eastern Time on August 21, 2026. Comments may be submitted in written form. Further details on how to submit comments are provided in the
Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the environmental document. Commission staff will consider all written comments during the preparation of the environmental document.
If you submitted comments on this project to the Commission before the opening of this docket on June 15, 2026, you will need to file those comments in Docket No. CP26-543-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the project, the Natural Gas Act conveys the right of eminent domain to the company. Therefore, if you and the company do not reach an easement agreement, the pipeline company could initiate condemnation proceedings in court. In such instances, compensation would be determined by a judge in accordance with state law. The Commission does not subsequently grant, exercise, or oversee the exercise of that eminent domain authority. The courts have exclusive authority to handle eminent domain cases; the Commission has no jurisdiction over these matters.
SESH provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” which addresses typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. This fact sheet along with other landowner topics of interest are available for viewing on the FERC website (
There are three methods you can use to submit your comments to the Commission. Please carefully follow these instructions so that your comments are properly recorded. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the eComment feature, which is located on the Commission's website (
(2) You can file your comments electronically by using the eFiling feature, which is located on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the Commission. Be sure to reference the project docket number (CP26-543-000) on your letter. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
Additionally, the Commission offers a free service called eSubscription which makes it easy to stay informed of all issuances and submittals regarding the dockets/projects to which you subscribe. These instant email notifications are the fastest way to receive notification and provide a link to the document files which can reduce the amount of time you spend researching proceedings. Go to
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
SESH proposes to install, replace, modify, and operate compression facilities and related appurtenances at existing compressor stations in George and Jefferson Davis Counties, Mississippi, and Richland Parish, Louisiana. The Tupelo Trail Project would provide an additional 110,000 dekatherms per day of natural gas to the Plant Daniel electric generation facility in Jackson County, Mississippi. According to SESH, its project would allow Southern Company (the Plant Daniel operator) to serve growing power generation demand, increase grid reliability, and facilitate Southern Company's planned conversion of an existing coal fired unit to natural gas.
The Tupelo Trail Project would consist of the following activities:
• installing a new compressor unit powered by a 23,470 horsepower Titan 130 natural gas turbine and related appurtenances at the existing Lucedale Compressor Station in George County, Mississippi;
• replacing an existing compressor with a new compressor at the Lucedale Compressor Station;
• replacing the existing engine on Compressor Unit 2 at the Gwinville Compressor Station in Jefferson Davis County, Mississippi;
• uprating compressor units and increasing compression at the Delhi, Gwinville, and Lucedale Compressor Stations by modifying software controls that limit horsepower;
• and performing associated appurtenant activities.
The general locations of the project facilities are shown in Appendix 1.
Installation, replacement, and modification of the proposed facilities at the Lucedale Compressor Station in George County, Mississippi would disturb 11.7 acres of land. Following construction, SESH would maintain 0.5 acre of additional land for permanent operation of the Lucedale Compressor Station; the remaining acreage would be restored and revert to former uses. Project-related activities at the Delhi and Gwinville Compressor Stations located in Richland Parish, Louisiana and Jefferson Davis County, Mississippi, respectfully would not require the use of land.
Any environmental document issued by the Commission will discuss impacts that could occur as a result of the construction and operation of the proposed project under the relevant general resource areas:
• geology and soils;
• water resources and wetlands;
• vegetation and wildlife;
• threatened and endangered species;
• cultural resources;
• socioeconomics;
• land use;
• air quality and noise; and
• reliability and safety.
Commission staff will also evaluate reasonable alternatives to the proposed project or portions of the project and make recommendations on how to lessen or avoid impacts on the various resource areas. Your comments will help Commission staff identify and focus on the issues that might have an effect on the human environment and potentially eliminate others from further study and discussion in the environmental document.
Following this scoping period, Commission staff will determine whether to prepare an Environmental Assessment (EA) or an Environmental Impact Statement (EIS). The EA or the EIS will present Commission staff's independent analysis of the issues. If Commission staff prepares an EA, a
With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate in the preparation of the environmental document.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is using this notice to initiate consultation with the applicable State Historic Preservation Office(s), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; Native American Tribes; environmental and public interest groups; other interested parties; and local libraries and media outlets. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project and includes a mailing address with their comments. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that Commission notices related to this environmental review are sent to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
(1) Send an email to
(2) Return the attached “Mailing List Update Form” (appendix 2).
Additional information about the project is available from the FERC website at
Public sessions or site visits will be posted on the Commission's calendar located at:
On April 1, 2026, Texas Eastern Transmission, LP (Texas Eastern) filed an application in Docket No. CP26-175-000 requesting an Authorization pursuant to Section 7(b) and 7(c) of the Natural Gas Act to abandon by removal four existing 8,000 horsepower turbine units and associated infrastructure and to install two 20,470 horsepower new Solar Titan 130 turbine units and related ancillary equipment. The new units would be installed in a new compressor building within the fenceline of the existing Athens Compressor Station located in Athens County, Ohio. The project would expand compression facilities to provide an additional 50,000 dekatherms per day (Dth/d) of incremental firm natural gas transportation capacity on Texas Eastern's pipeline system to serve Kentucky Utilities.
On April 14, 2026, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application (NOA) for the project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's environmental document for the project.
This notice identifies Commission staff's intention to prepare an environmental assessment (EA) for the project and the planned schedule for the completion of the environmental review.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the project's progress.
Texas Eastern is proposing to abandon by removal four existing natural gas General Electric Frame 3 turbine units and associated infrastructure and install two new 20,470 horsepower Solar Titan 130 turbine units and related ancillary equipment. The project involves a new
On May 13, 2026, the Commission issued a
In order to receive notification of the issuance of the EA and to keep track of formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This service provides automatic notification of filings made to subscribed dockets, document summaries, and direct links to the documents. Go to
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Additional information about the project is available from the FERC website (
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for a new license to continue to operate and maintain the Reusens Hydroelectric Project No. 2376 (project). The project is located on the James River in Bedford and Amherst Counties, Virginia. Commission staff has prepared an Environmental Assessment (EA) for the project.
The EA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
The Commission provides all interested persons with an opportunity to view and/or print the EA via the internet through the Commission's Home Page (
You may also register online at
Any comments should be filed on or before 5:00 p.m. Eastern Time on August 21, 2026.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202)502-6595 or
For further information, contact Laurie Bauer at (202) 502-6519 or by email at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental document that will discuss the environmental impacts of the Flat Lake Access Pipeline Project (Project) involving construction and operation of facilities by Steel Reef Pipelines US LLC (Steel Reef) in Divide County, North Dakota. The Commission will use this environmental document
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies regarding the project. As part of the National Environmental Policy Act (NEPA) review process, the Commission takes into account concerns the public may have about proposals and the environmental impacts that could result from its action whenever it considers the issuance of an authorization. This gathering of public input is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the environmental document on the important environmental issues. Additional information about the Commission's NEPA process is described below in the
By this notice, the Commission requests public comments on the scope of issues to address in the environmental document. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5:00 p.m. Eastern Time on August 21, 2026. Comments may be submitted in written form. Further details on how to submit comments are provided in the
Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the environmental document. Commission staff will consider all written comments during the preparation of the environmental document.
If you submitted comments on this project to the Commission before the opening of this docket on June 30, 2026, you will need to file those comments in Docket No. CP26-545-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
Steel Reef provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” which addresses typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. This fact sheet along with other landowner topics of interest are available for viewing on the FERC website (
There are three methods you can use to submit your comments to the Commission. Please carefully follow these instructions so that your comments are properly recorded. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the eComment feature, which is located on the Commission's website (
(2) You can file your comments electronically by using the eFiling feature, which is located on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the Commission. Be sure to reference the project docket number (CP26-545-000) on your letter. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
Additionally, the Commission offers a free service called eSubscription which makes it easy to stay informed of all issuances and submittals regarding the dockets/projects to which you subscribe. These instant email notifications are the fastest way to receive notification and provide a link to the document files which can reduce the amount of time you spend researching proceedings. Go to
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Steel Reef's proposed Project, referred to as the Border Crossing Facilities in its application, will consist of a 0.65-mile-long 10-inch-diameter pipeline designed to export up to 80 million cubic feet per day (MMcf/d) of sour natural gas from an existing Compressor Station near Fortuna, North Dakota, to the Flat Lake Gas Plant in Saskatchewan, Canada, and to import approximately 6 MMcf/d of fuel gas to supply the Compressor Station (via a collocated 6-inch-diameter pipeline).
The Project has associated facilities that would be constructed in support of the project, but do not fall under the jurisdiction of the FERC. The proposed intrastate pipeline would consist of 4.35 miles of new 6- and 10-inch-diameter pipelines from the riser extending southward to an existing compressor station. The intrastate facilities would be subject to the jurisdiction of the North Dakota Industrial Commission (NDIC) and would be non-jurisdictional to the FERC. In the EA, we will provide available descriptions of the non-jurisdictional facilities and include available environmental effect information under our analysis of trends cumulative impacts.
The general location of the project facilities is shown in appendix 1.
Steel Reef would limit its construction activities to 9.48 acres of agricultural land, comprised of 2.73 acres of new permanent right-of-way and 6.81 acres of temporary workspace. The new permanent pipeline right-of-way width would be 30 feet. Steel Reef would restore the temporary right-of-way to pre-abandonment conditions.
Any environmental document issued by the Commission will discuss impacts that could occur as a result of the construction and operation of the
• geology and soils;
• water resources, fisheries and wetlands;
• vegetation and wildlife;
• threatened and endangered species;
• cultural resources;
• land use;
• air quality and noise; and
• reliability and safety.
Commission staff will also evaluate reasonable alternatives to the proposed project or portions of the project and make recommendations on how to lessen or avoid impacts on the various resource areas. Your comments will help Commission staff identify and focus on the issues that might have an effect on the human environment and potentially eliminate others from further study and discussion in the environmental document.
Following this scoping period, Commission staff will determine whether to prepare an Environmental Assessment (EA) or an Environmental Impact Statement (EIS). The EA or the EIS will present Commission staff's independent analysis of the issues. If Commission staff prepares an EA, a
With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate in the preparation of the environmental document.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is using this notice to initiate consultation with the applicable State Historic Preservation Office(s), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; Native American Tribes; environmental and public interest groups; other interested parties; and local libraries and media outlets. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project and includes a mailing address with their comments. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that Commission notices related to this environmental review are sent to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
(1) Send an email to
(2) Return the attached “Mailing List Update Form” (appendix 2).
Additional information about the project is available from the FERC website at
Public sessions or site visits will be posted on the Commission's calendar located at:
The license for the Fellows Dam Hydroelectric Project No. 9648 was issued for a period ending June 30, 2026.
Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 9648 is issued to One Hundred River Street, LLC for a period effective July 1, 2026, through June 30, 2027, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.
If issuance of a new license (or other disposition) does not take place on or before June 30, 2027, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that One Hundred River Street, LLC is authorized to continue operation of the Fellows Dam Hydroelectric Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
The license for the Comtu Falls Hydroelectric Project No. 7888 was issued for a period ending June 30, 2026.
Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 7888 is issued to the Comtu Falls Corporation for a period effective July 1, 2026, through June 30, 2027, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.
If issuance of a new license (or other disposition) does not take place on or before June 30, 2027, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that the Comtu Falls Corporation is authorized to continue operation of the Comtu Falls Hydroelectric Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
The license for the Minnewawa Hydroelectric Project No. 7887 was issued for a period ending June 30, 2026.
Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 7887 is issued to Ashuelot River Hydro, Inc. for a period effective July 1, 2026, through June 30, 2027, or until the issuance of a new license for the project
If issuance of a new license (or other disposition) does not take place on or before June 30, 2027, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that Ashuelot River Hydro, Inc. is authorized to continue operation of the Minnewawa Hydroelectric Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
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j. Kram Hydro 1 filed its request to use the Traditional Licensing Process on April 21, 2026, and provided public notice of its request on April 19, 2026. In a letter dated July 22, 2026, the Director of the Division of Hydropower Licensing approved Kram Hydro 1's request to use the Traditional Licensing Process.
k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and/or the National Marine Fisheries Service (NMFS) under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR., Part 402; and NMFS under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the Arkansas State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. With this notice, we are designating Kram Hydro 1 as the Commission's non-federal representative for carrying out informal consultation, pursuant to section 7 of the Endangered Species Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act; and consultation pursuant to section 106 of the National Historic Preservation Act.
m. Kram Hydro 1 filed a Pre-Application Document (PAD, including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD may be viewed on the Commission's website (
o. You may register online at
p. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Federal Energy Regulatory Commission.
Notice of information collection renewal and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-603: Critical Energy/Electric Infrastructure Information Data Request (OMB Control No 1902-0197). There are no proposed changes to the reporting requirements.
Comments on the collections of information are due September 25, 2026.
Please submit comments via email to
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Kayla Williams may be reached by email at
This collection of information provides an alternative to seeking CEII in accordance with the Freedom of Information Act (FOIA).
In the aftermath of the September 11, 2001, terrorist attacks, the Commission determined that it was important to improve the appropriate treatment of CEII, both to assist requesters with a legitimate need for CEII, and to restrict access to the sensitive information due to the ongoing terrorism threat. The Commission promulgated 18 CFR 388.113 to achieve those goals.
Under 18 CFR 388.13(g)(5), a request for CEII must contain:
• The requester's name, title, address, and telephone number;
• The name, address, and telephone number of the person or entity on whose behalf the information is requested;
• A detailed Statement of Need;
• An executed non-disclosure agreement; and
• A signed statement confirming the information is accurate.
Under 18 CFR 388.133(h)(2), the non-disclosure agreement indicates the individual's willingness to adhere to limitations on the use and disclosure of the information requested, and stipulates at minimum that the CEII:
• Will be utilized solely for the purpose for which it was requested;
• May only be discussed with authorized recipients;
• Information utilized for modelling will not be disclosed;
• Must be kept in a secure place in a manner that would prevent unauthorized access;
• Must be destroyed or returned to the Commission upon request;
• Is strictly prohibited from disclosure to anyone outside the United States; and
• Is not subject to be released under either FOIA or Sunshine Laws.
In addition, the non-disclosure agreement provides that the Commission may audit the recipient's compliance with the non-disclosure agreement; that a recipient is obligated to protect the CEII even after a designation has lapsed
Export-Import Bank of the United States.
Notice.
This Notice is to inform the public, in accordance with the Export-Import Bank Act of 1945, as amended, the Export-Import Bank of the United States (“EXIM”) has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million. Comments received within the comment period specified below will be presented to the EXIM Board of Directors prior to final action on this Transaction.
Comments must be received on or before August 21, 2026 to be assured of consideration before final consideration of the transaction by the Board of Directors of EXIM.
Comments may be submitted through
To the extent that EXIM is reasonably aware, the item(s) being exported are not expected to be used to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry.
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before September 25, 2026. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
In 2013, the Commission adopted rules related to accessible emergency information and apparatus requirements for emergency information and video description.
In 2015, the Commission adopted rules to require the following: (1) apparatus manufacturers must provide a mechanism that is simple and easy to use for activating the secondary audio stream to access audible emergency information; and (2) starting no later than July 10, 2017, multichannel video programming distributors (MVPDs) must pass through the secondary audio stream containing audible emergency information when it is provided on linear programming accessed on second screen devices (
Finally, in 2020, the Commission adopted rules that included modernizing the term “video description” in the subject rules to the more widely understood “audio description.”
(a) Complaints alleging violations of the emergency information rules.
Section 79.2(c) of the Commission's rules provides that a complaint alleging a violation of § 79.2 of its rules, may be transmitted to the Consumer and Governmental Affairs Bureau by any reasonable means, such as the Commission's online informal complaint filing system, letter, facsimile transmission, telephone (voice/TRS/TTY), internet email, audio-cassette recording, Braille, or some other method that would best accommodate the complainant's disability. After the Commission receives the informal complaint, the Commission notifies the VPD or VPP of the complaint, and the VPD or VPP has 30 days to reply.
(b) Complaints alleging violations of the apparatus emergency information and audio description requirements.
Complaints alleging violations of the rules containing apparatus emergency information and audio description requirements, 47 CFR 79.105-79.106, may be transmitted to the Consumer and Governmental Affairs Bureau by any reasonable means, such as the Commission's online informal complaint filing system, letter in writing or Braille, facsimile transmission, telephone (voice/TRS/TTY), email, or some other method that would best accommodate the complainant's disability. Given that the population intended to benefit from the rules adopted will be blind or visually impaired, if a complainant calls the Commission for assistance in preparing a complaint, Commission staff will document the complaint in writing for the consumer. The Commission will forward such complaints, as appropriate, to the named manufacturer or provider for its response, as well as to any other entity that Commission staff determines may be involved, and may request additional information from any relevant parties when, in the estimation of Commission staff, such information is needed to investigate the complaint or adjudicate potential violations of Commission rules.
(c) Requests for Commission determination of technical feasibility of emergency information and audio description apparatus requirements.
The requirements pertaining to apparatus designed to receive or play back video programming apply only to the extent they are “technically feasible.” Parties may raise technical infeasibility as a defense when faced with a complaint alleging a violation of the apparatus requirements or they may file a request for a ruling under § 1.41 of the Commission's rules as to technical infeasibility before manufacturing or importing the product.
(d) Requests for Commission determination of achievability of emergency information and audio description apparatus requirements.
The requirements pertaining to certain apparatus designed to receive, play back, or record video programming apply only to the extent they are achievable. Manufacturers of apparatus that use a picture screen of less than 13 inches in size and of recording devices may petition the Commission, pursuant to 47 CFR 1.41, for a full or partial exemption from the audio description and emergency information requirements before manufacturing or importing the apparatus. Alternatively, manufacturers may assert that a particular apparatus is fully or partially exempt as a response to a complaint, which the Commission may dismiss upon a finding that the requirements of this section are not achievable. A petition for exemption or a response to a complaint must be supported with sufficient evidence to demonstrate that compliance with the requirements is not achievable (meaning with reasonable effort or expense), and the Commission will consider four specific factors when making such a determination.
(e) Petitions for purpose-based waivers of emergency information and audio description apparatus requirements.
The Commission may waive emergency information and audio description apparatus requirements for any apparatus or class of apparatus that is (a) primarily designed for activities other than receiving or playing back video programming transmitted simultaneously with sound, or (b) designed for multiple purposes, capable of receiving or playing video programming transmitted simultaneously with sound but whose essential utility is derived from other purposes. The Commission will address any requests for a purpose-based waiver on a case-by-case basis, and waivers will be available prospectively for manufacturers seeking certainty prior to the sale of a device.
(f) Submission and review of consumer eligibility to receive an accessible set-top box.
The Commission granted DIRECTV a waiver with respect to the set-top box models on which it is not able to implement audio functionality for emergency information, but conditioned such relief by requiring DIRECTV to provide, upon request and at no additional cost to customers who are blind or visually impaired, a set-top box
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before September 25, 2026. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.
Given that delays in compliance could impact the delivery of safety-of-life services to the public, it is imperative that the CMRS carriers be brought into compliance, required in the various orders, and that the reports and compliance plans be timely submitted by the carriers.
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before September 25, 2026. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
FCC Form 601 is a consolidated, multi-part application form that is used for market-based and site-based licensing for wireless telecommunications services, including public safety, which are filed through the Commission's Universal Licensing System (ULS) or any other electronic filing interface the Commission develops. FCC Form 601 is composed of a main form that contains administrative information and a series of schedules used for filing technical and other information. This form is used to apply for a new license, to amend or withdraw a pending application, to modify or renew an existing license, cancel a license, submit required notifications, request an extension of time to satisfy construction requirements, request an administrative update to an existing license (such as mailing address change), or request a Special Temporary Authority License. Respondents are required to submit FCC Form 601 electronically including when applying for an authorization for which the applicant was the winning bidder in a spectrum auction.
The Commission now seeks OMB approval to renew the existing information collection allowances and approval for information collections on FCC Form 601, with revisions to reflect regulatory and information collection changes adopted in the following items: the 900 MHz Report and Order, Space Launch Services, License Reaggregation, changes regarding use of the 5.850-5.925 GHz Band, and Educational Broadband Service Reform.
Under the part 26 framework established by the Commission, eligible space launch operators seeking authorization to use frequencies available for Space Launch Services must first apply for and obtain a non-exclusive 10-year nationwide spectrum license. After they obtain this license, operators must, for each launch (1) register in ULS the launch site and each corresponding station (fixed, base, itinerant, or mobile) that will be used in the space launch operation; (2) complete a frequency coordination process using a third-party frequency coordinator; and (3) following successful coordination, register in ULS the final approved technical and operating parameters associated with the coordinated launch prior to commencing the launch operation. These requirements are codified in §§ 26.106, 26.108, 26.202, and 26.301 of the rules, and the rule requirements are further elaborated in Public Notice, ET Docket No. 13-115, DA 25-270 (
Space launch operators will rely on FCC Form 601 for several of these steps. To apply for the nationwide non-exclusive license, operators will file an FCC Form 601 application. When
(1) A certification that the licenses meet the prerequisites for reaggregation specified in § 1.950;
(2) An electronic map and table that together identify all licenses and spectrum to be aggregated and identify the composite license requested;
(3) A certification that all licenses in the reaggregation request are active under the same FCC Registration Number at the time of filing;
(4) A per-license list of all special conditions and a statement acknowledging that the listed special conditions will continue to apply only to that portion of the reaggregated license with respect to the spectrum and/or geography at issue, as if the license had not been reaggregated; and
(5) A per-license list of all waivers granted and a statement of understanding that the listed waiver(s) do not automatically convey to any other portion of the reaggregated license. If applicable, the applicant shall include a statement indicating that it is seeking waiver relief through a separately filed waiver request seeking to expand the scope of previously granted relief.
Use of the 5.850-5.925 GHz Band. In the First Report and Order released on November 20, 2020 (ET Docket No. 19-138, FCC 20-164), the Commission determined that the most efficient use of the 75 megahertz in the 5.9 GHz band is to expand unlicensed operations in the lower 45 megahertz (5.850-5.895 GHz) and to reserve the upper 30 megahertz (5.895-5.925 GHz) for the Intelligent Transportation Service (ITS) using cellular vehicle-to-everything (C-V2X) technology. Dedicated Short Range Communications (DSRC) stations must discontinue operations in the 5895-5925 MHz portion of the band by December 14, 2026. No new DSRC station license applications were accepted after February 11, 2025.
FCC Form 601 Schedule M currently collects technical information for the DSRC Service under Part 90 Subpart M. In line with the Commission's actions in the 5.9 GHz Report and Order, the Commission proposes removing DSRC references and incorporating the new C-V2X service into FCC Form 601, along with corresponding updates to the Universal Licensing System (ULS) database.
We anticipate that these modifications—removing DSRC information and adding C-V2X data requirements—will not increase the burden or cost associated with completing FCC Form 601 and implementing updates to the ULS database.
The Commission seeks approval for a revision to its currently approved information collection on FCC Form 601 to incorporate the changes discussed above.
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it can further reduce the information collection burden for small business concerns with fewer than 25 employees.
Written comments and recommendations for the proposed information collection should be submitted on or before August 26, 2026.
Comments should be sent to
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “The National Survey of Family Growth (NSFG)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 21, 2026 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The National Survey of Family Growth (NSFG) (OMB Control No. 0920-0314, Exp. 9/30/2026)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).
Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through the National Center of Health Statistics (NCHS), shall collect statistics on “family formation, growth, and dissolution,” as well as “determinants of health” and “utilization of health care” in the United States. This clearance request is for continued data collection over the next three years (2026-2029).
The National Survey of Family Growth (NSFG) was conducted six times
The NSFG program produces descriptive statistics which document factors associated with birth and pregnancy rates, including contraception, infertility, marriage, cohabitation, and sexual activity, in the US household population 15-49 years (15-44 prior to 2015), as well as behaviors that affect the risk of HIV and other sexually transmitted diseases (STD). The survey also disseminates statistics on the medical care associated with contraception, infertility, pregnancy, and related health conditions.
NSFG data users include CDC/NCHS and other programs within CDC and elsewhere in HHS. The NSFG is also used by state and local governments (primarily for benchmarking to national data); private research and action organizations focused on men's and women's health, child well-being, and marriage and the family; academic researchers in the social and public health sciences; journalists; and many others.
This submission requests approval for a Revision to NSFG data collection for the next three years. The Revision request includes the continued use of survey questionnaires as have been used since January 2026, per the most recent OMB Non-Substantive Change Request approved in September 2025, as well as permission to conduct a small set of methodological studies designed to improve the efficiency and validity of NSFG data collection for the purposes described above.
CDC requests OMB approval for a total estimated annualized burden of 6,471 hours. There is no cost to respondents other than their time to participate.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Customer Surveys Generic Clearance for the National Center for Health Statistics. This Generic Clearance uses customer surveys to assess strengths in agency products and services.
CDC must receive written comments on or before September 25, 2026.
You may submit comments, identified by Docket No. CDC-2026-1288 by either of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected;
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Customer Surveys Generic Clearance for the National Center for Health Statistics (OMB Control No. 0920-0729)—Reinstatement—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).
As part of a comprehensive program, the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention, surveys its customers' satisfaction with the quality and relevance of the information it produces. NCHS conducts voluntary customer surveys to assess strengths in agency products and services. Results of these surveys will be used in future planning initiatives. NCHS requests a three-year approval from OMB for a Reinstatement of the Generic Clearance package for future customer surveys it plans to conduct. NCHS is authorized to collect data under Section 306 of the Public Health Service Act (42 U.S.C. 242k).
NCHS, the Nation's principal health statistics agency, compiles statistical information to guide actions to improve the health of the U.S. population. The national surveys and data systems administered by NCHS are a unique public resource for health information. Assessment of key data users' satisfaction with the quality and relevance of NCHS' products and services are of prime importance in evaluating our agency's performance. Voluntary customer surveys to ascertain strengths in agency products and services are useful tools for management in program planning. Data will be collected using a combination of methodologies appropriate to each survey. These may include evaluation forms, mail surveys, focus groups, automated and electronic technology (
NCHS is a unique public resource for health. These data allow NCHS to document the health status of the population and of important subgroups, identify disparities in health status and use of health care by population characteristics, monitor trends in health status and health care delivery, identify health problems, support biomedical and health services research, provide information for making changes in public policies and programs, and evaluate the impact of health policies and programs. NCHS collects data from birth and death records, medical records, interview surveys, and through direct physical exams and laboratory testing.
Information is at the core of the NCHS mission. It is critical that information be available to provide customers with quick and easy access to a wide range of information and data through a variety of channels. Customer satisfaction and customer input are critical for accomplishment of our mission as a key element of the national public health infrastructure, providing important surveillance information that helps identify and address critical health problems. Satisfaction can be enhanced through suggestions for ways to improve our outputs and services, whether presentation of data on the Web, publications, statistical services, or other products at NCHS.
Surveys of several groups are anticipated. Among these are federal clients and policy makers; state and local officials who rely on NCHS data; the broader educational, research, and public health community; and other data users. Other users may include self-selected broad-based groups of data users who register for and attend NCHS sponsored conferences as well as people who access the NCHS website.
CDC requests OMB approval for an estimated 2,250 annual burden hours. There is no cost to respondents other than their time to participate.
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Notice.
This quarterly notice lists Centers for Medicare & Medicaid Services (CMS) manual instructions, substantive and interpretive regulations, and other
It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice.
The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other interested parties. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services (the Secretary) under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently.
Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the
This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS website or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and “real time” accessibility. In addition, many of the websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website proves to be difficult, the contact person listed can provide information.
This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at
The Director of the Office of Strategic Operations and Regulatory Affairs of CMS, Kathleen Cantwell, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Notice.
This notice announces our decision to approve the National Committee for Quality Assurance's renewal application for Medicare Advantage “deeming authority” of Health Maintenance Organizations and Preferred Provider Organizations for a term of 6 years.
The notice is published on July 27, 2026.
Dawn Johnson Scott, (410) 786-3159 or Katie Schenck, (410) 786-0628.
Under the Medicare program, eligible beneficiaries may receive covered services through a Medicare Advantage (MA) organization that contracts with the Centers for Medicare & Medicaid Services (CMS). The regulations specifying the Medicare requirements that must be met for a Medicare Advantage Organization (MAO) to enter into a contract with CMS are located at 42 CFR 422.503(b). These regulations implement Part C of Title XVIII of the Social Security Act (the Act), which specifies the services that an MAO must provide and the requirements that the organization must meet to enter into an MA contract with CMS. Generally, for an entity to be an MAO, the organization must be licensed under State law, or otherwise authorized to operate under State law, as a risk bearing organization, as set forth in 42 CFR 422.400.
As a method of assuring compliance with certain Medicare requirements, an MAO may choose to become accredited by a CMS-approved accrediting organization (AO). By virtue of its accreditation by a CMS-approved AO, the MAO may be “deemed” compliant
At this time, CMS does not recognize accreditation of the following areas: Access to Services set out in § 422.156(b)(3) or the Part D areas of review set out at § 423.165(b) as part of the MA deeming program. AOs that apply for MA deeming authority are generally recognized by the health care industry as entities that accredit HMOs and PPOs. As we specify at § 422.157(b)(2)(ii), the term for which an AO may be approved by CMS may not exceed 6 years. For continuing approval, the AO must apply to CMS to renew their deeming authority for a subsequent approval period.
The National Committee for Quality Assurance (NCQA) was previously approved by CMS as an AO for MA deeming of HMOs and PPOs for a 6 year term beginning December 30, 2020 to December 30, 2026. On December 19, 2025, NCQA submitted its initial application to renew its deeming authority, including materials requested by CMS that included information intended to address the requirements set out in regulations at § 422.158(a) and (b) that are prerequisites for receiving approval of its accreditation program from CMS, and the renewal application was determined to be complete on January 8, 2026.
In a proposed notice that appeared in the March 10, 2026,
• The types of MA plans that it would review as part of its accreditation process.
• A detailed comparison of NCQA's accreditation requirements and standards with the Medicare requirements (for example, a crosswalk) in the following five deemable areas: Quality Improvement, Anti-Discrimination, Confidentiality and Accuracy of Enrollee Records, Information on Advance Directives, and Provider Participation Rules.
• Detailed information about the organization's survey process, including—
++ Frequency of surveys and whether surveys are announced or unannounced;
++ Copies of survey forms, and guidelines and instructions to surveyors;
++ Descriptions of—
— The survey review process and the accreditation status decision making process;
— The procedures used to notify accredited MAOs of deficiencies and to monitor the correction of those deficiencies; and
— The procedures used to enforce compliance with accreditation requirements.
• Detailed information about the individuals who perform surveys for the AO, including—
++ The size and composition of accreditation survey teams for each type of plan reviewed as part of the accreditation process;
++ The education and experience requirements surveyors must meet;
++ The content and frequency of the in-service training provided to survey personnel;
++ The evaluation systems used to monitor the performance of individual surveyors and survey teams; and
++ The organization's policies and practice for participation, in surveys or in the accreditation decision process, by an individual who is professionally or financially affiliated with the entity being surveyed.
• A description of the organization's data management and analysis system for its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system.
• A description of the organization's procedures for responding to and investigating complaints against accredited organizations, including policies and procedures regarding coordination of these activities with appropriate licensing bodies and ombudsmen programs.
• A description of the organization's policies and procedures for the withholding or removal of accreditation for failure to meet the AO's standards or requirements, and other actions the organization takes in response to noncompliance with its standards and requirements.
• A description of all types (for example, full, partial) and categories (for example, provisional, conditional, temporary) of accreditation offered by the organization, the duration of each type and category of accreditation and a statement identifying the types and categories that would serve as a basis for accreditation if CMS approves the AO.
• A list of all currently accredited MAOs and the type, category, and expiration date of the accreditation held by each of them.
• A list of all full and partial accreditation surveys scheduled to be performed by the AO.
• The name and address of each person with an ownership or control interest in the AO.
• CMS will also consider NCQA's past performance in the deeming program and results of recent deeming validation reviews or equivalency reviews conducted as part of continuing Federal oversight of the deeming program under § 422.157(d).
In accordance with section 1865(a)(3)(A) of the Act, the March 10, 2026 proposed notice solicited public comments regarding NCQA's request to renew its MA deeming authority for HMOs and PPOs.
A few commenters supported CMS' renewal of NCQA's deeming authority. Another comment raised issues that were outside of the scope of the proposed notice.
We compared the standards and survey process contained in NCQA's application with the Medicare conditions for accreditation. Our review and evaluation of NCQA's application for our continued approval were conducted as described in section II. of this final notice, and yielded the following:
• Under § 422.158(a)(2), NCQA submitted a crosswalk and standards that clearly crosswalked to our regulations, and any applicable oversight protocols, in each of five deemable areas: (1) Quality Improvement; (2) Anti-discrimination;
• NCQA submitted additional information/documentation regarding its survey process to address our regulations at §§ 422.158(a)(1) through (11), and (b)(1) through (3).
Based on the review and observations described in section II. of this final notice, we have determined that NCQA's accreditation program requirements meet or exceed our requirements. Therefore, we approved NCQA as a national AO with deeming authority for MA HMOs and PPOs on May 18, 2026 for a term of approval to continue through May 18, 2032. We informed NCQA of their renewal via a letter dated May 18, 2026.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Mehmet Oz, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the
Office of Refugee Resettlement, Administration for Children and Families, U.S. Department of Health and Human Services.
Request for public comments.
The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is requesting a 3-year extension with changes of the Mental Health Assessment Form and Onsite Health Intervention Form (formerly Public Health Investigation Form: Non-TB Illness, and Public Health Investigation Form: Active TB, OMB # 0970-0509, expiration 9/30/2026). Proposed revisions include merging two forms (Public Health Investigation Forms, Active TB and Non-TB Illness) into the single Onsite Health Intervention (OHI) Form. The proposed restructuring and revisions will improve transparency, lessen burden, improve data quality, and ensure alignment with ORR requirements. In addition, to ensure continuity of care, the request has been revised to include the sharing of health information with the Department of Homeland Security (DHS) in specific circumstances.
In compliance with the requirements of the Paperwork Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above. You can obtain copies of the proposed collection of information and submit comments by emailing
Data from scheduled mental health assessments and onsite health interventions is captured through the following forms under OMB # 0970-0509:
• Mental Health Assessment Form.
• Onsite Health Intervention Form (Formerly, Public Health Investigation Form: Active TB, and Public Health Investigation Form: Non-TB Illness).
The Mental Health Assessment Form (MHAF) has a corresponding instructional “Dear Colleague” letter that healthcare providers are expected to read at the initial visit with the child. The forms are used as worksheets by healthcare providers and care provider staff to compile information that would otherwise have been collected during the health assessment or onsite health intervention. Once completed, care provider staff transcribe the information from the form into ORR's secure, electronic system of record. Although the MHAF is not completed during emergency or urgent care visits, hospitalizations, or admissions to an out-of-network facility (
Data is used by ORR to monitor and support the health of unaccompanied alien children while in care, for case management of identified illnesses/conditions, and to ensure care provider compliance with ORR requirements. Finally, ORR has updated the stated uses of data sharing to include providing relevant health information to DHS when a child with healthcare needs is identified by DHS for repatriation.
ORR is proposing updates to streamline and strengthen health documentation by combining the two Public Health Investigation Forms into a single expanded Onsite Health Intervention Form that would cover quarantine for communicable disease exposure, triage with a licensed healthcare professional, and medication-related standing orders. The MHAF would also be revised to:
• Reduce duplicate documentation by removing the History section
• Improve compliance and care tracking by strengthening the disabilities and accommodations field and adding a field for all ordered or completed labs and imaging, and
• Improve data quality through clearer instructions by visit type, a healthcare provider acknowledgement and signature section authorizing record sharing with ORR, replacement of fixed diagnosis choices with free-text fields, and broader field reformatting.
The related Dear Colleague Letter would also be updated to reflect these MHAF changes.
In addition, language was updated to expand the purposes of data to include sharing relevant health data captured on the MHAF with DHS when a child in ORR custody has healthcare needs and is identified by DHS for repatriation. Shared information includes:
• Child's identifying information (name, alien number, date of birth).
• Active diagnoses or concerns that require management.
• Allergies.
• Current medications and dosages.
• Isolation/Quarantine requirements.
• Health-related accommodations (including durable medical equipment needs).
• Health-related ravel restrictions.
The purpose of sharing this data is to ensure children receive healthcare services and accommodation as recommended by their treating healthcare providers. Prior to sharing mental health information with DHS, ORR will request consent from the child.
The overall annual burden of response and recordkeeping time decreased by 32.7 and 43.9 percent, respectively.
The decrease is attributed to a significantly lower census of unaccompanied alien children in ORR care which reduced the number of respondents and responses per respondent. In addition, the average burden hours per response decreased for each form because unnecessary fields were removed and skip patterns were introduced for fields that are only needed for specific types of visits.
• Homeland Security Act (HSA), 6 U.S.C. 279—Transferred responsibilities for the care and placement of unaccompanied alien children from the Commissioner of the former Immigration and Naturalization Service to the Director of ORR.
• Unaccompanied Children Program Foundational Rule, 45 CFR part 410—Establishes a uniform set of standards and procedures concerning the placement, care, and services provided to unaccompanied alien children in ORR care that is consistent with ORR's statutory duties. § 410.1306(g) and 410.1307 require care provider programs to ensure children are provided with routine and emergency healthcare services while in care.
•
Administration for Children and Families, Department of Health and Human Services.
Notice of a new matching program.
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), ACF Tech, is providing notice of a re-established matching program between the Department of Veterans Affairs (VA) and State Public Assistance Agencies (SPAAs) participating in the Public Assistance Reporting Information System (PARIS) Program. The matching program provides the SPAAs with VA's compensation and pension data on a periodic basis to use in determining public assistance applicants' and recipients' eligibility for certain public assistance benefits. ACF Tech facilitates the matching program, and the Department of Treasury, Bureau of Fiscal Services, Do Not Pay (DNP) conducts the matches of SPAA and VA data and provides associated support.
The deadline for comments on this notice is August 21, 2026. The re-established matching program will commence not sooner than 30 days after publication of this notice, provided no comments are received that warrant a change to this notice. The matching program will be conducted for an initial term of 18 months (from approximately October 2026 through May 2027), and within 3 months of expiration may be renewed for 1 additional year if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement.
Interested parties may submit written comments on this notice by mail or email to HHS/ACF/OA/PARIS, 330 C Street SW, Washington, DC 20024,
General questions about the matching program may be submitted to Alicia Gumbs, PARIS Administrator, HHS/ACF/OA/PARIS, 330 C Street SW, Washington, DC 20024,
The Privacy Act of 1974, as amended (5 U.S.C. 552a), provides certain protections for records related to individuals applying for and receiving Federal benefits. The law governs the use of computer matching by Federal agencies when records in a system of records (meaning, Federal agency records about individuals retrieved by name or other personal identifier) are matched with records of other Federal or non-Federal agencies. The Privacy Act requires agencies involved in a matching program to the following:
1. Obtain approval of a Computer Matching Agreement, prepared in accordance with the Privacy Act, by the Data Integrity Board of each Federal agency, that is a source, or recipient of data used in the matching program. 5 U.S.C. 522a(o)(1), (u)(3)(A), and (u)(4).
2. Provide adequate advance notice of the matching program, including a copy of the agreement, to Congress and the Office of Management and Budget (OMB). 5 U.S.C. 552a(o)(2)(A)(i) and (r).
3. Publish advance notice of the matching program in the
4. Make the Computer Matching Agreement available to the public. 5 U.S.C. 552a(o)(2)(A)(ii).
5. Notify the individuals whose information will be used in the matching program that the information they provide is subject to verification through matching, as required by 5 U.S.C. 552a(o)(1)(D).
6. Verify match findings before suspending, terminating, reducing, or making a final denial of an individual's benefits or payments, or taking other adverse action against the individual, as required by 5 U.S.C. 552a(p).
7. Provide an annual report of the matching program activities to the head of the participating agency and OMB and make the report available to the public. 5 U.S.C. 552a(u)(3)(D).
This matching program meets these requirements.
• Individuals applying for or receiving Medicaid, TANF, SNAP, and/or general assistance benefits (public assistance clients); and
• Individuals receiving VA pay or pension benefits.
On an approximately quarterly basis, VA will provide DNP with a file containing VA benefit record data for most VA benefit and compensation recipients. SPAAs will also provide DNP with a non-Federal file containing identifying information, including Social Security Numbers (SSNs), about public assistance clients. DNP will compare the SSNs in each SPAA file to the VA file and will provide the SPAA with match results containing the following data elements (as applicable) about each public assistance client whose SSN matches the SSN of an individual receiving VA compensation or pension benefits:
VA File Number; Veteran/Beneficiary/Apportionee SSN and SSN Verification Indicator; Payee Type Code; Award Type, Award Line Type, and Award Status Codes; Gender Code; Last Name/First Name/Middle Name; Beneficiary Birth Date; Veteran/Spouse Aid and Attendance Code; Station Number; Spouse; Minor Child; School Child; Helpless Child; Parent; Combined Degree; Entitlement Type Code; Change Reason; Suspense Reason; Last Paid Date; Effective Date; Gross Amount; Net Award Amount; Payment Amount; Frequency Pay Type Code; Income for VA Purposes Amount; Beneficiary/
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments (including recommendations) on the collection of information by August 26, 2026.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-1244,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection request supports regulations and associated Agency forms. Sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371) establish provisions under which FDA issues regulations governing the use of radioactive drugs for basic scientific research. Specifically, § 361.1 (21 CFR 361.1) sets forth specific regulations about establishing and composing radioactive drug research committees (RDRCs) and their role in approving and monitoring basic research studies using radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and must not carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulations and include studies of metabolism, human physiology, pathophysiology, or biochemistry.
Section 361.1(c)(2) requires that each RDRC will select a chairman, who will sign all applications, minutes, and reports of the committee. Each committee will meet at least once each quarter in which research activity has been authorized or conducted. Minutes will be kept and will include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each RDRC will submit an annual report to FDA. The annual report will include the names and qualifications of the members of, and of any consultants used by, the RDRC, using Form FDA 2914 (Report on Research Use of Radioactive Drugs—Membership Summary). The annual report will also include a summary of each study conducted during the preceding year, using Form FDA 2915 (Report on Research Use of Radioactive Drugs—Study Summary).
We developed a guidance for industry and researchers titled “Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application” (August 2010) available at
Under § 361.1(d)(5), each investigator will obtain the proper consent required under the regulations. Each female research subject of childbearing potential must state in writing that she is not pregnant or, based on a pregnancy test, be confirmed as not pregnant.
Under § 361.1(d)(8), the investigator will immediately report to the RDRC all adverse effects associated with use of the drug, and the committee will then report to FDA all adverse reactions probably attributed to the use of the radioactive drug.
Section 361.1(f) sets forth labeling requirements for radioactive drugs. These requirements are not in the reporting burden estimate because they are information supplied by the Federal Government to the recipient for the purposes of disclosure to the public (5 CFR 1320.3(c)(2)).
Types of research studies not permitted under the regulations are also specified in § 361.1(a) and include those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the drug in humans for such purposes (
The primary purpose of this collection of information is to determine whether the research studies are being conducted in accordance with applicable statutes and regulations specified under 21 CFR 361.1 and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks. Respondents to this information collection are the chairperson or chairpersons of each individual RDRC, investigators, and participants in the studies. The burden estimates are based on our experience with these reporting and recordkeeping requirements and the number of submissions we received under the regulations over the past 3 years.
In the
FDA estimates the burden of this collection of information as follows:
Our estimated burden for the information collection reflects an overall decrease of 52 hours and a corresponding decrease of 97 responses. This is attributed to the Agency receiving fewer submissions over the last few years due to decreased subject enrollment during the pandemic.
Office of the Secretary, Department of Homeland Security.
Notice of determination.
The Secretary of Homeland Security has determined, pursuant to law, that it is necessary to waive certain laws, regulations, and other legal requirements in order to ensure the expeditious construction of barriers and roads in the vicinity of the international land border in the state of Texas.
This determination takes effect on July 27, 2026.
Important mission requirements of the Department of Homeland Security (“DHS”) include border security and the detection and prevention of illegal entry into the United States. Border security is critical to the nation's national security. Recognizing the critical importance of border security, Congress has mandated DHS to achieve and maintain operational control of the international land border. Secure Fence Act of 2006, Public Law 109-367, section 2, 120 Stat. 2638 (Oct. 26, 2006) (8 U.S.C. 1701 note). Congress defined “operational control” as the prevention of all unlawful entries into the United States, including entries by terrorists, other unlawful aliens, instruments of terrorism, narcotics, and other contraband.
Congress has provided to the Secretary of Homeland Security a number of authorities necessary to carry out DHS's border security mission. One of those authorities is found at section 102 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, as amended (“IIRIRA”). Public Law 104-208, Div. C, Tit. I, section 102, 110 Stat. 3009-546, 3009-554 (8 U.S.C 1103 note), as amended by the REAL ID Act of 2005, Public Law 109-13, Div. B, Tit. I, section 102, 119 Stat. 302, 306 (8 U.S.C. 1103 note), as amended by the Secure Fence Act of 2006, Public Law 109-367, section 3, 120 Stat. 2638 (8 U.S.C. 1103 note), as amended by the Department of Homeland Security Appropriations Act, 2008, Public Law 110-161, Div. E, Tit. V, section 564, 121 Stat. 2042, 2090. In section 102(a) of IIRIRA, Congress provided that the Secretary of Homeland Security shall take such actions as may be necessary to install additional physical barriers and roads (including the removal of obstacles to detection of illegal entrants) in the vicinity of the United States border to deter illegal crossings in areas of high illegal entry into the United States. In section 102(b) of IIRIRA, Congress mandated that in carrying out the authority of section 102(a), I provide for the installation of additional fencing, barriers, roads, lighting, cameras, and sensors to achieve and maintain operational control of the border. Finally, in section 102(c) of IIRIRA, Congress granted to the Secretary of Homeland Security the authority to waive all legal requirements that I, in my sole discretion, determine necessary to ensure the expeditious construction of barriers and roads authorized by section 102 of IIRIRA.
The United States Border Patrol Big Bend and Del Rio Sectors are areas of high illegal entry. Between fiscal year 2021 and fiscal year 2025, Border Patrol apprehended over 89,000 illegal aliens attempting to enter the United States between border crossings in the Big Bend Sector. In that same time period Border Patrol seized over 87,574 pounds of marijuana, over 867 pounds of cocaine, over 1,156 pounds of methamphetamine, over 12 pounds of heroin, and over 94 pounds of fentanyl. Between fiscal year 2021 and fiscal year 2025, Border Patrol apprehended over 1,410,330 illegal aliens attempting to enter the United States between border crossings in the Del Rio Sector. In that same time period Border Patrol seized over 277 pounds of marijuana, over 198 pounds of cocaine, over 353 pounds of methamphetamine, and over five pounds of fentanyl.
Since the President took office, DHS has delivered the most secure border in history. More can and must be done, however. As the statistics cited above demonstrate, the Big Bend and Del Rio Sectors are areas of high illegal entry where illegal aliens regularly attempt to enter the United States and smuggle illicit drugs, and given my mandate to achieve and maintain operational control of the border, I must use my authority under section 102 of IIRIRA to install additional barriers and roads in the Big Bend and Del Rio Sectors. Therefore, DHS will take immediate action to construct additional barriers and roads in a segment of the border in the Big Bend and Del Rio Sectors. The segment where such construction will occur is referred to herein as the “project area,” which is more specifically described in Section 2 below.
I determine that the following area in the vicinity of the United States border, located in the state of Texas within the U.S. Border Patrol Big Bend and Del Rio Sectors, is an area of high illegal entry (the “project area”): Starting at approximately GPS point 29.728522, −102.683945 and extending east to approximately GPS point 29.449892, −101.058017.
There is presently an acute and immediate need to construct additional physical barriers and roads in the vicinity of the border of the United States in order to prevent unlawful entries into the United States in the project area pursuant to section 102(a) and 102(b) of IIRIRA. In order to ensure the expeditious construction of additional physical barriers and roads in the project area, I have determined that it is necessary that I exercise the authority that is vested in me by section 102(c) of IIRIRA.
Accordingly, pursuant to section 102(c) of IIRIRA, I hereby waive in their entirety, with respect to the construction of physical barriers and roads (including, but not limited to, accessing the project areas, creating and using staging areas, the conduct of earthwork, excavation, fill, and site preparation, and installation and upkeep of physical barriers, roads, supporting elements, drainage, erosion controls, safety features, lighting, cameras, and sensors) in the project area, all of the following statutes, including all federal, state, or other laws, regulations, and legal requirements of, deriving from, or related to the subject of, the following statutes, as amended: The National Environmental Policy Act (Pub. L. 91-190, 83 Stat. 852 (42 U.S.C. 4321
This waiver does not revoke or supersede any other waiver determination made pursuant to section 102(c) of IIRIRA. Such waivers shall remain in full force and effect in accordance with their terms. I reserve the authority to execute further waivers from time to time as I may determine to be necessary under section 102 of IIRIRA.
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service (Service), invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA). With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The ESA also requires that we invite public comment before issuing permits for any activity otherwise prohibited by the ESA with respect to any endangered species.
Comments will be accepted on or before August 26, 2026. Comments submitted electronically using the Federal eRulemaking Portal (see
To ensure your comment is received and considered, you must submit it using one of the methods identified in the
Comment submission: All submissions must include the docket number [FWS-HQ-IA-2026-1783] for this document. You must submit comments using one of the following methods:
•
•
Comments submitted through any method not authorized in this document, or sent to an address not listed here, will not be considered. We will not accept comments via email, fax, or hand delivery. We are not required to consider comments that are submitted after the comment period ends or that are submitted via a method outside of these instructions. Comments containing profanity, vulgarity, threats, or other inappropriate content will not be considered.
We will post all comments at
Timothy MacDonald, by phone at 703-358-2185 or via email at
We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
You may submit your comments and materials by one of the methods in
When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. Provide sufficient information to allow us to authenticate any scientific or commercial data you include. The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) those that include citations to, and analyses of, the applicable laws and regulations.
You may view and comment on others' public comments at
If you submit a comment at
To help us carry out our conservation responsibilities for affected species, and
We invite comments on the following applications.
The applicant requests authorization to re-export biological samples derived from one captive-born giant panda (
The applicant requests a permit to export three live, captive-born Andean condors (
The applicant requests a permit to export 70 live, captive-born Panamanian golden frogs (
The applicant requests a permit to import two live, captive-born Lar gibbons (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species, to enhance the propagation or survival of the species. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species, to enhance the propagation or survival of the species. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests authorization to export and re-import nonliving museum specimens of endangered species previously accessioned into the applicant's collection for scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a permit authorizing the culling of excess swamp deer (
The following applicants request permits to import sport-hunted trophies of male bontebok (
After the comment period closes, we will make decisions regarding permit issuance. If we issue permits to any of the applicants listed in this notice, we will publish a notice in the
We issue this notice under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
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 LG Energy Solution Ltd. and LG Energy Solution Arizona, Inc. on July 21, 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 secondary cylindrical batteries, components thereof, and products containing the same. The complaint names as respondents: EVE Energy Co., Ltd. of China; EVE Energy North America Corporation of Lewis Center, OH; EVE Energy US Holding LLC of Forest, CA; Robert Bosch GmbH of Germany; Robert Bosch Tool Corporation of Mount Prospect, IL; Koki Holdings Co., Ltd. of Japan; Koki Holdings America Ltd. of Braselton, GA; Chervon (China) Trading Co., Ltd. of China; Nanjing Chevron Industry., Ltd. of China; and Chevron North America, Inc. of Naperville, IL. 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. 3926”) 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 a complaint was filed with the U.S. International Trade Commission on June 22, 2026, under section 337 of the Tariff Act of 1930, as amended, on behalf of Serendia, LLC of Los Angeles, California. Supplements were filed on July 6 and 13, 2026. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain dermatological treatment devices and components thereof by reason of the infringement of certain claims of U.S. Patent No. 9,320,536 (“the '536 patent”); U.S. Patent No. 9,775,774 (“the '774 patent”); U.S. Patent No. 10,869,812 (“the '812 patent”); and U.S. Patent No. 12,220,549 (“the '549 patent”). The complaint, as supplemented, further alleges that an industry in the United States exists as required by the applicable Federal Statute.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at
Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
Lisa Barton, The Office of the Secretary, Docket Services Division, U.S. International Trade Commission, telephone (202) 205-1802.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1-8, 11-13, and 16-18 of the '536 patent; claims 13 and 14 of the '774 patent; claims 2-6, 8, 9, 13-16, and 18 of the '812 patent; and claims 1-18 of the '549 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “RF microneedling dermatological treatment devices and components thereof, including the consoles, handpieces, and needle tips”;
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: Serendia, LLC, 3660 Wilshire Blvd., Suite 504, Los Angeles, CA 90010.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
InMode Ltd., Tavor Building, Shaar Yokneam, P.O. Box 533, Yokneam 2069206, Israel.
Invasix Inc., 17 Hughes, Irvine, CA 92618.
BTL Industries, Inc., 362 Elm Street, Suite 5, Marlborough, MA 01752.
BTL Industries Limited, 161 Cleveland Way, Hertfordshire, Stevenage SG1 6BU, England, United Kingdom.
BTL Industries JSC, Ul. Tsar Kaloyan 8, Et. 2, 1000 Sofia, Bulgaria.
BTL Healthcare Technologies A/S, Stepanska 535/6, 12000 Prague, Czech Republic.
BTL Enterprise Group A/S, Stepanska 535/6, 12000 Prague, Czech Republic.
BTL Medical Technologies S.R.O. Evropska 423/178, 16000 Prague, Czech Republic.
BTL Holding Limited, Spyrou Kyprianoy 38, 4154 Limassol, Cyprus.
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S.
The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at
Lisa Barton, The Office of the Secretary, Docket Services Division, U.S. International Trade Commission, telephone (202) 205-1802.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1-3, 5, 6, 12, 16, and 17 of the '275 patent and claims 1, 6-11, 17, 18, and 22-25 of the '470 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “adjustable child carrier products that contain adjustable components that make the carriers adaptable to ergonomically carry a child as the child grows”;
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: The Ergo Baby Carrier, Inc., 19700 South Vermont Avenue, Suite 250, Torrance, CA 90502.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
Mabe, LLC, 1463 N 825 E, Shelley, ID 83274-5055.
Quanzhou Baby Nice Infant and Child Products Co., Ltd., Cultural Activity Room, Xuhui City Property, No. 777 Songtang Road, Quanzhou City, Fujian Province, China 362714.
Xiamen Funwhale Technology LLC, Room 607-2, No. 15 Duiying Road, Jimei District, Xiamen City, Fujian Province, China 361000.
Xiamen New Baby Products Co., Ltd., Room 401, No. 361-1 Qiaoying Road, Jimei District/Area, Xiamen City, Fujian Province, China 361000.
Koi Trading Services, 516 N Diamond Bar Blvd., Suite 366, Diamond Bar, CA 91765.
Portier USA, LLC, 30 N Gould Street, Suite N, Sheridan, WY 82801.
Ava + Oliver, LLC, 3514B Waialae Avenue, Honolulu, HI 96816.
Artipoppe B.V., Nieuwe Rijksweg 66C, 4128 BN Lexmond, The Netherlands.
Bugaboo Xiamen Industrial Co. Ltd., No. 49 Haijing South 2 Roadfree TRA, Xiamen, Fujian Province, China 361000.
Bugaboo International B.V., Paasheuvelweg 9 a-b, 1105 BE Amsterdam, Zuidoost, The Netherlands.
Bugaboo North America, Inc., 37 West 26th Street, 6th Floor, New York, NY 10010.
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
In accordance with Departmental Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in
This proposed Consent Decree concerns a complaint filed by the United States against Wiregrass Construction Co., Inc., pursuant to 33 U.S.C. 1319, to obtain injunctive relief
The Department of Justice will accept written comments relating to this proposed Consent Decree for thirty (30) days from the date of publication of this Notice. Please address comments to Martha C. Mann, United States Department of Justice, Environmental Defense Section, P.O. Box 7611, Washington, DC 20044-7611, or
The proposed Consent Decree may be examined at the Clerk's Office, United States District Court for the Middle District of Alabama, One Church Street, Montgomery, Alabama 36104. In addition, the proposed Consent Decree may be examined electronically at
Notice of availability; correction.
The Department of Labor (DOL) is issuing this notice to clarify the status of OMB Control Number 1205-0521, DOL-Only Performance Accountability, Information, and Reporting System. Following publication notice dated January 7, 2026, which concluded on February 19, 2026, in
Notice of availability; request for comments.
The Grantee Quarterly Progress Report is used to collect information concerning activities conducted during the quarter by grantees under OSHA's Susan Harwood training grants. The information is used by OSHA to monitor progress and the use of Federal grant funds. The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before August 26, 2026.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Nicole Bouchet by telephone at 202-693-0213, or by email at
The Grantee Quarterly Progress Report is used to collect information concerning activities conducted during the quarter by grantees under OSHA's Susan Harwood training grants. The information is used by OSHA to monitor progress and the use of Federal grant funds. For additional substantive information about this ICR, see the related notice published in the
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Rock Burst Control Plan (Pertains to Underground Metal/Nonmetal Mines).”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Rock Burst Control Plan (Pertains to Underground Metal/Nonmetal Mines).” This information collection is intended to ensure that the underground MNM mine operator has a plan in place in the event of a rock burst to reduce the risks to miners.
Burden costs associated with the ICR include:
The associated standards that authorize the collection of information are described below.
Under 30 CFR 57.3461, (a) operators of [underground MNM] mines which have experienced a rock burst shall—
(1) Within 24 hours report to the nearest MSHA office each rock burst which:
(i) causes persons to be withdrawn;
(ii) impairs ventilation;
(iii) impedes passage; or
(iv) disrupts mining activity for more than one hour.
(2) The mine operators shall develop and implement a rock burst control plan within 90 days after a rock burst has been experienced.
(b) The plan shall include—
(1) mining and operating procedures designed to reduce the occurrence of rock bursts;
(2) monitoring procedures where detection methods are used; and
(3) other measures to minimize exposure of persons to areas prone to rock bursts.
(c) The plans shall be updated as conditions warrant.
(d) The plan shall be made available to MSHA inspectors and to miners or their representatives.
MSHA is soliciting comments concerning the proposed information collection titled “Rock Burst Control Plan (Pertains to Underground Metal/Nonmetal Mines).” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Rock Burst Control Plan (Pertains to Underground Metal/Nonmetal Mines). MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Safety Program for Surface Mobile Equipment.”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Safety Program for Surface Mobile Equipment.” This information collection is intended to ensure that mine operators will identify risks related to the movement and operation of surface mobile equipment in written safety programs. This will allow mines to eliminate or mitigate safety hazards and thereby reduce the likelihood of accidents, injuries, and fatalities.
Burden costs associated with the ICR include:
The associated standards that authorize the collection of information are described below.
Under 30 CFR 56.23000, 57.23000, and 77.2100, operators shall develop, implement, and update a written safety program for surface mobile equipment to reduce the number and rates of accidents, injuries, and fatalities.
Under 30 CFR 56.23002, 57.23002, and 77.2102, each operator shall develop and implement a written safety program for surface mobile equipment. Operators shall also designate a responsible person to evaluate and update the written safety program.
Under 30 CFR 56.23003(a), 57.23003(a), and 77.2103(a), a written safety program shall include the types of actions the operator will take to:
(i) Identify and analyze hazards and reduce the resulting risks related to the movement and the operation of surface mobile equipment; and
(ii) Identify currently available and newly emerging feasible technologies that can enhance safety at the mine and evaluate whether to adopt them.
Under 30 CFR 56.23003(a)(2), 57.23003(a)(2), and 77.2103(a)(2), a written safety program shall include actions the operators will take to develop and maintain procedures and schedules for routine maintenance and non-routine repairs for surface mobile equipment.
Under 30 CFR 56.23003(b), 57.23002(b), and 77.2103(b), the responsible person shall evaluate and update the written safety program at least annually, or as mining conditions or practices change that may adversely affect the health and safety of miners or other persons, as accidents or injuries occur, or as surface mobile equipment changes or modifications are made.
Under 30 CFR 56.23004(a), 57.23004(a), and 77.2104(a), the operator shall make the written safety program available for inspection by authorized representatives of the Secretary and provide a copy upon request.
Under 30 CFR 56.23004(b), 57.23004(b), and 77.2104(b), the operator shall make the written safety program available for inspection by miners and their representatives and, at no cost, provide a copy upon request.
Under 30 CFR 56.23003(a)(2), 57.23003(a)(2), and 77.2103(a)(2), a written safety program shall include actions the operators will take to train miners and other persons at the mine necessary to perform work to identify and address or avoid hazards related to surface mobile equipment.
MSHA is soliciting comments concerning the proposed information collection titled “Safety Program for Surface Mobile Equipment.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Safety Program for Surface Mobile Equipment. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Sealing of Abandoned Areas.”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Sealing of Abandoned Areas.” This information collection is intended to ensure adequate design and close monitoring of sealed abandoned areas to prevent explosive or toxic gases from migrating into the active working areas of underground coal mines, and thus provide sufficient protection for miners who may come across them. The standards provide for recordkeeping requirements addressing seal design, monitoring sealed atmospheres, constructing and repairing of seals, and training to identify and correct problems in sealing of abandoned areas.
Burden costs associated with the ICR include:
The associated standards that authorize the collection of information are described below.
Seal strengths specifications are provided under 30 CFR 75.335(a).
Under 30 CFR 75.335(b), seal design applications from seal manufacturers or mine operators shall be in accordance with 30 CFR 75.335(b)(1) or 30 CFR 75.335(b)(2) and submitted for approval to MSHA's Office of Technical Support, Pittsburgh Safety and Health Technology Center.
(1) An engineering design application shall—
(i) Address gas sampling pipes, water drainage systems, methods to reduce air leakage, pressure-time curve, fire resistance characteristics, flame spread index, entry size, engineering design and analysis, elasticity of design, material properties, construction specifications, quality control, design references, and other information related to seal construction;
(ii) Be certified by a professional engineer that the design of the seal is in accordance with current, prudent engineering practices and is applicable to conditions in an underground coal mine; and
(iii) Include a summary of the installation procedures related to seal construction; or
(2) Each application based on full-scale explosion tests or equivalent means of physical testing shall address the following requirements to ensure that a seal can reliably meet the seal strength requirements:
(i) Certification by a professional engineer that the testing was done in accordance with current, prudent engineering practices for construction in a coal mine;
(ii) Technical information related to the methods and materials;
(iii) Supporting documentation;
(iv) An engineering analysis to address differences between the seal support during test conditions and the range of conditions in a coal mine; and
(v) A summary of the installation procedures related to seal construction.
(3) Once the seal design is approved, the approval holder shall promptly notify MSHA, in writing, of all deficiencies of which they become aware.
(1) MSHA will notify the applicant if additional information or testing is required. The applicant shall provide this information, arrange any additional or repeat tests, and provide prior notification to MSHA of the location, date, and time of such test(s).
(2) MSHA will notify the applicant, in writing, whether the design is approved
Under 30 CFR 75.335(c), the installation of the approved seal design shall be subject to approval in the ventilation plan. The mine operator shall—
(1) Retain the seal design approval and installation information for as long as the seal is needed to serve the purpose for which it was built.
(2) Designate a professional engineer to conduct or have oversight of seal installation and certify that the provisions in the approved seal design specified in this section have been addressed and are applicable to conditions at the mine. A copy of the certification shall be submitted to the District Manager with the information provided in 30 CFR 75.335(c)(3) and a copy of the certification shall be retained as long as the seal is needed to serve the purpose for which it was built.
(3) Provide the following information for approval in the ventilation plan—
(i) The MSHA Technical Support Approval Number;
(ii) A summary of the installation procedures;
(iii) The mine map of the area to be sealed and proposed seal locations that include the deepest points of penetration prior to sealing. The mine map must be certified by a professional engineer or a professional land surveyor.
(iv) Specific mine site information, including—
(A) Type of seal;
(B) Safety precautions taken prior to seal achieving design strength;
(C) Methods to address site-specific conditions that may affect the strength and applicability of the seal including set-back distances;
(D) Site preparation;
(E) Sequence of seal installations;
(F) Projected date of completion of each set of seals;
(G) Supplemental roof support inby and outby each seal;
(H) Water flow estimation and dimensions of the water drainage system through the seals;
(I) Methods to ventilate the outby face of seals once completed;
(J) Methods and materials used to maintain each type of seal;
(K) Methods to address shafts and boreholes in the sealed area;
(L) Assessment of potential for overpressures greater than 120 psi in sealed area;
(M) Additional sampling locations; and
(N) Additional information required by the District Manager.
Under 30 CFR 75.336(a)(1), a certified person [a person who has been certified as a mine foreman (mine manager), an assistant mine foreman (section foreman), or a preshift examiner (mine examiner)] as defined in 30 CFR 75.100 shall monitor atmospheres of sealed areas. Sealed areas shall be monitored, whether ingassing or outgassing, for methane and oxygen concentrations and the direction of leakage. Each sampling pipe and approved sampling location shall be samples at least every 24 hours.
Under 30 CFR 75.336(e), a certified person shall promptly record each sampling result including the location of the sampling points, whether ingassing or outgassing, and the oxygen and methane concentrations. The results of oxygen and methane samples shall be recorded as the percentage of oxygen and methane measured by the certified person and any hazardous condition found in accordance with 30 CFR 75.363. The mine operator shall retain sampling records at the mine for at least 1 year from the date of the sampling.
Under 30 CFR 75.336(a)(3), mine operators with an approved ventilation plan addressing spontaneous combustion shall sample the sealed atmosphere in accordance with the ventilation plan.
Under 30 CFR 75.336(a)(2), the mine operator shall evaluate the atmosphere in the sealed area to determine whether sampling through the sampling pipes in seals and approved locations provides appropriate sampling locations of the sealed area. The mine operator shall make the evaluation immediately after the minimum 14-day required sampling, if the mine ventilation system is reconfigured, if changes occur that adversely affect the sealed area, or if the District Manager requests an evaluation. When the results of the evaluations indicate the need for additional sampling locations, the mine operator shall provide the additional locations and have them approved in the ventilation plan. The District Manager may require additional sampling locations and frequencies in the ventilation plan.
Under 30 CFR 75.336(a)(4), the District Manager may approve in the ventilation plan the use of a continuous monitoring system in lieu of monitoring provisions in this section.
Under 30 CFR 75.336(c), except as provided in section 75.336(d), when a sample is taken from the sealed atmosphere with seals of less than 120 psi and the sample indicates that the oxygen concentration is 10 percent or greater and methane is between 4.5 percent and 17 percent, the mine operator shall immediately take an additional sample and then immediately notify the District Manager. When the additional sample indicates that the oxygen concentration is 10 percent or greater and methane is between 4.5 percent and 17 percent, persons shall be withdrawn from the affected area which is the entire mine or other affected area identified by the operator and approved by the District Manager in the ventilation plan, except those persons referred to in § 104(c) of the [Mine] Act. The operator may identify areas in the ventilation plan to be approved by the District Manager where persons may be exempted from withdrawal. The operator's request shall address the location of seals in relation to: Areas where persons work and travel in the mine; escapeways and potential for damage to the escapeways; and ventilation systems and controls in areas where persons work or travel and where ventilation is used for escapeways. The operator's request shall also address the gas concentration of other sampling locations in the sealed area and other required information.
Under 30 CFR 75.336(c), before miners reenter the mine, the mine operator shall have a ventilation plan revision approved by the District Manager specifying the actions to be taken.
Under 30 CFR 75.337(c), a certified person designated by the mine operator shall directly supervise seal construction and repair, and—
(1) Examine each seal site immediately prior to construction or repair to ensure that the site is in accordance with the approved ventilation plan;
(2) Examine each seal under construction or repair during each shift to ensure that the seal is being constructed or repaired in accordance with the approved ventilation plan;
(3) Examine each seal upon completion of construction or repair to ensure that construction or repair is in accordance with the approved ventilation plan;
(4) Certify by initials, date, and time that the examinations were made; and
(5) Make a record of the examination at the completion of any shift during which an examination was conducted. The record shall include each deficiency and the corrective action taken. The record shall be countersigned by the mine foreman or equivalent mine official by the end of the mine foreman's or equivalent mine official's next regularly scheduled working shift. The record shall be kept at the mine for one year.
Under 30 CFR 75.337(d), upon completion of construction of each seal a senior mine management official, such as a mine manager or superintendent, shall certify that the construction, installation, and materials used were in accordance with the approved ventilation plan. The mine operator shall retain the certification for as long as the seal is needed to serve the purpose for which it was built.
Under 30 CFR 75.337(e), the mine operator shall—
(1) Notify the District Manager between two and fourteen days prior to commencement of seal construction;
(2) Notify the District Manager, in writing, within five days of completion of a set of seals and provide a copy of the certification required in 30 CFR 75.335(d) of this section; and
(3) Submit a copy of quality control results to the District Manager for seal material properties specified by 30 CFR 75.335 within 30 days of completion of quality control tests.
Under 30 CFR 75.337(f), welding, cutting, and soldering with an arc or flame are prohibited within 150 feet of a seal. An operator may request a different location in the ventilation plan to be approved by the District Manager. The operator's request must address methods the mine operator will use to continuously monitor atmospheric conditions in the sealed area during welding or burning; the airflow conditions in and around the work area; the rock dust and water application methods; the availability of fire extinguishers on hand; the procedures to maintain safe conditions, and other relevant factors.
Under 30 CFR 75.337(g):
(1) For seals constructed after April 18, 2008, one non-metallic sampling pipe shall be installed in each seal that shall extend into the center of the first connecting crosscut inby the seal. If an open crosscut does not exist, the sampling pipe shall extend one-half of the distance of the open entry inby the seal.
(2) Each sampling pipe shall be equipped with a shut-off valve and appropriate fittings for taking gas samples.
(3) The sampling pipes shall be labeled to indicate the location of the sampling point when more than one sampling pipe is installed through a seal.
(4) If a new seal is constructed to replace or reinforce an existing seal with a sampling pipe, the sampling pipe in the existing seal shall extend through the new seal. An additional sampling pipe shall be installed through each new seal to sample the area between seals, as specified in the approved ventilation plan.
Under 30 CFR 75.338(a), certified persons conducting sampling shall be trained in the use of appropriate sampling equipment, procedures, location of sampling points, frequency of sampling, size and condition of sealed area, and the use of continuous monitoring systems, if applicable, before they conduct sampling, and annually thereafter. The mine operator shall certify the date of training provided to certified persons and retain each certification for two years.
Under 30 CFR 75.338(b), miners constructing or repairing seals, designated certified persons, and senior mine management officials shall be trained prior to constructing or repairing a seal and annually thereafter. The mine operator shall certify the date of training provided to each miner, certified person, and senior mine management official and retain each certification for two years.
Under 30 CFR 75.339(a), the table entitled “Seal Recordkeeping Requirements” lists records the operator shall maintain and the retention period for each record.
Under 30 CFR 75.339(b), records required by sections 75.335, 75.336, 75.337 and 75.338 shall be retained at a surface location at the mine in a secure book that is not susceptible to alteration. The records may be retained electronically in a computer system that is secure and not susceptible to alteration, if the mine operator can immediately access the record from the mine site.
Under 30 CFR 75.339(c), upon request from an authorized representative of the Secretary of Labor, the Secretary of Health and Human Services, or from the authorized representative of miners, mine operators shall promptly provide access to any record listed in the table in this section.
Under 30 CFR 75.339(d), whenever an operator ceases to do business or transfers control of the mine to another entity, that operator shall transfer all records required to be maintained by this part, or a copy thereof, to any successor operator who shall maintain them for the required period.
MSHA is soliciting comments concerning the proposed information collection titled “Sealing of Abandoned Areas.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Sealing of Abandoned Areas. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Escape and Evacuation Plans.”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Escape and Evacuation Plans.” This information collection is intended to ensure maximum safety for miners and that miners have sufficient information and means to safely escape and evacuate underground MNM mines in the event of an emergency.
Burden costs associated with the ICR include:
The associated standard that authorizes the collection of information is described below.
Under 30 CFR 57.11053, a specific escape and evacuation plan and revisions thereof suitable to the conditions and mining system of the mine and showing assigned responsibilities of all key personnel in the event of an emergency shall be developed by the operator and set out in written form. Within 45 calendar days after promulgation of this standard a copy of the plan and revisions thereof shall be available to the Secretary or his authorized representative. Also, copies of the plan and revisions thereof shall be posted at locations convenient to all persons on the surface and underground. Such a plan shall be updated as necessary and shall be reviewed jointly by the operator and the Secretary or his authorized representative at least once every six months from the date of the last review. The plan shall include:
(a) Mine maps or diagrams showing directions of principal air flow, location of escape routes and locations of existing telephones, primary fans, primary fan controls, fire doors, ventilation doors, and refuge chambers. Appropriate portions of such maps or diagrams shall be posted at all shaft stations and in underground shops, lunchrooms, and elsewhere in working areas where persons congregate;
(b) Procedures to show how the miners will be notified of emergency;
(c) An escape plan for each working area in the mine to include instructions showing how each working area should be evacuated. Each such plan shall be posted at appropriate shaft stations and elsewhere in working areas where persons congregate;
(d) A fire fighting plan;
(e) Surface procedure to follow in an emergency, including the notification of proper authorities, preparing rescue equipment, and other equipment which may be used in rescue and recovery operations; and
(f) A statement of the availability of emergency communication and transportation facilities, emergency power and ventilation and location of rescue personnel and equipment.
MSHA is soliciting comments concerning the proposed information collection titled “Escape and Evacuation Plans.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Escape and Evacuation Plans. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized,
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Hazard Communication (HazCom)—30 CFR part 47.” This information collection is intended to ensure that operators evaluate the hazards of chemicals they produce or use and provide this information to miners, their representatives, and customers through HazCom programs. A typical HazCom program includes a list of all hazardous chemicals known at the mine, requirements for labeling containers of hazardous chemicals, availability of Material Safety Data Sheets (MSDS), and requirements for miner training.
Burden costs associated with the ICR include:
The associated standards that authorize the collection of information are described below.
Under 30 CFR 47.1, each operator must identify the chemicals at the mine, determine which chemicals are hazardous, establish a HazCom program, and inform each miner who can be exposed and other on-site operators whose miners can be exposed, about chemical hazards and appropriate protective measures.
Under 30 CFR 47.31(a), each operator must develop and implement a written HazCom program.
Under 30 CFR 47.31(b), each operator must maintain the HazCom program for as long as a hazardous chemical is known to be at the mine.
Under 30 CFR 47.32, the HazCom programs must include the following:
(a) How this part is put into practice at the mine through the use of—
(1) Hazard determination,
(2) Labels and other forms of warning,
(3) MSDSs, and
(4) Miner training.
(b) A list or other record identifying all hazardous chemicals known to be at the mine. The list must—
(1) Use a chemical identity that permits cross-referencing between the list, a chemical's label, and its MSDS; and
(2) Be compiled for the whole mine or by individual work areas.
(c) At mines with more than one operator, the methods for—
(1) Providing other operators with access to MSDSs, and
(2) Informing other operators about—
(i) Hazardous chemicals to which their miners can be exposed,
(ii) The labeling system on the containers of these chemicals, and
(iii) Appropriate protective measures.
Under 30 CFR 47.41(a), the operator must ensure that each container of a hazardous chemical has a label. If a container is tagged or marked with the appropriate information [as defined in 30 CFR 47.42], it is labeled.
(1) The operator must replace a container label immediately if it is missing or if the hazard information on the label is unreadable.
(2) The operator must not remove or deface existing labels on containers of hazardous chemicals.
Under 30 CFR 47.41(b), for each hazardous chemical produced at the mine, the operator must prepare a container label and update this label with any significant, new information about the chemical's hazards within 3 months of becoming aware of this information.
Under 30 CFR 47.41(c), for each hazardous chemical brought to the mine, the operator must replace an outdated label when a revised label is received from the chemical's manufacturer or supplier. The operator is not responsible for an inaccurate label obtained from the chemical's manufacturer or supplier.
Under 30 CFR 47.43, the operator may use signs, placards, process sheets, batch tickets, operating procedures, or other label alternatives for individual, stationary process containers, provided that the alternative—
(a) Identifies the container to which it applies,
(b) Communicates the same information as required on the label, and
(c) Is readily available throughout each work shift to miners in the work area.
Under 30 CFR 47.44(a), the operator do not have to label temporary, portable containers if he or she ensures that the miner using the portable container—
(1) knows the identity of the chemical, its hazards, and any protective measures needed, and
(2) leaves the container empty at the end of the shift.
Under 30 CFR 47.44(b), operators must mark the temporary, portable container with at least the common name of its contents.
Under 30 CFR 47.51, operators must have an MSDS for each hazardous chemical which they produce or use. The MSDS may be in any medium, such as paper or electronic, that does not restrict availability.
Under 30 CFR 47.51(a), for each hazardous chemical produced at the mine, the operator must prepare an MSDS, and update it with significant, new information about the chemical's hazards or protective measures within 3 months of becoming aware of this information.
Under 30 CFR 47.52, when an operator must prepare an MSDS for a hazardous chemical produced at the mine, the MSDS must—
(a) Be legible, accurate, and in English;
(b) Use a chemical identity that permits cross-referencing between the list of hazardous chemicals, the chemical's label, and its MSDS; and
(c) Contain information, or indicate if no information is available, for the categories listed in Table 47.57: identity, properties, physical, health hazards, exposure limits, carcinogenicity, safe use, control measures, emergency information, and date prepared.
Under 30 CFR 47.51(b), for each hazardous chemical brought to the mine, the operator must rely on the MSDS received from the chemical manufacturer or supplier, develop their own MSDS, or obtain one from another source.
Under 30 CFR 47.51(c), although the operator is not responsible for an inaccurate MSDS obtained from the chemical's manufacturer, supplier, or other source, operators must—
(1) Replace an outdated MSDS upon receipt of an updated revision, and
(2) Obtain an accurate MSDS as soon as possible after becoming aware of an inaccuracy.
Under 30 CFR 47.53, if the mine produces or uses hazardous waste, the operator must provide potentially exposed miners and designated representatives access to available information for the hazardous waste that—
(a) Identifies its hazardous chemical components,
(b) Describes its physical or health hazards, or
(c) Specifies appropriate protective measures.
Under 30 CFR 47.54, the operator must make MSDSs accessible to miners during each work shift for each hazardous chemical to which they may be exposed either—
(a) At each work area where the hazardous chemical is produced or used, or
(b) At an alternative location, provided that the MSDS is readily available to miners in an emergency.
Under 30 CFR 47.55(a), the operator must retain its MSDSs for as long as the hazardous chemical is known to be at the mine.
Under 30 CFR 47.55(b), operators must notify miners at least 3 months before disposing of the MSDS.
Under 30 CFR 47.71, upon request, the operator must provide access to all HazCom materials to miners and designated representatives.
Under 30 CFR 47.72(a), the operator must provide the first copy and each revision of the HazCom material without cost.
Under 30 CFR 47.72(b), fees for a subsequent copy of the HazCom material must be non-discriminatory and reasonable.
Under 30 CFR 47.73, for a hazardous chemical produced at the mine, the operator must provide customers, upon request, with the chemical's label or a copy of the label information, and the chemical's MSDS.
Under 30 CFR 47.81(a), operators may withhold the identity of a trade secret chemical, including the name and other specific identification, from the written list of hazardous chemicals, the label, and the MSDS, provided that the operator—
(1) Can support the claim that the chemical's identity is a trade secret,
(2) Identifies the chemical in a way that it can be referred to without disclosing the secret,
(3) Indicates in the MSDS that the chemical's identity is withheld as a trade secret, and
(4) Discloses in the MSDS information on the properties and effects of the hazardous chemical.
Under 30 CFR 47.81(b), the operator must make the chemical's identity available to miners, designated representatives, and health professionals in accordance with the standards.
Under 30 CFR 47.81(c), this subpart does not require the operator to disclose process or percentage of mixture information, which is a trade secret, under any circumstances.
Under 30 CFR 47.82(a), even if the operator has a trade secret claim, the operator must disclose to MSHA, upon request, any information which the standards require the operator to make available.
Under 30 CFR 47.82(b), the operator must make a trade secret claim, no later than at the time the information is provided to MSHA, so that MSHA can determine the trade secret status and implement the necessary protection.
Under 30 CFR 47.83(a), upon request and regardless of the existence of a written statement of need or a confidentiality agreement, the operator must immediately disclose the identity of a trade secret chemical to the treating health professional when that person determines that—
(1) A medical emergency exists, and
(2) The identity of the hazardous chemical is necessary for emergency or first-aid treatment.
Under 30 CFR 47.83(b), the operator may require a written statement of need and confidentiality agreement in accordance with the provisions of section 47.84 and 47.85 as soon as circumstances permit.
Under 30 CFR 47.84, upon request, the operator must disclose the identity of a trade secret chemical in a non-emergency situation to an exposed miner, the miner's designated representative, or a health professional providing services to the miner, if the following conditions are met.
(a) The request is in writing
(b) The request describes in reasonable detail an occupational health need for the information, as follows:
(1) To assess the chemical hazards to which the miner will be exposed.
(2) To conduct reassignment or periodic medical surveillance of the exposed miner.
(3) To conduct reassignment or periodic medical surveillance of the exposed miner.
(4) To provide medical treatment to the exposed miner.
(5) To select or assess appropriate personal protective equipment for the exposed miner.
(6) To design or assess engineering controls or other protective measures for the exposed miner.
(7) To conduct studies to determine the health effects of exposure.
(c) The request explains in detail why the disclosure of the following information would not satisfy the purpose described in paragraph (b) of this section:
(1) The properties and effects of the chemical.
(2) Measures for controlling the miner's exposure to the chemical.
(3) Methods of monitoring and analyzing the miner's exposure to the chemical.
(4) Methods of diagnosing and treating harmful exposures to the chemical.
(d) The request describes the procedures to be used to maintain the confidentiality of the disclosed information.
(e) The person making the request enters a written confidentiality agreement that he or she will not use the information for any purpose other than the health needs asserted and agrees not to release the information under any circumstances, except as authorized by § 47.85, by the terms of the agreement, or by the operator.
Under 30 CFR 47.86, to deny a written request for disclosure of the identity of a trade secret chemical, the operator must—
(a) Put the denial in writing,
(1) Including evidence to substantiate the claim that the chemical's identity is a trade secret,
(2) Stating the specific reasons why the request is being denied, and
(3) Explain how alternative information will satisfy the specific medical or occupational health need without revealing the chemical's identity.
(b) Provide the denial to the health professional, miner, or designated representative within 30 days of the request.
Under 30 CFR 47.87(a), the health professional, miner, or designated representative may refer the written denial to MSHA for review. The request for review must include a copy of—
(1) The request for disclosure of the identity of the trade secret chemical,
(2) The confidentiality agreement, and
(3) The operator's written denial.
Under 30 CFR 47.87(c), If MSHA determines that the confidentiality agreement would not sufficiently protect against unauthorized disclosure of the trade secret, MSHA may impose additional conditions to ensure that the occupational health services are provided without an undue risk of harm to the operator.
MSHA is soliciting comments concerning the proposed information collection titled “Hazard Communication (HazCom)—30 CFR part 47.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Hazard Communication (HazCom)—30 CFR part 47. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Hoist Operators' Physical Fitness.”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Hoist Operators' Physical Fitness.” This information collection is intended to ensure that hoist operators at MNM mines are physically capable of safely performing their assigned tasks to reduce risks to the individuals themselves and others requiring hoisting into or out of a mine.
Burden costs associated with the ICR include:
The associated standards that authorize the collection of information are described below.
Under 30 CFR 56.19057 (Surface Metal and Nonmetal Mines) and 57.19057 (Underground Metal and Nonmetal Mines), no person shall operate a hoist unless within the preceding 12 months he has had a medical examination by a qualified, licensed physician who shall certify his fitness to perform this duty. Such certification shall be available at the mine.
MSHA is soliciting comments concerning the proposed information collection titled “Hoist Operators' Physical Fitness.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Hoist Operators' Physical Fitness. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Mine Accident, Injury and Illness Report and Quarterly Mine Employment and Coal Production Report.”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Mine Accident, Injury and Illness Report and Quarterly Mine Employment and Coal Production Report.” This information collection is intended to ensure that MSHA has up to date information, including production, employment, and accidents and injuries that may have occurred at mines. This information allows MSHA and mine operators to monitor safety and health conditions in the mining industry, evaluate the results of health and safety efforts, develop new health and safety standards, establish priorities for technical assistance activities in health and safety, and effectively direct resources to improve safety and health in the mining industry.
Burden costs associated with the ICR include:
Authorization and the associated rule text are described in the following:
Under section 103(j) of the Mine Act, 30 U.S.C. 813(j), in the event of any accident occurring in any coal or other mine, the operator shall notify the Secretary thereof and shall take appropriate measures to prevent the destruction of any evidence which would assist in investigating the cause or causes thereof.
Under 30 CFR 50.10, the operator shall immediately contact MSHA at once without delay and within 15 minutes at the toll-free number, once the operator knows or should know that an accident has occurred involving:
(a) A death of an individual at the mine;
(b) An injury of an individual at the mine which has a reasonable potential to cause death;
(c) An entrapment of an individual at the mine which has a reasonable potential to cause death; or
(d) Any other accident.
Under section 103(d) of the Mine Act, 30 U.S.C. 813(d), all accidents, including unintentional roof falls (except in any abandoned panels or in areas which are inaccessible or unsafe for inspections), shall be investigated by the operator or his agent to determine the cause and the means of preventing a recurrence. Records of such accidents and investigations shall be kept and the information shall be made available to the Secretary or his authorized representative and the appropriate State agency. Such records shall be open for inspection by interested persons. Such records shall include man-hours worked and shall be reported at a frequency determined by the Secretary, but at least annually.
Under 30 CFR 50.11(b), each operator of a mine shall investigate each accident and each occupational injury at the mine. Each operator of a mine shall develop a report of each investigation. No operator may use Form 7000-1 as a report, except that an operator of a mine at which fewer than twenty miners are employed may, with respect to that mine, use Form 7000-1 as an investigation report respecting an occupational injury not related to an accident. No operator may use an investigation or an investigation report conducted or prepared by MSHA to comply with this paragraph. An operator shall submit a copy of any investigation report to MSHA at its request. Each report prepared by the operator shall include information described under 30 CFR 50.11(b)(1) through 50.11(b)(9).
Under 30 CFR 50.20(a), each operator shall maintain at the mine office a supply of MSHA Mine Accident, Injury, and Illness Report Form 7000-1. These may be obtained from the MSHA District Office. Each operator shall report each accident, occupational injury, or occupational illness at the mine. The principal officer in charge of health and safety at the mine or the supervisor of the mine area in which an accident or occupational injury occurs, or an occupational illness may have originated, shall complete or review the form in accordance with the instructions and criteria under 30 CFR 50.20-1 through 50.20-7. If an occupational illness is diagnosed as being one of those listed in 30 CFR 50.20-6(b)(7), the operator must report it under this part. The operator shall mail completed forms to MSHA within ten working days after an accident or occupational injury occurs or an occupational illness is diagnosed. When an accident specified in 30 CFR 50.10 occurs, which does not involve an occupational injury, sections A, B, and items 5 through 12 of section C of Form 7000-1 shall be completed and mailed to MSHA in accordance with the instructions in 30 CFR 50.20-1 and criteria contained in 30 CFR 50.20-4 through 50.20-6.
Under 30 CFR 50.20(b), each operator shall report each occupational injury or occupational illness on one set of forms. If more than one miner is injured in the same accident or is affected simultaneously with the same occupational illness, an operator shall complete a separate set of forms for each miner affected. To the extent that the form is not self-explanatory, an operator shall complete the form in accordance with the instructions in 30 CFR 50.20-1 and criteria contained in 30 CFR 50.20-2 through 50.20-7.
Under 30 CFR 50.30(a), each operator of a mine in which an individual worked during any day of a calendar quarter shall complete a MSHA Form 7000-2 in accordance with the instructions and criteria under 30 CFR 50.30-1 and submit the original to the MSHA, within 15 days after the end of each calendar quarter. These forms may be obtained from the MSHA District Office.
Each operator shall retain an operator's copy at the mine office nearest the mine for 5 years after the submission date.
Under 30 CFR 50.30(b), each operator of a coal mine in which an individual worked during any day of a calendar quarter shall report coal production on Form 7000-2.
Under 30 CFR 50.40(a), each operator of a mine shall maintain a copy of each [accident] investigation report required to be prepared under 30 CFR 50.11 at the mine office closest to the mine for five years after the concurrence.
Under 30 CFR 50.40(b), each operator shall maintain a copy of each [accident, injury, and illness] report submitted under 30 CFR 50.20 or [quarterly employment and coal production report under] 50.30 at the mine office closest to the mine for five years after submission. Upon request by the MSHA, an operator shall make a copy of any report submitted under 30 CFR 50.20 or 50.30 available to MSHA for inspection or copying.
MSHA is soliciting comments concerning the proposed information collection titled “Mine Accident, Injury and Illness Report and Quarterly Mine Employment and Coal Production Report.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Mine Accident, Injury and Illness Report and Quarterly Mine Employment and Coal Production Report. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Examinations and Testing of Electric Equipment.”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Examinations and Testing of Electric Equipment.” This information collection is intended to ensure that coal mine operators conduct examinations and tests of electric equipment and circuit breakers according to the standards, and address hazardous conditions associated with electric equipment at workplace. The collected information prevents unsafe conditions at coal mines, supports the evaluation of the effectiveness of electrical maintenance programs, and provides valuable information during accident investigations.
Burden costs associated with the ICR include:
The associated standards that authorize the collection of information are described below.
Under 30 CFR 75.512, all electric equipment in underground coal mines shall be frequently examined, tested, and maintained by a qualified person to ensure safe operating conditions. A record of such examinations shall be kept and made available to an authorized representative of the Secretary and to the miners in such mine.
Under 30 CFR 75.512-2, the examinations and tests required under 30 CFR 75.512 shall be made at least weekly. Permissible equipment shall be
Under 30 CFR 75.703-3 (d)(11), in grounding offtrack direct-current machines and the enclosures of their component parts, all grounding diodes in underground coal mines shall be tested, examined, and maintained as electric equipment and records of these activities be kept in accordance with the provisions of 30 CFR 75.512.
Under 30 CFR 77.502, electric equipment in surface coal mines and surface work areas of underground coal mines shall be frequently examined, tested, and properly maintained by a qualified person to assure safe operating conditions. When a potentially dangerous condition is found on electric equipment, such equipment shall be removed from service until such condition is corrected. A record of such examinations shall be kept.
Under 30 CFR 77.502-2, the examinations and tests required under 30 CFR 77.502 shall be conducted at least monthly.
Under 30 CFR 75.800, high-voltage circuits entering the underground area of any coal mine shall be protected by suitable circuit breakers of adequate interrupting capacity which are properly tested and maintained as prescribed by the Secretary. Such breakers shall be equipped with devices to provide protection against under-voltage grounded phase, short circuit, and overcurrent.
Under 30 CFR 75.800-3, circuit breakers and their auxiliary devices protecting underground high-voltage circuits shall be tested and examined at least once each month by a person qualified as provided in 30 CFR 75.153. Tests shall include: breaking continuity of the ground check conductor, where ground check monitoring is used; and actuating at least two (2) of the auxiliary protective relays. Examinations shall include visual observation of all components of the circuit breaker and its auxiliary devices, and such repairs or adjustments as are indicated by such tests and examinations shall be carried out immediately.
Under 30 CFR 75.800-4, the mine operator shall make a record of each test, examination, repair, or adjustment of all circuit breakers protecting high-voltage circuits which enter any underground area of the mine. These records shall be made in a secure book that is not susceptible to alteration or electronically in a computer system so as to be secure and not susceptible to alteration. These records shall be retained at a surface location at the mine for at least one year and shall be made available to authorized representatives of the Secretary, the representative of miners, and other interested persons.
Under 30 CFR 75.812, power centers and portable transformers shall be deenergized before they are moved from one location to another, except that, when equipment powered by sources other than such centers or transformers is not available, the Secretary may permit such centers and transformers to be moved while energized, if he determines that another equivalent or greater hazard may otherwise be created, and if they are moved under the supervision of a qualified person, and if such centers and transformers are examined prior to such movement by such person and found to be grounded by methods approved by an authorized representative of the Secretary and otherwise protected from hazards to the miner. A record shall be kept of such examinations. High-voltage cables, other than trailing cables, shall not be moved or handled at any time while energized, except that, when such centers and transformers are moved while energized as permitted under this section, energized high-voltage cables attached to such centers and transformers may be moved only by a qualified person and the operator of such mine shall require that such person wear approved and tested insulated wireman's gloves.
Under 30 CFR 75.812-2, the operator shall maintain a record of all examinations conducted in accordance with 30 CFR 75.812. Such record shall be kept in a book approved by the Secretary.
Under 30 CFR 77.800, high-voltage circuits supplying power to portable or mobile equipment at surface coal mines and surface areas of underground coal mines shall be protected by suitable circuit breakers of adequate interrupting capacity which are properly tested and maintained and equipped with devices to provide protection against under voltage, grounded phase, short circuit and overcurrent. High-voltage circuits supplying power to stationary equipment shall be protected against overloads by either a circuit breaker or fuses of the correct type and capacity.
Under 30 CFR 77.800-1, circuit breakers and their auxiliary devices protecting high-voltage circuits to portable or mobile equipment shall be tested and examined at least once each month by a person qualified as provided in 30 CFR 77.103. Tests shall include: breaking continuity of the ground check conductor where ground check monitoring is used; and, actuating any of the auxiliary protective relays. Examination shall include visual observation of all components of the circuit breaker and its auxiliary devices, and such repairs or adjustments as are indicated by such tests and examinations shall be carried out immediately.
Under 30 CFR 77.800-2, the operator shall maintain a written record of each test, examination, repair, or adjustment of all circuit breakers protecting high-voltage circuits. Such record shall be kept in a book approved by the Secretary.
Under 30 CFR 75.820(a), electrical work on all circuits and equipment associated with high-voltage longwalls in underground coal mines must be performed only by persons qualified under 30 CFR 75.153 to perform electrical work on all circuits and equipment.
Under 30 CFR 75.820(b)(3), prior to performing electrical work, a qualified person must lock out the disconnecting device with a padlock. When more than one qualified person is performing work, each person must install an individual padlock. Under 30 CFR 75.820(b)(4), a qualified person must tag the disconnecting device to identify each person working and the circuit or equipment on which work is being performed.
Under 30 CFR 75.821(a), at least once every 7 days, a person qualified in accordance 30 CFR 75.153 to perform electrical work on all circuits and equipment must test and examine each unit of high-voltage longwall equipment and circuits to determine that electrical protection, equipment grounding, permissibility, cable insulation, and control devices are being properly maintained to prevent fire, electrical shock, ignition, or operational hazards from existing on the equipment. Tests must include activating the ground-fault test circuit as required by 30 CFR 75.814(c).
Under 30 CFR 75.821(b), each ground-wire monitor and associated circuits must be examined and tested at least once each 30 days to verify proper operation and that it will cause the corresponding circuit-interrupting device to open.
Under 30 CFR 75.821(d), at the completion of examinations and tests required by this section, the person who makes the examinations and tests must certify by signature and date that they have been conducted. A record must be made of any unsafe condition found and any corrective action taken. Certifications and records must be kept for at least one year and must be made available for inspection by authorized representatives of the Secretary and representatives of miners.
Under 30 CFR 75.900, low- and medium-voltage power circuits serving three-phase alternating current equipment shall be protected by suitable circuit breakers of adequate interrupting capacity which are properly tested and maintained as prescribed by the Secretary. Such breakers shall be equipped with devices to provide protection against undervoltage, grounded phase, short circuit, and overcurrent.
Under 30 CFR 75.900-3, circuit breakers protecting low- and medium-voltage alternating current circuits serving three-phase alternating current equipment and their auxiliary devices shall be tested and examined at least once each month by a person qualified as provided in 30 CFR 75.153. In performing such tests, actuating any of the circuit breaker auxiliaries or control circuits in any manner which causes the circuit breaker to open, shall be considered a proper test. All components of the circuit breaker and its auxiliary devices shall be visually examined and such repairs or adjustments as are indicated by such tests and examinations shall be carried out immediately.
Under 30 CFR 75.900-4, the operator of any coal mine shall maintain a written record of each test, examination, repair, or adjustment of all circuit breakers protecting low- and medium-voltage circuits serving three-phase alternating current equipment used in the mine. Such record shall be kept in a book approved by the Secretary.
Under 30 CFR 77.900, low- and medium-voltage circuits supplying power to portable or mobile three-phase alternating current equipment shall be protected by suitable circuit breakers of adequate interrupting capacity which are properly tested and maintained and equipped with devices to provide protection against undervoltage, grounded phase, short circuit, and over-current.
Under 30 CFR 77.900-1, circuit breakers protecting low- and medium-voltage circuits serving portable or mobile three-phase alternating current equipment and their auxiliary devices shall be tested and examined at least once each month by a person qualified as provided in 30 CFR 75.153. In performing such tests, the circuit breaker auxiliaries or control circuits shall be actuated in any manner which causes the circuit breaker to open. All components of the circuit breaker and its auxiliary devices shall be visually examined and such repairs or adjustments as are indicated by such tests and examinations shall be carried out immediately.
Under 30 CFR 77.900-2, the operator shall maintain a written record of each test, examination, repair or adjustment of all circuit breakers protecting low- and medium-voltage circuits serving three-phase alternating current equipment and such record shall be kept in a book approved by the Secretary.
Under 30 CFR 75.1001-1(a), automatic circuit interrupting devices that will deenergize the affected circuit upon occurrence of a short circuit at any point in the system will meet the requirements of 30 CFR 75.1001.
Under 30 CFR 75.1001-1(b), automatic circuit interrupting shall be tested and calibrated at intervals not to exceed six months. Testing of such devices shall include passing the necessary amount of electric current through the device to cause activation. Calibration of such devices shall include adjustment of all associated relays to ±15 percent of the indicated value. An authorized representative of the Secretary may require additional testing or calibration of these devices.
Under 30 CFR 75.1001-1(c), a record of the tests and calibrations required by paragraph (b) of this section shall be kept, and shall be made available, upon request, to an authorized representative of the Secretary.
MSHA is soliciting comments concerning the proposed information collection titled “Examinations and Testing of Electric Equipment.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Examinations and Testing of Electric Equipment. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed.”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
•
•
• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed.” This information collection is intended to ensure that ventilation plans include all necessary details and are maintained properly to improve the safety and health of miners working in belt air mines.
Burden costs associated with the ICR include:
The associated standards that authorize the collection of information are described below.
Under 30 CFR 75.301, belt air course refers to the entry in which a belt is located and any adjacent entry(ies) not separated from the belt entry by
Under 30 CFR 75.350(a)(2), the air velocity in the belt entry must be at least 50 feet per minute. When requested by the mine operator, the district manager may approve lower velocities in the ventilation plan based on specific mine conditions. Air velocities must be compatible with all fire detection systems and fire suppression systems used in the belt entry.
Under 30 CFR 75.350(b), the use of air from a belt air course shall ventilate a working section, or an area where mechanized mining equipment is being installed or removed, is permitted only when evaluated and approved by the district manager in the mine ventilation plan. The mine operator must include in a ventilation plan a justification that the use of air from a belt entry would afford at least the same measure of protection as where belt haulage entries are not used to ventilate working places.
Under 30 CFR 75.350(b)(3)(ii), a permanent designated area (DA) for dust measurements must be established at a point no greater than 50 feet upwind from the section loading point in the belt entry when the belt air flows over the loading point or no greater than 50 feet upwind from the point where belt air is mixed with air from another intake air course near the loading point. The DA must be specified and approved in the ventilation plan.
Under 30 CFR 75.350(b)(6), in areas of the mine developed after the effective date of this rule, unless approved by the district manager, no more than 50% of the total intake air, delivered to the working section or to areas where mechanized mining equipment is being installed or removed, can be supplied from the belt air course. The locations for measuring these air quantities must be approved in the mine ventilation plan.
Under 30 CFR 75.350(b)(7) and (8), the air velocity in the belt entry must be at least 100 feet per minute and not exceed 1,000 feet per minute. When requested by the mine operator, the district manager may approve alternative velocities in the ventilation plan based on specific mine conditions.
Under 30 CFR 75.350(c), notwithstanding the provisions of escapeway, additional intake air may be added to the belt air course through a point-feed regulator. The location and use of point feeds must be approved in the mine ventilation plan.
Under 30 CFR 75.350(d)(1), if the air through the point-feed regulator enters a belt air course which is used to ventilate a working section or an area where mechanized mining equipment is being installed or removed, the air current that will pass through the point-feed regulator must be monitored for carbon monoxide or smoke at a point within 50 feet upwind of the point-feed regulator. A second point must be monitored 1,000 feet upwind of the point-feed regulator unless the mine operator requests that a lesser distance be approved by the district manager in the mine ventilation plan based on mine specific conditions.
Under 30 CFR 75.350(d)(5), the location(s) and use of a point-feed regulator(s) must be approved in the mine ventilation plan and shown on the mine ventilation map.
Under 30 CFR 75.301, atmospheric monitoring system (AMS) refers to a network consisting of hardware and software meeting the requirements of sections 75.351 and 75.1103-2 and capable of: measuring atmospheric parameters; transmitting the measurements to a designated surface location; providing alert and alarm signals; processing and cataloging atmospheric data; and, providing reports. Early-warning fire detection systems using newer technology that provides equal or greater protection, as determined by the Secretary, will be considered atmospheric monitoring systems for the purposes of this subpart.
Under 30 CFR 75.351(b)(3), a map or schematic must be provided at the designated surface location that shows the locations and type of AMS sensor at each location, and the intended air flow direction at these locations. This map or schematic must be updated within 24 hours of any change in this information.
Under 30 CFR 75.351(b)(4), the names of the designated AMS operators and other appropriate personnel, including the designated person responsible for initiating an emergency mine evacuation and the method to contact these persons, must be provided at the designated surface location.
Under 30 CFR 75.351(e)(1)(v), the locations of sensors-belt air course must be specified in the mine ventilation plan.
Under 30 CFR 75.352(e)(1)(v), any AMS used to monitor belt air course must have approved sensors to monitor for carbon monoxide at other locations in any entry that is part of the belt air course as required and specified in the mine ventilation plan.
The mine ventilation plan shall contain the information described in 30 CFR 75.371, and any additional provisions required by the district manager, including:
(ii) The locations (designated areas) where dust measurements would be made in the belt entry when belt air is used to ventilate working sections or areas where mechanized mining equipment is being installed or removed, in accordance with 30 CFR 75.350(b)(3).
(jj) The locations and approved velocities at dust measurement locations where air velocities in the belt entry are above or below the limits set forth in sections 75.350(a)(2) or 75.350(b)(7) and (8).
(kk) The locations where air quantities are measured as set forth in section 75.350(b)(6).
(mm) The location of any diesel-discriminating sensor and additional carbon monoxide or smoke sensors installed in the belt air course must be included in the mine ventilation plan.
Under 30 CFR 75.351(m), when a demonstrated need exists, time delays may be incorporated into the AMS. These time delays must only be used to account for non-fire related carbon monoxide alert and alarm sensor signals. These time delays are limited to no more than three minutes. The use and length of any time delays, or other techniques or methods which eliminate or reduce the need for time delays, must be specified and approved in the mine ventilation plan.
Under 30 CFR 75.351(n)(1), at least once each shift when belts are operated as part of a production shift, sensors used to detect carbon monoxide or smoke, and alarms installed must be visually examined.
Under 30 CFR 75.351(n)(2), at least once every seven days, alarms for AMS installed must be functionally tested for proper operation.
Under 30 CFR 75.351(n)(3), at intervals not to exceed 31 days—
(i) Each carbon monoxide sensor installed must be calibrated in accordance with the manufacturer's calibration specifications. Calibration must be done with a known concentration of carbon monoxide in air sufficient to activate the alarm;
(ii) Each smoke sensor installed must be functionally tested in accordance with the manufacturer's calibration specifications; and
(iii) Each methane sensor installed in accordance must be calibrated in accordance with the manufacturer's calibration specifications. Calibration must be done with a known concentration of methane in air sufficient to activate an alarm.
Under 30 CFR 75.351(o)(1), when an AMS is used to comply with ventilation requirements, individuals designated by the mine operator must make the following records by the end of the shift in which the following event(s) occur:
(i) If an alert or alarm signal occurs, a record of the date, time, location and type of sensor, and the cause for the activation.
(ii) If an AMS malfunctions, a record of the date, the extent and cause of the malfunction, and the corrective action taken to return the system to proper operation.
(iii) A record of the seven-day tests of alert and alarm signals; calibrations; and maintenance of the AMS must be made by the person(s) performing these actions.
Under 30 CFR 75.351(o)(2), the recording of the name, date and signature of the person entering the record is included.
Under 30 CFR 75.351(o)(3), the records required by this section must be kept either in a secure book that is not susceptible to alteration, or electronically in a computer system that is secure and not susceptible to alteration. These records must be maintained separately from other records and identifiable by a title, such as the `AMS log.'
Under 30 CFR 75.351(p), records must be retained for at least one year at a surface location at the mine and made available for inspection by miners and authorized representatives of the Secretary.
Under 30 CFR 75.352(a), when a malfunction, alert, or alarm signal is received at the designated surface location, the sensor(s) that are activated must be identified and the AMS operator must promptly notify appropriate personnel.
Under 30 CFR 75.352(b), upon notification of a malfunction, alert, or alarm signal, appropriate personnel must promptly initiate an investigation to determine the cause of the signal.
Under 30 CFR 75.352(c), if any sensor installed indicates an alarm or if any two consecutive sensors indicate alert at the same time, the following procedures must be followed unless the cause of the signal(s) is known not to be a hazard to miners:
(i) Appropriate personnel must notify miners in affected working sections, in affected areas where mechanized mining equipment is being installed or removed, and at other locations specified in the approved mine emergency evacuation and firefighting program of instruction; and
(ii) all personnel in the affected areas, unless assigned other duties under 30 CFR 75.1502 must be withdrawn promptly to a safe location identified in the mine emergency evacuation and firefighting program of instruction.
Under 30 CFR 75.352(e)(7), for those AMSs using sensors other than carbon monoxide sensors, an alternate detector and the alert and alarm levels associated with that detector must be specified in the approved mine ventilation plan.
Under 30 CFR 75.371(pp), the alternate detector and the alert and alarm levels associated with the detector must be included in the mine ventilation plan.
Under 30 CFR 75.301, carbon monoxide ambient level refers to the average concentration in parts per million (ppm) of carbon monoxide detected in an air course containing carbon monoxide sensors. This average concentration is representative of the composition of the mine atmosphere over a period of mining activity during non-fire conditions. Separate ambient levels may be established for different areas of the mine.
Under 30 CFR 75.351(j), carbon monoxide ambient levels and the means to determine these levels must be approved in the mine ventilation plan (section 75.371(hh)) for monitors installed in accordance with sections 75.340(a)(1)(ii), 75.340(a)(2)(ii), 75.350(b), and 75.350(d).
Under 30 CFR 75.371(hh), the ambient level in parts per million of carbon monoxide, and the method for determining the ambient level, in all areas where carbon monoxide sensors are installed must be included in the mine ventilation plan.
Under 30 CFR 75.371(nn), the mine ventilation plan shall contain the length of the time delay or any other method used to reduce the number of non-fire related alert and alarm signals from carbon monoxide sensors.
Under 30 CFR 75.351(i)(2), an AMS alert at 5 ppm carbon monoxide above the ambient level and alarm at 10 ppm carbon monoxide above the ambient level when carbon monoxide sensors are used; and alarm at a smoke optical density of 0.022 per meter when smoke sensors are used. Reduced alert and alarm settings approved by the district manager may be required for carbon monoxide sensors identified in the mine ventilation plan.
Under 30 CFR 75.371(oo), the reduced alert and alarm settings for carbon monoxide sensors must be included in the mine ventilation plan.
Under 30 CFR 75.301, point feeding refers to the process of providing additional intake air to the belt air course from another intake air course through a regulator.
Under 30 CFR 75.350(d)(1), the air current that will pass through the point-feed regulator must be monitored for carbon monoxide or smoke at a point within 50 feet upwind of the point-feed regulator. A second point must be monitored 1,000 feet upwind of the point-feed regulator unless the mine operator requests that a lesser distance be approved by the district manager in the mine ventilation plan based on mine specific conditions.
Under 30 CFR 75.371(ll), the mine ventilation plan shall contain the locations and use of point-feed
Under 30 CFR 75.350(b)(2), all miners must be trained annually in the basic operating principles of the AMS, including the actions required in the event of activation of any AMS alert or alarm signal. This training must be conducted prior to working underground in a mine that uses belt air to ventilate working sections or areas where mechanized mining equipment is installed or removed. It must be conducted as part of a miner's 30 CFR part 48 new miner training (section 48.5), experienced miner training (section 48.6), or annual refresher training (section 48.8).
Under 30 CFR 75.351(q)(1), all AMS operators must be trained annually in the proper operation of the AMS.
Under 30 CFR 75.351(q)(3), a record of the content of training, the person conducting the training, and the date the training was conducted, must be maintained at the mine for at least one year by the mine operator.
MSHA is soliciting comments concerning the proposed information collection titled “Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled “Safety Defects, Examination, Correction, and Records.”
All comments must be received on or before September 25, 2026.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that comments received after the deadline will not be considered.
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• MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at
Corliss A. Josephs-Conway, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal (MNM) mines.
The Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
To fulfill its statutory mandate to promote miners' health and safety, MSHA requires information under the information collection request (ICR) titled “Safety Defects; Examination, Correction, and Records.” This information collection is intended to ensure that compressed-air receivers, boilers, and self-propelled mobile equipment are inspected, defects are addressed, hazards are abated, and unsafe conditions are identified and corrected to provide MNM miners with safe working environment.
Burden costs associated with the ICR include:
The associated standards that authorize the collection of information are described below.
Under 30 CFR 56.13015(a) and 57.13015(a), compressed-air receivers and other unfired pressure vessels shall be inspected by inspectors holding a valid National Board Commission and in accordance with the applicable chapters of the National Board Inspection Code, a Manual for Boiler and Pressure Vessel Inspectors, 1979.
Under 30 CFR 56.13015(b) and 57.13015(b), records of inspections shall be kept in accordance with requirements of the National Board Inspection Code, and the records shall be made available to the Secretary or his authorized representative.
Under 30 CFR 56.13030(a) and 57.13030(a), fired pressure vessels (boilers) shall be equipped with water level gauges, pressure gauges, automatic pressure-relief valves, blowdown piping, and other safety devices approved by the American Society of Mechanical Engineers to protect against hazards from overpressure, flameouts, fuel interruptions and low water level, all as required by the appropriate sections, chapters and appendices listed in the ASME Boiler and Pressure Vessel Code, 1977 and the National Board Inspection Code, a Manual for Boiler and Pressure Vessel Inspectors.
Under 30 CFR 56.13030(b) and 57.13030(b), these gauges, devices and piping shall be designed, installed, operated, maintained, repaired, altered, inspected, and tested by inspectors holding a valid National Board Commission and in accordance with the appropriate sections, chapters and appendices listed in the ASME Boiler and Pressure Vessel Code and the National Board Inspection Code.
Under 30 CFR 56.13030(c) and 57.13030(c), records of inspections and repairs shall be kept in accordance with the requirements of the ASME Boiler and Pressure Vessel Code and the National Board Inspection Code. The records shall be made available to the Secretary or his authorized representative.
Under 30 CFR 56.14100(a) and 57.14100(a), self-propelled mobile equipment to be used during a shift shall be inspected by the equipment operator before being placed in operation on that shift.
Under 30 CFR 56.14100(b) and 57.14100(b), defects on any equipment, machinery, and tools that affect safety shall be corrected in a timely manner to prevent the creation of a hazard to persons.
Under 30 CFR 56.14100(c) and 57.14100(c), when defects make continued operation hazardous to persons, the defective items including self-propelled mobile equipment shall be taken out of service and placed in a designated area posted for that purpose, or a tag or other effective method of marking the defective items shall be used to prohibit further use until the defects are corrected.
Under 30 CFR 56.14100(d) and 57.14100(d), defects on self-propelled mobile equipment affecting safety, which are not corrected immediately, shall be reported to and recorded by the mine operator. The records shall be kept at the mine or nearest mine office from the date the defects are recorded, until the defects are corrected. Such records shall be made available for inspection by an authorized representative of the Secretary.
Under 30 CFR 56.18002(a) and 57.18002(a), a competent person designated by the operator shall examine each working place at least once each shift before miners begin work in that place, for conditions that may adversely affect safety or health.
Under 30 CFR 56.18002(b) and 57.18002(b), a record of each examination shall be made before the end of the shift for which the examination was conducted. The record shall contain the name of the person conducting the examination; date of the examination; location of all areas examined; and description of each condition found that may adversely affect the safety or health of miners.
Under 30 CFR 56.18002(c) and 57.18002(c), when a condition that may adversely affect safety or health is corrected, the examination record shall include, or be supplemented to include, the date of the corrective action.
Under 30 CFR 56.18002(d) and 57.18002(d), the operator shall maintain the examination records for at least one year, make the records available for inspection by authorized representatives of the Secretary and the representatives
MSHA is soliciting comments concerning the proposed information collection titled “Safety Defects, Examination, Correction, and Records.” MSHA is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The ICR is available on
The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 200 Constitution Avenue NW, Washington, DC 20210. Before visiting MSHA in person, call 202-693-9440 to make an appointment.
Questions about the information collection requirements may be directed to the person listed in the
This ICR concerns provisions for Safety Defects, Examination, Correction, and Records. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this ICR from the previous ICR.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed ICR; they will become a matter of public record and be available at
Wage and Hour Division, Department of Labor.
Notice.
The Department of Labor (Department) is soliciting comments concerning a proposed extension of the information collection request (ICR) titled, “Housing Occupancy Certificates Under the Migrant and Seasonal Agricultural Worker Protection Act.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995. The Department proposes to extend its information collection without change to existing requirements. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. A copy of the proposed information request can be obtained by contacting the office listed below in the
Written comments must be submitted to the office listed in the
You may submit comments identified by Control Number 1235-0005 by either one of the following methods:
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Daniel Navarrete, Division of Regulations, Legislation, and Interpretation, Wage and Hour Division, U.S. Department of Labor, Room S-3502, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-0406 (this is not a toll-free number). Alternative formats are available upon request by calling 1-866-487-9243. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
The Wage and Hour Division (WHD) of the Department of Labor (Department) administers the Migrant and Seasonal Agricultural Worker Protection Act (MSPA), 29 U.S.C. 1801
The Department is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Enhance the quality, utility, and clarity of the information to be collected;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department seeks approval for the extension of this information collection that requires any person owning or controlling any facility or real property to be occupied by migrant agricultural workers to obtain a certificate of occupancy.
Wage and Hour Division, Department of Labor.
Notice.
The Department of Labor (Department) is soliciting comments concerning a proposed extension of the information collection request (ICR) titled, “Employee Polygraph Protection Act.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995. The Department proposes to extend its information collection without change to existing requirements. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. A copy of the proposed information request can be obtained by contacting the office listed below in the
Written comments must be submitted to the office listed in the
You may submit comments identified by Control Number 1235-0005 by either one of the following methods:
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Daniel Navarrete, Division of Regulations, Legislation, and Interpretation, Wage and Hour Division, U.S. Department of Labor, Room S-3502, 200 Constitution Avenue NW, Washington, DC 20210; telephone: (202) 693-0406 (this is not a toll-free number). Alternative formats are available upon request by calling 1-866-487-9243. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
The Wage and Hour Division (WHD) of the Department of Labor (DOL) administers the Employee Polygraph Protection Act of 1988 (EPPA), 29 U.S.C. 2001
The Department of Labor is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Enhance the quality, utility, and clarity of the information to be collected;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; or
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor seeks approval for the extension of this information collection that requires employers to make, maintain, and preserve records in accordance with statutory and regulatory requirements.
Nuclear Regulatory Commission.
Opportunity To Request a Hearing and To Petition for Leave to Intervene; Order Imposing Procedures.
The U.S. Nuclear Regulatory Commission (NRC) received a license application, by letters dated February 25, 2026, March 15, 2026, and April 17, 2026, from Radiant Nuclear, LLC (Radiant) to possess special nuclear material at its R-50 microreactor facility, to be located in Oak Ridge, Tennessee. Radiant requests a special nuclear material license to possess fuel, consisting of coated uranium particles enriched to less than 20 weight percent uranium-235 (U-235), and load the fuel into assemblies intended for use in commercial microreactors. Because the license application contains Sensitive Unclassified Non-Safeguards Information (SUNSI), an order imposes procedures to obtain access to SUNSI for contention preparation.
A request for a hearing or petition for leave to intervene must be filed by September 25, 2026. Any potential party as defined in Section 2.4 of title 10 of the
Please refer to Docket ID NRC-2026-3598 when contacting the NRC about the availability of information regarding this action. You may obtain publicly available information related to this document using any of the following methods:
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James Downs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-7744; email:
Radiant notified the NRC, by a regulatory engagement plan dated October 13, 2023, of its intent to submit an application for a specific license under 10 CFR part 70, “Domestic Licensing of Special Nuclear Material,” for the possession of special nuclear material at its R-50 microreactor facility, to be located in Oak Ridge, Tennessee. The regulatory engagement plan also outlined Radiant's plans to request additional licenses from the NRC to address the manufacturing, transportation, and commercial use of the microreactors produced at the R-50 facility.
Prior to submission of the application, Radiant submitted a gap analysis for 10 CFR part 70 dated April 24, 2024. The gap analysis was used to inform the licensing framework for the application necessary to request licensing of the special nuclear material needed to fuel the microreactors that Radiant plans to manufacture. The NRC staff provided feedback on the gap analysis for 10 CFR part 70 by letter dated October 4, 2024.
Radiant submitted the license application under 10 CFR part 70 by letter dated February 25, 2026. The license application was supplemented by letters dated March 15, 2026, and April 17, 2026. The license application was accepted for a detailed technical review on May 1, 2026.
Radiant plans to locate a microreactor manufacturing facility in Oak Ridge, Roane County, Tennessee. The proposed facility will encompass approximately 84 acres (ac.) (34 hectares (ha)). The construction associated with the license application under 10 CFR part 70 is limited to the Fueling Building, which will house the licensed special nuclear material and contain the operation to load fuel into the assemblies that are intended for use in microreactors. Section 1.2 of the environmental report provides additional details regarding the proposed action.
The scope of Radiant's license application under 10 CFR part 70 is
Prior to a decision on the proposed action, the NRC will make the findings required by the Atomic Energy Act of 1954 as amended (the Act), and the NRC's regulations. The NRC's findings will be documented in a safety evaluation report. Additionally, in accordance with the National Environmental Policy Act of 1969, the NRC will prepare an environmental assessment (EA). The EA will be the subject of other notices in the
The documents identified in the following table are available to interested persons through ADAMS.
Within 60 days after the date of publication of this notice, any person (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult 10 CFR 2.309. If a petition is filed, the presiding officer will rule on the petition and, if
Petitions must be filed no later than 60 days from the date of publication of this notice in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii).
A State, local governmental body, Federally recognized Indian Tribe, or designated agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h) no later than 60 days from the date of publication of this notice. Alternatively, a State, local governmental body, Federally recognized Indian Tribe, or designated agency thereof, may participate as a non-party under 10 CFR 2.315(c).
For information about filing a petition and about participation by a person not a party under 10 CFR 2.315 see ADAMS Accession No. ML20340A053 and on the NRC's public website (
All documents filed in NRC adjudicatory proceedings including documents filed by an interested State, local governmental body, Federally recognized Indian Tribe, or designated agency thereof that requests to participate under 10 CFR 2.315(c), must be filed in accordance with 10 CFR 2.302. The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases, to mail copies on electronic storage media, unless an exemption permitting an alternative filing method, as further discussed, is granted. Detailed guidance on electronic submissions is located in the “Guidance for Electronic Submissions to the NRC” (ADAMS Accession No. ML13031A056) and on the NRC's public website (
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public website (
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website (
Participants who believe that they have good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted in accordance with 10 CFR 2.302(b)-(d). Participants filing adjudicatory documents in this manner are responsible for serving their documents on all other participants. Participants granted an exemption under 10 CFR 2.302(g)(2) must still meet the electronic formatting requirement in 10 CFR 2.302(g)(1), unless the participant also seeks and is granted an exemption from 10 CFR 2.302(g)(1).
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket, which is publicly available on the NRC's public website (
A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing Sensitive Unclassified Non-Safeguards Information (SUNSI).
B. Within 10 days after publication of this notice of hearing or opportunity for hearing, any potential party who believes access to SUNSI is necessary to respond to this notice may request access to SUNSI. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI submitted later than 10 days after publication of this notice will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.
C. The requestor shall submit a letter requesting permission to access SUNSI to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Deputy General Counsel for Licensing, Hearings, and Enforcement, Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The expedited delivery or courier mail address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email addresses for the Office of the Secretary and the Office of the General Counsel are
(1) A description of the licensing action with a citation to this
(2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1); and
(3) The identity of the individual or entity requesting access to SUNSI and the requestor's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention.
D. Based on an evaluation of the information submitted under paragraphs C, the NRC staff will determine within 10 days of receipt of the request whether:
(1) There is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding; and
(2) The requestor has established a legitimate need for access to SUNSI.
E. If the NRC staff determines that the requestor satisfies both D.(1) and D.(2), the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access to those documents. These conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order,
F. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI must be filed by the requestor no later than 25 days after receipt of (or access to) that information. However, if more than 25 days remain between the petitioner's receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline.
G. Review of Denials of Access.
(1) If the request for access to SUNSI is denied by the NRC staff after a determination on standing and requisite need, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.
(2) The requestor may challenge the NRC staff's adverse determination by filing a challenge within 5 days of receipt of that determination with: (a) the presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if this individual is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.
(3) Further appeals of decisions under this paragraph must be made pursuant to 10 CFR 2.311.
H. Review of Grants of Access. A party other than the requestor may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed within 5 days of the notification by the NRC staff of its grant of access and must be filed with: (a) the presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if this individual is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.
If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.
I. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. The attachment to this Order summarizes the general target schedule for processing and resolving requests under these procedures.
For the Nuclear Regulatory Commission.
Weeks of July 27, and August 3, 10, 17, 24, 31, 2026. The schedule for Commission meetings is subject to change on short notice. The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (
Public.
Members of the public may request to receive the information in these notices electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301-415-1969, or by email at
There are no meetings scheduled for the week of July 27, 2026.
There are no meetings scheduled for the week of August 3, 2026.
There are no meetings scheduled for the week of August 10, 2026.
There are no meetings scheduled for the week of August 17, 2026.
There are no meetings scheduled for the week of August 24, 2026.
There are no meetings scheduled for the week of August 31, 2026.
For more information or to verify the status of meetings, contact Wesley Held at 301-287-3591 or via email at
The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Opportunity to provide comments, request a hearing, and petition for leave to intervene.
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of an export application dated May 14, 2026, submitted by EnergySolutions Services Inc. (ESSI) to amend and renew an existing license authorizing the export of radioactive waste to Canada. The NRC is providing notice of the opportunity to comment, request a hearing, and petition to intervene on
Submit comments by August 26, 2026. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date. A request for a hearing or petition for leave to intervene must be filed by August 26, 2026.
You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Madelyn Nagel, telephone: 301-415-0371; email:
Please refer to Docket ID NRC-2026-3664 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
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The NRC encourages electronic comment submission through the Federal rulemaking website (
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
ESSI was issued XW010/04 on April 14, 2021, which expires on December 31, 2026, and authorizes the export of radioactive waste consisting of various materials contaminated with source, special nuclear, or byproduct material that were originally imported from Canada under an NRC general license for recycling and beneficial reuse. Any materials that cannot be recycled, do not meet specifications, have been volume-reduced, or result as waste from processing the imported materials will be sent back to the original Canadian generator for final disposition. ESSI submitted XW010/05 on May 14, 2026, requesting to amend and renew the existing export license authorizing the export of Canadian-origin radioactive waste from ESSI processing facilities in the State of Tennessee to Canada.
The NRC is providing notice of the receipt of the application and is providing the opportunity to submit written comments concerning the actions in this notice. Within 30 days from the date of publication of this notice, persons may submit written comments, as provided in section 110.81 of title 10 of the
Within 30 days after the date of publication of this notice any person may file a request for a hearing or petition for leave to intervene with respect to the actions in this notice. A hearing request or petition for leave to intervene must include the information specified in 10 CFR 110.82(b). Any request for hearing or petition for leave to intervene shall be served by the requestor or petitioner in accordance with 10 CFR 110.89(a), either by delivery, by mail, or filed with the NRC electronically in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012). Detailed guidance on electronic submissions may be found in the “Guidance for Electronic Submissions to the NRC” (ADAMS Accession No. ML13031A056)
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
The information concerning this application for an export license follows.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is announcing revisions to the Market Dominant and Competitive product lists of the Postal Service.
For additional information, this document can be accessed electronically through the Commission's website at
David A. Trissell, General Counsel, at 202-789-6800.
Pursuant to 39 U.S.C. 3642(d)(2) and 39 CFR part 3040, the Commission provides a Notice of Update to Product Lists by submitting a copy of the revised Market Dominant and Competitive product lists.
For many years, the Market Dominant and Competitive product lists were codified at 39 CFR part 3040, Appendix A and B to subpart A. However, as part of Docket No. RM2026-3, the Commission ended its practice of codifying these lists in order to reduce prohibitive publication costs and resource burdens.
Pursuant to 39 CFR part 3040, the Commission maintains a
Pursuant to 39 CFR 3040.103(d)(1), this document provides the revised product lists, which involves changes based on product additions, removals, and transfers.
1. The Commission establishes Docket No. MC2026-318 and provides notice of revisions to the Market Dominant and Competitive product lists.
2. The revisions to the Market Dominant and Competitive product lists identified in this document result from the Commission's most recent MCS update posted on the Commission's website on July 14, 2026, and supersede all previous product lists.
3. This Notice, or an abstract thereof, shall be published in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). The Public Representative does not represent any individual person, entity or particular point of view, and, when Commission attorneys are appointed, no attorney-client relationship is established. Section II also establishes comment deadline(s) pertaining to each such request.
The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.
Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review.
1.
None. See Section II for public proceedings.
This Notice will be published in the
2:00 p.m. on Thursday, July 30, 2026.
The meeting will be held via remote means and at the Commission's headquarters, 100 F Street, NE, Washington, DC 20549.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and
The subject matter of the closed meeting will consist of the following topics:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to examinations and enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting agenda items that may consist of adjudicatory, examination, litigation, or regulatory matters.
For further information, please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 15c1-6 states that any broker-dealer trying to sell to or buy from a customer a security in a primary or secondary distribution in which the broker-dealer is participating or is otherwise financially interested must give the customer written notification of the broker-dealer's participation or interest at or before completion of the transaction. The Commission estimates that approximately 325 respondents will collect information annually under Rule 15c1-6 and that each respondent will spend approximately 10 hours annually complying with the collection of information requirement for a total burden of approximately 3,250 hours per year in the aggregate.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number.
Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the SEC, including whether the information will have practical utility; (b) the accuracy of the SEC's estimate of the burden imposed by the proposed collection of information, including the validity of the methodology and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated, electronic collection techniques or other forms of information technology.
Please direct your written comments on this 60-Day Collection Notice to Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg via email to
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to adopt monthly fees for its proprietary market data feeds, TXSE BALE and TXSE FEED (each an “Exchange Data Feed” and collectively, the “Exchange Data Feeds”). The Exchange proposes to implement the rule change upon commencement of its operations as a national securities exchange.
The text of the proposed rule change is available on the Commission's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing to adopt the monthly fees it will charge Members
The Exchange offers two separate data feeds to subscribers—TXSE BALE, which provides the best-ranked order(s) to buy or sell in the TXSE Book
TXSE FEED is a TXSE-only market data feed that contains all displayed orders for securities trading on the Exchange (
1.
2.
TXSE BALE is a TXSE-only market data feed that contains top of book quotations and execution information based on equity orders entered into the trading system.
1.
2.
The Exchange proposes to add two additional Notes to Market Data Fees within the Proposed Section B. First, Market Data Fees will be pro-rated for each month. Specifically, Market Data Fees will be assessed in any month in which the Member is credentialed and will be pro-rated for partial-month credentialing based on the number of trading days credentialed divided by the total number of trading days in such month. Second, the Exchange proposes to clarify that a Multicast Service per Data Product is required for all Market Data subscribers (see Section C). These Notes are meant to promote clarity and facilitate market participants' understanding of the Exchange's Market Data pricing.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6(b)
The Exchange believes that the proposed market data fees are reasonable, equitable, not unfairly discriminatory, and otherwise consistent with the Act because, as described above, they are consistent with, and in some cases lower than, the
The Exchange believes that the proposed fees for the Exchange Data Feeds are reasonable when compared to fees for comparable products at 24X, MEMX, MIAX Pearl, and Cboe BZX, as illustrated in the table above, given that in nearly all cases, the Exchange's proposed fees are the same as or lower than the fees charged by those other exchanges.
The Exchange believes that its proposed fees are reasonable, fair, and equitable, and not unfairly discriminatory because they are designed to align with services provided. The Exchange believes that the proposed fees are equitably allocated because they will apply uniformly to all data recipients that choose to subscribe to the Exchange Data Feeds. Any Firm that chooses to subscribe to one or more Exchange Data Feeds is subject to the same fee schedule, regardless of what type of business it operates, and the decision to subscribe to one or more Exchange Data Feeds is based on objective differences in usage of Exchange Data Feeds among different Firms, which are still ultimately in the control of each particular Firm. The Exchange believes the proposed pricing among Exchange Data Feeds is equitably allocated because it is based upon the amount of information contained in each data feed. TXSE BALE can be utilized to trade on the Exchange but contains less information than the TXSE FEED (
The Exchange believes that the proposed fees are not unfairly discriminatory because they would apply to all data recipients that choose to subscribe to the same Exchange Data Feeds. Any subscriber that chooses to subscribe to the Exchange Data Feeds is subject to the same Fee Schedule, regardless of what type of business it operates. Because the proposed fees for TXSE FEED are higher, subscribers seeking lower cost options may instead choose to receive data from the Securities Information Processors or through TXSE BALE for a lower cost. Alternatively, subscribers can choose to pay for TXSE FEED in order to receive data in a single feed with depth-of-book information if such information is valuable to them. The Exchange notes that subscribers can also choose to subscribe to a combination of data feeds for redundancy purposes or to use different feeds for different purposes. In sum, each subscriber has the ability to choose the best business solution for itself.
The Exchange does not believe it is unfairly discriminatory to base pricing upon the amount of information contained in each data feed. As described above, TXSE BALE can be utilized to trade on the Exchange but contain less information than TXSE FEED (
In conclusion, the Exchange submits that its proposed fee structure satisfies the requirements of Sections 6(b)(4) and 6(b)(5) of the Act
Section 6(b)(8) of the Act requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange does not believe that the proposed fees for Exchange Data Feeds place certain market participants at a relative disadvantage compared to other market participants because, as noted above, the decision to subscribe to any Exchange Data Feeds is optional and proposed fees are associated with the usage of Exchange Data Feeds by each market participant based on the type of business it operates. The fees associated with the Exchange Data Feeds are based on objective differences in usage of Exchange Data Feeds among different Firms, which are still ultimately in the control of each particular Firm, and such fees do not impose a barrier to entry to smaller participants. Accordingly, the proposed fees for Exchange Data Feeds do not favor certain categories of market participants in a manner that would impose a burden on competition; rather, the allocation of the proposed fees reflects the types of Exchange Data Feeds consumed by various market participants and their usage thereof.
The Exchange does not believe the proposed fees place an undue burden on competition on other SROs that is not necessary or appropriate. In particular, market participants are not forced to subscribe to any of the Exchange Data Feeds, as described above. Additionally, other exchanges have similar market data fees in place for their participants, but with comparable and in some cases higher rates for market data feeds. Competing equities exchanges are free to adopt comparable fee structures subject to the SEC rule filing process.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Exchange Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend the rule change if it appears to the Commission that the action is necessary or appropriate in the public interest, for the protection of investors, or would otherwise further the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 13, 2026, the Nasdaq Stock Market LLC (“Exchange” or “Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On June 18, 2026, the Exchange filed Amendment No. 1 to the proposed rule change, which replaced and superseded
Nasdaq Rules require companies listed on the Nasdaq Global Select Market (“NGS”), Nasdaq Global Market (“NGM”) and Nasdaq Capital Market (“NCM”) to maintain certain minimum continued listing requirements.
The Exchange states that the compliance periods provided to a company that has failed to maintain compliance with continued listing requirements are designed to allow time for a company facing temporary business issues, a temporary decrease in the value of its securities, or temporary market conditions to take action to come back into compliance.
Accordingly, the Exchange proposes to adopt Nasdaq Rules 5450(a)(3) and 5550(a)(6) to require that companies listed on the NGM (or NGS) and NCM, respectively, maintain a minimum Market Value of Listed Securities (“MVLS”)
The Exchange also proposes to add to the list of circumstances in which a request for Hearings Panel review will not stay the suspension of a company's securities from trading. Specifically, the Exchange proposes to amend Nasdaq Rule 5815(a)(1)(B) to provide that a timely request for a hearing will not stay the suspension of the securities from trading pending the issuance of a written Hearings Panel decision where the company received a Staff Delisting Determination due to a failure to comply with the MVLS Requirement.
Finally, the Exchange proposes to adopt Nasdaq Rule 5815(c)(1)(I) to provide that in the case of a company that received a Staff Delisting Determination due to a failure to comply with the MVLS Requirement, the Hearings Panel may reverse a delisting decision where the Hearings Panel determines that the Staff Delisting Determination was in error, or grant an exception for a period not to exceed 180 days from the Staff Delisting Determination for the company to demonstrate that it meets all requirements for initial listing.
After careful review, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission has consistently recognized that the development and enforcement of meaningful listing standards
The Exchange proposes to adopt Nasdaq Rules 5450(a)(3) and 5550(a)(6) to require that companies listed on the NGS, NGM, and NCM must maintain a minimum MVLS of at least $5 million. The Exchange also proposes to amend Nasdaq Rule 5810(c)(1) to provide that companies that fail to maintain a minimum MVLS of at least $5 million for 30 consecutive business days (
The Exchange states that it has observed that the challenges facing companies that fail to maintain a minimum MVLS of at least $5 million generally are not temporary and may be so severe that the company is not likely to regain and maintain compliance with continued listing requirements.
Several commenters expressed support for Nasdaq's proposal.
Several commenters stated that Nasdaq's proposal to require the companies listed on the NGS, NGM, and NCM to maintain a minimum MVLS of at least $5 million will provide protection for investors from these abuses.
Other commenters raised concerns regarding the proposed rule change.
A commenter that expressed support for the proposal, however stated that “[t]he defining characteristic of ramp-and-dump schemes is the perpetrators'
As part of the Commission's consideration of the proposed MVLS Requirement, the Commission analyzed stock price and delistings data for companies listed on Nasdaq and on NYSE American.
The results of the Commission's analysis show that the number of issuers that would have failed to comply with the MVLS Requirement, if such requirement had been in place at the time, increased sharply from 2 issuers in 2021 to 140 issuers in 2023.
In addition, the Commission analyzed the relationship of securities that crossed specific MVLS thresholds between $1 million and $50 million, for various time durations between 30 and 90 trading days, and their MVLS after 180 calendar days of first crossing a specific MVLS threshold and specific duration.
The Commission's analysis also shows that issuers that would have failed to comply with the MVLS Requirement had a high likelihood of being delisted for reasons that indicate a failure to comply with other quantitative continued listing requirements.
Finally, the Commission's analysis indicates a fundamental tradeoff inherent in selecting a threshold for delisting: a more stringent threshold (
The Exchange has identified risks pertaining to securities with an MVLS below $5 million, including a heightened susceptibility to manipulation and difficulty maintaining fair and orderly markets in these securities. The results of the Commission's analysis support approval of the Exchange's proposal to impose the MVLS Requirement. The increased number of securities with an MVLS below $5 million in recent years, along with the significant likelihood that such securities will eventually be delisted, warrants the Exchange's consideration of the continued listing of securities with a low level of market capitalization.
It is reasonable for the Exchange to determine to raise its listing standards and list only securities of a higher quality. The imprimatur of listing on a particular exchange derives from investors' expectations that the listed issuer meets certain standards set by the exchange and that a listing exchange will use its judgment regarding the level at which to set those standards.
Several commenters stated that the proposed $5 million MVLS threshold would result in the delisting of companies based on sector-specific
Commenters also took the position that the proposal would lead to delisting of some companies that may recover.
The Exchange stated that it acknowledges the position taken by several commenters that some companies with a low market capitalization may meaningfully recover and states that it modified the Initial Proposal to allow the Hearings Panel to grant an exception from the Staff Delisting Determination for a period not to exceed 180 days for a company to demonstrate compliance with initial listing requirements.
The Commission recognizes the overall conclusion of the Lewis Report that the Exchange's proposal to immediately suspend and delist securities that fail to comply with the MVLS Requirement may result in the delisting of companies that later recover and that some of those companies may otherwise have remained listed on the Exchange. Both the Commission's analysis and the Lewis Report agree that a significant number of companies that failed to comply with the MVLS Requirement did not recover. Moreover, as discussed above, the Commission's analysis shows that 65% of the issuers that failed to comply with the MVLS Requirement had a MVLS under $5 million after 180 days.
Some commenters expressed concern that factors influencing MVLS may be outside the company's control and therefore a company's MVLS is not a reliable indicator of performance.
Several commenters stated that the rigid $5 million MVLS threshold, coupled with automatic suspension after 30 consecutive business days, could increase the potential for manipulative trading and market abuse
In response, the Exchange states that market manipulation is illegal and commenters should submit any evidence of violations to the appropriate authorities for investigation and enforcement.
MVLS, as a combination of the quantity of listed securities and their market value, is a reasonable measure to be used in a quantitative listing standard to determine whether a company should continue to be listed on the Exchange.
Several commenters raised concerns about the proposal's absence of a cure or compliance period that would allow companies that fail to comply with the MVLS Requirement to regain compliance before being delisted.
However, in support of the absence of a cure period, one commenter stated that the application of the proposal only after an issuer remains below the minimum MVLS threshold for 30 consecutive business days is a “meaningful persistence requirement” and a “feature [that] helps distinguish sustained deterioration from temporary volatility.”
While the Commission acknowledges that Exchange rules provide for a cure period for failure to meet certain continuing listing standards, the Exchange has proposed to immediately suspend and delist companies whose MVLS falls below $5 million for 30 consecutive business days based on concerns that such companies may have a heightened susceptibility to manipulation.
Several commenters stated that the proposal overlaps with recently adopted rules related to continued listing and Exchange proposals designed to address the same low-valuation risk factors identified in the current proposal.
While existing Nasdaq continued listing requirements may address some similar concerns, as discussed above, the risks of heightened susceptibility to manipulative trading activity and difficulty maintaining fair and orderly markets in the securities of companies that are not able to sustain an MVLS of at least $5 million support the adoption of the proposed MVLS Requirement. The Exchange has proposed, and the Commission has approved, certain price-based continued listing requirements that reduce the period of time for a company to regain compliance based on investor protection concerns.
One commenter referenced the recently adopted Nasdaq Rule IM-5101-4 and stated that the Commission's rationale when approving the rule—that concerns about securities susceptible to manipulation would be addressed through a case-by-case process tied to trading activity—is contradictory with the “automatic MVLS trigger with no cure period and no comparable individualized assessment” of the current proposal.
Several commenters stated that the proposal would make raising capital more difficult for small companies.
One commenter stated that the proposal may incentivize smaller issuers to seek listing on less regulated venues, rely more heavily on private capital markets with reduced transparency, or delay or forgo public listing.
Several commenters discussed the negative consequences of trading in the OTC market upon immediate delisting and suspension.
Several commenters stated that the proposal's disproportionate burden on small-cap issuers, emerging growth companies, and issuers operating in developing sectors is an unnecessary burden on competition under Section 6(b)(8) of the Act.
In response, the Exchange states that the proposal balances the goals of capital formation and investor protection by setting a transparent threshold where sustained trading under that threshold results in suspension of trading and delisting of the securities.
The Commission acknowledges that there are many benefits to companies and their shareholders related to being listed on a national securities exchange, including increased access to capital formation and promotion of market efficiency. Commenters have raised concerns that delisting companies that fall below the MVLS Requirement may lead to several negative outcomes, including, but not limited to, making raising capital more difficult for small companies
Several commenters suggested alternatives to the proposal.
Other commenters suggested that the Exchange provide enhanced public disclosures once an issuer approaches the minimum $5 million MVLS threshold,
Even if commenters' suggestions could provide alternative means to address concerns that securities with low market capitalization are susceptible to manipulative trading activity and may present difficulties with the maintenance of fair and orderly markets in these securities, these suggestions are not part of Nasdaq's proposal and the Commission must approve the proposal if it finds the proposal is consistent with the Act and the rules thereunder.
The Exchange proposes to amend Nasdaq Rule 5815(a)(1)(B) to provide that a timely request for a hearing will not stay the suspension of the securities from trading pending the issuance of a written Hearings Panel decision where the company received a Staff Delisting Determination due to a failure to comply with the MVLS Requirement.
Several commenters raised concerns regarding the removal of the automatic stay of suspension pending Hearings Panel review.
In response, the Exchange states that it continues to believe that immediate suspension from trading for a company that failed to maintain the MVLS Requirement is appropriate, and references previous Commission statements in In re Tassaway.
As discussed above, a company that fails to comply with the MVLS Requirement may be likely to have an insufficient investor base, public float, and trading interest necessary to promote fair and orderly markets in their securities and relatedly may have heightened susceptibility to manipulation. It is consistent with investor protection to prohibit the securities of such companies from continuing to trade on the Exchange during a review of the delisting determination.
The proposal is also consistent with Section 6(b)(7) of the Act in that it provides a fair procedure for the prohibition or limitation by the Exchange of any person with respect to access to services offered. A listed company whose security is subject to immediate suspension and delisting under the proposal after failing to comply with the MVLS Requirement will still be able to seek review of the Staff Delisting Determination by the Hearings Panel, as discussed below.
In the Initial Proposal, the Exchange proposed to modify Nasdaq Rule 5815(c)(1)(H) to provide that, in the case of a company that failed to comply with the MVLS Requirement, the Hearings Panel would only be permitted to reverse a delisting decision based on a determination that the Staff Delisting Determination was in error.
Two commenters explicitly supported the proposed modifications to Nasdaq Rule 5815(c)(1)(H) in the Initial Proposal.
In response to these concerns, in Amendment No. 1, the Exchange modifies this aspect of the proposal to allow the Hearings Panel, when reviewing a delisting decision based on a company's failure to comply with the MVLS Requirement, to grant an exception of up to 180 days for the company to come back into compliance by satisfying the Exchange's initial listing requirements. Specifically, instead of modifying existing Nasdaq Rule 5815(c)(1)(H),
Several commenters stated that proposed Nasdaq Rule 5815(c)(1)(I) does not provide a meaningful cure period to companies that fail to comply with the MVLS Requirement.
Commenters also expressed concern with the proposed requirement that a company that has been delisted, but has been granted an exception to the delisting determination, must meet initial listing standards instead of continued listing standards.
By providing the Hearings Panel the authority to grant an exception to a delisting determination, and allowing up to 180 days for a company to come back into compliance by satisfying the Exchange's initial listing requirements, the proposal will allow the Hearings Panel to determine whether the circumstances demonstrate that it is appropriate to provide a company with an opportunity to regain compliance and continue trading on the Exchange. The requirement that a company must satisfy the Exchange's initial, generally higher, listing standards,
Further, the proposal is consistent with Section 6(b)(7) of the Act in that it provides a fair procedure for the prohibition or limitation by the Exchange of any person with respect to access to services offered. A listed company whose security is subject to immediate suspension and delisting under the proposal after failing to comply with the MVLS Requirement will still be able to seek review of the Staff Delisting Determination by the Hearings Panel. Further, while such company's security will not trade on the Exchange during the pendency of any appeal, the Hearings Panel will continue to have authority under the proposal to grant an exception for a period not to exceed 180 days from Staff Delisting Determination for the company to demonstrate that it meets all requirements for initial listing.
For these reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with the Act.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's Rules at Options 7, Section 4 (Complex Order Fees and Rebates). Specifically, the Exchange proposes to compress the tiered schedule of Priority Customer Complex rebates.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend the complex order
Currently, the Exchange offers tiered complex order rebates for Select Symbols
The above rebates are provided per contract, per leg, if the order trades with Non-Priority Customer
The Exchange also offers additional tiered rebates, in addition to the existing Priority Customer Complex Tier rebates, for Select Symbols and for Non-Select Symbols, provided the Member has also transacted an average daily volume of greater than 10,000 contracts of FLEX Orders
The additional tiered rebate, in addition to the Priority Customer Complex Tier rebates, for Select Symbols is currently as follows:
The additional tiered rebate, in addition to the Priority Customer Complex Tier rebates, for Non-Select Symbols is currently as follows:
The Exchange proposes to compress this schedule of rebates. To do so, the Exchange will slightly widen the scope of Tier 3 (by increasing the upper bound to qualify for this tier from 0.550% to 0.600%), while collapsing the remainder of Tier 4 into Tier 5. Because of the widening of the scope of Tier 3, Members who currently qualify for Tier 4 with volume in the 0.550%-0.600% range will now, instead, fall under Tier 3.
The revised schedule of tiered complex order Priority Customer rebates for Select Symbols and Non-Select Symbols will be as follows:
The additional tiered rebate, in addition to the Priority Customer Complex Tier rebates, for Select Symbols will be as follows:
The additional tiered rebate, in addition to the Priority Customer Complex Tier rebates, for Non-Select Symbols will be as follows:
The amount of the Priority Customer tiered rebate, as well as the amount of the additional tiered rebates, will continue to be the same for Tiers 1-3. Meanwhile, the amount of these rebates formerly paid to Tier 5 will now be paid to Tier 4, and so on for the remaining tiers. The Exchange believes that these changes to its Pricing Schedule will help drive additional order flow to the Exchange, which will benefit all market participants by providing them the opportunity to interact with such increased order flow.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the
Likewise, in
Further, “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution'; [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers'. . . .”
The proposed amendments to compress the schedule of Priority Customer complex rebates are reasonable. The Exchange's proposal to compress the tier schedule by slightly widening the scope of Tier 3 (by increasing the upper bound of this tier from 0.550% to 0.600%) and collapsing the remainder of Tier 4 into Tier 5 is reasonable because the existing Tier 4 provided only a limited incremental rebate over Tier 3—an increase of $0.05 per contract in Select Symbols (from $0.40 to $0.45) and $0.05 per contract in Non-Select Symbols (from $0.80 to $0.85)—that might not have provided a sufficient incentive for Members to increase their complex order volume from the Tier 3 range to the Tier 4 range. By removing this intermediate tier, the Exchange creates a larger rebate increment between the new Tier 3 and the new Tier 4—$0.09 per contract in Select Symbols (from $0.40 to $0.49) and $0.10 per contract in Non-Select Symbols (from $0.80 to $0.90)—which is nearly double the prior step and which the Exchange believes will more effectively incentivize Members to direct additional Priority Customer complex order flow to the Exchange in order to reach the new Tier 4 threshold. National securities exchanges have routinely eliminated tiers that provided insufficient marginal incentive to drive additional volume, on the basis that such tiers were not accomplishing their intended objectives. The Exchange believes that the same rationale supports the proposed compression here. The Exchange also notes that the proposed compression will not disadvantage the majority of Members currently qualifying for old Tier 4: Members whose volume falls in the 0.600%-0.750% range of old Tier 4 will now qualify for the new Tier 4 and will receive a higher base rebate ($0.49 per contract in Select Symbols and $0.90 per contract in Non-Select Symbols, compared with $0.45 and $0.85, respectively, that they currently receive). Moreover, for Members who also qualify for the additional tiered rebates by having transacted an average daily volume of greater than 10,000 contracts of FLEX Orders in a given month, the benefit is compounded: the additional FLEX rebate for the new Tier 4 will increase from $0.04 to $0.06 per contract in Select Symbols and from $0.15 to $0.20 per contract in Non-Select Symbols, resulting in a total combined rebate increase from $0.49 to $0.55 per contract in Select Symbols and from $1.00 to $1.10 per contract in Non-Select Symbols. Only Members in the narrower 0.550%-0.600% portion of old Tier 4 will instead fall under the new Tier 3, but these Members will retain a meaningful rebate at the Tier 3 level, and the heightened rebate increment to the new Tier 4 provides them a stronger incentive to increase their volume. Additionally, the Exchange has limited resources to allocate to incentive programs and must, from time to time, reallocate resources to maximize their net impact on the Exchange, market quality, and participants. The Exchange believes that concentrating its rebate resources into tiers with more meaningful incremental rebate steps—rather than maintaining a greater number of narrowly differentiated tiers—will more effectively incentivize the submission of Priority Customer complex order flow to the Exchange, which will benefit all market participants by providing them the opportunity to interact with such increased order flow. Additionally, the proposed amendments to the additional tiered rebates available to Members who have also transacted an average daily volume of greater than 10,000 contracts of FLEX Orders in a given month are reasonable because all they do is make these additional tiered rebates compatible with the new Priority Customer complex rebate tiers by collapsing the additional rebates that were formerly paid to Tier 4 into Tier 5.
The proposed compressed schedule of Priority Customer complex rebates is also equitable and not unfairly discriminatory because the Exchange will uniformly apply the revised rebates to all Priority Customers who meet the applicable tier qualifications. All Members qualifying at a given tier level will receive the same rebate, and the tier qualifications remain based on objective, transparent volume criteria. Further, paying complex order rebates solely to Priority Customers is equitable and not unfairly discriminatory because Priority Customer liquidity benefits all market participants by providing more trading opportunities, which attracts Market Makers. An increase in the activity of Market Makers—particularly in response to pricing—facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants. The additional tiered rebates available to Members who have also transacted an average daily volume of greater than 10,000 contracts of FLEX Orders in a given month will likewise continue to be uniformly applied to all Members meeting the applicable criteria and are similarly designed to incentivize order flow that benefits all market participants. Additionally, the revised schedule of Priority Customer complex rebates, combined with the additional tiered Priority Customer Complex rebates for Members who have also transacted an average daily volume of greater than 10,000 contracts of FLEX Orders in a given month, will be reasonable and not unfairly discriminatory, because it will continue to be the case that the amount of the combined rebates will either stay flat, or increase, with every single step up to a higher tier.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The proposal does not impose an undue burden on inter-market competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes its proposal remains competitive with other options markets and will offer market participants with another choice of where to transact options. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The Exchange's proposed amendments to the schedule of Priority Customer complex rebates will not impose an undue burden on intra-market competition that is not necessary or appropriate in furtherance of the purposes of the Act. The compressed schedule will be uniformly applied to all Priority Customers; all Members qualifying at a given tier level will receive the same rebate, and the tier qualifications remain based on objective, transparent volume criteria that are equally accessible to all Members. Moreover, the compressed tier structure is pro-competitive because it eliminates a narrow intermediate tier whose limited incremental rebate—only $0.05 per contract in Select Symbols and $0.05 per contract in Non-Select Symbols over Tier 3—was not providing sufficient incentive to drive additional volume, and instead concentrates rebate resources into tiers with more meaningful step-ups. This benefits all Members because the resulting sharper incentive gradient between the new Tier 3 and new Tier 4—$0.09 per contract in Select Symbols and $0.10 per contract in Non-Select Symbols—is more likely to motivate Members to increase their Priority Customer complex order flow to the Exchange, which in turn enhances liquidity to the benefit of all market participants. While Members who currently qualify for Tier 4 with volume in the 0.550%-0.600% range will now fall under Tier 3 and receive a modestly lower base rebate, this does not impose an undue burden on intra-market competition. These Members will continue to receive a meaningful rebate at the Tier 3 level, and the compressed schedule provides a heightened incentive for these Members to increase their volume to the new Tier 4 threshold, which offers a higher rebate ($0.49 per contract in Select Symbols and $0.90 per contract in Non-Select Symbols) than the former Tier 4 ($0.45 and $0.85, respectively). Additionally, the combined effect of the base rebates and the additional tiered rebates available to qualifying Members will either stay flat or increase at every successive tier, ensuring that the incentive to direct additional volume to the Exchange is preserved at every level. The Exchange also believes that the increased Priority Customer order flow that the compressed schedule is designed to attract will enhance liquidity on the Exchange to the benefit of all market participants, including Market Makers and other Non-Priority Customer participants, by providing more trading opportunities, which in turn attracts additional market participants and facilitates tighter spreads. For these reasons, the proposed amendments to the additional tiered rebates available to Members who have also transacted an average daily volume of greater than 10,000 contracts of FLEX Orders in a given month will likewise not impose an undue burden on intra-market competition. These modified additional tiered rebates are a conforming adjustment to make the FLEX-based incentive structure compatible with the compressed Priority Customer complex rebate tiers, and they will be uniformly applied to all Members meeting the applicable tier qualifications.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
Pursuant to the provisions of Section 19(b)(1) under the Act,
The text of the proposed rule change is available at the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
On September 18, 2025, the Commission approved IEX's rule change proposal to adopt rules governing the trading of options on the Exchange in a new facility called “IEX Options”;
IEX's rules specify the registration requirements that an associated person of a Member
IEX's rule change proposal to adopt rules to govern the trading of options on the Exchange in the IEX Options facility
IEX Options requires every Options Member to have at least one Options Principal who satisfies the requirements of Rules 2.160 and 18.110.
IEX understands that several new and prospective Options Members
Registered General Securities Sales Supervisors qualify as such by passing the Series 9 and 10 (referred to as “Series 9/10”) examinations. While the Series 10 examination tests general sales supervision skills, the Series 9 examination has modules specific to the supervision of options trading,
Thus, in preparation for the commencement of options trading on the Exchange,
IEX also proposes to add a new subparagraph (i) to Rule 18.110, which will set forth the description of and qualifications for the General Securities Sales Supervisor registration category. IEX proposes to add the following language in this new subparagraph, which is based on the equivalent FINRA rule
(1) A person associated with a Member may register with the Exchange as a General Securities Sales Supervisor if his or her supervisory responsibilities in the securities business of a Member are limited to the securities sales activities of the Member, including the approval of customer accounts, training of sales and sales supervisory personnel and the maintenance of records of original entry or ledger accounts of the Member required to be maintained in branch offices by Exchange Act recordkeeping rules. A person registered solely as a General Securities Sales Supervisor shall not be qualified to perform any of the following activities: (i) supervision of market making commitments; (ii) supervision of the custody of broker-dealer or customer funds or securities for purposes of Exchange Act Rule 15c3-3; or (iii) supervision of overall compliance with financial responsibility rules for broker-dealers promulgated pursuant to the provisions of the Exchange Act.
(2) Each person seeking to register as a General Securities Sales Supervisor shall, prior to or concurrent with such registration become registered as a General Securities Representative and pass the General Securities Sales Supervisor qualification examinations (“Series 9/10”).
Footnote 3 to the chart in Rule 2.160(n) appears after the words “General Securities Principal (Series 24)” in the Options Principal row of the chart. IEX proposes to move footnote 3 from its current position, so that it will now appear in the next row of the chart after the words “General Sales Securities Supervisor.” Footnote 3's description currently reads, “Please refer to Rule 18.110 for a more detailed description of the requirements for registration as an Options Principal.” IEX proposes to add “or General Securities Sales Supervisor” to the end of footnote 3's description. Thus, the chart in Rule 2.160(n) will clearly direct readers to Rule 18.110 (Requirements for Options Participation), which pursuant to this rule proposal will now contain relevant information about the registration requirements for both Options Principals and General Securities Sales Supervisors.
All Members (including all Options Members) are required by IEX to participate in continuing education programs consisting of a Regulatory Element and a Firm Element to maintain
The Exchange believes that its proposal is consistent with the requirements of Sections 6(b)
The Exchange believes the proposed rule change is consistent with the provisions of Section 6(b)(5) of the Act,
Finally, the Exchange believes the proposed changes to the Regulatory Element to make them consistent with the current Regulatory Element rules and course offerings of FINRA will help ensure that all registered persons are aware of and able to receive timely and relevant training, which will, in turn, enhance compliance and investor protection, all in furtherance of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change would have no competitive impact and therefore would not impose any burden on competition. Rather, as described in the Purpose and Statutory Basis sections, the proposed rule change is designed to harmonize its rules with registration categories and continuing education requirements of FINRA, will reduce the regulatory burden placed on market participants engaged in trading activities across different markets.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
The Commission adopted Rule 17a-11 on July 11, 1971 in response to an operational crisis in the securities industry between 1967 and 1970. The rule requires broker-dealers that are experiencing financial or operational difficulties to provide notice to the Commission, the broker-dealer's designated examining authority (“DEA”), and the Commodity Futures Trading Commission (“CFTC”) if the broker-dealer is registered with the CFTC as a futures commission merchant. Rule 17a-11 is an integral part of the Commission's financial responsibility program which enables the Commission, a broker-dealer's DEA, and the CFTC to increase surveillance of a broker-dealer experiencing difficulties and to obtain any additional information necessary to gauge the broker-dealer's financial or operational condition.
Rule 17a-11 also requires over-the-counter derivatives dealers and broker-dealers that are permitted to compute net capital pursuant to Appendix E to Exchange Act Rule 15c3-1 to notify the Commission when their tentative net capital drops below certain levels.
To ensure the provision of these types of notices to the Commission, Rule 17a-11 requires every national securities exchange or national securities association to notify the Commission when it learns that a member broker-dealer has failed to send a notice or transmit a report required under the Rule.
Compliance with the Rule is mandatory. The Commission will generally not publish or make available to any person notices or reports received pursuant to Rule 17a-11. The Commission believes that information obtained under Rule 17a-11 relates to a condition report prepared for the use of the Commission, other federal governmental authorities, and securities industry self-regulatory organizations responsible for the regulation or supervision of financial institutions.
The Commission estimates that the total hour burden under Rule 17a-11 is approximately 201 hours per year.
Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the SEC, including whether the information will have practical utility; (b) the accuracy of the SEC's estimate of the burden imposed by the proposed collection of information, including the validity of the methodology and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated, electronic collection techniques or other forms of information technology.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments on this 60-Day Collection Notice to Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg via email to
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to establish fees for its Exchange Designated Complex Instruments (“EDCI”) Feed, a filtered subset of the Exchange's existing Complex Order Book (“COB”) Data Feed containing quotes, orders, and trade information only for Exchange Designated Complex Instruments. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Commission's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to establish fees for a subset of the Exchange's existing Complex Order Book
By way of background, the Exchange currently makes available its COB Feed to TPHs and non-TPHs. The COB Feed is a real-time data feed that includes data fields
EDCIs were previously introduced in 2024 as the Exchange believed that by permitting the Exchange creation of complex strategies, including commonly traded ones, that it would allow for the consolidation of liquidity within a single complex strategy that is currently spread across multiple customer-created complex instruments expressing the same or similar exposure profiles. Since then, the Exchange has introduced new initiatives in this space in response to customer demand, including the launch of vertical spreads for Mini-S&P 500 Index Options (“XSP Vertical Spreads”). EDCIs currently include the following instruments: XSP Vertical Spreads, box spreads, box swaps and jelly rolls. As Cboe continues to innovate, this list may continue to grow and interest in market data for EDCIs specifically is also anticipated to heighten.
Currently, participants can view orders and quotes for EDCIs (including the recently launched XSP Vertical Spreads) in the COB Feed—through either the C1 Complex Multicast TOP
As part of Cboe's initiative to make EDCI data more widely available, Cboe has established a new offering that is a subset of the existing COB Feed that contains quotes, orders and/or trade information only for EDCIs (the “EDCI Feed”). The Exchange does not offer the EDCI Feed as a product for a user or distributor to directly integrate from the Exchange as a stand-alone direct exchange feed. Instead, an Uncontrolled Distributor
Currently, a Creating Distributor's downstream distributors and users that are only interested in EDCIs are still required to pay the full cost of the COB Feed.
The Exchange now proposes that downstream distributors and users shall not incur any fees for the EDCI Feed itself.
In order for a Creating Distributor to be eligible to create the EDCI Feed, the Creating Distributor must: (i) complete and receive approval of a Data Order Form and System Description with Cboe identifying the data desired and describing any system(s) or service(s) that make use of or distribute Data, (ii) conform substantially with the technical specifications stated in the Cboe Titanium U.S. Options Complex Multicast TOP Specification and Cboe Titanium U.S. Options Complex Multicast PITCH Specification as they pertain to the unique EDCID messages (the “Cboe Specifications”), and (iii) report its user counts to Cboe on an ongoing basis.
The Exchange is establishing fees for the EDCI Feed at $0 for all fee categories at this time. Setting fees at $0 initially removes financial barriers to accessing EDCI-specific market data and facilitates broader distribution of this data to market participants while the product matures and market demand develops. The Exchange notes that the fee schedule for the EDCI Feed includes structural provisions—such as the External Distributor credit and the Digital Media Enterprise license option—that are consistent with the fee structures applicable to other Cboe market data products, including the Cboe EDGX Options Exchange Fee Schedule (see EDGX Options Top). Because all fees for the EDCI Feed are currently set at $0, these provisions do not have any impact on how fees are calculated at this time; however, the Exchange has included them to establish the complete fee framework so that if the Exchange proposes adjusted fees in the future, the structure will already incorporate these standard provisions. The Exchange reserves the right to submit a subsequent filing pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(2) thereunder to adjust fees for the EDCI Feed in the future as the product matures and market demand develops.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed fees are consistent with Section 6(b)(4) because the fees for the EDCI Feed are set at $0 for all market participants. Setting fees at $0 initially removes financial barriers to accessing EDCI-specific market data, thereby promoting the equitable allocation of reasonable fees. The fee structure applies uniformly to all market participants at this time. Any such proposal will be subject to the requirements of Section 6(b)(4) at that time and will reflect the equitable allocation of reasonable fees among the various categories of persons using the Exchange's facilities, consistent with established industry practice.
The Exchange believes that the $0 fee for the EDCI Feed is reasonable and appropriate when viewed in the context of the existing fee structure for the COB Feed. As noted above, the current fees for the full COB Feed include an Internal Distribution Fee of $3,000, an External Distribution Fee of $1,500, a Professional User Fee of $25 per device or User ID, and a Non-Professional User Fee of $1.00 per month per User. The COB Feed provides a comprehensive, full-depth data set encompassing all complex instruments traded on the Exchange—including both customer-created complex orders and Exchange Designated Complex Instruments. By contrast, the EDCI Feed is a narrow, filtered subset of the COB Feed that contains data for only one category of instruments: EDCIs. The EDCI Feed does not provide any data fields, messages, or content beyond what is already contained in the COB Feed.
The Exchange believes the $0 fee is reasonable because the EDCI Feed represents a smaller scope of data than the COB Feed. The COB Feed encompasses the entirety of the Exchange's complex order book, including all customer-created complex instruments across all classes and series, whereas the EDCI Feed is limited to only those instruments that the Exchange itself has designated—currently XSP Vertical Spreads, box spreads, box swaps, and jelly rolls. Given the narrow scope of the EDCI Feed relative to the breadth of the COB Feed, a fee of $0 reflects the proportionally limited informational content of the filtered product. Moreover, setting fees at $0 is consistent with the Exchange's objective of promoting broader dissemination of EDCI-specific data to market participants—particularly retail investors—who may not have the technical capability or economic justification to subscribe to the full COB Feed solely to access EDCI data. The Exchange believes that removing financial barriers to accessing this targeted subset of data will encourage adoption, enhance transparency, and promote informed trading decisions among a broader range of market participants.
The Exchange further notes that the fee structure for the EDCI Feed includes two provisions that are consistent with the fee structures applicable to other market data products offered by Cboe's affiliated exchanges. First, each External Distributor will be eligible to receive a credit against its monthly External Distribution Fee for the EDCI Feed equal to the amount of its monthly User Fees up to a maximum of the External Distribution Fee. This provision, which is modeled on the identical credit structure in the Cboe EDGX Options Exchange Fee Schedule (see EDGX Options Top), promotes the equitable allocation of fees by ensuring that External Distributors who generate sufficient User Fee revenue are not required to bear additional distribution
The Exchange believes the proposed EDCI Feed fees promote just and equitable principles of trade and remove impediments to a free and open market by enabling broader dissemination of Exchange market data for a targeted and growing category of instruments—Exchange Designated Complex Instruments—that are of particular interest to a wide range of market participants, including retail investors. The Exchange notes that the technical and operational mechanics of the EDCI Feed further support the reasonableness of the proposed fee structure. The EDCI Feed is not a new, independently generated data product; rather, it is created entirely through a filtering process applied to an existing Exchange data feed. Specifically, a Creating Distributor that wishes to create the EDCI Feed must first receive the full COB Feed—either via the C1 Complex Multicast TOP Feed (which provides top of book orders, quotations, and executions from the C1 COB) or the C1 Complex Multicast PITCH Feed (which provides depth of book orders, quotations, and execution information). The Creating Distributor then processes the Exchange Designated Complex Instrument Definition (“EDCID”) messages contained within the COB Feed. The EDCID message, as specified in the Cboe Titanium U.S. Options Complex Multicast PITCH Specification, “represents supplemental information associated with an exchange-designated complex instrument.” By identifying and filtering for EDCID messages, the Creating Distributor isolates only those data fields that pertain to Exchange Designated Complex Instruments and provides the resultant filtered data set—the EDCI Feed—to its downstream distributors and users. Downstream distributors receiving the EDCI Feed from a Creating Distributor do not need to subscribe to or process the full COB Feed; they receive the already-filtered EDCI Feed directly from the Creating Distributor. This process does not involve the creation of any new data or the introduction of any data fields beyond those already available in the COB Feed. The Exchange does not itself transmit a separate EDCI Feed to distributors; rather, the EDCI Feed is constructed by the Creating Distributor from the existing COB Feed data stream by pulling in EDCID messages.
EDCIs were introduced by the Exchange in 2024 to consolidate liquidity in commonly traded complex strategies that had previously been fragmented across multiple customer-created instruments expressing similar exposure profiles. Since their introduction, the Exchange has expanded its EDCI offerings, including the launch of XSP Vertical Spreads—a product that has attracted interest from the retail community. The Exchange anticipates that interest in EDCI data specifically will continue to grow as it introduces additional EDCI instruments over time.
The Exchange believes the proposed EDCI Feed fees will meaningfully improve the accessibility of this data. Currently, market participants who wish to receive EDCI-specific market data must subscribe to the full COB Feed—either through the C1 Complex Multicast TOP Feed or the C1 Complex Multicast PITCH Feed—which contains a broad range of data for all complex instruments traded on Cboe. Many market participants, particularly those in the retail community, do not have a need for or the technical capability to consume a full feed covering all complex instruments. By establishing fees for the EDCI Feed at $0, the Exchange facilitates access to targeted, actionable market data for participants who may otherwise forego integration of the COB Feed entirely due to its breadth and the technical resources required to consume it. The proposed fee structure enables downstream distributors and users to receive the EDCI Feed from Creating Distributors who create the filtered feed, thereby providing broader access without requiring each distributor to process the full COB Feed.
The Exchange further notes that the EDCI Feed will enable market participants to observe the competitive pricing available in EDCI instruments, including prices that may reflect tighter spreads driven by market maker participation and implied pricing. Wider distribution of this pricing information benefits investors, including retail participants, by improving transparency and price discovery in these instruments.
The Exchange also notes that it is well established in practice that market participants are not required to consume or act upon every message in a data feed, and latency-sensitive firms routinely filter or discard meaningful portions of feed data as part of their normal operations. The proposed EDCI Feed formalizes and facilitates this concept—permitting distributors to deliver to their downstream users only the specific data those users need, rather than requiring them to take in the full COB Feed. This approach reduces barriers to entry for market participants who wish to access EDCI data and is consistent with the broader goal of promoting efficient and accessible markets.
The Exchange does not believe the proposed rule change is unfairly discriminatory. The EDCI Feed fees apply equally to all distributors and users. The EDCI Feed will be available to all distributors on an equal basis, and any Creating Distributor that subscribes to the C1 Complex Multicast TOP Feed or the C1 Complex Multicast PITCH Feed will have the ability to create and distribute the EDCI Feed to its downstream distributors and users on the same terms. Downstream distributors may receive the EDCI Feed from Creating Distributors without subscribing to the COB Feed directly. The proposed fees do not advantage any particular class of market participant over another; rather, they are designed to lower barriers to accessing EDCI market data by establishing an accessible fee structure for a targeted product created from existing Exchange feeds. The Exchange further notes that a Creating Distributor that creates the EDCI Feed from the COB Feed is required to pay the applicable COB Feed fees for the data it receives from the Exchange. Downstream distributors that receive only the EDCI Feed from a Creating Distributor, and do not themselves receive the COB Feed, are not required to pay COB Feed fees; they will be charged $0 for the EDCI Feed. This approach ensures that fees are allocated in proportion to the scope of data that a distributor receives and makes available to its downstream users, which the Exchange believes is both equitable and consistent with the requirements of Section 6(b)(4).
The Exchange further believes that limiting eligibility to create the EDCI Feed to Uncontrolled Distributors is consistent with Section 6(b)(5) of the Act and is not unfairly discriminatory. An Uncontrolled Distributor, as defined in the Exchange's Fee Schedule, is an External Distributor that does not control the entitlements of and display of information to its Users outside the Distributor's own entity. By contrast, a Controlled Distributor controls the entitlements of and display of information to its Users outside the Distributor's own entity. This distinction is meaningful because Uncontrolled Distributors are in the business of making data available to other distributors—not solely to their own internal systems or direct users. The Exchange's objective in establishing the EDCI Feed is to promote the broadest possible dissemination of EDCI-specific market data to market participants, including retail investors. Uncontrolled Distributors, by their nature, serve this objective by providing data feeds to downstream distributors who can, in turn, make the data available to a wider population of users. Controlled Distributors that do not offer data distribution to other firms do not provide the same benefit to making the data as broadly available. The distinction between Controlled and Uncontrolled Distributors for purposes of EDCI Feed eligibility reflects the functional characteristics of each category and advances the Exchange's stated objective of broadening access to EDCI data.
Additionally, the Exchange believes that Uncontrolled Distributors are best able to meet the obligations of creating the EDCI Feed—Uncontrolled Distributors are in the business of data distribution and feed creation. As noted, Creating Distributors have obligations they must meet in order to redistribute a subset of the COB Feed, of which the Exchange believes Uncontrolled Distributors are best equipped to do so. Accordingly, the Exchange does not believe that limiting eligibility to Uncontrolled Distributors constitutes unfair discrimination under Section 6(b)(5).
Lastly, the Exchange notes that its process for administering the $0 EDCI Feed is not unfairly discriminatory and is directly supported by the same self-reporting and audit framework that the Exchange applies to all of its market data products under the Cboe Global Markets North American Data Policies (the “Data Policies”). With respect to Section 6(b)(4), the Exchange's ability to verify that a Creating Distributor is in fact filtering for and distributing only EDCI data—and not the full COB Feed—ensures that the $0 fee for the EDCI Feed is applied equitably and only to those distributors that are genuinely entitled to it, thereby preserving the integrity of the equitable allocation of reasonable fees. With respect to Section 6(b)(5), the uniform application of these compliance mechanisms to Creating Distributors on equal terms ensures that no Creating Distributor receives preferential treatment or is able to circumvent the fee structure to the disadvantage of other market participants. The Exchange recognizes that the establishment of a $0 fee for the EDCI Feed creates a potential incentive for a Creating Distributor to represent that it is filtering for and distributing only EDCI data while, in fact, receiving and redistributing the full COB Feed without paying the applicable COB Feed fees. The Exchange has addressed this risk through the same combination of contractual, technical, and audit-based controls that are already in place under the Data Policies for all market data products:
First, with respect to contractual controls, a Creating Distributor seeking to create and distribute the EDCI Feed must complete a Data Order Form and System Description with Cboe (and receive Cboe approval), which requires the Creating Distributor to identify the specific data desired, describe the data access method, and provide a detailed description of any system(s) or service(s) that make use of or distribute Data internally or externally. This requirement is set forth the Cboe Global Markets North American Data Policies (the “Data Policies”) and applies to all Data Recipients, not solely those receiving the EDCI Feed. Through this process, the Exchange obtains a written representation from the Creating Distributor regarding the specific data product it intends to create and distribute—namely, the filtered EDCI Feed and not the full COB Feed.
Second, with respect to technical controls, Creating Distributors that create the EDCI Feed from the COB Feed must conform substantially with the Cboe Specifications, as determined by Cboe in its sole discretion. This conformance requirement enables the Exchange to verify that the Creating Distributor's systems are configured to filter for and output only EDCID messages—rather than the full breadth of the COB Feed—before the Creating Distributor is authorized to distribute the EDCI Feed at the $0 fee. The EDCID message type serves as a clear, technically verifiable demarcation between EDCI-specific data and the broader COB Feed data, providing the Exchange with an objective basis upon which to assess whether a Creating Distributor's filtration is consistent with its representations.
Third, with respect to ongoing reporting and monitoring, the distributor must report their user counts to Cboe, as they already do with respect to other data feeds received from Cboe.
Fourth, and most critically, the Exchange retains comprehensive audit rights under the Data Policies. Pursuant to these rights, Cboe may conduct audits of Data Recipients to verify the accuracy of reports and to ensure that the type and amount of fees calculated or stated to be payable to Cboe are complete and accurate. This audit right provide the Exchange with a direct mechanism to detect and remedy any situation in which a Creating Distributor is receiving or redistributing the full COB Feed while representing that it is distributing only the filtered EDCI Feed at the $0 fee.
The Exchange emphasizes that these controls—the Data Order Form, technical conformance review, ongoing user count reporting, and comprehensive audit rights—are not novel mechanisms created solely for the EDCI Feed. Rather, they are the identical compliance tools that the Exchange applies to all market data products distributed under the Data Agreement and Data Policies. The concept of distributor self-reporting subject to the Exchange's right to audit is the established framework through which the Exchange administers its entire market data program. Accordingly, the Exchange's process for administering the $0 EDCI Feed fees does not represent a departure from existing procedures or require any new or untested compliance mechanisms. Rather, the proposed fee structure is implemented within, and reinforced by, the same regulatory and contractual infrastructure to support the equitable allocation of fees and the prevention of unfair discrimination in the Exchange's market data program. The Exchange believes this framework is fully adequate to prevent and detect the type of conduct described above and to ensure that the $0 fee for the EDCI Feed is administered in a manner consistent with the requirements of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Rather, the Exchange believes that the proposed EDCI Feed fees will enhance competition by providing a new,
The Exchange does not believe the proposed fee change imposes any burden on intramarket competition. The EDCI Feed fees apply equally to all market participants—the fees are set at $0 across all user categories (internal distribution, external distribution, professional users, and non-professional users). Market participants are not required to obtain the proposed EDCI Feed. Current subscribers to the COB Feed may continue their use of the COB Feed as they do today; however, the EDCI Feed is only intended to be an additional alternative available to market participants. Because the fees are $0, no market participant bears any incremental cost from the establishment of this fee structure.
The proposed EDCI Feed fees will further enhance competition between exchanges as other exchanges also offer market data feeds for their own complex order books and may also develop feeds that are a subset of existing market data feeds. The proposed fees, set at $0, do not disadvantage market participants on other exchanges; rather, they promote broader access to EDCI data.
The Exchange further notes that the data contained in the EDCI Feed is not new—it is a filtered subset of information already available to all market participants through the existing COB Feed. The proposal does not introduce any new data, nor does it provide any market participant with information that is not already accessible through the Exchange's existing market data offerings. As a result, the proposal does not alter the competitive landscape among market participants with respect to access to Exchange data. To the contrary, the Exchange believes the proposed rule change will enhance competition by lowering barriers to entry for market participants—particularly those in the retail community—who wish to access EDCI market data but for whom consuming the full COB Feed is not practicable.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 13f-2 is designed to fulfill the requirements of Exchange Act Section 13(f)(2) and provide greater transparency through the publication of certain short sale related data to investors and other market participants by requiring certain Institutional Investment Managers (“Managers”) to report to the Commission, on a monthly basis on Form SHO, certain short position data and short activity data for certain equity securities. More information about the short sale activity and gross short positions of reporting Managers
Rule 13f-2 and Form SHO increase transparency regarding short position and short activity data to both market participants and regulators. Certain provisions of Rule 13f-2 and related Form SHO impose “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (“PRA”). Form SHO and the aggregated data published pursuant to Rule 13f-2 increase transparency and provide several important benefits to market participants and regulators. Such aggregated information helps inform market participants regarding the overall short sale activity by reporting Managers. The Commission's regular access to Form SHO data bolsters the Commission's oversight of short selling, as Rule 13f-2 and Form SHO improve the utility of information available to the Commission and other regulators. The short sale related information collected under Rule 13f-2 and Form SHO fill an information gap for market participants and regulators because the short position data reported pursuant to Rule 13f-2 on Form SHO supplements the short sale information that is currently publicly available from FINRA and the exchanges. The title for the information collections is “Short Position and Short Activity Reporting by Institutional Investment Managers.”
There are approximately 1,000 respondents per year that require an aggregate total of approximately 269,808 hours to comply with Rule 13f-2 and related Form SHO. Each respondent makes an estimated 12 annual responses. Each response will take an estimated 20 hours to comply and 2 hours to file. Additionally, each month, the Commission estimates an additional 22 amended responses. Thus, the total hour burden per year is approximately 269,808 hours.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number.
Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the SEC, including whether the information will have practical utility; (b) the accuracy of the SEC's estimate of the burden imposed by the proposed collection of information, including the validity of the methodology and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated, electronic collection techniques or other forms of information technology.
Please direct your written comments on this 60-Day Collection Notice to Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg via email to
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
To increase the transparency of information available to brokers, dealers, and investors with respect to the loans or borrowing of securities, Rule 10c1-a requires, among other things, covered persons to report (or to rely on a reporting agent to fulfill its reporting obligations under certain conditions) to a registered national securities association (“RNSA”) within certain time periods, specified data elements concerning covered securities loans (“Rule 10c-1a information”). Rule 10c-1a also requires an RNSA to implement rules regarding the format and manner of its collection of Rule 10c-1a information, make publicly available certain data pertaining to reported securities loans, and comply with certain data retention and availability requirements. To implement the required rules, the Financial Industry Regulatory Authority (“FINRA”), currently the only RNSA, adopted its Rule 6500 Series to require the reporting of securities loans and provide for the public dissemination of certain loan information.
Currently, the securities lending market is opaque and has data gaps that create inefficiencies. The information collections are necessary to remediate these issues by giving investors, market participants, and regulators access to the material terms of securities lending transactions.
Rule 10c-1a will provide market participants with access to pricing and other material information regarding securities lending transactions, which will supplement the publicly available information involving securities lending, close data gaps in the market, and minimize information asymmetries between market participants. The gaps in securities lending data make it difficult for borrowers and lenders to ascertain market conditions and to know whether the terms that they receive for their loans are consistent with market conditions. These gaps also impact the ability of the Commission and other regulators to oversee transactions that are vital to fair, orderly, and efficient markets.
The data collected and made available through the respondents' compliance with Rule 10c-1a will improve price discovery in the securities lending market and reduce the information asymmetry in the market. Increasing the accessibility of data could lower barriers to entry for would-be participants in the securities lending market, as well as the securities markets more broadly, because all market participants, not just counterparties to a trade or those that subscribe to certain services, will be able to view and analyze transaction that are taking place in the securities lending market. As a result, the disclosure of the specified material terms of securities lending transactions might improve the efficiency and resiliency of the securities market by reducing frictions in the coat of borrowing securities, which may also have effects on the markets for the securities themselves.
Additionally, enhancing the transparency of data on securities lending transactions will allow market participants to determine whether the terms that they receive for their loans are consistent with market conditions. Such benefits would not accrue to the securities lending market or the broader securities markets if the information collections required by Rule 10c-1a are not implemented.
In December 2025, the Commission granted a temporary exemption from compliance with Rule 10c-1a regarding the date by which covered persons must report the applicable Rule 10c-1 information, and from compliance with Rules 10c-1a(g) and (h)(3) regarding the dissemination date. While Rule 10c-1a is effective, at this present time, covered persons are not yet required by Rule 10c-1a to report Rule 10c-1a information to an RNSA until September 28, 2028. An RNSA is not required to make certain information publicly available until March 29, 2029. During the time period covered by the Commission's order, covered persons and an RNSA may incur PRA burdens, voluntarily, as part of system testing and other measures to facilitate an orderly implementation of Rule 10c-1a. As such, the estimated burdens below take account of voluntary information collections.
The information collection burdens in Rule 10c-1a are directly related to either (1) covered persons capturing Rule 10c-1a information and reporting it to an RNSA either directly or by using a reporting agent); or (2) an RNSA collecting the Rule 10c-1 information reported to it and subsequently making certain data publicly available. Given the differences in the information collections appliable to the parties, the burdens applicable to covered persons, reporting agents, and RNSAs are separated in the discussion below.
The Commission estimates that providing covered persons
The Commission estimates that the ongoing annual PRA burden will be equivalent to the ongoing burden estimated for non-providing OATs reporters in the CAT Approval Order. Thus, the Commission estimates that each providing covered person will assume 1,350 PRA burden hours per year, for a total estimated ongoing annual industry burden of 349,650 hours.
The Commission estimates that a non-providing covered person
The Commission estimates that a non-providing covered person will assume shape of the ongoing annual PRA burden that a providing covered person will assume with regard to the development and reconfiguration of current systems to capture the Rule 10c-1a information. Therefore, the Commission estimates that each non-providing person will assume an ongoing annual PRA burden of 65 hours, for a total estimated ongoing annual industry burden of 163,350 hours.
Because these agreements are estimated to be standardized across the industry, the Commission estimates that the only terms that may require negotiation are price and the format in which the information will be provided. Therefore, to account for negotiation and any administrative tasks related to processing and executing agreements, the Commission estimates that non-providing covered persons will spend 30 hours on this task, which is annualized to 10 burden hours per entity, for a total estimated initial annual industry burden of 2,420 hours.
The Commission estimates that there are 128 reporting agents. This estimate is based on the number of broker-dealers that lent securities as of December 2025 (119), as well as the number of registered clearing agencies in 2026. Three requirements of Rule 10c-1a would subject reporting agents that assume the reporting obligation on behalf of a covered person subject to Rule 10c-1a(2) to initial and ongoing annual PRA burdens: (1) the development and monitoring of systems that would facilitate the provision of information to an RSNSA; (2) the written agreements with the persons who would be providing the reporting gent information; (3) entering into an agreement with an RNSA to provide the Rule 10c-1a information. These burdens are third-party disclosure burdens.
The Commission estimates that each reporting agent would incur 3,000 hours of initial burdens to develop and reconfigure their current systems to capture the required data elements, which is annualized to 1,000 PRA burden hours per entity, for a total estimated initial annual industry burden of 128,000 hours.
As with the initial burden for this requirement, reporting agents would provide the same information to the RNSA as a non-providing covered person, so the Commission believes that the burden estimates should be consistent. Therefore, the Commission estimates that each reporting agent would incur 1,350 hours of ongoing annual burden hours on this requirement, for a total estimated ongoing annual industry burden of 172,800 hours.
The Commission estimates that the only terms that may require negotiation are price and the format of the information that will be required to be provided. However, the Commission believes that this process will be highly automated. The Commission estimates that it will take reporting agents the dame amount of time to comply with this requirement of time as a non-providing covered person. Therefore, the Commission estimates that it will take reporting agents the same amount of time to comply with this requirement of time as non-providing covered persons. Therefore, the Commission estimates that each reporting agent would spend 30 hours on this task, which is annualized to 10 hours per entity, for a total estimated initial annual industry burden of 1,280 hours.
The Commission anticipates that reporting agents that enter into written agreements with RNSAs will not incur any ongoing annual burden to comply with the requirement once the agreement is signed because there will be no need to modify the written agreement or take additional action because the information will not vary. Therefore, the Commission estimates an initial annual industry burden for this requirement of 42 hours.
The Commission anticipates that this recordkeeping requirement will be highly automated Accordingly, the Commission estimates that reporting agents will spend on hour per week on upkeep and testing of records to ensure accuracy to comply with this requirement, resulting in a total of 52 hours per year of annual burden per reporting agent, for a total estimated ongoing annual industry burden of 6,656 hours.
The Commission estimates that the average one-time initial PRA burden related to developing the infrastructure to enable non-providing covered persons and reporting agents to provide the Rule 10c-1a information, assign a unique identifier to the covered securities loans, and make the rule's specified information publicly available is 10,924, for a total initial annualized industry burden of 3,641 hours.
The Commission estimates that an RNSA will assume ongoing annual PRA burdens of 7,739.5 hours related to ensuring that the infrastructure is up-to-date and remains in compliance with the rule, for a total estimated ongoing annual industry burden of 7,739.5 hours.
The Commission estimates that an RNSA will assume an ongoing annual PRA burden of 52 hours to retain the collected information, for a total estimated ongoing annual industry burden of 52 hours.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number.
Written comments are invited on: (a) whether these proposed collections of information are necessary for the proper performance of the functions of the SEC, including whether the information will have practical utility; (b) the accuracy of the SEC's estimate of the burdens imposed by the proposed collections of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated, electronic collection techniques or other forms of information technology.
Please direct your written comments on this 60-Day Collection Notice to Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg via email to
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from section 15(a) of the Act, as well as from certain disclosure requirements in rule 20a-1 under the Act, Item 19(a)(3) of Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A under the Securities Exchange Act of 1934, and sections 6-07(2)(a), (b), and (c) of Regulation S-X (“Disclosure Requirements”).
The requested exemption would permit Applicants to enter into and materially amend subadvisory agreements with subadvisors without shareholder approval and would grant relief from the Disclosure Requirements as they relate to fees paid to the subadvisors.
ETF Opportunities Trust and Hedgeye Asset Management, LLC.
The application was filed on May 27, 2025, and amended on December 18, 2025, March 3, 2026, June 29, 2026, and July 21, 2026.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at
The Commission:
Asaf Barouk, Senior Counsel, or Matthew Cook, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' fourth amended and restated application, dated July 21, 2026, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to adopt connectivity fees for physical connectivity at the primary and disaster recovery facilities, as well as connectivity fees for logical connectivity on the Texas Stock Exchange LLC (the “Exchange” or “TXSE”). The Exchange proposes to implement the rule change upon commencement of its operations as a national securities exchange.
The text of the proposed rule change is available on the Commission's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing to establish monthly connectivity fees. In advance of the Exchange's commencement of operations as a national securities exchange, the Exchange determined it was reasonable and appropriate to charge market participants for their connectivity to the Exchange.
The Exchange proposes to offer to both Members
Monthly physical connectivity fees for Members and non-Members will be assessed in any month the Member or non-Member is credentialed and will be pro-rated for partial-month credentialing based on the number of trading days credentialed divided by the total number of trading days in such month.
The Exchange also proposes to establish fees for logical connectivity sessions. These application sessions, commonly known as ports, are utilized to perform a particular function on the Exchange, such as order entry or order cancellation, receipt of drop copies, or proprietary market data dissemination. All market participants (Members and non-Members) will be charged per session per month.
The Exchange proposes to establish a $450 a month port fee for Order Entry
Monthly logical connectivity fees for Members and non-Members will be assessed in any month the Member or non-Member is credentialed and will be pro-rated for partial-month credentialing based on the number of trading days credentialed divided by the total number of trading days in such month. The Exchange will not charge for (1) Order Entry Ports or Drop Copy Ports in the disaster recovery facility, or (2) any Test Environment
As illustrated in the following table, the Exchange has sought to make its connectivity fees consistent with those of other exchanges,
The Exchange believes that this level of diligence and transparency is called for by the requirements of Section 19(b)(1) under the Act
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6(b)
The Exchange believes that the proposed fees for connectivity services to TXSE are reasonable, equitable, not unfairly discriminatory, and otherwise consistent with the Act because, as described above, they are consistent with, and in some cases lower than, the connectivity fees charged by other exchanges,
In addition, the proposed fees will help to encourage connectivity services usage in a way that aligns with the Exchange's regulatory obligations. As a national securities exchange, the Exchange is subject to Regulation Systems Compliance and Integrity (“Reg SCI”).
In conclusion, the Exchange submits that its proposed fee structure satisfies the requirements of Sections 6(b)(4) and 6(b)(5) of the Act
Section 6(b)(8) of the Act
The Exchange does not believe that the proposed rule change to establish connectivity fees would place certain market participants at the Exchange at a relative disadvantage compared to other market participants because the proposed connectivity pricing is associated with relative usage of the Exchange by each market participant and does not impose a barrier to entry to smaller participants. The Exchange believes its proposed pricing is reasonable considering what other exchanges charge and, when coupled with the availability of third-party providers that also offer connectivity solutions, that participation on the Exchange is affordable for all market participants, including smaller trading firms. As described above, the connectivity services purchased by market participants typically increase based on their additional message traffic and the complexity of their operations. The market participants that utilize more connectivity services typically utilize the most bandwidth, and those are the participants that consume the most resources from the network. Accordingly, the proposed fees for connectivity services do not favor certain categories of market participants in a manner that would impose a burden on competition; rather, the allocation of the proposed fees for connectivity reflects the network resources consumed by the various sizes of market participants.
The Exchange does not believe the proposed connectivity fees place an undue burden on competition on other SROs that is not necessary or appropriate. In particular, the proposed fees are comparable to and in some cases lower than fees charged by other exchanges for the same or similar services.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Exchange Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend the rule change if it appears to the Commission that the action is necessary or appropriate in the public interest, for the protection of investors, or would otherwise further the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4927-DR), dated June 30, 2026.
Issued on July 20, 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.
The notice of the President's major disaster declaration for the State of Louisiana, dated June 30, 2026, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is notice of an Administrative declaration of a disaster for the commonwealth of Pennsylvania dated July 21, 2026.
Issued on July 21, 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 disaster 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 physical damage is 217176 and for economic injury is 217180.
The commonwealth which received an SBA Administrative declaration is Pennsylvania.
Pursuant to the authority granted to the United States Small Business Administration under Section 309 of the Small Business Investment Act of 1958, as amended, and 13 CFR 107.1900 of the Code of Federal Regulations to function as a small business investment company under the Small Business Investment Company license number 09/09-0472 issued to TCPC SBIC LP said license is hereby declared null and void.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Public comment period.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), DOT Order 5610.1D,
The public comment period for the Draft Tiered EA will close on August 3, 2026.
The Draft Tiered EA is available for public review at
Public comments can be submitted electronically to
The Unique ID for this document is EAXX-021-12-000-1781778641.
For more information visit:
The FAA is the lead federal agency, and the National Aeronautics and Space Administration (NASA) and the U.S. Coast Guard (USCG) are cooperating agencies due to their special expertise and/or regulatory jurisdiction. Under the Proposed Action, the FAA is evaluating SpaceX's proposal to modify its existing vehicle operator license to authorize the expenditure of the Starship vehicle in additional downrange contingency landing areas within the Pacific Ocean. Specifically, the license modification would permit contingency landings in a newly designated Northern Pacific Contingency Landing Area as well as authorize the expansion of two previously evaluated contingency landing locations: (1) Hawaii and Central Pacific Ocean Contingency Landing Area and (2) Southeast (SE) Pacific Contingency Landing Area. The Draft Tiered EA also evaluates the potential environmental impacts associated with FAA's approval of related airspace closures.
The Draft TEA has been posted, and comments will be received through the Federal E-Rulemaking Portal:
Before including your address, phone number, email address, or other personal identifying information in your comment, be advised that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask the
FAA in your comment to withhold from public review your personal identifying information, the FAA cannot guarantee that we will be able to do so. All comments received during the comment period will be given equal weight and be taken into consideration in the preparation of the Final Tiered EA.
Federal Transit Administration (FTA), Department of Transportation (DOT).
Notice of funding opportunity (NOFO).
The Federal Transit Administration (FTA) announces the opportunity to apply for $610 million in competitive grants for the Fiscal Year (FY) 2026 Grants for Buses and Bus Facilities Program and Low or No Emission Grant Program; jointly referred to as the Grants for Buses and Bus Facilities Infrastructure Programs.
Complete proposals must be submitted electronically through the
Email Kirsten Wiard-Bauer, Office of Program Management at
The full text of the Notice of Funding Opportunity (NOFO) can be found on FTA's website at
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Reopening of comment period.
The National Highway Traffic Safety Administration (NHTSA) published a document in the
The comment period for the PRA notice published on May 29, 2026 is reopened and extended to August 26, 2026.
You may submit comments identified by Docket No. NHTSA-2026-1189 through any of the following methods:
•
•
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Michael Kuppersmith, Office of the Chief Counsel, National Highway Traffic Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590; 202-360-5259,
On May 29, 2026, in accordance with the Paperwork Reduction Act of 1995 (PRA) NHTSA published a 60-day notice in the
Under the PRA (44 U.S.C. 3506(c)(2)(A)), federal agencies are required to provide a 60-day public comment period on proposed information collections prior to submitting the request to the Office of Management and Budget (OMB) for review and approval. Due to an administrative error in the May 29, 2026 notice, the deadline for submitting comments was incorrectly specified as June 29, 2026, which provided only a 30-day comment period. Reopening the comment period for an additional 30 days ensures that the public receives the full 60-day comment period required under the PRA and will provide all interested parties with adequate time to review the information collection request and submit their comments.
Comments previously submitted during the original comment period do not need to be resubmitted, as they have already been incorporated into the administrative record and will be fully considered by NHTSA.
Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is proposing a new information collection to comply with the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act or the Act) requirement for entities seeking to issue payment stablecoins in the United States. The OCC is seeking a new OMB control number for this information collection.
Comments must be received by September 25, 2026.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
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Following the close of this notice's 60-day comment period, the OCC will publish a second notice with a 30-day comment period. You may review comments and other related materials that pertain to this information collection beginning on the date of publication of the second notice for this collection by the method set forth in the next bullet.
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For assistance in navigating
Shaquita Merritt, Clearance Officer, (202) 649-5490, Chief Counsel's Office, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
Under the PRA (44 U.S.C. 3501
The proposed rule sets out the process by which entities may seek OCC approval to become a PPSI or for foreign payment stablecoin issuers to register with the OCC. The OCC is now proposing a new information collection which includes the application forms which these entities will complete and submit to the OCC.
Proposed 12 CFR 15.30(b)(1) of the proposed rule outlines the information required for approval of PPSIs. Proposed 12 CFR 15.30(c) outlines the factors against which the OCC will evaluate substantially complete applications. These are:
(1) The ability of the applicant (or in the case of an applicant that is an insured national bank, Federal savings association or insured Federal branch, the subsidiary of the applicant) based on financial condition and resources, to meet the requirements for issuing payment stablecoins under subpart B of proposed 12 CFR part 15;
(2) Whether any officer or director of the applicant has been convicted of a felony offense involving insider trading, embezzlement, cybercrime, money laundering, financing of terrorism, or financial fraud;
(3) The competence, experience, and integrity of the officers, directors, and principal shareholders of the applicant, its subsidiaries, and parent companies, including:
(i) The record of those officers, directors, and principal shareholders of compliance with laws and regulations; and
(ii) The ability of those officers, directors, and principal shareholders to fulfill any commitments or conditions imposed by the OCC in connection with the application filed under this section or any prior application; and
(4) Whether the applicant's redemption policy meets the standards under proposed 12 CFR 15.12.
The application must include an overview of the applicant, a detailed business plan, and information to assess the above factors, including proposed activities and their permissibility; reserve policy and requirements; redemption policy and requirements; risk management policy and program, and certification that any filing or supporting material submitted to the OCC contains no material misrepresentations or omissions. In addition, the application must include or the applicant must ensure each director, executive officer, and principal shareholder also submits the information prescribed in the Interagency Biographical and Financial Report, available at
Proposed 12 CFR 15.32(b)(1) of the proposed rule outlines the information required for prior approval of foreign payment stablecoin issuers. Proposed 12 CFR 15.32(c) outlines the factors against which the OCC will evaluate applications for registration. These are:
(1) The Secretary of the Treasury's determination that the foreign payment stablecoin issuer is subject to a regulatory and supervisory regime comparable to the GENIUS Act with respect to payment stablecoins under section 18 of the GENIUS Act (12 U.S.C. 5916);
(2) The financial and managerial resources of the United States operations of the foreign payment stablecoin issuer;
(3) Whether the foreign payment stablecoin issuer will provide adequate information to the OCC to determine compliance with the GENIUS Act and this part;
(4) Whether the foreign payment stablecoin issuer presents a risk to the financial stability of the United States, including risks relating to ensuring timely redemption for United States customers; and
(5) Whether the foreign payment stablecoin issuer presents illicit finance risks to the United States.
The application must include an overview of the applicant, a detailed business plan, and information to assess the above factors, including evidence that the Secretary of the Treasury has determined that the applicant is subject to regulatory supervisory regime comparable to the GENIUS Act with respect to payment stablecoins, under section 18 of the GENIUS Act (12 U.S.C. 5916), a certification that the applicant will make available to the OCC all information that the OCC deems necessary to determine and enforce compliance with the GENIUS Act, the applicant's consent to United States jurisdiction relating to enforcement of the GENIUS Act and proposed part 15, and certification that any filing or supporting material submitted to the OCC contains no material misrepresentations or omissions.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Internal Revenue Service (IRS), Treasury.
Notice of Information Collection and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the IRS is inviting comments on the information collection request outlined in this notice.
Written comments should be received on or before September 25, 2026 to be assured of consideration.
Direct all written comments and recommendations to Andrés Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email at
Requests for additional information or copies of this collection should be directed to Ronald J. Durbala, (202)-317-5746 or via email at
The IRS, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the IRS assess its impact and minimize the burden of its information collection requirements. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record and be viewable on relevant websites. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information.
Internal Revenue Service (IRS) Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel's Joint Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions to improve customer service at the Internal Revenue Service. This meeting will be held as a virtual video conference via the Microsoft Teams platform.
The meeting will be held on Wednesday, August 19, 2026, at 2:00 p.m. Eastern Time.
Fred N. Smith, Jr. by email at
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988), that an open meeting of the Taxpayer Advocacy Panel's Joint Committee will be held on Wednesday, August 19, 2026, at 2:00 p.m. Eastern Time.
The public is invited to attend the meeting virtually, or by phone, and may provide oral comments or submit written statements for consideration. Due to meeting structure and time limitations, advance registration is required to attend or make public comments during the meeting. To register and receive meeting access information, please contact Fred N. Smith, Jr. at the contact information above no later than Friday, August 14, 2026.
Meeting materials, including the agenda and any handouts, will be made available prior to the meeting at
The agenda will include a committee discussion of new and continuing issues and other activities related to the new TAP year.
Internal Revenue Service (IRS), Treasury.
Notice of information collection and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the IRS is inviting comments on the information collection request outlined in this notice.
Written comments should be received on or before September 25, 2026 to be assured of consideration.
Direct all written comments and recommendations to Andrés Garcia, Internal Revenue Service, Room 6526,
Requests for additional information or copies of this collection should be directed to Ronald J. Durbala, (202)-317-5746 or via email at
The IRS, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the IRS assess its impact and minimize the burden of its information collection requirements. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record and be viewable on relevant websites. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information.
Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Internal Revenue Service (IRS), Treasury.
Notice of information collection; request for comments.
In accordance with the Paperwork Reduction Act of 1995, the IRS is inviting comments on the information collection request outlined in this notice.
Written comments should be received on or before September 25, 2026 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
View the latest drafts of the tax forms related to the information collection listed in this notice at
The IRS, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the IRS assess the impact and minimize the burden of its information collection requirements. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record, and viewable on relevant websites. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Departmental Offices, U.S. Department of the Treasury.
Notice of Information Collection; request for comment.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before August 26, 2026 to be assured of consideration.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Copies of the submissions may be obtained from Spencer W. Clark by emailing
Departmental Offices, U.S. Department of the Treasury.
Notice of Information Collection; request for comment.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before August 26, 2026 to be assured of consideration.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Copies of the submissions may be obtained from Spencer W. Clark by emailing
July 29, 2026, 10:00 a.m. to 1:00 p.m., Eastern Time
This meeting will take place at the Hyatt Regency Milwaukee, 333 West Kilbourn Ave. Milwaukee, WI 53203. The meeting will also 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: 977 0391 4125, 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 March 26, 2026, UCR Board meeting will be reviewed. The Board will consider action to approve.
The Federal Motor Carrier Safety Administrator (FMCSA) Deputy Administrator or representative will provide a report on any relevant agency activity.
The UCR Board Chair and UCR Executive Director will present and discuss proposed contracts for renewal of the current contracts between the UCR Plan and Seikosoft (2 FTEs) and the UCR Plan and DSL Transportation Services, Inc. (2 FTEs). Both contracts involve the employment of compliance specialists. The Board may take action to approve renewal of the contracts on terms and conditions approved by the Board.
The UCR Board Chair and UCR Executive Director will present and discuss a proposed contract for renewal of the current contract between the UCR Plan and Seikosoft. The Board may take action to approve renewal of the contract on terms and conditions approved by the Board.
The UCR Governance Task Force Chair, UCR Chief Legal Officer and UCR Executive Director will present and explain to the Board proposed amendments to the UCR Agreement recommended by the Governance Task Force. The Board may take action to initiate the process to amend the UCR Agreement pursuant to the UCR Agreement Amendment Policy. If initiated, the proposed amendments will be referred to an Amendments Subcommittee established by the UCR Board.
The UCR Board Chair and UCR Executive Director will present and explain a request from CVSA for the UCR Plan Board to sponsor Enforcement Training at CVSA's upcoming Annual Conference and Exhibition. The Board may take action to allow the UCR Plan to sponsor enforcement training at CVSA's upcoming Annual Conference and Exhibition.
The UCR Audit Subcommittee Chair will present a current state Compliance Summary Report to the Board.
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 efforts for various stakeholders.
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 Executive Director will provide an update on the 2027 Registration Year fee recommendation.
The UCR Finance Subcommittee Chair and UCR Executive Director will present the 2028 UCR Plan Registration Year fee recommendation submitted to the Board by the Finance Subcommittee at its July 9, 2026, Subcommittee meeting. The Board may take action to approve a 2028 UCR Plan Registration Year fee recommendation to be forwarded to USDOT/FMCSA for its consideration.
The UCR Depository Manager will review the revenues received from the 2024, 2025 and 2026 plan year registration fees
The UCR Finance Subcommittee Chair and UCR Depository Manager will provide an update on the UCR Plan's 2025 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 on behalf of the UCR Plan.
No substantive updates from the UCR Chief of Staff beyond the Management, Depository, Operations and Communication reports provided.
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 Chief Legal Officer will also report on other legal issues 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, July 21, 2026, at:
Elizabeth Leaman, Chair, Unified Carrier Registration Plan Board of Directors, (617) 305-3783,
Nuclear Regulatory Commission.
Proposed rule and guidance; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to reduce barriers to medical use licensing. This proposed rule responds to Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission,” which requires the NRC to conduct a review and wholesale revision of its regulations. This proposed rule, if adopted, would reduce overly prescriptive regulations, increase flexibility, and modernize radiation safety practices for the medical use of byproduct material. It also would enable more efficient and predictable licensing for emerging medical technologies and reduce unnecessary burden in training and experience requirements for medical authorized users. The NRC is revising guidance for this proposed rule. This proposed rule also would incorporate minor editorial corrections.
Comments must be submitted electronically using
Submit your comments, identified by Docket ID NRC-2025-1237, at
Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are public records; they are publicly displayed exactly as received, and will not be deleted, modified, or redacted. Comments may be submitted anonymously.
Follow the search instructions on
You can read a plain language description of this proposed rule at
Irene Wu, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-1951, email:
On May 23, 2025, President Donald J. Trump signed Executive Order (E.O.) 14300, “Ordering the Reform of the Nuclear Regulatory Commission.” E.O. 14300 directs the NRC to conduct a comprehensive review and wholesale revision of its regulations and guidance documents in alignment with objectives outlined in section 2 of the E.O. This rulemaking addresses section 5 of the E.O., focusing on the regulations in title 10 of the
The major provisions of this proposed rule include the following:
1. Broadening the definition of “physician” to include foreign-trained individuals as long as they are licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice medicine.
2. Replacing the recentness in training requirement (within 7 years) with a performance-based continuing education model and removing specific work experience requirements for generator systems due to changes in industry practice.
3. Eliminating the requirement for license amendments to add authorized users for diagnostic uses, allowing licensees to approve and document these users internally due to the lower risk of these non-therapeutic uses.
4. Removing prescriptive training hours requirements for physicians who have received significant radiation safety and clinical training during the completion of a clinical radiation specialty residency, while retaining the alternative board certification and cross-qualification pathways.
5. Updating work experience categories for “oral” and “parenteral” administration of any radioactive drug requiring a written directive, allowing flexibility for future radiopharmaceuticals.
6. Moving specialty board certification approval requirements to a new section for clarity and regulatory efficiency, removing specific accrediting body references in residency training requirements, and clarifying that required work experience may be supervised by an authorized user at an NRC or Agreement State licensed medical facility.
7. Codifying provisions for emerging medical technologies (EMTs) currently licensed under subpart K of 10 CFR part 35, by establishing clear licensing pathways, training and experience requirements, and performance-based safety criteria. The EMTs include modern gamma stereotactic radiosurgery (GSR) devices, ophthalmic source/applicator devices, generators, and microsources.
8. Establishing clear requirements for rubidium-82 (Rb-82) generators, including codified definitions for breakthrough, calibration flexibility for dynamic systems, and updated licensing and training provisions to codify enforcement guidance.
9. Removing the written directive requirement for diagnostic administrations of sodium iodide I-131, aligning regulatory oversight with current clinical practice and other diagnostic administrations with comparable risk.
10. Refining written directive and medical event reporting requirements to exclude events caused by emergent patient conditions or real-time clinical decisions, while preserving reporting for events with potential safety significance, such as those involving equipment defects or unintended harm, reducing unnecessary burden and improving regulatory clarity.
11. Refining embryo/fetus dose reporting requirements to exclude cases where pregnancy could not reasonably be determined prior to administration, aligning oversight with clinical realities and reducing unnecessary reporting.
12. Expanding decay-in-storage eligibility by increasing the allowable
13. Eliminating the license amendment requirement for human subject research already approved by an Institutional Review Board (IRB) and covered under existing medical use authorizations, streamlining research initiation while maintaining safety and ethical oversight.
14. Removing duplicative and prescriptive requirements for mobile medical services, aligning them with general radiation safety regulations and providing licensees greater flexibility without compromising protection of patients, workers, or the public.
15. Extending the temporary Radiation Safety Officer (RSO) duration and refining Radiation Safety Committee (RSC) requirements to reflect current clinical practice, reduce administrative burden, and focus oversight on higher-risk therapeutic uses requiring written directives.
16. Removing outdated and redundant provisions across 10 CFR part 35, including prescriptive mobile medical survey requirements, obsolete waiver clauses, and recordkeeping requirements, to modernize the regulatory framework.
This proposed rule is considered a deregulatory action and is expected to reduce barriers to medical use licensing by enabling more efficient and predictable licensing, increasing flexibility, and easing administrative burden for the NRC, Agreement States, licensees and individuals or entities that seek medical use licenses. Over the 5-year analysis period (2027-2031), the proposed revisions are estimated to generate net savings of $39.1 million (savings minus costs), undiscounted. Using 2024 as the base year, the net present value (NPV) of these net savings is $35.6 million, discounted at 3 percent, or $31.7 million, discounted at 7 percent. The licensees, accounting for the largest share of net savings, would save about $30.5 million over 5 years, undiscounted, with an NPV of $27.8 million discounted at 3 percent, or $24.8 million discounted at 7 percent. Overall, the projected annualized cost savings would be $7.2 million discounted at 3 percent, or $6.4 million discounted at 7 percent. Although this proposed rule would reduce barriers to medical-use licensing (including new technologies) and generate net savings, some costs would still be incurred over the 5-year period, primarily due to small increases in recordkeeping requirements from the proposed new regulations for new technologies and aligning with other modalities contained in 10 CFR part 35, as well as implementation costs. The additional recordkeeping costs, which represent operational costs for licensees, are estimated at $2.4 million (undiscounted), $2.2 million (discounted at 3 percent), and $2.0 million (discounted at 7 percent) over this 5-year period. Implementation costs for both NRC and industry stakeholders are estimated at about $2.9 million (undiscounted), $2.8 million (discounted at 3 percent), and $2.7 million (discounted at 7 percent). When compared with the projected savings, the operational (expanded recordkeeping requirements) costs account for a small share, about 6 percent of the projected net savings.
For more information, please see the regulatory analysis included later in this notice.
Please refer to Docket ID NRC-2025-1237 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
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Comments must be submitted electronically using
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
On May 23, 2025, President Donald J. Trump signed Executive Order (E.O.) 14300. Section 5, “Reforming and Modernizing the NRC's Regulations,” requires the NRC to undertake a review and wholesale revision of its regulations and guidance documents as guided by the policies set forth in section 2 of the E.O. This rulemaking addresses section 5 with a focus on the regulations and guidance documents pertaining to the medical use of byproduct material.
Since 1946, physicians have used byproduct material in the diagnosis, treatment, and research of medical conditions. Over the decades, the medical use of byproduct material has evolved significantly, driven by advances in isotopes, procedural complexity, and medical technologies. Today, more than 20 million patients undergo procedures involving byproduct material each year in the United States, a number expected to grow as new medical devices and radiopharmaceuticals are developed, researched, and approved by the U.S. Food and Drug Administration (FDA).
As part of its ongoing efforts to modernize the regulatory framework in accordance with E.O. 14300, the NRC has reviewed its regulations governing the medical use of byproduct material under 10 CFR part 35. This review has led the NRC to propose changes to the training and experience requirements to ensure they are risk-informed, reduce unnecessary burden on physicians who already receive substantial radiation safety training as part of their medical education, and enhance regulatory clarity. In addition, the NRC proposes to codify certain well-established EMTs and regulatory provisions specific to the use of Rb-82 generators. The NRC uses “well-established EMTs” to refer to EMTs with extensive operating experience and widespread clinical use, for which licensing and training practices are stable and supported by NRC and Agreement State experience. In selecting EMTs for codification, the NRC prioritized those with the most extensive history and highest levels of use and with performance-based safety criteria that can be standardized in 10 CFR part 35. These updates aim to improve efficiency and predictability in licensing and oversight. The proposed changes also seek to eliminate outdated or unnecessarily burdensome requirements, allow for flexibility to facilitate licensing of innovative devices and medical uses, align regulations with current clinical practices, and improve clarity for licensees. Nothing in this proposed rule would relieve licensees from complying with applicable FDA, Federal, or State requirements or National Institutes of Health grant compliance obligations related to the use of radioactive drugs or devices. These proposed changes are detailed in Section IV, “Discussion,” of this document.
Several key topics addressed in this proposed rule benefit from additional context and relevant background information, as provided in the following sections.
The training and experience requirements in 10 CFR part 35 are designed to ensure that individuals authorized to use byproduct material in medical applications possess the necessary knowledge, skills, and competencies to ensure radiation safety. The regulations in 10 CFR part 35 include provisions related to the training and experience of physicians who use or supervise the medical use of byproduct material, known as authorized users (AUs). The AU training and experience requirements in 10 CFR part 35 have evolved over time in response to changes in medical practice, stakeholder input, and broader shifts in medical education. The current framework includes requirements for classroom and laboratory training and supervised work experience that requires a prescriptive number of hours for all AUs, regardless of whether they completed residency training in a clinical radiation specialty. This is in addition to the individual (1) being a physician licensed to prescribe drugs in the practice of medicine by their respective State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico; (2) either having obtained written attestation that they are able to independently fulfill the radiation safety-related duties as an AU for the medical uses authorized, or having received board certification from a board recognized by the NRC or an Agreement State; and (3), in some cases, having obtained device-specific training. 10 CFR part 35 also contains training and experience requirements for other individuals important to radiation safety, including authorized medical physicists (AMPs), authorized nuclear pharmacists (ANPs), and RSOs.
The NRC last made significant revisions to the training and experience requirements in 2002 and 2005. Since then, stakeholders have raised concerns about the impact of these requirements, particularly the prescriptive number of hours required for unsealed use of byproduct material for therapy contained in § 35.390, “Training for use of unsealed byproduct material for which a written directive is required.” From 2015 to 2016, both the NRC staff and the Advisory Committee on the Medical Uses of Isotopes (ACMUI) independently reviewed the training and experience requirements for medical uses authorized under § 35.300, “Use of unsealed byproduct material for which a written directive is required.” In its March 2016 report, the ACMUI concluded that no changes to the 700-hour requirement were warranted at that time as they found no evidence that the requirement adversely affected patient access. However, the ACMUI recommended forming a subcommittee to periodically review the training and experience requirements and make recommendations as needed.
In 2016, the ACMUI established a subcommittee to review the training and experience requirements across all modalities regulated under 10 CFR part
The subcommittee's draft interim report, discussed in a public meeting on March 1, 2018, expressed concern about the declining number of nuclear medicine physicians and the potential long-term implications for patient access. While the subcommittee acknowledged the difficulty in quantifying the impact of this trend, it noted the absence of data suggesting a surplus of AUs and emphasized the need to consider future workforce needs.
In response to these ongoing concerns, the Commission issued Staff Requirements Memorandum (SRM)-M170817 on August 17, 2017, directing the NRC staff to evaluate whether tailored training and experience requirements should be established for different categories of radiopharmaceuticals, how those categories should be defined (
Following further engagement with stakeholders, including the ACMUI and Agreement States, the NRC staff submitted SECY-20-0005, “Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR part 35),” to the Commission on January 13, 2020. On January 27, 2022, the Commission issued SRM-SECY-20-0005, maintaining the existing training and experience requirements and directing staff to continue to obtain stakeholder input on training and experience requirements for EMTs as part of the broader rulemaking effort to update 10 CFR part 35.
At the time E.O. 14300 was issued on May 23, 2025, the NRC staff was actively evaluating training and experience requirements for Rb-82 generators and EMTs. The E.O. directed the NRC to undertake a comprehensive review and modernization of its regulations, including those governing the medical use of byproduct material. The proposed changes to training and experience in this rulemaking are in response to the E.O. and build upon the historical evolution of the training and experience requirements and the extensive body of stakeholder feedback and Commission direction developed over the past two decades.
Specifically, this proposed rulemaking removes prescriptive hours for physicians who have received significant radiation safety and clinical training over years of a clinical radiation specialty residency. In addition, it proposes to remove the requirement for diagnostic AUs to be listed on a license and removes outdated training topics and requirements associated with arbitrary dates of when physicians last received training, allowing licensees to focus training and experience on topics more relevant to clinical practice. Finally, the NRC proposes changes to the training and experience requirements' organization for all authorized individuals (
In 2002, the NRC added subpart K, “Other Medical Uses of Byproduct Material or Radiation from Byproduct Material,” (§ 35.1000) to 10 CFR part 35 to provide a flexible regulatory framework for licensing new or existing EMTs that do not fit within the existing subparts of 10 CFR part 35. The regulations in § 35.1000 define the process to obtain a license or license amendment for EMTs. EMTs often require unique provisions for training and experience, facility and equipment specifications, or other safety-related considerations that are not addressed in the existing 10 CFR part 35 subparts (subparts D through H). As a result, the NRC and Agreement States evaluate each EMT on a case-by-case basis to determine the specific risks associated with the EMT and any additional regulatory requirements needed for its medical use and may develop model- and vendor-specific licensing guidance to support consistent and safe licensing and use.
Licensing guidance for EMTs is developed with input from the ACMUI, vendors, and regulatory staff, and includes general licensing considerations, radiation safety protocols, and training and experience expectations for individuals authorized to use the technology. While not binding, licensing guidance for EMTs provides applicants with an acceptable means to satisfy the requirements for a license for the EMT. Applicants who commit to following the EMT licensing guidance may have those commitments incorporated as license conditions. Alternatively, applicants may propose other sets of regulations and specific conditions to use the EMT that become binding through license conditions in accordance with § 35.1000.
Since 2002, the NRC and Agreement States have licensed at least 18 EMTs under subpart K, including microspheres, GSR units, photon-emitting teletherapy systems, radiopharmaceutical generator systems, and ophthalmic applicator sources and devices. While subpart K offers a quick path for licensing EMTs with unique radiation safety needs as they are being introduced, continued licensing of well-established EMTs under subpart K offers limited regulatory benefit and can lead to inconsistencies and lack of clarity, as subpart K relies on guidance and the incorporation of license conditions rather than codified rules. This approach also places a resource burden on regulators due to frequent updates of EMT-specific guidance.
On June 27, 2023, the NRC published an associated regulatory basis document, “Rubidium-82 Generators, Emerging Technologies, and Other Medical Use of Byproduct Material Regulatory Basis Document,” for public comment. The majority of the comments were in favor of incorporating well-established EMTs into the main body of 10 CFR part 35. However, to meet the timeline established in E.O. 14300 for publishing this proposed rule, the scope of EMTs addressed in this proposal has been narrowed to focus on some well-established technologies with the most extensive history and highest levels of use, such as modern GSR devices, ophthalmic source/applicator devices, generators, and microsources. Uses and EMTs not included in this rulemaking include intravascular brachytherapy systems, liquid and diffusing brachytherapy sources and devices, and radioactive seed localization. While these technologies currently remain licensed under § 35.1000, and they may be incorporated into the main body of 10 CFR part 35 in a future rulemaking depending on NRC and industry need and available resources.
Rb-82 generators produce Rb-82 chloride, a positron-emitting radiopharmaceutical used for cardiac imaging. These generators differ from other generators licensed under § 35.200, “Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required,” due to the short 75
A written directive is the AU's written order for administration of byproduct material or radiation from byproduct material to a specific patient or human research subject. Section 35.40, “Written directives,” establishes requirements for which medical uses of byproduct material require written directives. Under the current regulations, a written directive is required for diagnostic administrations of sodium iodide I-131 in quantities greater than 1.11 megabecquerels (30 microcuries), even when the administration is solely for diagnostic purposes. This is the only diagnostic use that currently requires a written directive; all other uses requiring a written directive are therapeutic in nature and are subject to more stringent requirements commensurate with their higher risk. Because diagnostic sodium iodide I-131 currently requires a written directive, it is licensed under subpart E of 10 CFR part 35, which otherwise applies exclusively to therapeutic uses. In contrast, all other diagnostic uses of unsealed byproduct material are regulated under subpart D of 10 CFR part 35, which does not require a written directive and reflects the lower risk associated with diagnostic procedures.
The requirement for a written directive for diagnostic sodium iodide I-131 was established by rule on April 24, 2002. At that time, the radiation safety considerations associated with the diagnostic use of millicurie quantities of sodium iodide I-131 were considered to be more similar to therapeutic uses than to other diagnostic procedures, such as those involving technetium-99m (Tc-99m). However, the practice of nuclear medicine has evolved significantly since 2002. On October 1, 2007, the NRC published a final rule to amend 10 CFR part 35 to implement provisions of the Energy Policy Act of 2005 requiring the NRC to license medical use of accelerator-produced radioactive material, including positron emission tomography (PET) (72 FR 55864). This introduced diagnostic procedures involving higher radiation exposure risk and more complex safety considerations. As a result, the relative risk profile of diagnostic sodium iodide I-131 use has shifted.
Today, diagnostic sodium iodide I-131 is typically administered in unit dosages, often in capsule form, rather than as liquid preparations compounded onsite. This change has reduced the radiation safety risks associated with handling and administering radioactive material. Additionally, the training and expertise of diagnostic nuclear medicine staff have increased in parallel with the broader use of PET and other advanced imaging modalities. These developments have brought radiation safety considerations for diagnostic sodium iodide I-131 in line with those of other diagnostic procedures regulated under subpart D of 10 CFR part 35. There are also now over 50 years of operating experience using diagnostic dosages of sodium iodide I-131, contributing to a better understanding of diagnostic sodium iodide I-131 and safety considerations surrounding its use. For the foregoing reasons, this proposed rule would remove the requirement that diagnostic sodium iodide I-131 administrations need a written directive, moving its authorization from subpart E to subpart D of 10 CFR part 35.
Sections 35.3045, “Report and notification of a medical event,” and 35.3047, “Report and notification of a dose to an embryo/fetus or a nursing child,” establish the criteria for reporting medical events and dose to embryo/fetus from the administration of byproduct material or radiation from byproduct material. These events represent unintended deviations from the AU's planned administration of radioactive materials that may result in doses exceeding specified thresholds. Medical event reporting is consistent with item number 3 in the NRC's risk-informed, performance-based Medical Use Policy Statement, which states the NRC will, when justified by the risk to patients, regulate the radiation safety of patients primarily to assure the use of radionuclides is in accordance with the physician's directions. These reports enable the NRC to investigate safety concerns, ensure corrective actions are taken at a licensee level, and take action such as providing communication to the industry or working with the manufacturer and the FDA to prevent recurrence at the national level.
The NRC first required reporting of medical use errors, then termed “misadministrations,” in 1980. In 2002, the NRC comprehensively revised 10 CFR part 35, renaming “misadministrations” as “medical events” and refining the reporting criteria to focus on outcomes with potential radiation safety significance. The revised rule introduced a dose-based threshold to exclude events associated with most diagnostic procedures from reporting, recognizing their low risk. Despite these improvements, stakeholders have raised concerns that the current criteria may still result in the reporting of events that do not reflect licensee error, such as those caused by emergent patient conditions (
On April 24, 2002, § 35.92, “Decay-in-storage,” was revised to allow medical licensees to dispose of short-lived radioactive waste “without regard to its radioactivity” once they can confirm the waste has become indistinguishable from background. This provides medical licensees with a practical and cost-
This discussion section has been divided into multiple sections (Training and Experience, Emerging Medical Technologies, Rubidium-82 Generators, and Other Topics) and subsections to better present information on the major topics impacted by this proposed rule. Each section will discuss what action the NRC is proposing, why the action is being proposed, and who the action affects and how.
The NRC prepared an unofficial redline strikeout version of the proposed changes to regulatory text that is intended to help the reader identify the changes. The NRC is providing the unofficial redline as a reader tool only. Comments on the rule text should be made in this proposed rule.
The current definition of physician in § 35.2, “Definitions,” means a medical doctor (MD) or doctor of osteopathy (DO) licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine. The NRC is proposing to change this definition to remove the specific requirement for the individual to be an MD or DO. This change is intended to expand eligibility for foreign-trained physicians whose primary medical qualifications may not be titled MD or DO, but who are fully licensed to practice medicine in the United States, to become AUs. AUs must still meet the training and experience requirements in the applicable subparts of 10 CFR part 35.
In addition, the NRC is proposing to remove from regulations the listing of specific accrediting bodies for residency programs under the training and experience requirements for AU physicians in §§ 35.190. 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, and 35.690. Over time, both residency programs and their accrediting bodies have evolved to incorporate NRC requirements into their curricula. As a result, the NRC no longer finds it necessary to specify accrediting bodies in the regulations. Under this proposed rule, the residency programs would be required to include the proposed classroom and work experience topics to ensure that physicians receive training as part of a structured educational program. This approach allows for greater flexibility by permitting any accredited program, regardless of the accrediting body, to qualify, provided it includes the specified training topics.
The NRC is proposing to revise its regulations to recognize the structured and comprehensive nature of accredited residency programs in certain medical specialties that inherently include radiation safety training and experience as part of the clinical specialty. Specifically, the NRC proposes to remove the prescriptive requirements in §§ 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, and 35.690 for specific numbers of classroom, laboratory, and work experience hours for physicians who have completed residency training in specialties where radiation safety and the clinical use of byproduct material are inherently integrated into the curriculum. This proposed change acknowledges that the depth and scope of training provided in these accredited residency programs are tailored to the clinical application of byproduct materials. The NRC believes that successful completion of such a residency program along with written attestation from a preceptor or residency program director, provides sufficient assurance of an individual's competency to serve as an AU, without the need for fixed hour requirements.
To implement this change, the NRC is proposing to add a residency-based training and work experience pathway for the medical use of unsealed byproduct material in §§ 35.190, 35.290, 35.390, 35.392, 35.394, and 35.396. This new pathway would apply to §§ 35.190 (Training for uptake, dilution, and excretion studies), 35.290 (Training for imaging and localization studies), 35.390, and 35.396 (Training for the parenteral administration of unsealed byproduct material requiring a written directive), where current regulations do not explicitly reference residency training. For §§ 35.490 (Training for use of manual brachytherapy sources) and 35.690 (Training for use of remote afterloader units, teletherapy units, and GSR units), no new pathway would be created as the regulations already require completion of a residency. For all applicable sections, the NRC would remove the prescriptive hour requirements for classroom, laboratory, and work experience for individuals who have completed an accredited residency in specified specialties. This change would not amend the topics that must be covered for classroom and laboratory training and work experience that must be completed in a structured educational program. The topics listed in the regulations are essential to ensuring radiation safety. Individuals completing a residency-based pathway would still need to receive training and experience in all required topic areas during their residency. The written attestation from a preceptor or residency program director should confirm that the individual has completed the required training and experience as required and is able to independently fulfill the radiation safety-related duties as an AU for the medical use the individual is requesting.
The NRC would retain the NRC-approved specialty board pathway and alternate pathway with specified hours for individuals who have not completed residency training in specialties identified in regulations. Finally, the proposed regulations would retain the equivalent qualification pathways where an AU who is qualified for § 35.290 also is qualified for § 35.190, an AU who is qualified for § 35.390 also is qualified for §§ 35.290 and 35.190, and an AU who is qualified for 35.490 also is qualified for § 35.491, “Training for ophthalmic use of strontium-90.”
Currently, §§ 35.300, 35.392, 35.394, 35.396, and 35.491 require physicians to complete a prescribed number of cases to qualify as an AU. This fixed case requirement does not allow flexibility for physicians who can complete the required work experience and demonstrate the knowledge and competency in radiation safety-related duties through other means than a prescriptive number of cases for the medical use for which they are requesting AU status.
This proposed rule would replace the specified number of cases to qualify as an AU in the NRC's regulations with a requirement that the physician receive sufficient experience in casework during either their residency or the
In addition, §§ 35.300, 35.392, 35.394, and 35.396 currently state that the physician must have experience in administering dosages of radioactive drugs in their respective categories. However, the physical act of administering dosages of radioactive drugs is a practice of medicine and is not always performed by the physician seeking AU status. The purpose of training and experience for AUs is to ensure radiation safety rather than medical competency; this proposed rule revises this requirement to focus on preparing written directives and observing or performing the administration of dosages. While the AUs do not need to physically perform the administration, they must participate in the entire process, gaining experience in all required topics, to ensure they can independently perform all radiation safety-related duties for the medical use for which they are requesting AU status.
In addition, currently, § 35.59, “Recentness of training,” requires individuals to demonstrate related continuing education and experience if their required training and experience was obtained more than 7 years prior to the date of application. However, as the medical use of byproduct material continues to evolve at a quick pace, particularly with the expansion of radiopharmaceutical therapies, experience gained even a few years ago does not ensure that authorized individuals, such as AUs, possess current training or experience in the specific uses for which they are applying. In many cases, the uses for which individuals were originally trained differ significantly from current or emerging practices.
Inadequate training of staff, including AUs, before treating the first patient has been identified as a root cause of a significant number of events, including those described in NRC Information Notice 2024-04, “Recent Medical Events involving Administration of Therapeutic Radiopharmaceuticals.” Similarly, as documented in Information Notice 2019-07, “Methods to Prevent Medical Events,” NRC staff determined that several additional medical events were linked to insufficient training following the introduction of new equipment or software. The ACMUI has also concluded that many medical events involve users who perform treatments infrequently and recommended refresher training for AUs. These findings underscore the need for a performance-based continuing education requirement to ensure that authorized individuals maintain current knowledge and skills as practices and technologies evolve, particularly as the NRC proposes to remove the outdated recentness requirement in § 35.59.
The ACMUI and other stakeholders have recommended that licensees receive additional application-specific training for existing and future EMTs. This includes the potential for future radiopharmaceutical therapies to be licensed under 10 CFR part 35, subpart H. Stakeholders also have expressed concern that the current § 35.59 lacks clarity regarding what constitutes acceptable training and experience to meet the recentness requirement. This has led to uncertainty about what documentation should be submitted with license applications. To address these concerns, the NRC this proposed rule would revise § 35.59 to remove the prescriptive requirement to demonstrate recent training and experience at the time of application and would introduce a performance-based continuing education requirement. This would ensure authorized individuals maintain the necessary education and experience to support radiation safety and regulatory compliance for the uses they are authorized.
Recognizing the differing risk profiles between diagnostic and therapeutic uses, the NRC is proposing a change that would require AUs for diagnostic uses to maintain education or experience in the type of use. For uses requiring a written directive, AUs must maintain education and experience in the specific source, microsource, device, or radioactive drug. This proposed rule also would require instruction on changes to applicable regulations, license conditions, and the licensee's written radiation protection and written directive procedures. This is particularly important because AUs are responsible for supervising others under § 35.27, “Supervision,” and ensuring safe use of byproduct material. As part of this performance-based approach, licensees would no longer be required to submit documentation of recent training and experience with a license application. Instead, a new recordkeeping requirement would be added in a new section, § 35.2059, “Records of continuing education and training,” to ensure that licensees maintain appropriate documentation of continuing education and experience.
The NRC also is proposing to remove the specific work experience requirement for eluting generator systems, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs. Changes in industry practice have resulted in a limited number of generators in use at medical facilities, creating challenges for AU trainees to meet this portion of the experience requirement. The NRC believes that the classroom portion of the requirements for the chemistry of byproduct material could adequately cover the topics previously addressed through hands-on experience. This change would provide the necessary radiation safety information as an alternative to direct work experience.
The NRC is proposing to amend its regulations to eliminate the requirement for licensees to submit a license amendment before allowing an individual to serve as an AU for medical uses authorized under § 35.100, “Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required,” or § 35.200, “Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.” Under this proposed rule, licensees would be permitted to approve individuals as AUs for these non-therapeutic uses of unsealed byproduct material without prior NRC review and approval, provided the individual meets the applicable training and experience requirements specified in subpart D. Licensees would be required to maintain documentation of their internal review and approval process, including verification that the individual satisfies the relevant training and experience criteria. This documentation would be subject to NRC inspection.
This proposed change reflects the NRC's risk-informed, performance-based regulatory approach and acknowledges that the medical uses authorized under §§ 35.100 and 35.200, such as diagnostic imaging and localization studies, do not require a written directive and are considered lower-risk activities. By removing the license amendment
The NRC is proposing to amend §§ 35.390(b)(1)(ii)(G) and 35.14(a) to remove the prescriptive requirement that individuals seeking AU status must have experience with both low-dose (less than or equal to 1.22 gigabecquerels or 33 millicuries) and high-dose (greater than 1.22 gigabecquerels or 33 millicuries) oral administrations of sodium iodide I-131. Under the current regulation, applicants must document a minimum of three cases in each of these two categories. This rigid structure may not reflect the evolving landscape of radiopharmaceuticals. The proposed change would consolidate these two categories into a single, broader category: oral administration of any radioactive drug for which a written directive is required. This proposed revision eliminates the specific dose-based thresholds for sodium iodide I-131 and instead focuses on the route of administration and the requirement for a written directive. This approach is more risk-informed and performance-based. This proposed change preserves the integrity of the training and experience requirements while allowing for greater flexibility in how those requirements are met. It also would ensure that the regulation remains adaptable to future developments in radiopharmaceuticals that may be administered orally and require a written directive. This proposed amendment would only apply to the categories in § 35.390 for physicians seeking full authorization and does not remove or change the existing work experience requirements for those who desire the limited scope pathway provided in §§ 35.392, “Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries),” and 35.394, “Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).” These limited pathways would remain available for physicians who seek authorization for these specific uses without completing the training and experience requirements for all therapeutic uses of unsealed byproduct material authorized under § 35.390.
The NRC also is proposing to remove unnecessary limitations in the current § 35.390(b)(1)(ii)(G)(
Under the current regulations, § 35.50(c)(3) allows physicians to be simultaneously approved as both the RSO and AU on a new medical use license or permit, provided they also meet the requirements of § 35.50(d). The NRC is proposing to amend this regulation to allow individuals to seek this pathway on an existing license or permit. There is no safety basis for limiting this pathway solely to new licenses or permits, and this change would provide greater flexibility for an AU to become an RSO on a license at any time without compromising safety.
To improve clarity, the NRC is proposing to restructure the training and experience requirements in 10 CFR part 35 by consolidating the specialty board certification approval process into a new section, § 35.58, “Specialty board certification approval.” Currently, the specialty board certification requirements for AUs, RSOs, AMPs, and ANPs are embedded within multiple subparts throughout 10 CFR part 35. When a licensee is reviewing the requirements needed to complete a licensing application for approval as an AU, the requirements of a specialty board certification process is not needed to support the application. Therefore, the NRC is proposing a separation to clarify the training and experience requirements for AUs and to simplify the approval process for specialty boards.
The proposed amendment moves the specialty board approval process from §§ 35.50(a), 35.51(a), 35.55(a), 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a) to proposed new § 35.58.
In addition, this proposed rule would clarify that work experience required under each subpart may be obtained under the supervision of an AU at a medical facility authorized to use byproduct materials under that subpart. Under the proposed change, licensees would not be required to verify the training and experience of supervising individuals, as they are already authorized to use the material. This regulatory change would clarify who can supervise required work experience.
The NRC is proposing amendments to 10 CFR part 35 to modernize and expand the regulatory framework for medical use generators. Currently, § 35.204, “Permissible molybdenum-99, strontium-82, and strontium-85 concentrations,” provides specific concentration limits for parent radionuclides for molybdenum-99 (Mo-99)/Tc-99m and Rb-82 generators to limit such exposure, but provides no such limit for Germanium-68/Gallium-68 (Ge-68/Ga-68) generators or flexibility for other new or emerging generators. In addition, generator regulations are contained within subpart D, which are limited to diagnostic uses. As a result of this narrow regulatory framework, generator systems such as the Ge-68/Ga-68 generators have been regulated under § 35.1000. Additionally, the current regulatory requirements for breakthrough testing and effluent limits are prescriptive and located within the diagnostic subpart, which would not be appropriate for future therapeutic applications. As generator technologies become more common and new therapeutic generators are developed, reliance on § 35.1000 would create unnecessary delays in licensing and implementation because each new generator type would need to undergo case-by-case review and approval under
To address these issues, the NRC is proposing to revise and expand the regulatory provisions applicable to medical use generators to accommodate both diagnostic and therapeutic applications and to reduce reliance on § 35.1000 for licensing new generator systems. Specifically, the NRC is proposing to—
a. Revise § 35.2 to add a definition for “breakthrough” to reflect current industry practices and terminology.
b. Move generator breakthrough testing requirements contained in §§ 35.204 and 35.2204, “Records of molybdenum-99, strontium-82, and strontium-85 concentrations,” to new sections §§ 35.93, “Permissible concentrations for generator-produced radionuclides,” and 35.2093, “Records of generator breakthrough testing,” respectively. The proposed new § 35.93 would be located in subpart C (General Technical Requirements) as opposed to subpart D (Unsealed Byproduct Material—Written Directive Not Required) where the current generator breakthrough testing requirements in § 35.204 are contained. This move would support the anticipated licensing of therapeutic generators, which may not fall under the current scope of subpart D. In addition, the proposed § 35.93 would remove prescriptive requirements limited to specific generators and replace them with a more flexible approach that allows licensees to develop and implement written procedures to define acceptable breakthrough limits and testing frequencies that are consistent with generator labeling as set forth in its FDA product approval or nationally recognized standards. To ensure safety and regulatory alignment, the proposed changes would require that the limits and testing frequency be consistent with generator labeling as set forth in its FDA product approval or nationally recognized standards, such as those published by the United States Pharmacopeia (USP). These proposed changes align with the current recommendations outlined in the § 35.1000 licensing guidance for the Ge-68/Ga-68 generators and would ensure that breakthrough testing practices remain current with evolving safety and performance standards and allow flexibility for emerging generators. These proposed changes also would allow licensing of emerging generators without further rulemaking or a separate case-by-case licensing evaluation and guidance development under § 35.1000.
c. Include a requirement in § 35.93(a)(2) that licensees must ensure individuals using generator systems have received operational and safety training specific to the generator model. This codifies expectations that were previously addressed only in guidance (
d. Similar to § 35.204, the proposed § 35.93(a)(3) would prohibit the administration of generator eluate to patients or human research subjects if breakthrough measurements exceed the licensee's established limits. Section 35.93(c) would retain the requirement to report any such exceedance at the time of generator elution, but reference new proposed § 35.3093, “Report and notification for an eluate exceeding breakthrough limits,” instead of § 35.3204, “Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.” Section 35.93(d) would require licensees to retain records of each breakthrough test in accordance with § 35.2093, replacing the previous reference to § 35.2204.
e. Confirming changes would be made to information collections contained in § 35.8, “Information collection requirements: OMB approval,” and recordkeeping requirements would be moved from § 35.2204 to § 35.2093.
These proposed changes are intended to remove the need for licensing emerging generators under § 35.1000 in order to increase licensing efficiency, eliminate unnecessary prescriptiveness, align regulatory requirements with current standards, and ensure that the NRC's regulations remain adaptable to future innovations. By relocating generator requirements out of the diagnostic subpart and into a more general framework, the NRC aims to facilitate broader adoption of generator-based technologies commensurate with the NRC's role in maintaining appropriate oversight and safety assurance.
The NRC is proposing to amend subpart F to replace references to “strontium-90 sources” with “beta-emitting sources,” to reflect the broader range of beta-emitting isotopes that may be used in superficial ophthalmic treatments and remove the outdated assumption that only strontium-90 (Sr-90) is applicable. The proposed revised language would ensure that the regulation remains relevant as new technologies and isotopes are introduced into clinical use, reducing reliance on § 35.1000 licensing, such as what is currently done for the NeoVista Inc's Epi-Rad90 Sr-90 Ophthalmic System and Liberty Vision (LV) Yttrium-90 (Y-90) Disc and iWand®, by allowing these technologies to be licensed under subpart F instead. While § 35.400, “Use of sources for manual brachytherapy,” allows AUs who meet training and experience requirements under § 35.490 to currently use beta-emitting sources for superficial ophthalmic procedures, these proposed amendments would reduce training and experience criteria contained in § 35.491 for superficial ophthalmic procedures for all beta-emitting sources. These amendments aim to modernize regulatory language, support innovation in treatment methods, and align with the NRC's risk-informed, performance-based regulatory framework.
Specifically, the NRC is proposing to amend § 35.491 to modernize and clarify the training and experience requirements for physicians authorized for superficial beta emitter ophthalmic treatments, currently licensed under § 35.1000, and any new innovative superficial ophthalmic treatments. The section title would be amended to read, “Training for superficial ophthalmic use of beta-emitting sources,” and
As the proposed amendment would allow use of a broader range of isotopes instead of just one, the NRC is proposing to introduce device-specific training for the applicable AUs authorized via §§ 35.490 and 35.491. The applicable AUs would be able to satisfy this training either through a vendor-provided program for new users or through supervised instruction by an AU or AMP authorized to use the same device. This aligns with the current recommendations outlined in the § 35.1000 licensing guidance for Liberty Vision, ensuring that AUs are not only trained in radiation safety and clinical application but also are proficient in the specific operational and safety features of the device they will use.
In addition, confirming changes would be made to expand § 35.433, “Strontium-90 sources for ophthalmic treatments,” to allow for any beta-emitting source, not just Sr-90, to be used for ophthalmic treatments. This proposed rule also would make conforming changes to the recordkeeping requirement in § 35.2433, “Records of decay of strontium-90 sources for ophthalmic treatments,” to reflect the broader terminology, requiring licensees to retain records of the activity of each beta-emitting source. This proposed change does not alter the intent or scope of the recordkeeping requirement but instead updates the terminology to reflect current and future clinical practices.
Subpart H of 10 CFR part 35 establishes requirements for the use of sealed sources in photon-emitting remote afterloader units, teletherapy units, and GSR units. These requirements were originally developed based on the operational characteristics of the devices available at the time. For example, regulations for GSR units were developed in 2002 and calibration and spot check regulations contained in §§ 35.635, “Full calibration measurements on gamma stereotactic radiosurgery units,” and 35.645, “Periodic spot-checks for gamma stereotactic radiosurgery units,” were based on the NRC's review of units and clinical practice used in 1995. In 1995, the units used stationary sources, helmet collimators that needed to be changed manually, trunnions, and head frames drilled into the skull. However, the evolution of medical technology has introduced new units with design and engineering elements that make their operation significantly different than these previous units, resulting in their inability to be licensed under 10 CFR part 35 subpart H. As a result, modern GSR units are currently licensed under § 35.1000.
To support licensing these units under § 35.1000, the NRC developed several licensing guidance documents, including for Akesis Galaxy Rti, Leksell Gamma Knife® Perfexion
To reduce unnecessary regulatory burdens that may hinder innovation, the NRC is proposing to amend:
a. Section 35.2 to include a definition for “gamma stereotactic radiosurgery” and revise the existing definition of “teletherapy.” These changes are part of a broader initiative to modernize and clarify terminology used in 10 CFR part 35, improve consistency in regulatory language, and better reflect current clinical practices and medical community standards;
b. Section 35.610(a)(1) to allow flexibility in securing either the console or its keys, rather than requiring both, while still maintaining the requirement to secure the unit and treatment room when not in use; and
c. Sections 35.615(a) and (b) to remove the prescriptive requirement for a physical door to control access, while preserving the requirement that access to each treatment room entrance must be controlled using an electronic interlock.
These proposed changes preserve the core safety principles of the current regulations while allowing for alternative, modern mechanisms to ensure therapeutic units remain secure and controlled.
As GSR technology advances, the differences between units impacting radiation safety are increasing. With the proposal to allow more unit types to be licensed under subpart H, it is essential that AUs, operators, and calibrators receive training specific to the units they will use. To address this, the NRC is proposing to amend § 35.610(d)(1) to require vendor-provided operational and safety training for all individuals who will operate or calibrate the unit, including the AU, prior to the first use of a new or upgraded unit. Unlike traditional units for which subpart H was originally written, modern units may incorporate various types of immobilization devices, and in the event of an emergency, it is critical that responders are trained to safely release a patient from the specific device in use. Therefore, the NRC is proposing to revise § 35.610(e) to add a requirement to ensure emergency training includes instruction on the specific immobilization devices used with the unit. These amendments would ensure safety is maintained while subpart H is expanded to include different types of units, minimizing the need for future subpart K licensing.
GSR units have advanced along with their safety systems, which help ensure patients are treated accurately and as prescribed. This advancement is detailed in the ACMUI subcommittee report titled “Physical Presence Requirements for the Leksell Gamma Knife® Icon
a. The AU and AMP would still be required to be physically present at the initiation of treatment to ensure proper setup and confirm that the patient receives the intended dose to the correct location.
b. After initiation, the AU may leave the treatment area but must remain immediately available in case of an emergency or treatment interruption that requires a medical decision.
c. Given the high dose rates involved in GSR treatments, the AMP would still be required to remain physically present during the continuation of treatment.
d. The licensee would have the flexibility to designate other appropriate personnel to be physically present to respond to emergencies and remove the patient from the radiation field if necessary.
e. In the event of an unexpected interruption, both the AU and the AMP would be required to evaluate the situation before treatment re-initiation.
This proposed amendment reduces the amount of time the AU must be physically present during GSR
To allow modern and future radiation therapy units, including GSRs, to be licensed under 10 CFR part 35, subpart H, the NRC is proposing to modify or remove prescriptive spot check and full calibration requirements. These proposed changes would eliminate outdated, redundant, or overly prescriptive provisions, better accommodate modern equipment designs, and align with the NRC's risk-informed, performance-based regulatory framework.
Specifically, for GSRs, the NRC is proposing to amend the following full calibration requirements contained within § 35.635:
a. Remove all references to helmet factors in paragraphs (a)(3) and throughout (b). These references are obsolete because newer GSR technologies do not rely on physical helmets or use integrated collimation systems. Removing all references to helmet factors eliminates unnecessary specificity that no longer reflects current practice and equipment design.
b. Revise paragraph (a)(2)(iii) to include collimation components in required post-repair calibrations aligning with the current recommendations outlined in § 35.1000 licensing guidance for modern GSR units. The current language limits the calibration trigger to repairs involving source removal or source assembly components. This proposed rule includes “major repair of component(s) associated with the source assembly or collimation,” ensuring calibrations are conducted when critical components that affect dose distribution are modified. This clarification improves regulatory clarity without increasing burden.
c. Replace outdated and device-specific calibration checks in paragraph (b) with a more performance-based set of criteria. The list includes references to obsolete components (
d. Add a requirement for full calibration to verify the operability and availability of emergency response equipment required under § 35.610. This change would account for modern and future gamma stereotactic radiosurgery (GSR) units, which incorporate varied emergency response equipment that licensees must ensure is available and operational to respond in the event of an emergency, such as a stuck shutter. Although rare, such events have been reported to the NRC and resulted in sources continuing to be exposed following treatment where licensees have had to use emergency equipment. This requirement would not be expected to increase burden because licensees are already required to have emergency response equipment operational and available to implement emergency procedures specified in § 35.610 and perform full calibration of the unit in accordance with § 35.635.
Next, the NRC is proposing to amend § 35.645 to eliminate redundant and overly prescriptive requirements for periodic spot-checks of GSR units that are already addressed through nationally recognized standards or manufacturer protocols. Specifically, the NRC is proposing to—
a. Remove prescriptive specific spot checks for the GSR units contained in § 35.645(c)(1)-(2) and (d)(1)-(6), such as helmet microswitches, trunnion centricity, emergency timing circuits, and intercom systems. The prescriptive list of outdated requirements for modern GSR units would be replaced with a performance-based approach allowing licensees to follow written procedures established by the AMP and to rely on nationally recognized standards or NRC-accepted manufacturer instructions. NRC-accepted manufacturer instructions would be listed on the NRC's medical use toolkit on the emerging medical technology page after the NRC confirms the instructions to check the necessary systems and components as required per regulation and contain clear tolerance limits for licensee use. This change provides flexibility while maintaining safety and quality assurance.
b. Restructure § 35.645 to clearly define the frequency of required spot checks, aligning with the current recommendations outlined in § 35.1000 licensing guidance for modern GSR units.
c. Revise the current § 35.645(e) into proposed §§ 35.645(d) and (e) to permit the licensee to continue using the unit, provided that any system or device identified as not functioning properly is not used for treatment. The requirement in § 35.645(e) that a licensee must not use a unit if a malfunction is found in a system necessary for treatment would be retained.
d. For remote afterloader units, the NRC is proposing to amend § 35.643 to eliminate redundant and overly prescriptive requirements for periodic spot-checks that are already addressed through nationally recognized protocols or NRC-accepted manufacturer procedures. These changes are intended to streamline regulatory requirements, reduce unnecessary burden on licensees, and align with the NRC's risk-informed, performance-based regulatory framework. Specifically, the NRC is proposing to remove prescriptive specific spot checks for the high dose rate (HDR) units contained in § 35.643(d)(1)-(8), such as electrical interlocks, source exposure indicator lights, viewing and intercom systems, emergency response equipment, and computer clock settings. These requirements would be replaced with a performance-based approach allowing licensees to follow written procedures established by the AMP and to rely on nationally recognized standards or NRC-accepted manufacturer instructions, as described in § 35.643(b). NRC-accepted manufacturer instructions would be listed on the NRC's medical use toolkit on the EMT page after NRC confirms the instructions contain procedures and acceptable tolerance limits for necessary spot checks and calibrations. This shift would align required checks with standards and allow licensees to use innovative or emerging technologies while maintaining safety.
As very few teletherapy units currently exist in the U.S., the NRC is not proposing additional changes to remove prescriptive spot-check or full calibration requirements for these units, as was done for HDR and GSR. However, for consistency with the updates to HDR and GSR regulations, the NRC is proposing to amend spot check requirements contained within §§ 35.632(d) for teletherapy units. This amendment would allow licensees to
The NRC is proposing to establish a dedicated regulatory framework for microsource brachytherapy by developing a new subpart I under 10 CFR part 35 and making other conforming changes. These changes are intended to incorporate microsources, such as Y-90 microspheres, into traditional medical-use subparts in a way that reflects their unique characteristics. Due to microspheres' unique characteristics, they are currently licensed under § 35.1000. To support licensing these units under subpart K, the NRC developed two licensing guidance documents for 3 types of microspheres, TheraSphere®, SIR-Spheres®, and Eye90®. The use of microspheres for permanent implant manual brachytherapy has grown significantly over the past two decades, and the NRC anticipates continued growth and innovation in this area, including the development of new microsource systems. This proposed rule would eliminate the need to use subpart K for licensing microspheres, while still ensuring proper radiation safety oversight.
The new subpart I of 10 CFR part 35 mirrors the structure of existing subparts F and H but specific requirements would be tailored to the specific operational and safety considerations of microsource brachytherapy based on current licensing conditions contained in § 35.1000 licensing guidance to include microsources. The NRC is proposing to amend § 35.2 to add definitions for “microsource,” “microsource brachytherapy,” and “shunting,” and revise the definition of “prescribed dosage” to include microsources. Adding these definitions is part of a broader effort to modernize and clarify terminology used in 10 CFR part 35 to improve consistency in regulatory language and better reflect current clinical practices and medical community standards.
The NRC is proposing to amend written directive requirements in § 35.40 to include microsource brachytherapy. Specifically, the proposed amendments would—
a. Revise § 35.40(b)(5) to explicitly include “microsource brachytherapy” alongside permanent manual brachytherapy, ensuring that written directives for microsource treatments document the treatment site, radionuclide, and either total source strength or prescribed dosage before administration.
b. Update §§ 35.40(a)(2) and (b)(5) to include microsource brachytherapy with manual brachytherapy to allow changes to the written directive after administration but before the patient leaves the post-treatment recovery area.
c. Modernize terminology to reflect current clinical practice, replacing “permanent implant brachytherapy” with “permanent manual or microsource brachytherapy,” and allowing for documentation of either total source strength, prescribed dosage, or administered activity, which is particularly relevant for microsphere therapies.
Additionally, the proposed subpart I would introduce the following provisions:
a. Section 35.700 would establish the conditions under which microsources may be used, including sourcing from licensed manufacturers or use under an FDA-accepted investigational device exemption (IDE). This provision would ensure that microsources are obtained and used in a manner consistent with existing safety and quality standards.
b. Section 35.710 would outline safety procedures and instruction requirements. Specifically, § 35.710(a) would mandate that microsource administration devices be used in accordance with the Sealed Source and Device Registry, consistent with current licensing guidance. In addition, § 35.710(b) would require licensees to develop, implement, and maintain written procedures for responding to abnormal situations (
c. Proposed new § 35.790 would define the training and experience requirements for AUs of microsources in line with current § 35.1000 licensing guidance and changes described in Section IV.A., “Training and Experience,” of this document. Specifically, the proposed amendment would require:
i. Completion of a diagnostic and interventional radiology residency, along with classroom and laboratory training in radiation safety fundamentals.
ii. Supervised clinical experience involving at least three microsource cases, including hands-on work with ordering, preparing, administering, and evaluating treatments. Unlike the proposed changes that remove specific case requirements for unsealed byproduct material and superficial ophthalmic use of beta-emitting sources, this proposed rule retains a minimum of three microsource cases currently contained in the § 35.1000 licensing guidance for Y-90 microspheres and is being retained to ensure practitioners have sufficient experience to maintain safety given the continued high number of reported events and the unique delivery systems used for each microsource type.
iii. Written attestation from a qualified preceptor or residency program director confirming the individual's readiness to independently perform radiation safety duties.
Alternatively, prior authorization under § 35.390, 35.396, or 35.490 with supplemental microsource-specific training and attestation would meet the training and experience requirement. The addition of § 35.396 would allow for additional physicians to be licensed based on their prior training and experience under § 35.396, reducing burden from past § 35.1000 licensing guidance recommendations.
a. The regulations in § 35.2310 would establish the recordkeeping requirements for safety instruction provided under §§ 35.93, 35.310,
b. The regulations in § 35.2710 is a proposed new section that would establish the recordkeeping requirements associated with safety procedures and instruction for microsource use. This section would ensure that licensees maintain documentation of written procedures for managing abnormal situations involving microsource administration, aligning microsource recordkeeping requirement for procedures with other modalities contained in 10 CFR part 35 while adding minimal burden. The NRC is proposing these requirements to support accountability and reinforce safe clinical practice in the use of microsource brachytherapy systems.
The NRC is proposing to amend its regulations to reduce regulatory burden and increase flexibility for licensees in managing patients or human research subjects who cannot be released under § 35.75. Specifically, the NRC is proposing to combine safety precautions from individual modality subparts into a new section, § 35.76 contained in subpart C, which would be applicable to all uses. By combining the safety precautions, licensees would have flexibility to house individuals who cannot be released under § 35.75 in the same room, regardless of whether they received the same type of administration. This change would allow, for example, a patient who received radiopharmaceutical administration under subpart E to be roomed with a patient who received microsource administration under subpart I, provided the licensee can do so in accordance with 10 CFR part 20 dose limits. This would increase flexibility in patient management and facility use without compromising radiation safety.
The NRC is also proposing to revise the requirement that patients receiving unsealed byproduct material must have a private sanitary facility. This proposed rule would instead require that such patients have access to a sanitary facility used only by individuals who have received similar administrations, without leaving the controlled area. This change would support more efficient facility design and use while maintaining adequate protection against contamination and exposure in uncontrolled areas.
The NRC is proposing amendments to 10 CFR part 35 to reduce regulatory barriers that may delay or discourage the adoption of innovative EMTs. These changes are part of a broader initiative to modernize the medical use regulations and ensure they remain risk-informed, performance-based, and adaptable to technological advancements.
One set of proposed changes addresses the calibration of dose calibrators and survey instruments. Specifically, § 35.60(c) would be amended to permit licensees to submit written calibration procedures for NRC approval in cases where the instrumentation required under paragraph (a) cannot be calibrated using nationally recognized standards or the manufacturer's instructions. This revision would facilitate the use of innovative instrumentation for emerging and novel radioisotopes in medical applications without the need for licensing under subpart K or exemption as current licensees must calibrate these instruments using nationally recognized standards or manufacturer instructions. The NRC would evaluate the submitted procedures to determine whether they achieve calibration tolerances comparable to those established in nationally recognized standards. Conforming changes would be made to §§ 35.12(b)(2) and (c)(2). This approach is intended to support the safe and effective use of new technologies in nuclear medicine while reducing regulatory barriers that may hinder medical research and the development of future clinical applications involving byproduct material.
Similarly, the proposed revision to § 35.61 would reduce the prescriptiveness of survey instrument calibration requirements, allowing licensees greater flexibility to tailor calibration methods to the energy characteristics of new isotopes. Specifically, the proposed amendments would:
a. Revise § 35.61(a)(1) to require calibration of survey instruments for the radiation type and energy range measured, rather than specifying calibration of all scales up to 10 mSv (1000 mrem) per hour. This change would provide licensees with greater flexibility while ensuring that instruments are appropriately calibrated for their intended use.
b. Additionally, the requirement in § 35.61(a)(2) to calibrate two separate readings on each scale or decade would be removed, as it is overly prescriptive and not necessary to ensure accurate instrument performance. The requirement to conspicuously note the date of calibration on the instrument, currently in § 35.61(a)(3), would be retained as § 35.61(a)(2).
The NRC also is proposing to revise § 35.604, “Surveys of patients and human research subjects treated with a remote afterloader unit,” to remove the term “portable” from the description of survey instruments. This change would accommodate the use of innovative detection technologies, provided they meet performance and calibration requirements. The revised language would continue to ensure that radiation sources are properly surveyed and returned to a shielded position before the end of the procedure, while allowing licensees to adopt newer technologies within existing regulatory framework.
Another proposed change clarifies the licensing pathway for manual brachytherapy sources. Under current regulations, subpart F governs the use of sealed sources in manual brachytherapy, but the term “implant” in §§ 35.404(a) and (b), and 35.2404, “Records of surveys after source implant and removal,” has led to confusion regarding whether topically administered sources could be licensed under this subpart. The proposed revisions would clarify that manual brachytherapy sources both topically and inserted within a patient or human research subject are subject to subpart F. This clarification would streamline the licensing process for treatments such as those for skin cancers or post-surgical sites and ensure that licensees can efficiently implement innovative brachytherapy devices without compromising safety.
The NRC is proposing amendments to certain regulatory requirements in 10 CFR part 35 to clarify the intent and application of several regulatory provisions related to the medical use of byproduct material. These clarifications are part of the NRC's broader effort to ensure that its regulations remain clear, risk-informed, and aligned with current clinical practices, particularly as new technologies emerge and evolve.
One area of focus is §§ 35.57(b)(4) and 35.1000(c), which address the continued use of medical technologies initially licensed under subpart K. As these technologies become well established and are incorporated into traditional subparts of 10 CFR part 35, the NRC seeks to ensure that licensees and AUs do not need to reapply for approval to continue using them. The proposed changes would establish a clear regulatory pathway to preserve existing authorizations when a § 35.1000 use transitions into a standard subpart use, thereby reducing administrative burden and supporting continuity of care.
The NRC also is proposing to revise § 35.27(a)(1) to replace the phrase “written directive procedures” with “procedures for administrations requiring a written directive.” This change would align the language with § 35.41, “Procedures for administrations requiring a written directive,” and clarify that the regulation applies to the implementation of the written directive, not to the physician's clinical decision-making process. The proposed revision reinforces the NRC's intent to ensure that licensees have procedures in place to verify that the medical use of byproduct material is administered in accordance with the physician's instructions, as documented in the written directive.
Additionally, the NRC is proposing to revise § 35.41(b)(4) to remove prescriptive language that limits the applicability of the requirement for verifying computer-generated dose calculations to specific subparts such as § 35.600 or § 35.1000. This proposed change broadly applies to any modality that uses computer-generated dose calculations, regardless of the subpart under which it is licensed. The proposed revision would ensure that the requirement applies broadly, without inadvertently triggering subpart K licensing for modalities that adopt these technologies in the future.
Together, these proposed changes are intended to clarify regulatory intent, reduce unnecessary burden, support the safe and efficient adoption of EMTs, and ensure that the NRC's medical use regulations remain flexible, forward-looking, and focused on safety outcomes.
The proposed revision would include amendments to 10 CFR part 35, subpart A, “General Information,” subpart B, “General Administrative Requirements,” subpart C, “General Technical Requirements,” and subpart D, “Unsealed Byproduct Material—Written Directive Not Required,” to resolve outstanding regulatory issues regarding the use of Rb-82 generators that are currently dispositioned through use of enforcement discretion as described in EGM 13-003. To continue regulating Rb-82 generators without the need for enforcement discretion and without impacting safety, changes would be necessary to allow for the currently accepted methods for calibration of radiation detectors in a dynamic mode and to address dosage measurements for Rb-82 generators. These criteria are currently implemented under EGM 13-003 and remain in effect today. The proposed amendments would codify these requirements into regulation, eliminating the need for ongoing enforcement discretion while maintaining the same safety basis. The NRC is proposing to revise § 35.63 to address longstanding challenges associated with determining the activity of radiopharmaceutical dosages in certain clinical scenarios, particularly those involving short-lived isotopes administered via direct infusion systems, which cannot meet the regulations for measuring patient dosages before administration.
1. Specifically, the title of § 35.63 would be revised from “Determination of dosages of unsealed byproduct material for medical use” to “Determination of dosages for medical use” to reflect the broader applicability of the section. Paragraph (a) to § 35.63 would be amended to exempt incremental administrations that meet the criteria in new paragraph (e) from the requirement to determine and record the activity of each dosage before medical use.
2. Paragraphs (b) and (c), which describe acceptable methods for determining the activity of unit and non-unit dosages, respectively, would be retained but revised to clarify that they do not apply to incremental administrations that meet the criteria in paragraph (e).
3. A new paragraph (d) would be added to allow licensees to determine and record the activity of each incremental dosage administered from a direct infusion system using either a calibrated instrument that is part of the system or a combination of measurement and mathematical calculations.
4. Paragraph (e) would establish specific criteria under which incremental administrations may be performed using direct infusion systems. These criteria include: (1) the administered radioisotope must have a half-life of less than three minutes; (2) a written directive must not be required (for diagnostic use, a written directive would not be required because these administrations involve very short-lived isotopes delivered in small quantities through automated systems, making pre-administration measurement impractical and risk minimal); (3) the radioisotope must be administered directly from the generator or system without additional preparation steps; and (4) the administration must follow the manufacturer's guidelines and procedures. These provisions are designed to accommodate the unique characteristics of isotopes such as Rb-82, which cannot be practically measured before administration using traditional methods due to rapid decay and automated delivery systems.
5. The existing dosage deviation limit in paragraph (d) would be redesignated as paragraph (f) and retained without change, as would the recordkeeping requirement in paragraph (e), which would become paragraph (g). These proposed changes would accommodate the unique characteristics of isotopes such as Rb-82, which cannot be practically measured prior to administration using traditional methods, while maintaining adequate assurance that patients receive the prescribed dosage.
To address direct measurements allowed under the proposed addition of § 35.63(d), § 35.60(d) would be added to require licensees to test the infusion pump flow rate and radiation detectors used by developing, implementing, and maintaining written test procedures. These tests would continue to be required at least every 12 months to ensure continued accuracy and reliability of the infusion systems and associated detectors over time and following any repair that could affect calibration in accordance with EGM 13-003 and the proposed new § 35.60(e). Conforming changes would be made in §§ 35.60(f) and 35.2060, “Records of calibrations of instruments used to measure the activity of unsealed byproduct material,” to ensure licensees retain a copy of procedures used to verify the infusion pump flow rate. These criteria, with the exception of the proposed record keeping requirements for testing procedures under § 35.2060(b), are currently implemented under EGM 13-003 and remain in effect today. The new recordkeeping requirement would ensure traceability and regulatory oversight by documenting not only test results but also the approved methods used to obtain those results, while adding minimal burden. This would close a gap in current rules, align with best practices for quality assurance, and
The NRC is proposing to amend § 35.40 to remove the requirement that a written directive be prepared for diagnostic administrations of sodium iodide I-131. Currently only diagnostic administrations of sodium iodide I-131 in quantities greater than 1.11 megabecquerels (30 microcuries) require a written directive. This proposed change would reclassify these diagnostic uses under the licensing framework of 10 CFR part 35, subpart D, which governs diagnostic uses of unsealed byproduct material that do not require a written directive. To support this change, §§ 35.100 and 35.200 would be revised to remove the introductory clause referencing § 35.40(b) as a limiting condition. The revision would ensure consistency with the updated written directive requirements in § 35.40.
This revision also would reflect the evolution of clinical practice and radiation safety standards in diagnostic nuclear medicine. In the past decade, only one reported medical event involved a diagnostic administration of sodium iodide I-131 at a dosage level requiring a written directive. This event occurred because the licensee failed to complete the written directive before administration, even though the patient received the correct prescribed dosage. In contrast, there have been three medical events in the same period where patients scheduled for diagnostic administration of sodium iodide I-123 received the wrong radionuclide. Additionally, two older events (both more than 5 years ago) involved patients prescribed doses below the threshold requiring a written directive who instead received higher-than-intended doses of sodium iodide I-131. These examples show that diagnostic administrations of sodium iodide I-131 at dosage levels requiring a written directive have a risk profile comparable to other diagnostic administrations that do not require a written directive. By removing the written directive requirement for these diagnostic administrations, licensees would still be required to report any medical event that occurs, maintaining appropriate safety oversight while eliminating the unnecessary requirement.
The NRC is proposing to amend § 35.3045(a) to exclude requiring licensees to report events that result from emergent patient conditions that prevent completion of administration as planned. In addition, the NRC is proposing to add a definition of emergent patient conditions to § 35.2 to clarify that emergent patient conditions are unexpected developments or acute changes in patients' condition, such as vascular spasm or seizure, that occur during the administration which cause a deviation from the planned administration. To ensure the NRC takes appropriate actions to reduce occurrence of significant events, the NRC is also proposing to amend § 35.3045(b) to require reporting of an event under this proposed exclusion if the event is expected to cause unintended permanent functional damage to an organ or physiological system, as determined by a physician. This clarification does not introduce a new reporting category; rather, it aligns emergent patient condition events with existing requirements for events caused by actions of patients, known as patient intervention. This proposed change would be expected to reduce reporting burden by approximately nine events per year while ensuring the NRC is still notified of significant events that could cause unintended significant harm to patients. The proposed changes are intended to reduce unnecessary reporting burden; improve clarity; better align the rule with a risk-informed, performance-based regulatory framework; and continue to ensure significant events that result in unintended permanent functional damage are reported.
In addition, the NRC is proposing to amend § 35.40(a)(2) to allow AUs to revise the written directive during administration for all brachytherapy procedures, except for high dose-rate (HDR) remote afterloader treatments, provided the changes are documented and signed by the AU within 24 hours of the procedure. This change would provide clarity that licensees may use the post-administration portion of the written directive when determining whether a medical event occurred and allows AUs to approve real-time adjustments based on the medical needs of the patient, consistent with their medical judgment. This includes adjusting the written directive if stasis occurs during administration, consistent with the current Y-90 microsphere licensing guidance. However, to ensure leaks or defects in administration device or supplies are reported, the NRC is proposing to add § 35.3045(a)(3) to require reporting if the total dose or dosage delivered differs from the prescribed dose or dosage defined on the written directive before administration by 20 percent, as caused by a leak or defect in administration device or supplies, unless the event resulted from patient intervention or an emergent patient condition. This would ensure the NRC can take appropriate action to prevent reoccurrence of similar events.
Section 35.3047 requires licensees to report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the AU. Over the years, this has resulted in licensees reporting events where they made reasonable effort to determine pregnancy status but due to early gestational age or other medical conditions of the patient, they were unable to determine the patient's pregnancy status at the time of administration. Because this is a medical issue and there is no action for the NRC to take in these events, the NRC is proposing to amend the regulation to add § 35.3047(a)(2) to exclude requiring licensees to report these events when they made a reasonable effort to determine pregnancy status, but pregnancy could not be reasonably excluded prior to the administration by the licensee.
The NRC has determined that the proposed revisions to § 35.3045 would maintain adequate protection of public health and safety while improving the utility, clarity, and clinical relevance of medical event reporting. By focusing reporting requirements on events that may indicate a breakdown in safety controls, such as those caused by equipment defects or procedural errors, the rule continues to support the NRC's oversight mission while reducing unnecessary administrative burden on licensees.
The NRC is proposing to amend § 35.92 to increase the allowable physical half-life for byproduct material eligible for decay-in-storage from 120 days to 275 days. This change would allow licensees to use decay-in-storage for longer-lived materials, such as Lu-177m, which is becoming more prevalent in medical facilities as new lutetium-177 (Lu-177) radiopharmaceuticals receive FDA approval. In addition, this amendment
This proposed amendment would reduce unnecessary disposal costs and regulatory burden for medical licensees while maintaining public health and safety. Under the current rule, licensees must dispose of Lu-177 waste as low-level radioactive waste if it contains Lu-177m, even if the licensee has the space and shielding to safely store the material until it decays to background levels. As medical licensees already maintain secure, shielded storage areas for decay-in-storage, this proposed change would not require new infrastructure or introduce new risks. The proposed change supports the NRC's risk-informed, performance-based regulatory approach by focusing regulatory requirements on materials that pose a greater hazard, while allowing flexibility for low-risk materials.
Under § 35.6(c), licensees currently must seek a license amendment for certain proposed research involving humans even if they are licensed for the type of medical use involved and the research is approved by an institutional review board (IRB). This duplicative requirement has led to delays in research and increased administrative workload for both licensees and the NRC. Therefore, the NRC is proposing to amend § 35.6 to eliminate the requirement for licensees to submit a license amendment before conducting research involving human subjects, provided the licensee is already authorized for the medical use of byproduct material and has obtained IRB approval and informed consent from the research subject. Conforming changes also would be made to § 35.8 as the proposed change would reduce the need for a licensing amendment request. By removing the requirement for an unnecessary license amendment application, the NRC would facilitate timely and efficient research without compromising safety or ethical standards.
The NRC is proposing to amend regulations specific to mobile medical services contained in § 35.80 to eliminate prescriptive requirements that are redundant to regulations contained in 10 CFR part 20 and other sections of 10 CFR part 35. These changes would ensure regulations for mobile medical licensees are aligned with survey requirements in 10 CFR part 20, and consistent with requirements for transfer of byproduct material for other 10 CFR part 30 licensees. In addition, these proposed changes would reduce unnecessary limitations on licensees and align with the NRC's risk-informed, performance-based regulatory framework.
Specifically, the proposed amendments would remove the following provisions:
a. Section 35.80(a)(2), which requires licensees to check instruments used to measure the activity of byproduct material before use at a client's address. This requirement is overly prescriptive and redundant with § 35.60, which requires that all licensees possess and calibrate instruments used to measure activity of unsealed byproduct material and microsources before administration in accordance with specific requirements. Because § 35.60 provides reasonable assurance that patients receive prescribed dosages for both mobile and non-mobile medical licensees, § 35.80(a)(2) is unnecessary.
b. Section 35.80(a)(3), which requires licensees to check survey instruments for proper operation with a dedicated check source before use at each client's address. This is a standard health physics practice and is already encompassed by the broader requirement in § 20.1501(c) to perform adequate radiation surveys that are necessary to ensure compliance with radiation safety regulations contained in 10 CFR part 20 and are reasonable under the circumstances to evaluate the magnitude and extent of radiation levels, concentrations or quantities of residual radioactivity, and the potential radiological hazards of the radiation levels and residual radioactivity detected. The removal of this provision would eliminate unnecessary regulatory specificity and clarify that there are not different requirements for mobile medical licensees versus non-mobile medical licensees who can also transport survey instruments to different sites.
c. Section 35.80(a)(4), which requires licensees to survey all areas of use to ensure compliance with 10 CFR part 20 before leaving the client's address. Removing this provision would align regulations for mobile medical licensees with regulations for other 10 CFR part 30 licensees who have temporary job sites and would avoid duplicative regulation with § 20.1501 while ensuring radiation safety.
d. Section 35.80(b), which prohibits the delivery of byproduct material to a client unless the client is licensed to receive it. Section 20.1802 requires licensees to control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage, which would already preclude a mobile medical licensee from delivery of byproduct material to a client unless they would be able to safely secure it or the client has a license. Therefore, retaining this provision in § 35.80 is unnecessary.
Conforming changes are being proposed to remove associated survey records as currently required in § 35.2080(b). The proposed amendments would not introduce new risks or reduce the level of protection for workers, patients, or the public. Rather, they would remove outdated or duplicative requirements and provide licensees with greater flexibility in how they meet existing performance-based requirements, consistent with their capabilities.
Section 35.24 outlines the authority and responsibilities for licensees' radiation protection programs, including requirements for RSOs and RSCs. The NRC is proposing to revise § 35.24 to increase the allowable service period for temporary RSOs and to revise the required composition and applicability of RSCs to better reflect current clinical practices. This change would reduce regulatory burden on medical use licensees while maintaining appropriate oversight of radiation safety programs.
First, the NRC proposes to amend § 35.24(c) to extend the allowable duration for a qualified individual to serve as a temporary RSO from 60 days to 120 days per calendar year. Under the current rule, licensees may allow a qualified individual to act as a temporary RSO for up to 60 days without submitting a license amendment. However, the NRC has found that this timeframe is often insufficient for licensees to recruit, hire, and onboard a permanent RSO, particularly in specialized or rural medical settings. Extending the temporary RSO period to 120 days would provide licensees with greater flexibility during staffing transitions or extended absences, reduce the need for license amendments, and support continuity of oversight and safety by avoiding the need to designate multiple RSOs during a transition period.
Second, the NRC proposes to revise § 35.24(f) to clarify that an RSC is only required if a licensee is authorized for
Finally, the NRC proposes to revise the required composition of the RSC by removing the requirement to include a representative of the nursing service. The current rule specifies that the RSC must include an AU for each type of use, the RSO, a representative of management, and a representative of the nursing service. However, in modern medical practice, patients receiving therapeutic byproduct material are often treated on an outpatient basis and are not under the care of nursing staff. As a result, the nursing representative is frequently not involved in the radiation safety aspects of treatment. Removing this requirement would reduce administrative burden on licensees while preserving the core safety oversight functions of the RSC. Licensees may still choose to include a nursing representative or any other clinical staff member on the RSC at their discretion.
These proposed changes are consistent with the NRC's ongoing efforts to modernize its medical use regulations, reduce unnecessary regulatory burden, and align requirements with current clinical practice. The NRC has determined that these proposed amendments would not introduce new risks and would maintain adequate protection of public health and safety for workers, patients, and the public, while providing greater flexibility and clarity.
As part of the larger response to E.O. 14300, the NRC reviewed 10 CFR part 35 in its entirety to remove redundant regulations. As a result of this review, the NRC is proposing to remove § 35.5 because maintenance of records is already required by § 30.51, which applies to 10 CFR part 35 licensees.
In addition, the NRC reviewed 10 CFR part 35 to remove outdated regulations related to implementation of previous rulemakings. On October 1, 2007, the NRC published a final rule to amend 10 CFR part 35 to implement provisions of the Energy Policy Act of 2005 requiring that the NRC license the medical use of accelerator-produced radioactive material or discrete sources of radium-226 (72 FR 55864). In §§ 35.10(a) and 35.11(c)(1) and (2), the NRC regulations provide waivers for certain entities using this material from requiring a specific license until the entity submitted a medical use license application. As these waivers had end dates of no later than August 8, 2009, for § 35.10(a); December 1, 2008, for § 35.11(c)(1); and August 7, 2009, for § 35.11(c)(2), these paragraphs are outdated and would be removed. In addition, the clause “on or after October 24, 2002,” regarding calibration measurements of brachytherapy sources in § 35.432, is outdated and also would be removed.
The NRC is seeking advice and recommendations from the public on this proposed rule. The NRC is particularly interested in comments and supporting rationale from the public on the following:
1. The NRC is proposing to revise the definition of “teletherapy” in § 35.2 to clarify that it refers to external beams of ionizing radiation are delivered from an external source without stereotactic guidance. However, the NRC is also considering removing the specific reference to stereotactic guidance or adding additional clarifying language to further expand the definition. As such, the NRC is seeking comments on examples of teletherapy uses and whether the NRC would need to further revise the definition of teletherapy to ensure these teletherapy uses are included. Please provide the basis for your response.
2. As part of this rulemaking package, the NRC has developed guidance to clarify that the physical presence of an AU for the medical use of byproduct is not required under § 35.11(b)(1). 10 CFR 35.11(b)(1) permits licensees to allow individuals who are not AUs to perform certain tasks under the supervision of an AU who is named on the license or permit. As indicated, the NRC has developed guidance to clarify that there is no requirement regarding the location of the AU during the use. The current compatibility category of § 35.11(b) is category C, allowing Agreement States to be more restrictive and potentially require the physical presence of an AU. The NRC has received concerns from industry stakeholders that § 35.11(b) raises transboundary concerns as medical networks have grown and many cross state lines, such that the regulation should be compatibility category B. In addition, the industry stakeholders have expressed concerns that requiring an AU to be physically present or within a specified location of the medical use limits access to treatments in rural areas. As such, the NRC is considering changing this regulation to be compatibility category B. The NRC is requesting specific comments on the appropriate compatibility category for § 35.11(b).
3. The NRC is proposing to establish specific criteria in § 35.63 to allow incremental administrations to be performed using direct infusion systems, including a criterion that calls for the administered radioisotope to have a half-life of less than three minutes. These provisions are designed to accommodate the unique characteristics of isotopes such as Rb-82, which cannot be practically measured using traditional methods due to their rapid decay and automated delivery systems. The NRC is seeking feedback on whether the proposed three-minute timeframe is appropriate or if a higher threshold would be beneficial for a current or expected future medical use and if so, what length half-life would be appropriate (for example, 5 minutes or 10 minutes). Please provide the basis for your response.
4. The NRC is proposing to change § 35.92(a) to allow licensees to hold byproduct material with a physical half-life of less than or equal to 275 days, instead of 120 days, to allow licensees to hold Lu-177m and Co-57 flood sources for decay-in-storage. The NRC is seeking feedback on whether an even longer half-life limit would be beneficial for medical use in this context. Specifically, the NRC is considering increasing the physical half-life beyond 275 days if there is a radioisotope used in medicine that could benefit from such an increase without causing a significant increase in risk. Please comment on whether increasing the half-life limit beyond 275 days would provide a meaningful benefit to medical licensees. If you believe a longer limit would be appropriate, indicate what specific half-life (for example, 300 days or 365 days) you recommend and explain the medical use which would benefit from your recommendation. In addition, describe any safety or operational considerations the NRC should evaluate if the limit is extended further.
5. The NRC is proposing to change the definition of “physician” in § 35.2 to expand eligibility for individuals to become AUs. This change is intended to
6. The NRC is proposing to remove the requirement for a written directive for a diagnostic administration of sodium iodide I-131 in quantities greater than 1.11 megabecquerels (30 microcuries). The requirement was historically established to reduce the potential for unintended thyroid irradiation associated with irreversible thyroid uptake and to help prevent wrong-patient or wrong-procedure administrations. The NRC is seeking feedback on whether eliminating this written directive requirement could raise any safety concerns or otherwise affect patient protection beyond risks associated with diagnostic administrations. In particular, the NRC seeks input on whether current clinical practices of patient identification, procedure verification, and pregnancy screening provide sufficient assurance that diagnostic administration of sodium iodide I-131 are performed safely without the need for a written directive. The NRC is also seeking feedback on whether the removal of this requirement would reduce unnecessary administrative burden on licensees while maintaining adequate protection of patients. Please provide the technical or operational basis for your response, including any relevant experience, data, examples from clinical practices, or information on current institutional practices used to verify patient identity and the intended procedure.
7. The NRC is proposing to remove prescriptive requirements for specific numbers of classroom and laboratory training hours and work experience hours for physicians who have completed residency training in specialties where radiation safety and the clinical use of byproduct material are inherently integrated into the curriculum. This proposed rule identifies diagnostic radiology, nuclear medicine, and radiation oncology as specialties that would not need to complete these prescriptive training hours for training related to uptake, dilution, excretion, imaging, and localization studies. The NRC is seeking feedback on whether these residency programs do and would continue to include sufficient training in these areas, without the prescriptive hour requirements, as the NRC considers whether to remove or maintain the current requirements.
8. In addition, the NRC is proposing to keep the current training hours requirements for physicians who completed fellowship but is considering removing these training hours requirements provided the fellowship curriculum sufficiently integrates radiation safety and the clinical use of byproduct material to ensure the physician can independently fulfill radiation safety-related duties as an AU for medical use. Thus, the NRC is seeking feedback on whether any fellowship curriculum sufficiently integrates radiation safety and the clinical use of byproduct material to ensure the physician can independently fulfill radiation safety-related duties as an AU for medical use, and on any potential considerations of including fellowship training in addition to residency training for meeting the training and experience requirements in subparts D through H of 10 CFR part 35. Please provide the basis for your response.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), requires that agencies consider the impact of their rulemakings on small entities and, consistent with applicable statutes, consider alternatives to minimize these impacts on the businesses, organizations, and government jurisdictions to which they apply. An agency must prepare an Initial Regulatory Flexibility Analysis unless it determines and certifies that a rule, if promulgated, would not have a significant economic impact on a substantial number of small entities. Because the NRC has not made such a certification for this proposed rule, the NRC has prepared this analysis in accordance with 5 U.S.C. 603.
The NRC has established standards for determining which of its licensees qualify as small entities pursuant to 10 CFR 2.810, “NRC size standards.” These standards include an $8 million receipts-based threshold and related employee-based criteria. Approximately 30 percent of 4,250 NRC and Agreement State licensees (or about 1,275 licensees) qualify as small entities. This percentage is derived from the small-entity distribution used in the NRC's annual fee rule (91 FR 36470; June 16, 2026) and is applied here as a general indicator of the proportion of licensees that may qualify as small entities.
The Small Business Regulatory Enforcement Fairness Act requires that the NRC prepare a written compliance guide to assist small entities in complying with each rule for which a regulatory flexibility analysis is prepared. The proposed rule includes both deregulatory provisions and several new or revised recordkeeping requirements. These include updates associated with continuing education, documentation for emerging medical technologies, Rb-82 generator activities, expanded decay in storage provisions, and revised Radiation Safety Committee applicability. As discussed in Sections VII, “Regulatory Analysis,” these requirements apply to different subsets of licensees, and together represent a small portion of the overall amendments.
As shown in table 25, licensees would incur approximately $3.8 million in total costs over the five-year analysis period when discounted at 7 percent, consisting of about $1.8 million in implementation costs and about $2.0 million in recordkeeping costs. Applying the NRC's 30-percent small-entity proportion, small entities would experience approximately $1.1 million of this total, or about $0.5 million in implementation costs and $0.6 million in recordkeeping costs, discounted at 7 percent. Based on 1,275 small entities, this equates to roughly $430 to $470 per small entity over five years, or about $90 per year. These impacts are minimal.
Likewise, the estimated annual small-entity burden, discounted at 7 percent, would be $0.2 million, consisting of about $0.1 million in implementation burden and about $0.1 million in recordkeeping burden. Because the individual recordkeeping provisions apply to different subsets of licensees, the number of affected small entities varies by requirement.
The NRC is seeking public comment on the potential impact of this proposed rule on small entities. The NRC particularly desires comment from licensees who qualify as small businesses, specifically as to how the proposed regulation will affect them and how the regulation may be tiered or otherwise modified to impose less stringent requirements on small entities while still adequately protecting the public health and safety and common defense and security. Comments on how
(a) The size of the business and how the proposed regulation would result in a significant economic burden upon it as compared to a larger organization in the same business community;
(b) How the proposed regulation could be further modified to take into account the business's differing needs or capabilities;
(c) The benefits that would accrue, or the detriments that would be avoided, if the proposed regulation was modified as suggested by the commenter;
(d) How the proposed regulation, as modified, would more closely equalize the impact of NRC regulations as opposed to providing special advantages to any individuals or groups; and
(e) How the proposed regulation, as modified, would still adequately protect the public health and safety and common defense and security.
Comments should be submitted as indicated under the
This regulatory analysis is prepared in accordance with E.O. 12866, “Regulatory Planning and Review,” and E.O. 14215, “Ensuring Accountability for All Agencies.” E.O. 14215 requires independent agencies, such as the NRC, to comply with E.O. 12866 and submit significant actions for Office of Information and Regulatory Affairs (OIRA) review. The analysis assesses the costs and savings of the alternatives considered by the NRC and concludes that the proposed deregulation action in this rule is expected to reduce regulatory burden and generate cost savings for licensees, the NRC, and the Agreement States when compared to the no-action baseline. The regulatory analysis is detailed in the following paragraphs of this document. Comments on the analysis may be submitted to the NRC as indicated under the
The NRC was created by Congress in 1974 to ensure the safe use of radioactive materials for beneficial civilian purposes while protecting people and the environment. The NRC protects public health and safety and advances the Nation's common defense and security by enabling the safe and secure use and deployment of civilian nuclear energy technologies and radioactive materials through efficient and reliable licensing, oversight, and regulation for the benefit of society and the environment. From an economic perspective, common defense and national security are public goods for which the markets cannot maximize net benefits, and markets alone can sometimes create unintended impacts to public health and safety. Consistent with its statutory authority, the NRC provides reasonable assurance of adequate protection of public health and safety.
Section 5 of E.O. 14300 requires the NRC to undertake a review and wholesale revision of its regulations and guidance documents as guided by the policies set forth in section 2 of the E.O. This rulemaking is part of the NRC's response to the direction in section 5 of the E.O. because, in conducting the wholesale review of its regulations, the NRC reexamined the regulations pertaining to the use of certain nuclear material without a license and determined—based on past experience and practice—such uses can be expanded. Rulemaking is the most effective way to achieve this. Licensees may amend their current license for additional radionuclides; however, such amendments impose a cost on licensees and regulators without a proportionate benefit to public health and safety. Expanding the use of certain nuclear material without the need for a license also cannot be accomplished through guidance, as such guidance would conflict with the existing regulatory text. Therefore, amending the NRC's regulations is the most effective way to make this deregulatory change for all intended exempt uses.
This analysis uses current regulations under 10 CFR part 35 as the no-action baseline (Alternative 1), evaluates the changes proposed in this rule as the regulatory alternative (Alternative 2), and estimates the costs and savings of this proposed rule's implementation. Alternative 2 would revise 10 CFR part 35 to reduce barriers to medical use licensing and address E.O. 14300, section 5, by improving efficiency, predictability, and flexibility, while easing administrative burdens for the NRC, Agreement States, licensees, and applicants. The proposed changes include administrative updates, clarifications, and streamlined requirements that reduce redundancies and support the licensing of innovative technologies, all while maintaining the NRC's commitment to public health and safety.
To estimate the regulatory impact of the proposed changes, the NRC used input from agency subject matter experts, data from three related agency information collection requests approved by the Office of Management and Budget (OMB),
All costs and cost savings are expressed in 2024 dollars. The analysis covers a 5-year period, which provides a reasonable basis for projecting licensee activities. In accordance with OMB Circular A-4, the staff used NPV calculations to estimate the value of future cost savings in constant 2024 dollars, the most recent year for which complete annual data are available. NPV analysis allows for the comparison of costs and benefits that occur at different points in time by discounting them to a common base year. Consistent with OMB guidance, the analysis applies real discount rates of 3 percent and 7 percent. The 3-percent rate reflects the social rate of time preference and approximates the real return on long-term government debt. The 7-percent rate reflects the opportunity cost of capital and approximates the average pretax real rate of return on private-sector investments. The sign convention
The resulting estimates and underlying calculations are presented in the subsequent sections.
The estimated undiscounted costs and savings for major provisions are outlined in this section. These include updates to training and experience requirements, incorporation of certain well-established EMTs, revisions to requirements for the use of Rb-82 generators to codify existing enforcement guidance and provide regulatory clarity, changes to other requirements in different areas of medical use, and costs associated with implementing the rule.
As discussed in Sections III.A and IV.A, “Training and Experience,” the proposed changes would modernize and streamline the training and experience requirements for physician AUs. Most physician AUs undergo comprehensive residency programs that include radiation safety as part of the nature of the program that equips them with the necessary knowledge to ensure they can independently fulfill the radiation safety-related duties as an AU for medical use. By removing outdated and prescriptive topics from the regulations, the NRC seeks to reduce unnecessary administrative burdens for applicants while ensuring AUs are adequately prepared for their roles. Past experience has shown that many applicants submit incomplete or inadequate information, which results in additional time needed by the NRC, Agreement States, and applicants to resolve these issues. Because this proposed rule would reduce the complexity of training and experience criteria, it is expected that it would shorten licensing processing times and reduce the need to track incomplete information, some of which would no longer be required. Retaining preceptor statements for non-board-certified individuals and providing alternative pathways would ensure each physician has a pathway to become an AU while ensuring they have the knowledge to independently fulfill radiation safety duties. Finally, changing the definition of physician to include a path for foreign trained medical doctors would remove anti-competitive barriers.
These proposed changes to the training and experience requirements in 10 CFR part 35 would reduce ongoing NRC and Agreement State licensing resources in reviewing and approving requests from applicants and reduce licensee burden in developing license applications to add authorized individuals. Overall, these changes are designed to enhance licensing efficiency and reduce unnecessary burdens, while ensuring that AUs have sufficient training to ensure radiation safety in the medical use of byproduct material.
In addition, by removing the license amendment requirement for certain diagnostic uses of unsealed byproduct material, the NRC aims to reduce unnecessary regulatory burden on licensees while maintaining appropriate oversight. The approval of AUs for these uses would be evaluated as part of the NRC's routine inspection program, ensuring AUs have the necessary training and experience to support radiation safety without requiring pre-approval through the licensing process. As shown in table 2, these proposed changes are expected to reduce paperwork and administrative costs, yielding a reduction of 4,208 hours (or $1.2 million, undiscounted) for the licensees per year.
This proposed rule also would reduce unnecessary burden by eliminating outdated and overly broad training and experience requirements for physicians. Instead of mandating individuals provide documentation at time of licensing that they had training or experience within 7 years in uses and administrations that may no longer be relevant or practiced, sometimes in types of use they never will see in practice, the NRC is proposing to streamline requirements to focus solely on the procedures that licensees actively perform, ensuring more efficient and targeted preparation. These proposed changes are expected to reduce paperwork and associated administrative costs related to training and experience requirements. Under the current requirements, licensees must report the information listed in NRC forms 313 and 313a, by either using these forms or their own format, to document training and experience details. The proposed amendments would streamline reportable data by reducing the number of data fields and clarifying what information must be reported, which is expected to lessen burden. These proposed changes would reduce reporting time by an estimated 1.25 hours per submission. Of this reduction, 0.25 hours comes from less time spent reporting on the recentness of training. The remaining savings result from other burden reductions related to training and experience requirements, excluding the diagnostic AU category
Currently, § 35.59 requires individuals to demonstrate related continuing education and experience if their required training and experience was obtained more than 7 years prior to the date of application. This proposed rule would replace this prescriptive licensing requirement that may not align with uses the physician plans to perform with a performance-based continuing education requirement that ensures authorized individuals maintain the necessary education and experience to support radiation safety and regulatory compliance for the uses they are authorized to perform. Although licensees would incur an increase in recordkeeping cost, it is necessary to ensure physicians have necessary education and experience to support radiation safety and regulatory compliance for the uses they are authorized to perform to ensure safety while decreasing costs overall. As shown in table 4, the recordkeeping burden would increase by 1,063 hours (or $308,100, undiscounted) per year for licensees.
The NRC recognizes that, to realize these ongoing savings, licensees and training providers may need to update continuing education programs and revise recordkeeping practices to reflect the new requirements. The NRC has included an estimate for these activities within the overall implementation costs presented in table 24.
As discussed in Sections III.B. and IV.B, “Emerging Medical Technologies,” this proposed rule would codify provisions for 13 EMTs, by establishing clear licensing pathways, defined training and experience requirements, and performance-based safety criteria. Codifying these provisions would reduce reliance on EMT-specific guidance and eliminate the recurring burden associated with application reviews and guidance updates. Based on data presented in the regulatory basis, the NRC estimated measurable burden reductions would occur for well-established EMTs across the NRC, Agreement States, and licensees. Due to the timeline established in E.O. 14300 for publishing this proposed rule, the scope of EMTs addressed in this proposed rule has been narrowed to focus on those with the most extensive history and highest levels of use. In addition, the proposed regulations have been updated to align with the NRC's efforts to reduce burden by establishing performance-based requirements compared to current recommendations contained in licensing guidance where possible. To assess burden, the NRC used data from the regulatory basis for the EMTs listed. For EMTs not included in the regulatory basis, the NRC applied the same methodology from the regulatory basis to the updated EMT list, to ensure consistency. The regulatory basis originally presented cumulative burden estimates over a 15-year period, which the NRC converted to annual estimates for purposes of this regulatory
In addition to this burden reduction, the NRC would save 437 hours for licensing guidance development. As shown in table 6, the aggregate annual savings for the NRC, Agreement States, and licensees would be 13,304 hours (or $1.8 million, undiscounted). These estimated burden reductions reflect reduced staff time associated with licensing reviews license amendment processing, and related administrative and guidance-development activities for EMTs.
Licensees would benefit from the proposed change to codify provisions that reduce reliance on EMT-specific guidance and eliminate the recurring burden associated with application reviews and guidance updates. Specifically:
• Proposed changes that would align with recommended EMT-specific guidance are not expected to impose additional burdens on licensees. The NRC staff determined that no incremental costs are anticipated, and costs for these changes were not included.
• Proposed changes to § 35.60 would allow licensees to use instrumentation that cannot be calibrated according to nationally recognized standards or the manufacturer's instructions. This flexibility is optional and intended to support future innovations, but it is not expected to be used at this time. The NRC subject matter experts determined that no incremental costs are anticipated, and costs for these changes were not included.
• Proposed changes in § 35.41(b)(4) would require licensees to verify computer-generated dose calculations are transferred into a console correctly for all therapeutic uses, not just those authorized by §§ 35.600 and 35.1000. This proposed regulation would not be required for new modalities at this time as they do not currently use computer-driven consoles. The intent of this proposed regulation is to reduce future licensing costs associated with subpart K of 10 CFR part 35 licensing for innovative and emerging medical technologies; NRC subject matter experts determined that cost cannot be estimated at this time because none of these technologies are currently in use.
• Proposed changes in § 35.635(b)(6) would require licensees to determine the operability and availability of emergency response equipment in their full calibration. This requirement is not expected to increase burden because licensees are already required to have emergency response equipment operational and available to implement emergency procedures specified in § 35.610 and perform full calibration of the unit in accordance with § 35.635.
Although the proposed changes to the NRC's microsource regulations would introduce an additional burden on licensees, these changes are intended to make these regulations more flexible and better accommodate both current and future microsource use. The proposed changes that align with
Impacts related to EMT training requirements have already been accounted for in Section VII.B.1, “Training and Experience,” of this document.
As discussed in Sections III.C. and IV.C, “Rubidium-82 Generators,” of this document, this proposed rule would establish formal requirements for Rb-82 generators, including calibration flexibility for radiation detector instrumentation in dynamic use mode and updated licensing and training provisions to replace reliance on enforcement guidance. The proposed regulations are consistent with the criteria required to use enforcement discretion as described in EGM 13-003. Eliminating reliance on enforcement guidance would remove the recurring burden associated with enforcement discretion activities, such as, review of exemption requests and inspections associated with Rb-82 generators. The NRC converted the data presented in the regulatory basis, cumulative burden estimates over a 15-year period, into annual estimates for purposes of this regulatory analysis. As shown in table 8, the NRC estimates 3,145 burden hours (or $435,699, undiscounted) related to enforcement guidance activities would be eliminated on an annual basis across the NRC, Agreement States, and licensees under this proposed rule. These estimated burden reductions reflect reduced staff time associated with licensing, inspection, exemption review, and related administrative activities that would have supported the use of enforcement guidance for Rb-82 generators.
Licensees would incur a small increase in costs due to the recordkeeping requirements associated with this proposed rule change but would benefit and save costs overall from the proposed codification of EGM-13-003. As shown in table 9, the recordkeeping burden would increase by 253 hours (or $43,499, undiscounted) per year for licensees.
The proposed amendments discussed in this section seek to modify existing requirements in several areas of 10 CFR part 35, including those governing written directives, decay-in-storage requirements, medical event reporting criteria, and other provisions. These changes are intended to reduce regulatory burden, increase flexibility, and modernize radiation safety practices for the medical use of byproduct material.
The proposed changes to § 35.40 would remove the requirement that a written directive be prepared for diagnostic administrations of sodium iodide I-131 in quantities greater than 1.11 megabecquerels (30 microcuries). As a result, physicians would no longer need to prepare a written directive prior to these diagnostic administrations and licensees would no longer need to develop, implement, and maintain written procedures in accordance with § 35.41 to use this administration. In addition, physicians who do not perform any other administrations requiring a written directive besides diagnostic administrations of sodium iodide I-131 in quantities greater than 1.11 megabecquerels (30 microcuries) would be able to receive AU status under subpart D. This would reduce the training and experience needed for these physicians to be able to provide this administration as discussed Section VII.A of this document.
As shown in table 10, these proposed changes are expected to reduce paperwork and other administrative costs. A decrease of 15 records per licensee and a one-hour decrease in burden per procedure is estimated to save 6,323 hours (or $1.7 million, undiscounted) annually for licensees performing reporting and recordkeeping for the NRC and Agreement States.
The NRC is proposing to amend § 35.3045(a) to exclude requiring licensees to report events that result from emergent patient conditions that prevent completion of administration as planned unless the administration results or would result in damage as described in § 35.3045(b). In addition, NRC is proposing to amend § 35.40 to allow AUs for microsources to modify written directives after administration. To ensure the NRC continues to receive reports of leaks or defects in administration devices or supplies which can impact multiple licensees in a short time period, the NRC is proposing to add § 35.3045(a)(3). This addition would require reporting when such a leak or defect causes the total dose or dosage delivered to differ from the prescribed dose or dosage specified in the pre-administration portion of the written directive, unless the event results from patient intervention or an emergent patient condition. The cumulative result of these proposed changes would reduce the number of medical events, which would reduce burden in reporting these events to the
Additionally, the NRC is proposing to amend the regulation to add § 35.3047(a)(2) to exclude reporting of exposure to an embryo/fetus if the licensee made a reasonable effort to determine pregnancy status, but pregnancy could not be reasonably excluded prior to the administration by the licensee. As shown in table 12, the projected reductions related to these events are expected to result in a reduced burden of about 28 hours (or $7,903, undiscounted) per year for licensees.
In addition, both these changes would reduce burden to both the NRC and Agreement States as it would reduce reactive inspection follow-ups that occur when the NRC receives a medical or fetal/embryo event. As shown in table 13, the projected reduction related to these events would reduce burden by 48 hours per year for the NRC and 120
In addition, the NRC requires Agreement States to submit reports to the Nuclear Material Events Database (NMED) each time a qualifying medical event occurs at one of their licensee's facilities within their state. With this proposed rule, the number of respondents would decrease resulting in a reduction in reporting obligations to the NRC. As shown in table 14, the projected savings are expected to result in a reduced burden of about 145 hours (or $18,129, undiscounted) per year for Agreement States.
The NRC is proposing to amend § 35.92 to increase the allowable physical half-life for byproduct material eligible for decay-in-storage (DIS) from 120 days to 275 days. This proposed change would allow licensees to use DIS for longer-lived materials, such as Lu-177m, which is becoming more prevalent in medical facilities as new Lu-177 radiopharmaceuticals receive FDA approval. By allowing these materials to decay on-site until they are no longer radioactive, rather than requiring disposal as radioactive waste under subpart K of 10 CFR part 20, the proposed amendment would reduce waste disposal costs for licensees. NRC staff has determined this would likely result in fewer low level waste shipments overall, reducing costs associated with packaging, transportation, and disposal fees for the licensees. As shown in table 15, these reductions are estimated to yield annual undiscounted savings of $584,800 for licensees. This value is subject to the use of Lu-177 containing Lu-177m by licensees and savings may vary due to differences in licensee-specific practices.
Most licensees that would benefit from this proposed change already operate a DIS program for isotopes with half-lives of 120 days or less and maintain dedicated secured space that complies with regulatory requirements.
The NRC is proposing to amend § 35.6 to eliminate the requirement for licensees to submit a license amendment before conducting research involving human subjects, provided the licensee is already authorized for the medical use of byproduct material and has obtained IRB approval and informed consent from the research subject. This would reduce the number of license amendments required. As shown in table 17, the estimated reduction related to the elimination of research application information is expected to result in a reduced burden of 204 hours (or $35,033, undiscounted) per year for licensees.
In addition, this change would reduce burden to both the NRC and Agreement States as it would reduce license amendment review time. This proposed change would reduce the burden on both the NRC and Agreement States by decreasing the time needed to review license amendments. As shown in table 15, these reductions are estimated to yield annual undiscounted savings of $584,800 for both the NRC and Agreement States.
The NRC is proposing to amend regulations specific to mobile medical services contained in § 35.80 to eliminate prescriptive requirements that are redundant to regulations contained in 10 CFR part 20 and other sections of 10 CFR part 35. Conforming changes are being proposed to remove associated survey records as currently required in § 35.2080(b). As shown in table 19, these proposed changes are expected to reduce recordkeeping requirements, resulting in estimated annual savings of about 426 hours (or $73,156, undiscounted) per year for licensees.
The NRC proposes to amend § 35.24(c) to extend the allowable duration for a qualified individual to serve as a temporary RSO from 60 days to 120 days per calendar year. This would reduce the number of license amendments required. As shown in table 20, these proposed changes are expected to reduce paperwork burden, resulting in estimated annual savings of about 18 hours ($2,919, undiscounted) per year for licensees.
Similarly, the NRC and Agreement States would realize an estimated annual savings of 17 hours (or $2,186, undiscounted) per year for reduced requirements regarding reviewing and processing RSOs. This reduction is based on eliminating two RSO reviews per year for the NRC (at 1 hour per review) and 15 RSO reviews per year for the Agreement States (at 1 hour per review), as shown in table 21.
In addition, the NRC proposes to revise the requirements to the RSC contained in § 35.24(f). First, with the addition of microsources, this proposed rule is updated to include subpart I and K and clarifies that an RSC is only required if a licensee is authorized for two or more different types of uses or units that require written directives. As shown in table 22, the projected increase in burden is estimated at 42.5 hours (or $7,298, undiscounted) annually for licensees. This estimate is based on expanded reporting requirements due to the inclusion of microsources under subparts I and K of 10 CFR part 35.
In addition, this proposed rule would remove the requirements for a representative of the nursing service to be part of an RSC. This would reduce an average of 4 hours of a nurse's time for all licensees who are required to have an RSC. As shown in table 23, this elimination is estimated to yield 4,640 hours savings (or $525,731, undiscounted) annually for licensees.
For the purposes of this analysis, rulemaking costs consist of non-recurring expenses incurred by the NRC to complete the rulemaking process and transition to compliance with the final requirements. Implementation costs consist of non-recurring expenses incurred by the NRC, Agreement States, and affected licensees to transition to compliance with the final rule, including updates to guidance, procedures, and internal processes. Proposed provisions that would result in recurring costs are discussed in Sections VII.B.1 through VII.B.4 of this document and are therefore not included in this section. The NRC would incur about 1,000 hours of effort (or $158,000, undiscounted) to implement this rule, if finalized.
Agreement States would need to assess compatibility with the NRC's final rule, update state regulations and procedures as necessary, and inform affected licensees. While the rule is deregulatory, existing stringent requirements remain consistent with safety mandates. The NRC estimates that, if this proposed rule were to become final, Agreement States implementing this rule with respect to EMTs and Rb-82 generators, would incur an estimated cost of $760,000, undiscounted, as they would need to update their regulatory framework to reflect changes introduced by the NRC's final rule and ensure compatibility for licensing and oversight of these technologies. This effort ensures compliance with compatibility standards and provides the necessary authority for Agreement States to issue licenses for EMTs and Rb-82 generators. For the other changes associated with this proposed rule, because the effect of the rule would be deregulatory, the more stringent requirements currently required by Agreement States would be consistent with the mandate to adequately administer safety regulations. However, Agreement States would be likely to expend resources to amend state regulations and guidance documents to be consistent with this rule, if finalized. The NRC staff did not quantify these costs due to the expectation that the costs would be minor relative to the net benefits and are difficult to quantify.
Licensees and industry stakeholders would need to update compliance programs and internal procedures on the new requirements, if finalized. Because this would be a deregulatory rule, the implementation burden would be minimal and occur only during the initial period. The largest implementation burden would come from the revision to § 35.59 to replace the prescriptive recentness of training and experience requirement with a performance-based continuing education requirement. On average, each licensee is anticipated to spend 2 hours on implementation activities with licensees that have a greater number of AUs requiring more time than those with fewer AUs. In addition, there may be some implementation burden associated with appropriate licensees establishing a process to authorize diagnostic AUs without submitting a license amendment. However, this burden is expected to be small because licensees already maintain a process for preparing license applications to demonstrate that these individuals meet the authorized user training and experience requirements; the only change is that this information would no longer need to be submitted to the NRC. The remaining implementation burden would be relatively minor or would occur during the licensing process and due to the deregulatory action of the rule, would result in net burden reduction as already reflected above. As shown in table 24, the licensees implementing this rule would incur about 8,500 hours of effort, or an estimated cost of $1.9 million, undiscounted.
Overall, this proposed rule is considered a deregulatory action and would be expected to reduce barriers to medical use licensing by enabling more efficient and predictable licensing, increasing flexibility, and easing administrative burden for the NRC, Agreement States, licensees, and individuals or entities that seek medical use licenses. Over the 5-year analysis period (2027-2031), the proposed revisions are estimated to generate net savings of $39.1 million (savings minus costs), undiscounted. As shown in table 25, the NPV of these net savings would be $35.6 million, discounted at 3 percent, or $31.7 million, discounted at 7 percent. The projected annualized cost savings would be $7.2 million discounted at 3 percent, or $6.4 million discounted at 7 percent. Although this proposed rule would reduce barriers to medical use licensing and generate savings, some costs would still be incurred over the 5-year period, primarily due to expanded recordkeeping requirements and implementation costs. The additional recordkeeping costs, which represent operational costs for licensees, are estimated at $2.4 million (undiscounted), $2.2 million (discounted at 3 percent), and $2.0 million (discounted at 7 percent) over this 5-year period. Implementation costs for both NRC and industry stakeholders are estimated at about $2.9 million (undiscounted), $2.8 million (discounted at 3 percent), and $2.7 million (discounted at 7 percent). The combined implementation and compliance costs for both NRC and industry stakeholders, as well as expanded recordkeeping requirements in some areas for licensees, are estimated at about $5.3 million (undiscounted), $5.0 million (discounted at 3 percent), and $4.7 million (discounted at 7 percent).
The licensees, accounting for the largest share of net cost savings, would save about $30.5 million over the 5-year analysis horizon, undiscounted, with an NPV of $27.8 million discounted at 3 percent, or $24.8 million discounted at 7 percent. The Agreement States would realize net cost savings of about $7.4 million over 5 years, undiscounted, with an NPV of $6.7 million discounted at 3 percent, or $6.0 million discounted at 7 percent. During the same period, the NRC would save about $1.2 million over 5 years, undiscounted, with an NPV of $1.1 million discounted at 3 percent, or $964,000 discounted at 7 percent.
The annualized costs are approximately $970,000 per year at a 3 percent discount rate, and $865,000 per year at a 7 percent discount rate. The annualized cost savings are approximately $8.1 million per year at a 3 percent discount rate, and $7.2 million per year at a 7 percent discount rate. Therefore, the annualized net cost savings are estimated at $7.2 million per year at a 3 percent discount rate and $6.4 million per year at a 7 percent discount rate.
In addition to the quantified savings, the NRC notes that this proposed rule would be expected to provide qualitative benefits to medical use licensees by enhancing regulatory clarity and predictability. By consolidating and modernizing requirements, the rule reduces ambiguity that has historically led to inconsistent interpretations and delays. Clearer, performance-based standards for training, experience, and emerging technologies will foster greater confidence in compliance and reduce the need for repeated consultations with regulators. This improved transparency would support a more streamlined licensing process and strengthen trust between licensees and regulators.
This proposed rule also promotes innovation and adaptability in medical use licensing. Codifying pathways for emerging medical technologies and updating requirements for generator systems ensures that licensees can adopt new devices and therapies without prolonged reliance on case-by-case guidance. This forward-looking approach positions the regulatory framework to accommodate future
Finally, updates to training and experience requirements would allow licensees to receive authorization more quickly for future users and uses under § 35.300, which is critical given the anticipated growth in therapeutic radiopharmaceuticals. By recognizing accredited residency programs and introducing continuing education provisions, the rule aligns regulatory expectations with modern medical education practices. This flexibility helps address workforce challenges and supports timely onboarding of qualified practitioners, ensuring that patients benefit from expanded access to specialized care without unnecessary administrative delays.
The NRC's backfitting provisions (which are found in the regulations at §§ 50.109, 70.76, 72.62, and 76.76) and issue finality provisions of 10 CFR part 52 do not apply to this rule. The regulations in 10 CFR part 35 do not contain a backfitting provision, and this rulemaking would not impact activities authorized by 10 CFR parts 50, 52, 70, 72, or 76. As a result, this rulemaking would not constitute “backfitting” as defined in 10 CFR chapter I or otherwise affect the issue finality of a 10 CFR part 52 approval.
The NRC seeks to minimize potential negative consequences resulting from the cumulative effects of regulation (CER). The NRC believes that the de-regulatory impacts of this rulemaking activity are unlikely to cause implementation challenges for stakeholders. In addition, during the pendency of this rulemaking, the NRC is deprioritizing issuance of regulatory actions that might influence the implementation date for the new rule requirements (
To fully understand any potential CER implications that could result from this rulemaking, the NRC is asking the following questions. Response to these questions is voluntary and any input will be considered during development of the final rule.
1. The NRC is proposing an effective date that will be 30 days after the date of publication of a final rule. Does this provide sufficient time to implement the proposed requirements? Please provide a rationale for your response.
2. Are there unintended consequences related to this rulemaking and how should they be addressed? Please provide a rationale for your response.
3. Please comment on the NRC's cost and benefit estimates in the regulatory analysis that supports this proposed rule.
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885). The NRC requests comment on this document with respect to the clarity and effectiveness of the language used.
The NRC has prepared this environmental assessment (EA) of this proposed rule amending regulations to reduce barriers to medical use licensing to determine the significance of the environmental effects of the proposed agency action in accordance with the National Environmental Policy Act of 1969, as amended (NEPA) and NRC's NEPA implementing regulations in 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” As explained below, the NRC has determined that the proposed agency action to modernize NRC regulations for medical use licensing would have no significant effect on the quality of the human environment.
Proposed rule changes would occur in 10 CFR part 35. Conforming changes would be made to guidance at a later date consistent with changes to regulations. Table 26 lists the sections of the regulations being changed and affected guidance.
Conforming changes are administrative actions with no physical environmental effect and provide for the appropriate administrative and regulatory framework for byproduct material use under title 10 of the CFR. An example would be adding a reference to a newly created subsection in an existing regulation. All amendments to NRC regulations in this proposed rule occur within the affected regulation.
The NRC has determined that some of the changes to the regulations identified in this proposed rule meet criteria for categorical exclusion under § 51.22, “Categorical exclusions.” Categorical exclusions provide a mechanism to identify Federal actions that normally do not have a significant environmental effect on the human environment and for which neither an environmental assessment nor environmental impact statement is normally required. This ensures that resources are not expended on the environmental analysis of proposed actions that do not present the potential for significant environmental effects. Rule amendments with applicable categorical exclusions are presented in table 27 and no further NEPA analysis is required.
These proposed rule amendments belong to categories of actions that the
The following rulemaking actions meet the criterion for categorical exclusion under § 51.22(a)(1) or (2):
These proposed rule amendments include administrative and procedural changes—taking place in an office setting, relying on paper or electronic (
The NRC also evaluated rule amendments that have the potential to affect the human environment and determined that the proposed agency action (rulemaking) would not have a significant environmental effect. These rule amendments would clarify NRC regulations, would not change existing radiation protection and emergency preparedness requirements or overall risk, would continue to provide reasonable assurance of adequate protection of public health and safety, and would result in no new or different environmental effects. The following table presents the basis for why these proposed rule amendments would have no significant environmental effects.
These proposed rule amendments would modernize existing NRC regulations while ensuring the continued safe, effective, and efficient medical use licensing to provide reasonable assurance of adequate protection of public health and safety. As noted in table 28, these amendments consist of administrative and procedural changes and would not authorize any site-specific action on the part of the NRC or licensee. Implementation of these amendments would have no significantly different environmental effects than those from the current regulatory framework.
Implementation of this rule, if finalized, would result in no physical changes to the environment, and, therefore, the NRC has determined that this proposed agency action will not have a significant effect on the quality of the human environment. Proposed rule amendments are administrative in application, matters of procedure, clarify record keeping and reporting requirements, and would provide an equivalent level of safety and security as current NRC regulations.
Since no physical changes would occur in the human environment, the proposed agency action (rulemaking) would not affect any threatened or endangered species or historic properties. Accordingly, the NRC finds that this proposed rulemaking would have no significant environmental impact.
Under the no-action alternative (the status quo), NRC regulations would remain unchanged. As stated in Section B of this EA, this proposed rule would not have a significant effect on the quality of the human environment. Therefore, the no-action alternative and the proposed agency action (proposed rulemaking) would have the same environmental effect, although there would be costs attributable to reviewing the environmental effects of exemption and license amendment requests under the no-action alternative. Licensees would continue to comply with existing NRC regulations or request regulatory relief (exemption) from the regulations. The NRC would continue to evaluate the environmental effects of exemption and license amendment requests. The averted costs (benefits) of the rulemaking would not occur. The regulatory analysis for this proposed rule provides information about the costs and benefits of the no-action alternative and the proposed agency action, as discussed in Section VII., of this document, “Regulatory Analysis.”
The NRC is requesting public comment on this draft EA. Comments on this draft EA may be submitted to the NRC as indicated under the
As discussed in Section B of this EA, these proposed rule provisions would not have a significant effect on the quality of the human environment. For this reason, this proposed rule would not impact threatened or endangered species or critical habitat, and the NRC has determined that section 7 consultation under the Endangered Species Act of 1973, as amended, is not necessary. These proposed regulatory changes do not involve any ground disturbing activities or visual effects that would adversely affect historic properties. Therefore, the NRC has determined that consultation is not required under section 106 of the National Historic Preservation Act of 1966, as amended.
The NRC has prepared this EA to determine the environmental effects of the proposed agency action (rulemaking). Proposed rule amendments are primarily administrative or procedural in nature and thus would not have any physical environmental effect. As explained in the EA, the NRC has determined this proposed rulemaking would not change radiation protection and emergency preparedness requirements or overall risk, would continue to provide reasonable assurance of adequate protection of public health and safety, and would result in no new or different environmental effects. Therefore, the NRC concludes that the proposed regulatory changes would not have a significant effect on the quality of the human environment. Based on this conclusion, the NRC has determined there is no need to prepare an environmental impact statement. Accordingly, the NRC finds the proposed agency action would have no significant environmental impact. This environmental assessment and finding of no significant impact can be tracked with identification number NEPA ID EAXX-429-00-000-1770620320.
This proposed rule contains new and amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This proposed rule has been submitted to the Office of Management and Budget for review and approval of the information collections.
The NRC is proposing to amend its regulations to reduce barriers to medical use licensing. This proposed rule would reduce overly prescriptive requirements, increase regulatory flexibility, and modernize radiation safety practices for the medical use of byproduct material. It also would enable more efficient and predictable licensing for emerging medical technologies and reduce unnecessary burden associated with training and experience requirements for medical authorized users. This effort is consistent with, and implements, the direction in Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission,” which directs the NRC to conduct a comprehensive review and revision of its regulations.
This proposed rule addresses a wide range of topics, including the following areas that result in new or revised recordkeeping and reporting requirements involving:
• Research applications,
• Applications,
• Temporary RSOs,
• Instrument calibrations,
• Medical events,
• Dose to an embryo/fetus or a nursing child,
• Generator elutions,
• Radiation Safety Committees,
• Mobile medical services,
• Radiation safety,
• Continuing education,
• Decay-in-storage,
• Permissible concentrations for generator-produced radionuclides,
• Microsource brachytherapy, and
• Safety precautions for patients not eligible for release.
This supporting statement includes the burden associated with new and revised information collections in 10 CFR part 35, the Nuclear Material Events Database (NMED), and NRC Forms 313A (RSO), 313A (AMP), 313A (ANP), 313A (AUD), 313A (AUT), and 313A (AUS). It also includes burden associated with new information collection in proposed Form 313A (AUM).
The NRC is seeking public comment on the potential impact of the information collections contained in this proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility? Please explain your response.
2. Is the estimate of the burden of the proposed information collection accurate? Please explain your response.
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? Please explain your response.
4. How can the burden of the proposed information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology? Please explain your response.
A copy of the OMB clearance package and proposed rule are available in the “Availability of Documents” section of this document or may be viewed free of charge by contacting the NRC's Public Document Room reference staff at 1-800-397-4209, at 301-415-4737, or by email to
You may submit comments on any aspect of these proposed information collection(s), including suggestions for reducing the burden and on the above issues, by the following method:
Submit comments by August 26, 2026.
The NRC may not conduct or sponsor, and a person is not required to respond to a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.
The following are Executive orders that are related to this proposed rule:
The Office of Information and Regulatory Affairs (OIRA) has determined that this proposed rule is a significant regulatory action under section 3(f) of E.O. 12866; though not economically significant under section 3(f)(1). Accordingly, the NRC submitted this proposed rule to OIRA for review. The NRC is required to conduct an economic analysis in accordance with section 6(a)(3)(B) of E.O. 12866. More can be found in Section VII of this document, “Regulatory Analysis.”
The NRC has examined this proposed rule and has determined that it is consistent with the policies and directives outlined in E.O. 14154.
This action is tentatively determined to be a deregulatory action as defined by E.O. 14192. Details on the estimated costs of this proposed rule can be found in Section VII, of this document, “Regulatory Analysis.”
E.O. 14267 requires the NRC to identify anti-competitive regulations for rescission or modification. The NRC identified the definition of physician listed in § 35.2 because the regulation creates a barrier to market participation by limiting the pool of eligible employees to work in this role. The proposed modification of the regulation supports the objectives of E.O. 14267 by removing regulatory requirements that could create unnecessary barriers to entry for new market participants. In addition, the NRC identified that training and qualification requirements contained in 10 CFR part 35 create a barrier to entry and restrict the flexibility of training pathways by favoring existing qualification certifying organizations and specialty boards. The proposed modification of the regulation to expand flexible training options supports the objectives of E.O. 14267 by removing unnecessary barriers to entry for new market participants.
E.O. 14270, “Zero-Based Regulatory Budgeting to Unleash American Energy,” requires the NRC to insert a conditional sunset date into all new or amended NRC regulations provided the regulations are (1) promulgated under the Atomic Energy Act (AEA), the Energy Reorganization Act of 1974, as amended (ERA), or the Nuclear Waste Policy Act of 1982, as amended; (2) not statutorily required; and (3) not part of the NRC's permitting regime. The NRC determined that the regulatory changes proposed in this rule are required because they would be necessary for providing reasonable assurance of adequate protection of public health and safety and provide for the common defense and security and would be part of the NRC's permitting regime authorized by the AEA. Therefore, the NRC views this rulemaking to be
This proposed rule includes Federal regulations that, if adopted, would be enforceable by criminal penalty, as authorized by section 223 of the AEA. Therefore, per E.O. 14294, those regulations constitute “criminal regulatory offenses.”
For the purposes of section 223 of the AEA, the NRC is issuing this proposed rule that would amend 10 CFR part 35 under one or more of sections 161b, 161i, or 161o of the AEA, except as noted in § 35.4002(b). The applicability of criminal penalties to regulations in 10 CFR part 35 is set forth in § 35.4002(a). Willful violations of the 10 CFR part 35 regulations, other than those listed in § 35.4002(b), would be subject to criminal enforcement.
The working group that prepared this proposed rule included a representative from the Organization of Agreement States. Comments from the Agreement States representative were taken into consideration during the development of this proposed rule.
On the basis of the “Agreement State Program Policy Statement” approved by the Commission on October 2, 2017, and published in the
Compatibility Category A are those program elements that include basic radiation protection standards and scientific terms and definitions that are necessary to understand radiation protection concepts. Compatibility Category A program elements adopted by an Agreement State should be essentially identical to those of the NRC to provide uniformity in the regulation of agreement material on a nationwide basis.
Compatibility Category B pertains to a limited number of program elements that cross jurisdictional boundaries and should be addressed to ensure uniformity of regulation on a nationwide basis. For Compatibility Category B, the Agreement State program element shall be essentially identical to that of NRC.
Program elements in Compatibility Category C include those program elements that are important for an Agreement State to have in order to avoid conflict, duplication, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a national basis. An Agreement State program shall embody the essential objectives of the Category C program elements. Under Category C, Agreement State program elements may be more restrictive than NRC program elements; however, they should not be so restrictive as to prohibit a practice authorized by the AEA, as amended, and in the national interest without an adequate public health and safety or environmental basis related to radiation protection.
Compatibility Category D are those program elements that do not meet any of the criteria of Category A, B, or C, above, and are not required to be adopted by Agreement States for purposes of compatibility. An Agreement State has the flexibility to adopt and implement program elements within the State's jurisdiction that are not addressed by the NRC or that are not required for compatibility (
Compatibility Category NRC are those program elements that address areas of regulation that cannot be relinquished to the Agreement States under the AEA, or provisions of 10 CFR. The NRC maintains regulatory authority over these program elements and the Agreement States must not adopt these NRC program elements. However, an Agreement State may inform its licensees of these NRC requirements through a mechanism under the State's administrative procedure laws, as long as the State adopts these provisions solely for the purposes of notification and does not exercise any regulatory authority as a result.
Category H&S program elements embody the basic health and safety aspects of the NRC's program elements. Although H&S program elements are not required for purposes of compatibility, they do have particular health and safety significance. The Agreement State must adopt the essential objectives of such program elements to maintain an adequate program.
This proposed rule is a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among Agreement State and NRC requirements. For amended and redesignated requirements, the NRC is not proposing any changes to the current compatibility designations for those requirements. However, for § 35.300, which would not be revised as part of this proposed rulemaking, the NRC is proposing to change its compatibility designation as it was identified to have been erroneously assigned as Category B the last time the section was revised. Since § 35.300 does not have cross jurisdictional impacts, the NRC is proposing the compatibility category revert to its original designation of Category H&S (67 FR 20250; April 24, 2002). There are also several requirements pertaining to outdated regulations needed for implementation of previous rulemakings and duplicative requirements being removed. Agreement States are encouraged, but not required to, also remove those regulations. Agreement States keeping their equivalent to those outdated and duplicative requirements would not lead to a disorderly pattern of regulation on a nationwide basis.
The compatibility (A, B, C, D, and NRC) and adequacy (H&S) categories are designated in the following table:
The ACMUI established a subcommittee to review and comment on the draft proposed rule. The subcommittee will make its recommendations on this proposed rule at a publicly held teleconference with the full committee during the public comment period.
The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this proposed rule, the NRC would revise the NRC requirements in 10 CFR part 35 to reduce overly prescriptive regulations, increase flexibility, and modernize radiation safety practices for the medical use of byproduct material. This action also would enable more efficient and predictable licensing for emerging medical technologies and reduce unnecessary burden in training and experience requirements for medical authorized users. This action does not constitute the establishment of a standard that contains generally applicable requirements.
The NRC expects to update NUREG-1556, Volume 9, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses,” to make changes to conform with this rulemaking effort. To support an accelerated development schedule for this proposed rule, the updates will be made in a future revision of the guidance, rather than concurrently with this rulemaking. The NRC is issuing interim guidance, in the form of frequently asked questions, for implementation of the requirements in this rulemaking, as finalized. The draft guidance is available in ADAMS under Accession No. ML26167A223 and in the docket for this proposed rule (NRC-2025-1237). You may submit comments on the draft regulatory guidance by the methods outlined in the
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at
Biologics, Byproduct material, Criminal penalties, Drugs, Health facilities, Health professions, Labeling, Medical devices, Nuclear energy, Nuclear materials, Occupational safety and health, Penalties, Radiation
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing to amend 10 CFR part 35.
Atomic Energy Act secs. 81, 161, 181, 182, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282, 2021); Energy Reorganization Act sec. 201, 206 (42 U.S.C. 5841, 5846); 44 U.S.C. 3504 note.
The revisions and additions read as follows:
(1) Meets the requirements in §§ 35.59 and 35.190, 35.290, 35.390(b), 35.392(b), 35.394(b), 35.490(b), 35.590(b), or 35.690(b); or
(2) Is identified as an authorized user on—
(i) A Commission or Agreement State license that authorizes the medical use of byproduct material;
(ii) A permit issued by a Commission master material licensee that is authorized to permit the medical use of byproduct material;
(iii) A permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material; or
(iv) A permit issued by a Commission master material license broad scope permittee that is authorized to permit the medical use of byproduct material.
(1) In a written directive; or
(2) In accordance with the directions of the authorized user for procedures performed pursuant to §§ 35.100 and 35.200.
(b) Before conducting research, the licensee must—
(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy for the Protection of Human Subjects (Federal Policy); and
(2) Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subject.
(c) Nothing in this section relieves licensees from complying with the other requirements in this part.
The revision reads as follows:
(b) The approved information collection requirements contained in this part appear in §§ 35.12, 35.13, 35.14, 35.19, 35.24, 35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.59, 35.60, 35.61, 35.63, 35.67, 35.69, 35.70, 35.75, 35.76, 35.80, 35.92, 35.93, 35.190, 35.204, 35.290, 35.310, 35.315, 35.390, 35.392, 35.394, 35.396, 35.404, 35.406, 35.410, 35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 35.652, 35.655, 35.690, 35.710, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 35.2059, 35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 35.2093, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 35.2630, 35.2632, 35.2642,
The revisions read as follows:
(a) A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer byproduct material for medical use only in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) of this section.
(b) An application for a license for medical use of byproduct material must be made by—
(1) Filing an original NRC Form 313, “Application for Material License,” that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officer(s), authorized user(s), authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s); and
(2) Submitting procedures required by §§ 35.60, 35.610, 35.642, 35.643, and 35.645, as applicable.
(c) A request for a license amendment or renewal must be made by—
(1) Submitting an original of either—
(i) NRC Form 313, “Application for Material License”; or
(ii) A letter containing all information required by NRC Form 313; and
(2) Submitting procedures required by §§ 35.60, 35.610, 35.642, 35.643, and 35.645, as applicable.
(d) In addition to the requirements in paragraphs (b) and (c) of this section, an application for a license or amendment for medical use of byproduct material as described in § 35.1000 must also include:
(1) Any additional aspects of the medical use of the material that are applicable to radiation safety that are not addressed in, or differ from, subparts A through C, L, and M of this part;
(2) Identification of and commitment to follow the applicable radiation safety program requirements in subparts D through I of this part that are appropriate for the specific § 35.1000 medical use;
(3) Any additional specific information on—
(i) Radiation safety precautions and instructions;
(ii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and
(iii) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and
(4) Any other information requested by the Commission in its review of the application.
The revisions read as follows:
A licensee must apply for and must receive a license amendment—
(b) Before it permits anyone to work as an authorized user for medical use of byproduct material as described in §§ 35.300, 35.400, 35.600, 35.700, and 35.1000, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist under the license, except—
(1) For an authorized user, an individual who meets the requirements in §§ 35.59 and 35.390(b), 35.392(b), 35.394(b), 35.490(b), 35.590(b), and 35.690(b);
(f) Before it adds to or changes the areas of use identified in the application or on the license, including areas used in accordance with either § 35.100 or 35.200 if the change includes addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area. Other areas of use where byproduct material is used only in accordance with either § 35.100 or 35.200 are exempt;
(h) Before it revises procedures required by §§ 35.60, 35.610, 35.642, 35.643, 35.645, and 35.710, as applicable, where such revision reduces radiation safety; and
The addition and revision read as follows:
(a) * * *
(3) Radiation protection program changes that do not require a license amendment and are permitted under § 35.26.
(f) Licensees that are authorized for two or more different types of uses of byproduct material under subparts E, F, H, I, and K of this part which require a written directive, or two or more types of units under subpart H of this part, must establish a Radiation Safety Committee to oversee all uses of byproduct material permitted by the license. The Committee must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. The Committee may include other members the licensee considers appropriate.
(g) A licensee must provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to—
(1) Identify radiation safety problems;
(2) Initiate, recommend, or provide corrective actions;
(3) Stop unsafe operations;
(4) Verify implementation of corrective actions; and
(5) Verify the training and experience of an individual meets § 35.190 prior to authorizing use under §§ 35.100 and 35.290 prior to authorizing use under § 35.200.
(a) * * *
(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the licensee's written radiation protection procedures, procedures for administrations requiring a written directive, regulations of this chapter, and license conditions with respect to the use of byproduct material; and
(a) A written directive must be dated and signed by an authorized user before the administration of any therapeutic dosage of unsealed byproduct material or any therapeutic dose of radiation from byproduct material.
(1) If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record. A written directive must be prepared within 48 hours of the oral directive.
(2) After administration, the portion of the written directive described in (5)(ii) and (6)(ii) of this part must be signed and dated by an authorized user within 24 hours if the treatment site, total source strength, dose or activity administered changes.
(b) The written directive must contain the patient or human research subject's name and the following information—
(1) For an administration of a therapeutic dosage of unsealed byproduct material: the radioactive drug, dosage, and route of administration;
(2) For gamma stereotactic radiosurgery: the total dose for each treatment site(s); dose per fraction and the number of fractions for treatment plan with multiple fractions; and geometry settings;
(3) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;
(4) For high dose-rate remote afterloading brachytherapy: The radionuclide, treatment site, dose per fraction, number of fractions, and total dose;
(5) For permanent manual or microsource brachytherapy:
(i) Before administration: The treatment site, the radionuclide, and the total source strength or prescribed dosage; and
(ii) After administration but before the patient leaves the post-treatment recovery area: The treatment site, the number of sources and total source strength or activity administered, and the date; or
(6) For all other brachytherapy, including low, medium, and pulsed dose-rate remote afterloaders:
(i) Before administration: The treatment site, radionuclide, and dose; and
(ii) After administration but before completion of the procedure: The treatment site; number of sources; total source strength and exposure time (or the total dose); and date.
(d) The licensee must retain a copy of the written directive in accordance with § 35.2040.
(b) At a minimum, the procedures required by this section must address the following items that are applicable to the licensee's use of byproduct material—
(4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units;
(6) Determining, for permanent manual brachytherapy, within 60 calendar days from the date the administration was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-administration portion of the written directive, unless a written justification of patient unavailability is documented.
The revisions and additions read as follows:
(b)(1) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State under § 35.58(l), has experience with the radiation safety aspects of similar types of use of byproduct material for which the licensee seeks the approval of the individual as Radiation Safety Officer or an Associate Radiation Safety Officer, and meets the requirements in paragraph (d) of this section; or
(3) Has experience with the radiation safety aspects of types of use of byproduct material for which the individual is seeking approval both as the Radiation Safety Officer and the authorized user on the same medical use license or medical use permit issued by a Commission master material licensee. The individual must also meet the requirements in paragraph (d) of this section; or
(c) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(k); and
(d) Has training in radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a Radiation Safety Officer, an Associate Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.
The revision and addition read as follows:
(a) * * *
(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) and (c) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in § 35.51,
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(l); and
The revision and addition read as follows:
(a) * * *
(2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraph (a)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist; or
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(m).
The addition and revisions read as follows:
(b) * * *
(2) * * *
(i) For uses authorized under § 35.100 or 35.200, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine;
(4) Physicians identified as authorized users for the medical use of byproduct material under § 35.1000 on a license issued by the Commission or an Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State broad scope licensee, or a permit issued in accordance with a Commission master material broad scope license on or before [DATE 30 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
(i) For uses authorized under § 35.400 for ophthalmic treatments, need not comply with training requirements of § 35.491 except for device-specific training under § 35.491(c) for any devices for which they were not authorized prior to this date.
(ii) For uses authorized under § 35.600, need not comply with training requirements under § 35.690 except for device-specific training under § 35.690(c) for any devices for which they were not authorized prior to this date; and
(iii) For uses authorized under § 35.700, need not comply with training requirements of § 35.790 except for microsource training under § 35.790(c) for any microsources for which they were not authorized prior to this date.
The names of board certification that have been recognized by the Commission or an Agreement State to confirm a physician has adequate training and experience for medical use of byproduct material are posted on the NRC's Medical Uses Licensee Toolkit web page.
(a) To have its certification process recognized for unsealed byproduct material uses authorized under § 35.100, a specialty board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program as described in § 35.190(a)(1); or
(2) Successfully complete 60 hours of training and experience as described in § 35.190(a)(2); and
(3) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control.
(b) To have its certification process recognized for unsealed byproduct material uses authorized under § 35.200, a specialty board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program as described in § 35.290(a)(1); or
(2) Successfully complete 700 hours of training and experience as described in § 35.290(a)(2); and
(3) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control.
(c) To have its certification process recognized for unsealed byproduct material uses authorized under § 35.300, a specialty board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program in nuclear medicine or radiation oncology as described in § 35.390(a)(1); or
(2) Successfully complete an accredited residency training program in a related medical specialty and complete 700 hours of training and experience as described in § 35.390(a)(2); and
(3) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required.
(d) To have its certification process recognized under § 35.300 for oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries), a specialty board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program in nuclear medicine or radiation oncology as described in § 35.392(a)(1); or
(2) Successfully complete an accredited residency training program
(3) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required.
(e) To have its certification process recognized under § 35.300 for oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), a specialty board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program in nuclear medicine or radiation oncology as described in § 35.394(a)(1); or
(2) Successfully complete an accredited residency training program in a related medical specialty and complete 80 hours of training and experience as described in § 35.394(a)(2)(i) through (a)(2)(ii)(E); and
(3) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required.
(f) To have its certification process recognized for unsealed byproduct material uses authorized under § 35.300 for parenteral administration requiring a written directive, a specialty board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program in nuclear medicine or radiation oncology as described in § 35.396(a)(1); or
(2) Successfully complete an accredited residency training program in a related medical specialty and complete 80 hours of training and experience as described in § 35.396(a)(2)(i) through (a)(2)(ii)(E); and
(3) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required.
(g) To have its certification process recognized for unsealed byproduct material uses authorized under § 35.400, a specialty board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program in radiation oncology and training and experience as described in § 35.490(a)(1) and (2); and
(2) Pass an examination, administered by diplomates of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy;
(h) To have its certification process recognized for unsealed byproduct material uses authorized under § 35.500, a specialty board must require all candidates for certification to obtain training and experience described in § 35.590.
(i) To have its certification process recognized for unsealed byproduct material uses authorized under § 35.600, a specialty board must require all candidates for certification to:
(1) Successfully complete an accredited residency training program in radiation oncology and training and experience as described in § 35.690(a)(1) and (2); and
(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy;
(j) [Reserved]
(k) To have its certification process recognized for individuals fulfilling the responsibilities of the Radiation Safety Officer or an individual's assigned duties and tasks as an Associate Radiation Safety Officer, a specialty board must require all candidates for certification to:
(1)
(i) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science;
(ii) Have 5 or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics; and
(iii) Pass an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or
(2)
(i) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;
(ii) Have 2 years of full-time practical training and/or supervised experience in medical physics—
(A) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Commission or an Agreement State; or
(B) In clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in § 35.57, 35.290, or 35.390; and
(iii) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety;
(l) To have its certification process recognized for individuals fulfilling the responsibilities of an authorized medical physicist, a specialty board must require all candidates for certification to:
(1) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;
(2) Have 2 years of full-time practical training and/or supervised experience in medical physics—
(i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board whose certification process has been recognized under this section by the Commission or an Agreement State; or
(ii) In clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements in § 35.57, 35.490, or 35.690; and
(3) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery;
(m) To have its certification process recognized for individuals fulfilling the responsibilities of an authorized nuclear pharmacist, a specialty board must require all candidates for certification to:
(1) Have graduated from a pharmacy program accredited by the Accreditation
(2) Hold a current, active license to practice pharmacy;
(3) Provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and
(4) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, and research and development.
(a) The licensee must ensure an authorized user has continuing education and experience preceding the medical use of a source, microsource, device, or radioactive drug for administrations requiring a written directive. This must include, at a minimum—
(1) Education or experience in the administration of the source, microsource, device, or radioactive drug within the 7 years preceding administration; and
(2) Instruction on the regulations and licensee's written radiation protection procedures, written directive procedures, and license conditions with respect to the use.
(b) The licensee must ensure an authorized user has continuing education and experience preceding the medical use of a source, device, or radioactive drug for administrations not requiring a written directive. This must include, at a minimum—
(1) Education or experience in the type of use within the 7 years preceding administration; and
(2) Instruction on the regulations and licensee's written radiation protection procedures and license conditions with respect to the use.
(c) The training and experience specified in subpart B for Radiation Safety Officers, Associate Radiation Safety Officers, Authorized Medical Physicist, and Authorized Nuclear Pharmacists of this part must have been obtained within the 7 years preceding the date of use or the individual must have had related continuing education and experience since the required training and experience was completed.
(d) The licensee must retain a record of individuals' continuing education and experience and instruction required by paragraphs (a), (b), and (c) in accordance with § 35.2059.
(a) For direct measurements performed in accordance with § 35.63, a licensee must possess and use instrumentation to measure the activity of unsealed byproduct material and microsources before it is administered to each patient or human research subject.
(b) A licensee must calibrate the instrumentation required in paragraph (a) of this section in accordance with nationally recognized standards or the manufacturer's instructions.
(c) Except for direct measurement described in paragraph (d) of this section, if instrumentation required in paragraph (a) cannot be calibrated in accordance with nationally recognized standards or the manufacturer's instructions required in paragraph (b), the licensee must submit written procedures for approval used to calibrate the instrumentation required in paragraph (a) of this section.
(d) For direct measurements performed in accordance with § 35.63(d), if radiation detector instrumentation cannot be calibrated in dynamic use mode in accordance with paragraph (b) of this section, a licensee must develop, implement, and maintain written test procedures to ensure that—
(1) The infusion pump flow rate is consistent and accurate; and
(2) The radiation detector meets the manufacturer's specifications.
(e) A licensee must perform the tests required in paragraph (d) of this section at least every 12 months and following repair that affects the calibration.
(f) A licensee must retain a record of each instrument calibration, test, and procedure required by this section in accordance with § 35.2060.
The revision reads as follows:
(a) * * *
(1) Calibrate for the radiation type and energy range measured; and
(a) A licensee must determine and record the activity of each dosage before medical use of unsealed byproduct material and microsources, except for incremental administrations that meet the criteria in paragraph (d) of this section.
(b) For a unit dosage, this determination must be made by—
(1) Direct measurement of radioactivity; or
(2) A decay correction, based on the activity or activity concentration determined by—
(i) A manufacturer or preparer licensed under § 32.72 or distributor licensed under § 32.74 of this chapter or equivalent Agreement State requirements; or
(ii) An NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
(iii) A PET radioactive drug producer and except for incremental administrations that meet the criteria in paragraph (d) of this section, licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.
(c) For other than unit dosages, this determination must be made by—
(1) Direct measurement of radioactivity;
(2) Combination of measurement of radioactivity and mathematical calculations; or
(3) Combination of volumetric measurements and mathematical calculations, based on the radioactivity measurement made by:
(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(ii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.
(d) For incremental administrations from a direct infusion system that meet the criteria in paragraph (e) of this section, a licensee must determine and record the activity of each administered dosage by—
(1) Measurement of radioactivity using a calibrated instrument that is part of the direct infusion system or
(2) A combination of measurement of radioactivity and mathematical calculations.
(e) A licensee may perform incremental administrations as direct infusions only when the following criteria are met—
(1) The administered radioisotope has a half-life of less than three minutes.
(2) A written directive is not required.
(3) The radioisotope is administered through direct infusion from the generator or system without additional preparation steps.
(4) The administration is performed in accordance with the manufacturer's guidelines and procedures.
(f) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.
(g) A licensee must retain a record of the dosage determination required by this section in accordance with § 35.2063.
(b) A licensee in possession of a sealed source, excluding microsources, must—
(g) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources and microsources, must conduct a semi-annual physical inventory of all such sources in its possession. The licensee must retain each inventory record in accordance with § 35.2067(b).
Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radioactive drug, microsource, or device. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.
(a) In addition to the surveys required by Part 20 of this chapter, a licensee must survey with a radiation detection survey instrument at the end of each day of use in all restricted areas and after each use in all non-restricted areas. A licensee must survey all areas where unsealed byproduct material or microsources requiring a written directive was prepared for use or administered.
(a) For each patient or human research subject who cannot be released under § 35.75, a licensee must:
(1) Maintain the individual in a private room or in a room with another individual who also received such administration and cannot be released under § 35.75.
(2) For administrations involving unsealed byproduct material or microsources:
(i) Provide access for the individual, without leaving the controlled area, to a sanitary facility used only by individuals who have received such administrations; and
(ii) Handle contaminated materials and items removed from the room as radioactive waste, as appropriate; and
(3) Visibly post the individual's room with a “Radioactive Materials” sign; and
(4) Note on the door or in the individual's chart the location and duration visitors may stay in the patient's or human research subject's room.
(b) A licensee must notify the Radiation Safety Officer, or his or her designee, and an authorized user for the type of administration, as soon as possible if the patient or human research subject has a medical emergency or dies.
A licensee providing mobile medical service must obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the client's address and clearly delineates the authority and responsibility of the licensee and the client, and retain this letter in accordance with § 35.2080.
(a) A licensee that uses a radionuclide generator for preparing a radiopharmaceutical must:
(1) Develop, implement, and maintain written procedures to define acceptable breakthrough limits and breakthrough testing frequency consistent with manufacturer's generator labeling as set forth in its FDA product approval or nationally recognized standard.
(2) Prior to the first use for preparation of radioactive drugs of a new generator or existing generator with an upgrade that affects the operation and safety, provide operational and safety training to measure and test the eluate for breakthrough to all individuals who will elute the generator and training to process the eluate with reagent kits to all individuals who prepare radioactive drugs; and
(3) Not administer an eluate to patients or human research subjects if the breakthrough measurements exceed the limits established in paragraph (a) of this section.
(b) In addition to the requirements of § 19.12 of this chapter, the licensee must initially or when there are significant changes to the licensee's procedures, provide instruction in the licensee's procedures identified in paragraph (a) of this section to individuals involved in the use of generator systems, as appropriate to the individual's assigned duties.
(c) The licensee must report any measurement that exceeds the limits in paragraph (a) of this section at the time of generator elution, in accordance with § 35.3093.
(d) The licensee must retain a record of each breakthrough test in accordance with § 35.2093.
(e) A licensee must retain a record of individuals receiving instruction required by paragraphs (a) and (b) of this section, in accordance with § 35.2310.
A licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is—
Except as provided in § 35.57, the licensee must require an authorized user of unsealed byproduct material for the uses authorized under § 35.100 to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of residency
(2) Has completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. The training and experience must include, at a minimum—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.100 or equivalent Agreement State requirements, at a medical facility. The work experience must involve—
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(F) Administering dosages of radioactive drugs to patients or human research subjects; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under § 35.100. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.190, 35.290, or 35.390, or equivalent Agreement State requirements; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.190, 35.290, or 35.390, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be accredited and must include training and experience specified in the topic areas in paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(a); or
(c) Is an authorized user under § 35.290, 35.390, 35.396, or equivalent Agreement State requirements.
A licensee may use any unsealed byproduct material prepared for medical use for imaging and localization studies that is—
Except as provided in § 35.57, the licensee must require an authorized user of unsealed byproduct material for the uses authorized under § 35.200 to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of residency training in a nuclear medicine, diagnostic radiology, or radiation oncology accredited program which includes training and experience topic areas as described in § 35.290(a)(2); or
(2) Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. The training and experience must include, at a minimum—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use;
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.200 or equivalent Agreement State requirements, at a medical facility. The work experience must involve—
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures; and
(F) Administering dosages of radioactive drugs to patients or human research subjects; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under §§ 35.100 and 35.200. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.290, or 35.390, or equivalent Agreement State requirements; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.290, or 35.390, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be accredited and must include training and experience specified in the topic areas in paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(b); or
(c) Is an authorized user under § 35.390, 35.396, or equivalent Agreement State requirements.
Except as provided in § 35.57, the licensee must require an authorized user of unsealed byproduct material for the uses authorized under § 35.300 to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of accredited residency training in a nuclear medicine or radiation oncology which includes training and experience topics as described in § 35.390(a)(2); or
(2) Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. The training and experience must include, at a minimum—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.300 or equivalent Agreement State requirements, at a medical facility. A supervising authorized user must have experience in administering dosages in the same dosage category or categories (
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;
(F) [Reserved]
(G) Preparing written directives and observing or performing administration of dosages of radioactive drugs to patients or human research subjects from the two categories in this paragraph under the supervision of an authorized user for the use. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under § 35.1000. This supervised work experience must involve sufficient experience in each of the following categories to allow the supervising authorized user to evaluate the individual's ability to independently perform radiation safety related duties for the medical use for which the individual is requesting authorized user status—
(
(
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under § 35.300 for which the individual is requesting authorized user status. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.390, or equivalent Agreement State requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.390, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be accredited and must include training and experience specified in the topic areas in paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(c).
Except as provided in § 35.57, the licensee must require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of residency training in a nuclear medicine or radiation oncology accredited program which includes training and experience topic areas as described in § 35.392(a)(2); or
(2) Has completed training and experience, including 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training and experience must include, at a minimum—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.300, or equivalent Agreement State requirements, for oral administration of sodium iodide I-131 in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) at a medical facility. A supervising authorized user who meets the requirements in § 35.390(a)(2) must also have experience in administering dosages as specified in § 35.390(a)(2)(ii)(G)(
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of byproduct material;
(E) Using procedures to contain spilled byproduct material safely and
(F) Preparing written directives and observing or performing administration of dosages of radioactive drugs to patients or human research subjects for the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 under the supervision of an authorized user for the use. This supervised work experience must involve sufficient experience to allow the supervising authorized user to evaluate the individual's ability to independently perform radiation safety related duties for the medical use for which the individual is requesting authorized user status; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) or (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under § 35.300. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State requirements and has experience in administering dosages as specified in § 35.390(a)(2)(ii)(G)(
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State requirements, has experience in administering dosages as specified in § 35.390(a)(2)(ii)(G)(
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(d).
Except as provided in § 35.57, the licensee must require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of residency training in a nuclear medicine or radiation oncology accredited program which includes training and experience topic areas as described in § 35.394(a)(2); or
(2) Has completed training and experience, including 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training and experience must include, at a minimum—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation on protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.300, or equivalent Agreement State requirements, for oral administration of sodium iodide I-131 in quantities greater than 1.22 gigabecquerels (33 millicuries) at a medical facility. A supervising authorized user who meets the requirements in § 35.390(b) must also have experience in administering dosages as specified in § 35.390(a)(2)(ii)(G)(
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of byproduct material;
(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(F) Preparing written directives and observing or performing administration of dosages of radioactive drugs to patients or human research subjects for the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 under the supervision of an authorized user for the use. This supervised work experience must involve sufficient experience to allow the supervising authorized user to evaluate the individual's ability to independently perform radiation safety related duties for the medical use for which the individual is requesting authorized user status; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) or (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under § 35.300. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.390, 35.394, or equivalent Agreement State requirements, and has experience in administering dosages as specified in § 35.390(a)(2)(ii)(G)(
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.390, 35.394, or equivalent Agreement State requirements, has experience in administering dosages as specified in § 35.390(a)(2)(ii)(G)(
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(e).
Except as provided in § 35.57, the licensee must require an authorized user for the parenteral administration requiring a written directive, to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of residency training in a nuclear medicine or radiation oncology accredited program which includes training and experience topic areas as described in § 35.396(a)(2); or
(2) Has completed training and experience, including 80 hours of classroom and laboratory training,
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.300, or equivalent Agreement State requirements, for parenteral administrations at a medical facility. A supervising authorized user who meets the requirements in § 35.390(a)(2) must also have experience in administering dosages as specified in §§ 35.390(a)(2)(ii)(G)(
(A) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
(E) Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and
(F) Preparing written directives and observing or performing administration of dosages of radioactive drugs to patients or human research subjects for the parenteral administration of unsealed byproduct material under the supervision of an authorized user for the use. This supervised work experience must involve sufficient experience to allow the supervising authorized user to evaluate the individual's ability to independently perform radiation safety related duties for the medical use for which the individual is requesting authorized user status; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) or (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.390, 35.396, or equivalent Agreement State requirements. A preceptor authorized user who meets the requirements in § 35.390, 35.396, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.390, 35.396, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be accredited and must include training and experience specified in the topic areas in paragraph (a)(2) of this section; or
(b) Is an authorized user under § 35.390 for uses listed in § 35.390(a)(2)(ii)(G)(
(c) Is an authorized user under § 35.490, 35.690, or equivalent Agreement State requirements, and who meets the requirements in paragraph (a)(2) of this section; or
(d) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(f).
(a) Immediately after administering sources, topically or inserted within a patient or a human research subject, the licensee must conduct a survey to locate and account for all sources that have not been administered.
(b) Immediately after removing the last temporary source from a patient or a human research subject, the licensee must make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.
A licensee must have applicable emergency response equipment available near each treatment room to respond to a source—
(1) Dislodged from the patient; and
(2) Lodged within the patient following removal of the source applicators.
The revisions read as follows:
(a) Licensees who use beta-emitting sources for ophthalmic treatments must ensure that certain activities as specified in paragraph (b) of this section are performed by either:
(b) * * *
(1) Calculate the activity of each beta-emitting source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under § 35.432; and
(c) Licensees must retain a record of the activity of each beta-emitting source in accordance with § 35.2433.
Except as provided in § 35.57, the licensee must require an authorized user of a manual brachytherapy source for the uses authorized under § 35.400 to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of residency training in a radiation oncology accredited program, and
(2) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.400, or equivalent Agreement State requirements, at a medical facility. The work experience must involve—
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Checking survey meters for proper operation;
(C) Preparing, implanting, and removing brachytherapy sources;
(D) Maintaining running inventories of material on hand;
(E) Using administrative controls to prevent a medical event involving the use of byproduct material;
(F) Using emergency procedures to control byproduct material; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) and (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under § 35.400. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.490, or equivalent Agreement State requirements; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.490, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be accredited and must include training and experience specified in paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(g).
(c) For authorized use of beta-emitting sources for superficial ophthalmic radiotherapy, has received training required in § 35.491(c) of this part.
Except as provided in § 35.57, the licensee must require the authorized user of beta-emitting sources for superficial ophthalmic radiotherapy to be a physician who—
(a)
(1) Has completed training and experience, including 24 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of beta-emitting sources for superficial ophthalmic radiotherapy. The training and experience must include, at a minimum—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
(ii) Supervised clinical training in superficial ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of beta-emitting sources for the superficial ophthalmic treatment. This supervised work experience must involve sufficient experience to allow the supervising authorized user to evaluate the individual's ability to independently perform radiation safety related duties for the medical use for which the individual is requesting authorized user status. This supervised clinical training must involve—
(A) Examination of each individual to be treated;
(B) Calculation of the dose to be administered;
(C) Administration of the dose; and
(D) Follow up and review of each individual's case history; and
(2) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in § 35.57, 35.490, 35.491, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user of beta-emitting sources for superficial ophthalmic use; or
(b) Is an authorized user under § 35.490, or equivalent Agreement State requirements; and
(c) Has received training in device operation, safety procedures, and clinical use of the device. This training requirement may be satisfied by completing a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for use of the same device for which the individual is seeking authorization.
Except as provided in § 35.57, the licensee must require the authorized user of a diagnostic sealed source or a device authorized under § 35.500 to be a physician, dentist, or podiatrist who—
(a) Has completed 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include—
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity; and
(4) Radiation biology; or
(b) Is an authorized user for uses listed in § 35.200 or equivalent Agreement State requirements; or
(c) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(h); and
(d) Has completed training in the use of the device for the uses requested.
(a) * * *
(1) Secure the unit, the console or the console keys, and the treatment room when not in use or unattended;
(d) (1) Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee must ensure that vendor operational and safety training is provided to all individuals who will operate or calibrate the unit, and the authorized user. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified y the device manufacturer to provide the operational and safety training.
(e) A licensee must ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, prior to first use of a unit, type of immobilization device, or revised procedure, and at least annually.
(a) A licensee must control access to each entrance to the treatment room with an electrical interlock system that will—
(1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is secured;
(2) Cause the source(s) to be shielded in case of unauthorized entry or interlock interruption; and
(3) Prevent the source(s) from being exposed following an interlock interruption until the electrical interlock system is restored and access is controlled to each entrance and the source(s) on-off control is reset at the console.
(b) A licensee must require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.
(c) Except for low-dose remote afterloader units, a licensee must construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.
(d) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee must only conduct treatments which allow for expeditious removal of a decoupled or jammed source.
(e) In addition to the requirements specified in paragraphs (a) through (e) of this section, a licensee must—
(1) For medium dose-rate and pulsed dose-rate remote afterloader units, require—
(i) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and
(ii) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.
(2) For high dose-rate remote afterloader units, require—
(i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and
(ii) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.
(3) For gamma stereotactic radiosurgery units, require—
(i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments;
(ii) An authorized user to be immediately available during continuation of patient treatments;
(iii) An authorized medical physicist and appropriate staff who are trained in emergency response and are necessary in accordance with written procedures pursuant to § 35.610(a)(4) to be physically present for the continuation of treatment; and
(iv) If there is an unexpected interruption of treatment requiring operator re-initiation, an authorized user and authorized medical physicist will evaluate the situation to ensure treatment is being delivered in accordance with the treatment plan and written directive prior to re-initiation of the treatment.
(4) Notify the Radiation Safety Officer, or his/her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.
(f) A licensee must have applicable emergency response equipment available near each treatment room to respond to a source—
(1) Remaining in the unshielded position; or
(2) Lodged within the patient following completion of the treatment.
(a) A licensee authorized to use a teletherapy unit for medical use must perform full calibration measurements on each teletherapy unit—
(c) A licensee must use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.
(d) A licensee must make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies. In absence of such protocols, a licensee must make full calibration measurements required by paragraph (a) in accordance with NRC-approved or Agreement State-approved manufacturer procedures.
(e) A licensee must mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at intervals consistent with 1 percent decay for all other nuclides.
(g) A licensee must retain a record of each calibration in accordance with § 35.2632.
(a) A licensee authorized to use a remote afterloader unit for medical use must perform full calibration measurements on each unit—
(c) A licensee must use the dosimetry system described in § 35.630(a) to measure the output.
(d) A licensee must make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies. In absence of such protocols, a licensee must make full calibration measurements required by paragraph (a) of this section in accordance with NRC-approved or Agreement State-approved manufacturer procedures.
(e) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in paragraph (b) of this section, a licensee must perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 1 quarter.
(g) A licensee must mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay at intervals consistent with 1 percent physical decay.
(i) A licensee must retain a record of each calibration in accordance with § 35.2632.
(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform full calibration measurements on each unit—
(2) * * *
(iii) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the source(s) or major repair of component(s) associated with the source assembly or collimation; and
(3) At intervals not exceeding 1 year.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of—
(1) The output within ±3 percent;
(2) Condition, function, and accuracy of source(s), collimator(s), and treatment couch positioning and localizing, attenuation, and collimation devices;
(3) Isocenter coincidence;
(4) Timer accuracy and linearity over the range of use;
(5) On-off error;
(6) The operability and availability of retraction devices and emergency response equipment required per procedures required in § 35.610;
(7) System interlocks necessary to ensure pause in treatment in abnormal operations;
(8) Emergency timing circuits;
(9) The operability and availability of backup power devices or systems; and
(10) Operability of source(s), collimator(s), and treatment couch movement during treatment, as applicable.
(c) A licensee must use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.
(d) A licensee must make full calibration measurements required by paragraph (a) of this section in accordance with published protocols accepted by nationally recognized bodies. In absence of such protocols, licensee must make full calibration measurements required by paragraph (a) in accordance with NRC-approved or Agreement State-approved manufacturer procedures.
(e) A licensee must mathematically correct the outputs determined in paragraph (b)(1) of this section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.
(g) A licensee must retain a record of each calibration in accordance with § 35.2632.
(a) A licensee authorized to use a remote afterloader unit for medical use must perform spot-checks of each remote afterloader facility and on each unit—
(1) Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;
(2) Before each patient treatment with a low dose-rate remote afterloader unit; and
(3) After each source installation.
(b) A licensee must perform the measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist and in accordance with:
(1) Nationally recognized standards or published protocols accepted by nationally recognized bodies; or
(2) Manufacturer instructions accepted by the NRC, if nationally recognized standards or published protocols accepted by nationally recognized bodies do not exist.
(c) A licensee must have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist must notify the licensee as soon as possible in writing of the results of each spot-check.
(d) To satisfy the requirements of paragraph (a) of this section, spot-checks must, at a minimum, verify the performance of the following systems and functions:
(1) Emergency and safety systems;
(2) Computer systems controlling source output and timing; and
(3) Dosimetric and geometry accuracy.
(e) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
(f) A licensee must retain a record of each check required by paragraph (d) of this section and a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2643.
(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit in accordance with written procedures established by the authorized medical physicist and—
(1) Nationally recognized standards or published protocols accepted by nationally recognized bodies, or
(2) Manufacturer instructions accepted by the NRC, if nationally recognized standards or published protocols accepted by nationally recognized bodies do not exist.
(b) To satisfy the requirement of paragraph (a) of this section, spot-checks must—
(1) Before each patient use, confirm patient immobilization devices and localization systems, and any adaptors, are functional and fit appropriately.
(2) Before the first use of the unit on a given day and after each source installations:
(i) Verify systems and components that provide for safe termination of treatment and prevention of exposure to individuals other than the patient, and ensure that real-time monitoring and communication during administration are functional;
(ii) Confirm date and time of computer systems necessary for operation are correct; and
(3) On a monthly basis, spot-checks must verify:
(i) Systems and components to ensure accurate image guidance, as applicable, and geometric and dosimetry accuracy; and
(ii) Output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b) is within range specified by the procedure required in paragraph (a) of this section.
(c) Have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist must notify the licensee as soon as possible in writing of the results of each spot-check.
(d) A licensee must not use a system or device for medical use if the system is identified in paragraph (b)(1) of this section as not functioning appropriately.
(e) If the results of the checks required in paragraphs (b)(2) and (3) of this section indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
(f) A licensee must retain a record of each check required by paragraph (b) and a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2645.
Except as provided in § 35.57, the licensee must require an authorized user of a sealed source for a use authorized under § 35.600 to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of residency training in a radiation oncology accredited program; and
(2) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.600 or equivalent Agreement State requirements, at a medical facility, involving—
(A) Reviewing full calibration measurements and periodic spot-checks;
(B) Preparing treatment plans and calculating treatment doses and times;
(C) Using administrative controls to prevent a medical event involving the use of byproduct material;
(D) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;
(E) Checking and using survey meters; and
(F) Selecting the proper dose and how it is to be administered; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) and (2) and (c) of this section; and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.690, or equivalent Agreement State requirements for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.690, or equivalent Agreement State requirements, for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be accredited and must include training and experience specified in paragraph (a)(2) of this section; or
(b) Is certified by a medical specialty board whose certification process has been recognized under § 35.58(i); and
A licensee must only use microsources:
(a) Obtained from a manufacturer or preparer licensed under § 32.72 or 32.74 of this chapter or equivalent Agreement State requirements; or
(b) In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.
(a) Microsource administration devices that use microsources for brachytherapy and are listed in the Sealed Source and Device Registry must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry.
(b) A licensee must develop, implement, and maintain written procedures for responding to abnormal situations including microsource spills, equipment failures, and emergent conditions that affect the administration of microsources.
(c)(1) Prior to the first use for patient treatment of a new type of microsource or an existing type with a manufacturer upgrade to the delivery kit that affects the operation and safety of administration, a licensee must ensure that operational and safety training is provided to all individuals who operate the system and authorized user.
(2) A licensee must provide operational and safety instructions initially to all individuals who prepare or transfer microsources for administration and operate the unit at the facility, as appropriate to the individual's assigned duties. The instructions must include instruction in—
(i) The procedures identified in § 35.41; and
(ii) The operating procedures for the unit.
(d) In addition to the requirements of § 19.12, a licensee must provide radiation safety instruction, initially, and at least annually, to personnel caring for patients or human research subjects that cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—
(1) Patient or human research subject control;
(2) Visitor control, including—
(i) Routine visitation to hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and
(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter;
(1) Contamination control;
(2) Waste control; and
(3) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.
(e) A licensee must retain a record of individuals receiving instruction required by paragraphs (c) and (d) of this section, in accordance with § 35.2310.
(f) A licensee must retain a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2710.
Except as provided in § 35.57, the licensee must require an authorized user of microsources authorized under § 35.700 to be a physician who—
(a)(1) Has successfully completed a minimum of 3 years of residency training in diagnostic radiology and 1 year of interventional radiology in a residency or fellowship program(s), and
(2) Has completed the training and experience requirements that include—
(i) Classroom and laboratory training in the following areas—
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user at a medical facility that is authorized to use byproduct materials in § 35.700, or training provided by a microsource manufacturer. The work experience or training must involve—
(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(B) Performing quality control procedures on instruments used to determine the activity of microsource doses and performing checks for proper operation of survey meters;
(C) Calculating, measuring, and safely preparing patient or human research subject dosages; and
(D) Using procedures to contain spilled microsources safely using decontamination procedures; and
(iii) Work experience, under the supervision of an authorized user for the use of byproduct materials under § 35.700 or equivalent Agreement State requirements, at a medical facility. The work experience must involve—
(A) Using administrative controls to prevent a medical event involving the use of byproduct material; and
(B) Preparing written directives and observing or performing administration of microsource brachytherapy; and
(C) Evaluation of patient or research subject's treatments to determine whether the administered dosage was in accordance with the written directive or if a medical event occurred; and
(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) and (2); and is able to independently fulfill the radiation safety-related duties as an authorized user for microsource brachytherapy. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.790, or equivalent Agreement State requirements; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.790, or equivalent Agreement State requirements and concurs with the attestation provided by the residency program director. The residency training program must be accredited and must include training and experience specified in paragraph (a)(2) of this section; or
(b) [Reserved]
(c) Is an authorized user under § 35.390, 35.396, 35.490, or equivalent Agreement State requirements, and
(d)(1) Has received training and work experience in device operation, safety procedures, and clinical use for the type(s) of microsource for which authorization is sought. This training must include three hands on cases including work experience as described in paragraphs (a)(2)(ii) and (iii) for the type of microsource for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user who is authorized for the type(s) of microsources for which the individual is seeking authorization, and
(2) Has obtained written attestation that the individual has satisfactorily completed these requirements.
The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in § 35.57, 35.790, or equivalent Agreement State requirements for the type(s) of microsources for which the individual is requesting authorized status; or
(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.790, or equivalent Agreement State requirements, for the type(s) of microsources for which the individual is requesting authorized status, and concurs with the attestation provided by the residency program director. The residency training program must be accredited and must include training and experience specified in paragraph (d)(1) of this section.
(a) A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in subparts D through I of this part if—
(1) The applicant or licensee has submitted the information required by § 35.12(b) through (d); and
(2) The applicant or licensee has received written approval from the Commission in a license or license amendment and uses the material in accordance with the regulations and specific conditions the Commission considers necessary for the medical use of the material.
(b) A licensee may use byproduct material or a radiation source approved for medical use in accordance with the written approval from the Commission in a license or license amendment if the licensee obtained approval under § 35.1000 prior to [DATE 30 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
A licensee must maintain a record of continuing education and training required by § 35.59 until the individual is no longer authorized for medical use or listed on the license. The record must include a list of the topics covered, the date of the training, and the name(s) of the individual(s) who provided the training.
(a) A licensee must maintain a record of each instrument calibration and test required by § 35.60 for 3 years. The records must include the model and serial number of the instrument, if applicable; the date of, the results of, and the name of the individual who performed each calibration and test.
(b) A licensee must retain a copy of each procedure required by § 35.60(d) until the licensee no longer possesses the instrument.
(a) A licensee must maintain a record of dosage determinations required by § 35.63 for 3 years.
A licensee must retain a copy of each letter that permits the use of byproduct
A licensee must maintain a record of results of the breakthrough tests required by § 35.93(a) for 3 years. The record must include the eluate concentrations of the parent and daughter, the time and date of the measurement, and the name of the individual who made the measurement.
A licensee must maintain a record of safety instructions required by §§ 35.93, 35.310, and 35.410 and the operational and safety instructions required by § 35.610 and § 35.710 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.
A licensee must maintain a record of the surveys required by §§ 35.404 and 35.604 for 3 years. * * *
(a) A licensee must maintain a record of brachytherapy source accountability required by § 35.406 for 3 years.
(b) For temporary manual brachytherapy sources, the record must include—
(c) For permanent manual brachytherapy sources, the record must include—
(a) A licensee must maintain a record of the activity of a beta-emitting source required by § 35.433 for the life of the source.
b. In paragraph (b)(9), remove the word “signature” and add in its place the phrase “dated signature”; and
(a) A licensee must retain a record of each periodic spot-check for remote afterloader units required by § 35.643 for 3 years.
(b) The record must include, as applicable—
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for the remote afterloader unit and source;
(3) The equipment and systems checked, including—
(i) Emergency and safety systems;
(ii) Computer systems controlling source output and timing; and
(iii) Dosimetric and geometric accuracy.
(4) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
(c) A licensee must retain a copy of the procedures required by § 35.643(b) until the licensee no longer possesses the remote afterloader unit.
(a) A licensee must retain a record of each periodic spot-check for gamma stereotactic radiosurgery units required by § 35.645 for 3 years.
(b) The record must include—
(1) The date of the spot-check;
(2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;
(3) The systems and components checked, including—
(i) Patient immobilization devices and localization systems;
(ii) Emergency and safety systems;
(iii) Real-time monitoring and communication systems;
(iv) Computer systems necessary for operation (including date and time settings); and
(v) Image guidance;
(4) The calculated on-off error;
(5) A determination of trunnion centricity;
(6) The difference between the anticipated output and the measured output;
(7) An assessment of source output against computer calculations;
(8) Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and
(9) The name of the individual who performed the periodic spot-check and the dated signature of the authorized medical physicist who reviewed the record of the spot-check.
(c) A licensee must retain a copy of the procedures required by § 35.645(b) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.
A licensee must retain a copy of the procedures required by § 35.710(b) until the licensee is no longer authorized for the type of microsource.
The revisions read as follows:
(a) A licensee must report any event as a medical event, except for an event that results from patient intervention or emergent patient condition that prevents completion of administration as planned, in which—
(1) The administration of byproduct material or radiation from byproduct material, except permanent manual or microsource brachytherapy, results in—
(2) For permanent manual or microsource brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site or microsources administered at the correct site but shunted to a site other than the treatment site if shunting was evaluated
(i) The total source strength or activity administered differing by 20 percent or more from the total source strength or activity documented in the post-implantation portion of the written directive;
(ii) The total source strength or activity administered outside of the treatment site exceeding 20 percent of the total source strength or activity documented in the post-implantation portion of the written directive; or
(iii) An administration that includes any of the following:
(A) The wrong radionuclide;
(B) The wrong individual or human research subject;
(C) Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive;
(D) A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue; or
(3) The total dose or dosage that exceeds or results in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue delivered and differs from the prescribed dose or dosage defined on the written directive before administration by 20 percent caused by a leak or defect in administration device or supplies.
(b) A licensee must report any event resulting from patient intervention or emergent patient condition in which the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.
(a) A licensee must report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless;
(1) The dose to the embryo/fetus was specifically approved, in advance, by the authorized user, or
(2) The licensee made a reasonable effort to determine pregnancy status but pregnancy could not be reasonably excluded prior to the administration by the licensee.
(a) The licensee must notify by telephone the NRC Operations Center and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in § 35.93(a) at the time of generator elution. The telephone report to the NRC must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects; when the distributor was notified; and the action taken.
(b) By an appropriate method listed in § 30.6(a) of this chapter, the licensee must submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by paragraph (a) of this section.
For the Nuclear Regulatory Commission.