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Food and Drug Administration, HHS.
Final amendment; order; confirmation of effective date.
The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the
The effective date of June 26, 2025, for the final order published in the
For access to the docket to read background documents or comments received, go to
Stephanie A. Hice, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-348-1740 or Meridith L. Kelsch, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
In the
We gave interested persons until June 11, 2025, to file objections or requests for a hearing (90 FR 20104). We received no objections or requests for a hearing on the final order. Therefore, we find that the effective date of the final order that published in the
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Food and Drug Administration, HHS.
Final amendment; order; confirmation of effective date.
The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the
The effective date of June 26, 2025, for the final order published in the
For access to the docket to read background documents or comments received, go to
Rachel Morissette, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1278 or Barbara Little, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug
In the
We gave interested persons until June 11, 2025, to file objections or requests for a hearing. We explained that, to file an objection, a person must, among other things, specify with particularity the provision(s) of the regulation to which they object and the grounds for the objection (90 FR 20097 at 20100). Within each objection, persons also must specifically state whether they request a hearing. We received two general comments, one that did not address calcium phosphate or color additives and one that disagreed with the order, but the comments did not meet the requirements to be considered an objection under 21 CFR 12.22(a)(2) or (3). Therefore, we find that the effective date of the final order that published in the
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under authority delegated to the Commissioner of Food and Drugs, we are giving notice that no objections or requests for a hearing were filed in response to the May 12, 2025, final order. Accordingly, the amendments issued thereby became effective June 26, 2025.
Food and Drug Administration, HHS.
Final amendment; order; confirmation of effective date.
The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the
The effective date of June 26, 2025, for the final order published in the
For access to the docket to read background documents or comments received, go to
Stephen DiFranco, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2710 or Meridith L. Kelsch, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
In the
We gave interested persons until June 11, 2025 (90 FR 20101 at 20101) to file objections or requests for a hearing. We explained that, to file an objection, persons must, among other things, specify with particularity the provision(s) of the regulation to which they object and the grounds for the objection (Id. at 20103). Within each objection, persons also must specifically state whether they request a hearing (Id.). We received one comment about labeling of the color additive, but the comment did not meet the requirements to be considered an objection under 21 CFR 12.22(a)(2) or (3). Therefore, we find that the effective date of the final order that published in the
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under authority delegated to the Commissioner of Food and Drugs, we are giving notice that no objections or requests for a hearing were filed in response to the May 12, 2025, final order. Accordingly, the amendments issued thereby became effective June 26, 2025.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the pharmacogenetic assessment system into class II (special
This order is effective August 21, 2025. The classification was applicable on October 31, 2018.
Dina Jerebitski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 301-796-2411,
Upon request, FDA has classified the pharmacogenetic assessment system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 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 application 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 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 June 5, 2018, FDA received 23andMe, Inc.'s request for De Novo classification of the 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports. 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, 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 October 31, 2018, FDA issued an order to the requester classifying the device into class II and subsequently issued a correction dated January 23, 2019. In this final order, FDA is codifying the classification of the device by adding 21 CFR 862.3364.
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. 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. This device is 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 individually or cumulatively 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 system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 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 862 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Design verification and validation must include:
(i) Data appropriate, as determined by FDA, to demonstrate the analytical accuracy and reliability of the device in intended use specimens, including precision, reproducibility, accuracy, limits of detection, and interferences. This information must include:
(A) Data demonstrating appropriate, as determined by FDA, reproducibility for each genotype using each claimed sample type. Reproducibility data must be evaluated using specimens collected and processed in a manner consistent with the device's instructions for use, or, as determined by FDA, an appropriate alternative sample panel.
(B) Analytical data demonstrating the limits of detection, including the minimum amount of input deoxy-ribonucleic acid (DNA) that will consistently produce accurate results.
(C) Data demonstrating no clinically significant effects from endogenous and exogenous interferents relevant to each intended use specimen type. Interference data must also include an assessment of potentially interfering genetic sequences (
(D) Validation data appropriate, as determined by FDA, to support specimen collection and handling claims.
(E) Clinical data generated in intended use patient populations demonstrating the pharmacogenetic association between the genetic variant tested and any clinical claims or therapy-related recommendations associated with that genotype.
(ii) Results from an appropriate, as determined by FDA, user comprehension study that demonstrate the intended user can use the device safely. The user comprehension study must be designed to include the following:
(A) Study participants from a statistically sufficient sample size and a demographically diverse (
(B) An evaluation of all result comprehension concepts that are critical for safe use of the device.
(2) The labeling required under § 809.10 of this chapter must include:
(i) Clear information, written in language appropriate for the intended user, that describes instructions for how test results should be interpreted. These instructions must be supported by valid scientific evidence and include:
(A) Appropriate explanation of the claimed pharmacogenetic associations for all variants included in the test, any relevant variants not included in the test (
(B) Appropriate explanation of non-genetic and non-tested genetic factors that may impact interpretation of the test results;
(ii) Detailed descriptions of analytical performance including, as applicable, precision, reproducibility, accuracy, limits of detection, and interferences as specified in paragraph (b)(1)(i) of this section, in language appropriate for the intended user;
(iii) A warning statement that the patient should not use the test results to stop or change any medication, and that medications should always be taken as prescribed by a healthcare professional;
(iv) A limiting statement explaining that this test is not intended to inform the patient about their current state of health, including whether the patient should or should not take a medication, or how much of a medication the patient should take, as appropriate;
(v) A warning statement that the test does not diagnose any health conditions and is not a substitute for visits to a doctor or other healthcare professional; and
(vi) A prominent and conspicuous limiting statement that the test provides only a preliminary test result that needs to be confirmed using an independent pharmacogenetic test without such a limitation prior to making any medical decisions. Alternatively, appropriate design verification and validation activities, including the generation of robust analytical data demonstrating appropriate analytical accuracy and reliability of test results for each genetic variant included in the test report, must be performed that demonstrate that the test can be used to make well-informed clinical decisions.
(3) The test report must include an appropriate description of how the test results should be used by healthcare providers who may receive the test results from their patients, as applicable.
(4) Publicly available pre-purchase labeling with unrestricted access that contains the following information must be provided:
(i) A clear description of the test and its technology, the genotypes detected, and relevant clinical claims associated with each genotype;
(ii) A clear description of what information the test will provide. This includes variant information, the limitations associated with the test, and any precautionary information about the test the user should be aware of before purchase; and
(iii) A discussion of answers to frequently asked questions that is sufficient to provide intended users with an appropriate understanding of information specific to each pharmacogenetic association that is claimed.
(5) The genetic test must use a sample collection device that is FDA-cleared or -approved, or classified as 510(k) exempt, with an indication for in vitro diagnostic use in DNA testing.
(6) The intended use of the device must not include an indication for use in supporting or sustaining human life, being of substantial importance in preventing impairment of human health, or presenting a potential, unreasonable risk of illness or injury.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, Agency, or we) is classifying the menopause test system 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 menopause test system. 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 August 21, 2025. The classification was applicable on October 24, 2018.
Dina Jerebitski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 301-796-2411,
Upon request, FDA has classified the menopause test system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 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 application 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 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
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 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 January 22, 2018, FDA received Ansh Labs LLC's request for De Novo classification of the picoAMH ELISA test. 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, 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 October 24, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 862.1093.
FDA has identified the following risks to health associated specifically 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. 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. This device is 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 individually or cumulatively 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 system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 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 862 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Design verification and validation must include the following:
(i) An appropriate traceability plan to minimize the risk of drift in the menopause test system results over time.
(ii) Detailed documentation of a clinical study to demonstrate clinical performance or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(A) Results must demonstrate appropriate clinical performance relative to a well-accepted and appropriate comparator.
(B) Data must demonstrate accuracy of device output for each indicated specimen type throughout the device measuring range as appropriate for the intended use population.
(2) The labeling required under § 809.10 of this chapter must include the following:
(i) A statement in the indications for use that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions.
(ii) A limiting statement that the device is intended to be used for the determination of menopausal status only in conjunction with other clinical and laboratory findings prior to any diagnostic or treatment decisions.
(iii) A limiting statement appropriately describing the risks of false test results and that test results should not be relied upon in clinical decision making (
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens 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 multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens. 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 August 21, 2025. The classification was applicable on November 24, 2017.
Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 240-402-6357,
Upon request, FDA has classified the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 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 application 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 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 shall 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 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 4, 2017, FDA received BioFire Diagnostics, LLC's request for De Novo classification of the FilmArray Respiratory Panel 2
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, 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 November 24, 2017, 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 866.4001.
FDA has identified the following risks to health associated specifically 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. 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. This device is subject to premarket notification requirements under section 510(k).
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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 system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, 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 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) The intended use for the labeling required under § 809.10 of this chapter must include a description of what the device detects and measures, the specimen types, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate.
(2) The labeling required under § 809.10 of this chapter must include:
(i) A device description, including the parts that make up the device, ancillary reagents required but not provided, and an explanation of the methodology.
(ii) Performance characteristics from analytical studies, including cut-off (if applicable), analytical sensitivity (
(iii) Detailed instructions for minimizing the risk of potential users' exposure to the emerging respiratory pathogen(s) that may be present in test specimens and those used as control materials.
(iv) Detailed instructions for minimizing the risk of generating false positive test results due to carry-over contamination from positive test specimens and/or positive control materials.
(v) A warning statement that the interpretation of test results requires experienced healthcare professionals who have training in principles and use of infectious disease diagnostics and reporting of results, in conjunction with the patient's medical history, clinical signs and symptoms, and the results of other diagnostic tests.
(vi) A warning statement that culture should not be attempted in cases of positive results for an emerging respiratory pathogen unless a facility with an appropriate level of laboratory biosafety (
(vii) A warning statement that device positive results for one or more common respiratory pathogens do not rule out bacterial infection, or co-infection with other common respiratory pathogens.
(viii) A warning statement that respiratory pathogen(s) detected may not be the definite cause of disease.
(ix) A warning statement that the use of additional laboratory testing (
(x) A limiting statement that device negative results for the common respiratory pathogens do not preclude infection of a respiratory pathogen and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
(xi) A limiting statement that analyte targets (
(xii) A limiting statement that detection of pathogen nucleic acid sequences or other molecular signatures is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results. There is a risk of false negative values resulting from improperly collected, transported, or handled specimens.
(xiii) A limiting statement that there is a risk of false positive values resulting from cross-contamination by target organisms, their nucleic acids or amplified product, or from non-specific signals in the assay.
(xiv) A limiting statement that there is a risk of false negative results due to the presence of nucleic acid sequence variants in the pathogen targets of the device.
(xv) A limiting statement that device performance was not established in immunocompromised patients.
(xvi) A limiting statement that positive and negative predictive values are highly dependent on prevalence. The device performance was established during one or more specific respiratory seasons. The performance for some respiratory pathogens may vary depending on the prevalence and patient population tested. False positive test results are likely when prevalence of disease due to a particular respiratory pathogen is low or non-existent in a community.
(xvii) In situations where the performance of the device was estimated based largely on testing pre-selected banked retrospective clinical specimens and/or contrived clinical specimen, a limiting statement that the estimated device performance of that specific pathogen or pathogen subtype may not reflect the performance or prevalence in the intended use population.
(xviii) For devices with an intended use that includes detection of emerging respiratory pathogen(s), a limiting statement that testing with the device should not be performed unless the patient meets clinical and/or epidemiologic criteria for testing suspected specimens of the emerging respiratory pathogen.
(xix) For devices with an intended use that includes detection of emerging respiratory pathogen(s), a limiting statement that positive results obtained with the device for the emerging respiratory pathogen are for the presumptive identification of that pathogen and that the definitive identification of the emerging respiratory pathogen requires additional testing and confirmation procedures in consultation with the appropriate public health authorities (
(xx) For devices with an intended use that includes detection of emerging respiratory pathogen(s), a limiting statement that negative results for the emerging respiratory pathogen, even in the context of device positive results for one or more of the common respiratory pathogens, do not preclude infection with the emerging respiratory pathogen and should not be used as the sole basis for patient management decisions.
(xxi) For devices with an intended use that includes detection of emerging respiratory pathogen(s), a limiting statement that negative results for the emerging respiratory pathogen may be due to infection of the emerging respiratory pathogen at a specific respiratory tract location that may not be detected by a particular clinical specimen type. A negative result for the emerging respiratory pathogen in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious.
(xxii) For devices with an intended use that includes detection of emerging respiratory pathogen(s), a limiting statement that a nationally notifiable Rare Disease of Public Health Significance caused by an emerging respiratory pathogen must be reported, as appropriate, to public health authorities in accordance with local, state, and federal law.
(3) Design verification and validation must include:
(i) Performance results of an appropriate clinical study (
(ii) For devices with an intended use that includes detection of emerging respiratory pathogen(s) for which an FDA recommended panel is available, design verification and validation must include the performance results of an analytical study testing an FDA recommended reference panel of characterized samples that contain the emerging respiratory pathogen. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(iii) An appropriate risk mitigation strategy, including a detailed description of all procedures and methods, for the post-market identification of genetic mutations and/or novel respiratory pathogen isolates or strains (
(iv) For devices with an intended use that includes detection of multiple common respiratory pathogens, in addition to detecting emerging respiratory pathogen(s) in human clinical specimens, a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the common respiratory pathogens that the device is designed to detect is addressed. Also, address in detail how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory diagnosis of respiratory tract infection. Perform an evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(v) A detailed device description, including the parts that make up the device, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device (
(vi) A detailed description of the device software, including software applications and hardware-based devices that incorporate software.
(vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiate between the Influenza A virus subtypes in human clinical specimens, in addition to detecting emerging respiratory pathogen(s), a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. Perform an evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(4) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiate between the Influenza A virus subtypes in human clinical specimens, in addition to detecting emerging respiratory pathogen(s), the labeling required under § 809.10 of this chapter must include the following:
(i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary.
(ii) Where applicable, a warning statement that reads if infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria
(iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling required under § 809.10(b)(9) of this chapter must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required follow up actions or retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated (
(5) The manufacturer must perform annual analytical reactivity testing of the device with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the web page containing this information and must allow unrestricted viewing access.
(6) If one of the actions listed at section 564(b)(1)(A)-(D) of the FD&C Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the web page containing this information and must allow unrestricted viewing access.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the postnatal chromosomal copy number variation detection system 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 the postnatal chromosomal copy number variation detection system's classification. 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 August 21, 2025. The classification was applicable on January 17, 2014.
Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3572, Silver Spring, MD, 20993-0002, 301-796-6217,
Upon request, FDA has classified the postnatal chromosomal copy number variation detection system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 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 application 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 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 (PMA) 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.
For this device, FDA issued an order on December 13, 2013, finding the Affymetrix CytoScan Dx Assay not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order.
On December 23, 2013, FDA received Affymetrix, Inc.'s request for De Novo classification of the Affymetrix CytoScan Dx Assay. 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, 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on January 17, 2014, FDA issued an order to the requestor classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 866.5920.
FDA has identified the following risks to health associated specifically 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 the safety and effectiveness. 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. This device is 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 individually or cumulatively 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 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 system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, 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 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Design verification and validation must include the following information:
(i) A detailed description of all components in the test system that includes:
(A) A description of the assay components, array composition and layout, all required reagents, instrumentation, and equipment, including illustrations or photographs of non-standard equipment or methods;
(B) A description of the design of the array in terms of chromosomal coverage and probe density for different regions;
(C) An identification of the number of probes and size of the CNVs reported at the lower range of the assay;
(D) Detailed documentation of the device software, including standalone software applications and hardware-based devices that incorporate software;
(E) Methodology and protocols for detecting copy number and visualizing results;
(F) A description of the result outputs along with sample reports, and a description of any links to external databases provided by the device to the user or accessed by the device;
(G) Specifications for the methods to be used in specimen collection, extraction (including DNA criteria for DNA quality and quantity to perform the assay), and storage; and
(H) A description of appropriate internal and external controls that are recommended or provided. The description must identify those control elements that are incorporated into the testing procedure.
(ii) Information that demonstrates the performance characteristics of the system, including:
(A) Device reproducibility data generated, at a minimum, using three sites, with two operators at each site, for three non-consecutive days using at least three instruments. A well-characterized panel of samples that provide a wide range of CNVs (
(B) Device accuracy data using cell lines and clinical samples representing a variety of CNVs and syndromes. In this analytical study, accuracy must be determined for every CNV detected in a particular sample. The accuracy data provided must include the copy number state determination and endpoint accuracy. The accuracy samples must cover different genomic variations across the genome (
(C) Assay performance data for CNVs reported at the lower range of the assay for both gains and losses;
(D) Device analytical sensitivity data, including DNA input and limit of detection for mosaicism, if applicable;
(E) Device analytical specificity data, including interference, carryover, and cross-contamination data;
(F) Device stability data, including real-time stability under various storage times, temperatures, and freeze-thaw conditions;
(G) Specimen matrix comparison data if more than one specimen type or anticoagulant can be tested with the device;
(H) Data that demonstrates the clinical validity, including diagnostic yield, of the device using a minimum of 800 retrospective clinical samples that were collected prospectively and obtained from three or more clinical laboratories, with results interpretation equally divided between two or more qualified healthcare professionals (
(I) Data that demonstrates device results when a minimum of 100 apparently healthy, phenotypically normal individuals are tested and interpreted by one or more cytogeneticists blinded to the patient status.
(iii) Identification of risk mitigation elements used by the device, including a description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing.
(2) The labeling required under § 809.10 of this chapter must include:
(i) A warning statement that the device is not intended to be used for standalone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations;
(ii) Limitations regarding the assay's performance with respect to validated CNVs reported at the lower range of the assay, stratified by size range and range of probe numbers for gains and losses separately; and limitations regarding problematic (hypervariable) regions, loss of heterozygosity, mosaicism, and inability to detect balanced translocations, as appropriate;
(iii) A warning statement that interpretation of assay results is intended to be performed by qualified healthcare professionals such as clinical cytogeneticists or molecular geneticists; and,
(iv) A description of the performance studies performed in accordance with paragraph (b)(1)(ii) of this section and a summary of the results.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cancer predisposition risk assessment system 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 cancer predisposition risk assessment system. 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 August 21, 2025. The classification was applicable on March 6, 2018.
Dina Jerebitski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 301-796-2411,
Upon request, FDA has classified the cancer predisposition risk assessment system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 as, and remains within, class III and requires premarket approval unless and until FDA takes an
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 application 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 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 September 5, 2017, FDA received 23andMe, Inc.'s request for De Novo classification of the 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). 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, 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 March 6, 2018, FDA issued an order to the requester classifying the device into class II.
FDA has identified the following risks to health associated specifically 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. 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. This device is subject to
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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 system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, 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 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) The labeling required under § 809.10 of this chapter and any pre-purchase page and test report generated, unless otherwise specified, must include:
(i) An intended use that specifies in the indications for use the genetic variants detected by the test. The specific variants must be appropriately validated as described in paragraphs (b)(4)(xii) and (b)(4)(xiii) of this section.
(ii) A section addressed to users with the following information:
(A) A warning statement accurately disclosing the genetic coverage of the test in lay terms, including information on variants not queried by the test, and the proportion of pathogenic variants in the genes that the assay detects in a specific population as identified in paragraph (b)(1)(i) of this section. The warning statement must indicate that the test [does not/may not, as appropriate] detect all genetic variants related to the genetic disease, and that the absence of a variant tested does not rule out the presence of other genetic variants that may impact cancer risk. The warning statement must also include the relevant population for which the variants reported by the test are most relevant.
(B) A limiting statement explaining that some people may feel anxious about getting genetic test health results. This is normal. If the potential user feels very anxious, such user should speak to his or her doctor or other healthcare professional prior to collection of a sample for testing. This test is not a substitute for visits to a doctor or other healthcare professional. Users should consult with their doctor or other healthcare professional if they have any questions or concerns about the results of their test or their current state of health.
(C) A limiting statement that a user's ethnicity may affect whether the test is relevant for them and may also affect how their genetic health results are interpreted.
(D) A warning statement that the test is not a substitute for visits to a healthcare professional for recommended screenings, and should not be used to determine any treatments or medical interventions.
(E) A warning statement that the test does not diagnose cancer or any other health conditions and should not be used to make medical decisions. The warning statement must indicate that the results should be confirmed in a clinical setting before taking any medical action.
(F) A limiting statement explaining that other companies offering a genetic risk test may be detecting different genetic variants for the same disease, so the user may get different results using a test from a different company.
(G) If applicable, a limiting statement that states the test does not test for variants in other genes linked to hereditary cancer.
(H) A limiting statement explaining that this test does not account for non-genetic factors and that other factors such as environmental and lifestyle risk factors may affect the risk of developing a given disease.
(I) Information to a potential purchaser or actual test report recipient about how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre- and post-test counseling.
(J) A limiting statement explaining that this test is not intended to tell you anything about your current state of health, or be used to make medical decisions, including whether or not you should take a medication or how much of a medication you should take.
(K) A limiting statement explaining that the laboratory may not be able to process a sample, and a description of the next steps to be taken by the manufacturer and/or the customer, as applicable.
(iii) A section in the labeling required under § 809.10 of this chapter and any test report generated that is for healthcare professionals who may receive the test results from their patients with the following information:
(A) A limiting statement explaining that this test is not intended to diagnose a disease, determine medical treatment or other medical intervention, or tell the user anything about their current state of health.
(B) A limiting statement explaining that this test is intended to provide users with their genetic information to inform health-related lifestyle decisions
(C) A limiting statement explaining that any diagnostic or treatment decisions should be based on confirmatory prescription testing and/or other information that is determined to be appropriate for the patient (
(2) The genetic test must use a sample collection device that is FDA-cleared, -approved, or -classified as 510(k) exempt, with an indication for in vitro diagnostic use in over-the-counter DNA testing.
(3) The device's labeling must include a hyperlink to the manufacturer's public website where the manufacturer must make the information identified in paragraph (b)(3) of this section publicly available. The manufacturer's home page, as well as the primary part of the manufacturer's website that discusses the device, must provide a hyperlink to the web page containing this information and must allow unrestricted viewing access. If the device can be purchased from the website or testing using the device can be ordered from the website, the same information must be found on the web page for ordering the device or provided in a publicly accessible hyperlink on the web page for ordering the device. Any changes to the device that could significantly affect safety or effectiveness would require new data or information in support of such changes, which must also be posted on the manufacturer's website. The information must include:
(i) An index of the material being provided to meet the requirements in paragraph (b)(3) of this section and its location.
(ii) Technical information about the device, as specified in paragraph (b)(4) of this section.
(iii) A section that highlights summary information that allows the user to understand how the test works and how to interpret the results of the test. This section must, at a minimum, be written in plain language understandable to a lay user and include:
(A) Consistent explanations of the risk of disease associated with all variants included in the test, variants not included in the test, and specific considerations by ethnicity. If there are different categories of risk, the manufacturer must provide literature references and/or data that support the different risk categories. If there will be multiple test reports and multiple variants, the risk categories must be defined similarly among them. For example, “increased risk” must be defined similarly between different test reports and different variant combinations.
(B) Clear context for the user to understand the context in which the cited clinical performance data support the risk reported. This includes any risks that are influenced by ethnicity, age, gender, environment, and lifestyle choices.
(C) Materials that explain the main concepts and terminology used in the test that include:
(4) The device labeling must include a technical information section containing the following information:
(i) Gene(s) and variant(s) the test detects using standardized nomenclature, Human Genome Organization (HUGO) nomenclature and coordinates, as well as Single Nucleotide Polymorphism Database (dbSNP) reference SNP numbers (rs#).
(ii) A statement indicating that more than 1,000 variants in the BRCA1 and BRCA2 genes are known to increase cancer risk, as applicable.
(iii) Scientifically established disease-risk association of each variant detected and reported by the test. This risk association information must include:
(A) Genotype-phenotype information for the reported variants.
(B) When available, a table of expected frequency in the general population and different ethnicities, and risks of developing the disease in relevant ethnic populations and the general population.
(C) Information such as peer-reviewed published literature and/or professional guidelines used to determine what types and levels of evidence will distinguish whether the selected variants are reported as “are associated with increased risk” versus “may be associated with increased risk” of developing other cancers. All selected variants must be appropriately validated as required under paragraph (b)(1)(i) of this section. For selected variants reported as “are associated with increased risk,” the clinical evidence must be demonstrated with sufficient information (
(D) A statement about the current professional guidelines for testing these
(iv) The specimen type (
(v) Assay steps and technology used.
(vi) Specification of required ancillary reagents, instrumentation, and equipment.
(vii) Specification of the specimen collection, processing, storage, and preparation methods.
(viii) Specification of risk mitigation elements and description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing.
(ix) Information pertaining to the probability of test failure (
(x) When available, information specifying the probability of a false negative and false positive analytical result and any additional considerations by ethnicity.
(xi) Specification of the criteria for test result interpretation and reporting, including any distinctions between risk categories (
(xii) Information that demonstrates the performance characteristics of the test including:
(A) Accuracy of study results for each claimed specimen type.
(B) Precision and reproducibility data must be provided using multiple instruments and multiple operators, on multiple non-consecutive days, and using multiple reagent lots. The sample panel must include specimens from the claimed sample type (
(C) Analytical specificity data: data must be provided evaluating the test performance (
(D) Analytical sensitivity data: data must be provided demonstrating the minimum amount of DNA that will enable the test to perform correctly in 95 percent of runs.
(E) Device stability data: the manufacturer must establish upper and lower limits of input nucleic acid, sample, and reagent stability that will achieve the test's claimed accuracy and reproducibility. The manufacturer must evaluate stability using wild-type, heterozygous, and homozygous samples. Data supporting such claims must be provided.
(F) Specimen type and matrix comparison data: specimen type and matrix comparison data must be generated if more than one specimen type can be tested with this device, including failure rates for the different specimens.
(xiii) Clinical Performance Summary.
(A) Information to support the clinical performance of each variant in the specific condition which is labeled as “are associated with increased risk” and reported by the test must be provided, as identified in paragraph (b)(4)(iii)(C) of this section.
(B) Manufacturers must organize information by the specific variant combination as appropriate (
(xiv) User comprehension study: information on a study that assesses comprehension of the test process and results by potential users of the test must be provided, including the following, as appropriate:
(A) The test manufacturer must provide a genetic health risk education module to naïve user comprehension study participants prior to their participation in the user comprehension study. The module must define terms that are used in the test reports and explain the significance of genetic risk reports.
(B) The test manufacturer must perform pre- and post-test user comprehension studies. The comprehension test questions must directly evaluate the material being presented to the user as described in paragraph (b)(3)(ii) of this section.
(C) The manufacturer must provide a justification from a physician and/or genetic counselor that identifies the appropriate general and variant-specific concepts contained within the material being tested in the user comprehension study to ensure that all relevant concepts are incorporated in the study.
(D) The user comprehension study must meet the following criteria:
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the mutation detection test for myeloproliferative neoplasms 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 mutation detection test for myeloproliferative neoplasms. We are taking this action because we
This order is effective August 21, 2025. The classification was applicable on March 27, 2017.
Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 240-402-6357,
Upon request, FDA has classified the mutation detection test for myeloproliferative neoplasms device as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 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 application 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 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 1, 2016, FDA received QIAGEN Manchester Ltd.'s request for De Novo classification of the ipsogen JAK2 RGQ PCR Kit. 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, 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 March 28, 2017, 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 866.6070.
FDA has identified the following risks to health associated specifically 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
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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 system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, 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 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Design verification and validation must include:
(i) A detailed description of all components in the test, including the following:
(A) A detailed description, including illustrations or photographs of non-standard equipment or methods, of the test components, including all required reagents, instrumentation, and equipment.
(B) Detailed documentation of the device software, including standalone software applications and hardware-based devices that incorporate software.
(C) A detailed description of methodology and assay procedures including appropriate internal and external quality controls that are recommended or provided. The description must identify those control elements that are incorporated into the testing procedure.
(D) A detailed specification for sample collection, processing, and storage.
(E) A description of the criteria for test result interpretation and reporting including result outputs, analytical sensitivity of the assay, and the values that will be reported.
(ii) Information that demonstrates the performance characteristics of the test, including:
(A) For indications for use based on a threshold established in a predicate device of this generic type, device performance data from either a method comparison study to the predicate device or through a clinical study demonstrating clinical validity using well-characterized prospectively or retrospectively obtained clinical specimens, as appropriate, representative of the intended use population.
(B) For indications for use based on a threshold not established in a predicate device of this generic type, device performance data from a clinical study demonstrating clinical validity using well-characterized prospectively or retrospectively obtained clinical specimens, as appropriate, representative of the intended use population.
(C) Device reproducibility data generated, using a minimum of three sites, of which at least two sites must be external sites, with two operators at each site. Each site must conduct a study that includes at least two operators per site, two runs per operator per day over a minimum of three non-consecutive days evaluating a sample panel that contains allelic frequencies that span the claimed measuring range, and include the clinical threshold allelic frequency. Pre-specified acceptance criteria must be provided and followed.
(D) Information on device traceability and a description of the value assignment process for calibrators and controls.
(E) Device precision data using clinical samples and controls to evaluate the within-lot, between-lot, within-run, between-run, and total variation.
(F) Device linearity data generated from samples covering the device measuring range and for any standards used in the quantitation of allelic frequencies.
(G) Device analytic sensitivity data, including limit of blank and limit of detection.
(H) Device specificity data, including interference and cross-contamination.
(I) Device and clinical specimen stability data, including real-time stability (long-term storage and in-use stability) and stability evaluating various storage times, temperatures, and freeze-thaw conditions, as appropriate.
(iii) Identification of risk mitigation elements used by the device, including a detailed description of all additional procedures, methods, and practices incorporated into the instructions for use that mitigate risks associated with testing using the device.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) An intended use statement, including an indication for use that includes the variant(s)
for which the assay was designed and validated, for example, JAK2 G1849T.
(ii) A detailed description of the performance studies conducted to
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the anti-phospholipase A2 receptor immunological test system 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 the anti-phospholipase A2 receptor immunological test system's classification. 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 August 21, 2025. The classification was applicable on May 29, 2014.
Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3572, Silver Spring, MD 20993-0002, 301-796-6217,
Upon request, FDA has classified the anti-phospholipase A2 receptor immunological test system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 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 application 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 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 (PMA) 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.
For this device, FDA issued an order on March 10, 2014, finding the EUROIMMUN Anti-PLA2R IFA not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order.
On March 28, 2014, FDA received EUROIMMUN US Inc.'s, request for De Novo classification of the EUROIMMUN Anti-PLA2R IFA. 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, 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on May 29, 2014, FDA issued an order to the requestor classifying the device into class II. In this final order, FDA is codifying the
FDA has identified the following risks to health associated specifically 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. 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. This device is 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 individually or cumulatively 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. 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 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 system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, 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 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Design verification and validation must include:
(i) A detailed description of the device that includes:
(A) A detailed description of all parts of the test system, including a description of the assay parts in the kit and all required ancillary reagents;
(B) A detailed description of instrumentation and equipment, and illustrations or photographs of non-standard equipment or methods if applicable;
(C) Detailed documentation of the device software, including standalone software applications and hardware-based devices that incorporate software where applicable;
(D) A detailed description of appropriate internal and external quality controls that are recommended or provided. The description must identify those control elements that are incorporated into the recommended testing procedures;
(E) Detailed specifications for sample collection, processing, and storage;
(F) A detailed description of methodology and assay procedure; and
(G) Detailed specification of the criteria for test results interpretation and reporting.
(ii) Information that demonstrates the performance characteristics of the device, including:
(A) Device precision/reproducibility data generated from within-run, between-run, between-day, between-lot, between-operator, between-instruments, between-site, and total precision for multiple nonconsecutive days as applicable. A well-characterized panel of patient samples or pools from the intended use population that covers the device measuring range must be used;
(B) Device linearity data generated from patient samples covering the assay measuring range if applicable;
(C) Information on traceability to a reference material and description of value assignment of calibrators and controls if applicable;
(D) Device analytical sensitivity data, including limit of blank, limit of detection, and limit of quantitation if applicable;
(E) Device analytical specificity data, including interference by endogenous and exogenous substances, as well as cross-reactivity with samples derived from patients with other autoimmune diseases or conditions;
(F) Device instrument carryover data when applicable;
(G) Device stability data including real-time stability under various storage times and temperatures;
(H) Specimen stability data including stability under various storage times, temperatures, freeze-thaw, and transport conditions where appropriate;
(I) Method comparison data generated by comparison of the results obtained with the device to those obtained with a legally marketed predicate device with similar indication of use. Patient samples from the intended use population covering the device measuring range must be used;
(J) Specimen matrix comparison data if more than one specimen type or anticoagulant can be tested with the device. Samples used for comparison must be from patient samples covering the device measuring range;
(K) A description of how the assay cut-off (the medical decision point between positive and negative) was established and validated as well as supporting data;
(L) A clinical performance assessment established by comparing data generated by testing samples from the intended use population and differential diagnosis groups with the device to the clinical diagnostic standard. Diagnosis of pMGN must be based primarily on clinical history, physical examination, laboratory tests (including urinalysis), and renal biopsy. Membranous glomerulonephritis is considered to be idiopathic/primary when no secondary cause can be elucidated on the basis of clinical and laboratory criteria. The differential diagnosis groups must include secondary membranous glomerulonephritis, membranoproliferative glomerulonephritis, lupus nephritis, focal segmental glomerulosclerosis, IgA nephritis, diabetic nephropathy, systemic lupus erythematosus, systemic sclerosis, and Goodpasture syndrome. Diagnosis of autoimmune and immune-mediated diseases that are associated with membranous glomerulonephritis must be based on established diagnostic criteria and clinical evaluation. For all samples, clinical criteria, including demographic information, must be considered in the differentiation between pMGN and secondary membranous glomerulonephritis. The clinical validation results must demonstrate correlation clinical sensitivity and clinical specificity between the test values and the presence or absence of pMGN. The data must be summarized in tabular format comparing the interpretation of results to the disease status; and
(M) Expected/reference values generated by testing an adequate number of samples from apparently healthy normal individuals.
(iii) Identification of risk mitigation elements used by the device, including a description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing.
(2) The label required under § 809.10(a) and labeling required under § 809.10(b) of this chapter must include warnings relevant to the assay including:
(i) A warning statement that explains: The device is for use by laboratory professionals in a clinical laboratory setting;
(ii) A warning statement that explains: The test is not a standalone test but an adjunct to other clinical information. A diagnosis of pMGN or secondary MGN should not be made based on a single test result. The clinical symptoms, results on physical examination, and laboratory tests (
(iii) A warning statement that explains: Absence of circulating PLA2R autoantibody does not rule out a diagnosis of pMGN; and
(iv) A warning statement that explains: The assay has not been demonstrated to be effective for monitoring the stage of disease or its response to treatment.
(3) The labeling required under § 809.10(b) of this chapter must include a description of the protocol and performance studies performed in accordance with paragraph (b)(1)(ii) of this section and a summary of the results.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis 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 the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis's classification. 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 August 21, 2025. The classification was applicable on October 28, 2016.
Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3414, Silver Spring, MD, 20993-0002, 240-402-6357,
Upon request, FDA has classified the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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
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 application 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 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 shall 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 January 12, 2016, FDA received GeneOhm Sciences Canada, Inc. (BD Diagnostics)'s request for De Novo classification of the BD Max Vaginal Panel. 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, 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on October 28, 2016, FDA issued an order to the requestor classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 866.3975.
FDA has identified the following risks to health associated specifically 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. 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. This device is subject to
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. 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 have been approved under OMB control number 0910-0073, and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, 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 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Design verification and validation must include:
(i) Documentation with a detailed device description of device components; ancillary reagents required but not provided; and explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection.
(ii)Documentation with information that demonstrates the performance characteristics of the device, including:
(A)Limit of Detection;
(B)Precision (reproductivity);
(C)Analytical specificity;
(D) Analytical reactivity (inclusivity);
(E) Specimen stability; and
(F) Effects of interfering substances.
(iii) Detailed documentation from a prospective clinical study. As appropriate to the intended use, the prospective clinical study must be performed on an appropriate study population, including women of various ages and ethnicities. The prospective clinical study must compare the device performance to results obtained from well-accepted comparator methods.
(iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed explanation of the interpretation of results and acceptance criteria;
(ii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, clinical performance stratified by patient demographics such as race, ethnicity, age, and pregnancy status.
(iii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, a summary of device results in an asymptomatic population with demographic characteristics appropriate to the intended use population.
(iv) For devices with an intended use that includes detection of either Candida species or bacteria associated with bacterial vaginosis, a limitation that
Food and Drug Administration, HHS.
Final amendment: final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the laparoscopic gastrointestinal sizing tool 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 the classification of the laparoscopic gastrointestinal sizing tool. 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 August 21, 2025. The classification was applicable on February 4, 2020.
Pramodh Kariyawasam, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2536, Silver Spring, MD 20993-0002, 301-348-1911,
Upon request, FDA has classified the laparoscopic gastrointestinal sizing tool as class II (special controls), which we have determined will provide a
FDA may classify a device through an accessory classification request under section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision allows manufacturers or importers to request classification of an accessory distinct from another device upon written request. The classification is based on the risks of the accessory when used as intended as well as the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness, notwithstanding the classification of any other device with which such accessory is intended to be used. Until an accessory is reclassified by FDA, the classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, will continue to apply.
Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or importer may request appropriate classification of an accessory that has been granted marketing authorization as part of a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request. FDA must grant or deny the request not later than 85 days after receipt and, if granting, publish a notice in the
Alternatively, under section 513(f)(6)(C), a person filing a PMA or 510(k) may include a written request for the proper classification of an accessory that has not been classified distinctly from another device based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. When the written request is included in a submission for marketing authorization, FDA must grant or deny the request along with the response to the PMA or 510(k). Upon granting, FDA will publish a notice in the
On November 12, 2019, FDA received Torax Medical Inc.'s request for accessory classification of the LINX Reflux Management System—Esophagus Sizing Tool. 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, 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 February 4, 2020, 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 876.5360.
FDA has identified the following risks to health associated specifically 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. 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. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act (21 U.S.C. 360(k)).
At the time of classification, laparoscopic gastrointestinal sizing tools are for prescription use only. Prescription devices are exempt from the requirement for adequate directions
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if, after notice of our intent to exempt and consideration of comments, we determine that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. At a future date, we may publish a separate notice in the
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in the guidance document “Medical Device Accessories—Describing Accessories and Classification Pathways” have been approved under OMB control number 0910-0823; the collections of information in part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 regarding quality system regulation have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; and the collections of information in 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, 360l, 371.
(a)
(b)
(1) Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following:
(i) Trocar compatibility, which includes shaft bending force characterization;
(ii) Joint strength tensile testing;
(iii) Distal loop extension/retraction force characterization;
(iv) Material selection analysis, which includes corrosion and visual inspection; and
(v) Accuracy of the dimensional measurement.
(2) Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Labeling of the device must include the following:
(i) A statement regarding metal allergies if the device is made from metallic components;
(ii) Specific instructions for proper device use including information regarding the following:
(A) Inspection of device prior to use;
(B) Surgical access techniques or methodologies;
(C) Instructions for avoiding structural damage to vagus nerve bundle;
(D) Trocar compatibility;
(E) Sizing methodology; and
(F) Minimum and maximum dimensional parameters that the device is capable of measuring.
(iii) Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and
(iv) An expiration date.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices 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 orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices. 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 August 21, 2025. The classification was applicable on July 6, 2020.
Anne Talley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G225, Silver Spring, MD 20993-0002, 240-402-6536,
Upon request, FDA has classified orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices as class II (special controls), which we have determined will provide a reasonable
FDA may classify a device through an accessory classification request under section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision allows manufacturers or importers to request classification of an accessory distinct from another device upon written request. The classification is based on the risks of the accessory when used as intended as well as the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness, notwithstanding the classification of any other device with which such accessory is intended to be used. Until an accessory is reclassified by FDA, the classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, will continue to apply.
Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or importer may request appropriate classification of an accessory that has been granted marketing authorization as part of a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request. FDA must grant or deny the request not later than 85 days after receipt and, if granting, publish a notice in the
Alternatively, under section 513(f)(6)(C) of the FD&C Act, a person filing a PMA or 510(k) may include a written request for the proper classification of an accessory that has not been classified distinctly from another device based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. When the written request is included in a submission for marketing authorization, FDA must grant or deny the request along with the response to the PMA or 510(k). Upon granting, FDA will publish a notice in the
On April 15, 2020, FDA received RTI Surgical, Inc.'s request for accessory classification of coflex Interlaminar Technology Instrumentation. 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, 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 July 6, 2020, 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 888.4520.
FDA has identified the following risks to health associated specifically 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. 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. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act (21 U.S.C. 360(k)).
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if, after notice of our intent to exempt and consideration of comments, we determine that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. At a future date, we may publish a separate notice in the
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in the guidance document “Medical Device Accessories—Describing Accessories and Classification Pathways” have been approved under OMB control number 0910-0823; the collections of information in part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 regarding quality system regulation have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; and the collections of information in 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 888 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
(4) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with total disc replacement devices 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 orthopedic manual surgical instrumentation for use with total disc replacement devices. 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 August 21, 2025. The classification was applicable on June 24, 2020.
Michael Molyneaux-Francis, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4508, Silver Spring, MD 20993-0002, 240-402-5178,
Upon request, FDA has classified orthopedic manual surgical instrumentation for use with total disc replacement devices as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness for its intended use. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into the appropriate device class based on risk and the regulatory controls sufficient to provide reasonable assurance of safety and effectiveness.
FDA may classify a device through an accessory classification request under section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision allows manufacturers or importers to request classification of an accessory distinct from another device upon written request. The classification is based on the risks of the accessory when used as intended as well as the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness, notwithstanding the classification of any other device with which such accessory is intended to be used. Until an accessory is reclassified by FDA, the classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, will continue to apply.
Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or importer may request appropriate classification of an accessory that has been granted marketing authorization as part of a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request. FDA must grant or deny the request not later than 85 days after receipt and, if granting, publish a notice in the
Alternatively, under section 513(f)(6)(C) of the FD&C Act, a person
On March 31, 2020, FDA received Spinal Kinetics LLC's request for accessory classification of M6-C Artificial Cervical Disc Instrumentation. 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, 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 24, 2020, 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 888.4515.
FDA has identified the following risks to health associated specifically 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. 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. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act (21 U.S.C. 360(k)).
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if, after notice of our intent to exempt and consideration of comments, we determine that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. At a future date, we may publish a separate notice in the
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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 the guidance document “Medical Device Accessories-Describing Accessories and Classification Pathways” have been approved under OMB control number 0910-0823; the collections of information in part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 regarding quality system regulation have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; and the collections of information in 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 888 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
(4) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the liver iron concentration imaging companion diagnostic for deferasirox 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 liver iron concentration imaging companion diagnostic for deferasirox. 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 August 21, 2025. The classification was applicable on January 23, 2013.
Daniel Krainak, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3674, Silver Spring, MD 20993-0002, 301-796-0478,
Upon request, FDA has classified the liver iron concentration imaging companion diagnostic for deferasirox as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 as, 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 application 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 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
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 December 21, 2012, FDA received Resonance Health Services' request for De Novo classification of the FerriScan R2-MRI Analysis System. 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, 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 January 23, 2013, 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 892.1001.
FDA has identified the following risks to health associated specifically 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. 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. This device is 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 individually or cumulatively 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 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, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 892 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Design verification and validation must include nonclinical and clinical performance testing demonstrating the bias, precision, repeatability, and reproducibility of liver iron concentration measurements.
(2) Labeling must include specifying:
(i) Instructions for acceptance testing of images prior to processing;
(ii) Data processing quality assurance protocols; and
(iii) The sensitivity and specificity of liver iron concentration measurements.
Federal Highway Administration (FHWA), U.S. Department of Transportation (DOT).
Final rule.
FHWA rescinds a specific labeling provision of the rule issued on March 30, 1990, on Advance Construction of Federal-aid Projects.
This final rule is effective September 22, 2025.
For questions about this rulemaking, please contact Mr. Anthony DeSimone, FHWA Office of Infrastructure, 317-226-5307, or via email at
This document, as well as the notice of proposed rulemaking (NPRM), and all comments received may be viewed online at
FHWA is rescinding a specific provision of its rule on Advance Construction of Federal-Aid Projects, which was originally promulgated on December 8, 1983, at 48 FR 54972, and later amended on March 30, 1990, at 55 FR 11902. This provision is part of FHWA regulations, codified at 23 CFR part 630, subpart G, that prescribe procedures for advancing the construction of Federal-aid highway projects without obligating Federal funds apportioned or allocated to the State, known as Advance Construction (AC). 23 CFR 630.701. AC is authorized under 23 U.S.C. 115. Under the statute, FHWA
On December 8, 1983, FHWA issued a regulation revising FHWA's regulations concerning AC projects that existed at the time. Among the changes made, FHWA revised 23 CFR 630.703 to state: “Project designations [for advance construction projects] shall be the same as for regular Federal-aid projects except that until the project is converted to a regular Federal-aid project, the prefix letters ‘AC’ for advance construction shall be used as the first letters of each project designation.”
The requirements in 23 CFR 630.705(b) are not required by 23 U.S.C. 115. In addition, FHWA's current process of determining which projects are advance construction projects, versus Federal-aid projects where Federal-aid funds have already been obligated, does not require the use of the prefix “AC.” Accordingly, FHWA is eliminating this regulatory provision.
On May 30, 2025, at 90 FR 22872, FHWA published an NPRM proposing to rescind 23 CFR 630.705(b) and sought comment on all aspects of that proposal. The FHWA did not receive any public comments on its proposal and now adopts the proposal without change.
This rule does not meet the criteria of a “significant regulatory action” under Executive Order (E.O.) 12866, as amended by E.O. 14215 and E.O. 13563. Therefore, the Office of Management and Budget (OMB) has not reviewed this rule under those orders.
This rule rescinds regulations that are not in alignment with current FHWA process. For that reason, FHWA does not believe there are any costs to this rulemaking. FHWA anticipates some unquantified cost-savings associated
These changes would not adversely affect, in a material way, any sector of the economy. In addition, these changes would not interfere with any action taken or planned by another agency and would not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs. Consequently, a full regulatory evaluation is not required.
This final rule is an E.O. 14192 deregulatory action. Cost-savings are not quantified.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act of 1996; 5 U.S.C. 601
This rule would not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4, 109 Stat. 48) for State, local and Tribal governments, or the private sector of $100 million or more in any one year. Thus, the rule is not subject to the requirements of sections 202 and 205 of the UMRA.
This action has been analyzed in accordance with the principles and criteria contained in E.O. 13132. The FHWA has determined that this action does not have sufficient federalism implications to warrant the preparation of a federalism assessment. The FHWA has also determined that this action does not preempt any State law or State regulation or affect the States’ ability to discharge traditional State governmental functions.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number. This rule is deregulatory and so would not impose any additional information collection requirements.
FHWA has analyzed this rule pursuant to the National Environmental Policy Act (NEPA) and has determined that it is categorically excluded under 23 CFR 771.117(c)(20), which applies to the promulgation of rules, regulations, and directives. Categorically excluded actions meet the criteria for categorical exclusions under 23 CFR 771.117(a) and normally do not require any further NEPA approvals by FHWA. This rule would rescind regulations not in accordance with current FHWA processes. FHWA does not anticipate any adverse environmental impacts from this rule, and no unusual circumstances are present under 23 CFR 771.117(b).
E.O. 13175 requires Federal Agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. FHWA has assessed the impact of this rule on Indian tribes and determined that this rule would not have Tribal implications that require consultation under E.O. 13175.
A Regulation Identifier Number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in the spring and fall of each year. The RIN contained in the heading of this document can be used to cross reference this action with the Unified Agenda.
As required by 5 U.S.C. 553(b)(4), a summary of this rule can be found at
Government contracts, Grant programs—transportation, Highway safety, Highways and roads, Reporting and recordkeeping requirements, Traffic regulations.
Issued in Washington, DC, under authority delegated in 49 CFR 1.85.
For the reasons stated in the preamble, FHWA amends 23 Code of Federal Regulations Part 630, as set forth below:
23 U.S.C. 106, 109, 112, 115, 315, 320, and 402(a); Sec. 1110, 1501, and 1503 of Pub. L. 109-59, 119 Stat. 1144; Pub. L. 105-178, 112 Stat. 193; Pub. L. 104-59, 109 Stat. 582; Pub. L. 97-424, 96 Stat. 2106; Pub. L. 90-495, 82 Stat. 828; Pub. L. 85-767, 72 Stat. 896; Pub. L. 84-627, 70 Stat. 380; 23 CFR 1.32 and 49 CFR 1.81 and 1.85, and Pub. L. 112-141, 126 Stat. 405, sections 1303 and 1405.
Environmental Protection Agency (EPA).
Determination of adequacy.
The EPA is notifying the public that we have found the motor vehicle emissions budgets for the Klamath Falls, Oregon 2006 24-hour fine particulate matter standard nonattainment area adequate for transportation conformity purposes. The budgets were submitted on August 20, 2024, as part of Oregon's Klamath Falls Redesignation Request and Maintenance
This finding is effective September 5, 2025.
Tess Bloom, 1200 6th Avenue, Suite 155, Seattle, WA 98101;
Throughout this document, “we” and “our” refer to the EPA.
This document is an announcement of a finding that we have already made. The EPA Region 10 sent a letter to the Oregon Department of Environmental Quality on April 25, 2025 stating that the 2017 and 2037 fine particulate matter (PM
The motor vehicle emissions budgets for the 2037 future year will be 77 and 1448 lbs/day for PM
Transportation conformity is required by Clean Air Act section 176(c). The EPA's Transportation Conformity Rule requires that transportation plans, transportation improvement programs, and projects conform to state air quality implementation plans (SIPs) and establishes the criteria and procedures for determining whether or not they do.
The criteria by which we determine whether a SIP's motor vehicle emission budgets are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4). We've described our process for determining the adequacy of submitted SIP budgets in our July 1, 2004 (69 FR 40004) preamble starting at page 40038 and we used the information in these resources in making our adequacy determination. Please note that an adequacy review is separate from the EPA's completeness review and should not be used to prejudge the EPA's ultimate action on the redesignation request and maintenance plan.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Final rule; administrative change.
The Environmental Protection Agency (EPA) is updating the materials that are incorporated by reference (IBR) into the Washington State Implementation Plan (SIP). The regulations affected by this update have been previously submitted by Washington and approved by the EPA. This update affects the materials that are available for public inspection at the National Archives and Records Administration (NARA) and the EPA Regional Office.
This action is effective August 21, 2025.
The SIP materials for which incorporation by reference into 40 CFR part 52 is finalized through this action are available for inspection at the following locations: Environmental Protection Agency, Region 10, 1200 Sixth Avenue, Suite 155, Seattle, WA 98101; and
Jeff Hunt, EPA Region 10, 1200 Sixth Avenue, Suite 155, Seattle, WA 98101, at (206) 553-0256, or
Each State has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.
Each State must formally adopt the control measures and strategies in the SIP after the public has had an
The SIP is a living document which the State can revise as necessary to address the unique air pollution problems in the State. Therefore, the EPA from time to time must take action on proposed revisions containing new or revised State regulations. A submission from a State can revise one or more rules in their entirety, or portions of rules. The State indicates the changes in the submission (such as by using redline/strikethrough text) and the EPA then takes action on the requested changes. The EPA establishes a docket for its actions using a unique Docket Identification Number, which is listed in each action. These dockets and the complete submission are available for viewing on
On May 22, 1997 (62 FR 27968), the EPA revised the procedures for incorporating by reference, into the Code of Federal Regulations, materials approved by the EPA into each SIP. These changes revised the format for the identification of the SIP in 40 CFR part 52, streamlined the mechanisms for announcing the EPA approval of revisions to a SIP, and streamlined the mechanisms for the EPA's updating of the IBR information contained for each SIP in 40 CFR part 52. The revised procedures also called for the EPA to maintain “SIP Compilations” that contain the federally approved regulations and source-specific permits submitted by each State agency.
The EPA generally updates these SIP Compilations every few years. Under the revised procedures, the EPA must periodically publish an informational document in the rules section of the
Since the last IBR update, the EPA approved and incorporated by reference the following regulatory materials into the Washington SIP:
• Washington Administrative Code, Chapter 463-78, General and Operating Permit Regulations for Air Pollution Sources, section 78-005 (Adoption by Reference). For more information, see 89 FR 105456 (December 27, 2024).
• Washington Administrative Code, Chapter 173-400, General Regulations for Air Pollution Sources, sections 173-400-030 (Definitions), 173-400-081 (Startup and Shutdown), 173-400-082 (Alternative Emissions Limit That Exceeds an Emission Standard in the SIP), 173-400-136 (Use of Emission Reduction Credits (ERC)), and 173-400-171 (Public Notice and Opportunity for Public Comment). For more information, see 89 FR 105456 (December 27, 2024).
• Olympic Region Clean Air Agency Regulations, Rule 6.2 Outdoor Burning, section 6.2.7 (Recreational Burning). For more information, see 90 FR 5693 (January 17, 2025).
• Southwest Clean Air Agency Regulations, General Regulations for Air Pollution Sources, sections 400-040 (General Standards for Maximum Emissions), 400-070 (General Requirements for Certain Source Categories), 400-081 (Startup and Shutdown), and 400-107 (Excess Emissions). For more information, see 90 FR 19650 (May 9, 2025).
• Spokane Regional Clean Air Agency Regulation I, sections 1.01 (Policy), 1.04 (General Definitions), 2.08 (Falsification of Statements or Documents, and Treatment of Documents), 2.13 (Federal and State Regulation Reference Date), 4.04 (Stationary Sources and Source Categories Subject to Registration), 5.02 (New Source Review—Applicability and when Required), 5.04 (Information Required), 5.05 (Public Involvement), 5.07 (Processing NOC Applications for Stationary Sources), 5.08 (Portable Sources), 5.10 (Changes to an Order of Approval or Permission to Operate), 5.13 (Order of Approval Construction Time Limits), 6.04 (Emission of Air Contaminant: Detriment to Person or Property), 8.01 (Purpose), 8.02 (Applicability), 8.03 (Definitions), 8.04 (Emission Performance Standards), 8.05 (Opacity Standards), 8.06 (Prohibited Fuel Types), 8.07 (Curtailment), 8.08 (Exemptions), 8.09 (Procedure to Geographically Limit Solid Fuel Burning Devices), and 8.10 (Restrictions on Installation of Solid Fuel Burning Devices). For more information, see 90 FR 15930 (April 16, 2025).
• Washington Administrative Code, Chapter 173-400, General Regulations for Air Pollution Sources, sections 173-400-070 (Emission Standards for Certain Source Categories) and 173-400-107 (Excess Emissions). For more information, see 89 FR 105456 (December 27, 2024).
In this action, the EPA is providing notification of an update to the materials incorporated by reference into the Washington SIP as of June 1, 2025, and identified in 40 CFR 52.2470(c) and (d). This update includes SIP materials submitted by Washington and approved by the EPA since the last IBR update.
The EPA has determined that this action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make an action effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This administrative action simply codifies provisions which are already in effect as a matter of law in Federal and approved state programs,
In this document, The EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, The EPA is finalizing the incorporation by reference of regulations promulgated by Washington and local clean air agencies located in Washington, previously approved by the EPA and Federally effective before June 1, 2025, contained in 40 CFR 52.2470(c),
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, this action is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal Governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
The EPA also believes that the provisions of section 307(b)(1) of the Clean Air Act pertaining to petitions for judicial review are not applicable to this action. This is because prior EPA rulemaking actions for each individual component of the Washington SIP Compilation previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, the EPA believes judicial review of this action under section 307(b)(1) is not available.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(b)
(1) Material listed in paragraphs (c) and (d) of this section with an EPA approval date prior to June 1, 2025, was approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Material is incorporated as it exists on the date of the approval and notification of any change in the material will be published in the
(2) EPA Region 10 certifies that the rules/regulations provided by the EPA in the SIP compilation at the addresses in paragraph (b)(3) of this section are an exact duplicate of the officially promulgated State rules/regulations
(3) Copies of the materials incorporated by reference may be inspected at the Region 10 EPA Office at 1200 Sixth Avenue, Suite 155, Seattle, WA 98101. To obtain the material, please call (206) 553-0256. You may inspect the material with an EPA approval date prior to June 1, 2025, for Washington at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA email
Environmental Protection Agency (EPA).
Final determination.
The Environmental Protection Agency (EPA) is finalizing our determination that the Sacramento Metro, California area attained the 2008 8-hour ozone national ambient air quality standards (NAAQS) by its December 31, 2024 attainment date. This determination is based on quality-assured and certified ambient air quality monitoring data from 2022 through 2024. We are also finalizing a determination that the requirement for the State to have contingency measures for reasonable further progress (RFP) and attainment for the 2008 ozone NAAQS no longer applies for this area.
This determination is effective on September 22, 2025.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2025-0070. All documents in the docket are listed on the
Laura Lawrence, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105; phone: (415) 972-3407; email:
Throughout this document, “we,” “us,” and “our” refer to the EPA.
On March 21, 2025, the EPA proposed to determine that the Sacramento Metro area attained the 2008 ozone national ambient air quality standards (NAAQS) by its December 31, 2024 attainment date.
As discussed in section II.A of our proposed determination, an area is considered to have attained the 2008 ozone standards if there are no violations of the standards, as determined in accordance with 40 CFR 50.15, based on three consecutive years of complete, quality-assured, and certified monitoring data. A violation of the NAAQS occurs when the ambient ozone air quality monitoring data show that the design value (
The EPA proposed this determination to fulfill our statutory obligation under Clean Air Act (CAA or “Act”) section 181(b)(2) to determine whether the area attained the 2008 ozone NAAQS by its attainment date. Our proposed determination was based on complete, quality-assured and certified ozone air quality monitoring data for the 2022-2024 calendar years. A summary of the air quality monitoring data for these years is provided in Table 1.
Our proposed determination includes additional information about ozone air pollution, the NAAQS, and the statutory and regulatory bases for making a determination of attainment. The proposed determination also includes information about the Sacramento Metro nonattainment area, the Tribes whose lands are located within the nonattainment area, and the ozone air quality data considered for the determination (information about the monitoring network, the data certification process, data completeness considerations and other relevant information).
In our proposed rulemaking, we also proposed to determine that, if we finalized our determination of attainment by the attainment date, then the requirement for the area to have contingency measures for failure to meet RFP and failure to attain for the 2008 ozone NAAQS would no longer apply, because contingency measures would never be needed.
Concurrent with our publication of the proposed determination of attainment by the attainment date, the EPA issued an interim final determination, effective upon publication, to stay the offset sanction and to defer the highway funding sanction associated with the EPA's 2023 disapproval of the Sacramento Metro area's contingency measures submittal.
The EPA's proposed action provided a 30-day public comment period. During this period, we received three comment letters, which are included in the docket for this action. Two comment letters are from anonymous commenters, with identical content that is not germane to this action. The third comment letter was submitted by Air Law for All on behalf of the Center for Biological Diversity (CBD). Issues raised in this comment letter are summarized with response below.
The commenters argue that the EPA's approach is contrary to Congressional
The commenters speculate that the EPA may have failed to make milestone determinations for Sacramento Metro and other areas because of a prior “invalid” agency interpretation under which milestone requirements could be satisfied by a showing that control measures were timely implemented, citing
First, as a preliminary matter, we note that while the commenter refers to our conclusions regarding RFP contingency measures as a declaration that RFP contingency measures are “moot,” our proposed determination does not use this word. The commenter is mischaracterizing the EPA's action. We do not say, nor did we intend to imply, that the RFP contingency measures are “moot” in a legal sense. The EPA is not purporting to apply a judge-made doctrine as commenters suggest. Instead, the proposal explains the EPA's longstanding position, held for over 30 years,
Therefore, if we finalize our proposed determination that the Sacramento Metro area has attained the 2008 ozone NAAQS by the attainment date, then attainment contingency measures for the 2008 ozone NAAQS would never be required to be implemented, regardless of whether the area continued to attain the NAAQS, and RFP contingency measures could not be triggered and would therefore no longer be necessary.
The EPA's interpretation of the statute, as laid out in the 1995 Seitz Memo cited in the proposal, is based on the CAA's definition of “reasonable further progress” for the nonattainment requirements of part D.
The Tenth Circuit has recently recognized that “[t]he ‘purpose’ clause [in the CAA definition of RFP] simply explains that the emissions reductions (set either by part D or the EPA) are designed to ensure the area will eventually reach attainment.”
Relatedly, commenters are incorrect when they claim, or imply, that the EPA's position is based only on a reading of CAA section 182(g); a purported “preferred reading” that commenters do not explain further. The EPA mentioned CAA section 182(g) one time in the proposal in conjunction with other authorities explained above, including the 1995 Seitz Memo which discusses the EPA's position in reference to the definition of RFP in CAA section 171(1). Upon reexamination in light of the comment, this short statement about CAA 182(g) in the proposal appears to be a straightforward explanation of the basic mechanics of that provision. Commenters do not specify which portion of CAA section 182(g), or which language within 182(g), they believe the EPA is misreading or misapplying. Since the comment on this point is vague, the EPA cannot provide a specific response.
As a Severe-15 nonattainment area with a December 31, 2024 attainment date, the Sacramento Metro area's RFP milestones for the 2008 ozone NAAQS occurred in the years 2017, 2020, and 2023.
Additionally, in response to this comment, the EPA has reviewed emissions inventories for the 2017 milestone, which show the area achieving substantial early reductions to meet the milestone, consistent with the continuing progress demonstrated in the submitted MCDs. Under the 2008 ozone SIP Requirements Rule and 40 CFR 51.1110, the area was required to show an 18 percent reduction in VOC or NO
Our review of emissions inventory data therefore shows the area has achieved the required reductions in each RFP milestone for the 2008 ozone NAAQS, including in 2023 (the area's last applicable milestone prior to the attainment date), and RFP contingency measures for this NAAQS would not be required to be implemented, regardless of whether the area continues to attain the NAAQS.
Next, we find the commenter's legal arguments relating to Congressional intent to be unavailing. Nothing in our proposed action or interpretation of the CAA rests on an assumption that the EPA will fail to make milestone determinations or otherwise act illegally. To reiterate, when the EPA determines that an area has timely attained a NAAQS, the area no longer needs to demonstrate RFP.
Further, while we agree with the commenter that CAA section 182(g) does not require states to submit MCDs for milestones aligning with an area's attainment date when the area has timely attained, we disagree that this creates any inference that would contradict our determination. Indeed, we find this language in the Act to be supportive of the general point that the purpose of the RFP requirements is to ensure progress toward attainment by the applicable attainment date.
For the reasons above, we disagree that our proposed action exceeds the EPA's authority under the CAA.
Similarly, CAA section 182(b)(1)(A) specifies that attainment plans for Moderate and above areas:
Further, as the commenter notes and as we explained above, CAA section 182(g) includes a specific statutory exemption from the requirement to submit an MCD. That section does not require an ozone nonattainment area classified “Serious” or higher to demonstrate compliance with an RFP milestone that coincides with the attainment date once the area has attained.
Our action follows several similar actions for Phoenix, Ventura County, and Western Nevada County nonattainment areas.
Commenters are wrong to suggest this position related to the amount of reductions needed in an RFP plan is somehow inconsistent with the EPA's present determination in this action. The EPA's position is consistent. “[R]easonable further progress and attainment are two interconnected—but distinct—requirements.”
For the reasons discussed above, we disagree that it is inappropriate to finalize our proposed determination that contingency measures for RFP are no longer required upon a determination of attainment by the attainment date. We also disagree that it is inappropriate to relieve the sanctions associated with our previous disapproval of contingency measures for RFP and attainment for the Sacramento Metro area.
Pursuant to section 181(b)(2)(A) of the CAA and 40 CFR 51.1303, the EPA is making a final determination that the Sacramento Metro area attained the 2008 ozone NAAQS by the applicable attainment date of December 31, 2025. Once effective, this final action satisfies the EPA's obligation pursuant to CAA section 181(b)(2)(A) to determine, based on an area's air quality as of the attainment date, whether the area attained the standard by its applicable attainment date.
We are also making a final determination that the requirement for the Sacramento Metro area to have contingency measures for failure to meet RFP and failure to attain the 2008 ozone NAAQS by the attainment date no longer applies, because contingency measures cannot be triggered given the attainment of the NAAQS by the attainment date. This finding will not prevent the EPA, in the event that the Sacramento Metro area subsequently violates the NAAQS, from exercising its authority under the CAA to address violations of the NAAQS.
This attainment determination permanently stops the sanctions and FIP clocks triggered by the EPA's previous disapproval of the contingency measures requirement for the Sacramento Metro area, and permanently lifts the offset sanction that had previously been imposed. The offset sanction had previously been stayed and the highway funding sanction had previously been deferred by our interim final determination to stay and defer sanctions.
This determination of attainment does not constitute a redesignation to attainment under CAA section 107(d)(3). The EPA may redesignate an area if the state meets additional statutory criteria, including the EPA approval of a state plan demonstrating maintenance of the air quality standard for 10 years after redesignation, as required under CAA section 175A. As for all NAAQS, the EPA is committed to working with states that choose to submit redesignation requests for areas that are attaining the 2008 ozone NAAQS.
This action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
Additionally, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000) because it will not impose substantial direct costs on Tribal governments or preempt Tribal law. The EPA has identified Tribal areas within the Sacramento Metro nonattainment area. We note that this determination applies throughout the nonattainment area, including on Tribal lands within the nonattainment areas. However, as noted in our proposal and in section III of this document, the Sacramento Metro nonattainment area, including the Tribal lands within the nonattainment area, will remain designated nonattainment and will retain its existing classification.
The EPA notified the Tribes located within the boundaries of the Sacramento Metro nonattainment areas of our proposed determination and will notify these Tribes of this final determination. Because a final determination of attainment does not change the Tribe's existing nonattainment designation or classification, the EPA does not plan offer government-to-government consultation on this determination, however, it is our practice to initiate government-to-government consultation at the request of any Tribe.
This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 20, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
For the reasons stated in the preamble, part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(o)
Office of the Secretary, Department of Health and Human Services (HHS).
Interim final rule.
This document updates compliance and other dates presented in the final rule that appeared in the December 13, 2024
These regulations are effective August 20, 2025.
Michael Cimmino (410) 786-6408.
We published a final rule that appeared in the December 13, 2024,
The February 2025 final rule (90 FR 9290) acknowledged the impact of this delayed effective date on compliance and transition periods for covered entities and state Medicaid agencies. The December 2024 final rule initially specified a compliance date 36 months after its effective date, with an 8-month transition starting 28 months after the effective date and running to the compliance date. The February 2025 final rule altered the effective date to April 14, 2025, resulting in a new compliance date of April 14, 2028, with the 8-month transition period running from August 14, 2027, to April 14, 2028.
This interim final rule (IFR) updates compliance and other dates in the preamble and regulations text of the December 2024 final rule in accordance with the delay of effective date changes finalized in the February 2025 final rule. As a result of the changes published in the February 2025 final rule, the following provisions of the December 2024 final rule are updated as follows:
• The
++
++
• Summary of effective and compliance dates (section I.C. of the December 2024 final rule):
++ Beginning August 14, 2027, all covered entities, as agreed to by trading partners, may use either Version D.0 and Version 1.2, or Version F6 and Version 15, for 8 months as a transition period prior to full compliance, which begins 36 months after the effective date of the February 2025 final rule.
++ All covered entities must be in compliance with Version F6 and Version 15 beginning April 14, 2028.
++ Beginning August 14, 2027, state Medicaid agencies, as agreed to by trading partners, may use Version 3.0 or Version 10 for 8 months as a transition period prior to full compliance, which begins 36 months after the effective date of the February 2025 final rule.
++ State Medicaid agencies must be in compliance with Version 10 beginning April 14, 2028.
• Compliance Date for Version F6 and Version 15 (section III.C.1. of the December 2024 final rule)—The final transition and compliance dates for Version F6 and Version 15 at §§ 162.1102, 162.1202, 162.1302 and 162.1802:
++ All covered entities may, as agreed to by trading partners, use either Version D.0 and Version 1.2, or Version F6 and Version 15, beginning August 14, 2027.
++ All covered entities must comply with only Version F6 and Version 15 beginning April 14, 2028.
• Compliance Date for Version 10 (section III.C.2. of the December 2024 final rule)—At § 162.1902, we are finalizing the compliance date for Version 10 as beginning April 14, 2028, which aligns with the timeline we are adopting for Version F6 and Version 15. In addition, at § 162.1902, we are finalizing that, beginning August 14, 2027, which is 8 months before the compliance date, state Medicaid agencies may, as agreed to by trading partners, use either Version 3.0 or Version 10 for Medicaid pharmacy subrogation transactions.
• Regulations text of the December 2024 final rule. In the regulations text of this interim final rule, §§ 1162.1102, 162.1202, 162.1302, 162.1802, and 162.1902 are revised to reflect the transition and compliance dates (August 14, 2027 and April 14, 2028, respectively) noted previously.
Under 5 U.S.C. 553(b) and (c) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rulemaking in the
This interim final rule does not constitute a rule that would be subject to notice and comment. However, to the extent that 5 U.S.C. 553 applies to this action, it is exempt from its requirements because it constitutes a general statement of policy under 5 U.S.C. 553(b)(A). As described previously, the February 2025 final rule's delay in the effective date was intended to give agency officials the opportunity to further review and consider the December 2024 final rule. Here, we simply state the new compliance and other related dates for the requirements previously finalized in the December 2024 final rule that arose pursuant to the February 2025 final rule's delay of the effective date.
Moreover, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures just to incorporate the updated dates in this document, or further delaying the effective date, would be contrary to the public interest, as covered entities have requested that the updated dates be published in a timely manner in order to reduce confusion among the industry regarding the actual compliance and transition period dates. Additional notice and comment procedures and further delay in the effective date of this interim final rule are unnecessary as we are not altering our policies, but, rather, simply stating the updated compliance and other dates that had previously been proposed and subjected to notice and comment, and then finalized in the December 2024 final rule. We find that, should the notice, comment, and effective date requirements have been
This document does not impose new 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 requirements and burdens associated with the information collection requirements contained and were finalized in the December 2024 final rule. Therefore, the one-time burden was previously approved and accounted for in the information collection request previously approved under OMB control number 0938-0866 and titled “CMS-R-218: HIPAA Standards for Coding Electronic Transactions.”
OMB has determined that the establishment of standards for electronic transactions under HIPAA (which mandate that the private sector disclose information and do so in a particular format) constitutes an agency-sponsored third-party disclosure as defined under the Paperwork Reduction Act (PRA, 44 U.S.C. 3501
Should our assumptions be incorrect, this information collection request will be revised and reinstated to incorporate any additional transaction standards and modifications to transaction standards that were previously covered in the PRA package associated with OMB approval number 0938-0866.
As discussed in more detail in section II. of this interim final rule, consistent with the Presidential memorandum of January 20, 2025, “Regulatory Freeze Pending Review,” we delayed for 60 days the effective date of the December 2024 final rule to provide the Administration sufficient time to review any questions of fact, law, and policy. This interim final rule updates compliance and other dates in the preamble and regulations text of the December 2024 final rule in accordance with the delay of effective date changes finalized in the February 2025 final rule.
We have examined the impacts of this rule as required by Executive Order 12866, “Regulatory Planning and Review”; Executive Order 13563, “Improving Regulation and Regulatory Review”; Executive Order 14192, “Unleashing Prosperity Through Deregulation”; the Regulatory Flexibility Act (Pub. L. 96 354); section 1102(b) of the Social Security Act; section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4); Executive Order 13132, “Federalism”; and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages, and distributive impacts). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule that may: (1) have an annual effect on the economy of $200 million or more in any one year, or adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues for arising out of legal mandates, or the President's priorities.
This interim final rule is not a significant regulatory action under section 3(f) of Executive Order 12866. The temporary delay in the effective date until April 14, 2025, published in the February 2025 final rule (90 FR 9290), was necessary to give agency officials the opportunity for further review and consideration of the new regulation, consistent with the memorandum described previously. We estimate this temporary delay in the effective date could result in annualized net cost savings for the industry of approximately $992,500 and $1.04 million at the 7 percent and 3 percent discount rates, respectively. Additional details regarding the economic impacts can be found in the regulatory impact analysis in section VI. of the December 2024 final rule (89 FR 100773 through 100787).
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Individuals and states are not included in the definition of a small entity.
As stated earlier, this interim final rule updates compliance and other dates in the preamble and regulations text of the December 2024 final rule in accordance with the 60-day delay of effective date changes finalized in the February 2025 final rule. The temporary delay in the effective date until April 14, 2025, published in the February 2025 final rule (90 FR 9290), was necessary to give agency officials the opportunity for further review and consideration of the new regulation, consistent with the memorandum described previously. As a result, the Secretary has certified that this interim final rule will not have a significant impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For the purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This interim final rule will not significantly impact the operations of a substantial number of small rural hospitals, as these entities are not involved in the exchange of retail pharmacy transactions. Therefore, the Secretary has certified that this interim final rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates would require spending more in any 1 year than threshold amounts in 1995 dollars, updated annually for inflation. In 2025, that threshold is approximately $187 million. This interim final rule does not contain mandates that will impose spending costs on State, local, or tribal governments in the aggregate, or by the private sector, of more than $187 million in any 1 year.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This interim final rule will not impose substantial direct requirement costs on State and local governments, preempt State law, or otherwise have Federalism implications.
Executive Order 14192, titled “Unleashing Prosperity Through Deregulation,” was issued on January 31, 2025, and requires that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.” This interim final rule is expected to be an E.O. 14192 deregulatory action. We estimate that this interim final rule would generate $992,500 in annualized cost savings at a 7 percent discount rate, discounted relative to the year 2024, over a perpetual time horizon.
Administrative practice and procedures, Electronic transactions, Health facilities, Health insurance, Hospitals, Incorporation by reference, Medicaid, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR part 162 as set forth below:
42 U.S.C. 1320d—1320d-9 and secs. 1104 and 10109 of Pub. L. 111-148, 124 Stat. 146-154 and 915-917.
Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).
Final rule.
PHMSA is amending the Federal pipeline safety regulations to incorporate by reference all or parts of 19 updated industry standards. PHMSA is also clarifying certain regulatory provisions and making several editorial corrections.
The effective date of this final rule is January 10, 2026. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of January 10, 2026.
This final rule incorporates by reference 19 updated voluntary, consensus industry technical standards within the pipeline safety regulations (PSR, 49 Code of Federal Regulation (CFR) parts 190-199). The incorporation of these updated standards will maintain or improve public safety, prevent regulatory confusion, and reduce compliance burdens consistent with the requirements in the National Technology Transfer and Advancement Act (NTTAA) of 1995 (15 United States Code (U.S.C.) 272 (note)).
PHMSA incorporates more than 80 industry standards by reference into the PSRs. By updating these references on a periodic basis, PHMSA encourages innovation and technological development and reduces unnecessary compliance burdens.
PHMSA has determined that the updated standards adopted in this final rule will either maintain or enhance the protection of public safety. PHMSA has further concluded that the adoption of these standards is technically feasible, reasonable, cost-effective, and practicable, and that it produces benefits that justify any associated compliance costs.
The Office of Management and Budget (OMB) sets the policy for Federal use and development of voluntary, consensus industry technical standards in OMB Circular A-119 (“Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities”).
PHMSA has incorporated more than 80 industry standards by reference into the PSRs. The lists of publications incorporated into parts 191 (which regulates reporting), 192 (which regulates the transportation of gas by pipeline) and 195 (which regulates the transportation of hazardous liquids and carbon dioxide by pipeline) are found in §§ 192.7 and 195.3, respectively. Previous rules that incorporated updated industry standards by reference were published on May 24, 1996 (61 FR 26121); February 17, 1998 (63 FR 7721); June 14, 2004 (69 FR 32886); June 9, 2006 (71 FR 33402); February 1, 2007 (72 FR 4655 (correction)); August 11, 2010 (75 FR 48593); January 5, 2015 (80 FR 168); August 6, 2015 (80 FR 46847 (correction)), and April 29, 2024 (89 FR 33264).
The industry standards that are incorporated within the PSRs are developed or adopted by domestic and international standard-development organizations (SDOs). Approximately every two to five years, these organizations use agreed-upon procedures to update and revise their published standards to reflect the latest developments in technology, testing, and operational practices. New or updated industry standards often incorporate new technologies, materials, management practices, and other innovations that can improve the physical integrity, and the safe operation of pipeline facilities.
PHMSA employees participate in meetings held by 25 domestic SDOs that address the design, construction, maintenance, inspection, operation, and repair of pipeline facilities. PHMSA's subject-matter experts represent PHMSA in all dealings with the SDOs; participate in discussions and technical debates; register opinions; and vote in accordance with the procedures of the SDOs at each stage of the standards-development process (unless prohibited from doing so by law). PHMSA participates in this process to ensure its safety priorities are considered, and to avoid the need to develop separate, government-unique standards.
PHMSA also regularly reviews updated editions of currently referenced industry standards and amends the PSR to incorporate partially or fully updated standards. These updates ensure that the PSRs incorporate and facilitate the use of the latest technologies, materials, management and operational practices, testing, and other innovations. The adoption of more recent editions of industry standards also prevents conflicts between the standards referenced in the PSRs and updated versions of the same standards with which operators and suppliers may voluntarily comply, thereby (1) avoiding the confusion and expense associated with ensuring compliance with competing versions of the same standard; and (2) improving compliance and allowing the allocation of more operator resources toward safety. PHMSA reviewed the updated standards discussed in this final rule and finds them appropriate for IBR within the PSR.
Pursuant to section 24 of the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 (Pub. L. 112-90, 49 U.S.C. 60102(p), as amended), “the Secretary may not issue a regulation pursuant to this chapter that incorporates any documents or portions thereof unless the documents or portions thereof are made available to the public, free of charge.” Most of the updated standards incorporated by reference in this final rule can be viewed online for free.
The standards incorporated by reference in this final rule are reasonably available to interested parties in several ways. First, PHMSA has negotiated agreements to make viewable copies of the standards available to the public at no cost with all but two of the SDOs whose updated standards are incorporated by reference in this final rule. The organizations that agreed to the public access requirements of the statutory mandate discussed above are: the American Petroleum Institute (API), the American Gas Association (AGA), ASTM International (formerly the American Society for Testing and Materials), the Gas Technology Institute (GTI), the Manufacturers Standardization Society of the Valve and Fittings Industry, Inc. (MSS), the Association for Materials Protection and Performance (AMPP) (formerly NACE International), the National Fire Protection Association (NFPA), and the Plastics Pipe Institute (PPI).
The API standards identified in Section V.A. are available from the following website:
The ASTM standards identified in Section V.E. are available from the following website:
The AMPP: NACE standards identified in Section V.D. are available from the following website:
Finally, the NFPA standard identified in Section V.F. is available from the following website:
As of the date of publication of this final rule, PHMSA was not able to reach a general agreement with the American Society of Mechanical Engineers (ASME) to make the standards readily available online as ASME heavily relies on the revenue the standards generate.
Finally, the material can also reasonably be obtained by interested parties through the applicable publisher contact information listed §§ 192.7 and 195.3 of the amendatory text in this document. Additional information regarding standards availability can be found at
On August 29, 2022, PHMSA published a notice of proposed rulemaking (NPRM) to incorporate by reference all or parts of more than 20 updated industry standards and to make editorial corrections to certain regulations.
On January 16, 2025, PHMSA discussed the NPRM with the Technical Pipeline Safety Standards Committee (TPSSC) (also known as the Gas Pipeline Advisory Committee (GPAC)), and the Technical Hazardous Liquid Pipeline Safety Standards Committee (THLPSSC) (also known as the Liquid Pipeline Advisory Committee (LPAC)). The GPAC and LPAC are statutorily mandated Federal advisory committees that, respectively, advise PHMSA on proposed safety standards for gas and hazardous liquid and carbon dioxide pipeline facilities and any associated risk assessments.
A transcript of the GPAC and LPAC meeting and all presented materials is available both in the docket for the rulemaking and on the web page that PHMSA created for the meeting.
PHMSA received nine comments on the NPRM from the following individuals and organizations: the American Fuel & Petrochemical Manufacturers (AFPM), Association for Materials Protection & Performance (AMPP), the American Petroleum Institute (API), an anonymous commenter, David Rudolph, Dresser Utility Solutions, Joe Schmo, a joint comment from “the Associations” (Interstate Natural Gas Association of America (INGAA), American Gas Association (AGA), American Public Gas Association (APGA), API, GPA Midstream Association, and Plastic Pipe Institute (PPI)), and National Fire Protection Association (NFPA).
PHMSA below discusses comments received from stakeholders (in written comments or during the GPAC/LPAC meeting) on a handful of specific industry standards and editorial and technical corrections proposed by the NPRM for incorporation in the PSRs. In addition to discussing those specific comments, PHMSA incorporates by reference within this final rule its discussion of the proposals in the NPRM—including but not limited to, its description in the NPRM of the content of any updated standards and corrections, and the safety benefits anticipated from those amendments.
PHMSA received comments that generally were supportive of the proposals in the NPRM. API questioned PHMSA's failure to include the adoption of API Recommended Practice (RP) 1162, Public Awareness Programs for Pipeline Operators, Third Edition, in the NPRM. At the joint GPAC/LPAC meeting, an LPAC industry committee member also asked PHMSA to consider incorporating API RP 1162 by reference. A public PAC member took the opposite view and expressed support for PHMSA's decision to not incorporate the newer edition of that standard. PHMSA will consider action on this RP in a future rulemaking.
Both the GPAC and LPAC discussions and voting broadly were supportive of the proposed amendments in the NPRM. The GPAC unanimously voted to endorse each of the proposed IBR updates and miscellaneous amendments within parts 191 and 192 as “technically feasible, reasonable, cost-effective, and practicable”. The GPAC also called on PHMSA to continue to work towards an agreement with ASME to make its
The LPAC voted to endorse, with only two dissenting votes, the proposed IBR updates and miscellaneous amendments to part 195 as “technically feasible, reasonable, cost-effective, and practicable.” Two public committee members explained those dissenting votes by referring to concerns about the public availability of ASME standards, rather than by offering substantive objections to the proposals in the NPRM. Like the GPAC, these two members called on PHMSA to continue actively to pursue an agreement with ASME because of the importance of transparency between governing bodies and the general public. PHMSA will continue to work with ASME to reach an agreement for standards availability.
At the joint PAC meeting, a GPAC industry committee member encouraged PHMSA to consider an alternative effective date for standards update rulemakings, proposing January 1 as an implementation date or an alternative timeframe that allows operators adequate time to adjust their training and procedures. An LPAC industry member also suggested that PHMSA solicit comments from operators to gather input on time expectations for the implementation of standards. PHMSA agrees with these concerns and has set January 10, 2026, as the effective and compliance dates in the final rule to allow operators adequate implementation time.
API 1104 is a welding standard that PHMSA incorporates by reference within the PSRs. PHMSA currently incorporates the 21st edition of API 1104. In the NPRM, PHMSA stated that incorporating the 22nd edition, which published in July 2021 and includes extensive changes and expanded requirements compared to its predecessors, would require additional resources and training for industry. PHMSA requested comments from stakeholders regarding the use of the 22nd edition of API 1104: Welding Pipelines and Related Facilities to develop welding procedures, as well as comments regarding implementation of the 22nd edition from the perspective of welders, welding inspectors, and engineers. PHMSA also solicited comments on any potential issues that could result from incorporating the 22nd edition. Finally, PHMSA requested comments regarding the potential incorporation of Section 10 of the 22nd edition of API Std 1104 and its impact on the PSRs; in particular, on §§ 192.245 and 195.230.
PHMSA received a comment from the Associations expressing support for the currently incorporated by reference 21st edition of API 1104 and raising concerns with incorporating sections 5, 6 and 10 of the 22nd edition.
During the GPAC and LPAC discussions, committee members expressed general support for the incorporation of API 1104, 22nd edition and encouraged PHMSA to update the standard in a future standards rulemaking. An LPAC public member cautioned that all updates are not necessarily improvements, noting existing issues with the 20th edition of API 1104. PHMSA will determine whether to incorporate the 22nd edition of API 1104 in the future after further review.
NFPA 30 in an industry safety standard addressing the storage, handling, and use of flammable or combustible liquids, including waste liquids. In the NPRM, PHMSA proposed to update the edition of NFPA 30 that is incorporated by reference into the PSRs from the 2012 to the 2021 version. NFPA submitted comments in response to the NPRM, suggesting that PHMSA use the spelling of “ignitible” instead of “ignitable” and clarifying that NFPA did not revise its classification scheme (Class IA, IB, IC, II, IIIA, and IIIB) in the 2021 edition of NFPA 30 but, rather, made a nomenclature revision.
ASTM F1948 specifies requirements and test methods for the qualification of metallic mechanical fittings designed for use with outside-diameter-controlled thermoplastic gas distribution pipe and tubing. In the NPRM, PHMSA proposed to update the currently incorporated by reference version of ASTM F1948 from the 2012 to the 2020 edition. Dresser Pipeline Solutions (Dresser) submitted a comment in response to the NPRM and suggested that PHMSA delay the proposed update to allow ASTM to address Dresser's concerns with implementing the testing protocols in the 2020 edition.
This final rule incorporates the following updated industry standards and amendments into the 49 CFR parts 192 and 195. Availability information for each standard is specified in Section I of this preamble, and a summary of each standard is detailed below and in Section II of the NPRM.
1. API Recommended Practice (RP) 652, “Linings of Aboveground Petroleum Storage Tank Bottoms,” 5th edition, May 2020.
API RP 652 provides acceptable methods for controlling corrosion in aboveground petroleum storage tanks with tank-bottom linings. It also contains information pertinent to lining application, surface preparation, curing, the selection of lining materials, and the inspection of tank-bottom linings for new and existing storage tanks.
[Replaces incorporated by reference (IBR): API Recommended Practice 652, Linings of Aboveground Petroleum Storage Tank Bottoms, 3rd Edition, October 2005; Referenced in 49 CFR 195.579(d)]
2. API RP 2003, “Protection Against Ignitions Arising out of Static, Lightning, and Stray Currents,” 8th Edition, September 2015, reaffirmed March 2020.
API RP 2003 reflects the current state of technology and knowledge (based on experimentation and practical experience) applicable to the prevention of hydrocarbon ignition in petroleum industry applications due to static electricity, lightning, and stray currents. The use of the principles in this RP should lead to improved safety practices and evaluations of existing installations and procedures.
[Replaces API RP 2003, “Protection against Ignitions Arising out of Static, Lightning, and Stray Currents,” 7th Edition, January 2008; Referenced in 49 CFR 195.405(a).]
3. API Specification (Spec) 12F, “Specification for Shop-welded Tanks
API Spec 12F outlines design, fabrication, materials, and testing requirements for new, shop-fabricated, vertical, cylindrical, aboveground, welded-steel storage tanks that are designed according to the standard sizes and capacities for approximately atmospheric internal pressures. This specification is designed to provide the oil production industry with tanks for the storage of crude petroleum and other liquids.
[Replaces API Spec 12F, “Specification for Shop Welded Tanks for Storage of Production Liquids,” 12th Edition, October 2008, effective April 1, 2009; Referenced in 49 CFR 195.132(b), 195.205(b), 195.264(b), 195.264(e), 195.307(a), 195.565, 195.579(d).]
4. API 510, “Pressure Vessel Inspection Code: In-service Inspection, Rating, Repair, and Alteration,” 10th Edition, May 2014, including Addendum 1 (May 2017).
API 510 presents the current state of knowledge and technology applicable to the in-service alteration, inspection, repair, and rerating of steel pressure vessels, as well as the pressure-relieving devices that protect these vessels. This standard applies to all hydrocarbon and chemical process vessels.
[[Replaces API Std 510, “Pressure Vessel Inspection Code: In-Service Inspection, Rating, Repair, and Alteration,” 9th Edition, June 2006; Referenced in 49 CFR 195.205(b) and 195.432(c).]
5. API Standard (Std) 2510, “Design and Construction of LPG Installations,” 9th Edition, August 2020.
API Std 2510 presents the current state of knowledge and technology applicable to the design or construction of facilities that handle or store liquefied petroleum gas at marine or pipeline terminals, natural gas processing plants, petrochemical plants, refineries, and tank farms. This standard applies to storage vessels, loading and unloading systems, and piping.
[Replaces existing references to API Std 2510, “Design and Construction of LPG Installations,” 8th Edition, 2001; Referenced in 49 CFR 195.132(b); 195.205(b); 195.264(b), (e); 195.307(e); 195.428(c); and 195.432(c).]
1. ASME B16.40-2019, “Manually Operated Thermoplastic Gas Shutoffs and Valves in Gas Distribution Systems,” issued February 11, 2019.
ASME B16.40-2019 reflects the current state of knowledge and technology applicable to manually operated thermoplastic valves in nominal valve sizes of half an inch through 12 inches in diameter that are intended for use below the ground in thermoplastic fuel-gas distribution mains and service lines. The standard also sets qualification requirements for each basic valve design, as well as for newly manufactured valves.
[Replaces ASME B16.40-2008, “Manually Operated Thermoplastic Gas Shutoffs and Valves in Gas Distribution Systems,” March 18, 2008, approved by ANSI; Referenced in Section I of appendix B to Part 192].
2. ASME B31.4-2019, “Pipeline Transportation Systems for Liquids and Slurries: ASME Code for Pressure Piping, B31,” issued November 1, 2019.
ASME B31.4-2019 outlines requirements for liquid pipeline systems, liquid-transporting pipelines, and non-hazardous aqueous-slurry-transporting pipelines. This standard also outlines requirements for design, materials, construction, assembly, inspection, testing, operation, and maintenance.
[Replaces ASME B31.4-2006, “Pipeline Transportation Systems for Liquid Hydrocarbons and Other Liquids,” October 20, 2006; Referenced in 49 CFR 195.110(a).]
1. ANSI/ASNT ILI-PQ-2017, “In-line Inspection Personnel Qualification and Certification,” 2017 Edition, approved December 12, 2017.
ANSI/ASNT ILI-PQ-2017 applies the current state of data and technology to the qualification and certification of in-line inspection (ILI) personnel whose jobs require specific knowledge of the technical principles of ILI technologies, operations, regulatory requirements, and industry standards that are applicable to pipeline systems.
[Replaces ANSI/ASNT ILI-PQ-2005(2010), “In-line Inspection Personnel Qualification and Certification,” Reapproved October 11, 2010; Referenced in 49 CFR 192.493 and 195.591.]
1. ANSI/NACE SP0502-2010, Pipeline External Corrosion Direct Assessment Methodology, revised June 24, 2010.
ANSI/NACE SP0502-2010 covers the AMPP external corrosion direct assessment process for buried onshore ferrous pipeline systems. The standard serves as a guide for applying this process on pipeline systems.
2. NACE SP0102-2017, “In-Line Inspection of Pipelines,” March 10, 2017.
NACE SP0102-2017 is applicable to ILI of carbon-steel pipeline systems that are constructed of Grade B or greater material and are used to transport natural gas and hazardous liquids, including anhydrous ammonia, carbon dioxide, water (including brine), liquefied-petroleum gases, and other fluids that are not detrimental to the function or stability of ILI tools. NACE SP0102-2017 states that it applies the most current data and technology to carbon steel pipeline systems that transport hazardous liquids and/or natural gas in the vicinity of a right-of-way.
[Replaces NACE Standard Practice 0102-2010, “In-Line Inspection of Pipelines,” revised March 13, 2010; References 192.150(a); 192.493; 195.120; and 195.591.]
1. ASTM A372/A372M-20e1, “Standard Specification for Carbon and Alloy Steel Forgings for Thin-Walled Pressure Vessels,” approved March 1, 2020.
ASTM A372/A372M-20e1 presents the current state of knowledge and technology regarding the manufacture of relatively thin-walled forgings—including gas bottles—for use in pressure vessels. This specification covers carbon and alloy steel forgings.
[Replaces ASTM A372/A372M-10, “Standard Specification for Carbon and Alloy Steel Forgings for Thin-Walled Pressure Vessels,” approved October 1, 2010; References 49 CFR 192.177(b).]
2. ASTM A672/A672M-19, “Standard Specification for Electric-Fusion-Welded Steel Pipe for High-Pressure Service at Moderate Temperatures,” approved November 1, 2019.
ASTM A672/A672M-19 presents the current state of knowledge and technology regarding the manufacture of electric-fusion-welded pipe for use at moderate temperatures, including all temperatures for pipelines regulated by 49 CFR parts 192 and 195.
[Replaces ASTM A672/A672M-09, “Standard Specification for Electric-Fusion-Welded Steel Pipe for High-Pressure Service at Moderate Temperatures,” approved October 1, 2009; References 49 CFR 192.113 and 195.106(e) and appendix B to part 192.]
3. ASTM D2513-20, “Standard Specification for Polyethylene (PE) Gas Pressure Pipe, Tubing, and Fittings,” approved December 1, 2020.
ASTM D2513-20 presents the current state of knowledge and technology applicable to PE pipe, tubing, and
[Replaces ASTM D2513-18a, “Standard Specification for Polyethylene (PE) Gas Pressure Pipe, Tubing, and Fittings,” approved August 1, 2018; References appendix B to part 192.]
4. ASTM D2564-20, “Standard Specification for Solvent Cements for Poly (Vinyl Chloride) (PVC) Plastic Piping Systems,” approved August 1, 2020.
ASTM D2564-20 presents the current requirements for solvent cements that are used to join PVC piping systems. It addresses the requirements in Specification D1784 regarding PVC pipe that was created from compounds and includes Practice D2855's procedure for joining PVC fittings and pipe.
[Replaces ASTM D2564-12, “Standard Specification for Solvent Cements for Poly (Vinyl Chloride) (PVC) Plastic Piping Systems,” August 1, 2012; References 49 CFR 192.281(b)(2).]
5. ASTM F1055-16a, “Standard Specification for Electrofusion Type Polyethylene Fittings for Outside Diameter Controlled Polyethylene and Crosslinked Polyethylene (PEX) Pipe and Tubing,” approved November 15, 2016.
ASTM F1055-16a presents the current state of knowledge and technology applicable to the use of electrofusion PE fittings with outside-diameter-controlled PE and PEX pipe. The standard also includes requirements for materials, workmanship, and performance testing of pertinent plastic piping.
[Replaces ASTM F1055-98 (Reapproved 2006), “Standard Specification for Electrofusion Type Polyethylene Fittings for Outside Diameter Controlled Polyethylene Pipe and Tubing,” March 1, 2006; References 49 CFR 192.283(a) and appendix B to part 192.]
6. ASTM F1924-19, “Standard Specification for Plastic Mechanical Fittings for Use on Outside Diameter Controlled Polyethylene Gas Distribution Pipe and Tubing,” approved August 1, 2019.
ASTM F1924-19 presents the current state of knowledge and technology applicable to requirements and test methods for the qualification of plastic-bodied mechanical fittings for use with outside-diameter-controlled PE gas-distribution pipe that is nominal 2 IPS and smaller and that complies with Specification ASTM D2513. The standard also specifies general requirements for the material from which such fittings are made.
[Replaces ASTM F1924-12, “Standard Specification for Plastic Mechanical Fittings for Use on Outside Diameter Controlled Polyethylene Gas Distribution Pipe and Tubing,” April 1, 2012; References appendix B to part 192.]
7. ASTM F1948-20, “Standard Specification for Metallic Mechanical Fittings for Use on Outside Diameter Controlled Thermoplastic Gas Distribution Pipe and Tubing,” approved February 1, 2020.
ASTM F1948-20 presents the current requirements and test methods for the qualification of metallic mechanical fittings that are designed to be used with outside-diameter-controlled thermoplastic gas distribution pipe and tubing, as specified in Specification D2513, F2785, or F2945.
[Replaces ASTM F1948-12, “Standard Specification for Metallic Mechanical Fittings for Use on Outside Diameter Controlled Thermoplastic Gas Distribution Pipe and Tubing,” April 1, 2012; appendix B in part 192.]
8. ASTM F2620-20ae2, “Standard Practice for Heat Fusion Joining of Polyethylene Pipe and Fittings,” approved December 1, 2020.
ASTM F2620-20ae2 presents the current state of knowledge and technology applicable to creating joints via heat-fusion joining of PE pipe and fittings in a variety of environments, including in the field.
[Replaces ASTM F2620-19, “Standard Practice for Heat Fusion Joining of Polyethylene Pipe and Fittings,” approved February 1, 2019; References 49 CFR 192.281(c) and 192.285(b).]
9. ASTM F2785-21, “Standard Specification for Polyamide 12 Gas Pressure Pipe, Tubing, and Fittings,” approved July 1, 2021.
ASTM F2785-21 presents the current requirements and test methods for the characterization of PA12 pipe, tubing, and fittings for use in fuel gas mains and services for direct burial and re-liner applications. This standard is intended for the distribution of natural gas.
[Replaces ASTM F2785-12, “Standard Specification for Polyamide 12 Gas Pressure Pipe, Tubing, and Fittings,” August 1, 2012; References appendix B to part 192.]
1. NFPA 30, “Flammable and Combustible Liquids Code,” 2021 Edition, effective August 31, 2020.
NFPA 30 applies to the safe storage, handling, and use of flammable and combustible liquids.
[Replaces NFPA-30 (2012), “Flammable and Combustible Liquids Code,” 2012 Edition (June 20, 2011), Including Errata 30-12-1 (September 27, 2011) and Errata 30-12-2 (November 14, 2011); References 49 CFR 192.735(b) and 195.264(b).]
The final rule will not, however, update the following standards as proposed in the NPRM. PHMSA intends to update these standards in one or more separate rulemakings:
1. ASTM A578/A578M-17, “Standard Specification for Straight-Beam Ultrasonic Examination of Rolled Steel Plates for Special Applications,” November 1, 2017.
2. ASTM F1973-13(2018), “Standard Specification for Factory Assembled Anodeless Risers and Transition Fittings in Polyethylene (PE) and Polyamide 11 (PA11) and Polyamide 12 (PA12) Fuel Gas Distribution Systems,” February 1, 2018.
3. ASTM F2145-13(2018): Standard Specification for Polyamide 11 (PA 11) and Polyamide 12 (PA12) Mechanical Fittings for Use on Outside Diameter Controlled Polyamide 11 and Polyamide 12 Pipe and Tubing,” February 1, 2018.
4. ASTM F2600-09(2018), “Standard Specification for Electrofusion Type Polyamide-11 Fittings for Outside Diameter Controlled Polyamide-11 Pipe and Tubing,” February 1, 2018.
5. ASTM F2767-18, “Standard Specification for Electrofusion Type Polyamide-12 Fittings for Outside Diameter Controlled Polyamide-12 Pipe and Tubing for Gas Distribution,” April 1, 2018.
6. ASTM F2817-13(2019), “Standard Specification for Poly (Vinyl Chloride) (PVC) Gas Pressure Pipe and Fittings for Maintenance or Repair,” May 1, 2019.
7. ASTM F2945-18, “Standard Specification for Polyamide 11 Gas Pressure Pipe, Tubing, and Fittings,” September 1, 2018.
8. PPI T R 3/2021, “Policies and Procedures for Developing Hydrostatic Design Basis (HDB), Hydrostatic Design Stresses (HDS), Pressure Design Basis (PDB), Strength Design Basis (SDB), Minimum Required Strength (MRS) Ratings, and Categorized Required Strength (CRS) for Thermoplastic Piping Materials or Pipe,” June 16, 2021.
9. PPI T R 4/2021, “PPI HSB Listing of Hydrostatic Design Basis (HDB), Hydrostatic Design Stress (HDS), Strength Design Basis (SDB), Pressure Design Basis (PDB) and Minimum Required Strength (MRS) Ratings For Thermoplastic Piping Materials or Pipe,” June 16, 2021.
This final rule makes several miscellaneous editorial amendments and corrections to the PSRs. Some of these revisions include the removal of ASTM D638-03, Standard Test Method for Tensile Properties of Plastics from current § 192.7(e)(10), an action that should have occurred due to other changes made by the Plastic Pipe Rule (83 FR 58694), which published on November 20, 2018. The standard is no longer referenced in § 192.283(a)-(b) because of changes in the Plastic Pipe Rule that altered the language to read “in accordance with a listed specification,” which refers to Section I.A. and I.B. of appendix B to part 192. Additional standards are now incorporated for different material types, such as ASTM F2945 for PA11 and ASTM F2785 for PA12. ASTM D638 is a referenced document within both those standards and ASTM D2513 for PE. Therefore, ASTM D638 no longer needs to be directly incorporated by reference into § 192.7. Section 192.7(e)(10) (or, more precisely, § 192.7(f)(10) as revised by this final rule) will be reserved.
In addition, PHMSA is revising § 191.9: Distribution system: Incident report. Currently, § 191.9(a) references Department of Transportation Form RSPA F 7100.1, which is the previous version of the form. PHMSA is changing this reference to Department of Transportation Form PHMSA F 7100.1. PHMSA is also removing references to specific editions of the standards in this rule throughout parts 192 and 195, except in §§ 192.7 and 195.3. To determine the edition of the standard that is incorporated by reference, operators would refer to §§ 192.7 and 195.3. PHMSA already directs operators to these sections with the following language, which is used throughout parts 192 and 195 whenever a standard is referenced: “(incorporated by reference, see § 192.7)” or “(incorporated by reference, see § 195.3).” Failure to reference these sections may not serve as the basis for a request for leniency in an enforcement case. PHMSA plans to remove references to other specific editions of standards from parts 192 and 195 in future rules. Removing extraneous references to edition numbers will increase administrative efficiency and reduce regulatory uncertainty that could result from inadvertently referencing outdated editions of standards. These amendments simplify both future standards update rules and the PSRs.
Further, PHMSA is revising the definition of a moderate consequence area in § 192.3 to replace the reference to a Federal Highway Administration (FHWA) document, “Highway Functional Classifications Concepts, Criteria and Procedures.” PHMSA is also adding a new appendix, appendix G, to part 192, to provide the guidance on moderate consequence areas that currently is provided by the FHWA's “Highway Functional Classifications Concepts, Criteria and Procedures” document. The new appendix G includes guidance relevant to the terms “Designated Interstate,” “Freeway,” “Expressway,” and “Principal Arterial Roadway,” which appear in the definition of a moderate consequence area. The appendix repeats the information from the FHWA's document verbatim. PHMSA is not making any substantive change to the definition of a moderate consequence area.
PHMSA has decided to not move forward with the editorial change to remove the word “telephonic” from § 191.5(c). The National Response Center (NRC) no longer accepts electronic submission, so the amendment is unnecessary.
Finally, PHMSA is incorporating a number of other minor updates and changes, including:
• Amending § 191.22(c)(1)(i) to change “of” to “or” in the following phrase: “Construction of any planned rehabilitation,” to rectify a typographical error;
• Correcting the reference in § 192.327(g) from § 192.612(b)(3) to § 192.612(c)(3);
• Adding § 192.620(d) to the list of reference locations for NACE SP0502, which currently is listed in § 192.7(h)(4) and will be listed in § 192.7(e)(1) as revised by this final rule;
• Amending § 192.620(d)(7)(ii) to reference “NACE SP0502” instead of “NACE RP-0502-2002;”
• Amending the address in § 192.18(a)(2) to read: “ATTN: Information Resources Manager, Office of Pipeline Safety, Pipeline and Hazardous Materials Safety Administration, PHF-30, 1200 New Jersey Avenue SE, Washington, DC 20590;”
• Amending appendix B to part 192 to remove version numbers from the referenced standards;
• Amending appendix B to part 192 to standardize the structure of the references; and
• Amending § 195.54 to add DOT Form 7000-2.
This final rule is published under the authority of the Secretary of Transportation delegated to the PHMSA Administrator pursuant to 49 CFR 1.97. Among the statutory authorities delegated to PHMSA are those set forth in the Federal pipeline safety statutes (49 U.S.C. 60101
This final rule incorporates by reference more than a dozen updated standards. This final rule also makes several other minor clarifying and editorial changes to the PSRs.
Executive Order (E.O.) 12866 (“Regulatory Planning and Review”),
E.O. 12866 and DOT Order 2100.6B also require that PHMSA submit “significant regulatory actions” to the Office of Information and Regulatory Affairs (OIRA) within the Executive Office of the President's Office of Management and Budget (OMB) for review. This final rule is a not significant regulatory action pursuant to E.O. 12866; it also has not designated this rule as a “major rule” as defined by the Congressional Review Act (5 U.S.C. 801
PHMSA expects that the changes to the PSRs described in this final rule will result in unquantified public safety and environmental benefits associated with the updated standards. Though many of the amendments are editorial revisions or clarifications, others consist of substantive changes that reflect advancements in the state of knowledge (based on developments in technology, testing, and practical experience) compared to earlier versions of the same standards. PHMSA expects that updating the standards referenced in the PSR e will enhance the protection of public safety and the environment.
The administrative burden imposed from updating the standards referenced in this final rule will be negligible. Updates to consensus industry standards are generally accepted and followed on a voluntary basis throughout most of the pipeline industry. The majority of pipeline operators already purchase and voluntarily apply industry standards—including the updated standards that are the subject of this rulemaking—within their ordinary business practices. Most of the updated standards incorporated by reference in this final rule can be viewed online for free. Incorporation of the updated version of these standards within the PSRs will avoid the additional costs of complying with different versions of the same standards.
In addition to incorporating updated industry standards, PHMSA is adopting non-substantive editorial changes and clarifications of certain provisions of regulatory language. Since these editorial changes are minor, this final rule will not require pipeline operators to undertake significant new pipeline safety initiatives and will have negligible cost implications. The non-substantive changes will increase the clarity of the pipeline safety regulations, thereby improving compliance and helping to ensure the safety of the Nation's pipeline systems.
This final rule is an E.O. 14192 (“Unleashing Prosperity Through Deregulation”) deregulatory action. PHMSA estimates that the total costs of the rule on the regulated community will be less than zero. Nor does this rule implicate any of the factors identified in section 2(a) of E.O. 14219 (“Ensuring Lawful Governance and Implementing the President's ‘Department of Government Efficiency’ Deregulatory Initiative”) that are indicative of a regulation that is “unlawful . . . [or] that undermine[s] the national interest.”
The President has declared in E.O. 14156 (“Declaring a National Energy Emergency”)
This final rule is not a “significant energy action” under E.O. 13211 (“Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”),
PHMSA analyzed this final rule in accordance with the principles and criteria contained in E.O. 13132 (“Federalism”)
While the final rule may operate to preempt some State requirements, it will not impose any regulation that has substantial direct effects on the States, the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government. Section 60104(c) of Federal Pipeline Safety Laws prohibits certain State safety regulation of interstate pipelines. Under Federal Pipeline Safety Laws, States that have submitted a current certification under section 60105(a) can augment Federal pipeline safety requirements for intrastate pipelines regulated by PHMSA but may not approve safety requirements less stringent than those required by Federal law. A State may also regulate an intrastate pipeline facility that PHMSA does not regulate. The preemptive effect of the regulatory amendments in this final rule is limited to the minimum level necessary to achieve the objectives of the Federal Pipeline Safety Laws. Therefore, the consultation and funding requirements of E.O. 13132 do not apply.
The Regulatory Flexibility Act (5 U.S.C. 601
The Unfunded Mandates Reform Act (UMRA, 2 U.S.C. 1501
This final rule does not impose unfunded mandates under UMRA because it does not result in costs of $100 million or more (in 1996 dollars) per year for either State, local, or Tribal governments, or to the private sector.
The National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
The purpose of this final rule is to incorporate by reference (IBR) 19 updated voluntary, consensus industry technical standards (updated industry standards) within the PSR (49 CFR parts 190-199). These updated standards will maintain or improve public safety, prevent regulatory confusion, and reduce compliance burdens consistent with the requirements in the NTTAA of 1995 (15 United States Code (U.S.C.) 272 (note)).
PHMSA incorporates more than 80 industry standards by reference into the PSR. This final rule is needed because these standards become outdated over time as new editions become available. By updating these standards, PHMSA ensures better alignment of the PSR with the latest innovations in operational and management practices, materials, testing, and technological advancements; enhances compliance by avoiding conflict between different versions of the same industry standards; and facilitates safety-focused allocation of resources by pipeline operators.
If PHMSA were to select the No Action Alternative, no changes would be made to the current PSRs. There would not be better alignment of the PSR with the latest innovations in operational and management practices, materials, testing, and technological advancements; enhancement of compliance by avoiding conflict between different versions of the same industry standards; and facilitation of safety-focused allocation of resources by pipeline operators. Thus, the No Action Alternative does not fulfill the purpose and need of this action.
This alternative incorporates updated industry standards and amendments into the 49 CFR parts 192 and 195. These updated industry standards are developed through agreed-upon procedures and adopted by domestic and international standard development organizations, ensuring the voluntary, consensus industry standards reflect modern technology and technology practices. The amendments are summarized below and can be found in more detail in Section V of the Final Rule.
The Nation's pipelines are located throughout the United States, both onshore and offshore, and traverse a variety of environments that range from highly populated urban sites to remote, unpopulated rural areas and ecologically sensitive environments. Updating new industry standards or those already incorporated into the PSRs can provide operators with the advantages and added safety that may be associated with newer technologies. These standards are based on the accumulated knowledge and experience of owners, operators, manufactures, risk-management experts, and others involved in the pipeline industry, as well as government agencies that write regulations to ensure the products are moved safely throughout the country. Because the proposed rule is national in scope, it can be assumed the affected environment includes environmental resources such as air, land, water, cultural and socio-economic features throughout the entirety of the United States.
If PHMSA were to select the No Action Alternative, the PSR would remain as is and there would be no new impact on the human or natural environment. The No Action Alternative would not adopt these new editions and the PSRs would fall behind in the latest innovations in operational and management practices, materials, testing, and technological advancements, would not enhance compliance by avoiding conflict between different versions of the same industry standards, and would not facilitate safety-focused allocation of resources by pipeline operators. The No Action Alternative would not address the purpose and need for the final rule.
The amendments made under the Selected Action Alternative will either maintain or enhance the high safety standards currently achieved under the PSRs by aligning regulations with updated voluntary, consensus industry technical standards by reference. These industry standards often incorporate new technologies, materials, management practices, and other innovations that can improve the physical integrity, and the safe operation of pipeline facilities. By incorporating these updates by reference into the PSR, PHMSA can prevent conflicts between the standards referenced in the PSRs and updated versions of the same standards with which operators and suppliers may comply voluntarily, thereby (1) avoiding the confusion and expense associated with ensuring compliance with competing versions of the same
The risk of a pipeline incident depends on several factors, including but not limited to, the contents of the pipeline and the incident location, notably whether the incident occurs near a heavily populated area or sensitive environment. A release from a pipeline that transports hazardous liquid (as well as carbon dioxide) or natural gas—which is subject to PHMSA's jurisdiction—could harm the natural environment and the health and safety of the public. Remediation following a hazardous liquid release requires the removal and disposal of soil directly adjacent to and within the vicinity of pipelines, which results in the loss of vegetation. The replacement of this removed soil can result in the introduction of invasive species, which can degrade the ecological value of an area. In addition, a release could lead to contamination of air and water resources, including oceans, streams, and lakes.
Compliance with the PSR reduces the likelihood of accidental product release. Updating new industry standards or those already incorporated into the PSRs can provide operators with the advantages and added safety that may be associated with newer technologies. These standards are based on the accumulated knowledge and experience of owners, operators, manufactures, risk-management experts, and others involved in the pipeline industry, as well as government agencies that write regulations to ensure the products are moved safely throughout the country. PHMSA staff actively participates in the standards development process to ensure that each incorporated standard will enhance pipeline safety and environmental protection. PHMSA has qualitatively reviewed each of the standards described in this rule and determined that most of the updates involve minor changes, such as editorial changes, the inclusion of best practices, or similar changes. In a small number of instances, standards organizations have relaxed standards to reduce industry burden, but PHMSA has found that in all cases of such a change in this rulemaking, the change is justified by overlapping protections or technological innovation, and therefore would not lead to any degradation in safety or the environment.
PHMSA issued a Draft Environmental Assessment (DEA) with the NPRM on August 29, 2022, under Docket No. PHMSA-2020-0013, which proposed incorporating by reference all or parts of updated editions of some of the voluntary, consensus, industry technical standards into the PSR, along with non-substantive edits and clarifications to certain other provisions of the PSR.
The comment period for the NPRM and DEA closed on October 28, 2022. PHMSA received nine comments. Two were generally supportive of the proposed changes and their anticipated environmental benefits. The comments, along with PHMSA's responses are detailed in Section IV of the final rule.
Pursuant to 49 U.S.C. 60115, the GPAC and LPAC met on January 16, 2025, to assess the technical feasibility, reasonableness, cost-effectiveness, and practicability of the standards proposed in the NPRM. The GPAC and LPAC voted on and approved the regulatory amendments as proposed. The transcripts and the vote slides together constitute the GPAC and LPAC report for this rulemaking required under 49 U.S.C. 60115. No discussions were related to the environmental effects analysis of the NPRM as described in the DEA. The discussions, along with PHMSA's responses are detailed in Section IV of the final rule.
No other agencies or persons were consulted during the development of this Environmental Assessment.
Based on the analysis summarized in this EA and accompanying final rule, PHMSA finds that the Selected Action Alternative (final rule) will not have a significant impact on the human or natural environment. The amendments of the final rule will either maintain or enhance the protection of public safety by ensuring better alignment of the PSRs with the latest innovations in operational and management practices, materials, testing, and technological advancements; enhance compliance by avoiding conflict between different versions of the same industry standards; and facilitate safety-focused allocation of resources by pipeline operators. PHMSA determined that most of the updates involve minor changes, such as editorial changes, the inclusion of best practices, or similar changes. Therefore, PHMSA has determined that this rulemaking results in a finding of no significant impact to the human or natural environment.
PHMSA analyzed this final rule according to the principles and criteria in E.O. 13175 (“Consultation and Coordination with Indian Tribal Governments”)
PHMSA assessed the impact of the final rule and determined that it will not significantly or uniquely affect Tribal communities or Indian Tribal governments. The rulemaking's regulatory amendments have a broad, national scope; therefore, this final rule will not significantly or uniquely affect Tribal communities, much less impose substantial compliance costs on Native American Tribal governments or mandate Tribal action. For these reasons, PHMSA has concluded that the funding and consultation requirements of E.O. 13175 and DOT Order 5301.1A do not apply.
The Paperwork Reduction Act (44 U.S.C. 3501
E.O. 13609 (“Promoting International Regulatory Cooperation”) requires agencies to consider whether the impacts associated with significant variations between domestic and international regulatory approaches are unnecessary or may impair the ability of U.S. businesses to export and compete internationally.
Similarly, the Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing any industry standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. For purposes of these requirements, Federal agencies may participate in the establishment of international standards, so long as the standards have a legitimate domestic objective—such as helping to ensure safety—and do not operate to exclude imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they serve as the basis for U.S. standards.
PHMSA participates in the establishment of international standards to protect the safety of the U.S. public. PHMSA assessed the effects of the final rule and understands that it will not cause unnecessary obstacles to foreign trade.
E.O. 14028 (“Improving the Nation's Cybersecurity”)
The NTTAA directs Federal agencies to “use technical standards developed by voluntary consensus standard bodies instead of government-developed technical standards,” “when practical and consistent with applicable laws.” Consistent with that mandate, PHMSA incorporates more than 80 industry standards by reference into the PSRs; however, many standards become outdated over time as new editions become available. By updating these standards, PHMSA ensures better alignment of the PSRs with the latest innovations in operational and management practices, materials, testing, and technological advancements; enhances compliance by avoiding conflict between different versions of the same industry standards; and facilitates safety-focused allocation of resources by pipeline operators. This final rule adopts 19 updated voluntary, consensus industry technical standards. Other standards appear in the amendatory text of this document and have already been approved for the locations in which they appear.
The purpose of this final rule is to operate holistically in addressing various issues necessary to ensure safe operation of regulated gas and hazardous liquid (as well as carbon dioxide) pipelines, with a focus on providing pipeline operators the ability to use current technologies, improved materials, and updated industry and management practices. However, PHMSA recognizes that this rule incorporates by reference various updated industry standards that focus on unique topics. Therefore, PHMSA concludes that the regulatory amendments adopted herein incorporating various updated industry standards into the PSRs are severable and able to function independently if severed from each other. In the event a court were to invalidate one or more of the unique provisions of the final rule issued in this proceeding, the remaining provisions should stand, thus allowing their continued effect.
Incident, Notifications.
Incorporation by reference, Natural gas, Pipeline safety.
Anhydrous ammonia, Carbon dioxide, Incorporation by reference, Petroleum, Pipeline safety.
In consideration of the foregoing, PHMSA is amending 49 CFR parts 191, 192, and 195 as follows:
30 U.S.C. 185(w)(3), 49 U.S.C. 5121, 60101
30 U.S.C. 185(w)(3), 49 U.S.C. 5103, 60101
(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference material (IBR) is available for inspection at the Pipeline and Hazardous Materials Safety Administration (PHMSA) and the National Archives and Records Administration (NARA). Contact PHSMA at: Office of Pipeline Safety, Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590, 202-366-4046;
(b) American Petroleum Institute (API), 200 Massachusetts Avenue NW, Suite 1100, Washington, DC 20001-5571; phone: (202) 682-8000; website:
(1) API Recommended Practice 5L1, Recommended Practice for Railroad Transportation of Line Pipe, 7th edition, September 2009, (API RP 5L1), IBR approved for § 192.65(a).
(2) API Recommended Practice 5LT, Recommended Practice for Truck Transportation of Line Pipe, First edition, March 2012, (API RP 5LT), IBR approved for § 192.65(c).
(3) API Recommended Practice 5LW, Recommended Practice for Transportation of Line Pipe on Barges and Marine Vessels, 3rd edition, September 2009, (API RP 5LW), IBR approved for § 192.65(b).
(4) API Recommended Practice 80, Guidelines for the Definition of Onshore Gas Gathering Lines, 1st edition, April 2000, (API RP 80), IBR approved for § 192.8(a).
(5) API Recommended Practice 1162, Public Awareness Programs for Pipeline Operators, 1st edition, December 2003, (API RP 1162), IBR approved for § 192.616(a), (b), and (c).
(6) API Recommended Practice 1165, Recommended Practice for Pipeline SCADA Displays, First edition, January 2007, (API RP 1165), IBR approved for § 192.631(c).
(7) API Specification 5L, Line Pipe, 46th edition, April 2018, including Errata 1 (May 2018), (API Spec 5L); IBR approved for §§ 192.55(e); 192.112(a), (b), (c), (d), and (e); 192.113; appendix B to part 192.
(8) API Specification 6D, Specification for Valves, 25th edition, November 1, 2021, including Errata (December 2021), Errata 2 (April 2022), Errata 3 (October 2023), Addendum 1 (April 2023), Addendum 2 (September 2024), and Addendum 3 (March 2025), (API Spec 6D); IBR approved for § 192.145(a).
(9) API Standard 1104, Welding of Pipelines and Related Facilities, 21st edition, September 2013, including Errata 1 through 5 (April 2014 through September 2018), Addendum 1 (2014), and Addendum 2 (2016), (API Std 1104); IBR approved for §§ 192.225(a); 192.227(a); 192.229(b) and (c); 192.241(c); appendix B to part 192.
(10) API Recommended Practice 1170, Design and Operation of Solution-mined Salt Caverns Used for Natural Gas Storage, 2nd edition, November 2022 (API RP 1170); IBR approved for § 192.12(a).
(11) API Recommended Practice 1171, Functional Integrity of Natural Gas Storage in Depleted Hydrocarbon Reservoirs and Aquifer Reservoirs, 2nd edition, November 2022, including Errata 1, September 2023 (API RP 1171); IBR approved for § 192.12(a), (b), and (d).
(12) API Standard 1163, In-Line Inspection Systems Qualification, Second edition, April 2013, Reaffirmed August 2018, (API STD 1163), IBR approved for § 192.493.
(c) American Society of Mechanical Engineers (ASME). Two Park Avenue, New York, NY 10016; phone: (800) 843-2763 (U.S./Canada); website:
(1) ASME/ANSI B16.1-2005, Gray Iron Pipe Flanges and Flanged Fittings: (Classes 25, 125, and 250), August 31, 2006, (ASME/ANSI B16.1); IBR approved for § 192.147(c).
(2) ASME/ANSI B16.5-2003, Pipe Flanges and Flanged Fittings, October 2004, (ASME/ANSI B16.5); IBR approved for §§ 192.147(a); 192.607(f).
(3) ASME B16.40-2019, Manually Operated Thermoplastic Gas Shutoffs and Valves in Gas Distribution Systems, issued February 11, 2019, (ASME B16.40); IBR approved for appendix B to this part.
(4) ASME/ANSI B31G-1991 (Reaffirmed 2004), Manual for Determining the Remaining Strength of Corroded Pipelines, 2004, (ASME/ANSI B31G); IBR approved for §§ 192.632(a); 192.712(b).
(5) ASME B31.8-2018, Gas Transmission and Distribution Piping Systems, Issued November 20, 2018, (ASME B31.8); IBR approved for §§ 192.112(b); 192.619(a); 192.911(m).
(6) ASME B31.8S-2018, Managing System Integrity of Gas Pipelines, Issued November 28, 2018, (ASME B31.8S); IBR approved for §§ 192.13(d); 192.714(c) and (d); 192.903 note to Potential impact radius; 192.907(b); 192.911 introductory text, (i), and (l); 192.913(a) through (c); 192.917(a) through (e); 192.921(a); 192.923(b); 192.925(b); 192.933(c) and (d); 192.935(b); 192.937(c); 192.939(a); 192.945(a).
(7) ASME B36.10M-2018, Welded and Seamless Wrought Steel Pipe, Issued October 12, 2018, (ASME B36.10M); IBR approved for § 192.279.
(8) ASME Boiler & Pressure Vessel Code, Section VIII, Division 1 “Rules for Construction of Pressure Vessels,” 2007 edition, July 1, 2007, (ASME BPVC, Section VIII, Division 1); IBR approved for §§ 192.153(a), (b), and (d); 192.165(b).
(9) ASME Boiler & Pressure Vessel Code, Section VIII, Division 2 “Alternate Rules, Rules for Construction of Pressure Vessels,” 2007 edition, July 1, 2007, (ASME BPVC, Section VIII, Division 2); IBR approved for §§ 192.153(b), and (d); 192.165(b).
(10) ASME Boiler & Pressure Vessel Code, Section IX: “Qualification Standard for Welding and Brazing Procedures, Welders, Brazers, and Welding and Brazing Operators,” 2007 edition, July 1, 2007, ASME BPVC, Section IX; IBR approved for §§ 192.225(a); 192.227(a); appendix B to this part.
(d) American Society for Nondestructive Testing, (ASNT), 1201 Dublin Road, Suite #G04, Columbus, OH 43215; phone: (800) 222-2768; website:
(1) ANSI/ASNT ILI-PQ 2017, In-line Inspection Personnel Qualification and Certification, 2017 Edition, approved December 12, 2017, (ASNT ILI-PQ); IBR approved for § 192.493.
(2) [Reserved]
(e) Association for Material Protection and Performance (AMPP), (formerly NACE, International), 1440 South Creek Drive, Houston, Texas 77084; phone: (281) 228-6223 or (800) 797-6223; website:
(1) ANSI/NACE SP0502-2010, Pipeline External Corrosion Direct Assessment Methodology, revised June 24, 2010, (NACE SP0502); IBR approved for §§ 192.319(f); 192.461(h); 192.620(d); 192.923(b); 192.925(b); 192.931(d); 192.935(b); 192.939(a).
(2) NACE SP0102-2017, In-Line Inspection of Pipelines, March 10, 2017, (NACE SP0102); IBR approved for §§ 192.150(a); 192.493.
(3) NACE SP0204-2008, Standard Practice, “Stress Corrosion Cracking (SCC) Direct Assessment Methodology,” reaffirmed September 18, 2008, (NACE SP0204); IBR approved for §§ 192.923(b); 192.929(b).
(4) NACE SP0206-2006, Standard Practice, “Internal Corrosion Direct Assessment Methodology for Pipelines Carrying Normally Dry Natural Gas (DG-ICDA),” approved December 1, 2006, (NACE SP0206), IBR approved for §§ 192.923(b); 192.927(b), (c).
(f) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428; phone: (610) 832-9585; website:
(1) ASTM A53/A53M-22, Standard Specification for Pipe, Steel, Black and Hot-Dipped, Zinc-Coated, Welded and Seamless, approved July 1, 2022, (ASTM A53/A53M); IBR approved for § 192.113; appendix B to part 192.
(2) ASTM A106/A106M-19A, Standard Specification for Seamless Carbon Steel Pipe for High-Temperature Service, approved November 1, 2019, (ASTM A106/A106M); IBR approved for § 192.113; appendix B to part 192.
(3) ASTM A333/A333M-18, Standard Specification for Seamless and Welded Steel Pipe for Low-Temperature Service and Other Applications with Required Notch Toughness, approved November 1, 2018, (ASTM A333/A333M); IBR approved for § 192.113; appendix B to part 192.
(4) ASTM A372/A372M-20e1, Standard Specification for Carbon and Alloy Steel Forgings for Thin-Walled Pressure Vessels, approved March 1, 2020, (ASTM A372/A372M); IBR approved for § 192.177(b).
(5) ASTM A381/A381M-23, Standard Specification for Metal-Arc-Welded Carbon or High-Strength Low-alloy Steel Pipe for Use With High-Pressure Transmission Systems, approved November 1, 2023, (ASTM A381); IBR approved for § 192.113(a); appendix B to part 192.
(6) ASTM A578/A578M-17 (2023), “Standard Specification for Straight-Beam Ultrasonic Examination of Rolled Steel Plates for Special Applications,” reapproved November 1, 2023, (ASTM A578/A578M); IBR approved for § 192.112(c).
(7) ASTM A671/A671M-20, Standard Specification for Electric-Fusion-Welded Steel Pipe for Atmospheric and Lower Temperatures, approved March 1, 2020, (ASTM A671/A671M); IBR approved for § 192.113(a); appendix B to part 192.
(8) ASTM A672/A672M-19, Standard Specification for Electric-Fusion-Welded Steel Pipe for High-Pressure Service at Moderate Temperatures, approved November 1, 2019, (ASTM A672/672M); IBR approved for § 192.113(a); appendix B to this part.
(9) ASTM A691/A691M-19, Standard Specification for Carbon and Alloy Steel Pipe, Electric-Fusion-Welded for High-Pressure Service at High Temperatures, approved November 1, 2019, (ASTM A691/A691M); IBR approved for § 192.113; appendix B to part 192.
(10) [Reserved]
(11) ASTM D2513-20, Standard Specification for Polyethylene (PE) Gas Pressure Pipe, Tubing, and Fittings, approved December 1, 2020, (ASTM D2513); IBR approved for appendix B to this part.
(12) ASTM D2517-00, Standard Specification for Reinforced Epoxy Resin Gas Pressure Pipe and Fittings, (ASTM D2517), IBR approved for §§ 192.281(d); 192.283(a); appendix B to this part.
(13) ASTM D2564-20, Standard Specification for Solvent Cements for Poly(Vinyl Chloride) (PVC) Plastic Piping Systems, approved August 1, 2020, (ASTM D2564); IBR approved for § 192.281(b).
(14) ASTM F1055-16a, Standard Specification for Electrofusion Type Polyethylene Fittings for Outside Diameter Controlled Polyethylene and Crosslinked Polyethylene (PEX) Pipe and Tubing, approved November 15, 2016, (ASTM F1055); IBR approved for § 192.283(a); appendix B to this part.
(15) ASTM F1924-19, Standard Specification for Plastic Mechanical Fittings for Use on Outside Diameter Controlled Polyethylene Gas Distribution Pipe and Tubing, approved August 1, 2019, (ASTM F1924); IBR approved for appendix B to this part.
(16) ASTM F1948-20, Standard Specification for Metallic Mechanical Fittings for Use on Outside Diameter Controlled Thermoplastic Gas Distribution Pipe and Tubing, approved February 1, 2020, (ASTM F1948); IBR approved for appendix B to this part.
(17) ASTM F1973-21, Standard Specification for Factory Assembled Anodeless Risers and Transition Fittings in Polyethylene (PE) and Polyamide 11 (PA11) and Polyamide 12 (PA12) Fuel Gas Distribution Systems, November 1, 2021, (ASTM F1973); IBR approved for § 192.204(b); appendix B to this part.
(18) ASTM F2145-23, Standard Specification for Polyamide 11 (PA 11) and Polyamide 12 (PA12) Mechanical Fittings for Use on Outside Diameter Controlled Polyamide 11 and Polyamide 12 Pipe and Tubing, amended February 1, 2023, (ASTM F2145); IBR approved for appendix B to this part.
(19) ASTM F2600-09(2023), Standard Specification for Electrofusion Type Polyamide-11 Fittings for Outside Diameter Controlled Polyamide-11 Pipe and Tubing, reapproved November 1, 2023, (ASTM F2600); IBR approved for appendix B to this part.
(20) ASTM F2620-20ae2, Standard Practice for Heat Fusion Joining of Polyethylene Pipe and Fittings, approved December 1, 2020, (ASTM F2620); IBR approved for §§ 192.281(c); 192.285(b).
(21) ASTM F2767-18(2023), Specification for Electrofusion Type Polyamide-12 Fittings for Outside Diameter Controlled Polyamide-12 Pipe and Tubing for Gas Distribution, November 1, 2023 (ASTM F2767); IBR approved for appendix B to this part.
(22) ASTM F2785-21, Standard Specification for Polyamide 12 Gas Pressure Pipe, Tubing, and Fittings, approved July 1, 2021, (ASTM F2785); IBR approved for appendix B to this part.
(23) ASTM F2817-13 (Reapproved 2023), Standard Specification for Poly (Vinyl Chloride) (PVC) Gas Pressure Pipe and Fittings for Maintenance or Repair, approved July 1, 2023, (ASTM F2817); IBR approved for appendix B to this part.
(24) ASTM F2945-18 (Reapproved 2023) Standard Specification for Polyamide 11 Gas Pressure Pipe, Tubing, and Fittings, approved November 1, 2023 (ASTM F2945); IBR approved for appendix B to this part.
(g) [Reserved]
(h) Manufacturers Standardization Society of the Valve and Fittings Industry, Inc. (MSS), 127 Park St. NE, Vienna, VA 22180; phone: (703) 281-6613; email:
(1) ANSI/MSS SP-44-2019, Steel Pipeline Flanges, published April 2020, (MSS SP-44); IBR approved for § 192.147(a).
(2) [Reserved]
(i) National Fire Protection Association (NFPA), 1 Batterymarch Park, Quincy, Massachusetts 02169; phone: (800) 344-3555; website:
(1) NFPA 30, Flammable and Combustible Liquids Code, 2021 Edition, effective August 31, 2020, (NFPA 30); IBR approved for § 192.735(b).
(2) NFPA 58, Liquefied Petroleum Gas Code, 2020 edition, effective August 25, 2019, (NFPA 58); IBR approved for § 192.11.
(3) NFPA 59, Utility LP-Gas Plant Code, 2018 edition, effective September 6, 2017, (NFPA 59); IBR approved for § 192.11.
(4) NFPA 70, National Electrical Code (NEC), 2023 edition, effective September 1, 2022; IBR approved for §§ 192.163(e); 192.189(c).
(j) Pipeline Research Council International, Inc. (PRCI), 15059 Conference Center Drive Suite 130, Chantilly, VA 20151; phone: (703) 205-1600; website:
(1) AGA, Pipeline Research Committee Project, PR-3-805, A Modified Criterion for Evaluating the Remaining Strength of Corroded Pipe, December 22, 1989, (PRCI PR-3-805 (R-STRENG)), IBR approved for §§ 192.632(a); 192.712(b).
(2) [Reserved]
(k) Plastics Pipe Institute, Inc. (PPI), 105 Decker Court, Suite 825, Irving, TX 75062; phone: 469-499-1044, website:
(1) PPI TR-3, Policies and Procedures for Developing Hydrostatic Design Basis (HDB), Hydrostatic Design Stresses (HDS), Pressure Design Basis (PDB), Strength Design Basis (SDB), Minimum Required Strength (MRS) Ratings, and Categorized Required Strength (CRS) for Thermoplastic Piping Materials or Pipe, May 1, 2024; IBR approved for § 192.121(a).
(2) PPI TR-4, PPI HSB Listing of Hydrostatic Design Basis (HDB), Hydrostatic Design Stress (HDS), Strength Design Basis (SDB), Pressure Design Basis (PDB) and Minimum Required Strength (MRS) Ratings For Thermoplastic Piping Materials or Pipe, updated May 1, 2024, (PPI TR-4); IBR approved for § 192.121(b).
(a) * * *
(2) Sending the notification by mail to ATTN: Information Resources Manager, Office of Pipeline Safety, Pipeline and Hazardous Materials Safety Administration, PHF-30, 1200 New Jersey Avenue SE, Washington, DC 20590.
(a) * * *
(d) * * *
The revision reads as follows:
API Spec 5L, Line Pipe (incorporated by reference, see § 192.7).
ASTM A53/A53M, Standard Specification for Pipe, Steel, Black and Hot-Dipped, Zinc-Coated, Welded and Seamless (incorporated by reference, see § 192.7).
ASTM A106/A-106M, Standard Specification for Seamless Carbon Steel Pipe for High-Temperature Service (incorporated by reference, see § 192.7).
ASTM A333/A333M, Standard Specification for Seamless and Welded Steel Pipe for Low-Temperature Service and Other Applications with Required Notch Toughness (incorporated by reference, see § 192.7).
ASTM A381, Standard Specification for Metal-Arc-Welded Carbon or High-Strength Low-alloy Steel Pipe for Use With High-Pressure Transmission Systems (incorporated by reference, see § 192.7).
ASTM A671/A671M, Standard Specification for Electric-Fusion-Welded Steel Pipe for Atmospheric and Lower Temperatures (incorporated by reference, see § 192.7).
ASTM A672/A672M, Standard Specification for Electric-Fusion-Welded Steel Pipe for High-Pressure Service at Moderate Temperatures (incorporated by reference, see § 192.7).
ASTM A691/A691M, Standard Specification for Carbon and Alloy Steel Pipe, Electric-Fusion-Welded for High-Pressure Service at High Temperatures (incorporated by reference, see § 192.7).
ASTM D2513, Standard Specification for Polyethylene (PE) Gas Pressure Pipe, Tubing,
ASTM D2517, Standard Specification for Reinforced Epoxy Resin Gas Pressure Pipe and Fittings (incorporated by reference, see § 192.7).
ASTM F2785, Standard Specification for Polyamide 12 Gas Pressure Pipe, Tubing, and Fittings (incorporated by reference, see § 192.7).
ASTM F2817, Standard Specification for Poly (Vinyl Chloride) (PVC) Gas Pressure Pipe and Fittings for Maintenance or Repair (incorporated by reference, see § 192.7).
ASTM F2945, Standard Specification for Polyamide 11 Gas Pressure Pipe, Tubing, and Fittings (incorporated by reference, see § 192.7).
ASME B16.40, Manually Operated Thermoplastic Gas Shutoffs and Valves in Gas Distribution Systems (incorporated by reference, see § 192.7).
ASTM D2513, Standard Specification for Polyethylene (PE) Gas Pressure Pipe, Tubing, and Fittings (incorporated by reference, see § 192.7).
ASTM D2517, Standard Specification for Reinforced Epoxy Resin Gas Pressure Pipe and Fittings (incorporated by reference, see § 192.7).
ASTM F1055, Standard Specification for Electrofusion Type Polyethylene Fittings for Outside Diameter Controlled Polyethylene and Crosslinked Polyethylene (PEX) Pipe and Tubing (incorporated by reference, see § 192.7).
ASTM F1924, Standard Specification for Plastic Mechanical Fittings for Use on Outside Diameter Controlled Polyethylene Gas Distribution Pipe and Tubing (incorporated by reference, see § 192.7).
ASTM F1948, Standard Specification for Metallic Mechanical Fittings for Use on Outside Diameter Controlled Thermoplastic Gas Distribution Pipe and Tubing (incorporated by reference, see § 192.7).
ASTM F1973, Standard Specification for Factory Assembled Anodeless Risers and Transition Fittings in Polyethylene (PE) and Polyamide 11 (PA 11) and Polyamide 12 (PA 12) Fuel Gas Distribution Systems (incorporated by reference, see § 192.7).
ASTM F2145, Standard Specification for Polyamide 11 (PA 11) and Polyamide 12 (PA12) Mechanical Fittings for Use on Outside Diameter Controlled Polyamide 11 and Polyamide 12 Pipe and Tubing (incorporated by reference, see § 192.7).
ASTM F2600, Standard Specification for Electrofusion Type Polyamide-11 Fittings for Outside Diameter Controlled Polyamide-11 Pipe and Tubing (incorporated by reference, see § 192.7).
ASTM F2767, Specification for Electrofusion Type Polyamide-12 Fittings for Outside Diameter Controlled Polyamide-12 Pipe and Tubing for Gas Distribution (incorporated by reference, see § 192.7).
ASTM F2785, Standard Specification for Polyamide 12 Gas Pressure Pipe, Tubing, and Fittings (incorporated by reference, see § 192.7).
ASTM F2817, Standard Specification for Poly (Vinyl Chloride) (PVC) Gas Pressure Pipe and Fittings for Maintenance or Repair (incorporated by reference, see § 192.7).
ASTM F2945, Standard Specification for Polyamide 11 Gas Pressure Pipe, Tubing, and Fittings (incorporated by reference, see § 192.7).
These roadways serve major centers of metropolitan areas, provide a high degree of mobility, and can also provide mobility through rural areas. Unlike their access-controlled counterparts, these roadways can serve abutting land uses directly. Forms of access for other principal arterial roadways include driveways to specific parcels and at-grade intersections with other roadways. For the most part, roadways that fall into the top three functional classification categories (interstate, other freeways and expressways, and other principal arterials) provide similar service in both urban and rural areas. The primary difference is that multiple arterial routes usually serve a particular urban area, radiating out from the urban center to serve the surrounding region. In contrast, an expanse of a rural area of equal size would be served by a single arterial.
Minor arterials provide service for trips of moderate length, serve geographic areas that are smaller than their higher-arterial counterparts, and offer connectivity to the higher-arterial system. In an urban context, they interconnect and augment the higher-arterial system, provide intra-community continuity, and may carry local bus routes. In rural settings, minor arterials should be identified and spaced at intervals that are consistent with population density so that all developed areas are within a reasonable distance of a higher-level Arterial. In addition, minor arterials in rural areas are typically designed to provide relatively high overall travel speeds, with minimum interference to through movement. The spacing of minor-arterial streets typically may vary from
Collectors serve a critical role in the roadway network by gathering traffic from local roads and funneling it into the arterial network. Within the context of functional classification, collectors are broken down into two categories: major collectors and minor collectors. Until recently, this division was considered only in the rural environment. Currently, all collectors, regardless of whether they are within a rural area or an urban area, may be sub-stratified into major and minor categories. The determination regarding whether a given collector is a major or minor collector is frequently one of the biggest challenges in functionally classifying a roadway network. In the rural environment, collectors generally serve primarily intra-county travel (rather than statewide) and constitute those routes on which, independent of traffic volume, predominant travel distances are shorter than on arterial routes. Consequently, more moderate speeds may be posted. The distinctions between major collectors and minor collectors are often subtle. In general, major-collector routes are longer in length, have lower connecting-driveway densities, have higher speed limits, are spaced at greater intervals, have higher annual average traffic volumes, and may have more travel lanes than their minor-collector counterparts. Careful consideration should be given to these factors when assigning a major or minor collector designation. In rural areas, annual average daily traffic and spacing may be the most significant designation factors. Since major collectors offer more mobility and minor collectors offer more access, it is beneficial to reexamine these two fundamental concepts of functional classification. Overall, the total mileage of major collectors is typically lower than the total mileage of minor collectors, while the total collector mileage is typically one-third of the local roadway network.
30 U.S.C. 185(w)(3), 49 U.S.C. 5103, 60101
(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference material (IBR) is available for inspection at the Pipeline and Hazardous Materials Safety Administration (PHMSA) and the National Archives and Records Administration (NARA). Contact PHSMA at: Office of Pipeline Safety, Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590; phone: 202-366-4046; website:
(b) American Petroleum Institute (API), 200 Massachusetts Avenue NW, Suite 1100, Washington, DC 20001-
(1) API 510, Pressure Vessel Inspection Code: In-service Inspection, Rating, Repair, and Alteration, 10th Edition, May 2014, Including Addendum 1 (May 2017); IBR approved for §§ 195.205(b); 195.432(c).
(2) API Recommended Practice 5L1, Recommended Practice for Railroad Transportation of Line Pipe, 7th edition, September 2009, (API RP 5L1); IBR approved for § 195.207(a).
(3) API Recommended Practice 5LT, Recommended Practice for Truck Transportation of Line Pipe, First edition, March 12, 2012, (API RP 5LT); IBR approved for § 195.207(c).
(4) API Recommended Practice 5LW, Recommended Practice Transportation of Line Pipe on Barges and Marine Vessels, 3rd edition, September 2009, (API RP 5LW); IBR approved for § 195.207(b).
(5) API Recommended Practice 651, Cathodic Protection of Aboveground Petroleum Storage Tanks, 4th edition, September 2014, (API RP 651); IBR approved for §§ 195.565; 195.573(d).
(6) API Recommended Practice 652, Linings of Aboveground Petroleum Storage Tank Bottoms, 5th Edition, May 2020, (API RP 652); IBR approved for § 195.579(d).
(7) API Recommended Practice 1130, Computational Pipeline Monitoring for Liquids: Pipeline Segment, 3rd edition, September 2007, (API RP 1130); IBR approved for §§ 195.134(c); 195.444(c).
(8) API Recommended Practice 1162, Public Awareness Programs for Pipeline Operators, 1st edition, December 2003, (API RP 1162); IBR approved for § 195.440(a), (b), and (c).
(9) API Recommended Practice 1165, Recommended Practice for Pipeline SCADA Displays, First edition, January 2007, (API RP 1165); IBR approved for § 195.446(c).
(10) API Recommended Practice 1168, Pipeline Control Room Management, First edition, September 2008, (API RP 1168); IBR approved for § 195.446(c) and (f).
(11) API Recommended Practice 2003, Protection Against Ignitions Arising out of Static, Lightning, and Stray Currents, 8th Edition, September 2015, reaffirmed March 2020, (API RP 2003); IBR approved for § 195.405(a).
(12) API Recommended Practice 2026, Safe Access/Egress Involving Floating Roofs of Storage Tanks in Petroleum Service, 4th edition, July 2022, (API RP 2026); IBR approved for § 195.405(b).
(13) API Specification 5L, Line Pipe, 46th edition, April 2018, including Errata 1 (May 2018), (API Spec 5L); IBR approved for § 195.106(b) and (e).
(14) API Specification 6D, Specification for Valves, 25th edition, November 1, 2021, including Errata 1 (December 2021), Errata 2 (April 2022), Errata 3 (October 2023), Addendum 1 (April 2023), Addendum 2 (September 2024), and Addendum 3 (March 2025), (API Spec 6D); IBR approved for § 195.116(d).
(15) API Specification 12F, Specification for Shop-welded Tanks for Storage of Production Liquids, 13th Edition, January 2019, (API Spec 12F); IBR approved for §§ 195.132(b); 195.205(b); 195.264(e); 195.307(a); 195.565; 195.579(d).
(16) API Standard 620, Design and Construction of Large, Welded, Low-pressure Storage Tanks, 12th edition, effective October 2013, including Addendum 1 through 4 (November 2014), Addendum 2 (April 2018), Addendum 3 (March 2021), Addendum 4 (February 2025), Errata 1 (March 2025), (API Std 620); IBR approved for §§ 195.132(b); 195.205(b); 195.264(e); 195.307(b); 195.565; 195.579(d).
(17) API Standard 650, Welded Tanks for Oil Storage, 13th edition, March 2020, including Errata 1 (January 2021), (API Std 650); IBR approved for §§ 195.132(b); 195.205(b); 195.307(c); 195.565; 195.579(d).
(18) API Standard 653, Tank Inspection, Repair, Alteration, and Reconstruction, 3rd edition, December 2001, (including addendum 1 (September 2003), addendum 2 (November 2005), addendum 3 (February 2008), and errata (April 2008)), (API Std 653); IBR approved for §§ 195.205(b); 195.307(d); 195.432(b).
(19) API Standard 1104, Welding of Pipelines and Related Facilities, 21st edition, September 2013, including Errata 1 through 5 (April 2014 through September 2018), Addendum 1 (July 2014), and Addendum 2 (May 2016), (API Std 1104); IBR approved for §§ 195.214(a); 195.222(a) and (b); 195.228(b).
(20) API Standard 1163, In-Line Inspection Systems Qualification, Second edition, April 2013, (API Std 1163); IBR approved for § 195.591.
(21) API Standard 2000, Venting Atmospheric and Low-pressure Storage Tanks, 7th Edition, March 2014, Reaffirmed April 2020, (API Std 2000); IBR approved for § 195.264(e).
(22) API Standard 2350, Overfill Prevention for Storage Tanks in Petroleum Facilities, 5th edition, September 2020, including Errata 1 (April 2021), (API Std 2350); IBR approved for § 195.428(c).
(23) API Standard 2510, Design and Construction of LPG Installations, 9th Edition, August 2020, (API Std 2510); IBR approved for §§ 195.132(b); 195.205(b); 195.264(b) and (e); 195.307(e); 195.428(c); 195.432(c).
(c) American Society of Mechanical Engineers (ASME), Two Park Avenue, New York, NY 10016; phone: (800) 843-2763 (U.S/Canada); website:
(1) ASME/ANSI B16.9-2007, Factory-Made Wrought Buttwelding Fittings, December 7, 2007, (ASME/ANSI B16.9); IBR approved for § 195.118(a).
(2) ASME/ANSI B31G-1991 (Reaffirmed 2004), Manual for Determining the Remaining Strength of Corroded Pipelines, 2004, (ASME/ANSI B31G); IBR approved for §§ 195.452(h); 195.587; 195.588(c).
(3) ASME B31.4-2019, Pipeline Transportation Systems for Liquids and Slurries: ASME Code for Pressure Piping, B31, issued November 1, 2019, (ASME B31.4); IBR approved for § 195.110(a).
(4) ASME B31.8-2018, Gas Transmission and Distribution Piping Systems, Issued November 20, 2018, (ASME B31.8); IBR approved for §§ 195.5(a); 195.406(a).
(5) ASME Boiler & Pressure Vessel Code, Section VIII, Division 1, Rules for Construction of Pressure Vessels, 2007 edition, July 1, 2007, (ASME BPVC, Section VIII, Division 1); IBR approved for §§ 195.124; 195.307(e).
(6) ASME Boiler & Pressure Vessel Code, Section VIII, Division 2, Alternate Rules, Rules for Construction of Pressure Vessels, 2007 edition, July 1, 2007, (ASME BPVC, Section VIII, Division 2); IBR approved for § 195.307(e).
(7) ASME Boiler & Pressure Vessel Code, Section IX: Qualification Standard for Welding and Brazing Procedures, Welders, Brazers, and Welding and Brazing Operators, 2007 edition, July 1, 2007, (ASME BPVC, Section IX); IBR approved for § 195.222(a).
(d) American Society for Nondestructive Testing (ASNT), 1201 Dublin Road, Suite #G04, Columbus, OH 43215; phone: (800) 222-2768; website:
(1) ANSI/ASNT ILI-PQ-2017, In-line Inspection Personnel Qualification and Certification, 2017 Edition, approved December 12, 2017, (ASNT ILI-PQ); IBR approved for § 195.591.
(2) [Reserved]
(e) Association for Material Protection and Performance (AMPP) (formerly NACE), 1440 South Creek Drive, Houston, TX 77084; phone: (281) 228-6223 or (800) 797-6223; website:
(1) NACE SP0102-2017, In-Line Inspection of Pipelines, March 10, 2017,
(2) NACE SP0169-2007, Standard Practice, Control of External Corrosion on Underground or Submerged Metallic Piping Systems, reaffirmed March 15, 2007, (NACE SP0169), IBR approved for §§ 195.571; 195.573(a).
(3) NACE SP0204-2015, Stress Corrosion Cracking (SCC) Direct Assessment Methodology, Revised March 14, 2015, (NACE SP0204); IBR approved for § 195.588(c).
(4) ANSI/NACE SP0502-2010, Pipeline External Corrosion Direct Assessment Methodology, revised June 24, 2010, (NACE SP0502); IBR approved for § 195.588(b).
(f) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428; phone: (610) 832-9585; website:
(1) ASTM A53/A53M-22, Standard Specification for Pipe, Steel, Black and Hot-Dipped, Zinc-Coated, Welded and Seamless, approved July 1, 2022, (ASTM A53/A53M); IBR approved for § 195.106(e).
(2) ASTM A106/A106M-19A, Standard Specification for Seamless Carbon Steel Pipe for High-Temperature Service, approved November 1, 2019, (ASTM A106/A106M); IBR approved for § 195.106(e).
(3) ASTM A333/A333M-18, Standard Specification for Seamless and Welded Steel Pipe for Low-Temperature Service and Other Applications with Required Notch Toughness, approved November 1, 2018, (ASTM A333/A333M); IBR approved for § 195.106(e).
(4) ASTM A381/A381M-23, Standard Specification for Metal-Arc-Welded Carbon or High-Strength Low-alloy Steel Pipe for Use With High-Pressure Transmission Systems, approved November 1, 2023, (ASTM A381/A381M); IBR approved for § 195.106(e).
(5) ASTM A671/A671M-20, Standard Specification for Electric-Fusion-Welded Steel Pipe for Atmospheric and Lower Temperatures, approved March 1, 2020, (ASTM A671/A671M); IBR approved for § 195.106(e).
(6) ASTM A672/A672M-19, Standard Specification for Electric-Fusion-Welded Steel Pipe for High-Pressure Service at Moderate Temperatures, approved November 1, 2019, (ASTM A672/672M); IBR approved for § 195.106(e).
(7) ASTM A691/A691M-19, Standard Specification for Carbon and Alloy Steel Pipe, Electric-Fusion-Welded for High-Pressure Service at High Temperatures, approved November 1, 2019, (ASTM A691/A691M); IBR approved for § 195.106(e).
(g) Manufacturers Standardization Society of the Valve and Fittings Industry, Inc. (MSS), 127 Park St. NE, Vienna, VA 22180; phone: (703) 281-6613; website:
(1) MSS SP-75-2019 Standard Practice, High-Strength, Wrought, Butt-Welding Fittings, published December 2019, (MSS SP-75); IBR approved for § 195.118(a).
(2) [Reserved]
(h) National Fire Protection Association (NFPA), 1 Batterymarch Park, Quincy, MA 02169; phone: (800) 344-3555; website:
(1) NFPA 30, Flammable and Combustible Liquids Code, 2021 Edition, effective August 31, 2020; IBR approved for § 195.264(b).
(2) [Reserved]
(i) Pipeline Research Council International, Inc. (PRCI), 15059 Conference Center Drive Suite 130, Chantilly, VA 20151; phone: (703) 205-1600; website:
(1) AGA Pipeline Research Committee, Project PR-3-805, A Modified Criterion for Evaluating the Remaining Strength of Corroded Pipe, December 22, 1989, (PR-3-805 (RSTRENG)); IBR approved for §§ 195.452(h); 195.587; 195.588(c).
(2) [Reserved]
(a) Anticipated external loads (
The revision reads as follows:
(e) For aboveground breakout tanks built to API Std 2510 (incorporated by reference elsewhere in this part, see § 195.3) and first placed in service after October 2, 2000, pressure testing must be performed in accordance with ASME BPVC, Section VIII, Division 1 and ASME BPVC, Section VIII, Division 2 (both incorporated by reference, see § 195.3).
When conducting in-line inspection of pipelines required by this part, each operator must comply with the requirements and recommendations of API Std 1163, ASNT ILI-PQ, and NACE SP0102 (all incorporated by reference, see § 195.3). An in-line inspection may also be conducted using tethered or remote-control tools provided they generally comply with those sections of NACE SP0102 that are applicable.
Federal Deposit Insurance Corporation.
Notice of proposed rulemaking.
The Federal Deposit Insurance Corporation (FDIC) is seeking comment on a proposal that would amend signage requirements for insured depository institutions' (IDIs) digital deposit-taking channels and automated teller machines (ATMs) and like devices. The proposed changes are intended to address implementation issues and sources of potential confusion that have arisen following the adoption of current signage requirements for these banking channels. The proposal would provide additional flexibility to IDIs while also enabling consumers to better understand when they are conducting business with an IDI and when their funds are protected by the FDIC's deposit insurance coverage.
Comments must be received by the FDIC no later than October 20, 2025.
You may submit comments, identified by RIN 3064-AG14, by any of the following methods:
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Follow the search instructions on
This proposal, all comments received, and a summary of not more than 100 words of the proposed rule pursuant to the Providing Accountability Through Transparency Act of 2023 are available at
Division of Depositor and Consumer Protection: Monika Jansen, Senior Policy Analyst, (202) 898-6781,
On December 20, 2023, the FDIC adopted a final rule that, among other things, amended the FDIC's sign and advertisement of membership regulations under subpart A of 12 CFR part 328 (the 2023 Final Rule).
Under this proposed rulemaking, the FDIC seeks to minimize identified implementation issues, reduce burden, and address potential consumer confusion with respect to signage requirements for digital deposit-taking channels and ATMs and like devices. In particular, the FDIC proposes to amend signage requirements in 12 CFR 328.4 and 328.5. The FDIC is not proposing substantive amendments to other provisions under 12 CFR part 328.
The FDIC maintains stability and public confidence in the nation's financial system by, among other things, insuring the deposits of all IDIs. Section 18(a) of the Federal Deposit Insurance
In addition, section 18(a)(4) of the FDI Act
In the 2023 Final Rule, the FDIC updated signage requirements to apply across all banking channels to account for how depositors conduct business with IDIs in the modern banking landscape; namely the increasing use of digital channels and new services provided by ATMs and like devices. In particular, in the 2023 Final Rule, the FDIC established an FDIC official digital sign.
The amendments made in the 2023 Final Rule took effect on April 1, 2024; however, full compliance with the amendments was not required until January 1, 2025, to provide additional opportunity for IDIs to establish processes and systems and make technological updates necessary to implement the new regulatory requirements.
In March 2025, the FDIC delayed the compliance date for 12 CFR 328.5, which governs signage requirements for digital deposit-taking channels, and the compliance date for 12 CFR 328.4, which includes analogous requirements related to an IDI's ATMs and like devices, from May 1, 2025 to March 1, 2026.
Since the 2023 Final Rule was adopted, the FDIC has observed that, in practice, certain requirements may raise operational challenges for IDIs or result in consumer confusion. Following the adoption of the 2023 Final Rule, FDIC staff met with various stakeholders to discuss questions and concerns relating to the rule's requirements.
In particular, stakeholders identified challenges with implementing the display of the FDIC official digital and non-deposit signage on required pages and screens for digital deposit-taking channels, ATMs, and like devices. Some stakeholders stated that the signage requirements were “overly prescriptive” and “technical,” especially as to the specifications of the FDIC official digital sign. Additionally, some stakeholders stated that IDIs would benefit from additional flexibility in displaying the FDIC official digital sign on pages and screens where space is limited, particularly with respect to mobile banking.
Stakeholders also explained the difficulty in providing appropriate disclosures for customers moving to third-party websites or making certain transfers of funds between different accounts. Moreover, some stakeholders raised concerns that the signage requirements may cause consumers confusion when insured products are listed or advertised on the same page as non-deposit products, potentially leaving consumers unsure which products are FDIC-insured deposit products. These implementation challenges informed the FDIC's decision to twice delay the compliance date for the amended signage requirements for digital deposit-taking channels and ATMs and like devices. As part of the March 2025 delay of the compliance date, the FDIC stated its intention to propose changes for public comment.
To address concerns and challenges raised by stakeholders, the FDIC is proposing to clarify and provide greater flexibility with respect to the requirements regarding the (1) FDIC official digital sign design; (2) display of signage on digital deposit-taking channels; and (3) display of signage on ATMs and like devices. The FDIC believes the proposed amendments would advance the FDIC's policy objectives of helping consumers to better understand when they are doing business with an IDI and when their funds are FDIC-insured. The proposed amendments are described in greater detail below.
Section 328.5(b) sets forth requirements for the design of the FDIC official digital sign. Those requirements include specific text, color, font, and size requirements, such as specific hexadecimal color codes and wordmark sizes. The FDIC's rules provide some flexibility for cases in which the required colors would be illegible due to the color of the background on a digital deposit-taking channel. In such cases, the FDIC's rules allow for the digital sign to be displayed in white (hexadecimal color code #FFFFFF).
Since the publication of the 2023 Final Rule, the FDIC has received questions about the design of the FDIC official digital sign. Some industry stakeholders asked whether there is any flexibility with respect to the color codes and font sizes, stating that the prescriptive design standards may become obsolete and that even slight variations from the specifications may result in noncompliance. Other questioners noted implementation challenges if a digital deposit-taking channel was not designed to use the specified color and size standards or if a digital deposit-taking channel offered multiple viewing settings, such as “dark mode.” As stated in the preamble to the 2023 Final Rule, the FDIC continues to believe that an easily recognizable, consistent FDIC official digital sign conveys the certainty and confidence historically provided by the physical FDIC official sign at banks' teller windows.
Under the proposal, IDIs would have additional flexibility with respect to the color, font, and size that IDIs may use when displaying the FDIC official digital sign. While the proposed rule would still require the FDIC official digital sign to be displayed in either a combination of navy blue and black text or all-white text, the proposed rule would no longer prescribe specific hexadecimal color codes. The proposed rule would also no longer require a specific pixel size for the text in the FDIC official digital sign. In addition, the proposed rule would provide additional flexibility by allowing the font used for the FDIC official digital sign to be Source Sans Pro Web or a similar font. Finally, the proposed rule would eliminate font size requirements for the text of the FDIC official digital sign. Although the proposed rule would no longer provide for a specific font size, the FDIC official digital sign would have to be displayed in a clear and conspicuous manner, which would ensure its legibility. The FDIC notes that 12 CFR part 328 does not supersede or alter any other requirements that may apply to IDIs, including any requirements to comply with digital accessibility rules.
The proposed rule would also expressly permit IDIs to “wrap” the text of the FDIC official digital sign to address space constraints. In response to questions about whether any of the text in the FDIC official digital sign may be wrapped to better fit certain channels, such as mobile device applications, the FDIC provided guidance in “Questions and Answers Related to the FDIC's Part 328 Final Rule”
The FDIC is also proposing to more appropriately focus the display of the FDIC official digital sign on digital deposit-taking channel pages and screens that are most relevant for consumers. Section 328.5(d) requires IDIs to display the FDIC official digital sign on an IDI's digital deposit-taking channel's initial page or homepage of the website or application; landing or login pages; and pages where the customer may transact with deposits. Following the adoption of the 2023 Final Rule, IDIs and other industry stakeholders raised questions and concerns with implementing these requirements, particularly with respect to “landing pages” and “pages where the customer may transact with deposits.”
The FDIC received feedback that “landing page” is not a term commonly used by IDIs with respect to IDIs' banking websites and applications, and industry stakeholders requested further clarification on the FDIC's intent. The FDIC recognizes that the term “landing page” is duplicative of “login page,” which is a term that is commonly understood and covers the same intended types of pages and screens. For this reason, the FDIC is proposing to remove the requirement to display the FDIC official digital sign on an IDI's “landing page” while retaining the requirement for IDIs to display the FDIC official digital sign on the “login page” of an IDI's digital deposit-taking channel.
With respect to the requirement to display the FDIC official digital sign on “pages where the customer may transact with deposits,” IDIs and other stakeholders requested clarification on which pages and screens are included for purposes of this requirement. Several IDIs informed the FDIC of technical challenges in implementing the requirements on “transact with deposits” pages. Such difficulties may arise when customizing transaction screens to provide for the display of the FDIC official digital sign in instances where the page (
The FDIC appreciates the technical challenges and potential for consumer confusion and is proposing to remove the requirement to display the FDIC official digital sign on “pages where the customer may transact with deposits.” The FDIC is proposing instead to require IDIs to display the FDIC official digital sign on the IDI's digital deposit-taking channels' page or screen where the consumer initiates a deposit account opening. The FDIC believes that displaying the FDIC official digital sign at the deposit account opening stage would provide a consumer with information regarding the insurability of funds held in the account so that the consumer may make an informed decision when opening a deposit account.
The proposed rule would narrow the required digital deposit-taking channel pages and screens on which IDIs must display non-deposit signage. Section 328.5(g)(1) requires IDIs to clearly, continuously, and conspicuously display non-deposit signage “on each page relating to non-deposit products” that indicates that non-deposit products: are not insured by the FDIC; are not deposits; and may lose value.
Some IDIs and other industry stakeholders raised questions and concerns with respect to this requirement. For example, some IDIs requested clarification as to the meaning of a page “relating” to non-deposit products and whether this term includes pages and screens with incidental references to non-deposit products, such as an IDI's homepage, or if references to non-deposit products in navigation menus or tabs would trigger the requirement. The FDIC also recognizes that display of the non-deposit sign may confuse consumers as to which products are FDIC-insured and not insured, particularly when both the FDIC official digital sign and non-deposit sign are displayed on the same page with references to both FDIC-insured deposit products and non-deposit products.
To address the questions and concerns raised, the proposed rule
The proposed rule would continue to require IDIs to clearly, continuously, and conspicuously display the FDIC official digital sign and non-deposit signage on relevant pages. Following adoption of the 2023 Final Rule, many IDIs and other stakeholders requested clarification on where signage could be placed to meet the clear, continuous, and conspicuous standard. The proposed rule would provide IDIs with flexibility in meeting this standard given the unique designs of IDIs' websites and applications, as well as space constraints for smaller screens. The FDIC also recognizes additional clarification regarding this standard could be helpful for IDIs in implementing 12 CFR part 328's requirements. Accordingly, the proposed rule would provide a non-exhaustive list of examples on various placements of the FDIC official digital sign and non-deposit signage that would meet the clear, continuous, and conspicuous standard for IDIs' digital deposit-taking channels.
The FDIC is proposing to amend the requirement that an IDI provide a one-time notification to customers accessing third-party non-deposit products through an IDI's digital deposit-taking channel. Section 328.5(g)(2) requires IDIs to display a one-time notification when a bank customer logged into an IDI's digital deposit-taking channel attempts to access non-deposit products through a hyperlink (or similar web-linking feature) to a non-bank third-party platform. The FDIC's rules require the one-time notification to clearly and conspicuously indicate that the non-deposit products: are not insured by the FDIC; are not deposits; and may lose value. The FDIC's rules further require that a bank customer must dismiss the one-time notification before initially accessing the third-party's platform.
The FDIC received feedback from IDIs and other industry participants concerning the one-time notification requirement. IDIs cited operational challenges in implementing the one-time notification requirement, as well as concerns that the notification would be disruptive and would degrade the user experience for IDI customers.
The FDIC proposes to retain the requirement of a one-time notification when moving from an IDI to a non-bank and from an FDIC-insured deposit area to a non-deposit area. However, the proposal would provide IDIs additional flexibility with respect to the one-time notification requirement. Under the proposed rule, IDIs would be required to provide a notification that must be either dismissed by an act of the customer or dismissed automatically after the customer has been provided a reasonable opportunity to read the notification's content. For purposes of this requirement, a reasonable opportunity would constitute a period of time no less than three seconds.
Consistent with historical interpretations,
The FDIC is proposing to amend 12 CFR 328.4(c) to provide IDIs with additional flexibility in displaying the FDIC official digital sign on ATMs and like devices. Under 12 CFR 328.4(c), for ATMs that receive deposits and offer access to non-deposit products, IDIs are required to display the FDIC official digital sign clearly, continuously, and conspicuously on an ATM or like device's “home page or screen and on each transaction page or screen relating to deposits.”
A number of IDIs and other stakeholders contacted the FDIC with questions regarding the implementation of this requirement, particularly in relation to the requirement to display the digital sign on “each transaction page or screen relating to deposits.” IDIs also expressed concern that consumers could be confused if the FDIC official digital sign were displayed on pages that contained information about both insured and uninsured accounts or products. IDIs further highlighted that, as with the transaction page requirement for digital deposit-taking channels, displaying the FDIC official digital sign on transfer pages may be challenging or unfeasible if the IDI operating the ATM cannot determine the insured status of funds sent to recipient institution accounts.
The proposal aims to simplify compliance for IDIs and mitigate potential consumer confusion by requiring the display of the FDIC official digital sign only on the initial screen of an IDI's ATM or like device. For purposes of this proposed requirement, an ATM's “initial screen” is the screen that is displayed before an IDI's customer inserts a debit card or other credentials to access the device (sometimes referred to as a “welcome screen”). This simplified requirement would continue to help ensure that consumers are informed when consumers are doing business with an IDI, while providing greater certainty for IDIs as to which ATM pages or screens would require display of the FDIC official digital sign.
The FDIC is proposing to expand an alternative to the FDIC official digital sign requirement for certain ATMs and like devices. Section 328.4 provides a limited exception to the FDIC official digital sign requirement for ATMs and like devices that do not offer non-deposit products and were placed into service prior to January 1, 2025, permitting such devices to display either the FDIC official digital sign or the physical FDIC official sign.
Since issuing the 2023 Final Rule, the FDIC has received a range of questions from IDIs concerning the availability of the physical FDIC official sign exception for existing ATMs and like devices. The FDIC understands that there are costs associated with updating ATMs and like
Section 328.4(f) provides that a degraded or defaced physical FDIC official sign on ATMs and like devices would not be considered to be displayed in a clear and conspicuous manner, as its display would be of little or no benefit to consumers. The FDIC proposes removing this provision. The FDIC believes this provision is not needed because an institution is required to clearly and conspicuously display the sign, and if the sign is not clear to consumers, the institution would not be displaying it clearly.
Section 328.4(d) requires ATMs that receive deposits for an IDI and offer access to non-deposit products to clearly, continuously, and conspicuously display non-deposit signage “on each transaction page or screen relating to non-deposit products.” Such non-deposit signage must indicate that non-deposit products are not insured by the FDIC; are not deposits; and may lose value. The FDIC has received feedback that the 2023 Final Rule's non-deposit signage requirements for ATMs and like devices are overly broad and repetitive, as IDIs are required to display the non-deposit sign on each page within a single non-deposit transaction. In recognition of this and other considerations, the proposed rule would modify the non-deposit signage requirements for ATMs and like devices in two respects.
First, under the proposal, a narrower subset of ATMs and like devices would be subject to the non-deposit signage requirements. While the 2023 Final Rule's non-deposit signage requirements apply to an ATM or like device if it receives deposits for an IDI and offers access to non-deposit products, the proposal would apply to ATMs or like devices that receive deposits for an IDI and permit IDI customers to transact with one or more non-deposit products. This change would remove ATMs and like devices from the scope of the non-deposit signage requirements if, for example, they merely permit customers to view account balances for non-deposit products. Moreover, an IDI would only be required to display non-deposit signage for the IDI's own customers. The FDIC acknowledges the technical limitations IDIs face in verifying information for customers of other financial institutions using the IDI's ATMs and like devices (referred to as “non-customers”), including whether the non-customer is accessing FDIC-insured deposit accounts or non-deposit products. The proposed rule would not require IDIs to display non-deposit signage for pages and screens viewed by non-customers.
Second, the proposed rule would require the display of non-deposit signage on fewer pages and screens, reflecting a more focused approach. Although the 2023 Final Rule required non-deposit signage to be displayed on each transaction page or screen relating to non-deposit products, the proposal would require non-deposit signage to appear only on the initial transaction page or screen for a non-deposit product. This change would simplify IDIs' compliance with the non-deposit signage requirement while ensuring that signage continues to be displayed where it is most relevant to consumers: the first screen displayed upon beginning a transaction with a non-deposit product.
These changes would focus the non-deposit signage requirements on devices and screens that provide the disclosures to consumers at the most appropriate place and time.
The FDIC acknowledges that some IDIs are currently displaying signage on their digital deposit-taking channels and ATMs and like devices consistent with the 2023 Final Rule, while other IDIs are not displaying signage as permitted under the delayed compliance date period. The FDIC recognizes that all IDIs will need time to update systems and processes to implement changes in compliance with the proposed amendments. Accordingly, the FDIC proposes the compliance date of January 1, 2027. If the FDIC adopts a final rule amending the existing regulation, the FDIC would also review any associated Q&As published on the FDIC website as warranted based on the specific revisions adopted.
The FDIC also proposes to make a technical amendment to 12 CFR part 328. Section 328.5(c) currently provides for a “digital symbol” that is defined as the portion of the FDIC official digital sign “consisting of `FDIC' and the one line of smaller type to the right of `FDIC'.” While this provision defining the digital symbol is located in subpart A of 12 CFR part 328, 12 CFR part 328 discusses the use of the digital symbol only in subpart B, which addresses false advertising, misrepresentation of insured status, and misuse of the FDIC's name or logo. Given that the digital symbol concept applies specifically to the context of subpart B, the proposed rule would implement a technical amendment to transfer the text providing for, and defining, the digital symbol to 12 CFR 328.101 of subpart B. This non-substantive change would promote readability by ensuring that the definition is physically located in the relevant subpart of the regulation.
The proposed changes to 12 CFR part 328.4 and 328.5 are intended to clarify the requirements for the display of the FDIC official digital sign and non-deposit signage, as well as clarify when such signage is required for ATMs and similar devices. These requirements apply to all IDIs. To the extent that some IDIs have not already implemented changes to their digital operations to comply with 12 CFR part 328.4 and 328.5, the proposed rule would reduce the number of hours spent to update their systems. The proposed rule would also reduce the number of hours spent by all IDIs to maintain ongoing compliance with 12 CFR part 328.4 and 328.5. Given this decrease in burden, the proposed changes are not expected to result in any substantive direct costs to impacted IDIs. Instead, they are expected to generate cost savings in the form of reduced administrative effort and resource allocation. In addition, the proposed rule would benefit IDIs' customers, who would have a more streamlined and clutter-free browsing experience.
If adopted, the proposed rule could benefit IDIs by reducing implementation costs such as labor costs to make changes to an IDI's IT systems, contracting costs to make changes to in-house or third-party IT systems, costs to upgrade hardware for ATMs and similar
Although the FDIC cannot quantify all cost savings associated with the proposed rule, it has quantified certain estimated cost savings for IDIs associated with the changes to recordkeeping, reporting, and disclosure requirements for digital signage and non-deposit signage obligations. The FDIC recognizes that the cost estimates in the 2023 final rule may have understated the actual costs, and thus the estimated cost savings in this proposal may likewise understate the actual cost savings, but the FDIC is using the best estimates it has available.
As of this date, 4,471 IDIs are subject to 12 CFR part 328. As previously discussed, the proposed rule would pose two principal effects for affected IDIs. First, the proposal would reduce the number of digital screens or pages on which the FDIC official digital sign must appear. Second, the proposal would narrow certain non-deposit signage requirements. Based on these changes, the FDIC estimates an average reduction of 19 hours per IDI for implementation-related recordkeeping, reporting and disclosure activities only.
Although the 2023 Final Rule is already effective, compliance with 12 CFR 328.4 and 328.5 has been postponed until March 1, 2026.
While the quantified implementation cost savings may be relatively small, the unquantified implementation cost savings are likely to be material for some IDIs.
In addition to reducing implementation burden in the period leading to the proposed amended compliance date, the proposed rule would generate ongoing compliance cost savings in subsequent years. IDIs typically incur recurring compliance costs to maintain, review, and update their signage and related systems in accordance with regulatory requirements. Further, ongoing compliance with FDIC signage requirements can be a factor in costs for third-party service agreements, hardware replacement, as well as validation and testing of service delivery channels. The FDIC does not have the information necessary to quantify all ongoing cost savings associated with the proposed rule. However, the proposed rule would reduce the scope of these ongoing activities and thereby generate associated cost savings for IDIs. As noted above, these savings will vary across IDIs, based on the size and complexity of their operations.
For purposes of this analysis, the FDIC has quantified ongoing cost savings for IDIs associated with the changes to recordkeeping, reporting, and disclosure requirements for digital signage and non-deposit signage obligations only. The FDIC categorizes IDIs by asset size as a proxy for the complexity of digital operations, consistent with the methodology used in the 2023 Final Rule: IDIs with less than $10 billion in assets and those with $10 billion or more. According to the latest Call Report data, there are 4,311 IDIs in the smaller IDI group and 160 in the larger.
Using the same estimated average hourly labor cost of $118 as above, the estimated ongoing annual cost savings are approximately $374 per small IDI and $747 per large IDI, on average, for a total annual cost savings of approximately $1.6 million for smaller IDIs and approximately $120 thousand for larger IDIs. This yields a total estimated ongoing annual cost savings associated with changes to recordkeeping, reporting, and disclosure requirements of approximately $1.7 million across all FDIC-insured depository institutions.
The proposed changes may also result in indirect or intangible effects that are more difficult to quantify.
In addition, the proposed rule would benefit consumers by improving their experience with IDIs' digital channels. For example, the proposed changes would allow IDIs to tailor digital signage placement to better meet the needs of the customer, resulting in more targeted and less duplicative disclosures. The elimination of the notification dismissal requirement would reduce interruptions to the browsing experience. The removal of the requirement to display the FDIC official digital sign on “pages where the customer may transact with deposits” would eliminate consumer confusion about which products are
At the same time, the proposed changes may introduce some intangible costs. For example, reducing signage requirements could result in less visible or less consistent disclosure of deposit insurance coverage. IDIs that have already implemented changes to their digital operations to comply with 12 CFR part 328 may incur some costs to modify their systems in response to the proposed rule. More flexibility in how different institutions implement the requirements could potentially lead to greater variability in customer experience across the industry. The FDIC believes these effects will be minimal; under the proposed rule, 12 CFR part 328 would still require IDIs digital operations to provide clarity to consumers about the extent to which or the manner in which products are insured by the FDIC.
Finally, the timing of compliance may also influence intangible effects. Given the proposed extension of the compliance date until January 1, 2027, some institutions would benefit from increased flexibility in integrating the new requirements into ongoing system updates or signage cycles. However, a longer transition period may also lead to temporary inconsistencies in signage across institutions, which could affect customer experience to a limited extent.
The FDIC invites comments on all aspects of the supporting information provided in this Expected Effects section. The FDIC is particularly interested in comments on any significant benefits or costs that the agency has not identified.
The FDIC has considered several alternatives to the proposed rule that could meet the objectives of this rulemaking, including proposals suggested by commenters in response to the 2023 Final Rule. For the reasons described, the FDIC views the proposed rule as the most appropriate and effective means of achieving its policy objectives with respect to 12 CFR part 328.
The FDIC considered not promulgating any regulatory action to amend 12 CFR part 328. However, as previously discussed, the FDIC has identified challenges with, and potential improvements for, the FDIC's sign and advertisement regulations under subpart A of 12 CFR part 328. As discussed in section IV, Expected Effects, of this document, the proposed rule has clear, quantifiable cost savings, among other benefits, over this no-action alternative with minimal costs to IDIs and their customers.
The FDIC also considered eliminating the regulations in 12 CFR 328.4 and 328.5 to remove digital signage requirements entirely. However, as described in the 2023 Final Rule, the FDIC believes there are benefits to updates to 12 CFR part 328 to address potential uncertainties that could dilute or undermine the confidence that underpins banks and our nation's broader financial system. The proposed rule would advance the 2023 Final Rule's objective to ensure that consumers, businesses, and other entities better understand when their funds are protected by FDIC deposit insurance, while increasing the flexibility for IDIs in the marketing of their products and services.
The FDIC invites comments on alternatives to the proposed rule.
The Regulatory Flexibility Act (RFA) generally requires an agency, in connection with a proposed rule, to prepare and make available for public comment an initial regulatory flexibility analysis that describes the impact of the proposed rule on small entities.
As described in section IV, Expected Effects, of this document, the proposed rule would affect all institutions whose deposits are insured by the FDIC. According to recent Call Reports, there are 4,471 such IDIs.
As a result of the proposed rule, IDIs with less than $10 billion in assets
The proposed rule would also provide benefits other than the cost savings described above, including greater flexibility in signage design and placement, improved customer experience, and reduced staff time allocated to maintaining signage compliance across multiple channels and devices. As noted in section IV, Expected Effects, of this document, the FDIC is unable to quantify these effects. However, the FDIC believes these effects, while potentially substantive for certain IDIs, are likely to be minimal in the aggregate.
Given the expected effects of the proposed rule described above, the FDIC certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities.
The FDIC invites comments on all aspects of the supporting information provided in this RFA section. The FDIC is particularly interested in comments on any significant effects on small entities that the agency has not identified.
Certain provisions of the proposed rule contain “collections of information” within the meaning of the Paperwork Reduction Act (PRA) of 1995.
First, the proposal would reduce the number of digital screens or pages on which the FDIC official digital sign must appear. Under the 2023 Final Rule, IDIs are typically required to display the FDIC official sign across an open-ended number of locations, most likely at least six. The proposed rule would eliminate the requirement to post the official digital sign on pages where a consumer may transact with deposits, which could represent multiple pages (transfer pages, remote deposit capture pages, and account opening pages, for example). Overall, the proposed rule would reduce this requirement to four key locations on digital channels and ATMs and like devices: (a) on digital channels, the requirement would drop from an open-ended number of pages (initial or homepage, landing or login, and pages where a consumer may transact with deposits) to just three (initial or homepage, login page, and the screen used to initiate a deposit account opening); and (b) for ATMs and like devices, the requirement would be reduced from at least two or more screens (home and each deposit-related transaction screen) to only the initial screen.
Second, the proposal would narrow the non-deposit signage requirements: (a) for digital channels, non-deposit signage would no longer be required on all pages related to non-deposit products; instead, non-deposit signage would only be required on pages primarily dedicated to one or more non-deposit products, thereby reducing the number of applicable pages; and (b) for ATMs and like devices, the proposal would both limit the types of devices that require non-deposit signage (only those enabling transactions with non-deposit products) and reduce the number of screens where signage must appear (from all related screens to only the initial non-deposit product screen).
These proposed changes are reflected in information collections 3-5 on the table below. Based on available data, the estimated annual burden associated with the information collection would decrease.
Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility;
(b) The accuracy of the estimate of the burden of the information collection, 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 information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
All comments will become a matter of public record. Comments on aspects of this document that may affect reporting, recordkeeping, or disclosure requirements and burden estimates should be sent to the address listed in the
Section 722 of the Gramm-Leach Bliley Act
• Has the FDIC organized the material to suit your needs? If not, how could the proposed rule be more clearly stated?
• Are the requirements in the proposed rule clearly stated? If not, how could the proposed rule be more clearly stated?
• Does the proposed rule contain language or jargon that is not clear? If so, which language requires clarification?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the proposed rule easier to understand? If so, what changes to the format would make the proposed rule easier to understand?
• What else could the FDIC do to make the proposed rule easier to understand?
Pursuant to section 302(a) of the Riegle Community Development and Regulatory Improvement Act of 1994 (RCDRIA),
Executive Order 12866, as amended, provides that the Office of Information and Regulatory Affairs (OIRA) will review all “significant regulatory actions” as defined therein. OIRA has determined that this proposal is not a “significant regulatory action” for purposes of Executive Order 12866. The proposal, if finalized as proposed, is not expected to be an Executive Order 14192 regulatory action.
The FDIC invites comment on all aspects of this proposed rulemaking. In particular, the FDIC seeks feedback on the scope of the proposed rule and its requirements, and responses to the following specific questions:
(1) Do the proposed rule's requirements regarding the color, size, and font of the FDIC official digital sign's text provide a reasonable amount of flexibility while ensuring that the official digital sign is easily
(2) Are there substantive changes to the text of the FDIC official digital sign, such as including the phrase, “Deposits are FDIC-insured,” that would provide additional clarity? Should IDIs be permitted to amend or add to the text of the FDIC official digital sign? If so, please provide details regarding the level of flexibility or specific text suggestions. Are there downsides to changes to the text or additional flexibility?
(3) Should the proposed rule include a minimum size font for the text of the FDIC official digital sign? If so, would this work for mobile phone applications with a small amount of space? If not, are there other ways to ensure that the FDIC official digital sign is readable, legible, and clear?
(4) Do the proposed rule's requirements regarding the design of the FDIC official digital sign present technical challenges? If so, please provide specific examples and potential alternatives that would support the FDIC's stated policy objectives while mitigating compliance and other costs.
(5) Should the proposed rule clarify what “similar fonts” to Source Sans Pro Web are permissible for the display of the FDIC official digital sign? If so, please suggest ways of providing such clarification.
(6) Are there additional ways the FDIC could clarify which pages and screens of an IDI's digital deposit-taking channel would be required to display the FDIC official digital sign?
(7) Does the proposed rule sufficiently address the stated policy objective of addressing risk of confusion where consumers interact with deposits and non-deposit products through the same digital channels? Are there any additional or alternative requirements that would draw a clear distinction between deposits and non-deposit products on digital channels?
(8) Do the proposed rule's requirements regarding the display of the FDIC official digital sign present technical challenges that are not sufficiently mitigated by the flexibility provided? If so, are there ways to address those challenges while still displaying the FDIC official digital sign in a recognizable and consistent manner that mitigates consumer confusion?
(9) The proposed rule would require the display of non-deposit signage only on pages and screens that are “primarily dedicated” to one or more non-deposit products. Is the meaning of “primarily dedicated” sufficiently clear as to which pages and screens require the non-deposit signage?
(10) The proposed rule would require that the FDIC official digital sign and non-deposit signage on certain digital deposit-taking channels be displayed clearly, continuously, and conspicuously. How can the FDIC provide additional guidance on whether a particular instance of the FDIC official digital sign or non-deposit signage on a given page is displayed “clearly, continuously, and conspicuously”?
(11) Does the proposed rule's minimum three-second duration for the display of the one-time notification before automatic dismissal provide consumers with sufficient opportunity to read and understand the content of the notification? Is there an alternative duration that would set a more appropriate minimum standard for the display of the one-time notification? Are there other alternative approaches besides a minimum duration that would achieve the stated policy objectives?
(12) Should the one-time notification requirement apply when the third-party is an affiliate of an IDI? If so, why, and if not, why not?
(13) Is the proposed rule sufficiently clear as to which pages and screens on ATMs and like devices are required to display the FDIC official digital sign? If not, how could the proposed rule be clearer?
(14) The proposed rule would require non-deposit signage to be displayed on an ATM or like device only on the initial transaction page or initial transaction screen for a non-deposit product. Is it sufficiently clear which page or screen would be the “initial transaction page or initial transaction screen” for purposes of this requirement? If not, how could the requirement be clearer?
(15) For ATMs and like devices that display the physical FDIC official sign, are minimum standards for the condition, clarity, or conspicuousness of the sign necessary to ensure consumers are able to view the sign's content? If so, what should those standards be?
(16) What risks of consumer confusion or uncertainty, if any, are presented by having different signage requirements for ATMs and like devices based on the date on which they are placed into service?
(17) Do the proposed rule's requirements that the FDIC official digital sign be displayed on an ATM's initial screen and that non-deposit signage be displayed on the initial non-deposit product transaction page provide enough clarity about whether a product is insured while providing reasonable flexibility to IDIs?
(18) For IDIs that have complied with the 2023 Final Rule, is the proposed January 1, 2027 compliance date sufficient to allow IDIs to revise systems and processes to ensure digital deposit-taking channels, ATMs, and like devices comply with the proposed requirements, if implemented? What expenses would IDIs incur in making such revisions?
(19) Do the proposed amendments pose potential challenges to the ability of IDI to innovate with respect to how consumers engage with an IDI and its products and services?
Advertising, Bank deposit insurance, Savings associations, Signs and symbols.
For the reasons stated in the preamble, the Federal Deposit Insurance Corporation proposes to amend part 328 of title 12 of the
12 U.S.C. 1818, 1819 (Tenth), 1820(c), 1828(a).
(a)
(b)
(c)
(1) ATMs and like devices placed into service after January 1, 2027, that do not permit an insured depository institution's customer to transact with a non-deposit product; and
(2) ATMs and like devices placed into service on or before January 1, 2027.
(d)
(a)
(b)
(c)
(1) Initial page or homepage of the website or application;
(2) Login page; and
(3) Page or screen where the consumer initiates a deposit account opening.
(d)
(1)
(2)
(i)
(ii)
(iii)
(iv)
(e)
(1) The homepage of an insured depository institution's website that continuously displays the FDIC official digital sign near the top of the page and adjacent to the insured depository institution's name;
(2) The login page for an insured depository institution's mobile application that displays the FDIC official digital sign immediately adjacent to the username and password fields;
(3) The deposit account opening page for an insured depository institution's web-based application that displays the FDIC official digital sign near the top or center of the page; and
(4) With respect to non-deposit signage, a page on an insured depository institution's website promoting, for example, annuities available for purchase, with non-deposit signage appearing towards the bottom of a promotional text or graphic in a size generally consistent with other text on the page.
By order of the Board of Directors.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain ATR—GIE Avions de Transport Régional Model ATR42-300, -320, -500, ATR72-201, and -212A airplanes, and for all ATR—GIE Avions de Transport Régional Model ATR72-102, -202, -211, and -212 airplanes. This proposed AD was prompted by an inspection on the ATR final assembly line that found a fire extinguishing tube, located on the ceiling of the aft cargo compartment, disconnected from its sleeve. This proposed AD would require a functional check of the aft cargo fire extinguishing system and applicable on-condition actions, if necessary. For certain airplanes, this proposed AD would also require an additional functional check 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 October 6, 2025.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For European Union Aviation Safety Agency (EASA) material identified in this proposed AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; 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.
Alexis Whitaker, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 516-228-7309; 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 Alexis Whitaker, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 516-228-7309; email:
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2025-0080, dated April 11, 2025; corrected April 23, 2025 (EASA AD 2025-0080) (also referred to as the MCAI), to correct an unsafe condition for certain ATR—GIE Avions de Transport Régional Model ATR42-300, -320, -400, -500, ATR72-201, and -212A airplanes, and for all ATR—GIE Avions de Transport Régional Model ATR72-102, -202, -211, and -212 airplanes. Model ATR42-400 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this proposed AD therefore does not include those airplanes in the applicability. The MCAI states that during an inspection on the ATR final assembly line, a fire extinguishing tube, located on the ceiling of the aft cargo compartment, was found disconnected from its sleeve. Further investigations indicated that this condition might affect other ATR airplanes. This condition, if not detected and corrected, could affect the capability of the aft cargo compartment fire extinguishing system to contain a cargo compartment fire.
You may examine the MCAI in the AD docket at
EASA AD 2025-0080 specifies procedures for accomplishing a functional check for discrepancies, such as incorrectly installed distribution piping, of the aft cargo fire-extinguishing system, and depending on the results, corrective actions. Corrective actions include correcting and re-installing the distribution piping then repeating the functional check after re-installation, or obtaining and following repair instructions from the manufacturer if a detected discrepancy cannot be corrected. For airplanes on which a functional check and corrective actions have been accomplished using certain material, EASA AD 2025-0080 specifies performing an additional functional check and, depending on the results, corrective actions. 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 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 require accomplishing the actions specified in EASA AD 2025-0080 described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.
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 incorporate EASA AD 2025-0080 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2025-0080 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2025-0080 does not mean that operators need to comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2025-0080. Material required by EASA AD 2025-0080 for compliance will be available at
The FAA estimates that this AD, if adopted as proposed, would affect 103 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 on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition actions:
The FAA has received no definitive data on which to base the cost estimates for airplanes that require contacting ATR for repair instructions in order to comply with on-condition actions specified in this proposed AD.
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 October 6, 2025.
None.
This AD applies to the ATR—GIE Avions de Transport Régional airplanes identified in paragraphs (c)(1) and (2) of this AD, certificated in any category, as identified in European Union Aviation Safety Agency (EASA) AD 2025-0080, dated April 11, 2025; corrected April 23, 2025 (EASA AD 2025-0080).
(1) ATR42-300, -320, and -500 airplanes.
(2) ATR72-102, -201, -202, -211, -212, and -212A airplanes.
Air Transport Association (ATA) of America Code 26, Fire Protection.
This AD was prompted by an inspection on the ATR final assembly line that found a fire extinguishing tube, located on the ceiling of the aft cargo compartment, disconnected from its sleeve. The FAA is issuing this AD to address this condition, which if not detected and corrected, could affect the capability of the aft cargo compartment fire extinguishing system to contain a cargo compartment fire.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2025-0080.
(1) Where EASA AD 2025-0080 refers to its effective date, this AD requires using the effective date of this AD.
(2) Where EASA AD 2025-0080 refers to February 5, 2025 (the effective date of EASA AD 2025-0024), this AD requires using the effective date of this AD.
(3) Where EASA AD 2025-0080 refers to “any discrepancy”, this AD requires replacing that text with “any incorrectly installed distribution piping”.
(4) This AD does not adopt the “Remarks” section of EASA AD2025-0080.
Special flight permits may be issued in accordance with 14 CFR 21.197 and 21.199 to operate the airplane to a location where the airplane can be modified, provided no cargo is in the aft cargo compartment.
The following provisions also apply to this AD:
(1)
(2)
For more information about this AD, contact Alexis Whitaker, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 516-228-7309; email:
(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 this AD specifies otherwise.
(i) European Union Aviation Safety Agency (EASA) AD 2025-0080, dated April 11, 2025; corrected April 23, 2025.
(ii) [Reserved]
(3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(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 adopt a new airworthiness directive (AD) for all MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702), CL-600-2C11 (Regional Jet Series 550), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. This proposed AD 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 October 6, 2025.
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
• 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.
Fatin Saumik, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 228-7300; 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 Fatin Saumik, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 228-7300; email:
Transport Canada, which is the aviation authority for Canada, has issued Transport Canada AD CF-2024-41, dated December 5, 2024 (Transport Canada AD CF-2024-41) (also referred to as the MCAI), to correct an unsafe condition for all MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702), CL-600-2C11 (Regional Jet Series 550), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states that new or more restrictive airworthiness limitations have been developed.
The FAA is proposing this AD to address reduced structural integrity and reduced controllability of the airplane. You may examine the MCAI in the AD docket at
The FAA issued the following ADs that are related to this proposed AD:
• AD 2023-06-06, Amendment 39-22392 (88 FR 17682, March 24, 2023); corrected April 12, 2023 (88 FR 21900) (AD 2023-06-06), which applies to all MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, Model CL-600-2C11 (Regional Jet Series 550) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model C-600-2E25 (Regional Jet Series 1000) airplanes. AD 2023-06-06 requires revising the existing maintenance or inspection program, as applicable, to incorporate two aircraft maintenance manual (AMM) tasks.
• AD 2023-09-02, Amendment 39-22425 (88 FR 32625, May 22, 2023) (AD 2023-09-02), which applies to all MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series 100 & 440), CL-600-2C10 (Regional Jet Series 700, 701, and 702), CL-600-2C11 (Regional Jet Series 550), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. AD 2023-09-02 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive AMM and certification maintenance requirement (CMR) tasks.
• AD 2023-24-03, Amendment 39-22619 (88 FR 87331, December 18, 2023) (AD 2023-24-03), which applies to all MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series 100 & 440), CL-600-2C10 (Regional Jet Series 700, 701, and 702), CL-600-2C11 (Regional Jet Series 550), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. AD 2023-24-03 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive AMM and CMR tasks.
• AD 2025-11-11, Amendment 39-23057 (90 FR 24315, June 10, 2025) (AD 2025-11-11), which applies to all MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701, and 702), CL-600-2C11 (Regional Jet Series 550), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. AD 2025-11-11 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive AMM tasks.
Accomplishing the actions required by this proposed AD terminates the corresponding requirements of paragraph (h) of AD 2023-09-02 and paragraph (h) of AD 2023-24-03 for the AMM tasks identified in the material referenced in Transport Canada AD CF-2024-41 only.
Accomplishing the actions required by this AD terminates all requirements of AD 2023-06-06 and AD 2025-11-11.
The FAA reviewed Transport Canada AD CF-2024-41, which specifies new or more restrictive airworthiness limitations for airplane structures and safe life limits.
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 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 require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations, which are specified in Transport Canada AD CF-2024-41 described previously, as incorporated by reference. Any differences with Transport Canada AD CF-2024-41 are identified as exceptions in the regulatory text of this proposed AD.
This proposed AD would require revisions to certain operator maintenance documents to include new actions (
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 incorporate Transport Canada AD CF-2024-41 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with Transport Canada AD CF-2024-41 through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Material required by Transport Canada AD CF-2024-41 for compliance will be available at regulations.gov by searching for and locating Docket No. FAA-2025-2261 after the FAA final rule is published.
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 600 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
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 agency estimates the average total cost per operator 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 has 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 October 6, 2025.
This AD affects the ADs specified in paragraphs (b)(1) through (4) of this AD.
(1) AD 2023-06-06, Amendment 39-22392 (88 FR 17682, March 24, 2023); corrected April 12, 2023 (88 FR 21900) (AD 2023-06-06).
(2) AD 2023-09-02, Amendment 39-22425 (88 FR 32625, May 22, 2023) (AD 2023-09-02).
(3) AD 2023-24-03, Amendment 39-22619 (88 FR 87331, December 18, 2023) (AD 2023-24-03).
(4) AD 2025-11-11, Amendment 39-23057 (90 FR 24315, June 10, 2025) (AD 2025-11-11).
This AD applies to all MHI RJ Aviation ULC (Type Certificate Previously Held by Bombardier, Inc.) airplanes, certificated in any category, identified in paragraphs (c)(1) through (5) of this AD.
(1) Model CL-600-2C10 (Regional Jet Series 700, 701, and 702) airplanes.
(2) Model CL-600-2C11 (Regional Jet Series 550) airplanes.
(3) Model CL-600-2D15 (Regional Jet Series 705) airplanes.
(4) Model CL-600-2D24 (Regional Jet Series 900) airplanes.
(5) Model CL-600-2E25 (Regional Jet Series 1000) airplanes.
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 and reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, Transport Canada AD CF-2024-41, dated December 5, 2024 (Transport Canada AD CF-2024-41).
(1) Where Transport Canada AD CF-2024-41 refers to its effective date, this AD requires using the effective date of this AD.
(2) Where Transport Canada AD CF-2024-41 specifies to “complete the new or more restrictive limitations contained in the MHIRJ MRM CSP B-053 Part 2, revision 27, dated 15 September 2023, as applicable to the aeroplane model and configuration within the thresholds and repeat intervals or discard time identified within the tasks”, this AD requires replacing that text with “revise the existing maintenance or inspection program, as applicable, by incorporating the information specified in MHIRJ MRM CSP B-053 Part 2, Revision 27, dated September 15, 2023, except when incorporating Appendix A2, only incorporate the AMM tasks, including the interval limitation, specified in the limitations table in Appendix A2”.
(3) The initial compliance time for doing the tasks specified in the “Corrective Actions” section of Transport Canada AD CF-2024-41 is at the applicable time specified in paragraph (h)(3)(i) or (ii) of this AD.
(i) For tasks that have “thresholds” and “discard times” specified: The initial compliance time is at the applicable “thresholds” and “discard times” as specified in the material referenced in Transport Canada AD CF-2024-41, or within 30 days after the effective date of this AD, whichever occurs later.
(ii) For tasks that only have “intervals” specified: The initial compliance time is before the applicable interval limitation specified in the material referenced in Transport Canada AD CF-2024-41 since the date of issuance of the original airworthiness certificate or the original export certificate of airworthiness, 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 (g) of this AD, no alternative actions (
Accomplishing the actions required by this AD terminates the corresponding requirements of paragraph (h) of AD 2023-09-02 and paragraph (h) of AD 2023-24-03 for the AMM tasks identified in the material referenced in Transport Canada AD CF-2024-41 only.
Accomplishing the actions required by this AD terminates all requirements of AD 2023-06-06 and AD 2025-11-11.
The following provisions also apply to this AD:
(1)
(2)
For more information about this AD, contact Fatin Saumik, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 228-7300; email:
(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 this AD specifies otherwise.
(i) Transport Canada AD CF-2024-41, dated December 5, 2024.
(ii) [Reserved]
(3) 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
(4) You may view this material at the FAA, Airworthiness Products Section, Operational
(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 adopt a new airworthiness directive (AD) for all Gulfstream Aerospace LP Model Gulfstream 100, Astra SPX, and 1125 Westwind Astra airplanes. This proposed AD was prompted by a determination that new airworthiness limitations are necessary. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new 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 October 6, 2025.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For Civil Aviation Authority of Israel (CAAI) material identified in this proposed AD, contact CAAI, P.O. Box 1101, Golan Street, Airport City, 70100, Israel; telephone 972-3-9774665; fax 972-3-9774592; 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.
Trevor Carlton, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 404-474-5597; 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 Trevor Carlton, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 404-474-5597; email:
The CAAI, which is the aviation authority for Israel, has issued CAAI AD ISR I-32-25-01-7, dated January 13, 2025 (CAAI AD ISR I-32-25-01-7) (also referred to as the MCAI), to correct an unsafe condition for all Gulfstream Aerospace LP Model Gulfstream 100, Astra SPX, and 1125 Westwind Astra airplanes. The MCAI states an in-service failure of the nose landing gear (NLG) actuator-to-strut attachment pin was reported.
The FAA has determined that new airworthiness limitations are necessary for NLG actuator-to-strut attachment pins, part numbers (P/Ns) 2247.0500.007 and 2247.0500.008. The FAA is proposing this AD to prevent failure of the NLG actuator-to-strut attachment pin. The unsafe condition, if not addressed, could result in failure of the NLG to retract and lock after take-off or extend and lock before landing. You may examine the MCAI in the AD docket at
The FAA reviewed CAAI AD ISR I-32-25-01-7, which specifies new airworthiness limitations for safe life limits of the NLG actuator-to-strut attachment pins, P/Ns 2247.0500.007 and 2247.0500.008. This material is reasonably available because 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 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 require revising the existing maintenance or inspection program, as applicable, to incorporate new airworthiness limitations, which are specified in CAAI AD ISR I-32-25-01-7 described previously, as incorporated by reference. Any differences with CAAI AD ISR I-32-25-01-7 are identified as exceptions in the regulatory text of this proposed AD.
This proposed AD would require revisions to certain operator maintenance documents to include new actions (
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 incorporate CAAI AD ISR I-32-25-01-7 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with CAAI AD ISR I-32-25-01-7 through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Material required by CAAI AD ISR I-32-25-01-7 for compliance will be available at
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 alternative actions (
The FAA estimates that this AD, if adopted as proposed, would affect 86 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
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 agency estimates the average total cost per operator 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 has 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 October 6, 2025.
None.
This AD applies to all Gulfstream Aerospace LP Model Gulfstream 100, Astra SPX, and 1125 Westwind Astra airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 32, Landing gear.
This AD was prompted by a determination that new airworthiness limitations are necessary. The FAA is issuing this AD to prevent failure of the nose landing gear (NLG) actuator-to-strut attachment pin. The unsafe condition, if not addressed, could result in failure of the NLG to retract and lock after take-off or extend and lock before landing.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, CAAI AD ISR I-32-25-01-7, dated January 13, 2025 (CAAI AD ISR I-32-25-01-7).
(1) Where CAAI AD ISR I-32-25-01-7 refers to its effective date, this AD requires using the effective date of this AD.
(2) The initial compliance time for doing the tasks specified in the Action paragraph of CAAI AD ISR I-32-25-01-7 is at the applicable discard interval specified in the material referenced in the Action paragraph of CAAI AD ISR I-32-25-01-7, or within 3 months after the effective date of this AD, whichever occurs later.
(3) Where the Action paragraph of CAAI AD ISR I-32-25-01-7 specifies “to incorporate AMM Revision 26”, this AD requires replacing that text with “revise the existing maintenance or inspection program, as applicable, by incorporating the information in the Nose Landing Gear Actuator Attachment Pin—Life Limit (Scrap) tasks for SHL part numbers 2247.0500.007 and 2247.0500.008”.
(4) Where the Action paragraph of CAAI AD ISR I-32-25-01-7 specifies “to incorporate AMM Revision 32”, this AD requires replacing that text with “revise the existing maintenance or inspection program, as applicable, by incorporating the information in the NLG Actuator Attachment Pin—Life Limit (Scrap) tasks for SHL part numbers 2247.0500.007 and 2247.0500.008”.
After the existing maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(2)
(1) For more information about this AD, contact Trevor Carlton, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 404-474-5597; email:
(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 this AD specifies otherwise.
(i) Civil Aviation Authority of Israel (CAAI) AD ISR I-32-25-01-7, dated January 13, 2025.
(ii) [Reserved]
(3) For CAAI material identified in this AD, contact Civil Aviation Authority of Israel (CAAI), P.O. Box 1101, Golan Street, Airport City, 70100, Israel; telephone 972-3-9774665; fax 972-3-9774592; email
(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) 2021-20-16, which applies to all Airbus Helicopters Model AS355E, AS 355-F, AS 355-F1, AS355F2, AS355N, and AS355NP helicopters and certain Model AS 350B3 helicopters. AD 2021-20-16 requires repetitive cleaning and visual and detailed inspections of the right-hand side of the vertical fin spar and vertical fin upper attachments for discrepancies (cracking) with corrective action, if necessary. Since the FAA issued AD 2021-20-16, Airbus Helicopters developed a modification of the upper fin assembly. This proposed AD would require the same actions as AD 2021-20-16 and would also require replacement of the upper fin assembly with a modified upper fin assembly, which would constitute terminating action for the repetitive inspections. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this NPRM by October 6, 2025.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For European Union Aviation Agency (EASA) material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
• You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Parkway, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110. It is also available at
Steven Warwick, Aviation Safety Engineer, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; phone: (817) 222-5225; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address 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 regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.
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 Steven Warwick, Aviation Safety Engineer, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
The FAA issued AD 2021-20-16, Amendment 39-21754 (86 FR 57550, dated October 18, 2021) (AD 2021-20-16), for Airbus Helicopters Model AS355E, AS 355-F, AS 355-F1, AS355F2, AS355N, and AS355NP helicopters, all serial numbers, and Model AS 350B3 helicopters, all serial numbers except those that have Airbus Helicopters Modification 073148 in production. AD 2021-20-16 was prompted by MCAI originated by EASA, which is the Technical Agent for the Member States of the European Union. EASA issued EASA AD 2021-0099, dated April 9, 2021 (EASA AD 2021-0099), to correct an unsafe condition identified as cracking in the spar of the upper part of the vertical fin and fractures in the front attachment screws.
AD 2021-20-16 requires repetitive cleaning and detailed inspections for cracking of the vertical fin spar and vertical fin upper attachments, and corrective action if necessary. The FAA issued this AD to address cracking in the spar of the upper part of the vertical fin and fractures in the front attachment screws. This condition could lead to in-flight separation of the upper part of the vertical fin, resulting in loss of control of the helicopter.
Since the FAA issued AD 2021-20-16, EASA superseded EASA AD 2021-0099 through a series of ADs, the most recent being EASA AD 2024-0139, dated July 12, 2024 (EASA AD 2024-0139) (also referred to as “the MCAI”). EASA AD 2024-0139 states that after a further occurrence of a crack on a Model AS355NP helicopter, EASA concluded there was a need to temporarily reduce the never-exceed-speed (V
You may examine the MCAI in the AD docket at
The FAA reviewed EASA AD 2024-0139, which specifies procedures for amending the rotorcraft flight manual (RFM) and installing a placard to add a speed limitation. EASA AD 2024-0139 allows exceeding the speed limitation on certain maintenance flights and specifies accomplishing an inspection after each flight where the speed is exceeded. EASA AD 2024-0139 also requires repetitively inspecting the right-hand external side around the two top screws of certain upper fin spars for a crack. EASA AD 2024-0139 specifies that installing an upper fin assembly P/N 355A14-0522-1751 constitutes terminating action for the repetitive inspection requirements and the speed limitations. Lastly, EASA AD 2024-0139 prohibits installing affected upper fin assemblies on any helicopter.
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 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, it has notified the FAA of the unsafe condition
This proposed AD would require accomplishing the actions specified in EASA AD 2024-0139, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD. See “Differences Between this Proposed AD and the MCAI” for a general discussion of these differences.
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 incorporate EASA AD 2024-0139 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2024-0139 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2024-0139 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2024-0139. Material referenced in EASA AD 2024-0139 for compliance will be available at
While the service material referenced in EASA AD 2024-0139 requires accomplishing dye penetrant inspections, this proposed AD would require a dye penetrant inspection (DPI) if the affected part has previously been inspected by a DPI method; otherwise, this proposed AD would require a fluorescent penetrant inspection (FPI).
Where EASA AD 2024-0139 and the service material referenced in EASA AD 2024-0139 specify contacting Airbus Helicopters for repair instructions, this proposed AD would require using a method approved by the FAA, EASA, or Airbus Helicopters' EASA Design Organization Approval.
EASA AD 2024-0139 requires informing all flight crew and operating the helicopter accordingly, whereas this proposed AD would not because those actions are already required by FAA regulations.
EASA AD 2024-0139 allows a pilot to perform some actions, and this proposed AD would not.
The FAA estimates that this AD, if adopted as proposed, would affect 650 helicopters of U.S. registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.
Amending the RFM and installing a placard to incorporate a speed limitation would take approximately 1 work-hour and parts would cost $25 for an estimated cost of $110 per helicopter and $71,500 for the U.S. fleet.
Cleaning and inspecting the vertical fin spar would take 2.5 work-hours for an estimated cost of $213 per helicopter and $138,450 for the U.S. fleet, per inspection cycle.
Modifying the upper fin spar would take 19 work-hours and parts would cost $25,360 for an estimated cost of $26,975 per helicopter and $17,533,750 for the U.S. fleet.
If required, performing a DPI or FPI on the upper fin spar would take 1 work-hour for an estimated cost of $85 per helicopter.
The extent of damage found during the required inspection of the vertical fin spar could vary significantly from helicopter to helicopter. The agency has no way of determining how much damage may be found during these inspections, the cost to repair damaged parts of each helicopter, or the number of helicopters that might need these repairs.
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some 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 that the 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 October 6, 2025.
This AD replaces AD 2021-20-16, Amendment 39-21754 (86 FR 57550, dated October 18, 2021).
This AD applies to Airbus Helicopters Model AS 350B3, AS355E, AS 355-F, AS 355-F1, AS355F2, AS355N, and AS355NP helicopters, certificated in any category, as identified in European Union Aviation Safety Agency AD 2024-0139, dated July 12, 2024 (EASA AD 2024-0139).
Joint Aircraft System Component (JASC) Code 5531, Vertical Stabilizer, Spar/Rib Structure.
This AD was prompted by a report of a structural crack in the vertical attachment spar of the upper tail fin and fractures in its two front attachment screws. The FAA is issuing this AD to address cracking in the upper fin spar and fracturing of the front attachment screws. The unsafe condition, if not addressed, could result in in-flight separation of the upper part of the vertical fin and subsequent loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2024-0139.
(1) Where EASA AD 2024-0139 requires compliance in terms of flight hours, this AD requires using hours time-in-service.
(2) Where EASA AD 2024-0139 refers to its effective date or to any of the dates listed in paragraphs (h)(2)(i) through (iv) of this AD, this AD requires using the effective date of this AD.
(i) July 12, 2017 (the effective date of EASA AD 2017-0114, dated June 28, 2017).
(ii) April 23, 2021 (the effective date of EASA AD 2021-0099, dated April 9, 2021).
(iii) April 14, 2023 (the effective date of EASA AD 2023-0075, dated April 7, 2023).
(iv) May 18, 2023 (the effective date of EASA AD 2023-0089, dated May 4, 2023).
(3) Where paragraph (1) of EASA AD 2024-0139 specifies to inform all flight crew and operate the helicopter accordingly, this AD does not require those actions.
(4) Although the service material referenced in EASA AD 2024-0139 allows some actions to be performed by a pilot, this AD does not.
(5) Where the service material referenced in EASA AD 2024-0139 states “if you are not sure”, this AD requires replacing that text with “to confirm suspected cracks (scratch, line, misalignment, etc.)”.
(6) Where the service material referenced in EASA AD 2024-0139 states to do a dye-penetrant inspection (DPI), this AD requires the actions in paragraph (h)(6)(i), (ii), or (iii) of this AD, as applicable:
(i) If the right-hand (RH) side of the spar (a) has previously been inspected by a DPI method, accomplish a DPI of the RH side of the spar (a).
(ii) If the RH side of the spar (a) has not previously been inspected by a DPI, accomplish a fluorescent penetrant inspection (FPI) of the RH-hand side of the spar (a), instead of a DPI.
(iii) If you cannot determine whether the RH side of the spar (a) has previously been inspected by a DPI, clean all surfaces to be inspected and accomplish an FPI of the RH side of the spar (a) instead of a DPI.
(7) Where the service material referenced in EASA AD 2024-0139 refers to damage, for this AD, damage is defined as looseness, corrosion, broken or missing lockwire, loss of protective surface finish, deformation, fracture, crack, or nick.
(8) Where paragraph (8) of EASA AD 2024-0139 states “maintenance flight”, this AD requires replacing that text with “flight to perform an operational check as specified in 14 CFR 91.407”.
(9) Where paragraph (10) of EASA AD 2024-0139 and the service material referenced in EASA AD 2024-0139 specify contacting Airbus Helicopters for repair instructions, this AD requires using a repair method approved by the FAA, EASA, or Airbus Helicopters' EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
(10) Where the service material referenced in EASA AD 2024-0139 specifies to discard parts, this AD requires removing these parts from service.
(11) Where paragraph (16) of EASA AD 2024-00139 only allows credit for the initial actions in paragraphs (4) through (9) of EASA AD 2024-00139, this AD allows credit for any action in paragraphs (4) through (9) of EASA AD 2024-00139.
(12) This AD does not adopt the “Remarks” section of EASA AD 2024-0139.
Although the material referenced in EASA AD 2024-0139 specifies to submit certain information to the manufacturer, this AD does not require that action.
(1) The Manager, International Validation 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 local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (k) of this AD and email to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local Flight Standards District Office/certificate holding district office.
For more information about this AD, contact Steven Warwick, Aviation Safety Engineer, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; phone: (817) 222-5225; email:
(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) European Union Aviation Safety Agency (EASA) AD 2024-0139, dated July 12, 2024.
(ii) [Reserved]
(3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
(4) You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(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
Office of Surface Mining Reclamation and Enforcement, Interior.
Proposed rule; public comment period and opportunity for public hearing on proposed amendment.
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are announcing receipt of a proposed amendment to the Montana regulatory program (the Montana program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Montana submitted this proposed amendment to us, on its own initiative, following the passage of Montana House Bill 633 (HB 633) during the 2025 legislative session. Montana proposes several changes to the Montana Code Annotated (MCA). Montana proposes that objections to the Montana Department of Environmental Quality's (DEQ) decisions are limited to issues previously raised in a comment or written objection submitted during the relevant comment period. The submittal also requires cumulative hydrologic impact assessments to be published along with DEQ's acceptability determination. Also, Montana adds contingencies in HB 633 that will not be codified into law but that will apply to the proposed amendment: “Saving clause,” “Severability,” “Contingent voidness,” and “Effective date.”
We will accept written comments on this amendment until 4:00 p.m., Mountain Daylight Time (M.D.T.) September 22, 2025. If requested, we may hold a public hearing or meeting on the amendment on September 15, 2025. We will accept requests to speak at a hearing until 4:00 p.m., M.D.T. on September 5, 2025.
You may submit comments, identified by SATS No. MT-049-FOR, by any of the following methods:
•
•
•
In addition, you may review a copy of the amendment during regular business hours at the following location: Attn: Eric Dahlgren, Bureau Chief, Mining Bureau, Montana Department of Environmental Quality, 2401 Colonial Drive, Helena, MT 59601-0901, Telephone: (406) 444-5245, Email:
Attn: Jeffrey Fleischman, Field Office Director, Office of Surface Mining Reclamation and Enforcement, 100 East B Street, Casper, Wyoming 82602, Telephone: (307) 261-6550, Email:
Subject to OSMRE's oversight, section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its approved, State program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations.
On the basis of these criteria, the Secretary of the Interior conditionally approved the Montana program on April 1, 1980. You can find background information on the Montana program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Montana program in the April 1, 1980,
By letter dated June 6, 2025 (Administrative Record No. MT-049-01), Montana sent us an amendment to its program under SMCRA (30 U.S.C. 1201
Montana first proposes changes to procedures for contested case hearings at 82-4-206(1) of the MCA. Montana proposes that for an applicant, permittee, or person otherwise adversely affected by a DEQ decision to request a hearing with the Board of Environmental Review, that party must have submitted comments or written objections during the relevant comment period.
Second, at 82-4-231(8)(e), Montana proposes that where DEQ requires a cumulative hydrologic impact assessment, DEQ must publish a draft of that assessment along with DEQ's determination that the application is administratively complete and acceptable for review.
Third, at 82-4-231(9), Montana proposes that an applicant, permittee, landowner, or person adversely affected by DEQ's permit decision may request a hearing with the Board of Environmental Review only if they submitted a written objection pursuant to 82-4-231(8). Furthermore, the hearing must be limited to issues raised in written objections and issues not addressed by DEQ in its notice of determination published in accordance with 82-4-231(8)(e).
Finally, HB 633 adds four contingencies that affect the amended sections above, but that are not codified into the MCA. This includes a “Saving” clause that does not allow HB 633 to affect the rights and duties that matured, penalties that were incurred, or proceedings that were begun before the effective date; a “Severability” clause
The full text of the program amendment is available for you to read at the locations listed above under
Under the provisions of 30 CFR 732.17(h), we are seeking your comments on whether the amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of the State program.
If you submit written or electronic comments on the proposed rule during the 30-day comment period, they should be specific, confined to issues pertinent to the proposed regulations, and explain the reason for any recommended change. We appreciate any and all comments, but those most useful and likely to influence decisions on the final regulations will be those that either involve personal experience or include citations to and analyses of SMCRA, its legislative history, its implementing regulations, case law, other pertinent State or Federal laws or regulations, technical literature, or other relevant publications.
We cannot ensure that comments received after the close of the comment period (see DATES) or sent to an address other than those listed (see
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
If you wish to speak at the public hearing, contact the person listed under
To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at the public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been given an opportunity to be heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak and others present in the audience who wish to speak, have been heard.
If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contacting the person listed under
E.O. 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993, the approval of State program is exempted from OMB review under E.O.12866. E.O. 13563 reaffirms and supplements E.O. 12866.
When a State submits a program amendment to OSMRE for review, our regulations at 30 CFR 732.17(h) require us to publish a notice in the
Intergovernmental relations, Surface mining, Underground mining.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Maricopa County Air Quality Department (MCAQD) portion of the Arizona State Implementation Plan (SIP). This revision clarifies definitions used in a rule that limits volatile organic compounds (VOCs) emissions from petroleum solvents used in dry cleaning. We are proposing to approve the rule revisions under the Clean Air Act (CAA or “Act”). We are taking comments on this proposal and plan to follow with a final action.
Comments must be received on or before September 22, 2025.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2025-0303 at
La Kenya Evans-Hopper, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105; telephone number: (415) 972-3245; email address:
Throughout this document, “we,” “us,” and “our” refer to the EPA.
In April 2016, the EPA analyzed Maricopa County's SIP-approved rules to determine if any outdated rules could potentially be replaced by newer provisions that are currently only locally applicable. The analysis resulted in recommendations for updating the Arizona SIP by rescinding obsolete two- and three-digit rules either with, or without, replacement. On September 13, 2017, the Arizona Department of Environmental Quality (ADEQ) submitted to the EPA requests from MCAQD to act on a series of rules, including the rescission of various local rules (“2017 SIP Submittal”). Table 1 lists the rule addressed by this proposal with the dates that it was adopted by the local air agency and submitted to the EPA by ADEQ.
On March 13, 2018, the 2017 SIP submittal was deemed by operation of law to be complete. We have reviewed the submittal to ensure it meets the completeness criteria in 40 CFR part 51, appendix V.
On February 9, 1998 (63 FR 6489), we approved an earlier version of MCAQD Rule 333, “Petroluem Solvent Dry Cleaning,” (“Rule 333”), as revised on June 19, 1996, into the SIP. MCAQD adopted revisions to the SIP-approved version of Rule 333 on September 25, 2013, and ADEQ submitted them to us on September 13, 2017. In its submittal letter, ADEQ requested that, upon approval of the revised version of Rule 333, the EPA remove the old version of this rule from the SIP. If we finalize this rulemaking as proposed, the September 25, 2013 version of Rule 333 will replace the previously approved version of this rule in the SIP.
In 2016, the EPA reformatted the Arizona SIP as codified in the Code of Federal Regulations (CFR) into a tabulated “notebook” format. While developing the updated SIP tables for that conversion, the EPA worked closely with ADEQ and the local air agencies to clarify what was in their applicable SIP, including older provisions that had not been updated or replaced to reflect local rulemakings. The result of that coordination was that MCAQD requested to rescind or replace many obsolete rules in their federally enforceable SIP in favor of rules that reflect their current locally enforceable rulebook.
MCAQD Rule 333 regulates the emissions of VOCs from petroleum solvents used in dry cleaning and at dry cleaning facilities. Emissions of VOCs contribute to the production of ground-level ozone and smog that harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. MCAQD Rule 333 was revised to clarify that the definitions in MCAQD Rule 100
The EPA's technical support document (TSD) has more information about this rule.
Under the provisions of CAA section 110(l), SIP revisions must not interfere with attainment, reasonable further progress (RFP), or any other applicable requirement of the CAA. Therefore, we evaluated whether the revisions to Rule 333 would comply with CAA section 110(l).
Guidance and policy documents that we used to evaluate revision and/or relaxation requirements for the applicable criteria pollutants include the following:
1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
We evaluated the rule revisions to ensure they meet CAA requirements and are consistent with relevant guidance regarding SIP revisions. Based on our review, the revisions meet the relevant requirements and would strengthen the overall SIP by ensuring a consistent definition for VOC is being implemented in the MCAQD portion of the Arizona SIP. The revisions do not relax any requirements. The TSD has more information on our evaluation.
As authorized in section 110(k)(3) of the Act, the EPA proposes to approve the submitted rule because it fulfills all relevant requirements. We will accept comments from the public on this
In this document, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference Maricopa County Air Quality Department Rule 333, Petroleum Solvent Dry Cleaning, revised on September 25, 2013, which regulates VOC emissions from petroleum solvents used in dry cleaning. The EPA has made, and will continue to make, these materials available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it proposes to approve a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Alabama State Implementation Plan (SIP) submitted by the Alabama Department of Environmental Management (ADEM) on December 20, 2023. The proposed SIP revision consists of minor changes to certain air permit regulations that have been revised by the State agency since EPA last approved those provisions. EPA is proposing to approve the SIP revision pursuant to the Clean Air Act (CAA or Act).
Comments must be received on or before September 11, 2025.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2024-0387 at
Faith Goddard, Multi-Air Pollutant Coordination Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-8757. Ms. Goddard can also be reached via electronic mail at
On December 20, 2023, ADEM submitted a revision to Alabama Administrative Code (Ala. Admin. Code) Chapter 335-3-14 in the Alabama SIP.
The CAA NSR program is a preconstruction review and air permitting program that applies to certain new and modified stationary sources of air pollution regulated under the CAA. CAA section 110(a)(2)(C) provides that SIPs must include a program to regulate the construction and modification of any stationary source as necessary to assure that the national ambient air quality standards (NAAQS) are achieved and cites to more detailed CAA permitting requirements that pertain to the construction of major sources of air pollution, known collectively as the CAA NSR program. The CAA NSR program consists of the following three programs: (1) PSD for major stationary sources and major modifications in attainment and unclassifiable areas; (2) NNSR for major stationary sources and major modifications locating in or impacting nonattainment areas, and (3) minor NSR, which applies generally to attainment, unclassifiable, and nonattainment areas for new sources and modifications that fall below major NSR thresholds. Federal regulations setting forth these NSR programs are prescribed at 40 CFR part 51, subpart I,
In the December 20, 2023, SIP revision, ADEM seeks to revise Rule 335-3-14-.03 to correct a cross-reference citation at Rule 335-3-14-.03(1)(g)1 to the significant impact levels listed in subparagraph (1)(g).
In the December 20, 2023, SIP revision, ADEM seeks to revise Rule 335-3-14-.04 to make administrative changes at Rules 335-3-14-.04(2)(a)1 and 335-3-14-.04(2)(bbb) and a clarifying change at Rule 335-3-14-.04(15)(e).
In the December 20, 2023, SIP revision, ADEM seeks to revise Rule 335-3-14-.05 to make administrative changes at Rules 335-3-14-.05(1)(k) and 335-3-14-.05(4)(d), correct a spelling error at Rule 335-3-14-.05(3), and update outdated information and references at Rule 335-3-14-.05(4)(e).
For the reasons discussed in Section II of this NPRM, EPA is proposing to approve ADEM's December 20, 2023, SIP revision with changes to Ala. Admin. Code Rules 335-3-14-.03, .04, and .05. EPA is proposing to approve Rule 335-3-14-.03, as revised to incorporate an administrative correction; Rule 335-3-14-.04, as revised to incorporate administrative and clarifying changes; and Rule 335-3-14-.05, as revised to incorporate administrative changes, a correction, and an offset credit update. Given the nature of these changes, they will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable CAA requirement.
In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Georgia, through the Georgia Environmental Protection Division (GA EPD), on June 27, 2024, seeking to revise a source monitoring and reporting regulation by, among other things, removing the requirement for emissions statements in counties formerly designated as nonattainment for ozone and to revise the permit by rule regulation. EPA is proposing to approve these revisions pursuant to the Clean Air Act (CAA or Act).
Comments must be received on or before September 11, 2025.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2025-0045 at
Weston Freund, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-8773. Mr. Freund can also be reached via electronic mail at
EPA is proposing to approve changes to the Georgia SIP submitted by the State on June 27, 2024, to revise a source monitoring and reporting regulation and the permit by rule regulation.
Effective August 3, 2018, EPA designated seven counties in and around metropolitan Atlanta as nonattainment and classified them as a “marginal” nonattainment area for the 2015 8-hour ozone NAAQS (hereinafter referred to as the Atlanta 2015 8-hour Ozone Area).
Prior to the redesignation to attainment for the 2015 ozone NAAQS, Georgia was required to submit SIP revisions to include certain ozone nonattainment provisions within its SIP, including nonattainment new source review (NNSR) and emissions statements provisions.
As a result of the redesignation of the Atlanta 2015 8-hour Ozone Area to attainment for the 2015 8-hour ozone standard, Georgia's SIP is not required to contain emissions statements requirements for this standard within this geographic area. Georgia's June 27, 2024, revision, as discussed in more detail below, would therefore remove the emissions statements rules from Georgia's SIP as obsolete. The revision also seeks to make minor changes to the portion of the permit by rule regulation for coating and/or gluing operations that applies in certain counties formerly designated as nonattainment for ozone. Georgia's submittal includes a demonstration, pursuant to CAA section 110(l), that the revision would not interfere with any applicable requirement concerning attainment of the NAAQS and reasonable further progress (RFP) or any other applicable requirement of the CAA. EPA's analysis of Georgia's June 27, 2024, SIP revision and the Agency's rationale for proposing to approve these changes are provided below.
CAA section 182(a)(3)(B) requires states with an ozone nonattainment area to submit a SIP revision requiring stationary sources in the nonattainment area emitting volatile organic compounds (VOCs) or oxides of nitrogen (NOX) to provide certified annual emissions statements to the state showing actual VOC and NOX emissions from the source, with an exemption for stationary sources that emit less than 25 tons per year of VOCs or NOX provided that the SIP revision meets certain requirements. On March 9, 2022, EPA approved Georgia's SIP revision addressing the emissions statements requirement for the 2015 ozone NAAQS for the Atlanta Area.
Section 110(l) of the CAA prevents EPA from approving a SIP revision that would interfere with any applicable requirement concerning attainment and RFP, or any other applicable CAA requirement. EPA proposes to approve the revisions to Rule 391-3-1-.02(6)(a) described above because they will not interfere with any CAA requirement. Georgia has no areas designated by EPA as in nonattainment of the NAAQS, and therefore, the CAA emissions statements requirements for nonattainment areas are not applicable at this time. Furthermore, the revisions will not interfere with attainment of the NAAQS or RFP.
Rule 391-3-1-.03(11),
The June 27, 2024, revision modifies Rule 391-3-1-.03(11)(b)7.(ii)(IV) by removing the first use of the phrase “ozone non-attainment counties” which precedes, and is shorthand for, a list of the aforementioned 13 counties. The revision retains the list of 13 counties at that location and then removes the remaining use of the phrase “ozone non-attainment counties,” replacing it with the list of 13 counties. Because the changes merely remove the shorthand phrase “ozone non-attainment counties,” instead listing all 13 counties covered by the Rule 391-3-1-.03(11)(b)7.(ii)(IV), they does not relax or modify any existing requirements in this rule for sources located in these 13 counties.
Additionally, the submission replaces “section” and “paragraph” with “paragraph” and “subparagraph” respectively, throughout the rule for consistency. EPA is proposing to approve the aforementioned changes to Rule 391-3-1-.03(11)(b)7. in the Georgia SIP because they would not interfere with any applicable requirement concerning attainment and RFP, or any other applicable requirement of the Act.
In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, and as discussed in Sections I and II of this preamble, EPA is proposing to incorporate by reference the following rules into Georgia's SIP with a state-effective date of June 19, 2023: Rule 391-3-1-.02(6)(a),
For the reasons discussed above, EPA is proposing to approve the June 27, 2024, Georgia SIP revision consisting of the changes to Rule 391-3-1-.02(6),
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to redesignate the nonattainment area in Muscatine County, Iowa to attainment for the 2010 1-hour sulfur dioxide (SO
Comments must be received on or before September 22, 2025.
You may send comments, identified by Docket ID No. EPA-R07-OAR-2025-0818 to
Bethany Olson, Environmental Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-7905; email address:
Throughout this document “we,” “us,” and “our” refer to the EPA.
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2025-0818, at
The EPA is proposing to approve a SIP revision and redesignation request submitted on November 17, 2021, by the Iowa Department of Natural Resources (IDNR). The EPA is proposing to take the following three separate but related actions: (1) to add new or revised permits for Muscatine area sources into the Iowa SIP and remove certain air construction permits from the SIP; (2) to approve Iowa's maintenance plan for the 2010 1-hour SO
The EPA proposes to find that the State's submittal meets the requirements for redesignation under the CAA and the revisions do not interfere with any applicable requirement concerning attainment and reasonable further progress. The full State submission is included in the docket for this action.
The State submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice on this SIP submission from August 20, 2021, to September 20, 2021, and held a public hearing on September 20, 2021. IDNR received and responded to written comments from two sources, and included the comments and responses in its submission. In addition, as explained above and in more detail in the technical support document (TSD) which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.
On June 2, 2010 (75 FR 35520), the EPA signed the revised the primary SO
Following promulgation of a new or revised NAAQS, the EPA is required by CAA section 107(d) to designate areas throughout the nation as attaining or not attaining the NAAQS, or as unclassifiable. On August 5, 2013, the EPA designated a portion of Muscatine County, Iowa, as nonattainment for the 2010 primary 1-hour SO
The EPA's 2013 SO
Iowa submitted the required attainment plan submittal on May 26, 2016. The EPA proposed approval of Iowa's attainment plan on August 24, 2017 (82 FR 40086). The EPA published a supplemental notice of proposed rulemaking (SNPRM) on January 9, 2018, and included additional
Iowa's approved 2016 attainment plan provided a modeled attainment demonstration and satisfied the required nonattainment planning requirements mentioned above for the Muscatine NAA. In accordance with CAA title I, part D, subpart 1, the revision included a 2011 base-year and projection-year emissions inventories, a control strategy and air quality modeling demonstration, a reasonable available control measures/reasonably available control technology (RACM/RACT) analysis, a reasonable further progress (RFP) analysis, and contingency measures. The plan also included nonattainment new source review (NNSR) regulations previously approved by the EPA.
As discussed in sections V. and VI., below, the attainment plan included permit conditions to reduce SO
As a part of the EPA's approval of IDNR's attainment plan, air construction permits for the three NAA sources were incorporated into the Iowa SIP, including 52 GPC permits, four MPW permits, and two Monsanto permits. The control strategy for each source is described below.
GPC, a corn wet milling facility, was the largest source of SO
MPW is a municipal electric generating station with three coal-fired boilers (Units 7, 8, and 9) and an auxiliary boiler that is not capable of burning coal but has the potential to emit SO
Monsanto is a manufacturer and formulator of herbicides for agricultural use and had one coal-fired boiler (Boiler #8). Iowa issued final air construction permits to Monsanto that required a more stringent SO
On November 17, 2021, Iowa submitted a revision to its SIP that includes modifications to SIP-approved permits, includes a maintenance plan for the 2010 1-hour primary SO
On January 26, 2022, the EPA proposed to determine that the Muscatine NAA attained the 2010 1-hour SO
The CAA outlines the requirements for redesignation of a nonattainment area to attainment. Specifically, CAA section 107(d)(3)(E) allows for redesignation provided that the following criteria have been met: (1) the EPA has determined that the applicable NAAQS has been attained; (2) the applicable SIP has been fully approved by the EPA under CAA section 110(k); (3) the EPA has determined that the improvement in the area's air quality is due to permanent and enforceable reductions in emissions; (4) the area has a fully approved maintenance plan, including a contingency plan, under CAA section 175A; and (5) the State has met all applicable requirements for the area under CAA section 110 and part D. The EPA has provided direction for how it would consider if these conditions have been met with respect to the 2010 1-hour SO
CAA section 175A and additional EPA guidance, including the September 4, 1992 memorandum “Procedures for Processing Requests to Redesignate Areas to Attainment” (Calcagni Memo),
The EPA's evaluation of Iowa's redesignation request and maintenance plan is based on consideration of the five redesignation criteria provided under CAA section 107(d)(3)(E) and relevant guidance, including the aforementioned 2014 SO
CAA section 107(d)(3)(E)(i) requires that the EPA determine if a nonattainment area has attained the applicable NAAQS in order to redesignate the area to attainment. The 2014 SO
The EPA made a determination of attainment by the attainment date for the Muscatine NAA for the 2010 1-hour SO
The EPA also reviewed quality assured monitoring data recorded in the EPA's Air Quality System (AQS) in support of this action. Monitoring data are evaluated in accordance with 40 CFR 50.17 using data analysis procedures specified in 40 CFR part 50, appendix T. If the 3-year design value in the area violates the NAAQS prior to the EPA acting in response to the State's request, the EPA will not take final action to approve the redesignation request.
As shown in table 1, the design values in the Muscatine NAA have significantly decreased since 2013. The 3-year design value for the Muscatine NAA decreased by 90% from 2013 to present. The 2011-2013 design value for the area (composed of the 3-year average of the annual 99th percentile of 1-hour daily maximum SO
Iowa removed the Greenwood Cemetary Special Purpose Monitor (SPM) in 2023. The Greenwood Cemetary monitor only had two complete quarters in 2023 and, therefore, does not have a valid design value after 2022. Changes to the SPM network do not require concurrence from the EPA.
According to the 1992 Calcagni Memo, for pollutants such as SO
Therefore, the EPA's 2022 determination that the area had attained the standard by the attainment date, along with the most recent air quality monitoring data and the 2021 updated air quality modeling, are consistent with this proposed action to redesignate the area. The EPA proposes to find that Iowa has demonstrated that the requirements of CAA section 107(d)(3)(E)(i) have been met. Additional details on the EPA's review of the submitted air quality modeling and SO
CAA section 107(d)(3)(E)(ii) requires that the EPA fully approve the applicable implementation plan for the area under CAA section 110(k) in order to redesignate that area to attainment. The EPA has fully approved the applicable Iowa SIP for the Muscatine NAA under section 110(k) of the CAA for all requirements applicable for purposes of redesignation. An area cannot be redesignated to attainment if a required element of the SIP is the subject of a disapproval; a finding of failure to submit, or failure to implement the SIP; or a partial, conditional, or limited approval.
For redesignating a nonattainment area to attainment, CAA section 107(d)(3)(E)(iii) requires the EPA to determine that the air quality improvement in the area is due to permanent and enforceable reductions in emissions resulting from implementation of the SIP, applicable federal air pollution control regulations, and other permanent and enforceable reductions.
The implementation of multiple permanent and federally enforceable control measures at stationary point sources of SO
The air construction permits include specified control measures at each source. GPC converted its coal-fired boilers to only natural gas combustion in 2015 to comply with a separate consent order with the State of Iowa. The permit includes an SO
Collectively, the implemented controls and lower permitted SO
To redesignate a NAA to attainment, CAA section 107(d)(3)(E)(iv) requires the EPA to determine that the area has a fully approved maintenance plan pursuant to CAA section 175A. The Calcagni Memo provides further guidance on the content of a maintenance plan, explaining that a maintenance plan should address five requirements: the attainment emissions inventory, maintenance demonstration, monitoring, verification of continued attainment, and a contingency plan.
In conjunction with its request to redesignate the Muscatine NAA to attainment for the 2010 1-hour primary SO
In a maintenance plan, states should develop an attainment inventory to identify the level of emissions in the affected area which is sufficient to attain and maintain the SO
Iowa also provided actual SO
The EPA proposes to find the attainment emissions inventory provided in Iowa's maintenance plan to be acceptable. For additional information regarding the development of the attainment emissions inventory, please see section 7.1 of the 2021 State submittal in the docket for this action.
The Calcagni Memo describes two ways for a State to demonstrate maintenance of the NAAQS for a period of at least 10 years following the redesignation of the area: (1) the State can show that future emissions of a pollutant will not exceed the level of the attainment inventory, or (2) the State can model to show that the future mix of sources and emission rates will not cause a violation of the standard. The 2014 SO
Iowa provided updated dispersion modeling in its 2021 SIP submission to demonstrate that the Muscatine NAA will continue to attain and maintain the 2010 SO
The modeling demonstration is based on current maximum permitted allowable SO
The EPA reviewed the modeling analysis submitted by Iowa and finds the revised control measures for GPC, MPW, and Monsanto continue to provide for attainment of the 2010 SO
Any increase in maximum allowable SO
Iowa also provided projected emissions inventories based on the attainment inventory to further demonstrate that the area will continue to remain in attainment during the maintenance period. Emissions forecasts for the point-other, nonpoint, onroad, nonroad, and event (prescribed fire) sectors were estimated by multiplying the 2017 NEI data by population growth factors. Iowa developed growth factors for 2033 and two additional future years, 2035 and 2040, as shown in table 7-4 of the State submittal. The estimated growth factors are 1.0282 for 2033, 1.0297 for 2035, and 1.0309 for 2040. Iowa's emissions forecasts for the point-other, nonpoint, onroad, nonroad, and event (prescribed fire) sectors demonstrate nominal changes to annual SO
Iowa's emissions forecasts for the point-other, nonpoint, onroad, nonroad, and event (prescribed fire) sectors demonstrate nominal changes to annual SO
The 2014 SO
The 2014 SO
IDNR has the legal authority to enforce and implement the maintenance plan for the Muscatine 2010 SO
As previously indicated, IDNR will continue to operate its SO
In addition, IDNR will use emissions data to verify continued compliance with the permitted emission rates used for the model demonstration in the maintenance plan. Iowa's submittal describes the State's process for ensuring source compliance with the emissions limits, stack testing, monitoring, and recordkeeping requirements associated with the control measures in the SIP-approved construction permits for GPC, MPW, and Monsanto. All three facilities are also permitted under the Title V operating permit program. 567 IAC 22.108(5) requires semi-annual reports and identification of all instances of deviations from permit requirements, including the cause of the deviation and any corrective or preventative measures taken.
In addition, in compliance with the EPA's Air Emissions Reporting Requirements (80 FR 8787), Iowa develops a comprehensive emissions inventory of point, area, and mobile sources every three years. This triennial inventory compiled by the State is contained in the EPA's NEI, which is made publicly available every three years. The EPA proposes to find that the information provided in Iowa's maintenance plan demonstrates the State has the legal authority to implement and enforce all measures necessary to attain and to maintain the 2010 1-hour SO
Section 175A(d) of the CAA requires that a maintenance plan include such contingency measures as the EPA deems necessary to assure that the State will promptly correct a violation of the NAAQS that occurs after redesignation. The maintenance plan should identify the contingency measures to be adopted, a schedule and procedure for adoption and implementation, and a time limit for action by the State. In cases where attainment revolves around compliance of a single source or a small set of sources with emissions limits shown to provide for attainment, the EPA interprets CAA section 175A's requirement for “contingency provisions” to mean that the state agency has a comprehensive program to identify sources of violations of the SO
IDNR has committed to continuing implementation of all measures indicated in the 2016 attainment plan after redesignation of the Muscatine NAA. Furthermore, the State developed additional contingency provisions in the 2021 maintenance plan for added assurance that any violation of the NAAQS that occurs after redesignation of the area to attainment will promptly be corrected. The maintenance plan contains triggering indicators for contingency measures, a schedule for implementing these potential measures, and has specified multiple potential options to correct any NAAQS violation. SO
An action level response will occur when the 1-hour design value, based on the average of three consecutive years of 99th percentile daily maximum 1-hour SO
The EPA is proposing to conclude that the maintenance plan adequately addresses the five basic components of a maintenance plan: the attainment emissions inventory; maintenance demonstration; monitoring; verification of continued attainment; and a contingency plan. Therefore, the EPA proposes to determine that the maintenance plan for the Muscatine NAA meets the requirements of CAA section 175A and is thus proposing to approve the maintenance plan into the Iowa SIP.
In accordance with section 107(d)(3)(E)(v) of the CAA, to redesignate the Muscatine NAA to attainment, Iowa must meet all requirements applicable for purposes of redesignation to the Muscatine NAA under CAA section 110 (general SIP requirements) and part D of title I of the CAA (SIP requirements for nonattainment areas).
Pursuant to CAA section 110(a)(1), whenever new or revised NAAQS are promulgated, the CAA requires States to submit a plan (
Section 110(a)(2)(D) requires that SIPs contain certain measures to prevent sources in a State from significantly contributing to air quality problems in another State. To implement this provision, the EPA has required certain States to establish programs to address the interstate transport of air pollutants. The section 110(a)(2)(D) requirements for a state are not linked with a nonattainment area's designation and classification in that State and are therefore not applicable for purposes of an area's redesignation. The transport SIP submittal requirements, where applicable, continue to apply to a state regardless of the designation of any one area in the state.
In addition, other section 110 elements that are neither connected with nonattainment plan submissions nor linked with an area's attainment status are not applicable requirements for purposes of redesignation. The area will still be subject to these requirements after the area is redesignated. The section 110 and part D requirements which are linked with an area's designation and classification are the relevant measures to evaluate in reviewing a redesignation request. This approach is consistent with the EPA's existing policy on applicability (
The EPA approved elements of Iowa's July 19, 2013 SO
In addition to the CAA section 110 requirements, section 107(d)(3)(E)(v) requires that the state meet all the requirements applicable to the nonattainment area “under part D of this subchapter” for the nonattainment area to be redesignated. Both section 107 and part D are within subchapter 1 of the CAA. Part D, entitled “Plan Requirements for Nonattainment Areas,” consists of six subparts, of which only subparts 1 and 5 are applicable to SO
CAA section 172 requires states with nonattainment areas to submit plans that provide for timely attainment of the NAAQS. More specifically, CAA section 172(c) contains general requirements for nonattainment plans. A thorough discussion of these requirements is found in the General Preamble for Implementation of title I.
As noted in the General Preamble, certain attainment-related planning requirements under section 172(c) no longer have meaning for an area that is already attaining the NAAQS, and therefore are not applicable for purposes of redesignation. For example, for an area that is already attaining the NAAQS, there would be nothing for the State to provide to show reasonable further progress to attainment in that area. Similarly, the CAA section 172 requirements for the attainment demonstration, implementation of reasonably available control measures, including reasonably available control technology, and contingency measures that are triggered if an area fails to meet RFP or fails to attain are also not applicable for purposes of redesignation. Nevertheless, as discussed earlier, Iowa submitted and EPA approved an attainment plan addressing the attainment planning requirements.
With respect to CAA section 172(c)(3), Iowa was required to submit an actual current emissions inventory with its attainment plan. Iowa had submitted a base year inventory with its attainment plan SIP on May 26, 2016, and the EPA approved this element on November 17, 2020.
Section 173 of the CAA includes requirements for permit programs that are required in a nonattainment area for new sources as required by section 172(c)(5), known as nonattainment new source review (NNSR). However, the EPA has a longstanding interpretation that because the NNSR permit program is replaced by the PSD permit program upon an area's redesignation to attainment, nonattainment areas seeking redesignation to attainment do not need a fully approved part D NNSR program to be redesignated. A more detailed rationale for this view is described in a memorandum from Mary Nichols, Assistant Administrator for Air and Radiation, dated October 14, 1994, entitled, “Part D New Source Review Requirements for Areas Requesting Redesignation to Attainment.”
CAA section 175A requires that states seeking redesignation of an area to attainment submit a “maintenance plan” containing certain elements. Iowa included a maintenance plan for the Muscatine NAA with its November 17, 2021 redesignation request, which the EPA is proposing to approve in conjunction with the redesignation, and it is discussed in detail in section V., Criterion (4) of this document.
Section 176(c) of the CAA requires that Federal actions conform to the air quality planning goals in the applicable SIP. The requirement to determine conformity applies to transportation
Section 179(a) of the CAA addresses potential sanctions for the failure of a State to submit certain required SIP elements by statutory deadlines. The EPA is not aware of any missing or incomplete Muscatine NAA planning elements subject to section 179(a) of the CAA.
The subpart 5 requirements, which consist of sections 191 and 192 of the CAA, are specific provisions applicable to SO
Section 192 sets forth attainment dates for nonattainment areas under section 191. For SO
Based on the above, the EPA is proposing to find that Iowa has satisfied the applicable requirements for the redesignation of the Muscatine NAA under section 110 and part D of title I of the CAA.
Iowa's 2021 redesignation request and maintenance plan for the Muscatine NAA requests revisions to source-specific air construction permits relied upon in the 2016 attainment plan. The State's model-based attainment demonstration from its 2016 attainment plan, which the EPA approved on November 17, 2020, was based on SO
As part of the 2021 submission, Iowa also requests to remove eight permits for these three sources that were originally incorporated into the Iowa SIP pursuant to the 1971 24-hour SO
All of the permit changes requested by Iowa are summarized below and in sections 5.1
Iowa requests to remove twelve GPC permits relied upon in the 2016 attainment plan for emission points (stacks) no longer in service. The permit removals are described in table 5.
Iowa also requests that EPA remove eight permits from the SIP due to the revocation of the 24-hour and annual primary SO
Iowa requests to add five new permits into the SIP for the 2010 1-hour SO
Iowa also requests to modify twenty GPC permits, two MPW permits, and one Monsanto permit in the Iowa SIP that were relied upon in the 2016 attainment plan. Several revisions to GPC permits establish a Collection of Air Permits (CAP) which is a type of air construction permit issued by IDNR that combines the requirements and conditions for multiple emission points (and thus multiple permit numbers) into one document. The permit modifications are described in table 8.
With the proposed revisions, Iowa's SIP will contain a total of 51 air construction permits for the 2010 SO
The new and modified air construction permits include emission limits, timetables for compliance, reporting, and recordkeeping requirements. Each permit also contains performance testing (emissions testing) obligations with specific schedules, methods, and frequencies for compliance. Additionally, GPC, MPW, and Monsanto are major sources under the Title V operating permit program and are subject to semi-annual reports requirements.
The EPA reviewed the submitted permit revisions in accordance with the anti-backsliding provisions of CAA section 110(l). With the submitted permit revisions, the total maximum permitted allowable emissions for the three facilities in the NAA were reduced from 6,414 tpy in the 2016 attainment plan to 5,555 tpy in the 2021 maintenance plan. While some RACT limits were increased in the modified permits and new RACT limits were added in new permits, the EPA finds the resulting relatively small emissions increase is offset by larger emissions reductions from the removal or modification of other permits. To further demonstrate that the Muscatine NAA will continue to attain and maintain the 2010 SO
For the removal of source-specific permits due to the revocation of the 24-hour and annual primary SO
For these reasons, the EPA proposes to find that the submitted permit revisions in Iowa's 2021 SIP request will not interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171 of the CAA) or any other applicable requirement of the CAA, as required under section 110(l) of the Act. Accordingly, the EPA proposes to approve revisions to source-specific permits to add five new permits, replace twenty-three revised permits, and remove twenty permits for Muscatine area sources in the Iowa SIP as detailed in sections 5.1 and 9 of the State submission. For new or revised permits, the EPA is proposing to approve the entire permits into the SIP, consistent with Iowa's request.
The EPA is proposing to approve Iowa's redesignation request for the Muscatine NAA. Final approval of the redesignation request would change the legal designation of the portion of Muscatine County designated nonattainment at 40 CFR 81.316 to attainment for the 2010 1-hour primary SO
In this document, the EPA is proposing to include regulatory text in an EPA final rule that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to delete Iowa permits #74-A-015-S, #79-A-194-S, #79-A-195-S, #95-A-374, #74-A-175-S, #95-A-373, #76-A-161S3, #76-A-265S3, #15-A-078, #79-A-194-S2, #71-A-067-S4, #75-A-087-S1, #74-A-014-S1, #74-A-015-S2, #79-A-195-S2, #80-A-149-S5, #80-A-150-S5, #85-A-031-S2, #85-A-032-S2, #91-A-068-S2, #92-A-383-S2, #92-A-385-S1, #94-A-055-S1, #94-A-061-S1, #02-A-781-S2, #02-A-782-S2, #10-A-563-S1, #15-A-200, #15-A-201, #15-A-202, #15-A-209, #15-A-213, #15-A-486, #15-A-326, #03-A-471-S1, #05-A-926-S4, #06-A-1261-S1, #11-A-338-S1, #15-A-354, #15-A-199, #95-A-373-P3, #80-A-191-P3, and #82-A-092-P11. The EPA is proposing to add incorporation by reference of Iowa permits #17-A-298, #17-A-299, #19-A-515-S1, #18-A-136, #17-A-112, #80-A-149-S6, #80-A-150-S6, #85-A-031-S5, #85-A-032-S5, #91-A-068-S3, #92-A-383-S3, #92-A-385-S2, #94-A-055-S3, #94-A-061-S3, #02-A-781-S3, #02-A-782-S3, #10-A-563-S2, #15-A-200-S1, #15-A-201-S1, #15-A-213-S2, #15-A-486-S1, #15-A-326-S1, #03-A-471-S3, #06-A-1261-S2, #15-A-199-S1, #95-A-373-P4, #80-A-191-P4, and #82-A-092-P12 discussed in sections IV.-VII. of this preamble and as set forth below in the proposed amendments to 40 CFR part 52. The EPA has made, and will continue to make, these materials generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Maintenance plan, Redesignation, Sulfur oxides.
Environmental protection, Air pollution control, Designations, Intergovernmental relations, Redesignation, Reporting and recordkeeping requirements, Sulfur oxides.
For the reasons stated in the preamble, the EPA proposes to amend 40 CFR parts 52 and 81 as set forth below:
42 U.S.C. 7401
The revisions and addition read as follows:
(d) * * *
(e) * * *
(c)
42 U.S.C. 7401,
Rural Business-Cooperative Service, USDA.
Proposed collection; request for comments.
In accordance with the Paperwork Reduction Act of 1995, the United States Department of Agriculture's (USDA) The Rural Business Cooperative Service (RBCS) invites comments on this information collection for which the Agency intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by October 20, 2025.
Lisa Day, Regulations Management Division, Innovation Center, U.S. Department of Agriculture;
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RBCS is submitting to OMB as an extension to an existing collection. Comments are invited on: (a) 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) 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; (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 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.
Comments may be sent by the Federal eRulemaking Portal: Go to
All comments received will be available for public inspection during regular business hours at the same address. All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.
Rural Utilities Service (RUS), USDA.
Notice; request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the United States Department of Agriculture (USDA) Rural Utilities Service (RUS) announces its' intention to request an extension of a currently approved information collection and invites comments on this information collection.
Comments on this notice must be received by October 20, 2025 to be assured of consideration.
Comments may be submitted by the Federal eRulemaking Portal: Go to
Information on using
Kimble Brown, Rural Development Innovation Center—Regulations Management Division, United States Department of Agriculture, 1400 Independence Avenue SW, South Building, Washington, DC 20250-1522. Email
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies the following information collection that RUS is submitting to OMB as extension to an existing collection with Agency adjustment.
Title 7 Part 1792, Subpart C, Seismic Safety of Federally assisted New Building Construction, identifies acceptable seismic standards which must be employed in new building construction funded by loans, grants, or guarantees made by RUS or the Rural Telephone Bank (RTB) or through lien accommodations or subordinations approved by RUS or RTB. This subpart implements and explains the provisions of the loan contract utilized by the RUS for both electric and telecommunications borrowers and by the RTB for its telecommunications borrowers requiring construction certifications affirming compliance with the standards.
(a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) the accuracy of the agency's estimate of the burden of the collection 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 appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.
Copies of this information collection can be obtained from Kimble Brown, Rural Development Innovation Center—Regulations Management Division, at Email:
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Census Bureau, Department of Commerce.
Notice of information collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment on the proposed revision of the Annual Integrated Economic Survey (AIES), prior to the submission of the information collection request (ICR) to OMB for approval.
To ensure consideration, comments regarding this proposed information collection must be received on or before October 20, 2025.
Interested persons are invited to submit written comments by email to
Requests for additional information or specific questions related to collection activities should be directed to Edward Watkins, AIES Assistant Survey Director, by phone at 301-763-4750 or
Since survey year 2023 (collected in calendar year 2024), the Census Bureau has conducted the AIES on an annual basis. The AIES was created to integrate seven annual business surveys into one comprehensive survey. It was designed to combine Census Bureau collections to reduce respondent burden and increase data quality. The collections that were integrated into the AIES were the Annual Retail Trade Survey (ARTS), Annual Wholesale Trade Survey (AWTS), Service Annual Survey (SAS), Annual Survey of Manufactures (ASM), Annual Capital Expenditures Survey (ACES), Manufacturers' Unfilled Orders Survey (M3UFO), and the Report of Organization.
The AIES provides the only comprehensive national and subnational data on business revenues and expenses on an annual basis. The AIES covers domestic, nonfarm employer businesses with operations during the survey year. Nonemployer businesses are not within the scope of the AIES. The AIES will collect the following information from employer businesses in the sample:
•
•
•
•
• Capital expenditures and inventories.
• Robotic equipment.
Additional topics of collection in the AIES include sources of revenue for providers (
In survey year 2025 (which will be collected in calendar year 2026), the AIES will begin to use 2022 North American Industry Classification System (NAICS) codes in its sampling, collection, and dissemination operations. Prior to survey year 2025, the AIES employed 2017 NAICS codes.
Beginning with survey year 2025, the AIES will also implement a modular and subsampled content strategy to reduce respondent burden while still meeting data users' needs and preserving data quality. This replaces the more uniform content strategy previously employed by the AIES. Content will be structured into universal and subsampled modules. All companies will answer core questions, but more detailed topics (
Furthermore, starting with survey year 2025, the AIES will collect North American Product Classification System (NAPCS)-based data from retail, wholesale, and services businesses. This expansion standardizes product data collection across sectors of the economy, reduces the need for trade-specific revenue detail questions that had previously been asked in the AIES, and streamlines data collection by consolidating multiple revenue questions into a unified format.
In preparation for survey year 2025, the Census Bureau contacted stakeholders to identify items that could be removed from the AIES to reduce respondent burden. As a result of those conversations, the following items will be removed from the AIES:
The AIES will begin to collect capital expenditures by type (structures and equipment) in survey year 2025. This will be collected once every five years to meet stakeholder needs. Additionally, a new sample will be selected for survey year 2025. The AIES may include a prior year revenue question to aid with sample linking during survey year 2025. However, a final decision has not been made yet regarding the inclusion of the prior year revenue question.
The content and sampling changes that will be implemented for survey year 2025 should lead to an overall reduction in respondent burden. If the number of respondents and/or burden estimate presented in this notice change when the new sample is selected, the Census Bureau will include the updated information in the clearance request, which will be submitted later this year.
Data users will be able to access the AIES estimates through visualizations; the Census Bureau's dissemination platform,
The AIES will be collected via the internet using Centurion, the Census Bureau's secure online survey collection tool. In the rare situation where a respondent does not have access to the internet, the data may be collected by telephone. Respondents will receive an email and/or letter notifying them of their requirement to respond and how to access the survey. Responses will be due approximately 30 days from receipt of the notification. Select businesses will receive a due date reminder via a letter or email prior to the due date. After the due date, the Census Bureau will contact nonrespondents to remind them about the survey.
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include, or summarize, each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Notice of issuance of an amended Export Trade Certificate of Review for the Association for the Administration of Rice Quotas, Inc., Application No. 97-14A03.
The Secretary of Commerce, through the Office of Trade and Economic Analysis (OTEA), issued an amended Export Trade Certificate of Review to the Association for the Administration of Rice Quotas, Inc. on July 9, 2025.
Amanda Reynolds, Acting Director, OTEA, International Trade Administration, (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4011-21) (the Act) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325. OTEA is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the certification in the
The Association for the Administration of Rice Quotas, Inc. amended its Certificate as follows:
1. Made the necessary technical changes to account for the withdrawal of the United Kingdom (UK) from the European Union (EU), including allocations of TRQ volumes for U.S. milled/semi-milled rice across the EU and the UK. The Certificate covers exports of U.S. milled/semi-milled rice to both the EU and UK under the relevant TRQs.
2. Removed the following companies as Members of the Certificate:
4. Changed the names of the following Members of the Certificate:
The effective date of the amended certificate is April 10, 2025, the date on which AARQ'S application to amend was deemed submitted.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable August 21, 2025.
Dmitry Vladimirov or Thomas Schauer, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0665 or (202) 482-0410, respectively.
On April 30, 2025, the U.S. Department of Commerce (Commerce) initiated a less-than-fair-value (LTFV) investigation of imports of lattice boom crawler cranes from Japan.
Section 733(b)(1)(A) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in an LTFV investigation within 140 days after the date on which Commerce initiated the investigation. However, section 733(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 190 days after the date on which Commerce initiated the investigation if: (A) the petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.
On August 14, 2025, the petitioner
For the reasons stated above and because there are no compelling reasons to deny the request, Commerce, in accordance with section 733(c)(1)(A) of the Act, is postponing the deadline for the preliminary determination in this LTFV investigation by 50 days,
This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of fiberglass door panels from the People's Republic of China (China). The period of investigation is January 1, 2024, through December 31, 2024. Interested parties are invited to comment on this preliminary determination.
Applicable August 21, 2025.
Samuel Brummitt or T.J. Worthington, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-7851 or (202) 482-4567, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on April 15, 2025.
The product covered by this investigation is fiberglass door panels from China. For a complete description of the scope of this investigation,
In accordance with the
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
Commerce notes that, in making these findings, it relied, in part, on facts
As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final CVD determination in this investigation with the final determination in the companion LTFV investigation of fiberglass door panels from China based on a request made by the petitioner.
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and
Six exporters and/or producers of fiberglass door panels from China failed to provide responses to Commerce's quantity and value questionnaire. We find that, by not responding to Commerce's requests for information, each of these companies withheld requested information and significantly impeded this proceeding. Thus, in reaching our preliminary determination, pursuant to sections 776(a)(2)(A) and (C) of the Act, we are basing the subsidy rate for the non-responsive companies on facts otherwise available.
We further preliminarily determine that an adverse inference is warranted, pursuant to section 776(b) of the Act. By failing to submit responses to Commerce's questionnaires, the non-responsive companies did not cooperate to the best of their ability in this investigation. Accordingly, we preliminarily find that an adverse inference is warranted to ensure that the non-responsive companies will not obtain a more favorable result than had they fully complied with our requests for information. For more information on the application of adverse facts available to the non-responsive companies,
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of fiberglass door panels, as described in the scope of the investigation section, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of this notice in accordance with 19 CFR 351.224(b).
Consistent with 19 CFR 351.224(e), Commerce will analyze and, if appropriate, correct any timely allegations of significant ministerial errors by amending the preliminary determination. However, consistent with 19 CFR 351.224(d), Commerce will not consider incomplete allegations that do not address the significance standard under 19 CFR 351.224(g) following the preliminary determination. Instead, Commerce will address such allegations in the final determination together with issues raised in the case briefs or other written comments.
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
All interested parties will have the opportunity to submit scope case and rebuttal briefs on the preliminary decision regarding the scope of the LTFV and CVD investigations. The deadlines to submit scope case and rebuttal briefs will be provided in the preliminary scope decision memorandum accompanying the preliminary determination of the LTFV investigation. For all scope case and rebuttal briefs, parties must file identical documents simultaneously on the records of the ongoing LTFV and CVD investigations. No new factual information or business proprietary information may be included in either scope case or rebuttal briefs.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this investigation, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants and whether any participant is a foreign national; and (3) a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the ITC of its determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether imports of fiberglass door panels from China are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act, and 19 CFR 351.205(c).
The merchandise covered by this investigation consists of fiberglass door panels, including fiberglass sidelites, whether finished or unfinished, whether assembled or unassembled, whether pre-hung or included in an entry door system. The subject fiberglass door panels consist of at least one fiberglass skin, frames typically made of wood or composite stiles, bottom rails, and top rails, binding materials, including adhesives or fasteners, insulation foam, and may be assembled with glass lites (glass that is ultimately installed in the fiberglass door panel). Fiberglass sidelites (or “sidelights”) are typically smaller in width than fiberglass door panels, and consist of at least one fiberglass skin, frames typically made of wood or composite stiles, bottom rails, and top rails, binding materials, including adhesives or fasteners, insulation foam, and may be assembled with glass lites (glass that is ultimately installed in the fiberglass sidelite). Subject merchandise includes fiberglass door panels and sidelites whether the fiberglass skin surface is painted or unpainted, contains or does not contain cut-outs for door components, or assembled or unassembled with glass lites in the door.
Fiberglass door panels and sidelites are covered by the investigation whether they are imported attached to, or in conjunction with door components and accessories (including but not limited to door jambs, door handles, locks, hinges, door stoppers, door kicks, door thresholds, door sills, and trim), in a pre-hung door system, or an entry door system. Subject fiberglass door panels and sidelites are covered whether or not they are accompanied by other parts. However, if a subject fiberglass door panel or sidelite is imported in a pre-hung door system or entry door system, only the fiberglass door panel and sidelite, including when assembled with glass lites or when the glass lites are shipped with the subject merchandise for further assembly, are covered by the scope. Door
Subject merchandise may be fire-rated for up to 90 minutes and may contain flame retardant composites, including, but not limited to flame retardant foam or mineral core materials, including but not limited to low density calcium silicate. Fire-rated doors generally satisfy the National Fire Protection Association (NFPA) 252 Standard Methods of Fire Tests of Door Assemblies and UL10(b) and (c)-Standard for Safety-Fire Tests of Door Assemblies.
Subject merchandise also includes fiberglass door panels and sidelites that have been processed in a third country, including but not limited to one or more of the following: filling with insulation foam, trimming, cutting, notching, punching, drilling, painting, finishing, assembly, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope product. The inclusion of other parts, such as door components and accessories (including but not limited to door jambs, door handles, locks, hinges, door stoppers, door kicks, door thresholds, door sills, and trim) in a third country does not remove the fiberglass door panels and sidelites from the scope.
Excluded from the scope of this investigation are all products covered by the scope of the antidumping duty and countervailing duty orders on wood mouldings and millwork products from the People's Republic of China.
Excluded from the scope of this investigation are all products covered by the scope of the antidumping duty and countervailing duty proceedings on float glass products from China.
Imports of subject merchandise are classified under Harmonized Tariff Schedule of the United States (HTSUS) statistical number 3925.20.0010. Subject merchandise may also be classified under 4418.29.4000, 4418.29.8030, 4418.29.8060, or 7019.90.5150. The HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Western Pacific Fishery Management Council (Council) will hold its 157th Scientific and Statistical Committee (SSC), Executive and Budget Standing Committee (SC), and its 204th Council meeting to take actions on fishery management issues in the Western Pacific Region.
The meetings will be held between September 9 and September 17, 2025. For specific times and agendas, see
The 157th SSC, Executive and Budget SC, and 204th Council meetings will be held as a hybrid meeting for members and the public, with a remote participation option available via Webex. The Executive and Budget SC will be held as an in-person meeting. In-person attendance for the 157th SSC and Executive and Budget SC meetings will be hosted at the Council office, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813. In-person attendance for the 204th Council meeting will be hosted at the Ala Moana Hotel, Garden Lanai, 410 Atkinson Drive, Honolulu, HI 96814.
Specific information on joining the meeting, connecting to the web conference and providing oral public comments will be posted on the Council website at
Background documents for the 204th Council meeting will be available at
Kitty M. Simonds, Executive Director, Western Pacific Fishery Management Council; phone: (808) 522-8220.
The 157th SSC meeting will be held between 9 a.m. and 5 p.m. Hawaii Standard Time (HST) on September 9-10, 2025, and between 9 a.m. and 12 p.m. HST on September 11, 2025. The Executive and Budget SC meeting will be held between 1 p.m. and 4 p.m. HST on September 15, 2025. The 204th Council meeting will be held between 8:30 a.m. and 5 p.m. HST on September 16-17, 2025. Public Comment on Non-Agenda Items will be held between 4:30 p.m. and 5 p.m. HST on September 16, 2025.
Agenda items noted as “Final Action” refer to actions that may result in Council transmittal of a proposed fishery management plan, proposed plan amendment, or proposed regulations to the U.S. Secretary of Commerce, under Sections 304 or 305 of the Magnuson-Stevens Fishery Conservation and Management Act (MSA). In addition to the agenda items listed here, the Council and its advisory bodies will hear recommendations from Council advisors. An opportunity to
This meeting will be recorded (audio only) for the purposes of generating the minutes of the meeting. As public comments will be made publicly available, participants and public commenters are urged not to provide personally identifiable information (PII) at this meeting. Participation in the meeting by web conference, or by telephone, constitutes consent to the audio recording.
Non-emergency issues not contained in this agenda may come before the Council for discussion during its 204th meeting. However, Council final decisions will be restricted to those issues specifically listed in this document and any regulatory issue arising after publication of this document that requires emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.
These meetings are accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of web conference.
The North Pacific Fishery Management Council (Council) Crab Plan Team will meet September 8, 2025, through September 12, 2025.
The meeting will be held on Monday, September 8, 2025, through Friday, September 12, 2025, from 8 a.m. to 4 p.m. Alaska Time.
The meetings will be a web conference. Join online through the link at
Anita Kroska, Council staff; phone; (907) 271-2809; email:
The agenda will include (a) summer trawl survey results; (b) fishery summary 2024/2025; (c) Ecosystem Status Report; (d) risk table review; (e) Bristol Bay Red King Crab SAFE report and risk table; (f) Snow crab SAFE report and risk table; (g) BBRKC and snow crab report cards; (h) Tanner crab SAFE report and risk table; (i) Tanner crab ESP; (j) Pribilof Island Red King Crab SAFE report; (k) Pribilof Island Blue King Crab SAFE report; (l) Aleutian Island Golden King Crab proposed models; (m) Norton Sound Red King Crab model-based indices updates; (n) overfishing status updates; (o) Bering Sea Fisheries Research Foundation update; (p) Harvest Control Rules workshop discussion; and (q) additional topics. The agenda is subject to change, and the latest version will be posted at
You can attend the meeting online using a computer, tablet, or smart phone, or by phone only. Connection information will be posted online at:
Public comment letters will be accepted and should be submitted electronically to
United States Patent and Trademark Office, Department of Commerce.
Notice of information collection; request for comments.
The United States Patent and Trademark Office (USPTO) will submit the following information collection request 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 USPTO invites comments on this information collection renewal of 0651-0044 (Complaints Regarding Invention Promoters), which helps the USPTO assess the impact of its information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
To ensure consideration, you must submit comments regarding this information collection on or before September 22, 2025.
Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website,
• This information collection request may be viewed at
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•
•
A complaint submitted to the USPTO must be clearly marked, or otherwise identified, as a complaint. The complaint must include:
(1) the name and address of the complainant;
(2) the name and address of the invention promoter;
(3) the name of the customer;
(4) the invention promotion services offered or performed by the invention promoter;
(5) the name of the mass media in which the invention promoter advertised such services;
(6) an example of the relationship between the customer and the invention promoter; and
(7) a signature of the complainant.
Identifying information is necessary so that the USPTO can both forward the complaint to the invention promoters or invention promotion companies as well as notify the complainant that the complaint has been forwarded. Complainants should understand that the complaints will be forwarded to the invention promoter for response and that the complaint and response will be made available to the public as required by the Inventors' Rights Act. If the USPTO does not receive a response from the invention promoter within 30 days, the complaint will be published without a response. Under this program, the USPTO does not accept complaints that request confidentiality. The USPTO may refer submitted complaints to the USPTO Office of Enrollment and Discipline, as appropriate.
This information collection contains one form, PTO/2048A (Complaint Regarding Invention Promotion), which is used by the public to submit a complaint under this program. This form is available for download from the USPTO website. Use of this form is voluntary.
Complainants may submit a complaint without the form as long as the complaint includes the necessary information and the submission is clearly marked as a complaint filed under the Inventors' Rights Act. Invention promotion firms may use any format when responding to a submitted complaint; there is no associated USPTO form. Complaints and responses are posted at
The name of this information collection is being changed from “Invention Promoters/Promotion Firm Complaints” to “Complaints Regarding Invention Promoters' to better align with how this program is usually referenced.
• PTO/2048A (Complaint Regarding Invention Promoter).
Election Assistance Commission.
Rulemaking Petition: Notification of Availability.
On July 16, 2025, the Election Assistance Commission (EAC or Commission) received a petition for rulemaking submitted by America First Legal Foundation asking the Commission to amend EAC Regulations and the National Mail Voter Registration Form to require documentary proof of United States citizenship to register to vote in federal elections.
Comments must be submitted on or before October 20, 2025.
All comments must be in writing. Interested persons should not provide in their comments any information that they do not wish to make public, such as a home street address, personal email address, date of birth, phone number, social security number, driver's license number, or any information that is privileged or confidential.
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
Camden Kelliher, EAC General Counsel. Telephone: (202) 360-3160; Email:
On July 16, 2025, the Election Assistance Commission received a petition for rulemaking submitted by America First Legal Foundation, asking the Commission to amend 11 CFR 9428.4 and the federal voter registration form to require documentary proof of United States citizenship to register to vote in federal elections.
The National Voter Registration Act (NVRA) of 1993 (52 U.S.C. 20501-20511) created a single federal form that all states are required to accept and use for voter registration for federal elections. The EAC is responsible for maintaining and, as necessary, amending this form. The NVRA mandates that states “accept and use the mail voter registration application form prescribed by the [EAC] . . . for the registration of voters in elections for Federal office”; that the form contain the following question: “Are you a citizen of the United States of America?”; and that the form “include a statement that . . . specifies each eligibility requirement (including citizenship)” and “requires the signature of the applicant, under penalty of perjury.” The NVRA also empowers the EAC to “require . . . information . . . necessary to enable the appropriate State election official to assess the eligibility of the applicant and to administer voter registration and other parts of the election process.”
The Help America Vote Act (HAVA) requires that the NVRA form include a question about citizenship status, requiring attestation of United States citizenship under penalty of perjury, without necessitating documentary proof of citizenship (52 U.S.C. 21083(b)(4)(A)). The implementing regulations for this requirement are provided in 11 CFR 9428.4.
The petition submitted by America First Legal Foundation seeks to initiate a rulemaking process to amend 11 CFR 9428.4 and the federal voter registration form to require applicants to provide one of the following as proof of citizenship: U.S. Passport, State-issued Real ID-compliant driver's license indicating that the applicant is a citizen, an official military identification card that indicates the applicant is a citizen of the United States, or a valid Federal or State government-issued photo identification if such identification indicates that the applicant is a United States citizen or if such identification is otherwise accompanied by proof of United States citizenship.
The EAC seeks comments on the petition. The public may inspect the petition here:
On April 12, 2024, PacifiCorp (licensee), filed a Water Quality Management Plan (Plan) for the North Umpqua Hydroelectric Project No. 1927, in accordance with ordering paragraph (L) of the Commission's Order Amending License, Approving Revised Exhibits A, F, and G, Revising Project Description, and Incorporating Water Quality Certificate.
No motion in opposition to the request for withdrawal has been filed, and the Commission has taken no action to disallow the withdrawal. Pursuant to Rule 216(b) of the Commission's Rules of Practice and Procedure,
On August 18, 2025, the Commission issued an order in Docket No. EL25-100-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e, instituting an investigation to determine whether Ranchland Solar, LLC's Rate Schedule is considered
The refund effective date in Docket No. EL25-100-000 established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL25-100-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2024), within 21 days of the date of issuance of the order.
In addition to publishing the full text of this document in the
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFile” link at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organizations, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP 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 Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organization, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities 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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organization, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with
Take notice that the Commission received the following electric corporate filings:
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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organization, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA or “Agency”) is announcing the availability of and soliciting public comment on materials that are being submitted to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) for peer review on “Determining the Absence of Novel Proteins in the Saliva of Genetically Engineered Mosquitoes for Mosquito Control.” The white paper, charge questions, background documents, and related supporting materials are available for public review and comment. The FIFRA SAP will consider and review the documents at a 3-day virtual public meeting that was previously announced in the
The following is a chronological listing of the dates for the specific activities that are described in more detail under
September 22, 2025—Deadline to submit written comments on the peer review documents (white paper, charge questions, background documents, and related supported materials).
October 24, 2025—Deadline to submit a request for special accommodations to allow sufficient time for EPA to process the request before the meeting.
October 27, 2025 (12:00 p.m. ET)—Deadline to register to be listed on the meeting agenda to make oral comments during the virtual meeting.
October 30, 2025—Deadline to submit a written version of oral comments that will be made during the virtual meeting.
November 3-5, 2025—FIFRA SAP public virtual meeting.
November 5, 2025—Deadline for those not making oral comments to register to receive the links to observe the meeting.
The DFO, Alie Muneer, Mission Support Division, Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency; telephone number: (202) 564-6369 or the main office number: (202) 564-8450; email address:
EPA is announcing the availability of and soliciting public comment on the white paper, entitled “Determining the Absence of Novel Proteins in the Saliva of Genetically Engineered Mosquitoes for Mosquito Control,” charge questions, background documents, and related supporting materials, which are available in the docket. EPA will be soliciting comments from the FIFRA SAP on the Agency's draft memorandum for developers of GE mosquitoes and case studies with the intent to provide additional acceptable
This document provides instructions for accessing the materials provided to the FIFRA SAP, submitting written comments, and registering to provide oral comments and attend the virtual meeting.
The FIFRA SAP is a federal advisory committee established in 1975 under FIFRA, 7 U.S.C. 136
This action is directed to the public in general. This action may be of interest to persons who are or may be required to conduct testing of chemical substances under the FFDCA and FIFRA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
Do not submit CBI or other sensitive information electronically to EPA through
When preparing and submitting your comments, see the commenting tips at
The FIFRA SAP serves as one of the primary scientific peer review mechanisms of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide independent scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on human health and the environment. The FIFRA SAP is a federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act (5 U.S.C. 10). The FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA established a Science Review Board (SRB) consisting of at least 60 scientists who are available to the FIFRA SAP on an
Genetic engineering can be used to develop modified mosquitoes for mosquito control purposes. A hallmark of GE mosquitoes is their species-specific mode-of-action, as they rely on the mating of modified male mosquitoes with wild-type females that are present in the treatment area. GE male mosquitoes express reproductive incompatibilities that are designed to reduce the number of offspring emerging from these matings. When released in quantities and at frequencies sufficient to outcompete the wild-type males, fewer mosquitoes of that species emerge in the treatment area, reducing its population size over time. GE mosquitoes may be engineered to carry one or more genes that code for a pesticidal trait as well as other genes that are integral to its function. To date, EPA has granted one Experimental Use Permit for a GE
While for novel types of pesticides, such as a GE mosquito, EPA determines on a case-by-case basis the data and information needed to support the risk assessments, the base data are anchored in the established tiered biochemical data requirements at 40 CFR part 158. This information is then supplemented with product-specific information, such as the biology of the particular GE mosquito and any novel exposure potentials.
In the United States, various species of mosquitoes are known to transmit diseases that are of concern to humans. As such, these same species of mosquitoes may be engineered with the goal of reducing their population. For the human health risk assessment, determining the likelihood of the presence of GE females in the environment is important as female mosquitoes (but not males) bite humans and therefore may pose a unique intradermal route of pesticide exposure. Generally, the number of GE females in the environment is expected to be very low, however some GE females may either be incidentally released and/or emerge in the environment from matings.
EPA performs human health risk assessments and by definition risk is a function of both hazard and exposure. Determination on whether a protein is present in the saliva of female mosquitoes informs the likelihood of exposure, and thus overall risk, of humans to these proteins through the intradermal route. To that end, EPA has developed a draft memorandum that outlines genetic design considerations to minimize the likelihood for an engineered protein to be present in the saliva of GE females and to provide recommendations on specific tests to empirically determine protein absence in the saliva.
EPA will be soliciting advice from the SAP on specific aspects of the Agency's draft memorandum for developers of GE mosquitoes and case studies with the intent to provide additional acceptable methodologies. If appropriate, based on the recommendations from the FIFRA SAP, EPA will update and release the final memorandum to provide support to developers of these technologies on how EPA will utilize the data in its human health risk assessment.
These documents, including the white paper, charge questions, draft memorandum, background documents, and related supporting materials, mentioned in Unit II.B provided to the FIFRA SAP are available in the docket at
After the public meeting, the FIFRA SAP will prepare meeting minutes and a final report document summarizing its recommendations to the EPA. This document will also be posted in the docket and made available at
To ensure proper receipt of comments, it is imperative that you identify docket ID No. EPA-HQ-OPP-2025-0756 in the subject line on the first page of your comments and follow the instructions in this unit.
The Agency encourages written comments for this meeting be submitted by the deadlines set in the
To request time to present oral comments during the virtual public meeting, you must register online by the deadlines set in the
To participate in the virtual public meeting, you must register online to receive the webcast and streaming service meeting links and audio teleconference information for the meeting. Online registration will be available approximately one month prior to the meeting and will remain open through the end of the meeting. To make oral comments during the meeting, follow the instructions in this document.
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments must be received by October 20, 2025.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
2. By
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:
William N. Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the 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. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
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CMS takes the data collected from the approximately 3,200 IPPS providers participating in the Medicare program and runs the data through mathematical formulas to create the occupational mix adjustment to the wage index. CMS informs hospitals of the occupational mix adjusted wage indexes through notice and comment rulemaking each year.
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Interested parties such as hospitals, device manufacturers, pharmaceutical companies, and physicians apply for transitional pass-through payment for certain items used with services covered in the outpatient PPS. After we receive all requested information, we evaluate the information to determine if the creation of an additional category of medical devices for transitional pass-through payments is justified. We may request additional information related to the proposed new device category, as needed. We advise the applicant of our decision, and update the outpatient PPS during its next scheduled quarterly payment update cycle to reflect any newly approved device categories. We list below the information that we require from all applicants. The following information is required to process requests for additional categories of medical devices for transitional pass-through payments.
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by September 22, 2025.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:
William Parham at (410) 786-4669.
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. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
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Many providers/practices continue to lack basic knowledge and capacity to implement HIT to support data exchange between providers/practices, payers, and patients, and to use data for improving quality and outcomes. This “digital divide” creates burden for patients, families, caregivers, providers/practices and increases costs and administrative waste. This burden is disproportionate for underserved populations. Advancing the use of technology and using interoperable standards can reduce the overall cost and burden associated with data collection and supports communication across the care continuum and is an agency priority.
CMS has developed a 41-item Assessment of Health care Quality Technical Readiness (AHQT) for use with participating providers/practices under the QIN-QIO 13th SOW. Provider/practice burden associated with the collection and reporting of quality measurement data has historically been a pain point for the QIN-QIO and AI/AN programs, especially in outpatient clinical practices and critical access hospitals; this burden has been a barrier to both achievement of quality improvement contract goals and proper evaluation of their impact.
The results of the assessment will be used to determine which providers/practices may benefit from participation in a technical assistance pilot specific during the QIN-QIO 13th SOW intended to advance provider/practice capacity for engaging in quality improvement and reporting activities facilitated by HIT.
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.
The public meeting will be held on September 30, 2025, from 9:30 a.m. to 10:40 a.m. via Microsoft Teams. Either electronic or written comments
The public meeting will be held as a hybrid event with a virtual option and in-person option at the FDA White Oak Campus, Great Room, Section A.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Kichelle Joseph, Office of Finance, Budget, Acquisitions, and Planning, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 72064, Beltsville, MD 20705, 301-796-7251,
The meeting will include presentations from FDA on: (1) the 5-year plan for the Prescription Drug User Fee Act (PDUFA) VII, Biosimilar User Fee Act (BsUFA) III, and Generic Drug User Fee Amendments (GDUFA) III; and (2) the Agency's progress in implementing resource capacity planning as part of fee setting and modernized time reporting. This meeting is intended to satisfy FDA's commitment to host an annual public meeting in the third quarter of each fiscal year and can be found in the Commitment Letters listed below (sections II.B.2 of PDUFA VII (p. 58), III.B.2 of BsUFA III (p. 33), and VIII.D.3 of GDUFA III (p. 40-41)).
PDUFA VII, BsUFA III, and GDUFA III represent the reauthorization of these user fee programs for FYs 2023-2027 as part of the FDA User Fee Reauthorization Act of 2022, which was signed by the President on September 30, 2022. The complete set of performance goals for each program are available at:
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Each of these user fee programs' Commitment Letters included a set of commitments related to financial management. These included commitments to publish a 5-year financial plan and update that plan annually, continue activities to mature FDA's resource capacity planning capability, and modernize time reporting practices. In addition, each user fee program includes a commitment to host a public meeting in the third quarter of each fiscal year to discuss specific topics.
This meeting will provide FDA with the opportunity to update interested public stakeholders on topics related to the financial management of PDUFA VII, BsUFA III, and GDUFA III. These topics include the 5-year financial plans for each of these programs and FDA's progress toward implementing resource capacity planning as part of fee setting and modernized time reporting.
Persons interested in attending this public meeting must register by September 20, 2025 at 11:59 p.m. Eastern Time. If registration closes before the day of the public meeting, the Webinar Registration website will be updated.
If you need special accommodations due to a disability, please indicate this during registration or contact Kichelle Joseph at
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors
The meeting will be open to the public as indicated below. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting website (
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual grant applications conducted by the
Information is also available on the Institute's/Center's home page:
Federal Emergency Management Agency, Department of Homeland Security.
60-Day notice of extension and request for comments.
The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on an extension of a currently approved information collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, this notice seeks comments concerning all information collections related to FEMA Radiological Emergency Preparedness Program requirements.
Comments must be submitted on or before October 20, 2025.
To avoid duplicate submissions to the docket, please submit comments at
All submissions received must include the Agency name and Docket ID. Regardless of the method used to submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
Renae Connell, Emergency Management Specialist, FEMA/National Preparedness Division (NPD)/Technological Hazards Division (THD), 202.657.2294 and
Overview: Federal Emergency Management Agency (FEMA) runs the Radiological Emergency Preparedness (REP) Program. This program helps state, tribal, and local governments plan, train, and prepare for emergencies involving commercial nuclear power facilities. It ensures that these governments can respond to and recover from such incidents. Legal Background: Section 109 of the NRC Authorization Act of 1980 (Pub. L. 96-295) requires the Nuclear Regulatory Commission (NRC) to include emergency preparedness as a condition for licensing nuclear power plants. This means that before a plant can operate, there must be an emergency response plan that meets FEMA and NRC standards. If there is no state or local plan, an alternative plan must provide reasonable assurance that public health and safety are protected. Regulations: The NRC has set regulations in 10 CFR part 50, which include 16 planning standards for emergency plans. FEMA has similar standards in 44 CFR part 350. FEMA reviews offsite emergency plans and preparedness in communities around commercial nuclear power facilities. States must conduct joint exercises involving local governments, the state, and the NRC licensee to ensure these plans are effective (see 44 CFR part 350.9). Reasonable Assurance: FEMA defines “reasonable assurance” as having adequate plans and preparedness to protect public health and safety in the event of an incident at a commercial nuclear power facility. This includes having the right procedures, trained personnel, facilities, equipment, and regular drills and exercises. FEMA works with other Federal agencies, State, Tribal, and local governments, and industry stakeholders to make this determination. Voluntary Participation: While participation in offsite radiological emergency planning is voluntary, those who choose to participate must follow the program requirements in 44 CFR part 350 and the joint NRC/FEMA document NUREG-0654/FEMA-REP-1, Rev. 2, “Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants,” and the REP Program Manual (RPM) provides detailed guidance on these requirements.
Comments may be submitted as indicated in the
Federal Emergency Management Agency, Department of Homeland Security.
60 day notice of extension and request for comments.
The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on an extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the National Urban Search and Rescue Response System to perform work on public or private lands essential to save lives and protect property, including search and rescue and emergency medical care, and other essential needs.
Comments must be submitted on or before October 20, 2025.
To avoid duplicate submissions to the docket, please only submit comments at
All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
Catherine Deel, Chief, Finance and Administration Section, US&R Branch, FEMA, Response Directorate, Operations Division at
Section 303 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), 42 U.S.C. 5144, authorizes the President of the United States to form emergency support teams of Federal personnel to be deployed to an area affected by a major disaster or emergency. Section 403(a)(3)(B) of the Stafford Act provides that the President may authorize Federal departments and agencies to perform work on public or private lands essential to save lives and protect property, including search and rescue and emergency medical care, and other essential needs. Section 327 of the Stafford Act further authorizes the National Urban Search and Rescue Response System (“the System”) and outlines the Administrator's authorization to designate teams as well as outlines specific protections for System members. The information collection activity is authorized under the Office of Management and Budget's “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards” codified at 2 CFR part 200. The collection contains information from the programmatic and administrative activities of the Urban Search and Rescue Sponsoring Agencies relating to the Readiness and Response Cooperative Agreement awards.
Comments may be submitted as indicated in the
Federal Emergency Management Agency, Department of Homeland Security.
30-Day notice of extension and request for comments.
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget (OMB) for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. FEMA invites the general public to take this opportunity to comment on an extension of a currently approved information collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, this notice seeks comments concerning the nature of the information collection, the categories of respondents, the estimated burden (
Comments must be submitted on or before September 22, 2025.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Requests for additional information or copies of the information collection should be made to Director, Information Management Division, 500 C Street SW, Washington, DC 20472, email address
Section 322 of the Robert T. Stafford Disaster
This proposed information collection was previously published in the
Comments may be submitted as indicated in the
Office of the Deputy Secretary, HUD.
Notice of waiver.
This notice announces a waiver, granted by the Secretary, through the Deputy Secretary, of the minimum 30-day application period required under section 102(a) of the HUD Reform Act for four Fair Housing Initiatives Program (FHIP) notices of funding opportunities (NOFOs), which were published on HUD's website on July 29, 2025 (FR-6900-N-21-A, FR-6900-N-21-B, FR-6900-N-21-C, and FR-6900-N-71-A).
For information regarding this notice, contact Melody C. Taylor, Acting Deputy Assistant Secretary for Enforcement and Programs, Office of Fair Housing and Equal Opportunity, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20011; telephone number 202-213-5340 (this is not a toll-free number); email
Section 102(a) of the HUD Reform Act (42 U.S.C. 3545(a)) sets out the requirements for notice to the public regarding assistance available from HUD. Section 102(a)(3) requires publication of selection criteria not less than 30 days before the deadline for applications or requests for assistance. On July 29, 2025, the Department published four NOFOs for FHIP (the FHIP Education and Outreach Initiative (FR-6900-N-21-A); the FHIP—Fair Housing Organizations Initiative (FHOI) (FR-6900-N-21-B); the FHIP—Private Enforcement Initiative (PEI) (FR-6900-N-21-C); and the FHIP—Education and Outreach Initiative—Test Coordinator (FR-6900-N-71-A)) announcing the availability of over $22 million in Fiscal Year 2024 FHIP funds, which were appropriated in the Consolidated Appropriations Act, 2024 (Pub. L. 118-42).
The July 29, 2025, NOFOs announced a funding application deadline of 11:59 p.m. EST on August 21, 2025. The period was less than the 30-day minimum application requirement under section 102(a)(3). Section 102(a)(5) of the Reform Act permits the Secretary to waive the minimum 30-day application period “if the Secretary determines that the waiver is required for appropriate response to an emergency.” The Secretary is also required to publish, in the
The Secretary has granted a waiver of the 30-day minimum application requirement for the four previously referenced NOFOs. It was necessary for the Department to establish a slightly shortened application period for these NOFOs to address certain exigent and emergency circumstances. Specifically, HUD is required by statute to obligate the FHIP funds before they expire on September 30, 2025. Given that several activities must occur prior to obligating this funding, such as conducting eligibility and merit reviews, formulating award recommendations, and allowing time for HUD leadership to review award recommendations and make award determinations, HUD must ensure that there is adequate time for HUD to complete all necessary actions before the statutory deadline.
Due to the change in administration, HUD needed to review the prior administration's grantmaking practices for compliance with new Executive Orders and to align those practices with the current administration's Executive Orders and policies. Such review was time-intensive, including various consultations and approvals, and included revising HUD's NOFO template. This led to the four FHIP NOFOs, originally published in September 2024, being republished in July 2025 using language consistent with current Executive Orders and administration policies. Even if the above could have been conducted faster (which HUD does not concede), that would not change the reality that, at the current time, a shortened application period is necessary to ensure compliance with the statutorily-required September 30, 2025, deadline for obligation of funding.
Further, the limited reduction of the application period—from 30 to 23 days—is not a significant time reduction for application preparation purposes. A 23-day application period is a sufficient amount of time to apply to these long-standing FHIP programs. Further, any potential adverse impact on the applicants is mitigated by the fact that many (if not all) applicants will only need to update their prior applications for the September 2024 NOFOs.
As such, the circumstances demonstrated that an emergency existed that justified the granting of a waiver of the 30-day application period required under section 102(a) of the HUD Reform Act.
Fish and Wildlife Service, Interior.
Notice of availability; request for comment.
We, the Fish and Wildlife Service (Service), announce receipt of an application from Lydia Carpenter and one from Joshua Milligan 1031, LLC (applicant/applicants) for two separate incidental take permits (ITP) pursuant to the Endangered Species Act (ESA) and the National Environmental Policy Act under the approved General Conservation Plan (GCP) and final environmental impact statement (FEIS) for the Alabama beach mouse. A GCP is a mechanism that meets the definition of a conservation plan in the ESA and enables the programmatic permitting and conservation process to address a defined suite of proposed activities over a defined planning area. Each applicant requests an ITP to take the federally listed Alabama beach mouse incidental to the construction of a single-family home in Baldwin County, Alabama. We request public comment on these applications, which include the applicants' proposed habitat conservation plan (HCP) and on the Service's preliminary determination that the proposed permitting action may qualify under the terms of the Alabama beach mouse GCP. We certify that the applications received are statutorily complete and include the necessary information to enroll in the GCP.
We must receive your written comments on or before September 22, 2025.
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William Lynn, by U.S. mail (see
We, the Fish and Wildlife Service, announce receipt of an application under the approved GCP for the Alabama beach mouse from Lydia Carpenter and an application from Joshua Milligan 1031, LLC for an ITP under the Endangered Species Act, as amended (ESA; 16 U.S.C. 1531
The applicant Lydia Carpenter requests a 50-year ITP to take ABM via the conversion of 0.015 acres (ac) of occupied nesting, foraging, and sheltering habitat incidental to the construction of a deck with pool to an existing house on a 0.460-ac parcel located at 5609 Beach Boulevard in Gulf Shores, Alabama. The applicant proposes to mitigate for the take of ABM through an in-lieu fee of $1,476.60 to the Alabama Coastal Heritage Trust's ABM conservation fund.
Applicant Joshua Milligan 1031, LLC requests a 50-year ITP to take ABM via the conversion of approximately 0.036 acre (ac) of occupied nesting, foraging,
The Service has made a preliminary determination that reasonably foreseeable effects of the applicants' proposed projects, including the construction of a deck with a pool and a single-family home and associated infrastructure (
The Service will evaluate the application and the comments to determine whether to issue the requested ITP. We will also conduct an intra-Service consultation pursuant to section 7 of the ESA to evaluate the effects of the proposed take. After considering the preceding and other matters, we will determine whether the permit issuance criteria of section 10(a)(1)(B) of the ESA have been met. If met, the Service will issue ITP number PER16528606 to Lydia Carpenter and ITP number PER18606066 to Joshua Milligan 1031, LLC.
Before including your address, phone number, email address, or other personal identifying information in your comment, be aware that your entire comment, including your personal identifying information, may be made available to the public. If you submit a comment at
The Service provides this notice under section 10(c) of the ESA (16 U.S.C. 1531
National Invasive Species Council, Interior.
Notice of public meeting.
Pursuant to the provisions of the Federal Advisory Committee Act, notice is hereby given that a meeting of the Invasive Species Advisory Committee (ISAC) will meet as indicated below.
The Invasive Species Advisory Committee will convene by Zoom virtual platform on Tuesday, September 9, 2025, 1:00 p.m.-6:00 p.m. (EDT); Wednesday, September 10, 2025, 1:00 p.m.-6:00 p.m. (EDT); and, Thursday, September 11, 2025; 1:00 p.m.-6:00 p.m. (EDT).
The final agenda, Zoom URL and dial in information will be available on the National Invasive Species Council (NISC) website at least 48 hours in advance of the meeting at
For information concerning attending the ISAC meeting, submitting written comments to the ISAC, or requesting to address the ISAC, contact Kelsey Brantley, NISC Operations Director and ISAC Coordinator, National Invasive Species Council Staff, telephone (202) 577-7012; fax: (202) 208-4118, or email
Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point of contact in the United States.
The purpose of the ISAC is to provide advice to the NISC, as authorized by Executive Orders 13112 and 13751, on a broad array of issues related to preventing the introduction of invasive species and providing for their control and minimizing the economic, ecological, and human health impacts that invasive species cause. The Secretaries of the Interior, Agriculture, and Commerce co-chair the NISC. The NISC provides national leadership regarding invasive species issues.
The purpose of a virtual meeting on Tuesday, September 9, 2025, through Thursday, September 11, 2025, is to convene the full ISAC to finalize and formally approve guidance developed by its subcommittees on two (2) topics requested by NISC: 1) the impacts of invasive species on food security; and 2) the impacts of invasive species on marine biosecurity.
The final agenda and other reference documents for discussion during the meeting will be available for public viewing as they become available, but no later than 48 hours prior to the start of the meeting at
Interested members of the public may provide either oral or written comments to ISAC for consideration. Oral comments may be given during designated times as specified in the meeting agenda. Written comments must be submitted by email to Kelsey Brantley at
All comments will be included in the public record and will be electronically distributed to all ISAC members. The detailed meeting minutes will be available for public inspection within 90 days of the meeting.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Kansas State Historical Society (KSHS) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains and associated funerary objects in this notice to Dr. Nicole Klarmann, Kansas State Historical Society, 6425 SW 6th Avenue, Topeka, KS 66615-1099, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the KSHS, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, 10 individuals have been identified from the Curry site (14GR301) in Greenwood County, KS (UBS 1991-47). The 444 associated funerary objects are stone and shell disc beads, stone and bone tools, non-human bone, and a beaver tooth. These human remains and objects were first removed by the landowner and then by KSHS in 1966. To our knowledge, no known hazardous substances were used to treat any of the human remains or associated funerary objects.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
The KSHS has determined that:
• The human remains described in this notice represent the physical remains of 10 individuals of Native American ancestry.
• The 444 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Nez Perce Tribe; Pawnee Nation of Oklahoma; and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco, & Tawakonie), Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the KSHS must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The KSHS is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and
Repatriation of the human remains in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains in this notice to Haley McGraw, John Spellman Library at Grays Harbor College, 1620 Edward P. Smith Drive, Aberdeen, WA 98520, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the GHC Library and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, six individuals have been identified. No associated funerary objects are present. These remains may belong to up to six different individuals, and were recovered from a common grave near South Bay Hunt Club, Bay City, between Aberdeen, WA, and Westport, WA, in Grays Harbor County during the excavation of a parking lot. There were no associated funerary objects present, and there are currently no potentially hazardous substances present. The Department of Archaeology and Historic Preservation released these remains to us because they were determined to be Native American or possibly Native American. Ed Van Syckle, a historian, believes them to possibly belong to the Chehalis Indians or other nearby Tribes.
Cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
The GHC Library has determined that:
• The human remains described in this notice represent the physical remains of six individuals of Native American ancestry.
• There is a connection between the human remains described in this notice and the Confederated Tribes of the Chehalis Reservation; Quinault Indian Nation; and the Shoalwater Bay Indian Tribe of the Shoalwater Bay Indian Reservation.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the GHC Library must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The GHC Library is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Kansas State Historical Society (KSHS) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains and associated funerary objects in this notice to Dr. Nicole Klarmann, Kansas State Historical Society, 6425 SW 6th Avenue, Topeka, KS 66615-1099, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the KSHS, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, five individuals have been identified from Geary County, KS (UBS 1999-20, UBS 2010-07, UBS 2021-01, UBS 2023-07). No associated funerary objects are present. These remains were all removed from riverbeds, either from the Republican, Smoky Hill, or Kansas River, with no other provenience information available.
One associated funerary object includes a chert biface from the Timber Creek site (14CY32) in Clay County, KS (UBS 2023-20). This object was initially in the main collections of KSHS, however, it was moved to NAGPRA collections after learning that the site was two stone burial mounds. The University of Tennessee, Knoxville has the associated human remains from this site.
To our knowledge, no hazardous substances were used to treat any of the human remains or associated funerary objects.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
The KSHS has determined that:
• The human remains described in this notice represent the physical
• The one object described in this notice is reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Kaw Nation, Oklahoma; Pawnee Nation of Oklahoma; and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco, & Tawakonie), Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the KSHS must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The KSHS is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), New York University, College of Dentistry (NYUCD) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains in this notice to Gabriel Friedman, Senior Project Lead, Office of the Provost, New York University, 70 Washington Square South, New York, NY 10012, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of NYUCD, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing at least one individual has been identified. No associated funerary objects are present. In 1920, the human remains were excavated by Ralph Glidden from Santa Catalina Island in Los Angeles County, California as part of an archaeological expedition sponsored by the Museum of the American Indian, Heye Foundation and the Field Museum of Natural History (NMAI Archives, Box OC 126, Folder 27). The human remains were accessioned by the Department of Physical Anthropology of the Museum of the American Indian that same year. In 1956, the remains were transferred to Dr. Theodore Kazamiroff, NYUCD. A Notice of Inventory Completion published on October 11, 2022 in the
Based on the available information, a relationship of shared group identity can be identified reasonably between the geographical location and the culturally affiliated Indian Tribes. Santa Catalina Island, Los Angeles County, California is within the aboriginal and ancestral homeland of the culturally affiliated Indian Tribes. NYUCD has no knowledge or record of the presence of any potentially hazardous substances used to treat the human remains.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
NYUCD has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a reasonable connection between the human remains and the La Jolla Band of Luiseno Indians, California; Pala Band of Mission Indians; Pechanga Band of Indians (
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or
Repatriation of the human remains described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, NYUCD must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. NYUCD is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Sonoma State University intends to repatriate certain cultural items that meet the definition of unassociated funerary objects, sacred objects, and/or objects of cultural patrimony and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after September 22, 2025.
Send additional, written requests for repatriation of the cultural items in this notice to Elise-Alexandria Green, Sonoma State University, 1801 East Cotati Avenue, Rohnert Park, CA 94928, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Sonoma State University, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of 2,547 cultural items have been requested for repatriation from various sites from Humboldt, Trinity, and Mendocino counties. A total of 2,346 cultural items are identified as sacred objects and the other 201 are identified as objects of cultural patrimony.
A total of 115 lots of sacred objects were removed from CA-HUM-1229 in Garberville, California located in Humboldt County. The cultural items include flaked stone debitage and flaked obsidian. The cultural items were removed from the site during a PG&E project to replace transmission and distribution poles along the Garberville-Laytonville Transmission line. The cultural items have been housed at Sonoma State University since 2011 under Accession Number 2011-15.
The five sacred objects from Humboldt County are obsidian projectile points located at the Doublegate Ridge, Ford's Flat near Bridgeville, California, and Buck Mountain. These cultural items were all donated by J.R.R. and have been housed at Sonoma State University since 1982 under Accession Number 82-01.
The 1,930 lots of sacred objects were removed from CA-HUM-945 near Redway, California located in Humboldt County. The cultural items were collected during an archaeological test led by the Federal Highway Administration to evaluate the areas of CA-HUM-945 that would be impacted by the Redway sewer treatment plant upgrade. The cultural items are obsidian flakes, modern debris, faunal bone, sandstone tools, stone tools, quartzite flakes, modified chert, chert flakes, and chert projectile points. The cultural items have been housed at Sonoma State University since 1994 under Accession Number 94-33.
The 256 lots of sacred objects were donated to Sonoma State University by Jere Melo. The cultural items were removed from CA-MEN-1632 in Mendocino County. The cultural items are obsidian flakes, modified obsidian, stone debitage, sandstone tools, groundstone tools, chert projectile points, faunal bone, charcoal, shell and flake tools. The cultural items have been housed at Sonoma State University since 1986 under Accession Number 86-03.
The 40 lots of sacred objects donated to Sonoma State University by Jere Melo are chert flakes. At the time of their removal and donation the cultural items were identified to be from CA-MEN-1631 near Wheeler, California located in Mendocino County. However, CA-MEN-1631 has since been combined with CA-MEN-1632. The cultural items have been housed at Sonoma State University since 1986 under Accession Number 86-03.
The two objects of cultural patrimony were removed from Rohnerville, California located in Humboldt County. These cultural items include faunal bone and modified chert that were removed from the location during an archaeological survey. The cultural items have been housed at Sonoma State University since 1976 under Accession Number 76-09.
The two objects of cultural patrimony were removed near Dinsmore River in Humboldt County. There is little additional information as to how the cultural items were collected and became housed at Sonoma State. The cultural items are modified chert and have been housed at Sonoma State University since 1983 under Accession Number 83-01.
A total of 14 objects of cultural patrimony were removed from CA-HUM-1230 in Garberville, California located in Humboldt County. The cultural items are flaked stone debitage. The cultural items were removed from the site during a PG&E project to replace transmission and distribution poles along the Garberville-Laytonville Transmission line. The cultural items have been housed at Sonoma State University since 2011 under Accession Number 2011-13.
A total of three objects of cultural patrimony were removed from CA-HUM-1231 in Garberville, California located in Humboldt County. The cultural items are flaked stone debitage. The cultural items were removed from the site during a PG&E project to replace transmission and distribution poles along the Garberville-Laytonville Transmission line. The cultural items have been housed at Sonoma State University since 2011 under Accession Number 2011-14.
A total of two lots of objects of cultural patrimony were removed from CA-TRI-240 near Hyampom, California located in Trinity County. The cultural items are sandstone. There is little additional information as to how the cultural items were collected and made it to Sonoma State. The cultural items have been housed at Sonoma State University since 1982 under Accession Number 82-01.
A total of 19 objects of cultural patrimony were removed from CA-TRI-854 during the Kerawaka Creek Survey in Trinity County. The cultural items are chert projectile points and modified chert flakes. The cultural items have been housed at Sonoma State University since 1982 under Accession Number 82-01.
A total of one object of cultural patrimony was removed from CA-TRI-856 during the Kekwaka Creek Survey in Trinity County. The cultural item is a groundstone tool. The cultural item has been housed at Sonoma State University since 1982 under Accession Number 82-01.
A total of two objects of cultural patrimony were removed from CA-TRI-859 during the Kekawaka Creek Survey in Trinity County. The cultural items are a groundstone tool and modified chert. The cultural items have been housed at Sonoma State University since 1982 under Accession Number 82-01.
A total of one object of cultural patrimony was removed from CA-TRI-860 during the Kekawaka Creek Survey in Trinity County. The cultural item is a chert projectile point. The cultural item has been housed at Sonoma State University since 1982 under Accession Number 82-01.
There were 135 lots of objects of cultural patrimony donated to Sonoma State University by Jere Melo. At the time of the cultural object's removal and donation to Sonoma State, they were identified to have been removed from CA-MEN-1672 near Wheeler, California in Mendocino County. However, since then CA-MEN-1672 has been combined to fall within CA-MEN-1671. The cultural items are chert flakes, sandstone, groundstone tools, chert projectile points, faunal bone, and flake tools. The cultural items have been housed at Sonoma State University since 1986 under Accession Number 86-03.
A total of 20 lots of objects of cultural patrimony were donated to Sonoma State University by Jere Melo. The cultural items were removed from CA-MEN-1673 near Wheeler, California located in Mendocino County. The cultural items are chert flakes and chert projectile points. The cultural items have been housed at Sonoma State University since 1986 under Accession Number 86-03.
Based on records concerning the sacred objects, objects of cultural patrimony, and the institution in which they are housed, there is no evidence of the cultural items being treated with hazardous substances.
The Sonoma State University has determined that:
• The 2,346 sacred objects described in this notice are specific ceremonial objects needed by a traditional Native American religious leader for present-day adherents to practice traditional Native American religion, according to the Native American traditional knowledge of a lineal descendant, Indian Tribe, or Native Hawaiian organization.
• The 201 objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.
• There is a reasonable connection between the cultural items described in this notice and the Bear River Band of the Rohnerville Rancheria, California.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the Sonoma State University must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The Sonoma State University is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Oregon Museum of Natural and Cultural History has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains in this notice to Dr. Pamela Endzweig, University of Oregon Museum of Natural and Cultural History, 1224 University of Oregon, Eugene, OR 97403-1224, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Oregon Museum of Natural and Cultural History, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, one individual have been identified. No associated funerary objects are present. The human remains (catalogued as 20-1420, Accession 64) are represented by a single adult finger bone from the surface at the Narrows of Lower Klamath Lake, Siskiyou County, California, and were collected from authorized University of Oregon archaeological investigations and transferred to the Museum in 1940. The human remains were mistakenly catalogued as a non-human faunal element when they were initially
Human remains comprising two skeletal elements and representing, at least, two individuals have been identified. No associated funerary objects are present. One of the elements (catalogued as 11-261, Accession 65) is from an adult, possibly a male. The other element (catalogued as 11-260, Accession 65), is from an adult of indeterminate sex. It is unknown if the elements are related. The human remains were collected at an unknown date from the Narrows of Lower Klamath Lake, Siskiyou County, California and were transferred to the Museum by a private individual in 1940. The Narrows of Lower Klamath Lake are in the historic territory of Modoc peoples.
Human remains representing, at least, two individuals, have been identified. No associated funerary objects are present. The human remains (catalogued as 11-134, Accession 65) are from an adult individual and a child of 4-6 years, both of indeterminate sex. The human remains were collected at an unknown date from an unknown location and transferred to the Museum by a private individual in 1940. While their specific origin is not documented, archaeological collections given by the donor (the same private individual who donated the previous two individuals (11-260 and 11-261) are from the Klamath Lakes region in Klamath County, Oregon, and Siskiyou County, California, and it is likely that this origin applies to these remains as well. The Klamath Lakes region is in the historic territory of Klamath and Modoc peoples.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
The University of Oregon Museum of Natural and Cultural History has determined that:
• The human remains described in this notice represent the physical remains of five individuals of Native American ancestry.
• There is a connection between the human remains described in this notice and the Klamath Tribes and the Modoc Nation.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the University of Oregon Museum of Natural and Cultural History must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The University of Oregon Museum of Natural and Cultural History is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), The University of Tennessee, Knoxville, McClung Museum of Natural History & Culture (UTK), has completed an inventory of associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the associated funerary objects in this notice to Dr. Ellen Lofaro, University of Tennessee, Office of Repatriation, 5723 Middlebrook Pike, Knoxville, TN 37996, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of UTK, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
The five lots of associated funerary objects are faunal; lithics; ceramics; shell beads; and objects placed with or near human remains. These objects were recovered from the Wafford Farm site, 40HS218, in Humphreys County, TN, by an unknown individual before 1943. These objects were included in the George Barnes “collection” that was purchased by UTK in 1949. To our knowledge, no potentially hazardous substances have been used to treat any of the associated funerary objects.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location of the associated funerary objects described in this notice.
UTK has determined that:
• The five lots of objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the associated funerary objects described in this notice and The Chickasaw Nation.
Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, UTK must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. UTK is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), The University of Tennessee, Knoxville, Department of Anthropology (UTK), has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains and associated funerary objects in this notice to Dr. Ellen Lofaro, University of Tennessee, Office of Repatriation, 5723 Middlebrook Pike, Knoxville, TN 37996, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of UTK, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, one individual have been identified. The five lots of associated funerary objects are botanicals; ceramics; faunal; lithics; and objects placed with or near human remains. These individuals and objects were recovered from the Hamby site, 40CF214, in Coffee County, TN, by Charles Faulkner and James E. Cobb in March 1977. This site dates to the Late Middle Woodland (late Owl Hollow), post 600 CE. These individuals and objects were transferred to UTK after the excavation and retained. To our knowledge, no potentially hazardous substances have been used to treat any of the Ancestral remains or associated funerary objects.
Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains and associated funerary objects described in this notice.
UTK has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• The five lots of objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Alabama-Coushatta Tribe of Texas; Cherokee Nation; Eastern Band of Cherokee Indians; The Chickasaw Nation; The Muscogee (Creek) Nation; The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, UTK must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. UTK are responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of California, Santa Barbara (UCSB) Repository for Archaeological and Ethnographic Collections intends to repatriate certain cultural items that meet the definition of objects of cultural
Repatriation of the cultural items in this notice may occur on or after September 22, 2025.
Send additional, written requests for repatriation of the cultural items in this notice to Hugh Radde, University of California, Santa Barbara, 4129 Cheadle Hall, Santa Barbara, CA 93106-2033, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the UCSB Repository for Archaeological and Ethnographic Collections, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of six cultural items have been requested for repatriation. The six objects of cultural patrimony are five stone tools and one clam shell disc bead. It is unknown if the collections were exposed to hazardous substances.
Of the cultural items being requested, four objects of cultural patrimony are large bifacial stone tools made from various material types (Accession 128). As of 2025, one stone tool is missing from the collection. The items were donated to UC Santa Barbara in 1960 by Mrs. Freddie Curtis. Although the exact provenience is unknown, they were reportedly collected from the vicinity of Black Canyon near Mojave in Kern County, CA. The precise date of removal from the site is also unknown, but it is believed to have occurred prior to 1960.
Of the cultural items being requested, one object of cultural patrimony is a chipped stone item made of chert (Accession 250.49). On an unknown date, the item was removed from CA-KERN-455 in Kern County, CA. It was collected by Chester King in 1977 and was later transferred to UC Santa Barbara, though the date of transfer is also unknown.
Of the cultural items being requested, one object of cultural patrimony is a single clam shell disc bead (Accession 829.Kern). The item was collected from the surface of a location referred to as the Bitter Springs site in Kern County, California. The exact provenience and identity of the collector are unknown. The date of transfer to UC Santa Barbara is also unknown.
The UCSB Repository for Archaeological and Ethnographic Collections has determined that:
• The six objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.
• There is a connection between the cultural items described in this notice and the Tejon Indian Tribe.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the UCSB Repository for Archaeological and Ethnographic Collections must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The UCSB Repository for Archaeological and Ethnographic Collections is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the College of Marin has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains and associated funerary objects in this notice to Klaus Christiansen, College of Marin, 835 College Avenue, Kentfield, CA 94904, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the College of Marin, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, four individuals removed from CA-MRN-406 near Kentfield, California, have been identified. The 1,535 associated funerary objects are 22 projectiles points, 10 drills, 77 bifaces, 21 formed flake tools, eight flake tools, three core tools, 15 cores, 532 pieces of debitage, four millingstones, 22 mortars, one handstone, 40 pestles, three battered cobbles, two pitted stones, five miscellaneous ground stone implements, 16 charmstones, five stone pendants, two net weights, one stone bowl, two miscellaneous modified stone items, four bone buttons, one shell pendant, 151 fragments of faunal bone, 570 fragments of faunal shell, 12 quartz crystals, one fire-affected rock, two pieces of charcoal, one metal fragment, and two unmodified stones. The human
A lot of 3,635 associated funerary objects removed from CA-MRN-697 near Novato, California, are one projectile point, two bifaces, seven flake tools, 19 cores, 208 pieces of debitage, one shell bead, three shell pendants, two modified bone implements, 75 fragments of bone, 3,022 shell fragments, three pieces of feces, two quartz crystals, five pieces of ochre, 68 pieces of ash, 46 unmodified stones, 102 pieces of charcoal, two burnt seeds, and 67 historic-era items including one barbed wire, four bullet casings, one cap, one cut nail and two other nails, one marble, one piece of porcelain, five pull tabs, one piece of wire, 25 pieces of glass, and 25 pieces of metal. The associated funerary objects were collected in 2008 and 2010 by LSA Environmental Consultants during construction monitoring within the within the Indian Valley College campus and transferred to the College of Marin Kentfield campus on March 19, 2015.
Human remains representing, at least, two individuals removed from P-21-002691 near Novato, California, have been identified. The 10 associated funerary objects are faunal bone fragments. The collection history of the human remains and associated funerary objects is unknown.
Human remains representing, at least, one individual removed from CA-MRN-192 near Novato, California, have been identified. The one associated funerary object is a clam shell disc bead. The collection history of the human remains and associated funerary object is unknown.
Human remains representing, at least, one individual removed from CA-MRN-365 near Novato, California, have been identified. The 2,919 associated funerary objects are 13 bifaces, one formed flake tool, 18 flake tools, 29 cores, 953 pieces of debitage, one millingstone, one pestle, 1,044 fragments of faunal bone, 852 fragments of faunal shell, three bags of baked clay, and four bags of charcoal. The human remains and associated funerary objects were collected in the 1960s by College of Marin Professor Bruff.
An associated funerary object removed from either CA-MRN-192 or MRN-365 near Novato, California, is an
Human remains representing, at least, 10 individuals removed from an unknown location have been identified at the College of Marin Kentfield campus. The collection history of the human remains is unknown.
A lot of two associated funerary objects removed from CA-MRN-11 near Mill Valley, California, were identified on display at the College of Marin Kenfield campus and are a core tool and a piece of faunal shell. The collection history of the associated funerary objects is unknown.
A lot of five associated funerary objects removed from CA-MRN-12 near Mill Valley, California, were identified on display at the College of Marin Kenfield campus and are a steatite/soapstone bead, one clam shell disc bead, two Olivella shell beads, and one steatite/soapstone ear piece. The collection history of the associated funerary objects is unknown.
An associated funerary object removed from CA-MRN-170 near Novato, California, was identified on display at the College of Marin Kenfield campus and is a biface. The collection history of the associated funerary object is unknown.
A lot of 19 associated funerary objects removed from either CA-MRN-407 or MRN-408 near Tiburon, California, were identified on display at the College of Marin Kenfield campus and are four formed flake tools, five flake tools, six cores, and four pieces of debitage. The collection history of the associated funerary objects is unknown.
A lot of 37 associated funerary objects removed from an unknown location were identified on display at the College of Marin Kenfield campus and are 11 projectile points, seven bifaces, one formed flake tool, one flake tool, one core, two mortars, three pestles, three shell beads, one charmstone, one stone pendant, five net weights, and one
The College of Marin is unaware of any treatment of the total 8,165 associated funerary objects with pesticides, preservatives, or other substances that represent a potential hazard to the objects or to persons handling the objects.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
The College of Marin has determined that:
• The human remains described in this notice represent the physical remains of 18 individuals of Native American ancestry.
• The 8,165 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Federated Indians of Graton Rancheria, California.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the College of Marin must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The College of Marin is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), The University of Tennessee, Knoxville, Department of Anthropology (UTK), has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains and associated funerary objects in this notice to Dr. Ellen Lofaro, University of Tennessee, Office of Repatriation, 5723 Middlebrook Pike, Knoxville, TN 37996, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of UTK, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, two individuals have been identified. The four lots of associated funerary objects are botanicals; faunal and shell; lithics; and objects placed with or near human remains. These individuals and objects were recovered from the Griffin Rock Shelter, 40FR151, in Franklin County, TN, by Duane King of the University of Tennessee, Chattanooga (UTC). This site dates from the Late Terminal Woodland to early Mississippian periods with a Late Archaic period presence. The site is radiocarbon dated to 1050 +/− 55 BP calibrated to 944 +/− 54 CE. These individuals and objects were transferred to UTC and later transferred to UTK at an unknown time where they were retained. To our knowledge, no potentially hazardous substances have been used to treat any of the Ancestral remains or associated funerary objects.
Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains and associated funerary objects described in this notice.
UTK has determined that:
• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• The four lots of objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Alabama-Coushatta Tribe of Texas; Cherokee Nation; Eastern Band of Cherokee Indians; Poarch Band of Creek Indians; The Chickasaw Nation; The Muscogee (Creek) Nation; The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, UTK must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. UTK are responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Old Dartmouth Historical Society, d.b.a. New Bedford Whaling Museum (NBWM) intends to repatriate certain cultural items that meet the definition of sacred objects and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after September 22, 2025.
Send additional, written requests for repatriation of the cultural items in this notice to Naomi Slipp, The Old Dartmouth Historical Society, d.b.a. The New Bedford Whaling Museum, 18 Johnny Cake Hill, New Bedford, MA 02740, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the NBWM, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of three cultural items have been requested for repatriation. The three sacred objects are one adz (1992.24.12.), one boar tusk bracelet
The NBWM has determined that:
• The three sacred objects described in this notice are specific ceremonial objects needed by a traditional Native American religious leader for present-day adherents to practice traditional Native American religion, according to the Native American traditional knowledge of a lineal descendant, Indian Tribe, or Native Hawaiian organization.
• There is a reasonable connection between the cultural items described in this notice and the Hui Iwi Kuamo`o.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the NBWM must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The NBWM is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Westfield Athenaeum has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains in this notice to Max Vivacqua, Westfield Athenaeum, 6 Elm Street, Westfield, MA 01085, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Westfield Athenaeum, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, one individual have been identified. No associated funerary objects are present. In 1927, remains were donated to the Westfield Athenaeum after removal from a “Burial Ground Pochassic”.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
The Westfield Athenaeum has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a connection between the human remains described in this notice and the Stockbridge Munsee Community, Wisconsin.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains described in this notice to a requestor may occur on or after [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Illinois Urbana-Champaign has completed an inventory
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains and associated funerary objects in this notice to Krystiana Krupa, University of Illinois Urbana-Champaign, 601 E John Street, Champaign, IL 61820, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of Illinois Urbana-Champaign, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, two individuals have been identified. The 382 associated funerary objects are ceramic sherds, lithics, and faunal material (shell and bone fragments). In 1985, University of Illinois Urbana-Champaign personnel conducted a surface collection at the Last Site (22Ha511) in Hancock County, Mississippi and recovered the human remains of one individual. A second surface collection at the Campbell Bayou II site (22Ha513) in Hancock County, Mississippi recovered additional human remains from one individual. The human remains described here were misidentified as faunal remains at the time. No site or project reports were generated and little is known about these projects.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
The University of Illinois Urbana-Champaign has determined that:
• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• The 382 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Mississippi Band of Choctaw Indians; The Choctaw Nation of Oklahoma; and The Muscogee (Creek) Nation.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the University of Illinois Urbana-Champaign must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The University of Illinois Urbana-Champaign is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Pacific Grove Museum of Natural History (Pacific Grove Museum) intends to repatriate a certain cultural item that meets the definition of an object of cultural patrimony and that has a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural item in this notice may occur on or after September 22, 2025.
Send additional, written requests for repatriation of the cultural item in this notice to Rachel M. Miller, Pacific Grove Museum of Natural History, 165 Forest Avenue, Pacific Grove, CA 93950, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Pacific Grove Museum and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of one cultural item has been requested for repatriation. The item is described as a pipe made of steatite. The pipe is a gray-green speckled with a smooth texture to the stone. The steatite pipe measures out to be four inches in length. The pipe is believed to have originated in Puget Sound, eight miles south of Tacoma Washington in Pierce County. This item was found on the property of Roland Wilson; Pierce Co. Wash collected in the late 1880s and collected or accessioned by the museum in 1899 through various collectors and donors including: Roland Wilson.
The Pacific Grove Museum of Natural History informs the Puyallup Tribe of Indian that it has no record of this item
The Pacific Grove Museum has determined that:
• The one object of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.
• There is a connection between the cultural item described in this notice and the Puyallup Tribe of the Puyallup Reservation.
Additional, written requests for repatriation of the cultural item in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural item in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the Pacific Grove Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural item are considered a single request and not competing requests. The Pacific Grove Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Kansas State Historical Society (KSHS) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains and associated funerary objects in this notice to Dr. Nicole Klarmann, Kansas State Historical Society, 6425 SW 6th Avenue, Topeka, KS 66615-1099, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the KSHS, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, four individuals have been identified from Ingalls Mound (14AT316) in Atchison County, KS (UBS 1991-91). The 14 associated funerary objects are pottery sherds, a ground stone axe, rock, and a basalt ground stone pendant. The remains and objects were conveyed to KSHS in 1907.
Human remains representing, at least, two individuals have been identified from Doniphan County, KS (UBS 1989-16B). No associated funerary objects are present. Provenience information is unknown. The remains were exposed to glue, then de-glued using acetone, and then reconstructed with adhesive cyanoacrylate ester.
Human remains representing, at least, 32 individuals have been identified from Matter Mound (14JW303) in Jewell County, KS (UBS 1990-30). The 983 associated funerary objects are shell beads, animal bone beads, chipped stone tools, a pebble, and shell fragments. The human remains and objects are from a rock-filled burial mound first disturbed by pothunters and then excavated by KSHS. Some of the remains were encased in plaster and found to have glue present.
Human remains representing, at least, one individual have been identified from Jewell County, KS (UBS 2001-13A). No associated funerary objects are present. The provenience is uncertain, however, the museum exhibit said these remains were from the `last Indian raid in KS.'
Human remains representing, at least, one individual have been identified from site 14NH4 in Nemaha County, KS (UBS 2022-05). The two associated funerary objects are animal bones. The human and animal remains were found in the bed of Spring Creek and given to the local sheriff.
Human remains representing, at least, one individual have been identified from the Krob site (14RP319) in Republic County, KS (UBS 1989-16A). No associated funerary objects are present. The remains were found in front of a farmhouse by the landowner and at some point were reconstructed with glue. Shellac is also present.
Human remains representing, at least, one individual have been identified from site 14RP305 in Republic County, KS (UBS 2000-17). No associated funerary objects are present. The remains were disturbed by cultivation and removed by KSHS after reports of bone being found scattered across a field.
Human remains representing, at least, one individual have been identified from site 14RP64 in Republic County, KS (UBS 2021-10). The eight associated funerary objects are pottery sherds. The remains were found on a terrace above Salt Creek and were then conveyed to KSHS.
Human remains representing, at least, one individual have been identified from Republic County (UBS 1999-23). No associated funerary objects are present. These remains were found on a sandbar on the Republican River.
Human remains representing, at least, one individual have been identified from Smith County, KS (UBS 1989-18K). No associated funerary objects are present. This burial was disturbed by a bulldozer and then removed and taken to the Sternberg Museum.
Human remains representing, at least, two individuals have been identified from Marshall County, KS (UBS 2010-02) and Washington County, KS (UBS 2020-03). No associated funerary objects are present. These remains have minimal information and are limited to county-level provenience.
Human remains representing, at least, one individual have been identified from an unknown location (UBS 2016-05). No associated funerary objects are present. These remains were removed from the property of an archeologist after her death. No other provenience information is available.
Unless noted above, no known hazardous substances were used to treat any of the human remains or associated funerary objects.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
The KSHS has determined that:
• The human remains described in this notice represent the physical remains of 48 individuals of Native American ancestry.
• The 1,007 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Pawnee Nation of Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 11, 2025. If competing requests for repatriation are received, the KSHS must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The KSHS is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Kansas State Historical Society (KSHS) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains and associated funerary objects in this notice to Dr. Nicole Klarmann, Kansas State Historical Society, 6425 SW 6th Avenue, Topeka, KS 66615-1099, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the KSHS, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, one individual have been identified from site 14EW485 in Ellsworth County, KS (UBS 2010-06). No associated funerary objects are present. A human tooth was found in the collections by KSHS lab staff.
Human remains representing, at least, three individuals have been identified from the Davis site (14GE141) in Geary County, KS (UBS 1991-37). The 75 associated funerary objects are pottery sherds, projectile points, a scraper, chipped stone including quartz points and an obsidian core. Human remains and objects were removed from this mound by the landowner in 1879.
Human remains representing, at least, 13 individuals have been identified from the Schiller site (14GE305) in Geary County, KS (UBS 1991-46). The 817 associated funerary objects are projectile points, bone awls, bone hairpins, animal teeth, glass beads, shell beads, and bird bone beads and fragments. The human remains and objects were removed from a mound near Junction City in the 1880's and given to KSHS in 1903 and 1904.
Human remains representing, at least, five individuals have been identified from the Neimuller site (14GE301/14GE3) in Geary County, KS (UBS 1992-16). The 14 associated funerary objects are a pottery sherd, flint chips, and a shell fragment. KSHS completed a salvage excavation after the two stone mounds had already been looted and excavated over the decades.
Human remains representing, at least, three individuals have been identified from Geary County, KS (UBS 1995-16). The one associated funerary object is a bone bead. The remains were removed from a mound near Ft. Riley by an individual who then sold them to a museum.
Human remains representing, at least, one individual have been identified from the Henderson/Indian Statue site (14GE304) in Geary County, KS (UBS 2000-34). The 50 associated funerary objects are dart points, arrow points, cutting and scraping tools, pipestone, pottery, knives, an ax, and stone. This site was disrupted by pothunting and the erection of a statue. The landowner gave the human remains and objects to KSHS in 1900.
Human remains representing, at least, one individual have been identified from the Jewell site (14GE306) in Geary County, KS (UBS 2000-35). The six associated funerary objects are shell
The eight associated funerary objects from site 14LY304 in Lyon County, KS (UBS 2024-16) are faunal remains and a flake. A rock filled mound was found atop a ridge and was recorded by KSHS in 1964. The University of Tennessee, Knoxville has the associated human remains from this site.
Human remains representing, at least, four individuals have been identified from Range Mound (14ML307) in Mitchell County, KS (UBS 1990-29). The 281 associated funerary objects are shell beads, pottery sherds, bones from various animals including deer, puma, turtle, pronghorn, bobcat, badger, turkey, some modified, chipped stone tools and debris. The human remains and objects are from a rock-filled burial mound that was excavated by KSHS prior to a housing project taking place. There may be shellac on the remains.
Human remains representing, at least, seven individuals have been identified from White Mound (14MO323) in Morris County, KS (UBS 1991-56). The 2,116 associated funerary objects are partial pottery vessels, pottery sherds, projectile points, a scraper, chipped stone debris, shell disc beads, and shell pendants. KSHS excavated this mound as part of the Council Grove reservoir project in 1964. Some of the pots and bowls were reconstructed, however, the records do not specify which type of adhesive was used.
Human remains representing, at least, 11 individuals have been identified from the Vohs site (14OB401) in Osborne County, KS (UBS 1989-18J, UBS 1991-61). The 1,954 associated funerary objects are pottery sherds, shells, worked flint, projectile points, scrapers, rocks, quartzite, cutting tools, a possible knife, a possible shaft smoother, shale, core sections, crystalline, a glass button, hardened and baked clay, and limestone. The remains and objects were removed over time by the landowner and a collector through excavation and surface collecting.
Human remains representing, at least, one individual have been identified from Osborne County, KS (UBS 1990-06A). The 1,307 associated funerary objects are army brass buttons, mess kit and scissors, parts of a bridle and girth, brass bracelets, lead bullets, epaulet of a Lt. Colonel, doll dish, buttons, projectile points, musket caps, a brass spur, cloth, a scraper, non-human bones, a leather pouch, paint, rocks, stone, and beads. The remains and objects were excavated by a professor and his students in 1933. Varnish and glue are present on the remains.
Human remains representing, at least, two individuals have been identified from Osborne County, KS (UBS 1994-02). No associated funerary objects are present. These remains were removed by children playing near the North Fork Solomon River in Downs, KS in 1916.
Human remains representing, at least, one individual have been identified from the Markley House 1 site (14OT308) in Ottawa County, KS (UBS 2001-31). No associated funerary objects are present. Human teeth were found while excavating an earth lodge in the 1940's.
Human remains representing, at least, one individual have been identified from site 14OT402 in Ottawa County, KS (UBS 2008-07). The one associated funerary object is a celt. A bone fragment was found during lab analysis of an assemblage from this site.
Human remains representing, at least, one individual have been identified from the Minneapolis site (14OT5) in Ottawa County, KS (UBS 2011-08). The 14,007 associated funerary objects are bone or shell beads, mussel shells, various chipped stone tools, various ground stone tools, pottery sherds, daub, burned earth, animal bone, and various animal bone tools including needles, potential whistle, fishhook, scapula hoes, awls, pendants, digging stick tips. The human remains and objects were taken by a resident of Salina from the surface of the mound/house feature. Some of the human bone fragments have been reconstructed with glue.
Human remains representing, at least, one individual have been identified from site 14RU326 in Russell County, KS (UBS 1990-36). No associated funerary objects are present. The remains were said to be found on the surface of a pre-historic site on a terrace of Paradise Creek.
Human remains representing, at least, two individuals have been identified from site 14SA2 in Saline County, KS (UBS 1990-07). The 900 associated funerary objects are projectile points, scrapers, a pipe bowl, knife blades, manos, shaft smoothers, and pottery sherds. Two human teeth were found during lab processing and were removed from a possible ossuary.
The 233 associated funerary objects identified from the Salina Burial Pit/Whiteford-Price site (14SA1) in Saline County, KS (UBS 1991-74) are clam shell beads, biface sections, notched points, pottery sherds, worked bone, shells, corn, wax cast of a pot, abrader, chipped stone tools, salina burial pit key, and a pot with “Indian Burial Salina, Kansas” written on it (possible souvenir). Human remains were left in place, however, these objects were removed prior to the site being acquired by the state of Kansas, which then sealed the burial ground for protection. Some of the items may have been cleaned with acetone.
The 400 associated funerary objects identified from the Lindeman site (14SA412) in Saline County, KS (UBS 1996-23) are manos, abraders, hammerstone, a nutting stone, celt, scrapers, knives, a projectile point, bifaces, drills, debitage, flakes, a hoe, an awl, and pottery sherds. The human remains from this site were formerly repatriated. These are the objects removed from the site that should have originally remained with them.
Human remains representing, at least, one individual have been identified from the Blue Bead site (14SA301) in Saline County, KS (UBS 2003-01). The 13 associated funerary objects are faunal remains, debitage, burned material, glass, modern ceramic, and sandstone. Plowing and erosion exposed a burial which was removed by the landowner and given to a local museum.
Human remains representing, at least, one individual have been identified from site 14SA424 in Saline County, KS (UBS 2013-05). The 166 associated funerary objects are chipped stone tools, ground stone tools, animal bone, and pottery. The human remains and objects were removed by a local Salina resident from the ground's surface.
Human remains representing, at least, one individual have been identified from site 14SA415 in Saline County, KS (UBS 2021-05). The 921 associated funerary objects are pottery, various chipped stone tools, animal bone, charcoal, wood, burned earth, modified animal bone, and various ground stone tools. The human remains were found among funerary objects recovered near the Salina Burial pit and are associated with that site.
Human remains representing, at least, seven individuals have been identified from Clay County, KS (UBS 1996-20, UBS 1996-21, UBS 2000-39, 14CY458/UBS 2001-27), Cloud County, KS (UBS 2004-18), and Geary County, KS (14GE347/UBS 1990-19). No associated funerary objects are present. These remains were found in or near the Kansas River, the Republican River, or an unrecorded gravel bar.
Human remains representing, at least, four individuals have been identified from Ellsworth County, KS (UBS 1990-04), Ottawa County, KS (UBS 2016-08), and Saline County, KS (UBS 1998-17, UBS 2014-01). No associated funerary objects are present. These remains have
Unless noted above, no known hazardous substances were used to treat any of the human remains or associated funerary objects.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
The KSHS has determined that:
• The human remains described in this notice represent the physical remains of 72 individuals of Native American ancestry.
• The 23,270 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Pawnee Nation of Oklahoma and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco, & Tawakonie), Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the KSHS must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The KSHS is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Southern Ute Cultural Center and Museum (SUCCM) intends to repatriate certain cultural items that meet the definition of sacred objects and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after September 22, 2025.
Send additional, written requests for repatriation of the cultural items in this notice to Tallias Cantsee, Southern Ute Cultural Center and Museum, 398 Ouray Drive (737), Ignacio, CO 81137, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Southern Ute Cultural Center and Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of four cultural items have been requested for repatriation. The four sacred objects are three full pipestone stemmed hand carved Pipestone pipes and one lead banded pipestone pipe bowl that were donated to SUCCM in 2023.
These items were donated to SUCCM as a preservation effort by the donor to return a Pan-Native American collection that was being held in a basement and actively deteriorating due to uncontrolled environmental conditions. The donating party historically traded with Tribes in the early 1900's. While there was little to no provenience that accompanied the pipes, SUCCM researched pipes in the historical photographic record of similar institutions. According to the preponderance of evidence the Tribe that was creating and being photographed with full pipestone stemmed pipes, historically are the Lakota. The full pipestone stemmed pipes being a Lakota product was also confirmed with the Yankton Sioux Tribe THPO. The Yankton Sioux Tribe has also acknowledged that they are the Lakota Tribe for deferral in all pipe matters.
The Southern Ute Cultural Center and Museum has determined that:
• The four sacred objects described in this notice are specific ceremonial objects needed by a traditional Native American religious leader for present-day adherents to practice traditional Native American religion, according to the Native American traditional knowledge of a lineal descendant, Indian Tribe, or Native Hawaiian organization.
• There is a connection between the cultural items described in this notice and the Yankton Sioux Tribe of South Dakota.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the Southern Ute Cultural Center and Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of the Interior, Bureau of Land Management, Arizona State Office (BLM Arizona State Office) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the human remains in this notice to Raymond Suazo, Arizona State Director, BLM Arizona State Office, One North Central Avenue, Suite 800, Phoenix, AZ 85004, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the BLM Arizona State Office, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, six individuals have been identified from three sites located in Cochise County, AZ. No associated funerary objects are present.
In 1949, during a survey under the direction of Earl H. Swanson, human remains representing, at least, four individuals were found, recorded, and removed from AZ EE:8:3(ASM) (“Fairbanks Townsite”), a Hohokam site occupied between A.D. 70 and 1150. During surveys conducted in 1968, human remains representing, at least, one individual has been identified from AZ EE:8:38(ASM) (Big Metate Site), a Hohokam village site occupied between A.D. 200-1500 and AZ EE:8:46(ASM) (Turquoise Flat Site), occupied by the Hohokam between A.D. 500 and 1450. The human remains from all three sites are housed at the Arizona State Museum. No records indicating treatment of the human remains with any possibly hazardous substances have been found.
Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains described in this notice.
The BLM Arizona State Office has determined that:
• The human remains described in this notice represent the physical remains of six individuals of Native American ancestry.
• There is a connection between these human remains described in this notice and the Ak-Chin Indian Community; Gila River Indian Community of the Gila River Indian Reservation, Arizona; Pascua Yaqui Tribe of Arizona; Salt River Pima-Maricopa Indian Community of the Salt River Reservation, Arizona; and the Tohono O'odham Nation of Arizona.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, the BLM Arizona State Office must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The BLM Arizona State Office is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), San Diego State University (SDSU) has completed an inventory of associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the associated funerary objects in this notice may occur on or after September 22, 2025.
Send written requests for repatriation of the associated funerary objects in this notice to Jaime Lennox, San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of SDSU, and
No human remains are present. The 12 lots of associated funerary objects representing approximately 8,000+ associated funerary objects are one lot of ochre, one lot of unworked shell, one lot of ground stone, one lot of chipped stone, one lot of worked shell, one lot of non-human faunal remains, one lot of vegetal samples, one lot of charcoal samples, one lot of unworked stone, one lot of fire affected rock, one lot of ceramics, and one lot of post-contact items. The associated funerary objects were collected from site CA-SDI-5216 (SDM-W-1456; South Pointe Farms; Woodward Site) located in San Diego County, California between 1977 and 1978 by cultural resource management firm Scientific Resource Surveys, Inc. SDSU received the collection shortly thereafter and assigned the collection accession number SDSU-0015 (CMP-SDSU-0015). Previous repatriation of human remains from the collection (representing at minimum one individual) occurred in 2010 to the Tribes listed in the Determinations section below; the human remains were published in the
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the associated funerary objects described in this notice.
SDSU has determined that:
• The 12 lots of objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the associated funerary objects described in this notice and the Campo Band of Diegueno Mission Indians of the Campo Indian Reservation, California; Capitan Grande Band of Diegueno Mission Indians of California (Barona Group of the Capitan Grande Band of Mission Indians of the Barona Reservation, California; Viejas (Baron Long) Group of Capitan Grande Band of Mission Indians of the Viejas Reservation, California); Ewiiaapaayp Band of Kumeyaay Indians, California; Iipay Nation of Santa Ysabel, California; Inaja Band of Diegueno Mission Indians of the Inaja and Cosmit Reservation, California; Jamul Indian Village of California; La Posta Band of Diegueno Mission Indians of the La Posta Indian Reservation, California; Manzanita Band of Diegueno Mission Indians of the Manzanita Reservation, California; Mesa Grande Band of Diegueno Mission Indians of the Mesa Grande Reservation, California; San Pasqual Band of Diegueno Mission Indians of California; and the Sycuan Band of the Kumeyaay Nation.
Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the associated funerary objects described in this notice to a requestor may occur on or after September 22, 2025. If competing requests for repatriation are received, SDSU must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. SDSU is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.
Drug Enforcement Administration, Justice.
Notice of application.
Cambrex Charles City has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before September 22, 2025. Such persons may also file a written request for a hearing on the application on or before September 22, 2025.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on June 23, 2025, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616-3466, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import psilocybin for formulation development and clinical trial support for their customers. The remaining listed controlled substances will be imported to support the manufacture into other controlled substances which will be distributed to their customers. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Continuus Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before October 20, 2025. Such persons may also file a written request for a hearing on the application on or before October 20, 2025.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.33(a), this is notice that on July 14, 2025, Continuus Pharmaceuticals, 256 West Cummings Park, Woburn, Massachusetts 01801, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to bulk manufacture the listed controlled substance for research and development purposes only. No other activity for this drug code is authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
Cambrex High Point, Inc., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before September 22, 2025. Such persons may also file a written request for a hearing on the application on or before September 22, 2025.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on July 16, 2025, Cambrex High Point, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substance for research and development purposes. No other activity for this drug code is authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Vici Health Sciences, LLC. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before September 22, 2025. Such persons may also file a written request for a hearing on the application on or before September 22, 2025.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on May 30, 2025, Vici Health Sciences, LLC, 6655 Amberton Drive, Suite O, Elkridge, Maryland 21075-6202, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substance as part of a manufacturing process supporting research and clinical trial efforts. No other activity for this drug code is authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Cambrex High Point, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before October 20, 2025. Such persons may also file a written request for a hearing on the application on or before October 20, 2025.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.33(a), this is notice that on July 18, 2025, Cambrex High Point, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to manufacture the above listed controlled substances in bulk for use as an internal intermediates and distribution to its customers. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
Catalent CTS, LLC. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before September 22, 2025. Such persons may also file a written request for a hearing on the application on or before September 22, 2025.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on July 17, 2025, Catalent CTS, LLC., 10245 Hickman Mills Drive, Kansas City, Missouri 64137-1418, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substances as bulk and dosage unit products for clinical trials and distribution. In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to import a synthetic tetrahydrocannabinol. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Office on Violence Against Women, Department of Justice.
60-Day notice.
The Office on Violence Against Women, Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until October 20, 2025.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Tiffany Watson, Office on Violence Against Women, at 202-307-6026 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
7.
8.
If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.
Notice.
The Department of Labor's (DOL) Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, “Post Separation Data Collection for Former Job Corps Participants.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Consideration will be given to all written comments received by October 20, 2025.
A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained free by contacting
Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training, Office of Job Corps, 200 Constitution Avenue NW, N-4459, Washington, DC 20210; or by email:
Michelle Mills at
DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure 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 can be properly assessed.
The 2014 Workforce Innovation Opportunity Act (WIOA) authorizes the collection of information and required the Office of Job Corps to collect and report specific post enrollment outcomes for eligible Job Corps participants beginning in Program Year (PY) 2016. The WIOA performance reporting requirements, which replaced those of the 1998 Workforce Investment Act (WIA), are designed to provide a common set of metrics to be reported by similar programs. WIOA substantially changed many outcome metrics for Job Corps compared to those required under WIA. To collect the necessary information to meet the WIOA reporting requirements, the Office of Job Corps revised its Post Enrollment Data Collection (PEDC) system in 2019, which primarily collects data through survey instruments, and obtained OMB approval under the PRA for this modified system.
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 it is approved by OMB under the PRA 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 Control Number.
Interested parties are encouraged to provide comments to the contact shown in the
Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.
DOL 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 the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• 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, (
Notice.
The Department of Labor's (DOL) Employment and Training Administration (ETA) is soliciting comments concerning proposed revisions to the information collection request (ICR) entitled, “Agricultural Recruitment System Forms Affecting Migratory Farm Workers” (Office of Management and Budget (OMB) Control Number 1205-0134). This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Consideration will be given to all written comments received by October 20, 2025.
A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained free by contacting Laura Tramontana by email at
Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Office of Workforce Investment, Room C 4510, 200 Constitution Avenue NW, Washington, DC 20210; by email:
Laura Tramontana by email at
DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure 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 can be properly assessed.
This Information Collection Request (ICR) relates to the Notice of Proposed Rulemaking (NPRM) RIN 1205-AC25,
Wagner-Peyser Employment Service (ES) regulations at 20 CFR part 653, subpart F describe requirements for ARS clearance orders, including that SWAs must ensure the agricultural clearance form prescribed by the Department (Form ETA-790 or its subsequently issued form), and its attachments are complete when placing intrastate or interstate clearance orders seeking workers. (20 CFR 653.501(b)(1)). ETA created Form ETA-790B to process clearance orders that are not placed in connection to H-2A Applications for Temporary Employment Certification (non-criteria clearance orders).
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 it is approved by OMB under the PRA 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 Control Number.
Interested parties are encouraged to provide comments to the contact shown in the
Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.
DOL 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 the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• 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, (
Nuclear Regulatory Commission.
Director's decision under 10 CFR 2.206; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued a director's decision with regard to a petition dated December 5, 2023, as supplemented by public meeting transcript dated April 10, 2024, filed by Beyond Nuclear, Michigan Safe Energy Future, and Don't Waste Michigan (the petitioner), requesting that the NRC take action with regard to Holtec Palisades, LLC and Holtec Decommissioning International, LLC (the licensee). The petitioner's requests and the director's decision are included in the
The director's decision was issued on August 14, 2025.
Please refer to Docket ID NRC-2024-0123 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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Zachary M. Turner, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2258; email:
The text of the director's decision is attached.
For the Nuclear Regulatory Commission.
On September 28, 2023, Holtec Decommissioning International, LLC (Holtec), on behalf of Holtec Palisades, LLC, submitted a request to exempt the Palisades Nuclear Plant (Palisades) from certain requirements in Title 10 of the
The underlying concern in Contention 2 of the December 5, 2023, request is that Holtec has misused the decommissioning trust fund (DTF) to keep Palisades in a status to restart the reactor, rather than to decommission the plant. The petitioner cited 10 CFR 50.82(a)(8) regarding appropriate uses of the DTF. Specifically, the petitioner asserted the following:
1. Holtec expended $44 million from the Palisades DTF from June 28 to December 31, 2022.
2. Holtec continued improper utilization of the Palisades DTF from December 31, 2022, to the present.
The staff of the U.S. Nuclear Regulatory Commission (NRC) assembled a Petition Review Board (PRB) in accordance with Management Directive (MD) 8.11, “Review Process for 10 CFR 2.206 Petitions,” dated March 1, 2019, and its associated Directive Handbook 8.11, section III, dated March 1, 2019 (ML18296A043). On February 29, 2024 (ML24061A014), the petition manager informed the petitioner that the PRB's initial assessment was to not accept the petition for review. The PRB's position was that the petition did not meet the MD 8.11 criteria for acceptance under 10 CFR 2.206 because the issues raised regarding Holtec's use of the Palisades DTF in 2022 had already been addressed through the NRC's inspection and enforcement process.
In August and November 2023 (ML23276B452 and ML24045A147, respectively), the NRC completed inspections that addressed, in part, the use of the Palisades DTF. As a result of these inspections, the NRC identified several instances, totaling just over $57,000, of the licensee using the Palisades DTF to pay for activities not considered legitimate decommissioning
The NRC confirmed that the unauthorized reimbursements from the Palisades DTF resulted from inadvertent oversights or inattention to detail, or both, in the coding associated with the billing for various projects and community donations. The licensee has implemented several process revisions to address order coding modification issues and errors, as well as training to eliminate these issues from future DTF expenditures. The licensee also reimbursed the unauthorized expenses to the Palisades DTF. On February 20, 2024 (ML24045A147), the NRC issued Holtec a Severity Level IV noncited violation to address the illegitimate use of decommissioning funds at Palisades stemming from the staff's findings during the November 2023 inspection.
On February 29, 2024, the petition manager offered the petitioner an opportunity to address the PRB in a public meeting (ML24061A014), which subsequently took place on April 10, 2024. The transcript of that meeting (ML24114A016) is publicly available in ADAMS and is considered a supplement to the petition.
During the April 10, 2024, public meeting, the petitioner discussed DTF expenditures of $120 million noted in the 2023 Decommissioning Funding Status Report for Palisades, which was submitted to the NRC on March 29, 2024 (ML24089A117). The petitioner also raised concerns about whether the $120 million was properly used for decommissioning expenditures in accordance with NRC requirements and guidance.
Following the April 10, 2024, public meeting, the PRB met to consider what had been presented during the session. The PRB found that the issues regarding use of the Palisades DTF in 2022 have been thoroughly addressed through the NRC's inspection and enforcement process, as noted above. Therefore, the PRB did not accept those issues into the 10 CFR 2.206 process. The concerns the petitioner raised at the public meeting regarding the recently submitted 2023 expenditure report for Palisades involved new information that the NRC had not yet fully considered. Therefore, in accordance with MD 8.11, section III.C, the PRB accepted that portion of the petitioner's concern into the 10 CFR 2.206 process for further review.
On July 2, 2024, the NRC issued an acknowledgement letter (ML24137A014) informing the petitioner that the concerns raised in the petition, as supplemented, now meet the MD 8.11 criteria for acceptance.
Publicly available documents created or received at the NRC are accessible electronically through ADAMS in the NRC's library at
The petitioner asserts that Holtec misused the DTF to keep Palisades in a status to restart the reactor as opposed to decommissioning the plant. Specifically, as described in the April 10, 2024, public meeting transcript, the petitioner alleged that Holtec withdrew $120 million from the Palisades DTF, as noted in Holtec's 2023 Decommissioning Funding Status Report, and raised concerns about whether the $120 million was properly used for decommissioning expenditures in accordance with the current NRC requirements and guidance.
The NRC has a comprehensive, regulation-based framework that provides oversight of licensee DTFs. The regulation at 10 CFR 50.82(a)(8)(i) specifies that licensees may use DTFs if the following three criteria are met:
(A) The withdrawals are for expenses for legitimate decommissioning activities consistent with the definition of decommissioning in § 50.2;
(B) The expenditure would not reduce the value of the decommissioning trust below an amount necessary to place and maintain the reactor in a safe storage condition if unforeseen conditions or expenses arise; and
(C) The withdrawals would not inhibit the ability of the licensee to complete funding of any shortfalls in the decommissioning trust needed to ensure the availability of funds to ultimately release the site and terminate the license.
“Decommission” is defined in 10 CFR 50.2 as—
. . . to remove a facility or site safely from service and reduce residual radioactivity to a level that permits—
(1) Release of the property for the unrestricted use and termination of the license; or
(2) Release of the property under restricted conditions and termination of the license.
Furthermore, as outlined in Regulatory Guide 1.184, Revision 1, “Decommissioning of Nuclear Power Reactors,” issued October 2013 (ML13144A840), which licensees may follow as a method of compliance with decommissioning requirements, the licensee's ability to use the trust funds set aside for decommissioning depends on reaching certain milestones in the decommissioning process. The limitation on the accessibility of the decommissioning funds is designed to ensure that sufficient trust funds are always available to place the facility in a safe, stable condition that ultimately leads to decommissioning and license termination. Further information regarding the Palisades' specific decommissioning plans and cost estimates can be found in the “Post Shutdown Decommissioning Activities Report [PSDAR] including Site-Specific Decommissioning Cost Estimate [DCE] for Palisades Nuclear Plant,” dated December 23, 2020 (ML20358A232), as supplemented by letter dated March 1, 2023 (ML23060A039), which the NRC reviewed and approved by letter dated May 2, 2023 (ML23087A036).
On December 13, 2021, the NRC granted Holtec an exemption (ML21286A294 and ML21286A506) from the requirements of 10 CFR 50.82(a)(8)(i)(A) to allow the use of a portion of the funds from the Palisades DTF for spent fuel management and site restoration activities at Palisades, in accordance with Holtec's PSDAR and DCE.
As described in the NRC's letter to the petitioner dated July 2, 2024, the agency limited the scope of the 10 CFR 2.206 petition to a review of the new information presented during the April 10, 2024, public meeting and the independent validation that the expenses claimed against the Palisades DTF, not previously reviewed by the NRC, were legitimate decommissioning expenses as opposed to expenses related to the Palisades restart initiative. During the April 10, 2024, public meeting, the petitioner referenced $120 million of decommissioning expenditures, which can be found in enclosure 4 to Holtec's 2023 Decommissioning Funding Status Report. In table 1 of enclosure 4 of that report, Holtec characterized its Palisades decommissioning expenses for 2022 and 2023 as summarized in table 1.
Holtec's report shows that a total of $143 million of Palisades' decommissioning-related expenses were accounted for, with $44 million in expenses for 2022 and an additional $99 million in expenses for 2023. Notably, footnote 2 to table 1 clarifies that Holtec has only withdrawn $23 million of the $143 million of expenses from the Palisades DTF, and the $120 million of expenses had not been reimbursed as of December 31, 2023. Table 2 of enclosure 4 explains that Holtec intends to withdraw the $120 million of reimbursable funds from the DTF during the years 2040 and 2041 ($60 million is expected to be withdrawn each of these years). This approach ensures that sufficient money remains in the DTF to complete decommissioning and is consistent with the regulations in 10 CFR 50.82 and guidance provided in Regulatory Guide 1.184.
The NRC staff reviewed Holtec's decommissioning expenses during various routine inspections at Palisades and independently found that there have been several instances of misallocation of DTF funds, as described in the next section of this letter. The staff has taken appropriate action on these instances under its normal inspection and enforcement processes. However, as discussed below, the staff has determined that these misallocations are outside the scope of the petition because they were not related to Palisades' restart-specific initiatives.
The NRC staff performs routine inspections at Palisades, as required by the Decommissioning Power Reactor Inspection Program. Specifically, the NRC inspection activities at Palisades included review of Holtec's decommissioning expenditures, in accordance with NRC Inspection Procedure 71801, “Decommissioning Performance and Status Reviews at Permanently Shutdown Reactors,” dated January 1, 2021 (ML20240A293). Table 2 lists the NRC staff's inspection activities, their respective inspection reports, and their associated findings. The timeframe of the selected inspection reports below covers inspections for which the NRC staff reviewed Palisades' 2023 DTF expenses and withdrawals.
As previously described in the NRC's letter to the petitioner dated July 2, 2024, Holtec's use of the DTF up to October 2023 had already been reviewed by the NRC's routine inspection and enforcement processes, which independently identified several instances in which Holtec used the Palisades DTF for nondecommissioning activities, totaling just over $57,000. The staff described these issues in detail in Inspection Report Nos. 05000255/2023003, dated October 4, 2023 (ML23276B452), and 05000255/2023004, dated February 20, 2024 (ML24045A147), resulting in the NRC issuing a Severity Level IV noncited violation for Palisades.
As of the April 10, 2024, public meeting, the NRC staff had not yet completed a review of Holtec's 2023 Decommissioning Funding Status Report and inspection of Palisades DTF use for October through December 2023, and therefore the petition was held in abeyance until these processes could be completed. The NRC concluded its annual financial assurance report review for Holtec's 2023 Decommissioning Funding Status Report in a memorandum dated September 18, 2024 (ML24240A169). This review concluded that the licensee continued to satisfy the decommissioning funding assurance requirements of 10 CFR 50.82. In November 2024, the NRC conducted its routine DTF inspection at Palisades, which is documented in Inspection Report No. 05000255/2024004, dated February 14, 2025 (ML25041A225). This inspection concluded that no withdrawals from the DTF were made from October 1 through December 31, 2023, which is the timeframe encompassed by the petitioner's concern that had not already been reviewed when the staff accepted the petition. However, the inspection report does document several withdrawals made in 2024 that were not for legitimate decommissioning activities, which constituted a violation of NRC requirements. This review did not identify any withdrawals from the DTF for restart-specific activities; however,
In summary, the NRC has a comprehensive, regulation-based framework that provides for oversight of a licensee's use of the DTF. The NRC staff reviewed Holtec's 2023 Decommissioning Funding Status Report for Palisades, in addition to Holtec's 2023 decommissioning expenditures, and found that the NRC's inspection and enforcement process independently identified instances of DTF misuse for which the agency issued applicable violations as required by regulations. The sole unresolved item from the staff's inspections related to misuse of the DTF during the relevant timeframe does not relate to restart-specific activities. Therefore, based on the NRC's continuous oversight of Holtec's use of the Palisades DTF, no further action is necessary at this time to address the petitioner's concern.
As a result of the NRC staff's evaluation of the petitioner's concerns, the Office of Nuclear Reactor Regulation has denied the petitioners' request to take enforcement action concerning Holtec's use of the Palisades DTF. The PRB concludes that the issues raised regarding Holtec's use of the Palisades DTF in 2023 have already been addressed through the NRC's inspection and enforcement process, that violations related to these inspection findings have already been cited, and that there is no indication that withdrawals from the DTF were for restart-specific activities. Therefore, there is insufficient basis on which to take further enforcement-related action against Holtec, and the petitioner's request is denied.
In accordance with 10 CFR 2.206(c), a copy of this director's decision will be filed with the Secretary of the Commission for Commission review. As provided for by this regulation, the decision will constitute the final action of the Commission 25 days after the date of the decision unless the Commission, on its own motion, institutes a review of the decision within that time.
Dated at Rockville, Maryland, this 14th day of August 2025.
For the Nuclear Regulatory Commission.
By letter dated July 2, 2025 (Agencywide Documents Access and Management System Accession No. ML25183A399), the petitioner provided comments (ML25097A165) to the U.S. Nuclear Regulatory Commission (NRC) on the proposed director's decision regarding Holtec Decommissioning International, LLC's (Holtec's), misuse of decommissioning funds, to the enforcement process under Title 10 of the Code of Federal Regulations (10 CFR) 2.206, “Requests for action under this subpart,” regarding Palisades Nuclear Plant.
The petitioner's comments do not alter the NRC staff's conclusions in the proposed director's decision and therefore do not require modification to the final director's decision. This attachment provides the petitioner's comments on the proposed director's decision and the NRC's responses to the comments.
The petitioner's comments are summarized below.
(6) Absent the express authorization of the Commission, no part of the assets of the Fund may be used for, or diverted to, any purpose other than to fund the costs of decommissioning the nuclear power plant to which the Fund relates, and to pay administrative costs and other incidental expenses, including taxes, of the Fund.
That is, decommissioning funds must be spent on decommissioning. The proposed decision provides no discussion of how it is that expenditures for spent fuel management, costs indisputably incurred during the period following June 2022 during which Holtec actively sought and obtained federal and state assistance commitments for the restart of Palisades, can be deemed “costs of decommissioning.”
The regulation in 18 CFR 1.101, “Definitions,” defines “Commission” as the Federal Energy Regulatory Commission, as referenced within 18 CFR. Therefore, the regulation that you cited (18 CFR 35.32(a)(6)) is outside the NRC's jurisdiction. However, the NRC has a similar regulation at 10 CFR 50.82(a)(8)(i)) which states, in part, the following:
Decommissioning trust funds may be used by licensees if—
(A) The withdrawals are for expenses for legitimate decommissioning activities consistent with the definition of decommissioning in [10 CFR] 50.2.
The regulation in 10 CFR 50.2, “Definitions,” defines “Decommission” as—. . . to remove a facility or site safely from service and reduce residual radioactivity to a level that permits—
(1) Release of the property for unrestricted use and termination of the license; or
(2) Release of the property under restricted conditions and termination of the license.
Furthermore, on December 13, 2021, the NRC granted Holtec an exemption (ML21286A294, ML21286A506) from the requirements of 10 CFR 50.82(a)(8)(i)(A) to allow the use of a portion of the funds from the Palisades Decommissioning Trust Fund (DTF) for spent fuel management and site restoration activities at Palisades.
These points were previously detailed in the proposed director's decision section titled “Regulatory Requirements.”
In conclusion, the Petition Review Board has determined that the petitioner's comments did not provide any relevant additional information or support for the petition that was not previously considered. Thus, the comments did not change the conclusion of the proposed director's decision. The final director's decision denies the petitioner's request for enforcement action. The NRC appreciates the petitioner's comments and thanks the petitioner for raising concerns in the interest of protecting public health and safety.
Postal Service.
Notice.
The Postal Service gives notice of filing requests with the Postal Regulatory Commission to add certain Priority Mail Express International, Priority Mail International & First-Class Package International Service contracts to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
Date of notice: August 21, 2025.
Christopher C. Meyerson, (202) 268-7820.
The United States Postal Service hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), it filed with the Postal Regulatory Commission the following requests:
Documents are available at
On February 7, 2025, The Nasdaq Stock Market LLC (“Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On March 11, 2025, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change, and the issues raised therein. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 30, 2025, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On March 11, 2025, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 7.35 (Auctions) regarding the calculation of the Auction Reference Price. The proposed rule change is available on 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 those 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 proposes to amend Rule 7.35 (Auctions), which describes how the Exchange conducts auctions, to enhance reference price calculations for the Core Open Auction, Trading Halt Auction, and Closing Auction. The proposed change would reflect an augmented calculation of the Auction Reference Price, as defined in Rule 7.35(a)(8)(A), that more accurately reflects price movements in a dynamic market environment, thereby promoting greater transparency in the auction process and the Exchange's marketplace.
The Auction Reference Price is a price used in determining the Indicative Match Price
Rule 7.35(a)(8)(A) currently defines the Auction Reference Price for the Core Open Auction as the midpoint of the Auction NBBO or, if the Auction NBBO is locked, the locked price. If there is no Auction NBBO, the Auction Reference Price would be the prior trading day's Official Closing Price. The Auction Reference Price for the Closing Auction is defined as the last consolidated round-lot price of that trading day and, if none, the prior trading day's Official Closing Price. The Auction Reference Price for a Trading Halt Auction is defined as the last consolidated round-lot price of that trading day and, if none, the prior trading day's Official Closing Price (except as provided for in Rule 7.35(e)(7)(A)).
The Exchange proposes to amend Rule 7.35(a)(8)(A) regarding the
• The price of the last consolidated trade of at least one round lot of that trading day, or
• If there were no such trades, the midpoint of the Auction NBBO, or
• If the Auction NBBO is locked, the locked price, or
• If there is no Auction NBBO, the prior trading day's Official Closing Price for the initial calculation of the Auction Reference Price, and for each subsequent calculation of the Auction Reference Price, the most recently calculated Auction Reference Price.
With the addition of the price of the last consolidated trade of at least one round lot of that trading day as a benchmark for calculating the Auction Reference Price for the Core Open Auction, the Exchange proposes to distinguish between the initial calculation of the Auction Reference Price for the Core Open Auction and subsequent calculations pursuant to the cascading calculation, in the event that there is no Auction NBBO. For the initial calculation, the Exchange proposes that, if there is no Auction NBBO, the Auction Reference Price would, as currently, be the prior trading day's Official Closing Price. However, for subsequent calculations of the Auction Reference Price when there is no Auction NBBO, the Exchange proposes that the Auction Reference Price would instead be the most recent Auction Reference Price, which the Exchange believes would provide a more recent reference price for the auction. In addition, the Exchange proposes to specify that each Auction Reference Price calculation would be based on an evaluation of the period since the last calculation of the Auction Reference Price. This proposed change is intended to ensure that, in cases where there was no consolidated trade of at least one round lot in the period since the last calculation of the Auction Reference Price, the Auction Reference Price would instead be the midpoint of the Auction NBBO (or other price as provided for in Rule 7.35(a)(8)(A)) to reflect a more recent reference price for the auction.
The Exchange also proposes that Auction Reference Price calculations for the Core Open Auction, Closing Auction, and Trading Halt Auction would exclude trades on Trade Reporting Facilities during the Early Trading Session or Late Trading Session, which may not reflect the actual market in a security, thus providing for a more accurate snapshot of the current market.
The Exchange believes the proposed enhancements to the calculations of the Auction Reference Price for auctions on the Exchange would better reflect more recent trading activity, and such price may reflect a more recent valuation for a security, to the benefit of investors. The proposed rule change would therefore promote the fair and orderly operation of auctions on the Exchange by using reference prices that are consistent with the most recent market activity in a given security, which would also allow more buy and sell interest to participate in such auctions.
Because of the technology changes associated with the proposed changes, the Exchange proposes to announce the implementation date of these changes by Trader Update. Subject to approval of this proposed rule change, the Exchange anticipates that such changes will be implemented before the end of the fourth quarter of 2025.
The proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes the proposed change would promote just and equitable principles of trade, remove impediments to, and perfect the mechanism of, a free and open market and a national market system, and protect investors and the public interest because it is intended to enhance the process for reference price calculations for auctions conducted by the Exchange. Specifically, the proposed change is intended to reflect an augmented calculation of the Auction Reference Price for the Core Open Auction, Closing Auction, and Trading Halt Auction to more accurately reflect price movements in a dynamic market environment, thereby promoting transparency and removing impediments to and perfecting the mechanisms of a free and open market and a national market system. As noted above, the proposed changes to Rule 7.35(a)(8)(A) would reflect that the calculation of the Auction Reference Price for the Core Open Auction would take into account the price of the last consolidated sale of at least one round lot of the trading day and would be based on an evaluation of the period since the last calculation of the Auction Reference Price. In addition, the Auction Reference Price calculations for the Core Open Auction, Closing Auction, and Trading Halt Auction would exclude trades on Trade Reporting Facilities during the Early Trading Session or Late Trading Session. The Exchange believes that the proposed change would result in Auction Reference Prices that better reflect more recent trading activity and which may reflect a more recent valuation for a security. The Exchange believes that the proposed change would thus remove impediments to, and perfect the mechanism of, a free and open market and a national market system because it is intended to provide market participants with reference price information that could encourage additional liquidity in auctions conducted on the Exchange.
The Exchange believes that the proposed non-substantive grammatical changes to the Auction Reference Price definitions for the Early Open Auction, Closing Auction, and IPO Auction would remove impediments to, and perfect the mechanism of, a free and open market and a national market system and protect investors and the public interest because they are not intended to effect any change to these
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 is not intended to address competitive issues but rather is concerned solely with enhancing the quality of the reference prices the Exchange utilizes for the Core Open Auction, Closing Auction, and Trading Halt Auction. The proposed rule change does not implicate any intermarket competition concerns because it relates to how the Exchange would facilitate auctions in Exchange-listed securities.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be 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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange is filing with the Commission a proposed rule change to make a number of non-substantive changes to the rulebook. The text of the proposed rule change is provided in Exhibit 5 and 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 make a number of non-substantive changes to the rulebook. The Exchange believes these changes are necessary to correct inadvertent oversights to internal and external cross-references and other minor changes of a non-substantive nature in order to provide greater accuracy and clarity to the rulebook.
First, the proposed rule change corrects paragraph numbering under Rule 11.8, Order Types and Modifiers. Currently, Rule 11.8(b)(8) jumps to Rule 11.8(b)(10) and inadvertently omits subparagraph (9). As such, the Exchange is proposing to correct this paragraph numbering error by updating Rules 11.8(b)(10) and 11.8(b)(11) to Rules 11.8(b)(9) and 11.8(b)(10), respectively.
Next, the Exchange is proposing to correct two typos which appear as incorrect acronyms under Rule 11.10, Self Trade Protection (“STP”) Modifiers. Under current Rules 11.10(d)(4) and 11.10(d)(5), the Exchange inadvertently uses the acronym “ERSTP”, which in both instances should be corrected to “STP”.
Next, the Exchange proposes to correct an internal cross reference contained in Rule 11.17, Registration of Market Makers. Specifically, the
Next, the Exchange is proposing to update the citation to Rule 600(b) of Regulation NMS in Exchange Rule 12.6, Prohibition Against Trading Against Customer Orders. In 2024, the Commission amended Regulation NMS under the Act to update the rule that requires disclosures for order executions in national market system (“NMS”) stocks.
Lastly, the Exchange is proposing to update two citations to the Options Clearing Corporation By-Laws in Rule 23.1, Exercise of Options Contracts. Current Rule 23.1, Interpretation and Policy .01, indicates for purposes of the Rule, the terms “customer account” and “non-customer account” have the same meaning as defined in the Clearing Corporation By-Laws Article I(C)(28) and Article I(N)(2), respectively. The OCC has since updated their By-Laws and these definitions are currently numbered as IC.(37) and IN.(1), respectively.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes that the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general, will protect investors and the public interest by correcting errors and inaccuracies within the rules. Specifically, by correcting inadvertent numbering and spelling errors, inaccurate cross references, and by updating outdated citations, the proposed rule change is designed to protect investors by making the rulebook more accurate and adding clarity to the rules, thereby mitigating any potential investor confusion. The proposed rule change will have no impact on trading on the Exchange, as all the proposed rule changes are non-substantive in nature.
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 is not intended to address competitive issues but rather is concerned solely with correcting certain errors and adding clarity. The proposed rule change makes no substantive changes to the rules, and thus will have no impact on trading on the Exchange.
The Exchange neither solicited nor received comments on the proposed rule change.
The Exchange has filed the proposed rule change 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 public interest, for the protection of
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 February 6, 2025, Cboe BZX Exchange, Inc. (“BZX” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On March 11, 2025, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change and the issues raised therein. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On June 24, 2025, the NYSE Arca, Inc. (“Exchange” or “NYSE Arca”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change and the issues raised therein. Accordingly, the Commission, pursuant to Section 19(b)(2) of 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 (“Exchange Act” or “Act”),
This proposed rule change would (i) remove the signature block in its entirety from the Amended and Restated Participant Exchange Agreement (“New RPEA”), filed as the proposed changes in Exhibit 5 and approved by the Commission in File No. SR-OCC-2025-006,
OCC filed proposed changes to the text of the New RPEA as Exhibit 5 to File No. SR-OCC-2025-011. Material added to the New RPEA by File No. SR-OCC-2025-011 is marked by underlining, and material deleted is marked with strikethrough text.
This proposed rule change does not require any changes to the text of OCC's By-Laws or Rules. All terms with initial capitalization that are not otherwise defined herein have the same meaning as set forth in the New RPEA or OCC's By-Laws and Rules.
In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
On July 11, 2025, the Commission approved a proposed rule change by OCC concerning the adoption of the New RPEA between OCC and each of the national securities exchanges that list equity options (“Exchanges”).
First, OCC proposes to remove the signature block in its entirety from the proposed rule text of the New RPEA so that OCC may update it to reflect all parties to the Existing RPEA and allow all such parties to execute the New RPEA. OCC does not consider the signature block to be a rule of the clearing agency within the meaning of the Exchange Act
Second, OCC proposes to correct inadvertent typographical errors in Exhibit C of the New RPEA found in File No. SR-OCC-2025-006, which is the declaration of endorsement that would be executed by any Exchange that seeks to become a party to the New RPEA in the future. Specifically, OCC proposes to correct Exhibit C to the New RPEA to reflect such endorsement is to the “Amended and Restated Participant Exchange Agreement,” as opposed to the “Restated Participant Exchange Agreement” or “Amended Restated Participant Exchange Agreement.”
OCC believes the proposed changes are consistent with the requirements of the Exchange Act and the rules and regulations thereunder applicable to a registered clearing agency. In particular, OCC believes the proposed changes are consistent with Section 17A(b)(3)(F) of the Exchange Act, which requires, among other things, that the rules of a clearing agency be designed to foster cooperation and coordination with persons engaged in the clearance and settlement of securities transactions and to remove impediments to and perfect the mechanism of a national system for the prompt and accurate clearance and settlement of securities transactions.
Section 17A(b)(3)(I) of the Act
Written comments were not and are not intended to be solicited with respect to the proposed rule change and none have been received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.
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.
Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection.
All submissions should refer to file number SR-OCC-2025-011 and should be submitted on or before September 11, 2025.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 31, 2025, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On March 11, 2025, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change and the issues raised therein. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On February 7, 2025, The Nasdaq Stock Market LLC (“Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On March 11, 2025, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change, and the issues raised therein.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On February 6, 2025, Cboe BZX Exchange, Inc. (“BZX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On March 11, 2025, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change, and the issues raised therein. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On February 6, 2025, Cboe BZX Exchange, Inc. (“BZX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On March 11, 2025, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change, and the issues raised therein. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On February 12, 2025, Cboe BZX Exchange, Inc. (“BZX” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On March 11, 2025, pursuant to Section 19(b)(2) of the Act,
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change and the issues raised therein. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 1, 2025, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (“Commission”) an application on Form CA-1 (“Application”) under Section 17A of the Securities Exchange Act of 1934 (“Exchange Act”).
The Commission is publishing this notice to solicit comments on the Application. To grant ICC's request to register as a clearing agency for the purpose of clearing transactions involving U.S. Treasury securities, the Commission must find that it satisfies the requirements of the Exchange Act and the rules and regulations thereunder, including the determinations required under Exchange Act Section 17A(b)(3)(A) through (I).
The Application provides a description of ICC's ownership structure and management. The Application states that ICC is wholly owned by its parent company, ICE U.S. Holding Company, L.P.
The Application describes how ICC will clear transactions involving U.S. Treasury securities.
The Application provides information regarding ICC's risk management.
With respect to financial risk management, ICC also will require Treasury Participants to provide initial margin for their own transactions and for transactions of non-participants that they clear. In addition, ICC will require Treasury Participants to make variation payments due to the change in market value of their open positions and the open positions of non-participants that they clear. ICC will offer various net or gross margin position accounts that non-participants can use to meet these requirements. Finally, ICC will use its existing direct settlement model to manage the settlement of payments and mitigate risks associated with potential settlement failures.
The Application also states that ICC will establish and maintain a Treasury Guaranty Fund which the Application states “will be sized to provide financial resources based on Cover-2 regulatory standards.”
ICC also will establish and maintain a default management framework for clearing transactions involving U.S. Treasury securities, including a default resource waterfall, distinct from ICC's existing framework and waterfall for clearing transactions involving CDS. In resolving a default of a Treasury Participant, ICC may apply the margin and other property of the defaulting Treasury Participant within ICC's possession or control, as set forth in the default waterfall.
In addition to counterparty and financial risk management, the Application describes ICC's approach to operational resilience, availability and disaster recovery, and data backup.
The Application provides information regarding ICC's current and proposed fees.
ICC's application on Form CA-1, including each exhibit thereto referenced above, is available online at
Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments to Vanessa A. Countryman, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090. All submissions should refer to File Number 600-45.
To help the Commission process and review your comments more efficiently, please use only one method of submission. The Commission will post all comments on the Commission's internet website (
Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. All submissions should refer to File Number 600-45 and should be submitted on or before October 6, 2025.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative disaster declaration of a rural area for the State of Kansas dated August 15, 2025.
Issued on August 15, 2025.
Sharon Henderson, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration of a rural area, 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 21240C and for economic injury is 212410.
The States which received an EIDL Declaration are Kansas.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of New Mexico (FEMA-4886-DR) dated July 22, 2025.
Issued on August 16, 2025.
Sharon Henderson, Office of Disaster Recovery & 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 New Mexico, dated July 22, 2025, 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 a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of New Mexico (FEMA-4886-DR), dated August 16, 2025.
Issued on August 16, 2025.
Sharon Henderson, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on August 16, 2025, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications 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 212436 and for economic injury is 212440.
Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review.
The FHWA, on behalf of the State Department of Transportation (FDOT), is issuing this notice to announce actions taken by FDOT and other Federal agencies that are final agency actions. These actions relate to the proposed interchange on Interstate 95 at Pioneer Trail (County Road 4118) in Volusia County, State of Florida. These actions grant licenses, permits, or approvals for the project.
By this notice, the FHWA, on behalf of FDOT, is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal Agency actions on the listed highway project will be barred unless the claim is filed on or before January 20, 2026. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
The Department of the Army permit and additional project documents can be obtained by contacting FDOT Office of Environmental Management, 605 Suwannee Street, MS 37, Tallahassee, Florida 32399, during normal business hours are 8 a.m. to 5 p.m. (Eastern Standard Time), Monday through Friday, except State holidays.
Katasha Cornwell, Interim Director, Office of Environmental Management, FDOT; telephone (850) 414-5260; email:
Effective December 14, 2016, and as subsequently renewed on May 26, 2022, the FHWA assigned, and the FDOT assumed, environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that FDOT and other Federal agencies have taken final agency actions subject to 23 U.S.C. 139(l)(1) by issuing licenses, permits, or approvals for the proposed improvement highway project. The actions by FDOT and other Federal agencies on the project, and the laws under which such actions were taken are described in the Type 2 Categorical Exclusion and in other project records for the listed project. The permits and other documents for the listed project are available by contacting FDOT at the address provided above.
The project subject to this notice is:
Programmatic Approval and all laws under which such actions were taken, including but not limited to:
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National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice and request for comments on a request for approval of a new information collection.
The National Highway Traffic Safety Administration (NHTSA) invites public comments about our intention to request approval from the Office of Management and Budget (OMB) for a new information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes a collection of information for which NHTSA intends to seek OMB approval on Factors that Influence the Effectiveness of Hazard Anticipation and Attention Maintenance Training.
Comments must be submitted on or before October 20, 2025.
You may submit comments identified by the Docket No. NHTSA-2024-0096 through any of the following methods:
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For additional information or access to background documents, contact Christine Watson, Ph.D., Office of Behavioral Safety Research (NPD-320),
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The National Highway Traffic Safety Administration (NHTSA) is seeking approval for a one-time voluntary information collection from 168 participants ages 18 and 19 who do not yet have driver's licenses for a research study on novice driver training. Specifically, this collection involves developing and testing a novice driver training program on a smartphone-like platform and determining whether the effectiveness of the training differs for participants of different sexes, socioeconomic status (SES) strata, and trait levels of sensation seeking and aggressiveness.
To be eligible for the study, participants must be 18 or 19 years old, must not have an unrestricted driver's license or an intermediate/provisional license that allows driving independently, and must be interested in obtaining one in the next 12 months. Recruitment efforts will include posting information about the study on social media platforms, providing study information to contacts in local communities (
Prior to conducting the study, the research team will obtain review and approval of this data collection from an Institutional Review Board (IRB) that meets all Federal requirements in 45 CFR 46, is registered with the Office for Human Research Protections, and has a Federalwide Assurance. NHTSA will use the results of this study to produce a technical report containing summary descriptive and inferential statistics. The technical report will be shared with State highway safety offices, local governments, policymakers, researchers, educators, advocates, and others who may wish to use the data from this survey to support their work on novice and teen driver safety.
Novice teen drivers are more likely to crash in the first several months after they obtain licenses than more experienced drivers. Higher crash rates are observed for novice drivers who first obtain their licenses at ages 18 and 19,
Hazard anticipation training teaches novices to be aware of hazards on the road that are visible
The goal of this information collection is to test the effectiveness of a hazard anticipation and attention maintenance training program for novice drivers that takes relatively little time to complete and could support future efforts to deliver the training via smartphones. Another goal of the information collection is to determine whether the effectiveness of the training program differs for groups of novices who may be at higher risk,
Overall, 334 annual respondents will complete the screening questionnaire, and 60 of these respondents will undergo the informed consent process. Finally, of these 60, 54 annual respondents will enroll and participate in the study.
Although the study site has not been finalized, our descriptions assume that the study will be conducted in one potential study site area, Boston, Massachusetts. The study plans to recruit participants who are ages 18 and 19, who do not have an unrestricted driver's license or an intermediate/provisional license that allows driving independently, and who are interested in obtaining an unrestricted or intermediate/provisional license in the next 12 months. Participants may have a learner's permit. A screening questionnaire will be administered electronically to an estimated 1,002 potential participants (334 annually) to yield a total sample of 168 participants (56 annually). We estimate that approximately 18% (180 participants) of those who respond to the screening questionnaire will be eligible, interested, and will travel to the research center to undergo the informed consent procedure. Then, an estimated 168 participants (approximately 94% of those who undergo the informed consent process) are expected to consent and enroll in the study. Of the 168 enrolled participants, 84 will be from a low SES stratum (as determined by average poverty rate of zip code of residence at age 17) and 84 will be from a medium/high SES stratum. An equal number of males and females will be recruited within each SES group.
The research team expects to provide screening questionnaires to an estimated 1,002 potential participants to determine their eligibility for the study. The research team will post the opportunity on social media platforms likely to be seen by eligible participants and provide it to existing contacts (
Similar to a NHTSA behavioral study recently reviewed by OMB,
Finally, we estimate that approximately 94% (168 individuals) of those who undergo the informed consent process will consent and enroll in the study. For these participants, participation in the study is estimated at 240 minutes per participant (an annual burden of 224 hours for 56 annual respondents). Study tasks include (see Table 1):
i. An enrollment process (5 minutes);
ii. A pre-study questionnaire assessing participants' propensity to experience motion sickness in the computerized driving simulator (5 minutes);
iii. A pre-training hazard anticipation and attention maintenance test administered on a smartphone-like platform (20 minutes);
iv. A novice driver training program (placebo or treatment), administered on a smartphone-like platform (60 minutes);
v. A post-training hazard anticipation and attention maintenance test administered on a smartphone-like platform (20 minutes);
vi. A break (15 minutes);
vii. A drive on a computerized driving simulator (90 minutes); and
viii. A post-study questionnaire (25 minutes) that consists of: demographic questions; the Arnett Inventory of Sensation Seeking;
In total, NHTSA estimates that this information collection will yield a total annual burden of 322 hours (Table 1).
NHTSA estimates the opportunity cost to respondents using an average hourly wage. The May 2023 mean hourly wage for all occupations in the United States was $31.48 per hour.
Participation in this study is voluntary and there are no costs to participants beyond the time spent completing the study. The costs associated with travel to the research center are minimal and expected to be offset by the compensation that will be provided to the research participants.
Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT.
Notice.
PHMSA is publishing this notice to solicit public comments on a request for two special permit segment extensions and one new special permit segment submitted by Florida Gas Transmission Company, LLC (FGT), a subsidiary of Energy Transfer and Kinder Morgan, Inc. FGT is seeking relief from compliance with certain requirements in the Federal pipeline safety regulations. At the conclusion of the 30-day comment period, PHMSA will review the comments received from this notice as part of its evaluation to grant or deny the special permit request.
Submit any comments regarding this special permit request by September 22, 2025.
Comments should reference the docket number for this special permit request and may be submitted in the following ways:
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Confidential Business Information (CBI) is commercial or financial information that is both customarily and treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 United States Code 552), CBI is exempt from public disclosure. If your comments responsive to this notice contain commercial or financial information that is customarily treated
PHMSA received a special permit request from FGT on March 18, 2025, seeking special permit segment extensions, and seeking the addition of a new special permit segment to be incorporated into special permit PHMSA-2020-0001.
Special permit PHMSA-2020-0001 was granted on August 22, 2023 and is effective until March 31, 2032 for six special permit segments, which include 10,279 feet (approximately 1.947 miles) of the FGT natural gas transmission pipeline system located in Lake, Orange, and Osceola counties, Florida. FGT is requesting a new special permit segment of 3,587 feet (approximately 0.679 miles) and special permit segment extensions totaling 8,009 feet (approximately 1.517 miles). If granted, the combined length of the requested expansion would total 11,596 feet (approximately 2.196 miles).
The active special permit segment, requested new special permit segment, and requested extensions, are as follows:
Upon receipt of this request, PHMSA reviewed the currently active special permit's Final Environmental Assessment (FEA) and its findings. In consideration of this, PHMSA finds that the existing FEA and Finding of No Significant Impact remain adequate, pursuant to the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321
FGT's new special permit segment and extensions request, active special permit with conditions, and FEA are available for review and public comment in Docket No. PHMSA-2020-0001. PHMSA invites interested persons to review and submit comments in the docket on both the special permit segment extension request and the new special permit segment request. Please submit comments on any potential safety, environmental, and other relevant considerations implicated by the special permit request. Comments may include relevant data.
Before issuing a decision on the special permit request, PHMSA will evaluate all comments received on or before the comments closing date. PHMSA will consider each relevant comment it receives in making its decision to grant or deny this special permit request.
Issued in Washington, DC, on August 19, 2025 under authority delegated in 49 CFR 1.97.
Office of the Comptroller of the Currency (OCC), Treasury; Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC).
Joint notice and request for comment.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the OCC,
Comments must be submitted on or before September 22, 2025.
Interested parties are invited to submit written comments to any or all of the agencies. All comments will be shared among the agencies.
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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 following method:
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All public comments are available on the Board's website at
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Additionally, written comments and recommendations for the proposed information collections should be sent within 30 days of publication of this notice to
For further information about the information collections discussed in this notice, please contact any of the agency staff whose names appear below. In addition, copies of the FFIEC 102 reporting forms and instructions can be obtained at the FFIEC's website (
On May 2, 2025, the agencies requested public comment on a proposal to extend for three years, without revision, the FFIEC
The agencies will proceed with the extension without revision of the FFIEC 102, as proposed, and are sending the collections to OMB for review.
The Market Risk Regulatory Report for Institutions Subject to the Market Risk Capital Rule (FFIEC 102) is filed quarterly with the agencies and provides information for market risk institutions, defined for this purpose as those institutions that are subject to the market risk capital rule as incorporated into subpart F of the agencies' regulatory capital rules
The quarterly FFIEC 102 information collection is mandatory for market risk institutions: 12 U.S.C. 161 (national banks), 12 U.S.C. 324 (State member banks), 12 U.S.C. 1844(c) (bank holding companies), 12 U.S.C. 1467a(b) (savings and loan holding companies), 12 U.S.C. 5365 (U.S. intermediate holding companies), 12 U.S.C. 1817 (insured State nonmember commercial and savings banks), and 12 U.S.C. 1464 (savings associations). The FFIEC 102 information collections are not given confidential treatment.
The agencies invite comment on the following topics related to these collections of information:
(a) Whether the information collections are necessary for the proper performance of the agencies' functions, including whether the information has practical utility;
(b) The accuracy of the agencies' estimates of the burden of the information collections, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of information collections 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.
Comments submitted in response to this joint notice will be shared among the agencies. All comments will become a matter of public record.
Office of the Comptroller of the Currency (OCC), Treasury.
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 soliciting comment concerning the renewal of its information collection titled, “Lending Limits.” The OCC also is giving notice that it has sent the collection to OMB for review.
Comments must be received by September 22, 2025.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
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Written comments and recommendations for the proposed information collection should also be sent within 30 days of publication of this notice to
You may review comments and other related materials that pertain to this information collection following the close of the 30-day comment period for this notice by the method set forth in the next bullet.
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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
• Residential real estate loans or extensions of credit to one borrower in the lesser of the following two amounts: 10 percent of its capital and surplus; or the percent of its capital and surplus, in excess of 15 percent, that a state bank or savings association is permitted to lend under the state lending limit that is available for residential real estate loans or unsecured loans in the state where the main office of the national bank or savings association is located. Any such loan or extension of credit must be secured by a perfected first-lien security interest in 1-4 family real estate in an amount that does not exceed 80 percent of the appraised value of the collateral at the time the loan or extension of credit is made;
• Loans to small businesses to one borrower in the lesser of the following two amounts: 10 percent of its capital and surplus; or the percent of its capital and surplus, in excess of 15 percent, that a state bank is permitted to lend under the state lending limit that is available for loans to small businesses or unsecured loans in the state where the main office of the national bank or home office of the savings association is located; and
• Loans or extensions of credit to small farms to one borrower in the lesser of the following two amounts: 10 percent of its capital and surplus; or the percent of its capital and surplus, in excess of 15 percent, that a state bank or savings association is permitted to lend under the state lending limit that is available for loans or extensions of credit to small farms or unsecured loans in the state where the main office of the national bank or savings association is located.
An eligible national bank or savings association must submit an application to, and receive approval from, its supervisory office before using the supplemental lending limits in 12 CFR 32.7(a)(1)-(3). The supervisory office may approve a completed application if it finds that approval is consistent with safety and soundness. Section 32.7(b) provides that, in order for an application to be deemed complete, the application must include:
• Certification that the bank or savings association is an “eligible bank” or “eligible savings association;”
• Citations to relevant state laws or regulations;
• A copy of a written resolution by a majority of the bank's or savings association's board of directors approving the use of the limits in § 32.7(a) and confirming the terms and conditions for use of this lending authority; and
• A description of how the board will exercise its continuing responsibility to oversee the use of this lending authority.
Twelve CFR 32.9(b)(1) outlines three alternative methods (the Internal Model Method, the Conversion Factor Matrix Method, and the Current Exposure Method) for national banks and savings associations to use in calculating the credit exposure of non-credit derivative transactions. Twelve CFR 32.9(c) outlines two alternative methods for national banks and savings associations to use in calculating credit exposure arising from their securities financing transactions.
Under 12 CFR 32.9(b)(1)(i)(C), the use of a model (other than the model approved for purposes of 12 CFR 3.132(d) or 324.132(d)) must be approved in writing by the OCC specifically for part 32 purposes. If a national bank or savings association proposes to use an internal model that has been approved by the OCC for purposes of 12 CFR 3.132(d) or 324.132(d), the institution must provide written notification to the OCC prior to use of the model for lending limits purposes. OCC approval also is required for any substantive revisions to an approved model before that model is used for lending limit purposes.
Comments continue to be 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.
Office of the Comptroller of the Currency (OCC), Treasury; Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC).
Joint notice and request for comment.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the OCC, the Board, and the FDIC (the agencies) 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. On May 9, 2025, the Federal Financial Institutions Examination Council (FFIEC), of which the agencies are members, requested public comment for 60 days on a proposal to extend for three years, without revision, the Country Exposure Report (FFIEC 009) and the Country Exposure Information Report (FFIEC 009a), which are currently approved collections of information. The comment period for the May notice expired on July 8, 2025. As described in the
Comments must be submitted on or before September 22, 2025.
Interested parties are invited to submit written comments to any or all of the agencies. All comments will be shared among the agencies.
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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 following method:
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All public comments are available on the Board's website at
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Additionally, written comments and recommendations for the proposed information collections should be sent within 30 days of publication of this notice to
For further information about the proposed FFIEC reports discussed in this notice, please contact any of the agency staff whose names appear below. In addition, a copy of the proposed FFIEC 009 and FFIEC 009a report forms can be obtained at the FFIEC's website (
On May 9, 2025, the agencies requested public comment on a proposal to extend for three years, without revision, the FFIEC 009 and the FFIEC 009a.
The Country Exposure Report (FFIEC 009) is filed quarterly with the agencies and provides information on international claims of U.S. banks, savings associations, Edge and/or Agreement corporations, bank holding companies, savings and loan holding companies, and intermediate holding companies (U.S. banking organizations) that is used for supervisory and analytical purposes. The information is used to monitor the foreign country exposures of reporting institutions to determine the degree of risk in their portfolios and assess the potential risk of loss. The Country Exposure Information Report (FFIEC 009a) is a supplement to the FFIEC 009 and provides publicly available information on material foreign country exposures of U.S. banking organizations that file the FFIEC 009 report. On the FFIEC 009a, reporting institutions provide a list of countries in which they have lending exposures above 0.75 percent of their total assets or 15 percent of their total capital, whichever is less.
These information collections are mandatory under the following statutes: 12 U.S.C. 161 and 1817 (national banks), 12 U.S.C. 1464 (Federal savings associations), 12 U.S.C. 248(a)(1) and (2), 1844(c), and 3906 (State member banks and bank holding companies); 12 U.S.C. 1467a(b)(2)(A) (savings and loan holding companies); 12 U.S.C. 5365(a) (intermediate holding companies); and 12 U.S.C. 1817 and 1820 (insured State nonmember commercial and savings banks and insured State savings associations). The FFIEC 009 information collection is given confidential treatment (5 U.S.C. 552(b)(4) and (b)(8)). The FFIEC 009a information collection is not given confidential treatment.
Public comment is requested on all aspects of this joint notice. Comment is specifically invited on:
(a) Whether the proposed revisions to the collections of information that are the subject of this notice are necessary for the proper performance of the agencies' functions, including whether the information has practical utility;
(b) The accuracy of the agencies' estimates of the burden of the information collections as they are proposed to be revised, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of information collections 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.
Comments submitted in response to this joint notice will be shared among the agencies.
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 October 20, 2025 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
Requests for additional information or copies of this collection should be directed to Marcus McCrary at 470-769-2001.
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. 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 October 20, 2025 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. 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; correction.
The Department of the Treasury published a document in the
Copies of the submissions may be obtained from Spencer W. Clark by emailing
In the
Environmental Protection Agency (EPA).
Final rule; administrative change.
The Environmental Protection Agency (EPA) is revising the format for materials submitted by the State of California that are incorporated by reference into the California State Implementation Plan (SIP). The regulations and other materials affected by this format change have all been previously submitted by the State of California and approved by the EPA. This format revision will primarily affect the “Identification of plan—in part” sections, as well as the format of the SIP materials that will be available for public inspection at the EPA Regional Office and the National Archives and Records Administration (NARA). This action, which only relates to source-specific requirements and certain local and regional California air district rules, is the fourth of a series of actions intended to change the format for the entire California SIP.
This rule is effective on August 21, 2025.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2024-0527. SIP materials which are incorporated by reference into 40 CFR part 52 are available for inspection by appointment at Environmental Protection Agency, Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901. For information on the availability of this material at the EPA Regional Office, please contact the person in the
Doris Lo, EPA Region IX, 75 Hawthorne St., San Francisco, CA; telephone: (415) 972-3959; email address:
Throughout this document, the terms “we”, “us,” and “our” refer to the EPA. This supplementary information section is organized as follows:
Each State has a SIP containing, among other things, the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.
Each State must formally adopt the control measures and strategies to attain and maintain the NAAQS after the public has had an opportunity to comment on them. They are then submitted to the EPA as requested SIP revisions upon which the EPA must formally act. Once these control measures and strategies are approved by the EPA, after notice and comment rulemaking, they are incorporated into the federally approved SIP and are identified in part 52 (Approval and Promulgation of Implementation Plans), title 40 of the Code of Federal Regulations (40 CFR part 52). The EPA uses the process of incorporation by reference (IBR) to incorporate material into the CFR by referencing the original document(s) without publishing the full text of the material. The actual State regulations approved by the EPA are not reproduced in their entirety in 40 CFR part 52 but are “incorporated by reference,” which means that the EPA has approved a given State regulation with a specific effective date. This format allows both the EPA and the public to know which measures are contained in a given SIP and to help determine whether the State is enforcing the regulations. This format also assists the EPA and the public in taking enforcement action, should a State not enforce its SIP-approved regulations.
The SIP is a dynamic document, which the State can revise as necessary to address the unique air pollution problems in the State. Therefore, the EPA must periodically take action on State SIP revisions containing new and/or revised regulations and other materials in order to make them part of the federally-approved SIP. The EPA establishes a docket for its actions using a unique Docket Identification Number, which is listed in each action. These dockets and the complete submissions are available for viewing on
On May 22, 1997 (62 FR 27968), the EPA revised the formatting procedures for incorporating by reference federally-approved SIP revisions, as a result of consultations between the EPA and the Office of the Federal Register. These procedures include: (1) a revised SIP document for each State that would use the IBR process under the provisions of title 1 CFR part 51; (2) a revised mechanism for announcing the EPA's approval of revisions to an applicable SIP and updating both the document that has gone through the IBR process and the CFR; and (3) a revised format of the “Identification of Plan” sections for each applicable subpart in 40 CFR part 52 to reflect these revised IBR procedures. The description of the revised SIP document, IBR procedures, and “Identification of plan” format are discussed in further detail in the May 22, 1997
Under the revised SIP format, the federally-approved regulations, source-specific requirements, and nonregulatory provisions (entirely or portions of) submitted by each State agency have been compiled by the EPA into a “SIP compilation.” The SIP compilation contains the regulations, source-specific requirements, and nonregulatory and quasi-regulatory provisions approved by the EPA through previous rulemaking actions published in the
Each compilation contains three parts. Part one contains the regulations, part
EPA Region IX has developed and will maintain the SIP compilation for California. A copy of the full text of California's regulatory and source-specific SIP compilation will also be maintained at NARA.
Given the size of the California SIP, the EPA is revising the format of the California SIP in a phased manner. On May 26, 2016 (81 FR 33397), the EPA took the first action to revise the format of the “Identification of plan” section in subpart F in accordance with the revised format described in Section I.C. of this document. Through the first action, we revised the heading of § 52.220 to read “Identification of plan—in part” and added an introductory paragraph to convey our division of the California “Identification of plan” section into two sections:
• Amended § 52.220 (renamed “Identification of plan—in part”), which would continue for the time being to function as it has in the past to list past and newly-approved air district rules, local ordinances, source-specific requirements, and nonregulatory and quasi-regulatory provisions and which lists State statutes and State regulations approved on or prior to April 1, 2016; and
• New § 52.220a (“Identification of plan—in part”), which lists the State statutes and State regulations approved as part of the California SIP as of April 1, 2016, using the new table format.
This meant that subsequent EPA approvals of air district rules, local ordinances, source-specific requirements, and nonregulatory and quasi-regulatory provisions would continue to be promulgated in 40 CFR 52.220 using the paragraph format whereas subsequent EPA approvals of State statutes and State regulations would be promulgated in 40 CFR 52.220a using the table format. In preparation for future actions to revise the format of the remaining portions of the California SIP, the May 26, 2016 action also organized 40 CFR 52.220a into five paragraphs: (a) Purpose and scope; (b) Incorporation by reference; (c) EPA-approved regulations; (d) EPA-approved source-specific requirements; and (e) EPA-approved nonregulatory provisions and quasi-regulatory measures. “Nonregulatory provisions and quasi-regulatory measures” refers to items such as transportation control measures, certain nonregulatory statutory provisions, control strategies, and monitoring networks.
Our phased approach to converting the format of the California SIP anticipated that, over time, as the EPA completes further rulemaking actions to convert the format of the California SIP, § 52.220a would include a growing number of air district rules, local ordinances, source-specific requirements, and nonregulatory and quasi-regulatory provisions. Once the conversion process is completed, the EPA will redesignate § 52.220a as § 52.220 and rename it simply “Identification of plan.” At that point, all subsequent actions by the EPA to approve California SIP revisions will be promulgated using the new table format. The revised format does not affect Federal enforceability of the SIP and is consistent with the requirements of section 110(h)(1) of the Clean Air Act (CAA) concerning comprehensive SIP publication.
On June 4, 2025 (90 FR 23618), the EPA took a second action to revise the format of the California SIP by converting the format for local ordinances and air district rules approved on or prior to April 17, 2025, for the following air districts: Amador Air District, Antelope Valley Air Quality Management District (AQMD), Bay Area AQMD, Butte County AQMD, Calaveras County Air Pollution Control District (APCD), Colusa County APCD, Eastern Kern APCD, and El Dorado County AQMD. A third action was taken on July 7, 2025, (90 FR 29934) that converted the format for the nonregulatory provisions and quasi-regulatory measures portion of the California SIP.
In this fourth action to revise the format of the California SIP, we are converting the format and publishing the tables listing EPA-approved source-specific requirements as well as EPA-approved rules adopted by the following 21 California air districts: Feather River AQMD, Glenn County APCD, Great Basin Unified APCD, Imperial County APCD, Lake County AQMD, Lassen County APCD, Mariposa County APCD, Mendocino County AQMD, Modoc County APCD, Monterey Bay Air Resources District, North Coast Unified AQMD, Northern Sierra AQMD, Northern Sonoma County APCD, San Diego County APCD, San Luis Obispo County APCD, Santa Barbara County APCD, Shasta County AQMD, Siskiyou County APCD, Tehama County APCD, Tuolumne County APCD, and Yolo-Solano County AQMD. This format revision involves materials approved on or before June 30, 2025, that are part of the current applicable SIP. All subsequent actions by the EPA to approve California SIP revisions related to source-specific requirements or these 21 air districts will be promulgated in 40 CFR 52.220a, paragraph (c) using the new table format. EPA approvals of rules from Mojave Desert AQMD, Placer County APCD, Sacramento Metropolitan AQMD, San Joaquin Valley Unified APCD, South Coast AQMD, and Ventura County APCD will continue to be promulgated in 40 CFR 52.220 using the paragraph format. The format for portions of the California SIP related to rules from these remaining air districts will be revised in future rulemaking actions.
All revisions to the applicable SIP become federally enforceable as of the effective date of the revision to the applicable “Identification of plan” or “Identification of plan—in part” section found in each subpart of 40 CFR part 52. All future revisions to the relevant portion of the applicable SIP being converted to the new table format in this action become federally enforceable as of the effective date of the revisions to paragraph (c) or (d) of § 52.220a, in subpart F of 40 CFR part 52.
To facilitate enforcement of previously approved SIP provisions and provide a smooth transition to the new SIP processing system, the EPA will retain the “Identification of plan—in part” section for California appearing in 40 CFR 52.220 until the conversion process is completed. After the conversion of the entire California SIP is completed, the “Identification of plan—in part” section will be moved to 40 CFR 52.250 and renamed “Original identification of plan.” After an initial one or two-year period, the EPA will review its experience with the new SIP processing system and decide whether to retain the “Original identification of plan” section for some further period.
In this action, the EPA is revising the format for portions of the applicable California SIP related to source-specific requirements and the rules from the following 21 air districts: Feather River AQMD, Glenn County APCD, Great Basin Unified APCD, Imperial County APCD, Lake County AQMD, Lassen County APCD, Mariposa County APCD, Mendocino County AQMD, Modoc County APCD, Monterey Bay Air Resources District, North Coast Unified AQMD, Northern Sierra AQMD, Northern Sonoma County APCD, San Diego County APCD, San Luis Obispo County APCD, Santa Barbara County APCD, Shasta County AQMD, Siskiyou County APCD, Tehama County APCD, Tuolumne County APCD, Yolo-Solano County AQMD. This format revision involves materials approved on or before June 30, 2025, that are part of the current applicable SIP.
This action constitutes a “housekeeping” exercise to ensure that all EPA-approved revisions to the State programs that have occurred are accurately reflected in 40 CFR part 52. The requirements that apply to States and that relate to SIPs and SIP revisions are set forth in the Clean Air Act and in the EPA's regulations at 40 CFR part 51. When the EPA receives a formal SIP revision request, the Agency must publish the proposed revision in the
The EPA has determined that this rule falls under the “good cause” exemption in section 553(b)(B) of the Administrative Procedure Act (APA), which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3), which allows an agency to make a rule effective immediately, thereby avoiding the 30-day delayed effective date otherwise provided for in the APA. This action simply reformats and recodifies provisions that are already in effect as a matter of law in Federal and approved State programs. Under section 553 of the APA, an agency may find good cause where notice and public procedure are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” for this action because the EPA is merely reformatting and recodifying existing law. Immediate notice in the CFR benefits the public by removing outdated citations and making the IBR format clearer and more user-friendly.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is reformatting the materials incorporated by reference in previous rulemakings on submittals of the California SIP and SIP revisions, as described in section II of this preamble. The EPA has made, and will continue to make, these documents generally available through
This action does not impose additional requirements beyond those previously approved into the SIP and already imposed by State law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is an administrative action related to State program approval;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act (5 U.S.C. 801
The EPA has also determined that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the California SIP compilation had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, the EPA believes judicial review of this action under section 307(b)(1) is not available.
Environmental protection, Air pollution control, Carbon oxides, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping
For the reasons stated in the preamble, the Environmental Protection Agency amends part 52, chapter I, title 40 of the Code of Federal Regulations as follows:
42 U.S.C. 7401
This section identifies the local and regional air district rules, local ordinances, source-specific requirements, and nonregulatory materials submitted by the State of California and approved as part of the California state implementation plan. This section also identifies California statutes and state regulations submitted by the State of California and approved as part of the California state implementation plan on or prior to April 1, 2016. New or amended California statutes and state regulations approved after April 1, 2016, are identified in § 52.220a. New or amended local ordinances approved after April 17, 2025, are identified in § 52.220a. New or amended air district rules approved after April 17, 2025, are identified in § 52.220a for the following air districts: Amador Air District, Antelope Valley Air Quality Management District, Bay Area Air Quality Management District, Butte County Air Quality Management District, Calaveras County Air Pollution Control District, Colusa County Air Pollution Control District, Eastern Kern Air Pollution Control District, and El Dorado County Air Quality Management District. New or amended nonregulatory materials approved after July 3, 2025, are identified in § 52.220a. New or amended source-specific requirements approved after June 30, 2025, are identified in § 52.220a. New or amended air district rules approved after June 30, 2025, are identified in § 52.220a for the following air districts: Feather River Air Quality Management District, Glenn County Air Pollution Control District, Great Basin Unified Air Pollution Control District, Imperial County Air Pollution Control District, Lake County Air Quality Management District, Lassen County Air Pollution Control District, Mariposa County Air Pollution Control District, Mendocino County Air Quality Management District, Modoc County Air Pollution Control District, Monterey Bay Air Resources District, North Coast Unified Air Quality Management District, Northern Sierra Air Quality Management District, Northern Sonoma County Air Pollution Control District, San Diego County Air Pollution Control District, San Luis Obispo County Air Pollution Control District, Santa Barbara County Air Pollution Control District, Shasta County Air Quality Management District, Siskiyou County Air Pollution Control District, Tehama County Air Pollution Control District, Tuolumne County Air Pollution Control District, and Yolo-Solano County Air Quality Management District.
The additions and revisions read as follows:
(b) * * *
(1) * * *
(xii)
(xiii)
(xiv)
(xv)
(xvi)
(xvii)
(xviii)
(xix)
(xx)
(xxi)
(xxii)
(xxiii)
(xxiv)
(xxv)
(xxvi)
(xxvii)
(xxviii)
(xxix)
(xxx)
(xxxi)
(xxxii)
(xxxiii)
(xxxiv)
(xxxv)
(xxxvi)
(xxxvii)
(xxxviii)
(c) * * *
(d)