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Agricultural Marketing Service, USDA.
Final rule.
This final rule implements a recommendation from the California Walnut Board (Board) to make changes to the administrative requirements prescribed under the Federal marketing order for walnuts grown in California (Order). This final rule provides a schedule for required handler assessment payments, establishes interest and late payment charges on overdue assessments owed, and modifies the existing reporting requirements for handler acquisitions of walnuts.
Effective September 16, 2026.
Jeffery Rymer, Marketing Specialist, or Abigail Maharaj, Chief, West Region Branch, Market Development Division, Specialty Crops Program, AMS, USDA; telephone: (559) 487-5901; or email:
This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674) (the Act), amending Marketing Order No. 984, (7 CFR part 984, the Order), regulating the handling of walnuts grown in California. The Board locally administers the Order and is comprised of growers and handlers of California walnuts operating within the area of production, and a public member.
This action is exempt from the Office of Management and Budget (OMB) review process required by Executive Order 12866. This final rule amends existing Marketing Order No. 984, as amended (7 CFR part 984), Walnuts Grown in California, and is necessary for the continued operation of Marketing Order No. 984. Additionally, this action is exempt from the requirements of Executive Order 14192, “Unleashing Prosperity Through Deregulation,” pursuant to section 5(c).
This final rule has been reviewed under Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” which requires Federal agencies to consider whether their rulemaking actions would have Tribal implications. The Agricultural Marketing Service (AMS) has determined that this final rule is unlikely to 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.
This final rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” This final rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608(c)(15)(A) of the Act, any handler subject to an order may file with the U.S. Department of Agriculture (USDA) a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This final rule provides a defined payment schedule for required handler assessment payments. Additionally, the rule establishes interest and late payment charges on overdue handler assessments owed under the Order. Lastly, this action modifies the reporting requirements for walnut acquisitions. These changes were unanimously approved by the Board, in two separate votes, with eight in favor and none opposed, during Board meetings held on August 8, and November 6, 2024.
Section 984.69(a) of the Order provides that each handler shall pay the Board, on demand, his or her pro rata share of the Board's authorized expenses. Currently, each handler's assessment obligation is invoiced throughout the marketing year based upon the quantity of walnuts the handler has acquired and reported to the Board by January 15 of each year on the Order's CWB Form #1. However, the schedule of when assessments are invoiced, and payments are due, is not yet specified in the Order's regulations.
Further, § 984.69(c) of the Order provides the authority to establish late payment charges and interest charges on assessments that are not paid within the time period specified by the Board. While such late payment penalties are authorized under the Order, specific late payment charges and interest rate charges on past due assessments have not yet been established in the Order's regulations.
Additionally, § 984.73 of the Order provides the authority to require handlers to submit reports of their walnut receipts. Under that authority, § 984.473, “Report of walnut receipts,” was established to require handlers to report walnut acquisitions, on or before January 15 of each marketing year, on forms supplied by the Board. Currently, under that section of the Order, handlers are only required to submit one report each marketing year, with no provision providing instruction for reporting walnuts that may be acquired after January 15.
This final rule modifies the Order's current administrative requirements to enhance the efficient collection of assessments from handlers, strengthening the Board's oversight of the program operations and administration of the Order. The Board believes that these changes and additions will augment the Order's administrative requirements and incentivize compliance. AMS determined that these amendments
Specifically, this final rule adds a new § 984.348, “Payment of assessments,” to the Order's requirements to establish the payment schedule for handler assessments. Each handler would pay assessments, based on the quantity of walnut receipts reported by the handler pursuant to § 984.473, in three equal installments invoiced by the Board, on January 31, April 30, and July 31 of each marketing year. This specific payment schedule is based on industry practice. Based on Board discussions, establishing this schedule in the Order itself will help stabilize and smooth revenue streams by distributing assessment collection evenly over staggered payments. Such stability will help the Board's operability by reducing uncertainty about when assessments are due and provide handlers with clear expectations and timeframe. This schedule is not clear in the Order or provided for in its administrative regulations.
In addition, through the authority provided by § 984.69(c) of the Order, this final rule also establishes late payment penalties and interest charges for handler assessment payments under a new § 984.349, “Late payment and interest charges.” This, in conjunction with the establishment of the payment schedule, will help the Board address issues of handler confusion with late payment submissions. A late payment charge of ten percent (10%) will be imposed on any assessment payment that has not been received within sixty (60) days of the invoice date on the handler's assessment statement. Further, assessment payments not received within sixty (60) days after the invoice date will also be subject to an ongoing one and one-half percent (1.5%) per month interest charge, accruing monthly until the total balance due, including any late payment charge, is paid. The inclusion of a late payment penalty and interest charges provision establishes a clear formula for the Board to apply to a handler's account when in arrears. This final rule also provides an incentive for handlers to comply with the payment installment schedule.
Finally, this action modifies the reporting requirements in § 984.473, “Report of walnut receipts,” which requires handlers to report walnut acquisitions on or before January 15 of each marketing year on forms supplied by the Board. This final rule adds provisions for reporting walnuts that are acquired after the January 15 reporting deadline. Although the occurrence of walnuts arriving to handlers after January 15 is not common, when it does occur, it creates confusion concerning how the reporting requirements and assessment collections are applied to those late arriving walnuts. As such, the Board's solution is: each handler acquiring walnuts from growers after submission of his or her initial report of walnut receipts will also be required to file a revised report of walnut receipts by the 15th of the month following such receipt. Handlers must pay assessments on such receipts upon demand, as requested by the Board, following receipt of the revised report.
These changes collectively aim to reinforce the integrity of the Order, promote compliance, and reduce reliance on legal remedies for collection. By requiring transparency, timely reporting, and punctual payments, these measures are expected to facilitate the orderly marketing of California walnuts and enhance the continued effectiveness of the program for the benefit of industry stakeholders.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this final rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act are unique regulations in that they are brought about through group action of typically small entities.
There are approximately 68 handlers subject to regulation under the Order and approximately 4,500 growers of California walnuts in the production area. At the time this analysis was prepared, the Small Business Administration (SBA) defined small agricultural service firms as those having annual receipts of less than $34,000,000 (North American Industry Classification System (NAICS) code 115114, Postharvest Crop Activities), and small agricultural producers of walnuts as those having annual receipts of less than $3,750,000 (NAICS code 111335, Tree Nut Farming) (13 CFR 121.201).
Data from USDA's National Agricultural Statistics Service (NASS), indicate a three-year average value of utilized inshell walnut production of $737.1 million for the most recent seasons for which data is available (2022 through 2024 crop years). Dividing that figure by the number of walnut growers (4,500) yields an average annual crop value per grower of approximately $163,787. This figure is well below the SBA small agricultural producer threshold of $3,750,000 in annual sales. Assuming a normal distribution, this provides evidence that a large majority of walnut growers would likely be considered small agricultural producers according to the SBA definition. Additionally, data from NASS's 2022 Agricultural Census show that 96 percent of California farms growing walnuts at the time had walnut sales of less than $1 million.
Further, based on information from the Board, approximately 78 percent of California's walnut handlers shipped assessable walnuts valued under $34 million during the 2023-2024 marketing year and would, therefore, be considered small handlers according to the SBA definition. Considering the above-mentioned information, it is reasonable to conclude that a substantial majority of both walnut growers and handlers would be considered small business entities according to current SBA definitions.
This final rule provides a defined payment schedule for required handler assessment payments, establishes interest and late payment charges on overdue handler assessments, and modifies the reporting requirements for walnut acquisitions. These changes were recommended by the Board to enhance the efficiency of the Board's administrative function.
The Board discussed alternatives to the recommendations contained in this rule, including different options for the reporting of walnut acquisitions, the timing of assessment payment installments, various late payment penalty rates, and the appropriate interest rate charged on unpaid assessments. The Board also considered making no changes and maintaining the Order's status quo. However, the Board recognized the financial and administrative inefficiencies inherent in the existing administrative provisions and believed that taking no action would have been imprudent. Further, the Board determined that the late penalty and the interest rate charge would serve to incentivize compliance with the Order's provisions without being excessive and burdensome.
In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178, “Vegetable and Specialty Crops.” This final rule requires changes to the
This final rule may impose some additional reporting or recordkeeping requirements on either small or large California walnut handlers. However, the Board anticipates that the requirement to submit supplemental acquisition reports for walnuts that are acquired after the submission of the handler's initial CWB Form #1 report would only impact a small percentage of the total number of handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
A proposed rule concerning this action was published in the
Of the comments received, five suggested modifications to either the payment schedule, late payment and interest charges, and/or grace period. The commenters did not self-identify as handlers or producers within the regulated production area. These commenters stated they understood the need to strengthen administrative requirements through the payment schedule and the late penalty and interest charges in order to incentive the timely collection of assessments and efficient operation of the Order. However, the comments expressed concern with the proposal, citing the potential economic impact the proposal would have on small businesses. Of the four remaining comments, two expressed support for the proposals, one recommended a more thorough burden analysis to demonstrate positive impacts on small producers, one did not address the merits of the proposal, and one raised concern about possible procedural deficiencies.
Commenters recommended the addition or extension of a grace period, a tiered penalty structure based on the handler size, lower penalty rates and interest charges, and/or a more flexible payment schedule. This rule includes a 60-day grace period before late penalties are assessed, which AMS and the Board view to be reasonable and appropriate to reduce financial burden, especially for small businesses. Additional time and the creation of a tiered penalty structure, as suggested by some commenters, would extend the grace period and delay payments further, potentially encouraging late payments. It may also result in different interest rates rather than a flat penalty fee of 1.5 percent, potentially raising fairness concerns among handlers and producers. In addition, payments being made at different intervals would increase administrative burden. The Board, which locally administers the Order, believes that applying the 60-day grace period and monthly penalty structure creates regulatory consistency across all handlers which it believes necessary to ensure timely and consistent payments for its efficient operation.
Prior to making its recommendation to amend the Order's administrative requirements, the Board met on two occasions to discuss the proposal's impact on industry handlers. The Board considered the regulatory impact on small businesses in formulating its recommendation. Ultimately, Board members representing small businesses unanimously supported the proposed changes, as evidenced by meeting minutes.
Moreover, AMS notes that this final rule aligns with other marketing orders that utilize late payment and interest charges as a standard business practice. AMS has reviewed the comments and ultimately concluded that the regulatory changes are appropriate, will enhance the efficient collection of assessments, and penalties will be administered proportionately, without bias, to all handlers regardless of size.
One comment raised concerns regarding the new reporting requirement and the extra paperwork burden that would be experienced by small businesses and one commenter suggested simplifying the acquisition report or offering technical assistance. While the action may impose some additional reporting and recordkeeping requirements on handlers who acquire walnuts after January 15, AMS anticipates that the change will have a minimal impact on burden, will only impact a limited number of handlers because acquiring additional walnuts is uncommon, will not impose an undue burden on small businesses specifically, and that modifying the reporting requirement is necessary for the efficient and equitable administration of the Order.
Lastly, one comment raised concerns about procedural deficiencies and lack of adherence to the Administrative Procedure Act, the Regulatory Flexibility Act, the Paperwork Reduction Act, and Executive Order 12866 in the rulemaking process. Specifically, the commenter claims that AMS procedurally bypassed notice and comment, failed to present an analysis of the impacts on small businesses, and deprived interested parties a meaningful opportunity to comment. After reviewing the comment, AMS determined that all of the statutory and procedural requirements for rulemaking have been met regarding this action.
Contrary to the comment's assertions, AMS did not bypass notice and comment or invoke good cause. Interested persons had numerous opportunities to review pertinent information, present their views, and participate in the rulemaking process. AMS notes that in conducting all meetings publicly, the Board provided, rather than deprived, interested persons a meaningful opportunity to comment. In addition, AMS published a notice of proposed rulemaking in the
The proposed rulemaking also included an Initial Regulatory Flexibility Analysis, pursuant to requirements set forth in the Regulatory Flexibility Act, that considered and detailed for the public's review the economic impact of this final rule on small entities. AMS has provided adequate opportunity for interested persons to consider the proposal and provide comments. This final rule follows the applicable procedures and is compliant with the Regulatory Flexibility Act and Administrative Procedure Act. The comment also asserted that the affected information collection was not clearly identified and that OMB approval is required. As stated in the proposed rule, this final rule reiterates the affected information collection as CWB Form #1 and that revised changes to the form are minor, do not significantly increase burden,
Lastly, to address comments concerning Executive Order 12866, AMS reiterates that this final rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from the review process required by Executive Order 12866.
After consideration of all relevant material presented, including the information and recommendations submitted by the Board and other available information, AMS has determined that this final rule is consistent with and will effectuate the declared policy of the Act.
Marketing agreements, Nuts, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Agricultural Marketing Service amends 7 CFR part 984 as follows:
7 U.S.C. 601-674.
(a) Each handler shall pay assessments on walnut receipts reported by the handler pursuant to § 984.473(a) in three installments, invoiced by the Board, on January 31, April 30, and July 31 of each marketing year.
(b) Each handler shall pay assessments on walnut receipts reported by the handler pursuant to § 984.473(b), as requested by the Board, on demand.
(a) The Board shall impose a late payment charge of ten percent (10%) on any handler whose assessment payment has not been received within sixty (60) days of the invoice date shown on the handler's assessment statement.
(b) Payments not received more than sixty (60) days after the invoice date shown on the handler's assessment statement shall be subject to a one and one-half percent (1.5%) interest charge per month. Interest shall be applied to the total outstanding assessment balance, including any late payment charge, at the end of each subsequent thirty (30) day period until final payment is made.
(a) Each handler shall file a report of his or her walnut receipts from growers on or before January 15 of each marketing year on forms supplied by the Board.
(b) Each handler acquiring walnuts from growers after submission of their initial report of walnut receipts pursuant to paragraph (a) of this section shall file a revised report of walnut receipts by the 15th of the month following such receipt on forms supplied by the Board.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.
This order is effective September 16, 2026. See further discussion in section IV, “Implementation Strategy.”
Soma Ghosh, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3316, Silver Spring, MD 20993, 240-402-5333,
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Devices that were not introduced or delivered for introduction into interstate commerce for commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require approval of a premarket approval application (PMA), unless and until: (1) the Food and Drug Administration (FDA) reclassifies the device into class I or class II; or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices by means of the procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and our implementing regulations (part 807, subpart E (21 CFR part 807, subpart E)).
A postamendments device that has been initially classified into class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA, acting by administrative order, can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.
FDA relies upon “valid scientific evidence,” as stated in section 513(a)(3) of the FD&C Act and defined in 21 CFR
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the requirements under section 510(k) of the FD&C Act if FDA determines that a premarket notification (510(k)) is not necessary to provide reasonable assurance of the safety and effectiveness of the device type.
On June 11, 2025, FDA published a proposed order
Therefore, in accordance with section 513(f)(3) of the FD&C Act, FDA, on its own initiative, is issuing this final order to reclassify oncology therapeutic ISH-based test systems from class III to class II (special controls).
After the effective date of this order, for these class II devices, manufacturers may submit a premarket notification and obtain FDA clearance of the devices before marketing them, as opposed to having to submit a PMA and receive approval. This action will decrease regulatory burden on industry, as manufacturers will no longer have to submit a PMA for this type of device but can instead submit a 510(k) to the Agency for review prior to marketing their device. A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately provides patients with more timely access to this type of device.
FDA received comments from fewer than 5 commenters on the proposed order published in the
We describe and respond to the comments in section II.B of this document. The order of the comments and our response to them is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received. Certain comments are grouped together under a single number because the subject matter is similar. Please note that in some cases we separated different issues discussed by the same commenter and designate them as distinct comments for purposes of our responses.
(Comment 1) FDA received numerous comments supporting the proposed reclassification of oncology therapeutic ISH-based test systems, from class III to class II, subject to special controls. Citing, among other things, ISH as a long-established technology, commenters stated they believe that special controls could be established to provide reasonable assurance of the safety and effectiveness of these devices. In addition, commenters noted that the decreased regulatory burden resulting from the reclassification could increase development and availability of these tests, thus offering better diagnostic options for clinicians and improving patient access to diagnostics and therapies.
(Response 1) FDA agrees with the comments supporting this reclassification. Based on the information the Agency considered and analyzed in proposing to reclassify these devices, as well as comments received in response to the proposed order, FDA has determined that reclassifying oncology therapeutic ISH-based test systems from class III (premarket approval) into class II (special controls) is appropriate. Specifically, based on the totality of information available, FDA has determined that general controls are insufficient to provide a reasonable assurance of safety and effectiveness for these devices and there is sufficient information to establish special controls for these devices that together with general controls will provide a reasonable assurance of safety and effectiveness. In addition, FDA also expects that the reclassification of these devices will enable more manufacturers to develop this type of device such that health care providers and patients will benefit from increased access to appropriately safe and effective tests.
(Comment 2) One commenter requested the Agency's guidance and further deliberation on these matters, either preceding or during a reclassification panel meeting.
(Response 2) FDA has determined that a classification panel is unnecessary to reclassify oncology therapeutic ISH-based test systems from class III to class II. Section 513(f)(3) of the FD&C Act provides that FDA may ask an appropriate panel to review information and make a recommendation before issuing an order reclassifying a postamendments device (see also 21 CFR 860.134(c)(2)). FDA is reclassifying these postamendments class III devices on its own initiative and does not believe a panel recommendation is needed to help determine whether these devices should be reclassified from class III to class II nor to identify appropriate special controls. FDA has determined, based on the information discussed in the preamble to the proposed order and FDA's consideration of public comments, that the standard in section 513(a)(1)(B) of the FD&C Act is met. Specifically, FDA has determined that general controls are insufficient to provide a reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls, which with general controls will provide a reasonable assurance of the safety and effectiveness when applied to these devices.
(Comment 3) One commenter expressed appreciation for the Agency's use of the least burdensome approach through discussion of predetermined change control plans (PCCPs) in the preamble to the proposed order. The commenter requested the Agency allow applicants to seek FDA's alignment on device-specific PCCPs via pre-submission rather than a pre-market notification and further requested that the Agency consider permitting PCCPs for a planned modification to already PMA-approved devices to include artificial intelligence (AI)/machine learning (ML) driven digital pathology (DP) algorithms intended to aid the end user or seek aid from the end user for end result generation, via PCCPs.
(Response 3) The new classification regulation at § 864.1890 (21 CFR 864.1890) applies to previously approved oncology therapeutic ISH-based test systems and new devices that are determined to be substantially equivalent. We note that, at the time of publication of this final order, FDA has not classified, cleared, approved, or granted authorization for any oncology therapeutic ISH-based test systems that incorporate DP devices, including AI/ML algorithm-assisted DP devices.
As described in the preamble of the proposed order, manufacturers may wish to use PCCPs as a way to implement future modifications to their devices without needing to submit a new 510(k) for each significant change or modification
(Comment 4) One comment recommended the Agency reference and “include the principles” of FDA's guidance, “Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices” in this final order.
(Response 4) FDA appreciates this comment and acknowledges that the guidance “Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices” may be applicable under certain circumstances to oncology therapeutic ISH-based test systems (Ref. 3). When evaluating the applicability of this guidance to specific modifications to a particular test system, interested parties should follow the logic scheme and recommendations contained in the guidance.
(Comment 5) One commenter requested several changes to the proposed classification regulation. The commenter recommended revising the proposed codified text for § 864.1890 by adding a new paragraph titled “Device Description and Principle of Operation,” as § 864.1890(b). The suggested language would require, presumably in a submission to FDA and/or in the device labeling, detailed elements of a device's intended use/indication for use including specifications for the intended use population(s), biomarker lists, specimen type(s), system components, biomarker definitions as used in the therapeutic product trials and as detected by the test, along with the corresponding therapeutic product(s) or therapeutic product group, and a description of whether the device is qualitative, semi-quantitative, or quantitative. The commenter also proposed renumbering the identification provision as paragraph (a) and classification provision as paragraph (c).
The commenter also recommended adding a new labeling special control, to be incorporated as § 864.1890(c)(2)(i), which would require § 809.10 (21 CFR 809.10) compliant labeling and any product information and test output generated to include the intended use statement as outlined in the commenter's proposed § 864.1890(b).
(Response 5) While FDA agrees that labeling special controls, in addition to general controls, are needed to assure the safety and effectiveness of oncology therapeutic ISH-based test systems, FDA
FDA declines to adopt the proposed revisions at § 864.1890(b) to the codified text. Much of this information is already required to be submitted to FDA under existing general controls. For example, § 809.10(b)(2) requires the type of procedure to be included in labeling (
FDA also declines to incorporate the commenter's proposed edits to the labeling special control. The suggested revisions would require labeling to include an intended use statement referencing the commenter's proposed § 864.1890(b), which FDA is not adopting for the reasons described in the previous paragraph. Moreover, the commenter's suggested requirements duplicate or overlap with existing regulatory requirements under § 809.10 and part 801 (21 CFR part 801), as well as the labeling elements already encompassed by the Agency's proposed special controls. The Agency's proposed special controls, along with applicable statutory and regulatory requirements, address all of the necessary intended use statements and operational descriptions (
(Comment 6) One comment acknowledged the suitability of the analytical performance tests outlined in the proposed order but recommended that FDA consider incorporating surrogate samples for use in the precision/reproducibility data generation, where the sample type can be supported as representative. This would apply to situations where sufficient clinical specimens for the intended use specimen type(s) are unavailable for analytical validation testing. The comment stated that such an inclusion would facilitate manufacturers' ability to conduct adequate verification testing by using surrogate samples that are morphologically comparable to the intended-use clinical specimens.
(Response 6) Based on the information FDA considered and analyzed in proposing to reclassify these devices, as well as comments received in response to the proposed order, FDA acknowledges that certain exceptional clinical circumstances may warrant consideration of alternative approaches to the use of clinical specimens for the purpose of analytical validation testing (
In addition to the above modification, FDA, based in part on the comments received, has also removed the special control requiring device performance data demonstrating appropriate reagent stability. Upon further review of the information the Agency considered and analyzed in proposing to reclassify these devices, such as postmarket safety data from medical device reports and recalls, as well as comments received on the proposed special controls, FDA believes that a special control requiring reagent stability data is not necessary and that general controls, such as premarket notification (510(k)) requirements and quality system requirements set forth under part 820 (21 CFR part 820) are sufficient to ensure that reagents are appropriately assessed and labeled such that this special control is not necessary. As such, the Agency is removing proposed § 864.1890(b)(1)(viii).
(Comment 7) One comment recommended FDA revise the “Identification” language of proposed § 864.1890 to include the term “companion.”
(Response 7) FDA disagrees with the recommended edit and is finalizing the identification language in this final order without change. The comment did not provide context to support the suggested revision, and FDA continues to believe that the identification, as proposed, provides an appropriate level of clarity regarding the type of device intended to fall within the scope of § 864.1890.
(Comment 8) One comment expressed a desire to work with the Agency to address nuanced clinical performance adequacy scenarios as potentially applicable to future devices either via a pre-submission route or alternative mechanism.
(Response 8) FDA agrees that questions of this nature may be appropriate topics to discuss with the Agency through the Q-Submission program. Prior to submission, a sponsor may seek FDA input on specific questions regarding review topics relevant to a planned marketing submission by utilizing our Q-Submission program. Through the Q-Submission program FDA may provide input on device-specific requirements and recommendations intended to support a marketing submission. Additional information regarding the Q-Submission program can be found in FDA's final guidance document titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” (Ref. 1).
Sponsors may also review information on FDA's Center for Devices and Radiological Health's (CDRH) website regarding previously approved oncology therapeutic ISH-based test systems, such as Summary of Safety and Effectiveness Data (SSED) documents available in FDA's Premarket Approval Database,
(Comment 9) One comment requested that FDA evaluate other devices and therapies with comparable risk profiles to determine whether reclassification may be appropriate, with the goal of broadening availability of such devices. The comment also requested that FDA review and update the special controls for oncology therapeutic ISH-based test systems on a regular basis and ensure that clinical data supporting the development and implementation of the special controls is transparent and readily available to interested parties.
(Response 9) The FDA periodically reviews the classification of devices to ensure they are being regulated in the appropriate class (class III, II, I) with the necessary level of regulatory controls. CDRH has previously undertaken reclassification efforts as part of the Center's systematic approach, including the 2014-2015 Strategic Priorities,
Further, FDA acknowledges the comment's request that the Agency regularly review and update the special controls and ensure transparency. For class II devices, special controls are established to provide reasonable assurance of safety and effectiveness for the device type and are developed based on the totality of available scientific evidence at the time of classification or reclassification. As new information becomes available, including advances in scientific knowledge and changes in device technology, FDA may evaluate whether such developments and device modifications give rise to new benefit-risk considerations such that new or different special controls, in addition to general controls, are needed to assure the safety and effectiveness for the device type.
With respect to transparency, FDA strives to make publicly available the scientific basis for its regulatory decisions, consistent with applicable statutes and regulations. In general, the clinical and scientific information that forms the basis of the special controls is included in the public docket associated with the classification or reclassification action, to the extent permitted by law. FDA, therefore, believes that the current regulatory framework provides an appropriate mechanism for ensuring the relevance of special controls and the availability of supporting information. No changes to the final order have been made in response to this comment.
(Comment 10) One comment proposed edits to Table 1. Risks to Health and Mitigation Measures in the proposed order. The comment proposed additional mitigation measures to each of the three identified risks to health to include, for example, the addition of “
(Response 10) As discussed in response to comment 5, FDA disagrees that such line edits or clarifications are needed to the mitigations identified in the proposed order. The mitigation measures proposed to be added to table 1 correspond to this commenter's proposed additions to the codified, as described in comment 5. As noted in response to comment 5, the language proposed by the commenter is generally already covered for oncology therapeutic ISH-based test systems by the regulatory requirements for IVDs under part 801 and § 809.10, as well as the Agency's proposed special controls. FDA believes that the special controls set forth in the proposed order with the changes identified in this final order (see comment 5 and the Agency's response), together with general controls, are sufficient to effectively mitigate the risks to health identified in section V of the proposed order and are necessary to provide a reasonable assurance of the safety and effectiveness of oncology therapeutic ISH-based test systems. For these reasons, we decline to incorporate the proposed edits.
With regards to the commenter's recommendation to include “
(Comment 11) One comment requested clarification on how FDA's determination that devices under the relevant oncology therapeutic ISH-based test system product codes share similar purposes, designs, functions, and risk profiles would affect their use as predicate devices under the 510(k) pathway. The commenter also sought general guidance on how substantial equivalence would be evaluated in cases where a device's intended use or labeling is expanded, such as to include a new oncology therapeutic product, clinical indication, or clinical cut-off.
(Response 11) FDA acknowledges the commenter's request for clarification regarding the implications of this reclassification on the use of these devices as predicates under the 510(k) pathway. While the Agency has determined that devices within the relevant product codes share similar purposes, designs, functions, and overall risk profiles for purposes of reclassification, this determination does not alter the statutory and regulatory requirements applicable to demonstrating substantial equivalence. For a new device to be considered substantially equivalent to a predicate device, the new device must have the same intended use as the predicate device and the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness than the predicate device. Additional information can be found in FDA's final guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” (Ref. 4).
In accordance with section 513(i) of the FD&C Act and part 807, substantial equivalence determinations are made on a case-by-case basis and depend on the specific intended use and technological characteristics of the device under review. Any oncology therapeutic ISH-based test system with a new intended use or technological characteristics that raise different questions of safety and
(Comment 12) One comment requested that the Agency clarify that devices already on the market would be automatically reclassified into class II without the need for any additional premarket notification or submission, and that only future devices, or currently marketed devices with significant modifications, would be required to submit a premarket notification.
(Response 12) FDA appreciates the need to provide clarification on the implementation of this final order. To provide such clarification and assist in the efficient implementation of this final order, the Agency has added an implementation strategy in section IV of this final order. Among other things, section IV clarifies that upon its effective date the final order reclassifies devices that are oncology therapeutic ISH-based test systems as described within the scope of the proposed order and adopted as part of this final order, from class III (premarket approval) into class II (special controls). Oncology therapeutic ISH-based test systems with prior PMA approval may continue to be marketed per the previous marketing authorization and would not require an additional marketing application. For changes or modifications that could significantly affect the safety or effectiveness of such devices or a major change or modification in the intended use of such devices (see § 807.81(a)(3)), FDA expects that manufacturers will submit a 510(k) for the modified device.
(Comment 13) One comment encouraged FDA to issue a detailed guidance regarding the special controls described in the proposed order at the same time as the publication of this final order in the
(Response 13) At this time, FDA does not intend to issue a guidance document regarding compliance with the special controls identified in this final order. For the reasons discussed in the proposed order, the Agency believes that the special controls, as stated in § 864.1890(b), provide sufficiently clear and appropriate requirements, at a level of detail necessary to reasonably assure the safety and effectiveness of this device type. Should FDA determine in the future that further information is warranted, the Agency may consider issuing guidance. The Agency also believes information available to sponsors through other resources will be helpful in preparing 510(k)s for submission and complying with special controls. For example, sponsors may review information on CDRH's website regarding previously approved oncology therapeutic ISH-based test systems such as SSED documents available in FDA's Premarket Approval Database, which detail the clinical evidence, risks, and benefits for approved devices. In addition, the performance data and related valid scientific evidence included in 510(k)s reviewed by FDA may be a helpful resource. Once available, sponsors may consider reviewing the 510(k) Decision Summaries in FDA's 510(k) Premarket Notification Database to inform the types of performance the Agency expects for this type of device.
In this final order, FDA is adopting relevant findings, including the reasoning that supports those findings, from the June 11, 2025, proposed order. FDA has made revisions in this final order based, in part, on the comments received (see section II). FDA is issuing this final order to reclassify oncology therapeutic ISH-based test systems from class III into class II under a new device classification regulation with the name In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product, and to establish special controls by revising 21 CFR part 864 (adding § 864.1890).
Further, in this final order, FDA has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, along with general controls, provide a reasonable assurance of the safety and effectiveness for oncology therapeutic ISH-based test systems. As described in section II of this document, FDA has made revisions to the special controls as previously described in the proposed order. Based, in part, on comments regarding the proposed order, FDA has revised the design verification and validation special controls to add to the existing proposed § 864.1890(b)(1)(v) requirement the consideration of surrogate samples that adequately represent the intended use specimen type(s) and intended use biomarker(s), as appropriate, as determined by FDA, to supplement clinical specimens. Additionally, FDA has removed the proposed § 864.1890(b)(1)(viii) requiring device performance data demonstrating reagent stability.
Based on the information discussed in the preambles to the proposed order and this final order, including the comments received for the proposed order, FDA concludes that special controls, in addition to general controls, provide a reasonable assurance of the safety and effectiveness of oncology therapeutic ISH-based test systems. In this final order, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, along with general controls, provide a reasonable assurance of the safety and effectiveness of these devices. In addition, in this final order, to provide additional clarification and to efficiently implement this order, the Agency has added an implementation strategy in section IV.
Under the FD&C Act, 510(k) submissions are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m).
Under this final order, oncology therapeutic ISH-based test systems are prescription use IVD devices and as such, these tests must satisfy prescription labeling requirements for IVD products (see § 809.10(a)(4) and (b)(5)(ii)). This device type is subject to the submission and device clearance requirements of sections 510(k) and 513 of the FD&C Act and of part 807, subpart E, of FDA's regulations.
This final order is effective 30 days after the date of its publication in the
For oncology therapeutic ISH-based test systems that have not been offered for sale prior to the effective date of the final order, manufacturers must obtain 510(k) clearance before marketing the device (and for subsequent modifications to the device, as appropriate).
For oncology therapeutic ISH-based test systems that have been offered for sale prior to the effective date of the final order and have prior PMA approval, such devices may continue to be marketed under the previously issued PMA approval and do not require an additional marketing authorization.
For devices that have been legally marketed via PMA before the effective date of this final order, FDA expects that manufacturers will submit a 510(k) premarket notification when making a change or modification that could significantly affect the safety or effectiveness of the device or a major change or modification in the intended use of the device. See § 807.81(a)(3).
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final administrative order refers to previously approved collections of information found in FDA regulations. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 820 (Quality Management System Regulation) have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 (Investigational Device Exemptions) have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814, subparts A through E (Premarket Approval of Medical Devices) have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E (Premarket Notification Procedures) have been approved under OMB control number 0910-0120; and the collections of information in parts 801 and 809 (Device Labeling) have been approved under OMB control number 0910-0485.
Under section 513(f)(3) of the FD&C Act, FDA may issue final orders to reclassify devices. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as newly codified orders. Therefore, under section 513(f)(3) of the FD&C Act, we are codifying in this final order the classification of In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product in the new § 864.1890, under which these oncology therapeutic ISH-based test systems are reclassified from class III into class II.
The following references are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
Blood, Medical devices, Packaging and containers.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Design verification and validation must include:
(i) Specification for risk mitigation elements intended to mitigate risks
(ii) Specification of the criteria for test result interpretation and reporting, including device cut-off(s) (
(iii) Device performance data demonstrating appropriate analytical sensitivity from studies using interphase nuclei from intended use specimen type(s) that are considered karyotypically normal, or through an alternative approach, as determined to be appropriate by FDA (
(iv) Device performance data demonstrating appropriate analytical specificity of the device for the intended use specimen type(s), as determined to be appropriate by FDA (
(v) Device performance data demonstrating appropriate precision and reproducibility of the device using clinical specimens representing the intended use specimen type(s) and intended use biomarker(s) from the intended use population and investigating major sources of variability (
(vi) Device performance data demonstrating appropriate device robustness, as determined to be appropriate by FDA. The study must assess the tolerance ranges for various critical test and specimen parameters, as applicable.
(vii) Device performance data demonstrating linearity of quantitative results using samples covering the device measuring range, as applicable.
(viii) Device performance data demonstrating appropriate specimen stability based on the intended use specimen type(s) of the device, as applicable.
(ix) Clinical data generated using well-characterized clinical specimens representative of the intended use population demonstrating appropriate clinical performance of the device for its intended use, as determined to be appropriate by FDA.
(2) Labeling must include:
(i) An appropriate summary, as determined by FDA, of the performance studies performed and the results of those studies, including those that relate to all design verification and validation special controls.
(ii) A limiting statement, as appropriate, that explains that the test results are intended to be interpreted by a qualified or appropriately trained reader in conjunction with other diagnostic laboratory test results and/or pathology test results, relevant clinical information, and proper controls.
(iii) Language indicating that the test system is indicated for use with a corresponding FDA-approved oncology therapeutic product and device labeling must be consistent with the information set forth in the corresponding FDA-approved oncology therapeutic product labeling.
Alcohol and Tobacco Tax and Trade Bureau, Treasury.
Final rule; Treasury decision.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) establishes the 29,387-acre “Columbia Hills” American viticultural area (AVA) in Klickitat County, Washington. The newly established AVA is located entirely within the existing Columbia Valley viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
This final rule is effective September 16, 2026.
Karen A. Thornton, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW, Box 12, Washington, DC 20005; phone 202-453-1039, ext. 175.
In accordance with 5 U.S.C. 553(b)(4), a summary of this rule may be found at
Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury (Secretary) to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated certain administrative and enforcement authorities to the TTB Administrator through Treasury Order 120-01.
Part 4 of the TTB regulations (27 CFR part 4) authorizes TTB to establish definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission to TTB of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.
Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features as described in part 9 of the regulations and, once approved, a name and a delineated boundary codified in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.
Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and allows any interested party to petition TTB to establish a grape-growing region as an AVA. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions to establish or modify AVAs. Petitions to establish an AVA must include the following:
• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;
• An explanation of the basis for defining the boundary of the proposed AVA;
• A narrative description of the features of the proposed AVA affecting viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA;
• If the proposed AVA is to be established within, or overlapping, an existing AVA, an explanation that both identifies the attributes of the proposed AVA that are consistent with the existing AVA and explains how the proposed AVA is sufficiently distinct from the existing AVA and therefore appropriate for separate recognition;
• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and
• A detailed narrative description of the proposed AVA boundary based on USGS map markings.
TTB received a petition to establish the “Columbia Hills” AVA submitted on behalf of the owner of Cascade Cliffs Vineyard and Winery, which is located within the proposed AVA. The proposed Columbia Hills AVA is located in Klickitat County, Washington, and is entirely within the established Columbia Valley AVA (27 CFR 9.74). Within the proposed AVA, there are approximately 338 acres of vineyards owned by 19 different property owners, as well as 4 wineries. The distinguishing features of the proposed Columbia Hills are its topography, soils, and climate.
The proposed AVA is situated on the southern slopes of the Columbia Hills, a 35-mile-long ridgeline that parallels the north side of the Columbia River between Rowena Gap and the mouth of Rock Creek in Klickitat County, Washington. Erosion of the generally flat-lying layers of bedrock by ice-age flooding created a series of south-facing stepped terraces within the proposed AVA. Large, gently-sloped gravel bars deposited by ice-age floods also exist within the proposed AVA. The petition states that these gently-sloped terraces and gravel bars provide excellent locations for vineyards within the otherwise steeply sloped valley of the Columbia River.
The soils of the proposed Columbia Hills AVA are divided into two main soil map units—the Cheviot—Horseflat—Rockly—Kiona unit, which is described as “well-drained soils that formed in colluvium and residuum derived from basalt mixed with loess;” and the Ewall-Dallesport-Rock Outcrop unit, which consists of wind-deposited sand that was draped over the bedrock and gravel bars that were left behind when the ice-age floods ceased. The soils of the proposed AVA are well drained to excessively well drained and are typically much coarser than the loess-based soils that are common elsewhere in the Columbia River basin. The petition states that the coarse soils warm more quickly than finer soils and encourage vines to root deeply.
According to the petition, 80 percent of the land in the proposed Columbia Hills AVA is within a mile of the Columbia River, which acts as a thermal reservoir to moderate the climate near its shores. Due to its proximity to the river, the proposed AVA generally has warmer growing season temperatures than the surrounding regions, particularly during the early morning hours. Average growing season temperatures within the proposed AVA range from 63.9 to 67.7 degrees Fahrenheit (F), with average growing season maximum temperatures between 74.5 and 80.2 degrees F and average growing season minimum temperatures between 53 and 55.3 degrees F.
The average number of frost-free days within the proposed AVA ranges between 194 and 254 days. The average number of growing degree days (GDDs)
To the north of the proposed AVA, the topography is much steeper, higher, and less impacted by ice-age flooding than the proposed AVA. Soils are generally deep and derived from loess. Growing season average temperatures are lower, ranging from 57 to 59.5 degrees F, as are average growing season maximum and minimum temperatures, which range from 72 to 77 degrees F and 42 to 43 degrees F, respectively. Average annual GDD accumulations to the north of the proposed AVA are also lower, ranging from 1,834 to 2,309 GDDs. The average frost-free period to the north ranges from 142 to 164 days.
To the east of the proposed Columbia Hills AVA is the established The Burn of Columbia Valley AVA (27 CFR 9.276), which is relatively flat and has higher elevations that were less impacted by ice-age floods. The soils are primarily from the Van Nostern—Morrow—Bakeoven soil unit and contain large amounts of loess. Annual precipitation rates average less than 10 inches.
South of the proposed AVA, elevations are generally lower and the slopes have a northerly aspect. Soils are generally deep and derived from loess.
West of the proposed Columbia Hills AVA is the established Columbia Gorge AVA (27 CFR 9.178), which has higher elevations and a more diverse topography. Soils within the established Columbia Gorge AVA are also more diverse than within the proposed AVA due to large variations in bedrock, elevation, and slope angles. Temperatures are lower to the west of the proposed AVA, with average growing season temperatures ranging from 58.7 to 62 degrees F. Average GDD accumulations range from 2,107 to 2,647 GDDs.
TTB published Notice No. 235 in the
In Notice No. 235, TTB solicited comments on the accuracy of the name, boundary, and other required information submitted in support of the petition. In addition, given the proposed Columbia Hills AVA's location within the Columbia Valley AVA, TTB solicited comments on whether the evidence submitted in the petition sufficiently differentiates it from the established AVA. TTB also requested comments on whether the features of the proposed AVA are so distinguishable from the established AVA that the proposed AVA should no longer be part of the established AVA. The comment period closed February 3, 2025.
TTB received five comments in response to Notice No. 235, four of which specifically support the proposed AVA. One comment from a representative of V75 Vineyard (comment 4) describes the area as having a unique terroir distinct from other grape growing areas in the northwest. Another representative of V75 Vineyard (comment 2) describes the winds, growing degree days, and geology as unique features that support distinguishing this area within the larger Columbia Valley AVA. This commenter also notes the appropriateness of the AVA name for this region. The supporting comments from V75 Vineyard representatives (comments 2, 4, and 5) also express the view that establishing the proposed AVA will provide economic benefits to the region, helping support and market the region's vineyards and wines. A separate comment (comment 3) describes the proposed AVA as “one of the most interesting grape-growing/viticultural areas identified in years.”
The remaining comment (comment 1) expressed neither support nor opposition to the proposed AVA and just asked whether the proposed “Columbia Hills” name might be confused with the established Columbia Valley AVA. TTB notes that, as described more fully in the Notice No. 235, the petition provided evidence that the area of the proposed AVA is known by the name “Columbia Hills”, which is reflected in the Columbia Hills Natural Area Preserve and Columbia Hills Historical State Park. TTB did not receive any comments in response to Notice No. 235 questioning the sufficiency of the name evidence. As noted below in the section “Impact on Current Wine Labels,” because the Columbia Hills AVA is situated within and maintains features consistent with the Columbia Valley AVA, vintners will be able to use “Columbia Hills,” “Columbia Valley,” or both as appellations of origin for wines made primarily from grapes grown within the Columbia Hills AVA if the wines meet the eligibility requirements for these appellations. As with the establishment of any AVA, the extent to which wine consumers recognize the name of the AVA and associate the name with certain features of the wine depends upon the efforts of vineyard owners and winemakers in the region, which are factors beyond the establishment of the AVA.
After careful review of the petition and the comments received in response to Notice No. 235, TTB finds that the evidence provided by the petitioner supports establishing the Columbia Hills AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and parts 4 and 9 of the TTB regulations, TTB establishes the “Columbia Hills” AVA in Klickitat County, Washington, effective 30 days from the publication date of this document.
TTB has also determined that the Columbia Hills AVA will remain part of the established Columbia Valley AVA. As discussed in Notice No. 235, the Columbia Hills AVA shares some broad characteristics with the established AVA. For example, the proposed AVA and the Columbia Valley AVA both have growing seasons longer than 150 days, limited annual rainfall amounts, and GDD accumulations generally over 2,000. Unlike the surrounding Columbia Valley AVA, however, the proposed Columbia Hills AVA is not a large, treeless basin. Instead, the proposed AVA is a region of hillslopes and flood-carved terraces within a deeply incised river valley.
See the narrative description of the boundary of the Columbia Hills AVA in the regulatory text published at the end of this final rule.
The petitioners provided the required maps, and they are listed below in the regulatory text. The Columbia Hills AVA boundary may also be viewed on the AVA Map Explorer on the TTB website, at
Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.
With the establishment of the Columbia Hills AVA, its name,
The establishment of the Columbia Hills AVA will not affect the existing Columbia Valley AVA, and any bottlers using “Columbia Valley” as an appellation of origin or in a brand name for wines made from grapes grown within the Columbia Valley AVA will not be affected by the establishment of this new AVA. The establishment of the Columbia Hills AVA will allow vintners to use “Columbia Hills,” “Columbia Valley,” or both as appellations of origin for wines made primarily from grapes grown within the Columbia Hills AVA if the wines meet the eligibility requirements for these appellations.
TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.
It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866, as amended. Therefore, no regulatory assessment is required.
Karen A. Thornton of the Regulations and Rulings Division drafted this final rule.
Wine.
For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:
27 U.S.C. 205.
(a)
(b)
(1) Hood River OR-WA, 1982; and
(2) Goldendale, WA-OR, 1980.
(c)
(1) The beginning point is on the Hood River map at the intersection of the northern shoreline of the Columbia River and an unnamed creek due east of the marked “Cold Spring.” From the beginning point, proceed northerly along the unnamed creek to its intersection with the 300-meter elevation contour; then
(2) Proceed east along the 300-meter elevation contour to the eastern boundary of the Hood River map; then
(3) Proceed north along the map boundary for approximately 400 feet; then
(4) Proceed east onto the 320-meter elevation contour on the Goldendale map and continue east along the 320-meter elevation contour to its intersection with the boundary between Range 18 East and Range 19 East, south of Sand Spring Canyon; then
(5) Proceed southeast in a straight line for 9,000 feet (1.7 miles) to the intersection of the boundary between sections 31 and 32, T3N/R19E and the northern shoreline of the Columbia River; then
(6) Proceed west along the northern shoreline of the Columbia River, returning to the beginning point.
Coast Guard, Department of Homeland Security.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters on the Fox River, in Green Bay, WI. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with an overwater fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Sector Lake Michigan, or their designated representative.
This rule is effective on September 5, 2026, from 9 p.m. to 9:45 p.m.
To view available documents go to
If you have questions about this rule, contact MSTC Dylan Caikowski, Sector Lake Michigan, Waterways Management Division, U.S. Coast Guard; telephone (571) 608-0739, or email
The Coast Guard received notification that fireworks will be launched from land adjacent to the Fox River in Green Bay, WI. The Captain of the Port (COTP) Sector Lake Michigan has determined that potential hazards associated with fireworks are a safety concern for anyone within 500 feet of the fireworks display.
Therefore, the COTP is issuing this rule under the authority in 46 U.S.C. 70034, which is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.
Because of these potential hazards, the Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard was notified of this event on July 29, 2026, but we must establish this safety zone by September 5, 2026, to protect personnel, vessels, and the marine environment. Therefore, we do not have enough time to solicit and respond to comments.
For the same reason, the Coast Guard finds that under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the
This rule establishes a temporary safety zone on September 5, 2026, from 9 p.m. until 9:45 p.m. The safety zone will cover all navigable waters of the Fox River within 500 feet of the fireworks launch location in approximate GPS position 44°31.25′ N, 088°00.778′ W. Vessels and persons will not be allowed to enter the zone during this time, unless authorized by the Captain of the Port, Sector Lake Michigan or a designated representative.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analysis based on a number of these statutes and Executive orders.
The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the
Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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.
As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
This rule is a safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket.
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; DHS Delegation No. 00170.1, Revision No. 01.4.
(a)
(b)
(c)
(2) To seek permission to enter, contact the COTP or the COTP's representative on VHF-FM channel 16 or by telephone at (414) 747-7182. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of calcium carbonate (CAS # 471-34-1), in or on all food commodities when used in accordance with label directions and good agricultural practices. Columbia River Carbonates, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of calcium carbonate in or on all food commodities, in accordance with the terms of the exemption.
This regulation is effective August 17, 2026. Objections and requests for hearings must be received on or before October 16, 2026, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of this document).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2022-0743, is available at
Shannon Borges, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1606; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them:
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(c)(2)(A)(i) allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” FFDCA section 408(c)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider, among other things, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0743 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 16, 2026.
EPA's Administrative Law Judges Division (ALJD), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket at
In the
The notice of filing referenced a summary of the petition prepared by Columbia River Carbonates, which is available in the docket at
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” 21 U.S.C. 346a(c)(2)(A)(i). Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.”
Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C) and (D). FFDCA section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . . ” It provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) safety factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA supports the choice of a different factor.
Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider, among other things, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for calcium carbonate, including exposure resulting from the tolerance exemption established by this action.
A full explanation of the data upon which the EPA relied and its risk assessment based on those data can be found within the document entitled, “HH Assessment Calcium Carbonate.” This document, as well as other relevant information, is available in the docket for this action as described under
Calcium carbonate is of low acute toxicity. Calcium carbonate is of low acute oral toxicity (Toxicity Category III), of low acute dermal toxicity (Toxicity Category III) and inhalation toxicity (Toxicity Category IV). It is not an eye irritant (Toxicity Category IV), not a dermal irritant (Toxicity Category IV) and is not a dermal sensitizer in mice. A non-occupational and occupational short- and intermediate-term (1 day to 6 months) inhalation endpoint was found. The endpoint was derived from the 90-day inhalation toxicity study in rats. The no observed adverse effect level (NOAEL) of 0.123 mg/L and lowest observed adverse effect concentration (LOAEC) of 0.212 mg/L for portal of entry effects are based on increased bronchoalveolar lavage (BAL) derived enzymes changes (ALP and LDH) and increased neutrophil and protein levels in females. It was noted that the LOAEC was selected conservatively, and likely reflects an inflection point for the effects observed at the highest dose tested, due to the lack of measurements in the percent viable cells after the recovery period for the three middle doses and lack of weight information in the other two lung regions. There were no systemic effects up to the highest dose tested (0.399 mg/L). The level of concern (LOC) for short- and intermediate-term inhalation exposure is 30 (3X for interspecies extrapolation and 10X for intraspecies variation). The standard interspecies extrapolation uncertainty factor can be reduced from 10X to 3X due to the HEC calculation accounting for pharmacokinetic interspecies differences and not pharmacodynamic, interspecies differences. The total UF of 30X for occupational inhalation exposure scenarios includes: 3X for interspecies extrapolation, and 10X for intraspecies variability (LOC=30).
EPA concluded that an FQPA safety factor is not required at this time as the calcium carbonate toxicology database is complete and adequate to characterize potential pre- and post-natal toxicity to infants and children, there is no indication of increased quantitative or qualitative susceptibility in the developmental or reproduction toxicity studies, and no dietary endpoints have been identified.
In accordance with the FFDCA, EPA must consider and aggregate pesticide exposures and risks from three major sources: food, drinking water, and residential exposures. In evaluating dietary exposure to calcium carbonate from pesticide chemical residues in food or feed, EPA considered exposure under the petitioned-for tolerance exemption. Given that no toxicological endpoints were identified, EPA conducted a qualitative dietary exposure and risk assessment. EPA's dietary exposure assessment also includes exposure to pesticide residues in drinking water. Finally, as required under the FFDCA, EPA assessed the potential for “residential exposure,” which refers to non-occupational, non-dietary exposure. EPA did not conduct a quantitative aggregate exposure assessment as no endpoints were selected for oral and dermal exposures. While an inhalation endpoint was selected, the exposures cannot be combined as no endpoints were selected for oral and dermal exposures.
Based on the lack of toxicity in the available data, calcium carbonate and its metabolites are not expected to share a common mechanism of toxicity with other chemicals. For the purposes of this action, therefore, EPA has assumed that calcium carbonate does not have a common mechanism of toxicity with other substances.
EPA determines whether chronic dietary pesticide exposure is safe by comparing estimated aggregate food and drinking water exposure to the chronic population adjusted dose. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure exists.
Based on the data summarized in the calcium carbonate Human Health Risk Assessment, EPA has concluded that calcium carbonate does not pose any risks of concern to the U.S. population, including any subpopulations, based on aggregate exposure to calcium carbonate, for any exposure scenario. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the general U.S. population, or to infants and children, from aggregate exposure to calcium carbonate residues.
An analytical method is not required for calcium carbonate because the EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Based upon its evaluation in the Human Health Risk Assessment, the EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of calcium carbonate. Therefore, an exemption from the requirement of a tolerance is established for residues of calcium carbonate in or on all food commodities.
This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), because it establishes or modifies a pesticide tolerance or a tolerance exemption under FFDCA section 408 in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866.
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because actions that establish a tolerance under FFDCA section 408 are exempted from review under Executive Order 12866.
This action does not impose an information collection burden under the PRA 44 U.S.C. 3501
This action is not subject to the RFA, 5 U.S.C. 601
This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any State, local, or Tribal governments or the private sector.
This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects 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.
This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.
However, EPA's 2026
This action is not subject to Executive Order 13211 (66 FR 28355) (May 22, 2001) because it is exempt from review under Executive Order 12866.
This action does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
This action is subject to the CRA, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, EPA is amending 40 CFR chapter I as follows:
21 U.S.C. 321(q), 346a and 371.
An exemption from the requirement of a tolerance is established for residues of calcium carbonate in or on all raw agricultural commodities when used in accordance with label directions and good agricultural practices.
Food and Nutrition Administration (FNA), USDA.
Proposed rule; extension of comment period.
The U.S. Department of Agriculture's (USDA) Food and Nutrition Administration (FNA) is extending the public comment period on the proposed rule, “Supplemental Nutrition Assistance Program: Changes in Federal-State Administrative Cost Sharing,” which was published in the
The comment period for the proposed rule published June 24, 2026, at 91 FR 37837, is extended. To be assured of consideration, comments on this proposed rule must be received by FNA on or before September 8, 2026.
FNA invites interested persons to submit comments on this proposed rule. Comments may be submitted by any of the following methods:
Maribelle Balbes, FNA, 1320 Braddock Place, Alexandria, VA 22314, 703-605-4272, and
In response to section 10106 of Public Law 119-21, the One Big Beautiful Bill Act of 2025, this proposed rule would amend the Supplemental Nutrition Assistance Program (SNAP) regulations to codify the reduction of the amount of the Federal Government's share of annual SNAP State administrative costs from 50 percent to 25 percent, effective beginning in fiscal year 2027. The Department published the proposed rule in the
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Rolls-Royce Deutschland Ltd & Co KG (RRD) Model Trent XWB-75, XWB-79, XWB-79B, and XWB-84 engines. This proposed AD was prompted by reports of differential oil pressure measurements that were lower than expected on in-service engines. This proposed AD would require modification of the engine with an improved front bearing housing oil feed tube assembly. This proposed AD would also prohibit the installation of an affected front bearing housing oil feed tube assembly on any engine. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this NPRM by October 1, 2026.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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• For European Union Aviation Safety Agency (EASA) material identified in this proposed AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
• You may view this material at the FAA, Airworthiness Products Section,
Barbara Caufield, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198; phone: (781) 238-7146; 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
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 Barbara Caufield, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2024-0070, dated March 14, 2024 (EASA AD 2024-0070) (also referred to as the MCAI), to correct an unsafe condition on RRD Model Trent XWB-75, XWB-79, XWB-79B, and XWB-84 engines. The MCAI states that occurrences have been reported of in-service engines measuring differential oil pressures that were lower than expected. A manufacturer investigation identified a need to restrict excess oil supply to the front bearing housing bearing chamber because oil pressure could drop below the amber limit during operation at the extremes of the flight envelope. To address this potential unsafe condition, RRD developed a modification that introduced an improved oil tube assembly that re-distributes the oil flow between all bearing chambers and gearboxes, thereby increasing the overall differential oil pressure within the oil feed system. RRD also published service material with instructions for replacement of affected front bearing housing oil feed tube assemblies with the improved modification assemblies. The FAA is proposing this AD to prevent oil pressure from dropping below the safe operating range. This condition, if not addressed, could result in front bearing housing bearing chamber firing, which could lead to an engine in-flight shutdown (IFSD) or dual IFSD with consequent reduced control or loss of control of the airplane.
You may examine the MCAI in the AD docket at
The FAA reviewed EASA AD 2024-0070, which specifies procedures for modification of the engine with an improved front bearing housing oil feed tube assembly. EASA AD 2024-0070 also prohibits the installation of an affected front bearing housing oil feed tube assembly on any engine. 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 (CAA) 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 on other products of the same type design.
This proposed AD would require accomplishing the actions specified in the MCAI, described previously, as incorporated by reference, 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 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 2024-0070 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2024-0070 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 2024-0070 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 2024-0070. Material required by EASA AD 2024-0070 for compliance will be available at
The FAA estimates that this AD, if adopted as proposed, would affect 80 engines installed on airplanes of U.S. registry.
The FAA estimates the following costs to comply with 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 1, 2026.
None.
This AD applies to all Rolls-Royce Deutschland Ltd & Co KG Model Trent XWB-75, XWB-79, XWB-79B and XWB-84 engines.
Joint Aircraft System Component (JASC) Code 7931, Engine Oil Pressure.
This AD was prompted by reports of differential oil pressures that were lower than expected on in-service engines. The FAA is issuing this AD to prevent oil pressure from dropping below the safe operating range. The unsafe condition, if not addressed, could result in front bearing housing bearing chamber firing, which could lead to an engine in-flight shutdown (IFSD) or dual IFSD with consequent reduced control or loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraphs (h) and (i) of this AD: Perform all required actions within the compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) EASA AD 2024-0070, dated March 14, 2024 (EASA AD 2024-0070).
(1) Where EASA AD 2024-0070 refers to its effective date, this AD requires using the effective date of this AD.
(2) Where the service material referenced in EASA AD 2024-0070 specifies to discard certain parts, this AD requires those parts be removed from service.
(3) This AD does not adopt the “Remarks” paragraph of EASA AD 2024-0070.
Although the material referenced in EASA AD 2024-0070 specifies to submit certain information to the manufacturer, this AD does not include that requirement.
The Manager, AIR-520 Continued Operational Safety Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the AIR-520 Continued Operational Safety Branch, send it to the attention of the person identified in paragraph (k) of this AD and email to:
For more information about this AD, contact Barbara Caufield, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198; phone: (781) 238-7146; 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 2024-0070, dated March 14, 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, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. 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
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to revoke the Class E airspace at Diamond “O” Ranch Airport, Santa Elena, TX. The FAA is proposing this action due to the instrument procedures being cancelled and the decommissioning of the Santa Elena radio beacon (RBN).
Comments must be received on or before October 1, 2026.
Send comments identified by FAA Docket No. FAA-2026-9901 and Airspace Docket No. 26-ASW-13 using any of the following methods:
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FAA Order JO 7400.11K, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Raul Garza Jr., Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5874.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would remove the Class E airspace at the affected airport because it is no longer needed to support IFR operations.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it received on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Class E airspace relevant to this action is published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11K, dated August 4, 2025, and effective September 15, 2025. These updates would be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11K, which lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points, is publicly available as listed in the
The FAA is proposing an amendment to 14 CFR part 71 that would remove the Class E airspace extending upward from 700 ft. above the surface at Diamond “O” Ranch Airport, Santa Elena, TX due
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Order 2100.6B, “Policies and Procedures for Rulemakings” (March 10, 2025); and (3) is expected to result in, at most, de minimis costs from compliance with applicable operating requirements or minor flight rerouting for operators choosing to navigate around the controlled airspace. Since these proposed amendments are routine and the expected impact to operators is de minimis, the FAA certifies that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1G, “FAA National Environmental Policy Act Implementing Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Northwestern Memorial Healthcare Heliport, DeKalb, IL. The FAA is proposing this action to support new instrument procedures and instrument flight rule (IFR) operations.
Comments must be received on or before October 1, 2026.
Send comments identified by FAA Docket No. FAA-2026-9835 and Airspace Docket No. 26-AGL-19 using any of the following methods:
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FAA Order JO 7400.11K, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Raul Garza Jr., Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5874.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace extending upward from 700 feet above the surface at Northwestern Memorial Healthcare Heliport, DeKalb, IL, to support IFR operations at this airport.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it received on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Class E airspace is published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11K, dated August 4, 2025, and effective September 15, 2025. These updates would be published subsequently in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11K, which lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points, is publicly available as listed in the
The FAA is proposing an amendment to 14 CFR part 71 that would establish Class E airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Northwestern Memorial Healthcare Heliport, DeKalb, IL.
This action is the result of instrument procedures being developed for this airport to support IFR operations.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Order 2100.6B, “Policies and Procedures for Rulemakings” (March 10, 2025); and (3) is expected to result in, at most, de minimis costs from compliance with applicable operating requirements or minor flight rerouting for operators choosing to navigate around the controlled airspace. Since these proposed amendments are routine and the expected impact to operators is de minimis, the FAA certifies that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1G, “FAA National Environmental Policy Act Implementing Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Northwestern Memorial Healthcare Heliport.
Food and Drug Administration, HHS.
Notification; request for comments.
As required by the FDA Reauthorization Act of 2017 (FDARA), the Food and Drug Administration (FDA or Agency) has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, making them appropriate for class I classification. FDA is publishing this document proposing to classify these accessories into class I and distinct from other devices, as well as seeking public comment in accordance with procedures established by FDARA. This document does not represent FDA's final determination with respect to the proposed accessories listed in this document.
Either electronic or written comments on the notification must be submitted by October 16, 2026.
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:
•
• 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:
•
• 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
Ian Ostermiller, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-796-5678.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) sets forth a process to classify certain medical devices,
The accessories subject to this proposal are devices regulated under the FD&C Act. Specifically, section 201(h) of the FD&C Act defines a “device” to include, among other articles, an “accessory” (see 21 U.S.C. 321(h)). An accessory is a kind of device, and all articles that meet the definition of “device” are regulated under the FD&C Act. FDA has described our current thinking on which devices FDA would generally consider to be accessories in the guidance document, “Medical Device Accessories—Describing Accessories and Classification Pathways”(“Accessories Guidance”).
FDA regulates devices according to classes that reflect the regulatory controls necessary to provide reasonable assurance of their safety and effectiveness. Section 513 of the FD&C Act defines three classes of devices, which are class I (general controls), class II (special controls), and class III (premarket approval). Because accessories may have marketing
General controls, under section 513(h)(1) of the FD&C Act, are the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 of the FD&C Act (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, and 360j). These controls include, but are not limited to, provisions related to adulteration and misbranding, registration and listing, records and reports on devices, and good manufacturing practices. The provisions for good manufacturing practices under 21 CFR part 820, the Quality Management System Regulation, include requirements for design and development controls for the manufacture of certain devices. However, requirements for design and development controls generally do not apply to class I devices except those identified in § 820.10(c)(2) (21 CFR 820.10(c)(2)) and those automated with computer software.
FDA is publishing this document pursuant to the legal authorities discussed in this notification and providing the public with the opportunity to comment on the proposals. Once the comment period ends, FDA will consider the comments and publish in the
The classification of each accessory will be 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 of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used (see section 513(f)(6)(A) of the FD&C Act).
In general, FDA considers an accessory to be eligible for classification into class I distinct from another device if the accessory: (1) is not for use in supporting or sustaining human life, or of substantial importance in preventing impairment to human health (see 21 CFR 860.3, defining “life-supporting or life-sustaining device,” among other terms); (2) does not present a potential unreasonable risk of illness or injury; and (3) general controls alone would be sufficient to provide a reasonable assurance of safety and effectiveness of the accessory.
Note that by regulation, design and development controls apply to class I devices only if the devices are automated with computer software or are listed under § 820.10(c)(2). Thus, if an accessory is not automated with computer software but would require design controls to provide reasonable assurance of safety and effectiveness, FDA does not consider it eligible for distinct classification through this process.
Similarly, “device-specific accessories” are accessories designed for use with a specific parent device and/or system of devices, based upon unique dimensions, geometry, and/or deployment. In these cases, design specifications are critical to the proper use of the accessory in supporting, supplementing, and/or augmenting the performance of the parent device and/or the specific system. For such device-specific accessories, design and development controls are an important element of ensuring appropriate compatibility between the accessory and parent and/or system, and as such, device-specific accessories are not generally eligible for distinct classification through this process. In the
You may wish to propose additional accessories as suitable for distinct classification into class I using the factors described above where the accessories are otherwise eligible for classification under section 513(f)(6)(D)(i) of the FD&C Act. Should you wish to propose additional accessories, your comment should identify each accessory's product code and/or classification regulation, and it should briefly explain why you think general controls alone will provide reasonable assurance of safety and effectiveness for the accessory if distinctly classified.
FDA is proposing the following accessories, which have been granted marketing authorization as part of a premarket submission (
For each distinct classification that is finalized as proposed, FDA would place a classification regulation for each of these accessories in 21 CFR part 870, 876, or 878, as appropriate. Each of these accessories would be class I, exempt from the premarket notification procedures in 21 CFR part 807, subject to the applicable limitations of exemption (
In addition, FDA received comments in response to the December 2025 request posted on our website suggesting that FDA distinctly classify reprocessing aids or tools, as well as percutaneous catheterization accessories. However, the suggestions did not identify product codes or classification regulations. Further, FDA has not separately identified such devices suitable for distinct classification. Information submitted in response to this notification that describes devices by referring to specific product codes may facilitate the identification and potential distinct classification into class I for such accessories.
While this document contains no new collection of information, it does refer to previously approved collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:
Food and Drug Administration, HHS.
Proposed amendment; proposed order; request for comments.
The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “Cystoscopic system intended as an aid for detection of bladder cancer,” along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
Either electronic or written comments on the proposed order must be submitted by October 16, 2026. Please see Section X of this document for the proposed effective date when the new requirements would apply and for the proposed effective date of a final order based on this proposed order.
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:
•
• 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:
•
• 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.” FDA 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
Esther Kaplan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2604, Silver Spring, MD 20993, 301-796-1863,
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C
Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, and for which there is sufficient information to establish special controls to provide such assurance, including the issuance of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions FDA (the Agency or we) deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act).
Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act).
Devices that were not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976 (generally referred to as “postamendments devices”) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA action. Those devices remain in class III and require approval of a premarket approval application (PMA), unless and until: (1) FDA reclassifies the device into class I or II, or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of the premarket notification procedures in section 510(k) of the FD&C Act and part 807, subpart E, of FDA's regulations (21 CFR part 807, subpart E).
A postamendments device that has initially been classified into class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA, acting by administrative order, can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.
FDA relies on “valid scientific evidence,” as stated in section 513(a)(3) of the FD&C Act and defined in 21 CFR 860.7(c)(2), in the classification process to determine the level of regulation for devices.
In accordance with section 513(f)(3) of the FD&C Act, the Agency is issuing this proposed order to reclassify postamendments class III diagnostic endoscopic light source systems intended for use with an approved optical imaging agent for photodynamic blue light cystoscopy as an adjunct to white light cystoscopy for the detection of known or suspected bladder cancer, including carcinoma in situ, or in patients undergoing surveillance cystoscopy for bladder cancer (product code OAY),
Based on the PMA data available to FDA in accordance with section 520(h)(4) of the FD&C Act,
FDA believes the standard in section 513(a)(1)(B) of the FD&C Act is met as general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls, which, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of these devices.
Under the FD&C Act, premarket notification (510(k)) submissions are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt from 510(k) requirements under section 510(m) of the FD&C Act.
In accordance with section 513(f)(1) of the FD&C Act, cystoscopic systems intended as an aid for detection of bladder cancer were automatically classified into class III because they were not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, have not been reclassified into class I or class II, and have not been found substantially equivalent to a device placed in commercial distribution after May 28, 1976, which was subsequently classified or reclassified into class II or class I. Therefore, they are subject to the PMA requirements under section 515 of the FD&C Act (21 U.S.C. 360e).
On May 28, 2010, FDA approved an original PMA for the PDD System (P050027) (Ref. 1), which is the first approved cystoscopic system intended as an aid for detection of bladder cancer. The PDD System, when used in combination with the approved optical imaging drug CYSVIEW (hexaminolevulinate hydrochloride) (New Drug Application (NDA) 022555), was approved with an indication for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy (Ref. 1). The device is only to be used as an adjunct to white light cystoscopy (Ref. 2) and, therefore, is not intended to be used as the sole or definitive basis for diagnosis.
Approval of the PMA for the PDD System occurred on the same day as the approval of the NDA for CYSVIEW (hexaminolevulinate hydrochloride), consistent with recommendations made by the ODAC. On December 17, 2009, the ODAC met to discuss the benefit/risk assessment for CYSVIEW
FDA's approval of the PDD System included a postmarket study commitment for a prospective, randomized, controlled clinical study to assess the safety and efficacy of CYSVIEW (hexaminolevulinate hydrochloride) in the detection of carcinoma in situ of the bladder (Ref. 1).
As of the date of issuance of this proposed order, fewer than 6 years have passed since FDA's approval of certain other PMA supplements for the PDD System. Therefore, in accordance with the “six-year rule” described in section 520(h)(4) of the FD&C Act, no information from these documents has been used in support of this proposed
On April 29, 2015, FDA published a notice in the
In October 2022, FDA received a petition from the manufacturer of the PDD System requesting that FDA reclassify devices under product code OAY from class III to class II (the Reclassification Petition) (Docket No. FDA-2022-P-2644). In February 2024, the petitioner submitted a potential draft special control guidance document for devices under product code OAY for FDA to consider. FDA also heard from health care practitioners, patients, medical device manufacturers, a patient advocacy organization, and the holder of the NDA for CYSVIEW (hexaminolevulinate hydrochloride) in connection with the Reclassification Petition, who were in favor of reclassifying devices under product code OAY from class III to class II.
As discussed in this proposed order, FDA is now proposing, on its own initiative, to reclassify cystoscopic systems intended as an aid for detection of bladder cancer from class III to class II. FDA has considered the information available to the Agency and believes that there is sufficient information available to establish special controls and that the special controls proposed in section VII of this document, together with general controls, would provide a reasonable assurance of the safety and effectiveness of devices under product code OAY.
A review of data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database, which contains Medical Device Reports (MDRs) of adverse events, indicates that as of April 30, 2026, there have been 11 unique MDRs associated with product code OAY. Most of the adverse events were related to thermal injury from contact with the light cable. One adverse event was related to user injury, a cut, from a damaged device. Two MDRs reported that the blue light mode stopped working after the first use.
Based on a search of FDA's Medical Device Recalls database using product code OAY, as of June 15, 2026, there has been one recall involving a cystoscopic system intended as an aid for detection of bladder cancer. The recall was initiated by the device manufacturer on August 16, 2012, and was reported to be due to the system's instruction manuals containing a labeling error. The correction applied to the three component manuals indicated for use within the device. To address the labeling error, a Safety Alert letter was sent to all customers to inform them that there was a labeling error, including instructions on how to correct the error. The recall was classified as a class II
A cystoscopic system intended as an aid for detection of bladder cancer is a postamendments device classified into class III under section 513(f)(1) of the FD&C Act. A cystoscopic system intended as an aid for detection of bladder cancer is a prescription device intended for use with an approved optical imaging agent for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of bladder cancer, including carcinoma in situ, in patients suspected or known to have the lesion on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer. The device is not intended as the sole or definitive basis for diagnosis. The device system includes a cystoscope and accessories, including a light source, camera system, fluid light cables, and software. The device can be used in white light or blue light modes. The blue light mode is used to view tissue fluorescence, either via the eyepiece on the scope or on a video monitor, after application of an approved optical imaging agent. The optical imaging agent reacts with the bladder lesions to provide visualization under blue light through the cystoscope. As discussed in section VI of this document, tissue fluorescence observation under blue light offers enhanced detection of potential bladder cancer compared to tissue observation under white light.
FDA is proposing to reclassify cystoscopic systems intended as an aid for detection of bladder cancer from class III (premarket approval) to class II (special controls) and to establish a new name for the device type as described within the classification regulations. FDA proposes to revise 21 CFR part 876 to create a new device classification regulation with the name “Cystoscopic system intended as an aid for detection of bladder cancer.” The Agency believes that this name and the identification language included in this proposed order more accurately describes this device type.
In accordance with section 513(f)(3) of the FD&C Act and 21 CFR part 860, subpart C, FDA is proposing to reclassify cystoscopic systems intended as an aid for detection of bladder cancer, which are postamendments devices, from class III into class II, subject to section 510(k) of the FD&C Act.
FDA believes that there is sufficient data and information available to FDA
FDA is proposing to revise 21 CFR part 876 to create a new device classification regulation with the name “Cystoscopic system intended as an aid for detection of bladder cancer.” Under this proposed order, if finalized, cystoscopic systems intended as an aid for detection of bladder cancer will be identified as prescription devices. If the proposed order is finalized, these devices will be subject to the prescription labeling requirements for devices (see 21 CFR 801.109).
Under the FD&C Act, 510(k) submissions are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt from 510(k) requirements under section 510(m) of the FD&C Act.
This proposed order, if finalized, will decrease regulatory burden on industry, as manufacturers will no longer have to submit a PMA for this type of device but can instead submit a 510(k) to the Agency for review prior to marketing their device. The 510(k) pathway is less burdensome and generally more cost-effective for industry and FDA than the PMA pathway, the most stringent type of device marketing pathway. A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately may provide more timely patient access for this type of device. FDA expects that the reclassification of these devices would enable more manufacturers to develop this type of device such that patients would benefit from increased access to appropriately safe and effective devices used adjunctively to detect bladder cancer.
Additionally, manufacturers may wish to use predetermined change control plans (PCCPs) as a way to implement future modifications to their devices without needing to submit a new 510(k) for each significant change or modification
FDA is providing a substantive summary of the valid scientific evidence concerning the public health benefits of the use of cystoscopic systems intended as an aid for detection of bladder cancer and the risks to health of these devices (see further discussion of the special controls being proposed to mitigate these risks in section VII of this proposed order). FDA considered data from the original PMA for the PDD System (P050027) and one PMA supplement (P050027/S011) available to FDA under section 520(h)(4) of the FD&C Act, input from the ODAC, published peer-reviewed literature, and postmarket information regarding cystoscopic systems intended as an aid for detection of bladder cancer.
In 2025, the number of new cases of bladder cancer is estimated to have been 84,870, or 4.2 percent of all estimated new cancer cases. The number of deaths in the United States in 2025 from bladder cancer is estimated to have been 17,420, equating to 2.8 percent of all estimated cancer deaths (Ref. 15). Currently, a combination of methods is used for diagnosis of bladder cancer because no single available procedure detects all malignancies. The use of cystoscopic systems intended as an aid for detection of bladder cancer provides a benefit to the public health by improving visualization and identification of malignant lesions of the bladder not detected by white light cystoscopy alone (see discussion in section VI of this document). Use of the device in combination with an approved optical imaging agent can provide a source of adjunctive information when triaging patient care for bladder cancer.
Based on FDA's review of the data and information described in this section and section VI of this document, the Agency has identified the following risks to health associated with the use of cystoscopic systems intended as an aid for detection of bladder cancer:
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The safety and effectiveness of this device type have become well established since the initial approval in 2010 of the first cystoscopic system intended as an aid for detection of bladder cancer. FDA believes that cystoscopic systems intended as an aid for detection of bladder cancer, which are used with an approved optical imaging agent and intended as an adjunct to white light cystoscopy for the detection of known or suspected bladder cancer, should be reclassified from class III (premarket approval) into class II (special controls) on the basis that special controls, in addition to general controls, can be established to mitigate the risks to health identified in section V, and there is sufficient information to establish such special controls which, in addition to general controls, would provide a reasonable assurance of the safety and effectiveness of these devices. The proposed special controls are identified by FDA in section VII of this proposed order.
Taking into account the available evidence, including the health benefits of the use of these devices and the nature and known incidence of the risks to health of the devices, FDA, on its own initiative, is proposing to reclassify these postamendments class III devices into class II. FDA has considered and analyzed the following information to support this proposed reclassification: (1) data from the original PMA (P050027) and one PMA supplement (P050027/S011) for the PDD System, including information available in the SSED and device labeling, available to FDA in accordance with section 520(h)(4) of the FD&C Act, (2) input from the ODAC for CYSVIEW (hexaminolevulinate hydrochloride) when used in combination with the PDD System, (3) published peer-reviewed literature, and (4) MDR and recall data from the Agency's publicly available MAUDE and Medical Device Recalls databases. The available evidence demonstrates that there are public health benefits derived from the use of cystoscopic systems intended as an aid for detection of bladder cancer by improving visualization and identification of malignant lesions of the bladder not detected by white light cystoscopy alone. In addition, the nature of the associated risks to health are known, and special controls can be established to sufficiently mitigate these risks.
The data considered by the Agency included the results of non-clinical testing of the PDD System, which demonstrated that the device had acceptable optical performance, electrical safety, electromagnetic compatibility, and reprocessing methods (Ref. 7). The data also included the results of a pivotal clinical trial supporting the use of the PDD System with CYSVIEW (hexaminolevulinate hydrochloride) for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy, for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy, which met its primary effectiveness endpoints by exceeding the prespecified 10 percent threshold for patients who had a Ta or T1 lesion detected only with blue light (Ref. 7). FDA also considered data from postmarket clinical trial results supporting the expanded indications of the PDD System for carcinoma in situ and surveillance cystoscopy, which confirmed the increased efficacy of using photodynamic blue light cystoscopy with CYSVIEW (hexaminolevulinate hydrochloride) over white light cystoscopy in detecting non-muscle invasive bladder cancer, including carcinoma in situ (Ref. 8).
The data also included safety data from six studies conducted during clinical development of CYSVIEW (hexaminolevulinate hydrochloride) used in combination with the PDD System, as summarized in the PDD System SSED (Ref. 7). Adverse events included bladder spasm, dysuria, hematuria, bladder pain, procedural pain, urethral pain, urinary retention, headache, erythema, and pruritus (Refs. 7 and 8). These are common complications in patients undergoing cystoscopy procedures, which generally include administration of a general anesthetic, cystoscopy, and biopsy. In addition, concerns raised by the ODAC during its review of CYSVIEW (hexaminolevulinate hydrochloride) when used in combination with the PDD System included concerns about false positives that may lead to unnecessary biopsies, which were relevant to the device, in addition to concerns generally associated with use of the drug (
FDA performed a literature search of published peer-reviewed literature to evaluate the safety and effectiveness of FDA-approved cystoscopic systems intended as an aid for detection of bladder cancer using the optical imaging agent hexaminolevulinate hydrochloride. The most frequent adverse events reported in patients who underwent photodynamic blue light cystoscopy procedures were hematuria, dysuria, bladder spasm, urinary retention, and bladder pain (Refs. 8 to 10).
The literature search results also included studies comparing photodynamic blue light cystoscopy following white light cystoscopy to white light cystoscopy alone in detecting bladder cancer to determine if the use of photodynamic blue light cystoscopy increases the risk of false positive/negatives over existing white light technologies. These comparisons involved assessments of diagnostic accuracy to mitigate the risk of false positives and false negatives. Diagnostic accuracy was assessed via sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Effectiveness outcomes, including recurrence and residual disease, were also assessed in the comparison where data was available.
In comparisons of photodynamic blue light cystoscopy following white light cystoscopy versus white light
FDA did not identify new risks or safety and effectiveness concerns from the published literature that differed from the Agency's findings from the PMA data, ODAC materials, and postmarket safety data.
A search of FDA's publicly available MAUDE database revealed 11 MDRs for product code OAY as of April 30, 2026. These MDRs were reported to be related to user injury from a damaged device, thermal injury or damage from contact with an overheated light cable, and failure of the blue light mode to work after the device's first use.
Finally, a search of FDA's publicly available Medical Device Recalls database for product code OAY through January 5, 2026, revealed one product recall, a class II recall, related to a labeling error that was addressed by the manufacturer. The recall was terminated on May 8, 2013. The lack of other recalls, coupled with the low number of reported adverse events, indicate no significant postmarket safety signals for this device type (see further discussion of the MDR and recall data in section II of this proposed order).
Based on the Agency's review of the information described in this proposed order, FDA has determined that special controls, in addition to general controls, are necessary to provide a reasonable assurance of safety and effectiveness for cystoscopic systems intended as an aid for detection of bladder cancer and that sufficient information exists to establish such special controls. Therefore, FDA, on its own initiative, is proposing to reclassify these postamendments devices from class III (premarket approval) into class II (special controls), subject to 510(k) requirements.
FDA believes that cystoscopic systems intended as an aid for detection of bladder cancer can be reclassified into class II with the establishment of special controls. FDA believes that the following proposed special controls would mitigate each of the risks to health described in section V and that these special controls, in addition to general controls, would provide a reasonable assurance of safety and effectiveness for cystoscopic systems intended as an aid for detection of bladder cancer. Table 1 demonstrates how FDA believes each risk to health described in section V would be mitigated by the proposed special controls.
To mitigate the risk of false positive and false negative results, FDA believes that clinical data as well as non-clinical performance testing and certain labeling are needed as special controls. Clinical data are needed to demonstrate that the device can provide accurate detection of bladder cancer with appropriate sensitivity and specificity when used with the approved optical imaging agent(s) specified in the device labeling, as a determination of the likelihood of obtaining a false positive or false negative result needs to be confirmed through clinical biopsy samples in patients with known or suspected bladder cancer. This evaluation cannot be replicated in a non-clinical model, and non-clinical performance testing and labeling would not adequately mitigate this risk.
However, in addition to clinical data, non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must verify and validate filter specifications and functional characteristics, including spectrum and intensity of the illumination source, spectrum of any excitation or emission filters, excitation power and power density, and the optical performance of the cystoscopic system. This non-clinical performance testing would allow flexibility to evaluate appropriate performance based on the characteristics of the subject device without establishing a specific testing requirement that may not be applicable to a particular cystoscopic system intended as an aid for detection of bladder cancer.
In addition, special controls that require in the labeling a summary of clinical data available for the device, a warning that the device should not be used as the only or definitive basis for diagnosis, a statement describing the compatible approved optical imaging agent or agents with the cystoscope, and a detailed summary of the device technical parameters would further mitigate this risk.
The risk of device failure or malfunction can be mitigated by special controls requiring the non-clinical performance testing described above and software verification, validation, and hazard analysis. This risk would be further mitigated by special controls that require the device labeling to include statements related to any device-specific hazards (
The risk of electrical, mechanical, thermal, or light-related hazards leading to patient or user injury or discomfort can be mitigated by special controls that require (1) performance testing that demonstrates electrical, mechanical, thermal, and optical safety; (2) software verification, validation, and hazard analysis; and (3) device labeling that includes instructions on appropriate usage and maintenance of the device, including servicing.
The risk that the device may interfere with other devices due to radiofrequency or electromagnetic interference can be mitigated by a special control requiring performance testing that demonstrates electromagnetic compatibility and device labeling that includes relevant electromagnetic compatibility testing results.
The risks of infection and cross contamination for patient-contacting components can be mitigated by special controls requiring sterilization and reprocessing validation for device components intended to be sterilized by the user prior to use, shelf-life testing, and labeling that includes validated methods and instructions for sterilization and/or reprocessing of any reusable components and an expiration date for any components provided sterile.
The risk of adverse tissue reaction for patient-contacting devices can be mitigated by special controls that require elements of the device that may contact the patient to be demonstrated to be biocompatible and labeling that includes instructions for device maintenance and validated methods and instructions for reprocessing of any reusable components.
If this proposed order is finalized, cystoscopic systems intended as an aid for detection of bladder cancer will be identified as prescription devices. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5 if the conditions of 21 CFR 801.109 are met.
If this proposed order is finalized, cystoscopic systems intended as an aid for detection of bladder cancer will be reclassified into class II (special controls) and will be subject to premarket notification requirements under section 510(k) of the FD&C Act. As discussed in this proposed order, the intent is for the reclassification to be codified in the new classification regulation 21 CFR 876.1560. If finalized, firms will be required to comply with the particular mitigation measures set forth in the special controls. FDA believes that adherence to the special controls, in addition to the general controls, is necessary to provide a reasonable assurance of the safety and effectiveness of cystoscopic systems intended as an aid for detection of bladder cancer.
We have determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
While this proposed order contains no new collections of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 820 (Quality Management System Regulation) have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 807, subpart E (Premarket Notification Procedures) have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 801 (Device Labeling) have been approved under OMB control number 0910-0485, and the collections of information in 21 CFR part 814 (Premarket Approval of Medical Devices) have been approved under OMB control number 0910-0231.
FDA proposes that any final order based on this proposed order become effective 30 days after the date of its publication in the
Under section 513(f)(3) of the FD&C Act, FDA may issue final orders to reclassify devices. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as newly codified orders. Therefore, under section 513(f)(3) of the FD&C Act, in the proposed order, we are proposing to codify “Cystoscopic system intended as an aid for detection of bladder cancer” in the new 21 CFR 876.1560, under which these cystoscopic systems intended as an aid for detection of bladder cancer would be reclassified from class III into class II.
The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 876 be amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Clinical data must confirm accurate detection of bladder cancer when used with the approved optical imaging agent(s) specified in the device labeling based on output from the device including an assessment of appropriate sensitivity and specificity.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and must verify and validate filter specifications and functional characteristics including the following:
(i) Spectrum and intensity of the illumination source;
(ii) Spectrum of any excitation or emission filters;
(iii) Excitation power and power density; and
(iv) Optical performance of the cystoscopic system.
(3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, thermal, and optical safety of the device.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Performance data must demonstrate the sterility of the device or device components intended to be provided sterile.
(7) Performance data must validate the reprocessing instructions for reusable components of the device.
(8) Performance data must support the shelf life of the device or device components intended to be provided sterile by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(9) Labeling must include the following:
(i) A detailed summary of the device technical parameters.
(ii) An expiration date for the device or device components provided sterile.
(iii) Summary of clinical data available for the device.
(iv) A warning that the device should not be used as the only or definitive basis for diagnosis.
(v) A statement describing the approved optical imaging agent(s) that are compatible for use with the cystoscope and supported by the clinical data described in (b)(1).
(vi) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and reprocessing, as applicable, of any reusable components.
(vii) Statements related to any device specific hazards (
(viii) A warning to assess the device for damage prior to use and instructions on determining whether the device has reached the end of its use-life.
(ix) Instructions on appropriate usage and maintenance of the device, including relevant electromagnetic compatibility testing results and servicing.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
This document contains proposed regulations that would amend existing regulations that require certain trusts to report all charitable contributions and amounts permanently set aside for a charitable purpose on Form 1041-A,
Written or electronic comments and requests for a public hearing must be received by October 16, 2026.
Commenters are strongly encouraged to submit public comments electronically via the Federal eRulemaking Portal at
Concerning the proposed regulations, contact Ganesh Gangasingh or David D. Lee of the Office of Associate Chief Counsel (Passthroughs, Trusts, and Estates), (202) 317-6007 (not a toll-free number); concerning submissions of comments and/or requests for a public hearing, Publications and Regulations Section at (202) 317-6901 (not a toll-free number) or by email at
This document contains a proposed amendment to the Income Tax Regulations (26 CFR part 1) under section 6034 of the Internal Revenue Code (Code) relating to the return filing requirements of certain trusts. Section 6034(a) contains an express delegation of authority to the Secretary of the Treasury or the Secretary's delegate (Secretary) to require every trust described in section 4947(a)(2) to furnish the information prescribed by forms or regulations with respect to the taxable year. Section 6034(b) contains an express delegation of authority to the Secretary to require a trust not described in section 4947(a)(1) or (2) of the Code but claiming a deduction under section 642(c) of the Code for the taxable year to furnish the information prescribed by forms or regulations with respect to that taxable year.
These proposed regulations also are issued under the express delegation of authority under section 7805(a) of the Code, which authorizes the Secretary to “prescribe all needful rules and regulations for the enforcement of [the Code], including all rules and regulations as may be necessary by reason of any alteration of law in relation to internal revenue.”
In the case of an estate or trust (other than a “simple trust” meeting the specifications of sections 651 and 652 of the Code), section 642(c)(1) generally allows as a deduction in computing its taxable income (in lieu of the deduction allowed by section 170(a) of the Code, relating to the deduction for charitable contributions and gifts) any amount of the trust's gross income, without limitation, which pursuant to the terms of the trust's governing instrument is, during the taxable year, paid for a purpose specified in section 170(c) (determined without regard to section 170(c)(2)(A), which denies deductions for contributions to foreign charities). In addition, if a charitable contribution is paid at any time during the calendar year immediately following the close of such taxable year, then the trustee or administrator may elect, at such time and in such manner as the Secretary prescribes by regulations, to treat such contribution as having been paid during such taxable year.
Section 642(c)(2) also permits such a deduction in computing taxable income for a decedent's estate, and for a trust (other than a simple trust) that is required by its governing instrument to set aside amounts for such charitable purposes, but this provision generally applies only if the estate was established by a will executed, or the trust was created, on or before October 10, 1969, and certain other requirements are met. Such an estate or trust may deduct amounts in computing taxable income that are not paid until a later calendar year.
The predecessor provision to section 6034 under the Internal Revenue Code of 1939 was enacted in the Revenue Act of 1950, Public Law 81-814, 64 Stat. 906 (1950), as part of a larger package of substantive and procedural requirements imposed upon charities and related organizations. With regard to trusts claiming the income tax charitable deduction under the predecessor provision to section 642(c), Congress was concerned that deductions were being claimed for amounts accumulated in the trust that might not actually be paid to charity for an extended period.
Section 6034(a) provides that every trust described in section 4947(a)(2)
With regard to all other trusts that claim a charitable deduction under section 642(c) for the taxable year, section 6034(b)(1) generally requires the trust to furnish such information with respect to the taxable year as the Secretary may by forms or regulations prescribe, including (A) the amount of the deduction taken under section 642(c) within such year, (B) the amount paid out within such year that represents amounts for which deductions under section 642(c) were taken in prior years, (C) the amount for which such deductions were taken in prior years but that has not been paid out at the beginning of such year, (D) the cumulative amount paid out of principal in the current and prior years for the purposes described in section 642(c), (E) the total income of the trust within such year and the expenses attributable thereto, and (F) a balance sheet showing the assets, liabilities, and
Section 6034(b)(2) provides that the reporting requirements under section 6034(b)(1) do not apply to a trust for any taxable year if either (A) all the trust's net income for such year is required to be distributed currently to the trust beneficiaries, or (B) the trust is a charitable trust described in section 4947(a)(1).
Section 1.6034-1(a) generally follows the statutory provisions of section 6034(b), requiring that the categories of information specified in the statute be reported on Form 1041-A. Section 1.6034-1(a) also provides that every trust described in section 4947(a)(2) must file a Form 1041-A, unless an exception applies.
Section 6104 provides for public disclosure of tax information for certain tax-exempt organizations and trusts. Under section 6104(b), this includes the information required to be furnished by section 6034.
Section 6652(c)(2) imposes penalties on a trust and/or the persons required to file returns for the trust for failure to file a return required under section 6034. Section 6652(c)(2)(A) provides that the failure to file penalty generally is $10 per day up to a maximum of $5,000 per return.
Some deductions under section 642(c) are for a trust's distribution of its own income for purposes specified in section 170(c), but other deductions under section 642(c) can be for charitable contributions made by a passthrough entity in which the trust has an interest. A trust holding a partnership interest would take its distributive share of any of the partnership's charitable contributions by operation of section 702 of the Code, which requires, in determining a partner's income tax, that each partner take into account separately the partner's distributive share of the partnership's items, including charitable contributions (as defined in section 170(c)). Similarly, by operation of section 1366 of the Code, trusts that hold S corporation stock would take into account their pro rata share of the S corporation's items of, among other things, deduction or credit, the separate treatment of which could affect the liability for tax of any shareholder. In either case, it would be the underlying passthrough entity, not the trust, that makes the contribution giving rise to a deduction under section 642(c). The ability for trusts to take into account charitable contributions from passthroughs is addressed in Revenue Ruling 2004-5, 2004-1 C.B. 295 (concerning trusts holding partnership interests) and § 1.641(c)-1(d)(2)(ii) (concerning trusts holding stock in S corporations). In each case, a trust's share of the charitable deduction being passed through from the partnership or S corporation is reported to the IRS on the Schedule K-1 issued to the trust in connection with the entity's own annual return.
Commenters have requested that the Form 1041-A filing requirement be eliminated for each trust whose section 642(c) deductions consist solely of the trust's allocable share of a contribution made by a partnership or S corporation in which the trust holds an interest. Such trusts are not accumulating any income that may be distributed to charity in the future. Instead, these charitable deductions are based solely on the current contributions of a passthrough entity made directly to a charity and are not from any prior year's accumulation of income by the trusts. The trusts themselves never received the amounts that were given to charity and never made any direct charitable contributions. Under these circumstances, the commenters argue, the requirement to file Form 1041-A places an unnecessary burden on those trustees who may not be aware of this filing requirement and who may not have the necessary information to fill out the form.
The Treasury Department and IRS believe that an administrative exception should be created for trusts whose section 642(c) deductions consist solely of the trust's allocable share of a contribution made by a partnership or S corporation in which the trust holds an interest, because these trusts do not fall within the purpose of the information reporting requirement of section 6034(b). The Treasury Department and the IRS propose to remove the section 6034 reporting requirements for trusts whose charitable deduction is exclusively the result of contributions made by a passthrough entity in which the trust directly or indirectly holds an interest.
Additionally, there is a discrepancy between § 1.6034-1 and published instructions for Form 5227 (revised Dec. 2025). Section 1.6034-1 requires every trust described in section 4947(a)(2) to file a Form 1041-A, unless an exception applies. The published instructions for Form 5227, revised after the Pension Protection Act of 2006, state that Form 5227 replaces Form 1041-A for split-interest trusts (after noting that § 1.6034-1 references Form 1041-A). The Treasury Department and the IRS therefore propose updates to § 1.6034-1 to reflect that split-interest trusts must file Form 5227 (or a successor form) rather than Form 1041-A. Proposed § 1.6034-1(a) would clarify the filing requirements by providing that trusts described in section 4947(a)(2) must file a Form 5227 (or a successor form) for each taxable year and that every other trust claiming a charitable or other deduction under section 642(c) for the taxable year must file a Form 1041-A (or a successor form) for each taxable year.
The proposed regulations would create an additional exception under § 1.6034-1(b) for trusts whose section 642(c) deduction for a given taxable year arises solely as a result of the operation of section 702 or section 1366, representing a charitable contribution made at the level of a passthrough entity
The proposed regulations are proposed to apply to taxable years of trusts ending on or after the date these regulations are published as final regulations in the
The Office of Management and Budget's Office of Information and Regulatory Analysis has determined that this proposed regulation is not significant and is not subject to review under section 6(b) of Executive Order 12866. Therefore, a regulatory impact assessment is not required.
The Executive Order 14192 designation for this rule is expected to be deregulatory.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) generally requires that a Federal agency obtain the approval of the Office of Management and Budget (OMB) before collecting information from the public, whether such collection of information is mandatory, voluntary, or required to obtain or retain a benefit. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number. The burdens associated with the collections of information in these proposed regulations are included in Form 5227 and its instructions and approved under OMB control numbers 1545-0047 and 1545-0092 in accordance with PRA procedures under 5 CFR 1320.10.
Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that the proposed regulations would not have a significant economic impact on a substantial number of small entities. This rule primarily affects trusts, which are not small entities for purposes of the Regulatory Flexibility Act. Although it is anticipated that there may be an incremental economic impact on trustees and advisors that are small entities, including entities that provide tax and legal services that assist individuals and trusts in preparing tax returns, any impact would not be significant and would not affect a substantial number of small entities. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required.
Section 202 of the Unfunded Mandate Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Tribal government, in the aggregate, or by the private sector, of $100 million (updated annually for inflation). These proposed regulations do not include any Federal mandate that may result in expenditures by State, local, or Tribal governments or by the private sector in excess of that threshold.
Executive Order 13132 (Federalism) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial, direct compliance costs on State and local governments, is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. These proposed regulations do not have federalism implications and do not impose substantial, direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.
Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments) prohibits an agency from publishing any rule that has Tribal implications if the rule either imposes substantial, direct compliance costs on Indian Tribal governments, and is not required by statute, or preempts Tribal law, unless the agency meets the consultation and funding requirements of section 5 of the Executive order. This proposed rule does not have substantial direct effects on one or more federally recognized Indian tribes and does not impose substantial direct compliance costs on Indian Tribal governments within the meaning of the Executive order.
Pursuant to the Administrative Procedure Act at 5 U.S.C. 553(b)(4), a plain language summary of these proposed regulations is available on the rulemaking docket at
Before these proposed regulations are adopted as final regulations, consideration will be given to any comments that are submitted timely to the IRS as prescribed in the preamble under the
A public hearing will be scheduled if requested in writing by any person that timely submits electronic or written comments. Requests for a public hearing are also encouraged to be made electronically. If a public hearing is scheduled, notice of the date and time for the public hearing will be published in the
IRS notices and other guidance cited in this preamble are published in the Internal Revenue Bulletin (or Cumulative Bulletin) and are available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at
The principal authors of these proposed regulations are Ganesh Gangasingh and David Lee, Office of the Associate Chief Counsel (Passthroughs, Trusts, and Estates). However, other personnel from the Treasury Department and the IRS participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, the Treasury Department and the IRS propose to amend 26 CFR part 1 as follows:
26 U.S.C. 7805 * * *
The additions and revisions read as follows:
(a)
(b) * * *
(3)
(c)
(d)
(e)
Environmental Protection Agency (EPA).
Notice of filing of petitions and request for comment.
This document announces the Agency's receipt of and solicits public comment on initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities. The Agency is providing this notice in accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA uses the month and year in the title to identify when the Agency compiled the petitions identified in this notice of filing. Unit II. of this document identifies certain petitions received in 2025 and 2026 that are currently being evaluated by EPA, along with information about each petition, including who submitted the petition and the requested action.
Comments must be received on or before September 16, 2026.
Submit your comments, identified by docket identification (ID) number and the pesticide petition (PP) of interest identified in Unit II. of this document, online at
Each application summary in Unit II. specifies a contact division. The appropriate division contacts are identified as follows:
• RD (Registration Division) (Mail Code 7505T); Charles Smith; main telephone number: (202) 566-1030; email address:
This action provides information that is directed to the public in general.
EPA regulations for residues of pesticide chemicals in or on various food commodities are established under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), requires EPA to publish a notice of receipt of these petitions in the
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the receipt of pesticide petitions filed under FFDCA section 408 that request the establishment or modification of regulations for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comments on the requests before responding to the petitioner. Pursuant to 40 CFR 180.7(f), a summary of the petition identified in this document, prepared by the petitioner, is included in a docket. EPA has determined that the pesticide petitions described in this document contain data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2), and 40 CFR 180.7(b); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be
Based upon review of the data supporting these petitions and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA may establish a final tolerance or tolerance exemption that “may vary from that sought by the petitioner.” For example, EPA may determine that it is appropriate to vary the commodity name for consistency with EPA's Food and Feed Commodity Vocabulary, which is located here
1.
2.
This unit provides the following information about the petitions:
• The Pesticide Petition (PP) Identification (IN) number;
• EPA docket ID number for the petition;
• Information about the petition (
• The analytical method available to detect and measure the pesticide chemical residue or the petitioner's statement about why such a method is not needed; and
• The division to contact for that petition.
Additional information on the petitions may be obtained through the petition summaries that were prepared by the petitioners pursuant to 21 U.S.C. 346a(d)(2)(A)(i)(I) and 40 CFR 180.7(b)(1), which are included in the docket for the petition as identified in this unit.
•
•
•
•
21 U.S.C. 346a.
United States Commission on Civil Rights.
Notice of Commission public business meeting.
Friday, August 21, 2026, 10:00 a.m. EST.
Meeting to take place virtually and is open to the public. The meeting will be livestreamed on the Commission's YouTube page:
Joe Kim: 202-499-0263;
In accordance with the Government in Sunshine Act (5 U.S.C. 552b), the Commission on Civil Rights is holding a meeting to discuss the Commission's business for the month of August. This business meeting is open to the public. Computer assisted real-time transcription (CART) will be provided. The web link to access CART (in English) on Friday, August 21, 2026, is
Coilcraft, Inc. submitted a notification of proposed production activity to the FTZ Board (the Board) for its facility in Princeton, Illinois, within FTZ 176. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on August 11, 2026.
Pursuant to 15 CFR 400.14(b), FTZ production activity would be limited to the specific foreign-status material(s)/component(s) and specific finished product(s) described in the submitted notification (summarized below) and subsequently authorized by the Board. The benefits that may stem from conducting production activity under FTZ procedures are explained in the background section of the Board's website—accessible via
The proposed finished product is ferrous iron pre-fabrication material (duty free).
The proposed foreign-status material/component is ferrous iron raw materials (duty free).
The request indicates that certain materials/components are subject to duties under section 301 of the Trade Act of 1974 (section 301), depending on the country of origin. The applicable section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status (19 CFR 146.41).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to:
A copy of the notification will be available for public inspection in the “Online FTZ Information System” section of the Board's website.
For further information, contact Brian Warnes at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that the 18 companies under review of the antidumping duty (AD) order on aluminum extrusions from the People's Republic of China (China), covering the period of review (POR) May 1, 2024, through April 30, 2025, are not eligible to receive a separate rate and are, therefore, part of the China-wide entity.
Applicable August 17, 2026.
Robert Hedberg, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482- 0955.
On April 14, 2026, Commerce published the
The products covered by the
Commerce considers all companies for which a review was requested, and which did not demonstrate separate-rate eligibility, to be part of the China-wide entity. As stated above, the 18 companies under review are not eligible for a separate rate and are, thus, part of the China-wide entity because they did not provide the requisite documentation to establish separate rate eligibility.
Because no party requested a review of the China-wide entity, and Commerce no longer considers the China-wide entity as an exporter conditionally subject to administrative reviews,
Normally, Commerce discloses to interested parties the calculations performed in preliminary results within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of preliminary results in the
Pursuant to section 751(a)(2)(A) of the Act, and 19 CFR 351.212(b)(1), Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
Because we determine that certain companies under review did not demonstrate separate rate eligibility and are part of the China-wide entity, we will instruct CBP to apply an
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) for previously examined China and non-China exporters not listed in the Appendix that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding; (2) for all China exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate for the China-wide entity (
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.
This notice also serves as a final reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5) and 19 CFR 351.213(h)(1).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Meeting of the South Atlantic Fishery Management Council.
The South Atlantic Fishery Management Council (Council) will hold meetings of the Habitat and Ecosystem Committee; the Southeast Data, Assessment and Review Catch Advice and Data Committee; and the Snapper Grouper Committee. The meeting week will also include a formal public comment session and closed and open meetings of the Full Council.
The Council meeting will be held from 8:30 a.m. on Monday, September 14, 2026, until 12 p.m. on Friday, September 18, 2026.
Myra Brouwer, Deputy Director for Management, SAFMC; phone (843) 302-8436 or toll free (866) SAFMC-10; FAX (843) 769-4520; email:
Meeting information, including agendas, overviews, and briefing book materials will be posted on the Council's website at:
The Council will meet in closed session to receive a litigation brief, if needed, review proposed changes to the advisory panel policy to clarify term limits, consider establishing chair and vice chair positions for the Citizen Science Operations Advisory Panel (AP), hold a discussion related to membership in the Executive Committee, review the Award of Excellence criteria, and make appointments to APs and Southeast Data, Assessment, and Review (SEDAR) workshop observers.
Newly appointed Council members will be sworn in and the 2025 Law Enforcement Officer of the Year Award will be presented. The Council will receive the following reports: a litigation brief, state agencies, Council liaisons, and the Shrimp Workgroup. The Council will also receive an update on Executive Order 14276. The National Marine Fisheries Service (NMFS) Southeast Regional Office (SERO) and Southeast Fisheries Science Center (SEFSC) will provide updates to the Council, including a presentation on discards in South Atlantic fisheries and the Observer Program. The Council will also receive a presentation on landings of unmanaged species and an update on the Resilient Fisheries projects. A presentation to review information on the scoping process for potential Atlantic Large Whale Take Reduction Plan modifications will also be delivered. Lastly, the Council will receive updates on managed species outside its jurisdiction.
The Committee will receive a presentation on the Ecosystem Information Review project and a report from the Habitat and Ecosystem AP.
The Committee will receive a report from the SEDAR Steering Committee, review assessment updates and the SEDAR schedule, and conduct the stock risk rating for hogfish, black grouper, and gag. The Committee will review terms of reference for red grouper, snowy grouper, and vermilion snapper. The Committee will review and approve an outline and timeline for the Standardized Bycatch Reduction Methodology review and receive an update on the Southeast Reef Fish Survey and the Southeast Area Monitoring and Assessment Program.
The Committee will receive updates from the NMFS on amendments undergoing rulemaking and Exempted Fishing Permit applications. The Committee will continue discussion of Amendment 61 to the Snapper Grouper Fishery Management Plan to evaluate the composition of the Snapper Grouper Fishery Management Unit.
The Committee will discuss Amendment 44 to the Snapper Grouper Fishery Management Plan addressing jurisdictional and sector allocations of yellowtail snapper and mutton snapper, and Regulatory Amendment 39 to the Snapper Grouper Fishery Management Plan addressing sunsetting of Spawning Special Management Zones. The Committee will consider approving these two amendments for public hearings. The Committee will continue discussing Amendment 60 to the Snapper Grouper Fishery Management Plan addressing commercial management measures and receive a presentation on Vessel Monitoring Systems (VMS) and notification requirements. The Committee will review comments from public hearings held over the summer and approve all actions in the amendment. A public hearing on Amendment 60 will also be held, and comment will be accepted during the public comment period.
The Committee will continue discussing Regulatory Amendment 38 to the Snapper Grouper Fishery Management Plan, which addresses vessel limits for headboats, and will receive an update on the Snapper Grouper Management Strategy Evaluation (MSE) and the Wreckfish MSE. The Committee will provide comments and draft conclusions and recommendations for the Wreckfish Individual Transferable Quota Program Review. Lastly, the Committee will receive a report from the Blueline Tilefish Joint Sub-Committee and
The Council will hold elections for Chair and Vice Chair. The Council will then discuss a comprehensive amendment to address commercial trip limit sale and revise the abbreviated framework process. The Council will discuss potential modifications to the requirements for sea turtle release gear, management of cownose rays, and review and approve topics for the fall meeting of the Mackerel Cobia AP.
The Council will review its workplan, reports from the committees that met during the week and the June 2026 report from the Executive Committee, review upcoming meetings, and discuss any other business as needed.
Documents regarding these issues are available from the Council office (see
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of renewal incidental harassment authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA), as amended, notification is hereby given that NMFS has issued a renewal incidental harassment authorization (IHA) to Petrogas Pacific, LLC (Petrogas) to harass marine mammals incidental to Ferndale Pier Maintenance Activities in Ferndale, Washington.
This renewal IHA is valid from August 13, 2026, through July 31, 2027.
Electronic copies of the original application, renewal request, and supporting documents (including NMFS
Robert Pauline, Office of Protected Resources, NMFS, (301) 427-8401.
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to here as “mitigation measures”). NMFS must also prescribe requirements pertaining to monitoring and reporting of such takings. The definition of key terms such as “take,” “harassment,” and “negligible impact” can be found in the MMPA and NMFS's implementing regulations (see 16 U.S.C 1362; 50 CFR 216.103).
NMFS' regulations implementing the MMPA at 50 CFR 216.107(e) indicate that IHAs may be renewed for additional periods of time not to exceed 1 year for each reauthorization. In the notice of proposed IHA for the initial IHA, NMFS described the circumstances under which we would consider issuing a renewal for this activity, and requested public comment on a potential renewal under those circumstances.
Specifically, on a case-by-case basis, NMFS may issue a one-time 1-year renewal IHA following notice to the public providing an additional 15 days for public comments when: (1) up to another year of identical, or nearly identical, activities as described in the Detailed Description of Specified Activities section of the initial IHA issuance notice is planned; or (2) the activities as described in the Description of the Specified Activities and Anticipated Impacts section of the initial IHA issuance notice would not be completed by the time the initial IHA expires and a renewal would allow for completion of the activities beyond that described in the
• A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date (recognizing that the renewal IHA expiration date cannot extend beyond 1 year from expiration of the initial IHA). The request for renewal must include the following:
○ An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial
○ A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.
• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.
An additional public comment period of 15 days (for a total of 45 days), with direct notice by email, phone, or postal service to commenters on the initial IHA, is provided to allow for any additional comments on the proposed renewal. A description of the renewal process may be found on our website at:
On September 4, 2024, NMFS issued an IHA to Petrogas to take marine mammals incidental to Ferndale Pier Maintenance Activities in Ferndale, Washington (89 FR 73381, September 10, 2024), effective from August 1, 2025, through July 31, 2026. On May 15, 2026, NMFS received an application from Petrogas for the renewal of that initial IHA. As described in the application for renewal IHA, the activities for which incidental take is requested are nearly identical to those covered in the initial authorization but will not be completed prior to its expiration
As required, the applicant also provided a preliminary monitoring report (available at
The purpose of this construction project is to remove the existing timber Pier in Ferndale, Washington, that has served as a loading facility since 1965 and replace it with a new structure that meets current industry best practices. As described in detail in the notices for the initial 2025 IHA (89 FR 73381, September 10, 2024; 89 FR 47903, June 4, 2024) planned in-water construction activities included impact and vibratory installation of 9 permanent 30-inch steel pipe piles and removal of 69 existing 16-inch timber piles by vibratory hammer over 17 days. These 69 timber piles were not removed under the initial IHA. During the 2025 construction season, only 10 days of in-water construction were required to install the nine 30-inch steel piles by impact and vibratory installation between August 1, 2025, and October 31, 2025.
A minor change to the activities conducted by Petrogas was described in the renewal letter. We refer to the documents related to the previously issued IHA and describe any new or changed information here. These previous documents include the
Petrogas made a minor, unanticipated design change to the project. Nine permanent 30-inch steel piles were installed by vibratory and impact driving for the replacement North Mooring Dolphin (NMD) as planned under the initial IHA. However, an additional nine temporary 30-inch steel piles were installed by vibratory driving only around the old NMD to build a temporary work platform. One of these temporary 30-inch piles was removed under the initial IHA. The remaining 8 30-inch temporary piles and the existing 69 16-inch timber piles will be removed during the upcoming season by vibratory driving. Work is anticipated to require 5 days of in-water work.
A detailed description of the construction activities for which take is authorized here may be found in the Notices of the Proposed (89 FR 47903, June 4, 2024) and Final IHA (89 FR 73381, September 10, 2024) for the initial authorization. The renewal IHA is effective for a period not exceeding 1 year from the date of expiration of the initial IHA (July 31, 2027). The location and timing are identical to those described in the previous notices.
As noted above, Petrogas was forced to make a design change under the initial IHA. Petrogas initially planned to remove the large concrete cap of the NMD with a crane and place it on a barge. Since the cap weighed approximately 500 tons (453.6 metric tons), a very large crane was needed. Petrogas was not able to procure a crane large enough for this task, so an alternative plan was developed late in the planning, permitting and preparation process. The safest available plan was to build a temporary work platform around the NMD using eight temporary 30-inch steel piles for support and then cut the pile cap into smaller, manageable pieces. Note that an additional, temporary 30-inch pile was lightly placed to hold the pile form for installing the other eight temporary piles at the appropriate design angles. This single pile was removed under the initial IHA.
Under the initial IHA it was assumed that up to 1.5 30-inch steel piles would be installed via vibratory driver each day and 20 16-inch timber piles would be removed via vibratory driver each day. The renewal IHA assumes that the 8 temporary 30-inch steel piles and 20 16-timber piles would be removed via vibratory driver each day.
The mitigation and monitoring requirements as described in the initial IHA and the marine mammal monitoring plan were followed throughout the first year of work including during vibratory installation of the temporary steel 30-inch steel piles. The temporary pile drive time per day in the initial IHA is equivalent to those in the renewal for 16-inch timber piles (40 minutes), while the temporary drive time per day for vibratory driving of the 30-inch piles is 10 minutes greater per day for the renewal IHA (40 vs. 30 minutes). However, vibratory removal of 30-inch steel piles would be done in a single day under the renewal IHA compared to up to 5 days under the initial IHA. Vibratory removal of the existing 16-inch timber piles would take 4 days under either scenario. This assumes that Petrogas is able to work
A description of the marine mammals in the area of the activities for take is authorized, including information on abundance, status, distribution, and hearing, may be found in the Notices of the Proposed (89 FR 47903, June 4, 2024) and Final IHA (89 FR 73381, September 10, 2024) for the initial authorization. With the exception of harbor seals, NMFS has reviewed the monitoring data from the initial IHA, current stock assessment reports, information on relevant unusual mortality events, and other scientific literature, and determined there is no new information that affects which species or stocks have the potential to be affected or the pertinent information in the Description of the Marine Mammals in the Area of Specified Activities contained in the supporting documents for the initial IHA. According to Pearson
A description of the potential effects of the specified activity on marine mammals and their habitat for the activities for which incidental take is authorized here may be found in the Notice of the Proposed IHA (89 FR 47903, June 4, 2024) for the initial authorization. NMFS has reviewed the monitoring data from the initial IHA, current stock assessment reports, information on relevant unusual mortality events, and other scientific literature, and determined that there is no new information that affects our initial analysis of impacts on marine mammals and their habitat.
A detailed description of the methods used to estimate take for the specified activity are found in the Notices of the Proposed (89 FR 47903, June 4, 2024) and Final IHA (89 FR 73381, September 10, 2024) for the initial authorization. The source levels and marine mammal occurrence data applicable to this renewal authorization remain unchanged from the previously issued initial IHA (89 FR 73381, September 10, 2024).
Petrogas and NMFS reanalyzed the Level A harassment zones for vibratory pile installation and removal activities to reflect Petrogas' planned minor changes (table 1) as well as the 2024 Updated Technical Guidance as the initial analysis was based on the 2018 Technical Guidance (89 FR 73381, September 10, 2024). Results are shown in table 2.
For both the initial IHA and proposed IHA renewal, Petrogas and NMFS quantitatively assessed potential exposure of marine mammals to noise levels from pile driving over the NMFS threshold guidance using the following equation to provide an estimate of potential exposures within estimated harassment zones:
Level A harassment isopleths increased slightly for all hearing groups except for very high frequency cetaceans (categorized as high frequency cetaceans prior to application of the 2024 Technical Guidance). These changes do not impact NMFS' analysis related to the potential for Level A harassment, which is unlikely to occur.
Petrogas would continue to implement shutdown zones that are equivalent to the Level A harassment zones during all vibratory pile removal activities for all hearing groups, as described in the initial 2025 IHA (89 FR 73381, September 10, 2024). The same occurrence assumptions that were used to estimate take for the 2024 IHA and described in the associated proposed FRN (89 FR 47903, June 4, 2024) are applied here. The daily duration of vibratory removal of 30-inch piles has increased from 30 to 40 minutes while the estimated total number of in-water workdays has decreased from 17 to 5.
The calculated take by Level B harassment based on species density for Steller sea lions and California sea lions was one and six respectively. Petrogas has requested an increase to 10 Steller sea lion takes and 30 California sea lion takes by Level B harassment. While there are no haul-out sites nearby, there are haul-out sites in the greater Strait of Georgia, and animals of these species are known to travel significant distances in search for prey, possibly into the marine waters of the adjacent Cherry Point Aquatic Reserve. The initial IHA had also increased authorized take of sea lions above the calculated estimated take values. The marine mammal monitoring report submitted by Petrogas recorded a single sea lion observation which occurred when there was no driving activity underway. A total of 41 harbor porpoises and 22 harbor seals were observed with 7 porpoise and 9 seal takes by Level B harassment.
NMFS' authorized take for the renewal IHA are indicated in table 3. No take by Level A harassment is authorized.
The required mitigation, monitoring, and reporting measures included as requirements in this authorization are nearly identical to those included in the
(a) Petrogas must employ Protected Species Observers (PSO) and establish monitoring locations. The Holder must monitor the project area to the maximum extent possible based on the required number of PSOs, required monitoring locations, and environmental conditions.
(b) Monitoring must take place from 30 minutes prior to initiation of pile driving activity (
(c) Pre-start clearance monitoring must be conducted during periods of visibility sufficient for the lead PSO to determine that the shutdown zones are clear of marine mammals. Pile driving may commence following 30 minutes of observation when the determination is made that the shutdown zones are clear of marine mammals.
(d) If a marine mammal is observed entering or within the shutdown zones (table 4), pile driving activity must be delayed or halted.
(e) If pile driving is delayed or halted due to the presence of a marine mammal, the activity may not commence or resume until either the animal has voluntarily exited and been visually confirmed beyond the shutdown zone, or 15 minutes have passed without re-detection of the animal.
(f) Specific measures for avoiding take of killer whales and humpback whales:
(i) Prior to the start of pile driving activities each day, Petrogas must contact the ORCA network to obtain the latest sightings information for Southern Resident killer whale (SRKW) and humpback whales.
(ii) Petrogas must delay or halt pile driving activities if SRKW, unidentified killer whale (
(iii) If a SRKW, unidentified killer whale, or humpback whale enters the Level B harassment zone undetected, in-water pile driving must be suspended immediately upon detection and must not resume until the animal exits the Level B harassment zone or 15 minutes have passed without re-detection of the animal.
(g) Pile driving activity must be halted (as described in condition 4(d) of initial IHA) upon observation of either a species for which incidental take is not authorized or a species for which incidental take has been authorized but the authorized number of takes has been met, entering or within the harassment zone.
(h) Construction supervisors and crews, PSOs, and relevant Petrogas staff must avoid direct physical interaction with marine mammals during construction activity. If a marine mammal comes within 10 meters of such activity, operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions, as necessary to avoid direct physical interaction.
The required shutdown and monitoring zones shown in table 4 are identical to those included as part of the initial IHA.
A notice of NMFS' proposal to issue a renewal IHA to Petrogas was published in the
The planned action is identical to that of the initial authorization in terms of effects. The minor change of vibratory removal of an additional eight temporary 30-inch steel installed under the initial IHA does not modify our findings. The same marine mammals are affected, and the potential effects and estimated take are a subset of the initial IHA. Mitigation and monitoring requirements remain the same as the initial authorization apart from removing bubble curtain and soft-start measures since no impact driving is planned. While the population abundance of Northern Inland Waters stock of harbor seal has decreased slightly (now 15,898 animals changed from 16,451) there has been no effect on our findings.
With a subset of estimated take, the extensive analysis, as well as the associated findings included in the prior documents remain applicable. We found that the previous IHA had a negligible impact, and with the issuance of a renewal, the taking would be small relative to population size.
NMFS has concluded that there is no new information suggesting that our analysis or findings should change from those reached for the initial IHA. Based on the information and analysis contained here and in the referenced documents, NMFS has determined the following: (1) the required mitigation measures will effect the least practicable impact on marine mammal species or stocks and their habitat; (2) the authorized takes will have a negligible impact on the affected marine mammal species or stocks; (3) the authorized takes represent small numbers of marine mammals relative to the affected stock abundances; (4) Petrogas' activities will not have an unmitigable adverse impact on taking for subsistence purposes as no relevant subsistence uses of marine mammals are implicated by this action, and; (5) appropriate monitoring and reporting requirements are included.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental take authorizations with no anticipated serious injury or mortality) of the Companion Manual for NAO 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS determined that the issuance of the initial IHA qualified to be categorically excluded from further NEPA review. NMFS has determined that the application of this categorical exclusion remains appropriate for this renewal IHA.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531
No incidental take of ESA-listed species is authorized or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
NMFS has issued a renewal IHA to Petrogas for the take of marine mammals incidental to conducting Ferndale Pier Maintenance Activities in Ferndale, Washington effective from the date of issuance through July 31, 2027.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of intent to prepare an environmental impact statement; request for comments.
NMFS intends to prepare an environmental analysis in accordance with the National Environmental Policy Act (NEPA) to analyze the impacts of alternatives to amend the Atlantic Large Whale Take Reduction Plan (Plan) if determined to be necessary to reduce mortalities and serious injuries of North Atlantic right whales (
Comments must be received by October 16, 2026.
You may submit comments on this NOI, identified by NOAA-NMFS-2025-0041, by either of the following methods:
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More information, including a recorded presentation on the scoping period, a document that describes examples of measures under consideration and input requested, and the date of the public scoping remote meeting will be posted on the Plan website,
Jennifer Goebel, Atlantic Large Whale Take Reduction Team Coordinator, Greater Atlantic Region. Telephone: (978) 281-9175. Address: 55 Great Republic Drive, Gloucester, MA 01930. Email:
North Atlantic right whales (hereafter “right whales”) are listed as endangered under the Endangered Species Act (ESA) and considered depleted under the MMPA. After more than 2 decades of an increasing population trend peaking in 2011 with an estimated 484 whales, the population declined to an estimate of 359 living right whales in 2020 with a more recent increase to approximately 380 living right whales in 2024 (Linden 2025). The current population estimate is still well below the stock's optimum sustainable population (MMPA sec. 3(9)). An unusual mortality event (UME) was declared in 2017, when a total of 17 confirmed dead right whales were documented, many in Canadian waters. As of July 2026, the UME involves documented impacts to 176 individuals in both U.S. and Canadian waters, comprising 43 right whale mortalities, 41 seriously injured right whales, and 92 whales with sublethal injuries or illnesses. The UME considers observed and documented incidents, and while these incidents confirm human impacts on the population, the best available science predicts that the actual number of right whale deaths and serious injuries is higher, as many incidents are never observed. From 2017 through 2023, there were an estimated 147 deaths (Linden 2025). Estimated deaths for 2024, 2025, and 2026 are not yet available. NMFS will publish these data when they are available. Nevertheless, the combination of known and unknown human caused deaths and serious injuries appear to be hindering the ability of right whales to meet recovery goals.
One of the primary causes of mortality and serious injury (M/SI) of right whales is entanglement in fishing gear. Of the 176 documented incidents in the UME, 111 (63 percent) are attributed to entanglements, including 48 either killed by entanglements (11) or so seriously injured (37) that they are unlikely to survive, plus another 63 that are injured or in poor health (reduced body size, ability to reproduce) as the result of an entanglement. Scarring evidence of entanglement is observed on more than 85 percent of all right whales, with the vast majority having been entangled more than once, though only 7.8 percent of all entanglement events are seen with attached gear (Hamilton 2024). The 2023 North Atlantic Right Whale Stock Assessment Report established the potential biological removal (PBR) for the stock at 0.73 (Hayes
Changes in oceanographic conditions and associated changes in prey abundance and distribution exacerbated the right whale's population decline in the late 2010s. These changes shifted the overlap between right whales, fisheries and vessel traffic into areas where protections were not previously implemented, and increased the energy required by right whales traveling farther in search of food. Range-wide, human-caused annual M/SI likely remains higher than the calculation of PBR in 2023. We have not yet calculated PBR based on the most recent data but intend to do so as part of the process of re-convening the Atlantic Large Whale Take Reduction Team (Team) later this year. Further mitigation of entanglements in U.S. commercial fisheries may be necessary to ensure that U.S. fishery-caused M/SI is below that PBR, the short-term goal under the MMPA, and to work towards the MMPA long-term goal of insignificant levels of M/SI (defined as 10 percent of PBR), taking into account the economics of the fishery, the availability of existing technology, and existing State or regional fishery management plans. The insignificance level was last calculated at 0.073/year (Hayes
The MMPA mandates that NMFS develop and implement Take Reduction Plans for preventing the depletion and assisting in the recovery of certain marine mammal stocks that are killed or seriously injured incidental to commercial fisheries. Pursuant to the MMPA, NMFS convenes Take Reduction Teams composed of stakeholders to develop recommendations that achieve a short-term goal of reducing M/SI of marine mammals covered by the plan to a rate below each stock's PBR level. NMFS considers the Team's recommendations when amending and implementing Take Reduction Plans through the rulemaking process.
The Team was first convened in 1996 to recommend measures to reduce mortalities and serious injuries of right, humpback, and fin whales incidental to certain U.S. commercial fisheries. NMFS develops and implements measures under the Plan. Since 1997, the Plan has been amended several times to reduce the impacts of fishing gear on large whales, particularly on endangered right whales, through measures that include area closures; gear configuration requirements such as the use of sinking groundline, trawling up, and weak links; and gear marking rules. In 2021, a final rule (86 FR 51970; September 17, 2021) implemented modifications to reduce the risk of M/SI of right whales caused by entanglement in the northeast American lobster and Jonah crab trap/pot fishery by approximately 60 percent, which was analyzed in a final environmental impact statement (FEIS) published on July 2, 2021 (86 FR 35288).
In May 2022, NMFS convened the Team to address large whale M/SI caused by entanglements in the other fisheries regulated under the Plan, namely the U.S. East Coast gillnet, Atlantic mixed species trap/pot, and mid-Atlantic lobster and Jonah crab trap/pot fisheries, which were not addressed by the 2021 final rule. Scoping on measures to reduce the impacts of these fisheries was conducted from August 10, 2021 through October 21, 2021 (86 FR 43996; August 11, 2021). However, in the fall of 2022, the Team received new population information showing that the right whale population decline was continuing at a high rate and confirming that most mortalities are unobserved as carcasses, thus indicating a need for greater risk reduction than previously anticipated. In addition, a 2022 summary judgment decision in
Given the potential for additional needed risk reduction, NMFS opened a second 30-day scoping period to gather additional public input on further modifications to the Plan from September 9 to October 11, 2022 (87 FR 55405; September 9, 2026). The Team met again in November and December 2022, and although consensus was not reached, a majority of Team members present voted in favor of a suite of recommendations for additional risk reduction measures.
Shortly after the 2022 meetings were concluded, Congress passed the Consolidated Appropriations Act, 2023 (CAA). The CAA deemed the 2021 rule sufficient for the authorization of American lobster and Jonah crab trap/pot fisheries to be in full compliance with the MMPA and ESA until December 31, 2028, reflecting Congressional intent to provide the industry with regulatory stability while feasible solutions are developed. The CAA also directs NMFS to issue “new regulations for the American lobster and Jonah crab fisheries consistent with the [MMPA and ESA]” that “take effect by December 31, 2028.”
The purpose of this proposed NEPA action is to evaluate measures that may be needed in 2029 in order to fill the requirements both of section 118 of the MMPA, which regulates the taking of marine mammals incidental to U.S. commercial fishing operations and of the CAA. Scoping is an early step in the development of regulations to ensure compliance with the CAA.
To meet the timeline set by Congress in the CAA, we will convene a series of Team meetings in 2026 and 2027. During these meetings, the Team will discuss and may recommend measures to reduce right whale M/SI from U.S. commercial fishing gear to MMPA-compliant levels, should further reductions be required. Since the Team last met in 2022, new estimates for population abundance and mortality have been released (Linden 2025), which show a small but positive short-term (2021-2024) estimated population increase and a reduction in estimated mortality. Based on the 2023 PBR calculation and the 2019-2024 M/SI data (Hayes
If needed, NMFS anticipates employing a range of risk reduction targets to achieve PBR to take into account uncertainties regarding where and how M/SI occurs, with intent to rigorously evaluate the economic feasibility of any proposed measures. Given the annual variability and uncertainties in determining the extent to which estimated/unseen deaths and serious injuries of right whales are caused by U.S. commercial fisheries, NMFS anticipates that the Team would develop recommendations for broad risk reduction rather than a singular risk reduction target. Professional third-party facilitation of Team meetings is intended to forge mutually beneficial outcomes among the competing interests to minimize regulatory burdens and meet administration priorities, while fulfilling statutory requirements. At the Team meetings, the Team will develop recommendations for NMFS to consider in drafting a proposed rule. NMFS will incorporate any relevant new information available after Team deliberations into both proposed and final rules as appropriate during the multi-year rulemaking process. NMFS will also consider Team recommendations and any new information in furtherance of the Plan's long-term MMPA goal: to reduce, within
Any needed modifications to the Plan would be informed by Team recommendations, decades of discussions with Team members, as well as information obtained during scoping, and other available information. The Team will be provided with previously-discussed recommendations informed by new technologies, improved whale distribution data from increased survey efforts, and improved fishery-dependent data sources describing fishing gear distribution and configurations. A range of risk reduction considerations can be found in the scoping document on the website identified in the
Modifications analyzed may affect the following fisheries currently regulated by the Plan: (1) northeast trap/pot fisheries for American lobster and Jonah crab; (2) Mid-Atlantic gillnet fisheries for monkfish, spiny dogfish, smooth dogfish, bluefish, weakfish, menhaden, spot, croaker, striped bass, large and small coastal sharks, Spanish mackerel, king mackerel, American shad, black drum, skate species, yellow perch, white perch, herring, scup, kingfish, spotted seatrout, and butterfish; (3) northeast sink gillnet and anchored float gillnet fisheries for Atlantic cod, haddock, pollock, yellowtail flounder, winter flounder, witch flounder, American plaice, windowpane flounder, spiny dogfish, monkfish, silver hake, red hake, white hake, ocean pout, skate spp., mackerel, redfish, herring, menhaden, and shad; (4) northeast drift gillnet fisheries for shad, herring, mackerel, and menhaden and any residual large pelagic driftnet effort in New England; (5) Massachusetts mixed species trap/pot; (6) Atlantic mixed species trap/pot fisheries for hagfish, shrimp, conch/whelk, red crab, Jonah crab, rock crab, black sea bass, scup, tautog, cod, haddock, Pollock, redfish (ocean perch), white hake, spot, skate, catfish, stone crab, and cunner; (7) Mid-Atlantic trap/pot fisheries for lobster and Jonah crab; (8) Atlantic trap/pot fishery for Atlantic blue crab; (9) southeast Atlantic gillnet fisheries for finfish, including, but not limited to: king mackerel, Spanish mackerel, whiting, bluefish, pompano, spot, croaker, little tunny, bonita, jack crevalle, cobia, and striped mullet; and (10) Southeast Atlantic shark gillnet fisheries for large and small coastal sharks, including but not limited to blacktip, blacknose, finetooth, bonnethead, and sharpnose sharks.
To inform Team discussions and build on past efforts, NMFS requests information from the public on the following topics: (1) vertical line reduction through gear reduction measures (trap/line caps, reduced gillnet panel lengths or numbers, ropeless retrieval devices subject to rigorous testing for safety, affordability, and operational feasibility for the fleet) or gear configuration changes (increasing nets per string or traps per trawl; lower profile gillnets through tie downs or restricted panel heights); (2) fishing effort reductions through shorter soak times or restrictions to daytime fishing; (3) measures that reduce the likelihood of severe injuries including gear tending or gear modifications to reduce the weight of gear (single traps on weak rope); (4) reducing the breaking strength of nets and ropes so that entangled whales could break free; (5) seasonal restricted areas that would prohibit persistent buoy lines or be closed to fishing in those areas where right whales can be predicted to aggregate seasonally; (6) development of a dynamic area management program that would allow real-time responses to right whale aggregations; (7) modifications to the timing or dimensions of existing seasonal restrictions, seasonal closure areas, and exemption areas; (8) updates to gear marking requirements; (9) data gaps; and (10) any additional measures not mentioned above. For more details, please visit the Atlantic Large Whale Take Reduction Plan website at
NEPA (42 U.S.C. 4321
The environmental analysis will identify and describe the potential effects of Plan modifications on the human environment, including the natural and physical environment and the relationship of people with that environment, that are reasonably foreseeable and have a reasonably close causal relationship to the modifications. This may include such effects that occur at the same time and place as the alternatives and such effects that are later in time or occur in a different place. The alternatives that will be analyzed may include, but are not limited to, modifications to configurations of fishing gear including weak rope, weak links, trawling up, float line, line caps, effort controls, and the possible use of on-demand gear in some seasonal restricted areas; modification to fishing seasons and/or areas including the potential for dynamic management areas and changes to gear tending requirements; and modifications to gear marking requirements. Potential impacts to commercial fishermen in the above-mentioned fisheries may include, but are not limited to, severe economic strain on family-owned businesses, threats to the cultural heritage of coastal fishing communities, additional costs and labor to modify gear configurations and gear markings, labor costs associated with increased time required to retrieve gear under some gear modifications, safety hazards associated with increased time required to retrieve gear under some modifications, costs associated with the purchase of new gear, reduced profit due to reduced catches, associated gear modifications, gear moving, or gear removal and other costs associated with seasonally restricted access to fishing grounds. Potential impacts to Atlantic large whales include, but are not limited to, reduced M/SI due to a reduction in entanglement in fishing gear or reduced injury severity of any entanglements that do occur. Other potential impacts may include, but are not limited to, impacts (both beneficial and adverse) to other marine life, cultural resources, demographics, employment, and economics. Consideration of any irreversible and irretrievable commitments of Federal resources which would be involved in any proposed action should it be implemented may also be analyzed. Public comments on potential impacts
The environmental analysis may identify and describe: reasonably foreseeable environmental effects of the proposed agency action; reasonably foreseeable adverse environmental effects which cannot be avoided should the proposal be implemented; a reasonable range of alternatives to the proposed agency action, including an analysis of any negative environmental impacts of not implementing the proposed agency action in the case of a no action alternative that are technically and economically feasible and meet the purpose and need of the proposal; the relationship between local short-term uses of the environment and the maintenance and enhancement of long-term productivity; and any irreversible and irretrievable commitments of Federal resources which would be involved in the proposed agency action should it be implemented.
NMFS plans to convene the Team in 2026 and 2027 to develop consensus recommendations on Plan modifications, as necessary to ensure the impacts of U.S. commercial fisheries on Atlantic large whales complies with the MMPA, while also minimizing regulatory burdens. NMFS anticipates completing an Environmental Assessment or draft environmental impact statement (DEIS), if required, by late 2027. If a DEIS is required, NMFS will publish a notice of availability requesting public comments. After the public comment period ends, NMFS will review, consider, and respond to comments received and will develop the FEIS, if an FEIS is required. NMFS will make the FEIS available to the public at or around the time NMFS publishes the final rule. NMFS will make and issue a Record of Decision in late 2028, in order to meet the timeline set forth by Congress in the CAA.
This NOI commences a public scoping period in which NMFS requests public comment on issues and potential alternatives to modify the Plan to reduce M/SI of large whales in U.S. commercial fisheries to below PBR while also reducing regulatory burden. This is not a notice of proposed rulemaking. Throughout the scoping process, Federal agencies, state, tribal, local governments, and the general public have the opportunity to help NMFS determine reasonable alternatives and potential measures to be analyzed, as well as to provide additional information.
Everyone potentially impacted by or interested in changes to the Plan is invited to participate in the public scoping process by submitting written input via the
Information received through this scoping process will inform the potential development of alternative risk reduction measures for an environmental analysis on modifications to the Plan. Only inputs and suggestions that are within the scope of the proposed actions will be considered when developing the alternatives for analysis. The purpose is to develop measures to fulfill the requirements of section 118 of the MMPA, which regulates the taking of marine mammals incidental to U.S. commercial fishing operations and the CAA. NMFS is also soliciting comments on measures that would further the recovery goals of ESA-listed right whales as affected by fisheries regulated under the Plan, as well as topics related to incidental take authorizations and statements under the MMPA and ESA. NMFS implements additional endangered species conservation and recovery programs under the ESA and also affords marine mammals protections under multiple programs pursuant to the MMPA.
To promote informed decision-making, input should be as specific as possible and should provide as much detail as necessary to fully inform NMFS of the commenter's position. Input should explain why the issues raised are important to the consideration of potential environmental impacts and potential alternatives to a proposed action, as well as economic and other impacts affecting the quality of the human environment.
It is important that commenters provide their input prior to the close of the scoping period and clearly articulate their concerns and contentions. Input received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for a proposed action discussed in this notice. Input submitted anonymously will be accepted and considered.
Hamilton, P.K., Howe, K.R., Knowlton, A.R., Lockwood, D.J., McPherson, K.D., Pettis, H.M., Warren, A.M., Vance, S.L., and Zani, M.A. 2024. Maintenance of the North Atlantic Right Whale Catalog, Whale Scarring and Visual Health Databases, Anthropogenic Injury Case Students, and Near Real-Time Matching for Biopsy Efforts, Entangled, Injured, Sick, or Dead Whales. Final Report to the National Marine Fisheries Service 1305M2-18-P-NFFM-0108.
Hayes, S., E. Josephson, K. Maze-Foley, P.E. Rosel, and J. McCordic, Eds. 2024. U.S. Atlantic and Gulf of Mexico Marine Mammal Stock Assessments 2023. NOAA Technical Memorandum NMFS-NE-321. 372 pp.
Linden, D.W. 2025. Population size estimation of North Atlantic right whales from 1990-2024. NOAA NEFSC Technical Memorandum 20.
Pace, R.M., R. Williams, S.D. Kraus, A.R. Knowlton, H.M Pettis. 2021. Cryptic mortality in North Atlantic right whales. Conserv. Sci. Pract. 3:e346.
Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of intent to prepare an Environmental Impact Statement; request for comments.
NOAA announces its intent to prepare an Environmental Impact Statement (EIS) to evaluate the environmental impacts of issuing an exploration license to The Metals Company USA, LLC (TMC-USA) under the Deep Seabed Hard Mineral Resources Act (DSHMRA or “the Act”) for the application area designated by TMC-USA as “USA-B.” The proposed license, if issued, would authorize TMC-USA to conduct seabed mining exploration activities (
NOAA will consider written comments received by September 16, 2026.
Comments may be submitted to the Federal e-Rulemaking Portal at
Comments must be submitted by the date and electronic method described above to ensure that the comments are received, documented, and considered by NOAA. Comments sent by any other method, to any other address or individual, or received after the end of the comment period may not be considered. Comments that are not related to preparation of the EIS to evaluate the impacts of issuing an exploration license to TMC-USA for the Application B Area or that contain profanity, vulgarity, threats, or other inappropriate language will not be considered. To ensure full consideration by NOAA, comments must be submitted in English. Comments that are not submitted in English may not be posted to the public dockets on
Requests for additional information may be sent to
DSHMRA (30 U.S.C. 1401-1473) charges the NOAA Administrator with the responsibility for issuing to U.S. citizens licenses for exploration and permits for commercial recovery of hard mineral resources from areas beyond national jurisdiction. U.S. citizens must obtain licenses and permits from NOAA before undertaking deep seabed mining exploration or commercial recovery activities, respectively. NOAA may issue licenses and permits to U.S. citizens in areas beyond national jurisdiction under DSHMRA, provided all statutory and regulatory requirements are met, including under NEPA. Before issuing a license or permit, NOAA is required under DSHMRA to prepare an EIS on the environmental impacts of the activities proposed by the applicant (30 U.S.C. 1419(d)).
On July 28, 2025, NOAA received an amended application from TMC USA for a license to conduct seabed mining exploration activities in areas beyond national jurisdiction in the Clarion-Clipperton Zone of the central Pacific Ocean.
In Executive Order 14285, “Unleashing America's Offshore Critical Minerals and Resources,” issued on April 24, 2025, President Donald J. Trump stated that the U.S. “has a core national security and economic interest in maintaining leadership in deep sea science and technology and seabed mineral resources” and “must take immediate action to accelerate the responsible development of seabed mineral resources,” including polymetallic nodules containing strategic minerals, that are “vital to our national security and economic prosperity.” To advance U.S. leadership in responsible seabed mineral development, NOAA was directed to, among other things, “expedite the process for reviewing and issuing seabed mineral exploration licenses in areas beyond national jurisdiction under the Deep Seabed Hard Mineral Resources Act (30 U.S.C. 1401
In applying for an exploration license under DSHMRA, TMC-USA's objective is to determine the nature, location, and extent of hard mineral resources, and environmental characteristics in a 121,830.2 km
Pursuant to DSHMRA, NOAA plans to prepare an EIS that evaluates the proposed issuance of an exploration license to TMC-USA to carry out seabed mining exploration activities within the Application B Area.
NOAA will evaluate reasonable alternatives to the Proposed Action, including a no action alternative. Under the no action alternative, NOAA would deny issuance of an exploration license to TMC-USA, and the proposed exploration plan described in TMC-USA application would not be authorized to proceed under DSHMRA.
In the draft EIS, NOAA is considering analyzing the following preliminary alternatives:
• Issuance of an exploration license with terms, conditions, and restrictions to TMC-USA to conduct the exploration activities and environmental mitigation and monitoring measures as proposed in TMC-USA's exploration plan.
• Issuance of an exploration license with terms, conditions, and restrictions to TMC-USA to conduct the exploration activities as proposed in TMC-USA's exploration plan, with additional and/or modified environmental mitigation and monitoring measures.
• Denial of the license (
NOAA welcomes comments on all preliminary alternatives as well as suggestions for additional alternatives.
NOAA expects that the primary environmental impacts from exploration activities will include those from vessel and vehicle operation, (
As part of its compliance with NHPA section 106 and its implementing regulations (36 CFR part 800), NOAA seeks comment and input from the public regarding the identification of historic properties within the Proposed Action's area of potential effects, the potential effects on those historic properties from the activities proposed by the Applicant, and any information that supports identification of historic properties under the NHPA. NOAA also solicits proposed measures to avoid, minimize, or mitigate any adverse effects on historic properties.
NOAA has invited the Environmental Protection Agency, the U.S. Coast Guard, and the Departments of State, Energy, and the Interior to cooperate on this EIS. NOAA requests that additional parties that have an interest in cooperating on this EIS so indicate in their response to this Notice.
NOAA will consider input provided by Federal and State agencies, Territories, Tribal Governments, local governments, private parties, the public, and any other interested parties during this scoping process in the preparation of the EIS. Publication of this notice initiates the public scoping process to solicit public and agency comment regarding the full spectrum of environmental issues and concerns relating to the scope and content of the EIS including:
• information, studies, and analyses of the human and marine resources that could be affected;
• the nature and extent of the potential significant impacts on those resources;
• a reasonable range of alternatives to the proposed action; and
• mitigation and monitoring measures.
In accordance with DSHMRA, 30 U.S.C. 1419(d), NOAA anticipates that this decision making process will conclude within one year of the certification of TMC-USA's exploration application for the Application B Area.
United States Patent and Trademark Office, U.S. Department of Commerce.
Request for comments.
The United States Patent and Trademark Office (USPTO or Office) is seeking information to consider regarding the selection of locations for one or more community outreach offices (COOs) in the agency's Southwest Region, which comprises Arizona, Texas, New Mexico, Oklahoma, Kansas, and Missouri.
To ensure consideration, written comments must be received by 5 p.m. ET on or before September 16, 2026, and should be submitted in accordance with the instructions in the
Comments must be submitted electronically to
If submission of comments to
Chris Shipp, Chief of Staff, Office of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, at 571-272-8600.
Enabled by the 2011 Leahy-Smith America Invents Act (AIA), Public Law 112-29, the USPTO currently has regional offices (ROs) in Detroit, Michigan; San Jose, California (Silicon Valley); Dallas, Texas; and Alexandria, Virginia. The purposes of the regional offices, as originally defined in the AIA and amended by the Unleashing American Innovators Act of 2022 (UAIA), Public Law 117-328, 103 (2022), which was signed into law as part of the Consolidated Appropriations Act, 2023 on December 29, 2022, are to:
• Better connect patent filers and innovators with the Office, including by increasing outreach activities to individual innovators, small businesses, veterans, low-income populations, students, rural populations, and any geographic group of innovators that the Director may determine to be underrepresented in patent filings;
• Enhance patent examiner and administrative patent judge retention, including patent examiners and administrative patent judges from economically, geographically, and demographically diverse backgrounds;
• Improve recruitment of patent examiners;
• Decrease the number of patent applications waiting for examination; and
• Improve the quality of patent examination.
The USPTO has been focused on outreach and impact and is working on ways to better introduce, support, and assist those who may be new to the innovation ecosystem, enabling the involvement and participation of more individuals.
In addition to regional offices, the UAIA requires the USPTO to establish at least four COOs within five years from enactment of the Act (
• Further achieve the purposes described above for the ROs;
• Partner with local community organizations, institutions of higher education, research institutions, and businesses to create community-based programs that provide education regarding the patent system and promote the career benefits of innovation and entrepreneurship; and
• Educate prospective inventors, including individual inventors, small businesses, veterans, low-income populations, students, rural populations, and any geographic group of innovators that the Director may determine to be underrepresented in patent filings, about all public and private resources available to potential patent applicants, including the patent pro bono programs.
The Northern New England Community Outreach Office was established in January 2025 in Durham, New Hampshire. The Mountain West Community Outreach Office located in Salt Lake City, Utah, and the Northwest Frontier Community Outreach Office located in Bozeman, Montana, were established in February 2026. In July 2026, the USPTO announced two new COOs for the agency's Southeast Region, with one in Atlanta, Georgia, and another in Huntsville, Alabama.
The USPTO is seeking information to consider regarding the selection of locations for one or more COOs in Arizona, Texas, New Mexico, Oklahoma, Kansas, and Missouri.
The USPTO will use quantitative metrics and criteria to evaluate and assess the location selection for future COOs. The Office intends to consider the following classes of data (D) at a minimum:
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The USPTO welcomes input from all stakeholders on any matter that they believe is relevant to the overall planning and design or site selection of the USPTO COOs that will serve Arizona, Texas, New Mexico, Oklahoma, Kansas, and Missouri. Commenters are encouraged to address any or all of the statutory considerations listed in the UAIA and summarized above, any other considerations they believe the USPTO should consider, and the questions listed below.
To be considered, comments must be submitted to
With the addition of COOs to the agency's footprint, the USPTO envisions the joint mission of the COOs to be the cultivation and expansion of a vibrant innovation and entrepreneurship ecosystem supported by intellectual property across the United States. To accomplish this mission, the offices will conduct broad stakeholder engagement with innovators ranging from individual inventors to multinational business entities; establish and leverage partnerships and relationships to scale the USPTO's work; incentivize regional innovation and entrepreneurship, especially in key emerging areas (
The USPTO invites responses to the following questions:
1. Considering the envisioned mission described above, what essential services—including outreach, education, and customer service—should a COO provide to achieve the statutory purposes?
a. Should the services identified be delivered in person? Why or why not?
b. Should the services identified be delivered virtually? Why or why not?
2. What types of organizations should the COO seek to establish relationships and collaborations with to better leverage and scale its services?
3. Would there be a benefit for a COO to be co-located with other public sector entities/services (
a. If so, please describe the added value of having a shared location.
b. Which public sector entities/services would you suggest for the shared location(s)?
c. If not, please describe the benefit of having a unique location for a COO.
4. What unique services should the COOs individually provide, and how should the full range of services complement each other?
5. Considering the potential classes of data listed in Part I above, what additional key indicators or data would support COO site selection?
6. What other factors should the USPTO consider when planning for the new COOs?
Given the statutory purposes and considerations of COOs, as discussed in Part I, and the planning and design considerations identified in Part II:
7. Which location is ideal for one or more community outreach offices (COOs) in Arizona, Texas, New Mexico, Oklahoma, Kansas, and Missouri.
8. What else should the USPTO consider when determining the ideal
While the Office welcomes and values all comments from the public in response to this request, the comments submitted do not commit the Office to any further actions related to the comments, and the Office may not respond to any or every submitted comment. The Office nonetheless will consider all written submissions.
Any and all decisions made regarding the future locations of the COOs will be consistent with the criteria outlined in the UAIA and the goals and mission of the USPTO.
Defense Acquisition Regulations System; Department of Defense (DoD).
Notice and request for comments regarding a proposed extension of an approved information collection requirement.
In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of DoD's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use under Control Number 0704-0332 through November 30, 2026. DoD proposes that OMB approve an extension of the information collection requirement, to expire three years after the approval date.
DoD will consider all comments received by October 16, 2026.
You may submit comments, identified by OMB Control Number 0704-0332, using either of the following methods:
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Comments received generally will be posted without change to
Joy Dishaw, at 703-509-3255.
DoD has incorporated these information collection requirements into the DFARS in Appendix I, section I-112. Program participants agree to comply with these information collection requirements when they execute their mentor-protégé agreements, receiving the program's benefits in consideration.
This information is necessary to ensure that participants are fulfilling their obligations under the mentor-protégé agreements and furthering the purpose of the Mentor-Protégé Program as required by section 18(d)(7) of the Small Business Act (15 U.S.C. 637(d)(7). In accordance with 10 U.S.C. 4902, DoD uses the information to decide whether to approve continuation of the agreement. In addition, the information is necessary for program managers to direct developmental assistance to the most appropriate small business concerns and to ensure the program meets the Congressionally-mandated goal of enhancing the defense industrial base.
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental document that will discuss the environmental effects of the CP2 LNG Expansion Project involving construction and operation of facilities by Venture Global CP2 LNG, LLC and Venture Global CP Express, LLC (Applicants) in Cameron Parish, Louisiana and Jasper County, Texas. The Commission will use this environmental document in its decision-making process to determine whether the project is in the public interest.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies regarding the project. As part of the National Environmental Policy Act (NEPA) review process, the Commission takes into account concerns the public may have about proposals and the environmental effects that could result from its action whenever it considers the issuance of an authorization. This gathering of public input is referred to as “scoping.” The main goal of the scoping process is to focus the analysis
By this notice, the Commission requests public comments on the scope of issues to address in the environmental document. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5:00 p.m. Eastern Time on September 11, 2026. Comments may be submitted in written or oral form. Further details on how to submit comments are provided in the
Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental effects. Your input will help the Commission staff determine what issues they need to evaluate in the environmental document. Commission staff will consider all written and oral comments during the preparation of the environmental document.
If you submitted comments on this project to the Commission before the opening of these dockets on May 26, 2026, you will need to file those comments in Docket Nos. CP26-530-000 and CP26-533-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the project, the Natural Gas Act conveys the right of eminent domain to the company for facilities constructed under section 7 of the Natural Gas Act. Therefore, if you and the company do not reach an easement agreement, the pipeline company could initiate condemnation proceedings in court. In such instances, compensation would be determined by a judge in accordance with state law. The Commission does not subsequently grant, exercise, or oversee the exercise of that eminent domain authority. The courts have exclusive authority to handle eminent domain cases; the Commission has no jurisdiction over these matters.
The Applicants provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” which addresses typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. This fact sheet along with other landowner topics of interest are available for viewing on the FERC website (
There are four methods you can use to submit your comments to the Commission. Please carefully follow these instructions so that your comments are properly recorded. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the eComment feature, which is located on the Commission's website (
(2) You can file your comments electronically by using the eFiling feature, which is also on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the Commission. Be sure to reference the project docket numbers (CP26-530-000 and CP26-533-000) on your letter. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852; or
(4) In lieu of sending written comments, the Commission invites you to attend one of the public scoping sessions its staff will conduct in the project area, scheduled as follows:
The primary goal of these scoping sessions is to have you identify the specific environmental issues and concerns that should be considered in the environmental document. Individual oral comments will be taken on a one-on-one basis with a court reporter. This format is designed to receive the maximum amount of oral comments in a convenient way during the timeframe allotted.
Each scoping session is scheduled from 4:30 p.m. to 6:30 p.m. Central Daylight Time (CDT). You may arrive at any time after 4:30 p.m. There will not be a formal presentation by Commission staff when the session opens. If you wish to speak, the Commission staff will hand out numbers in the order of your arrival. Comments will be taken until 6:30 p.m. However, if no additional numbers have been handed out and all individuals who wish to provide comments have had an opportunity to do so, staff may conclude the session at 6:00 p.m. Please see appendix 1 for additional information on the session format and conduct.
Your oral comments will be recorded by a court reporter (with FERC staff or representative present) and become part of the public record for this proceeding. Transcripts will be publicly available on FERC's eLibrary system (see the last page of this notice for instructions on using eLibrary). If a significant number of people are interested in providing oral comments in the one-on-one settings, a time limit of 5 minutes may be implemented for each commentor. Although there will not be a formal presentation, Commission staff will be available throughout the scoping session to answer your questions about the environmental review process. The Applicants' representatives will also be present to answer project-specific questions.
It is important to note that the Commission provides equal consideration to all comments received, whether filed in written form or provided orally at a scoping session.
Additionally, the Commission offers a free service called eSubscription which makes it easy to stay informed of all issuances and submittals regarding the dockets/projects to which you subscribe. These instant email notifications are the fastest way to receive notification and provide a link to the document files which can reduce the amount of time you spend researching proceedings. Go to
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
The Project would increase the transportation capacity of the CP Express Pipeline System by approximately 1,900,000 dekatherms per day and increase the maximum peak liquefaction capacity by 11.7 million metric tonnes per annum. According to the Applicants, the Project would expand liquefied natural gas (LNG) production at the approved CP2 LNG Terminal Facilities where domestically produced natural gas is converted to LNG for storage and export to overseas markets.
The CP2 LNG Expansion Project would consist of the following facilities at the CP2 LNG Terminal and Marine Facilities in Cameron Parish, Louisiana:
• six liquefaction blocks, each with two single mixed refrigerant process units and ancillary support facilities;
• a 720-megawatt power plant, with five gas turbines, five heat recovery steam generators, and two steam generators;
• three gas pre-treatment facilities;
• two nitrogen removal units and three LNG expanders to remove excess nitrogen that may be present in the feed gas;
• three thermal oxidizers;
• five boil off gas compressors;
• additional utilities and safety systems; and
• one additional LNG loading dock (Berth 3) within the approved footprint of the existing, approved Marine Facilities on Monkey Island.
The following facilities would be constructed along the CP Express Pipeline in Jasper County, Texas:
• a new 227,000-horsepower greenfield compressor station (Silsbee Compressor Station); and
• two 1,000-foot-long, 48-inch-diameter natural gas pipeline laterals to provide suction and discharge to connect the compressor station to the existing, approved CP Express Pipeline.
The general location of the project facilities is shown in appendix 2.
The proposed Terminal Site Expansion would disturb about 69.2 acres during construction and operation. The proposed Marine Facilities Expansion would disturb about 20.4 acres during construction and 3.4 acres during operation. Construction and operation of the Terminal Site and Marine Facilities Expansion would occur within the previously authorized footprint of the Terminal and Marine Facilities. Construction of the proposed Silsbee Compressor Station and pipeline laterals would disturb about 73.7 acres and 4.6 acres, respectively. Following construction, the Applicants would maintain about 52.8 acres and 2.0 acres for permanent operation of the compressor station and pipeline laterals, respectively. The remaining acreage would be restored and revert to former uses.
Any environmental document issued by the Commission will discuss the effects that could occur as a result of the construction and operation of the proposed project under the relevant general resource areas:
• geology and soils;
• water resources and wetlands;
• vegetation and wildlife;
• threatened and endangered species;
• cultural resources;
• land use;
• socioeconomics;
• air quality and noise; and
• reliability and safety.
Commission staff will also evaluate reasonable alternatives to the proposed project or portions of the project and make recommendations on how to lessen or avoid effects on the various resource areas. Your comments will help Commission staff identify and focus on the issues that might have an effect on the human environment and potentially eliminate others from further study and discussion in the environmental document.
Following this scoping period, Commission staff will determine whether to prepare an Environmental Assessment (EA) or an Environmental Impact Statement (EIS). The EA or the EIS will present Commission staff's independent analysis of the issues. If Commission staff prepares an EA, a
With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate in the preparation of the environmental document.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is using this notice to initiate consultation with the applicable State Historic Preservation Offices, and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; Native American Tribes; environmental and public interest groups; other interested parties; and local libraries and media outlets. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project and includes a mailing address with their comments. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that Commission notices related to this environmental review are sent to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
If you need to make changes to your name/address, or if you would like to remove your name from the mailing list, please complete one of the following steps:
(1) Send an email to
(2) Return the attached “Mailing List Update Form” (appendix 3).
Additional information about the project is available from the FERC website at
Public sessions or site visits will be posted on the Commission's calendar located at
Take notice that the Commission received the following Complaints and Compliance filings in EL Dockets:
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:
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
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:
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
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:
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, contact the Office of Public Participation at (202) 502-6595 or
Environmental Protection Agency (EPA).
Notice of receipt and request for comment.
This document announces the Agency's receipt of and solicits comments on applications to register new pesticide products containing currently registered active ingredients that would entail a change in use pattern. The Agency is providing this notice in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA uses the month and year in the title to identify when the Agency compiled the applications identified in this notice of receipt. Unit II. of this document identifies certain applications received in 2025 and 2026 that are currently being evaluated by EPA, along with information about each application, including when it was received, who submitted the application, and the purpose of the application.
Comments must be received on or before September 16, 2026.
Submit your comments, identified by the docket identification (ID) number and the
Each application summary in Unit II. specifies a contact division. The appropriate division contacts are identified as follows:
• RD (Registration Division) (Mail Code 7505T); Charles Smith; main telephone number: (202) 566-1030; email address:
This action provides information that is directed to the public in general.
EPA is taking this action pursuant to section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136a(c)(4), and 40 CFR 152.102.
EPA is hereby providing notice of receipt and opportunity to comment on applications to register new pesticide products containing currently registered active ingredients that would entail a change in use pattern. EPA provides a notice of receipt on a monthly basis, using the month and year in the title to help distinguish one document from the other. This document identifies the applications that were received since the last notice that was issued and are currently being evaluated by EPA in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Notice of receipt of these applications does not imply a decision by the Agency on these applications. For actions being evaluated under EPA's public participation process for registration actions, there will be an additional opportunity for public comment on the proposed decisions. Please see EPA's public participation website for additional information on this process (
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2.
This unit provides the following information about each application received: The EPA File Symbol or Registration number(s); EPA docket ID number for the application; Name and address of the applicant; Name of the active ingredient, product type and proposed uses; and the division to contact for that application. Additional information about the application may also be available in the docket for the application as identified in this unit.
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Environmental Protection Agency (EPA).
Notice of charter reestablishment and request for nominations.
Notice is hereby given that the Environmental Protection Agency (EPA) has determined that, in accordance with the provisions of the Federal Advisory Committee Act (FACA), the Pesticide Program Dialogue Committee (PPDC) is in public interest and is necessary in connection with the performance of EPA's duties. Accordingly, PPDC will be reestablished for a two-year period and renewed as determined necessary. Copies of the PPDC charter will be filed with the appropriate congressional committees and the Library of Congress. In addition, EPA is seeking member nominations for the PPDC from qualified candidates to serve a two-year term. The purpose of PPDC is to provide advice and recommendations to the EPA Administrator on issues associated with regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. To maintain the representation outlined by the charter, nominees will be selected to represent: pesticide industry and trade associations; pesticide user, grower, and commodity groups; federal, state, local, and tribal governments; academia; animal welfare and public health organizations; environmental and public interest organizations; farm worker organizations; and the general public. Vacancies are expected to be filled by November 2026.
Nominations for the PPDC must be submitted within September 16, 2026.
Jeffrey Chang, Designated Federal Official (DFO) for the PPDC; telephone number: (202) 566-2213, email address:
This action is directed to the public in general, and may be of particular interest to persons who work in in agricultural settings or if you are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2025-1774, is available online at
In accordance with the Federal Advisory Committee Act (FACA), as amended, EPA is providing notice of the re-establishment of the charter of the Pesticide Program Dialogue Committee. This charter will be renewed for a two-year period, beginning on the date it is filed with the appropriate congressional committees.
The PPDC is a federal advisory committee chartered under FACA. EPA established the PPDC in September 1995 to provide policy advice, information and recommendations to the EPA Administrator through the Director of the Office of Pesticide Programs. The PPDC provides a public forum to discuss a wide variety of pesticide regulatory developments and reform initiatives, evolving public policy and program implementation issues associated with evaluating and reducing risks from the use of pesticides. The EPA will consider candidates from the following sectors: Pesticide industry and trade associations; pesticide user, grower, and commodity groups; federal, state, local, and tribal governments; academia; animal welfare and public
The PPDC usually meets twice a year, generally in the spring and the fall. Additionally, members may be asked to serve on work groups to develop recommendations to address specific policy issues. The average workload for members is approximately four to six hours per month.
Each representative member is appointed to serve up to a two-year term. Nominations are sought to fill 21 representative member positions. We are requesting nominations to fill vacancies to represent all organizations and interests listed above. Any interested person or organization may nominate qualified people to be considered for appointment to this advisory committee. Individuals may be self-nominated. Nominations may be submitted in electronic format to Jeffrey Chang at the address listed under
To be considered, all nominations should include:
• Current contact information for the nominee, including the nominee's name, organization (and position within that organization), current business address, email address, and daytime telephone number;
• Brief Statement describing the nominee's interest and availability in serving on the PPDC;
• Resume or curriculum vitae;
• Short biography (no more than 2 paragraphs) describing the professional and educational qualifications of the nominee, including a list of relevant activities, or any current or previous experience on advisory committees; and
• Letter[s] of recommendation from a third party supporting the nomination. The letter should describe how the nominee's experience and knowledge will bring value to the work of the PPDC.
Other sources, in addition to this
Pursuant to 41 CFR 102-3.65, this notice, announcing that the PPDC is being reestablished, must include the written public interest determination (PID) approved by the head of the agency described in 41 CFR 102-3.60(a) and any assessment provided by the General Services Administration's Committee Management Secretariat (the Secretariat). The PID included in this Unit has been provided to the Secretariat. The Secretariate has approved this PID without comment or assessment.
Pursuant to 41 U.S.C. 102-3.60(a), to establish, renew, reestablish, or merge a discretionary (agency discretion) advisory committee, an agency must first consult with the Secretariat and, as part of the consultation, provide a written public interest determination approved by the head of the agency to the Secretariat with a copy to the Office of Management and Budget. In addition, pursuant to 41 U.S.C. 102-3.35, an agency shall follow the same consultation process and document in writing the same determination of need before creating a subcommittee under a discretionary committee that is not made up entirely of members of a parent advisory committee. Information on the following factors for the committee was provided to the Secretariat to demonstrate that reestablishing the committee is in public interest:
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In conclusion, this public interest determination documents that reestablishing the committee is in the public interest, essential to the conduct of agency business, and that the information to be obtained is not already available through another advisory committee or source within the Federal Government.
Export-Import Bank of the United States.
Notice.
This Notice is to inform the public that the Export-Import Bank of the United States (“EXIM”) has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million. Consistent with EXIM's mandate to strengthen U.S. economic competitiveness and national security, the proposed transaction supports the development of critical mineral resources essential to resilient domestic supply chains and advanced manufacturing. Comments received within the comment period specified below will be presented to the EXIM Board of Directors prior to final action on this Transaction.
Comments must be received on or before September 11, 2026 to be assured of consideration before final consideration of the transaction by the Board of Directors of EXIM.
Comments may be submitted through
This project advances U.S. leadership by expanding domestic segment of the steel supply chain that is foundational to infrastructure, defense systems, transportation, manufacturing, energy, shipbuilding and defense related supply chains.
The transaction is expected to enhance supply chain resilience, reduce reliance on foreign sources for this strategically important industrial capacity and support high-quality U.S. jobs.
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The Commission may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written comments and recommendations for the information collection should be submitted on or before September 16, 2026.
Comments should be sent to
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the
The Commission is requesting emergency OMB processing of the information collection requirement(s) contained in this notice and has requested OMB approval no later than 35 days after the collection is received at OMB. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
In document FCC 16-169, the Commission adopted measures requiring the following:
(a) Each wireless provider and manufacturer that voluntarily transitions from TTY technology to RTT over wireless IP-based networks and services is encouraged to develop consumer and education efforts that include (1) the development and dissemination of educational materials that contain information pertinent to the nature, purpose, and timelines of the RTT transition; (2) internet postings, in an accessible format, of information about the TTY to RTT transition on the websites of covered entities; (3) the creation of a telephone hotline and an online interactive and accessible service that can answer consumer questions about RTT; and (4) appropriate training of staff to effectively respond to consumer questions. All consumer outreach and education should be provided in accessible formats including, but not limited to, large print, Braille, videos in American Sign Language and that are captioned and video described, emails to consumers who have opted to receive notices in this manner, and printed materials. Service providers and manufacturers are also encouraged to coordinate with consumer, public safety, and industry stakeholders to develop and distribute education and outreach materials. The information will inform consumers of alternative accessible technology available to replace TTY technology that may no longer be available to the consumer through their provider or on their device.
(b) Each wireless provider that requested or will request and receive a waiver of the requirement to support TTY technology over wireless IP-based networks and services must apprise its customers, through effective and accessible channels of communication, that (1) until TTY is sunset, TTY technology will not be supported for calls to 911 services over IP-based wireless services, and (2) there are alternative PSTN-based and IP-based accessibility solutions for people with disabilities to reach 911 services. These notices must be developed in coordination with public safety answering points (PSAPs) and national consumer organizations, and include a listing of text-based alternatives to 911, including, but not limited to, TTY capability over the PSTN, various forms of PSTN-based and IP-based TRS, and text-to-911 (where available). The notices will inform consumers on the loss of the use of TTY for completing 911 calls over the provider's network and alert them to alternatives service for which TTY may be used.
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments received are subject to public disclosure. In general, comments received will be made available without change and will not be modified to remove personal or business information including confidential, contact, or other identifying information. Comments should not include any information such as confidential information that would not be appropriate for public disclosure.
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Benjamin W. McDonough, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than September 1, 2026.
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Board of Governors of the Federal Reserve System.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments received are subject to public disclosure. In general, comments received will be made available without change and will not be modified to remove personal or business information including confidential, contact, or other identifying information. Comments should not include any information such as confidential information that would not be appropriate for public disclosure.
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Benjamin W. McDonough, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than September 16, 2026.
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Board of Governors of the Federal Reserve System.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $15,000,000, for Federal Fiscal Year 2026 funding to Public Health Center (PHC) of the Ministry of Health of Ukraine, subject to the availability of funds. Funding amounts for years 2-5 will be set at continuation. The award is expected to advance HIV and TB epidemic control in Ukraine with activities to include enhancing integrated HIV service delivery, improving antiretroviral therapy (ART) initiation and retention, and strengthening the national laboratory system to respond to emerging pathogens.
The period for this award will be September 30, 2026, through September 29, 2031.
Cristel Bender, Global Health Center, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE, Atlanta, GA 30329, Email:
The sole source award seeks to advance HIV and TB epidemic control in Ukraine with activities to include enhancing integrated HIV service delivery, improving ART initiation and retention, and strengthening the national laboratory system to respond to emerging pathogens. The sole source award will also support surveillance and response to pandemic, novel influenza, and other infectious disease threats in Ukraine.
PHC of the Ministry of Health of Ukraine is the only entity that can carry out this work, as it is the lead national public health institution. It has the legislative responsibility to coordinate, implement, and monitor the country's public health programs, including HIV prevention, care, and treatment. As the central authority in Ukraine's public health system, PHC has legal and regulatory authority over national HIV policies, guidelines, and surveillance
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces it is issuing an Order under Section 362 and 365 of the Public Health Service Act, and associated implementing regulations, continuing the suspension of the right to introduce certain persons from countries where an outbreak of a quarantinable communicable disease exists. This Order was issued on August 12, 2026, and shall remain in effect through 4:59 p.m. Eastern Daylight Time (EDT) on Friday, September 11, 2026. This Order may be amended or rescinded prior to that time at the discretion of the Director.
This action took effect August 12, 2026, at 5:00 p.m. EDT. Written comments must be received on or before September 1, 2026.
You may submit comments, identified by Docket No. CDC-2026-0892 by either of the methods listed below. Do not submit comments by email. CDC does not accept comments by email.
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Jordan Faircloth, Deputy Chief of Staff, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS V18-2, Atlanta, GA 30329. Phone: 404-639-7000. Email:
On May 18, 2026, the Acting Director of the Centers for Disease Control and Prevention signed an Order prohibiting the introduction of certain persons who have departed from, or were otherwise present within, specified countries during the last 21 days. On May 22, 2026, the Assistant Secretary for Health (ASH), HHS, signed an Amended Order that reflected updates to 42 CFR 71.40(f), which no longer provided an exemption for lawful permanent residents from such orders. CDC accepted comments on both the original Order and Amended Order through June 22, 2026, and received 3 comments.
The ASH continued the Order without change on June 21, 2026, for 30 days with a 15-day comment period; CDC received five comments in response. The ASH again continued the Order without change on July 13, 2026, for 30 days with a 15-day comment period, and no comments were received.
On August 12, 2026, the ASH signed a new Order continuing the previous Order without change. This order provides updated information regarding the status of the Ebola disease outbreak and CDC response efforts and maintains the previous travel restrictions.
This Order is effective for a period of 30 days. CDC will accept comments for this Order for 15 days using docket CDC-2026-0892.
A copy of the Order is provided below and a copy of the signed Order can be found at
The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), issues this Order pursuant to Sections 362 and 365 of the Public Health Service (PHS) Act, 42 U.S.C. 265 and 268, and their implementing regulations. This Order continues the suspension of the right to introduce “covered aliens,” as defined herein, into the United States for a period of thirty days, subject to the outcome of an ongoing comprehensive public health risk assessment. This Order is necessary to protect the health of the United States from the serious risk posed by the introduction of
This Order applies to covered aliens who have departed from, or were otherwise present within, DRC, Uganda, or South Sudan during the last 21 days (regardless of their country of origin). This Order is based on an assessment of the most recently available data and current conditions regarding the Ebola disease outbreak.
This Order is time-limited and shall be in effect for 30 days from the date of issuance. This Order is intended to address the serious risk of introduction of Ebola disease into the United States, while allowing the U.S. Government to continue an ongoing assessment of the current and evolving conditions of the Ebola disease outbreak in consultation with other stakeholders.
This Order is severable from previously issued Orders under Sections 362 and 365 of the Public Health Service (PHS) Act, 42 U.S.C. 265 and 268, and their implementing regulations under 42 CFR part 71. Any provision of this Order held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability.
I issue this Order pursuant to Sections 362 and 365 of the Public Health Service (PHS) Act, 42 U.S.C. 265 and 268, and their implementing regulations under 42 CFR part 71,
This Order applies to persons who have departed from, or were otherwise present within, DRC, Uganda, and South Sudan during the last 21 days (regardless of their country of origin), including lawful permanent residents of the United States, subject to the exceptions detailed below. For purposes of this Order, I refer to persons covered by the Order as “covered aliens.”
This Order does
• U.S. citizens and U.S. nationals;
• Members of the armed forces of the United States and associated personnel, U.S. government personnel serving overseas, associated personnel, and their spouses and children, subject to required assurances;
• Persons whom customs officers determine, with approval from a supervisor, should be excepted from this Order based on the totality of the circumstances, including consideration of significant law enforcement, officer and public safety, humanitarian, and public health interests. The U.S. Department of Homeland Security (DHS) will consult with CDC regarding the standards for such exceptions to help ensure consistency with current CDC guidance and public health recommendations; and
• Persons who would otherwise be subject to this Order, who are permitted to enter the United States based on an exception provisionally granted by CDC with confirmation based on a public health assessment at time of entry under a DHS-approved process documented and shared with CDC which includes appropriate public health mitigation protocols, per CDC guidance.
The purpose of this Order is twofold. First, this Order aims to continue minimizing the number of covered aliens entering the United States who have been within countries experiencing a known or suspected outbreak of Ebola disease and thereby reduce the risk of introduction of Ebola disease into the United States. Second, this Order is intended to facilitate an ongoing public health assessment and risk profile of the Ebola disease outbreak. Thirty days is the amount of time necessary for CDC to continue monitoring the situation and determine if there has been a material change to the risk of importation and whether this Order would remain in effect or requires modification. Such information will enable the acting CDC Director to make an informed determination regarding what restrictions are necessary going forward and provide the opportunity for the development of a comprehensive mitigation and containment plan in consultation with stakeholders.
Viral hemorrhagic fever refers to a group of severe illnesses caused by certain viruses that damage the body's blood vessels and affect the ability of the blood to clot properly. Viral hemorrhagic fevers include diseases such as Ebola, Marburg, Lassa fever, and dengue hemorrhagic fever.
Bundibugyo virus disease (BVD) is a severe and often fatal illness caused by one of the viruses in the Ebola family. Ebola disease outbreaks occur mainly in parts of sub-Saharan Africa and can spread rapidly in communities with limited healthcare resources. Ebola disease caused by the Bundibugyo virus is a rare form of Ebola first identified during an outbreak in Bundibugyo District, Uganda, in 2007. Bundibugyo virus is one of several species within the orthoebolavirus family and causes symptoms similar to other forms of Ebola, including fever, weakness, vomiting, diarrhea, and, in severe cases, hemorrhagic complications and organ failure. The disease spreads through direct contact with infected bodily fluids or contaminated materials.
The incubation period for Ebola disease caused by the Bundibugyo virus is typically between 2 and 21 days, with most people developing symptoms within 4 to 10 days after exposure. During this incubation period, infected persons do not spread the virus until symptoms begin.
Screening for Bundibugyo virus disease focuses on identifying symptoms and possible exposure history, such as recent travel to affected areas or contact with infected aliens. Suspected patients are evaluated for symptoms including fever, weakness, vomiting, diarrhea, and bleeding, and laboratory confirmation is performed using specialized tests such as PCR (polymerase chain reaction) to detect the virus in blood and other body fluid samples. Health authorities also use temperature checks, contact tracing, and isolation procedures to prevent transmission.
There are currently no widely approved vaccines or specific antiviral treatments for the Bundibugyo strain of Ebola disease. Treatment mainly consists of supportive care, including intravenous fluids, electrolyte replacement, oxygen support, pain and fever management, and treatment of secondary infections. Early medical care significantly improves survival chances. Robust public health measures such as early detection, rapid isolation, strong infection prevention measures (
The confirmed ongoing outbreak of Ebola virus disease caused by the Bundibugyo virus in DRC and Uganda continues to escalate in intensity. The outbreak remains centered in eastern DRC's Ituri Province, although cases have been identified in North Kivu, South Kivu, Haut-Uele, and Tshopo provinces. This geographic expansion is concerning, particularly given that response efforts are still not at the scale required for outbreak containment. On July 13, 2026, when the last Order was issued, DRC reported 1,873 confirmed cases and 672 deaths across 41 health zones. As of August 9, 2026, DRC reports 4,318 confirmed cases and 2,011 deaths across 53 health zones, with cases and deaths more than doubling since issuance of the July Order.
As recently as August 11, 2026, the ongoing Bundibugyo Ebola virus outbreak in DRC continues to spread despite response efforts. Although contact tracing for
As of August 11, 2026, Uganda reports 20 confirmed cases of Ebola disease and two confirmed deaths, as well as one probable case and one probable death. The last confirmed case was reported on June 21, 2026. Of the confirmed cases, 15 were imported cases and 5 were secondary cases linked to imported cases from DRC.
To date, South Sudan has not reported any confirmed Ebola disease cases in the current outbreak.
Travelers moving between affected countries and major international transit hubs could unknowingly carry the Bundibugyo virus before becoming ill. Such travelers may spread the outbreak beyond the affected countries and ultimately reach the United States. DRC, Uganda, and South Sudan are connected to the global aviation network through a series of regional and international transit hubs that provide pathways into the United States. Travelers departing from outbreak-affected regions frequently transit through densely populated metropolitan airports such as Addis Ababa Bole International Airport (ADD), Jomo Kenyatta International Airport (NBO) in Nairobi, Brussels Airport (BRU), Hamad International Airport (DOH) in Doha, Dubai International Airport (DXB), and Istanbul Airport (IST), all of which maintain extensive passenger connectivity to major U.S. gateway airports including John F. Kennedy International Airport (JFK), Washington Dulles International Airport (IAD), Hartsfield-Jackson Atlanta International Airport (ATL), Chicago O'Hare International Airport (ORD), and Los Angeles International Airport (LAX). These international transportation corridors support continuous movement of travelers between Central and East Africa and major U.S. metropolitan centers, increasing the likelihood that aliens exposed to Ebola disease could enter the United States before symptoms become apparent. Complex multi-leg itineraries and the rapid pace of international travel create substantial challenges for identifying potentially infected travelers before arrival.
A traveler infected in outbreak regions of DRC and Uganda may transit through multiple countries and major international airports before developing fever or other clinical signs of disease. The risk of Bundibugyo virus disease introduction into the United States is heightened by the virus's incubation period, which can extend up to 21 days, allowing infected persons to travel internationally while asymptomatic and therefore unlikely to be detected through routine symptom-based screening measures. The current outbreak has already demonstrated this risk: a physician infected while providing patient care in DRC traveled internationally before becoming ill and was diagnosed only after arriving in France.
Travelers utilizing air transit pathways originating in or passing through DRC, Uganda, and South Sudan include non-U.S. citizens, including regional migrants, foreign contract workers, humanitarian personnel, business travelers, students, refugees, and third-country nationals moving through international aviation hubs in Africa, the Middle East, and Europe. Many travelers entering U.S.-bound itineraries from these pathways may do so under temporary visas, refugee or asylum processing mechanisms, international organizational travel, or multi-country itineraries that obscure their original point of departure. As a result, public health screening and border security systems face heightened operational complexity in identifying travelers with recent exposure histories linked to Ebola-affected regions, particularly when travelers originate from or transit through multiple jurisdictions prior to arrival at major U.S. metropolitan airports.
CDC has issued a series of Travel Health Notices (THNs) for the region; the THNs for the affected provinces have escalated over time. On August 4, 2026, CDC escalated the THN issued for Ituri and North Kivu Provinces of DRC to a Level 4 (avoid all travel).
CDC modeling indicates that, absent rapid and sustained public health interventions, the outbreak could become one of the largest Ebola epidemics ever recorded.
Restricting entry of covered aliens into the United States reduces the volume of higher-risk international arrivals requiring public health monitoring and follow-up. By limiting the number of potentially exposed travelers entering through major U.S. ports of entry, federal, state, and local public health authorities have concentrated finite surveillance, screening, contact tracing, quarantine management, and medical monitoring resources on returning U.S. citizens and U.S. nationals, including those who have worked in the outbreak areas.
Paired with the DHS arrival restrictions redirecting travelers to specific U.S. airports,
CDC is issuing this Order pursuant to sections 362 and 365 of the Public Health Service Act (42 U.S.C. 265, 268) and the implementing regulation at 42 CFR 71.40. In accordance with these authorities, the CDC Director is permitted to prohibit, in whole or in part, the introduction into the United States of persons from designated foreign countries (or one or more political subdivisions or regions thereof) or places, only for such period of time that the Director deems necessary to avert the serious danger of the introduction of a quarantinable communicable disease,
(1) By reason of the existence of any quarantinable communicable disease in a foreign country (or one or more political subdivisions or regions thereof) or place there is serious danger of the introduction of such quarantinable communicable disease into the United States; and
(2) This danger is so increased by the introduction of persons from such country (or one or more political subdivisions or regions thereof) or place that a suspension of the right to introduce such persons into the United States is required in the interest of public health.
Section 362 and the implementing regulation provide the Director with a public health tool to suspend introduction of persons not only to prevent the introduction of a quarantinable communicable disease, but also to aid in continued efforts to mitigate spread of that disease.
The term “introduction into the United States” is defined in 42 CFR 71.40 as “the movement of a person from a foreign country (or one or more political subdivisions or regions thereof) or place, or series of foreign countries or places, into the United States so as to bring the person into contact with persons or property in the United States, in a manner that the Director determines to present a risk of transmission of a quarantinable communicable disease to persons, or a risk of contamination of property with a quarantinable communicable disease.” 42 CFR 71.40(b)(1). Similarly, the term “serious danger of the introduction of such quarantinable communicable disease into the United States” is defined as, “the probable introduction of one or more persons capable of transmitting the quarantinable communicable disease into the United States, even if persons or property in the United States are already infected or contaminated with the quarantinable communicable disease.” 42 CFR 71.40(b)(3).
Section 71.40(b)(2) defines “[p]rohibit, in whole or in part, the introduction into the United States of persons” in Section 362 to mean “to prevent the introduction of persons into the United States by suspending any right to introduce into the United States, physically stopping or restricting movement into the United States.”
As stated in the Final Rule for 42 CFR 71.40, CDC “may, in its discretion, consider a wide array of facts and circumstances when determining what is required in the interest of public health in a particular situation . . . includ[ing] . . . [t]he overall number of cases of disease; any large increase in the number of cases over a short period of time; the geographic distribution of cases; any sustained (generational) transmission; the method of disease transmission; morbidity and mortality associated with the disease; the effectiveness of contact tracing; the adequacy of state and local health care systems; and the effectiveness of state and local public health systems and control measures.”
As stated in 42 CFR 71.40, this Order does not apply to U.S. citizens, U.S. nationals, members of the armed forces of the United States and associated personnel if the Secretary of War provides assurance to the Director that the Secretary of War has taken or will take measures such as quarantine or isolation, or other measures maintaining control over such individuals, to prevent the risk of transmission of the quarantinable communicable disease into the United States, or United States government employees or contractors on orders abroad, or their accompanying family members who are on their orders or are members of their household, if the Director receives assurances from the relevant head of agency and determines that the head of the agency or department has taken or will take measures such as quarantine or isolation, to prevent the risk of transmission of a quarantinable communicable disease into the United States.
In addition, this Order does not apply to additional classes of persons excepted by the CDC Director. Creating exceptions in the Order is consistent with Section 362 and 42 CFR 71.40. Section 362 explicitly states that the prohibition of introduction into the United States may be “in whole or in part.” This phrase is also included in section 71.40(a) and, as explained in the Final Rule, is intended to allow the Director to narrowly tailor the use of the authority to what is required in the interest of public health.
This Order will be in effect for 30 days to avert the serious danger of the introduction, transmission, and spread of Ebola disease into the United States. Finally, as directed by 42 CFR 71.40(c), this Order sets out the following:
(1) The foreign countries (or one or more political subdivisions or regions thereof) or places from which the introduction of persons is being prohibited;
(2) The period of time or circumstances under which the introduction of any persons or class of persons into the United States is being prohibited;
(3) The conditions under which that prohibition on introduction will be effective, in whole or in part, including any relevant exceptions that the Director determines are appropriate;
(4) The means by which the prohibition will be implemented; and
(5) The serious danger posed by the introduction of the quarantinable communicable disease in the foreign country or countries (or one or more political subdivisions or regions thereof) or places from which the introduction of persons is being prohibited.
Based on the foregoing, I hereby determine that Ebola disease, a highly transmissible quarantinable communicable disease, is confirmed currently present in DRC and recently present in Uganda. There is a material risk that the outbreak will spread to South Sudan. I also determine that the prevalence of Ebola disease in these foreign countries constitutes a serious danger of the introduction of this disease into the United States due to the limited screening and testing and mitigation measures currently available. Finally, I determine that a temporary 30-day suspension of the right to introduce covered aliens is necessary to protect the public health from the serious danger of the introduction of Ebola disease into the United States, pending an ongoing public health assessment of the Ebola disease outbreak.
I consulted with the Department of State, DHS, and other federal departments as needed before I issued this Order and requested that DHS aid in the enforcement of this Order because CDC does not have the capability, resources, or personnel needed to do so.
Although this Order is not a rule subject to notice and comment under the Administrative Procedure Act (APA) and is issued with immediate effect, in order to ensure that the forthcoming public health risk assessment is informed by public input, the Order is being issued with a simultaneous 15-day comment period.
This Order takes effect at 5:00 p.m. Eastern Daylight Time on Wednesday, August 12, 2026. For individuals intending to travel to the United States by air, the Order will apply to flights departing after 4:59 p.m. Eastern Daylight Time on Wednesday, August 12, 2026.
In testimony whereof, the Assistant Secretary for Health, U.S. Department of Health and Human Services, has hereunto set his hand at Washington, DC this 12th day of August, 2026.
Dated: Admiral Brian Christine, MD, Assistant Secretary for Health (ASH) and Head of the United States Public Health Service (USPHS) Commissioned Corps Department of Health and Human Services.
Interested persons or organizations are invited to participate by submitting written views, recommendations, and data so that the public can provide input that may inform the forthcoming public health risk assessment and whether any subsequent exercise of this authority is necessary.
Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on
The authority for this order is Sections 362 and 365 of the Public Health Service Act (42 U.S.C. 265 and 268), as amended.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $30,000,000, for Federal Fiscal Year 2026 funding to the Ministry of Health (MOH), subject to the availability of funds. Funding amounts for years 2-5 will be set at continuation. The award is expected to help build and oversee national HIV and TB programs in Ethiopia through the MOH and its affiliates.
The period for this award will be September 30, 2026, through September 29, 2031.
Cristel Bender, Global Health Center, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Atlanta, GA 30329, Email:
The sole source award is intended to help build and oversee national HIV and TB programs in Ethiopia through the MOH and its affiliates.
The Ethiopia MOH is the only entity that can carry out this work, as it is the primary authority responsible for overseeing the health care system in Ethiopia, including preventing, providing care, and treating HIV/AIDS, mandated under Proclamation No. 1263/2021.
Additionally, these programs are authorized under Section 307 of the Public Health Service Act, as amended [42 U.S.C. 242l], Section 301 (a) [42 U.S.C. 241 (a)] of the Public Health Service Act, as amended.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $30,000,000, for Federal Fiscal Year 2026 funding to Zambia's University Teaching Hospital (UTH), subject to availability of funds. Funding amounts for years 2-5 will be set at continuation. The award is expected to improve HIV and TB clinical and laboratory service delivery at referral level hospitals and provincial-level referral facilities through the national government referral facility, UTH.
The period for this award will be September 30, 2026, through September 29, 2031.
Cristel Bender, Global Health Center, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE, Atlanta, GA 30329, Email:
The sole source award is expected to improve HIV and TB clinical and laboratory service delivery at referral level hospitals and provincial-level referral facilities through the national government referral facility, UTH.
UTH is the only entity that can carry out this work, as it is the country's national reference hospital, with a directive to provide inpatient and outpatient services for complicated cases, including advanced HIV disease cases.
Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services (HHS).
Notice of intent to award a single-source cooperative agreement; withdrawal.
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), is withdrawing the, `Announcement of the Intent to Award a Single-Source Cooperative Agreement to Burke Law Group, PLLC in Houston, Texas' published in the
Reina Byrd, Assistant Deputy Director, Unaccompanied Alien Children Bureau, 330 C St SW, Washington, DC 20201. Telephone: (202) 256-9497; Email:
In the
Burke Law Group subsequently notified ORR of its decision not to apply for the proposed cooperative agreement and withdrew from consideration on August 11, 2026. Therefore, ORR will not make the award to Burke Law Group announced in the notice published on August 6, 2026. This withdrawal does not affect ORR's continued efforts to ensure access to legal services for eligible UACs in ORR care.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #260 entitled “Type VII Veterinary Master File for Research and Development and Risk Reviews.” This guidance describes FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.
The announcement of the guidance is published in the
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• 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:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Policy and Regulations Staff, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Lynne Boxer, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-0611,
In the
This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Type VII Veterinary Master File for Research and Development and Risk Reviews. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032.
Persons with access to the internet may obtain the guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by October 16, 2026.
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:
•
• 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:
•
• 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
Patrick Clouser, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-402-5276,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This information collection supports the required data elements that respondents must submit when importing, or offering for import, an FDA-regulated article into the United States. Review of the data elements allows FDA to continue to meet its responsibilities pertaining to current submission requirements established by the U.S. Customs and Border Protection (CBP) related to the submission of entry information in using its Automated Commercial Environment (ACE) system, or any CBP-authorized electronic data interchange system.
Respondents (ACE filers) submit important and useful information about FDA-regulated products being imported or offered for import into the United States so that we may effectively and efficiently review products and determine their admissibility. Respondents must submit the data elements required for all imported products, as well as additional data elements as required for specific product types.
The information collection also includes our weekly entry filing program (WEF). More detailed information on Foreign Trade Zones (FTZ)/WEF, is available at
The information collection also includes our Import Trade Auxiliary Communication System (ITACS). ITACS is used by the import trade community and was implemented to improve communication with FDA. By utilizing ITACS, respondents to the information collection can establish an account and electronically check the status of FDA-regulated entries and lines, submit entry documentation, submit the location of goods availability for those lines targeted for examination by FDA, and check the estimated laboratory analysis completion dates for lines that have been sampled. For further information regarding ITACS, please visit our website at
The information collection also includes burden associated with the use of Form FDA 766 entitled “Application for Authorization to Relabel or Recondition Non-compliant Articles.” Form FDA 766 facilitates collection of information associated with certain general enforcement provisions for importing FDA-regulated articles into the United States. The form is available at
Relatedly, the information collection includes burden associated with the use of electronic Form FDA 5054 entitled “New Inquiry Form—Import Compliance Branch.” Form FDA 5054 facilitates both industry's responses to drug import inquiries and the Agency's ability to track receipts of those responses. The form interfaces with current Agency IT systems for optimal utility.
Finally, the information collection includes burden associated with recommendations found in the procedural Agency guidance entitled “Pre-Launch Activities Importation Requests (PLAIR),” (March 2022). Historically, when applicants with a pending new drug application, abbreviated new drug application, or Center for Drug Evaluation and Research-regulated biologics licensing application (information collection associated with these submissions is currently approved under OMB control number 0910-0001) sought to import unapproved finished dosage form drug products into the United States in preparation for market launch, we considered such requests, informally referred to as “PLAIRs,” on a case-by-case basis. Since implementing the PLAIR program in 2013, interest continues to increase, so we have developed a more formalized process as discussed in the guidance. The guidance is available at
We estimate the burden of the information collection as follows:
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIZENGRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
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:
•
• 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:
•
• 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
Patrick Clouser, Office of the Commissioner, Food and Drug Administration, 240-402-5276.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, BIZENGRI (zenocutuzumab-zbco). BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Subsequent to this approval, the USPTO received a patent term restoration application for BIZENGRI (U.S. Patent Nos. 9,248,181; 10,329,596; 11,279,770; 11,780,925; and 12,139,548) from Merus N.V. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated 10/8/2025, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BIZENGRI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for BIZENGRI is 2,909 days. Of this time, 2,634 days occurred during the testing phase of the regulatory review period, while 275 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,594 days, 1,133 days, 633 days, 23 days, or 23 days, respectively, of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of
Submit written comments (including recommendations) on the collection of information by September 16, 2026.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
This information collection supports implementation of provisions of section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) and of the licensing provisions of the Public Health Service Act (42 U.S.C. 201
• An Investigator IND is submitted by a physician who both initiates and investigates, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug or an approved product for a new indication or in a new patient population.
• Emergency Use IND allows FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with § 312.23 or § 312.20 (21 CFR 312.23 or 312.20). It is also used for patients who do not meet the criteria of an existing study protocol or if an approved study protocol does not exist.
• Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and FDA's review takes place.
There are two IND categories: commercial and research (non-commercial).
General IND requirements include submitting an initial application as well as amendments to that application; submitting reports on significant revisions of clinical investigation plans; submitting information to the clinical trials data bank (
Form FDA 1571 entitled “Investigational New Drug Application (IND)” and Form FDA 1572 entitled “Statement of Investigator,” were developed to assist respondents with the information collection and provide for uniform reporting of required data elements. The information is required to be submitted electronically. Individuals who are interested in receiving printed forms may send an email request to the FDA Forms Manager at
Human drug, biological product, and device product submissions must be accompanied by Form FDA 3674, as discussed in the guidance document entitled “Form FDA 3674—Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions” (updated November 2017), available from our website at
Regulations in part 312, subpart B, specify content and format requirements for applications, amendments, annual reporting, and withdrawals, including content and format requirements for protocol and information amendments. The regulations also explain phases of an investigation and set forth principles of IND submissions. To date we have developed and issued the following guidance documents to assist respondents:
• “
• “
All Agency guidance documents are issued in accordance with our Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time. We maintain a searchable guidance database on our
Regulations in part 312, subpart C, describe administrative actions pertaining to respondents' requests for and responses to clinical holds, terminations, and inactive IND status determinations, as well as various types of meetings (for example, End-of-Phase 2 and Pre-new drug application (NDA) meetings).
Regulations in part 312, subpart D, set forth sponsor and investigator responsibilities, including general responsibilities; transfer of obligations to a contract research organization; recordkeeping and record retention controls; reporting responsibilities; and responsibility for disposition of unused supply of investigational drug. The regulations also provide for investigator controls including review of ongoing investigations; compliance with requirements regarding the protection of human subjects and institutional review board assurance; and disqualification of clinical investigators.
Regulations in part 312, subpart E, sets forth requirements applicable to drugs intended to treat life-threatening and severely debilitating illnesses. The regulations establish procedures to reflect that physicians and patients accept greater risk or side effects from products that treat life-threatening and severely debilitating illnesses than they would accept from products that treat less serious illnesses. The procedures also reflect the recognition that the benefits of the drug need to be evaluated in light of the severity of the disease being treated.
Regulations in part 312, subpart F, include provisions pertaining to import and export requirements; foreign clinical studies not conducted under an IND; the disclosure of data and information in an IND; and the issuance of guidance documents. To date we have developed and issued the following guidance documents to assist respondents:
• “
• “
• “
• “
All Agency guidance documents are issued in accordance with our Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time. We maintain a searchable guidance database on our website at
Regulations in part 312, subpart G, provide for drugs for investigational use in laboratory research animals or in vitro tests.
Finally, 21 CFR 300.200 requires the submission of an annual report by sponsors and manufacturers who provide an “
In the
A third comment suggested FDA increase its estimate for effort attributable to reporting elements under 21 CFR parts 312.23 and 312.33, explaining that certain first time applicants may incur more burden that our figures suggest. We acknowledge that individual respondents may incur greater than or less than the estimate proffered, however, consistent with 5 CFR 1320.5(a)(1)(iv), figures are cumulative and averaged among respondents. The comment also recommended specific automated improvements that might facilitate the submission of IND applications. As announced in the
FDA greatly appreciates the comments it received, however we have made no changes to our estimates, which are as follows:
While we have corrected an inadvertent calculation error pertaining to 21 CFR 300.200, we have otherwise retained the currently approved estimates attributable to IND requirements. We also note that reporting activities applicable to the “Right to Try” provisions began in 2020 and we continue to monitor the information collection activity.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Amber Barrett, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by October 16, 2026.
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:
•
• 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:
•
• 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.”
•
Christopher Colburn, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301796-8758,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), requires the establishment of a Reportable Food Registry (the Registry) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. Section 417 of the FD&C Act (21 U.S.C. 350f) defines “reportable food” as an “article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.” (See section 417(a)(2) of the FD&C Act.) We believe that the most efficient and cost-effective means to implement the Registry is by utilizing our electronic Safety Reporting Portal. The information collection provisions associated with the submission of reportable food reports have been approved under OMB control number 0910-0291.
In conjunction with the reportable food requirements, section 417 of the FD&C Act also establishes third-party disclosure and recordkeeping burdens. Specifically, we may require the responsible party to notify the immediate previous source(s) and/or immediate subsequent recipient(s) of a reportable food (sections 417(d)(6)(B)(i) to (ii) of the FD&C Act). Similarly, we may also require the responsible party that is notified (
Notification to the immediate previous source(s) and immediate subsequent recipient(s) of the article of food may be accomplished by electronic communication methods such as email, fax, or text messaging or by telegrams, mailgrams, or first-class letters. Notification may also be accomplished by telephone call or other personal contacts, but we recommend that such notifications also be confirmed by one of the previous methods and/or documented in an appropriate manner. We may require that the notification include any or all of the following data elements: (1) the date on which the article of food was determined to be a reportable food; (2) a description of the article of food including the quantity or amount; (3) the extent and nature of the adulteration; (4) the results of any investigation of the cause of the adulteration if it may have originated with the responsible party, if known; (5) the disposition of the article of food, when known; (6) product information typically found on packaging including product codes, use-by dates, and the names of manufacturers, packers, or distributors sufficient to identify the article of food; (7) contact information for the responsible party; (8) contact information for parties directly linked in the supply chain and notified under section 417(d)(6)(B) or 417(d)(7)(C) of the FD&C Act, as applicable; (9) the information required by FDA to be included in the notification provided by the responsible party involved under section 417(d)(6)(B) or 417(d)(7)(C) of the FD&C Act or required to report under section 417(d)(7)(A) of the FD&C Act; and (10) the unique number described in section 417(d)(4) of the FD&C Act (section 17(d)(6)(B)(iii)(I), (d)(7)(C)(iii)(I), and (e) of the FD&C Act). We may also require that the notification provides information about the actions that the recipient of the notification will perform and/or any other information we may require (section 417(d)(6)(B)(iii)(II) and (III) and (d)(7)(C)(iii)(II) and (III) of the FD&C Act).
Section 417(g) of the FD&C Act requires that responsible persons
The congressionally identified purpose of the Registry is to provide a reliable mechanism to track patterns of adulteration in food which would support efforts by FDA to target limited inspection resources to protect the public health (see FDAAA, section 1005(a)(4)). The reporting and recordkeeping requirements described previously are designed to enable FDA to quickly identify and track an article of food (other than infant formula) for which there is a reasonable probability that the use of or exposure to such article of food will cause serious adverse health consequences or death to humans or animals. We use the information collected under these authorities to help ensure that such products are quickly and efficiently removed from the market.
As required under section 1005(f) of FDAAA and to assist industry, we have issued the guidance entitled, “Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007,” which is available at
We estimate the burden of this collection of information as follows:
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Office of the National Coordinator for Health IT, Office of the Secretary, HHS.
Request for public comments.
The Office of the National Coordinator for Health IT (ONC), Office of the Secretary (OS), Department of Health and Human Services, is seeking a three-year generic clearance to collect routine customer feedback on agency service delivery and program performance related to TEFCA.
Comments on the ICR must be received on or before September 16, 2026.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Talisha Searcy,
Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
The solicitation of feedback will target areas such as timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. If this information is not collected, vital feedback from TEFCA users and stakeholders on the ONC services will be unavailable.
Likely respondents to the data collections under this generic clearance will be the Qualified Health Information Networks® (QHINs
National Institutes of Health, HHS.
Notice.
The purpose of this notice is to inform the public of the information collection requirement for the NIDA Data Share, the data use terms and conditions, and to request a progress report statement at the time of renewal. In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Ming Zhan, Director, Office of Data Science and Coordination, National Institute on Drug Abuse, 3WFN Room 09D14, 11601 Landsdown St, Rockville MD 20852, or call non-toll-free number (301) 480-3506 or email your request, including your address to:
Formal requests for additional plans and instruments must be requested in writing.
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 127.
National Institutes of Health, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received by September 16, 2026.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Melissa Park, PRA Liaison, Office of Management Policy and Compliance, National Cancer Institute, 9609 Medical Center Drive, Room 2E196, Bethesda, MD 20892 or call non-toll-free number (240) 276-5717 or email your request, including your address to:
Formal requests for additional plans and instruments must be requested in writing.
This proposed information collection was previously published in the
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
OMB approval is requested for three years. There are no costs to respondents other than their time. The estimated annualized burden hours are 107.
Bureau of Ocean Energy Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Ocean Energy Management (BOEM) proposes this information collection request (ICR) to renew Office of Management and Budget (OMB) control number 1010-0191.
Comments must be received by BOEM no later than October 16, 2026.
Send written comments on this ICR by mail to the BOEM Information Collection Clearance Officer, Anna Atkinson, Bureau of Ocean Energy Management, 45600 Woodland Road, Sterling, Virginia 20166; or by email to
Anna Atkinson by email at
In accordance with the Paperwork Reduction Act of 1995, BOEM provides the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps BOEM assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand BOEM's information collection requirements and provide the requested data in the desired format.
BOEM is soliciting comments on the proposed ICR described below. BOEM is especially interested in public comments addressing the following issues: (1) is the collection necessary to the proper functions of BOEM; (2) what can BOEM do to ensure that this information is processed and used in a timely manner; (3) is the burden estimate accurate; (4) how might BOEM enhance the quality, utility, and clarity of the information to be collected; and (5) how might BOEM minimize the burden of this collection on the respondents, including minimizing the burden through the use of information technology?
Comments that you submit in response to this notice are a matter of public record. BOEM will include or summarize each comment in its ICR to OMB for approval of this information collection. You should be aware that your entire comment—including your address, phone number, email address, or other personally identifiable information included in your comment—may be made publicly available at any time.
Even if BOEM withholds your personally identifiable information in the context of this ICR, your comment is subject to the Freedom of Information Act (FOIA) (5 U.S.C. 552). Your information will only be withheld if a determination is made that one of the FOIA exemptions to disclosure applies. Such a determination will be made in accordance with the Department of the Interior's (DOI) FOIA implementing regulations (43 CFR part 2) and applicable law.
In order for BOEM to consider withholding from disclosure your personally identifiable information, you must identify, in a cover letter, any information contained in the submittal of your comments that, if released, would constitute a clearly unwarranted invasion of your personal privacy. You must also briefly describe any possible harmful consequences of the disclosure of information, such as embarrassment, injury, or other harm. Note that BOEM will make available for public inspection, in their entirety, all comments submitted by organizations and businesses, or by individuals identifying themselves as representatives of organizations or businesses.
BOEM protects proprietary information in accordance with FOIA, DOI's implementing regulations (43 CFR part 2), and the Outer Continental Shelf Lands Act (OCS Lands Act) (43 U.S.C. 1331
The OCS Lands Act, 43 U.S.C. 1331
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Safety and Environmental Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Bureau of Safety and Environmental Enforcement (BSEE) proposes to renew an information collection.
Interested persons are invited to submit comments on or before October 16, 2026.
Send your comments on this information collection request (ICR) by either of the following methods listed below:
• Electronically go to
• Email
To request additional information about this ICR, contact Kelly Odom by email at
In accordance with the PRA and 5 CFR 1320.8(d)(1), all information collections require approval under the PRA. We may not conduct, or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.
As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency 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 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 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.
This ICR includes three forms. The forms use and information consist of the following:
This information is used to ensure that industry has accurate and up-to-date data and information on wells and leasehold activities under their jurisdiction and to ensure compliance with approved plans and any conditions placed upon a suspension or temporary probation. It is also used to evaluate the remedial action in the event of well equipment failure or well control loss. The Form BSEE-0125 is updated and resubmitted in the event the well status changes. In addition, except for proprietary data, BSEE is required by the OCS Lands Act to make available to the public certain information submitted on BSEE-0125.
Information on the form:
Heading—ascertain the well name, status of completion/abandonment, and operator name.
Well at Total Depth—ascertain the lease No., area name, block No., and the latitude/longitude at total depth.
Well Status Information—ascertain well status data and measured/true vertical depth of the well.
Well at Producing Zone—ascertain the location and latitude/longitude of the producing zone.
Perforated Interval(s) This Completion—ascertain well measured/true vertical depth at the top and bottom of intervals perforated for production.
Hydrocarbon Bearing Intervals—identify the top and bottom of hydrocarbon bearing intervals penetrated by the well and the type hydrocarbon (oil/gas) present.
List of Significant Markers Penetrated—to make structural correlations, in conjunction with seismic data, with other wells drilled in the area. Anticipated marker areas not penetrated (
Subsea Completion—Identify wells that are completed with the wellhead (tree) at the ocean floor (mud line). This data is needed to ascertain that the wellhead is protected from being damaged and that the location is marked with a buoy.
Abandonment History of Well (Casing & Obstruction)—ensure that, upon permanent plugging, the casing is cut and removed to an elevation below the ocean floor (mud line) to eliminate any hazard to navigation (fishing, trawling) unless otherwise protected and/or the location marked with a buoy.
The BSEE uses this information to monitor the conditions of a well and status of drilling operations. We review the information to be aware of the well conditions and current drilling activity (
In addition, except for proprietary data, BSEE is required by the OCS Lands Act to make available to the public certain information submitted on Forms BSEE-0133 and -0133S.
General Information—Identifies the well name, lease operator, name of the contractor and rig or unit conducting drilling or remedial work, the water depth and the elevation.
Current Well Bore Information—This information is used to identify the well, surface location, and dates operations are initiated and concluded. Also identified is the bottom hole location, measured and true vertical depth of the well, drilling fluid (mud) weight, and blowout preventer test information needed to evaluate approval or modification applications to ensure safety and environmental protection.
Well Bore Historical Information—Identifies the dates drilling is initiated and completed or the well is abandoned, and final measured and true vertical depths reached. This information is needed to evaluate modification applications to ensure safety and protection of the environment.
Casing/Liner/Tubing Record—Identifies casing/liner/tubing hole size, pipe size, weight, grade, test pressures, setting depths, and cement volumes. This information is used to evaluate modification applications and to ascertain that operations are conducted in a safe manner as approved.
Well Activity Summary—This narrative summary provides the details of daily operations needed to confirm that operations are being conducted consistent with approved plans.
Open Hole Log Date—Serves to identify whether open hole logs, formation samples and surveys have been conducted so as to trigger the submittal of Form BSEE-0133S.
Significant Well Events—Serves to identify significant events, hazards or problems encountered during well operations and to provide narrative information detailing those events which occurred. BSEE needs this information in the assessment and approval of other well operations in the area that may encounter the same or similar hazards, risks or problems. Provides narrative information concerning any significant events. Attachments may be required, if necessary.
General Information—Identifies the well number/name, operator name, sidetrack/bypass number, and contact name/telephone/email.
Open Hole Tools, Mud Logs, and Directional Surveys—Identifies the dates and types of open hole operations, logs, tests, or surveys conducted; the service company(s) conducting the operations; and the top and bottom of those formations logged or surveyed. Serves as an inventory to ensure that BSEE receives the data from all open hole logs/tests/surveys conducted. Open hole data is utilized in the determination of oil and gas recoverable reserves and production limits. As permitted by the regulations, the data is also made available to the public.
Identify Other Open Hole Data Collection—Identifies the conduct of other specific analyses, samples and surveys and requires the narrative description of any other surveys conducted.
An agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Netlist, Inc. on August 11, 2026. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after
Proposed respondents, other interested parties, members of the public, and interested government agencies are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3930”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Office of Justice Programs, Department of Justice.
30-Day notice.
The National Institute of Justice, Office of Justice Programs, 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 30 days until September 16, 2026.
If you have 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: Benjamin Adams, Supervisory Social Science Analyst, National Institute of Justice, 999 North Capitol Street NE, Washington DC 20531 (email:
The proposed information collection was previously published in the
Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website
DOJ seeks PRA authorization for this information collection for two (2) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOJ notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
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If additional information is required, contact: Darwin Arceo, Department Clearance Officer, Enterprise Portfolio Management, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 4W-218 Washington, DC 20530.
Human Rights and Special Prosecutions Section, Criminal Division, Department of Justice.
30-Day notice.
The Criminal Division, 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 30 days until September 16, 2026.
To request additional information about this information collection request, please contact Ayn B. Ducao, Senior
The proposed information collection was previously published in the
Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website
DOJ seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOJ notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
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Qualifying T visa holders can petition DHS to adjust to Lawful Permanent Resident status if they meet statutory requirements under 8 U.S.C. 1255(l). To apply for an adjustment of status, a T visa holder must have remained continuously present in the U.S. for at least 3 years, or until completion of the investigation or prosecution, whichever is shorter. § 1255(l); 8 CFR 245.23(a). To apply for early adjustment of status within 3 years of receiving the T visa, the T visa holder must establish that the “Attorney General has determined that the investigation or prosecution is complete.” 8 U.S.C. 1255(l)(A). To establish their eligibility for early adjustment with USCIS, applicants with less than 3 years of continuous physical presence as T visa holders “must submit a document signed by the Attorney General or their designee, attesting that the investigation or prosecution is complete.” 8 CFR 245.23(e)(2)(i)(B).
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If additional information is required, contact: Darwin Arceo, Department Clearance Officer, Enterprise Portfolio Management, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC 20530.
Copyright Royalty Board (CRB), Library of Congress.
Notice requesting comments.
The Copyright Royalty Judges solicit comments on a motion of Allocation Phase Parties for partial distribution of 2023 cable royalty funds.
Comments are due on or before September 16, 2026.
Interested claimants must submit timely comments using eCRB, the Copyright Royalty Board's online
Anita Brown, CRB Program Specialist, at (202) 707-7658, or
Each year cable systems must submit royalty payments to the Register of Copyrights as required by the statutory license detailed in section 111 of the Copyright Act for the retransmission to cable subscribers of over-the air television and radio broadcast signals.
Allocation of the royalties collected occurs in one of two ways. In the first instance, the Judges may authorize distribution in accordance with a negotiated agreement among all claiming parties. 17 U.S.C. 111(d)(4)(A), 801(b)(3)(A). If all claimants do not reach agreement with respect to the royalties, the Judges must conduct a proceeding to determine the distribution of any royalties that remain in controversy. 17 U.S.C. 111(d)(4)(B), 801(b)(3)(B). Alternatively, the Judges may, on motion of claimants and on notice to all interested parties, authorize a partial distribution of royalties, reserving on deposit sufficient funds to resolve identified disputes. 17 U.S.C. 111(d)(4)(C), 801(b)(3)(C). On August 5, 2026, representatives of the Allocation Phase Parties claimant categories
Accordingly, this notice seeks comments from interested claimants on whether any reasonable objection exists that would preclude the distribution of the requested amounts of the 2023 cable royalty funds to the Allocation Phase Parties. Parties objecting to the proposed partial distribution must advise the Judges of the existence and extent of all objections by the end of the comment period. The Judges will not consider any objections with respect to the partial distribution that come to their attention after the close of the comment period.
Members of the public may read the motion by accessing the Copyright Royalty Board's electronic filing and case management system at
Copyright Royalty Board (CRB), Library of Congress.
Notice requesting comments.
The Copyright Royalty Judges solicit comments on a motion of Allocation Phase Parties for partial distribution of 2023 satellite royalty funds.
Comments are due on or before September 16, 2026.
Interested claimants must submit timely comments using eCRB, the Copyright Royalty Board's online electronic filing application, at
Anita Brown, CRB Program Specialist, at (202) 707-7658, or
Each year satellite providers must submit royalty payments to the Register of Copyrights as required by the statutory license detailed in section 119 of the Copyright Act for the retransmission to satellite subscribers of over-the-air television broadcast signals.
On August 5, 2026, representatives of the Allocation Phase Parties claimant categories
Accordingly, this notice seeks comments from interested claimants on
Members of the public may read the motion by accessing the Copyright Royalty Board's electronic filing and case management system at
Copyright Royalty Board (CRB), Library of Congress.
Notice announcing commencement of distribution proceedings with request for Petitions to Participate.
The Copyright Royalty Judges (Judges) announce the commencement of proceedings to determine distribution of 2023 royalties deposited with the Copyright Office under the satellite carrier license. The Judges also set the date by which all parties wishing to participate and share in the distribution of satellite retransmission royalties for 2023, must file Petitions to Participate and pay the accompanying $150 filing fee. The Judges seek a single Petition to Participate in either or both the allocation phase and the distribution phase of the satellite royalty proceeding. Any party that fails to file a petition to participate by the time set forth in this notice shall not be a participant at any stage of either proceeding, unless the Judges accept a late petition to participate pursuant to 37 CFR 351.1(d).
Petitions to Participate, the filing fee, and the additional required filing are due on or before September 16, 2026.
The petition to participate form is available online in eCRB, the Copyright Royalty Board's online electronic filing application, at
Anita Brown, CRB Program Specialist, (202) 707-7658,
Twice each year, satellite carriers deposit with the Copyright Office royalties payable for the privilege of retransmitting over-the-air television and radio broadcast signals via satellite. 17 U.S.C. 119. The Copyright Royalty Judges (Judges) oversee distribution of the royalties to copyright owners whose works are included in the retransmissions and who have filed a timely claim for royalties. Pursuant to 17 U.S.C. 803(b)(1), the Judges hereby give notice of the commencement of proceedings for distribution of satellite royalties deposited for broadcasts retransmitted in 2023 and call for interested parties to file Petitions to Participate.
Any party wishing to receive royalties payable for 2023 must file a Petition to Participate in each proceeding no later than September 16, 2026. If an interested party fails to file a Petition to Participate in response to this notice, that party will not be eligible for distribution of royalties for 2023 from the satellite fund, unless the Judges accept a late petition to participate pursuant to 37 CFR 351.1(d). The Judges will resolve all issues relating to distribution of satellite royalty funds for 2023, including existing motions regarding such funds, in this proceedings, Docket No. 24-CRB-0007-SD (2023).
The Judges have determined that controversies exist with regard to distribution of the satellite retransmission royalties that licensees deposited for 2023. Therefore, pursuant to Section 804(b)(8) of the Copyright Act, the Judges are causing this notice to be published in the
The Judges base their conclusion regarding 2023 satellite fund controversies upon the entirety of the records, including the initial motion for partial distribution. Motion of the Allocation Phase Parties for Partial Distribution of 2023 Satellite Royalty Funds (“Motion”) (eCRB no. 79335).
In the present proceeding, groups of claimants have identified themselves as arranged into program categories,
In order to share in the royalties at issue, any claimant not joined in one of the groups identified above must file a Petition to Participate, individually or jointly with other claimants. If, at a later point in the proceedings, a claimant chooses to join a group participating through joint counsel, that claimant may withdraw its individual Petition to Participate. The prerequisites to participation in a distribution proceeding are (1) the filing (individually or jointly) of a timely and otherwise valid claim for each royalty year at issue and (2) the filing (individually or jointly) of a timely and otherwise valid Petition to Participate.
Only attorneys who are members in good standing of the bar of one or more states may represent parties before the Judges. All corporate parties must appear through counsel. Only if the petitioning party is an individual, may he or she represent himself or herself without legal counsel. 37 CFR 303.2.
The Judges hereby commence the proceedings for 2023 satellite funds under the captioned docket number 24-CRB-0007-SD (2023).
Parties filing Petitions to Participate must comply with the requirements of section 351.1(b) of the Copyright Royalty Board's regulations.
In addition, each Petition to Participate filing must be accompanied by a filing that sets forth for each claim year, the name of each claimant, the corresponding claim number, an indication of whether the claim is an individual or joint claim, and the program category into which the claim may fall. Each Petition to Participate shall be accompanied by a Microsoft Excel spreadsheet in electronic form consisting of the following columns: Claimant; Claim Year; Claim Number; Claim Type; Allocation Phase Category. For “Claim Type,” participants shall enter “I” for an individual claimant, “J” for a joint claimant, and “W” for a claimant listed within a joint claim. The information in the column for “Claim Category” shall be coded 1 for syndicated programming and movies, 2 for live college and professional team sports, 3 for programs produced by local commercial television stations, 4 for public broadcasting, 5 for programs of a religious or devotional character, 6 for Canadian programs retransmitted within the United States, 7 for National Public Radio (all non-music content broadcast on NPR stations), and 8 for musical works carried on broadcast television signals. Claimants' characterization of their claims at this juncture is for ease of administration only and is not dispositive of the ultimate disposition of any claim.
Petitioners who seek to categorize any claim in a category not listed in the previous paragraph shall assign a number (starting with 9) to each new category and shall include a brief description of each new proposed category. Claimants, or claimant representatives, that assert multiple claims in a given claim year shall list each claim and claim number in a separate row. Petitioners are responsible to make a sufficient showing of a “significant interest” in the royalty funds at issue to avoid dismissal of the Petition to Participate.
Claimants whose claims do not exceed $1,000 in value and who include a statement in their Petitions to Participate that they will not seek distribution of more than $1,000 may file the Petition to Participate without payment of the filing fee.
Participants should conform filed electronic documents to the Judges' Guidelines for Electronic Documents, available online at
Copyright Royalty Board (CRB), Library of Congress.
Notice announcing commencement of distribution proceedings with request for Petitions to Participate.
The Copyright Royalty Judges (Judges) announce the commencement of proceedings to determine distribution of 2023 royalties deposited with the Copyright Office under the cable service statutory license. The Judges also set the date by which all parties wishing to participate and share in the distribution of cable retransmission royalties for 2023 must file Petitions to Participate and pay the accompanying $150 filing fee. The Judges seek a single Petition to Participate in either or both the allocation phase and distribution phase of the cable royalty proceeding. Any party that fails to file a petition to participate by the time set forth in this notice shall not be a participant at any stage of the proceeding, unless the Judges accept a late petition to participate pursuant to 37 CFR 351.1(d).
Petitions to Participate, the filing fee, and the additional required filing are due on or before September 16, 2026.
The petition to participate form is available online in eCRB, the Copyright Royalty Board's online electronic filing application, at
Anita Brown, CRB Program Specialist, (202) 707-7658,
Twice each year, cable services deposit with the Copyright Office royalties payable for the privilege of retransmitting over-the-air television and radio broadcast signals via cable. 17 U.S.C. 111. The Copyright Royalty Judges (Judges) oversee distribution of the royalties to copyright owners whose works are included in the retransmissions and who have filed a timely claim for royalties. Pursuant to 17 U.S.C. 803(b)(1), the Judges hereby give notice of the commencement of the proceeding for the distribution of cable royalties deposited for broadcasts retransmitted in 2023 and call for interested parties to file Petitions to Participate.
Any party wishing to receive royalties payable for 2023 must file a Petition to Participate in each proceeding no later than September 16, 2026. If an interested party fails to file a Petition to Participate in response to this notice, that party will not be eligible for distribution of royalties for 2023 from the cable fund, unless the Judges accept a late petition to participate pursuant to 37 CFR 351.1(d). The Judges will resolve all issues relating to distribution of cable royalty funds for 2023, including existing motions regarding such funds, in these proceedings, Docket No. 24-CRB-0006-CD (2023).
The Judges have determined that controversies exist with regard to distribution of the cable retransmission royalties that licensees deposited for 2023. Therefore, pursuant to Section 804(b)(8) of the Copyright Act, the Judges are causing this notice to be published in the
The Judges base their conclusion regarding 2023 cable fund controversies upon the entirety of the record, including the initial motion for partial distribution. Motion of the Allocation Phase Parties for Partial Distribution of 2023 Cable Royalty Funds (“Motion”) (eCRB no. 79333).
In the present proceedings, groups of claimants have identified themselves as arranged into program categories,
In order to share in the royalties at issue, any claimant not joined in one of the groups identified above must file a Petition to Participate, individually or jointly with other claimants. If, at a later point in the proceedings, a claimant chooses to join a group participating through joint counsel, that claimant may withdraw its individual Petition to Participate. The prerequisites to participation in a distribution proceeding are (1) the filing (individually or jointly) of a timely and otherwise valid claim for each royalty year at issue and (2) the filing (individually or jointly) of a timely and otherwise valid Petition to Participate.
Only attorneys who are members in good standing of the bar of one or more states may represent parties before the Judges. All corporate parties must appear through counsel. Only if the petitioning party is an individual, may he or she represent himself or herself without legal counsel. 37 CFR 303.2.
The Judges hereby commence the proceedings for the 2023 cable funds under the captioned docket number 24-CRB-0006-CD (2023).
Parties filing Petitions to Participate must comply with the requirements of section 351.1(b) of the Copyright Royalty Board's regulations.
In addition, each Petition to Participate filing must be accompanied by a filing that sets forth for each claim year, the name of each claimant, the corresponding claim number, an indication of whether the claim is an individual or joint claim, and the program category into which the claim may fall. Each Petition to Participate shall be accompanied by a Microsoft Excel spreadsheet in electronic form consisting of the following columns: Claimant; Claim Year; Claim Number; Claim Type; Allocation Phase Category. For “Claim Type,” participants shall enter “I” for an individual claimant, “J” for a joint claimant, and “W” for a claimant listed within a joint claim. The information in the column for “Claim Category” shall be coded 1 for syndicated programming and movies, 2 for live college and professional team sports, 3 for programs produced by local commercial television stations, 4 for public broadcasting, 5 for programs of a religious or devotional character, 6 for Canadian programs retransmitted within the United States, 7 for National Public Radio (all non-music content broadcast on NPR stations), and 8 for musical works carried on broadcast television signals. Claimants' characterization of their claims at this juncture is for ease of administration only and is not dispositive of the ultimate disposition of any claim.
Petitioners who seek to categorize any claim in a category not listed in the previous paragraph shall assign a number (starting with 9) to each new category and shall include a brief description of each new proposed category. Claimants, or claimant representatives, that assert multiple claims in a given claim year shall list each claim and claim number in a separate row. Petitioners are responsible to make a sufficient showing of a “significant interest” in the royalty funds at issue to avoid dismissal of the Petition to Participate.
Claimants whose claims do not exceed $1,000 in value and who include a statement in their Petitions to Participate that they will not seek distribution of more than $1,000 may file the Petition to Participate without payment of the filing fee.
Participants should conform filed electronic documents to the Judges' Guidelines for Electronic Documents, available online at
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). The Public Representative does not represent any individual person, entity or particular point of view, and, when Commission attorneys are appointed, no attorney-client relationship is established. Section II also establishes comment deadline(s) pertaining to each such request.
The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory
Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review.
None.
1.
2.
This Notice will be published in the
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 18(a)(2), 18(c) and 18(i) of the Act, under sections 6(c) and 23(c) of the Act for an exemption from rule 23c-3 under the Act, and for an order pursuant to section 17(d) of the Act and rule 17d-1 under the Act.
Applicants request an order to permit certain registered closed-end investment companies to issue multiple classes of shares, to impose early withdrawal charges, and to impose asset-based distribution and/or service fees.
Parvin Decentralized Fund and Parvin Fund Management, LLC
The application was filed on June 8, 2026 and amended on July 13, 2026.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at
The Commission:
Rachel Loko, Senior Special Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' amended and restated application, dated July 13, 2026, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at,
You may also call the SEC's Office of Investor Education and Assistance at (202) 551-8090.
For the Commission, by the Division of Investment Management, under delegated authority.
On June 15, 2026, Nasdaq ISE, LLC (“ISE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Currently, the Exchange's Short Term Option Series Program
Each calendar quarter, the Exchange applies the Qualifying Securities Criteria to individual stocks and Exchange-Traded Fund Shares to determine eligibility for the following quarter.
The Exchange may list two Short Term Option Daily Expirations for Qualifying Securities beyond the current week for each Monday and Wednesday expiration at one time.
The Exchange proposes to amend rules related to Qualifying Securities expirations to: (1) add the listing of up to two Tuesday and Thursday expirations for options on Exchange-Traded Fund Shares that meet the current Qualifying Securities Criteria;
The Exchange proposes to designate Exchange-Traded Fund Shares that meet the current Qualifying Securities Criteria as “Tier 1 Qualifying Securities.” Each calendar quarter, as it currently does for Qualifying Securities, the Exchange would apply the Qualifying Securities Criteria to Exchange-Traded Fund Shares to determine their eligibility for the following quarter as Tier 1 Qualifying Securities.
The Exchange states that the proposed Tuesday Qualifying Securities expirations on Exchange-Traded Fund Shares for Tier 1 Qualifying Securities (“Tuesday Tier 1 Qualifying Securities Expirations”) would be similar to the current Tuesday expirations in SPDR S&P 500 ETF Trust (“SPY”), Invesco QQQ Trust (“QQQ”), and iShares Russell 2000 ETF (“IWM”) in Short Term Option Daily Expirations
The Exchange also states that the proposed Thursday Qualifying Securities expirations on Exchange-Traded Fund Shares for Tier 1 Qualifying Securities (“Thursday Tier 1 Qualifying Securities Expirations”) would be similar to the current Thursday expirations in SPY, QQQ, and IWM in Short Term Option Daily Expirations
The Exchange states that the interval between strike prices for the proposed Tuesday and Thursday Tier 1 Qualifying Securities Expirations would be the same as those currently applicable to the Short Term Option Series Program.
The Exchange also proposes to expand the Short Term Option Series Program to permit the listing of up to two Monday and Wednesday expirations for options on Exchange-Traded Fund Shares that meet proposed new criteria as Qualifying Securities (“Monday and Wednesday Tier 2 Qualifying Securities Expirations”).
Each calendar quarter, the Exchange would apply the proposed criteria to Exchange-Traded Fund Shares to determine eligibility for the following quarter as Tier 2 Qualifying Securities.
For the proposed Tier 2 Qualifying Securities, the Exchange would be permitted to list two Short Term Option Daily Expirations beyond the current week for each Monday and Wednesday Tier 2 Qualifying Securities Expiration at one time.
The Exchange states that the proposed Monday Tier 2 Qualifying Securities Expirations would be similar to the Monday expirations for existing Qualifying Securities (including the Tier 1 Qualifying Securities), among other symbols that may list a Monday expiration in Short Term Option Daily Expirations
The Exchange states that the proposed Wednesday Tier 2 Qualifying Securities Expirations would also be similar to the current Wednesday expirations for existing Qualifying Securities (among other symbols that may list a Wednesday expiration) in Short Term Option Daily Expirations
In the event a Monday or Wednesday Tier 2 Qualifying Securities Expirations series expires on the same day that a standard expiration options series, Monthly Options Series, or Quarterly Options Series expires, the Exchange would skip that week's listing and instead list the following week; the two weeks therefore would not be consecutive.
The Exchange states that the interval between strike prices for the proposed Monday and Wednesday Tier 2 Qualifying Securities Expirations would be the same as those currently applicable to Monday and Wednesday expirations in existing Qualifying Securities (among other symbols that
After careful review, the Commission finds that the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission received one supportive comment letter on the proposal.
In support of its proposal, the Exchange states that it does not believe that any market disruptions would be encountered with the introduction of Tuesday and Thursday Tier 1 Qualifying Securities Expirations and Monday and Wednesday Tier 2 Qualifying Securities Expirations.
The Exchange's proposal, which is limited to Exchange-Traded Fund Shares that meet either the existing Qualifying Securities Criteria or the new Tier 2 Qualifying Securities Criteria, is reasonably designed as a limited expansion of the Short Term Options Series Program. The proposal would add a small overall number of weekly expirations because the Exchange will limit the number of Tuesday and Thursday Tier 1 Qualifying Securities Expirations to two Tuesday expirations and two Thursday expirations beyond the current week and the number of Monday and Wednesday Tier 2 Qualifying Securities Expirations to two Monday and two Wednesday expirations beyond the current week.
The existing Qualifying Securities Criteria applicable to Exchange-Traded Fund Shares—which require (1) an AUM greater than $50 billion based on NAV; (2) monthly options volume greater than 10 million options; (3) a position limit of at least 250,000 contracts; and (4) participation in the Penny Interval Program—should help to ensure that Tier 1 Qualifying Securities, as well as the options on such securities, are highly liquid and actively traded.
Further, as discussed above, the Tier 2 Qualifying Securities Criteria require Exchange-Traded Fund Shares to have (1) AUM greater than $25 billion based on NAV; (2) monthly options volume, as measured by sides traded in the last month preceding the quarter end, greater than 5 million options; (3) a position limit of at least 250,000 contracts; and (4) participate in the Penny Interval Program.
If the Exchange chooses to modify the Qualifying Securities Criteria, the proposed Tier 2 Qualifying Securities Criteria, or any other aspect of the proposal, it will be required to file a proposed rule change with the Commission, which will subject the proposed rule change to the notice and comment process.
Based on the foregoing, the Commission believes the proposal reasonably balances the Exchange's desire to accommodate investor demand by offering a wider array of investment opportunities with the need to avoid unnecessary proliferation of options series. Additionally, and as noted above, this limited expansion of Qualifying Securities expirations may provide the investing public and other market participants more flexibility to closely
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from section 15(a) of the Act, as well as from certain disclosure requirements in rule 20a-1 under the Act, Item 19(a)(3) of Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A under the Securities Exchange Act of 1934, and sections 6-07(2)(a), (b), and (c) of Regulation S-X (“Disclosure Requirements”).
The requested exemption would permit Applicants to enter into and materially amend subadvisory agreements with subadvisers without shareholder approval and would grant relief from the Disclosure Requirements as they relate to fees paid to the subadvisers.
Elevation Series Trust and Norris Perné and French LLP.
The application was filed on April 17, 2026 and amended on June 12, 2026.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at
The Commission:
Rachel Loko, Senior Special Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' amended application, dated June 12, 2026, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
You may also call the SEC's Office of Investor Education and Assistance at (202) 551-8090.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
The Exchange proposes to amend the MIAX Options Exchange Fee Schedule (“Fee Schedule”).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the exchange grouping of options exchanges within the routing fee table in Section
Currently, the Exchange assesses routing fees based upon (i) the origin type of the order; (ii) whether or not it is an order for standard option classes in the Penny Interval Program
In anticipation of the launch of the options trading facilities of MX2 and IEX in the second half of 2026, the Exchange has determined to amend the exchange groupings of options exchanges within the routing fee table to include MX2 and IEX and the anticipated associated costs of routing customer orders to MX2 and IEX for execution. In determining to amend its routing fee table to determine which category MX2 and IEX belong to the Exchange took into account anticipated transaction fees and rebates assessed by the away markets to which the Exchange routes orders, as well as the Exchange's anticipated clearing costs, administrative, regulatory, and technical costs associated with routing orders to an away market.
The Exchange's proposal to rename “Nasdaq BX Options” to “Nasdaq Texas Options” is a conforming and non-substantive change in nature designed to ensure that the Exchange's Fee Schedule accurately reflects the name of the away market orders are being routed to and executed on.
As a result of conducting a periodic review of the current transaction fees charged by away markets the Exchange has determined to remove “MIAX Pearl” from the “Routed, Public Customer that is not a Priority Customer, Non-Penny Program” 1.25 fee tier and amend the “Routed, Public Customer that is not a Priority Customer, Non-Penny Program” 1.40 fee tier to add “MIAX Pearl.” This change is being made as MIAX Pearl recently amended its fee schedule and increased the transaction fee per contract for orders in Non-Penny classes in Professional capacities which remove liquidity.
The impact of these proposed changes will be increased routing options for Members, a clearer Fee Schedule, and a Fee Schedule that better reflects the associated costs. The Exchange notes that routing through the Exchange is optional and that Members will continue to be able to choose where to route applicable Member orders. Under this proposed change, the Exchange will not amend the fees associated with the exchange groupings. This proposal merely seeks to add MX2 and IEX to the exchange groupings, amend the name of a market, and amend the exchange groupings as described in the routing fee table below.
According, with the proposed change, the routing fee table will be as follows:
The purpose of the proposal is to adjust and amend the routing fee groups for orders routed to other exchanges to better reflect the associated costs for that routed execution in Penny and Non-Penny classes as determined by the fees and rebates at the executing exchange. In determining to adjust and amend its groupings, the Exchange took into account anticipated transaction fees assessed by the away market to which the Exchange routes orders, as well as the Exchange's anticipated clearing costs, administrative, regulatory, and technical costs associated with routing orders to an away market. The Exchange uses unaffiliated routing brokers to route orders to the away markets; the costs associated with the use of these services are included in the routing fees specified in the Fee Schedule. This routing fees structure is not only similar to the Exchange's affiliates, MIAX Pearl, MIAX Emerald, and MIAX Sapphire, but is also comparable to the structure in place at Cboe BZX Options,
The proposed rule changes will become effective on August 1, 2026.
The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act
The Exchange believes the proposed change to add the new options facilities of MX2 and IEX to the exchange groupings of options exchanges within the routing fee table furthers the objectives of Section 6(b)(4) of the Act and is reasonable, equitable and not unfairly discriminatory because the proposed change will continue to apply in the same manner to all Members that are subject to routing fees. The Exchange believes the proposed change to add the new options facilities of MX2 and IEX to the routing fee table of exchange groupings furthers the objectives of Section 6(b)(5) of the Act and is designed to promote just and equitable principles of trade and is not unfairly discriminatory because the proposed change seeks to recoup costs that will be incurred by the Exchange when routing customer orders to MX2 and IEX on behalf of Members and does so in the same manner to all Members that are subject to routing fees. The costs to the Exchange to route orders to away markets for execution primarily includes transaction fees and rebates assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange believes that the proposed additions of MX2 and IEX to the exchange groupings would increase the routing options available to Members. The per-contract transaction fee amount associated with each grouping approximates the Exchange's all-in cost (plus an additional, non-material amount) to execute the corresponding contract at the corresponding exchange.
The Exchange believes that the proposed change is equitable and not unfairly discriminatory because all Members' orders in Penny classes and Non-Penny classes routed to MX2 and IEX will be uniformly assessed the corresponding fee.
The proposed non-substantive change to rename “Nasdaq BX Options” to “Nasdaq Texas Options” would enable the Exchange to continue to be so organized as to have the capacity to carry out the purposes of the Act and comply and enforce compliance with the provisions of the Act by its Members and persons associated with its Members, because it would ensure that the Exchange's Fee Schedule accurately reflects the correct name of the away market to which orders are being routed to and executed on and therefore contribute to the orderly operation of the Exchange by adding clarity and transparency. In addition, the proposed
The Exchange believes that the proposed changes to the exchange groupings of options exchanges within the routing fee table furthers the objectives of Section 6(b)(4) of the Act and is reasonable, equitable and not unfairly discriminatory because the proposed change will continue to apply in the same manner to all Members that are subject to routing fees. The Exchange believes the proposed changes to the routing fee table exchange groupings furthers the objectives of Section 6(b)(5) of the Act and is designed to promote just and equitable principles of trade and is not unfairly discriminatory because the proposed changes seek to recoup costs that are incurred by the Exchange when routing orders for Public Customers that are not Priority Customers to away markets on behalf of Members and does so in the same manner for all Members that are subject to routing fees. The costs to the Exchange to route orders to away markets for execution primarily includes transaction fees assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange believes that the proposed re-categorization of certain exchange groupings would enable the Exchange to better reflect the costs and fees associated with routing orders to other exchanges for execution.
The Exchange places away markets in the fee tier grouping that best approximates the Exchange's costs and fees to route the orders in that segment to that away market. The per-contract transaction fee amount associated with each grouping approximates the Exchange's all-in cost (plus an additional, non-material amount)
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed changes to add MX2 and IEX to the routing fee table will impose any burden on intramarket competition. Rather, the Exchange believes that the proposal will promote competition by increasing the available away markets to which Members can route orders to.
The proposed change to rename “Nasdaq BX Options” to “Nasdaq Texas Options” is not intended to address competitive issues but rather is concerned solely with updating the Exchange's Fee Schedule to reflect the name change of Nasdaq BX to Nasdaq Texas.
The Exchange's proposed re-categorization of certain exchange groupings is intended to enable the Exchange to recover the costs it incurs to route orders to away markets. The costs to the Exchange to route orders to away markets for execution primarily includes the transaction fees assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange does not believe that this proposal imposes any unnecessary burden on competition because it seeks to better reflect the costs and fees incurred by the Exchange when routing orders to away markets on behalf of Members and notes that at least one other options exchange has a similar routing fee structure.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
This proposed rule change would amend OCC's Rules to establish a procedures-based approach for determining product eligibility during overnight or extended trading sessions (“ETH”)
The proposed changes would allow OCC to accommodate requests from any participating Exchange, including CFE's request to trade options on index futures outside of regular trading hours and Cboe's proposal, which was approved by the Commission,
OCC filed the proposed changes to OCC's Rules and the Extended Trading Hours Set-Up and Monitoring Procedure as Exhibits 5A and 5B to File No. SR-OCC-2026-008, respectively. Material proposed to be added as currently in effect is underlined and material proposed to be deleted is marked in strikethrough text. All capitalized terms not defined herein have the same meaning as set forth in the OCC 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.
1.
OCC is a self-regulatory organization (“SRO”) that is registered as a covered clearing agency (“CCA”) under the Exchange Act, as amended, and a derivatives clearing organization (“DCO”) under the Commodity Exchange Act. OCC is also a derivatives clearing organization registered with the Commodity Futures Trading Commission (the “CFTC”) that clears futures products for CFE, and MIAX Futures Exchange, LLC (“MIAX”),
The clearance of trades that occur outside of regular trading hours presents OCC with certain additional considerations from a risk management perspective. First, OCC is limited in its ability to issue and collect intraday margin calls from a Clearing Member presenting increased risk to OCC. Second, trading outside of regular hours presents greater operational risk due to reduced Clearing Member operational and risk staff available to address issues that might arise during extended hours. Third, OCC has observed that for those products that currently trade ETH, the markets for such options typically have more limited market liquidity, which can lead to higher transaction costs for participants seeking to initiate or unwind positions during ETH sessions. These market dynamics carry risk management implications. Shallow market environments can manifest price gapping,
OCC manages these risks for products that currently trade in ETH sessions through its ETH procedures. In 2015, OCC established its ETH procedures
These ETH procedures were also designed to work in conjunction with the risk controls of the Exchanges that offer ETH sessions. Such Exchange risk controls consist of: (1) price reasonability checks, (2) controls to prevent orders from being executed beyond a certain percentage (determined by the Exchange), (3) activity based protections which focus on risk beyond price, such as a high number of trades occurring in a set period of time, and (4) kill switch capabilities, which may be initiated by the Exchange and can cancel all open quotes or all orders of a particular participant.
While these procedures were designed to facilitate the clearing of index options and index futures, Exchanges, including CFE and Cboe, have requested that OCC expand its support for other products during the ETH sessions. First, CFE has requested that OCC provide clearance and settlement services for options on VIX futures (“VX Futures Options”)
OCC has evaluated these proposed changes to Exchange rules to determine whether OCC has the legal authority, operational capacity and risk management processes in place to support the clearance and settlement of such products during such hours. OCC evaluates each proposed product using criteria that include, among other things: (1) compatibility with OCC's existing margin methodology, (2) availability of real-time settlement pricing, and (3) consistency with OCC's operations risk management requirements.
OCC has determined to treat the proposed early morning session as extended trading hours, and to extend OCC's ETH procedures to that activity. OCC believes that extending the ETH procedures to the early morning trading session is prudent from a risk management perspective to address potential operational and market risk associated with trading in such early morning session. OCC's ETH procedures have operated without disruption through multiple periods of high volatility since 2015. The proposed products are not new to OCC, as single-name equity options and options on VX futures are already cleared by OCC during regular trading hours and margined using OCC's existing margin
OCC's determination that its existing ETH procedures are adequate to manage the risks associated with the proposed extension of ETH rests not only on product compatibility, but also on the material enhancements and substantial build-out to its risk management processes and systems in the years since the ETH procedures were first implemented. For example, OCC has made enhancements to its proprietary margin methodology, the System for Theoretical Analysis and Numerical Simulations (“STANS”), including by, among other things:
(i) incorporating daily price and returns data of securities;
(ii) incorporating variations in implied volatility;
(iii) enhancing its models for generating theoretical values for listed options
(iv) establishing a risk-based liquidation charge to account for the costs of liquidating a defaulting Clearing Member's portfolio;
(v) establishing procedures for adjusting certain parameters when the products OCC clears and the markets it serves experience high volatility;
(vi) enhancing the models to better account for the risk of short-dated options;
(vii) implementing and enhancing backtesting procedures for monitoring the performance of the models and establishing a margin charge should OCC identify backtesting deficiencies at the Clearing Member level.
Further, OCC has made enhancements to its intraday risk monitoring and collection of margin resources to cover intraday risk, including by establishing an Intraday Risk Charge and thresholds for margin calls during regular trading hours, similar to the procedures for ETH established in 2014.
In addition, beginning in 2018, OCC also implemented a comprehensive stress testing methodology that it uses to size its Clearing Fund and call for additional resources if stressed exposures exceed certain thresholds, to ensure that OCC maintains sufficient financial resources to cover the loss of the two Clearing Member groups presenting the largest stressed exposures to OCC in extreme but plausible market conditions.
OCC has also determined that it may support the proposed afternoon session as regular trading hours, regardless of whether that trading session is classified as regular trading hours, a curb session, or some other designation under the rules of an Exchange. OCC believes treating such activity as within regular trading hours is consistent with the definition of ETH under its existing ETH procedures.
This proposed rule change would amend OCC's Rules to establish a legal framework governing OCC's authority to determine product eligibility and session hours for ETH clearing, and to accommodate Exchange proposals to expand the products and hours covered by its ETH procedures. Specifically, the proposed amendments would: (i) clarify that OCC determines what constitutes “regular trading hours” and “extended trading hours” for purposes of OCC's operations and risk management (
OCC manages the risk associated with clearance and settlement of trades in ETH sessions through ETH procedures, approved by the Commission, that include (i) qualification criteria for Clearing Member participation, (ii) systemic controls to detect unauthorized trading by participants that have not qualified to trade in ETH sessions, (iii) overnight monitoring of Clearing Members' credit risk during ETH sessions, (iv) credit controls to address potential increased exposure during ETH sessions, and (v) rule enforcement should Clearing Members trade in ETH sessions without prior approval. Under the proposed rule changes discussed below, these procedures would apply to the clearance and settlement of trading in hours that OCC has determined are outside of regular trading hours.
In order to mitigate risks associated with clearing for ETH sessions, Clearing Members that participate in such trading sessions are required to provide contact information to OCC for operational and risk personnel available to be contacted by OCC during such sessions. In addition, OCC requires that Clearing Members participating in an ETH session post additional margin in a designated account in order to mitigate against the risk that OCC cannot draft a Clearing Member's bank account during an ETH session.
With respect to providing operational and risk contacts, under OCC Rule 201(b), each Clearing Member is required to maintain facilities for conducting business with OCC, and a representative of the Clearing Member authorized in the name of the Clearing Member to take all action necessary for conducting business with OCC is required to be available at the facility during such hours as may be specified from time-to-time by OCC. Similarly, OCC Rules 203(c) and (d) require Clearing Members to ensure that they have the appropriate number of qualified personnel and to maintain the ability to process anticipated volumes and values of transactions. OCC uses this existing authority to require Clearing Members trading during ETH sessions to maintain operational and risk staff that may be contacted by OCC during such sessions.
OCC charges Clearing Members qualified to participate in ETH sessions additional margin requirement in an amount of the lesser of $10 million or 10% of the Clearing Member's net capital (“ETH margin add-on”), which is equal to the first monitoring risk threshold (described below) and which would be collected as part of regular morning settlement. Clearing Members must identify the proprietary account that would be charged the ETH margin add-on amount. The ETH margin add-on requirement is intended to provide OCC with additional margin assets should a Clearing Member's credit risk increase during ETH sessions.
OCC Clearing Members wishing to participate in trading activity during ETH trading sessions must receive OCC's approval, before an Exchange would grant trading privileges for such sessions. OCC also confirms that an Exchange offering ETH trading sessions has implemented a procedure to periodically (
OCC has implemented systemic controls so that trades submitted to OCC during ETH sessions that have been executed by Clearing Members not approved for such trading sessions would be reviewed by OCC staff after acceptance but before being processed (each such trade being a “Reviewed Trade”). OCC would contact the submitting Exchange regarding each Reviewed Trade in order to determine if the trade is a valid trade. If the Exchange determines that the Reviewed Trade was in error such that, as provided in Article VI, Section 7(c), a new or revised trade information is required to properly clear the transaction, OCC expects the Exchange would instruct OCC to disregard or “bust” the trade. If the Exchange determines that the Reviewed Trade was not in error, then OCC would clear the Reviewed Trade
OCC has implemented additional overnight monitoring in order to better monitor Clearing Members' credit risk during ETH sessions. Such monitoring of credit risk is similar to existing OCC practices concerning futures cleared during overnight trading hours and includes automated processes within ENCORE to measure, by Clearing Member: (i) the aggregate mark-to-market amounts of a Clearing Member's positions, including positions created during overnight trading, based on current prices using OCC's Portfolio Revaluation system, (ii) the aggregate incremental margin produced by all positions resulting from transactions executed during overnight trading, and (iii) with respect to options cleared during ETH sessions, the aggregate net trade premium positions resulting from trades executed during ETH trading (each of these measures being a “Credit Risk Number”). Hourly credit reports are generated containing the Credit Risk Numbers expressed in terms of both dollars and, except for the mark-to-market position values, as a percentage of net capital for each Clearing Member trading during ETH sessions. The Credit Risk Numbers are the same information used by OCC staff to evaluate Clearing Member exposure during regular trading hours and, in addition to OCC's knowledge of its Clearing Members' businesses, are effective measures of the risk presented to OCC by each Clearing Member. OCC's Operations staff review such reports as they are generated and, in the event that any of the Credit Risk Numbers for positions established by a Clearing Member during an ETH session exceeds established thresholds, staff would alert OCC's Market Risk staff
With respect to OCC's escalation thresholds, if any Credit Risk Number of a Clearing Member approved for ETH sessions is $10 million or more, or any Credit Risk Number equals 10% or more of the Clearing Member's net capital, an email is generated with a Level 1 Exceedance. This threshold functions as an early warning system, alerting Market Risk and Member Services to a developing credit risk situation before it reaches levels requiring more urgent intervention. At this tier, Operations staff notifies Market Risk and Member Services by email; Market Risk reviews the notification and assesses whether immediate action is warranted. More prescriptive remedial action is not required at this tier because the exposure level is covered by the pre-positioned ETH margin add-on, which OCC holds at the start of each ETH session. The higher thresholds require progressively more urgent action because they represent exposures that exceed that buffer.
If any Credit Risk Number of a Clearing Member approved for ETH sessions is $50 million or more, or equals 25% or more of the Clearing Member's net capital, Operations staff would be required to contact, by telephone and email: (i) Market Risk and Member Services, (ii) the applicable Exchange for secondary review, and (iii) the Clearing Member's designated contacts. The on-call Market Risk duty officer would also consider if additional action is necessary, which may include contacting a designated executive officer in order to issue an intra-day margin call pursuant to OCC Rule 609, increase the Clearing Member's margin requirement in order to prevent the withdrawal of a specified amount of excess margin collateral, if any, the Clearing Member has on deposit with OCC pursuant to OCC Rule 601, or contacting the Exchange in order to invoke use of its kill switch. A Rule 601 margin requirement increase and Rule 609 intraday margin call are tools that reflect the operational constraints for ETH trading during hours in which banks may not be open, such as overnight. If banks are not open, OCC would not be able to collect additional cash during the hours in which such trading was taking place. In that case, OCC Rule 601 serves as a real-time tool that takes effect immediately, preventing a Clearing Member from withdrawing excess collateral already on deposit with OCC, without requiring a cash transfer. When settlement banks reopen, Rule 609 enables OCC to collect additional funds where a Clearing Member's existing excess collateral is insufficient to cover the incremental risk incurred during ETH. OCC Rule 601 also allows OCC to reduce the amount it would need to draft for a Rule 609 margin call by the amount of excess collateral the Clearing Member has on deposit at OCC.
If any Credit Risk Number is $75 million or more, or equals 50% or more of the Clearing Member's net capital, Operations staff would be required to contact, by telephone and email, Market Risk staff, the on-call Market Risk duty officer and a designated executive officer. Such officer would be responsible for reviewing the circumstances and determining whether to implement credit controls, which are described in greater detail below and include: issuing an intra-day margin call, increasing a Clearing Member's margin requirement in order to prevent the withdrawal of a specified amount of excess margin collateral, if any, the Clearing Member has on deposit with OCC, whether further escalation is warranted in order for OCC to take protective measures pursuant to OCC Rule 305, or contact the Exchange in order to invoke use of its kill switch. OCC believes that these thresholds strike an appropriate balance between effective risk monitoring and operational efficiency.
In order to address credit risk associated with trading during ETH sessions, and as described above, OCC collects the ETH margin add-on from Clearing Members and monitors and analyzes the impact that positions established during such sessions have on a Clearing Member's overall exposure. Should the need arise based on threshold breaches described above, and pursuant to OCC Rule 609, OCC may require the deposit of additional margin (“intra-day margin”) by any Clearing Member that increases its incremental risk as a result of trading activity during ETH sessions. Should a Clearing Member's exposure significantly increase, OCC has the authority under OCC Rule 601 to increase a Clearing Member's margin requirement which would restrict its ability to withdraw excess margin collateral.
Furthermore, if a Clearing Member's trading activity during ETH sessions causes its exposure to exceed OCC's intra-day margin call threshold, OCC would require the Clearing Member to deposit intra-day margin equal to the incremental risk presented by the Clearing Member. Specifically, if a Clearing Member has a current risk charge
In addition to, or instead of, requiring additional intra-day margin, OCC Rule 601
Moreover, a designated executive officer may call an Exchange offering ETH sessions to invoke use of its kill switch. The kill switch would prevent a Clearing Member (or the market participant clearing through a Clearing Member) from executing trades on the Exchange during a given ETH session or, if needed, stop all trading during a given ETH session. Finally, pursuant to OCC Rule 307B, the Chief Executive Officer or the Chief Operating Officer of OCC, in certain circumstances, has the authority to impose limitations and restrictions on the transactions, positions and activities of a Clearing Member. This authority would be used, as needed, in the event a Clearing Member accumulates significant credit risk during ETH sessions, or a Clearing Member's activities during such trading sessions otherwise warrant OCC taking protective action.
In order to deter Clearing Members from attempting to participate in ETH sessions without authorization as well as appropriately enforce the above-described processes, OCC maintains authority to initiate a rule enforcement action against a Clearing Member that attempts to participate in ETH sessions without first obtaining the necessary approval. As described above, Clearing Members not approved for ETH sessions who trade during ETH sessions would have their trades reviewed by OCC staff. Clearing Members who attempted to participate in ETH sessions that did not obtain the necessary approval to do so may be subject to a minor rule violation fine.
OCC proposes amendments to its Rules and its ETH procedures to accommodate any participating Exchange request, including CFE's and Cboe's proposals for extended trading hours in VX Futures Options and multi-listed equity options, to establish a legal framework for the consideration of an Exchange's future extension of trading hours for these or other products. Specifically, OCC proposes to amend Rule 402, which is currently reserved, to establish a rule concerning products cleared outside of regular trading hours. In addition, OCC proposes to make changes to its ETH Procedure to amend the definition of “extended trading hours” to encompass not only hours in which U.S. payment systems are closed, as ETH is currently defined therein, but also to incorporate hours in which OCC has determined there may be heightened operational risk or market risk. In addition, OCC proposes to revise its ETH procedures to define the end of the ETH monitoring window as the start of regular trading hours. This revision would clarify to Clearing Members that OCC will conduct uninterrupted monitoring throughout all ETH sessions including the proposed early morning session between 6:30 a.m. and 8:25 a.m. CT.
Rule 402 would clarify that products executed on an Exchange outside of regular trading hours, as determined by OCC, would be subject to OCC's established procedures for the risk management of cleared contracts during ETH sessions, as is the case for index options and index futures traded in ETH sessions today. Accordingly, the amended Rule would provide OCC's authority to determine whether a product proposed to be traded at a particular time would be subject to OCC's procedures for the management of risk during regular trading hours or those for ETH. For example, OCC has determined that the proposed Exchange extension of trading hours for multi-listed equity options from 3:00 p.m. Central to 3:15 p.m. Central may be considered regular trading hours under OCC's rules. Such extension does not raise the same concerns, or to the same degree, about the availability of U.S. payment systems or Clearing Member staffing to support such trading during such hours that motivated the design of the ETH procedures. This rule also clarifies that it is OCC that determines whether particular hours are considered regular trading hours or extended trading hours for purposes of OCC's
Proposed Rule 402 would further provide that OCC would determine, at its sole discretion and for the protection of OCC, its Clearing Members and the general public, whether the risk of a product proposed by an Exchange to be traded in extended trading hours may be managed under OCC's existing ETH procedures. As such, Rule 402 documents OCC's authority to evaluate the proposed expansion of ETH sessions and products to determine whether OCC's risk management procedures are adequate to support the expansion. As discussed above, the current ETH procedures were designed with index options and index futures in mind. The procedures may not be sufficient to address the risks associated with the trading of all products at all hours, particularly the risks of overnight trading in equity options.
Should any other Exchange propose similar hours for similar products, the Rule would also allow OCC to accommodate that Exchange's request. OCC's review and determination of products or hours to be added to ETH sessions, as documented in proposed Rule 402, would also align OCC's Rules with provisions of the Participant Exchange Agreement. Specifically, the Participant Exchange Agreement provides that to the extent OCC agrees to undertake a program or project for a particular Exchange, OCC shall be prepared to undertake comparable programs and projects for each other Exchange that requests it to do so, without discrimination as to schedules, costs, or other terms and conditions. Accordingly, OCC cannot deny a request from a similarly situated Exchange for similarly situated products under the proposed framework. The Participant Exchange Agreement further provides that “each Exchange shall comply with operational specifications for Options including for extended and overnight trading hours specified by OCC and supported by OCC's By-Laws and Rules.”
In addition, OCC respectfully suggests that the Commission consider requesting that any Exchange submitting a proposal to extend its trading hours for products cleared by OCC to consult with OCC in advance of such proposal about OCC's anticipated treatment of such hours and any changes that will be necessary to OCC's ETH procedures to support the proposal, and encourage such Exchange provide that information in its filing. Providing such information in Exchange filings would allow the Commission to more wholistically evaluate an Exchange's proposal and its potential impact on clearance and settlement. In addition, should the Commission be concerned with how OCC proposes to classify the trading hours or the suitability of OCC's existing ETH procedures to manage the risks, such concerns could be addressed earlier in the process, thereby promoting efficiency and avoiding unnecessary delay to an Exchange's planned implementation of expanded trading hours.
Finally, proposed Rule 402 would provide that if OCC determines that an Exchange's proposal to allow trading in certain products at certain hours requires changes to OCC's existing ETH procedures, such changes would be made in accordance with (i) OCC's regulatory obligations and (ii) OCC's agreement with the Exchange, including the Participant Exchange Agreement or any agreement with a futures market under Article XII, Section 1 of OCC's By-Laws. Accordingly, Rule 402 would provide transparency that should OCC determine that changes to the ETH procedures are necessary, any such changes must be made consistent with OCC's regulatory obligations, including its obligation to file proposed rule changes with the Commission under Exchange Act Section 19(b)
OCC also proposes to formally file the ETH Procedure as a rule.
In addition to formally filing the ETH Procedure as a rule, OCC proposes to make the following changes:
Finally, OCC proposes to make certain additional conforming, clarifying, and non-substantive administrative changes to the ETH Procedure, including grammatical corrections and updated departmental references to reflect current organizational titles and responsibilities.
OCC proposes to amend Rule 307B to add a fifth use case to paragraph (a) to clarify the protective measures that may be imposed on a Clearing Member. The proposed amendment would codify OCC's existing authority under Rule 307B to authorize the Chief Executive Officer, Chief Operating Officer, or a Designated Officer of the Corporation, such as an FRM Officer, to revoke a Clearing Member's authorization to participate in ETH sessions as such officer deems necessary or appropriate in the circumstances. Such authority to revoke a Clearing Member's ETH authorization may be exercised where material changes to that Clearing Member's financial condition, operational readiness, or risk profile presents risks to OCC that warrant the imposition of protective measures. Prior to the proposed amendment, Rule 307B did not specifically address ETH participation; OCC's authority to restrict a Clearing Member's access to ETH session was derived from Rule 307B(a)(1) pursuant to which OCC may prohibit or impose limitations on the clearance of any transactions that increase credit or liquidity risk.
For the following reasons, OCC believes that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act,
Section 17A(b)(3)(F) of the Act
OCC believes the proposed changes are also consistent with the requirements in Rule 17ad-22(e)(1) under the Act.
Rule 17ad-22(e)(6)
OCC believes the proposed changes are also consistent with the requirements in Rule 17ad-22(e)(13) under the Act.
For the above reasons, OCC believes that the proposed rule change is consistent with Section 17A of the Exchange Act
Section 17A(b)(3)(I) of the Act
In addition, OCC does not believe that the proposed extension of the ETH procedures to the early morning sessions, including qualification criteria for ETH trading and the payment of the ETH margin add-on charge described above, imposes a burden on competition amongst OCC's Clearing Members that is not necessary or appropriate in furtherance of the Exchange Act. The qualification criteria and the charge would be applied uniformly across all Clearing Members participating in ETH sessions. OCC believes that the ETH margin add-on remains necessary and appropriate to ensure that OCC covers its credit exposure to its participants that produces margin levels commensurate with the risks and particular attributes of the options markets in such ETH sessions, consistent with Rule 17ad-22(e)(6)(i) under the Exchange Act.
For these reasons, OCC believes the proposed rule change would not impose a burden on competition not necessary or appropriate in furtherance of the purposes 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.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
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-2026-008 and should be submitted on or before September 8, 2026.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
2:00 p.m. on Thursday, August 20, 2026.
The meeting will be held via remote means and at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
The subject matter of the closed meeting will consist of the following topics:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to examinations and enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting agenda items that may consist of adjudicatory, examination, litigation, or regulatory matters.
For further information, please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
The Exchange proposes to amend the MIAX Sapphire Options Exchange Fee Schedule (“Fee Schedule”).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the exchange grouping of options exchanges within the routing fee table in Section 1)b) of the Fee Schedule, Fees for Customer Orders Routed to Another Options Exchange, to add applicable Member
Currently, the Exchange assesses routing fees based upon (i) the origin type of the order; (ii) whether or not it is an order for standard option classes in the Penny Interval Program
In anticipation of the launch of the options trading facilities of MX2 and IEX in the second half of 2026, the Exchange has determined to amend the exchange groupings of options exchanges within the routing fee table to include MX2 and IEX and the anticipated associated costs of routing customer orders to MX2 and IEX for execution. In determining to amend its routing fee table to determine which category MX2 and IEX belong to the Exchange took into account anticipated transaction fees and rebates assessed by the away markets to which the Exchange routes orders, as well as the Exchange's anticipated clearing costs, administrative, regulatory, and technical costs associated with routing orders to an away market.
The Exchange's proposal to rename “Nasdaq BX Options” to “Nasdaq Texas
As a result of conducting a periodic review of the current transaction fees charged by away markets the Exchange has determined to remove “MIAX Pearl” from the “Routed, Public Customer that is not a Priority Customer, Non-Penny Program” $1.25 fee tier and amend the “Routed, Public Customer that is not a Priority Customer, Non-Penny Program” $1.40 fee tier to add “MIAX Pearl.” This change is being made as MIAX Pearl recently amended its fee schedule and increased the transaction fee per contract for orders in Non-Penny classes in Professional capacities which remove liquidity.
The impact of these proposed changes will be increased routing options for Members, a clearer Fee Schedule, and a Fee Schedule that better reflects the associated costs. The Exchange notes that routing through the Exchange is optional and that Members will continue to be able to choose where to route applicable Member orders. Under this proposed change, the Exchange will not amend the fees associated with the exchange groupings. This proposal merely seeks to add MX2 and IEX to the exchange groupings, amend the name of a market, and amend the exchange groupings as described in the routing fee table below.
According, with the proposed change, the routing fee table will be as follows:
The purpose of the proposal is to adjust and amend the routing fee groups for orders routed to other exchanges to better reflect the associated costs for that routed execution in Penny and Non-Penny classes as determined by the fees and rebates at the executing exchange. In determining to adjust and amend its groupings, the Exchange took into account anticipated transaction fees assessed by the away market to which the Exchange routes orders, as well as the Exchange's anticipated clearing costs, administrative, regulatory, and technical costs associated with routing orders to an away market. The Exchange uses unaffiliated routing brokers to route orders to the away markets; the costs associated with the use of these services are included in the routing fees specified in the Fee Schedule. This routing fees structure is not only similar to the Exchange's affiliates, MIAX, MIAX Pearl, and MIAX Emerald, but is also comparable to the structure in place at Cboe BZX Options,
The proposed rule changes will become effective on August 1, 2026.
The Exchange believes that its proposal to amend its Fee Schedule is
The Exchange believes the proposed change to add the new options facilities of MX2 and IEX to the exchange groupings of options exchanges within the routing fee table furthers the objectives of Section 6(b)(4) of the Act and is reasonable, equitable and not unfairly discriminatory because the proposed change will continue to apply in the same manner to all Members that are subject to routing fees. The Exchange believes the proposed change to add the new options facilities of MX2 and IEX to the routing fee table of exchange groupings furthers the objectives of Section 6(b)(5) of the Act and is designed to promote just and equitable principles of trade and is not unfairly discriminatory because the proposed change seeks to recoup costs that will be incurred by the Exchange when routing customer orders to MX2 and IEX on behalf of Members and does so in the same manner to all Members that are subject to routing fees. The costs to the Exchange to route orders to away markets for execution primarily includes transaction fees and rebates assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange believes that the proposed additions of MX2 and IEX to the exchange groupings would increase the routing options available to Members. The per-contract transaction fee amount associated with each grouping approximates the Exchange's all-in cost (plus an additional, non-material amount) to execute the corresponding contract at the corresponding exchange.
The Exchange believes that the proposed change is equitable and not unfairly discriminatory because all Members' orders in Penny classes and Non-Penny classes routed to MX2 and IEX will be uniformly assessed the corresponding fee.
The proposed non-substantive change to rename “Nasdaq BX Options” to “Nasdaq Texas Options” would enable the Exchange to continue to be so organized as to have the capacity to carry out the purposes of the Act and comply and enforce compliance with the provisions of the Act by its Members and persons associated with its Members, because it would ensure that the Exchange's Fee Schedule accurately reflects the correct name of the away market to which orders are being routed to and executed on and therefore contribute to the orderly operation of the Exchange by adding clarity and transparency. In addition, the proposed change would reduce potential investor and market participant confusion and therefore remove impediments to and perfect the mechanism of a free and open market and a national market system by ensuring that investors and market participants can more easily navigate and understand the Exchange's Fee Schedule. The proposed change would not be inconsistent with the public interest and the protection of investors because investors will not be harmed and in fact would benefit from the increased transparency and clarity, thereby reducing potential confusion.
The Exchange believes that the proposed changes to the exchange groupings of options exchanges within the routing fee table furthers the objectives of Section 6(b)(4) of the Act and is reasonable, equitable and not unfairly discriminatory because the proposed change will continue to apply in the same manner to all Members that are subject to routing fees. The Exchange believes the proposed changes to the routing fee table exchange groupings furthers the objectives of Section 6(b)(5) of the Act and is designed to promote just and equitable principles of trade and is not unfairly discriminatory because the proposed changes seek to recoup costs that are incurred by the Exchange when routing orders for Public Customers that are not Priority Customers to away markets on behalf of Members and does so in the same manner for all Members that are subject to routing fees. The costs to the Exchange to route orders to away markets for execution primarily includes transaction fees assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange believes that the proposed re-categorization of certain exchange groupings would enable the Exchange to better reflect the costs and fees associated with routing orders to other exchanges for execution.
The Exchange places away markets in the fee tier grouping that best approximates the Exchange's costs and fees to route the orders in that segment to that away market. The per-contract transaction fee amount associated with each grouping approximates the Exchange's all-in cost (plus an additional, non-material amount)
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed changes to add MX2 and IEX to the routing fee table will impose any burden on intramarket competition. Rather, the Exchange believes that the proposal will promote competition by increasing the available away markets to which Members can route orders to.
The proposed change to rename “Nasdaq BX Options” to “Nasdaq Texas Options” is not intended to address competitive issues but rather is concerned solely with updating the Exchange's Fee Schedule to reflect the name change of Nasdaq BX to Nasdaq Texas.
The Exchange's proposed re-categorization of certain exchange groupings is intended to enable the Exchange to recover the costs it incurs to route orders to away markets. The costs to the Exchange to route orders to away markets for execution primarily includes the transaction fees assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange does not believe that this proposal imposes any unnecessary burden on competition because it seeks to better reflect the costs and fees incurred by the Exchange when routing orders to away markets on
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Cboe BZX Exchange, Inc. (the “Exchange” or “BZX”) proposes to amend its Fee Schedule by: (i) removing Step-Up Tier 2; (ii) adopting a new Single MPID Investor Tier; and (iii) removing the ETP and Closed-End Fund LMM Liquidity Provision Rates which expired on June 30, 2026. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Commission's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its Fee Schedule applicable to its equities trading platform (“BZX Equities”) by: (i) removing Step-Up Tier 2; (ii) adopting a new Single MPID Investor Tier; and (iii) removing the ETP and Closed-End Fund LMM Liquidity Provision Rates which expired on June 30, 2026. The Exchange proposes to implement these changes effective August 3, 2026.
The Exchange first notes that it operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. More specifically, the Exchange is only one of 17 registered equities exchanges, as well as a number of alternative trading systems and other off-exchange venues that do not have similar self-regulatory responsibilities under the Securities Exchange Act of 1934 (the “Act”), to which market participants may direct their order flow. Based on publicly available information,
Under footnote 2 of the Fee Schedule, the Exchange currently offers various Step-Up Tiers that provide enhanced rebates for orders yielding fee codes B,
Under footnote 4 of the Fee Schedule, the Exchange offers Single MPID Investor Tiers. In particular, the Exchange currently offers two Single MPID Investor Tiers that provide enhanced rebates for orders yielding fee codes B, V and Y where an MPID reaches certain add volume-based criteria. The Exchange now proposes to adopt a new Single MPID Investor Tier 3. The proposed criteria for Single MPID Investor Tier 3 is as follows:
• Single MPID Investor Tier 3 provides an enhanced rebate of $0.0032 per share in securities priced at or above $1.00 to qualifying orders (
For purposes of the proposed Single MPID Investor Tier 3, “Tape C ADV” means ADV in Tape C securities. “Tape C TCV” means TCV in Tape C securities. “Ex-Subdollar Tape C ADV” means Tape C ADV that excludes executions in securities priced below $1.00. “Ex-Subdollar Tape C TCV” means Tape C TCV that excludes executions in securities that have an average daily price below $1.00. These definitions are consistent with the existing definitions of “Ex-Subdollar ADAV” and “Ex-Subdollar TCV” that already appear on the Exchange's Fee Schedule and are tailored to apply to Tape C securities.
The proposed Single MPID Investor Tier 3, like other Single MPID Investor Tiers, is intended to provide an additional opportunity to incentivize MPIDs to earn an enhanced rebate by promoting increased displayed and non-displayed liquidity and Tape C participation, contributing to a deeper, more liquid market and providing even more execution opportunities for active market participants. Incentivizing an increase in liquidity adding volume through enhanced rebate opportunities encourages liquidity-adding Members on the Exchange to increase transactions and take execution opportunities provided by such increased liquidity, together providing for overall enhanced price discovery and price improvement opportunities on the Exchange. As such, increased overall order flow benefits all Members by contributing towards a robust and well-balanced market ecosystem. The Exchange notes that the proposed Single MPID Investor Tier 3 does not represent a significant departure from existing criteria. The Exchange further notes that the Ex-Subdollar alternative prongs are designed to prevent Members from being disadvantaged in months where elevated subdollar volume inflates TCV, ensuring that the tier criteria remains achievable and equitable regardless of market conditions.
Under footnote 14 of the Fee Schedule, the Exchange details pricing for its Lead Market Makers (“LMMs”) in BZX-listed securities. In particular, under footnote 14(B), the Exchange currently details the ETP and Closed-End Fund LMM Liquidity Provision Rates payable daily on a per-security basis to Qualified ETP LMMs, comprising Base Rates and Enhanced Rates tables (the “Base and Enhanced Rates”) based on average aggregate daily auction volume in ETP LMM Securities.
The Exchange now proposes to remove the Base and Enhanced Rates from its Fee Schedule. The Exchange previously updated the payout structure of its LMM program; performance tracking for the new payouts began in June 2026 with the new payouts starting in July 2026, and the prior payout
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.
As described above, the Exchange operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. The Exchange believes that its proposal to adopt Single MPID Investor Tier 3 reflects a competitive pricing structure designed to incentivize market participants to direct their order flow to the Exchange, which the Exchange believes would enhance market quality to the benefit of all Members. Specifically, the Exchange's proposed Single MPID Investor Tier 3 is not a significant departure from existing criteria, is reasonably correlated to the enhanced rebate offered by the Exchange and other competing exchanges,
In particular, the Exchange believes its proposed Single MPID Investor Tier 3 is reasonable because the proposed tier will be available to all Members and provide all Members with an opportunity to receive an enhanced rebate. The Exchange further believes its proposed Single MPID Investor Tier 3 will provide a reasonable means to encourage liquidity adding displayed orders in Members' order flow to the Exchange and to incentivize Members to continue to provide liquidity adding volume to the Exchange by offering them an opportunity to receive an enhanced rebate on qualifying orders. An overall increase in activity would deepen the Exchange's liquidity pool, offer additional cost savings, support the quality of price discovery, promote market transparency and improve market quality, for all investors.
The Exchange believes that its proposed Single MPID Investor Tier 3 is reasonable as the proposed criteria does not represent a significant departure from the criteria currently offered in the Fee Schedule. The Exchange also believes that the proposal represents an equitable allocation of fees and rebates and is not unfairly discriminatory because all Members will be eligible for the proposed Single MPID Investor Tier 3 and have the opportunity to meet the tier's criteria and receive the corresponding enhanced rebate if such criteria is met. Without having a view of activity on other markets and off-exchange venues, the Exchange has no way of knowing whether this proposed rule change would definitely result in any MPIDs qualifying for the proposed Single MPID Investor Tier 3. While the Exchange has no way of predicting with certainty how the proposed changes will impact Member activity, based on the prior month's volume, the Exchange anticipates that at least one MPID will be able to satisfy the proposed Single MPID Investor Tier 3. The Exchange also notes that proposed changes will not adversely impact any Member's ability to qualify for enhanced rebates offered under other tiers. Should a Member not meet the proposed new criteria, the Member will merely not receive that corresponding enhanced rebate.
The Exchange believes that its proposal to discontinue Step-Up Tier 2, the associated definitions, and reference to footnote 2 in the “Fee Codes and Associated Fees” section of the Fee Schedule is reasonable because the Exchange is not required to maintain this tier or provide Members an opportunity to receive enhanced rebates. The Exchange believes the proposal to discontinue this tier and remove the associated definitions and references to footnote 2 is also equitable and not unfairly discriminatory because it applies to all Members (
Furthermore, the Exchange believes that its proposal to remove the Base and Enhanced Rates that expired on June 30, 2026, is reasonable because the Exchange is not required to maintain these rates nor provide ETP LMMs an opportunity to receive the rates. The Exchange believes its proposal to remove the Base and Enhanced Rates is equitable and not unfairly discriminatory because it applies to all ETP LMMs uniformly (
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Rather, as discussed above, the Exchange believes that the proposed change would encourage the submission of additional order flow to a public exchange, thereby promoting market depth, execution incentives and enhanced execution opportunities, as well as price discovery and transparency for all Members. As a result, the Exchange believes that the proposed changes further the Commission's goal in adopting Regulation NMS of fostering competition among orders, which promotes “more efficient pricing of individual stocks for all types of orders, large and small.”
The Exchange believes the proposed rule changes do not impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. Particularly, the proposed adoption of Single MPID Investor Tier 3 does not impose an unnecessary burden as all Members are eligible to receive the enhanced rebate under the proposed tier. The Exchange does not believe the proposed changes burden competition, but rather, enhances competition as it is intended to increase the competitiveness of BZX by amending existing pricing incentives in order to attract order flow and incentivize participants to increase their participation on the Exchange, providing for additional execution opportunities for market participants and improved price transparency. Greater overall order flow, trading opportunities, and pricing transparency benefits all market participants on the Exchange by enhancing market quality and continuing to encourage Members to send orders, thereby contributing towards a robust and well-balanced market ecosystem.
The proposed changes to discontinue Step-Up Tier 2 and remove the associated definitions and references to footnote 2 will not impose any burden on intramarket competition because the change applies to all Members uniformly, as in, the tier and definitions will no longer be available to any Member.
The proposed change to remove the ETP and Closed-End Fund LMM Liquidity Provision Rates will not impose any burden on intramarket competition because the change applies to all ETP LMMs uniformly in that the prior rates will no longer be available to any ETP LMM.
Next, the Exchange believes the proposed rule changes do not impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange operates in a highly competitive market. Members have numerous alternative venues that they may participate on and direct their order flow, including other equities exchanges, off-exchange venues, and alternative trading systems. Additionally, the Exchange represents a small percentage of the overall market. Based on publicly available information, no single equities exchange has more than 15% of the market share.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the MIAX Sapphire Options Exchange Fee Schedule to: (1) reduce the initiating and contra-side fees applicable to Professional Customer orders for QCC and cQCC transactions on the Exchange's Electronic Book and Trading Floor; (2) reduce the rebates applicable to Professional Customer orders for QCC and cQCC transactions on the Exchange's Electronic Book and Trading Floor; and (3) establish a tiered fee structure applicable to Trading Floor transactions where a Member firm directs a paired order to the Trading Floor, the agency order is a customer of the Member firm, and the contra-side of the transaction is the Away Market Maker of the Member firm, depending on certain breakup percentages and minimum sizes (all terms described below).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the Fee Schedule to: (1) reduce the initiating and contra-side fees applicable to Professional Customer
First, the Exchange proposes to amend Sections 1)a)ii)-iii) and 1)c)ii)-
Next, the Exchange proposes to amend Sections 1)a)ii)-iii) of the Fee Schedule to reduce the rebates applicable to Professional Customer orders for QCC and cQCC transactions on the Exchange's Electronic Book. Currently, for EEMs
Next, the Exchange proposes to amend Sections 1)c)ii)-iii) of the Fee Schedule to reduce the rebates applicable to Professional Customer orders for QCC and cQCC transactions on the Exchange's Trading Floor. Currently, for Floor Brokers
The purpose of these changes is for business and competitive reasons. The Exchange believes that even with the proposal to remove the rebate payable to an EEM (or Floor Broker) entering a Professional Customer order as part of a QCC or cQCC transaction (electronic or on the Trading Floor) where the contra-side is a Priority Customer or Professional Customer, the Exchange's QCC and cQCC rebates remain competitive with those of other exchanges for Professional Customer orders.
Next, the Exchange proposes to amend Section 1)c)i) of the Fee Schedule to establish a tiered fee structure applicable to Trading Floor transactions where a Member firm directs a paired QFO or cQFO to the Trading Floor, the agency order is a customer of the Member firm, and the contra-side of the transaction is the Away Market Maker of the Member firm, depending on certain breakup percentages and minimum sizes.
For background, the Exchange assesses fees and applies rebates to both executed sides of the paired QFO or cQFO on the Trading Floor. cQFO fees and rebates are per executed side per
Currently, the Exchange assesses a $0.25 per contract fee for QFO and cQFO transactions in SPY/QQQ/IWM, Penny classes (excluding SPY/QQQ/IWM), and non-Penny classes, for Away Market Maker, Firm, and Broker-Dealer origins. The Exchange does not assess a fee (or provide a rebate) for QFO and cQFO transactions in SPY/QQQ/IWM, Penny classes (excluding SPY/QQQ/IWM), and non-Penny classes, for Firm and Broker-Dealer origins that are facilitating a Priority Customer or Professional Customer order.
The Exchange now proposes to establish a new row in the table in Section 1)c)i) of the Fee Schedule that will apply to transactions for Away Market Maker facilitation of customer orders for the same Member firm. The Exchange proposes to specify in third explanatory paragraph below the table of fees in Section 1)c)i) of the Fee Schedule that the rates for Away Market Maker Facilitation will apply to any Trading Floor transaction where a Member firm directs a paired order to the Trading Floor, where the agency order is a customer of the Member firm, and where the contra-side of the transaction is the Away Market Maker of the Member firm. Further, the Away Market Maker firm must notify the Exchange for participation in the Away Market Maker Facilitation program.
The Exchange proposes to establish a new table at the end of the explanatory text in Section 1)c)i) of the Fee Schedule, which will be titled “Away Market Maker Facilitation Breakup Table” (referred to herein as the “Breakup Table”). The Breakup Table will provide the proposed tiered fees for transactions where a Member firm directs a paired QFO or cQFO to the Trading Floor, the agency order is a customer of the Member firm, and the contra-side of the transaction is the Away Market Maker of the Member firm, depending on the following breakup percentages: 0 to 5% breakup will be assessed a per contract fee of $0.10; greater than 5% to 15% breakup will be assessed a per contract fee of $0.09; greater than 15% to 25% breakup will be assessed a per contract fee of $0.08; greater than 25% to 35% breakup will be assessed a per contract fee of $0.07; greater than 35% to 40% breakup will be assessed a per contract fee of $0.06; and greater than 40% breakup will be assessed a per contract fee of $0.05.
The Exchange also proposes to add the new note “*” to the Breakup Table and the corresponding note below table, which will provide as follows:
* These rates only apply to QFO or cQFO orders that are not part of a QCC, cQCC or Strategy transaction. For QFO volume to qualify these rates, the Away Market Maker must facilitate at least 1,000 initiating sides. For cQFO volume to qualify for these rates, the smallest leg must be at least 1,000 initiating sides.
The Exchange also proposes to amend the second sentence in the first paragraph of explanatory text below the tables in Section 1)c)i) of the Fee Schedule to specify that Floor Brokers will not be entitled to receive rebates from Away Market Maker Facilitation transactions. This concept is not new or novel as the Exchange does not provide the otherwise applicable rebate where a Firm or Broker-Dealer facilitates a Priority Customer or Professional Customer QFO or cQFO.
The purpose of these changes is for business and competitive reasons. The Exchange believes that the proposed changes may encourage Members to submit more customer orders to the Trading Floor where the contra-side is the Away Market Maker of the Member firm in order to be assessed the lower tiered fees than would otherwise apply to such transactions. The Exchange believes that this may, in turn, increase open outcry participation, which may promote increased executions on the Trading Floor to the benefit of all Floor Participants. The Exchange also notes that this concept is not new or novel. The Exchange currently offers Firms and Broker-Dealers the opportunity to not be assessed a fee when a Firm or Broker-Dealer facilitates a Priority Customer or Professional Customer QFO or cQFO on the Trading Floor.
The proposed changes are effective beginning August 1, 2026.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
There are currently 18 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based and singly-listed options, no single exchange had more than approximately 11-12% of the multiply-listed equity options market share for the month of June 2026.
The Exchange believes its proposal to reduce the initiating and contra-side fees applicable to Professional Customer orders for QCC and cQCC transactions on the Exchange's Electronic Book and Trading Floor is reasonable, equitable and not unfairly discriminatory because it may further incentivize Professional
The Exchange believes its proposal to reduce the rebates applicable to Professional Customer orders for QCC and cQCC transactions on the Exchange's Electronic Book and Trading Floor is reasonable, equitable and not unfairly discriminatory because the changes are for business and competitive reasons. The Exchange believes that even with the proposal to remove the rebate payable to an EEM (or Floor Broker) entering a Professional Customer order as part of a QCC or cQCC transaction (electronic or on the Trading Floor) where the contra-side is a Priority Customer or Professional Customer, the Exchange's QCC and cQCC rebates remain competitive with those of other exchanges.
The Exchange believes its proposal to establish a tiered fee structure where a Member firm directs a paired QFO or cQFO to the Trading Floor, the agency order is a customer of the Member firm, and the contra-side of the transaction is the Away Market Maker of the Member firm, depending on certain breakup percentages and minimum sizes is reasonable, equitable and not unfairly discriminatory because these changes are for business and competitive reasons. The Exchange believes that the proposed changes may encourage Members to submit more customer orders to the Trading Floor where the contra-side is the Away Market Maker of the Member firm in order to be assessed the lower tiered fees than would otherwise apply to such transactions. The Exchange believes that this may, in turn, increase open outcry participation, which may promote increased executions on the Trading Floor to the benefit of all Floor Participants. The Exchange believes this proposal is equitably allocated and not unfairly discriminatory because it is open to all Members of the Trading Floor and is not limited to a particular customer segment. Members may submit paired any combination of a paired QFO or cQFO where the contra-side is an Away Market Maker of that Member firm in order to receive the tiered reduced fees, so long as the minimum size threshold is met.
The Exchange believes that the proposed rule changes will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The proposed changes do not impose an undue burden on inter-market competition. The Exchange believes the proposed changes to reduce the fees and rebates applicable to initiating and contra-side Professional Customer orders entered as part of a QCC or cQCC transaction do not impose any burden on inter-market competition because other exchanges have similar fee structures for similar transactions.
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The Exchange believes that the proposed changes reflect this competitive environment because the changes modify the Exchange's fees and rebates in a manner designed to continue to incent participants to direct trading interest to the Exchange (both electronically and on the Trading Floor), to provide liquidity and to attract additional order flow. To the extent that Away Market Makers are encouraged to facilitate more Priority Customer and Professional Customer QFOs and cQFOs, all Exchange market participants stand to benefit from the improved market quality and increased opportunities for price improvement. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
In accordance with Section 6(b)(8) of the Act, the Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Instead, as discussed above, the Exchange believes that the proposed changes would encourage the submission of additional QCC and cQCC liquidity from Professional Customers (both electronically and on the Trading Floor), thereby promoting market depth, price discovery and transparency and enhancing order execution opportunities for all market participants. As a result, the Exchange believes that the proposed changes further the Commission's goal in adopting Regulation NMS of fostering integrated competition among orders.
The proposed change to establish a tiered fee structure where a Member firm directs a paired QFO or cQFO to the Trading Floor, the agency order is a customer of the Member firm, and the contra-side of the transaction is the Away Market Maker of the Member firm, depending on certain breakup percentages and minimum sizes is
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
The Exchange proposes to amend the MIAX Emerald Options Exchange Fee Schedule (“Fee Schedule”).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the exchange grouping of options exchanges within the routing fee table in Section 1)b) of the Fee Schedule, Fees for Customer Orders Routed to Another Options Exchange, to add applicable Member
Currently, the Exchange assesses routing fees based upon (i) the origin type of the order; (ii) whether or not it is an order for standard option classes in the Penny Interval Program
In anticipation of the launch of the options trading facilities of MX2 and IEX in the second half of 2026, the Exchange has determined to amend the exchange groupings of options exchanges within the routing fee table to include MX2 and IEX and the anticipated associated costs of routing customer orders to MX2 and IEX for execution. In determining to amend its routing fee table to determine which category MX2 and IEX belong to the Exchange took into account anticipated transaction fees and rebates assessed by the away markets to which the Exchange routes orders, as well as the Exchange's anticipated clearing costs, administrative, regulatory, and technical costs associated with routing orders to an away market.
The Exchange's proposal to rename “Nasdaq BX Options” to “Nasdaq Texas Options” is a conforming and non-substantive change in nature designed to ensure that the Exchange's Fee Schedule accurately reflects the name of the away market orders are being routed to and executed on.
As a result of conducting a periodic review of the current transaction fees charged by away markets the Exchange has determined to remove “MIAX Pearl” from the “Routed, Public Customer that is not a Priority Customer, Non-Penny Program” $1.25 fee tier and amend the “Routed, Public Customer that is not a Priority Customer, Non-Penny Program” $1.40 fee tier to add “MIAX Pearl.” This change is being made as MIAX Pearl recently amended its fee schedule and increased the transaction fee per contract for orders in Non-Penny classes in Professional capacities which remove liquidity.
The impact of these proposed changes will be increased routing options for Members, a clearer Fee Schedule, and a Fee Schedule that better reflects the associated costs. The Exchange notes that routing through the Exchange is optional and that Members will continue to be able to choose where to route applicable Member orders. Under this proposed change, the Exchange will not amend the fees associated with the exchange groupings. This proposal merely seeks to add MX2 and IEX to the exchange groupings, amend the name of a market, and amend the exchange groupings as described in the routing fee table below.
According, with the proposed change, the routing fee table will be as follows:
The purpose of the proposal is to adjust and amend the routing fee groups for orders routed to other exchanges to better reflect the associated costs for that routed execution in Penny and Non-Penny classes as determined by the fees
The proposed rule changes will become effective on August 1, 2026.
The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act
The Exchange believes the proposed change to add the new options facilities of MX2 and IEX to the exchange groupings of options exchanges within the routing fee table furthers the objectives of Section 6(b)(4) of the Act and is reasonable, equitable and not unfairly discriminatory because the proposed change will continue to apply in the same manner to all Members that are subject to routing fees. The Exchange believes the proposed change to add the new options facilities of MX2 and IEX to the routing fee table of exchange groupings furthers the objectives of Section 6(b)(5) of the Act and is designed to promote just and equitable principles of trade and is not unfairly discriminatory because the proposed change seeks to recoup costs that will be incurred by the Exchange when routing customer orders to MX2 and IEX on behalf of Members and does so in the same manner to all Members that are subject to routing fees. The costs to the Exchange to route orders to away markets for execution primarily includes transaction fees and rebates assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange believes that the proposed additions of MX2 and IEX to the exchange groupings would increase the routing options available to Members. The per-contract transaction fee amount associated with each grouping approximates the Exchange's all-in cost (plus an additional, non-material amount) to execute the corresponding contract at the corresponding exchange.
The Exchange believes that the proposed change is equitable and not unfairly discriminatory because all Members' orders in Penny classes and Non-Penny classes routed to MX2 and IEX will be uniformly assessed the corresponding fee.
The proposed non-substantive change to rename “Nasdaq BX Options” to “Nasdaq Texas Options” would enable the Exchange to continue to be so organized as to have the capacity to carry out the purposes of the Act and comply and enforce compliance with the provisions of the Act by its Members and persons associated with its Members, because it would ensure that the Exchange's Fee Schedule accurately reflects the correct name of the away market to which orders are being routed to and executed on and therefore contribute to the orderly operation of the Exchange by adding clarity and transparency. In addition, the proposed change would reduce potential investor and market participant confusion and therefore remove impediments to and perfect the mechanism of a free and open market and a national market system by ensuring that investors and market participants can more easily navigate and understand the Exchange's Fee Schedule. The proposed change would not be inconsistent with the public interest and the protection of investors because investors will not be harmed and in fact would benefit from the increased transparency and clarity, thereby reducing potential confusion.
The Exchange believes that the proposed changes to the exchange groupings of options exchanges within the routing fee table furthers the objectives of Section 6(b)(4) of the Act and is reasonable, equitable and not unfairly discriminatory because the proposed change will continue to apply in the same manner to all Members that are subject to routing fees. The Exchange believes the proposed changes to the routing fee table exchange groupings furthers the objectives of Section 6(b)(5) of the Act and is designed to promote just and equitable principles of trade and is not unfairly discriminatory because the proposed changes seek to recoup costs that are incurred by the Exchange when routing orders for Public Customers that are not Priority Customers to away markets on behalf of Members and does so in the same manner for all Members that are subject to routing fees. The costs to the Exchange to route orders to away markets for execution primarily
The Exchange places away markets in the fee tier grouping that best approximates the Exchange's costs and fees to route the orders in that segment to that away market. The per-contract transaction fee amount associated with each grouping approximates the Exchange's all-in cost (plus an additional, non-material amount)
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed changes to add MX2 and IEX to the routing fee table will impose any burden on intramarket competition. Rather, the Exchange believes that the proposal will promote competition by increasing the available away markets to which Members can route orders to.
The proposed change to rename “Nasdaq BX Options” to “Nasdaq Texas Options” is not intended to address competitive issues but rather is concerned solely with updating the Exchange's Fee Schedule to reflect the name change of Nasdaq BX to Nasdaq Texas.
The Exchange's proposed re-categorization of certain exchange groupings is intended to enable the Exchange to recover the costs it incurs to route orders to away markets. The costs to the Exchange to route orders to away markets for execution primarily includes the transaction fees assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange does not believe that this proposal imposes any unnecessary burden on competition because it seeks to better reflect the costs and fees incurred by the Exchange when routing orders to away markets on behalf of Members and notes that at least one other options exchange has a similar routing fee structure.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from sections 2(a)(32), 5(a)(1), 18(f)(1), 18(i), 22(d) and 22(e) of the Act and rule 22c-1 under the Act and under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act.
Applicants request an order (“Order”) that would permit a registered open-end management investment company to offer one class of exchange-traded shares that operates as an exchange-traded fund (an “ETF Class,” and such shares, “ETF Shares”) and one or more classes of shares that are not exchange-traded (each such class, a “Mutual Fund Class,” and such shares, “Mutual Fund Shares,” and each such fund, a “Multi-Class ETF Fund”). The Order would provide Multi-Class ETF Funds with two broad categories of relief: (i) the relief necessary to permit standard
Northern Lights Fund Trust and Ocean Park Asset Management, LLC.
The application was filed on July 8, 2026.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at
The Commission:
Thomas Ahmadifar, Branch Chief, or Deepak T. Pai, Senior Counsel at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' application, filed July 8, 2026, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system.
The SEC's EDGAR system may be searched at
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”)
The Exchange proposes to amend the MIAX Options Exchange Fee Schedule (“Fee Schedule”) to amend the Priority Customer Rebate Program (“PCRP”) (defined below) table to modify certain volume thresholds.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Section 1)a)iii) of the Fee Schedule to modify the PCRP table to amend certain volume thresholds.
Pursuant to the PCRP, the Exchange credits each Member
Pursuant to the PCRP, Priority Customer volume for transactions in simple, PRIME Agency, complex, and cPRIME Agency are aggregated to determine the appropriate volume tier threshold applicable to each transaction. Volume is recorded for, and credits are delivered to, the Member that submits the order to the Exchange. All fees and rebates are per contract per leg. MIAX aggregates the contracts resulting from Priority Customer Orders
Further, the Exchange established the cPRIME Agency Order Break-up Table in Section 1)a)iii) of the Fee Schedule which provides a tiered agency credit rate for cPRIME Agency Orders for Priority Customers dependent upon the break-up percentage, unless the Member is eligible to receive the alternative cPRIME Agency Order Credit amount for cPRIME Agency Orders in Tier 4 of the PRCP, in which case those orders will earn a credit of $0.12 per contract.
The cPRIME Agency Order Break-up Table provides a per contract agency credit based upon the break-up percentage of the order. Specifically, orders with a break-up % of 0-10% earn a credit of $0.05 per contract; orders with a break-up percentage greater than 10% to, and including 20%, earn a per contract credit of $0.06; orders with a break-up percentage greater than 20% to, and including 30%, earn a per contract credit of $0.07; orders with a break-up percentage greater than 30% to, and including 40%, earn a per contract credit of $0.08; orders with a break-up percentage greater than 40% will earn a per contract credit of $0.10, unless the Member is eligible to receive the alternative cPRIME Agency Order Credit amount for cPRIME Agency Orders in Tier 4 of the PCRP, in which case the order will earn a per contract credit of $0.12.
Currently, the PCRP table provides the following volume thresholds applicable to Priority Customer Orders, which are based on a percentage of national customer volume in multiply-listed options classes listed on MIAX during the relevant month: 0.00% to 0.50% in tier 1; above 0.50% to 1.50% in tier 2; above 1.50% to 2.00% in tier 3; above 2.00% to 3.50% in tier 4; and above 3.50% in tier 5.
The purpose of the proposed changes to certain volume thresholds for the PCRP is for business and competitive reasons in order to attract additional Priority Customer volume from Members. The Exchange believes that the proposed change to reduce the minimum volume threshold in tier 4 of the PCRP may encourage Members to submit more Priority Customer Orders to achieve the higher rebates in tier 4, which may lead to increased liquidity on the Exchange to the benefit of all market participants by providing more trading opportunities and tighter spreads.
The proposed changes are effective beginning August 1, 2026.
The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act
The Commission has repeatedly expressed its preference for competition
There are currently 18 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based and singly-listed options, no single exchange had more than approximately 11-12% of the multiply-listed equity options market share for the month of June 2026.
The Exchange believes its proposal to amend certain volume thresholds in the PCRP is reasonable, equitable and not unfairly discriminatory because it may further incentivize Priority Customer Orders to the Exchange by lowering the minimum volume threshold in tier 4. The Exchange believes that this may, in turn, encourage Members to submit more Priority Customer Orders for Members to achieve the higher tier 4 rebates, leading to increased liquidity on the Exchange to the benefit of all market participants by providing more trading opportunities and tighter spreads. The Exchange believes the proposed change to the PCRP is equitable and not unfairly discriminatory because it will apply equally to all market participants who provide Priority Customer Orders in various segments.
The Exchange believes its proposal to amend footnote “**” in Section 1)a)iii) of the Fee Schedule to add the words “or higher” following the words “tier 4” is reasonable, equitable and not unfairly discriminatory. This is a non-substantive change to take into account the new tier 5 of the PCRP, which was added for July 1, 2026, such that Members that achieve tier 4 or higher (
The Exchange believes that the proposed change will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange does not believe that the proposal will impose any burden on intra-market competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange believes its proposal to amend certain volume threshold in the PCRP will not impose any burden on intra-market competition. Instead, the Exchange believes this proposed change will promote competition because it will further incentivize Priority Customer Orders to the Exchange. The Exchange believes that this may, in turn, encourage Members to submit more Priority Customer Orders, leading to increased liquidity on the Exchange to the benefit of all market participants by providing more trading opportunities and tighter spreads.
The Exchange does not believe that the proposed changes will impose any burden on inter-market competition and the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. There are currently 18 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based options, no single exchange had more than approximately 11-12% of the multiply-listed equity options market share for the month of June 2026.
In such an environment, the Exchange must continually adjust its rebates and tiers to remain competitive with other options exchanges. Because competitors are free to modify their own fees and tiers in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited. The Exchange believes that the proposed rule changes reflect this competitive environment because they modify the Exchange's tiers in a manner that encourages market participants to continue to provide liquidity and to send order flow to the Exchange.
The Exchange believes its proposal to amend footnote “**” in Section 1)a)iii) of the Fee Schedule to add the words “or higher” following the words “tier 4” will not impose any burden on intra-market or inter-market competition because the proposed change is not intended to address any competitive issue; rather it is to add clarity to the Fee Schedule.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
The Exchange proposes to amend the MIAX Pearl Options Exchange Fee Schedule (“Fee Schedule”).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the exchange grouping of options exchanges within the routing fee table in Section (1)(b) of the Fee Schedule, Fees for Customer Orders Routed to Another Options Exchange, to add applicable Member
Currently, the Exchange assesses routing fees based upon (i) the origin type of the order; (ii) whether or not it is an order for standard option classes in the Penny Interval Program
In anticipation of the launch of the options trading facilities of MX2 and IEX in the second half of 2026, the Exchange has determined to amend the exchange groupings of options exchanges within the routing fee table to include MX2 and IEX and the anticipated associated costs of routing customer orders to MX2 and IEX for execution. In determining to amend its routing fee table to determine which category MX2 and IEX belong to the Exchange took into account anticipated transaction fees and rebates assessed by the away markets to which the Exchange routes orders, as well as the Exchange's anticipated clearing costs, administrative, regulatory, and technical costs associated with routing orders to an away market.
The Exchange's proposal to rename “Nasdaq BX Options” to “Nasdaq Texas Options” is a conforming and non-substantive change in nature designed to ensure that the Exchange's Fee Schedule accurately reflects the name of the away market orders are being routed to and executed on.
The impact of these proposed changes will be increased routing options for Members, a clearer Fee Schedule, and a Fee Schedule that better reflects the associated costs. The Exchange notes that routing through the Exchange is optional and that Members will continue to be able to choose where to route applicable Member orders. Under this proposed change, the Exchange will not amend the fees associated with the exchange groupings. This proposal merely seeks to add MX2 and IEX to the exchange groupings, amend the name of a market, and amend the exchange groupings as described in the routing fee table below.
According, with the proposed change, the routing fee table will be as follows:
The purpose of the proposal is to adjust and amend the routing fee groups for orders routed to other exchanges to better reflect the associated costs for that routed execution in Penny and Non-Penny classes as determined by the fees and rebates at the executing exchange. In determining to adjust and amend its groupings, the Exchange took into account anticipated transaction fees assessed by the away market to which the Exchange routes orders, as well as the Exchange's anticipated clearing costs, administrative, regulatory, and technical costs associated with routing orders to an away market. The Exchange uses unaffiliated routing brokers to route orders to the away markets; the costs associated with the use of these services are included in the routing fees specified in the Fee Schedule. This routing fees structure is not only similar to the Exchange's affiliates, MIAX, MIAX Emerald, and MIAX Sapphire, but is also comparable to the structure in place at Cboe BZX Options,
The proposed rule changes will become effective on August 1, 2026.
The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act
The Exchange believes the proposed change to add the new options facilities of MX2 and IEX to the exchange groupings of options exchanges within
The Exchange believes that the proposed change is equitable and not unfairly discriminatory because all Members' orders in Penny classes and Non-Penny classes routed to MX2 and IEX will be uniformly assessed the corresponding fee.
The proposed non-substantive change to rename “Nasdaq BX Options” to “Nasdaq Texas Options” would enable the Exchange to continue to be so organized as to have the capacity to carry out the purposes of the Act and comply and enforce compliance with the provisions of the Act by its Members and persons associated with its Members, because it would ensure that the Exchange's Fee Schedule accurately reflects the correct name of the away market to which orders are being routed to and executed on and therefore contribute to the orderly operation of the Exchange by adding clarity and transparency. In addition, the proposed change would reduce potential investor and market participant confusion and therefore remove impediments to and perfect the mechanism of a free and open market and a national market system by ensuring that investors and market participants can more easily navigate and understand the Exchange's Fee Schedule. The proposed change would not be inconsistent with the public interest and the protection of investors because investors will not be harmed and in fact would benefit from the increased transparency and clarity, thereby reducing potential confusion.
The Exchange believes that the proposed changes to the exchange groupings of options exchanges within the routing fee table furthers the objectives of Section 6(b)(4) of the Act and is reasonable, equitable and not unfairly discriminatory because the proposed change will continue to apply in the same manner to all Members that are subject to routing fees. The Exchange believes the proposed changes to the routing fee table exchange groupings furthers the objectives of Section 6(b)(5) of the Act and is designed to promote just and equitable principles of trade and is not unfairly discriminatory because the proposed changes seek to recoup costs that are incurred by the Exchange when routing orders for Public Customers that are not Priority Customers to away markets on behalf of Members and does so in the same manner for all Members that are subject to routing fees. The costs to the Exchange to route orders to away markets for execution primarily includes transaction fees assessed by the away markets to which the Exchange routes orders, in addition to the Exchange's clearing costs, administrative, regulatory and technical costs. The Exchange believes that the proposed re-categorization of certain exchange groupings would enable the Exchange to better reflect the costs and fees associated with routing orders to other exchanges for execution.
The Exchange places away markets in the fee tier grouping that best approximates the Exchange's costs and fees to route the orders in that segment to that away market. The per-contract transaction fee amount associated with each grouping approximates the Exchange's all-in cost (plus an additional, non-material amount)
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed changes to add MX2 and IEX to the routing fee table will impose any burden on intramarket competition. Rather, the Exchange believes that the proposal will promote competition by increasing the available away markets to which Members can route orders to.
The proposed change to rename “Nasdaq BX Options” to “Nasdaq Texas Options” is not intended to address competitive issues but rather is concerned solely with updating the Exchange's Fee Schedule to reflect the name change of Nasdaq BX to Nasdaq Texas.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of an application under Section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from Sections 18(a)(2), 18(c), 18(i), and 61(a) of the Act.
Applicants request an order to permit certain registered closed-end investment companies that have elected to be regulated as business development companies to issue multiple classes of shares with varying sales loads and asset-based distribution and/or service fees.
Stone Point Credit Income Fund and Stone Point Credit Income Adviser, LLC.
The application was filed on July 1, 2026.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at
The Commission:
Rachel Loko, Senior Special Counsel at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' Application, dated July 1, 2026, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the MIAX Pearl Options Exchange Fee Schedule (“Fee Schedule”) to amend certain fees and rebates applicable to transactions in non-Penny Classes (defined below) for certain origins.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The
The Exchange proposes to amend Section 1(a) of the Fee Schedule to: (1) amend the MIAX Pearl Market Maker
The Exchange currently assesses transaction rebates and fees to all market participants which are based upon the total monthly volume executed by the Member
The Exchange proposes to amend the Market Maker origin table to reduce the Maker rebates in certain tiers and increase the Taker fees in all tiers for Market Maker orders in non-Penny Classes that trade against all origins. Currently, pursuant to the Market Maker origin table, Market Makers qualify for the Maker rebate of ($0.80) per contract or Taker fee of $1.21 per contract in tier 1 for non-Penny Classes if the Market Maker executes above 0.00% to at least 0.20% of TCV. Market Makers can qualify for the Maker rebate of ($0.80) per contract or Taker fee of $1.21 per contract in tier 2 for non-Penny Classes by achieving at least one of the following three volume calculations: (i) if the Market Maker executes above 0.20% to at least 0.50% of TCV; or (ii) if the Market Maker executes above 0.55% in SPY/QQQ/IWM classes; or (iii) if the Market Maker executes above 0.30% in SPY/QQQ/IWM classes when adding liquidity to the Exchange.
The Exchange now proposes to amend the Market Maker origin table to: (i) reduce the Maker rebates from ($0.80) to ($0.55) per contract for tiers 1 and 2 for Market Maker orders in non-Penny Classes that trade against all origins; (ii) reduce the Maker rebate from ($0.80) to ($0.60) per contract for tier 3 for Market Maker orders in non-Penny Classes that trade against all origins; (iii) reduce the Maker rebate from ($0.80) to ($0.65) per contract for tier 4 for Market Maker orders in non-Penny Classes that trade against all origins; (iv) reduce the Maker rebate from ($0.80) to ($0.70) per contract for tier 5 for Market Maker orders in non-Penny Classes that trade against all origins; and (v) increase the Taker fees from $1.21 to $1.23 per contract for all tiers for Market Maker orders in non-Penny Classes that trade against all origins. The Exchange does not propose to amend any of the volume threshold criteria.
The purpose of the proposed changes to the Market Maker origin Maker rebates and Taker fees for non-Penny Classes is for business and competitive reasons. The Exchange believes that even with the proposed decrease to the Maker rebates for Market Maker orders in non-Penny Classes in certain tiers and the proposed increase to the Taker fees for Market Maker orders in non-Penny Classes in all tiers, the Exchange's Maker rebates and Taker fees for Market Maker orders in non-Penny Classes will remain competitive with the rebates offered and fees assessed by other exchanges for similar transactions.
The Exchange proposes to amend the Professional origin table to decrease the Maker rebates in certain tiers for Professional orders in non-Penny Classes that trade against all origins and increase the Taker fees in all tiers for Professional orders in non-Penny Classes that trade against all origins. The Professional origin table provides certain volume criteria thresholds for all tiers that are based upon the total monthly volume executed in all option classes by a Professional on MIAX Pearl as a percentage of TCV. Currently, Professionals can qualify for the following rebates and fees for transactions in non-Penny Classes: (i) Maker rebate of ($0.80) per contract or Taker fee of $1.21 per contract in tier 1 if the Professional executes above 0.00% to at least 0.20% of TCV; (ii) Maker rebate of ($0.80) per contract or Taker fee of $1.21 per contract in tier 2 if the Professional executes above 0.20% to at least 0.50% of TCV; (iii) Maker rebate of ($0.80) per contract or Taker fee of $1.21 per contract in tier 3 if the Professional executes above 0.50% to at least 0.85% of TCV; (iv) Maker rebate of ($0.80) per contract or Taker fee of $1.21 per contract in tier 4 if the Professional executes above 0.85% to at least 1.25% of TCV; (v) Maker rebate of ($0.80) per contract or Taker fee of $1.21 per contract in tier 5 if the Professional executes above 1.25% to at least 1.50% of TCV; and (vi) Maker rebate of ($0.80) per contract or Taker fee of $1.21 per contract in tier 6 if the Professional executes above 1.50%.
The Exchange now proposes to amend the Professional origin table to: (i) decrease the Maker rebates from ($0.80) to ($0.55) per contract for tiers 1 and 2 for Professional orders in non-Penny Classes that trade against all origins; (ii) decrease the Maker rebate from ($0.80) to ($0.60) per contract for tier 3 for Professional orders in non-Penny Classes that trade against all origins; (iii) decrease the Maker rebate from ($0.80) to ($0.65) per contract for tier 4 for Professional orders in non-Penny Classes that trade against all origins; (iv) decrease the Maker rebate from ($0.80) to ($0.70) per contract for tier 5 for Professional orders in non-Penny Classes that trade against all origins; and (v) increase the Taker fees from $1.21 to $1.23 per contract for all tiers for Professional orders in non-Penny Classes that trade against all origins. The Exchange does not propose to amend any of the volume threshold criteria.
The purpose of the proposed changes to the Professional origin Maker rebates and Taker fees for non-Penny Classes is for business and competitive reasons. The Exchange believes that even with the proposed decrease to the Maker rebates for Professional orders in non-Penny Classes in certain tiers and proposed increase to the Taker fees for Professional orders in non-Penny Classes in all tiers that the Exchange's Maker rebates and Taker fees will remain competitive with the rebates offered and fees assessed by at least one other exchange for similar transactions.
The proposed changes are effective beginning August 1, 2026.
The Exchange believes that its proposal to amend the Fee Schedule is consistent with Section 6(b) of the Act
The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
There are currently 18 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based and singly-listed options, no single exchange had more than approximately 11-12% of the multiply-listed equity options market share for the month of June 2026.
The Exchange believes the proposal to amend the Market Maker and Professional origins to reduce the Maker rebates in certain tiers in non-Penny Classes is reasonable, equitably allocated, and not unfairly discriminatory because the purpose of the proposed changes to the Maker rebates is for business and competitive reasons. Even with the proposed decrease, the Exchange believes the proposed Maker rebates will not discourage Market Maker and Professional order flow. The Exchange notes that despite the changes proposed herein, the Exchange's proposed Maker rebates for the Market Maker and Professional origin for tiers 1, 2, 3, 4, and 5 in non-Penny Classes remains competitive with the Maker rebates for similar executions that are charged by other equity options exchanges.
The Exchange believes the proposal to amend the Market Maker and Professional origins to increase Taker fees to $1.23 per contract in all tiers in non-Penny Classes is reasonable, equitably allocated, and not unfairly discriminatory because the purpose of the proposed changes to the Taker fees is for business and competitive reasons. Even with the proposed increase, the Exchange believes the proposed Taker fees will not discourage Market Maker and Professional order flow. The Exchange notes that despite the changes proposed herein, the Exchange's proposed Taker fee of $1.23 per contract for the Market Maker and Professional origin for all tiers in non-Penny Classes remains competitive with (and lower than) the Taker fee for similar executions that are charged by other equity options exchanges.
The Exchange believes that even with the proposed decrease to the Maker rebates for Market Maker and Professional orders in non-Penny Classes in certain tiers and proposed increase to the Taker fees for Market Maker and Professional orders in non-Penny Classes in all tiers, the Exchange's Maker rebates and Taker fees for Market Maker and Professional transactions in non-Penny Classes will continue to encourage such market participants to trade on the Exchange. In turn, this should continue to contribute to a deep and liquid market to the benefit of all market participants and allow the Exchange to maintain its attractiveness as a trading venue. The Exchange further believes the proposed decreased Maker rebates and increased Taker fees are equitable and not unfairly discriminatory because the proposed decreased rebates and increased fees will apply equally to all Market Makers and Professionals transacting in non-Penny Classes.
The Exchange does not believe that the proposed rule changes will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange does not believe that any of the proposed changes will impose any burden on intra-market competition. The Exchange believes that its proposal to reduce Maker rebates in certain tiers and increase Taker fees in all tiers for Market Maker and Professional transactions in non-Penny Classes will not impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because these changes are for business and competitive reasons. The Exchange notes that despite the changes proposed herein, the Exchange's rebates and fees remain competitive with the maker rebates offered and the taker fees assessed by other exchanges for similar executions in non-penny classes by those exchanges for their market maker and professional customers.
The Exchange does not believe that the proposed changes will impose any burden on inter-market competition and the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. There are currently 18 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based options, no single exchange had more than approximately 11-12% of the multiply-listed equity options market share for the month of June 2026.
In such an environment, the Exchange must continually adjust its rebates and tiers to remain competitive with other options exchanges. Because competitors are free to modify their own fees and tiers in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend its Fees Schedule to amend certain transaction fees for Cboe Magnificent 10 Index options (“MGTN options”), amend certain LMM Incentive Programs, and eliminate certain other LMM Incentive Programs. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Commission's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its Fees Schedule, effective August 3, 2026.
The Exchange proposes to amend certain fees for transactions in options on the Cboe Magnificent 10 Index (“MGTN options”) as follows:
• Fee code GO, appended to all Customer orders in MGTN options, assess a fee of $0.16 per contract. The Exchange proposes to decrease this fee to $0.10 per contract to these orders.
• Fee code GW, appended to all Market-Maker orders in MGTN options contra Customer that add liquidity and that are executed electronically, currently assesses no fee per contract. The Exchange proposes to assess a fee of $0.10 per contract to these orders.
The Exchange proposes to amend its Fees Schedule in connection with the GTH VIX/VIXW LMM Incentive Program by generally decreasing the quote width requirements. By way of background, the GTH VIX/VIXW LMM Incentive Program provides a rebate to Trading Permit Holders with an LMM appointment to the incentive program that meet certain quoting standards in a month. The Exchange notes that meeting or exceeding the quoting standards (both current and as proposed) in VIX and VIXW series to
The current GTH VIX/VIXW LMM Incentive Program provides that, if the appointed LMM provides continuous electronic quotes during GTH (
The Exchange proposes to amend the GTH1 and GTH2 SPX/SPXW LMM Incentive Programs. By way of background, each of the GTH1 and GTH2 SPX/SPXW LMM Incentive Program provides a rebate to Trading Permit Holders with an LMM appointment to the incentive program that meet certain quoting standards in a month. The Exchange notes that meeting or exceeding the quoting standards (both current and as proposed) in each program to receive the applicable rebate is optional for LMMs appointed to the program. Particularly, an LMM appointed to each incentive program is eligible to receive the corresponding rebate if it satisfies the applicable quoting standards, which the Exchange believes encourage appointed LMMs to provide liquidity in SPX and SPXW during GTH. The Exchange may consider other exceptions to the program's quoting standards based on demonstrated legal or regulatory requirements or other mitigating circumstances. In calculating whether an LMM appointed to the incentive program meets the program's quoting standards each month, the Exchange excludes from the calculation in that month the business day in which the LMM missed meeting or exceeding the quoting standards in the highest number of series.
The GTH1 SPX/SPXW LMM Incentive Program provides that if the appointed LMM provides continuous electronic quotes during GTH from 7:15 p.m. CST to 2:00 a.m. CST (“GTH1”) that meet or exceed the program's quoting standards
Similarly, the GTH2 SPX/SPXW LMM Incentive Program provides that if the appointed LMM provides continuous electronic quotes during GTH from 2:00 a.m. CST to 8:25 a.m. CST (“GTH2”) that meet or exceed the program's quoting standards
The Exchange proposes to adopt a new set of quoting standards for the GTH1 SPX/SPXW LMM Incentive Program as follows (new proposed widths are denoted with an asterisk).
The Exchange also proposes to adopt a new set of quoting standards for the GTH2 SPX/SPXW LMM Incentive Program as follows (new proposed widths are denoted with an asterisk):
The Exchange also proposes to increase the rebate offered by each of the GTH1 and GTH2 SPX/SPXW LMM Incentive Program for meeting the heightened quoting standards in a given month from $25,000 to $35,000.
The Exchange proposes to eliminate the RTH XSP LMM Incentive Program, the GTH1 XSP LMM Incentive Program, and the GTH2 XSP LMM Incentive Program (the “XSP LMM Incentive Programs”) from the Fees Schedule. By way of background, each XSP LMM Incentive Program provides a rebate to TPHs with LMM appointments to the respective incentive program that meet certain quoting standards in the applicable series in a month. Meeting or exceeding the quoting standards in an XSP LMM Incentive Program to receive the applicable rebate is optional for an LMM appointed to a program. An LMM appointed to an incentive program is eligible to receive the corresponding rebate if it satisfies the applicable quoting standards. The Exchange is not required to offer the XSP LMM Incentive Programs and no longer desires to do so, as of August 3, 2026. As such, the Exchange proposes deleting each of the XSP LMM Incentive Program details set forth in the Fees Schedule.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes the proposed changes to certain transaction fees for MGTN options are reasonable, equitable, and not unfairly discriminatory. The proposed fees are within the range of amounts assessed for the Exchange's other index products. Additionally, the Exchange believes it is reasonable to charge different fee amounts to different user types in the manner proposed because the proposed fees are consistent with the price differentiation that exists today for MGTN options and other index products. The proposed fees are also less than fees for these user types of index options listed for trading on other exchanges.
The Exchange believes the proposed change to the percentage of series in which an appointed LMM must provide continuous electronic quotes of VIX and VIXW series during GTH that meet or exceed the quoting standards for at least 90% of the time in a given month is reasonable. The proposed quoting standards are overall reasonably designed to continue to encourage LMMs appointed to the incentive programs to provide significant liquidity in these options, which benefits investors overall by providing more trading opportunities, tighter spreads, and added market transparency and price discovery. The proposed reduced percentage of series required to meet or exceed the quoting standards does not represent a significant departure from the current percentage threshold. The Exchange believes the slight easing of the standard for appointed LMMs to satisfy the requirements to receive the
The Exchange believes that the proposed change to the GTH VIX/VIX LMM Incentive Program is equitable and not unfairly discriminatory. Specifically, the proposed changes will apply equally to any TPHs with LMM appointments to the GTH VIX/VIXW LMM Incentive Program that seek to meet the program's quoting standards in order to receive the rebates offered under each respective program. The Exchange notes that meeting or exceeding the quoting standards (both current and as proposed) in VIX and VIXW series to receive the applicable rebate is optional for LMMs appointed to the program. The Exchange additionally notes that, if an LMM appointed to the GTH VIX/VIXW LMM Incentive Program does not satisfy the corresponding heightened quoting standard for any given month, then it simply will not receive the rebate offered by the respective program for that month.
Regarding the GTH VIX/VIXW LMM Incentive Program, generally, the Exchange believes it is reasonable, equitable, and not unfairly discriminatory to continue to offer these financial incentives, including as amended, to LMMs appointed to the program, because it benefits all market participants trading in the corresponding products during GTH. This incentive program encourages the LMMs appointed to the program to satisfy the quoting standards, which may increase liquidity and provide more trading opportunities and tighter spreads. Indeed, the Exchange notes that these LMMs serve a crucial role in providing quotes and the opportunity for market participants to trade VIX/VIXW options during GTH, which can lead to increased volume, providing for robust markets. The Exchange ultimately offers the LMM Incentive Program, as amended, to sufficiently incentivize the appointed LMMs to provide key liquidity and active markets in VIX/VIXW during the GTH session. The Exchange further believes this incentive program, as amended, will continue to encourage increased quoting to add liquidity in VIX/VIXW, thereby protecting investors and the public interest. The Exchange also notes that an LMM appointed to an incentive program may undertake added costs each month to satisfy that heightened quoting standards, such as having to purchase additional logical connectivity.
The Exchange believes it is reasonable to amend the quoting standards for each of the GTH SPX LMM Incentive Programs. The proposed quoting standards are overall reasonably designed to continue to encourage LMMS appointed to the incentive programs to provide significant liquidity in these options, which benefits investors overall by providing more trading opportunities, tighter spreads, and added market transparency and price discovery. The proposed changes adopt generally tighter width standards for each program. The Exchange believes that by adopting tighter width standards, the proposed rule change offers LMMs appointed to the programs a more challenging opportunity, thus further incentive, to strive to meet the quoting standards to receive the rebate on their SPX/SPXW options orders. As noted above, the proposed quoting standards are overall reasonably designed to continue to encourage LMMs appointed to the incentive programs to provide significant liquidity in these options, which benefits investors overall by providing more trading opportunities, tighter spreads, and added market transparency and price discovery. The Exchange also notes that the proposed amended quoting standards do not represent a significant departure from each program's current quote width and size standards and remain generally aligned with the current heightened standards in the programs.
The Exchange believes the proposed rule change to increase the amount of the rebate paid to an appointed LMM in each of the GTH SPX LMM Incentive Programs if the LMM satisfies the quoting standards is reasonable. The Exchange notes that LMMs appointed to the respective programs will continue to receive a monthly rebate. The Exchange believes the proposed rebate amounts are reasonably designed to continue to incentivize an LMM appointed to the respective program to meet the applicable quoting standards for SPX and SPXW options during the applicable GTH session, thereby providing liquid and active markets, which facilitates tighter spreads, increased trading opportunities, and overall enhanced market quality to the benefit of all market participants. The Exchange further believes the proposed increase rebate is reasonable and equitable because the amount continues to be in-line with the amounts of other rebates the Exchange offers through other LMM Incentive Programs. Additionally, the Exchange believes the increased rebate amount is reasonable and equitable given the proposed changes described above to generally tighten the widths for SPX and SPXW will make it more challenging for an LMM to meet the quoting standards to receive the rebate. The Exchange believes the proposed increase in the rebate amount may provide LMMs appointed to the programs with further incentive to strive to meet the narrower quote widths to receive the rebate, which benefits investors overall by providing more trading opportunities, tighter spreads, and added market transparency and price discovery.
The Exchange believes that the proposed changes to the GTH SPX LMM Incentive Programs are equitable and not unfairly discriminatory. Specifically, the proposed changes will apply equally to any TPHs with LMM appointments to the GTH SPX LMM Incentive Programs, as applicable, that seek to meet the programs' quoting standards to receive the rebates offered under each respective program. The Exchange additionally notes that, if an LMM appointed to either of the GTH SPX LMM Incentive Programs does not satisfy the corresponding quoting standard for any given month, then it simply will not receive the rebate offered by the respective program for that month.
Regarding the GTH SPX LMM Incentive Programs, generally, the Exchange believes it is reasonable, equitable, and not unfairly discriminatory to continue to offer these financial incentives, including as amended, to LMMs appointed to the programs, because it benefits all market participants trading in the corresponding products during GTH1 and GTH2. These incentive programs encourage the LMMs appointed to such programs to satisfy the applicable quoting standards, which may increase liquidity and provide more trading opportunities and tighter spreads.
The Exchange believes the proposed rule change to eliminate the XSP LMM Incentive Programs is reasonable, equitable, and not unfairly discriminatory. As noted above, the Exchange is not required to offer the XSP LMM Incentive Programs and no longer desires to do so. The proposed change is reasonable, as the Exchange wishes to reallocate resources to its other pricing programs and potentially develop other pricing programs that may benefit market participants. The Exchange also believes the proposed change is equitable and is not unfairly discriminatory because it applies to all Market-Makers equally. While no Market-Maker will be or continue to be eligible for the eliminated XSP LMM Incentive Programs, all Market-Makers remain eligible to participate in the Exchange's other pricing programs, including other LMM Incentive Programs offered by the Exchange.
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 Exchange does not believe that the proposed changes to certain MGTN option transaction fees will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed MGTN transaction fees for the separate types of market participants will be assessed automatically and uniformly to all such market participants, as applicable. As discussed above, while different fees are assessed to different market participants in some circumstances, these different market participants have different obligations and different circumstances as discussed above. For example, preferential pricing to Customers is a long-standing options industry practice which serves to enhance Customer order flow, thereby attracting Market-Makers to facilitate tighter spreads and trading opportunities to the benefit of all market participants. The Exchange does not believe the proposed changes to certain MGTN option transaction fees will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed changes apply to products exclusively listed on the Exchange. As noted above, the proposed fees are within the range of amounts assessed for the Exchange's other index products, excluding Underlying Symbol List A and are also less than fees for these user types of index options listed for trading on other exchanges.
The Exchange does not believe the proposed changes to the GTH LMM Incentive Programs will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because these changes will apply to all LMMs appointed to the applicable program in a uniform manner. The Exchange notes that meeting or exceeding the quoting standards (both current and as proposed) in a GTH LMM Incentive Program to receive the applicable rebate is optional for LMMs appointed to the program. If an LMM appointed to a GTH LMM Incentive Program does not satisfy the corresponding quoting standard for any given month, then the LMM simply will not receive the rebate offered by the respective program for that month. As noted above, to the extent the LMMs appointed to an incentive program receive a benefit that other market participants do not, these LMMs in their role as Market-Makers on the Exchange have different obligations and are held to different standards. For example, Market-Makers play a crucial role in providing active and liquid markets in their appointed products, thereby providing a robust market which benefits all market participants. Such Market-Makers also have obligations and regulatory requirements that other participants do not have. The Exchange also notes that an LMM appointed to a GTH LMM Incentive Program may undertake added costs each month to satisfy that heightened quoting standards, such as having to purchase additional logical connectivity. The Exchange also notes that the LMM Incentive Programs are designed to attract additional order flow to the Exchange, wherein greater liquidity benefits all market participants by providing more trading opportunities, tighter spreads, and added market transparency and price discovery, and signals to other market participants to direct their order flow to those markets, thereby contributing to robust levels of liquidity. As a result, the Exchange believes that the proposed change furthers the Commission's goal in adopting Regulation NMS of fostering competition among orders, which promotes “more efficient pricing of individual stocks for all types of orders, large and small.”
The Exchange does not believe that the proposed rule changes to the GTH LMM Incentive Programs will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed rule change applies only to products exclusively listed on the Exchange. As noted above, the incentive programs are designed to attract additional order flow to the Exchange, wherein greater liquidity benefits all market participants by providing more trading opportunities, tighter spreads, and added market transparency and price discovery, and signals to other market participants to direct their order flow to those markets, thereby contributing to robust levels of liquidity. To the extent that the proposed changes make the Exchange a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become Exchange market participants. Other exchanges are welcome to offer similar programs with respect to products exclusively listed on their markets.
Finally, the Exchange does not believe the proposed rule change to eliminate the LMM Incentive Programs will
The Exchange neither solicited nor received written comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
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 investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. § 3501
Form N-2 (17 CFR 239.14 and 274.11a-1) is the form used by closed-end management investment companies (“registered closed-end funds”) to register under the Investment Company Act of 1940 (15 U.S.C. 80a-1
Section 5 of the Securities Act (15 U.S.C. 77e) requires the filing of a registration statement prior to the offer of securities to the public and that the statement be effective before any securities are sold. The primary purpose of the registration process is to provide disclosure of financial and other information to current and potential investors for the purpose of evaluating an investment in a security. Section 5(b) of the Securities Act requires that investors be provided with a prospectus containing the information required in a registration statement prior to the sale, or at the time of confirmation or delivery, of the securities. A closed-end management investment company (that is not a BDC) is required to register as an investment company under Section 8(a) of the Investment Company Act (15 U.S.C. 80a-8(a)). Form N-2 permits a registered closed end fund and a BDC to provide investors with a prospectus covering essential information about the fund when the fund makes an initial or additional offering of its securities. More-detailed information is available to interested investors in the Statement of Additional Information, which is provided to investors upon request and without charge.
The purpose of Form N-2 is to meet the filing and disclosure requirements of the Securities Act and the Investment Company Act and to enable funds to provide investors with information necessary to evaluate an investment in a registered closed-end fund or BDC. The information filed with the Commission permits the verification of compliance with securities law requirements and assures the public availability and dissemination of the information. A registered closed-end fund or BDC must file a registration statement on Form N-2 only when making initial or additional offerings of securities under the Securities Act, or when amending its registration statement. Compliance with the disclosure requirements of Form N-2 is mandatory. Responses to the disclosure
We estimate that approximately 427 respondents file Form N-2 annually, with 1 response annually per respondent at 344 hours per response, including the time and the cost of preparing and reviewing disclosure, filing documents, and retaining records, for a total annual time burden of 146,888 hours. In addition, we estimate the total annual external cost burden associated with Form N-2 to be $9,914,940, based on 30 hours of outside services at a wage rate of $774 per hour for an attorney in the securities industry ($23,220 per response times 427 respondents).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number.
Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the SEC, including whether the information will have practical utility; (b) the accuracy of the SEC's estimate of the burden imposed by the proposed collection of information, including the validity of the methodology and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated, electronic collection techniques or other forms of information technology.
Please direct your written comments on this 60-Day Collection Notice to Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg via email to
By virtue of the authority vested in the Secretary of State by the laws of the United States, including 22 U.S.C. 2651a(a)(4), I hereby delegate to the Assistant Secretary for Economic, Energy, and Business Affairs (EEB), to the extent authorized by law, the authority to review and deny requests for reconsideration of sanctions imposed pursuant to a determination by the Secretary of State pursuant to the following executive orders: E.O. 14404, E.O. 14203, E.O. 14078, E.O. 14024, E.O. 13894, and E.O. 13846.
With respect to sanctions imposed pursuant to E.O. 14404 and E.O. 14024, the Assistant Secretary for EEB shall coordinate decisions on denial of requests for reconsideration with the Assistant Secretary for Arms Control and Nonproliferation, as appropriate.
Any authority covered by this delegation may also be exercised by the Secretary, the Deputy Secretary, the Deputy Secretary for Management and Resources, and the Under Secretary for Economic Growth, Energy, and the Environment. This delegation does not repeal or modify any other delegation currently in effect. Any reference in this delegation of authority to any executive order shall be deemed to be a reference to such executive order as amended from time to time.
This delegation of authority shall be published in the
Notice is hereby given of the following determinations: I hereby determine that certain objects, constituting a sculpture entitled “Satyr and Hermaphrodite,” being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary conservation, scientific research, and exhibition or display at The J. Paul Getty Museum at the Getty Villa, Pacific Palisades, California, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary conservation, scientific research, and exhibition or display within the United States as aforementioned are in the national interest. I have ordered that Public Notice of these determinations be published in the
Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval for an information collection renewal. The collection involves an aircraft operator's request for a privacy ICAO address through a web-based application process. The information to be collected is necessary to qualify for the authorized use of the privacy ICAO address services and for monitoring to support continued airworthiness and enforcement activities.
Written comments should be submitted by August 25, 2026.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
For technical questions concerning this action, contact Mr. Jamal A. Wilson, Surveillance and Broadcast Services, AJM 42, PIA Program Manager at
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation on claims for judicial review of actions by FHWA and other Federal agencies.
This notice announces actions taken by FHWA that are final. The actions relate to a proposed highway project, Interstate I-24, from I-40 in Nashville to I-840 near Murfreesboro, in Davidson County and Rutherford County, Tennessee, for approximately 26 miles. Those actions grant licenses, permits, and approvals for the project. The FHWA's Finding of No Significant Impact (FONSI) provides details on the Selected Alternative for the proposed improvements.
By this notice, FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(
For FHWA: Boday Borres, P.E., Division Administrator; FHWA, Tennessee Division Office; 404 BNA Drive, Building 200, Suite 508; Nashville, Tennessee, 37217; (615) 781-5770;
The FHWA, Tennessee Division Office's normal business hours are 7:30 a.m. to 4:00 p.m. (Central Time). For the Tennessee Department of Transportation (TDOT): Paige Heintzman, P.E., Public-Private Partnerships Director, TDOT; 312 Rosa L. Parks Avenue, 14th Floor, Nashville, Tennessee 37243; (615) 253-8314;
Notice is hereby given that FHWA has taken final agency actions by issuing a FONSI for the following highway project in the State of Tennessee: I-24 Southeast Choice Lanes project, PIN 134727.01. TDOT is proposing improvements to approximately 26 miles of I- 24 between I-40 and I-840 in Davidson and Rutherford counties, Tennessee. The proposed Project includes widening the existing interstate to accommodate the addition of two price-managed lanes (Choice Lanes) in each direction, adding additional interchange and access points, and interchange improvements throughout the corridor. The proposed Project would use the Public-Private Partnership (P3) model, under which TDOT would partner with a private entity responsible for the design, construction, financing, operation, and maintenance of the proposed Choice Lanes. The P3 model would also leverage the potential for innovations in design and flexibility during construction, as well as the revenue-generating mechanism of price-managed Choice Lanes, enabling accelerated project delivery.
The FHWA's actions and the laws under which such actions were taken are described in the Environmental Assessment (EA) for the project, approved on January 30, 2026, and the FONSI, approved on June 16, 2026, and in other documents in the project file. The EA, FONSI, and other project records are available by contacting the FHWA or TDOT at the addresses provided above. In addition, these documents can be viewed and downloaded from the project website at:
This notice applies to all Federal agency decisions that are final as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
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Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review of actions.
This notice announces actions taken by FHWA, U.S. Fish and Wildlife Service (USFWS), and National Oceanic and Atmospheric Administration, National Marine Fisheries Service (NMFS) that are final. The actions relate to a proposed bridge project, the Ala Wai Bridge Project, which crosses the Ala Wai Canal, Waikiki, City and County of Honolulu, State of Hawaii. These actions grant licenses, permits, and approvals for the project.
By this notice, FHWA is advising the public of final agency actions subject to 23 U.S.C. 139
For FHWA: Richelle Takara, Division Administrator, Federal Highway Administration, 300 Ala Moana Boulevard, Box 50206, Honolulu, Hawaii 96850, Telephone: (808) 541-2700. For HDOT: Robin Shishido, Deputy Director for Highways, State of Hawaii Department of Transportation, 869 Punchbowl Street, Honolulu, Hawaii 96813, Telephone: (808) 587-2220. For City and County of Honolulu: J. Roger Morton, Director of Transportation Services, City and County of Honolulu Department of Transportation Services, 711 Kapiolani Boulevard, Suite 1600, Honolulu, Hawaii 96813, Telephone: (808) 768-8303.
Notice is hereby given that FHWA, USFWS, and NMFS have taken final agency actions subject to 23 U.S.C. 139(
These actions by the Federal agencies, and the laws under which such actions
This notice applies to all Federal agency decisions on the project that are final as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. General: National Environmental Policy Act (42 U.S.C. 4321
2. Air: Clean Air Act, as amended (42 U.S.C. 7401-7671q).
3. Noise: Noise Control Act of 1972 (42 U.S.C. 4901-4918); Procedures for Abatement of Highway Traffic Noise and Construction Noise (23 U.S.C. 109(h), 109(i)); 42 U.S.C. 4331, 4332; sec. 339(b), Public Law 04-59, 109 Stat. 568, 605.
4. Land: Section 4(f) of the Department of Transportation Act of 1966 (49 U.S.C. 303;23 U.S.C. 138); Landscaping and Scenic Enhancement (Wildflowers) (23 U.S.C. 319).
5. Wildlife: Endangered Species Act (16 U.S.C. 1531-1544 and 1536); Marine Mammal Protection Act (16 U.S.C. 1361-1423h); Fish and Wildlife Coordination Act (16 U.S.C. 661-667(d)); Migratory Bird Treaty Act (MBTA) (16 U.S.C. 703-712); Magnuson-Stevens Fishery Conservation and Management Act of 1976, as amended (16 U.S.C. 1801
6. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended (54 U.S.C. 306108
7. Social and Economic: American Indian Religious Freedom Act (42 U.S.C. 1996); Farmland Protection Policy Act (FPPA) (7 U.S.C. 4201-4209); the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, as amended (42 U.S.C. 4601
8. Wetlands and Water Resources: Coastal Zone Management Act (16 U.S.C. 1451-1464); Land and Water Conservation Fund Act (16 U.S.C. 4601-4604); Safe Drinking Water Act (SDWA) (42 U.S.C. 300(f)-300(j)-26); Rivers and Harbors Act of 1899 (33 U.S.C. 401-406); Wetlands Mitigation (23 U.S.C. 119(g) and 133(b)(14)); Flood Disaster Protection Act (42 U.S.C. 4012a, 4106).
9. The analysis pertaining to any applicable Executive Order considered during the environmental review process to the extent such analysis may be challenged in court. Such Executive Orders may include: E.O. 11990 Protection of Wetlands; E.O. 11988 and 13690, Floodplain Management; E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13007 Indian Sacred Sites; E.O. 13287 Preserve America; E.O. 13175 Consultation and Coordination with Indian Tribal Governments; E.O. 11514 Protection and Enhancement of Environmental Quality; E.O. 13112 Invasive Species.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Denial of a petition for a defect investigation.
This notice sets forth the reasons for the denial of a defect petition (DP26002) submitted by Mr. Bhupinder Dhadda. The petition requested that the Agency initiate a safety defect investigation into wheel fastening practices on heavy-duty vehicles and vehicles utilizing 10-285.75 mm bolt circle wheels, with the focus of the investigation being the absence of a redundant mechanical wheel fastener mechanism. After conducting a technical review of the petition and other information, NHTSA's Office of Defects Investigation has concluded that the issues raised by the petition do not warrant a defect investigation at this time. Accordingly, the Agency has denied the petition.
Andrew Brady, Medium and Heavy-Duty Vehicle Defect Division, Office of Defects Investigation, NHTSA, 1200 New Jersey Avenue SE, Washington, DC 20590. Telephone: 202-751-5800. Email:
Interested persons may petition NHTSA requesting that the Agency initiate an investigation to determine whether a motor vehicle or an item of replacement equipment does not comply with an applicable motor vehicle safety standard or contains a defect that relates to motor vehicle safety. 49 U.S.C. 30162(a)(2); 49 CFR 552.1. Upon receipt of a properly filed petition, the Agency conducts a technical review of the petition, material submitted with the petition, and any additional information. 49 U.S.C. 30162(a)(2); 49 CFR 552.6. The technical review may consist solely of a review of information already in the possession of the Agency, or it may include the collection of information from a motor vehicle manufacturer or other sources. After conducting the technical review and considering appropriate factors, which may include, but are not limited to, the nature of the complaint, allocation of Agency resources, Agency priorities, the likelihood of uncovering sufficient evidence to establish the existence of a defect, and the likelihood of success in any necessary enforcement litigation, the Agency will grant or deny the petition.
The Office of Defects Investigation (ODI) received a petition on November 21, 2025, requesting a defect investigation to “determine whether the absence of a redundant mechanical wheel fastener locking mechanism constitutes a safety-related defect in motor vehicles and motor-vehicle equipment” in the heavy-vehicle sector. On March 4, 2026, NHTSA opened Defect Petition DP26002 to evaluate the petitioner's request. The petition itself can be reviewed at
The petition alleges that heavy-vehicle wheel fasteners can loosen once a vehicle is placed into service due to real-world stresses such as thermal
The petition focused on all vehicles utilizing the 10-285.75 mm bolt wheels, also known as 10 Hole 22.5″ Hub Pilot Wheels. ODI conducted a comprehensive search of Vehicle Owner Questionnaires (VOQ) and Early Warning Reporting (EWR) data for vehicles equipped with the subject wheels. Furthermore, ODI reviewed six months of the Federal Motor Carrier Safety Administration's Motor Carrier Management Information System (MCMIS) violation data for commercial vehicles cited for loose or missing wheel fasteners. After reviewing this data, ODI has found insufficient evidence to support the petitioner's claim that a safety-related defect exists.
The data indicates that instances of loose or missing fasteners typically occur at higher mileages following fleet maintenance activities, rather than because of an inherent vehicle manufacturing or design defect. Furthermore, commercial motor vehicle operators are required to conduct daily pre-trip inspections to detect and mitigate loose fasteners before operation. Given the lack of evidence establishing a systemic safety defect, ODI is denying this petition.
The denial of this petition does not foreclose the Agency from taking further action if warranted or making a future finding that a safety-related defect exists based upon additional information the Agency may receive.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Request for comments (RFC).
The National Highway Traffic Safety Administration (NHTSA) is requesting public comment on a proposal to remove two legacy test procedures from its signature consumer information program, the New Car Assessment Program (NCAP): the Dynamic Rollover Resistance Test (specifically, the “Fishhook” maneuver) and the Side Air Bag Out-of-Position (SAB-OOP) testing protocols. The Agency believes these program elements have achieved their original safety goals. This notice also proposes updates to both the mid- and long-term components of the 10-year roadmap established for future NCAP upgrades. These proposed changes are intended to modernize NCAP, focus resources on crash scenarios and technologies with the greatest potential for injury reduction, and ensure the program continues to provide the most impactful safety information to the public.
Comments should be submitted no later than October 16, 2026.
You may submit comments to the docket number identified in the heading of this document by one of the following methods:
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For technical issues, you may contact Taryn Rockwell, Office of Crashworthiness Standards by email at
NCAP was established in 1978 to provide consumers with comparative information on the safety performance of new vehicles, thereby incentivizing safety improvements that extend beyond the established Federal Motor Vehicle Safety Standards (FMVSS). The program uses a 5-Star Safety Rating System to communicate vehicle safety performance in three key areas: frontal crash protection, side crash protection, and rollover resistance. Separately, the program also conducts testing to assess the performance of advanced driver assistance systems (ADAS), pedestrian protection, the protection afforded by side air bags to out of position occupants, and child seat usability.
To maintain NCAP's effectiveness as a driver of safety innovation and consumer awareness, NHTSA periodically reviews its test procedures to ensure they accurately reflect the current vehicle fleet and provide data that assists consumers in their
On December 3, 2024, NHTSA published a 10-year roadmap
The inclusion of the specific programs and tests discussed in this notice—Dynamic Rollover and SAB-OOP—stems from a combination of Congressional mandates and Agency-led safety initiatives authorized under the Motor Vehicle Information and Cost Savings Act of 1972 (15 U.S.C. 1942
NCAP's current rollover rating system was established in response to Section 12 of the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act of 2000 (Pub. L. 106-414). Congress directed the Secretary of Transportation to “develop a dynamic test on rollovers by motor vehicles for the purposes of a consumer information program, and carry out a program for conducting such tests” and to “conduct a rulemaking to determine how best to disseminate these test results to the public.” Applicability was limited to those passenger cars, multipurpose passenger vehicles, and trucks having a gross vehicle weight rating (GVWR) of 4,536 kilograms (10,000 pounds) or less (referred as light vehicles in this notice). This mandate, codified at 49 U.S.C. 30117, led to the adoption of the dynamic Fishhook maneuver test in NCAP in 2003,
The Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) Act of 2005 (Pub. L. 109-59) further reinforced this testing regimen. Section 10307 required that automobile
Unlike the dynamic rollover test, SAB-OOP testing was not a direct Congressional mandate but rather an Agency-adopted protocol to monitor a voluntary industry commitment. In the late 1990s and early 2000s, the rapid introduction of side air bags raised concerns regarding the potential risk of injury to out-of-position
NHTSA published its first 10-year roadmap for upgrading NCAP on December 3, 2024
The current NCAP rollover resistance rating is derived from a statistical combination of a vehicle's SSF and its performance in the dynamic rollover test.
The SSF, which measures a vehicle's propensity to roll over based on its geometry, is designed to represent tripped rollovers (
Historically, NCAP utilized a dynamic rollover test, termed the Fishhook Maneuver, which evaluates a vehicle's
Untripped rollovers represent less than five percent of all rollover events. In untripped rollovers, the tire/road interface friction is the only external force acting on the vehicle to cause the rollover. The Fishhook maneuver approximates the steering a driver acting in panic might use in an effort to regain lane position after swerving to avoid an obstacle in the road. The rapid steering input followed by an over-correction is representative of a general loss of control situation. Performance in the dynamic test is determined by whether a vehicle's inside wheels simultaneously lift two or more inches from the test surface during the maneuver. Vehicles exhibiting a simultaneous wheel lift of two or more inches are said to have “tipped-up.”
The Agency utilizes two distinct logistic regression equations to calculate the risk of rollover, with each using SSF as a covariate. The equation selected for risk determination is based on whether the vehicle “tips up” during the dynamic maneuver:
Figure 1 presents the risk of vehicle rollover as a function of vehicle SSF for the two conditions (1) no tip-up and (2) tip-up in the Fishhook maneuver test using Equations 1 and 2, respectively. The difference in the risk of rollover for a given SSF for a vehicle that has a tip-up compared to a vehicle that does not tip-up in the dynamic test varies from 1.6 percent for vehicles with high SSF values to 4.8 percent for vehicles with low SSF values.
NHTSA proposes transitioning away from the NCAP Fishhook maneuver because the rigorous requirements of FMVSS No. 126 already provide the necessary safeguards to ensure dynamic stability to prevent untripped rollovers and therefore additional NCAP testing is unnecessary. When the dynamic rollover test using the Fishhook maneuver was introduced in NCAP, electronic stability control (ESC) was an emerging technology, and the test was effective in identifying vehicles with poor dynamic stability. However, with the full implementation of FMVSS No. 126 since 2012, virtually all light vehicles in the U.S. fleet are now equipped with robust ESC systems.
Unlike the Fishhook maneuver utilized in NCAP that evaluates on-road untripped rollover susceptibility, the Sine-with-Dwell maneuver, utilized in FMVSS No. 126, incites yaw motion and evaluates the responsiveness of ESC systems to mitigate oversteer and maintain lateral stability. The ESC systems meeting FMVSS No. 126 requirements assist the driver in keeping the vehicle on the road during impending loss-of control situations and thereby mitigate exposure of vehicles to off-road tripping mechanisms, in addition to ESC's primary function of preventing untripped rollovers.
Electronic stability control, as the name implies, is designed to improve vehicle stability when the system detects a loss of traction or steering control. In such situations, the system is designed to apply the brakes to wheels automatically and individually, such as to the outer front wheel to counter oversteering or the inner rear wheel to counter understeering, to help regain control and steer the vehicle where the driver intends to go.
Agency data indicates that modern ESC systems are highly effective at preventing the loss of control situations and wheel lift occurrences
Furthermore, the NCAP dynamic rollover test no longer serves its original purpose of incentivizing ESC adoption. This is true even for 12- and 15-passenger vans, which have historically presented a higher rollover risk compared to other light vehicle types. All 12- and 15-passenger vans tested by NCAP since 2015 were equipped with not only ESC but oftentimes roll stability control (RSC) as well.
Regarding the 2026 Ford Transit 15-passenger T-350 HD with dual rear wheel configuration, NCAP has not conducted a dynamic rollover test for this vehicle model because it exceeds the established weight threshold (as explained above). However, NHTSA has no reason to believe this model would tip-up during such an assessment since it is equipped with both ESC (though not required) and RSC, and its dual rear wheels contribute to a wider track width and lower center of gravity. The addition of RSC and dual rear wheels to this higher weight configuration suggests manufacturers are exercising due diligence to ensure adequate safety is afforded for all passenger van configurations irrespective of requirements imposed by Federal standards. Therefore, NHTSA does not believe removal of the dynamic rollover test from NCAP will generate a safety gap for consumers or organizations choosing to purchase 12- or 15-passenger vans, regardless of whether the associated GVWR for the procured models falls below or exceeds 4,536 kilograms.
The fact that no tip-ups have been observed during NCAP testing since ESC's full adoption in the vehicle fleet demonstrates that the SSF has been the primary differentiator for rollover risk since 2012. This should not be viewed as a detriment to safety, however; as a geometric measurement, the SSF provides a repeatable and reliable indicator of a vehicle's fundamental rollover susceptibility and has proven to correlate highly with actual crash statistics. Though ESC improves lateral stability and resistance to untripped rollovers, ESC may not provide the needed stability and prevent rollover after a vehicle has driven off the road. In such conditions, the SSF of a vehicle is correlated to the propensity of vehicle rollover. Since most real-world vehicle rollovers are tripped rollover events, rollover risk of a vehicle, determined by the equations 1 and 2 and presented in Figure 1, is mainly influenced by the vehicle's SSF. Therefore, the Agency believes that removing the dynamic rollover test while continuing to evaluate SSF measurements in NCAP should sufficiently ensure real-world rollover risk remains low. The Agency continues to fulfill its dynamic rollover testing mandate through the Sine-with-Dwell maneuver as required in FMVSS No. 126.
Regarding the mandate in 49 U.S.C. 30117(c)(1) requiring NHTSA to “develop a dynamic test on rollovers by motor vehicles for the purposes of a consumer information program” and to “carry out a program for conducting such tests[,]” NHTSA has developed both the Fishhook maneuver and the Sine-with-Dwell maneuver tests. While this RFC proposes to discontinue conducting the Fishhook maneuver test in NCAP, the Agency is not abandoning dynamic rollover testing. Rather, NHTSA will continue to conduct regular compliance testing of light vehicle models using the Sine-with-Dwell maneuver to ensure adherence to FMVSS No. 126, thereby maintaining a dynamic assessment program that satisfies the requirements of 49 U.S.C. 30117. Because a non-compliance carries significant consequences, vehicle manufacturers ensure their light vehicles comply with FMVSS No. 126. All light vehicles subject to FMVSS No. 126 would not tip-up in the Fishhook
To fulfill the mandate in 49 U.S.C. 30117(c)(2) to “disseminate the dynamic rollover test results to the public[,]” NHTSA will continue to provide rollover rating of light vehicles based on SSF (Equation 1) for the no tip-up condition on its website and on the Monroney label.
Streamlining the program by removing the redundant Fishhook maneuver will allow NHTSA to redirect significant resources (
In light of the aforementioned considerations, the Agency tentatively believes it is appropriate to remove the Fishhook maneuver from NCAP at this time, relying instead on the Sine-with-Dwell maneuver requirements of FMVSS No. 126 starting with model year 2027 vehicles.
• Do commenters agree with the Agency's assessment that the Dynamic Rollover Test (Fishhook maneuver) no longer provides relevant consumer information due to the prevalence of FMVSS No. 126-compliant ESC systems, and that the Sine-with-Dwell maneuver serves as a sufficient replacement?
• Do commenters agree with the Agency's assessment that the Dynamic Rollover Test is no longer needed in NCAP for 12- and 15-passenger vans since these vehicles are equipped with FMVSS No. 126-compliant ESC systems?
NCAP's SAB-OOP testing was implemented in 2003 to assess the potential injury risk to occupants, particularly smaller adults and children, who are in an abnormal, out-of-position posture relative to a deploying side air bag. As mentioned, this testing was adopted preemptively to ensure that early-generation side air bags did not induce injuries due to aggressive deployment.
Under the TWG procedures, a 5th percentile female side impact test dummy (SID-IIs), a Hybrid III (HIII) three-year-old child test dummy, and a HIII six-year-old child test dummy are placed in several positions close to a vehicle's side air bag systems. Any side air bags that deploy from vehicle seat backs (seat-mounted), from the door or rear quarter panel, typically just below the windowsill (side-mounted), or from the roof rail above the door (roof-mounted) can be assessed. After the dummy is positioned as specified in the procedures, the air bag is deployed statically, and the dummy injury measures stemming from the deployment of the air bag are recorded. The measured forces are compared to established Injury Assessment Reference Values (IARVs), which are very similar to those in FMVSS No. 208, “Occupant crash protection,” for out-of-position testing of frontal air bags. Unlike FMVSS No. 208 out-of-position testing, however, the SAB-OOP does not include objective test procedures that yield reliable results.
NHTSA is proposing to remove the SAB-OOP tests from NCAP because the specific, extreme out-of-position scenarios included in the TWG test protocol have not demonstrated a correlation with real-world injury data. A critical responsibility of any regulatory agency is to perform retrospective analysis of its programs to ensure that they further their intended goals. While the Agency generally observes approximately two SAB-OOP test failures per year during its testing of the vehicle fleet, to date, not a single failure could be related to real-world incidents for those specific vehicle models. Conversely, NHTSA identified a real-world crash where an occupant sustained injuries resulting from side air bag deployment in a vehicle model that passed all the TWG SAB-OOP tests.
NHTSA has also found that even minor deviations in dummy positioning have shown vastly different injury readings, thus challenging the objectivity of the TWG test procedures. Furthermore, because the TWG test procedures allow for adjustments to test positions on a case-by-case basis to ascertain the “worst-case” scenario, the Agency has found it difficult to repeat and reproduce test results. Therefore, NHTSA has been unable to issue recall proceedings for any failures observed during testing. These difficulties also raise questions as to whether the testing itself provides meaningful, actionable information to consumers and manufacturers or merely diverts testing resources away from true safety-enhancing activities and provides consumers with a false sense of security.
In addition, conducting TWG SAB-OOP tests in NCAP is burdensome for both vehicle manufacturers and NHTSA. For NCAP's TWG SAB-OOP procedure, manufacturers are asked to submit data for up to 30 test positions per vehicle,
• Do commenters agree with the Agency's assessment that it is now appropriate to remove the SAB-OOP assessments from NCAP?
• What specific data, if any, is available regarding the residual real-world safety benefit of NCAP SAB-OOP testing in vehicles equipped with current-generation side air bag systems?
In December 2024, NHTSA established a 10-year roadmap for NCAP to modernize the program and provide a clear, long-term vision for vehicle safety in the U.S.
The published roadmap was divided into mid-term (2024-2028) and long-term (2029-2033) initiatives focused on four core areas: Crashworthiness, Crash Avoidance, Vulnerable Road User (VRU) safety, and Vehicle Safety Ratings. Included items were evaluated and selected based on four prerequisites: (1) the update to the program would address a safety need, (2) there are, or may soon be, system designs that can mitigate the safety problem, (3) existing or new system designs have the potential to improve safety, and (4) a performance-based objective test procedure exists that can assess system performance.
The mid-term updates in the roadmap included actions that met the four prerequisites and for which the Agency could reasonably anticipate start and completion times. For the crash avoidance program, these included: the adoption of enhanced automatic emergency braking (AEB), lane keeping
The long-term updates comprised a variety of new technologies having safety potential, but which are not sufficiently mature, such that additional research, test procedure development, and product development, is necessary. For the crash avoidance program, these included: advanced lighting systems, intersection AEB, enhanced LKA, higher-speed AEB with additional scenarios, driver monitoring systems, and intelligent speed assist. For the crashworthiness program, roadmap items included: addition of the 5th percentile small female THOR dummy (THOR-05F) in front and rear seats of frontal crash tests, and adoption of the 5th percentile female WorldSID dummy (WorldSID-05F) in side impact crash tests. Finally, for the VRU safety program, adopted initiatives included: intersection AEB for bicyclists and motorcyclists; BSW and BSI technologies for motorcyclist and bicyclist protection; adoption of the advanced pedestrian legform, aPLI, for crashworthiness pedestrian protection; enhanced PAEB; and driver visibility.
NHTSA is proposing updates to the December 2024 mid-term and long-term components of NCAP's 10-year roadmap to align with the availability of resources, progress in research activities, and a better understanding of the state of technology. On September 22, 2025, NHTSA published a notice
The proposed updated NCAP roadmap spans the years 2026 to 2035, with the mid-term portion spanning 2026 to 2030 and the long-term portion spanning 2031 to 2035. The NCAP roadmap includes four phases for each NCAP initiative, along with a completion milestone for each phase. The four phases are: (1) Research phase, if applicable, (2) Request for comment (RFC) phase, (3) Final decision phase, and (4) Implementation phase. The planned updates to the NCAP roadmap are in the following three safety programs: crashworthiness, crash avoidance, and vulnerable road user safety. Updates are also planned for the vehicle safety rating category. A summary of the mid-term and long-term actions for the updated 10-year roadmap is presented in Tables 1 and 2, respectively. The timeframe shown for the research, RFC, and final decision phases is presented in calendar years. Figures 1 and 2 present the details of the proposed updated mid-term and long-term components of the 10-year roadmap, respectively.
Some of the items in the long-term component of the December 2024 NCAP roadmap have been moved to the mid-term component because the needed research has been completed. For example, NHTSA plans to initiate work on a request for comment notice on adaptive driving beam (ADB) and semi-automatic beam switching (SABS) in 2027. Other items moved from the long-term to the mid-term component are (1) use of aPLI
Because the rulemaking process to standardize NHTSA's most advanced dummies, the THOR-50M and WorldSID-50M, is ongoing and because the Agency continues to conduct research to complete enhancements to its frontal and side test procedures to accommodate these dummies, incorporation of the THOR-50M and the frontal oblique crash test has been delayed by two years, and the incorporation of the WorldSID-50M into NCAP's side impact test has been moved to the long-term component. However, NHTSA plans to include in the mid-term component SID-IIs chest and abdominal deflection to assess overall injury potential in the side impact test program (both the moving deformable barrier (MDB) test and the side pole impact test).
NHTSA is adding a new item to the proposed mid-term component of the roadmap that was not included in the December 2024 NCAP roadmap. Specifically, the Agency is updating its Child Restraint System (CRS) Ease-of-Use rating program with proposed implementation in the fourth quarter of 2028. NHTSA established the CRS Ease-of-Use (EOU) program to help caregivers more easily select and properly use child restraints. Recognizing that correct use is critical to the safety performance of a CRS, the CRS EOU program evaluates and rates the clarity of instructions, labeling, and the usability of installation features. The CRS EOU program is being updated to improve objectivity of assessments and to align better with current CRS designs, features, and labeling.
The proposed long-term component of the roadmap has also been updated to reflect the state of research supporting upgrades to NCAP. The crash avoidance program upgrades in the long-term component of the roadmap are as follows:
• Enhanced LKA (Higher Speed, Curved Road and/or Road Edge Detection Scenarios): While substantial research on enhanced LKA has been completed,
• Driver Monitoring System for Drowsiness: NHTSA's driver monitoring system (DMS) research for drowsiness is underway with data collection planned to begin after NHTSA obtains approval under the Paperwork Reduction Act (PRA). The test procedure for confirmation of performance for DMS for drowsiness detection will be affected by challenges of assuring reliable results given the necessary involvement of humans or human surrogates in the test procedure. Because of these challenges, and to allow sufficient time to gather needed information to support inclusion of DMS for drowsiness in NCAP, this item's implementation into NCAP is now anticipated to start with model year 2036.
• Driver Monitoring System for Distraction: NHTSA's ongoing driver distraction research includes a multi-year research effort examining DMS for driver distraction mitigation that begins in 2026. Similar to drowsiness DMS, this effort will also be affected by substantial challenges in assuring reliable results given the necessary involvement of humans or human surrogates in the test procedure. Due to these challenges, and to allow sufficient time for PRA approval, the topic is not included in this proposed roadmap while NHTSA gathers needed information to support inclusion of DMS for driver distraction mitigation in NCAP.
• Intelligent Speed Assist: NHTSA's multi-year research on intelligent speed assist (ISA) began in 2024 and consists of three separate studies. The first study examines ISA enabling technologies (
NHTSA continues to prioritize activities related to the development of the advanced 5th percentile female frontal crash test dummy, THOR-05F. While NHTSA has already completed substantial required research,
NHTSA's research on enhanced AEB for bicyclists and motorcyclists and enhanced PAEB with additional crash scenarios is ongoing and expected to be completed by the end of 2028. The Agency plans to implement enhanced AEB for bicyclists, motorcyclists, and pedestrians starting with model year 2034. NHTSA plans to complete test procedure development for assessing driver visibility in 2029. In 2030, NHTSA will conduct analysis to evaluate whether driver visibility meets the four prerequisites for inclusion in NCAP.
NHTSA is committed to maintaining NCAP as a relevant and forward-looking consumer information program. The proposed removal of dynamic rollover and SAB-OOP testing is a strategic effort to reallocate resources toward more critical safety initiatives, such as the development of the statutorily mandated ADAS rating system, a requirement under Section 24322 of the Fixing America's Surface Transportation (FAST) Act of 2015 (Pub. L. 114-94) and Section 24213 of IIJA. In addition, the updates to NCAP's 10-year roadmap are intended to assist vehicle manufacturers in planning for future vehicle design improvements.
Interested parties are strongly encouraged to submit thorough and detailed comments relating to each of the relevant areas discussed in this notice. Please see Appendix A for a summarized list of specific questions that have been posed in this notice. Comments submitted will help NHTSA make informed decisions as it strives to advance NCAP by encouraging continuous safety improvements for new vehicles and enhancing consumer information.
Your comments must be written in English. To ensure that your comments are correctly filed in the Docket, please include the docket number indicated in this document in your comments.
Your comments must not be more than 15 pages long (49 CFR 553.21). NHTSA established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.
If you are submitting comments electronically as a PDF (Adobe) file, NHTSA asks that the documents submitted be scanned using an Optical Character Recognition (OCR) process, thus allowing NHTSA to search and copy certain portions of your submissions.
Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the Agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at
You should submit a redacted “public version” of your comment (including redacted versions of any additional documents or attachments) to the docket using any of the methods identified under
You also need to submit a request for confidential treatment directly to the Office of Chief Counsel. Requests for confidential treatment are governed by 49 CFR part 512. Your request must set forth the information specified in Part 512. This includes the materials for which confidentiality is being requested (as explained in more detail below); supporting information, pursuant to § 512.8; and a certificate, pursuant to § 512.4(b) and part 512, Appendix A.
You are required to submit to the Office of Chief Counsel one unredacted “confidential version” of the information for which you are seeking confidential treatment. Pursuant to § 512.6, the words “ENTIRE PAGE CONFIDENTIAL BUSINESS INFORMATION” or “CONFIDENTIAL BUSINESS INFORMATION CONTAINED WITHIN BRACKETS” (as applicable) must appear at the top of each page containing information claimed to be confidential. In the latter situation, where not all information on the page is claimed to be confidential, identify each item of information for which confidentiality is requested within brackets: “[ ].”
You are also required to submit to the Office of Chief Counsel one redacted “public version” of the information for which you are seeking confidential treatment. Pursuant to § 512.5(a)(2), the redacted “public version” should include redactions of any information for which you are seeking confidential treatment (
NHTSA is currently treating electronic submission as an acceptable method for submitting confidential business information to the Agency under Part 512. Please do not send a hard copy of a request for confidential treatment to NHTSA's headquarters. The request should be sent to Dan Rabinovitz in the Office of the Chief Counsel at
We will consider all comments received before the close of business on the comment closing date indicated above under
Issued under authority delegated in 49 CFR 1.95.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Standard Form 5510, “Authorization Agreement for Preauthorized Payment”.
Written comments should be received on or before October 16, 2026 to be assured of consideration.
Direct all written comments and requests for additional information
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Annual Financial Statement of Surety Companies-Schedule F.
Written comments should be received on or before October 16, 2026 to be assured of consideration.
Direct all written comments and requests for additional information to Bureau of the Fiscal Service, Bruce A. Sharp, T1-G, PO Box 1328, Parkersburg, WV 26106-1328, or
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 16, 2026 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of this collection should be directed to Jason Schoonmaker, (801) 620-6008.
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.