Forest Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Food and Drug Administration
National Institutes of Health
Reclamation Bureau
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Nuclear Regulatory Commission.
Regulatory guide; withdrawal.
The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide (RG) 3.65, “Standard Format and Content of Decommissioning Plans for Materials Licensees.” This RG is being withdrawn because it is not needed to endorse NUREG-1757, “Consolidated Decommissioning Guidance: Decommissioning Process for Materials Licensees,” Volume 1, “Decommissioning Process for Materials Licensees.” NUREG-1757 provides the most current guidance on decommissioning nuclear facilities to support license termination for applicants, licensees, and NRC staff reviewers.
The effective date of the withdrawal of RG 3.65 is April 9, 2025.
Please refer to Docket ID NRC-2025-0067 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
•
•
•
James Smith, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-6103; email:
The NRC is withdrawing RG 3.65, “Standard Format and Content of Decommissioning Plans for Materials Licensees.” RG 3.65 provides guidance on the decommissioning leading to termination of a materials license. In May 2008, RG 3.65, Revision 1, was issued and endorsed the method described in NUREG-1757, Volume 1, Revision 2 (ADAMS Accession No. ML063000243), to provide applicants and licensees with consolidated and updated guidance for decommissioning to support termination of a materials license. The NRC staff uses NUREG-1757 as the primary guidance document while reviewing these applications and licenses. Since NUREG-1757 provides the most current guidance, the NRC has determined that RG 3.65 is no longer needed.
The withdrawal of RG 3.65 does not alter any prior or existing NRC licensing approval or the acceptability of licensee commitments to RG 3.65. Although RG 3.65 is being withdrawn, current licensees may continue to use it, and this withdrawal does not affect any existing licenses or agreements. However, applicants and licensees should use NUREG-1757 to support future requests or applications for NRC licensing actions related to the guidance in RG 3.65.
As noted in the
A member of the public may, at any time, submit suggestions to the NRC for improvement of existing RGs or for the development of new RGs. Suggestions can be submitted on the NRC's public website at
For the Nuclear Regulatory Commission.
In rule document 2025-05531 beginning on page 14577 in the issue of Thursday, April 3, 2025, make the following correction:
On page 14577, in the second column, under the
Federal Communications Commission.
Final rule; petition for reconsideration.
This document amends the Table of FM Allotments, of the Federal Communications Commission's (Commission) rules, by substituting Channel 272A for vacant Channel 264A at Koloa, Hawaii. The staff engineering analysis determines that Channel 272A at Koloa can be allotted consistent with the minimum distance separation requirements of the Commission's rules with a site restriction of 8.3 kilometers (5.2 miles) northwest of the community. The reference coordinates are 21-58-24 NL and 159-29-45 WL.
Effective May 16, 2025.
Rolanda F. Smith, Media Bureau, (202) 418-2054,
This is a synopsis of the Commission's
Radio, Radio broadcasting.
Federal Communications Commission.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:
47 U.S.C. 154, 155, 301, 303, 307, 309, 310, 334, 336, 339.
(b)
In rule document 2025-05430 appearing on page 14054 in the issue of Friday, March 28, 2025, make the following corrections:
1. On page 14054, in the third column, in the 33rd line, “JAN 2025” should read “MAR 2025”.
Environmental Protection Agency (EPA).
Proposed rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is proposing to approve the portion of the State Implementation Plan (SIP) submittal from the State of Louisiana demonstrating that the State satisfies the interstate transport requirements of section 110(a)(2)(D)(i)(I), also known as the “good neighbor” provision of the CAA, for the 2010 1-hour sulfur dioxide (SO
Written comments must be received on or before May 9, 2025.
Submit your comments, identified by Docket Number EPA-R06-OAR-2013-0465, at
Nevine Salem, (214) 665-7222,
Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.
On June 2, 2010, the EPA established a revised primary 1-hour SO
Section 110(a)(2)(D)(i)(I) of the CAA requires a State's SIP include provisions prohibiting any source or other type of emissions activity in the State from emitting any air pollutant in amounts that will contribute significantly to nonattainment, or interfere with maintenance, of the NAAQS in any other State. EPA has long interpreted this language to enact a “functional prohibition” on certain emissions from upwind States, necessitating the EPA's independent assessment whether those emissions will occur or have been adequately controlled in the State where they originate.
In this proposed action, the EPA has considered information from the 2010 1-hour SO
After the promulgation of a new or revised NAAQS, the EPA is required to designate areas as “nonattainment,” “attainment,” or “unclassifiable” pursuant to CAA section 107(d)(1)-(2). The process for designating areas following promulgation of a new or revised NAAQS is contained in CAA section 107(d). The EPA promulgated the 2010 1-hour SO
For Louisiana, the EPA designated St. Bernard Parish area as nonattainment during the initial round of SO
Although SO
In this proposed rulemaking, and consistent with prior SO
As discussed in section III, and in further detail in the Technical Support Document (TSD) for this action, the EPA reviewed Louisiana's SO
Consistent with our prior evaluations of other States' SO
In other SO
We find that there is sufficient information to allow the EPA to make a determination that under baseline conditions and likely future emissions scenarios no Louisiana sources are contributing or will contribute to any out-of-state SO
On June 4, 2013, Louisiana submitted to the EPA a SIP revision to address the requirements of CAA section 110(a)(1) and (2), including section 110(a)(2)(D)(i)(I) for the 2010 SO
The 2005 Clean Air Interstate Rule
Both CAIR and CSAPR focused on achieving widespread reductions in PM
While the rationale provided by Louisiana is not an adequate basis on its own by which the EPA can determine the approvability of the State's submission, the EPA may elect to consider additional information to assist in reaching a conclusion as to whether the submission may be approved, in whole or in part, as satisfying the Act's requirements, or does not meet the Act's requirements. Here, the EPA may consider all relevant information, or generate new data and analysis, to make an independent judgment in evaluating States' compliance with the good neighbor provision, which concerns the effects of States' emissions in other States. Therefore, the EPA considered additional available information as described below and in more detail in the TSD for this action, to determine if Louisiana's SIP complies with 110(a)(2)(D)(i)(I) requirements.
For this CAA section 110(a)(2)(D)(i)(I) evaluation of the 2010 SO
As shown in Table 1, the majority of SO
As described in this section, the EPA proposes that an assessment of Louisiana's satisfaction of the Prong 1 and 2 requirements under CAA section 110(a)(2)(D)(i)(I) for the 2010 1-hour SO
The EPA notes that if this information were insufficient to draw a reasonable conclusion concerning whether Louisiana is “significantly contributing” or not, then it would not be possible to propose approval based only on this information. In other words, in general, the absence of information concerning whether interstate transport is occurring is not in itself sufficient justification for approving a good neighbor SIP submission. For example, if there were inadequate monitoring or modeling information to characterize the effects of a large, near-border source of SO
Prong 1 of the “good neighbor” provision requires States' plans to prohibit emissions that will contribute significantly to nonattainment of the NAAQS in another State. The EPA's evaluation
Based on the EPA's analysis, we propose to determine that there are no SO
• There are no monitors recording violations of the 2010 1-hour SO
• Downward SO
• A source-specific analyses of every Louisiana 100 tpy source located within 50 km of the State border indicates that the sources do not contribute to nonattainment in other States. These analyses draw upon available emissions data, monitoring data, air quality modeling, control retirements, wind rose data, and other relevant information to assess the likelihood of air quality impacts from these sources to areas in surrounding States. A detailed discussion of each source-specific analysis is contained in section IV.B.1 of the TSD accompanying this action. Below we cover some of the principal evidence that confirms that emissions from Louisiana do not contribute to nonattainment in other States.
○ The closest monitor to the Nelson facilities has consistently recorded DVs well below the standard for years 2012-2023, indicating that these facilities are not causing exceedances in Louisiana and would not cause exceedances in Texas.
○ Now retired, the monitor in the vicinity of the Reynolds facility in Calcasieu Parish recorded DVs well below the standard from 2017-2020. Considering this historic air quality data with emissions trends in Calcasieu Parish (largely unchanged since 2017) support a determination that these sources are not likely to contribute to nonattainment in Texas.
○ Finally, the Orange monitor, located 2 km from the border of Louisiana in Texas, has also recorded DVs below the standard from 2019-2023, further supporting a determination that emissions from Calcasieu Parish sources are not contributing to nonattainment across the border with Texas.
○ For the St. Bernard Parish sources, nearby monitors (Chalmette Vista and Meraux) have consistently recorded DVs below the NAAQS. Coupling this monitored air quality information with the fact that these sources are 49 km from the State line supports a determination that emissions from these sources are not contributing to nonattainment across the border into Mississippi.
○ For the sources in northwestern Louisiana, low DVs at the Shreveport monitor, coupled with predominant wind patterns that are more likely to transport emissions from these facilities to this monitor than to Texas, support that the northwestern Louisiana sources of emissions are unlikely contributing to nonattainment in Texas. Additionally, DRR modeling results for Dolet Hills Power Station and International Paper's Mansfield Mill indicate no SO
○ For the Baton Rouge area sources, the EPA considered DRR modeling from Big Cajun II that predicted maximum concentrations below the standard within Pointe Coupee Parish. Coupling these results in combination with the fact that emissions from the sources included in the modeling have dropped 85% since the modeling was conducted supports a determination that Big Cajun II will not contribute to nonattainment of the NAAQS in Mississippi. Additionally, two active monitors (Capitol and Port Allen) downwind of Oxbow have consistently low DVs, and given Oxbow's 46 km distance from the border, this evidence further indicates that these Baton Rouge area sources will not contribute to nonattainment of the standard in Texas.
○ For the DeRidder Paper Mill, the small magnitude of the source's SO
○ For the Bogalusa Mill, extrapolation of PSD modeling predicts maximum impacts from the facility well below the standard, the small magnitude of the source's SO
○ Further there are SIP-approved and federal emissions control regulations within Louisiana that will continue to ensure that SO
Based on this evaluation, as more thoroughly discussed in our TSD for this action, the EPA proposes to find that sources within Louisiana will not significantly contribute to nonattainment of the 2010 1-hour SO
Prong 2 of the “good neighbor” provision requires State plans to prohibit emissions that will interfere with maintenance of a NAAQS in another State. The EPA's evaluation of whether Louisiana has met its Prong 2 transport obligations was accomplished by considering all available information, with a focus on current air quality data, SO
Based on the EPA's analysis, we propose to find that SO
• Current 2021-2023 DVs for SO
• State-wide emissions trends in Louisiana and surrounding States indicate generally declining SO
• Source-specific analyses show that facility-level emissions are decreasing as a result of emissions unit shutdowns and control technology installation, indicating that emissions are not anticipated to increase relative to baseline emissions;
• Current Louisiana statutes, SIP-approved measures, and federal emissions control programs control SO
• Louisiana's SIP-approved PSD, major New Source Review (NSR) regulations and minor source NSR permit programs address future new and modified SO
Based on this evaluation, as more thoroughly discussed in our TSD for this action, the EPA proposes to find that sources within Louisiana will not interfere with maintenance of the 2010 1-hour SO
The EPA is proposing to approve the Prong 1 and Prong 2 portions of the infrastructure SIP submission submitted by the State of Louisiana on June 4, 2013, addressing interstate transport for the 2010 1-hour SO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Sulfur dioxide, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Forest Service, Agriculture (USDA).
Notice.
The Forest Service (Forest Service or Agency), U.S. Department of Agriculture, provides direction to employees through issuances in its Directive System, comprised of the Forest Service Manual and Forest Service Handbooks. The Agency must provide public notice of and opportunity to comment on directives that formulate standards, criteria, or guidelines applicable to Forest Service programs. Once per quarter, the Agency provides advance notice of proposed and interim directives that will be made available for public comment during the next three months; proposed and interim directives that were previously published for public comment but not yet finalized and issued; and notice of final directives issued in the last three months.
This notice identifies proposed and interim directives that have been published for public comment between January 1, 2025, and March 31, 2025; proposed and interim directives that were previously published for public comment but not yet finalized and issued; and final directives that have been issued since October 1, 2024.
Questions or comments may be submitted by email to the contact listed below.
JoLynn Anderson, (971) 313-1718 or
Consistent with 16 U.S.C. 1612(a) and 36 CFR part 216, the Forest Service publishes notice of the opportunity for public comment on Agency Directives that formulate standards, criteria, and guidelines applicable to Forest Service programs. Agency procedures for providing public notice and opportunity to comment are specified in Forest Service Handbook (FSH) 1109.12, Chapter 30, Providing Public Notice and Opportunity to Comment on Directives.
No Directives were published for comment between January 1, 2025, to March 31, 2025. Additionally, there are no proposed or final Directives scheduled to be published for comment in Fiscal Year 2025 Quarter 3.
The following Directives have been published in previous quarters:
1. FSM 2040 National Forest System Monitoring.
1. FSH 2209.16-chapter 10 Allotment Management Handbook;
2. FSM 3800 Landscape Scale Restoration.
U.S. Commission on Civil Rights.
Notice of public meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Montana Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public business meeting via Zoom at 3 p.m. MT on Wednesday, May 21, 2025.
Wednesday, May 21, 2025, from 3 p.m.-4:30 p.m. Mountain Time.
The meeting will be held via Zoom Webinar.
Ana Victoria Fortes, Designated Federal Officer, at
This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Liliana Schiller, Support Services Specialist, at
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Ana Victoria Fortes at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the
U.S. Commission on Civil Rights.
Notice of virtual business meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Maryland Advisory Committee (Committee) to the U.S. Commission on Civil Rights will a public meeting via Zoom. The purpose is for the committee to meet as a newly appointed committee.
Wednesday April 30, 2025, at 1 p.m. Eastern Time.
Brooke Peery, Designated Federal Officer, at
Committee meetings are available to the public through a registration link (above). Any interested members of the public may attend committee meetings. An open comment period will be provided to allow members of the public to make oral statements as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of each meeting will include a list of persons who are present. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the scheduled meeting. Written comments may be emailed to Evelyn Bohor at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the file sharing website,
On behalf of Logitech, Arvato USA LLC submitted a notification of proposed production activity to the FTZ Board (the Board) for its facility in Ontario, California within FTZ 50, Site 59. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on April 1, 2025.
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 products include peripherals (audio, computer, sim racing), content creation equipment, and video conference devices (duty rates are duty-free).
The proposed foreign-status materials/components include: microphones (streaming; video conference); speakers (Bluetooth with single driver; Bluetooth with multiple drivers; personal computer; personal computer with single driver); headsets (wired; wireless); virtual reality pens; remotes (gaming; presentation); conferencing displays; desktop streaming LED lights; sim racing components (wheels; pedals); flight simulators; adaptive gaming controllers; webcams; conference webcams; video conferencing components (systems; cameras; table mounts; wall brackets; scheduler touch screen devices); USB receivers; pads (wireless charging; mouse); keyboards (wired; wireless); mouses (wired; wireless); palm rests (duty rate ranges from duty-free to 2.0%). The request indicates that certain materials/components are subject to duties under section 1702(a)(1)(B) of the International Emergency Economic Powers Act (section 1702), and section 301 of the Trade Act of 1974 (section 301), depending on the country of origin. The applicable section 1702 and 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 Juanita Chen at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of the determinations by the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on diffusion-annealed, nickel-plated flat rolled steel products (nickel-plated steel products) from Japan would likely lead to the continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of this AD order.
Applicable March 31, 2025.
Lilit Astvatsatrian, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6412.
On May 29, 2014, Commerce published in the
On March 31, 2025, the ITC published its determination, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the
The diffusion-annealed, nickel-plated flat-rolled steel products included in this
Imports of merchandise included in the scope of this
As a result of the determinations by Commerce and the ITC that revocation of the
The effective date of the continuation of the
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 terms of an APO is a violation which is subject to sanction.
This five-year (sunset) review and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act and published in accordance with section 777(i) of the Act, and 19 CFR 351.218(f)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Based on affirmative final determinations by the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission (ITC), Commerce is issuing antidumping duty (AD) and countervailing duty (CVD) orders on melamine from India.
Applicable April 9, 2025.
Myrna Lobo (AD) or Paul Kebker (CVD), AD/CVD Operations, Offices VII and IV,
In accordance with sections 705(d), 735(d), and 777(i) of the Tariff Act of 1930, as amended (the Act), on February 12, 2025, Commerce published its affirmative final determination of sales at less than fair value (LTFV) from India and its affirmative final determination that countervailable subsidies are being provided to producers and exporters of melamine from India.
On March 31, 2025, the ITC notified Commerce of its affirmative final determination that an industry in the United States is materially injured within the meaning of section 705(b)(1)(A)(i) of the Act.
The products covered by these orders are melamine from India. For a complete description of the scope of the orders,
On March 31, 2025, in accordance with section 735(d) of the Act, the ITC notified Commerce of its final determination that an industry in the United States is materially injured within the meaning of section 735(b)(1)(A)(i) of the Act by reason of imports of melamine that are sold in the United States at less than fair value. Therefore, in accordance with sections 735(c)(2) and 736 of the Act, Commerce is issuing this AD order. Because the ITC determined that imports of melamine from India are materially injuring a U.S. industry, unliquidated entries of such merchandise from India, entered or withdrawn from warehouse for consumption, are subject to the assessment of antidumping duties.
Therefore, in accordance with section 736(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise, for all relevant entries of melamine from India. Antidumping duties will be assessed on unliquidated entries of melamine from India entered, or withdrawn from warehouse, for consumption on or after September 24, 2024, the date of publication of the
With respect to the ITC's negative critical circumstances determination on imports of melamine from India, we will instruct CBP to lift the suspension of liquidation and to refund all cash deposits for estimated antidumping duties with respect to entries of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after June 26, 2024 (
Commerce intends to instruct CBP to reinstitute the suspension of liquidation of melamine from India, effective on the date of publication of the
The estimated weighted-average dumping margins are as follows:
Section 733(d) of
The provisional measures period, beginning on the date of publication of the
As stated above, based on the above-referenced affirmative determination by the ITC that an industry in the United States is materially injured within the meaning of section 705(b)(1)(A)(i) of the Act, by reason of subsidized imports of melamine from India, in accordance with sections 705(c)(2) and 706 of the Act, Commerce is issuing this CVD order. Because the ITC determined that imports of melamine from India are materially injuring a U.S. industry, unliquidated entries of such merchandise entered, or withdrawn from warehouse, for consumption, are subject to the assessment of countervailing duties.
Therefore, in accordance with section 706(a) of the Act, Commerce will direct CBP to assess, upon further instruction by Commerce, countervailing duties on all relevant entries of melamine from India, which are entered, or withdrawn from warehouse, for consumption on or after July 22, 2024, the date of the publication of the
With respect to the ITC's negative critical circumstances determination on imports of melamine from India, we will instruct CBP to lift the suspension of liquidation and to refund all cash deposits for estimated countervailing duties with respect to entries of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after April 23, 2024 (
In accordance with section 706 of the Act, Commerce intends to instruct CBP to reinstitute the suspension of liquidation of melamine from India, effective on the date of publication of the ITC's final affirmative injury determination in the
Commerce also intends, pursuant to section 706(a)(1) of the Act, to instruct CBP to require cash deposits equal to the amounts as indicated below. Accordingly, effective on the date of publication of the ITC's final affirmative injury determination in the
The estimated CVD subsidy rates as published in Commerce's
Section 703(d) of the Act states that the suspension of liquidation pursuant to an affirmative preliminary determination may not remain in effect for more than four months. Commerce published the
Therefore, in accordance with section 703(d) of the Act, Commerce instructed CBP to terminate the suspension of liquidation and to liquidate, without regard to countervailing duties, unliquidated entries of melamine from India entered, or withdrawn from warehouse, for consumption, on or after November 19, 2024, the first day provisional measures were no longer in effect, until and through the day preceding the date of publication of the
On September 20, 2021, Commerce published the
In accordance with the
Interested parties who wish to be added to the annual inquiry service list for an order must submit an entry of appearance to the annual inquiry service list segment for the order in ACCESS within 30 days after the date of publication of the order. For ease of administration, Commerce requests that law firms with more than one attorney representing interested parties in an order designate a lead attorney to be included on the annual inquiry service list. Commerce will finalize the annual inquiry service list within five business days thereafter. As mentioned in the
Commerce may update an annual inquiry service list at any time as needed based on interested parties' amendments to their entries of appearance to remove or otherwise modify their list of members and representatives, or to update contact information. Any changes or announcements pertaining to these procedures will be posted to the ACCESS website.
In the
This notice constitutes the AD and CVD orders with respect to melamine from India, pursuant to sections 736(a) and 706(a) of the Act. Interested parties can find a list of AD and CVD orders currently in effect at
These orders are issued and published in accordance with sections 736(a) and 706(a) of the Act, and 19 CFR 351.211(b).
The merchandise subject to these orders is melamine (Chemical Abstracts Service (CAS) registry number 108-78-01, molecular formula C3 H6 N6). Melamine is also known as 2,4,6- triamino-s-triazine; 1,3,5-Triazine-2,4,6- triamine; Cyanurotriamide; Cyanurotriamine; Cyanuramide; and by various brand names. Melamine is a crystalline powder or granule. All melamine is covered by the scope of these orders irrespective of purity, particle size, or physical form. Melamine that has been blended with other products is included within this scope when such blends include constituent parts that have been intermingled, but that have not been chemically reacted with each other to produce a different product. For such blends, only the melamine component of the mixture is covered by the scope of these orders. Melamine that is otherwise subject to these orders is not excluded when commingled with melamine from sources not subject to these orders. Only the subject component of such commingled products is covered by the scope of these orders.
The subject merchandise is provided for in subheading 2933.61.0000 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheading and CAS registry number are provided for convenience and customs purposes, the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies were being provided to producers and exporters of certain softwood lumber products (softwood lumber) from Canada during the period of review (POR), January 1, 2023, through December 31, 2023. Commerce is also rescinding this review with respect to 46 companies. Interested parties are invited to comment on these preliminary results.
Applicable April 9, 2025.
Samuel Brummitt, Kristen Johnson, and T.J. Worthington, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-7851, (202) 482-4793, and (202) 482-4567, respectively.
On January 3, 2018, Commerce published the countervailing duty (CVD) order on softwood lumber from Canada in the
On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days.
For a complete description of the events that followed the initiation of this review,
The products covered by this order are certain softwood lumber products from Canada. For a complete description of the scope of the
Pursuant to 19 CFR 351.213(d)(3), it is Commerce's practice to rescind an administrative review of a CVD order where it concludes that there were no reviewable entries of subject merchandise during the POR for an exporter or producer. Normally, upon completion of an administrative review, the suspended entries are liquidated at the CVD assessment rate for the review period.
Based on our analysis of CBP data and comments received from interested parties, we determine that 46 producers/exporters, for which a review had been requested, had no reviewable shipments, sales, or entries of subject merchandise during the POR. Accordingly, absent evidence of a shipment on the record, Commerce is rescinding the administrative review of the following companies, pursuant to 19 CFR 351.213(d)(3):
For further information,
Commerce is conducting this CVD administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
There are 245 companies for which a review was requested and not rescinded but were not selected as mandatory respondents. The statute and Commerce's regulations do not directly address the establishment of rates to be applied to companies not selected for individual examination where Commerce limits its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, Commerce normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation.
Section 705(c)(5)(A)(i) of the Act instructs Commerce, as a general rule, to calculate an all-others rate equal to the weighted average of the countervailable subsidy rates established for producers and/or exporters individually examined, excluding any zero,
For the period January 1, 2023, through December 31, 2023, we preliminarily determine the following estimated countervailable subsidy rates:
Commerce intends to disclose its calculations performed to interested parties for these preliminary results within five days of the date of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance. Pursuant to 19 CFR 351.309(c)(1)(ii), we have modified the deadline for interested parties to submit case briefs to Commerce to no later than 21 days after the date of the publication of this notice.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c)(2), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must do so within 21 days of publication of these preliminary results by submitting a written request to the Assistant Secretary for Enforcement and Compliance using ACCESS.
In accordance with 19 CFR 351.221(b)(4)(i), Commerce has preliminarily assigned the subsidy rates as indicated above. Pursuant to section 751(a)(2)(C) of the Act, upon issuance of the final results, Commerce shall determine, and CBP shall assess, countervailing duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 41 days after the date of publication of the final results of this review in the
For the companies for which this review is rescinded, Commerce will instruct CBP to assess countervailing duties on all appropriate entries at a rate equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period January 1, 2023, through December 31, 2023, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue rescission instructions to CBP no earlier than 41 days after the date of publication of the notice of rescission in the
Pursuant to section 751(a)(1) of the Act, Commerce intends, upon publication of the final results, to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts indicated above for each of the respective companies listed above and in Appendix II with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed companies, we will instruct CBP to collect cash deposits of estimated countervailing duties at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.
Unless the deadline is extended, Commerce intends to issue the final results of this administrative review,
We are issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) is conducting an administrative review of the antidumping duty (AD) order on certain superabsorbent polymers (SAP) from the Republic of Korea (Korea). The period of review (POR) is June 7, 2022, through November 30, 2023. Commerce preliminarily determines that sales of subject merchandise have not been made below normal value (NV) by LG Chem, Ltd. (LGC) during the POR. Interested Parties are invited to comment on these preliminary results.
Applicable April 9, 2025.
Charles DeFilippo, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3797.
On December 1, 2023, Commerce published in the
The merchandise subject to the
Commerce is conducting this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). We calculated constructed export price in accordance with section 772 of the Act. We calculated NV in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
As a result of this review, we preliminarily determine that the following estimated weighted-average dumping margin exists for the period June 7, 2022, through November 30, 2023:
Commerce intends to disclose the calculations performed for these preliminary results to interested parties within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in the
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance. Pursuant to 19 CFR 351.309(c)(1)(ii), we have modified the deadline for interested parties to submit case briefs to Commerce to no later than 21 days after the date of the publication of this notice.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their briefs that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS by 5 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing.
All submissions, including case and rebuttal briefs, as well as hearing requests, should be filed via ACCESS.
Upon completion of the administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. Pursuant to 19 CFR 351.212(b)(1), because LGC reported the entered value for all of its U.S. sales, we calculated importer-specific
Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by LGC for which it did not know that the merchandise it sold to an intermediary (
In accordance with section 751(a)(2)(C) of the Act, the final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. 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
The following 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) the cash deposit rate for the company listed above will be that established in the final results of this review, except if the rate is less than 0.50 percent and, therefore,
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, no later than 120 days after the date of publication of this notice in the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 351.221(b)(4).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of cancellation; SEDAR 98 Assessment Webinar I for Gulf of America Red Snapper.
The SEDAR 98 assessment process for Gulf of America red snapper will consist of a Data Workshop, a series of assessment webinars, and a Review Workshop. See
The SEDAR 98 Assessment Webinar I was to be held April 15, 2025, from 10 a.m. until 1 p.m., Eastern Time.
Julie A. Neer, SEDAR Coordinator; (843) 571-4366; email:
The meeting notice published on March 26, 2025 (90 FR 13734). This announces that the meeting is cancelled and will be rescheduled at a later date.
On January 20, 2025, President Trump issued Executive Order 14172 to rename the Gulf of Mexico as the Gulf of America. Any reference to Gulf of America red snapper in SEDAR reports and other documents refers to the same species of red snapper listed in 50 CFR part 622, Appendix A, Table I (Gulf of Mexico Reef Fish).
National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of public meeting.
This notice sets forth the schedule and proposed agenda for a meeting of the Science Advisory Board (SAB). The members will discuss issues outlined in the section on Matters to be considered.
The meeting date is April 29, 2025. The meeting is scheduled on April 29, 2025 from 10:00 a.m. to 5:00 p.m. Eastern Daylight Time (EDT). The time and the agenda topics described below are subject to change. For the latest agenda please refer to the SAB website:
This meeting will be held virtually. The link for the webinar registration will be posted, when available, on the SAB website:
Casey Stewart, Executive Director, SSMC3, Room 11360, 1315 East-West Hwy., Silver Spring, MD 20910; Phone Number: 240-381-0833; Email:
The NOAA Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.
Office of Career, Technical, and Adult Education (OCTAE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before June 9, 2025.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Adam Flynn-Tabloff, (202) 245-7405.
The Department, 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 Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Career, Technical, and Adult Education (OCTAE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before June 9, 2025.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Adam Flynn-Tabloff, (202) 245-7405.
The Department, 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 Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
U.S. Department of Energy.
Notice of request for comments.
The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request with the Office of Management and Budget (OMB).
Comments regarding this proposed information collection must be received on or before June 9, 2025. If you anticipate any difficulty in submitting comments within that period, contact the person listed in the
Written comments may be sent to Beth Kelly, Deputy Assistant General Counsel, by email at
Beth Kelly, Deputy Assistant General Counsel, (202) 246-6500, or
Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
This information collection request contains:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
This document of the Department of Energy was signed on April 3, 2025, by David R. Taggart, Acting General Counsel, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following 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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organizations, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental document that will discuss the environmental impacts of the Cape Cod Canal Bridge Relocation Project involving construction and operation of facilities by Algonquin Transmission, LLC (Algonquin) in Barnstable County, Massachusetts. The Commission will use this environmental document in its decision-making process to determine whether the project is in the public convenience and necessity.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies regarding the project. As part of the National Environmental Policy Act (NEPA) review process, the Commission takes into account concerns the public may have about proposals and the environmental impacts that could result from its action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. This gathering of public input is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the environmental document on the important environmental issues. Additional information about the Commission's NEPA process is described below in the
By this notice, the Commission requests public comments on the scope of issues to address in the environmental document. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC, on or before 5:00 p.m. Eastern Time on May 5, 2025. 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 impacts. Your input will help the Commission staff determine what issues they need to evaluate in the environmental document. Commission staff will consider all written or oral comments during the preparation of the environmental document.
If you submitted comments on this project to the Commission
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 planned 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 planned facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the project, the Natural Gas Act conveys the right of eminent domain to the company. Therefore, if you and the
A fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” 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
(2) You can file your comments electronically by using the eFiling feature, which is located on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the Commission. Be sure to reference the project docket number (PF25-4-000) 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.
(4) In lieu of sending written comments, the Commission invites you to attend the public scoping session 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.
The scoping session is scheduled from 6:00 p.m. to 8:00 p.m. Eastern Time. You may arrive at any time after 6:00 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 8:00 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 7:30 p.m. Please see appendix 1 for additional information on the session format and conduct.
Your scoping 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.
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. 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. Representatives from Algonquin will also be present to answer project-specific questions.
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
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organizations, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Algonquin plans to modify its existing interstate natural gas pipeline system facilities within the Town of Bourne, Barnstable County, Massachusetts, to accommodate the planned replacement of the Bourne Bridge and Sagamore Bridge by the Cape Cod Canal Bridges
The Cape Cod Canal Bridge Relocation Project (Project) would consist of the following facilities and activities:
• removal/relocation of approximately 1.14 miles of existing 8-inch- and 18-inch-diameter pipelines adjacent to the existing Sagamore and Bourne Bridges;
• removal and relocation of two existing mainland meter and regulating (M&R) stations—Sagamore and Bourne;
• installation of two new M&R stations—Pave Paws Road and Bourne Rotary; and
• installation approximately 3.4 miles of 16-inch-diameter and approximately 2.2 miles of 18-inch-diameter pipeline to replace National Grid's existing pipelines currently attached to the existing Bourne and Sagamore Bridges.
The general location of the project facilities is shown in appendix 2.
Construction of the planned facilities would disturb about 73 acres of land for the aboveground facilities and the pipeline. Following construction, Algonquin would maintain about 21 acres for permanent operation of the project's facilities; the remaining acreage would be restored and revert to former uses. Algonquin is designing the Project pipeline facilities with collocation with existing utility and road rights-of-way as a primary siting factor.
Any environmental document issued by Commission staff will discuss impacts that could occur as a result of the construction and operation of the planned 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;
• air quality and noise; and
• reliability and safety.
Commission staff will also evaluate reasonable alternatives to the planned project or portions of the project and make recommendations on how to lessen or avoid impacts on the various resource areas. Your comments will help Commission staff identify and focus on the issues that might have an effect on the human environment and potentially eliminate others from further study and discussion in the environmental document.
Although no formal application has been filed, Commission staff have already initiated a NEPA review under the Commission's pre-filing process. The purpose of the pre-filing process is to encourage early involvement of interested stakeholders and to identify and resolve issues before the Commission receives an application. As part of the pre-filing review, Commission staff will contact federal and state agencies to discuss their involvement in the scoping process and the preparation of the environmental document.
If a formal application is filed, Commission staff will then 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 environmental 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 related to this project to formally cooperate in the preparation of the environmental document.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is using this notice to initiate consultation with the applicable State Historic Preservation Office(s), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. 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
(1) Send an email to
(2) Return the attached “Mailing List Update Form” (appendix 3).
Once Algonquin files its application with the Commission, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Only intervenors have the right to seek rehearing of the Commission's decision and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214). Motions to intervene are more fully described at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
Public sessions or site visits will be posted on the Commission's calendar located at
Notice is hereby given that, on April 2, 2025, the eXtensible Business Reporting Language (XBRL) taxonomies, validation rules, and rendering files needed to file the 2024 FERC Form No. 60
This notice does not change any details regarding the implementation of Version 2025-04-01 taxonomies, validation rules, and rendering files for FERC Form Nos. 1, 1-F, 2, 2-A, 3-Q electric, 3-Q natural gas, 6, 6-Q and 714, which are currently available for download in the eForms portal's Taxonomy History page at
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
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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organizations, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
On March 3, 2025, Southern California Edison Company (transferor) and Lower Tule Hydro, LLC (transferee) filed an application for a transfer of license of the 2.52-megawatt Lower Tule River Hydroelectric Project No. 372. The project is located on the Middle Fork Tuolumne River in Tulare County, California and occupies federal land within the Sequoia National Forest administered by the U.S. Forest Service.
Pursuant to 16 U.S.C. 801, the applicants seek Commission approval to transfer the license for the project from Southern California Edison Company to Lower Tule Hydro, LLC. The transferee will be required by the Commission to comply with all the requirements of the license as though it were the original licensee.
(For transferee) Ted S. Sorenson, PE, Sorenson Engineering, Inc., 711 E Turtle Point Drive, Ivins, UT 84738, (208) 589-6908,
In lieu of electronic filing, you may submit a paper copy. Submissions sent via 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, Maryland 20852. The first page of any filing should include docket number P-372-101. Comments emailed to Commission staff are not considered part of the Commission record.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organizations, Tribal members, and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
As announced in the February 20, 2025 Notice in this proceeding, the Federal Energy Regulatory Commission (Commission) will convene a Commissioner-led technical conference in the above-referenced proceeding. The two-day technical conference will take place from 9:00 a.m. to 4:00 p.m. Eastern Time on Wednesday, June 4, 2025, and Thursday, June 5, 2025, in the Kevin J. McIntyre Commission Meeting Room at the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The purpose of this technical conference is to discuss generic issues related to resource adequacy constructs, including the roles of capacity markets in the Regional Transmission Organization (RTO)/Independent System Operator (ISO) regions that utilize them and alternative constructs in RTO/ISO regions without capacity markets. The conference will start with a panel discussion on resource
The Commission does not intend to discuss at this technical conference any specific proceeding pending before the Commission. The Commission will issue a further supplemental notice before the technical conference that will include a list of related proceedings that are pending before the Commission at the time of the technical conference and any revisions to the attached agenda.
All panelists must submit pre-filed statements outlining their views on the topics of the technical conference, which may address some or all of the questions associated with their panel that are most pertinent to them, and may also address related issues. Panelists must submit a pre-filed statement no later than Friday, May 16, 2025. Commission staff will post these statements on the FERC technical conference web page prior to the conference and in eLibrary. With the exception of opening statements on Panel 1, which may be delivered orally, all other panels will proceed immediately to questions from the Chairman and Commissioners.
All interested persons are invited to file pre-technical conference comments in eLibrary on the issues of the conference, including the questions listed in the attached agenda. Commenters need not answer all the questions but are encouraged to organize responses using the numbering and sequencing in the attached agenda.
The technical conference will be open to the public. Advance registration is not required, and there is no fee for attendance. Information will also be posted on the Calendar of Events on the Commission's website,
The technical conference will be transcribed and webcast. Transcripts will be available for a fee from Ace Reporting (202-347-3700). A link to the webcast of this event will be available in the Commission Calendar of Events at
Commission technical conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
For more information about this technical conference, please contact Tim Bialecki at
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
i.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
j. The application is not ready for environmental analysis at this time.
k.
The project has not operated since 2006 and some of the facilities noted above are in a deteriorated condition. For instance, the license application states the project's crest gate and slide gate are both inoperable and in need of repair. Stone Ridge proposes to rehabilitate the project and operate it in a similar manner to the prior project at the site (FERC No. 9709); specifically, in a run-of-river mode, with a continuous minimum flow release of 160 cubic feet per second into West Canada Creek. Stone Ridge is currently conducting environmental studies to help it develop and finalize a set of proposed protection, mitigation, and enhancement (PM&E) measures to supplement the license application. Stone Ridge estimates the rehabilitated project would have an annual generation capacity of 6,500-7,000 megawatt-hours.
l. A copy of the application can be viewed on the Commission's website at
You may also register online at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organizations, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
m.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC) regulations, 18 CFR part 380, Commission staff reviewed Pacific Gas and Electric Company's (PG&E) application for an amendment to the license of the Battle Creek Hydroelectric Project No. 1121 to support a new Phase 2 of the Battle Creek Salmon and Steelhead Restoration Project (Restoration Project) and have prepared an Environmental Assessment (EA) for the proposed amendment.
The EA contains Commission staff's analysis of the potential environmental effects of not constructing the tailrace connector and any changes that have occurred since it was originally evaluated in a 2005 Environmental Impact Statement, and concludes that the proposed amendment, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
The EA may be viewed on the Commission's website at
You may also register online at
All comments must be filed by May 5, 2025.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, Tribal members, and others access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
For further information, contact Rebecca Martin at 202-502-6012 or
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before June 9, 2025. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
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
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than April 24, 2025.
1.
Board of Governors of the Federal Reserve System.
General Services Administration (GSA).
Notice; request for comments.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding the Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.
Submit comments on or before June 9, 2025.
Submit comments identified by Information Collection 3090-0297 via
Camille Tucker, Office of Governmentwide Policy, GSA, at 202-255-1648, or via email at
The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study.
This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance.
Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study.
Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) has determined that FLUMADINE (rimantadine hydrochloride) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Awo Archampong-Gray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-796-0110,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.
FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, is the subject of NDA 019649, held by Sun Pharmaceutical Industries Inc. (Sun Pharma), and initially approved on September 17, 1993. FLUMADINE is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older) and for prophylaxis against influenza A virus in children (1 year to 16 years of age).
In a letter dated November 27, 2023, Sun Pharma notified FDA that FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.
After reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, was not withdrawn from sale for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn for sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to FLUMADINE. Additional ANDAs that refer to FLUMADINE (rimantadine hydrochloride) tablet, 100 mg, may be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice; request for information; extension of comment period.
The Food and Drug Administration (FDA or we) is extending the comment period for a request for information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to
FDA is extending the comment period on the notice published January 15, 2025 (90 FR 3873). Either electronic or written comments on the notice must be submitted by June 16, 2025.
You may submit comments and information 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.” We will review this copy, including the claimed confidential information, in our 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
Jesse Lunzer, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2879.
In the
We have received requests for a 90-day extension of the comment period. In general, the requests explained that industry needed more time to collect, review, and summarize the information requested for the global supply chain.
We have considered the requests and are extending the comment period for an additional 60 days. We believe that this extension will allow adequate time for interested persons to submit comments.
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and
This notice is published in the
You may submit either electronic or written comments and information 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 below (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
Deborah Kim, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6349, Silver Spring, MD 20993-0002, 301-796-9053,
Section 511A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360a-2), as added by section 3044 of the Cures Act (Pub. L. 114-255), was signed into law on December 13, 2016. This provision clarified FDA's authority to identify and efficiently update susceptibility test interpretive criteria, including through the recognition by FDA of standards established by standards development organizations (SDOs). It also clarified that sponsors of antimicrobial susceptibility testing devices may rely on listed susceptibility test interpretive criteria to support premarket authorization of their devices, provided they meet certain conditions, which allows for a more streamlined process for incorporating up-to-date information into such devices.
In the
On March 1, 2018, FDA published a notice in the
At least every 6 months after the establishment of the Susceptibility Test Interpretive Criteria web page, FDA is
Once a year, FDA is required to compile the new notices published on the Susceptibility Test Interpretive Criteria web page, publish them in the
As of May 28, 2024, the following standards are no longer recognized: “Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing, 33rd ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2023.”
As of May 28, 2024, with certain exceptions, FDA recognizes the standard published in: “Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing, 34th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2024.”
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of May 9, 2025.
Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137,
The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of May 9, 2025. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved NDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on May 9, 2025 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Food and Drug Administration, HHS.
Notice of availability; reopening of the comment period.
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing the availability of a draft guidance for industry (GFI) that appeared in the
FDA is reopening the comment period on the notice of availability published January 7, 2025 (90 FR 1143). Submit either electronic or written comments by June 9, 2025 to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance.
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:
•
• 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
Lynne Boxer, Center for Veterinary Medicine, Food and Drug, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0611,
In the
The Agency received a request for a 60-day extension of the comment period for the draft guidance. The requestor indicated they needed more time to complete development of comments to submit in response to the draft guidance. FDA has considered the request and is reopening the comment period for the draft guidance for 60 days until June 9, 2025. The Agency believes that a 60-day reopening of the comment period allows adequate time for interested persons to submit comments to ensure that the agency can consider the comments on this draft guidance before it begins work on the final version of the guidance.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Helen Ryan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 301-796-1328,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
ETHYOL (amifostine) for injection, 500 mg/vial, is the subject of NDA 020221, held by Cosette Pharmaceuticals, Inc., and initially approved on December 8, 1995. ETHYOL is a cytoprotective agent indicated for reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ETHYOL is also indicated for reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.
ETHYOL (amifostine) for injection, 500 mg/vial, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.
Seacross Pharma USA, Inc. submitted a citizen petition dated November 5, 2024 (Docket No. FDA-2024-P-5232), under 21 CFR 10.30, requesting that the Agency determine whether ETHYOL (amifostine) for injection, 500 mg/vial, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that ETHYOL (amifostine) for injection, 500 mg/vial, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this drug product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ETHYOL (amifostine) for injection, 500 mg/vial, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list ETHYOL (amifostine) for injection, 500 mg/vial, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) has determined that DECADRON (dexamethasone sodium phosphate) solution/drops, equivalent to (EQ) 0.1 percent phosphate, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Michelle Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-402-0374,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
DECADRON (dexamethasone sodium phosphate) solution/drops, EQ 0.1 percent phosphate, is the subject of NDA 011984, held by Merck and Co., Inc., and initially approved on September 2, 1959. DECADRON is indicated for the treatment of the following conditions: Ophthalmic: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies; and Otic: Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
DECADRON (dexamethasone sodium phosphate) solution/drops, EQ 0.1 percent phosphate, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.
Odin Pharmaceuticals, LLC, submitted a citizen petition dated August 30, 2024 (Docket No. FDA-2024-P-4158), under 21 CFR 10.30, requesting that the Agency determine whether DECADRON (dexamethasone sodium phosphate) solution/drops, EQ 0.1 percent phosphate, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that DECADRON (dexamethasone sodium phosphate) solution/drops, EQ 0.1 percent phosphate, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that DECADRON (dexamethasone sodium phosphate) solution/drops, EQ 0.1 percent phosphate, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of DECADRON (dexamethasone sodium phosphate), solution/drops, EQ 0.1 percent phosphate, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list DECADRON (dexamethasone sodium phosphate) solution/drops, EQ 0.1 percent phosphate, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) has determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram (mg)/spray, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Helen Ryan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 301-796-1328,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, is the subject of NDA 021642, held by Endo Operations Ltd., and initially approved on January 31, 2005. NASCOBAL is a vitamin B12 indicated for vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement; treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia; and prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal.
In a letter dated July 26, 2024, Endo Operations Ltd. notified FDA that NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.
Robert van Osdel submitted a citizen petition dated September 7, 2024 (Docket No. FDA-2024-P-4293), under 21 CFR 10.30, requesting that the Agency determine whether NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this drug product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA or Agency) is exploring Clinical Data Interchange Standards Consortium (CDISC) Dataset-JavaScript Object Notation (Dataset-JSON) version 1.1 as a new exchange standard, with the long-term potential to replace Statistical Analysis System (SAS) version 5 XPORT Transport Format (XPT), for submission of electronic study data to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). FDA is requesting comments on whether to accept Dataset-JSON to exchange electronic study data as part of regulatory applications in the future. In particular, FDA is requesting feedback on the risks and benefits of industry adopting Dataset-JSON as a new exchange standard for submitting electronic study data to FDA and any integration challenges with existing tools and systems.
Either electronic or written comments must be submitted by June 9, 2025.
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
• 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
Chenoa Conley, Center for Drug Evaluation and Research, Food and Drug Administration,
In recent years, JSON has become a universal format within the global web and is the preferred choice for a variety of publicly available web services. While JSON is a standard for data exchange, Dataset-JSON is a JSON-based schema specifically designed for exchanging tabular datasets that is based on CDISC Dataset-JSON version 1.0 with enhancements, including smaller file sizes, additional metadata, and simpler processing. CDISC Dataset-JSON supports file and Application Programming Interface based data exchange, is widely supported across technologies, and can link to Define-XML for additional metadata.
In 2022, the Agency completed a high-level assessment on the costs and benefits of a potential transition to a modern data exchange format. Options evaluated included SAS version 8 XPT, Extensible Markup Language, and JSON. The assessment findings were based on a weighted evaluation of Agency requirements, which indicated JSON as the optimal modern format with the potential to serve as a replacement to SAS version 5 XPT. From September 2023 to April 2024, FDA collaborated with the CDISC and Pharmaceutical Users Software Exchange (PHUSE) to execute a pilot that tested the feasibility of using CDISC Dataset-JSON as a transport format for study data submitted with regulatory applications. The CDISC-PHUSE pilot results demonstrated that CDISC Dataset-JSON has the potential to serve as a transport file for study data. For additional information on the CDISC-PHUSE pilot titled “Dataset-JSON as an Alternative Transport Format for Regulatory Submissions: Final Pilot Report” can be found at:
JSON has become ubiquitous on the web and is the most commonly used format to represent Health Level Seven/Fast Healthcare Interoperability Resource, the standard specified for the use of electronic healthcare records by the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology.
Through this notice, FDA is requesting comments from industry on adoption risks and benefits and any integration challenges with existing tools and systems associated with the use of Dataset-JSON to exchange electronic study data as part of regulatory applications. A future transition to Dataset-JSON is being considered to improve the Agency's ability to receive and process regulatory submission information and ensure alignment with the FDA's Data Modernization Action Plan. More information about the FDA Data Modernization Action Plan can be found at:
If the Agency makes the decision to adopt Dataset-JSON as the new format for electronic submissions in the future, the Agency intends to do so in accordance with the final guidance titled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data” (available at:
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-796-3471,
In the
On page 3877, in the table, the entry for ANDA 209325 is removed.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) has determined that VIBRAMYCIN (doxycycline) for oral suspension, equivalent (EQ) 25 milligrams (mg) base/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Madeleine Giaquinto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 240-863-8976,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
VIBRAMYCIN (doxycycline) for oral suspension, EQ 25 mg base/5 mL, is the subject of NDA 050006, held by Pfizer Inc., and initially approved on December 6, 1967. VIBRAMYCIN is indicated for the treatment of infections as specified in its labeling.
VIBRAMYCIN (doxycycline) for oral suspension, EQ 25 mg base/5 mL, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.
Strides Pharma Inc., submitted a citizen petition dated January 8, 2025 (Docket No. FDA-2025-P-0100), under 21 CFR 10.30, requesting that the Agency determine whether VIBRAMYCIN (doxycycline) for oral suspension, EQ 25 mg base/5 mL, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that VIBRAMYCIN (doxycycline) for oral suspension, EQ 25 mg base/5 mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that VIBRAMYCIN (doxycycline) for oral suspension, EQ 25 mg base/5 mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of VIBRAMYCIN (doxycycline) for oral suspension, EQ 25 mg base/5 mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list VIBRAMYCIN (doxycycline) for oral suspension, EQ 25
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant and cooperative agreement applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism.
This will be a virtual meeting and will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to view the virtual meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast at the following link:
A portion of this meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Paulette S. Gray, Ph.D., Director, Division of Extramural Activities, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Room 7W444, Bethesda, MD 20892, (240) 276-6340,
Susan R.B. Weiss, Ph.D., Director, Division of Extramural Research, Office of the Director, National Institute on Drug Abuse, National Institutes of Health, Three White Flint North, Room 09D08, 1601 Landsdown Street, Bethesda, MD 20892, (301) 443-6480,
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, Topics in Neurobehavior, Neuropsychology and Neurodevelopment, April 29, 2025, 09:30 a.m. to April 30, 2025, 07:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the
This meeting is being amended to change the contact person from Sulagna Banerjee to Dario Dieguez, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892,
Notice is hereby given of a change in the meeting of the National Institute on Minority Health and Health Disparities Special Emphasis Panel, April 21, 2025, 8:00 a.m. to April 25, 2025, 10:00 p.m., National Institutes of Health, NIMHD, DEM II, Suite 800, 6707 Democracy Boulevard, Bethesda, MD, 20892 which was published in the
This meeting notice is being amended to change the meeting dates from April 21, 2025, 8:00 a.m. to April 25, 2025, 10:00 p.m. to June 23, 2025, 10:00 a.m.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Heart, Lung, and Blood Advisory Council.
The meeting will be held virtually and is open to the public as indicated below. Individuals who plan to attend the virtual meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be access from the NIH Videocasting and Podcase website
Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has procedures at
Information is also available on the Institute's/Center's home page:
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, Fellowships: Brain Disorders and Related Neurosciences, April 24, 2025, 9:30 a.m. to April 25, 2025, 7 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
This meeting is being amended to change the contact person from Sulanga Banerjee to Nilkantha Sen, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892,
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the National Human Genome Research Institute Special Emphasis Panel, April 22, 2025, 1 p.m. to April 22, 2025, 5 p.m., NHGRI, 6700B Rockledge Dr., Bethesda, MD 20817 which was published in the
Amend to change Scientific Review Officer due to staffing changes. The meeting is closed to the public.
Bureau of Reclamation, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Reclamation (Reclamation), are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before June 9, 2025.
Send your comments on this information collection request (ICR) by mail to Jessica Torrey, Supervisory Civil Engineer, Denver Federal Center, PO Box 25007, MS 86-68540, Denver, CO 80225; or by email to
To request additional information about this ICR, contact Jessica Torrey by email at
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
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.
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
National Archives and Records Administration (NARA).
Notice of proposed extension request.
We are proposing to request an extension from the Office of Management and Budget (OMB) of two currently approved information collections. The first information collection is used by former Federal civilian employees or other authorized individuals to request information from or copies of documents in Official Personnel Files (OPF) or Employee Medical Files (EMF). The second information collection is used to connect veterans and Schedule A-eligible applicants with an opportunity for noncompetitive employment. Information will be collected from people who are interested in these opportunities to consider them for the positions and match them with possible jobs. The collection includes approval of a form, NARA Employment Interest Questionnaire, NA Form 3102. We invite you to comment on these information collections up for renewal.
We must receive written comments on or before June 9, 2025.
Send comments to Paperwork Reduction Act Comments (MP), Room 4100; National Archives and Records Administration; 8601 Adelphi Road; College Park, MD 20740-6001, or email them to
Kellie Shipley, Paperwork Reduction Act Officer, by email at
Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), we invite the public and other Federal agencies to comment on proposed information collections. If you have comments or suggestions, they should address one or more of the following points: (a) whether the proposed information collection is necessary for NARA to properly perform its functions; (b) our estimate of the burden of the proposed information collection and its accuracy; (c) ways we could enhance the quality, utility, and clarity of the information we collect; (d) ways we could minimize the burden on respondents of collecting the information, including through information technology; and (e) whether the collection affects small businesses.
We will summarize any comments you submit and include the summary in our request for OMB approval. All comments will become a matter of public record.
In this notice, we solicit comments concerning the following information collections:
1.
2.
SPPC has developed a Resume Repository (retained in a spreadsheet) to store resumes of qualified individuals who may meet our hiring needs. The Repository helps our agency find highly motivated veterans and Schedule A candidates who are eager to demonstrate their abilities in the workplace through excepted service positions, which could become permanent positions after trial period requirements have been met.
We collect the information for the Repository through an online form, NARA Employment Interest Questionnaire, NA Form 3102, which includes the following information for each individual: Applicant name, email address, phone number, types of positions applicant is interested in (may be multiple areas of interest), applicant's desired location(s), and minimum starting grade level applicant is willing to accept.
We enter the collected information from the questionnaire into the Repository spreadsheet, which managers and supervisors can use to sort and filter by position(s) of interest and/or duty location. We include resumes and cover letters as a link beside each candidate's entry so managers can view them and consider the candidate when looking for an employee. Managers have unlimited access to the Repository information and resumes to select qualified applicants to fill vacancies through a direct, non-competitive hire.
The Schedule A and veterans recruitment questionnaire link will be listed in our agency's information on the OPM website, in information provided by other agencies and organizations with similar programs, and on various pages of our agency's website at
Candidates must be U.S. citizens, eligible veterans, or be eligible under the Schedule A hiring authority.
1:30 p.m., Monday, April 14, 2025.
via ZOOM.
Parts of this meeting will be open to the public. The rest of the meeting will be closed to the public.
Special Board of Directors meeting.
The General Counsel of the Corporation has certified that in her opinion, one or more of the exemptions set forth in the Government in the Sunshine Act, 5 U.S.C. 552b(c)(2) permit closure of the following portion(s) of this meeting:
Everything except the Executive (Closed) Session.
Executive (Closed) Session.
Jenna Sylvester, Paralegal, (202) 568-2560;
Nuclear Regulatory Commission.
Proposed state agreement; request for comment.
As required by section 274e. of the Atomic Energy Act of 1954, as amended (AEA), the U.S. Nuclear Regulatory Commission (NRC or Commission) is publishing the proposed Agreement for public comment (Appendix A). The NRC is also publishing the summary of a draft assessment by the NRC staff of the State of Connecticut's regulatory program. Comments are requested on the proposed Agreement and its effect on public health and safety. Comments are also requested on the draft staff assessment, the adequacy of the State of Connecticut's program, and the adequacy of the staffing of the State's program, as discussed in this document.
Submit comments by April 18, 2025. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Duncan White, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-2598; email:
Please refer to Docket ID NRC-2025-0010 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
•
•
•
The NRC encourages electronic comment submission through the Federal rulemaking website (
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
By letter dated October 31, 2024, Governor Ned Lamont of the State of Connecticut requested that the U.S. Nuclear Regulatory Commission (NRC or Commission) enter into an Agreement with the State of Connecticut as authorized by Section 274b. of the Atomic Energy Act of 1954, as amended (AEA). Under the proposed Agreement, the Commission would discontinue, and the State of Connecticut would assume, regulatory authority over certain types of byproduct materials as defined in the AEA, source material, and special nuclear material in quantities not sufficient to form a critical mass.
Under the proposed Agreement, the NRC would discontinue its authority over 104 licenses and would transfer its regulatory authority over those licenses to the State of Connecticut. The NRC periodically reviews the performance of the Agreement States to assure compliance with the provisions of Section 274.
Section 274e. of the AEA requires that the terms of the proposed Agreement be published in the
(a) Section 274b. of the AEA provides the mechanism for a State to assume regulatory authority from the NRC over certain radioactive materials and activities that involve use of these materials. The radioactive materials, sometimes referred to as “Agreement materials,” are byproduct materials as defined in Sections 11e.(1), 11e.(2), 11e.(3), and 11e.(4) of the AEA; source material as defined in Section 11z. of the AEA; and special nuclear material as defined in Section 11aa. of the AEA, restricted to quantities not sufficient to form a critical mass.
The radioactive materials and activities (which together are usually referred to as the “categories of materials”) that the State of Connecticut requests authority over are:
1. The possession and use of byproduct material as defined in Section 11e.(1) of the Act;
2. The possession and use of byproduct material as defined in Section 11e.(3) of the Act;
3. The possession and use of byproduct material as defined in Section 11e.(4) of the Act;
4. The possession and use of source material; and
5. The possession and use of special nuclear material, in quantities not sufficient to form a critical mass.
(b) The proposed Agreement contains articles that:
(i) Specify the materials and activities over which authority is transferred;
(ii) Specify the materials and activities over which the Commission will retain regulatory authority;
(iii) Continue the authority of the Commission to safeguard special nuclear material, protect restricted data, and protect common defense and security;
(iv) Commit the State of Connecticut and the NRC to exchange information as necessary to maintain coordinated and compatible programs;
(v) Provide for the reciprocal recognition of licenses;
(vi) Provide for the suspension or termination of the Agreement; and
(vii) Specify the effective date of the proposed Agreement.
The Commission reserves the option to modify the terms of the proposed Agreement in response to comments, to correct errors, and to make editorial changes. The final text of the proposed Agreement, with the effective date, will be published after the Agreement is approved by the Commission and signed by the NRC Chairman and the Governor of Connecticut.
(c) The regulatory program is authorized by law under the Connecticut General Statutes (Conn. Gen. Stat.) Title 22a, Chapter 446a, Section 22a-152 (§ 22a-152), which provides the Governor with the authority to enter into an Agreement with the Commission. The State of Connecticut law contains provisions for the orderly transfer of regulatory authority over affected licenses from the NRC to the State. In a letter dated October 31, 2024, Governor Lamont certified that the State of Connecticut has a program for the control of radiation hazards that is adequate to protect public health and safety within the State of Connecticut for the materials and activities specified in the proposed Agreement, and that the State desires to assume regulatory responsibility for these materials and activities. After the effective date of the Agreement, licenses issued by the NRC would continue in effect as State of Connecticut licenses until the licenses expire or are replaced by State-issued licenses.
(d) The draft staff assessment finds that the Connecticut Department of Energy and Environmental Protection's Radioactive Materials Program is adequate to protect public health and safety and is compatible with the NRC's regulatory program for the regulation of Agreement materials.
The NRC staff has examined the State of Connecticut's request for an Agreement with respect to the ability of the State's radiation control program to regulate Agreement materials. The examination was based on the Commission's Policy Statement, “Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement,” (46 FR 7540, January 23, 1981, as amended by Policy Statements published at 46 FR 36969, July 16, 1981, and at 48 FR 33376, July 21, 1983) (Policy Statement), and the Office of Nuclear Material Safety and Safeguards Procedure SA-700, “Processing an Agreement.” The Policy Statement has 28 criteria that serve as the basis for the NRC staff's assessment of the State of Connecticut's request for an Agreement. The following section will reference the appropriate criteria numbers from the Policy Statement that apply to each section.
(a)
The educational requirements for the Radioactive Materials Program staff are specified in the State of Connecticut's personnel position descriptions and meet the NRC criteria with respect to
The State of Connecticut performed an analysis of the expected workload under the proposed Agreement. Based on the NRC staff review of the State of Connecticut's analysis, the State has an adequate number of staff to regulate radioactive materials under the terms of the proposed Agreement. The State of Connecticut will employ the equivalent of four full-time equivalent professional and technical staff to support the Radioactive Materials Program.
The State of Connecticut has indicated that the Radioactive Materials Program has an adequate number of trained and qualified staff in place. The State of Connecticut has developed qualification procedures for license reviewers and inspectors that are similar to the NRC's procedures. The Radioactive Materials Program staff has accompanied the NRC staff on inspections of NRC licensees in Connecticut and participated in licensing training at NRC's Region I with Division of Radiological Safety and Security staff. The Radioactive Materials Program staff is also actively supplementing its experience through meetings, discussions, and facility visits with the NRC licensees in the State of Connecticut and through self-study, in-house training, and formal training.
Overall, the NRC staff concluded that the Radioactive Materials Program staff identified by the State of Connecticut to participate in the Agreement materials program has sufficient knowledge and experience in radiation protection, the use of radioactive materials, the standards for the evaluation of applications for licensing, and the techniques of inspecting licensed users of Agreement materials.
(b)
The NRC staff verified that the State of Connecticut adopted by reference the relevant NRC regulations in parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 61, 70, 71, and 150 of title 10 of the
(c)
(d)
(e)
(f)
(g)
(h)
(i)
The State of Connecticut also provides for “timely renewal.” This provision affords the continuance of licenses for which an application for renewal has been filed more than 30
The State of Connecticut regulations, in the Regulations of Connecticut State Agencies, Use and Control of Radioactive Materials; Civil Penalties, Sections 22a-153-1 to 22a-153-150, provide exemptions from the State's requirements for the NRC and the U.S. Department of Energy (DOE) contractors or subcontractors. The proposed Agreement commits the State of Connecticut to use its best efforts to cooperate with the NRC and the other Agreement States in the formulation of standards and regulatory programs for the protection against hazards of radiation, and to assure that the State's program will continue to be compatible with the Commission's program for the regulation of Agreement materials. The proposed Agreement specifies the desirability of reciprocal recognition of licenses and commits the Commission and the State of Connecticut to use their best efforts to accord such reciprocity. Consistent with NRC requirements, the State of Connecticut would be able to recognize the licenses of other jurisdictions by general license, as appropriate.
Section 274d. of the AEA provides that the Commission shall enter into an Agreement under Section 274b. with any State if:
(a) The Governor of that State certifies that the State has a program for the control of radiation hazards adequate to protect the public health and safety with respect to the Agreement materials within the State, and that the State desires to assume regulatory responsibility for the Agreement materials; and
(b) The Commission finds that the State program is in accordance with the requirements of Subsection 274o, and in all other respects compatible with the Commission's program for regulation of such materials, and that the State program is adequate to protect the public health and safety with respect to the materials covered by the proposed Agreement.
The NRC staff has reviewed the proposed Agreement, the certification of Connecticut Governor Lamont, and the supporting information provided by the Radioactive Materials Program of the Connecticut Department of Energy and Environmental Protection. Based upon this review, the NRC staff concludes that the State of Connecticut Radioactive Materials Program satisfies the Section 274d criteria as well as the criteria in the Commission's Policy Statement “Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement.” The NRC staff also concludes that the proposed State of Connecticut program to regulate Agreement materials, as comprised of statutes, regulations, procedures, and staffing, is compatible with the Commission's program and is adequate to protect the public health and safety with respect to the materials covered by the proposed Agreement. Therefore, the proposed Agreement meets the requirements of Section 274 of the AEA.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
For the Nuclear Regulatory Commission.
Subject to the exceptions provided in Articles II, IV, and V, the Commission shall discontinue, as of the effective date of this Agreement, the regulatory authority of the Commission in the State under Chapters 6, 7 and 8, and Section 161 of the Act with respect to the following materials:
A. Byproduct material as defined in Section 11e.(1) of the Act;
B. Byproduct material as defined in Section 11e.(3) of the Act;
C. Byproduct materials as defined in Section 11e.(4) of the Act;
D. Source materials; and
E. Special nuclear materials, in quantities not sufficient to form a critical mass.
This Agreement does not provide for the discontinuance of any authority, and the Commission shall retain authority and responsibility, with respect to:
A. The regulation of the construction, operation, and decommissioning of any production or utilization facility or any uranium enrichment facility;
B. The regulation of byproduct material as defined in Section 11e.(2) of the Act;
C. The regulation of the export from or import into the United States of byproduct, source, or special nuclear material, or of any production or utilization facility;
D. The regulation of the disposal into the ocean or sea of byproduct, source, or special nuclear material waste as defined in regulations or orders of the Commission;
E. The regulation of the disposal of such other byproduct, source, or special nuclear material as the Commission determines by regulation or order should, because of the hazards or potential hazards thereof, not be so disposed without a license from the Commission;
F. The evaluation of radiation safety information on sealed sources or devices containing byproduct, source, or special nuclear material and the registration of the sealed sources or devices for distribution, as provided for in regulations or orders of the Commission;
G. The regulation of activities not exempt from Commission regulation as stated in 10 CFR part 150; and
H. The regulation of the land disposal of byproduct, source, or special nuclear material received from other persons;
With the exception of those activities identified in Article II, paragraphs A., C. through E. and G., this Agreement may be amended, upon application by the State and approval by the Commission to include the additional areas specified in Article II, paragraphs B., F., and H., whereby the State may then exert regulatory authority and responsibility with respect to those activities.
Notwithstanding this Agreement, the Commission may from time to time by rule, regulation, or order, require that the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source, byproduct, or special nuclear material shall not transfer possession or control of such product except pursuant to a license or an exemption for licensing issued by the Commission.
This Agreement shall not affect the authority of the Commission under Subsection 161b. or 161i. of the Act to issue rules, regulations, or orders to promote the common defense and security, to protect restricted data, or to guard against the loss or diversion of special nuclear material.
The Commission will cooperate with the State and other Agreement States in the formulation of standards and regulatory programs of the State and the Commission for (a) protection against hazards of radiation; and (b) to assure that Commission and State programs for protection against the hazards of radiation are coordinated and compatible. The State agrees to cooperate with the Commission and other Agreement States in the formulation of standards and regulatory programs of the State and the Commission for: (a) protection against the hazards of radiation; and (b) to assure that the State's program will continue to be compatible with the program of the Commission for the regulation of materials covered by this Agreement.
The State and the Commission agree to keep each other informed of proposed changes in their respective rules and regulations, and to provide each other the opportunity for early and substantive contribution to the proposed changes.
The State and the Commission agree to keep each other informed of events, accidents, and licensee performance that may have generic implication or otherwise be of regulatory interest.
The Commission and the State agree that it is desirable to provide reciprocal recognition of licenses for the materials listed in Article I licensed by the other party or by any other Agreement State.
Accordingly, the Commission and the State agree to develop appropriate rules, regulations, and procedures by which reciprocity will be accorded.
The Commission, upon its own initiative after reasonable notice and opportunity for hearing to the State, or upon request of the Governor of Connecticut, may terminate or suspend all or part of this Agreement and reassert the licensing and regulatory authority vested in it under the Act, if the Commission finds that (1) such termination or suspension is required to protect the public health and safety, or (2) the State has not complied with one or more of the requirements of Section 274 of the Act. Pursuant to Section 274j. of the Act, the Commission may, after notifying the Governor, temporarily suspend all or part of this Agreement without notice or hearing if, in the judgment of the Commission, an emergency situation exists with respect to any material covered by this Agreement creating danger which requires immediate action to protect the health or safety of persons either within or outside of the State and the State has failed to take steps necessary to contain or eliminate the cause or danger within a reasonable time after the situation arose. The Commission shall periodically review actions taken by the State under this Agreement to ensure compliance with Section 274 of the Act which requires a State program to be adequate to protect the public health and safety with respect to the materials covered by this Agreement and to be compatible with the Commission's program.
This Agreement shall become effective on September 30, 2025, and shall remain in effect unless and until such time as it is terminated pursuant to Article VIII.
Executed at Hartford, Connecticut this [date] day of [month], 2025.
For the United States Nuclear Regulatory Commission.
For the State of Connecticut.
Nuclear Regulatory Commission.
Generic communications; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is announcing the availability of the latest version of NRC Form 3, “Notice to Employees.” The NRC Form 3 describes certain responsibilities and rights of employers and employees who engage in NRC-regulated activities, including how employees can report violations or other safety concerns directly to the NRC. Licensees are required by law to post the form at prominent locations at the workplace to permit workers to view it easily.
The revised form is available immediately.
Please refer to Docket ID NRC-2025-0035 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
•
•
•
Sandra Mendez, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-287-9426; email:
Paragraph 19.11(e)(1) of title 10 of the
A new version of NRC Form 3 was issued in September 2024, to make a correction to Region III's mailing address. To view the current version of NRC Form 3 (09/2024), please go to
For the Nuclear Regulatory Commission.
U.S. Office of Special Counsel (OSC).
Notice and request for public comment.
The U.S. Office of Special Counsel is seeking approval from the Office of Management and Budget (OMB) for the reinstatement of an expired information collection request (ICR) under the Paperwork Reduction Act (PRA). OSC is statutorily required to conduct an annual survey assessing the effectiveness of its operations, including the handling of Prohibited Personnel Practice (PPP) complaints, whistleblower disclosures, and enforcement efforts. The collection gathers feedback from individuals who have sought OSC's assistance.
Written comments must be received on or before June 9, 2025.
Submit written comments to:
Hnin Khaing, Senior Litigation Counsel, at (202) 804-7000 or via email at
OSC is an independent agency responsible for investigating allegations of prohibited personnel practices (PPPs) under 5 U.S.C. 2302(b), protecting whistleblowers, enforcing certain federal employment laws under titles 5 and 38 of the U.S. Code, and overseeing compliance with the Hatch Act regarding political activities. Pursuant to section 13 of Public Law 103-424 (1994) (5 U.S.C. 1212 note), OSC is required to conduct an annual survey to evaluate its services. Specifically, the survey must:
1. Determine whether individuals seeking OSC's assistance were fully informed of their rights;
2. Assess whether individuals achieved success either at OSC or the Merit Systems Protection Board (MSPB); and
3. Evaluate the level of satisfaction of individuals with the treatment received from OSC, regardless of the outcome.
This annual survey consists of four electronic questionnaires with up to 12 questions each, targeting individuals who have:
OSC publishes the survey results annually in its report to Congress. Prior annual reports are available at
To comply with statutory requirements, OSC must complete the review of survey responses before the end of fiscal year 2025. Timely data collection is essential to OSC's mission and reporting obligations to Congress.
OSC invites public comment on the following issues:
1. Whether the proposed collection of information is necessary for the proper performance of OSC's functions, including whether the information has practical utility;
2. The accuracy of OSC'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 or other forms of information technology.
U.S. Office of Special Counsel (OSC).
Notice of request for public comment.
In accordance with the Paperwork Reduction Act of 1995, the U.S. Office of Special Counsel is seeking public comment on an extension of a currently approved information collection activity for its Alternative Dispute Resolution (ADR) Program. The ADR Survey is distributed to participants following the conclusion of their ADR process and is used to assess program effectiveness and identify areas for improvement. The survey gathers feedback from mediation participants to help OSC improve the ADR process. Participation in the survey is voluntary, and responses are submitted anonymously.
Written comments must be received on June 9, 2025.
You may submit comments by any of the following methods:
•
•
Susan Ullman, Acting Associate Special Counsel, at (202) 804-7000 or via email 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). Section II also establishes comment deadline(s) pertaining to each such request.
The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.
Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review.
1.
2.
3.
4.
5.
None.
This Notice will be published in the
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Cboe BZX Exchange, Inc. (“BZX” or the “Exchange”) is filing with the Securities and Exchange Commission (“Commission” or “SEC”) a proposed rule change to list and trade shares of the Fidelity Solana Fund (the “Trust”),
The text of the proposed rule change is also available on the Exchange'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.
This Amendment No. 1 to SR-CboeBZX-2025-048 amends and replaces in its entirety the proposal as originally submitted on March 25, 2025. The Exchange submits this Amendment No. 1 in order to clarify certain points and add additional details to the proposal.
The Exchange proposes to list and trade the Shares under BZX Rule 14.11(e)(4),
Since 2017, the Commission has approved or disapproved exchange filings to list and trade series of Trust Issued Receipts, including spot-based Commodity-Based Trust Shares, on the basis of whether the listing exchange has in place a comprehensive surveillance sharing agreement with a regulated market of significant size related to the underlying commodity to be held (the “Winklevoss Test”).
The Commission recently issued orders granting approval for proposals to list bitcoin- and ether-based commodity trust shares and bitcoin-based, ether-based, and a combination of bitcoin- and ether-based trust issued receipts (these funds are substantively identical to the Trust, but hold bitcoin and/or ether, respectively, instead of Solana (also referred to as “SOL”)) (“Spot Bitcoin ETPs” and “Spot ETH ETPs”). In both the Spot Bitcoin ETP Approval Order and Spot ETH ETP Approval Order, the Commission found that sufficient “other means” of preventing fraud and manipulation had been demonstrated that justified dispensing with a surveillance-sharing agreement. Specifically, the Commission found that while the Chicago Mercantile Exchange (“CME”) futures markets for both bitcoin and ether were not of “significant size” related to their respective spot markets, the Exchange demonstrated that other means could be reasonably expected to assist in surveilling for fraudulent and manipulative acts and practices in the specific context of the proposals.
As further discussed below, both the Exchange and the Sponsor believe that this proposal and the included analysis are sufficient to establish that the proposal is consistent with the Act itself and, additionally, that there are sufficient “other means” of preventing fraud and manipulation that warrant dispensing of the surveillance-sharing agreement with a regulated market of significant size, as was done with both Spot Bitcoin ETPs and Spot ETH ETPs, and that this proposal should be approved.
SOL is a digital asset that is created and transmitted through the operations of the peer-to-peer Solana Network, a decentralized network of computers that operates on cryptographic protocols. No single entity is known to own or operate the Solana Network, the infrastructure of which is understood to be collectively maintained by a decentralized user base. The Solana Network allows people to exchange tokens of value, called SOL, which are recorded on a public transaction ledger known as a blockchain. SOL can be used to pay for goods and services, including computational power on the Solana Network, or it can be converted to fiat currencies, such as the U.S. dollar, at rates determined on Digital Asset Trading Platforms or in individual end-user-to-end-user transactions. Furthermore, the Solana Network was designed to allow users to write and implement smart contracts—that is, general-purpose code that executes on every computer in the network and can instruct the transmission of information and value based on a sophisticated set of logical conditions. Using smart contracts, users can create markets, store registries of debts or promises, represent the ownership of property, move funds in accordance with conditional instructions and create digital assets other than SOL on the Solana Network. Smart contract operations are executed on the Solana blockchain in exchange for payment of SOL. Like the Ethereum network, the Solana Network is one of a number of projects intended to expand blockchain use beyond just a peer-to-peer money system.
The Solana protocol introduced the Proof-of-History (“PoH”) timestamping mechanism. PoH automatically orders on-chain transactions by creating a historical record that proves an event has occurred at a specific moment in time. PoH is intended to provide a transaction processing speed and capacity advantage over other blockchain networks like Bitcoin and Ethereum, which rely on sequential production of blocks and can lead to delays caused by validator confirmations.
In addition to the PoH mechanism described above, the Solana Network uses a proof-of-stake consensus mechanism to incentivize SOL holders to validate transactions. Unlike proof-of-work, in which miners expend computational resources to compete to validate transactions and are rewarded coins in proportion to the amount of computational resources expended, in proof-of-stake, validators “stake” coins to compete to be randomly selected to validate transactions and are rewarded coins in proportion to the amount of coins staked. Certain malicious activity may result in the forfeiture or “slashing” of a portion of the staked coins. Proof-of-stake is viewed as more
As noted above, this proposal is to list and trade shares of the Trust that would hold spot Solana and, as described below, cause the Trust to stake a portion of its SOL.
The Commission has approved numerous series of Trust Issued Receipts,
More recently, the Commission has applied the Winklevoss Test while also recognizing that the “regulated market of significant size” standard is not the only means for satisfying Section 6(b)(5) of the Act, specifically providing that a listing exchange could demonstrate that “other means to prevent fraudulent and manipulative acts and practices” are sufficient to justify dispensing with the requisite surveillance-sharing agreement.
Over the past several years, U.S. investor exposure to SOL, through over-the-counter funds that invest in SOL (“OTC SOL Funds”) and digital asset trading platforms, has grown into billions of dollars with a fully diluted market cap averaging greater than $90 billion over the last 180 days. The Exchange believes that approving this proposal (and comparable proposals) provides the Commission with the opportunity to allow U.S. investors with access to SOL in a regulated and transparent exchange-traded vehicle that would act to limit risk to U.S. investors by: (i) reducing premium and discount volatility; (ii) reducing management fees through meaningful competition; and (iii) providing an alternative to self-custodying SOL.
The policy concerns that the Exchange Act is designed to address are also otherwise mitigated by the size of the market for the underlying reference asset (averaging greater than $90 billion fully diluted value over the last 180 days). The trading volumes of SOL to USD and SOL to USD-stablecoin pairs trade an average daily volume of approximately $2 billion across six leading cryptocurrency trading platforms by volume—Coinbase,
Further, SOL is arguably less susceptible to manipulation than other commodities that underlie ETPs; there may be inside information relating to the supply of the physical commodity such as the discovery of new sources of supply or significant disruptions at mining facilities that supply the commodity that simply are inapplicable as it relates to certain crypto assets, including SOL. Further, the Exchange believes that the fragmentation across SOL trading platforms and increased adoption of SOL, as displayed through increased user engagement and trading volumes, and the Solana Network make manipulation of SOL prices through continuous trading activity unlikely. Moreover, the linkage between the SOL markets and the presence of arbitrageurs in those markets means that the manipulation of the price of SOL price on any single venue would require manipulation of the global SOL price in order to be effective. Arbitrageurs must have funds distributed across multiple SOL trading platforms in order to take advantage of temporary price dislocations, thereby making it unlikely that there will be strong concentration of funds on any particular SOL trading platform. As a result, the potential for manipulation on a particular SOL trading platform would require overcoming the liquidity supply of such arbitrageurs who are effectively eliminating any cross-market pricing differences. For all of these reasons, SOL is not particularly susceptible to manipulation, especially as compared to other approved ETP reference assets.
CSC Delaware Trust Company is the trustee (“Trustee”). The Trust will engage Fidelity Service Company, Inc. (“FSC”), a Sponsor affiliate, to be the administrator (“Administrator”). The transfer agent (“Transfer Agent”) will
According to the Registration Statement, each Share will represent a fractional undivided beneficial interest in and ownership of the Trust. The Trust's assets will only consist of SOL, cash, and cash equivalents.
According to the Registration Statement, the Trust will be neither an investment company registered under the Investment Company Act of 1940, as amended,
The Sponsor may stake, or cause to be staked, all or a portion of the Trust's SOL through one or more trusted staking providers (“Staking Providers”). In consideration for any staking activity in which the Trust may engage, the Trust would receive all or a portion of the staking rewards generated through staking activities, which may be treated as income to the Trust. The Trust will not acquire and will disclaim any incidental right (“IR”) or IR asset received, for example as a result of forks or airdrops, and such assets will not be taken into account for purposes of determining NAV.
When the Trust creates or redeems its Shares, it will do so in cash or in-kind. In connection with cash creations and cash redemptions, the authorized participants will submit orders to create or redeem Baskets of Shares in exchange for cash. When the Trust creates or redeems its Shares in cash, it will do so in transactions in blocks of Shares that are based on the quantity of SOL attributable to each Share of the Trust (
According to the Registration Statement and as further described below, the Trust's investment objective is to seek to track the performance of SOL, as measured by the performance of the Fidelity Solana Reference Rate (the “Index”), adjusted for the Trust's expenses and other liabilities. In seeking to achieve its investment objective, the Trust will hold SOL and will value its Shares daily as of 4:00 p.m. ET using the same methodology used to calculate the Index. All of the Trust's SOL will be held by the Custodian(s).
As described in the Registration Statement, The Trust will use the Index to calculate the Trust's NAV. The Trust will determine the SOL Index price and value its Shares daily based on the value of SOL as reflected by the Index. The Index will be calculated daily and aggregates the notional value of SOL trading across major SOL spot trading platforms.
NAV means the total assets of the Trust (which includes all SOL and cash and cash equivalents) less total liabilities of the Trust. The Administrator determines the NAV of the Trust on each day that the Exchange is open for regular trading, as promptly as practical after 4:00 p.m. ET based on the closing value of the Index. The NAV of the Trust is the aggregate value of the Trust's assets less its estimated accrued but unpaid liabilities (which include accrued expenses). In determining the NAV, the Administrator values the SOL held by the Trust based on the closing value of the Index as of 4:00 p.m. ET. The Administrator also determines the NAV per Share. The NAV for the Trust will be calculated by the Administrator once a day and will be disseminated daily to all market participants at the same time.
In addition to the price transparency of the Index, the Trust will provide information regarding the Trust's SOL holdings as well as additional data regarding the Trust. The website for the Trust, which will be publicly accessible at no charge, will contain the following information: (a) the current NAV per Share daily and the prior business day's NAV per Share and the reported BZX
The Intraday Indicative Value (“IIV”) will be updated during Regular Trading Hours to reflect changes in the value of the Trust's SOL holdings during the trading day. The IIV disseminated during Regular Trading Hours should not be viewed as an actual real-time update of the NAV, which will be calculated only once at the end of each trading day. The IIV may differ from the NAV because NAV is calculated, using the closing value of the Index, once a day at 4:00 p.m. ET, whereas the IIV draws prices from the last trade on each constituent platform in an effort to produce a relevant, real-time price). The Trust will provide an IIV per Share updated every 15 seconds, as calculated by the Exchange or a third-party financial data provider during the Exchange's Regular Trading Hours (9:30 a.m. to 4:00 p.m. ET). The IIV will be widely disseminated on a per Share basis every 15 seconds during the Exchange's Regular Trading Hours through the facilities of the CTA and Consolidated Quotation System (CQS) high speed lines. In addition, the IIV will be available through on-line information services, such as Bloomberg and Reuters.
The price of SOL will be made available by one or more major market data vendors, updated at least every 15 seconds during Regular Trading Hours.
As noted above, the Index is calculated every 15 seconds and information about the Index and Index value, including index data and key elements of how the Index is calculated, will be publicly available at
Quotation and last sale information for SOL is widely disseminated through a variety of major market data vendors, including Bloomberg and Reuters. Information relating to trading, including price and volume information, in SOL is available from major market data vendors and from the trading platforms on which SOL are traded. Depth of book information is also available from SOL trading platforms. The normal trading hours for SOL trading platforms are 24 hours per day, 365 days per year.
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's BZX Official Closing Price and trading volume information for the Shares will be published daily in the financial section of newspapers. Quotation and last-sale information regarding the Shares will be disseminated through the facilities of the CTA.
The Custodian's services (i) allow SOL to be deposited from a public blockchain address to the Trust's SOL account, (ii) allow SOL to be withdrawn from the SOL account to a public blockchain address as instructed by the Trust, and (iii) allow SOL to be staked. The custody agreement requires the Custodian to hold the Trust's SOL in cold storage, unless required to facilitate withdrawals as a temporary measure. The Custodian will use segregated cold storage SOL addresses for the Trust which are separate from the SOL addresses that the Custodian uses for its other customers and which are directly verifiable via the SOL blockchain. The Custodian will safeguard the private keys to the SOL associated with the Trust's SOL account. The Custodian will at all times record and identify in its books and records that such SOL constitutes the property of the Trust. The Custodian will not withdraw the Trust's SOL from the Trust's account with the Custodian, or loan, hypothecate, pledge or otherwise encumber the Trust's SOL, without the Trust's instruction. The Sponsor may appoint an additional or replacement custodian and the Trust may enter into a custodian agreement with such custodian.
The Shares will be subject to BZX Rule 14.11(e)(4), which sets forth the initial and continued listing criteria applicable to Commodity-Based Trust Shares. The Exchange represents that, for initial and continued listing, the Trust must be in compliance with Rule 10A-3 under the Act. A minimum of 100,000 Shares will be outstanding at the commencement of listing on the Exchange. The Exchange will obtain a representation that the NAV will be calculated daily and that the NAV and information about the assets of the Trust will be made available to all market participants at the same time. The Exchange notes that, as defined in Rule 14.11(e)(4)(C)(i), the Shares will be: (a) issued by a trust that holds (1) a specified commodity
Upon termination of the Trust, the Shares will be removed from listing. The Trustee, CSC Delaware Trust Company, is a trust company having substantial capital and surplus and the experience and facilities for handling corporate trust business, as required under Rule 14.11(e)(4)(E)(iv)(a) and that no change will be made to the trustee without prior notice to and approval of the Exchange. The Exchange also notes that, pursuant to Rule 14.11(e)(4)(F), neither the Exchange nor any agent of the Exchange shall have any liability for damages, claims, losses or expenses caused by any errors, omissions or delays in calculating or disseminating any underlying commodity value, the current value of the underlying commodity required to be deposited to the Trust in connection with issuance of Commodity-Based Trust Shares; resulting from any negligent act or omission by the Exchange, or any agent of the Exchange, or any act, condition or cause beyond the reasonable control of the Exchange, its agent, including, but not limited to, an act of God; fire; flood;
The Exchange is able to obtain information regarding trading in the Shares and the underlying SOL or any other SOL derivative through members acting as registered Market Makers, in connection with their proprietary or customer trades.
As a general matter, the Exchange has regulatory jurisdiction over its Members and their associated persons, which include any person or entity controlling a Member. To the extent the Exchange may be found to lack jurisdiction over a subsidiary or affiliate of a Member that does business only in commodities or futures contracts, the Exchange could obtain information regarding the activities of such subsidiary or affiliate through surveillance sharing agreements with regulatory organizations of which such subsidiary or affiliate is a member.
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares. The Exchange will halt trading in the Shares under the conditions specified in BZX Rule 11.18. Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) the extent to which trading is not occurring in the SOL underlying the Shares; or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. Trading in the Shares also will be subject to Rule 14.11(e)(4)(E)(ii), which sets forth circumstances under which trading in the Shares may be halted.
If the IIV or the value of the Index is not being disseminated as required, the Exchange may halt trading during the day in which the interruption to the dissemination of the IIV or the value of the Index occurs. If the interruption to the dissemination of the IIV or the value of the Index persists past the trading day in which it occurred, the Exchange will halt trading no later than the beginning of the trading day following the interruption.
In addition, if the Exchange becomes aware that the NAV with respect to the Shares is not disseminated to all market participants at the same time, it will halt trading in the Shares until such time as the NAV is available to all market participants.
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. BZX will allow trading in the Shares during all trading sessions on the Exchange. The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in BZX Rule 11.11(a) the minimum price variation for quoting and entry of orders in securities traded on the Exchange is $0.01 where the price is greater than $1.00 per share or $0.0001 where the price is less than $1.00 per share. The Shares of the Trust will conform to the initial and continued listing criteria set forth in BZX Rule 14.11(e)(4).
The Exchange represents that its surveillance procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Commodity-Based Trust Shares. FINRA conducts certain cross-market surveillances on behalf of the Exchange pursuant to a regulatory services agreement. The Exchange is responsible for FINRA's performance under this regulatory services agreement.
The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares or any other SOL derivative with other markets and other entities that are members of the ISG, and the Exchange, or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading in the Shares or any other SOL derivative from such markets and other entities.
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
The Sponsor has represented to the Exchange that it will advise the Exchange of any failure by the Trust or the Shares to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Exchange Act, the Exchange will surveil for compliance with the continued listing requirements. If the Trust or the Shares are not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under Exchange Rule 14.12.
Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (i) the procedures for the creation and redemption of Creation Baskets (and that the Shares are not individually redeemable); (ii) BZX Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the
In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Shares. Members purchasing the Shares for resale to investors will deliver a prospectus to such investors. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
The Exchange believes that the proposal is consistent with Section 6(b) of the Act
The Commission has approved numerous series of Trust Issued Receipts,
More recently, the Commission has applied the Winklevoss Test while also recognizing that the “regulated market of significant size” standard is not the only means for satisfying Section 6(b)(5) of the Act. In the specifically providing that a listing exchange could demonstrate that “other means to prevent fraudulent and manipulative acts and practices” are sufficient to justify dispensing with the requisite surveillance-sharing agreement.
The Exchange believes that the proposal is designed to protect investors and the public interest. Over the past several years, U.S. investor exposure to SOL has grown into the billions of dollars, mostly through transactions in spot SOL on digital asset trading platforms. The Exchange believes that approving this proposal (and comparable proposals) provides the Commission with the opportunity to allow U.S. investors with access to SOL in a regulated and transparent exchange-traded vehicle that would act to limit risk to U.S. investors by: (i) reducing premium and discount volatility; (ii) reducing management fees through meaningful competition; and (iii) providing an alternative to custodying SOL.
The policy concerns that the Exchange Act is designed to address are also otherwise mitigated by the fact that the size of the market for the underlying reference asset (averaging greater than $90 billion fully diluted value over the last 180 days). The geographically diverse and continuous nature of SOL trading makes it difficult and prohibitively costly to manipulate the price of SOL and, in many instances, the SOL market can be less susceptible to manipulation than the equity, fixed income, and commodity futures markets. There are a number of reasons this is the case, including that there is not inside information about revenue, earnings, corporate activities, or sources of supply; manipulation of the price on any single venue would require manipulation of the global SOL price in order to be effective; a substantial over-the-counter market provides liquidity and shock-absorbing capacity; the SOL market's 24/7/365 nature provides constant arbitrage opportunities across all trading venues; and it is unlikely that any one actor could obtain a dominant market share.
Further, SOL is arguably less susceptible to manipulation than other commodities that underlie ETPs; there may be inside information relating to the supply of the physical commodity such as the discovery of new sources of supply or significant disruptions at mining facilities that supply the commodity that simply are inapplicable as it relates to bitcoin. Further, the Exchange believes that the fragmentation across SOL trading platforms, the relatively slow speed of transactions, and the capital necessary to maintain a significant presence on each trading platform make manipulation of SOL prices through
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed on the Exchange pursuant to the initial and continued listing criteria in Exchange Rule 14.11(e)(4). The Exchange believes that its surveillance procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Commodity-Based Trust Shares. The Sponsor has represented to the Exchange that it will advise the Exchange of any failure by the Trust or the Shares to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Exchange Act, the Exchange will surveil for compliance with the continued listing requirements. If the Trust or the Shares are not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under Exchange Rule 14.12. The Exchange may obtain information regarding trading in the Shares and listed SOL derivatives via the ISG, from other exchanges who are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement.
In addition to the price transparency of the Index, the Trust will provide information regarding the Trust's SOL holdings as well as additional data regarding the Trust. The website for the Trust, which will be publicly accessible at no charge, will contain the following information: (a) the current NAV per Share daily and the prior business day's NAV per Share and the reported BZX Official Closing Price;
The IIV will be updated during Regular Trading Hours to reflect changes in the value of the Trust's SOL holdings during the trading day. The IIV may differ from the NAV because NAV is calculated, using the closing value of the Index, once a day at 4:00 p.m. ET whereas the IIV draws prices from the last trade on each constituent platform to produce a relevant, real-time price. The IIV disseminated during Regular Trading Hours should not be viewed as an actual real-time update of the NAV, which will be calculated only once at the end of each trading day. The Trust will provide an IIV per Share updated every 15 seconds, as calculated by the Exchange or a third-party financial data provider during the Exchange's Regular Trading Hours (9:30 a.m. to 4:00 p.m. ET). The IIV will be widely disseminated on a per Share basis every 15 seconds during the Exchange's Regular Trading Hours through the facilities of the CTA and CQS high speed lines. In addition, the IIV will be available through on-line information services such as Bloomberg and Reuters.
The price of SOL will be made available by one or more major market data vendors, updated at least every 15 seconds during Regular Trading Hours.
As noted above, the Index is calculated every 15 seconds and information about the Index and Index value, including index data and key elements of how the Index is calculated, will be publicly available at
Quotation and last sale information for SOL is widely disseminated through a variety of major market data vendors, including Bloomberg and Reuters. Information relating to trading, including price and volume information, in SOL is available from major market data vendors and from the trading platforms on which SOL are traded. Depth of book information is also available from SOL trading platforms. The normal trading hours for SOL trading platforms are 24 hours per day, 365 days per year.
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's BZX Official Closing Price and trading volume information for the Shares will be published daily in the financial section of newspapers. Quotation and last-sale information regarding the Shares will be disseminated through the facilities of the CTA.
In sum, the Exchange believes that this proposal is consistent with the requirements of Section 6(b)(5) of the Act, that on the whole the manipulation concerns previously articulated by the Commission are sufficiently mitigated to the point that they are outweighed by investor protection issues that would be resolved by approving this proposal.
The Exchange believes that the proposal is, in particular, designed to protect investors and the public interest. The investor protection issues for U.S. investors has grown significantly over the last several years, through premium/discount volatility and management fees for OTC SOL Funds. As discussed throughout, this growth investor protection concerns need to be re-evaluated and rebalanced with the prevention of fraudulent and manipulative acts and practices concerns that previous disapproval orders have relied upon.
For the above reasons, the Exchange believes that the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Act. The Exchange notes that the proposed rule change, rather will facilitate the listing and trading of an additional exchange-traded product that will enhance competition among both market participants and listing venues, to the benefit of investors and the marketplace.
The Exchange neither solicited nor received comments on the proposed rule change.
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.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change, as modified by Amendment No. 1, is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 25, 2024, the Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change SR-OCC-2024-010, pursuant to Section 19(b) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”)
On September 4, 2024, OCC partially amended the proposed rule change to include as Exhibit 2 an information memorandum OCC published on its website informing OCC's membership of the details of the margin add-on charge.
On January 8, 2025, OCC filed Amendment No. 2 to the proposed rule change to (1) incorporate certain modifications to address comments from industry participants, (2) conform the proposed rule change to the Commission's final rule amending the Covered Clearing Agency (“CCA”) Standards regarding intraday margin calls,
OCC is a central counterparty (“CCP”), which means that, as part of its function as a clearing agency, it interposes itself as the buyer to every seller and the seller to every buyer for certain financial transactions. As the CCP for the listed options markets in the United States,
At the start of each business day, OCC collects the required margin for each marginable account calculated by OCC's proprietary System for Theoretical Analysis and Numerical Simulation (“STANS”) based on the account's end-of-day positions from the previous business day. OCC also has broad authority to require additional margin deposits and to make intraday margin calls if, for example, the value of securities deposited as margin collateral does not accurately address changes in a Clearing Member's account during the business day,
Since these margin collection processes were established, OCC observed a significant increase in the volume of contracts it clears, particularly of short-dated option (“SDO”) contracts, including those traded on the day of their expiration (“zero-days-to-expiration” or “0DTE” options).
Apart from the increased exposure to risks from its Clearing Members' intraday trading activity posed by the proliferation of SDOs and 0DTE options, OCC's current margining system does not generate margin calls based on intraday position changes across other products more generally. OCC collects margin at the start of each business day using the STANS margin calculation,
To help address such credit risk exposure, OCC proposes to implement (1) a margin add-on charge (the “Intraday Risk Charge”); and (2) monitoring and escalation criteria to facilitate margin calls for any Clearing Member whose intraday activity exceeds certain thresholds (“Intraday Monitoring Thresholds”). The monitoring, escalation, and calculation of the Intraday Risk Charge would be conducted through OCC's current Watch Level surveillance system, which is governed by OCC's Third-Party Risk Management Framework.
OCC proposes to add OCC Rule 601(i) to its Rule Book to establish the Intraday Risk Charge. Rule 601(i)(1) would state that OCC may require a Clearing Member to deposit additional margin assets to mitigate any increased risk exposure to OCC that may not otherwise be covered by already calculated margin requirements. Additionally, under the proposed Rule 601(i)(1), OCC would be able to assess the Intraday Risk Charge as part of the Clearing Member's daily margin requirement, as needed, to mitigate exposure and cover uncollateralized risk resulting from intraday trading activities. Rule 601(i)(2) would state that the Intraday Risk Charge will generally be the average of the daily peak intraday risk increases from portfolio position changes measured between 11:00 a.m. Central Time and 12:30 p.m. Central Time over the preceding month determined pursuant to OCC's policies and procedures.
OCC also proposes to amend its Margin Policy and internal policies and procedures to further detail the calculation and application of the Intraday Risk Charge.
In OCC's view, a considerable limitation of its current monitoring system is that, because the STANS margin calculation is based on end-of-day positions and the current portfolio revaluation process only tracks price movements during the current trading session, the margin requirement may not account for overnight and intraday position changes, such as intraday SDOs and 0DTE options trading activity.
The Intraday Risk Charge, generally, would be calculated monthly based on the average of the previous month's daily peak intraday risk increases calculated from the 20-minute snapshots between 11:00 a.m. and 12:30 p.m. Central Time over the number of business days in the previous calendar month. The Intraday Risk Charge would be calculated on the first business day of the month and would be based on data and STANS outputs generated over the lookback period of the previous month. For example, a given Clearing Member's Intraday Risk Charge for the calendar month of March 2025 would be
The calculation of the peak intraday activity would capture all products that OCC clears, including SDOs and 0DTE options. The Intraday Risk Charge would apply to all margin accounts other than cross-margin accounts for OCC's cross-margining program with the Chicago Mercantile Exchange, which do not currently support intraday position feeds.
The Proposed Rule Change would authorize OCC to increase or decrease the amount of the Intraday Risk Charge for a particular Clearing Member under certain conditions. The Intraday Risk Charge could be increased following a member's business expansion. The Proposed Rule Change would also authorize OCC to increase the Intraday Risk Charge intramonth when OCC determines that OCC maintains insufficient margin resources to cover the pattern or distribution of risk increases over the previous lookback period. OCC's authority to decrease the amount of the charge would be limited to a Clearing Member's (i) business reduction, (ii) termination of account(s), (iii) transfer of positions to different account(s), or (iv) imposition of protective measures under OCC Rule 307B.
The Proposed Rule Change would describe material aspects of the Intraday Risk Charge more specifically by inserting a new section on the Intraday Risk Charge in OCC's Margin Policy. The new Intraday Risk Charge section would provide that, periodically throughout each trading day and during extended trading hours, OCC's systems measure the intraday exposure to each margin account for which intraday position information is available to identify intraday risk increases above the baseline STANS risk measurement. The Margin Policy would define “risk increases” in this context as results that show an increase to a portfolio's prior night calculated risk measurement based on the STANS expected shortfall and stress test components.
The Margin Policy would be amended to provide that, on at least a monthly basis, OCC's Financial Risk Management department (“FRM”) reviews and verifies the daily peak increases in the Intraday Risk Charge Measurement Time based on a referenced procedure maintained by FRM's Market Risk business unit.
The Margin Policy would be amended to describe the processes governing the imposition of the Intraday Risk Charge. The proposed language would provide that, with FRM Officer approval,
OCC also proposes to establish monitoring and escalation criteria to identify and address instances in which a Clearing Member's intraday risk increase deviates significantly from its preceding month's average verified peak intraday risk increases, as determined between 12:30 a.m. and 3:15 p.m. Central Time over the lookback period. OCC's amended proposal removes any reference to the Intraday Risk Charge with respect to the Intraday Monitoring Thresholds and explicitly limits the issuance of a margin call to a single intraday collection time at or around 12:00 p.m. Central Time. Aside from stating that intraday margin calls would be issued at a single intraday collection time, the amended Margin Policy would require that any margin calls outside of the collection time must be approved by the Chief Financial Risk Officer, Chief Executive Officer, Chief Operations Officer, or Chief Risk Officer. As amended by the Proposed Rule Change, the Margin Policy would charge FRM with establishing thresholds for monitoring changes in each Clearing Member's intraday risk: the Intraday Monitoring Thresholds. FRM would review changes in each member's intraday risk against such thresholds at least daily. If a Clearing Member's intraday risk breached the Intraday Monitoring Threshold(s), the Proposed Rule Change would authorize an FRM Officer to issue a margin call, make a margin adjustment to lock up excess collateral, or recommend protective measures under OCC Rule 307. Such a
According to the proposed changes to OCC's Margin Policy, an FRM Officer may decide against issuing a margin call if, in the Officer's judgment, the intraday call is not necessary to effectively manage the risk posed to OCC based on the specific facts and circumstances, including, but not limited to (1) circumstances in which issuing an intraday margin call would not align with broader systemic objectives such as minimizing potential procyclical effects and potential participant defaults; (2) if the risk increase can be attributed to one or more intraday events or actions including, but not limited to, portfolio level changes resulting from positive offsetting P&L amounts or positive offsetting asset values for options and collateral, or from non-risk increasing events such as the substitution of collateral or the pledging of additional valued securities within the same account; or (3) if the risk increase in the account is the result of a corporate action or the result of position transfers between accounts, such as delayed Clearing Member Trade Assignment (“CMTAs”) from execution only accounts, or when a P&L unrealized loss generates a margin call that exceeds the intraday margin call.
The Proposed Rule Change also would establish governance requirements related to the review and potential adjustment of the Intraday Monitoring Thresholds. Specifically, the Margin Policy would be revised to state that FRM coordinates a review of the Intraday Monitoring Thresholds, as well as the calculation and lookback period, on at least an annual basis, or on an
OCC's original implementation timeline was a minimum of 14 days and a maximum of 120 days following regulatory approval.
In response, OCC amended the Initial Filing to extend the implementation timeframe (subject to regulatory approval) to September 2025, with a public announcement of the specific implementation date at least four weeks prior to implementation.
OCC's extension of the implementation timeline to September 2025 is a reasonable balance between commenters' concerns and OCC's need both to ensure that it is collecting sufficient margin to mitigate the risks arising from the significant increase in intraday and overnight trading activity it has observed (and is not presently capturing) and to meet the upcoming compliance date for the Commission's recent final rule amending the CCA Standards regarding intraday margin calls. While commenters generally stated that they needed more time to prepare for the Intraday Risk Charge, there is no indication that, from a technical or operational standpoint, the Intraday Risk Charge is any different from other updated margin requirements that Clearing Members and industry participants have accommodated in the past.
Section 19(b)(2)(C) of the Exchange Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Exchange Act and the rules and regulations thereunder applicable to such organization.
The description of a proposed rule change, its purpose and operation, its effect, and a legal analysis of its consistency with applicable requirements must all be sufficiently detailed and specific to support an affirmative Commission finding,
After carefully considering the Proposed Rule Change, the Commission finds that the proposal is consistent with the requirements of the Exchange Act and the rules and regulations thereunder applicable to OCC. More specifically, the Commission finds that the proposal is consistent with Sections 17A(b)(3)(F) and 17A(b)(3)(I) of the Exchange Act,
Section 17A(b)(3)(F) of the Exchange Act requires, among other things, that a clearing agency's rules are designed to assure the safeguarding of securities and funds which are in the custody or control of the clearing agency or for which it is responsible.
As discussed in Section II above, since the inception of OCC's ETH and intraday monitoring system, there has been a significant uptick in the number of options contracts, including SDO and 0DTE contracts, that OCC clears. Although OCC's current portfolio revaluation process captures changes related to price movements, it does not capture the intraday credit risk related to position changes that exists between the point of margin collection at the beginning of each business day and the point of margin collection at the beginning of the next business day for all products cleared. As such, OCC's margin monitoring system does not account for OCC's exposure to intraday trading activity in a Clearing Member's portfolio. This results in a margin requirement that may not be sufficient to cover any additional risk resulting
For example, if a Clearing Member buys a large number of options in the morning and sells them in the afternoon, such intraday risk is not captured by OCC's current portfolio evaluation process. As a result, OCC may not collect sufficient margin collateral to address a Clearing Member's default. The Intraday Risk Charge is designed to address OCC's potential future exposure to risk posed by such intraday position changes by imposing the Intraday Risk Charge as a margin add-on charge. As described above in Section II.A, OCC would set the Intraday Risk Charge monthly based on each Clearing Member's intraday activity from the preceding month. Under a limited set of circumstances, OCC would have the authority to adjust the Intraday Risk Charge intramonth. Further, OCC would establish a process for monitoring member activity and calling for additional margin where such activity exceeds the Intraday Monitoring Thresholds, as described above in Section II.B.
Together, the collection of the Intraday Risk Charge and authority to issue margin calls based on the Intraday Monitoring Thresholds would increase the likelihood that OCC collects sufficient margin collateral to mitigate OCC's potential future credit exposure to a Clearing Member default. Increasing the likelihood that OCC collects sufficient margin collateral to address a Clearing Member's default would, in turn, assure the safeguarding of non-defaulting Clearing Members' collateral by reducing the likelihood that OCC would be forced to charge losses to the Clearing Fund, which is mutualized among Clearing Members.
Accordingly, OCC's proposal to adopt the Intraday Risk Charge and the Intraday Monitoring Thresholds is consistent with the requirements of Section 17A(b)(3)(F) of the Exchange Act.
Section 17A(b)(3)(I) of the Exchange Act requires that the rules of a clearing agency do not impose any burden on competition not necessary or appropriate in furtherance of the Act.
The Commission received various comments expressing concern that the Proposed Rule Change would lead to an increased burden on competition. Some commenters stated that additional margin requirements under the proposal would negatively impact market makers, who would be subject to pass-through costs and, as a result, would be more likely to pull out of market participation altogether, thus reducing liquidity and quality across the market.
In response, OCC stated that it did not observe a disproportionate impact on smaller brokers.
Relatedly, commenters recommended that OCC provide Clearing Members with tools that identify which of their clients are generating peak intraday exposures.
In this instance, the burden on competition stemming from a higher impact on some members than on others is necessary and appropriate in furtherance of the Act to reduce OCC's overall margin risk. Under the Proposed Rule Change, the intraday risk that is currently unaccounted for would be based on the profile of the portfolio held by certain Clearing Members during a limited 90-minute window throughout the entire trading day and extended trading hours. The Proposed Rule Change focuses on a Clearing Member's portfolio composition and trading activity, and aims to address the risk in position changes that exists between the point of margin collection at the beginning of each business day and the point of margin collection at the beginning of the next business day, a risk that is not accounted for under OCC's current margin collection system and that OCC is therefore carrying itself.
This type of agnostic approach aims to balance the potential competitive effects of the proposal against OCC's requirement under the Exchange Act and the rules and regulations thereunder to manage its credit risk by, among other things, collecting sufficient margin to appropriately address this risk, as well as the goal of preventing the mutualization of losses among non-defaulting firms in the event of a Clearing Member default. For example, to the extent that a Clearing Member would be charged the Intraday Risk Charge or be subject to a margin call under the Intraday Monitoring Thresholds, the increased margin collection would be based on the securities held by the member and its trading activity during specific times, consistent with OCC's requirement to collect margin to appropriately address the associated risk. Specifically, as noted, OCC is required to manage its credit risk, including by maintaining sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence.
With respect to commenters' concern regarding potential pass-through costs, OCC responded that it “cannot direct whether or how Clearing Members assign or allocate the Intraday Risk Charge to their customers”
Therefore, for the reasons stated above, the Proposed Rule Change is consistent with Section 17A(b)(3)(I) of the Exchange Act.
Rule 17Ad-22(e)(4)(i) under the Exchange Act requires that a CCA establish, implement, maintain, and enforce written policies and procedures reasonably designed to effectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by maintaining sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence.
OCC proposes to adopt the Intraday Risk Charge and the Intraday Monitoring Thresholds to address margin requirement gaps identified in its current intraday margining systems. As described above in Section II.A, the Intraday Risk Charge would be based on the increased risk identified during a limited timeframe through OCC's current margin monitoring system, which recalculates the STANS margin risk using portfolio position sets updated every 20 minutes between 8:30 a.m. and 6:30 p.m. Central Time, and at
Several commenters opposed the Initial Filing, stating that agency-only, executing broker-dealers who do not maintain custody over any customer positions would be harmed by the Proposed Rule Change because the 20-minute snapshots would not accurately reflect the entirety of each trade, would not account for hedging or offsetting, and would not account for the common business practice of end-of-day allocation among customer accounts, thus leading to double-margining.
Acknowledging the commenters' concerns, OCC filed Amendment No. 3, which shortened the period on which the Intraday Risk Charge would be based. By reducing this period to a limited series of 20-minute snapshots between 11:00 a.m. and 12:30 p.m. Central Time, the Proposed Rule Change responds to the concern that the originally proposed measurements of snapshots were too frequent and unpredictable. According to OCC, under the narrower window in the Proposed Rule Change, Execution-Only Clearing Members
In response to the amendments, a commenter stated that executing brokers may not be in a position to allocate trades ahead of the narrowed window because they may not receive client allocations until the end of the trading day.
Some commenters have suggested that OCC provide an exemption for Clearing Members acting solely as executing dealers.
To support its “call . . . for OCC to exempt executing brokers that are OCC Clearing members with CMTA capabilities from any Intraday Risk Charge,” one commenter suggested that, if such an executing broker defaults, the trades could be passed onto another Clearing Member via CMTA, which would provide a mechanism to transfer positions to other OCC Clearing Members in the event of a default scenario.
OCC also highlighted the potential knock-on effects for non-defaulting Clearing Members in the event that such intraday risk is left unaddressed. Specifically, OCC stated that it “is exposed to the risks posed by intraday price changes and any new contracts held by Clearing Members during the trading day to the extent those risks render the margin requirements that OCC sets and collects each morning insufficient to cover losses that may arise from the default of one of its Clearing Members.”
Some commenters framed their concern as one of “double-margining,” because positions could be counted twice—once when they are held at the executing broker, and a second time when they are transferred and held at the OCC Clearing Member serving as their prime broker.
OCC also stated in its response to these comments that “mechanisms exist to reduce the likelihood of OCC assessing an Intraday Risk Charge to an Executing Clearing Member.”
The Proposed Rule Change also allows OCC to account for instances where information from an individual snapshot may not capture a trade in its entirety. Specifically, the Intraday Risk Charge process would allow for a manual review of the 20-minute snapshot information, as described in Section II.A above. FRM would review and verify the daily peak increases on at least a monthly basis, taking into consideration the monitoring system's known limitations, such as a 20-minute snapshot not capturing a complete trade
Some commenters stated that OCC's proposal to use a one-month lookback period to assess a monthly margin add-on is unreasonable and poorly designed.
OCC's use of a one-month lookback period to assess the Intraday Risk Charge is reasonable and appropriately designed. As OCC stated in its response to such comments, “the use of historical lookbacks for projecting potential future exposures is a common practice in the financial industry,” and OCC's “proposed approach of establishing a margin add-on using a historical lookback as a buffer to account for variability in margin requirements is not unique among clearing agencies.”
The use of a one-month lookback period also is consistent with other OCC practices related to collateral collection for financial risk management,
One commenter suggested that OCC should (i) apply the Intraday Risk Charge in a phased approach, starting by applying it only to 0DTE and then, only if necessary, extending the Intraday Risk Charge to other cleared activity; (ii) develop new functionality to monitor in real-time the intraday risks it faces from Clearing Members; and (iii) sunset the Intraday Risk Charge within two years, once OCC has such capability.
Commenters stated that, while formulating and issuing the proposal, OCC did not engage with the industry.
Some commenters suggested an altogether different approach than the changes that comprise the Proposed Rule Change. Specifically, a commenter suggested that OCC rerun its margin methodology intraday as the basis for collecting intraday margin.
The different approach suggested is distinct from what was proposed. The Proposed Rule Change provides for the daily application of a margin add-on as part of a member's margin requirement each morning, similar to other add-ons within OCC's rules.
Commenters raised concerns regarding the confidentiality of certain exhibits, stating that they are unable to measure the impact of the proposal because certain supporting exhibits are confidential.
Another commenter stated that the Initial Filing was missing “any analysis of the estimated margin costs associated with the Proposal and the impact on OCC members and their clients.”
Taken together, as discussed above, the Proposed Rule Change will increase the likelihood that OCC would maintain sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence. Accordingly, the Proposed Rule Change is consistent with the requirements of Rule 17Ad-22(e)(4)(i) under the Exchange Act.
Rule 17Ad-22(e)(6)(ii) under the Exchange Act requires,
As described in Section II.A. above, the Proposed Rule Change would establish an Intraday Risk Charge that is calculated based on the average of the daily peak intraday risk increases from portfolio position changes measured using 20-minute snapshots between 11:00 a.m. and 12:30 p.m. Central Time over the preceding month. Separately and independently from the Intraday Risk Charge, OCC would monitor verified intraday risk increases for the purpose of issuing margin calls at 20-minute intervals between the hours of 12:30 a.m. through 3:15 p.m. Central Time, as described in Section II.B., above. Thus, the Proposed Rule Change would establish a risk-based margin system that monitors intraday exposures on an ongoing basis.
In addition to the margin collection capabilities under OCC Rules 609 and 307, the Proposed Rule Change would amend the Margin Policy to define Intraday Monitoring Thresholds for monitoring intraday exposure for purposes of issuing potential margin calls. These amendments to the Margin Policy would not only allow for a single mid-day collection time, but also facilitate decisions to issue or not issue unscheduled margin calls based on certain criteria and subject to articulated governance processes. The Proposed Rule Change also would require documentation of such decision-making. As such, the Proposed Rule Change would grant OCC the authority and operational capacity to make intraday margin calls as frequently as circumstances warrant, and require the necessary documentation underlying the decision to not make an intraday call. Accordingly, the Proposed Rule Change is consistent with the requirements of Rule 17Ad-22(e)(6)(ii) under the Exchange Act.
Rule 17Ad-22(e)(2)(v) under the Exchange Act requires that a CCA establish, implement, maintain, and enforce written policies and procedures reasonably designed to provide for governance arrangements that specify clear and direct lines of responsibility.
Along with establishing the Intraday Risk Charge and the Intraday Monitoring Thresholds, the Proposed Rule Change would modify OCC's Margin Policy and internal documents to include specific governance arrangements and evaluation criteria related to the Intraday Risk Charge and Intraday Monitoring Thresholds. For example, as stated in Section II.A above, FRM Officer approval would be necessary to impose the monthly Intraday Risk Charge. Adjustments could occur at the time of the determination of the Intraday Risk Charge amount or on an intra-month basis but would be limited to clearly defined circumstances, where reductions would be limited to business reduction, account terminations, transfer of positions to different account(s), or the imposition of protective measures under Rule 307B, and increases would be limited to business expansions. If the FRM Officer recommends any changes to an Intraday Risk Charge, the MRWG would be required to review and would be authorized to escalate the recommendation to the Office of the Chief Executive Officer, who would then review and be authorized to approve the changes.
Similarly, as described in Sections II.B and II.C above, relating to the Intraday Monitoring Thresholds, OCC's amended Margin Policy states that intraday margin calls would be issued at a single intraday collection time and requires that any margin calls outside of the collection time must be approved by the Chief Financial Risk Officer, Chief Executive Officer, Chief Operations Officer, or Chief Risk Officer. The revised Margin Policy also specifies that an FRM Officer may decide against issuing a margin call at the single intraday collection time if, in the Officer's judgment, the intraday call is not necessary to effectively manage the risk posed to OCC based on the specific facts and circumstances; and the FRM Officer must document such a determination.
Additionally, FRM will coordinate a review of the thresholds, calculation, and lookback period for the Intraday Risk Charge and Intraday Monitoring Thresholds on an at least annual basis, or more frequently as needed. Although OCC would retain the authority to
One commenter expressed uncertainty regarding whether the proposed monitoring and escalation criteria for Clearing Members whose intraday activity may exceed certain thresholds relative to its Intraday Risk Charge is properly designed.
Together, the proposed discretion to issue margin calls and related governance processes relating to the Intraday Risk Charge and Intraday Monitoring Thresholds are consistent with OCC's established internal policies and procedures.
Accordingly, the proposed changes to further detail OCC's processes for governing its Intraday Risk Charge and the Intraday Monitoring Thresholds are consistent with the requirements of Rule 17Ad-22(e)(2)(v) under the Exchange Act.
On the basis of the foregoing, the Commission finds that the Proposed Rule Change is consistent with the requirements of the Exchange Act, and in particular, the requirements of Section 17A of the Exchange Act and the rules and regulations thereunder.
It is therefore ordered, pursuant to Section 19(b)(2) of the Exchange Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend its Price List to adopt fees for orders routed pursuant to the Midpoint Ping routing strategy. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the NYSE Price List to adopt fees for orders routed pursuant to the Midpoint Ping routing strategy, as defined in Rule 7.37(c)(9)(A). The Exchange proposes to implement the fee change effective April 1, 2025.
The Exchange operates in a highly competitive market. The Securities and Exchange Commission (“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.”
While Regulation NMS has enhanced competition, it has also fostered a
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can move order flow, or discontinue or reduce use of certain categories of products. While it is not possible to know a firm's reason for shifting order flow, the Exchange believes that one such reason is because of fee changes at any of the registered exchanges or non-exchange venues to which a firm routes order flow. Accordingly, competitive forces constrain exchange transaction fees because market participants can readily trade on competing venues if they deem pricing levels at those other venues to be more favorable.
The Exchange has amended its rules to provide for the optional Midpoint Ping routing strategy, which is available for MPL-IOC Orders.
In connection with the upcoming availability of the Midpoint Ping routing strategy on April 7, 2025,
• Under “Transactions in stocks with a per share stock price of $1.00 or more,” in “Routing Fee—per share,” the Exchange proposes to add new rule text to provide for a routing fee of “$0.0030 for orders routed pursuant to the Midpoint Ping routing strategy (as defined in Rule 7.37(c)(9)(A)).”
• In the section titled “Transaction Fees and Credits For Tape B and C Securities” in the first bullet under “Routing Fees,” relating to securities at or above $1.00, the Exchange proposes to add text specifying “$0.0030 per share for orders routed pursuant to the Midpoint Ping routing strategy (as defined in Rule 7.37(c)(9)(A)).”
The Exchange believes that this routing functionality would offer member organizations the opportunity to access midpoint liquidity on other trading venues (and, specifically, on the Exchange's affiliated equity exchanges). This routing functionality is completely optional, and member organizations can readily select from among various providers of routing services, including other exchanges and non-exchange venues. Member organizations that choose not to utilize this routing strategy would continue to be able to trade on the Exchange as they currently do.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
As discussed above, the Exchange operates in a highly competitive market. 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.”
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can shift order flow, or discontinue or reduce use of certain categories of products, in response to fee changes. Accordingly, changes to exchange transaction fees can have a direct effect on the ability of an exchange to compete for order flow.
The Midpoint Ping routing strategy is intended to provide member organizations with the option to, after interacting with interest on the Exchange Book, route remaining quantities of MPL-IOC Orders to other NYSE Group equity exchanges. This routing functionality is provided by the Exchange on a voluntary basis, and no
The Exchange believes its proposal equitably allocates its fees among market participants. The Exchange believes that the proposal represents an equitable allocation of fees because it would apply uniformly to all member organizations, in that all member organizations will have the ability to utilize the Midpoint Ping routing strategy, and each such member organization would be charged the proposed fee when utilizing the functionality. Without having a view of member organizations' activity on other exchanges and off-exchange venues, the Exchange has no way of knowing whether this proposed rule change would serve as a disincentive to utilize the order type. However, the Exchange believes that a number of member organizations would seek to utilize the functionality, which would facilitate access to midpoint liquidity on other trading venues.
The Exchange reiterates that the routing functionality offered by the Exchange is completely optional and that the Exchange operates in a highly competitive market in which market participants can readily select between various providers of routing services with different product offerings and different pricing. The Exchange believes that the proposed fee structure for orders routed pursuant to the Midpoint Ping routing strategy is a fair and equitable approach to pricing.
The Exchange believes that the proposal is not unfairly discriminatory. The Exchange believes it is not unfairly discriminatory as the proposal to charge a fee would be assessed on an equal basis to all member organizations that use the Midpoint Ping routing strategy. Moreover, this proposed rule change neither targets, nor will it have a disparate impact on, any particular category of market participant. The Exchange believes that this proposal does not permit unfair discrimination because the changes described in this proposal would be applied to all similarly situated member organizations. Accordingly, no member organization already operating on the Exchange would be disadvantaged by the proposed allocation of fees. The Exchange further believes that the proposed rule change would not permit unfair discrimination among member organizations because the Midpoint Ping routing strategy would remain available to all member organizations on an equal basis, and each such participant would be charged the same fee for using the functionality.
Finally, the submission of orders to the Exchange is optional for member organizations in that they could choose whether to submit orders to the Exchange and, if they do, the extent of its activity in this regard. The Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
No written comments were solicited or received with respect to the proposed rule change.
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.
U.S. Small Business Administration.
Amendment 4.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Kentucky (FEMA-4860-DR), dated March 4, 2025.
Issued on April 1, 2025.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the Commonwealth of Kentucky, dated March 4, 2025, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before April 29, 2025.
Send comments identified by docket number FAA-2018-0768 using any of the following methods:
•
•
•
•
Alexander Kem at
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before April 29, 2025.
Send comments identified by docket number FAA-2024-1316 using any of the following methods:
•
•
•
•
Nia Daniels, (202) 267-7626, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of Limitation on Claims for Judicial Review.
This notice announces actions taken by the FHWA that are final. The action relates to the SR 510 Yelm Loop—New Alignment Phase 2 Project, located in the City of Yelm, Thurston County. The Project will construct approximately three miles of new highway composed of one travel lane in each direction, starting at Cullens Road (at the terminus of Phase 1) and ending at the intersection of SR 507 and 170th Street. The highway will be classified limited access between Cullens Road and 103rd Avenue, and managed access between 103rd Avenue and SR 507.
The FHWA's National Environmental Policy Act (NEPA) Finding of No Significant Impact (FONSI) provides details on the Selected Alternative for the proposed improvements.
A claim seeking judicial review of the Federal agency actions on the listed highway project will be barred unless the claim is filed on or before September 8, 2025. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Liana Liu, P.E., Area Engineer, Federal Highway Administration, 711 S Capitol
Notice is hereby given that FHWA has taken final agency actions within the meaning of 23 U.S.C. 139(l)(1) by issuing a NEPA FONSI for the SR 510 Yelm Loop—New Alignment Phase 2 Project in Thurston County, Washington. The action(s) by FHWA and the laws under which such actions were taken, are described in the FONSI and the associated agency records. That information is available by contacting FHWA at the addresses provided above.
The project will complete construction of a two-phased limited access highway located in the City of Yelm. The project will provide a new east-west roadway to reduce congestion in Yelm's downtown core. The new road would minimize intersections and prohibit driveway access in order to increase capacity, shorten travel times, and reduce the potential for collisions. A FONSI for the project was signed on March 12, 2025.
Information about the FONSI and associated records are available from FHWA at the addresses provided above and can be found at:
1.
2.
3.
4.
5.
7.
8.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition; renewal of exemption.
FMCSA announces its final decision to renew the exemption granted to McKee Foods Transportation, LLC (MFT), USDOT #1025678, from the hours-of-service (HOS) regulations pertaining to the use of a sleeper berth. The exemption renewal allows MFT team drivers to take the equivalent of 10 consecutive hours off duty by splitting sleeper berth time into two periods totaling 10 hours, provided neither of the two periods is less than two hours. FMCSA has analyzed the exemption application and the public comments and has determined that the exemption, subject to the terms and conditions set forth below, is likely to achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.
The exemption is effective for the period of April 20, 2025, through April 20, 2030.
Mrs. Pearlie Robinson, Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards, FMCSA; 202-366-4225;
To view comments, go to
To view documents mentioned in this notice as being available in the docket, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved absent such exemption, pursuant to the standard in 49 U.S.C. 31315(b)(1). The Agency must publish its decision in the
FMCSA's HOS regulations in 49 CFR part 395 limit the time commercial motor vehicle (CMV) drivers may drive and also require certain off-duty periods to ensure that individuals stay awake and alert while driving. Section 395.1(g)(1)(ii) allows a driver using the sleeper berth exception to accumulate the equivalent of at least 10 consecutive hours off duty by taking a combination of either two periods of sleeper-berth time or a combination of off-duty time and sleeper-berth time (in both cases totaling 10 hours) if: (1) neither rest period is shorter than 2 hours; (2) one rest period is at least 7 consecutive hours long; and (3) driving time before and after each rest period, when added together does not exceed 11 hours driving and does not violate the 14-hour driving “window” limit.
MFT has requested a renewal of its exemption “for the maximum available period” from the sleeper berth requirements, which previously were set forth in 49 CFR 395.1(g)(1)(ii)(A)(1-2). FMCSA revised the sleeper berth provisions in 2020 so that the relevant requirements are now codified at 49 CFR 395.1(g)(1)(ii)(A) and (B) [85 FR 33396, June 1, 2020]. MFT's application for exemption was described in a
In its original application, MFT stated that it is committed to maintaining its outstanding safety record by focusing on continuous improvement, promoting technologies to enhance safety, conducting thorough inspections and having well-communicated policies in place to address both safety and compliance-related topics. To ensure an equivalent level of safety, MFT reiterates the safeguards it included with its 2014 application: (1) Every week, all transportation operations shut down one hour prior to sundown on Friday until one hour after sundown on Saturday, resulting in an automatic minimum 26-hour off-duty home time for all drivers each weekend. This is in addition to home time during the week; (2) All tractors are equipped with speed limiters; (3) Drivers will continue using electronic logging devices (ELDs) (previously referred to as electronic on-board recording devices) to track their duty time and HOS compliance; (4) Drive time is reduced from 11 hours to 10 hours. Team drivers are limited to 10 hours of driving prior to completing their required 10 hours of sleeper-berth time; and (5) Behavior-based event data is monitored from the ELD to enhance safety measures to help reduce the probability of accidents on the road.
The Agency received 63 comments, 41 supporting the exemption, 13 opposing it, and 9 neither supporting nor opposing the exemption but offering general comments about the HOS regulations. The Truck Safety Coalition (TSC), Citizens for Reliable and Safe Highways (CRASH), and Parents Against Tired Truckers (PATT) filed joint comments opposing the exemption. These three organizations noted that FMCSA found in its 2020 HOS rulemaking that short sleeper berth increments were not sufficient to obtain restorative rest. They also stated that FMCSA had denied a comparable request in the recent past from Matthew Kilmer (88 FR 43410). They asserted that the safeguards McKee proposed in 2014 are not sufficient and all carriers are now required to use ELDs. They also noted that MFT did not share if the speed limiters are required to be used and at what speed they are set.
Trucking With the Schmitts wrote, “This request MUST be denied,” citing a concern that the exemption could “open the door for a huge number of similar exemption requests.” AWM Associates, LLC, shared the concern that the exemption would cause an influx of similar requests and suggested that FMCSA should consider revising the sleeper berth regulations because “to extend the variation to one carrier is an economic disadvantage to the remainder of the trucking community.” An anonymous individual commented, “McKee Foods does not have any special situation, or drivers that somehow need less sleep, to warrant such a request.”
Other themes in opposition included: (1) the split is not safe; (2) the HOS rules should be the same for all companies; (3) if McKee's team drivers are safer using the requested split sleeper berth exemption, then the HOS rules should be revised to allow all teams to use the same provisions; and (4) no special rules should be applied to anyone, companies, corporations or individuals.
The Tennessee Trucking Association (TTA), the National Association of Manufacturers (NAM), and James Stark were among the commenters who supported the exemption. TTA said, “[MFT] have received the Tennessee Trucking Association Fleet Safety Award the last 7 years. In my opinion they are very dedicated to safety, and I see no reason why you shouldn't grant them the HOS exemption again.” The NAM noted that “Their [MFT's] April 2024 Driver Out-of-Service Rate is approximately one-sixth the national average, and their April 2024 DOT Accident Rate per Million Milles [sic] is more than two-and-a-half times lower than the national average.” James Stark said, “Absolutely allow drivers to split sleeper berth hours, as they see fit with two periods of no less than 3 hours per period.”
Other themes in support of the exemption included: (1) exemption should be implemented nationwide; (2) flexible hours for team driving are imperative for safety; and (3) all drivers should be allowed the 5/5 split option.
In response to the joint comments filed by TSC, CRASH, and PATT, the Agency is aware that preventing fatigue is a complex process considering numerous factors such as time of day, amount and timing of sleep, time awake and time on task. In its 2020 HOS final rule, FMCSA concluded that there was not sufficient data to support reducing the longer sleeper berth period to 6 hours (85 FR 33423). FMCSA continues to lack sufficient data to conclude that a 6/4 or 5/5 sleeper berth split applied across all motor carrier operations would achieve a level of safety equivalent to the current regulations. With respect to MFT's operations, however, MFT has operated under the exemption with specific terms and conditions, including a 26-hour off duty period every week, and daily driving time limit of 10 hours, since March 2015. FMCSA has not observed any adverse safety impact from MFT's operation under the exemption for 10 years.
With regard to comments about the Agency's denial of Matthew Kilmer's application, Mr. Kilmer requested an exemption allowing himself as a driver
The Agency reviewed MFT's application, comments to the docket, and the company's safety record including crashes and inspection data from April 2020 to December 2024. Since 2015 when the exemption was first granted, this exemption has not had an adverse effect on MFT's safety record. FMCSA therefore concludes that renewing the exemption for another five years, under the terms and conditions listed below, will likely maintain a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption.
This exemption from the requirements of 49 CFR 395.1(g)(1)(ii)(B) is effective from April 20, 2025, through April 20, 2030, 11:59 p.m. local time.
This exemption applies to MFT team drivers only. When operating under this exemption, team drivers employed by MFT are provided a limited exemption from the sleeper-berth requirements of 49 CFR 395.1(g)(1)(ii)(B) to allow them to split sleeper-berth time into two periods totaling at least 10 hours, provided neither of the two periods is less than 2 hours in length (an 8/2, 7/3, 6/4, or 5/5 split). All other provisions of 49 CFR part 395 continue to apply, including the calculation provisions in 49 CFR 395.1(g)(1)(iii). The guidance document dated September 21, 2015, which was posted to the docket with Document ID FMCSA-2014-0071-0042, no longer applies because it was based on the 2015 HOS regulations that are no longer in effect.
(1) Each week, all MFT transportation operations will shut down between one hour prior to sundown on Friday and one hour after sundown on Saturday, allowing drivers using the exemption a minimum 26 hours off-duty period, in addition to a minimum of two days at home during the week.
(2) All tractors will be equipped with speed limiters, which must be used by drivers operating under the exemption.
(3) Drivers are limited to 10 hours of driving time, rather than 11 hours, during the work shift specified in 49 CFR 395.3(a)(1).
(4) MFT will monitor behavior-based event data from the ELD to enhance safety measures to reduce the probability of crashes.
(5) MFT and its drivers must comply with all other requirements of the Federal Motor Carrier Safety Regulations (49 CFR parts 350-399).
(6) MFT drivers must have a copy of this notice in their possession while operating under the terms of the exemption. This notice serves as the exemption document and must be presented to law enforcement officials upon request.
(7) MFT may be investigated to evaluate compliance with the terms and conditions of this exemption, in addition to the FMCSRs.
In accordance with 49 U.S.C. 31315(d), as implemented by 49 CFR 381.600, during the period this exemption is in effect, no State shall enforce any law or regulation that conflicts with or is inconsistent with this exemption with respect to a firm or person operating under the exemption. States may, but are not required to, adopt the same exemption with respect to operations in intrastate commerce.
MFT must notify FMCSA within 5 business days of any accidents (as defined by 49 CFR 390.5), involving the operation of any of its CMVs while utilizing this exemption. The notification must include the following information:
Reports filed under this provision shall be emailed to
FMCSA does not believe MFT, or the drivers covered by this exemption, will experience any deterioration of their safety record. The exemption will be rescinded if: (1) MFT or drivers operating under the exemption fail to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objects of 49 U.S.C. 31136(e) and 31315(b).
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice and request for comments on a new information collection.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) summarized below will be submitted to the Office of Management and Budget (OMB) for review and approval. This document describes a new collection of information for which NHTSA intends to seek OMB approval titled “Examining the Effectiveness of Lane Departure Warning and Lane Keep Assist Advanced Driver Assistance Systems (ADAS) for Improving Driver Response.” A
Comments must be submitted on or before May 9, 2025.
Written comments and recommendations for the proposed information collection, including suggestions for reducing burden, should be submitted to OMB at
For additional information or access to background documents, contact Jeremiah Singer, National Highway Traffic Safety Administration, 1200 New Jersey Ave. SE, Washington, DC 20590; email
Under the PRA (44 U.S.C. 3501
Recruitment of study respondents will be from the area near the testing facility in Blacksburg, Virginia, and surrounding areas. The target for the study is a total of 50 participants; however, the research team has provided sufficient additional recruitment such that the target sample will be achieved given expected reductions in respondents due to ineligibility and attrition. The respondents will participate in two separate driving data collection sessions during the course of the research after undergoing a series of evaluations for suitability of inclusion in the study.
Respondents will be asked to complete a brief questionnaire related to their previous knowledge of, and experience with, LDW systems and LKA systems. Respondents will next perform a series of controlled driving tests on the Virginia Smart Roads facilities with one of the test vehicles that has been instrumented with a Data Acquisition System (DAS). The DAS includes video cameras and sensors that allow for collecting continuous data that encompasses driver behavior and vehicle performance. Each series of controlled driving tests on the Smart Roads will last about 2 hours and will be preceded by a 15-minute familiarization with the vehicle, followed by a 30-minute post-driving questionnaire and debriefing session. The drivers who complete the first session will return a different day for a second driving session in which they will be instructed to drive a prescribed route on public roads in Southwest Virginia. This second driving session will last approximately 4 hours, with a 15-minute break in the middle of the session; this will be preceded by a 45-minute preparation and followed by a 30-minute post-driving questionnaire and debriefing. The planned data collection activities discussed herein have been approved by an Institutional Review Board.
Numerous studies have found that LSS reduce the likelihood of a crash. Based on the comparison of multiple prevention systems and warning-only systems, studies have suggested that prevention systems are more effective than warning-only systems. Crash situations typically unfold quickly; thus, a driver's response to the warning may be too late to prevent a crash, particularly when the driver is distracted, drowsy, or fails to notice the warning quickly. While studies have demonstrated the effectiveness of LSS at reducing the intended crash types and the potential of LSS to save countless lives with widespread use, these systems are unfortunately associated with a “nuisance” factor resulting from false or unnecessary alerts. This leads to system deactivation, with indications that drivers turn LDW systems off as much as 50 percent of the time due to annoying alerts and overly aggressive steering corrections. Once deactivated, all potential safety benefits of LSS are lost, highlighting the importance of reducing false or unnecessary alerts to maximize driver acceptance and the likelihood that the system remains enabled. LSS, if properly designed, evaluated, and used, have the potential to reduce the occurrence of, or at the very least mitigate the severity of, a significant number of lane-departure crashes. NHTSA needs to learn more about the effectiveness of LSS, the human factors that affect LDW and LKA performance, and the system characteristics that will favor better acceptance. This data collection has been designed to evaluate key LSS-related technologies, with a particular focus on driver and system performance, as well as driver acceptance. The outcomes will provide a wide variety of stakeholders with valuable information about LSS design features to maximize the safety benefits of these systems and will inform NHTSA in future activities involving these systems.
NHTSA will use the information collected to produce a technical report containing summary statistics and tables that will be made available publicly through the agency website and the National Transportation Library.
An estimated 113 respondents annually will answer a Recruitment Screener over the phone to determine if they qualify for the study. Participants will be screened over the phone to determine eligibility, with recruitment personnel recording responses on a paper form using an anonymized identifier. Respondents are expected to take an average of 15 minutes to complete the questionnaire and will complete this questionnaire once, resulting in 28 annual burden hours.
Based on an estimate that 25 percent of those who begin the screening process will be eligible and interested in participating in the study, 28 respondents annually will be scheduled for an appointment to go to the contractor's facilities in Blacksburg, Virginia, for the consenting process and, subsequently, the full study. The consenting process includes an overview of the study, an explanation of the consent form, and an opportunity for the potential participants to ask questions and get clarification. Those individuals who consent to the study and enroll will complete the Informed Consent form and move on to the next process. This consenting process is expected to take 30 minutes, resulting in 14 annual burden hours.
NHTSA anticipates a minimal amount of attrition following the consenting process; thus 27 respondents annually are expected to complete the Vision-Hearing Form. This collection involves an experimenter administering a vision and hearing evaluation to ensure that respondents meet the basic vision requirements of driver's licensure in Virginia (20/40) and to confirm that they can hear instructions provided by the experimenter when looking away. This evaluation is expected to take 5 minutes, resulting in 2 annual burden hours.
Following the vision and hearing evaluation, the 27 annual respondents will be asked to complete a 10-minute Knowledge Experience Questionnaire related to their previous knowledge of and experience with the systems under evaluation. Completion of this form will take 10 minutes per respondent and is to be completed once, resulting in 5 annual burden hours.
To assess preferences regarding LDW modality and timing under dynamic scenarios, study participants will experience a series of controlled driving tests with the LDW mockup vehicle on the Smart Roads test track at the contractor's facility. Each participant will drive continuously on closed loops while experiencing modality and timing conditions (independent and in combination, where applicable) incorporated in the LDW mockup vehicle, while data are collected by the DAS. No other traffic will be present on the part of the Smart Roads in use during participant sessions. After the participant performs a few loops to become familiar with the vehicle and the test track without instructions to depart the lane, they will be instructed to gradually deviate towards one of the lines until the departure warnings are triggered. Drivers will then be instructed to carefully perform a corrective maneuver back to the center of the lane after the warning. Not including the questionnaire elements referenced below, this driving session is expected to take 100 minutes, including vehicle familiarization, drive time, and breaks. For 27 respondents annually, this results in 45 annual burden hours.
During the behind-the-wheel session, drivers will verbally answer questions administered by the experimenter. This “post-condition” questionnaire, with an estimated completion time of 5 minutes, will be administered up to 12 times for a total time of 60 minutes per participant. Note that this allotted time is in addition to the actual driving time. Administered to 27 respondents annually, this results in a total of 27 annual burden hours.
Following completion of the full driving session, respondents will be asked to complete a final post-drive questionnaire, capturing feedback pertaining to all conditions experienced. The estimated completion time is 5 minutes. Administered to 27 respondents annually, this results in 2 annual burden hours. At the conclusion of this first driving session and questionnaires, participants will receive
To assess driver response to
Each respondent in the first group, 16 respondents annually, will drive a prescribed route using the LDW mockup vehicle. Each driving session will be part of a sub-study that aims to clarify the effects of the two independent LDW design variables (modality and activation timing) on driver performance safety indicators (
At the halfway point, when the respondents take their 15-minute break, they will also complete the “post-route” questionnaire. This is estimated to take 10 minutes but is distinct from their break time. They will complete this same questionnaire after completing their second half of the drive. For 16 respondents annually, this equates to 5 annual burden hours.
Each participant from the second group, 11 respondents annually, will complete the same prescribed drive but will use the LDW/LKA factory vehicle rather than the LDW mockup vehicle. This experiment will address objective driver performance and subjective qualitative preferences under four system activation modes (none, LDW only, LKA only, and LDW with LKA). At the halfway point, a member of the research team will switch the modality/timing combination. A remote experimenter tool will allow the experimenter to monitor the session and allow interfacing with the DAS. The total driving session duration for each participant will be approximately 4 hours. Including orientation to the research vehicle and prescribed route, along with a 15-minute break at the halfway point, the total estimated time to complete this driving session is approximately 5 hours and 10 minutes. For 11 respondents annually, this equates to 57 annual burden hours.
At the halfway point when respondents take their 15-minute break, they will also complete the “post-route” questionnaire. This is estimated to take 10 minutes but is distinct from their break time. They will complete this same questionnaire a second time after completing their second half of the drive. For 11 respondents annually, this equates to 4 annual burden hours.
The 11 information collections described above are summarized in the following table, showing the number of annual respondents, frequency of response, time per response, and associated burden.
The respondents will not incur any reporting or recordkeeping cost from the information collection.
U.S.-China Economic and Security Review Commission.
Notice of open public hearing.
Notice is hereby given of the following hearing of the U.S.-China Economic and Security Review Commission. The Commission is mandated by Congress to investigate, assess, and report to Congress annually on “the national security implications of the economic relationship between the United States and the People's Republic of China.” Pursuant to this mandate, the Commission will hold a public hearing in Washington, DC on April 24, 2025 on “China's Domestic Energy Challenges and Its Growing Influence Over International Energy Markets.”
The hearing is scheduled for Thursday, April 24, 2025 at 9:30 a.m.
Members of the public will be able to attend in person at or near the U.S. Capitol and adjacent Congressional office buildings (specific building and room number to be announced) or view a live webcast via the Commission's website at
Any member of the public seeking further information concerning the hearing should contact Jameson Cunningham, 444 North Capitol Street NW, Suite 602, Washington, DC 20001; telephone: 202-624-1496, or via email at
The hearing will be co-chaired by Commissioner Carte Goodwin and Commissioner Hal Brands. Any interested party may file a written statement by April 24, 2025 by transmitting it to the contact above. A portion of the hearing will include a question and answer period between the Commissioners and the witnesses.
National Cemetery Administration, Department of Veterans Affairs.
Notice.
National Cemetery Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Comments must be received on or before June 9, 2025.
Comments must be submitted through
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, NCA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of NCA's functions, including whether the information will have practical utility; (2) the accuracy of NCA's estimate of the burden of the proposed collection of information; (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 or the use of other forms of information technology.
The burden decreased since the previous approval due to a decrease in the number of respondents and responses. The number of respondents declined to 303 from the previous approval of 380 respondents in 2022. Due to fewer respondents, the cost to respondents declined from $887 in 2022 to an estimated $792 resulting in $95 in respondent cost savings. The cost to the
(b) The Attorney General shall take all appropriate action to issue written guidance to implement the provisions of subsection (a) of this section.
(c) The Attorney General shall further issue a letter to each provider stating that there has been no violation of the statute and that there is no liability for any conduct that occurred during the above-specified period, as well as for any conduct from the effective date of the Act until the date of this order.
(d) Because of the national security interests at stake and because section 2(d) of the Act vests authority for investigations and enforcement of the Act only in the Attorney General, attempted enforcement by the States or private parties represents an encroachment on the powers of the Executive. The Attorney General shall exercise all available authority to preserve and defend the Executive's exclusive authority to enforce the Act.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.