On February 10, 2025, the President issued Proclamation 10895, “Adjusting Imports of Aluminum into the United States” (90 FR 9087) (Aluminum Proclamation). Clause (9) of the Aluminum Proclamation requires that I, as Secretary of the United States Department of Commerce, certify that adequate systems are in place to fully, efficiently, and expediently process and collect tariff revenue for covered aluminum articles outside of Chapter 76 of the Harmonized Tariff Schedule of the United States (HTS). I so certify for all aluminum articles and derivative aluminum articles in Annex 1 to Proclamation 10895 that are outside of Chapter 76 of the HTS.

On February 10, 2025, the President issued the Proclamation 10896, “Adjusting the Imports of Steel into the United States” (90 FR 9817) (Steel Proclamation). Clause (8) of the Steel Proclamation requires that I, as Secretary of the United States Department of Commerce, certify that adequate systems are in place to fully, efficiently, and expediently process and collect tariff revenue for covered steel articles. I so certify for all steel articles and derivative steel articles in Annex 1 to Proclamation 10896.

This preliminary determination is issued in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). On November 4, 2024, Commerce published the notice of initiation of this countervailing duty (CVD) investigation. 1 On December 19, 2024, Commerce postponed the deadline for this preliminary determination until March 7, 2025. 2

For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. 3 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The products covered by this investigation are molded fiber products from China. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the Preamble to Commerce's regulations, 4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). 5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. Commerce intends to issue its preliminary decision regarding comments concerning the scope of the less-than-fair-value (LTFV) and CVD investigations in the preliminary determination of the companion LTFV investigations. We will incorporate the scope decisions from the LTFV investigations into the scope of the final CVD determination for this investigation after considering any relevant comments submitted in scope case and rebuttal briefs. 6

Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific. 7 For a full description of the methodology underlying our preliminary determination, see the Preliminary Decision Memorandum.

Commerce notes that, in making these findings, it relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available. 8 For further information, see the “Use of Facts Otherwise Available and Adverse Inferences” section in the Preliminary Decision Memorandum.

In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion LTFV investigation of molded fiber products from China based on a request made by the petitioners. 9 Consequently, the final CVD determination will be issued on the same date as the final LTFV determination, which is currently scheduled to be issued no later than July 21, 2025, unless postponed.

One potential exporter and/or producer of molded fiber products from China did not respond to Commerce's quantity and value (Q&V) questionnaire ( i.e., the non-responsive company). 10 We find that, by not responding to the Q&V questionnaire, this company withheld requested information and significantly impeded this proceeding. Thus, in reaching our preliminary determination, pursuant to sections 776(a)(2)(A) and (C) of the Act, we are basing the CVD subsidy rate for the non-responsive company on facts otherwise available.

We further preliminarily determine that an adverse inference is warranted, pursuant to section 776(b) of the Act. By failing to submit a response to Commerce's Q&V questionnaire, the non-responsive company did not cooperate to the best of their ability in this investigation. For more information on the application of AFA to the non-responsive company, see “Use of Facts Otherwise Available and Adverse Inferences” in the Preliminary Decision Memorandum.

Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and de minimis rates and any rates based entirely under section 776 of the Act.

In this investigation, Commerce preliminarily calculated individual estimated countervailable subsidy rates for Guangxi Firstpak Environmental Technology Co., Ltd. (Firstpak) and Zhejiang Zhongxin Environmental Protection Technology Group Co., Ltd. (Zhejiang Zhongxin) that are not zero, de minimis, or based entirely on the facts otherwise available. Commerce calculated the all-others rate using a weighted-average of the individual estimated subsidy rates calculated for the examined respondents using each company's publicly-ranged values for the merchandise under consideration. 11

This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). On November 4, 2024, Commerce published the notice of initiation of this countervailing duty (CVD) investigation. 1 On December 19, 2024, Commerce postponed the deadline for this preliminary determination until March 7, 2025. 2

For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. 3 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The products covered by this investigation are molded fiber products from Vietnam. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the Preamble to Commerce's regulations, 4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). 5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. Commerce intends to issue its preliminary decision regarding comments concerning the scope of the less-than-fair-value (LTFV) and CVD investigations in the preliminary determination of the companion LTFV investigations. We will incorporate the scope decisions from the LTFV investigations into the scope of the final CVD determination for this investigation after considering any relevant comments submitted in scope case and rebuttal briefs. 6

Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific. 7 For a full description of the methodology underlying our preliminary determination, see the Preliminary Decision Memorandum.

Commerce notes that, in making these findings, it relied, in part, on facts available, and, because it finds that certain respondents did not act to the best of their ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available. 8 For further information, see the “Use of Facts Otherwise Available and Adverse Inferences” section in the Preliminary Decision Memorandum.

In accordance with section 703(e)(1) of the Act, Commerce preliminarily determines that critical circumstances exist with respect to imports of subject merchandise from the mandatory respondent Vietnam Yuzhan Packaging Technology Co. Ltd. (Yuzhan), as well as HC Packaging Asia (Industrial Park), Honha Eco Pulp Viet Nam Paper Tray, and Pulp Tray, Martin Vietnam Co. Ltd., which have been assigned a rate based on total adverse facts available (AFA), and also with respect to all other producers and exporters that enter subject merchandise under the all-others subsidy rate. For a full description of the methodology and results of Commerce's analysis, see the Preliminary Decision Memorandum.

In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final CVD determination in this investigation with the final determination in the companion LTFV investigation of molded fiber products from Vietnam, based on a request made by the petitioner. 9 Consequently, this final CVD determination will be issued on the same date as the final determination for the LTFV investigation, which is currently scheduled to be issued no later than July 21, 2025, unless postponed.

Three potential exporters and/or producers of molded fiber products from Vietnam did not respond to Commerce's quantity and value (Q&V) questionnaire ( i.e., the non-responsive companies). 10 We find that, by not responding to the Q&V questionnaire, these companies withheld requested information and significantly impeded this proceeding. Thus, in reaching our preliminary determination, pursuant to sections 776(a)(2)(A) and (C) of the Act, we are basing the CVD subsidy rate for the non-responsive companies on facts otherwise available.

We further preliminarily determine that an adverse inference is warranted, pursuant to section 776(b) of the Act. By failing to submit responses to Commerce's Q&V questionnaire, the non-responsive companies did not cooperate to the best of their ability in this investigation. For more information on the application of AFA to the non-responsive companies, see “Use of Facts Otherwise Available and Adverse Inferences” in the Preliminary Decision Memorandum.

Sections 703(d) and 705(c)(5)(A) of the Act provide that, in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any rates that are zero, de minimis, or based entirely under section 776 of the Act. If the rates established for all exporters and producers individually investigated are zero, de minimis, or determined entirely under facts available, Commerce may use any reasonable method to establish an all-others rate. 11

Commerce calculated an individual estimated countervailable subsidy rate for Yuzhan, the only individually examined exporter/producer in this investigation. Because the only individually calculated rate is not zero, de minimis, or based entirely on facts otherwise available, the estimated weighted-average rate calculated for Yuzhan is the rate assigned to all other producers and exporters, pursuant to section 705(c)(5)(A)(i) of the Act.

Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:

Commerce intends to disclose its calculations and analysis performed in connection with this preliminary determination within five days of its 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).

Consistent with 19 CFR 351.224(e), Commerce will analyze and, if appropriate, correct any timely allegations of significant ministerial errors by amending the preliminary determination. However, consistent with 19 CFR 351.224(d), Commerce will not consider incomplete allegations that do not address the significance standard under 19 CFR 351.224(g) following the preliminary determination. Instead, Commerce will address such allegations in the final determination together with issues raised in the case briefs or other written comments.

Section 703(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the later of: (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered; or (b) the date on which notice of initiation of the investigation was published. Commerce preliminarily finds that critical circumstances exist for imports of subject merchandise produced and/or exported by Yuzhan, the non-responsive companies ( i.e., HC Packaging Asia (Industrial Park), Honha Eco Pulp Viet Nam Paper Tray, and Pulp Tray, Martin Vietnam Co. Ltd.), and all other producers and exporters whose imports enter under the all-others subsidy rate. Pursuant to section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in the scope of the investigation, entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice, in accordance with section 703(e)(2)(A) of the Act. Further, pursuant to 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the rates indicated above.

As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.

All interested parties will have the opportunity to submit scope case and rebuttal briefs on the preliminary decision regarding the scope of the LTFV and CVD investigations. The deadlines to submit scope case and rebuttal briefs will be provided in the preliminary scope decision memorandum. For all scope case and rebuttal briefs, parties must file identical documents simultaneously on the records of the ongoing LTFV and CVD molded fiber products investigations. No new factual information or business proprietary information may be included in either scope case or rebuttal briefs.

Case briefs or other written comments, excluding scope comments, may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. 12 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 13 Interested parties who submit case or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 14

As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this investigation, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 15 Further, we request that interested parties limit their public executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final determination in this investigation. We request that interested parties include footnotes for relevant citations in the executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 16

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants and whether any participant is a foreign national; and (3) a list of the issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

In accordance with section 703(f) of the Act, Commerce will notify the ITC of its determination. If the final determination is affirmative, the ITC will determine, before the later of 120 days after the date of this preliminary determination or 45 days after the final determination, whether imports of molded fiber products from Vietnam are materially injuring the U.S. industry.

This determination is issued and published in accordance with sections 703(f) and 777(i) of the Act, and 19 CFR 351.205(c).

On June 8, 2022, Commerce published its Final Results in the 2019-2020 AD administrative review of rebar from Mexico. Commerce found that the application of adverse facts available (AFA), pursuant to sections 776(a) and (b) of the Tariff Act of 1930, as amended (the Act), was warranted in determining Grupo Simec's dumping margin and assigned a dumping margin of 66.70 percent. 2 Additionally, Commerce assigned the companies not selected for individual examination, Grupo Acerero and Sidertul, a dumping margin equal to the simple average of the dumping margins for Deacero S.A.P.I. de C.V., the other mandatory respondent, and Grupo Simec, consistent with the guidance in section 735(c)(5)(B) of the Act. 3

Grupo Simec appealed Commerce's Final Results. On April 25, 2024, the CIT remanded the Final Results to Commerce to: (1) reopen the record of the administrative review to accept Grupo Simec's October 18, 2021, filing, and to request other information as needed; (2) conduct a new analysis to determine if the application of AFA is warranted; and (3) re-analyze the non-selected company rate and make any needed adjustments. 4

In its final remand redetermination, issued on November 21, 2024, Commerce calculated a weighted-average dumping margin of 0.00 percent for Grupo Simec. 5 In addition, because of the change in Grupo Simec's calculated margin, the non-selected companies' rate also changed. As a result, Grupo Acerero and Sidertul are each assigned a weighted-average dumping margin of 0.00 percent in accordance with section 735(c)(5)(B) of the Act. 6 On February 28, 2025, the CIT sustained Commerce's final redetermination. 7

In its decision in Timken, 8 as clarified by Diamond Sawblades, 9 the U.S. Court of Appeals for the Federal Circuit held that, pursuant to sections 516A(c) and (e) of the Act, Commerce must publish a notice of court decision that is not “in harmony” with a Commerce determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's February 28, 2025, judgment constitutes a final decision of the CIT that is not in harmony with Commerce's Final Results. Thus, this notice is published in fulfillment of the publication requirements of Timken.

Because there is now a final court judgment, Commerce is amending its Final Results with respect to Grupo Simec, Grupo Acerero, and Sidertul as follows:

Because Grupo Simec, Grupo Acerero, and Sidertul each have a superseding cash deposit rate, i.e., there have been final results published in a subsequent administrative review, we will not issue revised cash deposit instructions to U.S. Customs and Border Protection (CBP). This notice will not affect the current cash deposit rate.

At this time, Commerce remains enjoined by CIT order from liquidating entries that: were produced and/or exported by Grupo Simec, 10 produced and exported by Grupo Acerero, produced and/or exported by Sidertul, and were entered, or withdrawn from warehouse, for consumption during the period November 1, 2019 through October 31, 2020. These entries will remain enjoined pursuant to the terms of the injunction during the pendency of any appeals process.

In the event the CIT's ruling is not appealed, or, if appealed, upheld by a final and conclusive court decision, Commerce intends to instruct CBP to assess antidumping duties on unliquidated entries of subject merchandise produced and/or exported by Grupo Simec, produced and exported by Grupo Acerero, and produced and/or exported by Sidertul, in accordance with 19 CFR 351.212(b). We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific ad valorem assessment rate is not zero or de minimis. Where an import-specific ad valorem assessment rate is zero or de minimis, 11 we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

This notice is issued and published in accordance with sections 516A(c) and (e) and 777(i)(1) of the Act.

The Scallop Advisory Panel will meet to review input from the Visioning Sessions and discuss the development of the Long-Term Scallop Strategic Plan. They also plan to review progress on the LAGC IFQ Program Review. Other business will be discussed, if necessary.

Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cate O'Keefe, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are proposed or, if the taking is limited to harassment, a notice of a proposed IHA is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the monitoring and reporting of the takings. The definitions of all applicable MMPA statutory terms used above are included in the relevant sections below and can be found in section 3 of the MMPA (16 U.S.C. 1362) and NMFS regulations at 50 CFR 216.103.

On May 10, 2024, NMFS received a request from Hoonah for an IHA to take marine mammals incidental to pile driving and removal activities associated with the Hoonah Cargo Dock project in Hoonah, Alaska. Following NMFS' review of the application, Hoonah submitted a revised versions on September 10, 2024 and October 15, 2024. The application was deemed adequate and complete on October 22, 2024. Hoonah's request is for take of eight species of marine mammals by Level B harassment and, for a subset of these species, Level A harassment. Neither Hoonah nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

NMFS previously issued an IHA to Hoonah for the Hoonah Cargo Dock project (86 FR 27410, May 20, 2021), and later changed the effective dates of the IHA in a re-issuance (87 FR 27571, May 9, 2022). However, due to COVID and inflation no work under the IHA was conducted. Since then, Hoonah has made several changes to their project plan and, therefore, a new IHA is appropriate.

There are no changes from the proposed IHA to the final IHA.

Hoonah plans to install a cargo dock at the Hoonah Marine Industrial Center (HMIC) in Hoonah, Alaska starting in September 2025. Work would occur on approximately 107 days over a span of 5 months. Construction of the sheet pile cargo dock, barge ramp, and breasting dolphins will require impact and vibratory pile installation and down-the-hole (DTH) drilling (referred to as tension anchoring).

The construction of the sheet pile cargo dock, barge ramp, and breasting dolphins will include the installation of 542 (330 linear feet (ft), or 100.6 linear meters (m)) steel sheet piles, 5 steel wye piles, 1 steel X pile, 3 20-inch (in), or 0.51-m steel fender piles, 2 16-in (0.41 m) fender piles, 7 H-piles, 4 36-in (0.91 m) steel pipe piles, and 6 36-in (0.91 m) steel batter piles. The installation and removal of 50 temporary 24-in (0.61 m) steel pipe piles will be completed to support the permanent pile installation. Piles will be installed with vibratory and impact hammers, and temporary piles will be removed with a vibratory hammer. 8-to-10-in (0.20 to 0.25 m) steel pipe casings will be placed in each steel pipe/batter piles as tension anchors and set with tension anchoring.

A detailed description of the planned construction project is provided in the Federal Register notice for the proposed IHA (90 FR 1084, January 7, 2025). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specified activity.

A notice of NMFS' proposal to issue an IHA to Hoonah was published in the Federal Register on January 7, 2025 (90 FR 1084). That notice described, in detail, Hoonah's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. In that notice, we requested public input on the request for authorization described therein, our analyses, the proposed authorization, and any other aspect of the notice of proposed IHA, and requested that interested persons submit relevant information, suggestions, and comments. During the 30-day public comment period, NMFS did not receive any public comments.

Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and more general information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS' website ( https://www.fisheries.noaa.gov/find-species ).

Table 1 lists all species or stocks for which take is expected and authorized for this activity and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no serious injury or mortality is anticipated or authorized here, PBR and annual serious injury and mortality (M/SI) from anthropogenic sources are included here as gross indicators of the status of the species or stocks and other threats.

Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS' U.S. Alaska and Pacific SARs. All values presented in table 1 are the most recent available at the time of publication and are available online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments.

As indicated above, all 8 species (with 12 managed stocks) in table 1 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur. All species that could potentially occur in the project area are included in table 6 of the IHA application. While gray whales and sperm whales have been documented in the area, the temporal and/or spatial occurrence of these species is such that take is not expected to occur, and they are not discussed further beyond the explanation provided here. Gray whales are considered to be very rare (no local knowledge of sightings in the project area) and sperm whales are considered to be rare (no sightings in recent years) within the project area.

Additional information relevant to our analyses (beyond that included above, in the application, and on NMFS website) is included below, as appropriate. In addition, the Northern sea otter ( Enhydra lutris kenyoni ) may be found in the project area. However, sea otters are managed by the U.S. Fish and Wildlife Service and are not considered further in this document.

A detailed description of the species likely to be affected by Hoonah's construction project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (90 FR 1084, January 7, 2025); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to the NMFS website ( https://www.fisheries.noaa.gov/find-species ) for generalized species accounts.

Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007, 2019) recommended that marine mammals be divided into hearing groups based on directly measured (behavioral or auditory evoked potential techniques) or estimated hearing ranges (behavioral response data, anatomical modeling, etc. ). Generalized hearing ranges were chosen based on the ~65 decibel (dB) threshold from composite audiograms, previous analyses in NMFS (2018), and/or data from Southall et al. (2007) and Southall et al. (2019). We note that the names of two hearing groups and the generalized hearing ranges of all marine mammal hearing groups have been recently updated (NMFS 2024) as reflected below in in table 2.

For more detail concerning these groups and associated frequency ranges, please see NMFS (2024a) for a review of available information.

The effects of underwater noise from Hoonah's pile driving and tension anchoring activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the project area. The notice of the proposed IHA (90 FR 1084, January 7, 2025) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from Hoonah's construction activity on marine mammals and their habitat. That information and analysis is referenced in this final IHA determination and is not repeated here; please refer to the notice of the proposed IHA (90 FR 1084, January 7, 2025).

This section provides an estimate of the number of incidental takes authorized through the IHA, which will inform NMFS' consideration of “small numbers,” the negligible impact determinations, and impacts on subsistence uses.

Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance, which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

Authorized takes will primarily be by Level B harassment as use of the acoustic sources ( i.e., pile driving and tension anchoring) has the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result, primarily for very high frequency species and phocids because predicted auditory injury zones are larger than for high-frequency species and otariids. The mitigation and monitoring measures are expected to minimize the severity of the taking to the extent practicable.

As described previously, no serious injury or mortality is anticipated or authorized for this activity. Below we describe how the authorized take numbers are estimated.

For acoustic impacts, generally speaking, we estimate take by considering: (1) acoustic thresholds above which NMFS believes the best available science indicates marine mammals will likely be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available ( e.g., previous monitoring results or average group size). Below, we describe the factors considered here in more detail and present the authorized take estimates.

NMFS recommends the use of acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur auditory injury of some degree (equated to Level A harassment). We note that the criteria for auditory injury, as well as the names of two hearing groups, have been recently updated (NMFS 2024a) as reflected below in the Level A Harassment section.

Level B Harassment —Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source or exposure context ( e.g., frequency, predictability, duty cycle, duration of the exposure, signal-to-noise ratio, distance to the source), the environment ( e.g., bathymetry, other noises in the area, predators in the area), and the receiving animals (hearing, motivation, experience, demography, life stage, depth) and can be difficult to predict ( e.g., Southall et al., 2007, 2021, Ellison et al., 2012). Based on what the available science indicates and the practical need to use a threshold based on a metric that is both predictable and measurable for most activities, NMFS typically uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS generally predicts that marine mammals are likely to be behaviorally harassed in a manner considered to be Level B harassment when exposed to underwater anthropogenic noise above root-mean-squared pressure received levels (RMS SPL) of 120 dB (referenced to 1 micropascal (re 1 μPa)) for continuous ( e.g., vibratory pile driving, drilling) and above RMS SPL 160 dB re 1 μPa for non-explosive impulsive ( e.g., seismic airguns) or intermittent ( e.g., scientific sonar) sources. Generally speaking, Level B harassment take estimates based on these behavioral harassment thresholds are expected to include any likely takes by temporary threshold shift (TTS) as, in most cases, the likelihood of TTS occurs at distances from the source less than those at which behavioral harassment is likely. TTS of a sufficient degree can manifest as behavioral harassment, as reduced hearing sensitivity and the potential reduced opportunities to detect important signals (conspecific communication, predators, prey) may result in changes in behavior patterns that would not otherwise occur.

Hoonah's planned activity includes the use of continuous (vibratory pile driving, tension anchoring) and impulsive (impact pile driving, tension anchoring) sources, and therefore the RMS SPL thresholds of 120 and 160 dB re 1 μPa are applicable. Tension anchoring has both continuous and intermittent components. When evaluating Level B harassment, NMFS recommends treating tension anchoring as a continuous source and applying the RMS SPL thresholds of 120 dB re 1 μPa.

Level A Harassment —NMFS' Updated Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 3.0) (Updated Technical Guidance, 2024) identifies dual criteria to assess auditory injury (Level A harassment) to five different underwater marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). Hoonah's planned activity includes the use of impulsive (impact pile driving, tension anchoring) and non-impulsive (vibratory pile driving, tension anchoring) sources. Tension anchoring includes both impulsive and non-impulsive characteristics. When evaluating Level A harassment, NMFS recommends treating tension anchoring as an impulsive source.

The 2024 Updated Technical Guidance criteria include both updated thresholds and updated weighting functions for each hearing group. The thresholds are provided in the table below. The references, analysis, and methodology used in the development of the criteria are described in NMFS' 2024 Updated Technical Guidance, which may be accessed at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance-other-acoustic-tools.

Here, we describe operational and environmental parameters of the activity that are used in estimating the area ensonified above the acoustic thresholds, including source levels and transmission loss coefficient.

The sound field in the project area is the existing background noise plus additional construction noise from the planned project. Vessel traffic and other commercial and industrial activities in the project area may contribute to elevated background noise levels which may mask sounds produced by the project. Marine mammals are expected to be affected via sound generated by the primary components of the project ( i.e., vibratory pile driving and removal, impact pile driving, and tension anchoring).

Transmission loss ( TL ) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6-dB reduction in sound level for each doubling of distance from the source (20*log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10*log[range]). A practical spreading value of 15 is often used under conditions, such as the project site, where water increases with depth as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions. Practical spreading loss is assumed here.

The intensity of pile driving sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. In order to calculate the distances to the Level A harassment and the Level B harassment sound thresholds for the methods and piles being used in this project, the applicant and NMFS used acoustic monitoring data from other locations to develop proxy source levels for the various pile types, sizes and methods. The project includes vibratory, and impact pile installation of steel pipe piles and vibratory removal of steel pipe piles, steel fender piles, steel sheet piles, steel H-piles, steel wye piles, steel X piles, and steel batter piles and tension anchoring drilling. Source levels for each pile size and driving method are presented in table 4.

NMFS recommends treating DTH systems as both impulsive and continuous, non-impulsive sound source types simultaneously. Thus, impulsive thresholds are used to evaluate Level A harassment, and continuous thresholds are used to evaluate Level B harassment. NMFS (2022) outlines its recommended source levels for DTH systems. NMFS has applied that guidance in this analysis (see table 4 for NMFS' accepted source levels).

All Level B harassment isopleths are reported in table 5 below. The maximum (underwater) area ensonified above the thresholds for behavioral harassment is 43 square kilometers (km 2 ; 16.6 square miles (mi 2 )). However, that zone will be truncated by land masses that will obstruct underwater sound transmission and will be limited to Port Fredrick (see figure 4 in Trident's application).

The ensonified area associated with Level A harassment is more technically challenging to predict due to the need to account for a duration component. Therefore, NMFS developed an optional User Spreadsheet tool to accompany the 2024 Updated Technical Guidance that can be used to relatively simply predict an isopleth distance for use in conjunction with marine mammal density or occurrence to help predict potential takes. We note that because of some of the assumptions included in the methods underlying this optional tool, we anticipate that the resulting isopleth estimates are typically going to be overestimates of some degree, which may result in an overestimate of potential take by Level A harassment. However, this optional tool offers the best way to estimate isopleth distances when more sophisticated modeling methods are not available or practical. For stationary sources such as pile driving, the optional User Spreadsheet tool predicts the distance at which, if a marine mammal remained at that distance for the duration of the activity, it would be expected to incur auditory injury. Inputs used in the optional User Spreadsheet tool, and the resulting estimated isopleths, are reported below.

The Scientific and Statistical Committee (SSC) will meet to Consider revising recommendations for the overfishing limits (OFL) and acceptable biological catches (ABC) for Atlantic herring: specifically review updated information provided by the Council's Atlantic Herring Plan Development Team (PDT) and the Atlantic States Marine Fisheries Commission's Atlantic Herring Technical Committee (TC) including: (1) Stock projections with an updated fishing year (FY) 2024 fishery catch estimate and a risk analysis prepared by the PDT/TC, and (2) Outcomes from the March 2025 peer review of the Research Track Stock Assessment and recommend Atlantic herring OFLs and ABCs for FYs 2025 and 2026, based on the new information and consider default specifications for FY2027. The Committee will also receive an overview of and discuss the SSC work plan for 2025. They will also provide input on potential themes for the ninth meeting of the Council Coordination Committee's Scientific Coordination Subcommittee. Other business will be discussed, as necessary.

Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cate O'Keefe, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

The following items are on the agenda, although agenda items may be addressed out of order (changes will be noted on the Council's website when possible.)

Although non-emergency issues not contained in this agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c).

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to Shelley Spedden, (302) 526-5251, at least 5 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

Section 315(f) of the Coastal Zone Management Act (CZMA) requires NOAA to conduct periodic evaluations of federally approved national estuarine research reserves. The evaluation process includes holding one or more public meetings, considering public comments, and consulting with interested Federal, State, and local agencies and members of the public. During the evaluation, NOAA will consider the extent to which the Wells Reserve Management Authority has met the national objectives and has adhered to the management plan approved by the Secretary of Commerce, the requirements of section 315(b)(2) of the CZMA, and the terms of financial assistance under the CZMA. When the evaluation is complete, NOAA's Office for Coastal Management will place a notice in the Federal Register announcing the availability of the final evaluation findings.

Authority: 16 U.S.C. 1461.

The Mackerel Cobia Advisory Panel (AP) will receive the final report from the Mackerel Port Meetings effort and an update on recent Council discussions relative to possible management action. The AP will discuss and provide recommendations on giant manta ray interactions with the cobia fishery, the For-Hire Electronic Reporting Improvement Amendment, For-Hire Limited Entry Amendment, and review the Council's Research and Monitoring Prioritization Plan. The AP will receive an update on activities conducted by the Citizen Science Program. Finally, AP members will participate in a mock run through of the Council's stakeholder engagement initiative, Lines of Communication.

These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES ) 5 days prior to the meeting.

Authority: 16 U.S.C. 1801 et seq.

The purpose of this meeting is to consider issues on the Pacific Council's April meeting. Topics may include Research and Data Needs, Council Operations and Priorities, and the Office of National Marine Sanctuaries Coordination Report. The HMSMT may develop supplemental reports for Pacific Council consideration.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ( kris.kleinschmidt@noaa.gov; (503) 820-2412) at least 10 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

The Scallop Committee will meet to review input from the Visioning Sessions and discuss the development of the Long-Term Scallop Strategic Plan. They will also review progress on the LAGC IFQ Program Review. Other business will be discussed, if necessary.

Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cate O'Keefe, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

The EAS will meet via webinar to discuss items relevant to ecosystem management in advance of the Pacific Council's April 10-15, 2025, meeting. A detailed meeting agenda will be available on the Pacific Council's website prior to the meeting.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ( kris.kleinschmidt@noaa.gov; (503) 820-2412) at least 10 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

The MMPA requires NMFS to authorize the incidental take of ESA-listed marine mammals in commercial fisheries provided it can make the following determinations: (1) the incidental mortality and serious injury (M/SI) from commercial fisheries will have a negligible impact on the affected species or stocks; (2) a recovery plan for all affected species or stocks of threatened or endangered marine mammals has been developed or is being developed pursuant to the ESA; and (3) where required under MMPA section 118, a take reduction plan (TRP) has been developed or is being developed, a monitoring program is established, and vessels participating in the fishery are registered. We have made a preliminary determination that the Category II CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery meets these three requirements and propose to issue a permit to the fishery to authorize the incidental take of ESA-listed marine mammal species or stocks (Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA stocks of humpback whale; CA/OR/WA stock of sperm whale) under the MMPA for a period of 3 years. We solicit public comments on the proposed issuance of the permit and the underlying preliminary determination.

The MMPA LOF classifies each commercial fishery as a Category I, II, or III fishery based on the level of mortality and injury of marine mammals occurring incidental to each fishery as defined in 50 CFR 229.2. Section 118(c)(2) of the MMPA requires fishing vessels that operate in Category I and II fisheries to register with NMFS and are subsequently authorized to incidentally take marine mammals during commercial fishing operations. However, that authorization is limited to those marine mammals that are not listed as threatened or endangered under the ESA. Section 118(a)(2) of the MMPA, 16 U.S.C. 1387(a)(2), also requires an additional authorization at section 101(a)(5) of the MMPA, 16 U.S.C. 1371, for incidental taking of ESA-listed marine mammals. Section 101(a)(5)(E) of the MMPA, 16 U.S.C. 1371, states that NMFS, as delegated by the Secretary of Commerce, for a period of up to 3 consecutive years shall allow the incidental, but not intentional, taking of marine mammal species or stocks designated as depleted because of their listing as an endangered species or threatened species under the ESA, 16 U.S.C. 1531 et seq., by persons using vessels of the United States, while engaging in commercial fishing operations, if NMFS makes certain determinations. NMFS must determine, after notice and opportunity for public comment, that: (1) incidental M/SI from commercial fisheries will have a negligible impact on the affected species or stock; (2) a recovery plan has been developed or is being developed for such species or stock pursuant to the ESA; and (3) where required under section 118 of the MMPA, a monitoring program has been established, vessels engaged in such fisheries are registered in accordance with section 118 of the MMPA, and a TRP has been developed or is being developed for such species or stock.

The LOF includes a list of marine mammal species or stocks incidentally killed or injured in each commercial fishery. We evaluated ESA-listed stocks or species included on the final 2024 MMPA LOF (89 FR 12257, February 16, 2024) as killed or seriously injured following NMFS' Procedural Directive 02-238 “Process for Distinguishing Serious from Non-Serious Injury of Marine Mammals.” Based on this evaluation, we propose to issue a permit under MMPA section 101(a)(5)(E) to vessels registered in the Category II CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery, as classified on the final 2024 MMPA LOF, to incidentally kill or seriously injure individuals from the Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA stocks of humpback whale and CA/OR/WA stock of sperm whale.

NMFS regularly evaluates commercial fisheries for purposes of making a negligible impact determination (NID) and issuing section 101(a)(5)(E) authorizations with the annual LOF as new information becomes available. More information about the fisheries is available in the 2024 MMPA LOF (89 FR 12257, February 16, 2024) and on the internet at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/list-fisheries-summary-tables.

We reviewed the best available scientific information to determine if the fishery met the three requirements of MMPA section 101(a)(5)(E) for issuing a permit. This information is included in the 2024 MMPA LOF (89 FR 12257, February 16, 2024), the SARs for these species (available at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports ), recovery plans for these species (available at: https://www.fisheries.noaa.gov/national/endangered-species-conservation/recovery-species-under-endangered-species-act ), and other relevant information, as detailed further in the document describing the preliminary determination supporting the permit (available at: https://www.regulations.gov/docket/NOAA-NMFS- 2025-0007).

Prior to issuing a MMPA 101(a)(5)(E) permit to take ESA-listed marine mammals incidental to commercial fishing, NMFS must determine if the M/SI incidental to commercial fisheries will have a negligible impact on the affected marine mammal species or stocks. NMFS satisfies this requirement by making a NID. Although the MMPA does not define “negligible impact,” NMFS has issued regulations providing a qualitative definition of “negligible impact,” defined in 50 CFR 216.103, as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

NMFS uses a quantitative approach for determining negligible impact detailed in NMFS Procedural Directive 02-204-02 (directive), “Criteria for Determining Negligible Impact under MMPA section 101(a)(5)(E),” which became effective on June 17, 2020 (NMFS 2020). The procedural directive is available online at: https://www.fisheries.noaa.gov/national/laws-and-policies/protected-resources-policy-directives. The directive describes NMFS' process for determining whether incidental M/SI from commercial fisheries will have a negligible impact on ESA-listed marine mammal species/stocks (the first requirement necessary for issuing a MMPA section 101(a)(5)(E) permit as noted above).

The directive first describes the derivation of two Negligible Impact Thresholds (NIT), which represent levels of removal from a marine mammal species or stock. The first, Total Negligible Impact Threshold (NIT t ), represents the total amount of human-caused M/SI that NMFS considers negligible for a given stock. The second, lower threshold, Single NIT (NIT s ) represents the level of M/SI from a single commercial fishery that NMFS considers negligible for a stock. NIT s was developed in recognition that some stocks may experience non-negligible levels of total human-caused M/SI but one or more individual fisheries may contribute a very small portion of that M/SI, and the effect of an individual fishery may be considered negligible.

The directive describes a detailed process for using these NIT values to conduct a NID analysis for each fishery classified as a Category I or II fishery on the MMPA LOF. The NID process uses a two-tiered analysis. The Tier 1 analysis first compares the total human-caused M/SI for a particular stock to NIT t . If NIT t is not exceeded, then all commercial fisheries that kill or seriously injure the stock are determined to have a negligible impact on the particular stock. If NIT t is exceeded, then the Tier 2 analysis compares each individual commercial fishery's M/SI for a particular stock to NIT s . If NIT s is not exceeded, then the commercial fishery is determined to have a negligible impact on that particular stock. For transboundary, migratory stocks, where the M/SI that occurs outside of U.S. waters is uncertain, we assume that total M/SI exceeds NIT t and proceed directly to the Tier 2 NIT s analysis. If a commercial fishery has a negligible impact across all ESA-listed stocks, then the first of three findings necessary for issuing a MMPA 101(a)(5)(E) permit to the commercial fishery has been met ( i.e., a NID). If a commercial fishery has a non-negligible impact on any ESA-listed stock, then NMFS cannot issue a MMPA 101(a)(5)(E) permit for the fishery to incidentally take ESA-listed marine mammals.

These NID criteria rely on the best available scientific information, including estimates of a stock's minimum population size and human-caused M/SI levels, as published in the most recent SARs and other supporting documents, as appropriate. Using these inputs, the quantitative negligible impact thresholds allow for straightforward calculations that lead to clear negligible or non-negligible impact determinations for each commercial fishery analyzed. In rare cases, robust data may be unavailable for a straightforward calculation, and the directive provides instructions for completing alternative calculations or assessments where appropriate.

NMFS evaluated the impact of the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery following the directive and based on the best available scientific information, made a preliminary NID. The NID analysis is presented in the accompanying MMPA 101(a)(5)(E) evaluation document that provides summaries of the information used to evaluate each ESA-listed stock documented on the 2024 MMPA LOF as killed or injured incidental to the fishery (available at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/list-fisheries-summary-tables ). The draft MMPA 101(a)(5)(E) evaluation document is available at: https://www.regulations.gov/docket/NOAA-NMFS-2025-0007.

The Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA stocks of humpback whale are transboundary stocks. The CA/OR/WA stock of sperm whales is also a transboundary stock based on the description of the stock's geographic range in the 2023 SAR (Carretta et al. 2024). A recent study by Wild et al. (2024) found that after foraging in the Gulf of Alaska, tagged male sperm whales travelled south, along the west coast of North America, down to Mexican waters. Because the M/SI that occurs outside of U.S. waters for these transboundary stocks is uncertain, we assumed that total M/SI exceeds NIT t for these stocks and proceeded directly to the Tier 2 NIT s analysis.

Based on the criteria outlined in the directive, the most recent SARs, and the best available scientific information, NMFS has determined that the M/SI of Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA stocks of humpback whale and CA/OR/WA stock of sperm whale incidental to the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery will have a negligible impact on these stocks. Accordingly, this MMPA 101(a)(5)(E) requirement is satisfied for CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery (see draft MMPA 101(a)(5)(E) determination document is available at: https://www.regulations.gov/docket/NOAA-NMFS-2025-0007 ). Summaries of the NID analyses are provided below.

The Category II CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery has documented incidental M/SI of the Central America/Southern Mexico-CA/OR/WA stock of humpback whale. The 2022 SAR includes a mean annual total commercial fishery-related M/SI (8.1) (data from 2016-2020) for the Central America/Southern Mexico-CA/OR/WA stock of humpback whale (Carretta et al. 2023). This comprises M/SI from all commercial fisheries, including the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery, as well as fishery-related M/SI for the stock not assigned to a specific commercial fishery.

A more recent publication, Carretta 2023, includes bycatch data from 1990 through 2022 for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery. Using M/SI from 2018-2022 from Carretta 2023, estimated M/SI of humpback whales (Central America/Southern Mexico-CA/OR/WA stock) in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery is 0.170 (Carretta 2023). Since this M/SI (0.170) is less than NIT s (0.68), NMFS preliminarily determined that the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery has a negligible impact on the Central America/Southern Mexico-CA/OR/WA stock of humpback whale (see accompanying MMPA 101(a)(5)(E) evaluation document).

The Category II CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery has documented incidental M/SI of the Mainland Mexico-CA/OR/WA stock of humpback whale. The 2022 SAR includes a mean annual total commercial fishery-related M/SI (11.4) (data from 2016-2020) for the Mainland Mexico-CA/OR/WA stock of humpback whale (Carretta et al. 2023). This comprises M/SI from all commercial fisheries, including the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery, as well as fishery-related M/SI for the stock not assigned to a specific commercial fishery.

A more recent publication, Carretta 2023, includes bycatch data from 1990 through 2022 for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery. Using M/SI from 2018-2022, estimated M/SI of humpback whales (Mainland Mexico-CA/OR/WA stock) in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery is 0.231 (Carretta 2023). Since this M/SI (0.231) is less than NIT s (1.70), NMFS preliminarily determined that the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery has a negligible impact on the Mainland Mexico-CA/OR/WA stock of humpback whale (see accompanying MMPA 101(a)(5)(E) evaluation document).

The Category II CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery has documented incidental M/SI of the CA/OR/WA stock of sperm whale in the 2023 SAR. Mean annual total commercial fishery-related M/SI for the CA/OR/WA stock of sperm whales from 2017-2021 is 0.52 (Carretta et al. 2024). This comprises M/SI from all commercial fisheries, including the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery, as well as fishery-related M/SI for the stock not assigned to a specific commercial fishery.

Carretta 2023, includes bycatch data from 1990 through 2022 for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery. Using M/SI from 2018-2022, estimated M/SI of sperm whales (CA/OR/WA stock) in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery is 0.00 (Carretta 2023). Since this M/SI (0.00) is less than NIT s (0.523), NMFS preliminarily determined that the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery has a negligible impact on the CA/OR/WA stock of sperm whale (see accompanying MMPA 101(a)(5)(E) evaluation document).

The most recent SARs for the Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA stocks of humpback whale and CA/OR/WA stock of sperm whale include fishery-related M/SI not assigned to a specific commercial fishery. This unattributed fishery-related M/SI could be from any number of commercial, recreational, or tribal fisheries. However, because this fishery is observed (~20 percent observer coverage) we are confident that any unobserved humpback or sperm whale M/SI in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery is accounted for in the model-based M/SI estimates for these stocks (Carretta 2023). Given this, any unattributed fishery-related M/SI that may be incidental to this specific commercial fishery is already accounted for, and we did not include unattributed mortality in the calculations for NID Tier 2 analyses (described above). NMFS is actively monitoring the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery through a fishery observer program. If additional fishery-related M/SI is documented through the observer program and required reporting that indicates additional M/SI of the Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA stocks of humpback whale or CA/OR/WA stock of sperm whale is occurring, then NMFS will re-evaluate the NIDs and the permit.

A recovery plan for sperm whales has been developed (see https://www.fisheries.noaa.gov/national/endangered-species-conservation/recovery-species-under-endangered-species-act ).

A recovery plan for the globally ESA-listed humpback whale species was developed in 1991. In 2016, NMFS revised the listing status of the humpback whale under the ESA. The globally listed endangered species was divided into 14 distinct population segments (DPSs), the species-level listing was removed, and NMFS listed four DPSs as endangered and one DPS as threatened (81 FR 62260, September 8, 2016). In June 2022, NMFS published a recovery outline for the Central America, Mexico, and Western North Pacific DPSs of humpback whales ( https://www.fisheries.noaa.gov/resource/document/recovery-outline-central-america-mexico-and-western-north-pacific-distinct ). The recovery outline serves as an interim guidance document and, with the existing species-wide recovery plan, directs recovery efforts, including recovery planning, for the Central America and Mexico DPSs of humpback whales. These DPSs correspond with the Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA stocks of humpback whales, respectively. Once finalized, the new recovery plan will replace the species-wide recovery plan.

Accordingly, the requirement that a recovery plan has been developed pursuant to the ESA is satisfied.

The MMPA section 118 requires the development and implementation of a TRP for each strategic stock that interacts with a Category I or II fishery. Subject to available funding, the Secretary shall give highest priority to the development of TRPs for species or stocks whose M/SI exceeds potential biological removal level, have a small population size, and which are declining most rapidly. The stocks considered for these permits are designated as strategic stocks under the MMPA because the stocks or a component of the stocks are listed as threatened species or endangered species under the ESA (MMPA section 3(19)(C)). A TRP for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery and the affected marine mammal species or stocks (Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA stocks of humpback whale and CA/OR/WA stock of sperm whale) has been developed ( see Pacific Offshore Cetacean Take Reduction Plan).

Accordingly, the requirement under MMPA section 118 to have a TRP in place or in development is satisfied (see preliminary determination supporting the permit available on the internet at https://www.regulations.gov/docket/NOAA-NMFS-2025-0007 ).

Under MMPA section 118(d), NMFS is to establish a program for monitoring incidental M/SI of marine mammals from commercial fishing operations. The CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery is monitored by a NMFS fishery observer program. Accordingly, the requirement under MMPA section 118 to have a monitoring program in place is satisfied.

MMPA section 118(c) requires that vessels participating in Category I and II fisheries register to obtain an authorization to take marine mammals incidental to fishing activities. NMFS has integrated the MMPA registration process, implemented through the Marine Mammal Authorization Program, with existing state and Federal fishery license, registration, or permit systems for Category I and II fisheries on the LOF. Therefore, the requirement for vessel registration is satisfied.

Based on the above evaluation for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery as it relates to the three requirements of MMPA section 101(a)(5)(E), we propose to issue a MMPA 101(a)(5)(E) permit to the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery to authorize the incidental take of ESA-listed species or stocks during commercial fishing operations. If, during the 3-year authorization, there is a significant change in the information or conditions used to support any of these determinations, NMFS will re-evaluate whether to amend or modify the authorization, after notice and opportunity for public comment. NMFS solicits public comments on the proposed permit and the preliminary determinations supporting the permit.

ESA section 7(a)(2) requires Federal agencies to ensure that actions they authorize, fund, or carry out do not jeopardize the continued existence of any species listed under the ESA, or destroy or adversely modify designated critical habitat of any ESA-listed species. The effects of CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery on ESA-listed marine mammals for which a permit is proposed here, were analyzed in the appropriate ESA section 7 Biological Opinion on the commercial fishery (see https://repository.library.noaa.gov/view/noaa/51058 ), and incidental take was exempted for those ESA-listed marine mammals for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery in accordance with the Biological Opinions' incidental take statement. Under section 7 of the ESA, Biological Opinions quantify the effects of the proposed action on ESA-listed species and their critical habitat and, where appropriate, exempt take of ESA-listed species that is reasonably certain to occur, as specified in the incidental take statement.

Under MMPA section 101(a)(5)(E), NMFS analyzes previously documented M/SI incidental to commercial fisheries through the NID process, and when the necessary findings can be made, issues a MMPA section 101(a)(5)(E) permit that allows for an unspecified amount of incidental taking of specific ESA-listed marine mammal stocks while engaging in commercial fishing operations. Thus, the applicable standards and resulting analyses under the MMPA and ESA differ, and as such, do not always align.

NEPA requires Federal agencies to evaluate the impacts of alternatives for their actions on the human environment. Because the proposed permit would not modify any fishery operation and the effects of the fishery operations have been evaluated in accordance with NEPA, no additional NEPA analysis beyond that conducted for the associated Fishery Management Plans is required for the permit. Issuing the proposed permit would have no additional impact on the human environment or effects on threatened or endangered species beyond those analyzed in these documents.

Meeting information, including the webinar registration link, online public comment form, agenda, and briefing book materials will be posted on the Council's website at: https://safmc.net/council-meetings/. Comments become part of the Administrative Record of the meeting and will automatically be posted to the website and available for Council consideration.

At this meeting, the Council's Executive Committee will review the 2025 Council budget and the status of funding disbursements. The Committee will consider if the 2025 budget requires modifications to address funding levels and availability. The meeting will include a closed session to discuss personnel and contract topics.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES ) 5 days prior to the meeting.

Note: The times and sequence specified in this agenda are subject to change.

Authority: 16 U.S.C. 1801 et seq.

The Pacific Council is scheduled to identify preliminary research and data need priorities during their April 2025 meeting, to address the Magnuson-Stevens Act requirement for Council's to develop and communicate multi-year research needs in order to support the management of U.S. west coast fisheries. The Pacific Council's Scientific and Statistical Committee recommendations on current research and data needs will be published in the advanced briefing book material prior to this briefing. The briefing presentation is aimed at a broad audience of Pacific Council members, advisory body members, and the public.

The Pacific Council and the Pacific Council's Scientific and Statistical Committee are scheduled to consider preliminary research and data need priorities at their April 2025 meeting in San Jose, CA.

Although nonemergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent of the workshop participants to take final action to address the emergency.

Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ( kris.kleinschmidt@noaa.gov; (503) 820-2412) at least 10 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

On 12/17/2024 (89 FR 104108), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.

After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the service(s) and impact of the additions on the current or most recent contractors, the Committee has determined that the service(s) listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the service(s) to the Government.

2. The action will result in authorizing small entities to furnish the service(s) to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service(s) proposed for addition to the Procurement List.

Accordingly, the following service(s) are added to the Procurement List:

On 1/7/2025 (90 FR 9136), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.

After consideration of the relevant matter presented, the Committee has determined that the service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the service(s) to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service(s) deleted from the Procurement List.

Accordingly, the following and service(s) are deleted from the Procurement List:

This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

In accordance with 41 CFR 51-5.3(b), the Committee intends to add this services requirement to the Procurement List as a mandatory purchase only for the contracting activity listed at the location listed with the proposed qualified nonprofit agency as the authorized source of supply. Prior to adding the service to the Procurement List, the Committee will consider other pertinent information, including information from Government personnel and relevant comments from interested parties regarding the Committee's intent to geographically limit this services requirement.

The following service(s) are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

The following product(s) are proposed for deletion from the Procurement List:

This meeting is being held under the provisions of chapter 10 of title 5, United States Code ((commonly known as the “Federal Advisory Committee Act” or “FACA”), section 552b of title 5, United States Code (popularly known as the “Government in the Sunshine Act”), and 41 CFR 102-3.140 and 102-3.150.

The purpose of this Department of the Air Force Scientific Advisory Board meeting is to provide dedicated time for members to begin collaboration on research and formally commence the Department of the Air Force Scientific Advisory Board's FY25 Secretary of the Air Force directed studies.

[All times are Eastern Time].

In accordance with section 1009(d) of title 5, United States Code and 41 CFR 102-3.155, the Administrative Assistant of the Air Force, in consultation with the Air Force General Counsel, has agreed that the public interest requires this meeting of the United States Department of the Air Force Scientific Advisory Board be closed to the public because it will involve discussions involving classified matters covered by section 552b(c)(1) of title 5, United States Code.

Written Statements: Any member of the public wishing to provide input to the United States Department of the Air Force Scientific Advisory Board should submit a written statement in accordance with 41 CFR 102-3.140(c), section 1009(a)(3) of title 5, United States Code, and the procedures described in this paragraph. Written statements can be submitted to the Designated Federal Officer at the address detailed above at any time. The Designated Federal Officer will review all submissions with the Department of the Air Force Scientific Advisory Board Chairperson and ensure they are provided to members of the Department of the Air Force Scientific Advisory Board. Written statements received after the meeting that is the subject of this notice may not be considered by the Scientific Advisory Board until the next scheduled meeting.

In July 2019, the Navy defended lawsuits in the U.S. District Court for the Western District of Washington challenging the Navy's 2018 Final Environmental Impact Statement (EIS) and 2019 Record of Decision (ROD) for EA-18G “Growler” Airfield Operations at Naval Air Station (NAS) Whidbey Island Complex. These cases were later consolidated.

In 2022, the Court found the Navy's EIS and ROD violated the National Environmental Policy Act (NEPA) by “failing to disclose the basis for greenhouse gas emissions calculations, failing to quantify the impact of increased operations on classroom learning, failing to take a hard look at species-specific impacts on birds, and failing to give detailed consideration to the El Centro, California, alternative.” All other claims were dismissed with prejudice. Therefore, the public meetings for the Draft Amended Analysis will be limited to these four areas identified by the Court.

Notice of the availability of the Draft Amended Analysis was distributed to federal, state, and local agencies, elected officials, local tribes (Jamestown S'Klallam Tribe, Lummi Tribe of the Lummi Reservation, Samish Indian Nation, Stillaguamish Tribe of Indians of Washington, Suquamish Indian Tribe of the Port Madison Reservation, Swinomish Indian Tribal Community, Tulalip Tribes of Washington, Upper Skagit Indian Tribe, and organizations.

Based on available information, it appears that constraints on transits through the English Channel, the Malacca Strait, the Northern Sea Passage, the Singapore Strait, the Panama Canal, the Strait of Gibraltar, and the Suez Canal may have created shipping conditions that call for careful consideration by the Federal Maritime Commission (Commission) in connection with the determination of its policies and the carrying out of its duties. The Commission has a statutory mandate to monitor and evaluate conditions affecting shipping in U.S. foreign trade. 46 U.S.C. 42101. Section 42101(a) provides that the Commission “shall prescribe regulations affecting shipping in foreign trade . . . to adjust or meet general or special conditions unfavorable to shipping in foreign trade,” when those conditions are the result of a foreign country's laws or regulations or the “competitive methods, pricing practices, or other practices” used by the owners, operators, or agents of “vessels of a foreign country.”

The Commission will conduct this investigation in accordance with its procedures for a nonadjudicatory investigation set forth in 46 CFR part 502, subpart R.

Recent events have indicated that transit constraints at several critical points in the global shipping supply chain have led to conditions that are appropriate for the Commission to investigate. Such constraints have affected transits through the English Channel, the Malacca Strait, the Northern Sea Passage, the Singapore Strait, the Panama Canal, the Strait of Gibraltar, and the Suez Canal. The significance of these chokepoints is described below.

The English Channel, with its narrow width of 21 miles and heavy traffic, experiences congestion, limited passing opportunities, and an elevated risk of collisions, especially near busy ports like Dover and Calais. 1 Navigational challenges are compounded by strong tidal currents, variable weather conditions, and hazards such as shallow areas and sandbanks, requiring precise maneuvering. The region's strict environmental regulations, geopolitical tensions, security risks, and ongoing issues like smuggling and illegal migration can further cause delays and disruptions. Additionally, political developments, border controls, and customs checks add complexities, with the Channel's proximity to sensitive areas between the UK and France sometimes leading to heightened security concerns.

The Malacca Strait, with its narrow width, shallow areas, and limited navigational infrastructure in remote sections, presents significant challenges for large vessels, particularly in low visibility or harsh weather conditions such as monsoons, storms, and strong currents. These factors increase the risk of accidents and restrict the passage of deep-draft vessels. The high traffic volume, especially during peak seasons, leads to congestion, delays, and limited passing opportunities, further heightening the risk of accidents. Piracy, including hijackings and robberies, remains a significant concern, particularly in remote areas, while regional political instability and territorial disputes create additional security risks and potential disruptions  2 to transit.

The Northern Sea Passage is emerging as a critical maritime chokepoint as new shipping routes open, a development that could reshape global trade patterns. As the region's waters become ice-free for longer periods, the Northern Sea Passage offers a shortcut between Europe and Asia, reducing travel time and fuel consumption. However, this has sparked competition over governance, with Russia seeking control over the shortest maritime route between Europe and Asia, and imposing fees, while other nations push for international access. The Northern Sea Passage's strategic importance is further amplified by increased military activity from Russia and China, including new bases  3 and icebreakers, 4 reflecting its growing value for nuclear deterrence and missile defense. As a result, both Russia and NATO forces are ramping up their military presence, increasing the potential for tensions and conflicts  5 over access to the region's trade routes and resources.

The narrow Singapore Strait presents significant challenges for maritime navigation, with limited passing opportunities that increase delays and the risk of accidents, particularly for large vessels that require precise navigation in congested areas. Shallow zones restrict the passage of deep-draft vessels, necessitating careful maneuvering to avoid grounding. 6 The Strait is also subject to unpredictable weather conditions, including heavy rains, storms, and strong currents, which can slow vessel movement and complicate navigation, especially for larger ships. Environmental risks such as oil spills, marine pollution, and stringent regulations further constrain passage and cause delays. Although piracy has decreased, the Strait still faces security threats, including hijackings and robberies  7 in remote areas, along with potential disruptions due to regional political tensions.

While the Panama Canal underwent a major expansion in 2016 with the addition of a third set of locks to accommodate “New Panamax” vessels, 8 it still faces significant capacity limitations and cannot accommodate the largest ships, such as ultra-large container vessels. During periods of high demand, congestion leads to delays, causing costly disruptions to global supply chains. 9 The canal relies on freshwater from nearby lakes to operate its locks, and prolonged droughts, exacerbated by unpredictable rainfall patterns, can significantly reduce available water levels, impacting its functionality and efficiency. These environmental factors increase the canal's vulnerability to operational disruptions, especially during dry spells.

The Panama Canal also holds substantial geopolitical importance, crucial to the interests of the United States. Political instability or disruptions in its operation could have far-reaching consequences.

Panama's Ship Registry is one of the world's largest ship registries with over 8,000 vessels reportedly registered under the Panamanian flag. Remedial measures the Commission can take in issuing regulations to address conditions unfavorable to shipping in U.S. foreign trade include refusing entry to U.S. ports by vessels registered in countries responsible for creating unfavorable conditions. See 46 U.S.C. 42107.

The Strait of Gibraltar, at just eight miles wide, is one of the world's busiest shipping lanes, with heavy traffic and limited space for large vessels, raising the risk of collisions, congestion, and delays, especially during peak periods. 10 Navigational challenges such as strong currents, winds, and fog further complicate passage, while environmental risks like oil spills and pollution, along with strict regulations, create additional constraints. Geopolitical tensions between Spain, Morocco, 11 and issues surrounding the status of Gibraltar, along with piracy and smuggling, contribute to security concerns and potential disruptions in the region.

The Suez Canal, handling between 10% and 12% of global trade, 12 is one of the busiest waterways in the world. Its narrow width and single-lane format often leads to delays, especially during peak seasons. Events such as the 2021 Ever Given blockage highlighted the canal's vulnerabilities, causing massive trade disruptions, 13 while its shallow depth makes it prone to weather-related issues, further increasing the risk of accidents. The canal's strategic importance also makes it a focal point for geopolitical tensions, including conflicts involving the Houthis and the Gaza Crisis, 14 as well as threats from piracy and terrorism. Additionally, environmental concerns have arisen due to the potential spread of invasive species by ships passing through the waterway.

The Commission notes that other significant constraints affecting U.S. shipping may arise quickly in the global maritime environment. For example, when the Singapore-flagged containership Dali struck a bridge in Baltimore, Maryland in March 2024, six people were killed and maritime access to the Port of Baltimore was blocked, a situation that persisted for many weeks and led to losses that have been estimated to reach as high as $4 billion. 15

The Commission will investigate whether constraints in global maritime chokepoints have created unfavorable shipping conditions caused by the laws, regulations or practices of foreign governments or the practices of foreign-flag vessel owners or operators. The Commission “has extensive regulatory duties under the various acts it is charged with administering,” and conducting investigations is “essential to the proper exercise” of those duties.” 46 CFR 502.281. In particular, the Commission is authorized to initiate investigations on its own motion “when in its discretion the Commission determines that information is required for the purpose of rulemaking or is necessary or helpful in the determination of its policies or the carrying out of its duties, including whether to institute formal proceedings directed toward determining whether any of the laws which the Commission administers have been violated.” 46 CFR 502.282. Among the Commission's duties are to identify in its annual report to Congress “any otherwise concerning practices by ocean common carriers” with certain characteristics identified by Congress. 46 U.S.C. 46106(b)(7). Accordingly, the Commission, upon issuing an Order of Investigation, may authorize its representatives to conduct such an investigation; may hold investigational hearings; may issue orders or subpoenas to gather testimony or documentary evidence; may order that testimony be taken by deposition; and may order the filing of reports or answers to written questions. 46 CFR 502.283 through 502.288; see generally 46 CFR part 502, subpart R (Nonadjudicatory Investigations).

At the early stage of the investigation, the Commission will focus on providing a route for interested parties to provide information, perspectives, and proposed solutions. Discussion of remedial measures or any other actions, if needed, would occur later in the process, and would be accompanied by the opportunity for additional public comment.

The Commission has determined that the above-described situation meets the threshold requirements for consideration under the relevant regulatory authority. See 46 CFR part 502, subpart R. The Commission has therefore determined to initiate an investigation. See 46 CFR 502.282. The Commission has designated its General Counsel to lead the investigation. The General Counsel will update the Commission quarterly on the status of constraints in the maritime chokepoints identified herein, as well as any similar issues that may arise, and may propose that the Commission initiate one or more specific proceedings under 46 U.S.C. 42101 and related statutes. To that end, the Commission issues this Order of Investigation. See 46 CFR 502.283.

Interested persons are requested to submit written comments containing experiences, arguments, and/or data relevant to the above-described maritime chokepoints, particularly concerning the effects of laws, regulations, practices or other actions by foreign governments, and/or the practices of owners or operators of foreign-flag vessels, on shipping conditions in these chokepoints. The Commission's jurisdiction under 46 CFR 502.282 is broad, and the agency welcomes comments not only from government authorities and container shipping interests, but also from tramp operators, bulk cargo interests, vessel owners, individuals and groups with relevant information on environmental and resource-conservation considerations, and anyone else with relevant information or perspectives on these matters.

In particular, the Commission welcomes information and perspectives on the following:

1. What are the causes, nature, and effects, including financial and environmental effects, of constraints on one or more of the maritime chokepoints described above?

2. To what extent are constraints caused by or attributable to the laws, regulations, practices, actions, or inactions of one or more foreign governments?

3. To what extent are constraints caused by or attributable to the practices, actions, or inactions of owners or operators of foreign-flag vessels?

4. What will likely be the causes, nature, and effects, including financial and environmental effects, of any continued transit constraints during the rest of 2025?

5. What are the best steps the Commission might take, over the short term and the long term, to alleviate transit constraints and their effects?

6. What are the obstacles to implementing measures that would alleviate the above transit constraints and their effects, and how can these be addressed?

As the Commission proceeds with this investigation, it may determine to request additional comment or gather information through other means as authorized under 46 CFR part 502, subpart R.

Copies of the agency questions are available at the following links:

FMCS solicits comments to:

i. Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.

ii. Enhance the accuracy of the agency's estimates of the burden of the proposed collection of information.

iii. Enhance the quality, utility, and clarity of the information to be collected.

iv. Minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic collection technologies or other forms of information technology.

Agency: Federal Mediation and Conciliation Service.

Title: Stakeholder Survey for Qualitative Feedback on Agency Service Delivery.

OMB Number: 3076-0017.

Type of Request: Extension without change of a currently approved collection.

Affected Public: Federal government, Private Sector, to include businesses or other for-profits and not-for-profit institutions, and State and local governments.

Frequency: Annually.

Burden: The total annual burden estimate is that FMCS will receive approximately 1,213 responses per year that will take about 3 minutes each to complete.

This information collection provides a means to garner qualitative client and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. This feedback will provide insights into client or stakeholder perceptions, experiences, and expectations. The surveys will provide notice of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services.

The surveys are not statistical surveys that yield quantitative results that can be generalized to the population of study. These collections will allow for ongoing, collaborative, and actionable communication between the Agency and its clients and stakeholders. It will also allow feedback to contribute directly to improving program management. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. Collecting this information is critical for ensuring quality service offered to the public.

The official records are electronic records.

The general public uses Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453, to request the use of public space in Federal buildings and on Federal grounds for cultural, educational, or recreational activities. A copy, sample, or description of any material or item proposed for distribution or display must also accompany this request.

Respondents: 8,000.

Responses per Respondent: 1.

Hours per Response: 0.05.

Total Burden Hours: 400.

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.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division, by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 3090-0044, Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453, in all correspondence.

Sage has informed FDA that ZULRESSO (brexanolone) solution, 100 mg/20 mL, is no longer marketed and has requested that FDA withdraw approval of NDA 211371 under the process in § 314.150(c) (21 CFR 314.150(c)). Sage has also, by its request, waived its 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 NDA 211371, and all amendments and supplements thereto, is hereby withdrawn as of April 14, 2025. Approval of the entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from this notice. Introduction or delivery for introduction into interstate commerce of ZULRESSO (brexanolone) solution, 100 mg/20 mL, 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)). Any ZULRESSO (brexanolone) solution, 100 mg/20 mL, that is in inventory on April 14, 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.

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 April 14, 2025. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved new drug application or ANDA 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 April 14, 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.

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 April 14, 2025. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved new drug application or ANDA 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 April 14, 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.

Section 306(a)(2)(A) of the FD&C Act mandates permanent debarment if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. On June 20, 2023, following a guilty plea, the U.S. District Court for the Southern District of Florida-Miami Division entered a judgment against Garmendia for one count of conspiracy to commit wire fraud in violation of 18 U.S.C. 1349.

Garmendia's conviction is based upon conduct from on or about September 2015 through on or about March 2018, committed in his capacity at AMB Research Center, Inc. (AMB Research), a medical clinic that conducted clinical trials of new drugs for pharmaceutical companies and sponsors. Garmendia was co-owner of AMB Research and served as vice president and back-up study coordinator. Garmendia and his co-conspirators did willfully, that is, with the intent to further the object of the conspiracy, and knowingly combine, conspire, confederate, and agree with each other to commit wire fraud, that is: to knowingly, and with the intent to defraud, devise and intend to devise a scheme and artifice to defraud and to obtain money and property by means of materially false and fraudulent pretenses, representations, and promises, knowing that the pretenses, representations, and promises were false and fraudulent when made, and, for the purpose of executing the scheme and artifice, did transmit and cause to be transmitted by means of wire communication and interstate and foreign commerce, certain writings, signs, signals, pictures, and sounds, in violation of 18 U.S.C. 1349.

Specifically, AMB Research entered into a clinical trial agreement with a contract research organization to lead a pharmaceutical company's clinical trial designed to evaluate the safety and efficacy of an investigational drug intended to treat persons with Clostridium difficile-associated diarrhea (CDAD clinical trial). Garmendia and his co-conspirators conspired to unlawfully enrich themselves by, among other things, securing contracts to conduct the CDAD clinical trial; fabricating and falsifying documents, study data, and other items related to the CDAD clinical trial to obtain payments and inflate the payments due and owing to the conspirators under the clinical trial agreement; receiving payment for the CDAD clinical trial by making material false and fraudulent representations; and using the fraudulently obtained funds for personal use and benefit, the use and benefit of others, and to further the conspiracy. Garmendia's conduct included direct involvement in falsifying and fabricating study documents. In addition, Garmendia transported study documents to the principal investigator for purposes of obtaining a signature for the CDAD clinical trial at AMB Research. Garmendia received $80,027.44 in proceeds from payments made to AMB Research for the CDAD clinical trial.

Garmendia is subject to permanent debarment based on a finding by the Office of Regulatory Affairs (ORA), under section 306(a)(2)(A) of the FD&C Act, that he was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. By letter dated January 8, 2024, ORA informed Garmendia of the proposal to permanently debar him from providing services in any capacity to a person having an approved or pending drug product application. The letter also offered Garmendia an opportunity to request a hearing, providing 30 days from the date of Garmendia's receipt of the letter in which to file the request and 60 days from the date of Garmendia's receipt of the letter to support any hearing request with information sufficient to justify a hearing. In a letter dated February 6, 2024, Garmendia requested a hearing. More than 60 days have passed from the date Garmendia received ORA's letter, and Garmendia has not filed any additional information to justify a hearing.

Under the authority delegated to him by the Commissioner of Food and Drugs, the Director, Office of Scientific Integrity (OSI Director), has considered Garmendia's request for a hearing. Hearings will be granted upon a showing of a genuine and substantial issue of fact; not on issues of policy or law, on mere allegations, denials, or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged, even if accurate (see 21 CFR 12.24(b)). Garmendia has failed to present any arguments or evidence raising a genuine and substantial issue of fact to support his hearing request. Accordingly, the OSI Director denies Garmendia's request for a hearing.

Therefore, the OSI Director, under section 306(a)(2)(A) of the FD&C Act and authority delegated to him by the Commissioner of Food and Drugs, finds that Garmendia has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product.

As a result of the foregoing findings, Garmendia is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective March 14, 2025 (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any person with an approved or pending drug product application, who knowingly uses the services of Garmendia, in any capacity during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Garmendia, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Garmendia during his period of debarment (section 306(c)(1)(B) of the FD&C Act).

The Office of the Secretary (OS) Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Office of the General Counsel (OGC), should now read as follows:

The General Counsel is responsible for providing all legal services and advice to the Secretary, Deputy Secretary, and all subordinate organizational components of the Department, which legal advice, to the maximum extent permitted under Executive Order 14215 (Feb. 18, 2025), shall be binding on the Department unless overturned by the Secretary. Under direction of the General Counsel, the Office of the General Counsel (OGC) serves as the sole officially designated source of legal advice and services to the Department's operating and staff divisions (except the OIG) to ensure that all the operating and staff divisions receive uniform advice. OIG is authorized to have its own Office of the Counsel to the Inspector General (OCIG) with respect to matters solely within the OIG's jurisdiction. See 62 FR 30859 (June 5, 1997).

The Office of the General Counsel, under the supervision of a General Counsel, consists of:

The Immediate Office of the General Counsel consists of the General Counsel, his or her executive assistant(s), a Principal Deputy General Counsel, such other Deputy General Counsel as the Secretary deems appropriate and appoints, such other Special Assistant Deputy General Counsel, Senior Counsel, Counsel, Senior Advisors and attorneys and staff as the General Counsel deems appropriate, and the Office of Legal Resources (OLR).

a. The General Counsel. The General Counsel is the chief legal officer of the Department and is directly responsible to the Secretary.

b. Principal Deputy General Counsel. The Principal Deputy General Counsel is the second-ranking legal officer of the Department and is usually a non-career inferior officer appointed by the Secretary and is directly responsible to the General Counsel and the Secretary.

c. Deputy General Counsel. The Deputy General Counsel report to the General Counsel and each shall be responsible for overseeing such substantive legal areas and corresponding OGC portfolios as designated by the General Counsel. Deputy General Counsel may be assigned oversight of one or more portfolios within the Office of the General Counsel. In addition, certain Deputy General Counsel may generally be responsible for OGC management and operations, oversight of OLR, and such litigation, substantive, or programmatic portfolios and other duties as determined by the General Counsel. For performance evaluation purposes, it is OGC's policy that, when feasible, a career Deputy General Counsel will be assigned to serve as the rating official for all career Associate General Counsel, Chief Counsel, the OLR Director, and any career Senior Counsel or Senior Advisor.

i. Chief Counsel for Food, Research, and Drugs. One Deputy General Counsel will be appointed as the Chief Counsel for Food, Research, and Drugs and will be responsible for supervising the Associate General Counsel, and their staff, who provide legal services to the National Institutes of Health and the Food and Drug Administration.

ii. Special Assistant Deputy General Counsel. The General Counsel may designate one or more attorneys to act as a special assistant and to carry the title Special Assistant Deputy General Counsel. Any Special Assistant Deputy General Counsel shall report directly to the General Counsel or to such Deputy General Counsel as the General Counsel may designate.

d. Senior Counsel, Special Counsel, Counsel, or Senior Advisor to the General Counsel: Senior Counsel, Special Counsel, Counsel, or Senior Advisors to the General Counsel perform such duties as may be assigned to them by the General Counsel, Principal Deputy General Counsel, Deputy General Counsel, or Chief Counsel for Food, Research, and Drugs.

a. General Counsel Vacancy. In the event of the General Counsel's absence, or in the event of a “vacancy” in the position of General Counsel as a result of death, resignation, or an inability to perform the functions and duties of the office, the Principal Deputy General Counsel shall act in the General Counsel's stead, or serve as the Acting General Counsel as dictated by the Vacancies Reform Act of 1998, 5 U.S.C. 3345 et seq.

b. Principal Deputy General Counsel Vacancy. In the event of the absence of or vacancies in offices of both the General Counsel and the Principal Deputy General Counsel, the Deputy General Counsel with the greatest seniority in that position shall perform the functions of or serve as the Acting General Counsel as dictated by the Vacancies Reform Act of 1998.

The Office of Legal Resources shall be headed by a Director, who is responsible for providing personnel, budget, correspondence, and information technology support to the Office of the General Counsel as well as providing legal information law services through the Law Library. The Office of Legal Resources includes six branches, each headed by a Director or Manager:

Each OGC Division is under the general supervision of the General Counsel. Each OGC office head reports directly to the designated Deputy General Counsel on substantive legal matters, litigation strategy, and other matters as directed by the General Counsel. The OGC office heads who provide legal services to the National Institutes of Health and the Food and Drug Administration will report directly to the Chief Counsel for Food, Research, and Drugs. There are ten divisions in the Office of the General Counsel:

1. The Advanced Research Projects Agency for Health (ARPA-H) Division shall be headed by a Chief Counsel/Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel.

2. The Centers for Medicare & Medicaid Services Division (CMSD) shall be headed by an Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel. The Division consists of three groups each headed by a Deputy Associate General Counsel reporting to the Associate General Counsel:

The Associate General Counsel may designate supervisory attorneys to report to the Deputy Associate General Counsel as appropriate.

3. The Children, Families, and Aging Division (CFAD) shall be headed by an Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel. CFAD also includes a Deputy Associate General Counsel, who reports to the Associate General Counsel. The Associate General Counsel may designate supervisory attorneys to report to the Deputy Associate General Counsel as appropriate.

4. The Civil Rights, Privacy, and Technology Division (CRD) shall be headed by an Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel. The Division will be responsible for providing legal advice on all civil rights, health policy, privacy, and related policy and enforcement matters in the Department, with the exception of defending claims filed by employees of HHS. The Division consists of two groups, each headed by a Deputy Associate General Counsel who reports to the Associate General Counsel:

5. The Ethics Division (ETH) shall be headed by an Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel. The Division consists of two branches, each headed by a Deputy Associate General Counsel reporting to the Associate General Counsel:

The Associate General Counsel and Deputy Associate General Counsel for Ethics Advice and Policy simultaneously serve by secretarial delegation as the Department's Designated Agency Ethics Official and Alternate Designated Agency Ethics Official, respectively.

6. The Food and Drug Division (FDD) shall be headed by a Chief Counsel who shall be an Associate General Counsel and who shall report directly to the Chief Counsel for Food, Research, and Drugs in the Immediate Office of the General Counsel. The Division consists of two branches, each of which is headed by one or more Deputy Associate General Counsel who report to the Associate General Counsel:

7. The General Law Division (GLD) shall be headed by an Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel. The Division consists of two branches, each headed by a Deputy Associate General Counsel reporting to the Associate General Counsel, as well as Assistant Deputy Associate General Counsel selected by the Associate General Counsel to provide oversight and supervision of Sections within the Division:

8. The Legislation Division (GCL) shall be headed by an Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel.

9. The Public Health Division (Ph.D.) shall be headed by an Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel or the Chief Counsel for Food, Research, and Drugs. The Division consists of four branches, each of which is headed by a Deputy Associate General Counsel reporting to the Associate General Counsel:

10. The National Complex Litigation and Investigations Division (NCLID) shall be headed by an Associate General Counsel, who reports to the General Counsel through a designated Deputy General Counsel. The Division shall also have a designated Deputy Associate General Counsel for E-Discovery, who reports to the Associate General Counsel.

Each OGC Regional Office is under the general supervision of the General Counsel. Each OGC office head reports directly to the designated Deputy General Counsel on substantive legal matters, litigation strategy, and other matters as directed by the General Counsel. There are four OGC regional offices:

1. OGC Region 1—Philadelphia shall be headed by a Chief Counsel, who reports to the General Counsel through a designated Deputy General Counsel. The office has a Deputy Chief Counsel, who reports to the Chief Counsel.

2. OGC Region 2—Atlanta shall be headed by a Chief Counsel, who reports to the General Counsel through a designated Deputy General Counsel. The office consists of two branches, each of which is headed by a Deputy Chief Counsel reporting to the Chief Counsel:

3. OGC Region 3—Kansas City shall be headed by a Chief Counsel, who reports to the General Counsel through a designated Deputy General Counsel.

4. OGC Region 4—Denver shall be headed by a Chief Counsel, who reports to the General Counsel through a designated Deputy General Counsel. The office has a Deputy Chief Counsel, who reports to the Chief Counsel.

1. The General Counsel. The General Counsel is authorized to promulgate such directives and issue such legal opinions as may be necessary to carry out the responsibilities of the Office. The General Counsel, directly or through attorneys in the Office of the General Counsel, undertakes the following activities unless an applicable statute provides otherwise or the General Counsel has delegated the responsibility elsewhere:

a. Furnishes all legal services and advice to the Secretary, Deputy Secretary, and all offices, branches, and units of the Department in connection with the operations and administration of the Department and its programs, unless otherwise expressly delegated by statute to another agency or official.

b. Furnishes legal services and advice on such other matters as may be submitted by the Secretary, the Deputy Secretary, any other senior leaders, and other persons authorized by the Secretary to request such service or advice.

c. Represents the Department in all litigation when such direct representation is not precluded by law, and in other cases, supervises the conduct of such litigation.

d. Acts as the Department's representative in communicating with the Department of Justice, including all United States Attorneys, on all civil and criminal matters.

e. Acts as the Department's representative in communicating with Office of White House Counsel and the Offices of General Counsel for any other Department or Agency.

f. Authorizes indemnification of Department employees, as appropriate, pursuant to 45 CFR part 36.

g. Provides legal review of all proposals for Federal legislation originating within the Department, as well as all proposed Federal legislation submitted to the Department or to any operating division of the Department for comment; as appropriate, prepares or reviews reports and letters to congressional committees, the Office of Management and Budget, and others on proposed Federal legislation; and prescribes procedures to govern the routing and review, within the Department, of material relating to proposed Federal legislation.

h. Supervises all legal activities of the Department and its operating and staff divisions, except with respect to certain matters within the jurisdiction of the OIG

i. Ensures that no one in the Department, other than those in OGC or expressly authorized by the General Counsel to do so, provides any legal advice to anyone in the Department that implies that they are functioning as a departmental lawyer.

j. Issues all Advisory Opinions except those relating to the Anti-Kickback Act (SSA 1128B(b)), the Anti-Inducement Act (SSA 1128A(a)(5)), and the Ethics in Patient Referral Act of 1989.

The Divisions within OGC provide legal counsel to their clients, as described below, subject to the professional supervision and control of the General Counsel and the designated Deputy General Counsel.

1. The Advanced Research Projects Agency for Health (ARPA-H) Division. The ARPA-H Division provides legal services to ARPA-H.

2. Centers for Medicare & Medicaid Services Division (CMSD). CMSD provides legal services to the Centers for Medicare & Medicaid Services (CMS), the Office of Medicare Hearings and Appeals (OMHA) and the Departmental Appeals Board (DAB).

3. Children, Families, and Aging Division (CFAD). CFAD provides legal services to the Administration for Children and Families and its various agencies, including the Office of Refugee Resettlement and Administration for Community Living. In addition, the Division advises the Department on the 477 initiative authorized by the Indian Employment, Training, and Related Services Demonstration Act of 2017.

4. Civil Rights, Privacy, and Emerging Technology Division (CRD). CRD provides legal services for the Office for Civil Rights (OCR) and provides advice with respect to the enforcement of civil rights laws, conscience statutes, the Health Insurance and Portability and Accountability Act of 1996 (Social Security Act §  1171 et seq. ), the Health Information Technology for Economic and Clinical Health (HITECH) Act, and the rules implementing them with respect of HHS-funded programs and activities. CRD also provides legal services to the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC). CRD does not defend claims filed by HHS employees.

5. Ethics Division (ETH). ETH administers and oversees Department-wide implementation of comprehensive government ethics program requirements under the Ethics in Government Act of 1978 as amended, Executive Order 12731, and implementing regulations at 5 CFR part 2638. This includes providing legal advice, training, and policy instruction and guidance consistent with core ethics program elements, including conflict of interest, impartiality, financial disclosure, outside activities, political activity, lobbying, pre-clearance ethics agreements, gifts, and travel payments from non-federal sources.

ETH also communicates on matters related to government ethics with the Office of Counsel to the President, the Office of Government Ethics, the Office of Special Counsel, the Office of Inspector General, Special Investigations Unit, the Department of Justice, the Office of Personnel Management, and the General Services Administration.

In addition, ETH develops component-specific conduct regulations and implementing procedures.

6. Food and Drug Division (FDD). FDD acts as the legal advisor to the Commissioner of Food and Drugs and provides legal services to the Food and Drug Administration (FDA). This includes representing the FDA in connection with judicial and administrative proceedings involving programs administered by the FDA, providing legal advice and policy guidance for programs administered by the FDA, and reviewing proposed and final regulations and Federal Register notices prepared by FDA. FDD acts as the Department and FDA's primary liaison to the Department of Justice and other federal departments for programs administered by FDA; all criminal prosecutions, investigations, and civil matters may be referred to the Department of Justice only through or in consultation with the Chief Counsel, appropriate Deputy General Counsel or the General Counsel.

7. General Law Division (GLD). GLD provides advice and representation with respect to laws and regulations that are applicable Government-wide including laws and regulations that govern business management activities and administrative operations such as procurement, contracting, personnel, budget, appropriations, federal real property, employment, information disclosure and privacy (but not health information privacy) and federal tort claims. In addition, the Associate General Counsel for GLD acts as the Department Claims Officer.

8. Legislation Division (GCL). GCL:

a. Drafts all proposed legislation originating in the Department, reviews specifications for such proposed legislation, and reviews all proposed legislation submitted to the Department or to any constituent unit of the Department for comment.

b. Prepares or reviews reports and letters to congressional committees, the Office of Management and Budget, and others on proposed legislation.

c. Reviews proposed testimony of Department officials before congressional committees relating to pending or proposed legislation.

d. Acts as Department liaison with the Office of Management and Budget on legislative matters.

e. Prescribes procedures to govern the routing and review, within the Department, of material relating to proposed federal legislation.

9. National Complex Litigation and Investigation Division (NCLID). NCLID provides legal services to all agencies and offices within the Department, as directed by the General Counsel. NCLID provides legal services in connection with complex litigation or anticipated complex litigation by or against the Department. Such litigation may include cases for which other OGC divisions or regional offices request NCLID participation, cases spanning multiple OGC divisions or regional offices, or cases outside the scope of other OGC divisions or regional offices. NCLID administers the OGC-wide e-discovery program and coordinates the use of e-discovery technology with agencies and offices within the Department. NCLID will also conduct internal investigations at the request of the Secretary, Deputy Secretary, or General Counsel.

10. Public Health Division (Ph.D.). Ph.D. provides legal services to all Public Health Service agencies (except to FDA) and their programs, including the Office of the Surgeon General and the Commissioned Corps of the U.S. Public Health Service. The represented Public Health Service agencies include, but are not limited to: (i) the Office of the Assistant Secretary for Health, and its various programs; (ii) the Office of the Secretary's Office of Minority Health; (iii) the Centers for Disease Control and Prevention; (iv) the National Institutes of Health; (v) the Health Resources and Services Administration; (vi) the Indian Health Service; (vii) the Substance Abuse and Mental Health Services Administration; (viii) the Agency for Healthcare Research and Quality, (ix) the Administration for Strategic Preparedness and Response, and (x) the Agency for Toxic Substances and Disease Registry.

There are four OGC Regional Offices, each led by a Chief Counsel. Regional offices within OGC provide a full range of legal services, subject to the professional supervision and direction of the General Counsel and the designated Deputy General Counsel. This includes providing legal advice and representation in administrative and judicial litigation regarding programs operated by the Centers for Medicare and Medicaid Services, the Administration for Children and Families, the Administration for Community Living, and Public Health Service agencies including the Indian Health Service, the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration, and the Centers for Disease Control and Prevention; and providing legal advice and representation in administrative and judicial litigation relating to business management activities and administrative operations, such as employment and labor relations, information disclosure and privacy, federal tort claims, and suspensions, disallowances, and other recoveries of payments made under HHS programs, of HHS components operating in their regions.

The HHS regional offices are located in the following cities and cover all states and territories of the United States, as well as three independent states in the Pacific.

1. OGC Region 1—Philadelphia.

2. OGC Region 2—Atlanta.

3. OGC Region 3—Kansas City (MO).

4. OGC Region 4—Denver.

The Office of the Citizenship and Immigration Services Ombudsman (CIS Ombudsman) was created under section 452 of the Homeland Security Act of 2002 (Pub. L. 107-296) to: (1) assist individuals and employers in resolving problems with U.S. Citizenship and Immigration Services (USCIS); (2) to identify areas in which individuals and employers have problems in dealing with USCIS; and (3) to the extent possible, propose changes in the administrative practices of USCIS to mitigate problems. This form is used by individuals and employers who are experiencing problems with USCIS during the processing of immigration benefits. Authorities that support this information collection include:

• Section 452 of the Homeland Security Act provides the legal authority for the CIS Ombudsman.

The information is collected on the DHS Form 7001, Case Assistance Request, which is available electronically or via pdf on the CIS Ombudsman website. Individuals and employers (or their legal representatives) experiencing problems with USCIS may submit a DHS Form 7001. The information contained on the form allows the CIS Ombudsman to identify the problem encountered by individuals and employers seeking immigration benefits and inquire with USCIS to resolve the issue. In the past, this information has been used to understand the issue the customer is trying to resolve, to obtain information needed to research USCIS systems, and to relay USCIS communications to the customer. This information has been collected on the electronic or paper DHS Form 7001 for over a decade. The electronic version is automatically integrated into the CIS Ombudsman's Case Assistance Analytics and Data Integration (CAADI) case management system; paper versions received by email, mail or fax are ingested manually and saved electronically in the case management system.

(a) Proposed form enhancements:

To enhance the form's usability:

• Limit each request to one immigration issue.

• Remove questions customers did not historically answer correctly.

• Enhance the instructions in each form section.

• Re-order form sections (see below) to reflect the customer's perspective.

The revised form will include these re-ordered, merged, and re-named sections. Delete former Section 4, Form Type.

The CIS Ombudsman collects and processes requests for case assistance, the majority of which are submitted electronically through the DHS website. This form provides the most efficient means for collecting and processing the required data. The electronic form feeds the information collected directly into CAADI. Per Paperwork Reduction Act (PRA) requirements, a fillable PDF version is also available on the website and may be emailed or printed and mailed or faxed to the CIS Ombudsman. The information on the paper forms are manually entered and then scanned into the CAADI system and then destroyed. Using the paper method may result in delays due to mail delivery and intake processing. Once approved, the online and PDF versions of the new form will be posted on the CIS Ombudsman's website at https://www.dhs.gov/case-assistance. The paper form remains available because some individuals are unable to access or lack the skill to use the electronic version of the DHS Form 7001. The CIS Ombudsman has enhanced completion of the DHS Form 7001 on mobile devices to further reduce paper use.

(a) See Section 2 for proposed form enhancements.

(b) New Format for Hard Copy Version: Once the renewed form is approved, the CIS Ombudsman will roll out a redesigned and updated hard copy version of the form in PDF format for both ease of use and compliance with the 21st Century Integrated Digital Experience Act.

(c) New Foreign Language Capabilities: The form must be submitted in English, but it will be translated into the following five most frequently requested languages to make it easier for immigrants from these countries to complete the form and instructions. The CIS Ombudsman also initiated translation and interpretation services for customers with limited English proficiency in October 2024.

(d) New Online Portal: The CIS Ombudsman launched a new web portal to provide better customer service while also saving staff time. Currently, customers who have submitted the Form 7001 call or email the CIS Ombudsman to check their case status, and where applicable, the CIS Ombudsman emails customers to request additional documents needed to process the request. The new web portal provides customers with an online self-service tool, enabling staff to focus on more complex customer inquiries. Customers can access the new web portal via a link on the online Form 7001 web page. The web portal then shares data with CAADI to provide two functions: (1) the Online Case Status Check functionality allows individuals and employers to check the current status of their case online; and (2) the Online Document Upload functionality allows individuals and employers to submit additional documentation for a previously submitted case. Users now have the ability to upload on-demand as well as in response to email requests initiated by the CIS Ombudsman. Case assistance request number and email address are required for submission, and a confirmation email is sent after document upload is successful. Customers do not have to create an account or login but are required to provide their case assistance request number, which was provided in their submission confirmation email, and their email address. The email address is needed to verify the identity of the requestor.

a. What's new in 2024 for the customer:

b. Before you submit: You will see a simpler, cleaner online DHS Form 7001, Request for Case Assistance page with an easy link to our Tips for Submitting a Case Assistance Request.

i. The tips address specific situations like signing on behalf of clients and requests involving multiple form types or family members.

c. While you complete the form: Instead of a series of accordion sections, you will see an interactive form with these new features:

i. A progress bar to help you see how much of the form you have completed.

ii. Sections that adapt the questions based on your answers to help you know what fields to complete.

iii. Alerts in each section that tell you if you are missing information.

iv. A clearer view of the forms and/or beneficiaries you have already added.

v. A screen for reviewing and editing your answers before submitting.

vi. Your CIS Ombudsman Request Number appearing on the confirmation page after you submit the form.

d. After you submit: Use these two new features:

i. Upload Requested Documents (after submitting your request) : If you experience problems uploading documents when you submit DHS Form 7001 or if you need to add more documents afterwards, you can use this tab to upload documents.

ii. Check the Status of Your Request: You can use this tab to track the status of your case assistance request. You will also see an overview of the different steps your request goes through as we work on it.

(e) Usability Test: The CIS Ombudsman also completed a usability test on the form.

a. What was the purpose of the UX? To identify any pain points in completing the online form, both on a computer and a mobile phone.

b. How many participants? Six: 3 were familiar with the form and 3 were not.

c. Here is a list of customer findings and recommended form fixes by section:

(a) General Observations:

1. Average completion time for all six participants was 50 minutes. One completed the form in 20 minutes, while it took others over an hour to complete.

2. Some instructions are placed after the field requesting the related information.

a. For example, in Section 1A customers are asked to upload supporting documents but the instructions and functionality are in Section 8.

3. Some people wondered if they could go back and edit their data.

a. FIX: Add a note to the General Instructions that you can make edits at the end before submitting the form.

(b) General Instructions:

1. None of the participants opened and read the instructions.

a. FIX: Enhance the instructions within each section of the form.

(c) Section 1A—Actions Taken:

1. When we ask if they've already contacted USCIS, some did not understand that we are asking whether they used USCIS' customer service options.

a. FIX: suggest we make this very clear in our public-facing materials and engagements.

2. Some wanted to enter their complete history rather than focusing on the past 60-90 days as we want them to.

a. FIX: Instructions should emphasize we want their most RECENT contact date with USCIS and why we are asking.

3. Some wanted to tell whole life story in the small comment box about actions taken because they didn't read question carefully—and then later wanted to go back.

a. FIX: Recommend combining 1A and 1B.

4. Instructions above box say to attach documents without stating how to do so.

a. FIX: Add text on where and how to upload documents.

(d) Section 1B—Other Actions: Recommendation is to merge Sections 1A & B.

1. Can we delete Option 1: Contacted a U.S. government department or agency for assistance. People may assume it refers to USCIS.

2. Option 2: Congressional inquiry, “Response Received, Yes or No?”—do we want to know if they received a response to the congressional inquiry or if Congress received a response to their inquiry to USCIS?

a. FIX: add text to state we want the congressional response sent to the individual.

(e) Section 2—Reasons for Request:

1. We start with what actions did you take; the intent was to weed out people whose issues weren't ripe for a request for case assistance. But from their perspective, they want to tell us their problem and ask for our help and that's what we should let them do first.

a. FIX: Recommend moving this section before Section 1; see #3 below.

2. Checkbox comments: use plain language, shorten text, and alphabetize the list.

a. FIX: Edit the master redlined form accordingly.

3. Some said they already provided an explanation of their issue in section 1a, then retyped it here.

a. FIX: Reduce to one explanation box and emphasis that we need to know what happened when they contacted USCIS.

(f) Section 3—Applications/Petitions Filed:

1. For Form I-90, sub-options are confusing.

a. FIX: Do we need to know these things?

1. 10-year renewal.

2. initial issue or replacement.

2. Unable to cut and paste receipt number, even w/o dashes.

a. FIX: Ask developers if possible.

3. Some were confused about what is meant by “Primary”; others were confused about which form to submit.

a. FIX: Should we reformat this section to make it simpler? Options include:

1. Put the instructions at the top.

1. Check the “Primary” box next to the USCIS receipt number for which you seek assistance.

2. Receipt date/Filing date need to be clarified; language on Form 797 varies.

4. Recommend moving the view that shows that you submitted a form up at the top rather than below because folks thought it didn't save and started to put it in again.

a. FIX: Clarify instructions: after you SAVE, scroll down, and click on NEXT.

(g) Section 4—Type of Benefit: Recommendation is to delete this section.

(h) Section 5—Applicant Name:

1. Move Applicant Name to the top of the form with one form per person.

2. Confusion around selecting individual or organization. Do we want the individual's contact info or their attorney's?

a. FIX: Make it clear we will not contact a represented individual directly.

3. One participant said completing this section and #6 slows them down because it is not easy to cut and paste info from other sources into the form.

a. FIX: Ask developers if possible.

(i) Section 6—Contact Information:

1. Again, confusion about whose information to enter.

a. FIX: add instructions at the top and refer to Section 5.

b. The PDF version [with CX revisions] includes these instructions:

1. Provide contact information for the individual (applicant/petitioner) or employer encountering difficulties with USCIS.

2. If you provide a legal representative's contact information instead of the individual or employer's contact information you must submit the Notice of Entry of Appearance (Form G-28) that you already have submitted to USCIS for the application/petition for which you seek our assistance. Full legal representative contact information can be added in Section 10 of this form.

2. Almost all participants were confused about email vs. snail mail options.

a. FIX: Box language has been adjusted as of 9/20/24.

3. Adding USPS address verification would be useful.

a. FIX: Added USPS address verification code in November 2024.

(j) Section 7—Identification:

1. Unable to cut and paste in the A-Number.

a. FIX: Ask developers if possible.

(k) Section 8—Supporting Documents:

1. First mention of G-28; mention earlier in the form?

a. FIX: Ask if submitter is an attorney, congressional rep, or DSO up front. If so, ask to upload appropriate form.

2. Suggest moving instructions in footer to top of section: file size/name/type.

a. Also add this information to the General Instructions.

3. Some had difficulty uploading documents, encountering either a delay or a blank screen.

a. There is a virus scan “pending” message.

(l) Section 11—Beneficiary Information:

1. Suggest delete this section if not useful or only make it appear for I-129 petitioners, and if can be just for H-2A/H-2B, even better.

2. If retained, add an N/A option.

When we last revised Form 7001, for the first time we added an addendum to allow certain petitioning employers to include beneficiary employee information that is needed for the CIS Ombudsman to inquire with USCIS. In the past, the CIS Ombudsman did not have a designated place to collect this beneficiary employee information and as a result, this caused delays in seeking assistance because the CIS Ombudsman had to reach out to petitioning employers for additional information.

If this information is not collected, the CIS Ombudsman will not be able to assist individuals and employers experiencing problems who request our assistance during the processing of an immigration benefit with USCIS.

The CIS Ombudsman follows fundamental ombudsman principles, such as confidentiality, neutrality, and independence while undertaking its statutory mission. In addition:

(a) Section 1367 confidentiality and prohibited source provisions prohibit employees of DHS, Department of State, or Department of Justice from permitting the use or disclosure of any information relating to an individual for a pending or approved application or petition for victim-based immigration benefits to anyone other than a sworn officer or employee of these Departments for legitimate agency purposes, unless one of several exceptions apply.

Section 1367 is flagged for applicable customers in their CAADI case record. It can be set by the analyst but is also triggered by the specific form types. We follow USCIS procedures regarding confidential cases.

(b) Pursuant to the Privacy Impact Assessment for CAADI, any risk that information in the CAADI system may be accessed by individuals without the proper clearances and without a need to know is mitigated as follows: (1) CIS Ombudsman personnel receive annual privacy training and introductory training on CAADI before they are given an account name and password, and specialized access and security control training as a prerequisite for authorization to use the system; and (2) all staff are able to see information on any case, but the ability to edit information is restricted through user permissions and standard DHS rules of behavior.

The time estimate to complete the current form was increased from 30 to 50 minutes based on the customer usability study. However, the steps we will and have taken to reduce completion time using the new form are summarized in the responses to Questions 2 and 3.

The Office of Management and Budget is particularly interested in comments which:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

Agency: Department of Homeland Security (DHS).

Title: Request for Case Assistance Form.

OMB Number: 1601-0004.

Frequency: On Occasion.

Affected Public: Individuals or Households.

Number of Respondents: 23,591.

Estimated Time per Respondent: 50 mins.

Total Burden Hours: 19,659.

The Commission instituted this investigation on January 23, 2025, based on a complaint filed by Maxell, Ltd. of Kyoto, Japan (“Maxell”). 90 FR 8032-33 (Jan. 23, 2025). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based on the importation into the United States, the sale for importation, and the sale within the United States after importation of certain mobile electronic devices by reason of the infringement of certain claims of U.S. Patent No. 8,130,280; U.S. Patent No. 11,490,004; U.S. Patent No. 11,750,915; U.S. Patent No. 11,509,953; U.S. Patent No. 12,108,103; and U.S. Patent No. 11,445,241 (“the '241 patent”). Id. The complaint further alleges that a domestic industry exists. Id. The notice of investigation names as respondents Samsung Electronics Co., Ltd. of Suwon-Shi, Republic of Korea and Samsung Electronics America, Inc. of New Jersey (collectively, “Samsung”). Id. The Office of Unfair Import Investigations is not named as a party. Id.

On February 6, 2025, Maxell filed a motion to amend the complaint and notice of investigation to add infringement allegations as to claims 15 and 24 of the '241 patent. Maxell explained that, prior to institution, it submitted a first public supplement to assert claims 15 and 24 of the '241 patent. The notice of investigation, however, did not reflect this supplement. Therefore, Maxell argued that good cause exists because this motion is to address a clerical error in the notice of investigation.

On February 18, 2025, Samsung filed an opposition to Maxell's motion. Samsung argued that there was no clerical error in the notice of investigation, and that Maxell failed to properly add claims 15 and 24 of the '241 patent during the pre-institution stage because Maxell needed to file an amended complaint pursuant to Commission Rule 210.14(a), 19 CFR 210.14(a), to add any additional claims as opposed filing a supplement. Samsung also argued that it would be unduly prejudiced if Maxell's motion is granted.

On February 21, 2025, the ALJ issued the subject ID (Order No. 6) granting Maxell's motion to amend the complaint and notice of investigation pursuant to Commission Rule 210.14(b), 19 CFR 210.14(b). The ID finds that the notice of investigation expressly acknowledged Maxell's public supplements, including the first public supplement that alleged infringement of claims 15 and 24 of the '241 patent, and this acknowledgment is “indicative of a clerical oversight in the listing of instituted asserted claims.” ID at 2; see 90 FR at 8032. The ID also finds that even if there was no clerical error, Maxell has now moved in a timely manner to add claims 15 and 24. Id. at 3. Lastly, the ID finds that any prejudice to Samsung is low because Samsung was on notice of Maxell's intent to add claims 15 and 24. Id. at 3-4.

No petitions for review of the ID were filed.

The Commission has determined not to review the ID.

The Commission vote for this determination took place on March 10, 2025.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

Abstract: Regulations prescribe who may represent individuals in immigration proceedings. The Assistant Director for Policy (or the Assistant Director for Policy's delegate), in the exercise of discretion, may accord recognition to organizations to practice before EOIR and the Department of Homeland Security (DHS). See 8 CFR 1292.11, 1292.13(a). To be eligible for initial recognition, an organization must: (1) establish that it is a non-profit religious, charitable, social service, or similar organization; (2) demonstrate that it provides immigration legal services primarily to low-income and indigent clients within the United States; (3) demonstrate the organization's currently valid federal tax-exempt status or pending application for federal tax-exempt status; (4) apply simultaneously to have at least one employee or volunteer approved as an Accredited Representative (using Form EOIR-31A); (5) demonstrate access to adequate knowledge, information, and experience in immigration law and procedure; and (6) designate at least one authorized officer to act on the organization's behalf. 8 CFR 1292.11(a), (d). The organization applies for recognition by submitting a Form EOIR-31 to the Assistant Director for Policy (or the Assistant Director for Policy's delegate) along with proof that they have served a copy of Form EOIR-31 on the U.S. Citizenship and Immigration Services (USCIS) offices in the jurisdictions where the organization offers or intends to offer immigration legal services. See 8 CFR 1292.13(a).

1. Type of Information Collection: Renewal with change of a currently approved collection. EOIR has made non-substantive changes to the current Form EOIR-31. These changes include revisions to the form's Privacy Act notice; addition of the expiration date for OMB approval on the form; updates to the address to which applications can be submitted; and addition of an alternative method by which applications can be submitted.

2. The Title of the Form/Collection: Request for New Recognition, Renewal of Recognition, Extension of Recognition of a Non-profit Religious, Charitable, Social Service, or Similar Organization.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: the form number is EOIR-31, and the sponsoring component is Executive Office for Immigration Review, United States Department of Justice.

4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Non-profit organizations seeking initial recognition, renewal of recognition, or extension of recognition to be recognized as legal service providers by the Office of Legal Access Programs of the Executive Office for Immigration Review (EOIR). Other: None. Abstract: This information collection will allow an organization to request and renew recognition of the organization to appear before EOIR and/or the Department of Homeland Security, or to extend recognition from a designated office to its other locations. This information collection is necessary to determine whether an organization meets the eligibility requirements for recognition pursuant to 8 U.S.C. 1103, 1229a, 1362 and 8 CFR 1292.11-19. Requests can be made using a fillable .pdf application or electronic submission.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 210 respondents will complete the form annually for initial recognition with an average of 2 hours per response. It is estimated that 90 respondents will complete the form annually for renewal of recognition with an average of 7 hours per response. It is estimated that 20 respondents will complete the form annually for standalone extension office requests with an average of 2 hours per response.

6. An estimate of the total annual burden (in hours) associated with the collection: The estimated annual burden hours associated with this collection is 1,055 hours.

7. An estimate of the total annual cost burden associated with the collection, if applicable:

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

Abstract: Regulations prescribe who may represent individuals in immigration proceedings. The Assistant Director for Policy (or the Assistant Director for Policy's delegate), in the exercise of discretion, may accord recognition to organizations, which are then able to seek full or partial accreditation of their representative(s) to practice before EOIR and the Department of Homeland Security (DHS). See 8 CFR 1292.12, 1292.13(a). For this to occur, the Assistant Director for Policy (or the Assistant Director for Policy's delegate) must first approve a request for recognition from an eligible organization. Then, the Assistant Director for Policy (or the Assistant Director for Policy's delegate) must approve a request from a recognized organization for accreditation of its representative(s). An individual who receives full accreditation may represent aliens before EOIR and DHS; an individual who receives partial accreditation may represent aliens before DHS only. 8 CFR 1292.12(a).

1. Type of Information Collection: Renewal with change of a currently approved collection. EOIR has made non-substantive changes to the current Form EOIR-31A. These changes include revisions to the form's Privacy Act notice; addition of the expiration date for OMB approval on the form; updates to the address to which applications can be submitted; and addition of an alternative method by which applications can be submitted.

2. The Title of the Form/Collection: Request by Organization for Accreditation or Renewal Accreditation of Non-Attorney Representative.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: the form number is EOIR-31A, and the sponsoring component is Executive Office for Immigration Review, United States Department of Justice.

4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Non-profit organizations seeking accreditation or renewal of accreditation of its representatives by the Office of Legal Access Programs of the Executive Office for Immigration Review. Other: None. Abstract: This information collection will allow an organization to seek accreditation or renewal of accreditation of a non-attorney representative to appear before EOIR and/or the Department of Homeland Security. This information collection is necessary to determine whether a representative meets the eligibility requirements for accreditation pursuant to 8 U.S.C. 1103, 1229a, 1362 and 8 CFR 1292.11-19. Requests can be made using a fillable .pdf application or electronic submission.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 747 respondents will complete the form annually for initial accreditation with an average of 3 hours per response. It is estimated that 314 respondents will complete the form annually for renewal of accreditation with an average of 7 hours per response.

6. An estimate of the total annual burden (in hours) associated with the collection: The estimated annual burden hours associated with this collection is 4,439 hours.

7. An estimate of the total annual cost burden associated with the collection, if applicable:

If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.

The Department's regulation at 29 CFR 2510.3-102 states that monies that a participant pays to, or has withheld by, an employer for contribution to an employee benefit plan become “plan assets” for purposes of Title I of ERISA and the related prohibited transaction provisions of the Internal Revenue Code (the Code) as of the earliest date on which such monies can be reasonably segregated from the employer's general assets.

The regulation also establishes specific maximum time limits for contributions becoming plan assets that apply to employee pension benefit plans (with a special rule for SIMPLE IRA plans) and employee welfare benefit plans. The regulation sets a maximum time limit of 15 business days following the end of the month in which the participant contribution amounts are received or withheld by the employer. The regulation includes a procedure through which an employer receiving or withholding participant contributions for an employee pension benefit plan may obtain a 10-business-day extension of the 15-day maximum time period for contributions received or withheld in a single month if certain requirements, including information collection requirements, are met.

The regulation requires, among other things, that the employer provide written notice to plan participants within five business days after the end of the extension period and the employer's transfer of the contributions to the plan, for which the employer elected to take the extension that month. The notice must explain why the employer could not transfer the participant contributions within the maximum time period, state that the participant contributions in question have in fact been transmitted to the plan, and provide the date on which this was done. The employer must also provide a copy of the participant notice to the Secretary, along with a certification that the notice was distributed to participants and that the other requirements under the extension procedure were met, within five business days after the end of the extension period. For additional substantive information about this ICR, see the related notice published in the Federal Register on July 9, 2024 (89 FR 56416).

Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.

DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

Agency: DOL-EBSA.

Title of Collection: Definition of Plan Assets—Participant Contributions.

OMB Control Number: 1210-0100.

Affected Public: Private sector, Businesses or other for-profits, Not-for-profit institutions.

Total Estimated Number of Respondents: 251.

Total Estimated Number of Responses: 251.

Total Estimated Annual Time Burden: 12 hours.

Total Estimated Annual Other Costs Burden: $201.

Prohibited Transaction Exemption (PTE) 90-1 provides an exemption from the restrictions of ERISA section 406 and Code section 4975, in part, for certain transactions between insurance company pooled separate accounts and parties in interest to plans that invest assets in the pooled separate accounts. PTE 90-1 provides an exemption for certain transactions between a party in interest with respect to a plan and an insurance company pooled separate account in which the plan has an interest or any acquisition or holding by the pooled separate account of employer securities or employer real property, provided that the party in interest is not the insurance company (or an affiliate of the insurance company) which holds the plan assets in its pooled separate account or any other separate account of the insurance company and that the amount of the plan's investment in the separate account does not exceed certain specified percentages (or that the separate account is a specialized account with a policy of investing, and invests, substantially all of its assets in certain specified short-term obligations).

PTE 90-1 also provides specific, additional relief for the following types of transactions with a party in interest: (1) furnishing goods to an insurance company pooled separate account, (2) leasing of real property of the pooled separate account, (3) transactions involving persons who are parties in interest to a plan solely because they are service providers or provide nondiscretionary services to the plan; (4) the insurance company's provision of any services provided to an insurance company pooled separate account (in which the plan has an interest) by the insurance company or its affiliate in connection with the management of the real property investments of the pooled separate account, and (5) furnishing of services, facilities, and goods incidental to the services and facilities by a place of public accommodations owned by the separate account.

In addition to other specified conditions, the insurance company intending to rely on the general exemption or any of the specific exemptions must maintain records of the transactions to which the exemption applies for a period of six years from the date of the transaction and make the records available on request to specified interested persons (including plan fiduciaries, participant and beneficiaries, contributing employers, the Department, and the Internal Revenue Service). For additional substantive information about this ICR, see the related notice published in the Federal Register on July 9, 2024 (89 FR 56416).

Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.

DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

Agency: DOL-EBSA.

Title of Collection: PTE 1990-1; Insurance Company Pooled Separate Accounts.

OMB Control Number: 1210-0083.

Affected Public: Private sector, Businesses or other for-profits, Not-for-profit institutions.

Total Estimated Number of Respondents: 46.

Total Estimated Number of Responses: 460.

Total Estimated Annual Time Burden: 77 hours.

Total Estimated Annual Other Costs Burden: $0.

Prohibited Transaction Exemption (PTE) PTE 94-20 provides an exemption for banks, broker-dealers, and their affiliates that are parties in interest to a plan to engage in foreign currency transactions with the plan, provided the transaction is directed by a plan fiduciary that is independent of the bank, broker-dealer, and any affiliate thereof and that certain other conditions are satisfied. To protect the interests of participants and beneficiaries of the employee benefit plan, the exemption requires, among other things, that a bank, broker-dealer, and any affiliate wishing to rely on the exemption (1) maintain written policies and procedures applicable to trading in foreign currencies with an employee benefit plan; (2) provide a written confirmation statement of each foreign currency transaction to the independent plan fiduciary directing the transaction for the plan; and (3) maintain records of the transactions for a period of six years from the date of the transaction and make them available upon request to specified interested persons, including plan fiduciaries, participants and beneficiaries, the Internal Revenue Service, and the Department. For additional substantive information about this ICR, see the related notice published in the Federal Register on July 9, 2024 (89 FR 56416).

Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.

DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

Agency: DOL-EBSA.

Title of Collection: Foreign Currency Transactions, Prohibited Transaction Class Exemption 1994-20.

OMB Control Number: 1210-0085.

Affected Public: Private sector, Businesses or other for-profits, Not-for-profit institutions.

Total Estimated Number of Respondents: 225.

Total Estimated Number of Responses: 1125.

Total Estimated Annual Time Burden: 188 hours.

Total Estimated Annual Other Costs Burden: $0.

NASA intends to grant an exclusive, co-exclusive, or partially exclusive patent license in the United States to practice the inventions described and claimed in: U.S. Patent No. 11,394,168 entitled “MICRO NON-PLANAR RING OSCILLATOR WITH OPTIMIZED OUTPUT POWER AND MINIMIZED NOISE IN A REDUCED SIZE PACKAGE” to AVO Photonics, Inc. having its principal place of business in Horsham, PA. The fields of use may be limited. NASA has not yet made a final determination to grant the requested license and may deny the requested license even if no objections are submitted within the comment period.

This notice of intent to grant an exclusive, co-exclusive or partially exclusive patent license is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective license will comply with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Information about other NASA inventions available for licensing can be found online at http://technology.nasa.gov.

Please refer to Docket ID NRC-2024-0183 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:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2024-0183.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. Draft NUREG-1482, Revision 4, is available in ADAMS under Accession No. ML24277A142.

• NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2024-0183 in your comment submission.

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 https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

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.

Draft NUREG-1482, Revision 4 is applicable, unless stated otherwise, to editions and addenda (up to and including the 2020 Edition) to the OM Code that are incorporated by reference in paragraph 50.55a of title 10 of the Code of Federal Regulations (10 CFR), “Codes and standards.” The NRC staff discusses in this report IST program topics such as the NRC process for the review of the OM Code, conditions on the use of the OM Code, interpretations of the OM Code, and development of IST programs for new reactors. In this report, the NRC staff provides guidance included in NUREG-1482, Revision 3 that has been updated to reflect IST lessons learned and operating experience since the report was previously issued.

Effective August 16, 2024, the NRC amended 10 CFR 50.55a in a final rule (89 FR 58039; July 17, 2024) to provide more flexibility for nuclear power plant licensees by expanding the code of record interval from 10 years (120 months) to two consecutive IST and inservice inspection (ISI) program intervals. This rulemaking also incorporated by reference revisions to three NRC regulatory guides to approve new, revised, and reaffirmed ASME Code Cases. Accordingly, draft NUREG-1482, Revision 4 includes the new terminology for the code of record interval rather than the previous 120-month interval when discussing IST and ISI programs and also includes a new Appendix C that summarizes the final rule and its conditions.

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 ( http://www.prc.gov ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301. 1

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. See 39 CFR 3041.110(n); 39 CFR 3041.205(a). Such requests are reviewed in summary proceedings pursuant to 39 CFR 3041.325(c)(2) and 39 CFR 3041.505(f)(1). Pursuant to 39 CFR 3041.405(c)-(d), the Commission does not appoint a Public Representative or request public comment in proceedings to review such requests.

1. Docket No(s).: MC2025-1205 and K2025-1204; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage Contract 1338 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: March 10, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Kenneth Moeller; Comments Due: March 18, 2025.

2. Docket No(s).: MC2025-1210 and K2025-1209; Filing Title: USPS Request to Add USPS Ground Advantage Contract 12 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: March 10, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Maxine Bradley; Comments Due: March 18, 2025.

3. Docket No(s).: MC2025-1211 and K2025-1210; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 635 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: March 10, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Christopher Mohr; Comments Due: March 18, 2025.

4. Docket No(s).: MC2025-1212 and K2025-1211; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage Contract 1341 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: March 10, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Maxine Bradley; Comments Due: March 18, 2025.

5. Docket No(s).: MC2025-1213 and K2025-1212; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage Contract 1342 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: March 10, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Kenneth Moeller; Comments Due: March 18, 2025.

None. See Section II for public proceedings.

This Notice will be published in the Federal Register .

For Applicants' representations, legal analysis, and conditions, please refer to Applicants' third amended and restated application, dated March 3, 2025, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at https://www.sec.gov/edgar/searchedgar/companysearch. You may also call the SEC's Office of Investor Education and Advocacy at (202) 551-8090.