Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Title: Uniform Grant Application Package for Discretionary Grant Programs.

Form Number: SF-424 Form, SF-LLL, FNS-887, FNS-906, FNS-908.

OMB Number: 0584-0512.

Expiration Date: July 31, 2025.

Type of Request: Revision of a currently approved collection.

Abstract: FNS has a number of discretionary grant programs. (Consistent with the definition in 2 CFR part 200, the term “grant” as used in this notice includes cooperative agreements.) The authorities for these grants vary and will be cited as part of each grant application solicitation. The purpose of the revision to the currently approved collection for the Uniform Grant Application Package for Discretionary Grant Programs is to continue the authority for the established uniform grant application package and to update the number of collection burden hours, accounting for noncompetitive grants issued by FNS into this information collection request package. FNS is revising the uniform collection package to allow and account for all of FNS' competitive and noncompetitive discretionary grant programs to collect information from grant applicants that are needed to evaluate and rank applicants and protect the integrity of the grantee selection process. This revision also encompasses the submittal of associated State Plan information and the use of program-specific forms, including but not limited to, Form FNS-887 Farm to School Coversheet. Under certain criteria, all FNS discretionary grant programs will be eligible to use the uniform grant application package. Before soliciting applications for a competitive or noncompetitive discretionary grant program, FNS will decide whether the uniform grant application package will meet the needs of that grant program. If FNS decides to use the uniform grant application package, FNS will note in the grant solicitation that applicants must use the uniform grant application package, and that the information collection has already been approved by OMB. If FNS decides not to use the uniform grant application package or determines that it needs grant applicants to provide additional information not contained in the uniform package, then FNS will publish at least a 30-day notice soliciting comments on its proposal to collect different or additional information before making the grant solicitation, if not already discussed in this notice. This notice discusses and gives 60-day notice to the public that State Plan information will be collected in association with grants covered by this information collection and program-specific supplemental forms will also be used, including but not limited to, Form FNS-887 Farm to School Coversheet. State Plans can discuss a wide range of information associated with the use of grant funds including, but not limited to, the goals of the project, the implementation plan, associated schedule for implementation and expected and actual results. Applicants complete Form FNS-887, Farm to School Coversheet, when applying for a farm to school grant.

The uniform grant application package will include: General information and instructions; a checklist; a requirement for the program narrative statement describing how the grant goals and objectives will be reached; the Standard Form (SF) 424 series forms (SF-424, SF-424A, and SF-424B) that request basic grant project information, budget information, and a disclosure of lobbying activities certification (SF-LLL); the Grant Program Accounting System & Financial Capability Questionnaire (FNS-906); and the Standardized Performance Progress Report (FNS-908). The revised information collection covered by this notice is related to the requirements for the program narrative statement. The requirements for the program narrative statement described in 2 CFR part 200, Appendix I and will apply to all types of grantees—State and Local governments, Indian Tribal organizations (ITOs), Business such as Non-Profit organizations, Institutions of Higher Education, and For-Profit organizations. The information collection burden related to the SF-424 series, and the lobbying certification forms have been separately approved by OMB under OMB Control Numbers: 4040-0020 February 28, 2026.

This collection also encompasses requirements for States to prepare and submit State Plans as part of, or in follow-up to, the application process for grants covered under OMB number 0584-0512, as well as the use of program-specific forms including, but not limited to Form FNS-887 Farm to School Coversheet. This collection has two different affected publics: State, Local & Tribal government as well as Business-for-profit and not-for-profit organizations. The respondent type for Business are usually Institutes of Higher Education, Colleges and Universities, or non-profit organizations.

FNS is requesting 4,153 total respondents (3,573 for SLT and 580 for Business'), we are also seeking 351,595 total annual burden hours and 135,077 total annual responses and since generic clearance are granted three years of burden upfront, this renewal is requesting 1,054,785 burden hours and 405,231 annual responses for next three years. This includes 454,935 total burden hours for reporting and 3,645 total burden hours for recordkeeping.

The estimates below are for pre- and post-award reporting and post-award recordkeeping for competitive and non-competitive grant opportunities for State, Local or Tribal government (known as Indian Tribal Organizations or ITOs). Below are the breakdowns for each affected public, for each type of grants available (competitive and non-competitive) for the reporting and recordkeeping burden activities involved before and then after grants are awarded to these affected publics.

Affected Public (Competitive): State and Local governments, Indian Tribal Organizations (ITOs).

Estimated Number of Respondents: 2,123.

Estimated Number of Responses per Respondent: 8.

Estimated Total Annual Responses: 16,984.

Estimated Average Hours per Response: 5.90149552.

Estimated Total Annual Reporting Burden Hours: 100,231.

Affected Public: State and Local governments, Indian Tribal Organizations (ITOs).

Estimated Number of Respondents: 1,616.

Estimated Number of Responses per Respondent: 5.

Estimated Total Annual Responses: 8,080.

Estimated Average Hours per Response: 5.59504950.

Estimated Total Annual Reporting Burden Hours: 45,208.

Affected Public (Competitive): State and Local governments, Indian Tribal Organizations (ITOs).

Estimated Number of Recordkeepers: 1,616.

Estimated Number of Responses per Respondent: 9.

Estimated Total Annual Responses: 14,544.

Estimate Average Hours per Response: 0.02502750.

Estimated Annual Hours per Recordkeeper: 364.

Affected Public (Competitive): Business—Non-Profit organizations, Institutions of Higher Education, and For-Profit organizations.

Estimated Number of Respondents: 510.

Estimated Number of Responses per Respondent: 9.

Estimated Total Annual Responses: 4,590.

Estimated Average Hours per Response: 6.08061002.

Estimated Total Annual Reporting Burden Hours: 27,910.

Affected Public (Competitive): Business—Non-Profit organizations, Institutions of Higher Education, and For-Profit organizations.

Estimated Number of Respondents: 186.

Estimated Number of Responses per Respondent: 5.

Estimated Total Annual Responses: 930.

Estimated Average Hours per Response: 6.01827956.

Estimated Total Annual Reporting Burden Hours: 5,597.

Affected Public (Competitive): Business Non-Profit organizations, Institutions of Higher Education, and For-Profit organizations.

Estimated Number of Recordkeepers: 186.

Estimated Number of Responses per Respondent: 9.

Estimated Total Annual Responses: 1,674.

Estimate Average Hours per Response: 0.0250896.

Estimated Annual Hours per Recordkeeper: 42.

Affected Public (Noncompetitive): State and Local governments, Indian Tribal Organizations (ITOs).

Estimated Number of Respondents: 1,450.

Estimated Number of Responses per Respondent: 8.

Estimated Total Annual Responses: 11,600.

Estimated Average Hours per Response: 5.96577586.

Estimated Total Annual Reporting Burden Hours: 69,203.

Affected Public (Noncompetitive): State and Local governments, Indian Tribal Organizations (ITOs).

Estimated Number of Respondents: 1,416.

Estimated Number of Responses per respondent: 5.

Estimated Total Annual Responses: 7,080.

Estimate Average Hours per Response: 5.6.

Estimated Total Annual Burden Reporting Hours: 39,648.

Affected Public (Noncompetitive): State and Local governments, Indian Tribal Organizations (ITOs).

Estimated Number of Respondents: 1,416.

Estimated Number of Responses per respondent: 9.

Estimated Total Annual Responses: 12,744.

Estimate Average Hours per Response: 0.02510985.

Estimated Total Annual Burden Reporting Hours: 320.

Affected Public (Noncompetitive): Business Non-Profit organizations, Institutions of Higher Education, and For-Profit organizations.

Estimated Number of Respondents: 70.

Estimated Number of Responses per Respondent: 9.

Estimated Total Annual Responses: 630.

Estimated Average Hours per Response: 5.2888888.

Estimated Total Annual Reporting Burden Hours: 3,332.

Affected Public (Noncompetitive): Business Non-Profit organizations, Institutions of Higher Education, and For-Profit organizations.

Estimated Number of Respondents: 2,184.

Estimated Number of Responses per respondent: 5.

Estimated Total Annual Responses: 10,920.

Estimate Average Hours per Response: 5.6.

Estimated Total Annual Burden Reporting Hours: 61,152.

Affected Public (Noncompetitive): Business Non-Profit organizations, Institutions of Higher Education, and For-Profit organizations.

Estimated Number of Respondents: 2,184.

Estimated Number of Responses per respondent: 9.

Estimated Total Annual Responses: 19,656.

Estimate Average Hours per Response: 0.02497964.

Estimated Total Annual Burden Reporting Hours: 491.

The Forest Service published a notice of intent (NOI) in the Federal Register on April 18, 2014, 79 FR 21892; a notice of availability (NOA) for the draft EIS on October 2, 2015, 80 FR 59775; an amended NOA to extend the comment period for the draft EIS on December 11, 2015, 80 FR 76980; a NOA for the final EIS on June 29, 2018, 83 FR 30730; and an amended NOA to withdraw the final EIS on July 2, 2018, 83 FR 31535. This withdrawal of the NOI and draft EIS is based on the timeline for this project.

Committee meetings are available to the public through a registration link (above). Any interested members of the public may attend committee meetings. An open comment period will be provided to allow members of the public to make oral statements as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of each meeting will include a list of persons who are present. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email ebohor@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the scheduled meeting. Written comments may be emailed to Evelyn Bohor at ebohor@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at 1-202-656-8937.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the file sharing website, https://tinyurl.com/mnshz8n9. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at ebohor@usccr.gov.

This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Liliana Schiller, Support Services Specialist, at lschiller@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Ana Victoria Fortes at afortes@usccr.gov . Persons who desire additional information may contact the Regional Programs Coordination Unit at (202) 681-0857.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the file sharing website, www.box.com . Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at the above phone number.

On December 28, 2023, Commerce selected the following companies as the mandatory respondents in this administrative review: Chandan Steel Limited (Chandan); and BFN/Viraj. 1 On November 19, 2024, Commerce published the Preliminary Results in the Federal Register and invited interested parties to comment. 2 On December 9, 2024, Commerce tolled certain deadlines in this administrative proceeding by 90 days. 3 The deadline for the final results is now June 17, 2025. For a complete description of the events that have occurred since the Preliminary Results, see the Issues and Decision Memorandum. 4 Commerce conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).

The merchandise covered by the Order is flanges from India. For a complete description of the scope of the Order, see the Issues and Decision Memorandum.

The issues raised in the case brief are addressed in the Issues and Decision Memorandum. A list of the issues raised is attached to this notice in Appendix I. 6 The Issues and 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 Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Based on comments received from BFN/Viraj regarding our Preliminary Results, we made certain changes to the margin calculations for BFN/Viraj, 7 which also affected the rate calculated for companies not selected for individual review.

Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a less-than-fair-value (LTFV) investigation, for guidance when calculating the weighted-average dumping margin for respondents that were not individually examined in an administrative review. Section 735(c)(5)(A) of the Act provides that the all-others rate should be calculated by weight averaging the weighted-average dumping margins determined for individually examined respondents, excluding rates that are zero, de minimis, or based entirely on facts available.

For the final results, we calculated estimated weighted-average dumping margins for Chandan and BFN/Viraj that are not zero, de minimis, or based entirely on facts otherwise available. Accordingly, we continue to calculate the review-specific rate using a weighted average of the estimated weighted-average dumping margins calculated for the examined respondents using each company's public ranged sales values for the merchandise under consideration. 8 The companies not selected for individual examination are listed in Appendix II.

As a result of this review, we determine that the following estimated weighted-average dumping margins exist for the period October 1, 2022, through September 30, 2023:

Commerce intends to disclose to interested parties the calculations performed for these final results of review within five days of any public announcement or, if there is no public announcement, within five days of the publication of this notice in the Federal Register , in accordance with 19 CFR 351.224(b).

Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Pursuant to 19 CFR 351.212(b)(1), for Chandan and BFN/Viraj, we calculated importer-specific ad valorem assessment rates based on the ratio of the total amount of dumping calculated for the examined sales to the total entered value of the sales. For the companies identified in Appendix II that were not selected for individual examination, we will assign an assessment rate based on the methodology described in the “Rate for Companies Not Selected for Individual Review” section, above.

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Chandan and BFN/Viraj for which the reviewed companies did not know that the merchandise they sold to the intermediary ( i.e., a reseller, trading company, or exporter) was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate ( i.e., 7.00 percent), 10 if there is no rate for the intermediate company(ies) involved in the transaction. 11

Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed above will be the rate established in the final results of this review; (2) for merchandise exported by producers or exporters not covered by this review but covered in a prior segment of this proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered by this review, a previous review, or the LTFV investigation, but the producer is, then the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the producer of the merchandise; (4) the case deposit rate for all other producers or exporters will continue to be 7.00 percent, 12 the all-others rate established in the LTFV investigation. These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or increase in the amount of antidumping duties by the amount of the countervailing duties.

This notice serves as the only reminder to parties subject to APO of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.221(b)(5).

On March 31, 2025, notice was published in the Federal Register (90 FR 14250) that a request for a permit had been submitted by the above-named applicant. The requested permit was issued on May 28, 2025 under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), and the regulations governing the taking of marine mammals (50 CFR part 216).

The permit authorizes filming of 13 species of non-listed marine mammals in the Southern Ocean and Antarctica to collect footage and images for documentaries and other media. The permit is valid until April 30, 2030.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

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.

To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq. ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action ( i.e., the issuance of an IHA) with respect to potential impacts on the human environment.

This action is consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NAO 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.

We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA requests.

On January 14, 2025, NMFS received a request from the City of Whittier (CoW) for an IHA to take marine mammals incidental to construction activities for the Whittier Harbor Rebuild Phase III Project in Whittier, Alaska. Following NMFS' review of the application, CoW submitted a revised version on March 18, 2025. The application was deemed adequate and complete on March 14, 2025. CoW's request is for take of killer whales ( Orcinus orca ), Dall's porpoise ( Phocoenoides dalli ), harbor seals ( Phoca vitulina ), and Steller sea lions ( Eumetopias jubatus ) by Level B harassment only. Neither CoW nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

The CoW has requested an IHA to remove and subsequently install in-water structures and piles. The purpose of the project is to provide safe moorage for the boating public by removing and replacing all timber piles and three damaged floats in the highly trafficked Whittier Harbor. There have been two previous expansions (in 1980 and 2010) since the construction of the Harbor in 1972; however, the Harbor's slip waitlist is currently around 360 vessels long, which equates to a five to seven year waiting period. Several components that currently exist at the site (specifically float systems A, G, and H) consist of broken and rotted wood components well past the standard life expectancy of such structures. This proposed project is crucial to continue the operation of businesses and residents to the citizens of Whittier.

To date, Phases I and II have been completed (in the early 2000s (around 2008-2009)) and Phase III is necessary for the final improvements to the harbor. To complete Phase III of the Whitter Harbor Rebuild Project, three of the harbor's 11 float systems (consisting of 42 boat slips and their associated walkways, and water/fire systems) require pile driving via a vibratory hammer. Overall, CoW would need to remove 155 existing creosote-treated timber piles (12- to 16-inch (in; 30.5- to 40.6-centimeter (cm))), 10 existing steel piles (16-in (40.6-cm)), 3 walkway floats, and 42 float “fingers” ( i.e., a small floating pontoon or structure that both separates and provides access to berthed boats in a marina; they facilitate the transit of passengers to a berthed vessel) that make up the boat slips, and subsequently install 90 steel piles (16-in (40.6-cm)), 3 new walkway floats, and 42 new float “fingers”.

Given the use of vibratory pile driving to both remove and install piles, there is potential for take of marine mammals, by Level B harassment only; no take by Level A harassment is expected or requested for this project.

CoW anticipates that this project would require up to 104 hours over 29 non-consecutive days during a 6 to 7 month period. Currently, construction activities are anticipated for fall 2025.

The proposed project would occur in the Whittier Harbor, located within the city limits of Whittier in southcentral Alaska (latitude: 60.77774, longitude: −148.6890). The Whittier Harbor is east of the Whittier cruise ship dock and Cliffside Marina and west of the ferry terminal. The construction work would occur nearshore behind the breakwater located at the project site (see figure 1).

Within Whittier Harbor, 360 slips measuring 0 to 60-feet (ft) in length (0 to 18.3 meters (m)) for both commercial and recreational activities currently exist. The Harbor was constructed in 1972 and expanded twice (in 1980 and in 2010) but still retains an extensive waitlist for slips (approximately 360 vessels long), with a duration of five to seven years. The Harbor is utilized by a mix of commercial/business interests (primarily fishing charters and ocean cruises) as well as residents of Whittier. Furthermore, the Harbor also serves as a substantial revenue stream to the City of Whittier through moorage, other fees, and a vessel property tax for year-round moorage. This project is necessary because the existing timber piles throughout the Harbor have significantly aged and need to be replaced and the existing float system for A, G, and H floats also require replacement given advanced age. The issues with the Harbor's existing structures ( i.e., rotted wood, cracked surfacing, and holes) pose as safety risks for users in this highly trafficked area in Whittier.

The Project is broken up into the Project Unit West and the Project Unit East (see figure 13 in the ITA application). Collectively across the Project, CoW has proposed to remove up to 155 existing 12- to 16-in (30.5- to 40.6-cm) creosote-treated timber piles, 10 existing 16-in (40.6-cm) steel piles, three walkway floats ( i.e., A, G, and H), and 42 float “fingers” which make up the boat slips on walkway floats G and H. In their place, CoW would install 90 16-in (40.6-cm) steel piles; three new walkway floats for A (10-ft x 226-ft (3-m x 69-m)), G (6-ft x 272-ft (2-m x 83-m)), and H (6-ft x 256-ft (2-m x 78-m)); install 42 new float “fingers” for floats G and H (measuring 2-ft x 7-in x 24-ft (0.6-m x 17.8-cm x 1.2-m)); a new fire suppression and water system for the new floats; and other float components, which would be installed out of the water ( i.e., mooring cleats, walers, fenders, and power pedestals). Pile driving using a vibratory hammer only would be necessary to install all in-water components; no impact hammer would be necessary. CoW would utilize two types of vibratory hammers: the ICE 44/Eccentric moment (4,400 inch-pounds (497 Newton-meters (Nm)) on a 41-ft x 148-ft (12.5-m x 45-m) barge, and the ICE 28/Eccentric moment (2,800 inch-pounds (315 Nm)) on a 38-ft x 70-ft (11.6-m x 21-m) barge.

For the activities, CoW would utilize several construction vessels, including:

• One 100-ft x 400-ft (30.5-m x 122-m) (or similar) supply barge carrying new replacement floats and piles;

• Two construction crane barges: one, approximately 41-ft x 148-ft (12.5-m x 45-m) barge to support areas accessible by it and to carry removed A, G, and H floats and timber piles;

• One, approximately 38-ft x 70-ft (1.6-m x 21.3-m), barge to support construction in confined spaces;

• One, approximately 25-ft x 26-ft (7.6-m x 7.9-m), tug to transport and maneuver project barges; and

• Two skiffs, transported to the project site by barge, to support construction and potentially marine mammal monitoring activities.

At Whittier, all barges would be secured with below-surface anchors. Upon demolition of the existing old structures, the larger construction barge would tow the removed timber piles and floats for A, G, and H to Valdez for disposal at the local landfill.

All construction is expected to begin in mid-September 2025 and continue through the spring of 2026. CoW estimates that all in-water pile-driving activities (removal and installation) are expected to occur for a total of 104 hours over 29 days, of which the days may not be consecutive as other activities occur between bouts of pile driving. Overall, the entire project is expected to occur over 6 to 7 months. This IHA, if issued, would authorize take incidental to the third (non-consecutive) year of work (2025-2026); the initial two projects (Phase I and II) were completed in the early 2000s (around 2008-2009).

All of the quantitative information found here can be found in table 1 below.

Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).

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 2 lists all species or stocks for which take is expected and proposed to be authorized for CoW's activities in Whittier 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 proposed to be 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' draft 2024 Alaska and Pacific SARs. All values presented in table 2 are the most recent available at the time of publication (including from the draft 2024 SARs) and are available online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments.

As indicated above in table 2, all four species (with five managed stocks) 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 proposed project areas are included in section 4 and table 5 of CoW's IHA application. For humpback whales ( Megaptera novaeangliae), the inland waters of Southeast Alaska are a seasonal feeding biologically important area (BIA) from May through September (Wild et al., 2023). However, the applicant has requested no take of this species given they would shut down/delay any pile driving activities in the event that a humpback whale is observed at the edge of the Level B harassment isopleth. Because of this, no take is expected to occur given the enhanced mitigation measures. Furthermore, Whittier Harbor is located in a small passageway of the Prince William Sound area, and represents a tiny portion of the available habitat for humpback whales. The AT1 Transient stock of killer whales (consisting of seven individuals) has been reported in the area of Whittier, but the likelihood of this stock occurring in the project area during the short proposed project timeframe (29 days) during active pile driving is low, and no take of this stock is proposed for authorization. Therefore, they are not discussed further in this notice. In addition, sea otters ( Enhydra lutris ) may be found in both the Prince William Sound and Whittier, Alaska. However, this species is managed by the U.S. Fish and Wildlife Service (see https://www.fws.gov/species/sea-otter-enhydra-lutris ) and therefore not discussed further in this document.

For more details on the species that are likely to occur near the project area and may be taken by CoW's proposed activities, see CoW's IHA application, the draft SARs, and NMFS' website.

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 can 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 (2024), 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 table 3. Of the species that could be potentially taken in the proposed project area, none are considered low-frequency (LF) cetaceans, one is considered a high-frequency (HF) cetacean, one is considered a very high-frequency (VHF) cetacean, one is an otariid pinniped, and one is a phocid pinniped.

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

This section includes a summary and provides a discussion of the ways in which components of the specified activity may impact marine mammals and their habitat. The Estimated Take of Marine Mammals section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take of Marine Mammals section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and whether those impacts are reasonably expected to, or reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Acoustic effects on marine mammals during the specified activities are expected to potentially occur from vibratory pile removal and installation. The effects of underwater noise from CoW's proposed activities have the potential to result in take by Level B harassment of marine mammals in the project area.

Overall, the proposed activities would result in the removal of 165 piles (155 timber and 10 steel) by vibratory pile driving, 3 walkway floats, and 42 float “fingers”. CoW would then install 90 steel piles by vibratory pile driving, 3 new walkway floats, and 42 float “fingers” in Whittier Harbor. There are a variety of types and degrees of effects to marine mammals, prey species, and habitat that could occur because of the proposed project. Below we provide a brief description of the types of sound sources that would be generated by the project, the general impacts from these types of activities, and an analysis of the anticipated impacts on marine mammals from the project, with consideration of the proposed mitigation measures.

Activities associated with the proposed project that have the potential to incidentally take marine mammals though exposure to sound would include vibratory pile removal and installation. Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the substrate. Vibratory hammers typically produce less sound ( i.e., lower levels) than impact hammers. Peak sound pressure levels (SPLs) may be 180 dB or greater, but are generally 10 to 20 dB lower than SPLs generated during impact pile driving of the same-sized pile (Oestman et al., 2009; California Department of Transportation (CALTRANS; 2015, 2020). Sounds produced by vibratory hammers are non-impulsive; compared to sounds produced by impact hammers, the rise time is slower, reducing the probability and severity of injury, and the sound energy is distributed over a greater amount of time (Nedwell and Edwards, 2002; Carlson et al., 2005).

The introduction of anthropogenic noise into the aquatic environment from vibratory pile driving is the primary means by which marine mammals may be harassed from CoW's specified activities. Anthropogenic sounds cover a broad range of frequencies and sound levels and can have a range of highly variable impacts on marine life from none or minor to potentially severe responses depending on received levels, duration of exposure, behavioral context, and various other factors. Broadly, underwater sound from active acoustic sources, such as those in the Project, can potentially result in one or more of the following: temporary or permanent hearing impairment, non-auditory physical or physiological effects, behavioral disturbance, stress, and masking (Richardson et al., 1995; Gordon et al., 2003; Nowacek et al., 2007; Southall et al., 2007; Götz et al., 2009).

We describe the more severe effects of certain non-auditory physical or physiological effects only briefly as we do not expect that use of the vibratory hammer is reasonably likely to result in such effects (see below for further discussion). Potential effects from impulsive sound sources can range in severity from effects such as behavioral disturbance or tactile perception to physical discomfort, slight injury of the internal organs and the auditory system, or mortality (Yelverton et al., 1973). Non-auditory physiological effects or injuries that theoretically might occur in marine mammals exposed to high level underwater sound or as a secondary effect of extreme behavioral reactions ( e.g., change in dive profile as a result of an avoidance reaction) caused by exposure to sound include neurological effects, bubble formation, resonance effects, and other types of organ or tissue damage (Cox et al., 2006; Southall et al., 2007; Zimmer and Tyack, 2007; Tal et al., 2015). The project activities considered here do not involve the use of devices such as explosives or mid-frequency tactical sonar that are associated with these types of effects.

In general, animals exposed to natural or anthropogenic sound may experience physical and psychological effects, ranging in magnitude from none to severe (Southall et al., 2007, 2019). Exposure to anthropogenic noise has the potential to result in auditory threshold shifts and behavioral reactions ( e.g., avoidance, temporary cessation of foraging and vocalizing, changes in dive behavior). It can also lead to non-observable physiological responses, such an increase in stress hormones. Additional noise in a marine mammal's habitat can mask acoustic cues used by marine mammals to carry out daily functions, such as communication and predator and prey detection.

The degree of effect of an acoustic exposure on marine mammals is dependent on several factors, including, but not limited to, sound type ( e.g., impulsive vs. non-impulsive), signal characteristics, the species, age and sex class ( e.g., adult male vs. mom with calf), duration of exposure, the distance between the noise source and the animal, received levels, behavioral state at time of exposure, and previous history with exposure (Wartzok et al., 2004; Southall et al., 2007). In general, sudden, high-intensity sounds can cause hearing loss, as can longer exposures to lower-intensity sounds. Moreover, any temporary or permanent loss of hearing, if it occurs at all, will occur almost exclusively for noise within an animal's hearing range. We describe below the specific manifestations of acoustic effects that may occur based on the activities proposed by CoW.

Richardson et al. (1995) described zones of increasing intensity of effect that might be expected to occur in relation to distance from a source and assuming that the signal is within an animal's hearing range. First (at the greatest distance) is the area within which the acoustic signal would be audible (potentially perceived) to the animal but not strong enough to elicit any overt behavioral or physiological response. The next zone (closer to the receiving animal) corresponds with the area where the signal is audible to the animal and of sufficient intensity to elicit behavioral or physiological responsiveness. The third is a zone within which, for signals of high intensity, the received level is sufficient to potentially cause discomfort or tissue damage to auditory or other systems. Overlaying these zones to a certain extent is the area within which masking ( i.e., when a sound interferes with or masks the ability of an animal to detect a signal of interest that is above the absolute hearing threshold) may occur; the masking zone may be highly variable in size.

Below, we provide additional detail regarding potential impacts on marine mammals and their habitat from noise in general, starting with hearing impairment, as well as from the specific activities CoW plans to conduct, to the degree it is available.

Hearing Threshold Shifts. NMFS defines a noise-induced threshold shift (TS) as a change, usually an increase, in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS, 2018, 2024). The amount of threshold shift is customarily expressed in dB. TS can be permanent or temporary. As described in NMFS (2018, 2024) there are numerous factors to consider when examining the consequence of TS, including, but not limited to, the signal temporal pattern ( e.g., impulsive or non-impulsive), likelihood an individual would be exposed for a long enough duration or to a high enough level to induce a TS, the magnitude of the TS, time to recovery (seconds to minutes, or hours to days), the frequency range of the exposure ( i.e., spectral content), the hearing frequency range of the exposed species relative to the signal's frequency spectrum ( i.e., how animal uses sound within the frequency band of the signal; e.g., Kastelein et al., 2014), and the overlap between the animal and the source ( e.g., spatial, temporal, and spectral).

Auditory Injury (AUD INJ). NMFS (2024) defines AUD INJ as damage to the inner ear that can result in destruction of tissue, such as the loss of cochlear neuron synapses or auditory neuropathy (Houser, 2021; Finneran, 2024). AUD INJ may or may not result in a permanent threshold shift (PTS). PTS is subsequently defined as a permanent, irreversible increase in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS, 2024). PTS does not generally affect more than a limited frequency range, and an animal that has incurred PTS has some level of hearing loss at the relevant frequencies; typically animals with PTS or other AUD INJ are not functionally deaf (Au and Hastings, 2008; Finneran, 2016). Available data from humans and other terrestrial mammals indicate that a 40-dB threshold shift approximates AUD INJ onset (see Ward et al., 1958, 1959; Ward, 1960; Kryter et al., 1966; Miller, 1974; Ahroon et al., 1996; Henderson et al., 2008). AUD INJ levels for marine mammals are estimates, as with the exception of a single study unintentionally inducing PTS in a harbor seal ( Phoca vitulina ) (Kastak et al., 2008), there are no empirical data measuring AUD INJ in marine mammals largely due to the fact that, for various ethical reasons, experiments involving anthropogenic noise exposure at levels inducing AUD INJ are not typically pursued or authorized (NMFS, 2024).

Temporary Threshold Shift (TTS). TTS is a temporary, reversible increase in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS, 2024), and is not considered an AUD INJ. Based on data from marine mammal TTS measurements (see Southall et al., 2007, 2019), a TTS of 6 dB is considered the minimum threshold shift clearly larger than any day-to-day or session-to-session variation in a subject's normal hearing ability (Finneran et al., 2000, 2002; Schlundt et al., 2000). As described in Finneran (2015), marine mammal studies have shown the amount of TTS increases with the 24-hour cumulative sound exposure level (SEL 24 ) in an accelerating fashion: at low exposures with lower SEL 24 , the amount of TTS is typically small and the growth curves have shallow slopes. At exposures with higher SEL 24 , the growth curves become steeper and approach linear relationships with the sound exposure level (SEL).

Depending on the degree (elevation of threshold in dB), duration ( i.e., recovery time), and frequency range of TTS, and the context in which it is experienced, TTS can have effects on marine mammals ranging from discountable to more impactful (similar to those discussed in auditory masking, below). For example, a marine mammal may be able to readily compensate for a brief, relatively small amount of TTS in a non-critical frequency range that takes place during a time when the animal is traveling through the open ocean, where ambient noise is lower and there are not as many competing sounds present. Alternatively, a larger amount and longer duration of TTS sustained during time when communication is critical for successful mother/calf interactions could have more severe impacts. We note that reduced hearing sensitivity as a simple function of aging has been observed in marine mammals, as well as humans and other taxa (Southall et al., 2007), so we can infer that strategies exist for coping with this condition to some degree, though likely not without cost.

Many studies have examined noise-induced hearing loss in marine mammals (see Finneran (2015) and Southall et al. (2019) for summaries). TTS is the mildest form of hearing impairment that can occur during exposure to sound (Kryter, 2013). While experiencing TTS, the hearing threshold rises, and a sound must be at a higher level in order to be heard. In terrestrial and marine mammals, TTS can last from minutes or hours to days (in cases of strong TTS). In many cases, hearing sensitivity recovers rapidly after exposure to the sound ends. For cetaceans, published data on the onset of TTS are limited to captive bottlenose dolphin ( Tursiops truncatus ), beluga whale ( Delphinapterus leucas ), harbor porpoise ( Phocoena phocoena ), and Yangtze finless porpoise ( Neophocoena asiaeorientalis ) (Southall et al., 2019). For pinnipeds in water, measurements of TTS are limited to harbor seals, elephant seals ( Mirounga angustirostris ), bearded seals ( Erignathus barbatus ) and California sea lions ( Zalophus californianus ) (Kastak et al., 1999, 2007; Kastelein et al., 2019b, 2019c, 2021, 2022a, 2022b; Reichmuth et al., 2019; Sills et al., 2020). TTS was not observed in spotted ( Phoca largha ) and ringed ( Pusa hispida ) seals exposed to single airgun impulse sounds at levels matching previous predictions of TTS onset (Reichmuth et al., 2016). These studies examine hearing thresholds measured in marine mammals before and after exposure to intense or long-duration sound exposures. The difference between the pre-exposure and post-exposure thresholds can be used to determine the amount of threshold shift at various post-exposure times.

The amount and onset of TTS depends on the exposure frequency. Sounds below the region of best sensitivity for a species or hearing group are less hazardous than those near the region of best sensitivity (Finneran and Schlundt, 2013). At low frequencies, onset-TTS exposure levels are higher compared to those in the region of best sensitivity ( e.g., a low frequency noise would need to be louder to cause TTS onset when TTS exposure level is higher), as shown for harbor porpoises and harbor seals (Kastelein et al., 2019a, 2019c). Note that in general, harbor seals and harbor porpoises have a lower TTS onset than other measured pinniped or cetacean species (Finneran, 2015). In addition, TTS can accumulate across multiple exposures, but the resulting TTS will be less than the TTS from a single, continuous exposure with the same SEL (Mooney et al., 2009; Finneran et al., 2010; Kastelein et al., 2014, 2015). This means that TTS predictions based on the total, SEL 24 will overestimate the amount of TTS from intermittent exposures, such as sonars and impulsive sources. Nachtigall et al. (2018) describe measurements of hearing sensitivity of multiple odontocete species (bottlenose dolphin, harbor porpoise, beluga ( Delphinapterus leucas ), and false killer whale ( Pseudorca crassidens )) when a relatively loud sound was preceded by a warning sound. These captive animals were shown to reduce hearing sensitivity when warned of an impending intense sound. Based on these experimental observations of captive animals, the authors suggest that wild animals may dampen their hearing during prolonged exposures or if conditioned to anticipate intense sounds. Another study showed that echolocating animals (including odontocetes) might have anatomical specializations that might allow for conditioned hearing reduction and filtering of low-frequency ambient noise, including increased stiffness and control of middle ear structures and placement of inner ear structures (Ketten et al., 2021). Data available on noise-induced hearing loss for mysticetes are currently lacking (NMFS, 2024). Additionally, the existing marine mammal TTS data come from a limited number of individuals within these species.

Relationships between TTS and AUD INJ thresholds have not been studied in marine mammals, and there are no measured PTS data for cetaceans, but such relationships are assumed to be similar to those in humans and other terrestrial mammals. AUD INJ typically occurs at exposure levels at least several dB above that inducing mild TTS ( e.g., a 40-dB threshold shift approximates AUD INJ onset (Kryter et al., 1966; Miller, 1974), while a 6-dB threshold shift approximates TTS onset (Southall et al., 2007, 2019). Based on data from terrestrial mammals, a precautionary assumption is that the AUD INJ thresholds for impulsive sounds (such as impact pile driving pulses as received close to the source) are at least 6 dB higher than the TTS threshold on a peak-pressure basis and AUD INJ cumulative sound exposure level thresholds are 15 to 20 dB higher than TTS cumulative sound exposure level thresholds (Southall et al., 2007, 2019). Given the higher level of sound or longer exposure duration necessary to cause AUD INJ as compared with TTS, it is considerably less likely that AUD INJ could occur.

Behavioral Effects. Exposure to noise also has the potential to behaviorally disturb marine mammals to a level that rises to the definition of harassment under the MMPA. Generally speaking, NMFS considers a behavioral disturbance that rises to the level of harassment under the MMPA a non-minor response—in other words, not every response qualifies as behavioral disturbance, and for responses that do, those of a higher level, or accrued across a longer duration, have the potential to affect foraging, reproduction, or survival. Behavioral disturbance may include a variety of effects, including subtle changes in behavior ( e.g., minor or brief avoidance of an area or changes in vocalizations), more conspicuous changes in similar behavioral activities, and more sustained and/or potentially severe reactions, such as displacement from or abandonment of high-quality habitat. Behavioral responses may include changing durations of surfacing and dives, changing direction and/or speed; reducing/increasing vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); eliciting a visible startle response or aggressive behavior (such as tail/fin slapping or jaw clapping); and avoidance of areas where sound sources are located. In addition, pinnipeds may increase their haul out time, possibly to avoid in-water disturbance (Thorson and Reyff, 2006).

Behavioral responses to sound are highly variable and context-specific and any reactions depend on numerous intrinsic and extrinsic factors ( e.g., species, state of maturity, experience, current activity, reproductive state, auditory sensitivity, time of day), as well as the interplay between factors ( e.g., Richardson et al., 1995; Wartzok et al., 2004; Southall et al., 2007, 2019; Weilgart, 2007; Archer et al., 2010). Behavioral reactions can vary not only among individuals but also within an individual, depending on previous experience with a sound source, context, and numerous other factors (Ellison et al., 2012), and can vary depending on characteristics associated with the sound source ( e.g., whether it is moving or stationary, number of sources, distance from the source). In general, pinnipeds seem more tolerant of, or at least habituate more quickly to, potentially disturbing underwater sound than do cetaceans, and generally seem to be less responsive to exposure to industrial sound than most cetaceans. Please see Appendices B and C of Southall et al. (2007) and Gomez et al. (2016) for reviews of studies involving marine mammal behavioral responses to sound.

Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok et al., 2004). Animals are most likely to habituate to sounds that are predictable and unvarying. It is important to note that habituation is appropriately considered as a “progressive reduction in response to stimuli that are perceived as neither aversive nor beneficial,” rather than as, more generally, moderation in response to human disturbance (Bejder et al., 2009). The opposite process is sensitization, when an unpleasant experience leads to subsequent responses, often in the form of avoidance, at a lower level of exposure.

As noted above, behavioral state may affect the type of response. For example, animals that are resting may show greater behavioral change in response to disturbing sound levels than animals that are highly motivated to remain in an area for feeding (Richardson et al., 1995; Wartzok et al., 2004; National Research Council (NRC), 2005). Controlled experiments with captive marine mammals have shown pronounced behavioral reactions, including avoidance of loud sound sources (Ridgway et al., 1997; Finneran et al., 2003). Observed responses of wild marine mammals to loud-pulsed sound sources ( e.g., seismic airguns) have been varied but often consist of avoidance behavior or other behavioral changes (Richardson et al., 1995; Morton and Symonds, 2002; Nowacek et al., 2007).

Available studies show wide variation in response to underwater sound; therefore, it is difficult to predict specifically how any given sound in a particular instance might affect marine mammals perceiving the signal ( e.g., Erbe et al., 2019). If a marine mammal does react briefly to an underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. If a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant ( e.g., Lusseau and Bejder, 2007; Weilgart, 2007; NRC, 2005). However, there are broad categories of potential response, which we describe in greater detail here, that include alteration of dive behavior, alteration of foraging behavior, effects to breathing, interference with or alteration of vocalization, avoidance, and flight.

Avoidance and displacement. Changes in dive behavior can vary widely and may consist of increased or decreased dive times and surface intervals as well as changes in the rates of ascent and descent during a dive ( e.g., Frankel and Clark, 2000; Costa et al., 2003; Ng and Leung, 2003; Nowacek et al., 2004; Goldbogen et al., 2013a, 2013b; Blair et al., 2016). Variations in dive behavior may reflect interruptions in biologically significant activities ( e.g., foraging) or they may be of little biological significance. The impact of an alteration to dive behavior resulting from an acoustic exposure depends on what the animal is doing at the time of the exposure and the type and magnitude of the response.

Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure, so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators ( e.g., bubble nets or sediment plumes), or changes in dive behavior. Acoustic and movement bio-logging tools also have been used in some cases to infer responses to anthropogenic noise. For example, Blair et al. (2015) reported significant effects on humpback whale foraging behavior in Stellwagen Bank in response to ship noise including slower descent rates, and fewer side-rolling events per dive with increasing ship nose. In addition, Wisniewska et al. (2018) reported that tagged harbor porpoises demonstrated fewer prey capture attempts when encountering occasional high-noise levels resulting from vessel noise as well as more vigorous fluking, interrupted foraging, and cessation of echolocation signals observed in response to some high-noise vessel passes. As for other types of behavioral response, the frequency, duration, and temporal pattern of signal presentation, as well as differences in species sensitivity, are likely contributing factors to differences in response in any given circumstance ( e.g., Croll et al., 2001; Nowacek et al., 2004; Madsen et al., 2006; Yazvenko et al., 2007). A determination of whether foraging disruptions incur fitness consequences would require information on or estimates of the energetic requirements of the affected individuals and the relationship between prey availability, foraging effort and success, and the life history stage of the animal.

Respiration rates vary naturally with different behaviors, and alterations to breathing rate as a function of acoustic exposure can be expected to co-occur with other behavioral reactions, such as a flight response or an alteration in diving. However, respiration rates in and of themselves may be representative of annoyance or an acute stress response. Various studies have shown that respiration rates may either be unaffected or could increase, depending on the species and signal characteristics, again highlighting the importance in understanding species differences in the tolerance of underwater noise when determining the potential for impacts resulting from anthropogenic sound exposure ( e.g., Kastelein et al., 2001; 2005; 2006; Gailey et al., 2007). For example, harbor porpoise respiration rates increased in response to pile driving sounds at and above a received broadband SPL of 136 dB (zero-peak SPL: 151 dB micropascal (re 1 μPa); SEL of a single strike (SEL ss ): 127 dB re 1 square micropascals per second (μPa 2 -s; Kastelein et al., 2013).

Avoidance is the displacement of an individual from an area or migration path because of the presence of a sound or other stressors, and is one of the most obvious manifestations of disturbance in marine mammals (Richardson et al., 1995). For example, gray whales are known to change direction—deflecting from customary migratory paths—in order to avoid noise from seismic surveys (Malme et al., 1984). Harbor porpoises, Atlantic white-sided dolphins ( Lagenorhynchus actusus ), and minke whales ( Balaenoptera acutorostrata ) have demonstrated avoidance in response to vessels during line transect surveys (Palka and Hammond, 2001). In addition, beluga whales in the St. Lawrence Estuary in Canada have been reported to increase levels of avoidance with increased boat presence by way of increased dive durations and swim speeds, decreased surfacing intervals, and by bunching together into groups (Blane and Jaakson, 1994). Avoidance may be short-term, with animals returning to the area once the noise has ceased ( e.g., Bowles et al., 1994; Goold, 1996; Stone et al., 2000; Morton and Symonds, 2002; Gailey et al., 2007). Longer-term displacement is possible, however, which may lead to changes in abundance or distribution patterns of the affected species in the affected region if habituation to the presence of the sound does not occur ( e.g., Blackwell et al., 2004; Bejder et al., 2006; Teilmann et al., 2006).

A flight response is a dramatic change in normal movement to a directed and rapid movement away from the perceived location of a sound source. The flight response differs from other avoidance responses in the intensity of the response ( e.g., directed movement, rate of travel). Relatively little information on flight responses of marine mammals to anthropogenic signals exist, although observations of flight responses to the presence of predators have occurred (Connor and Heithaus, 1996; Bowers et al., 2018). The result of a flight response could range from brief, temporary exertion and displacement from the area where the signal provokes flight to, in extreme cases, marine mammal strandings (England et al., 2001). However, it should be noted that response to a perceived predator does not necessarily invoke flight (Ford and Reeves, 2008), and whether individuals are solitary or in groups may influence the response.

Behavioral disturbance can also impact marine mammals in more subtle ways. Increased vigilance may result in costs related to diversion of focus and attention ( i.e., when a response consists of increased vigilance, it may come at the cost of decreased attention to other critical behaviors such as foraging or resting). These effects have generally not been demonstrated for marine mammals, but studies involving fishes and terrestrial animals have shown that increased vigilance may substantially reduce feeding rates ( e.g., Beauchamp and Livoreil, 1997; Fritz et al., 2002; Purser and Radford, 2011). In addition, chronic disturbance can cause population declines through reduction of fitness ( e.g., decline in body condition) and subsequent reduction in reproductive success, survival, or both ( e.g., Harrington and Veitch, 1992; Daan et al., 1996; Bradshaw et al., 1998). However, Ridgway et al. (2006) reported that increased vigilance in bottlenose dolphins exposed to sound over a 5-day period did not cause any sleep deprivation or stress effects.

Many animals perform vital functions, such as feeding, resting, traveling, and socializing, on a diel cycle (24-hour cycle). Disruption of such functions resulting from reactions to stressors such as sound exposure are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall et al., 2007). Consequently, a behavioral response lasting less than one day and not recurring on subsequent days is not considered particularly severe unless it could directly affect reproduction or survival (Southall et al., 2007). Note that there is a difference between multi-day substantive ( i.e., meaningful) behavioral reactions and multi-day anthropogenic activities. For example, just because an activity lasts for multiple days does not necessarily mean that individual animals are either exposed to activity-related stressors for multiple days or, further, exposed in a manner resulting in sustained multi-day substantive behavioral responses.

Physiological stress responses. An animal's perception of a threat may be sufficient to trigger stress responses consisting of some combination of behavioral responses, autonomic nervous system responses, neuroendocrine responses, or immune responses ( e.g., Selye, 1950; Moberg, 2000). In many cases, an animal's first and sometimes most economical (in terms of energetic costs) response is behavioral avoidance of the potential stressor. Autonomic nervous system responses to stress typically involve changes in heart rate, blood pressure, and gastrointestinal activity. These responses have a relatively short duration and may or may not have a significant long-term effect on an animal's fitness.

Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction, altered metabolism, reduced immune competence, and behavioral disturbance ( e.g., Moberg, 1987; Blecha, 2000). Increases in the circulation of glucocorticoids are also equated with stress (Romano et al., 2004).

The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and “distress” is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficient to restore normal function.

Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well studied through controlled experiments and for both laboratory and free-ranging animals ( e.g., Holberton et al., 1996; Hood et al., 1998; Jessop et al., 2003; Krausman et al., 2004; Lankford et al., 2005; Ayres et al., 2012; Yang et al., 2022). Stress responses due to exposure to anthropogenic sounds or other stressors and their effects on marine mammals have also been reviewed (Fair and Becker, 2000; Romano et al., 2002b) and, more rarely, studied in wild populations ( e.g., Romano et al., 2002a). For example, Rolland et al. (2012) found that noise reduction from reduced ship traffic in the Bay of Fundy was associated with decreased stress in North Atlantic right whales ( Eubalaena glacialis ). In addition, Lemos et al. (2022) observed a correlation between higher levels of fecal glucocorticoid metabolite concentrations (indicative of a stress response) and vessel traffic in gray whales. Yang et al. (2022) studied behavioral and physiological responses in captive bottlenose dolphins exposed to playbacks of “pile-driving-like” impulsive sounds, finding significant changes in cortisol and other physiological indicators but only minor behavioral changes. These and other studies lead to a reasonable expectation that some marine mammals will experience physiological stress responses upon exposure to acoustic stressors and that it is possible that some of these would be classified as “distress.” In addition, any animal experiencing TTS would likely also experience stress responses (NRC, 2005), however distress is an unlikely result of this project based on observations of marine mammals during previous, similar construction projects.

Vocalizations and Auditory Masking. Since many marine mammals rely on sound to find prey, moderate social interactions, and facilitate mating (Tyack, 2008), noise from anthropogenic sound sources can interfere with these functions, but only if the noise spectrum overlaps with the hearing sensitivity of the receiving marine mammal (Southall et al., 2007; Clark et al., 2009; Hatch et al., 2012). Chronic exposure to excessive, though not high-intensity, noise could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions (Clark et al., 2009). Acoustic masking is when other noises such as from human sources interfere with an animal's ability to detect, recognize, or discriminate between acoustic signals of interest ( e.g., those used for intraspecific communication and social interactions, prey detection, predator avoidance, navigation) (Richardson et al., 1995; Erbe et al., 2016). Therefore, under certain circumstances, marine mammals whose acoustical sensors or environments are being severely masked could also be impaired from maximizing their performance fitness in survival and reproduction. The ability of a noise source to mask biologically important sounds depends on the characteristics of both the noise source and the signal of interest ( e.g., signal-to-noise ratio, temporal variability, direction), in relation to each other and to an animal's hearing abilities ( e.g., sensitivity, frequency range, critical ratios, frequency discrimination, directional discrimination, age or TTS hearing loss), and existing ambient noise and propagation conditions (Hotchkin and Parks, 2013).

Marine mammals vocalize for different purposes and across multiple modes, such as whistling, echolocation click production, calling, and singing. Changes in vocalization behavior in response to anthropogenic noise can occur for any of these modes and may result from a need to compete with an increase in background noise or may reflect increased vigilance or a startle response. For example, in the presence of potentially masking signals, humpback whales and killer whales have been observed to increase the length of their songs (Miller et al., 2000; Fristrup et al., 2003) or vocalizations (Foote et al., 2004), respectively, while North Atlantic right whales have been observed to shift the frequency content of their calls upward while reducing the rate of calling in areas of increased anthropogenic noise (Parks et al., 2007). Fin whales ( Balaenoptera physalus ) have also been documented lowering the bandwidth, peak frequency, and center frequency of their vocalizations under increased levels of background noise from large vessels (Castellote et al., 2012). Other alterations to communication signals have also been observed. For example, gray whales, in response to playback experiments exposing them to vessel noise, have been observed increasing their vocalization rate and producing louder signals at times of increased outboard engine noise (Dahlheim and Castellote, 2016). Alternatively, in some cases, animals may cease sound production during production of aversive signals (Bowles et al., 1994, Wisniewska et al., 2018).

Under certain circumstances, marine mammals experiencing significant masking could also be impaired from maximizing their performance fitness in survival and reproduction. Therefore, when the coincident (masking) sound is human-made, it may be considered harassment when disrupting or altering critical behaviors. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect (though not necessarily one that would be associated with harassment).

The frequency range of the potentially masking sound is important in determining any potential behavioral impacts. For example, low-frequency signals may have less effect on high-frequency echolocation sounds produced by odontocetes but are more likely to affect detection of mysticete communication calls and other potentially important natural sounds such as those produced by surf and some prey species. The masking of communication signals by anthropogenic noise may be considered as a reduction in the communication space of animals ( e.g., Clark et al., 2009) and may result in energetic or other costs as animals change their vocalization behavior ( e.g., Miller et al., 2000; Foote et al., 2004; Parks et al., 2007; Di Iorio and Clark, 2010; Holt et al., 2009). Masking can be reduced in situations where the signal and noise come from different directions (Richardson et al., 1995), through amplitude modulation of the signal, or through other compensatory behaviors, including modifications of the acoustic properties of the signal or the signaling behavior (Hotchkin and Parks, 2013). Masking can be tested directly in captive species ( e.g., Erbe, 2008), but in wild populations it must be either modeled or inferred from evidence of masking compensation. There are few studies addressing real-world masking sounds likely to be experienced by marine mammals in the wild ( e.g., Branstetter et al., 2013).

Since noises generated from the proposed construction activities are mostly concentrated at low frequencies (<2 kHz), these activities likely have less effect on mid-frequency echolocation sounds produced by odontocetes (toothed whales). However, lower frequency noises are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey noise. Low-frequency noise may also affect communication signals when they occur near the frequency band for noise and thus reduce the communication space of animals ( e.g., Clark et al., 2009) and cause increased stress levels ( e.g., Holt et al., 2009). Unlike TS, masking, which can occur over large temporal and spatial scales, can potentially affect the species at population, community, or even ecosystem levels, in addition to individual levels. Masking affects both senders and receivers of the signals, and at higher levels for longer durations, could have long-term chronic effects on marine mammal species and populations. However, the noise generated by CoW's proposed activities will only occur intermittently, across an estimated 46 days during the proposed authorization period in a relatively small area focused around the proposed construction site. Thus, while CoW's proposed activities may mask some acoustic signals that are relevant to the daily behavior of marine mammals, the short-term duration and limited areas affected make it very unlikely that the fitness of individual marine mammals would be impacted.

While in some cases marine mammals have exhibited little to no obviously detectable response to certain common or routine industrialized activities (Cornick et al., 2011; Horley and Larson, 2023), it is possible some animals may at times be exposed to received levels of sound above the Level B harassment thresholds during the proposed project. This potential exposure in combination with the nature of planned activity ( e.g., vibratory pile driving) means it is possible that take by Level B harassment could occur over the total estimated period of activities; therefore, NMFS, in response to the CoW's IHA application, proposes to authorize take by Level B harassment from the CoW's proposed construction activities.

Airborne Acoustic Effects. Pinnipeds that occur near the project site could be exposed to airborne sounds associated with construction activities that have the potential to cause behavioral harassment, depending on their distance from these activities. Airborne noise would primarily be an issue for pinnipeds that are swimming or hauled out near the project site within the range of noise levels elevated above airborne acoustic harassment criteria. Within the project area, no haul-out areas are known. Cetaceans are not expected to be exposed to airborne sounds that would result in harassment as defined under the MMPA.

We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with their heads above water. Most likely, any airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled out pinnipeds (if any are opportunistically present) to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to flush from haul-outs, temporarily abandon the area, and or move further from the source. However, these animals would previously have been `taken' because of exposure to underwater sound above the behavioral harassment thresholds, which are in all cases larger than those associated with airborne sound. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.

CoW's proposed activities could have localized, temporary impacts on marine mammal habitat, including prey, by increasing in-water SPLs. Increased noise levels may affect acoustic habitat and adversely affect marine mammal prey near the project area (see discussion below). Elevated levels of underwater noise would ensonify the project areas where both fishes and mammals occur and could affect foraging success. Additionally, marine mammals may avoid the area during the proposed construction activities; however, displacement due to noise is expected to be temporary and is not expected to result in long-term effects to the individuals or populations.

The total area likely impacted by CoW's activities is relatively small compared to the available habitat in and around Whittier Harbor. Avoidance by potential prey ( i.e., fish) of the immediate area due to increased noise is possible. The duration of fish and marine mammal avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution, and behavior is anticipated. Any behavioral avoidance by fish or marine mammals of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the nearby vicinity.

The proposed project will occur within the approximate footprint of existing marine infrastructure. The nearshore and intertidal habitat where the proposed project will occur is an area of relatively high marine vessel traffic. Most marine mammals do not generally use the area within the footprint of the project area. Temporary, intermittent, and short-term habitat alteration may result from increased noise levels during the proposed construction activities. Effects on marine mammals will be limited to temporary displacement from pile installation and removal noise, and effects on prey species will be similarly limited in time and space.

Water quality. Temporary and localized reduction in water quality will occur because of in-water construction activities. Most of this effect would occur during the installation and removal of piles when bottom sediments are disturbed. The installation and removal of piles using the vibratory hammer would disturb bottom sediments and may cause a temporary increase in suspended sediment in the project area. During pile extraction, sediment attached to the pile moves vertically through the water column until gravitational forces cause it to slough off under its own weight. The small resulting sediment plume is expected to settle out of the water column within a few hours. Studies of the effects of turbid water on fish (marine mammal prey) suggest that concentrations of suspended sediment can reach thousands of milligrams per liter before an acute toxic reaction is expected (Burton, 1993).

Effects to turbidity and sedimentation are expected to be short-term, minor, and localized. Following the completion of sediment-disturbing activities, suspended sediments in the water column should dissipate and quickly return to background levels in all construction scenarios. Turbidity within the water column has the potential to reduce the level of oxygen in the water and irritate the gills of prey fish species in the proposed project area. However, turbidity plumes associated with the project would be temporary and localized, and fish in the proposed project area would be able to move away from and avoid the areas where plumes may occur. Therefore, it is expected that the impacts on prey fish species from turbidity, and therefore on marine mammals, would be minimal and temporary. In general, the area likely impacted by the proposed construction activities is relatively small compared to the available marine mammal habitat in and around Whittier Harbor.

Potential Effects on Prey. Sound may affect marine mammals through impacts on the abundance, behavior, or distribution of prey species ( e.g., crustaceans, cephalopods, fishes, and zooplankton). Marine mammal prey varies by species, season, and location and, for some, is not well documented. Studies regarding the effects of noise on known marine mammal prey are described here.

Fishes utilize the soundscape and components of sound in their environment to perform important functions such as foraging, predator avoidance, mating, and spawning ( e.g., Zelick et al., 1999; Fay, 2009). Depending on their hearing anatomy and peripheral sensory structures, which vary among species, fishes hear sounds using pressure and particle motion sensitivity capabilities and detect the motion of surrounding water (Fay et al., 2008). The potential effects of noise on fishes depends on the overlapping frequency range, distance from the sound source, water depth of exposure, and species-specific hearing sensitivity, anatomy, and physiology. Key impacts to fishes may include behavioral responses, hearing damage, barotrauma (pressure-related injuries), and mortality.

Fish react to sounds that are especially strong and/or intermittent low-frequency sounds and behavioral responses such as flight or avoidance are the most likely effects. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. The reaction of fish to noise depends on the physiological state of the fish, past exposures, motivation ( e.g., feeding, spawning, migration), and other environmental factors. Hastings and Popper (2005) identified several studies that suggest fish may relocate to avoid certain areas of sound energy. Additional studies have documented effects of pile driving on fishes ( e.g. Scholik and Yan, 2001, 2002; Popper and Hastings, 2009). Several studies have demonstrated that impulse sounds might affect the distribution and behavior of some fishes, potentially impacting foraging opportunities or increasing energetic costs ( e.g., Fewtrell and McCauley, 2012; Pearson et al., 1992; Skalski et al., 1992; Santulli et al., 1999; Paxton et al., 2017). However, some studies have shown no or slight reaction to impulse sounds ( e.g., Peña et al., 2013; Wardle et al., 2001; Jorgenson and Gyselman, 2009; Cott et al., 2012). More commonly, though, the impacts of noise on fishes are temporary.

SPLs of sufficient strength have been known to cause injury to fishes and fish mortality (summarized in Popper et al., 2014). However, in most fish species, hair cells in the ear continuously regenerate and loss of auditory function likely is restored when damaged cells are replaced with new cells. Halvorsen et al. (2012b) showed that a TTS of 4 to 6 dB was recoverable within 24 hours for one species. Impacts would be most severe when the individual fish is close to the source and when the duration of exposure is long. Injury caused by barotrauma can range from slight to severe and can cause death, and is most likely for fish with swim bladders. Barotrauma injuries have been documented during controlled exposure to impact pile driving (Halvorsen et al., 2012a; Casper et al., 2013, 2017).

Fish populations in the proposed project area that serve as marine mammal prey could be temporarily affected by noise from pile installation and removal. The frequency range in which fishes generally perceive underwater sounds is 50 to 2,000 Hz, with peak sensitivities below 800 Hz (Popper and Hastings, 2009). Fish behavior or distribution may change, especially with strong and/or intermittent sounds that could harm fishes. High underwater SPLs have been documented to alter behavior, cause hearing loss, and injure or kill individual fish by causing serious internal injury (Hastings and Popper, 2005).

Zooplankton is a food source for several marine mammal species, as well as a food source for fish that are then preyed upon by marine mammals. Population effects on zooplankton could have indirect effects on marine mammals. Data are limited on the effects of underwater sound on zooplankton species, particularly sound from construction (Erbe et al., 2019). Popper and Hastings (2009) reviewed information on the effects of human-generated sound and concluded that no substantive data are available on whether the sound levels from pile driving, seismic activity, or any human-made sound would have physiological effects on invertebrates. Any such effects would be limited to the area very near (1 to 5 m (3.28 to 16.4 ft)) the sound source and would result in no population effects because of the relatively small area affected at any one time and the reproductive strategy of most zooplankton species (short generation, high fecundity, and very high natural mortality). No adverse impact on zooplankton populations is expected to occur from the specified activity due in part to large reproductive capacities and naturally high levels of predation and mortality of these populations. Any mortalities or impacts that might occur would be negligible.

The greatest potential impact to marine mammal prey during construction would occur during vibratory pile driving. In-water construction activities would only occur during daylight hours, allowing fish to forage and transit the project area in the evening. Vibratory pile driving would possibly elicit behavioral reactions from fishes such as temporary avoidance of the area but is unlikely to cause injuries to fishes or have persistent effects on local fish populations. Construction is expected to have minimal permanent and temporary impacts on benthic invertebrate species, which are known marine mammal prey source. In addition, the area in question is generally considered low-quality habitat since it is already highly developed and experiences a high level of anthropogenic noise from normal operations and other vessel traffic.

This proposed project is not expected to result in any habitat related effects that could cause significant or long-term negative consequences for individual marine mammals or their populations, since installation and removal of in-water piles would be temporary and intermittent. The total seafloor area affected by pile installation and removal is a very small area compared to the vast foraging area available to marine mammals outside this project area. For marine mammals, while the area is commonly used or traversed, the proposed project area does not contain any particularly high-value habitat and is not usually important to any of the other species potentially affected by CoW's proposed activities. While opportunistic foraging could occur, more foraging habitat is available in the Passage Canal and Prince William Sound. Overall, the area impacted by the project is relatively small compared to the available habitat just outside the project area, and there are no areas of particular importance that would be impacted by this project during the period planned for activities to occur ( i.e., September through September). Any behavioral avoidance by fish of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the nearby vicinity. As described in the preceding, the potential for the CoW's construction to affect the availability of prey to marine mammals or to meaningfully impact the quality of physical or acoustic habitat is considered insignificant. Therefore, impacts of the project are not likely to have adverse effects on marine mammal foraging habitat in the proposed project area.

In summary, given the relatively small areas potentially being effected, as well as the temporary and mostly transitory nature of the proposed construction activities, any adverse effects from CoW's activities on prey habitat or prey populations are expected to be minor and temporary. The most likely impact to fishes at the project site would be temporary avoidance of the area. Any behavioral avoidance by fish of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the nearby vicinity. Thus, we preliminarily conclude that impacts of the specified activities are not likely to have more than short-term adverse effects on any prey habitat or populations of prey species. Further, any impacts to marine mammal habitat are not expected to result in significant or long-term consequences for individual marine mammals, or to contribute to adverse impacts on their populations.

This section provides an estimate of the number of incidental takes proposed for authorization 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 would be by Level B harassment only, in the form behavioral reactions for individual marine mammals resulting from exposure to vibratory pile driving. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures ( i.e., enhanced shutdown zone around the approximate 25 m (82 ft) distance to the Level A harassment threshold) discussed in detail below in the Proposed Mitigation section, Level A harassment is neither anticipated nor proposed to be authorized. Additionally, as described previously, no serious injury or mortality is anticipated or proposed to be authorized for this activity. Below we describe how the proposed take numbers are estimated.

For acoustic impacts, generally speaking, we estimate take by considering: (1) acoustic criteria above which NMFS believes the best available science indicates marine mammals will likely be behaviorally harassed or incur some degree of AUD INJ; (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 proposed take estimates.

NMFS recommends the use of acoustic criteria 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 AUD INJ of some degree (equated to Level A harassment). We note that the criteria for AUD INJ, as well as the names of two hearing groups, have been recently updated (NMFS, 2024) 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 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.

For in-air sounds, NMFS predicts that harbor seals exposed above received levels of 90 dB re 20 μPa (RMS) will be behaviorally harassed, and other pinnipeds will be harassed when exposed above 100 dB re 20 μPa (RMS). Generally speaking, Level B harassment take estimates based on these behavioral harassment thresholds are expected to include any likely takes by 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 ( e.g., conspecific communication, predators, prey) may result in changes in behavior patterns that would not otherwise occur.

CoW's proposed construction includes the use of continuous ( i.e., vibratory pile driving) sources, and therefore the RMS SPL threshold of 120 dB re 1 μPa is applicable.

Level A harassment. NMFS' Updated Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 3.0) (NMFS, 2024) identifies dual criteria to assess AUD INJ (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) (table 4). CoW's proposed construction includes the use of a non-impulsive (vibratory pile driving) source.

The 2024 Updated Technical Guidance criteria include both updated thresholds and updated weighting functions for each hearing group. The thresholds are provided in table 4. 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 proposed project area is the existing background noise and any additional construction noise produced from the proposed project. Marine mammals are only expected to be affected by sound generated by CoW's primary component of the project ( i.e., vibratory pile driving). The source level assumed for both removal and installation activities is based on reviews of measurements of the same or similar types and dimensions of piles available in the literature and from similar coastal construction projects. The source levels for the piles and activity are presented in table 5. The source levels for vibratory removal and installation of piles of the same material and diameter are assumed to be the same.

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:

Absent site-specific acoustical monitoring with differing measured TL, a practical spreading value of 15 is used as the TL coefficient in the above formula. Site-specific TL data for Whittier is not available; therefore, the default coefficient of 15 is used to determine the distances to the Level A harassment and Level B harassment thresholds.

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 vibratory 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, the resulting estimated isopleths, and the resulting zones of influence ( i.e., areas in square kilometers (km 2 )) are reported below in tables 6, 7, and 8, respectively.

In this section, we provide information about the occurrence of marine mammals, including density or other relevant information, which will inform the take calculations. Next, we describe how all of the information described above is synthesized to produce a quantitative estimate of the take that is reasonably likely to occur and proposed for authorization.

CoW provided estimation count information based on a synthetization of different resources, including a local whale watching company, reports from previous marine construction projects in the Whittier area, and the available scientific literature (Solstice Alaska Consulting, Inc., 2022; Alaska Department of Transportation and Public Facilities, 2019; Moran et al., 2018; Olsen et al., 2018; Solstice Alaska Consulting, Inc., 2024; Leonard and Wisdom, 2020). Frequency of sightings were determined by first grouping each species/stock into “ common, ” “ infrequent, ” “ rare, ” or “ very rare ”. Species/stocks who were determined as “ common ” or “ infrequent” were assumed that they could occur at least once per day; other species/stocks who were labeled as “ rare ” or “ very rare ” were assumed that occurrence in the project area would be approximately two to four times per month.

More specific information on the occurrence information incorporated into the analysis can be found in table 6 of CoW's ITA application and is not repeated here; instead, we reference the reader there for additional information. For NMFS' analysis, we reviewed the group sizes and occurrence information synthesized in the application and we provide the numerical values here in table 9.

Next, all available information was utilized to determine the proposed take for marine mammals incidental to CoW's project. In using the daily occurrence estimates for each species, the estimated group sizes and the number of days or months for each specific type of pile driving were multiplied together (see the below formula):

The results of this analysis can be found in table 10, where the number of takes that NMFS proposes for authorization are presented.

In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to the activity, and other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting the activity or other means of effecting the least practicable adverse impact upon the affected species or stocks, and their habitat (50 CFR 216.104(a)(11)).

In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, NMFS considers two primary factors:

(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned), the likelihood of effective implementation (probability implemented as planned), and;

(2) The practicability of the measures for applicant implementation, which may consider such things as cost and impact on operations.

In addition to the measures described later in this section, CoW would be required to follow these general mitigation measures:

• Take proposed to be authorized, by Level B harassment only, would be limited to the species and numbers listed in tables 2 and 10. Proposed construction activities must be halted upon observation of either a species for which incidental take would not be authorized or a species for which incidental take would be authorized but the authorized number of takes has been met, entering or is within the harassment zone;

• The taking by Level A harassment, serious injury, or death of any of the species listed in tables 2 and 10 or any taking of any other species of marine mammal would be prohibited and would result in the modification, suspension, or revocation of the IHA, if issued. Any taking exceeding the authorized amounts listed in table 10 would be prohibited and would result in the modification, suspension, or revocation of the IHA, if issued;

• Ensure that construction supervisors and crews, the marine mammal monitoring team, and relevant CoW staff are trained prior to the start of all construction activities, so that responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures are clearly understood. New personnel joining during the project must be trained prior to commencing work;

• CoW, construction supervisors and crews, protected species observers (PSOs), and relevant project staff must avoid direct physical interaction with marine mammals during construction activities. If a marine mammal comes within 10 m (32.8 ft) of such activity, operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions, as necessary to avoid direct physical interaction;

• If poor weather conditions restrict the PSO's ability to make observations within the Level A and B harassment zone of pile driving ( e.g., if there is excessive wind or fog), pile installation and removal will be halted; and

• Employ PSOs and establish monitoring locations as described in Section 5 of the IHA and within CoW's Marine Mammal Monitoring Plan (see the proposed Plan found on NMFS' website: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities ). CoW would be required to monitor the project area to the maximum extent possible based on the required number of PSOs, required monitoring locations, and environmental conditions.

Additionally, the following mitigation measures apply to CoW's in-water construction activities.

CoW would be required to establish pre- and post-monitoring zones with radial distances (based on the distances to the Level B harassment threshold), as identified in table 11, for all construction activities. All pre-start clearance monitoring must be conducted during periods of visibility sufficient for the PSO to determine that the shutdown zones (indicated in table 12) are clear of marine mammals. All monitoring would be required to take place from 30 minutes prior to initiation of pile driving activity ( i.e., pre-clearance monitoring) through 30 minutes post-completion of pile driving activity. Pile driving may commence following 30 minutes of observation when the determination is made that the shutdown zones are clear of marine mammals (see table 12 further below).

If a break in vibratory pile driving occurs for a duration of 30 minutes or longer, CoW must begin the 30-minute pre-clearance monitoring again to ensure the applicable monitoring zones are clear of marine mammals.

CoW would be required to establish shutdown zones with radial distances, as identified in table 12, for all construction activities. The purpose of a shutdown zone is generally to define an area within which shutdown of the activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). The shutdown zone during vibratory pile driving is based on the greatest distance to Level A harassment threshold ( i.e., 24.8 m (81.4 ft) (refer to table 8)), initially rounded up to the nearest whole number (25 m (82 ft)). A general 10-m (32.8-ft) shutdown zone would be required for all other activities where harassment is not expected ( i.e., movement of the barges to the pile locations, movement of the barges during position and removal of the float systems, and positioning/stabbing of the pile on the substrate using a crane).

PSOs will be stationed at various land-based observations points during the proposed construction activities and will monitor continuously during in-water work. If a marine mammal is observed entering or within the shutdown zones indicated in table 12, pile-driving activity must be delayed or halted. If pile driving is delayed or halted due to the presence of a marine mammal, the activity may not commence or resume until either the animal has voluntarily exited and been visually confirmed beyond the shutdown zones or 15 minutes have passed without re-detection of the animal. If a marine mammal comes within or approaches the shutdown zone indicated in table 12, such operations must cease.

CoW would also be required to establish shutdown zones for all marine mammals for which take has not been authorized or for which incidental take has been authorized but the authorized number of takes has been met. These zones are equivalent to the Level B harassment zones for each activity. If a marine mammal species for which take is not authorized by this IHA, if issued, enters the shutdown zone, all in-water activities would cease until the animal leaves the zone or has not been observed for at least 15 minutes. CoW would then be required to notify NMFS about the species and precautions taken. Vibratory pile driving would proceed if the non-IHA species is observed to leave the Level A harassment zone or if 15 minutes have passed since the last observation.

If shutdown and/or clearance procedures would result in an imminent safety concern, as determined by CoW or its designated officials, the in-water activity would be allowed to continue until the safety concern has been addressed, and the animal would be continuously monitored.

All marine mammals would be monitored in the Level B harassment zone and throughout the area as far as visual monitoring can take place. If a marine mammal enters the Level B harassment zone, in-water activities would continue and the animal's presence within the estimated harassment zone would be documented.

Based on our evaluation of the proposed mitigation measures, NMFS has preliminarily determined that the measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present while conducting the activities. Effective reporting is critical, for both compliance as well as ensuring that the most value is obtained from the required monitoring.

Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:

• Occurrence of marine mammal species or stocks in the area in which take is anticipated ( e.g., presence, abundance, distribution, density);

• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) action or environment ( e.g., source characterization, propagation, ambient noise); (2) affected species ( e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the activity; or (4) biological or behavioral context of exposure ( e.g., age, calving or feeding areas);

• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;

• How anticipated responses to stressors impact either: (1) long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;

• Effects on marine mammal habitat ( e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and,

• Mitigation and monitoring effectiveness.

CoW would be required to abide by all monitoring and reporting measures contained within the IHA, if issued, and their Marine Mammal Monitoring Plan (see the proposed Plan found on NMFS' website: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities ). A summary of those measures, and additional requirements proposed by NMFS, is described below.

Marine mammal monitoring must be conducted in accordance with the conditions in this section and the IHA, if issued. Marine mammal monitoring during vibratory pile driving activities would be conducted by PSOs who meet the following requirements:

• PSOs must be independent of the activity contractor (for example, employed by a subcontractor) and have no other assigned tasks during monitoring periods;

• At least one PSO would have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization;

• Other PSOs may substitute relevant experience, education (degree in biological science or related field), or training for prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization; and

• Where a team of three or more PSOs is required, a lead observer or monitoring coordinator would be designated. The lead observer would be required to have prior experience performing the duties of a PSO during construction activities pursuant to a NMFS-issued incidental take authorization.

PSOs must also have the following additional qualifications:

• Ability to conduct field observations and collect data according to assigned protocols;

• Experience or training in the field identification of marine mammals, including the identification of behaviors;

• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;

• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and

• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

CoW would be required to establish monitoring locations as described in the “Marine Mammal Monitoring Plan” (see the proposed Plan found on NMFS' website: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities ). For all pile-driving activities, at least two PSOs would be onsite during in-water activities associated with the proposed Project. These PSOs would be stationed at the Whittier Harbor breakwater near the picnic shelter (“Station 1”), at the Whittier fuel dock (“Station 2”), and at the City of Whittier campground (“Station 3”). The number and locations of PSOs would be based on two work scenarios: during more generic activities, such as all in-water construction not involving any pile driving and during all barge movement (“Scenario #1”); and, during removal and installation of piles using an active vibratory pile hammer (“Scenario #2”). See figure 2 for the planned PSO locations. PSOs would record all observations of marine mammals, regardless of distance from the pile being driven, as well as the additional data indicated below and in the draft IHA, if issued.

Monitoring would be conducted 30 minutes before, during, and 30 minutes after all in water construction activities. All PSOs would have access to high-quality binoculars and/or spotting scopes to monitor distances, hand-held global positioning system (GPS) unit/grid-maps and compass/clinometer, and portable two-way radios for maintaining contact with work crews, CoW inspectors, and other PSOs. In addition, CoW would record all incidents of marine mammal occurrence, regardless of distance from the construction activities, and would document any behavioral reactions in concert with distance from piles being driven or removed. Pile driving activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than 30 minutes.

CoW would conduct briefings between construction supervisors and crews, PSOs, CoW staff prior to the start of all pile-driving activities and when new personnel join the work. These briefings would explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

Although take of AT1 killer whales is not proposed to be authorized, given the limited likelihood for their presence to overlap the project area in space and time, NMFS has included in the proposed IHA recent photographs (from 2021) of the dorsal fins of all seven members of the AT1 stock. These images are provided courtesy of the North Gulf Oceanic Society ( http://www.whalesalaska.org ) and would be used to aid PSOs in the identification of these specific individual killer whales and to implement mitigation, if necessary, to avoid take.

CoW would be required to submit an annual draft summary report on all construction activities and marine mammal monitoring results to NMFS within 90 days following the end of construction or 60 calendar days prior to the requested issuance of any subsequent IHA for similar activity at the same location, whichever comes first. The draft summary report would include an overall description of construction work completed, a narrative regarding marine mammal sightings, and associated raw PSO data sheets (in electronic spreadsheet format). Specifically, the report must include:

• Dates and times (begin and end) of all marine mammal monitoring;

• Construction activities occurring during each daily observation period, including: (a) how many and what type of piles were driven or removed; (b) the method of removal and installation ( i.e., vibratory pile driving); and (c) the total duration of time needed to drive each pile via vibratory driving;

• PSO locations during marine mammal monitoring; and

• Environmental conditions during monitoring periods (at beginning and end of PSO shift and whenever conditions change significantly), including Beaufort sea state and any other relevant weather conditions including cloud cover, fog, sun glare, and overall visibility to the horizon, and estimated observable distance.

Upon observation of a marine mammal, the following information must be reported:

• Name of PSO who sighted the animal(s) and PSO location and activity at the time of the sighting;

• Time of the sighting;

• Identification of the animal(s) ( e.g., genus/species, lowest possible taxonomic level, or unidentified), PSO confidence in identification, and the composition of the group if there is a mix of species;

• Distance and bearing of each observed marine mammal relative to the pile being driven or removed for each sighting;

• Estimated number of animals (min/max/best estimate);

• Estimated number of animals by cohort ( e.g., adults, juveniles, neonates, group composition, etc. );

• Animal's closest point of approach and estimated time spent within the estimated harassment zone(s);

• Description of any marine mammal behavioral observations ( e.g., observed behaviors such as feeding or traveling), including an assessment of behavioral responses thought to have resulted from the activity ( e.g., no response or changes in behavioral state such as ceasing feeding, changing direction, flushing, or breaching);

• Number of marine mammals detected within the estimated harassment zones, by species; and

• Detailed information about implementation of any mitigation ( e.g., shutdowns and delays), a description of specified actions that ensured, and resulting changes in behavior of the animal(s), if any.

If no comments are received from NMFS within 30 days after the submission of the draft summary report, the draft report would constitute the final report. If CoW received comments from NMFS, a final summary report addressing NMFS' comments must be submitted within 30 days after receipt of comments.

In the unanticipated event that the specified activity causes the take of a marine mammal in a manner prohibited by the IHA (if issued), such as an injury, serious injury, or mortality, CoW must immediately cease the specified activities and report the incident to the NMFS Office of Protected Resources ( PR.ITP.MonitoringReports@noaa.gov and ITP.potlock@noaa.gov ), and the NMFS Alaska 24-hour Regional Stranding Hotline (877) 925-7773 or (877) 9-AKR-PRD. The report must include the following information:

• Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);

• Species identification (if known) or description of the animal(s) involved;

• Condition of the animal(s) (including carcass condition if the animal is dead);

• Observed behaviors of the animal(s), if alive;

• If available, photographs or video footage of the animal(s); and

• General circumstances under which the animal was discovered.

Activities would not resume until NMFS can review the circumstances surrounding the prohibited take. NMFS would work with CoW to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. CoW cannot resume their activities until NMFS has notified them via letter, email, or telephone.

If CoW discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent ( e.g., in less than a moderate state of decomposition as described in the next paragraph), then CoW would immediately report the incident to the NMFS Office of Protected Resources ( PR.ITP.MonitoringReports@noaa.gov and ITP.potlock@noaa.gov ), and the NMFS Alaska 24-hour Regional Stranding Hotline at (877) 925-7773 or (877) 9-AKR-PRD. The report would include the same information identified in the paragraph above. Activities would be able to continue while NMFS reviews the circumstances of the incident. NMFS would work with CoW to determine whether modifications in the activities are appropriate.

Finally, in the event that CoW discovers an injured or dead marine mammal and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in the IHA ( e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), CoW would report the incident to the Permits and Conservation Division, Office of Protected Resources, NMFS, and the NMFS Alaska Stranding Hotline and/or by email to the Alaska Regional Stranding Coordinator, within 24 hours of the discovery. CoW would provide photographs, video footage (if available), or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network.

NMFS has defined negligible impact 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 (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival ( i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any impacts or responses ( e.g., intensity, duration), the context of any impacts or responses ( e.g., critical reproductive time or location, foraging impacts affecting energetics), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS' implementing regulations (54 FR 40338, September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the baseline ( e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).

To avoid repetition, the discussion of our analysis applies to all of the species listed in tables 2 and 10, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar. There is little information about the nature or severity of the impacts, or the size, status, or structure of any of these species or stocks that would lead to a different analysis for this activity.

Pile driving activities associated with CoW's proposed construction project have the potential to disturb or displace marine mammals. Specifically, the project activities may result in take, in the form of Level B harassment only, from underwater sounds generated from vibratory pile driving and removal. Potential takes could occur if individuals are present in the ensonified zone when these activities are underway.

The takes by Level B harassment would be due to potential behavioral disturbance. No serious injury or mortality would be expected, even in the absence of required mitigation measures, given the nature of the activities. The potential for harassment would be further minimized through the construction method and the implementation of the planned mitigation measures (see the Proposed Mitigation section). Any potential for take by Level A harassment is also not expected, given the nature of the activities and the small distance to the Level A harassment threshold. The potential for this is further reduced through the required mitigation measures proposed. Given the small harassment zone estimated for vibratory pile driving and the proximity of this zone near the construction barge, an animal would have to remain within the area estimated to be ensonified above the Level A harassment threshold for multiple hours. This is highly unlikely given the small size of the construction location, marine mammal movement in the area ( i.e., no residential species), and the use of observers stationed around the construction site.

Behavioral responses of marine mammals to pile driving in Whittier are expected to be mild, short term, and temporary. Marine mammals within the Level B harassment zones may not show any visual cues they are disturbed by activities or they could become alert, avoid the area, leave the area, or display other mild responses that are not observable, such as changes in vocalization patterns. Given vibratory pile driving would occur for only a portion of the project's duration, any harassment that may occur would be expected to be temporary. Additionally, many of the species present in region would only be present temporarily based on seasonal patterns or during active transit between other habitats. Pinnipeds in the area would have the ability to haul-out to avoid the activities and no in-air harassment is anticipated from the construction activities planned given the type of activities and short isopleths to the Level B harassment threshold (refer to table 8). These temporarily present species would then be exposed to even smaller periods of noise-generating activity, further decreasing the impacts.

Any impacts on marine mammal prey that would occur during CoW's proposed activities would have, at most, short-term effects on foraging of individual marine mammals, and likely no effect on the populations of marine mammals as a whole. Indirect effects on marine mammal prey during the construction are expected to be minor, and these effects are unlikely to cause substantial effects on marine mammals at the individual level, with no expected effect on annual rates of recruitment or survival.

For all species and stocks, take would occur within a limited, confined area of the stock's range, and, there are no known BIAs near the project area that are expected to be impacted by CoW's proposed activities. While Steller sea lions and harbor seals are the species most likely to occur within the immediate project area, the nearest haul out for Steller sea lions is over 40 km (24.9 mi) away, with the closest known sighting (on a mooring buoy) located approximately 8 km (5 mi) away, all of which is outside of the ensonified zone. For harbor seals, although they have been observed occasionally hauling out within Whittier Harbor, there are no known rookeries or major haul-out areas near the project area. Any other species are likely to be transiting through or by Whittier Harbor but are not expected to remain for any extended duration.

In addition, it is unlikely that minor noise effects in a small, localized area of habitat would have any effect on the reproduction or survival of any individuals, much less the stocks' annual rates of recruitment or survival. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activities would have only minor, short-term effects on individuals. The specified activities are not expected to impact rates of recruitment or survival and would not be expected to result in population-level impacts.

In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from this activity are not expected to adversely affect any of the species or stocks through effects on annual rates of recruitment or survival:

• No serious injury or mortality is anticipated or proposed to be authorized;

• No take by Level A harassment was requested, is expected, or is proposed for authorization;

• For all species and stocks, Whittier Harbor is a very small and peripheral part of their range;

• The intensity of anticipated takes by Level B harassment is relatively low for all stocks. Level B harassment would be primarily in the form of behavioral disturbance, resulting in avoidance of the project areas around where vibratory pile driving is occurring;

• Effects on species that serve as prey for marine mammals from the activities are expected to be short-term and, therefore, any associated impacts on marine mammal feeding are not expected to result in significant or long-term consequences for individuals, or to accrue to adverse impacts on their populations;

• Although the Prince William Sound is part of the critical habitat designated for Steller sea lions (both terrestrial and aquatic habitats), the nearest Steller sea lion haul-out is over 40 km (24.9 mi) away, with the closest known sighting (on a mooring buoy) located approximately 8 km (5 mi) away, all of which is outside of the ensonified zone;

• The project area does not overlap any areas of known important habitat ( i.e., BIAs) for marine mammals;

• The ensonified areas are very small relative to the overall habitat ranges of all species and stocks; and

• There is a lack of anticipated significant or long-term negative effects to marine mammal habitat.

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.

As noted previously, only take of small numbers of marine mammals may be authorized under sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. When the predicted number of individuals to be taken is fewer than one-third of the species or stock abundance, the take is considered to be of small numbers (see 86 FR 5322, January 19, 2021). Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.

The instances of take NMFS has proposed to authorize is below one-third of the estimate stock abundance for all species. The number of animals proposed for authorization that could be taken from these stocks would be considered small relative to the relevant stocks' abundances even if each estimated taking occurred to a new individual. While there is a potential for some individuals to be taken multiple times per day, PSOs would count them as separate takes if they cannot be individually identified.

Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals would be taken relative to the population size of the affected species or stocks.

In order to issue an IHA, NMFS must find that the specified activity will not have an “unmitigable adverse impact” on the subsistence uses of the affected marine mammal species or stocks by Alaskan Natives. NMFS has defined “unmitigable adverse impact” in 50 CFR 216.103 as an impact resulting from the specified activity: (1) That is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by: (i) Causing the marine mammals to abandon or avoid hunting areas; (ii) Directly displacing subsistence users; or (iii) Placing physical barriers between the marine mammals and the subsistence hunters; and (2) That cannot be sufficiently mitigated by other measures to increase the availability of marine mammals to allow subsistence needs to be met.

While Alaska Natives have historically hunted sea lions and harbor seals in the Prince William Sound, subsistence species hunted more today consist of salmon, halibut, shellfish, and plants ( i.e., wild berries) with a significant decline in marine mammal hunting overall (Poe et al., 2010). CoW has indicated that the last recorded harvest of marine mammals in Whittier was in 1990 during the harvest of seven marine mammals (per ADF&G, 2024b). While other coastal communities along the Prince William Sound report more recent subsistence harvests ( i.e., Cordova, Chenega, and Tatitlek), subsistence hunters have had to travel further form their communities to be successful when harvesting marine mammals (Keating et al., 2020). However, per Fall and Zimpelman (2016), these reported travel ranges do not extend into the Passage Canal and Cordova, Chenega, and Tatitlek are located at least 60 miles (96.56 km) away by boat.

Because of this, NMFS agrees with CoW's preliminary determination that the proposed project is not likely to adversely affect the availability of any marine mammal species/stocks that would traditionally be used for subsistence purposes, or would affect any subsistence harvest in the region because of the following reasons:

• There is no recently recorded subsistence harvest of marine mammals in the area;

• The construction activities would be localized and temporary in nature;

• The proposed mitigation measures would minimize any disturbances of marine mammals in the area;

• NMFS expects that any effects on marine mammals would not rise above behavioral impacts and would be temporary in nature; and

• No serious injury or mortality is expected to result from the project activities, therefore, the project would not result in a signify ant change to the availability of subsistence resources.

Based on the description of the specified activity, the measures described to minimize adverse effects on the availability of marine mammals for subsistence purposes, and the proposed mitigation and monitoring measures; NMFS has preliminarily determined that there will not be an unmitigable adverse impact on subsistence uses from CoW's proposed activities.

Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531 et seq. ) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally whenever we propose to authorize take for endangered or threatened species, in this case with the Alaska Regional Office.

NMFS is proposing to authorize take of Steller sea lions (Western DPS), which are listed under the ESA. The Permits and Conservation Division has requested initiation of section 7 consultation with the Alaska Regional Office for the issuance of this IHA. NMFS will conclude the ESA consultation prior to reaching a determination regarding the proposed issuance of the authorization.

As a result of these preliminary determinations, NMFS proposes to issue an IHA to CoW for conducting construction activities as part of the Whittier Harbor Rebuild Phase III Project in Whittier, Alaska from September 15, 2025 through September 14, 2026, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. A draft of the proposed IHA can be found at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities.

We request comment on our analyses, the proposed authorization, and any other aspect of this notice of proposed IHA for CoW's proposed Whittier Harbor Rebuild Phase III Project. We also request comment on the potential renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform decisions on the request for this IHA or a subsequent renewal IHA.

On a case-by-case basis, NMFS may issue a one-time, 1-year renewal IHA following notice to the public providing an additional 15 days for public comments when (1) up to another year of identical or nearly identical activities as described in the Description of Proposed Activity section of this notice is planned or (2) the activities as described in the Description of Proposed Activity section of this notice would not be completed by the time the IHA expires and a renewal would allow for completion of the activities beyond that described in the Dates and Duration section of this notice, provided all of the following conditions are met:

• A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date (recognizing that the renewal IHA expiration date cannot extend beyond 1 year from expiration of the initial IHA).

• The request for renewal must include the following:

(1) An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor ( e.g., reduction in pile size) that the changes do not affect the previous analyses, mitigation and monitoring requirements, or take estimates (with the exception of reducing the type or amount of take).

(2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.

• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.

The MMPA requires NMFS to authorize the incidental take of ESA-listed marine mammals in Category I and II commercial fisheries provided: (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 determined 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 are issuing a permit to the fishery to authorize the incidental take of ESA-listed marine mammal species or stocks (Central America/Southern Mexico-CA/Oregon (OR)/Washington (WA) and Mainland Mexico-CA/OR/WA stocks of humpback whale; CA/OR/WA stock of sperm whale) under the MMPA through December 31, 2027.

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. Section 118(a)(2) of the MMPA, 16 U.S.C. 1387(a)(2), also requires an additional authorization for these fisheries at section 101(a)(5) of the MMPA, 16 U.S.C. 1371(a)(5), for incidental taking of ESA-listed marine mammals. Section 101(a)(5)(E) of the MMPA, 16 U.S.C. 1371(a)(5), 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 marine mammal species or stocks listed under the ESA 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 are issuing 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 (90 FR 12148, March 14, 2025).

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 determinations 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' regulations provide 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).” 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 NIT (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 even though 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 by stock 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 generally 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 the requirements of MMPA 101(a)(5)(E) are not met, and NMFS cannot issue a 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. In using this information, 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, and made a NID. The NID analysis is presented in the accompanying MMPA 101(a)(5)(E) evaluation document 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 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. The CA/OR/WA stock of sperm whales is also transboundary 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 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 MMPA 101(a)(5)(E) determination document, 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 and Mainland Mexico-CA/OR/WA stocks of humpback whale and the CA/OR/WA stock of sperm whale. The 2022 SAR (data from 2016-2020) includes mean annual total commercial fishery-related M/SI for the Central America/Southern Mexico-CA/OR/WA stock of humpback whale (8.1) and Mainland Mexico-CA/OR/WA stock of humpback whale (11.4) (Carretta et al. 2023). The 2023 SAR (data from 2017-2021) includes a mean annual total commercial fishery-related M/SI for the CA/OR/WA stock of sperm whales of 0.52 (Carretta et al. 2024). These comprise 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 (2024), includes bycatch data from 1990 through 2023 for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery. NMFS used M/SI from 2019-2023 from Carretta (2024) for the NID analyses discussed below.

Estimated M/SI of the Central America/Southern Mexico-CA/OR/WA stock of humpback whales in the fishery is 0.17 (Carretta 2024) and is less than NIT s (0.68). Estimated M/SI of the Mainland Mexico-CA/OR/WA stock of humpback whales in the fishery is 0.231 (Carretta 2024) and is less than NIT s (1.70). Estimated M/SI of sperm whales fishery is zero (Carretta 2024) and is less than NIT s (0.523). Since M/SI for all three stocks are less than their respective NIT s thresholds, NMFS 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 and Mainland Mexico-CA/OR/WA stocks of humpback whale and 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 2024). 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 this fishery through a fishery observer program. If additional fishery-related M/SI is documented through the observer program and/or required reporting 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.

MMPA section 118 requires the development and implementation of a TRP for each strategic stock that interacts with a Category I or II fishery. The stocks considered for this permit 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 https://www.fisheries.noaa.gov/national/marine-mammal-protection/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 determinations 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 are issuing an 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 three particular ESA-listed species or stocks during commercial fishing operations. The permit covers the period from publication of this notice until December 31, 2027, when the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery will be phased out as mandated by the Driftnet Modernization and Bycatch Reduction Act of 2022. If, during the authorization period, 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.

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, were analyzed in the appropriate ESA section 7 Biological Opinion on the commercial fishery (see https://repository.library.noaa.gov/view/noaa/51058 ), and issued incidental take 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 an 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 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 Plan is required for the permit. Issuing the permit would have no additional impact on the human environment or effects on threatened or endangered species beyond those analyzed in these documents.

On March 14, 2024, NMFS published a notice and request for comments in the Federal Register for the proposed issuance of a permit under MMPA section 101(a)(5)(E) (90 FR 12148). The public comment period closed on April 14, 2025. NMFS received three comment letters opposing the proposed issuance of a permit to the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery and its underlying preliminary determinations. Only responses to significant comments pertaining to the proposed permit and preliminary determinations under MMPA section 101(a)(5)(E) for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery are addressed below.

Comment 1: Center for Biological Diversity (CBD) comments that the Driftnet Modernization and Bycatch Reduction Act of 2022 required the phase-out of the CA drift gillnet fishery within 5 years. They state that NMFS must not authorize the fishery to incidentally take ESA-listed species or stocks after December 29, 2027.

Response: NMFS agrees. The Driftnet Modernization and Bycatch Reduction Act was enacted on December 29, 2022, and it phases out the use of large mesh drift gillnet gear by December 2027. The permit issued to the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery authorizing the incidental take of specific ESA-listed marine mammal species or stocks under the MMPA will expire on December 31, 2027.

Comment 2: CBD states that the 2023 “Biological Opinion on Continued Operation of the Large Mesh Drift Gillnet Fishery” anticipated incidental take of endangered fin whales, and NMFS failed to analyze if this take of fin whales is negligible under MMPA section 101(a)(5)(E). They assert that issuing an incidental take statement for fin whales in the Biological Opinion, and not authorizing the take under the MMPA, violates the ESA and MMPA.

Response: Following NMFS' Procedural Directive 02-238 “Process for Distinguishing Serious from Non-Serious Injury of Marine Mammals,” NMFS evaluated ESA-listed stocks or species included on the final 2024 MMPA LOF (89 FR 12257, February 16, 2024) as killed or seriously injured in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery. Based on this evaluation, we proposed 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 (90 FR 12148, March 14, 2025).

Fin whales are not included on the list of marine mammal species/stocks killed or injured in the Category II CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery in the most recent final LOF (2024). In addition, there has not been an observed fin whale M/SI in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery since 1999.

Although NMFS predicted that there would be incidental take of one fin whale in the fishery in the 2023 “Biological Opinion on Continued Operation of the Large Mesh Drift Gillnet Fishery” over a 5-year period (NMFS 2023), given there have been no documented fin whale M/SI in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery since 1999 and the specific requirements of MMPA 101(a)(5)(E), additional take authorization under MMPA section 101(a)(5)(E) is not required for the remaining years the fishery is in operation (until December 31, 2027). In addition, using M/SI from 2019-2023, estimated M/SI of fin whales (CA/OR/WA stock) in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery is zero (Carretta 2024). Therefore, 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 fin whale.

Comment 3: CBD states that NMFS' proposed MMPA 101(a)(5)(E) authorization did not use the best available science regarding the number of large whale entanglements on the West Coast. They note that the Federal Register notice uses M/SI data from Carretta 2023; however, a more recent publication provides data through 2024 (Carretta 2024). CBD further states that the analysis does not reference the 2024 West Coast large whale entanglement summary. CBD also comments that the NID for the Central America DPS of humpback whales does not consider background levels of M/SI occurring from other commercial fisheries.

Response: In this final permit, NMFS updated the NID analyses 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 using M/SI data from 2019-2023 in the Carretta (2024) publication (see accompanying MMPA 101(a)(5)(E) evaluation document). The M/SI estimates in the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery from 2019-2023 (Carretta 2024) were identical to the M/SI estimated reported from 2018-2022 (Carretta 2023). As such, the NIDs remain the same as analyzed in the proposed permit for the fishery (90 FR 12148, March 14, 2025).

In addition, the West Coast Large Whale Entanglement Summary (NMFS 2025) referenced by CBD published in April 2025 after the proposed MMPA 101(a)(5)(E) permit for the CA thresher shark/swordfish drift gillnet (≥14 in mesh)/Pacific highly migratory species drift gillnet fishery published in the Federal Register (90 FR 12148, March 14, 2025). In 2024, there were no confirmed entanglements of humpback whales in CA drift gillnet gear nor any documented sperm whale entanglements (NMFS 2025). While there was one report of a humpback whale entangled in an unknown gillnet, we do not have evidence to link this entanglement to the CA drift gillnet fishery (NMFS 2025).

Comment 4: CBD comments that NMFS is not developing nor has developed a recovery plan for ESA-listed humpback whale DPSs. They assert that because NMFS identified 14 humpback whale DPSs in 2016, the 1991 recovery plan is out of date and does not meet the requirements of MMPA section 101(a)(5)(E). They continue that NMFS cannot rely on the recovery outline published in June 2022, and that the revised recovery plan for humpback whales has been postponed indefinitely.

Response: As noted, a recovery plan for the humpback whale species (global listing) was developed in 1991. 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 ). This recovery outline serves as an interim guidance document and, along with the existing species-wide recovery plan, directs recovery efforts, including recovery planning, for the Central America (Central America/Southern Mexico-CA/OR/WA stock) and Mexico (Mainland Mexico-CA/OR/WA stock) DPSs of humpback whales. NMFS is actively developing a new recovery plan specific to the ESA-listed DPSs; it has not been postponed indefinitely as CBD purports. Once finalized, this new recovery plan will replace the species-wide recovery plan that was published in 1991.

Title: Practitioner Conduct and Discipline.

OMB Control Number: 0651-0017.

Needs and Uses: The Director of the USPTO has the authority to establish regulations governing the conduct and discipline of agents, attorneys, or other persons representing applicants and other parties before the USPTO (35 U.S.C. 2, 32-33). The USPTO Rules of Professional Conduct, set forth in 37 CFR part 11, subpart D, prescribe the manner in which agents, attorneys, and other persons (collectively, “practitioners”) representing applicants and other parties before the USPTO should conduct themselves professionally. Part 11 outlines practitioners' responsibilities for recordkeeping and reporting violations or complaints of misconduct to the USPTO. Part 11, subpart C, sets forth the manner by which the USPTO investigates misconduct and imposes discipline.

The USPTO Rules of Professional Conduct require all practitioners to maintain complete records of all funds, securities, and other properties of clients coming into their possession, and to render appropriate accounts to the client regarding the funds, securities, and other properties of clients coming into the practitioner's possession, collectively known as “client property.” These recordkeeping requirements are necessary to maintain the integrity of client property. State bars require attorneys to perform similar recordkeeping.

Part 11 also requires a practitioner to report knowledge of certain violations of the USPTO Rules of Professional Conduct to the USPTO. The Director of the Office of Enrollment and Discipline (OED) may, after notice and an opportunity for a hearing, suspend, exclude, or disqualify any practitioner from further practice before the USPTO based on non-compliance with the USPTO Rules of Professional Conduct. Practitioners who have been excluded or suspended from practice before the USPTO, and practitioners transferred to disability inactive status, must maintain records of their compliance with the suspension or exclusion order, or the transfer to disability inactive status. These records are necessary to demonstrate eligibility for reinstatement. Reports of alleged violations of the USPTO Rules of Professional Conduct are used by the Director of OED to conduct investigations and disciplinary hearings, as appropriate.

This information collection covers the various reporting and recordkeeping requirements set forth in part 11 for practitioners representing applicants and other parties before the USPTO. Also covered are petitions for reinstatement for suspended or excluded practitioners and the means for reporting violations or complaints of misconduct to the USPTO.

Forms:

• PTO-107R (Reinstatement—Data Sheet—Register of Patent Attorneys and Agents). PTO-107R is also approved for use under USPTO information collection 0651-0012.

Type of Review: Extension and revision of a currently approved information collection.

Affected Public: Individuals or households.

Respondent's Obligation: Required to obtain or retain benefits.

Frequency: On occasion.

Estimated Number of Annual Respondents: 52,411 respondents.

Estimated Number of Annual Responses: 52,411 responses.

Estimated Time per Response: The USPTO estimates that the responses in this information collection that require reporting to the USPTO will take the public approximately 1 to 3 hours to complete. This includes the time to gather the necessary information, create the document, and submit the completed item to the USPTO. The USPTO Rules of Professional Conduct also require practitioners to maintain various records to maintain the integrity of client property and meet other requirements. Additional recordkeeping requirements are applicable to practitioners under suspension or exclusion. The USPTO estimates it will take a practitioner approximately 1 to 20 hours to perform these recordkeeping actions.

Estimated Total Annual Respondent Burden Hours: 58,187 hours.

Estimated Total Annual Respondent Non-Hourly Cost Burden: $5,439.

Changes from the 60-Day Federal Register Notice: Since the 60-day Federal Register notice was published, the estimated postage costs have decreased from $10.75 to $10.40 per mailed item. This lowers the estimated total postage costs from $22 to $21. This results in the total annual respondent non-hourly cost decreasing from $5,440 to $5,439.

Section 4314(c)(1) through (5) of title 5, U.S.C., requires each agency to establish, in accordance with regulations, one or more Senior Executive Service performance review boards. The boards shall review and evaluate the initial appraisal of senior executives' performance by supervisors and make recommendations to the appointing authority or rating official relative to the performance of these executives.

The Department of the Army Performance Review Board will be composed of a subset of the following individuals:

Background: The existing Red River waterway, known as the J. Bennett Johnston (JBJ) Waterway, is a navigation system that commences at the confluence of Old and Red Rivers and proceeds upstream for 236 miles to the Shreveport-Bossier City area. The JBJ Waterway project consists of a shallow draft navigation channel with five navigation locks. The portion of the Red River above Shreveport, Louisiana is presently unsuitable for commercial navigation. In 2005, USACE completed a draft Feasibility Report for the proposed SWARRN system. At the time of the report, USACE concluded there were not sufficient National Economic Development (NED) benefits to warrant recommending a project plan to authorize and extend shallow-draft navigation upstream of Shreveport, Louisiana. A recent market analysis and economic update completed by USACE showed the potential for improved NED benefits. In addition, USACE guidance allows the consideration of Regional Economic Development, Environmental Quality and other benefits to be applied when evaluating the feasibility of proposed water resources projects. Because of the improved economic benefits conditions, the Natural Resources Division (non-Federal Interest) has initiated an action to proceed with additional analyses and a feasibility study under the Section 203 authority.

Alternatives: The EIS will evaluate an array of alternatives and the most feasible of the alternatives will be recommended. Alternatives will consist of the `No-Action' alternative and alternatives to extend the heads of shallow-draft navigation into Southwest Arkansas. The shallow-draft navigation alternatives include: (1) extending navigation from Shreveport, Louisiana to Garland, Arkansas; (2) extending navigation from Shreveport, Louisiana to Fulton, Arkansas; and, (3) extending navigation from Shreveport, Louisiana to Index, Arkansas. Each plan requires providing vertical lifts in the waterway through a series of locks and dams. Approximately 54 feet of vertical lift is needed to reach Garland requiring two locks and dams; 75 feet of vertical lift to reach Fulton requiring three locks and dams; and, 102 feet of vertical lift to reach Index requiring three high lift locks and dams. Each shallow-draft navigation alternative will require a navigation channel geometry with a depth up to 12 feet, and revetments and dikes to provide channel and bank stabilization. All feasible and reasonable alternatives will be considered for detailed analysis.

Summary of Expected Effects: The EIS will analyze the potential impacts on the human and natural environment resulting from the proposed actions for the project. The scoping, public involvement, and interagency coordination processes are requesting data and information to help identify and define the range of potential significant issues that will be considered. Resources and issues that may be significantly impacted may include wetlands and other waters of the U.S.; aquatic resources; threatened and endangered species and their critical habitats; cultural resources; soils; navigation and navigable waters; transportation and traffic; hydrology and hydraulics; induced flooding; air, water, and noise quality, and cumulative effects of related projects in the regional area. It is anticipated that with larger pools behind each lock and dam, there will be an increase in shallow-water habitat and an increase in groundwater levels in the vicinity of the pools. In addition, it is anticipated that there may be unavoidable net loss of forested and wetland acres and Least Tern sandbar habitat due to inundation that may require mitigation. Short-term air and water quality impacts are expected from construction activities but should recover post-construction. Possible cultural resources sites and anomalies will be investigated, assessed, and identified. National and regional economic and recreational benefits are expected to be accrued as a result of extending waterborne commerce and with creating navigation pools within the waterway.

Environmental Reviews and Consultation Requirements: The alternatives are being coordinated with Federal, State, regional, and local agencies. The U.S. Fish and Wildlife Service (USFWS) will be assisting in the documentation of existing conditions and assessment of effects of project alternatives through Fish and Wildlife Coordination Act consultation procedures. The USFWS will also provide a Fish and Wildlife Coordination Act report. Coordination with the USFWS regarding threatened or endangered species within the proposed project footprint would be ongoing throughout the planning process. Endangered Species Act, Section 7 consultation, would be initiated should the tentatively selected plan have the potential to affect a protected species. Consultation will also be done with the State Historic Preservation Office and federally recognized Indian Tribes. The proposed action will involve evaluation for compliance with guidelines established by Section 404(b) of the Clean Water Act; application (to the State of Louisiana and State of Arkansas) for Water Quality Certification pursuant to Section 401 of the Clean Water Act; and certification of state lands, easements, and rights of way. The EIS will be distributed for review to all interested agencies, organizations, and individuals.

National Environmental Policy Act (NEPA) Schedule: The draft EIS (DEIS) is presently scheduled to be available for public review and comment in May 2026. A 45-day public review period will be provided for interested parties and agencies to review and comment on this draft document. All interested parties are encouraged to respond to this notice and provide a current address if they wish to be notified of the DEIS circulation. A Record of Decision would be approved and signed no earlier than 30 days after the Final EIS is published.

Public Involvement and Scoping: USACE invites all affected Federal, State, and local agencies, affected federally recognized Indian Tribes, other interested parties, and the public to participate in the NEPA process during development of the DEIS. Besides providing information, this notice requests input on alternatives and issues of concern.

To ensure that public comments are considered in the DEIS preparation process, members of the public, interested persons, and entities must submit their comments to USACE by mail, email. All comments and suggestions must be submitted by July 7, 2025. All personally identifiable information (for example, name, address, etc.) voluntarily submitted by a commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

Scoping meeting(s) were held prior to the publication of this Notice of Intent (NOI) on July 30, 2024 in Shreveport, Louisiana and on July 31, 2024 in Texarkana, Texas to present information and receive comments from the public. These meetings were publicly announced through press releases, special public notices, USACE social media platforms, and the project website at: https://www.mvk.usace.army.mil/Missions/Programs-and-Project-Management/Project-Management/SW-Ark-Red-River-Nav-Channel-Extension/ .

Content for the completed scoping meeting and information on the investigation to extend navigation within the Red River through Southwest Arkansas can be directly accessed at https://redrivernavigation.waterplanroom.com/ .

Statutory Authority and Function: NACIE is authorized by section 6141 of the Elementary and Secondary Education Act of 1965 (ESEA), as amended (20 U.S.C. 7471). In accordance with section 6141 of the ESEA, NACIE shall advise the Secretary of Education and the Secretary of Interior on the funding and administration (including the development of regulations and administrative policies and practices) of any program, including any program established under Title VI, Part A of the ESEA, with respect to which the Secretary of Education has jurisdiction and (1) that includes Indian children or adults as participants or (2) that may benefit Indian children or adults. Also in accordance with section 6141 of the ESEA, NACIE shall make recommendations to the Secretary of Education for filling the position of Director of Indian Education whenever a vacancy occurs and shall submit to the Congress, no later than June 30 of each year, a report on its activities that includes recommendations that are considered appropriate for the improvement of Federal education programs that include Indian children or adults as participants or that may benefit Indian children or adults, and recommendations concerning the funding of any such program.

Meeting Agenda: The purpose of the meeting is to convene NACIE and conduct open business. On June 17, 2025, NACIE will conduct the following business: (1) discuss fiscal year 2026 planning activities; (2) discuss subcommittee activities; and (3) approve annual report to Congress 2024-2025. On June 18, 2025, NACIE will conduct the following business: (4) discuss and hear updates from Federal representatives regarding technical assistance, best practices, and development of regulatory or non-regulatory actions; and (5) hear comments from members of the public.

Instructions for Accessing the Meeting: The public may access the NACIE meeting via Zoom. The web link to register and access is https://www.zoomgov.com/meeting/register/VGXBqyrsT8enIigUXjTlLw . There is no deadline to register, and the public may register and virtually enter the meeting at any time.

Public Comment: Members of the public interested in submitting written comments may do so via email to Julian Guerrero at Julian.Guerrero@ed.gov . Written comments related to the June 17-18, 2025, NACIE meeting should be submitted no later than 11:59 p.m. ET on June 8, 2025.

Members of the public may also make oral comment during the open meeting on June 18, 2025. Requests to make oral comment will be accepted on a first requested, first served basis. Each commenter must use the “raise your hand” feature and enter “I request to make an oral comment” into the meeting chat. Each commenter will have a maximum of three minutes to state his or her comment and/or question. Please note that written comments and oral comments made during the open meeting should pertain to the work of NACIE.

Reasonable Accommodations: The virtual meeting is accessible to individuals with disabilities. If you will need an auxiliary aid or service for the meeting ( e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice no later than June 8, 2025. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

Access to Records of the Meeting: The Department will post the official minutes of this meeting on the Office of Elementary and Secondary Education website, https://ed.gov/, within 90 days after the meeting. Pursuant to 5 U.S.C. 1009(b), the public may also inspect NACIE records at the Office of Indian Education, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202, Monday-Friday, 8:30 a.m. to 5 p.m. ET. Please email Julian Guerrero at Julian.Guerrero@ed.gov to schedule an appointment.

Electronic Access to this Document: The official version of this document is published in the Federal Register . Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.govinfo.gov/ . At this site, you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site. You also may access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov .

Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Authority: Section 6141 of the ESEA, as amended (20 U.S.C. 7471).

Part F of title IV of the Higher Education Act of 1965, as amended (HEA), specifies the criteria, data elements, calculations, and tables that make up the Need Analysis.

Section 478 of the HEA requires the Secretary to annually update the following five tables for inflation: the Income Protection Allowance (IPA), the Adjusted Net Worth (NW) of a Business or Farm, the Asset Protection Allowance, the Assessment Schedules and Rates, and the Employment Expense Allowance. The updates are based, in general, upon increases in items such as, but not limited to, the Consumer Price Index (CPI).

The Secretary updates the above tables to account for inflation that took place between April 2020 and April in the year prior to the beginning of each award year. The increases in the tables must be based on a percentage equal to the percentage increase in the Consumer Price Index for All Urban Consumers (CPI-U) for April of the applicable year.

This notice includes the 2026-27 AY values for the tables in sections 1 (Income Protection Allowance), 2 (Adjusted Net Worth of a Business or Farm), 3 (Asset Protection Allowance), 4 (Assessment Schedules and Rates), and 5 (Employment Expense Allowance).

1. Income Protection Allowance (IPA). This allowance is the amount of living expenses associated with the maintenance of an individual or family that offset the family's income. The allowance varies by family size and marital status. The IPA for dependent students is $11,770. The IPAs for parents of dependent students and independent students are listed in the tables below.

2. Adjusted Net Worth (NW) of a Business or Farm. A portion of the full NW (assets less debts) of a business or farm is excluded from the calculation of an SAI because (1) the income produced from these assets is already assessed in another part of the formula, and (2) the formula protects a portion of the value of the assets.

The portion of these assets included in the contribution calculation is computed according to the following schedule. This schedule is used for parents of dependent students, independent students without dependents other than a spouse, and independent students with dependents other than a spouse.

This action is directed to the public in general and may be of particular interest to those involved in the manufacture (defined under TSCA section 3(9) to include import), processing, distribution, use, and disposal of DBP and DEHP, related industry trade organizations, non-governmental organizations with an interest in human and environmental health, state and local governments, Tribal Nations, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA. As such, the Agency has not attempted to describe all the specific entities that this action might apply to. If you need help determining applicability, consult the appropriate technical contact listed under FOR FURTHER INFORMATION CONTACT .

The Agency is conducting this risk evaluation under TSCA section 6, 15 U.S.C. 2605, which requires that EPA conduct risk evaluations on chemical substances and identifies the minimum components EPA must include in the risk evaluations. Each risk evaluation must be conducted consistent with the best available science, be based on the weight of the scientific evidence, and consider reasonably available information, and not consider costs or non-risk factors. 15 U.S.C. 2625(h), (i), and (k). See also the implementing procedural regulations at 40 CFR part 702.

EPA is announcing the availability of and seeking public comment on these draft risk evaluations conducted under TSCA for DBP and DEHP. The purpose of risk evaluation under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, and without consideration of costs or non-risk factors. EPA has used the best available science to prepare this draft risk evaluation and, based on the weight of scientific evidence, to preliminarily determine that DBP and DEHP present unreasonable risk to health and the environment driven primarily by certain conditions of use analyzed in the draft evaluations.

1. Submitting CBI. Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703, as applicable.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

DBP is a common chemical name for the chemical substance 1,2-Benzenedicarboxylic acid, 1,2-dibutylester (CASRN 84-74-2). DEHP is a common chemical name for the chemical substance 1,2-Benzenedicarboxylic acid, 1,2-bis(2-ethylhexyl) ester (CASRN 117-81-7). DBP and DEHP are manufactured (including imported), processed, distributed, and disposed as part of industrial, commercial, and consumer conditions of use. DBP and DEHP are used primarily as plasticizers in polyvinyl chloride (PVC). These phthalates are also used in adhesives, sealants, paints, coatings, rubbers, and non-PVC plastics, as well as for other applications. Between 2016 and 2019 the productions volumes of DBP and DEHP were between 1 to 10 million pounds and between 10 to 50 million pounds, respectively, based on the 2020 TSCA Chemical Data Reporting data.

In December 2019, EPA announced its designation of DBP and DEHP as high priority substances for risk evaluation under TSCA (Ref. 1). In June 2020, EPA sought public comment on the draft scopes of the DBP and DEHP risk evaluations (Ref. 2), and, after considering public comments, issued the final scope in September 2020 (Ref. 3). These documents, other supporting documents, and public comments are in the docket established for each chemical at https://www.regulations.gov. In addition, as will be announced separately in the Federal Register , the draft risk evaluations for DBP and DEHP will also undergo peer review by the Science Advisory Committee on Chemicals (SACC) and will be included in the SACC peer review docket (Docket ID No. EPA-HQ-OPPT-2024-0551), along with other materials related to that peer review.

EPA seeks feedback on the assessment of risk presented in the draft risk evaluations for DBP (Docket ID No. EPA-HQ-OPPT-2018-0503) and DEHP (Docket ID No. EPA-HQ-OPPT-2018-0433), which are available in the chemical specific dockets as identified, and encourages all potentially interested parties, including individuals, governmental and non-governmental organizations, non-profit organizations, academic institutions, research institutions, and private sector entities to comment on the draft risk evaluations. To the extent possible, the Agency asks commenters to please cite any public data related to or that support comments provided, and to the extent permissible, describe any supporting data that are not publicly available.

EPA welcomes specific input on each section of the draft risk evaluation for each chemical, and is particularly interested in comments and information related to the following topics:

• Information on the use of personal protective equipment (PPE) and engineering controls during the manufacture, processing, and use of DBP and DEHP for each condition of use.

• Information that could be used to replace upper-bound or screening level assumptions, particularly for the conditions of use that may significantly contribute to unreasonable risk;

• Application of the Revised Draft Technical Support Document for the Cumulative Risk Analysis (CRA) within the individual chemical risk evaluations;

• The use of transcriptomics data in the weight of scientific evidence for environmental hazard assessment of DBP and the environmental hazard assessment of DEHP;

• The human health and environmental hazard endpoints used in the risk characterizations;

• Application of a flux-limited approach to estimating dermal absorption; and

• Approaches used to estimate chemical migration rate for ingestion via mouthing in the consumer exposure assessments.

After consideration of comments received from the public and the SACC on the draft risk evaluations, EPA will issue final risk evaluations for DBP and DEHP. A separate forthcoming Federal Register notice will announce the peer review by the SACC.

Under TSCA section 6, EPA must determine in the final risk evaluations, based on the weight of scientific evidence, whether or not the chemicals present an unreasonable risk to health or the environment under the chemical's conditions of use. This includes consideration of risks to potentially exposed susceptible subpopulations (PESS) who may be at greater risks than the general population, such as children and workers. TSCA prohibits EPA from considering non-risk factors ( e.g., costs/benefits) during risk evaluation.

If EPA determines that a chemical presents an unreasonable risk to health or the environment, the chemical will move to risk management action under TSCA section 6(a) for the relevant conditions of use. EPA is required to implement, via regulation, regulatory restrictions on the manufacture (including import), processing, distribution, use or disposal of the chemical to eliminate the identified unreasonable risk. EPA is given a range of risk management options under TSCA, including labeling, recordkeeping or notice requirements, actions to reduce human exposure or environmental release, and a ban of the chemical or of certain uses. Like the prioritization and risk evaluation processes, there is an opportunity for public comment on any proposed risk management actions.

For more information about the TSCA risk evaluation process for existing chemicals, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT .

Authority: 15 U.S.C. 2601 et seq.

This is a proposed renewal of the ICR, which expires on October 31, 2025. An agency may not conduct, or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

This notice allows 60 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets .

Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate forms of information technology. The EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, another Federal Register notice will be published to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: The EPA promulgated the Air Emissions Reporting Requirements (AERR) (40 CFR part 51, subpart A) to coordinate emissions inventory reporting requirements with existing requirements of the Clean Air Act (CAA) and 1990 Amendments. Under this reporting, 54 State and territorial air quality agencies, including the District of Columbia, as well as an estimated 9 local air quality agencies, must submit emissions data every 3 years for all point sources and some non-point, on-road mobile, and non-road mobile sources of volatile organic compounds, oxides of nitrogen, carbon monoxide, sulfur dioxide, particulate matter less than or equal to 10 micrometers in diameter, particulate matter less than or equal to 2.5 micrometers in diameter, ammonia, and lead. Based on submissions from the 2020 and 2023 National Emissions Inventory (NEI), the EPA also assumes that 5 Tribal air agencies voluntarily submit point sources for triennial inventories and 5 Tribal air agencies voluntarily submit nonpoint or other sources in triennial years. Other voluntary activities in triennial years include reporting hazardous air pollutant emissions for point sources, reporting wildfire and prescribed fire activity data, providing documentation for nonpoint sources that do not use EPA emissions calculation tools, and reporting season-day emissions data.

In addition, the air quality agencies must submit annual emission data for point sources with the potential to emit at greater than specified levels of those pollutants. Fewer agencies are required to report during these interim years because of higher emissions thresholds. However, the approach used in this notice includes the same number of agencies reporting point sources every year, but reduces the hours required to adjust for the lower burden in non-triennial years.

The data collected from the emission reporting is necessary to compile and make publicly available a national inventory of air pollutant emissions. The information collected supports both EPA's implementation of the CAA, and State/Local/Tribal air agencies in fulfilling their requirements under CAA sections 110(a), 172, 182, 187, and 189 to implement primary and secondary national ambient air quality standards (NAAQS). A comprehensive inventory updated at regular intervals is essential to allow the EPA to fulfill its mandate to monitor and plan for the attainment and maintenance of the NAAQS established for criteria pollutants in the CAA.

The number and frequency of data collection and submittal is expected to remain the same for 2025-2027.

The EPA is aware of costs that were not reflected in past ICR renewals. Those costs are related to (1) voluntary reporting activities by the respondents; (2) costs of data systems used by respondents to report under the AERR; and (3) costs to industry to comply with AERR-related State regulations that implement reporting required by the AERR. Such costs are estimated and included in this ICR renewal.

Form Numbers: None.

Respondents/affected entities: Entities potentially affected by this collection request are generally State, territorial, and local government air quality managements programs. Tribal governments are not affected unless they have sought and obtained “Treatment as a State” (TAS) status under the Tribal Authority Rule and, on that basis, are authorized to implement and enforce the AERR rule. For the most recent 2023 triennial inventory, no Tribes have TAS for emissions inventory reporting, and 2 Tribal agencies voluntarily reported to the NEI.

Additionally, State and local agencies collect data from owners/operators to be able to provide it to the EPA. Thus, owners/operators of subject facilities are also affected by this collection. This renewal application includes the burden to these owners/operators for the first time so that EPA can ensure that such costs are covered. The EPA seeks information from state and local air agencies to indicate the degree to which emissions data collection is due to the AERR rather than something that these agencies would impose even in the absence of the AERR.

Respondent's obligation to respond: This information is collected under 23 U.S.C. 101; 42 U.S.C. 7401-7671q, and the authority of the AERR. This information is mandatory and, as specified, cannot be treated as confidential by the EPA.

Estimated number of respondents: 68 (total including voluntarily reporting) State, local and Tribal agencies and 12,379 owners/operators reporting to State and local agencies.

Frequency of response: Annual.

Total estimated burden: 60,497 hours per year, including 14,516 for voluntary activities for State, local, Tribal air agencies and 144,993 hours per year for owners/operators. Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $21,776,607 per year for State, local, and Tribal air agencies including $1,449,776 for voluntary activities and $15,756,457 in annualized capital, operation, and maintenance costs. $16,567,945 per year for owners/operators.

Changes in estimates: The ICR currently approved by OMB does not include burden for owners/operators, the burden to maintain information technology systems used to collect and report emissions data to the EPA, or the burden of voluntary activities. Beyond those changes, the total hours per year for State, local, and Tribal air agencies for required activities has increased by 627 hours per year across all agencies, which reflects improved calculation approaches. Finally, these estimates reflect the latest hourly wage rates available from the Bureau of Labor Statistics.

On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. The OMB inventory, as well as copies of the PRA Submission, supporting statements (which contain more detailed information about the information collections and burden estimates than this notice), and approved collection of information instrument(s) are available at https://www.reginfo.gov/public/do/PRAMain. These documents are also available on the Federal Reserve Board's public website at https://www.federalreserve.gov/apps/reportingforms/review or may be requested from the agency clearance officer, whose name appears above. On the page displayed at the link above, you can find the supporting information by referencing the collection identifier, FR 27.

Collection title: New Hire Information Collection.

Collection identifier: FR 27.

OMB control number: 7100-0375.

General description of collection: This information collection provides for the electronic collection of certain personnel information from new hires using a secure web-based portal, the New Hire Portal, before the first day of employment of a new hire. As part of the onboarding process for new hires, a Human Resources (HR) professional at the Board identifies the necessary information that must be collected from the new hire, which is dependent upon the type of hire that the person is. The types of hires include Regular Hires, which are hires who are being hired into a non-intern position and not transferring from a non-federal agency, including a Governor or Board officer; Intern Hires, which are hires being hired into an intern position; and Federal Transfers, which are hires who are transferring from another federal agency. Once the HR professional has identified the types of information that will be necessary, the new hire is sent an email asking him or her to provide certain information through the New Hire Portal prior to their official start date.

The New Hire Portal is broken out into different sections and each section corresponds to the hardcopy forms that new employees previously filled out and provided to the Board during or after the first day of New Employee Orientation. The information collection now involves a new hire electronically providing this personnel information and filling out the applicable sections of the New Hire Portal before their first day of orientation. The sections of the portal that each new hire is asked to complete electronically depend upon the type of position that the new hire has been offered at the Board.

Frequency: Event-generated.

Respondents: The FR 27 panel comprises individuals who are new hires to the Board but have not yet become employees.

Total estimated number of respondents: Regular Hire, 235; Intern Hire, 131; Federal Transfer, 39; Governor/Officer, 9; Contingent Worker, 637.

Estimated average hours per response: Regular Hire, 1.78; Intern Hire, 1.71; Federal Transfer, 1.95; Governor/Officer, 1.86; Contingent Worker, 1.5.

Total estimated change in burden: 1,298.

Total estimated annual burden hours: 1,691.

Current actions: On March 11, 2025, the Board published a notice in the Federal Register (90 FR 11738) requesting public comment for 60 days on the extension, with revision, of the FR 27. The Board proposed to revise the FR 27 by changing the collection platform from the New Hire Portal to Workday Onboarding in June 2025, adding two new categories of hires categorized as Officers/Governors and Contingent Workers, restructuring sections into individual tasks, adding new data fields, removing data fields, and relabeling data fields. There will also be a change in the login process, as all respondents, except Contingent Workers, will be required to complete identity proofing and set up a secure account through a separate system, Login.gov, before accessing Workday Onboarding. The Designation of Beneficiary Unpaid Compensation of Deceased Employee form and Executive Death and Dismemberment Benefit for Officers and Governors questionnaire, previously not subject to PRA, will now be collected prior to a hire's first day of employment. The Board will no longer collect information for use on the FEGLI Program Designation of Beneficiary form through the New Hire Information Collection. The Board will also no longer collect information to populate the state tax form prior to the hire's start date, so it will no longer be subject to PRA. The Board will begin collecting Form I-9 (Employment Eligibility Verification) electronically through Workday Onboarding, rather than via a PDF. The comment period for this notice expired on May 12, 2025. The Board received one comment from one individual. The comment expressed support for the extension, with revision, of the FR 27. The Board will adopt the extension, with revision, of the FR 27 as originally proposed.

Title: Executive Branch Qualified Trust Documents.

Type of Information Collection: Extension of a currently approved collection.

Type of Review Request: Regular.

Respondents: Any current or prospective executive branch officials who seek to establish or have established a qualified blind or diversified trust under the Ethics in Government Act of 1978 to avoid conflicts of interest while in office.

Estimated Average Annual Number of Respondents: 2.

Total Estimated Time per Response: 20 minutes to 100 hours (see table below for detailed explanation).

Estimated Average Total Annual Burden: 120 hours.

OMB Control Number: 3209-0007.

Abstract: OGE is the supervising ethics office for the executive branch of the Federal Government under the Ethics in Government Act of 1978 (EIGA). Accordingly, OGE administers the qualified trust program for the executive branch. Presidential nominees to executive branch positions subject to Senate confirmation and any other executive branch officials may seek OGE approval for EIGA-qualified blind or diversified trusts as one means to avoid conflicts of interest. The requirements for EIGA-qualified blind and diversified trusts are set forth in section 13104(f) of the Ethics in Government Act, 5 U.S.C. 13104(f), and OGE's implementing financial disclosure regulations at subpart D of 5 CFR part 2634.

In order to ensure that all applicable requirements are met, OGE is the sponsoring agency for twelve model certificates and model trust documents for qualified blind and diversified trusts. See 5 CFR 2634.402(e)(3), 2634.402(f)(3), 2634.404(e) through (g), 2634.405(d)(2), 2634.407(a); 2634.408(b)(1) through (3), 2634.408(d)(4), 2634.409, and 2634.414. The various model certificates and model trust documents are used by settlors, trustees, and other fiduciaries in establishing and administering these qualified trusts. OGE plans to submit these model certificates and model trust documents (described in detail in the table below) to OMB for renewed approval pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.

The twelve model documents, along with their burden estimates, are as follows:

These estimates are based on the amount of time imposed on professional trust administrators or private representatives. OGE notes that only one set of the various model trust provisions (items (B) through (H)) will be prepared for a single qualified trust, and only prior to the establishment of that qualified trust. Likewise, other model documents listed above are used in connection with establishing the qualified trust (items (I), (J), and (K)). The remaining model documents are used after the trust's creation (items (A) and (L)). Accordingly, OGE notes that the majority of the time burden for any given trust is imposed during the creation of the trust.

At the present time, there are no active qualified trusts in the executive branch. However, OGE anticipates possible limited use of these model documents during the forthcoming three-year period. OGE estimates that there may be an average of one individual per year who initiates a qualified trust using these model documents during calendar years 2026 through 2028. OGE has accordingly estimated the average annual number of respondents to be two, which represents one respondent establishing a qualified trust and one respondent maintaining a previously established qualified trust. Based on the above, OGE estimates an average annual time burden during the next three years of 120 hours. Using an estimated rate of $300 per hour for the services of a professional trust administrator or private representative, the estimated annual cost burden is $36,000.

Under OMB's implementing regulations for the Paperwork Reduction Act, any recordkeeping, reporting, or disclosure requirement contained in a rule of general applicability is deemed to involve ten or more persons. See 5 CFR 1320.3(c)(4)(i). OGE intends to submit all twelve qualified trust model certificates and model documents described above (all of which are included under OMB paperwork control number 3209-0007) for a three-year extension of approval without modification.

Request for Comments: Agency and public comments are invited specifically on the need for and practical utility of this information collection, on the accuracy of OGE's burden estimate, on the enhancement of quality, utility, and clarity of the information collected, and on minimizing the burden to the public. Comments received in response to this notice will be summarized for, and may be included with, the OGE request for extension of OMB approval. The comments will also become a matter of public record.

Specifically, OGE seeks public comment on the following:

• Do the model qualified blind trusts provide sufficient direction to establish a trust under the Qualified Trust Program? If not, what provisions could be clearer or what language should be changed?

• Do the model qualified diversified trusts provide sufficient direction to establish a trust under the Qualified Trust Program? If not, what provisions could be clearer or what language should be changed?

• Do the Additional Trust Documents provide sufficient information for individuals to comply with the logistical requirements ( e.g., procedure for securing approval of proposed communications) of the Qualified Trust Program? If not, what provisions could be clearer or what language should be changed?

FDA is announcing the availability of a draft document entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers.” This guidance provides information on the most frequently asked questions regarding transfer of ownership from one 510(k) holder to another. An owner or operator of an establishment who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use is generally required to register the establishment and submit listing information for all devices in commercial distribution. 1 Under section 510(k) of the FD&C Act, each person who is required to register their establishment must generally submit a 510(k) to FDA at least 90 days before proposing to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use if the device is being introduced into commercial distribution for the first time. 2 When a 510(k) clearance for a specific device is sold or transferred from one person to another, the new 510(k) holder must list their device in the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM), an internet-based registration and listing system, if engaged in activities requiring listing. 3 When listing, if the device is not significantly changed or modified, 4 the new 510(k) holder must supply the original FDA-assigned premarket submission number  5 unless submitting a new 510(k), in which case the new 510(k) holder would supply the new FDA-assigned premarket submission number. 6 The new 510(k) holder must, if not previously entered into an operation described in 21 CFR 807.20(a), register within 30 days after entering into such an operation and submit device listing information, including the FDA-assigned submission number, 7 at that time. 8 A device manufactured, prepared, propagated, compounded, or processed in an establishment that is not duly registered under section 510, or a device that is not included in a list required by section 510(j), is misbranded. 9

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

As we develop any final guidance on this topic, FDA will consider comments on the applicability of Executive Order 14192, per OMB guidance M-25-20, and in particular, on any costs or cost savings.

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00001808 and complete title to identify the guidance you are requesting.

While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:

In the Federal Register of April 29, 2024 (89 FR 33371), FDA published the notice of availability for a draft guidance #287 entitled “Raw Data for Safety and Effectiveness Studies,” giving interested persons until June 28, 2024, to comment on the draft guidance. FDA received three comment submissions on the draft guidance, two from industry associations and one from a contract research facility. Those comments were considered as the guidance was finalized. A summary of changes includes: clarification that we are not asking sponsors to submit all raw data, addition of a link to CVM's Data Quality Resources website, and clarification on file format for data submitted in our eSubmitter platform. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated April 2024.

This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Raw Data for Safety and Effectiveness Studies.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

FDA considered the applicability of Executive Order 14192, per OMB guidance in M-25-20, and finds this action to be deregulatory in nature.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 514 have been approved under 0910-0032.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

FDA is announcing the availability of the proposed order OTC000038 pursuant to section 505G(c) of the FD&C Act (21 U.S.C. 355h(c)), which specifies FDA's proposed requirements for making a minor change in the dosage form of certain OTC monograph drugs, without the issuance of a separate order under section 505G(b) of the FD&C Act amending an applicable monograph to add the new dosage form or otherwise finding the new dosage form to be GRASE. Section 505G(c) of the FD&C Act applies to drugs described in section 505G(a)(1) or (a)(2) of the FD&C Act or that are otherwise the subject of an order under section 505G(b). More specifically, section 505G(c)(3) of the FD&C Act directs FDA to issue one or more administrative orders specifying the requirements for determining whether a minor dosage form change to a drug made by a sponsor pursuant to section 505G(c) of the FD&C Act will affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product.

This proposed order also fulfills a commitment made by FDA under the terms of the “Over-the-Counter Monograph User Fee Program Performance Goals and Procedures,” commonly referred to as the OMUFA commitment letter (the document can be accessed at https://www.fda.gov/media/106407/download and the document with the updated goal dates for fiscal years 2021 to 2025 can be accessed at https://www.fda.gov/media/146283/download ). The OMUFA commitment letter specifies goals and timelines mutually agreed upon by FDA and industry with respect to various OTC monograph drug activities conducted by FDA. FDA committed to issuing a proposed order outlining key requirements to clarify which types of minor changes to solid oral dosage forms are permissible without the issuance of an order finding the new dosage forms to be GRASE (when the applicable OTC monograph does not already provide for these types of changes), together with related draft guidance (FDA is publishing notice of the draft guidance for industry “Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs” elsewhere in this issue of the Federal Register ).

Consistent with section 505G(c)(3) of the FD&C Act, FDA proposes to specify the requirements for determining whether a particular minor dosage form change to a drug made by a sponsor pursuant to section 505G(c) will affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug product in comparison to a suitable reference product. This proposed order specifies these requirements for when the minor dosage form change is from a tablet or capsule dosage form to one of the following dosage forms: chewable tablet, ODT, or film. The proposed order, if finalized, will permit these minor changes in the dosage form of OTC monograph drugs that are both highly soluble and highly permeable and in conformity with the requirements of the order, section 505G(c) of the FD&C Act, and other applicable requirements, without the issuance of a separate order under section 505G(b) of the FD&C Act to amend the applicable OTC monograph to add the new dosage form or otherwise find the new dosage form to be GRASE.

FDA plans to separately consider minor changes in dosage form under section 505G(c) of the FD&C Act from tablets or capsules to chewable tablets, ODTs, or films for OTC monograph drugs with active ingredients that are not both highly soluble and highly permeable ( i.e., drugs that have: (1) low solubility and high permeability; (2) high solubility and low permeability; and (3) low solubility and low permeability). In the future, FDA plans to issue a separate notice announcing a request for information that would seek comments on minor changes in dosage form under section 505G(c) of the FD&C Act for these types of drugs. Any comments on minor changes in solid oral dosage forms under section 505G(c) for OTC monograph drugs that are not both highly soluble and highly permeable that are submitted to the docket for this proposed order (OTC000038) will be considered outside the scope of this proposed order and will not be considered as part of a finalization of proposed order OTC000038.

As we develop any final order on this topic, FDA will consider comments on the applicability of Executive Order 14192, in particular, on any costs or cost savings.

The proposed order can be viewed in the OTC Monographs@FDA portal at https://dps.fda.gov/omuf. The proposed order contains instructions for commenting on the proposed order. Comments to the proposed order must be submitted electronically to the Federal eRulemaking Portal https://www.regulations.gov.

OTC Monographs@FDA provides a resource for the public to view administrative orders (proposed, final, and interim final orders) for OTC Monograph Drugs and view OTC Monographs. In the future, OTC Monographs@FDA will facilitate the public's ability to submit, search, and view comments and data for proposed, final, and interim final orders.

This proposed order contains no collections of information that are subject to clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The proposed order is issued under section 505G(c) of the FD&C Act. Under section 505G(o) of the FD&C Act, the PRA does not apply to collections of information made under section 505G of the FD&C Act. Moreover, the labeling changes proposed in this order are excluded from the definition of “collection of information” under the PRA by 5 CFR 1320.3(c)(2), which states that “The public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included within this definition.” Therefore, clearance by the Office of Management and Budget under the PRA is not required for collections of information, if any, in a final order issued under section 505G of the FD&C Act that results from this proposed order.

FDA is issuing the proposed order OTC000037 pursuant to section 505G(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h(b)(2)), which permits the Agency to issue an administrative order at its initiative. Section 505G(b)(7) of the FD&C Act (21 U.S.C. 355h(b)(7)) explicitly permits an administrative order issued under section 505G(b)(2) to include requirements for the packaging of a drug to encourage use in accordance with labeling, such as through requirements for unit-dose packaging, requirements for products intended for use by pediatric populations, and requirements to reduce risk of harm from unsupervised ingestion.

This proposed order, if finalized, establishes packaging requirements for OTC monograph drugs in an ODT or film dosage form that are subject to an OTC monograph listed in the proposed order. In addition to meeting the applicable OTC monograph conditions and other applicable requirements under section 505G of the FD&C Act, these OTC monograph drugs in ODT or film dosage forms would, if the proposed order is finalized, be explicitly required to be packaged in single-unit or unit-dose containers in order to be considered generally recognized as safe and effective and not misbranded.

As we develop any final order on this topic, FDA will consider comments on the applicability of Executive Order 14192, in particular, on any costs or cost savings.

The proposed order can be viewed in the OTC Monographs@FDA portal at https://dps.fda.gov/omuf. The proposed order contains instructions for commenting on the proposed order. Comments to the proposed order must be submitted electronically to the Federal eRulemaking Portal https://www.regulations.gov.

OTC Monographs@FDA provides a resource for the public to view administrative orders (proposed, final, and interim final orders) for OTC Monograph Drugs and view OTC Monographs. In the future, OTC Monographs@FDA will facilitate the public's ability to submit, search, and view comments and data for proposed, final, and interim final orders.

The proposed order is issued under section 505G(b)(2) of the FD&C Act. Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) does not apply to collections of information made under section 505G of the FD&C Act. Therefore, clearance by the Office of Management and Budget under the PRA is not required for collections of information, if any, in a final order issued under section 505G of the FD&C Act that results from this proposed order.

FDA is announcing the availability of a draft guidance for industry titled “Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.” This draft guidance is being issued pursuant to section 505G(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h(c)) as a companion to proposed C001, which specifies the requirements for making a minor dosage form change from a tablet or capsule to a chewable tablet, orally disintegrating tablet, or film for over-the-counter (OTC) monograph drugs without an order issued under section 505G(b) (21 U.S.C. 355h(b)) amending an applicable monograph to add the new dosage form (or otherwise finding such change to be generally recognized as safe and effective).

Section 505G of the FD&C Act was added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136), which was enacted on March 27, 2020. As described in section 505G(c)(3) of the FD&C Act (21 U.S.C. 355h(c)(3)), the Agency will issue one or more administrative orders under 505G(c) specifying requirements for making a minor dosage form change, together with guidance for applying such requirements to specific dosage forms. In the Over-the-Counter Monograph User Fee Program Performance Goals and Procedures, commonly referred to as the OMUFA Commitment Letter (the document can be accessed at https://www.fda.gov/media/106407/download?attachment, and the document with updated goal dates for fiscal years 2021-2025 can be accessed at https://www.fda.gov/media/146283/download?attachment ), FDA and industry agreed to specific performance goals and timelines for various OTC monograph drug activities conducted by the Agency. In the OMUFA Commitment Letter, FDA committed to issuing a proposed administrative order regarding minor changes to solid oral dosage forms (along with a draft guidance) specifying requirements for determining when such changes are permissible without the issuance of an order finding the new dosage forms to be generally recognized as safe and effective (when the applicable OTC monograph does not already provide for these types of changes). Issuance of proposed C001 and this draft guidance fulfills this commitment.

C001 proposes requirements for a minor change in dosage form of an OTC monograph drug from a capsule or tablet to a chewable tablet, orally disintegrating tablet, or film when the drug meets the requirements under sections 505G(c) of the FD&C Act, C001, and all other applicable requirements. This draft guidance provides recommendations for how requestors can comply with the requirements described in C001. Specifically, this guidance provides recommendations for complying with the order to demonstrate that a minor change in solid oral dosage form from a tablet or capsule to a chewable tablet, orally disintegrating tablet, or film will not affect the safety or effectiveness of a drug. It also provides recommendations for complying with the order to demonstrate that such a change will not materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product. These recommendations include procedures for demonstrating that the active ingredient has high solubility and high permeability and that the drug product is rapidly dissolving. The draft guidance also provides additional dosage form-specific considerations for the dosage forms that are subject to C001 and recommendations regarding recordkeeping requirements.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes, administrative orders, and regulations.

As we develop any final guidance on this topic, FDA will consider comments on the applicability of Executive Order 14192, per OMB guidance M-25-20, and in particular, on any costs or cost savings.

Under section 505G(o) of the FD&C Act (21 U.S.C. 355h(o)), the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) does not apply to collections of information made under section 505G of the FD&C Act. This draft guidance is issued pursuant to section 505G(c), which requires FDA to issue guidance for applying the requirements in an administrative order to specific dosage forms. Information collection in this draft guidance for this purpose is covered under section 505G(o). Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required for this collection of information.

In addition, this draft guidance refers to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR parts 210 and 211 relating to current good manufacturing practice requirements have been approved under OMB control number 0910-0139. The collections of information for OTC monograph drug products have been approved under OMB control number 0910-0340.

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov .

Notice of this meeting is given under the authority of the Federal Advisory Committee Act, Title 5 U.S.C., ch. 10. The COAC provides advice to the Secretary of the Department of Homeland Security, the Secretary of the Department of the Treasury, and the Commissioner of U.S. Customs and Border Protection (CBP) on matters pertaining to the commercial operations of CBP and related functions within the Department of Homeland Security and the Department of the Treasury.

The COAC is committed to ensuring all participants have equal access regardless of disability status. If you require a reasonable accommodation due to a disability to fully participate, please contact Mrs. Latoria Martin at (202) 344-1440 as soon as possible.

Please feel free to share this information with other interested members of your organization or association.

To facilitate public participation, we are inviting public comments on the issues the committee will consider prior to the formulation of recommendations as listed in the Agenda section below.

There will be a public comment period after each subcommittee update during the meeting on June 18, 2025. During the meeting, comments may be submitted via the trade events mailbox at tradeevents@cbp.dhs.gov or through the Microsoft Teams chat feature. Please note the public comment period for speakers may end before the time indicated on the schedule that is posted on the CBP web page: http://www.cbp.gov/trade/stakeholder-engagement/coac.

The COAC will hear from the current subcommittees on the topics listed below:

1. The Intelligent Enforcement Subcommittee will provide updates on the work completed and topics discussed in its working groups. The Antidumping/Countervailing Duty (AD/CVD) Working Group will provide updates regarding its work and discussions on importer compliance with AD/CVD and other trade remedy measures and requirements. The Intellectual Property Rights (IPR) Process Modernization Working Group will provide updates concerning progress associated with its proposed recommendations specific to IPR enforcement and facilitation. The Forced Labor Working Group (FLWG) will submit proposed recommendations for the committee's consideration and provide updates on continued discussions regarding trade outreach and clarification of requirements. In particular, the FLWG anticipates providing proposed recommendations regarding suggested updates to the “Uyghur Forced Labor Prevention Act (UFLPA) U.S. Customs and Border Protection Operational Guidance for Importers.”

2. The Next Generation Facilitation Subcommittee will provide updates on all of its working groups. The Automated Commercial Environment (ACE) Modernization (formerly ACE 2.0) Working Group will report on its discussions about trade priorities. The Broker Modernization Working Group (BMWG) remains focused on the enhancement of the end user experience and improving the administration of the Customs Broker License Exam (CBLE) and will provide updates. This quarter, the Modernized Entry Processes Working Group (MEPWG) continued its National Customs Automation Program (NCAP) discussions and will provide updates on its efforts concerning the reconciliation test. The MEPWG will also discuss areas where CBP could provide further guidance on the Broker Cybersecurity Incident Procedures in the form of Frequently Asked Questions. The Customs Interagency Industry Working Group (CIIWG) will discuss its resubmission, with supporting ACE records, of previous examples it provided to CBP of duplicative data elements scenarios currently required in ACE. The CIIWG also anticipates providing updates on the Global Business Identifier (GBI) program.

3. The Secure Trade Lanes Subcommittee will provide updates on five of its seven active working groups. The Export Modernization Working Group has met two times this quarter. The March meeting was a kickoff for 2025 to establish action items and priorities after the closure of the public comment period for the Rail Export notice of proposed rulemaking (NPRM). The April meeting focused on defining Progressive Filing and reviewing the finalized flowchart for Air Mode. The working group tasked members with another review of the previously submitted recommendations to identify any additions or revisions that may be needed. The Drawback Task Force has met twice this quarter and, in particular, continues its work on the list related to the error validations and the updates of the transmission codes for the ACE Document Image System (DIS). There is the potential for proposed recommendations this quarter regarding updates to the error dictionary, but more conversation is needed prior to presenting proposed recommendations to the full committee. The De Minimis Working Group met two times this past quarter. In these meetings, the discussion centered mostly around CBP's enforcement of the $800 limit per person per day and ACE processing of de minimis shipments per Executive Order 14256 (90 FR 14899, April 7, 2025). The De Minimis Working Group does not have any proposed recommendations for this public meeting. The Centers Working Group continues to evaluate its previously proposed recommendations and will determine whether any additional proposed recommendations may come from that review or from new topics that are discussed within the working group. The FTZ/Warehouse Working Group has completed its initial review of the foreign trade zone (FTZ) regulations (19 CFR part 146) and is continuing to review several sections of the regulations in particular. When the working group completes its review of the FTZ regulations, it intends to submit proposed recommendations for updates and changes to the regulations for the full committee's consideration; the working group will also review the bonded warehouse regulations, FTZ manual, and the Bonded Warehouse Manual. The Cross-Border Recognition Working Group has not met this quarter and remains on hiatus. The Trade Partnership and Engagement Working Group is focusing efforts on reviewing an updated handbook for Customs Trade Partnership Against Terrorism (CTPAT) Trade Compliance Program members as well as a review of the CTPAT Minimum Security Criteria to drive efficiency and eliminate redundancies in the program. The Pipeline Working Group did not meet this quarter and will not have any proposed recommendations at the upcoming meeting.

Meeting materials will be available on June 9, 2025, at: http://www.cbp.gov/trade/stakeholder-engagement/coac/coac-public-meetings.

Important mission requirements of the Department of Homeland Security (“DHS”) include border security and the detection and prevention of illegal entry into the United States. Border security is critical to the nation's national security. Recognizing the critical importance of border security, Congress has mandated DHS to achieve and maintain operational control of the international land border. Secure Fence Act of 2006, Public Law 109-367, section 2, 120 Stat. 2638 (Oct. 26, 2006) (8 U.S.C. 1701 note). Congress defined “operational control” as the prevention of all unlawful entries into the United States, including entries by terrorists, other unlawful aliens, instruments of terrorism, narcotics, and other contraband. Id. Consistent with that mandate, the President's Executive Order on Securing Our Borders directs that I take all appropriate action to deploy and construct physical barriers to ensure complete operational control of the southern border of the United States. Executive Order 14165, section 3 (Jan. 20, 2025).

Congress has provided to the Secretary of Homeland Security a number of authorities necessary to carry out DHS's border security mission. One of those authorities is found at section 102 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, as amended (“IIRIRA”). Public Law 104-208, Div. C, 110 Stat. 3009-546, 3009-554 (Sept. 30, 1996) (8 U.S.C. 1103 note), as amended by the REAL ID Act of 2005, Public Law 109-13, Div. B, 119 Stat. 231, 302, 306 (May 11, 2005) (8 U.S.C. 1103 note), as amended by the Secure Fence Act of 2006, Public Law 109-367, section 3, 120 Stat. 2638 (Oct. 26, 2006) (8 U.S.C. 1103 note), as amended by the Department of Homeland Security Appropriations Act, 2008, Public Law 110-161, Div. E, Title V, section 564, 121 Stat. 2090 (Dec. 26, 2007). In section 102(a) of IIRIRA, Congress provided that the Secretary of Homeland Security shall take such actions as may be necessary to install additional physical barriers and roads (including the removal of obstacles to detection of illegal entrants) in the vicinity of the United States border to deter illegal crossings in areas of high illegal entry into the United States. In section 102(b) of IIRIRA, Congress mandated the installation of additional fencing, barriers, roads, lighting, cameras, and sensors on the southwest border. Finally, in section 102(c) of IIRIRA, Congress granted to the Secretary of Homeland Security the authority to waive all legal requirements that I, in my sole discretion, determine necessary to ensure the expeditious construction of barriers and roads authorized by section 102 of IIRIRA.

The United States Border Patrol Tucson Sector is an area of high illegal entry. In fiscal year 2024, the United States Border Patrol (“Border Patrol”) apprehended over 463,000 illegal aliens attempting to enter the United States between border crossings in the Tucson Sector. In that same time period, Border Patrol seized over 473 pounds of marijuana, 70 pounds of cocaine, three pounds of heroin, over 550 pounds of methamphetamine, and 1,130 pounds of fentanyl.

Owing to the high levels of illegal entry within the Tucson Sector, I must use my authority under section 102 of IIRIRA to install additional barriers and roads in the Tucson Sector. Therefore, DHS will take immediate action to construct additional barriers and roads in segments of the border in the Tucson Sector. The segments where such construction will occur are referred to herein as the “project area,” which is more specifically described in Section 2 below.

I determine that the following area in the vicinity of the United States border, located in the State of Arizona within the U. S. Border Patrol Tucson Sector, is an area of high illegal entry (the “project area”):

• Starting approximately one (1.0) mile west of Border Monument 121 and extending east along the border to Border Monument 117; and

• Starting at Border Monument 99 and extending west along the border for approximately thirty-three and four tenths (33.4) miles.

There is presently an acute and immediate need to construct additional physical barriers and roads in the vicinity of the border of the United States in order to prevent unlawful entries into the United States in the project area pursuant to section 102(a) of IIRIRA. In order to ensure the expeditious construction of additional physical barriers and roads in the project area, I have determined that it is necessary that I exercise the authority that is vested in me by section 102(c) of IIRIRA.

Accordingly, pursuant to section 102(c) of IIRIRA, I hereby waive in their entirety, with respect to the construction of physical barriers and roads (including, but not limited to, accessing the project areas, creating and using staging areas, the conduct of earthwork, excavation, fill, and site preparation, drainage and erosion control, and installation and upkeep of physical barriers and roads) in the project area, all of the following statutes, including all federal, state, or other laws, regulations, and legal requirements of, deriving from, or related to the subject of, the following statutes, as amended: The National Environmental Policy Act (Pub. L. 91-190, 83 Stat. 852 (Jan. 1, 1970) (42 U.S.C. 4321 et seq. )); the Endangered Species Act (Pub. L. 93-205, 87 Stat. 884 (Dec. 28, 1973) (16 U.S.C. 1531 et seq. )); the Federal Water Pollution Control Act (commonly referred to as the Clean Water Act (33 U.S.C. 1251 et seq. )); the National Historic Preservation Act (Pub. L. 89-665, 80 Stat. 915 (Oct. 15, 1966), as amended, repealed, or replaced by Public Law 113-287 (Dec. 19, 2014) (formerly codified at 16 U.S.C. 470 et seq., now codified at 54 U.S.C. 100101 note and 54 U.S.C. 300101 et seq. )); the Migratory Bird Treaty Act (16 U.S.C. 703 et seq. ); the Migratory Bird Conservation Act (16 U.S.C. 715 et seq. ); the Clean Air Act (42 U.S.C. 7401 et seq. ); the Archeological Resources Protection Act (Pub. L. 96-95 (16 U.S.C. 470aa et seq. )); the Paleontological Resources Preservation Act (16 U.S.C. 470aaa et seq. ); the Federal Cave Resources Protection Act of 1988 (16 U.S.C. 4301 et seq. ); the National Trails System Act (16 U.S.C. 1241 et seq. ), the Safe Drinking Water Act (42 U.S.C. 300f et seq. ); the Noise Control Act (42 U.S.C. 4901 et seq. ); the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act (42 U.S.C. 6901 et seq. ); the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9601 et seq. ); the Archaeological and Historic Preservation Act (Pub. L. 86-523, as amended, repealed, or replaced by Public Law 113-287 (Dec. 19, 2014) (formerly codified at 16 U.S.C. 469 et seq., now codified at 54 U.S.C. 312502 et seq. )); the Antiquities Act (formerly codified at 16 U.S.C. 431 et seq. and 16 U.S.C. 431a et seq., now codified at 54 U.S.C. 320301 et seq. ); the Historic Sites, Buildings, and Antiquities Act (formerly codified at 16 U.S.C. 461 et seq., now codified at 54 U.S.C. 320301-320303 & 320101-320106); the Eagle Protection Act (16 U.S.C. 668 et seq. ); the Native American Graves Protection and Repatriation Act (25 U.S.C. 3001 et seq. ); the Administrative Procedure Act (5 U.S.C. 551 et seq. ); Section 438 of the Energy Independence and Security Act (42 U.S.C. 17094); the National Fish and Wildlife Act of 1956 (Pub. L. 84-1024 (16 U.S.C. 742a, et seq. )); the Fish and Wildlife Coordination Act (Pub. L. 73-121 (16 U.S.C. 661 et seq. )); the Wild and Scenic Rivers Act (Pub. L. 90-542 (16 U.S.C. 1281 et seq. )); the Farmland Protection Policy Act (7 U.S.C. 4201 et seq. ); the Federal Land Policy and Management Act (Pub L. 94-579 (43 U.S.C. 1701 et seq. )); the National Wildlife Refuge System Administration Act (Pub. L. 89-669 (16 U.S.C. 668dd-668ee)); the National Wildlife Refuge System Improvement Act of 1997 (Pub. L. 105-57); the Wild Horse and Burro Act (16 U.S.C. 1331 et seq. ); the National Park Service Organic Act and the National Park Service General Authorities Act (Pub. L. 64-235, 39 Stat. 535 (Aug. 25, 1916) and Public Law 91-383, 84 Stat. 825 (Aug. 18, 1970) as amended, repealed, or replaced by Public Law 113-287, 128 Stat. 3094 (Dec. 19, 2014) (formerly codified at 16 U.S.C. 1, 2-4 and 16 U.S.C. 1a-1 et seq., now codified at 54 U.S.C. 100101-100102, 54 U.S.C. 100301-100303, 54 U.S.C. 100501-100507, 54 U.S.C. 100701-100707, 54 U.S.C. 100721-100725, 54 U.S.C. 100751-100755, 54 U.S.C. 100901-100906, 54 U.S.C. 102101-102102)); 16 U.S.C. 450y (Pub. L. 77-216, 55 Stat. 630 (Aug. 18, 1941), as amended by Public Law 82-478, 66 Stat. 510 (July 9, 1952)); 67 Stat. c18 (Nov. 5, 1952); The National Forest Management Act of 1976 (16 U.S.C. 1600 et seq. ); The Multiple Use and Sustained Yield Act of 1960 (16 U.S.C. 528-531).

This waiver does not revoke or supersede any other waiver determination made pursuant to section 102(c) of IIRIRA. Such waivers shall remain in full force and effect in accordance with their terms. I reserve the authority to execute further waivers from time to time as I may determine to be necessary under section 102 of IIRIRA.

In accordance with the PRA of 1995, as part of our continuing effort to reduce paperwork and respondent burdens, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provides the requested data in the desired format.

We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comments addressing the following issues:

(1) is the collection necessary to the proper functions of the USGS minerals information mission; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how the USGS might enhance the quality, utility, and clarity of the information to be collected; and (5) how the USGS might minimize the burden of this collection on the respondents, including through the use of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personally identifiable information (PII) in your comment, you should be aware that your entire comment—including your PII—may be made publicly available at any time. While you can ask us in your comment to withhold your PII from public review, we cannot guarantee that we will be able to do so.

Abstract: The National Mining and Minerals Policy Act of 1970 (30 U.S.C. 21(a)) and the National Materials and Minerals Policy, Research and Development Act of 1980 (30 U.S.C. 1601 et seq. ) mandate that the Secretary of the Interior collect, evaluate, and analyze information concerning mineral occurrence, production, and use for the domestic mineral industry and to inform Congress of important domestic mining and minerals industries developments, including crises. Many of the responsibilities regarding mineral resources are delegated to the USGS by Secretary's Order No. 3193, “Transfer of Selected Functions from the U.S. Bureau of Mines to the U.S. Geological Survey,” and are carried out, in part, through this information collection. Respondents to these forms supply the USGS with domestic exploration, development, and production data. These data and derived information will be published as a chapter in the “Minerals Yearbook.”

Title of Collection: Mine, Development, and Mineral Exploration Supplement.

OMB Control Number: 1028-0060.

Form Number: USGS Form 9-4000-A.

Type of Review: Renewal with extension of a currently approved information collection.

Respondents/Affected Public: Businesses or other for-profit institutions: U.S. nonfuel minerals and exploration operations.

Total Estimated Number of Annual Respondents: 324.

Total Estimated Number of Annual Responses: 324.

Estimated Completion Time per Response: 45 minutes.

Total Estimated Number of Annual Burden Hours: 243.

Respondent's Obligation: Voluntary.

Frequency of Collection: Annually.

Total Estimated Annual Non-hour Burden Cost: There are no “non-hour cost” burdens associated with this ICR.

An agency may not conduct or sponsor, nor is a person required to respond to, a collection of information unless it displays a currently valid OMB control number.

The authorities for this action are the PRA of 1995, the National Mining and Minerals Policy Act of 1970, and the National Materials and Minerals Policy, Research and Development Act of 1980.

The HEARTH Act makes a voluntary, alternative land leasing process available to Tribes, by amending the Indian Long-Term Leasing Act of 1955, 25 U.S.C. 415. The HEARTH Act authorizes Tribes to negotiate and enter into business leases of Tribal trust lands with a primary term of 25 years, and up to two renewal terms of 25 years each, without the approval of the Secretary of the Interior (Secretary). The HEARTH Act also authorizes Tribes to enter into leases for residential, recreational, religious, or educational purposes for a primary term of up to 75 years without the approval of the Secretary. Participating Tribes develop Tribal Leasing regulations, including an environmental review process, and then must obtain the Secretary's approval of those regulations prior to entering into leases. The HEARTH Act requires the Secretary to approve Tribal regulations if the Tribal regulations are consistent with the Department of the Interior's (Department) leasing regulations at 25 CFR part 162 and provide for an environmental review process that meets requirements set forth in the HEARTH Act. This notice announces that the Secretary, through the Assistant Secretary—Indian Affairs, has approved the Tribal regulations for Jamul Indian Village of California.

The Department's regulations governing the surface leasing of trust and restricted Indian lands specify that, subject to applicable Federal law, permanent improvements on leased land, leasehold or possessory interests, and activities under the lease are not subject to State and local taxation and may be subject to taxation by the Indian Tribe with jurisdiction. See 25 CFR 162.017. As explained further in the preamble to the final regulations, the Federal Government has a strong interest in promoting economic development, self-determination, and Tribal sovereignty. 77 FR 72440, 72447-48 (December 5, 2012). The principles supporting the Federal preemption of State law in the field of Indian leasing and the taxation of lease-related interests and activities applies with equal force to leases entered into under Tribal leasing regulations approved by the Federal Government pursuant to the HEARTH Act.

Section 5 of the Indian Reorganization Act, 25 U.S.C. 5108, preempts State and local taxation of permanent improvements on trust land. Confederated Tribes of the Chehalis Reservation v. Thurston County, 724 F.3d 1153, 1157 (9th Cir. 2013) (citing Mescalero Apache Tribe v. Jones, 411 U.S. 145 (1973)). Similarly, section 5108 preempts State taxation of rent payments by a lessee for leased trust lands, because “tax on the payment of rent is indistinguishable from an impermissible tax on the land.” See Seminole Tribe of Florida v. Stranburg, 799 F.3d 1324, 1331, n.8 (11th Cir. 2015). In addition, as explained in the preamble to the revised leasing regulations at 25 CFR part 162, Federal courts have applied a balancing test to determine whether State and local taxation of non-Indians on the reservation is preempted. White Mountain Apache Tribe v. Bracker, 448 U.S. 136, 143 (1980). The Bracker balancing test, which is conducted against a backdrop of “traditional notions of Indian self-government,” requires a particularized examination of the relevant State, Federal, and Tribal interests. We hereby adopt the Bracker analysis from the preamble to the surface leasing regulations, 77 FR at 72,447-48, as supplemented by the analysis below.

The strong Federal and Tribal interests against State and local taxation of improvements, leaseholds, and activities on land leased under the Department's leasing regulations apply equally to improvements, leaseholds, and activities on land leased pursuant to Tribal leasing regulations approved under the HEARTH Act. Congress's overarching intent was to “allow Tribes to exercise greater control over their own land, support self-determination, and eliminate bureaucratic delays that stand in the way of homeownership and economic development in Tribal communities.” 158 Cong. Rec. H. 2682 (May 15, 2012). The HEARTH Act was intended to afford Tribes “flexibility to adapt lease terms to suit [their] business and cultural needs” and to “enable [Tribes] to approve leases quickly and efficiently.” H. Rep. 112-427 at 6 (2012).

Assessment of State and local taxes would obstruct these express Federal policies supporting Tribal economic development and self-determination, and also threaten substantial Tribal interests in effective Tribal government, economic self-sufficiency, and territorial autonomy. See Michigan v. Bay Mills Indian Community, 572 U.S. 782, 810 (2014) (Sotomayor, J., concurring) (determining that “[a] key goal of the Federal Government is to render Tribes more self-sufficient, and better positioned to fund their own sovereign functions, rather than relying on Federal funding”). The additional costs of State and local taxation have a chilling effect on potential lessees, as well as on a Tribe that, as a result, might refrain from exercising its own sovereign right to impose a Tribal tax to support its infrastructure needs. See id. at 810-11 (finding that State and local taxes greatly discourage Tribes from raising tax revenue from the same sources because the imposition of double taxation would impede Tribal economic growth).

Similar to BIA's surface leasing regulations, Tribal regulations under the HEARTH Act pervasively cover all aspects of leasing. See 25 U.S.C. 415(h)(3)(B)(i) (requiring Tribal regulations be consistent with BIA surface leasing regulations). Furthermore, the Federal Government remains involved in the Tribal land leasing process by approving the Tribal leasing regulations in the first instance and providing technical assistance, upon request by a Tribe, for the development of an environmental review process. The Secretary also retains authority to take any necessary actions to remedy violations of a lease or of the Tribal regulations, including terminating the lease or rescinding approval of the Tribal regulations and reassuming lease approval responsibilities. Moreover, the Secretary continues to review, approve, and monitor individual Indian land leases and other types of leases not covered under the Tribal regulations according to 25 CFR part 162.

Accordingly, the Federal and Tribal interests weigh heavily in favor of preemption of State and local taxes on lease-related activities and interests, regardless of whether the lease is governed by Tribal leasing regulations or 25 CFR part 162. Improvements, activities, and leasehold or possessory interests may be subject to taxation by Jamul Indian Village of California.

The supplemental plat, in one sheet, showing the amended lotting in section 5, Township 1 North, Range 5 East, accepted April 8, 2025, and officially filed April 9, 2025, for Group 9120, Arizona.

This plat was prepared at the request of the Salt River Pima-Maricopa Indian Community.

The plat, in six sheets, representing the dependent resurvey of a portion of the south, east and west boundaries, a portion of the subdivisional lines and the metes-and-bounds survey of a portion of the Red Rock Secret Mountain Wilderness boundary, Township 19 North, Range 5 East, accepted December 30, 2024, and officially filed January 7, 2025, for Group 1216, Arizona.

This plat was prepared at the request of the United States Forest Service.

The plat, in two sheets, representing the dependent resurvey of a portion of the north boundary, a portion of the subdivisional lines, a portion of certain mineral surveys, and the dependent resurvey of the metes-and-bounds survey in section 1, the subdivision of certain sections and the metes-and-bounds surveys in certain sections, Township 1 North, Range 8 East, accepted December 30, 2024, and officially filed January 7, 2025, for Group 1229, Arizona.

This plat was prepared at the request of the BLM.

The supplemental plat, in one sheet, showing the amended lotting in section 26, fractional Township 13 North, Range 20 West, accepted April 8, 2025, and officially filed April 9, 2025, for Supplemental Group 9119, Arizona.

The plat, in one sheet, representing the dependent resurvey of a portion of the east boundary of the San Juan de las Boquillas y Nogales Land Grant, and a portion of the south boundary, fractional Township 19 South, Range 21 East, accepted December 30, 2024, and officially filed January 7, 2025, for Group 1233, Arizona.

This plat was prepared at the request of the Bureau of Land Management.

A person or party who wishes to protest against any of these surveys must file a written notice of protest by the date indicated in DATES caption above in this publication with the Arizona State Director, Bureau of Land Management, stating that they wish to protest.

A statement of reasons for a protest may be filed with the notice of protest to the State Director, or the statement of reasons must be filed with the State Director within 30 days after the protest is filed. Before including your address, or other personal information in your protest, please be aware that your entire protest, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before May 24, 2025. Pursuant to Section 60.13 of 36 CFR part 60, comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Nominations submitted by State or Tribal Historic Preservation Officers

KEY: State, County, Property Name, Multiple Name(if applicable), Address/Boundary, City, Vicinity, Reference Number.

In accordance with the PRA and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on August 30, 2024 (89 FR 70665). No comments were received.

As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:

(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;

(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;

(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response.

Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Abstract: The Federal Water Pollution Control Act (FWPCA), as amended by the Oil Pollution Act of 1990 (OPA), requires that a spill-response plan be submitted for offshore facilities prior to February 18, 1993. The OPA specifies that after that date, an offshore facility may not handle, store, or transport oil unless a plan has been submitted. Regulations at 30 CFR part 254 establish requirements for spill-response plans for oil-handling facilities seaward of the coastline, including associated pipelines.

BSEE uses the information collected under 30 CFR part 254 to determine compliance with OPA by lessees/operators. Specifically, BSEE needs the information to:

• Determine that lessees/operators have an adequate plan and are sufficiently prepared to implement a quick and effective response to a discharge of oil from their facilities or operations.

• Review plans prepared under the regulations of a State and submitted to BSEE to satisfy the requirements in 30 CFR part 254 to ensure that they meet minimum requirements of OPA.

• Verify that personnel involved in oil-spill response are properly trained and familiar with the requirements of the spill-response plans and to lead and witness spill-response exercises.

• Assess the sufficiency and availability of contractor equipment and materials.

• Verify that enough quantities of equipment are available and in working order.

• Oversee spill-response efforts and maintain official records of pollution events.

• Assess the efforts of lessees/operators to prevent oil spills or prevent substantial threats of such discharges.

Title of Collection: 30 CFR part 254, “Oil-Spill Response Requirements for Facilities Located Seaward of the Coastline.”

OMB Control Number: 1014-0007.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Potential respondents include Federal Outer Continental Shelf (OCS) oil, gas, and sulfur lessees and/or operators and holders of pipeline rights-of-way.

Total Estimated Number of Annual Respondents: Currently there are approximately 60 oil and gas drilling and production operators on the OCS. Not all the potential respondents will submit information in any given year, and some may submit multiple times.

Total Estimated Number of Annual Responses: 1,439.

Estimated Completion Time per Response: Varies from .5 hour to 165 hours, depending on activity.

Total Estimated Number of Annual Burden Hours: 53,007.

Respondent's Obligation: Most responses are mandatory; while some are required to obtain or retain a benefit.

Frequency of Collection: Submissions are on occasion, monthly, annually, and biennially.

Total Estimated Annual Nonhour Burden Cost: None.

An agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Commission instituted this investigation on March 19, 2025, based on a complaint filed by Klein Tools, Inc., of Lincolnshire, IL. 90 FR 12790 (Mar. 19, 2025). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain glow fish tape systems, safety helmet systems, and components thereof by reason of the infringement of certain claims of U.S. Patent Nos. 11,452,327; U.S. Patent No. 11,713,209; and U.S. Patent No. 12,187,573. Id. The complaint further alleges that a domestic industry exists. Id. The Commission's notice of investigation named as respondent Milwaukee Electric Tool Corporation, of Brookfield, WI (“Respondent”). Id. The Office of Unfair Import Investigations is not participating in the investigation. Id.

On May 1, 2025, the CALJ issued Order No. 6, granting Complainant's motion for leave to amend the complaint and notice of investigation to add allegations of infringement of claims 1-4 of the '265 patent against Respondent. No petitions for review of the ID were filed.

The Commission has determined not to review the subject ID. The Notice of Investigation is amended to include allegations of infringement of claims 1-4 of the '265 patent against Respondent.

The Commission vote for this determination took place on May 30, 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).

The Commission instituted this investigation on September 27, 2024, based upon a complaint filed on behalf of Balanced Body, Inc. of Sacramento, California (“Complainant”). 89 FR 79306-07 (Sept. 27, 2024). 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 upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain exercise equipment and subassemblies thereof by reason of infringement of one or more of claims 1-15, 19-21, and 23-26 of U.S. Patent No. 8,721,511 (“the '511 patent”), the claim of U.S. Patent No. D659,205 (“the D'205 patent”), and the claim of U.S. Patent No. D659,208 (“the D'208 patent”) (collectively, the “asserted patents”). Id. The complaint further alleges that a domestic industry exists. Id. at 79306. The Commission's notice of investigation named as respondents: Guangzhou Oasis, LLC d/b/a trysauna.com of Boulder, Colorado (“Trysauna”); Ciga Pilates of Hong Kong; Shandong Tmax Machinery Technology Co., Ltd. of Dezhou City, China (“Tmax”); Shandong VOG Sports Products Co., Ltd. of Dezhou City, China (“VOG Sports”); Dezhou Bodi Fitness Equipment Co., Ltd. of Dezhou City, China (“Dezhou”); and Suzhou Selfcipline Sports Goods Co., Ltd. of Suzhou, China (“Selfcipline”). Id. at 79307. The Office of Unfair Import Investigations (“OUII”) is also a party to this investigation. Id.

On March 10, 2025, the Commission terminated the investigation as to respondent Ciga Pilates based on withdrawal of the complaint. Order No. 9 (Feb. 11, 2025), unreviewed by Comm'n Notice (Mar. 10, 2025).

On April 9, 2025, the Commission found the remaining respondents Trysauna, Tmax, VOG Sports, Dezhou, and Selfcipline (collectively, “Defaulting Respondents”) in default. Order No. 11 (Mar. 10, 2025), unreviewed by Comm'n Notice (Apr. 9, 2025).

On April 16, 2025, the Commission terminated the investigation as to claims 2-15, 20-21, and 23-26 of the '511 patent. Order No. 13 (Mar. 24, 2025), unreviewed by Comm'n Notice (Apr. 16, 2025).

On April 10, 2025, Complainant filed a motion for summary determination of violation of section 337 by the Defaulting Respondents based on infringement of the remaining asserted claims, including claims 1 and 19 of the '511 patent, the claim of the D'205 patent, and/or the claim of the D'208 patent. Complainant requested issuance of a general exclusion order (“GEO”) and a limited exclusion order (“LEO”) against the Defaulting Respondents as to all products that infringe the asserted claims. Complainant also requested a bond of 100 percent for the entered value of the infringing articles imported during the period of Presidential review.

On April 24, 2025, OUII filed a response supporting-in-part Complainant's motion for summary determination of violation.

On April 30, 2025, the ALJ issued the subject initial determination (Order No. 15) granting-in-part and deferring-in-part Complainant's motion for summary determination of violation of section 337. Specifically, the ID found a violation by each of VOG Sports, Dezhou, and Selfcipline with respect to imported products infringing claim 1 of the '511 patent and the claim of the D'208 patent. The ID also found the domestic industry requirement is satisfied and the evidence supporting its finding of a violation by each of VOG Sports, Dezhou, and Selfcipline with respect to imported products infringing claim 1 of the '511 patent and the claim of the D'208 patent to be substantial, reliable, and probative. The ALJ indicated that Complainant had shown entitlement to a GEO with respect to both claim 1 of the '511 patent and the claim of the D'208 patent under 19 U.S.C. 1337(g)(2), as well as to a bond of 100 percent of the entered value of the infringing articles imported during the period of Presidential review, but the ALJ noted that any requested relief would be premature as there are still unresolved issues apart from the aforementioned findings of violation. ID at 26-27.

On May 9, 2025, Complainant filed a notice of withdrawal of its request for a GEO as to the claims on which the ALJ deferred summary determination in the subject ID. See Complainant's Notice of Withdrawal of Its Request for a General Exclusion Order as to Certain Patent Claims and Renewed Request for Recommended Determination on Remedy and Bond at 1.

On May 12, 2025, the ALJ issued an order (Order No. 16) stating that Complainant's notice of withdrawal resolves all issues pending before the ALJ and the investigation is now in the “remedy phase.” The order also includes a supplemented Recommended Determination not addressing the requested LEO but reiterating, as detailed in connection with the subject ID (Order No. 15), that a GEO should issue as to claim 1 of the '511 patent and the claim of the D'208 patent, and that a 100 percent bond be set. Order No. 16 at 3.

No party filed a petition for review of the subject ID (Order No. 15).

The Commission has determined not to review the subject ID.

In connection with the final disposition of this investigation, the statute authorizes issuance of, inter alia, (1) an exclusion order that could result in the exclusion of the subject articles from entry into the United States; and/or (2) cease and desist orders that could result in the respondents being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843, Comm'n Op. at 7-10 (Dec. 1994).

The statute requires the Commission to consider the effects of that remedy upon the public interest. The public interest factors the Commission will consider include the effect that an exclusion order and cease and desist orders would have on: (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission's determination. See Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

Written Submissions: Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. In the initial submission, Complainant is also requested to identify the remedy sought and submit proposed remedial orders for the Commission's consideration. Complainant is further requested to state the date that the asserted patents expire, to provide the HTSUS subheadings under which the accused products are imported, and to supply the identification information for all known importers of the products at issue in this investigation. The initial written submissions and proposed remedial orders must be filed no later than close of business on June 13, 2025. Reply submissions must be filed no later than the close of business on June 20, 2025. All submissions from third parties and/or interested government agencies are limited to 10 pages. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.

In accordance with 21 CFR 1301.33(a), this is notice that on May 5, 2025, Usona Institute, Inc, 2780 Woods Hollow Road, Room 2413, Fitchburg, Wisconsin 53711, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

The company plans to bulk manufacture the listed controlled substances for use in chemical process development as well as pre-clinical and clinical research. No other activities for these drug codes are authorized for this registration.

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: Section 274B of the Immigration and Nationality Act (INA) prohibits employment discrimination on the basis of citizenship status or national origin; retaliation or intimidation by an employer against an individual seeking to exercise his or her right under this section; and “document abuse” or over-documentation by the employer, which occurs when the employer asks an applicant or employee for more or different documents than required for employment eligibility verification under INA section 274A, with the intent of discriminating against the employee in violation of section 274B. Individuals who believe that they have suffered discrimination in violation of section 274B may file a charge with the DOJ Immigrant and Employee Rights Section (IER). The IER then has 120 days to determine whether to file a complaint with the EOIR Office of the Chief Administrative Hearing Officer (OCAHO) on behalf of the individual charging party. If the IER chooses not to file a complaint, the individual may then file his or her own complaint directly with OCAHO. This information collection may be used by an individual to file his or her own complaint with OCAHO. The Form EOIR-58 elicits, in a uniform manner, all the required information for OCAHO to assign a section 274B complaint to an Administrative Law Judge for adjudication. Non-substantive revisions are being made throughout the form and instructions to improve formatting, clarity, and grammar. EOIR has also made changes updating the IER mailing address, revising the Privacy Act notice to include a citation to OCAHO's System of Record Notice (SORN), and revising the amount of time estimated to complete the form. Additionally, to account for anticipated expansion of electronic filing capabilities in the future, EOIR is also revising the instructions to clarify differences in filing procedures for those forms filed by mail versus forms filed electronically.

1. Type of Information Collection: Extension and Revision of a previously approved collection.

2. The Title of the Form/Collection: Unfair Immigration-Related Employment Practices Complaint Form.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: The form number is EOIR-58, and the sponsoring DOJ component is EOIR.

4. Affected public who will be asked or required to respond, as well as the obligation to respond: Affected Public are individuals who wish to file a complaint alleging unfair immigration-related employment practices under INA section 274B. Individuals are obligated to respond to obtain/retain a benefit. However, using this form is voluntary and individuals may alternatively file a written submission alleging unfair immigration-related employment practices under INA section 274B, provided that the alternative submission format meets the requirements for OCAHO complaints as set forth in 28 CFR 68.7. The Form EOIR-58 is simply an optional form provided by OCAHO to guide potential complainants and their representatives to provide the information necessary to satisfy the requirements of 28 CFR 68.7.

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 38 respondents will complete the form annually with an average of 1 hour per response.

6. An estimate of the total annual burden (in hours) associated with the collection: The total annual burden hours for this collection is 38 hours.