Background

On September 3, 2024, Commerce published the notice of initiation of the second sunset reviews of the Order, 1 pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 2 On September 18, 2024, Commerce received a notice of intent to participate from Thomas Steel Strip Corporation (Thomas Steel), a domestic interested party, within the 15-day period specified in 19 CFR 351.218(d)(1)(i). 3 Thomas Steel claimed interested party status under section 771(9)(C) of the Act, as a producer of the domestic like product in the United States.

On October 3, 2024, Thomas Steel filed an adequate substantive response within the deadline specified in 19 CFR 351.218(d)(3)(i). 4 Commerce did not receive a substantive response from any respondent interested party. On October 31, 2024, Commerce notified the U.S. International Trade Commission (ITC) that it did not receive an adequate substantive response from respondent interested parties. 5 As a result, pursuant to section 751(c)(3)(A) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce conducted an expedited (120-day) sunset review of the Order .

The merchandise covered by the Order is nickel-plated steel products from Japan. For a complete description of the scope of the Order, see the Issues and Decision Memorandum. 6

A complete discussion of all issues raised in this sunset review, including the likelihood of the continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the Order was to be revoked, is provided in the Issues and Decision Memorandum. A list of the topics discussed in the Issues and Decision Memorandum is included as an appendix to this notice. 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 http://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed at http://access.trade.gov/public/FRNoticesListLayout.aspx.

Pursuant to sections 751(c)(1), and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the Order would be likely to lead to the continuation or recurrence of dumping. We determine that the weighted-average dumping margin likely to prevail would be up to 77.70 percent. 7

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). 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 terms of an APO is a sanctionable violation.

We are issuing and publishing these final results in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act, and 19 CFR 351.221(c)(5)(ii).

The ETTAC is mandated by Section 2313(c) of the Export Enhancement Act of 1988, as amended, 15 U.S.C. 4728(c), to advise the Environmental Trade Promotion Working Group of the Trade Promotion Coordinating Committee, through the Secretary of Commerce, on the development and administration of programs to expand U.S. exports of environmental technologies, goods, services, and products. The ETTAC was most recently re-chartered through August 12, 2026.

On Tuesday, January 28, 2025 from 9:00 a.m. to 5:00 p.m. ET, the ETTAC will hold the first meeting of its current charter term. During the meeting, committee members will deliberate on priority topics to address during the 2024-2026 ETTAC charter and determine subcommittee topics and ETTAC leadership. An agenda will be made available one week prior to the meeting upon request to Megan Hyndman.

The meeting will be open to the public and time will be permitted for public comment before the close of the meeting. Members of the public seeking to attend the meeting are required to register by Wednesday, January 22, at 5:00 p.m. EST, via the contact information provided above. This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to OEEI at Megan.Hyndman@trade.gov or (202) 823-1839 no less than one week prior to the meeting. Requests received after this date will be accepted, but it may not be possible to accommodate them.

Written comments concerning ETTAC affairs are welcome any time before or after the meeting. To be considered during the meeting, written comments must be received by Wednesday, January 22, 2025, at 5:00 p.m. EST to ensure transmission to the members before the meeting. Draft minutes will be available within 30 days of this meeting.

On December 11, 2008, Commerce published the AD orders on innersprings from South Africa and Vietnam and, on February 19, 2009, Commerce published the AD order on innersprings from China in the Federal Register . 1 On September 3, 2024, Commerce published the notice of initiation of the third sunset reviews of the Orders, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 2

On September 10, 2024, Commerce received notices of intent to participate in these sunset reviews from Leggett and Platt Incorporated (Leggett) within the deadline specified in 19 CFR 351.218(d)(1)(i). 3 Leggett claimed domestic interested party status under section 771(9)(C) of the Act as a producer of the domestic like product in the United States. On October 3, 2024, Commerce received adequate substantive responses from Leggett within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). 4 We received no substantive responses from respondent interested parties.

On October 31, 2024, Commerce notified the U.S. International Trade Commission that it did not receive substantive responses from respondent interested parties. 5 Pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce is conducting expedited (120-day) sunset reviews of the Orders.

The products covered by the Orders are innersprings from China, South Africa, and Vietnam. For a full description of the scope of the Orders, see the Issues and Decision Memorandum. 6

A complete discussion of all issues raised in these sunset reviews is contained in the Issues and Decision Memorandum. 7 A list of topics discussed in the Issues and Decision Memorandum is included as an appendix to this notice. 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 http://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be directly accessed at http://access.trade.gov/public/FRNoticesListLayout.aspx.

Pursuant to sections 751(c)(1), and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the Orders would likely lead to the continuation or recurrence of dumping and that the magnitude of the dumping margins likely to prevail would be weighted-average dumping margins up to 234.51 percent for China, 121.39 percent for South Africa, and 116.31 percent for Vietnam. 8

This notice serves as the only reminder to interested parties subject to an APO of their responsibility concerning the return/destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

We are issuing and publishing these final results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act, and 19 CFR 351.218(e)(1)(ii)(C)(2) and 351.221(c)(5)(ii).

Section 315 of the National Marine Sanctuaries Act (NMSA) (16 U.S.C. 1445a) authorizes the Secretary of Commerce to establish advisory councils to advise and make recommendations regarding the designation and management of national marine sanctuaries. ONMS is establishing a new sanctuary advisory council for CHNMS to serve as a liaison with the local community and to provide guidance and advice to ONMS regarding the sanctuary management plan. The advisory council for CHNMS was not established when ONMS published its annual announcement on May 24, 2024 that was advertising to fill vacant seats on the other 18 councils (89 FR 45854). Therefore, ONMS is adding the new advisory council to the list of sites with open vacancies and announcing that it is soliciting applications to fill the seats of this council. Applications are due Friday March 7, 2025.

In the following SUPPLEMENTARY INFORMATION section, NOAA provides details regarding ONMS, the role of advisory councils, and contact information for CHNMS.

ONMS serves as the trustee for a network of underwater parks encompassing more than 629,000 square miles of marine and Great Lakes waters from Washington State to the Florida Keys, and from Lake Huron to American Samoa. The network includes a system of 17 national marine sanctuaries and the Papahānaumokuākea and Rose Atoll marine national monuments. National marine sanctuaries protect our nation's most vital coastal and marine natural and cultural resources, and through active research, management, and public engagement, sustain healthy environments that are the foundation for thriving communities and stable economies.

One of the many ways ONMS ensures public participation in the designation and management of national marine sanctuaries is through the formation of advisory councils. Advisory councils are community-based groups established to provide advice and recommendations to ONMS on issues including management, science, service, and stewardship, as well as to serve as liaisons between their constituents in the community and the site. Pursuant to section 315(a) of the NMSA, advisory councils are exempt from the requirements of the Federal Advisory Committee Act. Additional information on ONMS and its advisory councils can be found at https://sanctuaries.noaa.gov.

Under section 315 of the NMSA, advisory council members may be appointed from among: (1) Persons employed by Federal or State agencies with expertise in natural resources management; (2) members of relevant regional fishery management councils; and (3) representatives of local user groups, conservation and other public interest organizations, scientific organizations, educational organizations, or others interested in the protection and multiple use management of sanctuary resources (16 U.S.C. 1455a(b)).

The charter for each advisory council defines the number and type of seats and positions on the council. The advisory council charter for CHNMS identifies the following non-governmental voting seat types: Indigenous Cultural Knowledge; Public-at-Large (San Luis Obispo County, Santa Barbara County); Conservation; Education; Research; Tourism and Recreation; Ports, Harbors, and Maritime Transportation; Offshore Energy and Telecommunications; Commercial Fishing; and Recreational Fishing. Additionally, the charter identifies the following governmental voting seat types: Santa Ynez Band of Chumash Indians; local San Luis Obispo County; and Santa Barbara County representatives; State representative.

Additionally, the council will have non-voting seats for: Bureau of Ocean Energy Management; Bureau of Safety and Environmental Enforcement; NOAA's National Marine Fisheries Service; U.S. Coast Guard; Department of Defense; U.S. Forest Service; California Department of Fish and Wildlife; California Coastal Commission; California State Lands Commission; Central Coast Regional Water Quality Control Board; California State Parks. The council will also have a non-voting Student Leadership seat for students over the age of 18.

To the extent more representation is needed, NOAA intends to work with the advisory council to establish an Indigenous Cultures Advisory Panel as a working group of the advisory council with adequate space for Indigenous community members and others. NOAA would respectfully expect this group to create unique and essential advice and guidance that is informed by knowledge of local Indigenous culture. More information about the working group and its establishment will be available after the advisory council is appointed. NOAA encourages interested individuals to attend advisory council meetings and review the council's website and posted meeting notes to learn more about the planned Indigenous Cultures Advisory Panel. NOAA also encourages interested individuals to apply to the advisory council's Indigenous Cultural Knowledge seats, once applications are made available.

For the CHNMS advisory council, applicants will be chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; views regarding the protection and management of marine or Great Lakes resources; and possibly (though not required) the length of residence in the area affected by the site. Council members and alternates for CHNMS serve two and half or three-year terms, as reflected in the signed charter.

More information on advisory council membership and processes, and materials related to the purpose, policies, and operational requirements for advisory councils can be found in the charter for a particular advisory council ( https://sanctuaries.noaa.gov/management/ac/council_charters.html ) and the National Marine Sanctuary Advisory Council Implementation Handbook ( https://nmssanctuaries.blob.core.windows.net/sanctuaries-prod/media/docs/2022-sanctuary-advisory-council-handbook.pdf ). For more information about the new advisory council for CHNMS, including seat descriptions and application materials, please visit https://sanctuaries.noaa.gov/chumash-heritage/advisory/.

Authority. The collection of information concerning the solicitation for applications for sanctuary advisory councils is authorized under the NMSA, 16 U.S.C. 1445a, and Executive Order 13178, and in accordance with the Privacy Act of 1974, as amended, (Privacy Act, 5 U.S.C. 552a).

Purposes. The collection of names, contact information, professional information, qualifications, and answers to the application questions is required in order for ONMS to evaluate and appoint members to the sanctuary advisory councils. The information collected will be reviewed by NOAA employees, and may also be reviewed by current sanctuary advisory council members as part of the evaluation process.

Routine Uses. NOAA will use the application information for the purposes set forth above. The Privacy Act authorizes disclosure of the collected information for the following purposes: to NOAA staff for work-related purposes; for other purposes as set forth in the Privacy Act; and for routine uses published in one or more of the following Privacy Act System of Records Notices, as applicable: COMMERCE/DEPT-11, Candidates for Membership, Members, and Former Members of Department of Commerce Advisory Committees, available at https://www.commerce.gov/opog/privacy/SORN/SORN-DEPT-11; COMMERCE/DEPT-18, Employees Personnel Files Not Covered by Notices of Other Agencies, available at https://www.commerce.gov/opog/privacy/SORN/SORN-DEPT-18; and OPM/GOVT-1, General Personnel Records, available at https://www.opm.gov/information-management/privacy-policy/sorn/opm-sorn-govt-1-general-personnel-records.pdf, which cover certain records regarding Federal employees and may also cover records of individuals who are not Federal employees who, through their service on a sanctuary advisory council, may be considered as volunteers providing gratuitous services to the agency without compensation; and, for individuals who are also members of a Regional Fishery Management Council, COMMERCE/NOAA-13, Personnel, Payroll, Travel, and Attendance Records of the Regional Fishery Management Councils.

Effects of Not Providing Information. Providing the application information is voluntary; however, if the information is not provided, the individual will not be considered for appointment as a member of a sanctuary advisory council.

Consent. By submitting an application to ONMS for appointment to a sanctuary advisory council, you are consenting to the use and disclosure of the information for the purposes and routine uses described above. However, if you prefer that your application be reviewed by NOAA employees only and not disclosed to current council members as part of the evaluation process, please contact the sanctuary advisory council coordinator to request internal review only, which will not result in any disadvantage or impact regarding your candidacy, or for any questions regarding this Privacy Act Statement.

ONMS has a valid Office of Management and Budget (OMB) control number (0648-0397) for the collection of public information related to the processing of ONMS national marine sanctuary advisory council applications across the National Marine Sanctuary System. Establishing a sanctuary advisory council for CHNMS fits within the estimated reporting burden under that control number. See https://www.reginfo.gov/public/do/PRASearch (Enter Control Number 0648-0397). Therefore, ONMS will not request an update to the reporting burden certified for OMB control number 0648-0397.

Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to: Office of National Marine Sanctuaries, 1305 East West Highway, N/NMS, Silver Spring, Maryland 20910.

Notwithstanding any other provisions of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., unless that collection of information displays a currently valid OMB control number. The OMB control number is #0648-0397.

Authority: 16 U.S.C. 1431 et seq.

The FMP for U.S. West Coast Fisheries for HMS and its implementing regulations at title 50 in the Code of Federal Regulations, part 660, subpart K, regulate commercial and recreational fishing for HMS in the U.S. exclusive economic zone off the coasts of Washington, Oregon, and California and in adjacent high seas waters. NMFS published Amendment 6 and its implementing regulations on May 8, 2023 (88 FR 29545). Amendment 6 authorizes deep-set buoy gear (DSBG) as an additional gear type for catching swordfish and other HMS in Federal waters off of California and Oregon. The Pacific Fishery Management Council recommended that NOAA Fisheries authorize DSBG as an additional commercial gear type to improve the economic viability of the West Coast-based swordfish fishery while minimizing bycatch to the extent practicable. The regulations also established a limited entry (LE) regime for “phased-in” permitting of DSBG fishing within Federal waters of the Southern California Bight (see 50 CFR 660.707(g)). Tier 9 is the final phase of that LE permit regime.

As required by the regulations at § 660.707(g)(12), once the list of initial approved qualifiers for tiers 1 through 8 is exhausted, NMFS may begin accepting applications under tier 9. Additionally, as required by regulations, NMFS must announce the opening of tier 9 in the Federal Register . This notice serves as that announcement.

Therefore, beginning on February 1, 2025, and ending on March 31, 2025, NMFS will accept applications for initial issuance of LE DSBG permits under tier 9. NMFS will continue to accept applications for tier 9 permits on an annual basis and issue up to 25 permits per year until a total of 300 LE DSBG permits are issued, unless NMFS determines that the maximum number of permits should be fewer than 300 and publishes a subsequent rulemaking. The process for initial issuance of LE DSBG permits to applicant that qualify under tier 9, which can be found at § 660.707(g)(12), is summarized below.

To qualify for a LE DSBG permit under tier 9, an applicant must be a “person” as defined at § 660.702 and must not already own a LE DSBG permit either individually or as a shareholder in a business which owns a LE DSBG permit.

To apply for a LE DSBG permit under tier 9 in 2025, a person must submit a complete application to NMFS through the National Permits System website no later than 11:59 p.m. Pacific daylight time on March 31, 2025. A complete initial issuance application package consists of the following: a completed initial issuance application form, which may include ownership interest for businesses, and as required under § 660.707(g)(3)(ii); a current copy of the U.S. Coast Guard Documentation Form or State registration form for the vessel that will be registered to the permit; and payment of required fees. NMFS may require additional documentation as it deems necessary to make a determination on the application. The initial issuance application package will be considered incomplete until the required information is submitted. NMFS will decline to act on an incomplete application.

NMFS will issue LE DSBG permits to approved applicants under tier 9 on a first come, first served basis, according to the date and time that their application was submitted through the National Permits System. NMFS will issue up to 25 permits each year. If NMFS approves more than 25 applications in a single year, the approved applicants above 25 (who were not issued a permit) will receive priority for permit issuance the following year, according to the date and time that their complete applications were received.

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

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

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

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.

May 10, 2024, NMFS received a request from Hoonah for an IHA to take marine mammals incidental to pile driving and removal activities associated with the Hoonah Cargo Dock project in Hoonah, Alaska. Following NMFS' review of the application, Hoonah submitted a revised versions on September 10, 2024 and October 15, 2024. The application was deemed adequate and complete on October 22, 2024. Hoonah's request is for take of 8 species of marine mammals by Level B harassment and, for a subset of these species, Level A harassment. Neither Hoonah nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

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

Hoonah is proposing to install a cargo dock at the Hoonah Marine Industrial Center (HMIC) in Hoonah, Alaska (figure 1). The purpose of this project is to install a dock that will enable barges to land, unload, and load during all tidal conditions and seasons. The project is needed to allow for the safe, reliable, and economical transport of freight to and from Hoonah, which is only accessible by air and sea. The construction of the sheet pile cargo dock, barge ramp, and breasting dolphins will require impact and vibratory pile installation and down-the-hole (DTH) drilling (referred to as tension anchoring).

Sounds resulting from pile driving, pile removal, and tension anchoring may result in the incidental take of marine mammals by Level A and Level B harassment in the form of auditory injury or behavioral harassment. Underwater sound would be constrained to Port Fredrick and would be truncated by land masses in the inlet. Construction activities would start in September 2025 and last 5 months.

The proposed IHA would be effective from September 1, 2025 through August 31, 2026. Vibratory and impact pile driving and tension anchoring are expected to start in September 2025 and take 107 days over a span of 5 months. All pile driving and removal would be completed during daylight hours.

The project would take place at the HMIC in Hoonah, Alaska, which is located within Port Fredrick on Icy Strait. The proposed dock would be constructed at an existing barge ramp, adjacent to the Hoonah ferry terminal and tank farm.

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

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 this activity and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no serious injury or mortality is anticipated or 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' U.S. Alaska and Pacific SARs. All values presented in table 2 are the most recent available at the time of publication and are available online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments.

As indicated above, all 8 species (with 12 managed stocks) in table 2 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur. All species that could potentially occur in the project area are included in table 6 of the IHA application. While gray whales and sperm whales have been documented in the area, the temporal and/or spatial occurrence of these species is such that take is not expected to occur, and they are not discussed further beyond the explanation provided here. Gray whales are considered to be very rare (no local knowledge of sightings in the project area) and sperm whales are considered to be rare (no sightings in recent years) within the project area.

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

The Mainland Mexico—CA/OR/WA and Hawaii stocks of humpback whale occur in the project area. Wild et al. (2023) identified Glacier Bay and Icy Strait as a Biologically Important Area (BIA) for humpback whales for feeding during the months of May through October, with an importance score of two (indicating an area of moderate importance), an intensity score of two (indicating an area of moderate comparative significance) and a data support score of three (highest relative confidence in the available supporting data). Humpback whales have been observed within Port Fredrick and Icy Strait, with most sightings occurring from late May through October (SolsticeAK 2024).

Steller sea lions were listed as threatened range-wide under the ESA on November 26, 1990 (55 FR 49204). Steller sea lions were subsequently partitioned into the western and eastern Distinct Population Segments (DPSs; western and eastern stocks) in 1997 (62 FR 24345, May 5, 1997). The eastern DPS remained classified as threatened until it was delisted in November 2013. The western DPS (those individuals west of the 144° W longitude or Cape Suckling, Alaska) was upgraded to endangered status following separation of the DPSs, and it remains endangered today. There is regular movement of both DPSs across this 144° W longitude boundary especially within a core mixing zone (Jemison et al., 2013). The proposed project is located outside of the known core mixing zone of eastern DPS and western DPS Steller sea lions; however, western DPS animals have been recorded within the Lynn Canal extended mixing zone which includes the proposed project area (Hastings et al., 2020; Jemison et al., 2013). Therefore, while both DPSs could be observed within the project area, most are expected to be from the unlisted eastern DPS.

Steller sea lions do not follow traditional migration patterns, but will move from offshore rookeries in the summer to more protected haulouts closer to shore in the winter. They use rookeries and haulouts as resting spots as they follow prey movements and take foraging trips for days, usually within a few miles (mi) of their rookery or haulout. They are generalist marine predators and opportunistic feeders based on seasonal abundance and location of prey. Steller sea lions forage in nearshore as well as offshore areas, following prey resources. They are highly social and are often observed in large groups while hauled out but alone or in small groups when at sea (NMFS 2023b).

Steller sea lions are common in the proposed project area and reside in the area year-round. The nearest rookery to the proposed project is White Sisters (~72 kilometers (km) (44.5 mi southwest of project) and the nearest major haulout is The Sisters (13 km (8 mi) northeast of project) (AFSC 2023).

Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007, 2019) recommended that marine mammals be divided into hearing groups based on directly measured (behavioral or auditory evoked potential techniques) or estimated hearing ranges (behavioral response data, anatomical modeling, etc. ). Generalized hearing ranges were chosen based on the ~65 decibel (dB) threshold from composite audiograms, previous analyses in NMFS (2018), and/or data from Southall et al. (2007) and Southall et al. (2019). We note that the names of two hearing groups and the generalized hearing ranges of all marine mammal hearing groups have been recently updated (NMFS 2024) as reflected below in in table 3.

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

This section 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.

The marine soundscape is comprised of both ambient and anthropogenic sounds. Ambient sound is defined as the all-encompassing sound in a given place and is usually a composite of sound from many sources both near and far. The sound level of an area is defined by the total acoustical energy being generated by known and unknown sources. These sources may include physical ( e.g., waves, wind, precipitation, earthquakes, ice, atmospheric sound), biological ( e.g., sounds produced by marine mammals, fish, and invertebrates), and anthropogenic sound ( e.g., vessels, dredging, aircraft, construction).

The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10 to 20 dB from day to day (Richardson et al., 1995). The result is that, depending on the source type and its intensity, sound from the specified activity may be a negligible addition to the local environment or could form a distinctive signal that may affect marine mammals.

In-water construction activities associated with the project would include impact pile installation, vibratory pile installation and removal, and tension anchoring. Impact hammers typically operate by repeatedly dropping and/or pushing a heavy piston onto a pile to drive the pile into the substrate. Sound generated by impact hammers is impulsive, characterized by rapid rise times and high peak levels, a potentially injurious combination (Hastings and Popper, 2005). Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the sediment. Vibratory hammers typically produce less sound ( i.e., lower levels) than impact hammers. Peak 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; 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). Tension anchoring through DTH systems would also be used during the proposed construction. A DTH hammer is essentially a drill bit that drills through the bedrock using a rotating function like a normal drill, in concert with a hammering mechanism operated by a pneumatic (or sometimes hydraulic) component integrated into the DTH hammer to increase speed of progress through the substrate ( i.e., it is similar to a “hammer drill” hand tool). The sounds produced by the DTH methods contain both a continuous non-impulsive component from the drilling action and an impulsive component from the hammering effect. Therefore, NMFS treats DTH systems as both impulsive and continuous, non-impulsive sound source types simultaneously.

The likely or possible impacts of Hoonah's proposed activity on marine mammals could involve both non-acoustic and acoustic stressors. Potential non-acoustic stressors could result from the physical presence of the equipment and personnel; however, any impacts to marine mammals are expected to be primarily acoustic in nature.

The introduction of anthropogenic noise into the aquatic environment from pile driving is the primary means by which marine mammals may be harassed from the proposed activity. 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). In general, exposure to pile driving and tension anchoring noise has the potential to result in an auditory threshold shift (TS) and behavioral reactions ( e.g., avoidance, temporary cessation of foraging and vocalizing, changes in dive behavior). Exposure to anthropogenic noise can also lead to non-observable physiological responses, such as 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 effects of pile driving noise on marine mammals are dependent on several factors, including, but not limited to, sound type ( e.g., impulsive vs. non-impulsive), the species, age and sex class ( e.g., adult male vs. mom with calf), duration of exposure, the distance between the pile and the animal, received levels, behavior at time of exposure, and previous history with exposure (Wartzok et al., 2004; Southall et al., 2007). Here we discuss physical auditory effects (threshold shifts) followed by behavioral effects and potential impacts on habitat.

NMFS defines a noise-induced 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). The amount of TS is customarily expressed in dB. A TS can be permanent or temporary. As described in NMFS (2018), 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 an 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 —NMFS defines auditory injury as damage to the inner ear that can result in destruction of tissue . . . which may or may not result in permanent threshold shift (PTS; NMFS, 2024a). NMFS defines PTS 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, 2024a). PTS does not generally affect more than a limited frequency range, and an animal that has PTS has incurred some level of hearing loss at the relevant frequencies; typically, animals with PTS 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 PTS onset (see Ward et al., 1958, 1959, 1960; Kryter et al., 1966; Miller, 1974; Ahroon et al., 1996; Henderson et al., 2008). PTS levels for marine mammals are estimates, as with the exception of a single study unintentionally inducing PTS in a harbor seal (Kastak et al., 2008), there are no empirical data measuring PTS in marine mammals largely due to the fact that, for various ethical reasons, experiments involving anthropogenic noise exposure at levels inducing PTS are not typically pursued or authorized (NMFS, 2018).

Temporary Threshold Shift —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, 2018). Based on data from cetacean TTS measurements (Southall et al., 2007, 2019), a TTS of 6 dB is considered the minimum TS clearly larger than any day-to-day or session-to-session variation in a subject's normal hearing ability (Schlundt et al., 2000; Finneran et al., 2000, 2002). As described in Finneran (2015), marine mammal studies have shown the amount of TTS increases with cumulative sound exposure level (SEL cum ) in an accelerating fashion: At low exposures with lower SEL cum , the amount of TTS is typically small and the growth curves have shallow slopes. At exposures with higher SEL cum , the growth curves become steeper and approach linear relationships with the noise 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 serious (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 a time when communication is critical for successful mother/calf interactions could have more serious 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 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., 2019a, 2019b, 2021, 2022a, 2022b; Reichmuth et al., 2019; Sills et al., 2020). These studies examined 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 TS at various post-exposure times.

The amount and onset of TTS depends on the exposure frequency. Sounds at low frequencies, well below the region of best sensitivity for a species or hearing group, are less hazardous than those at higher frequencies, 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 ( i.e., 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 have a lower TTS onset than other measured pinniped 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 cum 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, 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. Additionally, the existing marine mammal TTS data come from a limited number of individuals within these species.

Relationships between TTS and PTS thresholds have not been studied in marine mammals, but such relationships are assumed to be similar to those in humans and other terrestrial mammals. PTS typically occurs at exposure levels at least several dBs above that inducing mild TTS ( e.g., a 40-dB TS approximates PTS onset (Kryter et al., 1966; Miller, 1974), while a 6-dB TS approximates TTS onset (Southall et al., 2007, 2019). Based on data from terrestrial mammals, a precautionary assumption is that the PTS 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 PTS 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 PTS as compared with TTS, it is considerably less likely that PTS could occur.

Behavioral Harassment —Exposure to noise from pile driving and removal and tension anchoring also has the potential to behaviorally disturb marine mammals. 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. 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. However, 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; National Research Council (NRC), 2005).

Disturbance may result in changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); or avoidance of areas where sound sources are located. Pinnipeds may increase their haulout 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., 2003; Southall et al., 2007; 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-C of Southall et al. (2007) and Gomez et al. (2016) for a review 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 showed 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. However, 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.

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. In response to playbacks of vibratory pile driving sounds, captive bottlenose dolphins showed changes in target detection and number of clicks used for a trained echolocation task (Branstetter et al. 2018). Similarly, harbor porpoises trained to collect fish during playback of impact pile driving sounds also showed potential changes in behavior and task success, though individual differences were prevalent (Kastelein et al. 2019d).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.

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.

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., Seyle, 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). 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., 2002a) and, more rarely, studied in wild populations ( e.g., Romano et al., 2002b). 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. 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, 2003), however distress is an unlikely result of this project based on observations of marine mammals during previous, similar projects in the area.

Masking —Sound can disrupt behavior through masking, or interfering 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). Masking occurs when the receipt of a sound is interfered with by another coincident sound at similar frequencies and at similar or higher intensity, and may occur whether the sound is natural ( e.g., snapping shrimp, wind, waves, precipitation) or anthropogenic ( e.g., pile driving, shipping, sonar, seismic exploration) in origin. 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. Masking of natural sounds can result when human activities produce high levels of background sound at frequencies important to marine mammals. Conversely, if the background level of underwater sound is high ( e.g., on a day with strong wind and high waves), an anthropogenic sound source would not be detectable as far away as would be possible under quieter conditions and would itself be masked.

Airborne Acoustic Effects —Although pinnipeds are known to haul out regularly at two harbor seal haulout sites within Port Fredrick, NMFS expects that incidents of take resulting solely from airborne sound are unlikely due to their proximity. One of the haulouts (CE79A) is located approximately 10 km (6.25 mi) from the project site and is outside of the ensonfied zone for this action. The other (CF39A) is located approximately 3 km (2 mi) from the project site and will be ensonified during some vibratory and impact pile driving activities. Neither of these haulouts are listed as a “key haulout,” or a haulout with 50 or more individuals present at the time of survey (AFSC 2024).

Cetaceans are not expected to be exposed to airborne sounds that would result in harassment as defined under the MMPA. 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 the acoustic criteria. 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, 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 to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon the area and move further from the source. However, these animals would likely previously have been “taken” because of exposure to underwater sound above the behavioral harassment thresholds, which are generally 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.

Hoonah's construction activities could have localized, temporary impacts on marine mammal habitat by increasing in-water SPLs and slightly decreasing water quality. No net habitat loss is expected, since its proposed location is an existing barge ramp that already experiences frequent vessel traffic and is adjacent to an active road, ferry terminal, dock, boat haulout pier, and boat yard. Construction activities are localized and would likely have temporary impacts on marine mammal habitat through increases in underwater sounds. Increased noise levels may affect acoustic habitat (see masking discussion above) and adversely affect marine mammal prey in the vicinity of the project area (see discussion below). During pile driving activities, elevated levels of underwater noise would ensonify the project area where both fishes and marine mammals may occur and could affect foraging success. Additionally, marine mammals may avoid the area during construction; 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.

Temporary and localized reduction in water quality would occur because of in-water construction activities as well. Most of this effect would occur during the installation and removal of piles when bottom sediments are disturbed. The installation of piles would disturb bottom sediments and may cause a temporary increase in suspended sediment in the project area. In general, turbidity associated with pile installation is localized to about 25-ft (7.6-m) radius around the pile (Everitt et al., 1980). Pinnipeds are not expected to be close enough to the pile driving areas to experience effects of turbidity, and could avoid localized areas of turbidity. Therefore, we expect the impact from increased turbidity levels to be discountable to marine mammals and do not discuss it further.

The proposed activities would not result in permanent impacts to habitats used directly by marine mammals outside of the actual footprint of the constructed dock. 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 in Port Fredrick and the surrounding waters. Pile extraction and installation and tension anchoring may have impacts on benthic invertebrate species primarily associated with disturbance of sediments that may cover or displace some invertebrates. The impacts would be temporary and highly localized, and no habitat would be permanently displaced by construction. Therefore, it is expected that impacts on foraging opportunities for marine mammals due to construction of the dock would be minimal.

It is possible that avoidance by potential prey ( i.e., fish) in the immediate area may occur due to temporary loss of this foraging habitat. The duration of fish avoidance of this area after pile driving stops is unknown, but we anticipate a rapid return to normal recruitment, distribution and behavior. Any behavioral avoidance by fish of the disturbed area would still leave large areas of fish and marine mammal foraging habitat in the nearby vicinity in the in the project area and surrounding waters.

Construction activities would produce continuous ( i.e., vibratory pile driving and tension anchoring) and intermittent ( i.e., impact driving and tension anchoring) sounds. Sound may affect marine mammals through impacts on the abundance, behavior, or distribution of prey species ( e.g., fish). Marine mammal prey varies by species, season, and location. Here, we describe studies regarding the effects of noise on known marine mammal prey.

Fish 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 which 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 fish, although several are based on studies in support of large, multiyear bridge construction projects ( 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., Pena et al., 2013; Wardle et al., 2001; Jorgenson and Gyselman, 2009; Cott et al., 2012).

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. (2012a) 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., 2012b; 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).

The greatest potential impact to fishes during construction would occur during impact pile driving and tension anchoring. The duration of impact pile driving would be limited to the final stage of installation (“proofing”) after the pile has been driven as close as practicable to the design depth with a vibratory driver. Only a total of 10 tension anchors will be set over a total of 5 days of construction. 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 could 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 also would have minimal permanent and temporary impacts on benthic invertebrate species, a marine mammal prey source.

The area impacted by the project is relatively small compared to the available habitat in the remainder of Port Fredrick and the surrounding areas, and there are no areas of particular importance that would be impacted by this project. 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 Hoonah's construction to affect the availability of prey to marine mammals or to meaningfully impact the quality of physical or acoustic habitat is considered to be insignificant.

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

As described previously, no serious injury or mortality is anticipated or 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 thresholds above which NMFS believes the best available science indicates marine mammals will likely be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available ( e.g., previous monitoring results or average group size). Below, we describe the factors considered here in more detail and present the proposed take estimates.

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

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

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

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

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

The DAF has decided to replace the aging F-15C/D fighter aircraft at the 104th Fighter Wing (104 FW) at Westfield-Barnes Regional Airport, Westfield, Massachusetts; 144th Fighter Wing (144 FW) at Fresno Yosemite International Airport, Fresno, California; and the 159th Fighter Wing (159 FW) at Naval Air Station Joint Reserve Base New Orleans, Belle Chasse, Louisiana. At the 104 FW, 18 F-15C aircraft will be replaced with up to 21 F-35A aircraft. At the 144 FW, 18 F-15C aircraft will be replaced with up to 21 F-15EX aircraft. At the 159 FW 18 F-15C/D aircraft will be replaced with up to 21 F-15EX aircraft.

The DAF decision documented in the ROD was based on matters discussed in the Final Environmental Impact Statement, inputs from the public and regulatory agencies, and other relevant factors. The Final Environmental Impact Statement was made available to the public on November 15, 2024 through a Notice of Availability in the Federal Register (89 FR 90280) with a waiting period that ended on December 16, 2024.

Authority: This Notice of Availability is published pursuant to the regulations (40 CFR part 1506.6) implementing the provisions of the National Environmental Policy Act (42 U.S.C. 4321, et seq. ) and the Air Force's Environmental Impact Analysis Process (32 CFR parts 989.21(b) and 989.24(b)(7)).

Section 1260H of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283) requires the Secretary of Defense to identify and publish a list of “Chinese military companies” annually until December 31, 2030. Paragraph (b)(2) of this section requires the Secretary of Defense to publish the unclassified portion of such list in the Federal Register (FR).

The Deputy Secretary of Defense has determined that the following entities qualify as “Chinese military companies” in accordance with Section 1260H  1 :

* Subsidiaries Listed with Parent Companies

The Deputy Secretary of Defense has determined that the following previously listed entities should be removed from the most recent Section 1260H List announced on January 31, 2024:

Entities that are included on the 1260H List may request reconsideration of this decision. Requests for reconsideration should include:

1. The listed entity's name and mailing address (including email address) and an authorized representative's name and mailing address (including email address) and

2. A statement indicating the entity's intent to request reconsideration of the Department's determination, including a detailed description with supporting evidence of why the listed entity should be removed from the 1260H List.

The request for removal may also include additional information such as arguments and evidence that establishes that an insufficient basis exists for the listing or that the circumstances resulting in the listing no longer apply.

Requests for reconsideration must be emailed to osd.pentagon.ousd-a-s.list.1260h-list@mail.mil .

Purpose of Program: NACTEP provides grants to improve career and technical education (CTE) programs that are consistent with the purposes of the Carl D. Perkins Career and Technical Education Act of 2006 (the Act or Perkins V), and that benefit Native Americans and Alaska Natives.

Assistance Listing Number: 84.101A.

OMB Control Number: 1894-0006.

Background: This notice invites applications for a NACTEP competition that implements section 116 of the Act. Section 116 of the Act authorizes the Secretary of Education (Secretary) to award grants to, or enter into cooperative agreements or contracts with, Indian Tribes, Tribal organizations, and Alaska Native entities to operate CTE projects that improve CTE for Native American and Alaska Native students.

Under section 116 of the Act, a Bureau-funded school (as defined in this notice) is not eligible to apply for NACTEP funds for its general education program. Its application must be to carry out a supplemental CTE program in its secondary school.

Tribal Consultation: In accordance with the Department's commitment to engage in regular and meaningful consultation and collaboration with Indian Tribes, the Office of Career, Technical, and Adult Education (OCTAE) and the White House Initiative on American Indian and Alaska Native Education conducted a Tribal Consultation regarding NACTEP on July 23, 2024. Consistent with its trust responsibility to Tribes and its Tribal Consultation Policy, the Department sought views from elected officials of federally recognized Tribes as well as stakeholders and educators from the Tribal community to inform the Department's policy decisions related to potential grant competition priorities, the timing of the program's project performance period, funding available under the Perkins V state formula grant, and grant consolidation under the provisions of Public Law 115-93, the Indian Employment, Training and Related Services Consolidation Act of 2017 (25 U.S.C. 3401 et seq. ), which amended the Indian Employment and Related Services Demonstration Act of 1992, Public Law 102-477 (related to which a Tribe may submit a “477 plan”). The consultation also included discussion of student stipends, direct assistance to students, and the independent evaluation requirement established by the notice of final requirements, definitions, and selection criteria for this program (Notice of Final Requirements), published in the Federal Register on February 26, 2013 (78 FR 12955). Representatives from participating Tribal nations expressed the need for flexibility in the program in order to address locally identified needs, noting continued interest in CTE programs that support careers in the trades, including plumbing, electrical, carpentry, and construction. Other Tribal stakeholders mentioned the need for CTE programs that prepare students for careers in cybersecurity and computer science, healthcare, math, early childhood education, and natural resource management. A few participants referenced the need for culturally competent programming and culturally responsive models that support indigenized curricula. Tribal leaders expressed a need for continued direct assistance to students under NACTEP to allow the use of funds for childcare, transportation, and technology in order to support families through responsive programming. Tribal participants expressed an interest in utilizing NACTEP funding to strengthen cross-agency coordination to better support the transition between secondary and postsecondary education.

Executive Order 14112:

Executive Order 14112, “Reforming Federal Funding and Support for Tribal Nations to Better Embrace Our Trust Responsibilities and Promote the Next Era of Tribal Self-Determination”, 1 issued by President Joseph R. Biden on December 6, 2023, calls for Federal programs to provide Tribal Nations with the flexibility to improve economic growth, address the specific needs of their communities, and realize their vision for their future and for agencies to improve our Nation-to-Nation relationships by reducing administrative burdens and by administering funding in a manner that provides Tribal Nations with the greatest possible autonomy to address the specific needs of their people. Additionally, Executive Order 14112 requires Federal agencies to reduce barriers Tribal Nations face in accessing the Federal funding and resources for which they are eligible and that they need to help grow their economies and provide their citizens with important services. This NACTEP competition serves the goals of both the Executive Order and Perkins V. It provides an opportunity to reduce potential funding barriers for CTE programs by reducing the number of program and application requirements, which makes it easier for applicants and increases flexibility for programs that address locally-identified needs.

Priorities: This competition has one absolute priority. The Absolute Priority is from section 116 of the Act.

Absolute Priority: For FY 2025, and any subsequent year in which we make awards from the list of unfunded applications from this competition, this priority is an absolute priority. Under 34 CFR 75.105(c)(3), we consider only applications that meet the Absolute Priority.

The priority is:

Authorized Program.

To meet this priority, applicants must propose and carry out a career and technical education program consistent with the Carl D. Perkins Act of 2006. (20 U.S.C. 2302(5))

Note: If an applicant with an open NACTEP grant receives a grant under this competition, they must demonstrate that the activities and objectives of the grant will not duplicate or overlap with the expenses, activities, and objectives of other open grants with the same or similar activities and objectives. (2 CFR 200.403 and 200.404)

Requirements:

This notice includes two application and three program requirements that are based on statutory requirements or the Notice of Final Requirements. The source is noted after each requirement.

The application requirements are:

(1) Demonstration of Eligibility. (a) An eligible applicant (as determined by the Act) must include documentation in its application showing that it and, if appropriate, its consortium members are eligible to apply.

(b) As defined in the Indian Self-Determination and Education Assistance Act (ISDEAA) (25 U.S.C. 5304(l)), the term “Tribal organization” means the recognized governing body of any Indian Tribe; any legally established organization of Indians which is controlled, sanctioned, or chartered by such governing body or which is democratically elected by the adult members of the Indian community to be served by such organization and which includes the maximum participation of Indians in all phases of its activities: provided, that in any case where a contract is let or grant made to an organization to perform services benefiting more than one Indian Tribe, the approval of each such Indian Tribe shall be a prerequisite to the letting or making of such contract or grant. In accordance with this statutory definition, any Tribal organization proposing to provide NACTEP services for the benefit of more than one Indian Tribe must first obtain the approval of each Indian Tribe it proposes to serve and must submit documentation of such approval with its NACTEP application and that documentation of Tribal approval is a prerequisite to the awarding of a NACTEP grant to any Tribal organization proposing to serve more than one Indian Tribe. (Notice of Final Requirements).

(2) Career and technical education agreement. Any applicant that is not proposing to provide CTE directly to its students and proposes instead to use NACTEP funds to pay one or more qualified educational entities to provide education to its students must include with its application a written career and technical education agreement between the applicant and that entity. This written agreement must describe the commitment between the applicant and each educational entity and must include, at a minimum, a statement of the responsibilities of the applicant and the entity. The agreement must be signed by the appropriate individuals on behalf of each party, such as the authorizing official or president of a Tribe or Tribal organization, a college president, or a college dean. (Notice of Final Requirements).

The program requirements are:

Requirement 1—Authorized Use of NACTEP Funds:

Section 116(c) of the Act requires that funds awarded under NACTEP be used to carry out “career and technical education programs” (20 U.S.C. 2326(c), as the term “career and technical education” is defined by the Act as amended by the Strengthening Career and Technical Education for the 21st Century Act (20 U.S.C. 2302(5)). Grantees may use funds awarded under NACTEP to—

(1) Provide preparatory, refresher, and remedial education services that are designed to enable students to achieve success in career and technical education programs or programs of study.

(2) Provide stipends to students who are enrolled in career and technical education programs and who have acute economic needs which cannot be met through work-study programs. Stipends shall not exceed reasonable amounts as prescribed by the Secretary.

Note: As noted in the Eligibility section below, and consistent with section 116(b)(1) of Perkins V, a Bureau-funded secondary school is not eligible to directly apply for NACTEP funds for its general education secondary school program.

Note: Each organization, Tribe, or entity receiving assistance under this section may consolidate such assistance in a 477 plan in accordance with the provisions of the Indian Employment, Training and Related Services Demonstration Act of 1992 (25 U.S.C. 3401 et seq. ) 20 U.S.C. 23236(f). Consistent with that statute, any request to consolidate NACTEP funds into a 477 plan must be made separately to the U.S. Department of Interior. Please see section IV on Application Submission for more information.

Requirement 2—Direct Assistance to Students:

A grantee may provide direct assistance to students if the following conditions are met:

(1) The recipient of the direct assistance is an individual who is a member of a special population and who is participating in the grantee's NACTEP project.

(2) The direct assistance is needed to address barriers to the individual's successful participation in that project.

(3) The direct assistance is part of a broader, more generally focused program or activity to address the needs of an individual who is a member of a special population.

Note: Direct assistance to individuals who are members of special populations is not, by itself, a “program or activity for special populations”.

(4) The grant funds used for direct assistance must be expended to supplement, and not supplant, assistance that is otherwise available from non-Federal sources. (20 U.S.C. 2391(a)). For example, generally, a postsecondary educational institution could not use NACTEP funds to provide child care for single parents if non-Federal funds previously were made available for this purpose, or if non-Federal funds are used to provide child care services for single parents participating in non-CTE programs and these services otherwise would have been available to CTE students in the absence of NACTEP funds.

(5) In determining how much of the NACTEP grant funds it will use for direct assistance to an eligible student, a grantee must consider whether the specific services to be provided are a reasonable and necessary cost of providing CTE programs for special populations. However, the Assistant Secretary does not envision a circumstance in which it would be a reasonable and necessary expenditure of NACTEP project funds for a grantee to use a majority of a project's budget to pay direct assistance to students, in lieu of providing the students served by the project with CTE. (Notice of Final Requirements).

Requirement 3—ISDEAA Statutory Hiring Preference:

(1) Awards that are primarily for the benefit of Indians are subject to the provisions of section 7(b) of the Indian Self-Determination and Education Assistance Act (ISDEAA) (Pub. L. 93-638). That section requires that, to the greatest extent feasible, a grantee—

(i) Give to Indians preferences and opportunities for training and employment in connection with the administration of the grant; and

(ii) Give to Indian organizations and to Indian-owned economic enterprises, as defined in section 3 of the Indian Financing Act of 1974 (25 U.S.C. 1452(e)), preference in the award of subcontracts and subgrants in connection with the administration of the grant. (25 U.S.C. 5307(b))

(2) For purposes of Requirement 3, an Indian is a member of any federally recognized Indian Tribe. (25 U.S.C. 5304(d)).

Definitions: These definitions are from the Act or the Notice of Final Requirements. The source of each definition is noted after the definition.

Acute economic need means an income that is at or below the national poverty level according to the latest available data from the U.S. Department of Commerce or the U.S. Department of Health and Human Services Poverty Guidelines. (Notice of Final Requirements).

Alaska Native or Native means a citizen of the United States who is a person of one-fourth degree or more Alaska Indian (including Tsimshian Indians not enrolled in the Metlaktla Indian Community)  2 Eskimo, or Aleut blood, or a combination thereof. The term includes—

(a) Any Native, as so defined, either or both of whose adoptive parents are not Natives; and

(b) In the absence of proof of a minimum blood quantum, any citizen of the United States who is regarded as an Alaska Native by the Native village or Native group of which he or she claims to be a member and whose father or mother is (or, if deceased, was) regarded as Native by any village or group. Any decision of the Secretary of the Interior regarding eligibility for enrollment will be final. (20 U.S.C. 2326(a)(1); 43 U.S.C. 1602(b)).

Alaska Native group means any Tribe, band, clan, village, community, or village association of Natives in Alaska composed of less than twenty-five Natives, who comprise a majority of the residents of the locality. (43 U.S.C. 1602(d)).

Alaska Native village means any Tribe, band, clan, group, village, community, or association in Alaska listed in sections 1610 and 1615 of the Alaska Native Claims Settlement Act, or that meets the requirements of chapter 33 of the Alaska Native Claims Settlement Act, and that the Secretary of the Interior determines was, on the 1970 census enumeration date (as shown by the census or other evidence satisfactory to the Secretary of the Interior, who shall make findings of fact in each instance), composed of twenty-five or more Natives. (43 U.S.C. 1602(c)).

Alaska regional corporation means an Alaska Native regional corporation established under the laws of the State of Alaska in accordance with the provisions of chapter 33 of the Alaska Native Claims Settlement Act. (43 U.S.C. 1602(g)).

Alaska village corporation means an Alaska Native village corporation organized under the laws of the State of Alaska as a business for profit or nonprofit corporation to hold, invest, manage and/or distribute lands, property, funds, and other rights and assets for and on behalf of an Alaska Native village, in accordance with the terms of chapter 33 of the Alaska Native Claims Settlement Act. (43 U.S.C. 1602(j)).

Bureau means the Bureau of Indian Affairs of the U.S. Department of the Interior. (25 U.S.C. 2021(2)).

Bureau-funded school means—

(a) A Bureau-operated elementary or secondary day or boarding school or Bureau-operated dormitory for students attending a school other than a Bureau school. (25 U.S.C. 2021(3) and (4));

(b) An elementary school, secondary school, or dormitory that receives financial assistance for its operation under a contract, grant, or agreement with the Bureau under section 102, 103(a), or 208 of the ISDEAA (25 U.S.C. 5321, 5322(a), or 5355) or under the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2504 et seq. ). (25 U.S.C. 2021(3) and (6)); or

(c) A school for which assistance is provided under the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2501 et seq. ). (25 U.S.C. 2021(3)).

Career and technical education (CTE) means organized educational activities that—

(a) Offer a sequence of courses that—

(1) Provides individuals with rigorous academic content and relevant technical knowledge and skills needed to prepare for further education and careers in current or emerging professions, which may include high-skill, high-wage, or in-demand industry sectors or occupations, which shall be, at the secondary level, aligned with the challenging State academic standards adopted by a State under section 1111(b)(1) of the ESEA;

(2) Provides technical skill proficiency or a recognized postsecondary credential, which may include an industry-recognized credential, a certificate, or an associate degree; and

(3) May include prerequisite courses (other than a remedial course)  3 that meet the requirements of this paragraph (a);

(b) Include competency-based, work-based, or other applied learning that supports the development of academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, employability skills, technical skills, and occupation-specific skills, and knowledge of all aspects of an industry, including entrepreneurship, of an individual;

(c) To the extent practicable, coordinate between secondary and postsecondary education programs through programs of study, which may include coordination through articulation agreements, early college high school programs, dual or concurrent enrollment program opportunities, or other credit transfer agreements that provide postsecondary credit or advanced standing; and

(d) May include career exploration at the high school level or as early as the middle grades (as such term is defined in section 8101 of the ESEA). (20 U.S.C. 2302(5)).

CTE concentrator means—

(a) At the secondary school level, a student served by an eligible recipient who has completed at least 2 courses in a single career and technical education program or program of study; and

(b) At the postsecondary level, a student enrolled in an eligible recipient who has—

(1) Earned at least 12 credits within a career and technical education program or program of study; or

(2) Completed such a program if the program encompasses fewer than 12 credits or the equivalent in total. (20 U.S.C. 2302(12))

Direct assistance to students means tuition, dependent care, transportation, books, and supplies that are necessary for a student to participate in a CTE program or program of study supported with NACTEP funds. (Notice of Final Requirements).

In-demand industry sector or occupation means—

(a) An industry sector that has a substantial current or potential impact (including through jobs that lead to economic self-sufficiency and opportunities for advancement) on the State, regional, or local economy, as appropriate, and that contributes to the growth or stability of other supporting businesses, or the growth of other industry sectors; or

(b) An occupation that currently has or is projected to have a number of positions (including positions that lead to economic self-sufficiency and opportunities for advancement) in an industry sector so as to have a significant impact on the State, regional, or local economy, as appropriate. (20 U.S.C. 2302(26); 29 U.S.C. 3102).

Indian means a person who is a member of an Indian Tribe. (20 U.S.C. 2302(27); 25 U.S.C. 5304(d)).

Indian Tribe means any Indian Tribe, band, nation, or other organized group or community, including any Alaska Native village or regional or village corporation as defined in or established pursuant to the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq. ), which is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians. (20 U.S.C. 2302(27); 25 U.S.C. 5304(e)).

Institution of higher education means—

(a) An educational institution in any State that—

(1) Admits as regular students only persons having a certificate of graduation from a school providing secondary education, or the recognized equivalent of such a certificate or persons who meet the requirements of section 1091(d) of this title;

(2) Is legally authorized within such State to provide a program of education beyond secondary education;

(3) Provides an educational program for which the institution awards a bachelor's degree or provides not less than a 2-year program that is acceptable for full credit toward such a degree, or awards a degree that is acceptable for admission to a graduate or professional degree program, subject to review and approval by the Secretary;

(4) Is a public or other nonprofit institution; and

(5) Is accredited by a nationally recognized accrediting agency or association or, if not so accredited, is an institution that has been granted pre-accreditation status by such an agency or association that has been recognized by the Secretary of Education for the granting of pre-accreditation status, and the Secretary has determined that there is satisfactory assurance that the institution will meet the accreditation standards of such an agency or association within a reasonable time.

(b) The term also includes—

(1) Any school that provides not less than a 1-year program of training to prepare students for gainful employment in a recognized occupation and that meets the provisions of paragraphs (1), (2), (4), and (5) of paragraph (a); and

(2) A public or nonprofit private educational institution in any State that, in lieu of the requirement in paragraph (a)(1) of this definition, admits as regular students individuals who are beyond the age of compulsory school attendance in the State in which the institution is located or, (B) who will be dually or concurrently enrolled in the institution and a secondary school. (20 U.S.C. 2302(30); 20 U.S.C. 1001(a) and (b)).

Professional development means activities that—

(a) are an integral part of eligible agency, eligible recipient, institution, or school strategies for providing educators (including teachers, principals, other school leaders, administrators, specialized instructional support personnel, career guidance and academic counselors, and paraprofessionals) with the knowledge and skills necessary to enable students to succeed in career and technical education, to meet challenging State academic standards under section 1111(b)(1) of ESEA, or to achieve academic skills at the postsecondary level; and

(b) Are sustained (not stand-alone, 1-day, or short-term workshops), intensive, collaborative, job-embedded, data-driven, and classroom-focused, to the extent practicable evidence-based, and may include activities that—

(1) Improve and increase educators'—

(A) Knowledge of the academic and technical subjects;

(B) Understanding of how students learn; and

(C) Ability to analyze student work and achievement from multiple sources, including how to adjust instructional strategies, assessments, and materials based on such analysis;

(2) Are an integral part of eligible recipients' improvement plans;

(3) Allow personalized plans for each educator to address the educator's specific needs identified in observation or other feedback;

(4) Support the recruitment, hiring, and training of effective educators, including educators who became certified through State and local alternative routes to certification;

(5) Advance educator understanding of—

(A) Effective instructional strategies that are evidence-based; and

(B) Strategies for improving student academic and technical achievement or substantially increasing the knowledge and teaching skills of educators;

(6) Are developed with extensive participation of educators, parents, students, and representatives of Indian Tribes (as applicable), of schools and institutions served under the Act;

(7) Are designed to give educators of students who are English learners in career and technical education programs or programs of study the knowledge and skills to provide instruction and appropriate language and academic support services to those students, including the appropriate use of curricula and assessments;

(8) As a whole, are regularly evaluated for their impact on increased educator effectiveness and improved student academic and technical achievement, with the findings of the evaluations used to improve the quality of professional development;

(9) Are designed to give educators of individuals with disabilities in career and technical education programs or programs of study the knowledge and skills to provide instruction and academic support services to those individuals, including positive behavioral interventions and supports, multi-tier system of supports, and use of accommodations;

(10) Include instruction in the use of data and assessments to inform and instruct classroom practice;

(11) Include instruction in ways that educators may work more effectively with parents and families;

(12) Provide follow-up training to educators who have participated in activities described in this definition that are designed to ensure that the knowledge and skills learned by the educators are implemented in the classroom;

(13) Promote the integration of academic knowledge and skills and relevant technical knowledge and skills, including programming jointly delivered to academic and career and technical education teachers; or

(14) Increase the ability of educators providing career and technical education instruction to stay current with industry standards. (20 U.S.C. 2302(40)).

Program of study means a coordinated, nonduplicative sequence of academic and technical content at the secondary and postsecondary level that—

(A) Incorporates challenging State academic standards, including those adopted by a State under section 1111(b)(1) of ESEA;

(B) Addresses both academic and technical knowledge and skills, including employability skills;

(C) Is aligned with the needs of industries in the economy of the State, region, Tribal community, or local area;

(D) Progresses in specificity (beginning with all aspects of an industry or career cluster and leading to more occupation-specific instruction);

(E) Has multiple entry and exit points that incorporate credentialing; and

(F) Culminates in the attainment of a recognized postsecondary credential. (20 U.S.C. 2302(41)).

Recognized postsecondary credential means a credential consisting of an industry-recognized certificate or certification, a certificate of completion of an apprenticeship, a license recognized by the State involved or Federal Government, or an associate or baccalaureate degree. (20 U.S.C. 2302(43); 29 U.S.C. 3102(52)).

Secondary school means a nonprofit institutional day or residential school, including a public secondary charter school, that provides secondary education, as determined under State law, except that the term does not include any education beyond grade 12. (20 U.S.C. 2302(44); 20 U.S.C. 7801(45)).

Special populations means—

(a) Individuals with disabilities;

(b) Individuals from economically disadvantaged families, including low-income youth and adults;

(c) Individuals preparing for non-traditional fields; (d) Single parents, including single pregnant women;

(e) Out-of-workforce individuals;

(f) English learners;

(g) Homeless individuals described in section 725 of the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11434a);

(h) Youth who are in, or have aged out of, the foster care system; and

(i) Youth with a parent who—

(i) Is a member of the armed forces (as such term is defined in section 101(a)(4) of title 10, United States Code); and

(ii) Is on active duty (as such term is defined in section 101(d)(1) of such title). (20 U.S.C. 2302(48)).

Support services means services related to curriculum modification, equipment modification, classroom modification, supportive personnel (including paraprofessionals and specialized instructional support personnel), and instructional aids and devices. (20 U.S.C. 2302(50)).

Tribally controlled college or university means an institution of higher education that is formally controlled, or has been formally sanctioned, or chartered, by the governing body of an Indian Tribe or Tribes, except that no more than one such institution shall be recognized with respect to any such Tribe. (20 U.S.C. 2302(50); 25 U.S.C. 1801(a)(4)).

Tribal organization means the recognized governing body of any Indian Tribe; any legally established organization of Indians that is controlled, sanctioned, or chartered by such governing body or that is democratically elected by the adult members of the Indian community to be served by such organization and that includes the maximum participation of Indians in all phases of its activities: Provided, that, in any case where a contract is let or grant made to an organization to perform services benefiting more than one Indian Tribe, the approval of each such Indian Tribe shall be a prerequisite to the letting or making of such contract or grant. (20 U.S.C. 2302(53); 25 U.S.C. 5304(l)).

Work-based learning means sustained interactions with industry or community professionals in real workplace settings, to the extent practicable, or simulated environments at an educational institution that foster in-depth, firsthand engagement with the tasks required of a given career field, that are aligned to curriculum and instruction. (20 U.S.C. 2302 (55)).

Program Authority: 20 U.S.C. 2301, et seq., particularly 2326(a)-(g).

Note: Projects will be awarded and must be operated in a manner consistent with the nondiscrimination requirements contained in Federal civil rights laws.

Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, 97, 98, and 99. (b) The Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Guidance for Federal Financial Assistance in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) Notice of Final Requirements.

Note: As of October 1, 2024, grant applicants must follow the provisions stated in the OMB Guidance for Federal Financial Assistance (89 FR 30046, April 22, 2024) when preparing an application. For more information about these regulations please visit: www.cfo.gov/resources-coffa/uniform-guidance/.

Note: The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian Tribes.

Note: The regulations in 34 CFR part 86 apply to institutions of higher education only.

Type of Award: Discretionary grants.

Estimated Available Funds: $21,000,000.

Note: Contingent upon the availability of funds and the quality of applications, the Department anticipates making awards for the first 12-month budget period using FY 2024 appropriations available in FY 2025 and FY 2025 appropriations, if any, that become available in FY 2026. The Department may make partial awards using FY 2024 appropriations available in FY 2025 and award the remaining funds using FY 2025 appropriations available in FY 2026 when they become available.

Contingent upon the availability of funds and the quality of applications, we may make additional awards later in FY 2026 or in subsequent years from the list of unfunded applications from this competition.

Estimated Range of Awards: $150,000 to $650,000 for each 12-month budget period ( i.e., a total of approximately $750,000 to $3,250,000 for a full 60 month project period).

Estimated Average Size of Awards: $500,000 for each 12-month budget period.

Estimated Number of Awards: 30-35.

Note: The Department is not bound by any estimates in this notice.

Project Period: Up to 60 months.

1. Eligible Applicants: (a) The following entities are eligible to apply under this competition:

(1) A federally recognized Indian Tribe.

(2) A Tribal organization.

(3) An Alaska Native entity.

(4) A Bureau-funded school, except for a Bureau-funded school proposing to use its award to support general education secondary school programs.

(b) Any Tribe, Tribal organization, Alaska Native entity, or eligible Bureau-funded school may apply individually or as part of a consortium with one or more eligible Tribes, Tribal organizations, Alaska Native entities, or eligible Bureau-funded schools. (Eligible applicants seeking to apply for funds as a consortium must meet the requirements in 34 CFR 75.127 through 75.129, which apply to group applications.)

Note: A Tribal college or university may apply as a Tribal organization if it meets the criteria set forth in the definition of a Tribal organization, above.

Note: If you are a nonprofit organization, under 34 CFR 75.51, you may demonstrate your nonprofit status by providing: (1) proof that the Internal Revenue Service currently recognizes the applicant as an organization to which contributions are tax deductible under section 501(c)(3) of the Internal Revenue Code; (2) a statement from a State taxing body or the State attorney general certifying that the organization is a nonprofit organization operating within the State and that no part of its net earnings may lawfully benefit any private shareholder or individual; (3) a certified copy of the applicant's certificate of incorporation or similar document if it clearly establishes the nonprofit status of the applicant; or (4) any item described above if that item applies to a State or national parent organization, together with a statement by the State or parent organization that the applicant is a local nonprofit affiliate.

2. a. Cost Sharing or Matching: This program does not require cost sharing or matching.

b. Supplement-Not-Supplant: This competition involves supplement-not-supplant funding requirements. In accordance with section 211(a) of the Act (20 U.S.C. 2391(a)), funds under this program may not be used to supplant non-Federal funds used to carry out CTE activities. Further, the prohibition against supplanting also means that grantees will be required to use their negotiated restricted indirect cost rates under this program. (34 CFR 75.563)

We caution applicants not to plan to use funds under NACTEP to replace otherwise available non-Federal funding for direct assistance to students and family assistance programs. For example, NACTEP funds must not be used to supplant Tribal and other non-Federal funds with Federal funds in order to pay the costs of students' tuition, dependent care, transportation, books, supplies, and other costs associated with participation in a CTE program.

Funds under NACTEP should not be used to replace Federal student financial aid. The Act does not authorize the Secretary to fund projects that serve primarily as entities through which students may apply for and receive tuition and other financial assistance.

c. Indirect Cost Rate Information: This program uses a restricted indirect cost rate. For more information regarding indirect costs, or to obtain a negotiated indirect cost rate, please see www.ed.gov/about/ed-offices/ofo#Indirect-Cost-Division.

d. Administrative Cost Limitation: This program does not include any program-specific limitation on administrative expenses. All administrative expenses must be reasonable and necessary and conform to Cost Principles described in 2 CFR part 200 subpart E of the Guidance for Federal Financial Assistance.

e. Limitation on Services: Section 215 of the Act (20 U.S.C. 2395) forbids the use of Perkins funds for the education of students prior to the middle grades. The term middle grades refers to grades 5 through 8, as defined in section 8101 of ESEA.

3. Subgrantees: Under 34 CFR 75.708 (b) and (c), a grantee under this competition may award subgrants—to directly carry out project activities described in its application—to the following types of entities: institutions of higher education, nonprofit organizations, Tribal organizations, Bureau-funded schools operating a secondary school CTE program, or Alaska Native entities. The grantee may only award subgrants to entities it has identified in an approved application, including any amendments to an approved application.

1. Application Submission Instructions: Applicants are required to follow the Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on December 7, 2022 (87 FR 75045) and available at www.federalregister.gov/documents/2022/12/07/2022-26554/common-instructions-for-applicants-to-department-of-education-discretionary-grant-programs, which contain requirements and information on how to submit an application.

Note: OCTAE invites an applicant to indicate whether it intends to consolidate its NACTEP grant funds into a current or future 477 plan in accordance with the provisions of Public Law 115-93, the Indian Employment, Training and Related Services Consolidation Act of 2017 (25 U.S.C. 3401 et seq. ). Consistent with that statute, any request to consolidate NACTEP funds into a 477 plan must be made separately to the U.S. Department of Interior. For further information on the integration of grant funds under this program and related programs, contact the Division of Workforce Development, Office of Indian Services, Bureau of Indian Affairs, U.S. Department of the Interior at Office of Indian Services, Division of Workforce Development, Bureau of Indian Affairs, 1849 C Street NW, MS-3645-MIB, Washington, DC 20245, Telephone: (202) 219-3938.

NACTEP grantees who are in their last year of NACTEP funding from a previous grant and have currently integrated that previous grant under an approved 477 plan must apply for a new NACTEP grant under this competition by submitting an application that meets all of the requirements included in this notice. If such an applicant receives a new NACTEP grant under this competition and wants to consolidate the new NACTEP grant in a 477 plan, it must notify the U.S. Department of Interior that it plans to do so.

2. Submission of Proprietary Information: Given the types of projects that may be proposed in applications for NACTEP, your application may include business information that you consider proprietary. In 34 CFR 5.11 we define “business information” and describe the process we use in determining whether any of that information is proprietary and, thus, protected from disclosure under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552, as amended).

Because we plan to make successful applications available to the public on the Department's website, you may wish to request confidentiality of business information.

Consistent with Executive Order 12600 (Predisclosure Notification Procedures for Confidential Commercial Information), please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).

3. Intergovernmental Review: This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.

4. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

5. Recommended Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. We recommend that you (1) limit the application narrative to 35 pages and (2) use the following standards:

• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.

• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions as well as all text in charts, tables, figures, and graphs.

• Use a font that is either 12 point or larger, and no smaller than 10 pitch (characters per inch).

• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.

The recommended page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the recommended page limit does apply to all of the application narrative.

6. Notice of Intent to Apply: The Department will be able to review grant applications more efficiently if we know the approximate number of applicants that intend to apply. Therefore, we strongly encourage each potential applicant to notify us of their intent to submit an application. To do so, please email the program contact person listed under FOR FURTHER INFORMATION CONTACT with the subject line “Intent to Apply,” and include the applicant's name and a contact person's name and email address. Applicants that do not submit a notice of intent to apply may still apply for funding; applicants that do submit a notice of intent to apply are not bound to apply or bound by the information provided.

1. Selection Criteria: The selection criteria for this program are from section 116(e) of Perkins V (20 U.S.C. 2326(e)), the Notice of Final Requirements, or 34 CFR 75.210. The source is noted after each criterion.

The maximum score for each criterion is indicated in parentheses.

(a) Need for project (Up to 11 points). In determining the need for the proposed project, we consider the following factors:

(1) The extent to which the proposed project involves, coordinates with, or encourages Tribal economic development plans. (20 U.S.C. 2326(e)(1)). (Up to 5 points).

(2) The extent of the need for the services to be provided or the activities to be carried out by the proposed project, as evidenced by data on such phenomena as local labor market demand or occupational trends, or from surveys, recommendations from accrediting agencies, or Tribal economic development plans. (Notice of Final Requirements). (Up to 3 points)

(3) The extent to which the proposed project will provide support, resources, or services; or otherwise address the needs of the target population, including addressing the needs of underserved populations most affected by the issue, challenge, or opportunity, to be addressed by the proposed project and close gaps in educational opportunity. (34 CFR 75.210(a)(2)(iii)). (Up to 3 points)

(b) Quality of the project design (Up to 26 points). In determining the quality of the design of the proposed project, we consider the following factors:

(1) The extent to which the proposed project proposes specific, measurable targets, connected to strategies, activities, resources, outputs, and outcomes, and uses reliable administrative data to measure progress and inform continuous improvement. (34 CFR 75.210(c)(2)(v)). (Up to 16 points).

(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs, as evidenced by the applicant's description of programs and activities that align with the target population's needs. (Notice of Final Requirements). (Up to 10 points).

(c) Quality of the project services (Up to 24 points). In determining the quality of the services to be provided by the proposed project, we consider the following factors:

(1) The quality and sufficiency of strategies for ensuring equitable and adequate access and participation for project participants who experience barriers based on one or more of the following: economic disadvantage; gender; race; ethnicity; color; disability; age; language; living in a rural location; experiencing homelessness or housing insecurity; involvement with the justice system; and pregnancy, parenting, or caregiver status. This determination includes the steps developed and described in the form Equity For Students, Teachers, And Other Program Beneficiaries (OMB Control No. 1894-0005) (section 427 of the General Education Provisions Act (20 U.S.C. 1228a)). (34 CFR 75.210(d)(2)). (Up to 12 points).

(2) The extent to which the services to be provided by the proposed project will create opportunities for students to receive an industry-recognized credential; become employed in high-skill, high-wage, and high-demand occupations; or both. (Notice of Final Requirements). (Up to 7 points).

(3) The extent to which the training or professional development services to be provided by the proposed project would be of sufficient quality, intensity, and duration to lead to improvements in practice among the project staff and instructors, including the extent to which the proposed training and professional development plans address ways in which learning gaps will be addressed and how continuous review of performance will be conducted to identify training needs. (Notice of Final Requirements). (Up to 5 points).

(d) Adequacy of resources (Up to 19 points). In determining the adequacy of resources for the proposed project, we consider the following factors:

(1) The extent to which the budget is adequate to support the proposed project and the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project. (34 CFR 75.210(f)(2)(iii)). (Up to 7 points).

(2) The relevance and demonstrated commitment ( e.g., through written career and technical education agreements, memoranda of understanding, letters of support and commitment, or commitments to employ project participants, as appropriate) of the applicant, members of the consortium, local employers, or Tribal entities to be served by the project. (Notice of Final Requirements). (Up to 6 points).

(3) The extent to which the costs are reasonable in relation to the number of persons to be served, the depth and intensity of services, and the anticipated results and benefits. (34 CFR 75.210(f)(2)(iv)). (Up to 6 points).

(e) Quality of the management plan (Up to 20 points). In determining the quality of the management plan for the proposed project, we consider the following factors:

(1) The feasibility of the management plan to achieve project objectives and goals on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks. (34 CFR 75.210(g)(2)(i)). (Up to 10 points).

(2) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project. (Notice of Final Requirements). (Up to 5 points).

(3) The extent to which the proposed project team maximizes diverse perspectives, for example by reflecting the lived experiences of project participants, or relevant experience working with the target population. (34 CFR 75.210(e)(3)(iv)). (Up to 5 points).

2. Additional Selection Factor: In accordance with the requirement in section 116(e) of the Act, we have included the following additional selection factor from the Notice of Final Requirements:

We will award five points to applications from Tribally controlled colleges or universities that—

(a) Are accredited or are candidates for accreditation by a nationally recognized accreditation organization as an institution of postsecondary CTE; or

(b) Operate CTE programs that are accredited or are candidates for accreditation by a nationally recognized accreditation organization and issue certificates for completion of CTE programs (20 U.S.C. 2326(e)).

3. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

4. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.206, before awarding grants under this competition, the Department conducts a review of the risks posed by applicants. Under 2 CFR 200.208, the Secretary may impose special conditions and, under 2 CFR 3474.10, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

5. Integrity and Performance System: If you are selected under this competition to receive an award that over the course of the project period may exceed the simplified acquisition threshold (currently $250,000), under 2 CFR 200.206(a)(2) we must make a judgment about your integrity, business ethics, and record of performance under Federal awards—that is, the risk posed by you as an applicant—before we make an award. In doing so, we must consider any information about you that is in the integrity and performance system (currently referred to as the Federal Awardee Performance and Integrity Information System (FAPIIS)), accessible through the System for Award Management (SAM). You may review and comment on any information about yourself that a Federal agency previously entered and that is currently in FAPIIS.

Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.

1. Appeal process: Any applicant denied funding under this NACTEP competition may request a hearing to review the Secretary's decision not to make the award. The Secretary will implement the appeal process in accordance with the procedures in 34 CFR 401.1. In accordance with those procedures, any applicant denied funding will have 30 calendar days to make a written request to the Secretary for a hearing to review the Secretary's decision. (25 U.S.C. 5321(b); 34 CFR 401.1).

2. Indian Self-Determination Contracts: Section 116(b)(2) of the Act provides that grants or contracts awarded under section 116 of the Act are subject to the terms and conditions of section 102 of the ISDEAA (25 U.S.C. 5321) and must be conducted in accordance with the provisions of sections 4, 5, and 6 of the Act of April 16, 1934 (25 U.S.C. 5345-5347) (Johnson-O'Malley Act), that are relevant to the programs administered under section 116(b) of the Act. The Act of April 16, 1934, authorizes the Secretary of the Interior to enter into contracts for the education of Indians and other purposes. Section 102 of the ISDEAA authorizes Indian Tribes to request self-determination contracts from the Department of Interior. Accordingly, an Indian Tribe or Tribal organization that has applied to the Secretary for funding under NACTEP and has been notified of its selection to be a funding recipient may submit a request to both the Secretary of Education (via the contact person listed under FOR FURTHER INFORMATION CONTACT ) and the relevant Department of Interior contact person to operate its NACTEP project through a section 102 Indian self-determination contract.

After successful applicants are selected under this NACTEP competition, the Secretary will review any requests to operate a project under an Indian self-determination contract pursuant to the ISDEAA. If a request for an Indian self-determination contract is approved, the Indian Tribe or Tribal organization submitting the request will be required, to the extent possible, to operate its project in accordance with the ISDEAA, relevant provisions in sections 4, 5, and 6 of the Act of April 16, 1934 (25 U.S.C. 5345-5347), the Act, and the non-statutory program requirements specified in this notice.

The CTE programs provided through an Indian self-determination contract would have to be substantively the same as were proposed in the initial NACTEP application and approved by the Department. Any Indian Tribe or Tribal organization that is selected to receive funding under this competition, but whose request to operate the project under an Indian self-determination contract is denied, may appeal the denial to the Secretary. If you have questions about ISDEAA self-determination contracts, please contact the person listed under FOR FURTHER INFORMATION CONTACT .

3. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may also notify you informally.

If your application is not evaluated or not selected for funding, we notify you.

4. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

5. Open Licensing Requirement: Unless an exception applies, if you are awarded a grant under this competition, you will be required to openly license to the public grant deliverables created in whole, or in part, with Department grant funds. When the deliverable consists of modifications to pre-existing works, the license extends only to those modifications that can be separately identified and only to the extent that open licensing is permitted under the terms of any licenses or other legal restrictions on the use of pre-existing works. Additionally, a grantee or subgrantee that is awarded competitive grant funds must have a plan to disseminate these public grant deliverables. The dissemination plan can be developed and submitted after your application has been reviewed and selected for funding. For additional information on the open licensing requirements please refer to 2 CFR 3474.20.

6. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. See the standards in 2 CFR 170.105 to determine whether you are covered by 2 CFR part 170.

(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

7. Performance Measures: The Department has established the following performance measures for purposes of Department reporting under 34 CFR 75.110, which it will use to evaluate the overall performance of the grantee's project, as well as NACTEP as a whole:

(a) At the secondary level: An increase in—

(1) The percentage of CTE concentrators who graduate high school, as measured by—

(A) The four-year adjusted cohort graduation rate (defined in section 8101 of ESEA); and

(B) At the grantee's discretion, the extended-year adjusted cohort graduation rate (defined in section 8101 of ESEA);

(2) The percentage of CTE concentrators graduating from high school having attained postsecondary credits in the relevant CTE program earned through a dual or concurrent enrollment program or another credit transfer agreement;

(3) The percentage of CTE concentrators graduating from high school having participated in work-based learning;

(4) The percentage of CTE concentrators graduating from high school having attained a recognized postsecondary credential; and

(5) The percentage of CTE concentrators who, after exiting from secondary education, are in postsecondary education or advanced training, military service, or a service program, or are employed.

(b) At the postsecondary level: An increase in—

(1) The percentage of CTE concentrators who remain enrolled in postsecondary education, are in advanced training, military service, or a service program, or are employed; and

(2) The percentage of CTE concentrators who receive a recognized postsecondary credential.

Project-Specific Performance Measures:

In addition to the performance measures noted above, applicants may propose project-specific performance measures and performance targets consistent with the objectives of the proposed project. Examples of such project-specific performance measures could include student recruitment, student participation in work-based learning at the postsecondary level, and teacher and faculty participation in professional development.

Note: All grantees will be expected to submit a semi-annual and an annual performance report addressing these performance measures, to the extent that these performance measures apply to each grantee's NACTEP project.

6. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, whether the grantee has made substantial progress in achieving the performance targets in the grantee's approved application.

In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document and a copy of the application package in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3, braille, large print, audiotape, compact disc, or other accessible format.

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

You may also access Department documents 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.

The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Evaluation of Teacher Residencies: District Perspective.

OMB Control Number: 1850-NEW.

Type of Review: New ICR.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 31.

Total Estimated Number of Annual Burden Hours: 93.

Abstract: The U.S. Department of Education (ED)'s Institute of Education Sciences (IES) requests clearance for data collection activities to evaluate teacher residency programs' contributions to the teacher workforce. Specifically, this request covers the collection of data to understand the extent to which teacher residency programs funded by ED's Teacher Quality Partnership (TQP) grants help diversify the teacher pipeline and fill hard-to-staff teaching positions in their partner districts. The Higher Education Act established the TQP program to support partnerships between teacher preparation programs and high-need districts to implement teacher residency programs. The study will collect data on newly hired teachers from the school districts and charter school networks (referred to throughout as “districts”) that partner with TQP grantees. If some districts are unable to provide data on new hires from TQP-funded residency programs, we will collect those data from TQP grantees.

Title: FERC-725, Certification of Electric Reliability Organization; Procedures for Electric Reliability Standards.

OMB Control No.: 1902-0225.

Type of Request: Three-year extension of the FERC-725 information collection requirements with no changes to the current reporting and recordkeeping requirements.

Abstract: The FERC-725 contains the following information collection elements:

Self-Assessment and ERO (Electric Reliability Organization) Application: The Commission requires the ERO to submit to FERC a performance assessment report every five years. The next assessment is due in 2025. Each Regional Entity submits a performance assessment report to the ERO.

Submitting an application to become the ERO is also part of this collection. 1

Reliability Assessments: 18 CFR 39.11 requires the ERO to assess the reliability and adequacy of the Bulk-Power System in North America. Subsequently, the ERO must report to the Commission on its findings. Regional entities perform similar assessments within individual regions. Currently the ERO submits to FERC three assessments each year: long term, winter, and summer. In addition, the North American Electric Reliability Corporation (NERC, the Commission-approved ERO) also submits various other assessments as needed.

Reliability Standards Development: Under section 215 of the Federal Power Act (FPA), 2 the ERO is charged with developing Reliability Standards. Regional Entities may also develop regional specific standards and have standard experts on staff to work with entities below the regional level.

Reliability Compliance: Reliability Standards are mandatory and enforceable upon approval by the Commission. In addition to the specific information collection requirements contained in each standard (cleared under other information collections), there are general compliance, monitoring and enforcement information collection requirements imposed on applicable entities. Audits, spot checks, self-certifications, exception data submittals, violation reporting, and mitigation plan confirmation are included in this area.

Stakeholder Survey: The ERO uses a stakeholder survey to solicit feedback from registered entities  3 in preparation for its five-year self-performance assessment. The Commission assumes that the ERO will perform another survey prior to the 2025 self-assessment.

Other Reporting: This category refers to all other reporting requirements imposed on the ERO or regional entities in order to comply with the Commission's regulations. For example, FERC may require NERC to submit a special reliability assessment or inquiry. This category captures these types of one-time filings required of NERC or the Regions.

The Commission implements its responsibilities through 18 CFR part 39.

Type of Respondent : Electric Reliability Organization, Regional entities, and registered entities.

Estimate of Annual Burden:   4 The Commission estimates the total annual burden and cost  5 for this information collection in the table below. For hourly cost (for wages and benefits), we estimate that 70% of the time is spent by Electrical Engineers (code 17-2071, at $79.31/hr.), 10% of the time is spent by Legal (code 23-0000, at $162.66/hr.), and 20% by Information and Record Clerk (code 43-4199, at $44.74/hr.). Therefore, we use the weighted hourly cost (for wages and benefits) of $80.73(rounded) {or [(0.70) * ($79.13/hr.)] + [(0.10) * $162.66/hr.] + [(0.20) * $44.74/hr.]}.

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

This action is directed to the public in general and may be of particular interest to those involved in the manufacture, processing, distribution, use, and disposal of the chemical being evaluated, 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 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 all chemical substance 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.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

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.

EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.

EPA Registration Number: 88847-7. Docket ID number: EPA-HQ-OPP-2024-0576. Applicant: Vestaron Corporation, 4025 Stirrup Creek Drive, Suite 400, Durham, NC 27703 USA. Active ingredient: U1-AGTX-Ta1b-qa. Product type: Insecticide. Proposed use: Outdoor Terrestrial Use. Contact: BPPD.

Authority: 7 U.S.C. 136 et seq.

On January 2, 2025, the Commission issued a policy statement to provide guidance to shippers and other third parties on bringing class action complaints at the Commission. As the policy statement explains, class action complaints are not precluded by Title 46 or the Commission's interpretation of the statute. In accordance with 46 CFR 502.12, the Commission may follow the Federal Rules of Civil Procedure “for situations which are not covered by a specific Commission rule . . . to the extent that they are consistent with sound administrative practice.” The Commission may use the procedures of Rule 23 of the Federal Rules of Civil Procedure to evaluate class action complaints filed with the Commission because the requirements under § 502.12 are satisfied.

The policy statement can be found at the following link: https://www2.fmc.gov/readingroom/proceeding/24-29/.

This document is issued under authority of 5 U.S.C. 552, 46 U.S.C. 46105 and 46 CFR 502.12.

The FTC's Office of Management and Budget (“OMB”) clearance (OMB Control No.: 3084-0137) for the collection of information under the Red Flags, Card Issuers, and Address Discrepancy Rules (“Rules”), 1 which implement sections 114 and 315 of the Fair and Accurate Credit Transactions Act of 2003 (“FACT Act”), as amended by the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”)  2 and the Red Flags Program Clarification Act of 2010 (“Clarification Act”), 3 is set to expire on January 31, 2025. Accordingly, on August 22, 2024, the Commission published a Federal Register Notice seeking public comment on the proposal to renew this OMB clearance for an additional three-year period. See 89 FR 67938 (Aug. 22, 2024). In response to the Federal Register Notice, the Commission received two germane comments.

The two comments were generally supportive of the information collection, although the two commenters indicated that they believe that the federal government's efforts in the context of personal data protections should be expanded. 4 The Commission thanks the commenters for their submissions, and notes that the Commission has also supported greater personal data protections for American consumers by, among other things, encouraging Congress to enact comprehensive federal privacy legislation. 5 However, such initiatives would be beyond the scope of this PRA renewal request. Accordingly, for the foregoing reasons, the Commission declines to make any adjustments to its prior burden estimates or to modify its initial proposal.

Title of Collection: Red Flags Rule, 16 CFR 681.1; Card Issuers Rule, 16 CFR 681.2; Address Discrepancy Rule, 16 CFR part 641.

OMB Control Number: 3084-0137.

Type of Review: Extension of currently approved collection.

Abstract: The Red Flags Rule requires financial institutions and certain creditors to develop and implement written Identity Theft Prevention Programs. The Card Issuers Rule requires credit and debit card issuers to assess the validity of notifications of address changes under certain circumstances. The Address Discrepancy Rule provides guidance on what covered users of consumer reports must do when they receive a notice of address discrepancy from a nationwide consumer reporting agency. Collectively, these three anti-identity theft provisions are intended to prevent impostors from misusing another person's personal information for a fraudulent purpose. The Rules implement sections 114 and 315 of the FACT Act.

Red Flags Rule: Utilities; motor vehicle dealerships; telecommunications firms; colleges and universities; hospitals; nursing homes; public warehouse and storage firms; fuel dealers; financial transaction processing firms; certain creditors;  6 and other categories of persons that qualify as financial institutions.

Card Issuers Rule: State-chartered credit unions; general merchandise stores; colleges and universities; telecommunications firms; and certain creditors. 7

Address Discrepancy Rule: Users of consumer reports that are motor vehicle dealers described in section 1029(a) of the Dodd-Frank Act, 12 U.S.C. 5519, and that are predominantly engaged in the sale and servicing of motor vehicles, the leasing and servicing of them, or both.

Estimated Number of Respondents: 238,942 (165,494 for Red Flags Rule + 18,500 for Card Issuers Rule + 54,948 for Address Discrepancy Rule).

Estimated Annual Burden Hours: 398,479 hours (358,124 hours for Red Flags Rule + 18,608 hours for Card Issuers Rule + 21,747 hours for Address Discrepancy Rule).

Estimated Annual Labor Costs: $22,350,652 ($21,850,471 for Red Flags and Card Issuers Rule + $500,181 for Address Discrepancy Rule).

Estimated Annual Non-Labor Costs: $0.

On August 22, 2024, the FTC sought public comment on the information collection requirements associated with the Rules. 89 FR 67938 (Aug. 22, 2024). Two germane comments were received during the first public comment period and are addressed above. Pursuant to OMB regulations, 5 CFR part 1320, that implement the PRA, 44 U.S.C. 3501 et seq., the FTC is providing this second opportunity for public comment while seeking OMB approval to renew the pre-existing clearance for the Rules. For more details about the Rules' requirements and the basis for the calculations summarized above, see 89 FR 67938.

Your comment—including your name and your state—will be placed on the public record of this proceeding. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone's Social Security number; date of birth; driver's license number or other state identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for ensuring that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential”—as provided in section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including, in particular, competitively sensitive information, such as costs, sales statistics, inventories, formulas, patterns devices, manufacturing processes, or customer names.

FDA is announcing the availability of a final guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (2024 503B Interim Policy Guidance). This guidance finalizes the draft guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act” issued on December 7, 2023 (88 FR 85293), and replaces the guidance of the same title issued in January 2017 (2017 503B Interim Policy Guidance).

Section 503B of the FD&C Act (21 U.S.C. 353b) sets forth the conditions that must be satisfied for human drug products compounded by an outsourcing facility to be exempt from the following three sections of the FD&C Act: (1) section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements). One of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for these exemptions is that the outsourcing facility does not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of the Department of Health and Human Services identifying bulk drug substances for which there is a clinical need (the 503B bulks list) (see section 503B(a)(2)(A)(i)) or (2) the drug product compounded from such bulk drug substances appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing (see section 503B(a)(2)(A)(ii) of the FD&C Act).

FDA is developing the 503B bulks list, and this guidance describes FDA's interim policy regarding outsourcing facilities that compound human drug products using bulk drug substances while the list is being developed. This guidance revises the policy described in FDA's 2017 503B Interim Policy Guidance with respect to categorization of certain substances nominated for inclusion on the 503B bulks list. This guidance ends the categorization of bulk drug substances into Categories 1, 2, or 3 for those bulk drug substances nominated on or after the date of publication of this guidance.

The 2024 503B Interim Policy Guidance describes the conditions under which FDA does not intend to take action against an outsourcing facility for compounding a drug product using certain bulk drug substances that are not eligible for use in compounding under section 503B of the FD&C Act because they do not appear on the 503B bulks list and are not used to compound a drug product that appears on FDA's drug shortage list at the time of compounding, distribution, and dispensing. One of these conditions is that the bulk drug substance appears in Category 1. As described in this guidance, FDA does not intend to categorize bulk drug substances nominated for inclusion on the 503B bulks list on or after the publication date of this guidance. However, FDA intends to consider such substances for inclusion on the 503B bulks list in accordance with the process and clinical need standard established in the FD&C Act (see section 503B(a)(2)(A)(i) of the FD&C Act). FDA is evaluating bulk drug substances nominated for the 503B bulks list on a rolling basis. Substances that appear in Category 1 (including substances nominated with adequate supporting information prior to the date of publication of this guidance) may continue to be within the scope of the policy for Category 1 substances, as described in the guidance, until FDA makes a final determination whether these substances will be placed on the 503B bulks list in accordance with section 503B(a)(2)(A)(i) of the FD&C Act or unless the Agency removes the substances from Category 1 based on, for example, information about safety risks.

Prior to preparing this guidance, FDA considered comments received on the draft guidance. Editorial changes were made to improve clarity, such as updating references to the publication date of this final guidance.

This 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 the “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” 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.

This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Persons with access to the internet may obtain the guidance at either 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.

FDA is announcing the availability of a draft guidance for industry entitled “Study of Sex Differences in the Clinical Evaluation of Medical Products.” Analyzing sex-related differences in medical product response is an important component of assessing product safety and effectiveness, to help understand safety and effectiveness across the intended patient population, and can inform what goes into product labeling to improve patient care. Differences in physiology between females and males can lead to differences in disease manifestation, pharmacokinetics, pharmacodynamics, and response to treatment, among other things. Topics addressed in this guidance include: (1) practices to improve the recruitment, enrollment, and retention of females in clinical trials, to help ensure the generalizability of research results to intended patient populations; (2) statistical considerations for analyzing sex differences; and (3) reporting results based on analyses of sex differences.

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 “Study of Sex Differences in the Clinical Evaluation of Medical Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078.

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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

We are announcing the availability of a guidance for industry entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. 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.

FALCPA (Pub. L. 108-282) was enacted in August 2004 and, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by defining the term “major food allergen” and requiring that the presence of any major food allergen be declared on the labels of FDA-regulated foods. FALCPA defined a major food allergen as milk, egg, fish ( e.g., bass, flounder, or cod), Crustacean shellfish ( e.g., crab, lobster, or shrimp), tree nuts ( e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans and as a food ingredient that contains protein derived from these foods (section 201(qq) of the FD&C Act (21 U.S.C. 321(qq))). In addition, the FASTER Act (Pub. L. 117-11) was enacted in April 2021 and, in part, amended the definition of major food allergen in the FD&C Act to include sesame.

Since the passage of FALCPA, FDA has received numerous questions about food allergen labeling requirements. To explain FALCPA's requirements as well as FDA's current thinking on issues relating to the regulation of food allergens, on October 5, 2005, FDA issued the first edition of a guidance entitled “Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004.” We subsequently updated the guidance in December 2005 (Edition 2), April 2006 (Edition 3), and October 2006 (Edition 4).

In the Federal Register of November 30, 2022 (87 FR 73561), FDA issued a draft guidance for industry entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5).” The draft guidance was a revision of Edition 4 originally entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004” that contained revised and new questions and answers relating to food allergens, including questions and answers about FALCPA and the FASTER Act. We gave interested parties an opportunity to submit comments for us to consider before beginning work on the final version of the guidance. We received numerous comments on the draft guidance and have made modifications in this final guidance where appropriate. On November 30, 2022, FDA also issued a final guidance, “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5),” that contained the questions and answers from Edition 4 that remained unchanged, with the exception of editorial changes such as renumbering and organizational changes, and therefore were reissued as final guidance. The revised final guidance announced in this notice consolidates both the draft and final guidance that issued on November 30, 2022.

The revised final guidance contains questions and answers about food allergen labeling requirements, including the labeling of sesame, milk, eggs, incidental additives, highly refined oils, dietary supplement products, and certain specific packing and labeling situations ( e.g., individual units within a multiunit package). We have made some changes from the draft guidance. For example, we have expanded our historical interpretation of the terms “milk” and “eggs;” for purposes of the definition of a “major food allergen” under section 201(qq) of the FD&C Act and for purposes of complying with the food allergen labeling requirements of the FD&C Act. FDA has historically interpreted “milk” as milk from the domesticated cow and “eggs” as eggs from the domesticated chicken. However, the final guidance sets forth that for purposes of the definition of a “major food allergen” under section 201(qq) of the FD&C Act, FDA considers “milk” as milk from domesticated cows, goats, sheep, or other ruminants and FDA considers “eggs” as eggs from domesticated chickens, ducks, geese, quail, and other fowl. In addition, the final guidance revises the list of tree nuts that FDA considers as major food allergens.

We also have revised several questions and answers to update and clarify information presented in previous editions, including questions related to the labeling of fish and Crustacean shellfish.

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in section 403(w) of the FD&C Act (21 U.S.C. 343(w)) have been approved under OMB control number 0910-0792.

Persons with access to the internet may obtain the guidance document at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/FoodGuidances, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

I. Background

We are announcing the availability of a guidance for industry entitled “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. 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.

In the Federal Register of January 25, 2023 (88 FR 4749), we made available a draft guidance for industry entitled “Action Levels for Lead in Food Intended for Babies and Young Children” and gave interested parties an opportunity to submit comments by March 27, 2023, for us to consider before beginning work on the final version of the guidance. In the Federal Register of April 6, 2023 (88 FR 20525), we announced that we were reopening the comment period until May 8, 2023, to allow interested parties additional time to submit comments. We received several comments on the draft guidance and have modified the final guidance where appropriate. Changes to the guidance include clarifications to the foods that the guidance addresses, including the age range of the foods' intended consumers. We added information about the method that FDA uses to test for lead in food and made several editorial changes to improve clarity of the guidance. We also collected and analyzed additional samples from our Toxic Elements Program and special FDA surveys to inform our exposure and achievability assessments. The guidance announced in this notice finalizes the draft guidance dated January 2023.

In accordance with § 109.6 (21 CFR 109.6), this guidance establishes the following action levels for lead in processed food intended for babies and young children less than 2 years old: 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats; 20 ppb for single-ingredient root vegetables; and 20 ppb for dry infant cereals. Consistent with § 109.6(d), these action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)). We intend to consider these action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.

This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

FDA is announcing the availability of a final guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (2024 503A Interim Policy Guidance). This guidance finalizes the draft guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act” issued on December 7, 2023 (88 FR 85296), and replaces the guidance of the same title issued in January 2017 (2017 503A Interim Policy Guidance).

Section 503A of the FD&C Act (21 U.S.C. 353a) sets forth the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act: (1) section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice requirements). One of the conditions that must be met for a compounded drug product to qualify for these exemptions is that a licensed pharmacist or licensed physician compounds the drug product using bulk drug substances that (1) comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapters on pharmacy compounding; (2) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary of the Department of Health and Human Services (Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary under subsection (c) of section 503A of the FD&C Act (the 503A bulks list). (See section 503A(b)(1)(A)(i) of the FD&C Act.)

FDA is developing the 503A bulks list, and this guidance describes FDA's interim policy for licensed pharmacists in State-licensed pharmacies and Federal facilities and for licensed physicians who compound human drug products using bulk drug substances while the list is being developed. This guidance revises the policy described in FDA's 2017 503A Interim Policy Guidance with respect to categorization of certain substances nominated for inclusion on the 503A bulks list. This guidance ends the categorization of bulk drug substances into Categories 1, 2, or 3 for those bulk drug substances nominated on or after the date of publication of this guidance.

The 2024 503A Interim Policy Guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or physician for compounding drug products using certain bulk drug substances that are not eligible for use in compounding under section 503A of the FD&C Act because they are not the subject of an applicable USP or NF monograph, components of FDA-approved drug products, or on the 503A bulks list at § 216.23(a) (21 CFR 216.23(a)). One of these conditions is that the bulk drug substance appears in Category 1. As described in the guidance, FDA does not intend to categorize bulk drug substances nominated for inclusion on the 503A bulks list on or after the publication date of this guidance. However, FDA intends to consider such substances for inclusion on the 503A bulks list in accordance with the process and criteria established in the FD&C Act and FDA regulations (see section 503A(b)(1)(A) of the FD&C Act and § 216.23(c)). FDA is evaluating bulk drug substances nominated for the 503A bulks list on a rolling basis. Substances that appear in Category 1 (including substances nominated with adequate supporting information prior to the date of publication of this guidance) may continue to be within the scope of the policy that applies to Category 1 substances, as described in this guidance, until FDA promulgates a final rule determining whether they will be placed on the 503A bulks list in accordance with section 503A(b)(1)(A)(i)(III) of the FD&C Act or unless the Agency removes the substances from Category 1 based on, for example, information about safety risks.

Prior to preparing this guidance, FDA considered comments received on the draft guidance. Editorial changes were made to improve clarity, such as updating references to the publication date of this guidance.

This 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 “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” 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.

This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Persons with access to the internet may obtain the 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.