In accordance with the Federal Advisory Committee Act, 5 U.S.C. App. 10 and 7 U.S.C. 6518(e), as amended, AMS is announcing a meeting of the NOSB. The NOSB makes recommendations to USDA about whether substances should be allowed or prohibited in organic production and/or handling, assists in the development of standards for organic production, and advises the Secretary on other aspects of the implementation of the Organic Foods Production Act, 7 U.S.C. 6501 et seq. NOSB is holding a public meeting to discuss and vote on proposed recommendations to USDA, to obtain updates from the USDA National Organic Program (NOP) on issues pertaining to organic agriculture, and to receive comments from the organic community. The meeting is open to the public. Registration is only required to sign up for oral comments. All meeting documents and instructions for participating will be available on the AMS website at https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-providence-ri.

Please check the website periodically for updates. Meeting topics will encompass a wide range of issues, including substances petitioned for addition to, or removal from, the National List of Allowed and Prohibited Substances (National List), substances on the National List that are under sunset review, and guidance on organic policies.

Meeting Accommodations: The meeting hotel is compliant with the Americans with Disabilities Act, and the USDA provides reasonable accommodation to individuals with disabilities where appropriate. If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpretation, assistive listening devices, or other reasonable accommodation to the person listed under FOR FURTHER INFORMATION CONTACT . Determinations for reasonable accommodation will be made on a case-by-case basis.

Background

Under the regulations in “Subpart H—Plants for Planting” (7 CFR 319.37-1 through 319.37-23, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) prohibits or restricts the importation of plants for planting (including living plants, plant parts, seeds, and plant cuttings) to prevent the introduction of quarantine pests into the United States. Quarantine pest is defined in §  319.37-2 as a plant pest or noxious weed that is of potential economic importance to the United States and not yet present in the United States, or present but not widely distributed and being officially controlled. In accordance with §  319.37-20, APHIS may impose quarantines and other restrictions on the importation of specific types of plants for planting. These restrictions are listed in the USDA Plants for Planting Manual. 1

Section 319.37-10 restricts the importation of plants for planting in approved growing media, with exceptions. Paragraph (d) of § 319.37-10 states that certain types of plants for planting, as listed in the USDA Plants for Planting Manual, may be imported when they are established in a growing medium approved by the Administrator and produced in accordance with additional requirements specified in the manual.

On March 3, 2020, we published in the Federal Register (85 FR 12441-12442, Docket No. APHIS-2019-0015) a notice  2 proposing to authorize the importation of Phalaenopsis spp. orchid plants from the Republic of Costa Rica in approved growing media into the United States, including territories, subject to all relevant requirements included in the USDA Plants for Planting Manual and in a bilateral workplan agreed to between APHIS and the national plant protection organization (NPPO) of the Republic of Costa Rica.

We solicited comments concerning our proposal for 60 days ending May 4, 2020. We did not receive any comments.

Therefore, in accordance with the regulations in § 319.37-10(d), we are announcing our decision to authorize the importation into the United States, including territories, of Phalaenopsis spp. orchid plants for planting in approved growing media from the Republic of Costa Rica subject to the phytosanitary measures listed in the risk management document that accompanied the initial notice. We are adding these phytosanitary measures to the USDA Plants for Planting Manual.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the burden requirements included in this notice are covered under the Office of Management and Budget control number 0579-0049.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this notice, please contact Mr. Joseph Moxey, APHIS' Paperwork Reduction Act Specialist, at (301) 851-2483.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Authority: 7 U.S.C. 1633, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

Rechartering of Existing Committees: Pursuant to the Federal Advisory Committee Act (5 U.S.C. 10), FAS gives notice that the Secretary and Trade Representative intends to renew the APAC and the following six ATACs:

• Animals and Animal Products;

• Fruits and Vegetables;

• Grains, Feed, Oilseeds, and Planting Seeds;

• Processed Foods;

• Sweeteners and Sweetener Products; and,

• Tobacco, Cotton, Peanuts and Hemp (newly revised title).

In 1974, Congress established a private sector advisory committee system to ensure that U.S. trade policy and negotiation objectives adequately reflect U.S. commercial and economic interests. The private sector advisory committee system currently consists of three tiers:

• The President's Advisory Committee for Trade Policy and Negotiations;

• Five general policy advisory committees, including the APAC; and,

• Several technical advisory committees, including the ATACs.

In 1974, Congress established a private-sector advisory committee system to ensure that U.S. trade policy and negotiation objectives adequately reflect U.S. commercial and economic interests.

As provided for in the law and their charters, the APAC has the following responsibilities:

(A) The Committee will advise, consult with, and make recommendations to the Secretary and Trade Representative concerning the trade policy of the United States and the matters arising in the administration of such policy; (B) The Committee will provide information and advice regarding the following: negotiating objectives and bargaining positions of the United States before the United States enters into trade agreements, the operation of any trade agreement once entered into, and matters arising in connection with the administration of the trade policy of the United States; and (C) The Committee will furnish such other advisory opinions and reports as the Secretary and Trade Representative deem necessary; and the ATACs have similar responsibilities:

Each committee has a chairperson, who is elected from the membership of that committee. Committees meet as needed, and all committee meetings are typically held in Washington, DC, or by telephone conference. Committee meetings may be closed if USTR determines that a committee will be discussing issues that justify closing a meeting or portions of a meeting, in accordance with 19 U.S.C. 2155(f).

Throughout the year, members are requested to review sensitive trade policy information and provide comments regarding trade negotiations. In addition to their other advisory responsibilities, at the conclusion of negotiations of any trade agreement, all committees are required to provide a report on each agreement to the President, Congress, USTR, and USDA.

All committee members are appointed by and serve at the discretion of the Secretary and Trade Representative. Committee appointments are typically for a period of four years but may be renewed for an additional term. Each committee member must be a U.S. citizen and must represent a U.S. entity with an interest in agricultural trade and must not be registered with the Department of Justice under the Foreign Agents Registration Act. To attend most meetings, committee members must have a current security clearance. New members will be guided in how to apply for a security clearance and their appointment will be contingent on successful completion of the investigation. Committee members serve without compensation and are not reimbursed for their travel expenses. No person may serve on more than one USDA advisory committee at the same time unless a specific exception is granted by the USDA Committee Management Officer. No entity may have more than one representative on any single trade advisory committee.

Eligibility: Nominations for APAC and ATAC membership are open to individuals representing U.S. entities with an interest in agricultural trade without regard to race, color, religion, sex, national origin, age, mental or physical handicap, marital status, or sexual orientation. Equal opportunity practices in accordance with U.S. Government policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee take into account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and persons with disabilities. Members should have expertise and knowledge of agricultural trade as it relates to policy and commodity specific issues. Members will normally come from an entity with an interest in agriculture, and will serve as a Representative, presenting the views and interests of a particular U.S. entity that has an interest in the subject matter of the committee.

However, should a member be appointed primarily for his or her expertise, and not as a representative of an interest group, he or she shall be designated as a Special Government Employee (SGE). SGEs are subject to specific provisions of the ethics laws, including disclosure of financial interests, if they are appointed because of their personal knowledge, background, or expertise. USDA will assist SGEs in disclosing their financial interest and will provide ethics training on an annual basis.

Appointments are made of individuals only and are not transferrable. No person, company, producer, farm organization, trade association, or other entity has a right to membership on a committee. In making appointments, every effort will be made to maintain balanced representation on the committees with representation from producers, farm and commodity organizations, processors, traders, and consumers. Geographical diversity on each committee will also be sought.

Nominations: Nominating a person to serve on any of the committees requires submission of a current resume for the nominee and the USDA AD-755 (Advisory Committee Membership Background Information, OMB Number 0505-0001), available on the internet at: https://www.fas.usda.gov/trade-advisorycommittees-applying-membership. A cover letter should also be submitted indicating the specific committee for which the individual is being nominated, why the nominee wants to be a committee member, and his or her qualifications for membership, and how the submitter learned about this call for nominations. The cover letter should also include the statements required below related to Federally Registered Lobbyists and Foreign Firms. If applicable, the application should include a sponsor letter on the non-Federal governmental entity letterhead containing a brief description of the manner in which international trade affects the entity and why the applicant should be considered for membership. Forms may also be requested by sending an email to ATACs@usda.gov, or by phone at (202) 868-7059.

Federally Registered Lobbyists: All nominees must provide a statement confirming their lobbyist status.

Pursuant to the Revised Guidance on the Appointment of Lobbyists to Federal Advisory Committees, Boards and Commissions, published by the Office of Management and Budget (OMB) on August 13, 2014, federally-registered lobbyists are no longer prohibited from serving on the advisory committees in a representative capacity. OMB's revised guidance clarifies that the eligibility restriction does not apply to advisory committee members who are specifically appointed to represent the interests of a nongovernmental entity, a recognizable group of persons or nongovernmental entities (an industry sector, labor unions, environmental groups, etc.), or state or local governments. The lobbyist prohibition continues to apply to persons serving on advisory committees in their individual capacity ( e.g., SGEs).

Foreign Firms: If the nominee is to represent an entity or corporation with ten percent or greater non-U.S. ownership, the nominee must state the extent to which the organization or interest to be represented by the nominee is owned by non-U.S. citizens, organizations, or interests and demonstrate at the time of nomination that this ownership interest does not constitute control and will not adversely affect his or her ability to serve as an advisor on the U.S. agriculture advisory committee for trade.

Background

After Commerce initiated these sunset reviews  1 of the Orders, 2 pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act), domestic interested parties  3 timely submitted complete notices of intent to participate in, 4 and adequate substantive responses regarding, the reviews. 5 The domestic interested parties claimed domestic interested party status under section 771(9)(C) of the Act as producers of the domestic like product in the United States. 6 Commerce did not receive a substantive response from any respondent interested party, nor was a hearing requested. On March 23, 2023, Commerce notified the International Trade Commission that it did not receive adequate substantive responses from respondent interested parties. 7 As a result, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce conducted expedited (120-day) sunset reviews of the Orders.

The merchandise covered by the Orders is fine denier PSF, not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. For a complete description of the scope of the Order, see the Issues and Decision Memorandum. 9

A complete discussion of all issues raised in these sunset reviews, including the likelihood of continuation or recurrence of dumping and the magnitude of the dumping margins likely to prevail if the Orders were revoked, is provided in the Issues and Decision Memorandum. A list of the sections in the Issues and Decision Memorandum is in the 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 https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

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 continuation or recurrence of dumping, and that the magnitude of the dumping margins likely to prevail are weighted-average margins up to 103.06 percent for China, 21.43 percent for India, 45.23 percent for South Korea, and 48.86 percent for Taiwan.

This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a). 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 of sunset reviews 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 19 CFR 351.221(c)(5)(ii).

Background

On March 16, 2018, Commerce published in the Federal Register the CVD order on fine denier PSF from India. 1 On February 1, 2023, Commerce initiated the first sunset review of the Order, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 2 On February 15, 2023, Commerce received a timely notice of intent to participate from Auriga Polymers Inc., Fiber Industries LLC, Nan Ya Plastics Corporation, America, and Sun Fiber LLC (collectively, the domestic interested parties) within the 15-day deadline specified in 19 CFR 351.218(d)(1)(i). 3 The domestic interested parties claimed interested party status under section 771(9)(C) of the Act and 19 CFR 351.102(b)(29)(v) as producers of the domestic like product.

On March 3, 2023, Commerce received an adequate substantive response to the Initiation Notice from the domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). 4 We received no substantive responses from any other interested parties, including the Government of India, and no interested party requested a hearing. On March 23, 2023, Commerce notified the U.S. International Trade Commission that it did not receive an adequate substantive response from respondent interested parties, and that Commerce would conduct an expedited (120-day) sunset review of the Order, 5 pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(B)-(C).

The product covered by the Order is fine denier PSF. For a complete description of the scope of the Order, see the Issues and Decision Memorandum. 6

All issues raised in this sunset review are addressed in the accompanying Issues and Decision Memorandum. A list of the issues discussed in the Issues and Decision Memorandum is attached as the 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 https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNotices/ListLayout.aspx.

Pursuant to sections 751(c)(1) and 752(b) of the Act, Commerce determines that revocation of the Order would likely lead to continuation or recurrence of countervailable subsidies at the following net countervailable subsidy rates:

This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a). Timely written notification of the 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.

Commerce is issuing and publishing these final results and notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act and 19 CFR 351.218.

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data Workshop, (2) a series of assessment webinars, and (3) A Review Workshop. The product of the Data Workshop is a report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The assessment webinars produce a report that describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The product of the Review Workshop is an Assessment Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGOs; International experts; and staff of Councils, Commissions, and state and federal agencies.

The items of discussion during the webinar are as follows:

Panelists will review the data sets being considered for the assessment.

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

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES ) at least 5 business days prior to each workshop.

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

The Maine Department of Marine Resources submitted a complete application for an Exempted Fishing Permit (EFP) to conduct commercial fishing activities that the regulations would otherwise restrict to test alternative gear retrieval systems that only uses one traditional surface buoy. This EFP would exempt the participating vessels from the gear marking requirements at 50 CFR 697.21(b)(2) to allow the use of trawls of more than three traps with one surface marking and § 648.84(b) to allow the use of gillnet gear with one surface marking. The EFP would be valid from June 1, 2023, or the date it is issued, whichever is later, through September 30, 2024.

This EFP would allow 15 federally permitted vessels to test alternative gears to reduce entanglement risk to protected species, mainly the North Atlantic right whale, in trap/pot and sink gillnet fisheries. Participating vessels would replace one traditional surface marking with either a spring-tag or a timed-release retrieval system. A spring-tag retrieval system uses a low breaking strength (<1700 lb (771.11 kg)) buoy line that releases a stowed retrieval line of greater breaking strength when subjected to tension (>75 lb (34.02 kg)). A timed-release retrieval system releases a stowed line after a programmed pre-set soak time. Vessels would be required to use one traditional surface-marking on the other end of trap trawls of more than three traps and on the other end of all gillnet gear.

Each vessel would modify two existing pieces of gear total, one using a spring-tag on one end and a traditional endline on the other and one using a timed-release on one end and a traditional endline on the other, resulting in no additional vertical lines in the water. Other than gear markings, all trap trawls and gillnet strings would be consistent with the regulations of the management area where the vessel is fishing and would be fished in accordance with the participating vessels' standard operations (number and length of trips, soak times, trap limits, etc.). The researchers anticipate 52 hauls of 26 modified trap trawls (1,352 total hauls) in Lobster Management Areas 1 and 3 and Maine state waters. Trap trawls would be consistent with Atlantic Large Whale Take Reduction Plan (ALWTRP) regulations. Trawls would not exceed 50 traps per trawl and would soak for approximately 3 days (and not more than 30 days). The researchers anticipate 52 hauls of 4 modified gillnet strings (208 total hauls) in Statistical Areas 513, 514, 515, and Maine state waters. Gillnets would be consistent with ALWTRP and Harbor Porpoise Take Reduction Plan regulations. Gillnets would use 15-30.5 cm (5.9-12 in) mesh, would not exceed 3,200 m (10,498.7 ft), and would soak for a period of approximately 24 hours (and not more than 30 days).

The Department and the gear manufacturer will distribute gear and train all participants on its use. Scientific observers may accompany the participants on up to two trips per vessel, within budget and safety limitations. The Department would provide standardized data collection sheets to all participants, but individually-identifiable data will only be made public with the express permission of the vessel owner.

This project would test novel and emerging technologies, including low-cost gear retrieval and sub-sea gear-marking systems, in fixed-gear fisheries to evaluate their impacts on fishing activity and entanglement risk to protected species, mainly the North Atlantic right whale. The project objectives are to: (1) Assess changes to fishing operations from the use of alternative retrieval systems under a variety of oceanographic conditions over a full year; (2) compare the time timed-release retrieval lines remain in the water column to that of traditional persistent buoy lines; (3) identify fishing areas that may be best suited for these alternative retrieval systems; (4) assess changes to fishing operations from the use of alternative gear-marking systems; and, (5) compare data on multiple sub-sea gear-location systems with other methods of ranging gear locations ( e.g. surface buoy or digital chart marker).

The Department has proposed the following best management and risk reduction practices:

• Experimental buoy lines will be marked with unique white and blue markings above the experimental timed and spring-tagline retrieval systems, in addition to and above the required regional markings;

• All vessels would provide mandatory, weekly gear loss reports;

• All vessels would report all right whale sightings to NMFS via ne.rw.survey@noaa.gov or NOAA (866-755-6622) or the U.S. Coast Guard (Channel 16);

• All vessels would adhere to a 10-knot speed limit when transiting dynamic management areas, transiting areas closed to vertical lines, and/or when whales are observed;

• All vessels would adhere to current approach regulations that create a 500-yard (457.2-meter or 1,500-foot) buffer zone in the presence of a surfacing right whale and would depart immediately at a safe and slow speed. Hauling any gear would immediately cease (by removal) to accommodate the regulation and be reinitiated only after it was reasonable to assume the whale left the area;

• Law enforcement would be able to inspect gear at any time because one traditional surface-marking will be present at all times. The PI would notify law enforcement agencies of project participants and activities in advance of the project start date, including:

○ Materials related to the redeployment of alternative retrieval gear systems, most relevant to the spring-tagline retrieval system, as the timed-release system can be redeployed without intervention;

○ Information necessary to continue relevant enforcement operations with participant gear.

If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate the completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.

All comments received are a part of the public record and will generally be posted for public viewing at https://www.noaa.gov/organization/information-technology/foia-reading-room without change. All personal identifying information ( e.g., name, address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “anonymous” as the signature if you wish to remain anonymous).

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

Pursuant to Objective 2.1 of the National Strategy for Ocean Mapping, Exploring, and Characterizing the United States Exclusive Economic Zone, this SOMP was drafted to encourage consistency in data acquisition, stewardship and data management for seafloor mapping. The draft SOMP is organized into the following seven chapters:

Data Management, Bathymetry, Seabed and Lakebed Backscatter, Water Column Sonar, Side Scan Sonar, Sub-bottom, and Magnetometer. Public comments to improve the draft SOMP are welcome on one, a few, or all sections. Questions that might be considered while reviewing the draft SOMP include:

• Are the SOMP chapters comprehensive and explanatory?

• Is the SOMP understandable?

• As a protocol, will it be helpful to your organization, sector, or interest group?

• How do you anticipate your organization or sector will participate in SOMP implementation?

• What specific improvements to the SOMP would be of value to your organization/sector?

• What is missing in the SOMP that would facilitate use if added?

• Are there authoritative sources for the SOMP chapters that are missing or should be considered?

Authority: 33 U.S.C. 883e.

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

The Council is developing the Habitat Blueprint to provide direction for its habitat program. The Habitat Blueprint will address program goals and objectives, document actions to address habitat requirements of the Magnuson-Stevens Act, and provide guidance on the role and use of the Council's Habitat Advisory Panel.

At the June 28 meeting, the Working Group will review the draft Blueprint and the Council's web-based habitat and ecosystem mapping tools. At the August 16 meeting the Working Group will review the draft Habitat Blueprint and develop recommendations for consideration by the Council's Habitat Committee.

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

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

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

Agenda Tuesday, June 27, 2023

The Council will begin this meeting with brief announcements, followed by reports on recent activities from the Council's Chair and Executive Director, the Greater Atlantic Regional Fisheries Office (GARFO) Regional Administrator, the Northeast Fisheries Science Center (NEFSC) Director, the NOAA Office of General Counsel, the Mid-Atlantic Fishery Management Council liaison, staff from the Atlantic States Marine Fisheries Commission (ASMFC), and representatives from the U.S. Coast Guard and NOAA's Office of Law Enforcement. Next, the Council will receive a presentation on the final report of the Council Coordination Committee's Subcommittee on Area-Based Management. The Skate Committee report will follow with two items: (1) a progress report on the development of 2024-2025 skate specifications and potential initiation of a framework adjustment to include measures to expand possession of smooth and barndoor skates; and (2) a presentation on and Council discussion of a final white paper containing potential approaches to support thorny skate rebuilding. Then, members of the public will have the opportunity to speak during an open comment period on issues that relate to Council business but are not included on the published agenda for this meeting. The Council asks the public to limit remarks to 3-5 minutes. These comments will be received both in person and through the webinar. A guide for how to publicly comment through the webinar is available on the Council website at https://s3.amazonaws.com/nefmc.org/NEFMC-meeting-remote-participation_generic.pdf.

After the lunch break, the Council will take up the Atlantic Herring Committee report and approve a problem statement for action to revisit the inshore midwater trawl exclusion zone contained in Herring Amendment 8. The Council also will consider a potential change in priorities to identify time/area closure options to reduce bycatch of river herring and shad in midwater trawl and small-mesh bottom trawl fisheries. Next on the agenda is a presentation on a NOAA Fisheries comment opportunity under an advance notice of proposed rulemaking (ANPR) for updating National Standard Guidelines 4, 8, and 9. The Council will receive input on the draft guidelines from its Scientific and Statistical Committee (SSC) and staff before formulating its own comments. The Council then will receive a brief overview of NOAA's Technical Guidance for National Standard 1 Reference Points and Status Determinations. The Council will discuss which process it prefers to use to develop comments on the technical guidance. The Council then will adjourn for the day.

The Council will begin the second day of its meeting with a presentation on the Greater Atlantic Regional Fisheries Office and Northeast Fisheries Science Center draft strategic plan. The Groundfish Committee report will come next. The Council will initiate Framework Adjustment 66, which may include: (1) 2024-26 specifications for redfish, northern windowpane flounder, and southern windowpane flounder, (2) 2024-25 specifications for white hake and U.S./Canada resources of Eastern Georges Bank cod, Eastern Georges Bank haddock, and Georges Bank yellowtail flounder, (3) a revised white hake rebuilding plan, and (4) Atlantic halibut management measures. The Council also will consider a potential change in priorities to revise Gulf of Maine haddock specifications for 2024 and 2025 in Framework 66. The Council will initiate a separate framework adjustment to revise acceptable biological catch (ABC) control rules for groundfish and receive Scientific and Statistical Committee feedback on control rule options. Finally, the Council will receive an update on its Atlantic Cod Management Transition Plan. Next up will be the Monkfish Research Set-Aside (RSA) Program Working Group, which will provide a progress report on a Council work priority to review and improve the Monkfish RSA program.

After the lunch break, the Council will receive an update on a joint New England and Mid-Atlantic Fishery Management Council action to reduce Atlantic sturgeon bycatch in large-mesh monkfish and dogfish gillnet fisheries. As part of this discussion, the Council will approve the range of alternatives for Monkfish Framework Adjustment 15, which will contain the proposed sturgeon measures. Next, the Council will receive a presentation from the National Fish and Wildlife Foundation (NFWF) on its competitive grant funding programs, including the Electronic Monitoring and Reporting Program and the New England Gear Innovation Fund, which is a new program that seeks to address issues related to right whale fishing gear entanglements. The Council will close out the day with a discussion on the East Coast Climate Change Scenario Planning initiative. The Council will: (1) review findings from the February 2023 East Coast Climate Change Scenario Planning Summit; (2) receive Northeast Region Coordinating Council (NRCC) feedback on the summit findings; and (3) discuss the findings and next steps.

The Council will begin the third day of its meeting by hearing from the Ecosystem-Based Fishery Management (EBFM) Committee. The Council will receive: (1) the final report on the prototype management strategy evaluation (pMSE) for EBFM and the Georges Bank example Fishery Ecosystem Plan (eFEP); and (2) suggestions from a subpanel of the SSC intended to help improve the results of the pMSE's model scenarios. The Council also will receive an update on planning for upcoming deep-dive public information workshops on EBFM. The Scallop Committee then will present three items related to the Atlantic Sea Scallop Research Set-Aside (RSA) Program for Council consideration: (1) approval of longer-term RSA survey awards; (2) adoption of survey guiding principles; and (3) approval of 2024-2025 RSA priorities. The Council also will initiate action for fishing year 2024 specifications, 2025 defaults, and other measures. Another important scallop-related item will be covered under the next agenda item, the Habitat Committee report.

After the lunch break, the first item under the Habitat Committee report will focus on the Northern Edge of Georges Bank. The discussion will include an update and proposed timeline for action to potentially authorize scallop fishery access to the habitat management area at the top of Closed Area II on Georges Bank. The habitat report also will include a work plan update on the Essential Fish Habitat Review, followed by a Bureau of Ocean Energy Management (BOEM) update on the Gulf of Maine offshore wind call area and other wind developments. The Risk Policy Working Group will report next with an update on its efforts to address the terms of reference for revising the Council's Risk Policy. The Council then will receive a series of reports related to Atlantic Highly Migratory Species, which will cover: (1) the NOAA Fisheries HMS Management Division's presentation on (a) the proposed rule for Amendment 15 to the 2006 Consolidated HMS Fishery Management Plan; (b) the advance notice of proposed rulemaking on electronic reporting; and (c) scoping for Amendment 16 shark issues; (2) the HMS Advisory Panel report on the May 2023 meeting; and (3) the Advisory Committee to the U.S. Section to the International Commission on the Conservation of Atlantic Tunas (ICCAT) report on its April meeting. Finally, the Council will close out the meeting with other business.

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

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies (see ADDRESSES ) at least 5 days prior to the meeting date.

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

Background

From the air we breathe to the food we eat, the ocean touches every aspect of our lives. 1 Coastlines are home to approximately 40 percent of the U.S. population, 2 and as it sustains and connects us, the ocean is woven into our cultures and communities. All people—regardless of race, background, income, ability, Tribal affiliation, or ZIP Code—should have equitable access to the benefits provided by the ocean, such as well-paying jobs, healthy and plentiful food, wetlands that protect from damaging storms, space for cultural and religious practices, multiple sources of energy, recreation, transportation, and trade. But even as many communities in the United States have thrived in recent decades, many other communities have been left behind. Communities do not share equitably in the benefits provided by the ocean or equitably bear the burden of the negative impacts of human activities associated with the ocean: climate change, sea level rise and coastal flooding, increased storm intensity, pollution, overfishing, loss of habitat biodiversity, and other threats.

Communities with environmental justice concerns face entrenched disparities that are often the legacy of racial discrimination and marginalization, redlining, exclusionary zoning, and other discriminatory decisions or patterns. Examples of such decisions and patterns include the inequitable placement of polluting infrastructure, such as ports and landfills, and inadequate responses to natural hazards, such as storms and typhoons. Communities with a significant proportion of people who are Black, Latino, Indigenous and Native American, Asian American, Native Hawaiian, or Pacific Islander may be disproportionately impacted by these issues, as well as communities with a significant proportion of people who experience persistent poverty or other forms of social inequality. Communities experiencing environmental injustices also include geographically dispersed and mobile populations, such as migrant fishers or those who have been displaced by environmental hazards or inequitable development practices. Environmental injustices may also be cumulative and convergent as people face multiple climate and social challenges over time.

The Federal Government is dedicated to building upon and strengthening its commitment to deliver environmental justice to all communities across America. Restoring and protecting a healthy environment wherever people live, play, work, learn, grow, and worship is of the utmost importance to the Biden-Harris Administration. All communities deserve a healthy and resilient ocean, and opportunities to pursue traditional and cultural practices and participate in a sustainable blue economy where good jobs, skills training, and economic benefits are shared.

The Ocean Policy Committee, a Congressionally mandated, Cabinet-level interagency committee charged with coordinating Federal ocean policy, 3 will develop an Ocean Justice Strategy in consultation with Federally recognized Tribes and input from Territorial, State, and local governments, Indigenous communities, the private sector, and the public. The Ocean Justice Strategy will aim to identify barriers and opportunities to fully integrate environmental justice principles into ocean-related activities of the Federal Government.

The Ocean Justice Strategy will: (1) assess how the Federal Government should define ocean justice; (2) describe barriers to and opportunities for ocean justice; (3) describe how ocean justice should apply to the scientific enterprise of knowledge building, including the appropriate consideration, inclusion, and application of Indigenous Knowledge;  4 (4) describe how ocean justice should apply to access to and management of the ocean, coasts, and Great Lakes; and (5) describe how ocean justice will be implemented by the Federal Government to build on and expand the work of Tribal, Territorial, State, and local governments, Indigenous communities, the private sector, and the public.

At the Federal level, the Ocean Justice Strategy will take into account all relevant Biden-Harris Administration actions and reports, including: Executive Order 13985 of January 20, 2021 (Advancing Racial Equity and Support for Underserved Communities Through the Federal Government), 5 Executive Order 14008 of January 27, 2021 (Tackling the Climate Crisis at Home and Abroad), 6 Executive Order 14091 of February 16, 2023 (Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government), 7 Executive Order 14096 of April 21, 2023 (Revitalizing Our Nation's Commitment to Environmental Justice for All), 8 the Ocean Climate Action Plan, 9 the National Nature Assessment, 10 Opportunities to Accelerate Nature-Based Solutions, 11 the America the Beautiful initiative, 12 and Guidance for Federal Departments and Agencies on Indigenous Knowledge. 13

You may provide information on as many topics below as you choose. Clearly indicate in your submission which questions you are addressing. The OPC is seeking input from the public on the following:

• Definitions. What is ocean justice? How do you define ocean justice in the context of your community and your work?

• Barriers to Ocean Justice. What are the barriers to realizing ocean justice? What key challenges do you face in achieving ocean justice? What ocean justice challenges do you see as central to Federal Government action?

• Opportunities for Ocean Justice. What elements, activities, and components should the Ocean Justice Strategy include? What injustices related to the ocean should the Federal Government better address? What successful regional or local efforts to remedy past harms or advance ocean justice should be applied nationwide? What examples do you have of instances when the Federal Government made a just decision related to the ocean, and how might that be scaled up or broadened? What does ocean justice in Federal actions and decision-making look like in practice?

• Research and Knowledge Gaps. What are the research and knowledge gaps that we need to address for the Federal Government to create and advance an effective Ocean Justice Strategy and take equitable and ambitious action?

• Tools and Practices. How can the Federal Government harness existing environmental justice tools and practices, such as the Climate and Economic Justice Screening Tool (CEJST), 14 EJ Screen, 15 and EnviroAtlas, 16 to answer questions about justice in ocean policy? What new tools and practices are necessary to advance ocean justice?

• Partnerships and Collaboration. What ocean justice solutions can or should be led by non-Federal entities? Where and how can the Federal Government partner with Tribal, Territorial, State, and local governments, as well as external stakeholders across regions and sectors, to effectively remedy past harms and advance ocean justice?

• Additional Considerations. What else would you like considered in the development of the Ocean Justice Strategy?

Please note that this Federal Register notice is designed to complement existing Federal activities in this space. The OPC will consider comments submitted in response to its previous request for information on the Ocean Climate Action Plan  17 to inform the development of the Ocean Justice Strategy.

The Department of Air Force (DAF) approved the three GBSD locations and their subsequent sequencing (June 2020). Based on this decision, the DAF will sequentially replace all land-based Minuteman III intercontinental ballistic missile in the United States with the Sentinel system, including the motors, interstages, propulsion system rocket engine, and missile guidance set. All missile alert facilities, launch facilities, communication systems, infrastructure, and technologies, including interconnecting utility corridors, will be modernized, replaced, or reused as necessary to support the Sentinel system.

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 March 31, 2023, through a Notice of Availability in the Federal Register (Volume 88, Number 62, Page 19302) with a waiting period that ended on May 1, 2023.

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)).

Title; Associated Form; And OMB Number: Application for Discharge of Member or Survivor of Member of Group Certified to Have Performed Active Duty with the Armed Forces of the United States; DD Form 2168; OMB Control Number 0704-0100.

Needs and Uses: This information collection requirement is necessary to implement section 401 of Public Law 95-202 (codified at 38 U.S.C. 106 Note), which directs the Secretary of Defense: (1) To determine if civilian employment or contractual service rendered to the Armed Forces of the United States by certain groups shall be considered Active Duty service, and (2) to award members of approved groups an appropriate certificate where the nature and duration of service so merits. This information is collected on DD Form 2168, “Application for Discharge of Member of Group Certified to have Performed Active Duty with the Armed Forces of the United States,” which provides the necessary data to assist each of the Military Departments in determining if an applicant was a member of a group which has performed active military service. Those individuals who have been recognized as members of an approved group shall be eligible for benefits administered by the Veterans' Administration.

Affected Public: Individuals or households.

Annual Burden Hours: 250.

Number of Respondents: 500.

Responses per Respondent: 1.

Total Annual Responses: 500.

Average Burden per Response: 30 minutes.

Frequency: On occasion.

Information provided by the applicant will include: The name of the group served with; dates and place of service; highest grade/rank/rating held during service; highest pay grade; military installation where ordered to report; specialty/job title(s). If the information requested on a DD Form 2168 is compatible with that of a corresponding approved group, and the applicant can provide supporting evidence, he or she will receive veteran's status in accordance with the provisions of DoD Directive 1000.20. Information from the DD form 2168 will be extracted and used to complete the DD Form 214, “Certificate for Release of Discharge from Active Duty.”

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Efficacy Evaluation of the Mathematics Intervention Toolkit for the Elementary Grades.

OMB Control Number: 1850-NEW.

Type of Review: A new ICR.

Respondents/Affected Public: Individuals and Households.

Total Estimated Number of Annual Responses: 9,630.

Total Estimated Number of Annual Burden Hours: 3,106.

Abstract: The U.S. Department of Education (ED) requests OMB clearance for data collection related to the Regional Educational Laboratory (REL) program. ED, in consultation with REL Northeast and the Islands (REL-NEI) under contract 91990022C0013 has planned a study of the efficacy of a professional development (PD) course for fourth and fifth grade math intervention teachers in the state of Massachusetts. Researchers at WestEd will carry out a school-level randomized controlled trial (RCT) to evaluate the efficacy of the PD course and investigate how and whether the PD course is helping teachers improve their practices and boost student learning. OMB approval is being requested for REL-NEI's data collection for this project, including pre and post measures of student skills and attitudes, and teacher knowledge, beliefs, and feedback regarding instructional practice and implementation of the PD course.

Elementary math achievement is a topic of national concern. Students who leave elementary school with a strong foundation in mathematics, particularly fractions, are better prepared to succeed in middle school mathematics and algebra. Algebra is a well-documented gatekeeper to advanced high school math coursework, which is consistently linked to increased post-secondary opportunities and earnings. On the 2019 NAEP report card, only 41% of grade 4 students scored Proficient or above in math, and these numbers are lower for students from marginalized backgrounds. These opportunity gaps persist at the secondary level, so need to be addressed as soon as they appear.

Given this need, district leaders in Massachusetts are seeking ways to bolster learning for students who struggle with mathematics. Some of these approaches adopted by districts target core instruction, but districts are also interested in strengthening their approaches to intervention. Together with the Massachusetts Partnership to Support Student Learning Through Math Intervention, REL-NEI is designing a toolkit PD course to build educators' knowledge of and ability to implement the recommendations of a new What Works Clearinghouse (WWC) Practice Guide, Assisting Students Struggling with Mathematics: Intervention in the Elementary Grades. By using the PD course's extensive resources, districts will be able to provide teachers with in-depth PD on the recommendations and how to implement them by using specific instructional practices. Teachers will learn to use these practices effectively, helping them to optimize intervention time to improve student learning. Their students will be actively engaged in doing math, communicating their ideas, and progressing toward clear learning goals with feedback and support.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Full-Service Community Schools Annual Performance Report.

OMB Control Number: 1810-NEW.

Type of Review: A new ICR.

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

Total Estimated Number of Annual Responses: 42.

Total Estimated Number of Annual Burden Hours: 378.

Abstract: The collection of this information is part of the government-wide effort to improve the performance and accountability of all federal programs, under the Government Performance and Results Act (GPRA) passed in 1993, the Uniform Guidance, and the Education Department General Administrative Regulations (EDGAR). Under GPRA, a process for using performance indicators to set program performance goals and to measure and report program results was established. To implement GPRA, the U.S. Department of Education (ED) developed GPRA measures at every program level to quantify and report program progress required by the Elementary and Secondary Education Act of 1965 (ESEA), as amended. Under the Uniform Guidance and EDGAR, recipients of federal awards are required to submit performance and financial expenditure information. The GPRA program-level measure (established under section 4625(4)(C) of the Elementary and Secondary Education Act of 1965, as amended), the 13 additional program indicators (established through a Notice of Final Priorities, Requirements, Definitions, and Selection Criteria (NFP) published in the Federal Register on July 13, 2022, 87 FR 41675)), and budget information for the Full-Service Community Schools (FSCS) Program are reported in the Annual Performance Report (APR). The APR is required under 2 CFR 200.328 and 34 CFR 75.118 and 75.590. It provides data on the status of funded projects that correspond to the scope and objectives established in the approved applications and any amendments. To ensure that accurate and reliable data are reported to Congress on program implementation and performance outcomes, the FSCS APR collects data from grantees in a consistent format to calculate these data in the aggregate.

Background Section 202(c) of the Federal Power Act

The U.S. Department of Energy is issuing this Notice pursuant to 10 CFR 1021.343(a) to document emergency actions taken in accordance with section 202(c) of the Federal Power Act (FPA) (16 U.S.C. 824a(c)). FPA section 202(c) provides that “[d]uring the continuance of any war in which the United States is engaged, or whenever the [Secretary of Energy] determines that an emergency exists by reason of a sudden increase in the demand for electric energy, or a shortage of electric energy or of facilities for the generation or transmission of electric energy, or of fuel or water for generating facilities, or other causes, the [Secretary of Energy] shall have authority, either upon [her] own motion or upon complaint, with or without notice, hearing ore report, to require by order such temporary connections of facilities and generation, delivery, interchange, or transmission of electric energy as in [her] judgment will best meet the emergency and serve the public interest.

On September 1, 2022, the California Independent System Operator Corporation (CAISO) submitted to the Department a Request for Emergency Order Under Section 202(c) of the Federal Power Act (Application) with the Department “to preserve the reliability of bulk electric power system in California.” In its Application, CAISO cited extreme heat and forecasted a supply deficiency to meet demand during peak demand hours. CAISO requested the authority to direct the operation of three natural gas-fired generating resources capable of providing 28 megawatts of additional generation supply (the Covered Resources). CAISO stated that the emergency order it was requesting could result in exceedances of National Ambient Air Quality Standards under the Clean Air Act. Given the permit limits of the Covered Resources, CAISO anticipated that the additional capacity could not be made available absent an order under FPA section 202(c).

On September 2, 2022, the Acting Under Secretary for Infrastructure, acting pursuant to delegated authority, issued Order No. 2022-22-1 (the CAISO Order). As set forth in the CAISO Order, the Acting Under Secretary for Infrastructure found that an emergency exists in California due to a shortage of electric energy, a shortage of facilities for the generation of electric energy, and other causes, and that the issuance of the CAISO Order would meet the emergency and serve the public interest.

The CAISO Order authorized the CAISO to dispatch the Covered Resources from September 2, 2022 to September 8, 2022, solely under the following conditions: (i) the issuance and continuation of an Energy Emergency Alert Level 2 (EEA2) condition or greater between the hours of 14:00 Pacific Daylight Time and 22:00 Pacific Daylight Time; and (ii) a transmission emergency that requires operation of a Covered Resource to prevent or mitigate load curtailment during any operating hour. Under the CAISO Order, the CAISO was required to exhaust all reasonably and practically available resources prior to dispatching the Covered Resources.

The CAISO Order requires that CAISO provide a report by October 10, 2022, to include all source-specific data for dates between September 2, 2022 and September 8, 2022, during which the Covered Resources operated. The report must include, “for each unit: (1) the hours of operation, as well as the hours in which any permit limit was exceeded, and (2) a preliminary description of each permit term that was exceeded and the manner in which such exceedance occurred.” The CAISO Order also requires the CAISO to “submit a final report by November 14, 2022, with any revisions to the information reported on December 12, 2022.” However, because no facilities operated above permitted levels during the emergency as authorized by the DOE order, no environmental impacts resulted from DOE issuing the order. Consequently, DOE has decided not to prepare a special environmental analysis.

On September 7, 2022, the CAISO submitted to the Department a Request for Modification of Emergency Order Pursuant to Section 202(c) of the Federal Power Act (Request for Modification) in which it requested that the CAISO Order be amended to add two units at Calpine's Greenleaf Unit 1 site in Yuba City, California (the Greenleaf Units) as additional Covered Resources and that the Greenleaf Units be permitted to operate through September 9, 2022, and otherwise in accordance with the terms of CAISO Order. In its Request for Modification, the CAISO reported that the water injection pump failed at the Greenleaf Units on September 6, 2022. Operation of the Greenleaf Units could cause exceedance of permitted emissions limits, and thus could result in suspension of their operation absent the issuance of an emergency order permitting operation of the Greenleaf Units during specified conditions.

On September 7, 2022, the Acting Under Secretary for Infrastructure issued Amendment Number 1 to Order No. 202-22-1 (Amendment Number 1), finding that the circumstances which led to her previous determination that California was experiencing a shortage of electric energy was continuing and that Amendment Number 1 would help meet the emergency conditions in the CAISO control area and serve the public interest. Amendment Number 1 added the Greenleaf Units as Covered Resources subject to all of the terms of the CAISO Order, except that the Greenleaf Units could be operated through September 9, 2022. All other terms of CAISO Order remained in effect and applied to all of the Covered Resources, including the Greenleaf Units. The CAISO Order as amended by Amendment Number 1 is referred to herein as the Amended CAISO Order.

On September 7, 2022, the CAISO submitted to the Department a Request for Extension of Emergency Order Pursuant to Section 202(c) of the Federal Power Act (Extension Application) to the Department. In its Extension Application, the CAISO requested an extension of the expiration date of the Amended CAISO Order through September 12, 2022. The CAISO stated that California was experiencing extreme heat, which the CAISO forecasted to continue through at least September 9, 2022, and the extended and excessive heat as well as wildfire risk could “exacerbate electric grid reliability issues at any time.” Consequently, the CAISO believed it prudent to ask that the expiration date of the Amended CAISO Order be extended through September 12, 2022.

On September 8, 2022, the Acting Under Secretary for Infrastructure issued Amendment Number 2 to Order No. 202-22-1 (Amendment Number 2), finding that an emergency continued to exist in California due to a shortage of electric energy and that issuance of the extension would help to meet the emergency conditions and serve the public interest. Amendment Number 2 extended the expiration date of the Amended CAISO Order through September 12, 2022. All other terms of the Amended CAISO Order remained in effect, including the obligation of the CAISO to exhaust all reasonably and practically available resources prior to dispatching the Covered Resource and the obligation to report information regarding the environmental impacts of the operation of the Covered Resources permitted by the CAISO Order. As required by FPA section 202(c), the Department consulted with the Environmental Protection Agency (EPA) in considering the CAISO's request for an extension of the Amended CAISO Order. The EPA did not request any additional conditions be included in the Amended CAISO Order. Because no facilities operated above permitted levels during the emergency as authorized by the DOE order, no environmental impacts resulted from DOE issuing the order. Consequently, DOE has decided not to prepare a special environmental analysis.

The CAISO Order, Amendment Number 1, Amendment Number 2, and other documents referenced herein can be found on the Department's website at Federal Power Act Section 202(c): CAISO September 2022 | Department of Energy. The reports required by the Amended CAISO Order will be posted to the Department's website when they become available.

This document of the Department of Energy was signed on May 15, 2023, by Puesh M. Kumar, Director for the Office of Cybersecurity, Energy Security, and Emergency Response, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Title: FERC-725B(5) (Mandatory Reliability Standards, Critical Infrastructure Protection (CIP-003-9))—Temporary Placeholder for FERC-725B that is pending approval at OMB

OMB Control No.: 1902-NEW.

Type of Request: New collection request for FERC-725B(5)—temporary placeholder for FERC-725B information collection requirements with changes to the reporting requirements.

Abstract: On August 8, 2005, Congress enacted the Energy Policy Act of 2005. 1 The Energy Policy Act of 2005 added a new section 215 to the Federal Power Act (FPA), 2 which requires a Commission-certified Electric Reliability Organization to develop mandatory and enforceable Reliability Standards, 3 including requirements for cybersecurity protection, which are subject to Commission review and approval. Once approved, the Reliability Standards may be enforced by the Electric Reliability Organization subject to Commission oversight, or the Commission can independently enforce Reliability Standards.

On February 3, 2006, the Commission issued Order No. 672, 4 implementing FPA section 215. The Commission subsequently certified the North American Electric Reliability Corporation (NERC) as the Electric Reliability Organization. The Reliability Standards developed by NERC become mandatory and enforceable after Commission approval and apply to users, owners, and operators of the Bulk-Power System, as set forth in each Reliability Standard. 5 The CIP Reliability Standards require entities to comply with specific requirements to safeguard bulk electric system (BES) Cyber Systems  6 and their associated BES Cyber Assets. These standards are results-based and do not specify a technology or method to achieve compliance, instead leaving it up to the entity to decide how best to comply.

The Commission has approved multiple versions of the CIP Reliability Standards submitted by NERC, partly to address the evolving nature of cyber-related threats to the Bulk-Power System. High impact systems include large control centers. Medium impact systems include smaller control centers, ultra-high voltage transmission, and large substations and generating facilities. The remainder of the BES Cyber Systems are categorized as low impact systems. Most requirements in the CIP Reliability Standards apply to high and medium impact systems; however, a technical controls requirement in Reliability standard CIP-003, described below, applies only to low impact systems.

The Commission is currently revising CIP-003 on this submission of Docket No. RD23-3-000 to update CIP-003-8 to CIP-003-9.

The FERC-725B information collection requirements are subject to review by the Office of Management and Budget (OMB) under section 3507(d) of the Paperwork Reduction Act of 1995. 7 OMB's regulations require approval of certain information collection requirements imposed by agency rules. 8 Upon approval of a collection of information, OMB will assign an OMB control number and expiration date. Respondents subject to the filing requirements will not be penalized for failing to respond to these collections of information unless the collections of information display a valid OMB control number. The Commission solicits comments on the Commission's need for this information, whether the information will have practical utility, the accuracy of the burden estimates, ways to enhance the quality, utility, and clarity of the information to be collected or retained, and any suggested methods for minimizing respondents' burden, including the use of automated information techniques.

Reliability Standard CIP-003-9 Security Management Controls: requires entities to specify consistent and sustainable security management controls that establish responsibility and accountability to protect BES Cyber Systems against compromise that could lead to mis-operation or instability on the Bulk-Power System. Specifically, the Reliability Standard CIP-003-9 is being revised to add requirements for entities to adopt mandatory security controls for vendor electronic remote access used at low impact BES Cyber Systems. It is part of the implementation of the Congressional mandate of the Energy Policy Act of 2005 to develop mandatory and enforceable Reliability Standards to better ensure the reliability of the nation's Bulk-Power System.

Type of Respondents: Business or other for profit, and not for profit institutions.

Estimate of Annual Burden:   9

The Commission bases its paperwork burden estimates on the changes in paperwork burden presented by the proposed revision to CIP Reliability Standard CIP-003-9 as compared to the current Commission-approved Reliability Standard CIP-003-8. As discussed above, the immediate order addresses the area of modification to the CIP Reliability Standards: adopting mandatory security controls for vendor electronic remote access used at low impact BES Cyber Systems.

The CIP Reliability Standards, viewed as a whole, implement a defense-in-depth approach to protecting the security of BES Cyber Systems at all impact levels. 10 The CIP Reliability Standards are objective-based and allow entities to choose compliance approaches best tailored to their systems. 11 The NERC Compliance Registry, as of January 4, 2023, identifies approximately 1,592 U.S. entities that are subject to mandatory compliance with Reliability Standards. Of this total, we estimate that 1,579 entities will face an increased paperwork burden under Reliability Standard CIP 003-9, estimating that a majority of these entities will have one or more low impact BES Cyber Systems. Based on these assumptions, the Commission estimates the total annual burden and cost as follows:

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

Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: The Responsible Appliance Disposal Program (RAD) is a voluntary partnership program sponsored by the Environmental Protection Agency (EPA) that reduces emissions of ozone-depleting substances (ODS) and their substitutes, including hydrofluorocarbons (HFCs), that can be attributed to improper disposal of appliances. Appliances can contain ODS or HFC refrigerants and foams as well as universal wastes such as mercury, used oil, and polychlorinated biphenyls (PCB). Federal law requires refrigerant recovery and proper management of universal waste but does not require the recovery of appliance foam. Foam blowing agents and refrigerants in appliances may also have high ozone-depletion and/or global warming potentials. The RAD program works with utilities, retailers, manufacturers, federal agencies/states/municipalities, waste removal service providers, affiliates, and others to dispose of appliances using best environmental practices.

Form numbers: 5900-481; 5900-482.

Respondents/affected entities: The following is a list of North American Industry Classification System (NAICS) codes for organizations potentially affected by the information requirements covered under this ICR are Utilities (2211), Manufacturers (3352), Retailers (449210), federal agencies/states/municipalities (9924110), and Waste Removal Service Providers (56211).

Respondent's obligation to respond: Voluntary.

Estimated number of respondents: 52 (over three years).

Frequency of response: Annual, and when desired.

Total estimated burden: 292 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $43,702 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in estimates: There is no change to the total estimated respondent burden compared with the 292 hours for the ICR currently approved by OMB. While the total number of respondents increased, the number of expected new Partners decreased. Therefore, the increase in burden associated with existing Partner activities is offset by the decrease in burden associated with new Partner activities.

I. General Information A. Does this action apply to me?

This action is directed to the public in general. This action may, however, be of interest to all who manufacture, process, or distribute industrial chemicals. Because other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2003-0004, is available at https://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

Under contract number 68HERD23D0002 Task Order number 68HERD23F0105, contractor Agile Decision Sciences, LLC located at 350 Voyager Way, Suite 100B, Huntsville, AL 35806-3200 and subcontractor Abaco-Blackfish JV, LLC located at 107 Harrison Street, NE Leesburg, VA 20176-2309 will support the operations of the TSCA Confidential Business Information Center (CBIC), providing records services to EPA personnel and contractors, as well as those companies who submit information in compliance with TSCA. The efficient and ongoing operation of services in the CBIC are vital to Agency personnel to make informed decisions on environmental issues and other information that maybe claimed as TSCA CBI in accordance with the TSCA Security Manual.

In accordance with 40 CFR 2.306(j), EPA has determined that under EPA contract number 68HERD23D0002 Task Order number 68HERD23F0105, Agile Decision Sciences, LLC and Abaco-Blackfish JV, LLC will require access to CBI submitted under all Sections of TSCA to perform successfully the duties specified under the contract. Agile Decision Sciences, LLC and Abaco-Blackfish JV, LLC personnel will be given access to information claimed or determined to be CBI information submitted to EPA under all sections of TSCA.

EPA is issuing this notice to inform all submitters of information under all sections of TSCA that EPA will provide Agile Decision Sciences, LLC and Abaco-Blackfish JV, LLC access to these CBI materials on a need-to-know basis only. All access to TSCA CBI under this contract will take place at EPA Headquarters and in accordance with EPA's TSCA CBI Protection Manual and the Rules of Behavior for Virtual Desktop Access to OPPT Materials, including TSCA CBI.

Access to TSCA data, including CBI, will continue until April 02, 2028. If the contract is extended, this access will also continue for the duration of the extended contract without further notice. Agile Decision Sciences, LLC and Abaco-Blackfish JV, LLC personnel will be required to sign nondisclosure agreements and will be briefed on specific security procedures for TSCA CBI.

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

The EEOC's Demographic Information on Applicants (OMB No. 3046-0046) is intended for use by federal agencies in gathering data on the race, ethnicity, sex, and disability status of job applicants. This form is used by the EEOC and other agencies to gauge progress and trends over time with respect to equal employment opportunity goals.

On March 8, 2023, the Commission published a 60-Day Notice informing the public of its intent to request from OMB an extension without change of the information collection requirements associated with a Commission form (Demographic Information on Applicants OMB No. 3046-0046). 88 FR 14363 (March 8, 2023). Pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35, and OMB regulation 5 CFR 1320.8(d)(1), the Commission solicited public comment to enable it to:

(1) Evaluate whether the proposed data collection tool will have practical utility by enabling a federal agency to determine whether recruitment activities are effectively reaching all segments of the relevant labor pool in compliance with the laws enforced by the Commission and whether the agency's selection procedures allow all applicants to compete on a level playing field regardless of race, national origin, sex, or disability status;

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

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

(4) Minimize the burden of the collection of information on applicants for federal employees who choose to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

The Commission received three comments unrelated to these topics.

Collection Title: Demographic Information on Applicants.

OMB Control No.: 3046-0046.

Description of Affected Public: Individuals submitting applications for federal employment. 1

Number of Annual Responses: 9,092.

Estimated Time per Response: 3 minutes.

Total Annual Burden Hours (EEOC only): 455. 2

Annual Federal Cost: None.

Abstract: Under section 717 of title VII and 501 of the Rehabilitation Act, the Commission is charged with reviewing and approving federal agencies' plans to affirmatively address potential discrimination before it occurs. Pursuant to such oversight responsibilities, the Commission has established systems to monitor compliance with title VII and the Rehabilitation Act by requiring federal agencies to evaluate their employment practices through the collection and analysis of data on the race, national origin, sex, and disability status of applicants for both permanent and temporary employment.

While several federal agencies (or components of such agencies) have obtained OMB approval for the use of forms collecting data on the race, national origin, sex, and disability status of applicants, it is not an efficient use of government resources for each federal agency to separately seek OMB approval. Accordingly, to avoid unnecessary duplication of effort and a proliferation of forms, the EEOC seeks approval of a form to be used by federal agencies.

Response by applicants is completely optional. The information obtained will be provided in the form of aggregate data and used by federal agencies only for evaluating whether an agency's recruitment activities are effectively reaching all segments of the relevant labor pool and whether the agency's selection procedures allow all applicants to compete on a level playing field regardless of race, national origin, sex, or disability status. The voluntary responses provided by applicants are treated in a highly confidential manner and play no part in the selection of the individual for employment. The information is not provided to any panel rating the applications, to selecting officials, to anyone who can affect the application or to the public. Rather, the information is used in summary form to determine trends over many selections within a given occupational or organization area. No information from the form is entered into an official personnel file.

The present Notice is for a three-year extension without change to the Commission's existing form for collecting voluntary demographic information from federal applicants. The Commission remains engaged in interagency discussions about equitable data collection, including (a) the Federal Interagency Technical Working Group on Race and Ethnicity Standards convened by OMB; and (b) the Subcommittee on Sexual Orientation, Gender Identity, and Variations in Sex Characteristics convened by the National Science and Technology Council's Subcommittee on Equitable Data. As the work of those groups continues, the Commission may seek authorization from OMB, pursuant to the Paperwork Reduction Act, to amend the race, ethnicity, and/or sex questions on the Demographic Information on Applicants form.

Burden Statement: Because of the predominant use of online application systems, which require only pointing and clicking on the selected responses, and because the form requests only seven questions regarding basic information, the EEOC estimates that an applicant can complete the form in approximately 3 minutes or less. Based on past experience, we expect that 9,092 applicants will choose to complete the form for vacancies at the EEOC annually.

Upon approval of this common form by OMB, federal agencies may request OMB approval to use this common form without having to publish notices and request public comments for 60 and 30 days. Each agency must account for the burden associated with their use of the common form. 3

The General Services Administration routinely hires, reassigns, promotes, or transfers Federal employees to duty stations in foreign areas ( i.e., outside of the United States and its territories and possessions). Under the Administrative Expenses Act of 1946 (60 stat. 808), as amended, agencies are permitted to use appropriated funds to pay for the various costs incurred for permanent change of station (PCS) to the foreign area (see further 5 U.S.C. 5722 et seq. ). Such costs include: (1) travel and relocation expenses of the new appointee (or employee) and his or her immediate family from the place of actual residence in the U.S. to the place of employment outside the U.S.; (2) return travel and relocation expenses for an employee and his family from his post outside the U.S. to his or her actual place of residence in the U.S.; and (3) the additional expenses of transporting a privately owned motor vehicle, as authorized under 5 U.S.C. 5723 and 5727(c). Under these relocation authorities, in return for these benefits, the job candidate (or employee) must agree to remain in the agency's service for at least 12 months ( i.e., 1 year). Additional information concerning this authority is found within the GSA Government Travel Regulations at 41 CFR part 302-3, subpart F.

To more effectively memorialize the agency costs incurred, and the appointee's (or employee's) resulting service obligation, GSA has redeveloped its existing form GSA 5040, Overseas Employment Services Agreement. This form serves as: (1) an information collection device to determine eligibility for, and then memorialize, the compensation, foreign allowances, and travel and transportation benefits provided, and (2) an enforceable service agreement for PCS travel and transportation costs, pursuant to the Federal Claims Collection Act of 1966 and the Debt Collection Act Amendments of 1996 (see further 31 U.S.C. 3711 et seq. ).

Respondents: 25.

Responses per Respondent: 1.

Total Annual Responses: 25.

Hours per Response: 1.

Total Burden Hours: 25.

A 60-day notice was published in the Federal Register at 88 FR 9521, on February 14, 2023.

A total of nine (9) comments were received; however, they involved proposed wording changes for the form and did not address, or change, the original estimate of the administrative burden. A summary of the comments, and our responses, are as follows.

Comment 1: A commenter suggested that the nomenclature of military bases in Box 6 be revised to reflect military “installations.”

Response: This response is accepted, and the names will be changed to reflect military installations.

Comment 2: A commenter suggested that a general response, such as “Nationwide,” be permissible for writing into Box 8b, which describes the anticipated U.S. duty station upon conclusion of overseas duty.

Response: This response is accepted and the Instruction for Box 8b will be revised to suggest that users can use descriptive, but generic, responses when appropriate.

Comment 3: A commenter noted that there was an erroneous reference to direct-deposit forms in the Privacy Act Statement.

Response: This response is accepted. We will have the form corrected to have this reference removed.

Comment 4: A commenter questioned the authority for Box 11 as well as the information provided in the Instruction for that question at the back of the form. Box 11 discusses the employee benefits known as “home leave” and the 45-day ( i.e., 360 hour) annual leave accrual ceiling. These two authorities are related because to be eligible for home leave, the job candidate must first be eligible for the 45-day leave accrual ceiling under 5 U.S.C. 6304(b). Both the 45-day leave ceiling and home leave are reserved for employees that are originally hired, reassigned, or transferred from the United States and then placed into a foreign area. Generally, job candidates already in a foreign area are not eligible for either benefit unless they can demonstrate that they were originally hired from the United States, have been in continuous employment with the U.S. government or a U.S. entity, and have return relocation benefits memorialized by written transportation agreements during all periods of foreign service.

Response: The eligibility requirements discussed in Box 11 and the Instruction are an explication of the governing statute (5 U.S.C. 6304(b)) and Civil Service regulation (5 CFR 630.602). We have decided to keep the narrative language within Box 11 the same, however, we have decided to shorten the language within the Instruction statement related to Box 11 to reduce possible confusion.

Comment 5: A commenter suggested that Box 12 be removed from the form and that the form be signed not by a human resources specialist but instead by the hiring manager. Box 12 concerns documentation of which overseas allowances and differentials are authorized for the job candidate.

Response: We partially accept the comment and will change the form's signature to that of the hiring manager, as the commenter suggested. We note that under GSA administrative order 5450.39D ADM CHGE 1 that generally the hiring manager's organization decides which overseas allowances are appropriate to provide, based upon the lexicon of those that are available based on eligibility. Generally, the hiring manager's organization is responsible for paying for the allowances offered, since the allowances are used as optional tools for recruitment and retention. We will not remove Box 12, however, because it is important to document on this form which allowances and differentials are approved and then offered to the job candidate.

Comment 6: A commenter from GSA's human resources function recommended that Box 11 be removed from the form. Box 11, as discussed above, concerns home leave and the 45-day annual leave accrual ceiling. The commenter believed that human resources specialists are unfamiliar with paid leave authorities and do not have sufficient background to understand how to assist with, or administer, these leave authorities.

Response: We have chosen not to accept this comment. It is important to have Box 11 to both review the eligibility, and then to document that eligibility, for home leave as well as for the 45-day annual leave ceiling. We also believe that current skills gaps can be addressed and ameliorated through a proper future training regimen.

Comment 7: A commenter suggested that in Box 9 a reference be removed to obsolete Form 5042, Overseas Employment Transportation Agreement.

Response: We agree that the reference to the obsolete form should be removed. The historical business purpose of Form 5042 (that of a transportation agreement) has been fully merged into the new Form 5040, the subject of this Federal Register notice.

Comments 8 and 9: One commenter submitted two substantially similar comments essentially suggesting that the main certifying signature on the form be applied by the hiring manager rather than by a human resources specialist.

Response: As discussed earlier, we accept this comment and will change the certifying signature to be that of the hiring manager. As the primarily first-line representative of the agency, the hiring manager is in the best position to know the specific circumstances of the job offer, and the conditions of employment offered to the job candidate.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division, by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 3090-XXXX, Overseas Employment Agreement; GSA Form 5040.

I. Background

Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product under the FD&C Act. On October 18, 2022, Ms. Rico was convicted as defined in section 306(l)(1) of the FD&C Act in the U.S. District Court for the Southern District of Florida, Miami Division, when the court accepted her plea of guilty and entered judgment against her for one count of conspiracy to commit mail fraud and wire fraud in violation of 18 U.S.C. 1349.

The factual basis for this conviction is as follows: As contained in the Information, entered into the docket on March 16, 2021, and the Factual Proffer in support of Ms. Rico's guilty plea, entered into the docket on August 8, 2022, both from her case, Ms. Rico was a clinical research coordinator employed at Tellus Clinical Research, Inc. (Tellus). Tellus was a medical research clinic that conducted clinical trials on behalf of pharmaceutical company sponsors. Among the clinical research trials conducted by Tellus were two different studies of an investigational drug intended to treat opioid dependency sponsored by Sponsor 1 and managed by Contract Research Organization (CRO) 1 (the opioid dependency trials); two studies of an investigational drug intended to treat irritable bowel syndrome in female patients sponsored by Sponsor 2 and by CRO 2 (the IBS trials); and one study of an investigational injectable drug intended to treat diabetic nephropathy sponsored by Sponsor 3 and managed by CRO 3 (the diabetes trial). One of Ms. Rico's co-conspirators was the clinical investigator hired by the sponsors and/or the CROs for each of these five studies (the Studies). Ms. Rico served as a study coordinator for the Studies. In that role, she was responsible for administering procedures to subjects in the Studies and preparing honest and accurate written records, including records known as “case histories,” describing the participation of the subjects in the Studies.

Ms. Rico and her co-conspirators caused false information to be entered in subject case histories to make it appear that subjects had, among other things, satisfied eligibility criteria to participate in the Studies, provided informed consent to participate in the Studies, received physical examinations, received or been administered the investigational drug for the Studies, and received payments for visits to Tellus for the Studies when, in truth and in fact, Ms. Rico knew that such events had not occurred.

For example, on or about March 12, 2014, Ms. Rico initialed case history documentation in the first Opioid dependency study for subject, N.F., the mother of one of Ms. Rico's co-conspirators, wherein Ms. Rico indicated falsely that N.F. was eligible to participate in the study, provided a urine sample that tested positive for opiates and buprenorphine, received study medication from one of Ms. Rico's co-conspirators, and that another co-conspirator witnessed N.F. receive the study medication. Ms. Rico knew that N.F. was not eligible to participate in the study, had not provided a urine sample that tested positive for opiates or buprenorphine, and had not received any study medication, and these representations were false. In addition, on or about June 9, 2015, Ms. Rico initialed case history documentation for subject G.C., falsely representing that G.C. was a study subject participating in the second IBS study, that G.C. had visited Tellus, that Ms. Rico had obtained G.C.'s urine and blood for analysis as required by the protocol governing IBS Study 2, that Ms. Rico had performed an electrocardiogram on G.C., and that Ms. Rico had dispensed IBS Study 2 medication to G.C. In truth, Ms. Rico knew that G.C. was not participating in the second IBS study and that these representations were false.

Furthermore, Ms. Rico knew that subjects in the IBS trials were required to make daily phone calls to an “e-diary” system (a toll-free number maintained by a third party) and report their personal experience with the study drug. In furtherance of the conspiracy, Ms. Rico and her co-conspirators knowingly placed telephone calls to the e-diary system, using the subjects' individual PIN numbers, for purposes of reporting fabricated data on behalf of subjects in the IBS studies. Ms. Rico and her co-conspirators placed these fraudulent telephone calls on behalf of more than 10 subjects in the IBS trials. Ms. Rico also participated in falsifying and fabricating data in connection with the diabetes trial. For example, on or about November 20, 2015, Ms. Rico initialed case history documentation for subject S.D. in the diabetes trial, falsely representing that she witnessed one of her co-conspirators dispense the study drug to subject S.D. at Tellus. In truth, Ms. Rico knew these representations were false. For her work as a clinical research coordinator at Tellus and for her participation in the conspiracy, Ms. Rico received approximately $240,000.

In 2016, FDA conducted a regulatory inspection of Tellus relating to allegations of fraudulent and fabricated data submitted in the IBS trials. For the purpose of preventing FDA investigators from learning the truth about fabricated data at Tellus, Ms. Rico contacted certain individuals enrolled as subjects in the IBS trials and instructed them to lie to FDA investigators regarding their participation in the IBS trials. Among other things, Ms. Rico instructed subjects to falsely represent to FDA investigators that they had participated in an IBS study at Tellus, received physical examinations and electrocardiograms, and met with a doctor who matched the physical description of one of Ms. Rico's co-conspirators.

As a result of this conviction, FDA sent Ms. Rico by certified mail on January 20, 2023, a notice proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(A) of the FD&C Act, that Ms. Rico was convicted, as set forth in section 306(l)(1) of the FD&C Act, of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product under the FD&C Act. The proposal also offered Ms. Rico an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted an election not to use the opportunity for a hearing and a waiver of any contentions concerning this action. Ms. Rico received the proposal on February 1, 2023. She did not request a hearing within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and any contentions concerning her debarment (21 CFR part 12).

Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(a)(2)(A) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Ms. Rico has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product under the FD&C Act.

As a result of the foregoing finding, Ms. Rico is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application, effective (see DATES ) (see sections 306(a)(2)(A) and 306(c)(2)(A)(ii) of the FD&C Act). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Ms. Rico in any capacity during her debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Rico provides services in any capacity to a person with an approved or pending drug product application during her period of debarment, she will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug application from Ms. Rico during her period of debarment, other than in connection with an audit under section 306(c)(1)(B) of the FD&C Act. Note that, for purposes of sections 306 and 307 of the FD&C Act, a “drug product” is defined as a drug subject to regulation under section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, 382) or under section 351 of the Public Health Service Act (42 U.S.C. 262) (section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))).

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, are the subject of NDA 021190, held by Bristol Myers Squibb Co., and initially approved on December 20, 2000. BUSPAR is indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.

In correspondence dated December 28, 2012, Bristol Myers Squibb Co. requested withdrawal of NDA 021190 for BUSPAR (buspirone hydrochloride). In the Federal Register of December 5, 2014 (79 FR 72186), FDA announced that it was withdrawing approval of NDA 021190, effective January 5, 2015.

Epic Pharma, LLC submitted a citizen petition dated January 10, 2023 (Docket No. FDA-2023-P-0120), under 21 CFR 10.30, requesting that the Agency determine whether BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, were withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. 1

Accordingly, the Agency will continue to list BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to BUSPAR (buspirone hydrochloride) capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Antimicrobial Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.

The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders and makes appropriate recommendations to the Commissioner.

The Committee shall consist of a core of 13 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Non-Federal members of this committee will serve as Special Government Employees, representatives or Ex-Officio members. Federal members will serve as Regular Government Employees or Ex-Officios. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative.

Further information regarding the most recent charter and other information can be found at https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT ). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports implementation of section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384), and applicable regulations in part 251 (21 CFR part 251). The purpose of section 804 of the FD&C Act is to reduce the cost of covered products to American consumers without imposing additional risk to public health and safety. The regulations in part 251 set forth procedures Section 804 Importation Program sponsors (SIP Sponsors) must follow when submitting plans to implement time-limited programs to begin importation of drugs from Canada. The regulations also establish criteria for FDA review and authorization of a SIP proposal or supplemental proposal. Additionally, the regulations set forth requirements for eligible prescription drugs and requirements for entities that engage in importation of eligible prescription drugs. Finally, the regulations provide for exempt eligible prescription drugs that meet certain requirements from section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)).

Description of Respondents: Respondents to the collection of information are SIP Sponsors (States or Indian Tribes, or in certain future circumstances, pharmacists or wholesale distributors, and any cosponsor(s)), importers (pharmacists or wholesaler distributors), and manufacturers of eligible prescription drugs.

We estimate the burden of the collection of information as follows:

We have established a web page at https://www.fda.gov/about-fda/reports/importation-drugs-originally-intended-foreign-markets to communicate news and information about FDA efforts to implement the Section 804 Importation Program. To date, however, no SIP proposals have been authorized since publication of the final rule on October 1, 2020 (85 FR 62094). We have therefore retained figures based on our original impact analysis estimating that 40 SIP sponsors will each submit a SIP proposal or pre-import request. We assume burden attributable to the required retention and disclosure of records pertaining to these information collection activities will be distributed among respondents for an average of 100 responses and 6,040 hours annually.

The meeting is the sixth in a series of Federal advisory committee meetings regarding the development of recommendations to advance equity, justice, and opportunity for AA and NHPI communities. The meeting is open to the public and will be live streamed. The Commission, co-chaired by HHS Secretary Xavier Becerra and the U.S. Trade Representative Ambassador Katherine Tai, advises the President on: the development, monitoring, and coordination of executive branch efforts to advance equity, justice, and opportunity for AA and NHPI communities in the United States, including efforts to close gaps in health, socioeconomic, employment, and educational outcomes; policies to address and end anti-Asian bias, xenophobia, racism, and nativism, and opportunities for the executive branch to advance inclusion, belonging, and public awareness of the diversity and accomplishments of AA and NHPI people, cultures, and histories; policies, programs, and initiatives to prevent, report, respond to, and track anti-Asian hate crimes and hate incidents; ways in which the Federal Government can build on the capacity and contributions of AA and NHPI communities through equitable Federal funding, grantmaking, and employment opportunities; policies and practices to improve research and equitable data disaggregation regarding AA and NHPI communities; policies and practices to improve language access services to ensure AA and NHPI communities can access Federal programs and services; and strategies to increase public-and private-sector collaboration, and community involvement in improving the safety and socioeconomic, health, educational, occupational, and environmental well-being of AA and NHPI communities.

Information is available on the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders website at https://www.hhs.gov/about/whiaanhpi/commission/index.html. The names of the 25 members of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders are available at https://www.hhs.gov/about/whiaanhpi/commission/commissioners/index.html.

Purpose of Meeting: The President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders, authorized by Executive Order 14031, will meet to discuss full and draft recommendations by the Commission's six Subcommittees on ways to advance equity, justice, and opportunity for Asian American, Native Hawaiian, and Pacific Islander communities. The Subcommittees are: Belonging, Inclusion, Anti-Asian Hate, Anti-Discrimination; Data Disaggregation; Language Access; Economic Equity; Health Equity; and Immigration and Citizenship Status.

Background: Asian American, Native Hawaiian, and Pacific Islander communities are among the fastest growing racial and ethnic populations in the United States according to the U.S. Census Bureau. However, in recent years, AA and NHPI individuals have faced increasing hate crimes and incidents that threaten their safety, as well as harmful stereotypes that often ignore socioeconomic, health, and educational disparities impacting these diverse communities.

Tragic acts of anti-Asian violence increased during the COVID-19 pandemic, casting a shadow of fear and grief over many AA and NHPI communities, in particular East Asian communities. Long before this pandemic, AA and NHPI communities in the United States, including South Asian and Southeast Asian communities, have faced persistent xenophobia, religious discrimination, racism, and violence. At the same time, AA and NHPI communities were overrepresented in the pandemic's essential workforce in healthcare, food supply, education, and childcare, with more than four million AA and NHPIs manning the frontlines throughout the pandemic.

Many AA and NHPI communities, and in particular Native Hawaiian and Pacific Islander communities, were disproportionately burdened by the COVID-19 public health crisis. Evidence suggests that Native Hawaiians and Pacific Islanders were three times more likely to contract COVID-19 compared to white people and nearly twice as likely to die from the disease. On top of these health inequities, many AA and NHPI workers, families, and small businesses faced devastating economic losses during the crisis.

The challenges AA and NHPI communities face are often exacerbated by a lack of adequate data disaggregation and language access. The President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders works to advise the President on executive branch efforts to address these challenges and advance equity, justice, and opportunity for AA and NHPI communities.

Public Participation at Meeting: Members of the public may attend virtually or in person, depending on the portion of the meeting. Registration is required through the following links:

Written public comments: Written comments are welcomed throughout the development of the Commission's recommendations to promote equity, justice, and opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders and may be emailed to AANHPICommission@hhs.gov at any time. Respond concisely and in plain language. You may use any structure or layout that presents your information well. You may respond to some or all of our questions, and you can suggest other factors or relevant questions. You may also include links to online material or interactive presentations. Clearly mark any proprietary information and place it in its own section or file. Your response will become Government property, and we may publish some of its non-proprietary content.

Oral public comments: Individuals may submit a request to make an oral public comment at the July 7, 2023, meeting in response to the questions below. Advance copy of public comment must be sent via email at AANHPICommission@hhs.gov with the subject line “PACAANHPI: In-person Response to <insert the issue and question>” no later than 11:59 p.m. ET on Friday, June 23, 2023. Submissions received after the deadline will not be considered for oral public comment.

Registration for oral public comment is on a first-come, first-served basis. Comments are limited to two (2) minutes or less. After the maximum number of speakers is exceeded, individuals registered to provide oral comment will be placed on a wait list and notified should an opening become available. You will be notified via email no later than July 5, 2023, if you have been identified to provide in-person public comment.

The Commission is particularly interested in soliciting comments on the following questions:

1. Belonging, Inclusion, Anti-Asian Hate, Anti-Discrimination Subcommittee Questions:

a. Please provide feedback on the experiences of Asian Americans, Native Hawaiians, and Pacific Islanders in the Child Protection/Child Welfare system.

b. What are promising practices, services, or prevention and intervention strategies that advance the well-being of AA and NHPI children and families who encounter the child protection/child welfare systems?

2. Language Access Subcommittee Questions:

a. How can the Federal Government promote the preservation, teaching, learning of, maintenance and utilization of AA and NHPI languages?

b. Are there any programs you recommend the Commission examine that provide meaningful language access to government benefits and services to persons with limited English proficiency?

3. Economic Equity Subcommittee Questions:

a. To what extent does the Native Hawaiian community have access to or understand how to access resources for job training and housing assistance at the local, state, and federal level?

b. How familiar is the public with the federal government resources available to support small businesses, loans, or grants?

c. How can the government better provide culturally sensitive and affordable housing for AA and NHPI communities?

4. Health Equity Subcommittee Questions:

a. What are the mental health concerns impacting communities in the Pacific Islands and what are some of the ways communities are trying to address them?

b. What are the biggest concerns around health for Native Hawaiians?

c. What are some of the biggest barriers to obtaining health care in Hawaii and other Pacific Islands?

d. What could improve your communities' ability to obtain federal services such as housing assistance, SSI/SSDI, SNAP/WIC, FEMA assistance, etc.?

5. Immigration and Citizenship Status Subcommittee Questions:

a. What are the main policy implications for Pacific Islanders who have either immigrated or moved away from their island homelands to other locations in the United States?

b. Pacific Islanders have a unique history with the United States that differs from most immigrants or migrants to this country. What should the responsibility of the federal government be to Pacific Islanders in light of this historical relationship?

c. As immigration-related agencies within the U.S. Department of Homeland Security (DHS) like the U.S. Citizenship and Immigration Services (USCIS), Immigration and Customs Enforcement (ICE), and Customs and Border Protection (CBP), work to expand language services, how should they decide which languages and which processes should be prioritized for implementation? Are there specific forms or processes that DHS agencies should prioritize providing language services for immediately? If so, which forms and language translations should be prioritized?

d. What can be done to address negative stereotypes and improve group relations between Pacific Islanders and other communities both in the Pacific Islands and throughout the United States?

Authority: Executive Order 14031. The President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders is governed by provisions of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. app.), which sets forth standards for the formation and use of Federal advisory committees.

The BSC will provide input to the NTP on programmatic activities and issues. The preliminary agenda topics include a presentation on needed research capabilities to support predictive toxicology and evidence evaluation, including the development and implementation of computational, alternative, literature-based, and quality assessment tools and methodologies. The NIEHS proposes to obtain support for these activities via contract mechanism due to the scope of the required capabilities and availability of personnel with relevant experience to perform these activities exceeding the internal resources available. The preliminary agenda, roster of BSC members, background materials, public comments, and any additional information, when available, will be posted on the BSC meeting web page ( https://ntp.niehs.nih.gov/go/165 ) or may be requested in hardcopy from the Designated Federal Officer for the BSC. Following the meeting, summary minutes will be prepared and made available on the BSC meeting web page within 90 calendar days of the meeting.

Meeting Attendance Registration: The meeting is open to the public with time scheduled for oral public comments. Registration is not required to view the virtual meeting; the URL for the virtual meeting will be provided on the BSC meeting web page ( https://ntp.niehs.nih.gov/go/165 ) by noon the day before the meeting. TTY users should contact the Federal TTY Relay Service at 800-877-8339. Requests should be made at least five business days in advance of the event.

Written Public Comments: NTP invites written public comments. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.

The deadline for submission of written comments is July 5, 2023, by 5:00 p.m. EDT. Written public comments should be submitted through the meeting web page. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP web page, and the submitter will be identified by name, affiliation, and sponsoring organization (if any).

Oral Public Comment Registration: The agenda allows for public comment periods on the agenda topics (up to five commenters per topic, up to five minutes per speaker per topic). Oral comments will be received only during the formal comment periods indicated on the preliminary agenda. Persons wishing to make an oral comment are required to register online at https://ntp.niehs.nih.gov/go/165 by July 5, 2023, by 5:00 p.m. EDT. Registration is on a first-come, first-served basis. Each organization is allowed one time slot per topic. After the maximum number of speakers is exceeded, individuals registered to provide oral comment will be placed on a wait list and notified should an opening become available. Logistical information for presentations will be provided to commenters approximately 2-3 days before the meeting.

If possible, oral public commenters should send a copy of their slides and/or statement or talking points to Ms. Robbin Guy by email: robbin.guy@nih.gov by July 5, 2023; 5:00 p.m. EDT.

Meeting Materials: The preliminary meeting agenda will be available on the meeting web page ( https://ntp.niehs.nih.gov/go/165 ) by 5:00 p.m. on June 12, 2023, and updated one week before the meeting. Individuals are encouraged to access the meeting web page periodically to stay abreast of the most current information regarding the meeting.

Background Information on the BSC: The BSC is a technical advisory body comprised of scientists from the public and private sectors that provides primary scientific oversight to the NTP. Specifically, the BSC advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and their overall scientific quality. Its members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, epidemiology, risk assessment, carcinogenesis, mutagenesis, cellular biology, computational toxicology, neurotoxicology, genetic toxicology, reproductive toxicology or teratology, and biostatistics. Members serve overlapping terms of up to four years. The BSC usually meets periodically. The authority for the BSC is provided by 42 U.S.C. 217a, section 222 of the Public Health Service Act (PHS), as amended.

The BSC is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. ch.10), which sets forth standards for the formation and use of advisory committees.

Executive Order 12862 directs Federal agencies to provide service to the public that matches or exceeds the best service available in the private sector. In order to work continuously to ensure that our programs are effective and meet our customers' needs, the Department of Homeland Security (hereafter “the Agency”) seeks to obtain OMB approval of a generic clearance to collect qualitative feedback on our service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Improving agency programs requires ongoing assessment of service delivery, by which we mean systematic review of the operation of a program compared to a set of explicit or implicit standards, as a means of contributing to the continuous improvement of the program.

The Agency will collect, analyze, and interpret information gathered through this generic clearance to identify strengths and weaknesses of current services and make improvements in service delivery based on feedback. The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable. The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:

• Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency (if released, procedures outlined in Question 16 will be followed);

• Information gathered will not be used for the purpose of substantially informing influential policy decisions 1;

• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study;

• The collections are voluntary;

• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;

• The collections are non-controversial and do not raise issues of concern to other Federal agencies;

• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; and

• With the exception of information needed to provide renumeration for participants of focus groups and cognitive laboratory studies, personally identifiable information (PII) is collected only to the extent necessary and is not retained.

If these conditions are not met, the Agency will submit an information collection request to OMB for approval through the normal PRA process. To obtain approval for a collection that meets the conditions of this generic clearance, a standardized form will be submitted to OMB along with supporting documentation ( e.g., a copy of the comment card). The submission will have automatic approval, unless OMB identifies issues within 5 business days. The types of collections that this generic clearance covers include, but are not limited to:

The Agency has established a manager/managing entity to serve for this generic clearance and will conduct an independent review of each information collection to ensure compliance with the terms of this clearance prior to submitting each collection to OMB. If appropriate, agencies will collect information electronically and/or use online collaboration tools to reduce burden.

Small business or other small entities may be involved in these efforts but the Agency will minimize the burden on them of information collections approved under this clearance by sampling, asking for readily available information, and using short, easy-to-complete information collection instruments. Without these types of feedback, the Agency will not have timely information to adjust its services to meet customer needs. If a confidentiality pledge is deemed useful and feasible, the Agency will only include a pledge of confidentiality that is supported by authority established in statute or regulation, that is supported by disclosure and data security policies that are consistent with the pledge, and that does not unnecessarily impede sharing of data with other agencies for compatible confidential use. If the agency includes a pledge of confidentiality, it will include a citation for the statute or regulation supporting the pledge. This is a new collection.

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

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

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

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

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

Agency: Department of Homeland Security (DHS)/United States Secret Service (USSS).

Title: Generic Information Collection: USSS Customer Satisfaction Surveys.

OMB Number: 1620-NEW.

Frequency: On Occasion.

Affected Public: Stakeholders/participants who engage with USSS programs, investigations, and inspections; including, individuals/households and Federal, State, and Local governments.

Number of Respondents: 160,000.

Estimated Time per Respondent: 2 Minutes.

Total Burden Hours: 5,333 Hours.

Background

Section 101(a)(5)(D) of the Marine Mammal Protection Act of 1972 (MMPA; 16 U.S.C. 1361, et seq. ) authorizes the Secretary of the Interior (Secretary) to allow, upon request, the incidental, but not intentional, taking by harassment of small numbers of marine mammals in response to requests by U.S. citizens (as defined in title 50 of the Code of Federal Regulations (CFR) in part 18, at 50 CFR 18.27(c)) engaged in a specified activity (other than commercial fishing) in a specified geographic region during a period of not more than 1 year. The Secretary has delegated authority for implementation of the MMPA to the U.S. Fish and Wildlife Service (“Service” or “we”). According to the MMPA, the Service shall allow this incidental taking if we make findings that the total of such taking for the 1-year period:

(1) is of small numbers of marine mammals of a species or stock;

(2) will have a negligible impact on such species or stocks; and

(3) will not have an unmitigable adverse impact on the availability of these species or stocks for taking for subsistence use by Alaska Natives.

If the requisite findings are made, we issue an authorization that sets forth the following, where applicable:

(a) permissible methods of taking;

(b) means of effecting the least practicable adverse impact on the species or stock and its habitat and the availability of the species or stock for subsistence uses; and

(c) requirements for monitoring and reporting of such taking by harassment, including, in certain circumstances, requirements for the independent peer review of proposed monitoring plans or other research proposals.

The term “take” means to harass, hunt, capture, or kill, or to attempt to harass, hunt, capture, or kill any marine mammal. “Harassment” means any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (the MMPA defines this as “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 (the MMPA defines this as “Level B harassment”).

The terms “negligible impact” and “unmitigable adverse impact” are defined in 50 CFR 18.27 ( i.e., regulations governing small takes of marine mammals incidental to specified activities) as follows: “Negligible impact” is an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival. “Unmitigable adverse impact” means an impact resulting from the specified activity: (1) that is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by (i) causing the marine mammals to abandon or avoid hunting areas, (ii) directly displacing subsistence users, or (iii) placing physical barriers between the marine mammals and the subsistence hunters; and (2) that cannot be sufficiently mitigated by other measures to increase the availability of marine mammals to allow subsistence needs to be met.

The term “small numbers” is also defined in 50 CFR 18.27. However, we do not rely on that definition here as it conflates “small numbers” with “negligible impacts.” We recognize “small numbers” and “negligible impacts” as two separate and distinct considerations when reviewing requests for incidental harassment authorizations (IHA) under the MMPA (see Natural Res. Def. Council, Inc. v. Evans, 232 F. Supp. 2d 1003, 1025 (N.D. Cal. 2003)). Instead, for our small numbers determination, we estimate the likely number of takes of marine mammals and evaluate if that take is small relative to the size of the species or stock.

The term “least practicable adverse impact” is not defined in the MMPA or its enacting regulations. For this IHA, we ensure the least practicable adverse impact by requiring mitigation measures that are effective in reducing the impact of project activities, but they are not so restrictive as to make project activities unduly burdensome or impossible to undertake and complete.

If the requisite findings are made, we shall issue an IHA, which may set forth the following, where applicable: (i) permissible methods of taking; (ii) other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stock for taking for subsistence uses by coastal-dwelling Alaska Natives (if applicable); and (iii) requirements for monitoring and reporting take by harassment.

On September 16, 2022, Turnagain Marine Construction (hereafter “TMC” or “the applicant”) submitted a request to the Service for authorization to take by Level A and Level B harassment a small number of northern sea otters ( Enhydra lutris kenyoni ) (hereafter “sea otters” or “otters” unless another species is specified) from the Southcentral Alaska stock. The Service sent requests for additional information on November 1, November 30, and December 14, 2022. We received updated versions of the request on November 11, November 23, December 1, and December 22, 2022. The Service determined the December 22, 2022, application to be adequate and complete. TMC expects take by harassment may occur during the construction of their cruise ship berth and associated facilities on the western shore of Passage Canal in Whittier, Alaska.

The specified activity (hereafter “project”) will include installation and removal of piles for the construction of a 152-by-21 meter (m) (500-by-70-foot (ft)) floating cruise ship dock in Whittier, Alaska (figure 1) between April 2023 and April 2024. TMC will install and remove 72 91-centimeter (cm) (36-inch (in)) diameter steel piles and will permanently install the following types of piles: 36 91-cm (36-in) diameter steel piles, 16 107-cm (42-in) diameter steel piles, and 20 122-cm (48-in) diameter steel piles. Dock components that will be installed out of water include bull rail, fenders, mooring cleat, pre-cast concrete dock surface, and mast lights. Pile-driving activities will occur over 129 non-consecutive days for approximately 321 hours during the course of 1 year from date of issuance of the IHA. If the IHA is issued after TMC's intended start date in April 2023, its schedule for conducting the specified activities may be adjusted accordingly. Pile installation will be done with a combination of impact, vibratory, and down-the-hole (DTH) drilling. Temporary piles will be removed with the vibratory hammer. Materials and equipment will be transported via barges, and workers will be transported to and from the barge work platform via skiff.

Additional project details may be reviewed in the application materials available as described under ADDRESSES or may also be requested as described under FOR FURTHER INFORMATION CONTACT .

There are three sea otter stocks in Alaska: Southeast Alaska stock, Southcentral Alaska stock, and the Southwest Alaska stock. Only the Southcentral Alaska stock is represented in the project area. Detailed information about the biology of this stock can be found in the most recent Southcentral Alaska draft stock assessment report (USFWS 2023), which can be found at https://www.regulations.gov/document/FWS-R7-ES-2022-0155-0004 and was announced in the Federal Register at 88 FR 7992, February 7, 2023.

Sea otters may be distributed anywhere within the specified project area other than upland areas; however, they generally occur in shallow water near the shoreline. They are most commonly observed within the 40-m (131-ft) depth contour (USFWS 2023), although they can be found in areas with deeper water. Ocean depth is generally correlated with distance to shore, and sea otters typically remain within 1 to 2 kilometers (km) (0.62 to 1.24 miles (mi)) of shore (Riedman and Estes 1990). They tend to be found closer to shore during storms, but venture farther out during good weather and calm seas (Lensink 1962; Kenyon 1969).

Sea otters are nonmigratory and generally do not disperse over long distances (Garshelis and Garshelis 1984), usually remaining within a few kilometers of their established feeding grounds (Kenyon 1981). Breeding males stay for all or part of the year in a breeding territory covering up to 1 km (0.62 mi) of coastline, while adult females maintain home ranges of approximately 8 to 16 km (5 to 10 mi), which may include one or more male territories. Juveniles move greater distances between resting and foraging areas (Lensink 1962; Kenyon 1969; Riedman and Estes 1990; Tinker and Estes 1996). Although sea otters generally remain local to an area, they are capable of long-distance travel. Sea otters in Alaska have shown daily movement distances greater than 3 km (1.9 mi) at speeds up to 5.5 km per hour (hr) (km/hr; 3.4 mi/hr) (Garshelis and Garshelis 1984).

The Southcentral Alaska sea otter stock occurs in the center of the sea otter range in Alaska and extends from Cape Yakataga in the east to Cook Inlet in the west, including Prince William Sound, the eastern Kenai Peninsula coast, and Kachemak Bay (USFWS 2023). Between 2014 and 2019, aerial surveys were conducted in three regions of the Southcentral Alaska sea otter stock: (1) Eastern Cook Inlet, (2) Outer Kenai Peninsula, and (3) Prince William Sound by aerial transects flown at 91 m (298.56 ft) of altitude. The combined estimates of the three regions resulted in approximately 21,617 (SE = 2,190) sea otters and an average density of 1.96 sea otters per square kilometer (km 2 ) for the Southcentral Alaska stock (Esslinger et al. 2021). We applied the average density of sea otters in Prince William Sound, 2.03 sea otters/km 2 (Esslinger et al. 2021).

We characterized “noise” as sound released into the environment from human activities that exceeds ambient levels or interferes with normal sound production or reception by sea otters. The terms “acoustic disturbance” or “acoustic harassment” are disturbances or harassment events resulting from noise exposure. Potential effects of noise exposure are likely to depend on the distance of the sea otter from the sound source, the level and intensity of sound the sea otter receives, background noise levels, noise frequency, noise duration, and whether the noise is pulsed or continuous. The actual noise level perceived by individual sea otters will also depend on whether the sea otter is above or below water and atmospheric and environmental conditions. Temporary disturbance of sea otters or localized displacement reactions are the most likely effects to occur from noise exposure.

Pile driving and marine construction activities will fall within the hearing range of sea otters. Controlled sound exposure trials on southern sea otters ( Enhydra lutris nereis ) indicate that sea otters can hear frequencies between 125 hertz (Hz) and 38 kilohertz (kHz) with best sensitivity between 1.2 and 27 kHz (Ghoul and Reichmuth 2014). Aerial and underwater audiograms for a captive adult male southern sea otter in the presence of ambient noise suggest the sea otter's hearing was less sensitive to high-frequency (greater than 22 kHz) and low-frequency (less than 2 kHz) sound than terrestrial mustelids but was similar to that of a California sea lion ( Zalophus californianus ). However, the sea otter was still able to hear low-frequency sounds, and the detection thresholds for sounds between 0.125-1 kHz were between 116-101 decibels (dB), respectively. Dominant frequencies of southern sea otter vocalizations are between 3 and 8 kHz, with some energy extending above 60 kHz (McShane et al. 1995, Ghoul and Reichmuth 2012).

Exposure to high levels of sound may cause changes in behavior, masking of communications, temporary or permanent changes in hearing sensitivity, discomfort, and injury to marine mammals. Unlike other marine mammals, sea otters do not rely on sound to orient themselves, locate prey, or communicate under water; therefore, masking of communications by anthropogenic sound is less of a concern than for other marine mammals. However, sea otters, especially mothers and pups, do use sound for communication in air (McShane et al. 1995), and sea otters may monitor underwater sound to avoid predators (Davis et al. 1987).

Noise exposure criteria for identifying underwater noise levels capable of causing Level A harassment to marine mammal species, including sea otters, have been established using the same methods as those used by the National Marine Fisheries Service (NMFS) (Southall et al. 2019). These criteria are based on estimated levels of sound exposure capable of causing a permanent shift in sensitivity of hearing ( i.e., a permanent threshold shift (PTS) (NMFS 2018)). PTS occurs when noise exposure causes hairs within the inner ear system to die (Ketten 2012). Although the effects of PTS are, by definition, permanent, PTS does not equate to total hearing loss.

Sound exposure thresholds incorporate two metrics of exposure: the peak level of instantaneous exposure likely to cause PTS and the cumulative sound exposure level (SEL CUM ) during a 24-hour period. They also include weighting adjustments for the sensitivity of different species to varying frequencies. PTS-based injury criteria were developed from theoretical extrapolation of observations of temporary threshold shifts (TTS) detected in lab settings during sound exposure trials (Finneran 2015). Southall and colleagues (2019) predict PTS for sea otters, which are included in the “other marine carnivores” category, will occur at 232 dB peak or 203 dB SEL CUM for impulsive underwater sound and 219 dB SEL CUM for nonimpulsive (continuous) underwater sound.

Thresholds based on TTS have been used as a proxy for Level B harassment ( i.e., 70 FR 1871, January 11, 2005; 71 FR 3260, January 20, 2006; 73 FR 41318, July 18, 2008). Southall et al. (2007) derived TTS thresholds for pinnipeds based on 212 dB peak and 171 dB SEL CUM . Exposures resulting in TTS in pinnipeds were found to range from 152 to 174 dB (183 to 206 dB SEL) (Kastak et al. 2005), with a persistent TTS, if not a PTS, after 60 seconds of 184 dB SEL (Kastak et al. 2008). Kastelein et al. (2012) found small but statistically significant TTSs at approximately 170 dB SEL (136 dB, 60 minutes (min)) and 178 dB SEL (148 dB, 15 min). Based on these findings, Southall et al. (2019) developed TTS thresholds for sea otters, which are included in the “other marine carnivores” category, of 188 dB SEL CUM for impulsive sounds and 199 dB SEL CUM for nonimpulsive sounds.

The NMFS (2018) criteria do not identify thresholds for avoidance of Level B harassment. For pinnipeds (seals and sea lions), NMFS has adopted a 160-dB threshold for Level B harassment from exposure to impulsive noise and a 120-dB threshold for continuous noise (NMFS 1998, HESS 1999, NMFS 2018). These thresholds were developed from observations of mysticete (baleen) whales responding to airgun operations ( e.g., Malme et al. 1983; Malme and Miles 1983; Richardson et al. 1986, 1995) and from equating Level B harassment with noise levels capable of causing TTS in lab settings. Southall et al. (2007, 2019) assessed behavioral response studies and found considerable variability among pinnipeds. The authors determined that exposures between approximately 90 to 140 dB generally do not appear to induce strong behavioral responses from pinnipeds in water. However, they found behavioral effects, including avoidance, become more likely in the range between 120 to 160 dB, and most marine mammals showed some, albeit variable, responses to sound between 140 to 180 dB. Wood et al. (2012) adapted the approach identified in Southall et al. (2007) to develop a probabilistic scale for marine mammal taxa at which 10 percent, 50 percent, and 90 percent of individuals exposed are assumed to produce a behavioral response. For many marine mammals, including pinnipeds, these response rates were set at sound pressure levels of 140, 160, and 180 dB, respectively.

We have evaluated these thresholds and determined that the Level B threshold of 120 dB for nonimpulsive noise is not applicable to sea otters. The 120-dB threshold is based on studies in which gray whales ( Eschrichtius robustus ) were exposed to experimental playbacks of industrial noise (Malme et al. 1983; Malme and Miles 1983). During these playback studies, southern sea otter responses to industrial noise were also monitored (Riedman 1983, 1984). Gray whales exhibited avoidance to industrial noise at the 120-dB threshold; however, there was no evidence of disturbance reactions or avoidance in southern sea otters. Thus, given the different range of frequencies to which sea otters and gray whales are sensitive, the NMFS 120-dB threshold based on gray whale behavior is not appropriate for predicting sea otter behavioral responses, particularly for low-frequency sound.

Based on the lack of sea otter disturbance response or any other reaction to the playback studies from the 1980s, as well as the absence of a clear pattern of disturbance or avoidance behaviors attributable to underwater sound levels up to about 160 dB resulting from low-frequency broadband noise, we assume 120 dB is not an appropriate behavioral response threshold for sea otters exposed to continuous underwater noise.

Based on the best available scientific information about sea otters, and closely related marine mammals when sea otter data are limited, the Service has set 160 dB of received underwater sound as a threshold for Level B harassment by disturbance for sea otters for this proposed IHA. Exposure to unmitigated in-water noise levels between 125 Hz and 38 kHz that are greater than 160 dB—for both impulsive and nonimpulsive sound sources—will be considered by the Service as Level B harassment. Thresholds for Level A harassment (which entails the potential for injury) will be 232 dB peak or 203 dB SEL for impulsive sounds and 219 dB SEL for continuous sounds (table 1).

The NMFS (2018) guidance neither addresses thresholds for preventing injury or disturbance from airborne noise, nor provides thresholds for avoidance of Level B harassment. Southall et al. (2007) suggested thresholds for PTS and TTS for sea lions exposed to nonpulsed airborne noise of 172.5 and 159 dB re (20 µPa) 2 -s SEL. Conveyance of underwater noise into the air is of little concern since the effects of pressure release and interference at the water's surface reduce underwater noise transmission into the air. For activities that create both in-air and underwater sounds, we will estimate take based on parameters for underwater noise transmission. Considering sound energy travels more efficiently through water than through air, this estimation will also account for exposures to sea otters at the surface.

Sea otters may be more resistant to the effects of sound disturbance and human activities than other marine mammals. For example, observers have noted no changes from southern sea otters in regard to their presence, density, or behavior in response to underwater sounds from industrial noise recordings at 110 dB and a frequency range of 50 Hz to 20 kHz and airguns, even at the closest distance of 0.5 nautical miles (<1 km or 0.6 mi) (Riedman 1983). Southern sea otters did not respond noticeably to noise from a single 1,638 cubic centimeters (cm 3 ) (100 cubic inches [in 3 ]) airgun, and no sea otter disturbance reactions were evident when a 67,006 cm 3 (4,089 in 3 ) airgun array was as close as 0.9 km (0.6 mi) to sea otters (Riedman 1983, 1984). However, southern sea otters displayed slight reactions to airborne engine noise (Riedman 1983). Northern sea otters were observed to exhibit a limited response to a variety of airborne and underwater sounds, including a warble tone, sea otter pup calls, calls from killer whales ( Orcinus orca ) (which are predators to sea otters), air horns, and an underwater noise harassment system designed to drive marine mammals away from crude oil spills (Davis et al. 1988). These sounds elicited reactions from northern sea otters, including startle responses and movement away from noise sources. However, these reactions were observed only when northern sea otters were within 100 to 200 m (328 to 656 ft) of noise sources. Further, northern sea otters appeared to become habituated to the noises within 2 hours or, at most, 3-4 days (Davis et al. 1988).

Noise exposure may be influenced by the amount of time sea otters spend at the water's surface. Noise at the water's surface can be attenuated by turbulence from wind and waves more quickly compared to deeper water, reducing potential noise exposure (Greene and Richardson 1988, Richardson et al. 1995). Additionally, turbulence at the water's surface limits the transference of sound from water to air. A sea otter with its head above water will be exposed to only a small fraction of the sound energy traveling through the water beneath it. The average amount of time that sea otters spend above the water each day while resting and grooming varies between males and females and across seasons (Esslinger et al. 2014, Zellmer et al. 2021). For example, female sea otters foraged for an average of 8.78 hours per day compared to male sea otters, which foraged for an average of 7.85 hours per day during the summer months (Esslinger et al. 2014). Male and female sea otters spend an average of 63 to 67 percent of their day at the surface resting and grooming during the summer months (Esslinger et al. 2014). Few studies have evaluated foraging times during the winter months. Garshelis et al. (1986) found that foraging times increased from 5.1 hours per day to 16.6 hours per day in the winter; however, Gelatt et al. (2002) did not find a significant difference in seasonal foraging times. It is likely that seasonal variation is determined by seasonal differences in energetic demand and the quality and availability of prey sources (Esslinger et al. 2014). These findings suggest that the large portion of the day sea otters spend at the surface may help limit sea otters' exposure during noise-generating operations.

Sea otter sensitivity to industrial activities may be influenced by the overall level of human activity within the sea otter population's range. In locations that lack frequent human activity, sea otters appear to have a lower threshold for disturbance. Sea otters in Alaska exhibited escape behaviors in response to the presence and approach of vessels (Udevitz et al. 1995). Behaviors included diving or actively swimming away from a vessel, entering the water from haulouts, and disbanding groups with sea otters swimming in multiple different directions (Udevitz et al. 1995). Sea otters in Alaska were also observed to avoid areas with heavy boat traffic in the summer and return to these areas during seasons with less vessel traffic (Garshelis and Garshelis 1984). In Cook Inlet, sea otters drifting on a tide trajectory that would have taken them within 500 m (0.3 mi) of an active offshore drilling rig were observed to swim in order to avoid a close approach of the drilling rig despite near-ambient noise levels (BlueCrest 2013).

Individual sea otters in Passage Canal will likely show a range of responses to noise from pile-driving activities. Some sea otters will likely dive, show startle responses, change direction of travel, or prematurely surface. Sea otters reacting to pile-driving activities may divert time and attention from biologically important behaviors, such as feeding and nursing pups. Sea otter responses to disturbance can result in energetic costs, which increases the amount of prey required by sea otters (Barrett 2019). This increased prey consumption may impact sea otter prey availability and cause sea otters to spend more time foraging and less time resting (Barrett 2019). Some sea otters may abandon the project area and return when the disturbance has ceased. Based on the observed movement patterns of sea otters ( i.e., Lensink 1962; Kenyon 1969, 1981; Garshelis and Garshelis 1984; Riedman and Estes 1990; Tinker and Estes 1996), we expect some individuals will respond to pile-driving activities by dispersing to nearby areas of suitable habitat; however, other sea otters, especially territorial adult males, are less likely to be displaced.

The reactions of wildlife to disturbance can range from short-term behavioral changes to long-term impacts that affect survival and reproduction. When disturbed by noise, animals may respond behaviorally ( e.g., escape response) or physiologically ( e.g., increased heart rate, hormonal response) (Harms et al. 1997; Tempel and Gutiérrez 2003). Theoretically, the energy expense and associated physiological effects from repeated disturbance could ultimately lead to reduced survival and reproduction (Gill and Sutherland 2000; Frid and Dill 2002). For example, South American sea lions ( Otaria byronia ) visited by tourists exhibited an increase in the state of alertness and a decrease in maternal attendance and resting time on land, thereby potentially reducing population size (Pavez et al. 2015). In another example, killer whales that lost feeding opportunities due to boat traffic faced a substantial (18 percent) estimated decrease in energy intake (Williams et al. 2006). In severe cases, such disturbance effects could have population-level consequences. For example, increased disturbance by tourism vessels has been associated with a decline in abundance of bottlenose dolphins ( Tursiops spp.) (Bejder et al. 2006; Lusseau et al. 2006). However, these examples evaluated sources of disturbance that were longer term and more consistent than the temporary and intermittent nature of the specified project activities.

These examples illustrate direct effects on survival and reproductive success, but disturbances can also have indirect effects. Response to noise disturbance is considered a nonlethal stimulus that is similar to an antipredator response (Frid and Dill 2002). Sea otters are susceptible to predation, particularly from killer whales and eagles, and have a well-developed antipredator response to perceived threats. For example, the presence of a harbor seal ( Phoca vitulina ) did not appear to disturb southern sea otters, but they demonstrated a fear response in the presence of a California sea lion by actively looking above and beneath the water (Limbaugh 1961).

Although an increase in vigilance or a flight response is nonlethal, a tradeoff occurs between risk avoidance and energy conservation. An animal's reactions to noise disturbance may cause stress and direct an animal's energy away from fitness-enhancing activities such as feeding and mating (Frid and Dill 2002; Goudie and Jones 2004). For example, southern sea otters in areas with heavy recreational boat traffic demonstrated changes in behavioral time budgeting, showing decreased time resting and changes in haulout patterns and distribution (Benham 2006; Maldini et al. 2012). Chronic stress can also lead to weakened reflexes, lowered learning responses (Welch and Welch 1970; van Polanen Petel et al. 2006), compromised immune function, decreased body weight, and abnormal thyroid function (Selye 1979).

Changes in behavior resulting from anthropogenic disturbance can include increased agonistic interactions between individuals or temporary or permanent abandonment of an area (Barton et al. 1998). Additionally, the extent of previous exposure to humans (Holcomb et al. 2009), the type of disturbance (Andersen et al. 2012), and the age or sex of the individuals (Shaughnessy et al. 2008; Holcomb et al. 2009) may influence the type and extent of response in individual sea otters.

Vessel collisions with marine mammals can result in death or serious injury. Wounds resulting from vessel strike may include massive trauma, hemorrhaging, broken bones, or propeller lacerations (Knowlton and Kraus 2001). An animal may be harmed by a vessel when the vessel runs over the animal at the surface, the animal hits the bottom of a vessel while the animal is surfacing, or the animal is cut by a vessel's propeller.

Vessel strike has been documented as a cause of death across all three stocks of northern sea otters in Alaska. Since 2002, the Service has conducted 1,433 sea otter necropsies to determine cause of death, disease incidence, and the general health status of sea otters in Alaska. Vessel strike or blunt trauma was identified as a definitive or presumptive cause of death in 65 cases (4 percent) (USFWS 2020). In most of these cases, trauma was determined to be the ultimate cause of death; however, there was a contributing factor, such as disease or biotoxin exposure, which incapacitated the sea otter and made it more vulnerable to vessel strike (USFWS 2023).

Vessel speed influences the likelihood of vessel strikes involving sea otters. The probability of death or serious injury to a marine mammal increases as vessel speed increases (Laist et al. 2001, Vanderlaan and Taggart 2007). Sea otters spend a considerable portion of their time at the water's surface (Esslinger et al. 2014). They are typically visually aware of approaching vessels and can move away if a vessel is not traveling too quickly. Mitigation measures to be applied to vessel operations to prevent collisions or interactions are included below in the proposed authorization portion of this document under Avoidance and Minimization.

Sea otters exhibit behavioral flexibility in response to vessels, and their responses may be influenced by the intensity and duration of the vessel's activity. As noted above, sea otter populations in Alaska were observed to avoid areas with heavy vessel traffic but return to those same areas during seasons with less vessel traffic (Garshelis and Garshelis 1984). Sea otters have also shown signs of disturbance or escape behaviors in response to the presence and approach of survey vessels including sea otters diving and/or actively swimming away from a vessel, sea otters on haulouts entering the water, and groups of sea otters disbanding and swimming in multiple different directions (Udevitz et al. 1995).

Additionally, sea otter responses to vessels may be influenced by the sea otter's previous experience with vessels. Groups of southern sea otters in two locations in California showed markedly different responses to kayakers approaching to within specific distances, suggesting a different level of tolerance between the groups (Gunvalson 2011). Benham (2006) found evidence that the sea otters exposed to high levels of recreational activity may have become more tolerant than individuals in less-disturbed areas. Sea otters off the California coast showed only mild interest in vessels passing within hundreds of meters and appeared to have habituated to vessel traffic (Riedman 1983, Curland 1997). These findings indicate that sea otters may adjust their responses to vessel activities depending on the level of activity. Vessel activity during the project includes the transit of three barges for materials and construction, all of which will remain onsite, mostly stationary, to support the work; additionally, two skiffs will be used during the project: one for transporting workers short distances to the crane barge and the other for marine mammal monitoring during pile driving. Vessels will not be used extensively or over a long duration during the planned work; therefore, we do not anticipate that sea otters will experience changes in behavior indicative of tolerance or habituation.

Physical and biological features of habitat essential to the conservation of sea otters include the benthic invertebrates that sea otters eat and the shallow rocky areas and kelp beds that provide cover from predators. Sea otter habitat in the project area includes coastal areas within the 40-m (131-ft) depth contour where high densities of sea otters have been detected.

Industrial activities, such as pile driving, may generate in-water noise at levels that can temporarily displace sea otters from important habitat and impact sea otter prey species. The primary prey species for sea otters are sea urchins ( Strongylocentrotus spp. and Mesocentrotus spp.), abalone ( Haliotis spp.), clams ( e.g., Clinocardium nuttallii, Leukoma staminea, and Saxidomus gigantea ), mussels ( Mytilus spp.), crabs ( e.g., Metacarcinus magister, Pugettia spp ., Telemessus cheiragonus, and Cancer spp.), and squid ( Loligo spp.) (Tinker and Estes 1996, LaRoche et al. 2021). When preferential prey are scarce, sea otters will also eat kelp, slow-moving benthic fishes, sea cucumbers ( e.g., Apostichopus californicus ), egg cases of rays, turban snails ( Tegula spp.), octopuses ( e.g., Octopus spp.), barnacles ( Balanus spp.), sea stars ( e.g., Pycnopodia helianthoides), scallops ( e.g., Patinopecten caurinus), rock oysters ( Saccostrea spp.), worms ( e.g., Eudistylia spp.), and chitons ( e.g., Mopalia spp.) (Riedman and Estes 1990, Davis and Bodkin 2021).

Several studies have addressed the effects of noise on invertebrates (Tidau and Briffa 2016, Carroll et al. 2017). Behavioral changes, such as an increase in lobster ( Homarus americanus ) feeding levels (Payne et al. 2007), an increase in avoidance behavior by wild-caught captive reef squid ( Sepioteuthis australis ) (Fewtrell and McCauley 2012), and deeper digging by razor clams ( Sinonovacula constricta ) (Peng et al. 2016) have been observed following experimental exposures to sound. Physical changes have also been observed in response to increased sound levels, including changes in serum biochemistry and hepatopancreatic cells in lobsters (Payne et al. 2007) and long-term damage to the statocysts required for hearing in several cephalopod species (André et al. 2011, Solé et al. 2013). De Soto et al. (2013) found impaired embryonic development in scallop ( Pecten novaezelandiae ) larvae when exposed to 160 dB. Christian et al. (2003) noted a reduction in the speed of egg development of bottom-dwelling crabs following exposure to noise; however, the sound level (221 dB at 2 m or 6.6 ft) was far higher than the planned project activities will produce. Industrial noise can also impact larval settlement by masking the natural acoustic settlement cues for crustaceans and fish (Pine et al. 2012, Simpson et al. 2016, Tidau and Briffa 2016).

While these studies provide evidence of deleterious effects to invertebrates as a result of increased sound levels, Carroll et al. (2017) caution that there is a wide disparity between results obtained in field and laboratory settings. In experimental settings, changes were observed only when animals were housed in enclosed tanks, and many were exposed to prolonged bouts of continuous, pure tones. We would not expect similar results in open marine conditions. It is unlikely that noises generated by project activities will have any lasting effect on sea otter prey given the short-term duration of sounds produced by each component of the planned work.

Noise-generating activities that interact with the seabed can produce vibrations, resulting in the disturbance of sediment and increased turbidity in the water. Although turbidity is likely to have little impact on sea otters and prey species (Todd et al. 2015), there may be some impacts from vibrations and increased sedimentation. For example, mussels ( Mytilus edulis ) exhibited changes in valve gape and oxygen demand, and hermit crabs ( Pagurus bernhardus ) exhibited limited behavioral changes in response to vibrations caused by pile driving (Roberts et al. 2016). Increased sedimentation is likely to reduce sea otter visibility, which may result in reduced foraging efficiency and a potential shift to less-preferred prey species. These outcomes may cause sea otters to spend more energy on foraging or processing the prey items; however, the impacts of a change in energy expenditure are not likely seen at the population level (Newsome et al. 2015). Additionally, the benthic invertebrates may be impacted by increased sedimentation, resulting in higher abundances of opportunistic species that recover quickly from industrial activities that increase sedimentation (Kotta et al. 2009). Although sea otter foraging could be impacted by industrial activities that cause vibrations and increased sedimentation, it is more likely that sea otters would be temporarily displaced from the project area due to impacts from noise rather than vibrations and sedimentation.

The planned specified activities will occur near marine subsistence harvest areas used by Alaska Natives from Whittier and the surrounding areas. The majority of sea otter harvest in this area occurs more than 3.2 km (2 mi) outside of Whittier. Since 2012, there have been 75 sea otters harvested in the Whittier area, and most of those were taken prior to 2017. From 2018 through 2021, only eight sea otters were harvested from the Whittier area.

The planned project would occur within the Whittier city limits, where firearm use is prohibited. The area potentially affected by the planned project does not significantly overlap with current subsistence harvest areas. Construction activities will not preclude access to hunting areas or interfere in any way with individuals wishing to hunt. Despite no conflict with subsistence use being anticipated, the Service will conduct outreach with potentially affected communities to see whether there are any questions, concerns, or potential conflicts regarding subsistence use in those areas. If any conflicts are identified in the future, TMC will develop a plan of cooperation specifying the steps necessary to minimize any effects the project may have on subsistence harvest.

Below we provide definitions of three potential types of take of sea otters. The Service does not anticipate and is not authorizing lethal take as a part of this proposed IHA; however, the definitions of these take types are provided for context and background:

Lethal Take —Human activity may result in biologically significant impacts to sea otters. In the most serious interactions, human actions can result in mortality of sea otters.

Level A Harassment —Human activity may result in the injury of sea otters. Level A harassment, for nonmilitary readiness activities, is defined as any act of pursuit, torment, or annoyance that has the potential to injure a marine mammal or marine mammal stock in the wild.

Level B Harassment —Level B Harassment for nonmilitary readiness activities means any act of pursuit, torment, or annoyance that 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, feeding, or sheltering. Changes in behavior that disrupt biologically significant behaviors or activities for the affected animal are indicative of take by Level B harassment under the MMPA.

The Service has identified the following sea otter behaviors as indicative of possible Level B harassment:

• Swimming away at a fast pace on belly ( i.e., porpoising);

• Repeatedly raising the head vertically above the water to get a better view (spyhopping) while apparently agitated or while swimming away;

• In the case of a pup, repeatedly spyhopping while hiding behind and holding onto its mother's head;

• Abandoning prey or feeding area;

• Ceasing to nurse and/or rest (applies to dependent pups);

• Ceasing to rest (applies to independent animals);

• Ceasing to use movement corridors;

• Ceasing mating behaviors;

• Shifting/jostling/agitation in a raft so that the raft disperses;

• Sudden diving of an entire raft; or

• Flushing animals off a haulout.

This list is not meant to encompass all possible behaviors; other behavioral responses may equate to take by Level B harassment. Relatively minor changes in behavior such as increased vigilance or a short-term change in direction of travel are not likely to disrupt biologically important behavioral patterns, and the Service does not view such minor changes in behavior as indicative of a take by Level B harassment.

We assumed all animals exposed to underwater sound levels that meet the acoustic exposure criteria defined above in Exposure Thresholds will experience take by Level A or Level B harassment due to exposure to underwater noise. Spatially explicit zones of ensonification were established around the planned construction location to estimate the number of otters that may be exposed to these sound levels. We determined the number of otters present in the ensonification zones using density information generated by Esslinger et al. (2021).

The project can be divided into four major components: DTH drilling, vibratory drilling, pile driving using an impact driver, and skiff use to support construction. Each of these components will generate a different type of in-water noise. Vibratory drilling and the use of skiffs will produce nonimpulsive or continuous noise; impact driving will produce impulsive noise; and DTH drilling is considered to produce both impulsive and continuous noise (NMFS 2020).

The level of sound anticipated from each project component was established using recorded data from several sources listed in tables 2 through 5. We used the NMFS Technical Guidance and User Spreadsheet (NMFS 2018, 2020) to determine the distance at which sound levels would attenuate to Level A harassment thresholds, and empirical data from the proxy projects were used to determine the distance at which sound levels would attenuate to Level B harassment thresholds (table 1). The weighting factor adjustment included in the NMFS user spreadsheet accounts for sounds created in portions of an organism's hearing range where they have less sensitivity. We used the weighting factor adjustment for otariid pinnipeds as they are the closest available physiological and anatomical proxy for sea otters. The spreadsheet also incorporates a transmission loss coefficient, which accounts for the reduction in sound level outward from a sound source. We used the NMFS-recommended transmission loss coefficient of 15 for coastal pile-driving activities to indicate practical spread (NMFS 2020).

We calculated the harassment zones for DTH drilling with input from NMFS. The sound pressure levels produced by DTH drilling were provided by NMFS in 2022 via correspondence with Solstice Alaska Consulting, who created the application for this IHA on behalf of TMC. We then used the NMFS Technical Guidance and User Spreadsheet (NMFS 2018, 2020) to determine the distance at which these sounds would attenuate to Level A harassment thresholds. To estimate the distances at which sounds would attenuate to Level B harassment thresholds, we used the NMFS-recommended transmission loss coefficient of 15 for coastal pile-driving activities in a practical spreading loss model (NMFS 2020) to determine the distance at which sound levels attenuate to 160 dB re 1 µPa. However, due to the differences in how PTS and TTS thresholds are calculated, as well as limited data of underwater sound pressure levels from DTH drilling, the resultant Level A isopleths are larger than the Level B isopleths.

Sound levels for all sources are unweighted and given in dB re 1µPa. Nonimpulsive sounds are in the form of mean maximum root mean square (RMS) sound pressure level (SPL) as it is more conservative than cumulative sound exposure level (SEL) or peak SPL for these activities. Impulsive sound sources are in the form of SEL for a single strike.

To determine the number of sea otters that may experience in-water sounds >160 dB re 1µPa due to pile driving, we multiplied the area ensonified to >160 dB re 1µPa by the density of animals (2.03 sea otters/km 2 ) derived from surveys conducted off Prince William Sound (Esslinger 2021). We applied the same methodology to determine the number of sea otters that may experience sounds capable of causing PTS. The number of sea otters expected to be exposed to such sound levels can be found in tables 2 through 5. To calculate the area ensonified for each type of pile-driving activity, the coordinates of the piles were mapped in ArcGIS Pro. We used a representative pile of each size around which to map the Level A and Level B harassment zones. We chose representative piles that were farthest from shore so that the zones that are intercepted by land have the largest in-water areas possible. The majority of these radii are small enough that their defined circles will fall entirely in the water, and in these instances, the area was calculated as πr 2 . The exceptions are the Level A and Level B zones generated by impact pile driving the 36-in permanent and 42-in piles, as well as the Level B zone generated by impact pile driving the 48-in piles; for these, we used ArcGIS Pro to map and calculate the area of the water ensonified by those activities.

The area ensonified by the worker transit skiff was estimated by multiplying the vessel's anticipated daily track length by twice the 160 dB radius plus πr 2 to account for the rounded ends of the track line. It was estimated that the distance of each trip would be no more than 457.2 m (1,500 ft).

The monitoring skiff will travel in a triangle of perimeter approximately 7 km (4.3 mi) between Emerald Island, the north shore of Passage Canal, and Gradual Point. To estimate the area ensonified by the monitoring skiff, we used ArcGIS Pro to plot the points of the triangle, map the track line between those points, and apply a buffer of 10 m (33 ft; the 160-dB radius) on either side of the track line.

We assumed that the different types of activities would occur sequentially and that the total number of days of work would equal the sum of the number of days required to complete each type of activity. While it is possible that on some days more than one type of activity will take place, which would reduce the number of days of exposure within a year, we cannot know this information in advance. As such, the estimated number of days and, therefore, exposures per year is the maximum possible for the planned work. Where the number of exposures expected per day was zero to three or more decimal places ( i.e., <0.00X), the number of exposures per day was assumed to be zero.

In order to minimize exposure of sea otters to sounds above Level A harassment thresholds, TMC will implement shutdown zones ranging from 10 to 260 m (33 to 853 ft), based on the pile size and type of pile driving or marine construction activity, where operations will cease should a sea otter enter or approach the specified zone. Soft-start and zone clearance prior to startup will also limit the exposure of sea otters to sound levels that could cause PTS. However, TMC has requested, and the Service proposes to authorize, small numbers of take by Level A harassment during impact pile driving and DTH drilling.

We estimate that 544 takes of 37 sea otters by Level B harassment and 70 takes of 7 sea otters by Level A harassment may occur due to TMC's planned cruise ship dock construction activities. In order to conduct this analysis and estimate the potential amount of take by harassment, several critical assumptions were made.

Level B harassment is equated herein with behavioral responses that indicate harassment or disturbance. There is likely a portion of animals that respond in ways that indicate some level of disturbance but do not experience significant biological consequences.

We used the sea otter density for the Whittier area from surveys and analyses conducted by Esslinger (2021). Methods and assumptions for these surveys can be found in the original publication.

We used sound source verification from recent pile-driving activities in a number of locations within and beyond Alaska to generate sound level estimates for construction activities. Environmental conditions in these locations, including water depth, substrate, and ambient sound levels are similar to those in the project location, but not identical. Further, estimation of ensonification zones were based on sound attenuation models using a practical spreading loss model. These factors may lead to actual sound values differing slightly from those estimated here.

We assumed that all piles will be installed and removed while submerged in water. Some of the 36-in permanent piles supporting the approach trestle, and the associated temporary 36-in piles used for the templates to install the permanent piles, will be located in the intertidal zone. Work performed at lower tidal heights would likely result in decreased transmission of sounds to the water column. However, as the timing of pile installation and removal was not known in advance, we accounted for the possibility that all work may occur at a tidal height that allows for full sound transmission.

Finally, the pile-driving activities described here will also create in-air noise. Because sea otters spend over half of their day with their heads above water (Esslinger et al. 2014), they will be exposed to an increase in-air noise from construction equipment. However, we have calculated Level B harassment with the assumption that an individual may be harassed only one time per 24-hour period, and underwater sound levels will be more disturbing and extend farther than in-air noise. Thus, while sea otters may be disturbed by noise both in-air and underwater, we have relied on the more conservative underwater estimates.

The applicant plans to conduct pile driving and marine construction activities in Whittier, Alaska, over the course of a year from the date of issuance of the IHA. A summary of total estimated take during the project by source is provided in table 6.

Over the course of the project, we estimate 544 instances of take by Level B harassment of 37 northern sea otters from the Southcentral Alaska stock due to behavioral responses of TTS associated with noise exposure. Although multiple instances of Level B harassment of individual sea otters are possible, these events are unlikely to have significant consequences for the health, reproduction, or survival of affected animals and therefore would not rise to the level of an injury or Level A harassment.

The use of soft-start procedures, zone clearance prior to startup, and shutdown zones is likely to decrease both the number of sea otters exposed to sounds above Level A harassment thresholds and the exposure time of any sea otters venturing into a Level A harassment zone. This reduces the likelihood of losses of hearing sensitivity that might impact the health, reproduction, or survival of affected animals. Despite the implementation of mitigation measures, it is anticipated that some sea otters will experience Level A harassment via exposure to underwater sounds above threshold criteria during impact and DTH pile-driving activities. Due to sea otters' small body size and low profile in the water, as well as the relatively large size of the Level A harassment zone associated with these activities, we anticipate that sea otters will at times avoid detection before entering Level A harassment zones for those activities. We anticipate that PSOs will be able to reliably detect and prevent take by Level A harassment of sea otters up to 20 m away; conversely, we anticipate that at distances greater than 20 m, sea otters will at times avoid detection. Throughout the project, we estimate 70 instances of take by Level A harassment of 7 sea otters.

Sea otters exposed to sound from the specified activities are likely to respond with temporary behavioral modification or displacement. The specified activities could temporarily interrupt the feeding, resting, and movement of sea otters. Because activities will occur during a limited amount of time and in a localized region, the impacts associated with the project are likewise temporary and localized. The anticipated effects are short-term behavioral reactions and displacement of sea otters near active operations.

Sea otters that encounter the specified activity may exert more energy than they would otherwise due to temporary cessation of feeding, increased vigilance, and retreating from the project area. We expect that affected sea otters will tolerate this exertion without measurable effects on health or reproduction. Most of the anticipated takes will be due to short-term Level B harassment in the form of TTS, startling reactions, or temporary displacement. While mitigation measures incorporated into TMC's request will reduce occurrences of Level A harassment to the extent practicable, a small number of takes by Level A harassment would be authorized for impact and DTH pile-driving activities, which have Level A harassment zone radii ranging in size from 57.9 to 256 m (190 to 840 ft).

With the adoption of the mitigation measures incorporated in TMC's request and required by this proposed IHA, anticipated take was reduced. Those mitigation measures are further described below.

To assess whether the authorized incidental taking would be limited to “small numbers” of marine mammals, the Service uses a proportional approach that considers whether the estimated number of marine mammals to be subjected to incidental take is small relative to the population size of the species or stock. Here, predicted levels of take were determined based on the estimated density of sea otters in the project area and ensonification zones developed using empirical evidence from similar geographic areas.

We estimate TMC's specified activities in the specified geographic region will take no more than 544 takes of 37 sea otters by Level B harassment and 70 takes of 7 sea otters by Level A harassment during the 1-year period of this proposed IHA (see Sum of Take from All Sources ). Take of 44 animals is 0.2 percent of the best available estimate of the current Southcentral Alaska stock size of 21,617 animals (Esslinger et al. 2021) ((44 ÷ 21,617) × 100 ≉ 0.2) and represents a “small number” of sea otters of that stock.

We propose a finding that any incidental take by harassment resulting from the specified activities cannot be reasonably expected to, and is not reasonably likely to, adversely affect the sea otter through effects on annual rates of recruitment or survival and will, therefore, have no more than a negligible impact on the Southcentral Alaska stock of northern sea otters. In making this finding, we considered the best available scientific information, including the biological and behavioral characteristics of the species, the most recent information on species distribution and abundance within the area of the specified activities, the current and expected future status of the stock (including existing and foreseeable human and natural stressors), the potential sources of disturbance caused by the project, and the potential responses of marine mammals to this disturbance. In addition, we reviewed applicant-provided materials, information in our files and datasets, published reference materials, and species experts.

Sea otters are likely to respond to planned activities with temporary behavioral modification or temporary displacement. These reactions are not anticipated to have consequences for the long-term health, reproduction, or survival of affected animals. Most animals will respond to disturbance by moving away from the source, which may cause temporary interruption of foraging, resting, or other natural behaviors. Affected animals are expected to resume normal behaviors soon after exposure with no lasting consequences. Each sea otter is estimated to be exposed to construction noise for between 4 and 129 days per year, resulting in repeated exposures. However, injuries ( i.e., Level A harassment or PTS) due to chronic sound exposure is estimated to occur at a longer time scale (Southall et al. 2019). The area that will experience noise greater than Level B thresholds due to pile driving is small (less than 0.18 km 2 ), and an animal that may be disturbed could escape the noise by moving to nearby quiet areas. Further, sea otters spend over half of their time above the surface during the summer months (Esslinger et al. 2014), and likely no more than 70 percent of their time foraging during winter months (Gelatt et al. 2002), thus their ears will not be exposed to continuous noise, and the amount of time it may take for permanent injury is considerably longer than that of mammals primarily under water. Some animals may exhibit some of the stronger responses typical of Level B harassment, such as fleeing, interruption of feeding, or flushing from a haulout. These responses could have temporary biological impacts for affected individuals but are not anticipated to result in measurable changes in survival or reproduction.

The total number of animals affected and severity of impact is not sufficient to change the current population dynamics at the stock scale. Although the specified activities may result in approximately 614 incidental takes of 44 sea otters from the Southcentral Alaska stock, we do not expect this level of harassment to affect annual rates of recruitment or survival or result in adverse effects on the stock.

Our proposed finding of negligible impact applies to incidental take associated with the specified activities as mitigated by the avoidance and minimization measures identified in TMC's mitigation and monitoring plan. These mitigation measures are designed to minimize interactions with and impacts to sea otters. These measures and the monitoring and reporting procedures are required for the validity of our finding and are a necessary component of the proposed IHA. For these reasons, we propose a finding that the specified project will have a negligible impact on the Southcentral Alaska stock of northern sea otters.

We find that the mitigation measures required by this proposed IHA will effect the least practicable adverse impacts on the stocks from any incidental take likely to occur in association with the specified activities. In making this finding, we considered the biological characteristics of sea otters, the nature of the specified activities, the potential effects of the activities on sea otters, the documented impacts of similar activities on sea otters, and alternative mitigation measures.

In evaluating what mitigation measures are appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses, we considered the manner and degree to which the successful implementation of the measures are expected to achieve this goal. We considered the nature of the potential adverse impact being mitigated (likelihood, scope, range), the likelihood that the measures will be effective if implemented, and the likelihood of effective implementation. We also considered the practicability of the measures for applicant implementation ( e.g., cost, impact on operations). We assessed whether any additional, practicable requirements could be implemented to further reduce effects, but did not identify any.

To reduce the potential for disturbance from acoustic stimuli associated with the activities, TMC will implement mitigation measures, including the following:

• Using the smallest diameter piles practicable while minimizing the overall number of piles;

• Using a project design that does not include dredging or blasting;

• Using pile caps made of high-density polyethylene or ultra-high-molecular-weight polyethylene softening materials during impact pile driving;

• Minimizing the use of the impact hammer to the extent possible by using a vibratory hammer to advance piles as deeply as possible;

• Employing an 18-m (60-ft) deep bubble curtain during all impact pile driving as well as during all pile-driving activities in less than 18 m (60 ft) of water to reduce noise impacts;

• Not reducing sound source levels due to the planned use of pile caps and a bubble curtain to calculate the most conservative harassment and shutdown zones;

• Development of a marine mammal monitoring and mitigation plan;

• Establishment of shutdown and monitoring zones;

• Visual mitigation monitoring by designated protected species observers (PSO);

• Site clearance before startup;

• Soft-start procedures; and

• Shutdown procedures.

The Service has not identified any additional ( i.e., not already incorporated into TMC's request) mitigation or monitoring measures that are practicable and would further reduce potential impacts to sea otters and their habitat.

The project will not preclude access to harvest areas or interfere with the availability of sea otters for harvest. Additionally, the planned cruise ship berth and associated facilities are located within the City of Whittier, where firearm use is prohibited. We therefore propose a finding that TMC's anticipated harassment will not have an unmitigable adverse impact on the availability of any stock of northern sea otters for taking for subsistence uses. In making this finding, we considered the timing and location of the planned activities and the timing and location of subsistence harvest activities in the project area.

The purposes of the monitoring requirements are to document and provide data for assessing the effects of specified activities on sea otters; to ensure that take is consistent with that anticipated in the small numbers, negligible impact, and subsistence use analyses; and to detect any unanticipated effects on the species. Monitoring plans include steps to document when and how sea otters are encountered and their numbers and behaviors during these encounters. This information allows the Service to measure encounter rates and trends and to estimate numbers of animals potentially affected. To the extent possible, monitors will record group size, age, sex, reaction, duration of interaction, and closest approach to the project activity.

As proposed, monitoring activities will be summarized and reported in formal reports. TMC must submit monthly reports for all months during which noise-generating work takes place as well as a final monitoring report that must submitted no later than 90 days after the expiration of the IHA. We will require an approved plan for monitoring and reporting the effects of pile driving and marine construction activities on sea otters prior to issuance of an IHA. We will require approval of the monitoring results for continued operation under the IHA.

We find that these proposed monitoring and reporting requirements to evaluate the potential impacts of planned activities will ensure that the effects of the activities remain consistent with the rest of the findings.

We have prepared a draft environmental assessment in accordance with the NEPA (42 U.S.C. 4321 et seq.). We have preliminarily concluded that authorizing the nonlethal, incidental, unintentional take by Level B harassment of up to 544 takes of 37 sea otters and by Level A harassment of up to 70 takes of 7 sea otters from the Southcentral Alaska stock in the specified geographic region during the specified activities during the regulatory period would not significantly affect the quality of the human environment and, thus, preparation of an environmental impact statement for this proposed IHA is not required by section 102(2) of NEPA or its implementing regulations. We are accepting comments on the draft environmental assessment as specified above in DATES and ADDRESSES .

Under the ESA (16 U.S.C. 1536(a)(2)), all Federal agencies are required to ensure the actions they authorize are not likely to jeopardize the continued existence of any threatened or endangered species or result in destruction or adverse modification of critical habitat. The specified activities would occur entirely within the range of the Southcentral Alaska stock of northern sea otters, which is not listed as threatened or endangered under the ESA. The authorization of incidental take of sea otters and the measures included in the proposed IHA would not affect other listed species or designated critical habitat.

It is our responsibility to communicate and work directly on a Government-to-Government basis with federally recognized Alaska Native Tribes in developing programs for healthy ecosystems. We seek their full and meaningful participation in evaluating and addressing conservation concerns for protected species. It is our goal to remain sensitive to Alaska Native culture, and to make information available to Alaska Natives. Our efforts are guided by the following policies and directives:

(1) The Native American Policy of the Service (January 20, 2016);

(2) The Alaska Native Relations Policy (currently in draft form);

(3) Executive Order 13175 (January 9, 2000);

(4) Department of the Interior Secretary's Orders 3206 (June 5, 1997), 3225 (January 19, 2001), 3317 (December 1, 2011), and 3342 (October 21, 2016);

(5) The Alaska Government-to-Government Policy (a departmental memorandum issued January 18, 2001); and

(6) The Department of the Interior's policies on consultation with Alaska Native Tribes and organizations.

We have evaluated possible effects of the specified activities on federally recognized Alaska Native Tribes and organizations. The Service has determined that, due to this project's locations and activities, the Tribal organizations and communities near Whittier, Alaska, as well as relevant Alaska Native Claims Settlement Act corporations, will not be impacted by this project. Regardless, we will be reaching out to them to inform them of the availability of this proposed IHA and offer them the opportunity to consult.

We invite continued discussion, either about the project and its impacts or about our coordination and information exchange throughout the IHA process.

We propose to authorize the nonlethal, incidental take by Level A and Level B harassment of 614 takes of 44 sea otters from the Southcentral Alaska stock. Authorized take may be caused by pile driving and marine construction activities conducted by Turnagain Marine Construction (TMC) in Whittier, Alaska, over the course of a year from the date of issuance of the IHA. We do not anticipate or authorize any lethal take to sea otters resulting from these activities.

(1) Activities must be conducted in the manner described in the December 22, 2022, revised request from TMC for an IHA and in accordance with all applicable conditions and mitigation measures. The taking of sea otters whenever the required conditions, mitigation, monitoring, and reporting measures are not fully implemented as required by the IHA is prohibited. Failure to follow the measures specified both in the revised request and within this proposed authorization may result in the modification, suspension, or revocation of the IHA.

(2) If project activities cause unauthorized take ( i.e., greater than 614 takes of 44 of the Southcentral Alaska stock of northern sea otters, a form of take other than Level A or Level B harassment, or take of one or more sea otters through methods not described in the IHA), TMC must take the following actions:

(i) cease its activities immediately (or reduce activities to the minimum level necessary to maintain safety);

(ii) report the details of the incident to the Service within 48 hours; and

(iii) suspend further activities until the Service has reviewed the circumstances and determined whether additional mitigation measures are necessary to avoid further unauthorized taking.

(3) All operations managers, vehicle operators, and machine operators must receive a copy of this IHA and maintain access to it for reference at all times during project work. These personnel must understand, be fully aware of, and be capable of implementing the conditions of the IHA at all times during project work.

(4) This IHA will apply to activities associated with the specified project as described in this document and in TMC's revised request. Changes to the specified project without prior authorization may invalidate the IHA.

(5) TMC's revised request is approved and fully incorporated into this IHA unless exceptions are specifically noted herein. The request includes:

(i) TMC's original request for an IHA, dated September 16, 2022;

(ii) Revised applications, dated November 11, November 23, December 1, and December 22, 2022;

(iii) Marine Mammal Mitigation and Monitoring Plan;

(iv) Google Earth package;

(v) Bubble curtain schematics; and

(vi) Pile coordinates.

(6) Operators will allow Service personnel or the Service's designated representative to visit project worksites to monitor for impacts to sea otters and subsistence uses of sea otters at any time throughout project activities so long as it is safe to do so. “Operators” are all personnel operating under TMC's authority, including all contractors and subcontractors.

(7) Construction activities must be conducted using equipment that generates the lowest practicable levels of underwater sound within the range of frequencies audible to sea otters.

(8) During all pile-installation activities, regardless of predicted sound levels, a physical interaction shutdown zone of 20 m (66 ft) must be enforced. If a sea otter enters the shutdown zone, in-water activities must be delayed until either the animal has been visually observed outside the shutdown zone, or 15 minutes have elapsed since the last observation time without redetection of the animal.

(9) If the impact driver has been idled for more than 30 minutes, an initial set of three strikes from the impact driver must be delivered at reduced energy, followed by a 1-minute waiting period, before full-powered proofing strikes.

(10) In-water activity must be conducted in daylight. If environmental conditions prevent visual detection of sea otters within the shutdown zone, in-water activities must be stopped until visibility is regained.

(11) All in-water work along the shoreline must be conducted during low tide when the site is dewatered to the maximum extent practicable.

Vessel operators must take every precaution to avoid harassment of sea otters when a vessel is operating near these animals. The applicant must carry out the following measures:

(12) Vessels must remain at least 500 m (0.3 mi) from rafts of sea otters unless safety is a factor. Vessels must reduce speed and maintain a distance of 100 m (328 ft) from all sea otters unless safety is a factor.

(13) Vessels must not be operated in such a way as to separate members of a group of sea otters from other members of the group and must avoid alongshore travel in shallow water (<20 m) whenever practicable.

(14) When weather conditions require, such as when visibility drops, vessels must adjust speed accordingly to avoid the likelihood of injury to sea otters.

(15) Vessel operators must be provided written guidance for avoiding collisions and minimizing disturbances to sea otters. Guidance will include measures identified in paragraphs (C)(12) through (15) of this section.

(16) Operators shall work with protected species observers (PSOs) to apply mitigation measures and shall recognize the authority of PSOs up to and including stopping work, except where doing so poses a significant safety risk to personnel.

(17) Duties of the PSOs include watching for and identifying sea otters, recording observation details, documenting presence in any applicable monitoring zone, identifying and documenting potential harassment, and working with operators to implement all appropriate mitigation measures.

(18) A sufficient number of PSOs will be available to meet the following criteria: 100 percent monitoring of exclusion zones during all daytime periods of underwater noise-generating work; a maximum of 4 consecutive hours on watch per PSO; a maximum of approximately 12 hours on watch per day per PSO.

(19) All PSOs will complete a training course designed to familiarize individuals with monitoring and data collection procedures. A field crew leader with prior experience as a sea otter observer will supervise the PSO team. Initially, new or inexperienced PSOs will be paired with experienced PSOs so that the quality of marine mammal observations and data recording is kept consistent. Resumes for candidate PSOs will be made available for the Service to review.

(20) Observers will be provided with reticule binoculars (7×50 or better), big-eye binoculars or spotting scopes (30×), inclinometers, and range finders. Field guides, instructional handbooks, maps, and a contact list will also be made available.

(21) Observers will collect data using the following procedures:

(i) All data will be recorded onto a field form or database.

(ii) Global positioning system data, sea state, wind force, and weather will be collected at the beginning and end of a monitoring period, every hour in between, at the change of an observer, and upon sightings of sea otters.

(iii) Observation records of sea otters will include date; time; the observer's locations, heading, and speed (if moving); weather; visibility; number of animals; group size and composition (adults/juveniles); and the location of the animals (or distance and direction from the observer).

(iv) Observation records will also include initial behaviors of the sea otters, descriptions of project activities and underwater sound levels being generated, the position of sea otters relative to applicable monitoring and mitigation zones, any mitigation measures applied, and any apparent reactions to the project activities before and after mitigation.

(v) For all sea otters in or near a mitigation zone, observers will record the distance from the sound source to the sea otter upon initial observation, the duration of the encounter, and the distance at last observation in order to monitor cumulative sound exposures.

(vi) Observers will note any instances of animals lingering close to or traveling with vessels for prolonged periods of time.

(22) Monitoring of the shutdown zone must continue for 30 minutes following completion of pile installation.

(23) Prior to conducting the work, TMC will take the following steps to reduce potential effects on subsistence harvest of sea otters:

(i) Avoid work in areas of known sea otter subsistence harvest;

(ii) Discuss the planned activities with subsistence stakeholders including Southcentral Alaska villages and traditional councils;

(iii) Identify and work to resolve concerns of stakeholders regarding the project's effects on subsistence hunting of sea otters; and

(iv) If any concerns remain, develop a POC in consultation with the Service and subsistence stakeholders to address these concerns.

(24) TMC must notify the Service at least 48 hours prior to commencement of activities.

(25) Monthly reports will be submitted to the Service's Marine Mammal Management office (MMM) for all months during which noise-generating work takes place. The monthly report will contain and summarize the following information: dates, times, weather, and sea conditions (including the Beaufort Scale sea state and wind force conditions) when sea otters were sighted; the number, location, distance from the sound source, and behavior of the sea otters; the associated project activities; and a description of the implementation and effectiveness of mitigation measures with a discussion of any specific behaviors the sea otters exhibited in response to mitigation.

(26) A final report will be submitted to the Service's MMM within 90 days after completion of work or expiration of the IHA. The report will include:

(i) A summary of monitoring efforts (hours of monitoring, activities monitored, number of PSOs, and, if requested by the Service, the daily monitoring logs).

(ii) A description of all project activities, along with any additional work yet to be done. Factors influencing visibility and detectability of marine mammals ( e.g., sea state, number of observers, and fog and glare) will be discussed.

(iii) A description of the factors affecting the presence and distribution of sea otters ( e.g., weather, sea state, and project activities). An estimate will be included of the number of sea otters exposed to noise at received levels greater than or equal to 160 dB (based on visual observation).

(iv) A description of changes in sea otter behavior resulting from project activities and any specific behaviors of interest.

(v) A discussion of the mitigation measures implemented during project activities and their observed effectiveness for minimizing impacts to sea otters. Sea otter observation records will be provided to the Service in the form of electronic database or spreadsheet files.

(27) Injured, dead, or distressed sea otters that are not associated with project activities ( e.g., animals known to be from outside the project area, previously wounded animals, or carcasses with moderate to advanced decomposition or scavenger damage) must be reported to the Service within 24 hours of the discovery to either the Service's MMM (1-800-362-5148, business hours); or the Alaska SeaLife Center in Seward (1-888-774-7325, 24 hours a day); or both. Photographs, video, location information, or any other available documentation must be provided to the Service.

(28) All reports shall be submitted by email to fw7_mmm_reports@fws.gov.

(29) TMC must notify the Service upon project completion or end of the work season.

If you wish to comment on this proposed authorization, the associated draft environmental assessment, or both documents, you may submit your comments by either of the methods described in ADDRESSES . Please identify if you are commenting on the proposed authorization, draft environmental assessment, or both, make your comments as specific as possible, confine them to issues pertinent to the proposed authorization, and explain the reason for any changes you recommend. Where possible, your comments should reference the specific section or paragraph that you are addressing. The Service will consider all comments that are received before the close of the comment period (see DATES ). The Service does not anticipate extending the public comment period beyond the 30 days required under section 101(a)(5)(D)(iii) of the MMPA.

Comments, including names and street addresses of respondents, will become part of the administrative record for this proposal. Before including your address, telephone number, email address, or other personal identifying information in your comment, be advised that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comments to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so.

The purpose for which the withdrawal was first made requires this extension for continued use of the lands as a magnetic and seismological observatory.

By virtue of the authority vested in the Secretary of the Interior by section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is ordered as follows:

1. Subject to valid existing rights, E.O. No. 8854 (6 FR 4181 (1941)), as modified by PLO No. 6458 (48 FR 40232 (1983)) and extended by PLO No. 7581 (68 FR 52613 (2003)), which withdrew 117.13 acres of public land from all forms of appropriation under the public land laws, including the mining laws, but not from the mineral leasing laws, for the Sitka Magnetic Observatory site, and reserved it for use by the United States Geological Survey as a magnetic and seismological observatory in Sitka, Alaska, is hereby extended for an additional 20-year period.

2. The withdrawal extended by this Order will expire on September 5, 2043, unless, as a result of a review conducted prior to the expiration date, pursuant to Section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f), the Secretary determines that the withdrawal shall be further extended.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Detroit Institute of Arts. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Detroit Institute of Arts.

Human remains representing, at minimum, two individuals were removed from a location most likely in the upper peninsula of Michigan. On May 19, 2021, Detroit Institute of Arts staff encountered these human remains (X1989.3768) during a comprehensive review of the Indigenous America collection. No known individuals were identified. The two associated funerary objects (X1989.3768) are one rim sherd and one rodent rib fragment.

The human remains and associated funerary objects in this notice were removed from a known geographic location. This location is the aboriginal land of one or more Indian Tribes. The following information was used to identify the aboriginal land: a final judgment of the Indian Claims Commission, the United States Court of Claims, a treaty, an Act of Congress, and an Executive Order.

Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes, the Detroit Institute of Arts has determined that:

• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.

• The two objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• No relationship of shared group identity can be reasonably traced between the human remains and associated funerary objects and any Indian Tribe.

• The human remains and associated funerary objects described in this notice were removed from the aboriginal land of the Absentee-Shawnee Tribe of Indians of Oklahoma; Bad River Band of the Lake Superior Tribe of Chippewa Indians of the Bad River Reservation, Wisconsin; Bay Mills Indian Community, Michigan; Chippewa Cree Indians of the Rocky Boy's Reservation, Montana; Citizen Potawatomi Nation, Oklahoma; Eastern Shawnee Tribe of Oklahoma; Forest County Potawatomi Community, Wisconsin; Grand Traverse Band of Ottawa and Chippewa Indians, Michigan; Hannahville Indian Community, Michigan; Keweenaw Bay Indian Community, Michigan; Kickapoo Traditional Tribe of Texas; Kickapoo Tribe of Indians of the Kickapoo Reservation in Kansas; Kickapoo Tribe of Oklahoma; Lac Courte Oreilles Band of Lake Superior Chippewa Indians of Wisconsin; Lac du Flambeau Band of Lake Superior Chippewa Indians of the Lac du Flambeau Reservation of Wisconsin; Lac Vieux Desert Band of Lake Superior Chippewa Indians of Michigan; Little River Band of Ottawa Indians, Michigan; Little Shell Tribe of Chippewa Indians of Montana; Little Traverse Bay Bands of Odawa Indians, Michigan; Match-e-be-nash-she-wish Band of Pottawatomi Indians of Michigan; Menominee Indian Tribe of Wisconsin; Miami Tribe of Oklahoma; Minnesota Chippewa Tribe, Minnesota (Six component reservations: Bois Forte Band (Nett Lake); Fond du Lac Band; Grand Portage Band; Leech Lake Band; Mille Lacs Band; White Earth Band); Nottawaseppi Huron Band of the Potawatomi, Michigan; Ottawa Tribe of Oklahoma; Peoria Tribe of Indians of Oklahoma; Pokagon Band of Potawatomi Indians, Michigan and Indiana; Prairie Band Potawatomi Nation; Red Cliff Band of Lake Superior Chippewa Indians of Wisconsin; Red Lake Band of Chippewa Indians, Minnesota; Sac & Fox Nation of Missouri in Kansas and Nebraska; Sac & Fox Nation, Oklahoma; Sac & Fox Tribe of the Mississippi in Iowa; Saginaw Chippewa Indian Tribe of Michigan; Sault Ste. Marie Tribe of Chippewa Indians, Michigan; Seneca Nation of Indians; Seneca-Cayuga Nation; Shawnee Tribe; Sokaogon Chippewa Community, Wisconsin; St. Croix Chippewa Indians of Wisconsin; Tonawanda Band of Seneca; Turtle Mountain Band of Chippewa Indians of North Dakota; and the Wyandotte Nation.

Written requests for disposition of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in ADDRESSES . Requests for disposition may be submitted by:

1. Any one or more of the Indian Tribes identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization, or who shows that the requestor is an aboriginal land Indian Tribe.

Disposition of the human remains and associated funerary objects described in this notice to a requestor may occur on or after July 10, 2023. If competing requests for disposition are received, the Detroit Institute of Arts must determine the most appropriate requestor prior to disposition. Requests for joint disposition of the human remains and associated funerary objects are considered a single request and not competing requests. The Detroit Institute of Arts is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.9 and 10.11.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Denver Museum of Nature & Science. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records held by the Denver Museum of Nature & Science.

The 83 cultural items listed in this notice were removed from several locations in the State of New York and Ontario, Canada, beginning in 1965. Of this number, 79 cultural items were purchased by collectors Mary and Francis Crane, who donated their collection to the Denver Museum of Nature & Science (then the Denver Museum of Natural History) between 1968 and 1983. In 1965, the Cranes purchased from Gerald Fenstermaker eight Medicine Faces (AC.8544, AC.9717, AC.9722, AC.9724, AC.9727, AC.9728, AC.9729, AC.9742); two Corn Husk Faces (AC.9709, AC.9711); two Husk Face Figurines comprising a set (AC.9825A-B); three Medicine Face Figurines comprising a set (AC.9826A-C); nine Medicine Face Figurines comprising a set (AC.8554A-I); and 10 Medicine Face Figurines comprising a set (AC.11957A-J). These cultural items had been removed from various locations in the State of New York and Ontario, Canada. Between 1965 and 1967, the Cranes purchased from Howard B. Roloff three Corn Husk Faces (AC.8341, AC.8381 AC.9714); 25 Medicine Faces (AC.8375, AC.8379, AC.8390, AC.8391, AC.8444, AC.10284, AC.10285, AC.10319, AC.10330, AC.10333A-K, AC.8406A-E); 12 Medicine Face Figurines comprising a set (AC.8285A-L); and four Medicine Face Figurines comprising a set (AC.10328). These cultural items had been acquired from the Six Nations of the Grand River Reserve in Ontario, Canada. In 1969, the Cranes purchased a figurine wearing a Medicine Face from the Las Novedades Gallery in Taos, NM (AC.7684). The figurine is identified as Haudenosaunee.

In 1990, one Medicine Face (A1648.1) was transferred from the Museum's Education Collection to its Anthropology Collection. In 1999, during a NAGPRA consultation, representatives of the Haudenosaunee Confederacy suggested that this cultural item is a copy of an older mask made by Elon Webster, an Onondaga carver from the Tonawanda Reservation in New York.

In 1989, the Museum purchased three cultural items from William H. Hensler of Aurora, CO. Hensler had acquired these items from Iroqrafts, an arts and crafts store located on the Six Nations of the Grand River Reserve in Canada. The items are three Medicine Faces (A1633.1, A1633.2, and A1633.3). Museum records indicate that A1633.1 and A1633.2 were made by “He Keeps Ice” and are affiliated with the Cayuga Wolf clan, and that A1633.3 was made by “Across the River” and is affiliated with the Mohawk Turtle Clan.

The Denver Museum of Nature & Science acknowledges that the Haudenosaunee Confederacy predates the establishment of the geopolitical borders that separate its territories. Haudenosaunee communities maintain unbroken political, cultural, spiritual, and economic ties to their lands. The cultural items listed in this notice belong to the Confederacy, and as Keepers of the Central Fire of the Haudenosaunee, the Onondaga Nation is responsible for their care and protection. In a letter dated Feb. 21, 2022, Christine G. Abrams, Acting Chair of the Haudenosaunee Standing Committee on Burial Rules and Regulations, informed the Museum that the Standing Committee had approved the Onondaga Nation's request to repatriate Medicine Faces, Corn Husk Faces, and figurines wearing Medicine Faces or Corn Husk Faces designated as “Haudenosaunee,” “Iroquois,” and “Grand River,” as well as those with multiple affiliations.

The cultural items in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: anthropological, folkloric, geographical, historical, oral traditional, other relevant information, and expert opinion.

Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the Denver Museum of Nature & Science has determined that:

• The 83 cultural items described above have ongoing historical traditional or cultural importance central to the Native American Group or culture itself, rather than property owned by an individual.

• The 83 cultural items described above are specific ceremonial objects needed by traditional Native American religious leaders for the practice of traditional Native American religions by their present-day adherents.

• There is a relationship of shared group identity that can be reasonably traced between the cultural items and the Onondaga Nation.

Additional, written requests for repatriation of the cultural items in this notice must be sent to the Responsible Official identified in ADDRESSES. Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural items in this notice to a requestor may occur on or after July 10, 2023. If competing requests for repatriation are received, the Denver Museum of Nature & Science must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The Denver Museum of Nature & Science is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.8, 10.10, and 10.14.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Rochester Museum & Science Center. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Rochester Museum & Science Center.

Human remains representing, at minimum, seven individuals were removed from the Palmer (F.A. Rider) Site (Ap1 001) in Broome County, NY. The individuals were excavated during RMSC expeditions in 1931, 1933, and 1948. No known individuals were identified. Of the eight associated funerary objects listed in this notice, two objects are present and accounted for in the RMSC collections and six objects are currently missing. (Rochester Museum & Science Center continues to look for these missing objects.) The two present associated funerary objects are one lot of sherds and one lot of bear skeletons. The six currently missing associated funerary objects are one deer skull; two stone net sinkers; one miniature pot; and two body sherds.

Human remains representing, at minimum, 27 individuals were removed from the Roger P. Clark Site (Bgh 002) in Broome County, NY. The individuals were excavated by the Rochester Museum in 1929 and 1930. No known individuals were identified. The one associated funerary object is a lot of mixed soil and bone fragments.

Human remains representing, at minimum, one individual were removed from the Roger P. Clark Site (Bgh 002) in Broome County, NY. The individual was removed by Mr. Clark in 1930. No known individual was identified. The one associated funerary object is one lot of brass thimbles with thongs.

The human remains and associated funerary objects in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following type of information was used to reasonably trace the relationship: geographical.

Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the Rochester Museum & Science Center has determined that:

• The human remains described in this notice represent the physical remains of 35 individuals of Native American ancestry.

• The 10 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a relationship of shared group identity that can be reasonably traced between the human remains and associated funerary objects described in this notice and the Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Indian Nation; Oneida Nation; Onondaga Nation; and the Tuscarora Nation.

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after July 10, 2023. If competing requests for repatriation are received, the Rochester Museum & Science Center must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The Rochester Museum & Science Center is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.9, 10.10, and 10.14.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Fine Arts Museums of San Francisco. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records held by the Fine Arts Museums of San Francisco.

On an unknown date the one cultural item was removed from Acoma, NM. The cultural item is a shield. The provenance of the shield is documented by two art exhibitions and accompanying catalogues at the Art Institute of Chicago and the Aspen Center for the Visual arts in 1977 and 1979, respectively. In 1977, Robert & Sharon Ashton of Santa Fe, NM, were listed as the owners of the shield. From 1979 to 1985, the shield was in the private collection of Jonathan and Philip M. Holstein of The Thundercloud Corporation, Aspen, CO. In 1985, the shield was sold to Thomas W. Weisel. It was in the Thomas W. Weisel Family Collection, Ross, CA, from 1985 until 2013, when it was gifted to the Fine Arts Museums of San Francisco. The shield is both a sacred object and an object of culturally patrimony.

The cultural item in this notice is connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: art historical, oral traditional, other relevant information, and expert opinion.

Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the Fine Arts Museums of San Francisco has determined that:

• The one cultural item described above is a specific ceremonial object needed by traditional Native American religious leaders for the practice of traditional Native American religions by their present-day adherents.

• The one cultural item described above has ongoing historical, traditional, or cultural importance central to the Native American group or culture itself, rather than property owned by an individual.

• There is a relationship of shared group identity that can be reasonably traced between the cultural item and the Pueblo of Acoma, New Mexico.

Additional, written requests for repatriation of the cultural item in this notice must be sent to the Responsible Official identified in ADDRESSES . Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural item in this notice to a requestor may occur on or after July 10, 2023. If competing requests for repatriation are received, the Fine Arts Museums of San Francisco must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural item are considered a single request and not competing requests. The Fine Arts Museums of San Francisco is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.8, 10.10, and 10.14.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Kansas City Museum. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Kansas City Museum.

In 1943, human remains representing, at minimum, one individual were removed from Amchitka Island, AK, (catalogue number: 1961.56.8). The collector removed these human remains while stationed at a now-abandoned nuclear test site on Amchitka Island, in the Aleutian Islands, and subsequently donated them to the Kansas City Museum. The human remains—a jawbone fragment without teeth and a jawbone fragment with a single tooth—belong to an individual of unknown age and sex. The one associated funerary object is a faunal tooth, possibly from a bear.

The human remains and associated funerary objects in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: geographical, historical, and expert opinion.

Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the Kansas City Museum has determined that:

• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.

• The one object described in this notice is reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a relationship of shared group identity that can be reasonably traced between the human remains and associated funerary object described in this notice and the Native Village of Atka.

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after July 10, 2023. If competing requests for repatriation are received, the Kansas City Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The Kansas City Museum is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.9, 10.10, and 10.14.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Kansas City Museum. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Kansas City Museum.

In 1954, human remains representing, at minimum, one individual were removed from site 23PL1, commonly referred to as the Renner Site, in Platte County, MO. These human remains (catalogue number: I.1995.268 (part of 2000.7)) were excavated with the private landowner's permission during an archeological project conducted jointly by the Kansas City Museum, the University of Missouri, and the Kansas City Archaeological Society. The human remains—skull fragments—belong to a subadult of unknown sex. No associated funerary objects are present.

The human remains and associated funerary objects in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: geographical, historical, and expert opinion.

Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the Kansas City Museum has determined that:

• The human remains described in this notice represent the physical remains of at least one individual of Native American ancestry.

• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and the Pawnee Nation of Oklahoma.

Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the human remains in this notice to a requestor may occur on or after July 10, 2023. If competing requests for repatriation are received, the Kansas City Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The Kansas City Museum is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.9, 10.10, and 10.14.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of UC Davis and UC Berkeley. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records held by UC Davis and UC Berkeley.

The four cultural items listed in this notice were removed from a site along the American River (CA-SAC-157) in Sacramento County, CA.

In 1981, as a part of an archeology course, Richard Burrill, Cordova Senior High School, removed archeological items from CA-SAC-157. Subsequently, these items were donated to the Folsom Historical Society, and in 2016, they were transferred to the UC Davis Shields Library. The items include two lots of unassociated funerary objects, only one of which is present and accounted for in the UC Davis collections. The unassociated funerary objects are one lot consisting of abalone shells and one lot consisting of projectile points, flakes, a scraper, a net weight, and a clamshell disc bead.

On February 16, 1942, Jeremiah B. Lillard, Harry Wanzer, and the Sacramento County Board of Education gifted archeological items from CA-SAC-157 to the Phoebe A. Hearst Museum at the University of California, Berkeley. These items include one lot of unassociated funerary objects consisting of sinkers, mortars, and pestles.

On June 3, 1938, the Phoebe A. Hearst Museum of Anthropology at the University of California, Berkeley, acquired archeological items from CA-SAC-157 that were excavated by Robert Fleming Heizer and the University of California Field Party. These items include one lot of objects of cultural patrimony consisting of awls, ulnas, points, pestles, mortars, shells, and flakes.

The cultural items in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: anthropological, archeological, folkloric, geographical, historical, kinship, linguistic, oral traditional, and other relevant information or expert opinion.

Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, UC Davis and UC Berkeley have determined that:

• The three lots of cultural items described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony and are believed, by a preponderance of the evidence, to have been removed from a specific burial site of a Native American individual.

• The one lot of cultural items described above has ongoing historical, traditional, or cultural importance central to the Native American group or culture itself, rather than property owned by an individual.

• There is a relationship of shared group identity that can be reasonably traced between the cultural items and the Wilton Rancheria, California.

Additional, written requests for repatriation of the cultural items in this notice must be sent to the Responsible Official identified in ADDRESSES . Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural items in this notice to a requestor may occur on or after July 10, 2023. If competing requests for repatriation are received, UC Davis and UC Berkeley must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. UC Davis and UC Berkeley are responsible for sending a copy of this notice to the Indian Tribe identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.8, 10.10, and 10.14.

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, Reclamation is rescinding the INTERIOR/WBR-37, Trespass Cases, SORN from its inventory. This system was used to manage Reclamation's trespass cases and investigations records. During a review of systems of records, Reclamation determined that trespass case records are covered by DOI's Department-wide SORN for incident reporting and law enforcement investigations, INTERIOR/DOI-10, Incident Management, Analysis and Reporting System, 79 FR 31974 (June 3, 2014); modification published at 86 FR 50156 (September 7, 2021). Reclamation has migrated trespass case records into the Department-wide system and is rescinding the INTERIOR/WBR-37, Trespass Cases, SORN to eliminate an unnecessary duplicate notice in accordance with OMB Circular A-108, Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act.

Rescinding the INTERIOR/WBR-37, Trespass Cases, SORN will have no adverse impacts on individuals as the records are covered under INTERIOR/DOI-10, Incident Management, Analysis and Reporting System, and individuals may continue to seek access or correction to their records under this notice. This rescindment will also promote the overall streamlining and management of DOI Privacy Act systems of records. This notice hereby rescinds the INTERIOR/WBR-37, Trespass Cases, SORN as identified below.

Scope. —For purposes of these investigations, Commerce has defined the subject merchandise as file folders consisting primarily of paper, paperboard, pressboard, or other cellulose material, whether coated or uncoated, that has been folded (or creased in preparation to be folded), glued, taped, bound, or otherwise assembled to be suitable for holding documents. The scope includes all such folders, regardless of color, whether or not expanding, whether or not laminated, and with or without tabs, fasteners, closures, hooks, rods, hangers, pockets, gussets, or internal dividers. The term “primarily” as used in the first sentence of this scope means 50 percent or more of the total product weight, exclusive of the weight of fasteners, closures, hooks, rods, hangers, removable tabs, and similar accessories, and exclusive of the weight of packaging.

Subject folders have the following dimensions in their folded and closed position: lengths and widths of at least 8 inches and no greater than 17 inches, regardless of depth.

The scope covers all varieties of folders, including but not limited to manila folders, hanging folders, fastener folders, classification folders, expanding folders, pockets, jackets, and wallets.

Excluded from the scope are:

• mailing envelopes with a flap bearing one or more adhesive strips that can be used permanently to seal the entire length of a side such that, when sealed, the folder is closed on all four sides;

• binders, with two or more rings to hold documents in place, made from paperboard or pressboard encased entirely in plastic;

• binders consisting of a front cover, back cover, and spine, with or without a flap; to be excluded, a mechanism with two or more metal rings must be included on or adjacent to the interior spine;

• non-expanding folders with a depth exceeding 2.5 inches and that are closed or closeable on the top, bottom, and all four sides ( e.g., boxes or cartons);

• expanding folders that have (1) 13 or more pockets, (2) a flap covering the top, (3) a latching mechanism made of plastic and/or metal to close the flap, and (4) an affixed plastic or metal carry handle;

• folders that have an outer surface (other than the gusset, handles, and/or closing mechanisms, if any) that is covered entirely with fabric, leather, and/or faux leather;

• fashion folders, which are defined as folders with all of the following characteristics: (1) plastic lamination covering the entire exterior of the folder, (2) printing, foil stamping, embossing ( i.e., raised relief patterns that are recessed on the opposite side), and/or debossing ( i.e., recessed relief patterns that are raised on the opposite side), covering the entire exterior surface area of the folder, (3) at least two visible and printed or foil stamped colors other than the color of the base paper, and other than the printing of numbers, letters, words, or logos, each of which separately covers no less than 10 percent of the entire exterior surface area, and (4) patterns, pictures, designs, or artwork covering no less than thirty percent of the exterior surface area of the folder;

• portfolios, which are folders having (1) a width of at least 16 inches when open flat, (2) no tabs or dividers, and (3) one or more pockets that are suitable for holding letter size documents and that cover at least 15 percent of the surface area of the relevant interior side or sides; and

• report covers, which are folders having (1) no tabs, dividers, or pockets, and (2) one or more fasteners or clips, each of which is permanently affixed to the center fold, to hold papers securely in place.

Background. —The final phase of these investigations is being scheduled pursuant to sections 705(b) and 731(b) of the Tariff Act of 1930 (19 U.S.C. 1671d(b) and 1673d(b)), as a result of affirmative preliminary determinations by Commerce that certain benefits which constitute subsidies within the meaning of § 703 of the Act (19 U.S.C. 1671b) are being provided to manufacturers, producers, or exporters in India of paper file folders, and that such products from China, India, and Vietnam are being sold in the United States at less than fair value within the meaning of § 733 of the Act (19 U.S.C. 1673b). The investigations were requested in petitions filed on October 12, 2023, by the Coalition of Domestic Folder Manufacturers, Hastings, Minnesota and Naperville, Illinois.

For further information concerning the conduct of this phase of the investigations, hearing procedures, and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).

Participation in the investigations and public service list. —Persons, including industrial users of the subject merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the final phase of these investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11 of the Commission's rules, no later than 21 days prior to the hearing date specified in this notice. A party that filed a notice of appearance during the preliminary phase of the investigations need not file an additional notice of appearance during this final phase. The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the investigations.

Please note the Secretary's Office will accept only electronic filings during this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, https://edis.usitc.gov. ) No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list. —Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in the final phase of these investigations available to authorized applicants under the APO issued in the investigations, provided that the application is made no later than 21 days prior to the hearing date specified in this notice. Authorized applicants must represent interested parties, as defined by 19 U.S.C. 1677(9), who are parties to the investigations. A party granted access to BPI in the preliminary phase of the investigations need not reapply for such access. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Staff report. —The prehearing staff report in the final phase of these investigations will be placed in the nonpublic record on September 19, 2023, and a public version will be issued thereafter, pursuant to § 207.22 of the Commission's rules.

Hearing. —The Commission will hold a hearing in connection with the final phase of these investigations beginning at 9:30 a.m. on Tuesday, October 3, 2023. Requests to appear at the hearing should be filed in writing with the Secretary to the Commission on or before September 27, 2023. Any requests to appear as a witness via videoconference must be included with your request to appear. Requests to appear via videoconference must include a statement explaining why the witness cannot appear in person; the Chairman, or other person designated to conduct the investigation, may in their discretion for good cause shown, grant such a request. Requests to appear as remote witness due to illness or a positive COVID-19 test result may be submitted by 3pm the business day prior to the hearing. Further information about participation in the hearing will be posted on the Commission's website at https://www.usitc.gov/calendarpad/calendar.html.

A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference, if deemed necessary, to be held at 9:30 a.m. on September 29, 2023. Parties shall file and serve written testimony and presentation slides in connection with their presentation at the hearing by no later than 4:00 p.m. on October 2, 2023. Oral testimony and written materials to be submitted at the public hearing are governed by sections 201.6(b)(2), 201.13(f), and 207.24 of the Commission's rules. Parties must submit any request to present a portion of their hearing testimony in camera no later than 7 business days prior to the date of the hearing.

Written submissions. —Each party who is an interested party shall submit a prehearing brief to the Commission. Prehearing briefs must conform with the provisions of § 207.23 of the Commission's rules; the deadline for filing is September 26, 2023. Parties shall also file written testimony in connection with their presentation at the hearing, and posthearing briefs, which must conform with the provisions of § 207.25 of the Commission's rules. The deadline for filing posthearing briefs is October 11, 2023. In addition, any person who has not entered an appearance as a party to the investigations may submit a written statement of information pertinent to the subject of the investigations, including statements of support or opposition to the petition, on or before October 11, 2023. On October 24, 2023, the Commission will make available to parties all information on which they have not had an opportunity to comment. Parties may submit final comments on this information on or before October 26, 2023, but such final comments must not contain new factual information and must otherwise comply with § 207.30 of the Commission's rules. All written submissions must conform with the provisions of § 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on Filing Procedures, available on the Commission's website at https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's procedures with respect to filings.

Additional written submissions to the Commission, including requests pursuant to § 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.

In accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

Authority: These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.21 of the Commission's rules.

I. Background

The Department of Labor, as part of the continuing effort to reduce paperwork and respondent ( i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, the collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq. ) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of effort in obtaining information (29 U.S.C. 657).

OSHA conducts peer reviews of a draft product for quality by specialists in the field who were not involved in producing the draft. The selection of participants in a peer review is based on expertise, considering their independence and any actual or potential conflicts of interest. The Office of Management and Budget published the Final Information Quality Bulletin for Peer Review on December 15, 2004. The Bulletin states “. . . the agency must address reviewers' potential conflicts of interest (including those stemming from ties to regulated businesses and other stakeholders) and independence from the agency.” The Bulletin requires agencies to adopt or adapt the committee selection policies employed by the National Academy of Sciences (NAS) when selecting peer reviewers who are not government employees. To fulfill this requirement, OSHA has developed a Conflict of Interest (COI) and Disclosure Form, based on NAS' Conflict of Interest Disclosure form. This form will be used to determine whether a conflict exists for a potential peer review panel member.

OSHA has a particular interest in comments on the following issues:

• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions, including whether the information is useful;

• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;

• The quality, utility, and clarity of the information collected; and

• Ways to minimize the burden on employers who must comply—for example, by using automated or other technological information collection and transmission techniques.

There are no changes in burden hours from the previous Information Collection Request for obtaining the necessary background information and disclosure of conflict-of-interest information to ensure that invited experts are not compromised.

OSHA will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirements.