Along with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), the United States Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) are responsible for the oversight and review of organisms modified or developed using genetic engineering and the foods derived from them. In 1986, the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) was published by the Office of Science and Technology Policy (OSTP). The Coordinated Framework explains the regulatory roles for EPA, FDA, and the USDA (APHIS and FSIS), and how Federal agencies use existing Federal statutes to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding innovation. The Coordinated Framework was subsequently updated in 1992 (see 57 FR 6753) and 2017 (see 2017_coordinated_framework_update.pdf ) taking into account advances that had occurred in the field of biotechnology.

The regulations in 7 CFR part 340 govern the movement (importation, interstate movement, and release into the environment) of certain organisms, to include plants, plant pests, and biocontrol organisms, modified or produced through genetic engineering. APHIS first issued these regulations in 1987 under the authority of the Federal Plant Pest Act of 1957 and the Plant Quarantine Act of 1912, two acts that were subsumed into the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq. ) in 2000, along with other provisions. Since 1987, APHIS has amended the regulations seven times, in 1988, 1990, 1993, 1994, 1997, 2005, and 2020.

The most recent update was on May 18, 2020, when we published in the Federal Register (85 FR 29790-29838, Docket No. APHIS-2018-0034) a final rule that marked the first comprehensive revision of the regulations since they were established in 1987. The May 2020 final rule provided clear, predictable, and efficient regulatory pathways for innovators, facilitating the development of plants developed using genetic engineering that are unlikely to pose plant pest risks.

The May 2020 final rule included regulatory exemptions for certain categories of modified plants. Plants are exempt from regulation in accordance with paragraphs (b), (c), and (d) of § 340.1. Additionally, § 340.4 of the 2020 final rule included a regulatory status review (RSR) process for APHIS to determine if a plant developed or modified using genetic engineering is unlikely to pose an increased plant pest risk relative to the plant pest risk posed by the respective non-modified or other appropriate comparator(s) and therefore is not subject to the regulations. Because most microbes  1 are not “plants,” they do not qualify for an exemption under § 340.1 and are not eligible for an RSR under § 340.4.

Under the May 2020 final rule, modified  2 microbes that are plant pests (as the term is defined in § 340.3); or have received deoxyribonucleic acid (DNA) from a plant pest and the DNA from the donor organism either is capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease; or are used to control plant pests and could pose a plant pest risk, are subject to the regulations. 3

The May 2020 final rule included permitting exemptions for some microorganisms. A permit for interstate movement is not required for disarmed Agrobacterium tumefaciens, provided that it is moved as a secure shipment, the cloned genetic material is stably integrated into the genome, and the cloned material does not include the complete infectious genome of a plant pest. In response to comments on the proposed rule about interagency coordination, in the May 2020 final rule, we also added paragraph (f) to § 340.5, which contains an exemption from permitting requirements for any modified microorganism that is currently registered with the EPA as a microbial pesticide, so long as the microorganism is not a plant pest as the term is defined in § 340.3.

However, the May 2020 rule did not include up-front regulatory exemptions or a regulatory review process for modified microorganisms. While several commenters on the proposed rule requested that APHIS develop a process to evaluate the regulatory status of non-plant modified organisms, based on the subject organism's potential plant pest risk, the commenters did not provide specifics on what factors APHIS should consider in such a process. At the time, APHIS stated that further discussion and outreach with impacted developers and other stakeholders would be required before pursuing rulemaking.

On September 12, 2022, President Biden issued Executive Order (E.O.) 14081, 4 “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” with the goal of accelerating biotechnology innovation and growing America's bioeconomy across multiple sectors, including health, agriculture, and energy. Among other objectives, E.O. 14081 aims to support the safe use of biotechnology by clarifying and streamlining regulations in service of a science- and risk-based, predictable, efficient, and transparent regulatory system to support the safe use of products of biotechnology. Among other things, E.O. 14081 directs the EPA, the FDA, and USDA to identify any regulatory ambiguities, gaps, or uncertainties in the January 2017 update to the Coordinated Framework for the Regulation of Biotechnology or subsequent policy changes made by the agencies, through engaging with developers and stakeholders and horizon scanning for novel biotechnology products, and to provide a plan with processes and timelines to implement regulatory reform.

On December 20, 2022, in connection with E.O. 14081, the White House Office of Science and Technology Policy (OSTP)—on behalf of the primary agencies that regulate the products of biotechnology (EPA, FDA, and USDA), issued a request for information, 5 or RFI. The RFI requested relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly regarding new and emerging biotechnology products. The RFI indicated that the information provided would inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products.

There has been significant investment and growth over the last few years in the development of modified microbes for agricultural and industrial uses, including for use as biopesticides, fertilizers, biofuel production, and the manufacture of chemicals and other materials. A number of comments were received that discussed APHIS' regulation of modified microbes. Commenters expressed various concerns including the lack of clarity regarding the regulation of modified microbes generally, a lack of a clear and predictable pathway to commercialization, and what were perceived as onerous regulatory requirements. Commenters suggested APHIS develop regulatory pathways for commercialization for modified microbes, including exemptions and a process similar to the RSR process described in § 340.4 for modified plants. Suggestions for exemptions included exemptions based on the modification similar to exemptions provided for modified plants listed in § 340.1, exemptions based on the species of microbe, and exemptions based on the trait ( e.g., barcoding traits). Suggestions were also made to improve the efficiency of the permitting system for modified microbes by reducing information requirements for certain movement permits (approved under OMB control number 0579-0471) and to set permit conditions that are risk-based and in alignment with agricultural practices.

On March 23, 2023, APHIS made available for review a draft Guide for Submitting Permit Applications for Microorganisms Developed using Genetic Engineering Under 7 CFR part 340 on its website at https://www.aphis.usda.gov/aphis/newsroom/stakeholder-info/sa_by_date/sa-2023/microorganism-guide. We indicated that comments should be submitted to Regulations.gov and received by May 22, 2023. Comments received within that 60-day comment period were similar to those received to the RFI related to potential pathways to commercialization for modified microbes. For example, commenters expressed concern that there were no processes for modified microbes similar to the up-front exemptions at § 340.1 and the Regulatory Status Review process at § 340.4 for modified plants.

Based on this background information, we are soliciting public comments regarding the following questions:

1. Describe new or emerging categories of biotechnology products that are relevant to the development and use of modified microorganisms. To assess new and emerging technologies with modified microbes, what expertise and resources are needed in the government to evaluate the overall plant pest risk of modified microbes?

2. Describe areas where the clarity and/or efficiency of regulations governing modified microorganisms could be improved ( e.g., definitions that need to be provided or revised, barriers to obtaining the data necessary to achieve commercialization).

3. Describe key elements of a regulatory framework that would enable a scientifically sound assessment of a modified microorganism's plant pest risk, in order to inform regulatory decision-making by APHIS.

a. Describe any biological features of microorganisms that APHIS should consider when determining whether a modification changes the plant pest risk, and thus the regulatory status of a modified microorganism ( e.g., the potential for horizontal gene transfer, the production of airborne spores, its ecological role, or the ability to remain dormant for long periods of time).

b. What criteria, data, and information should be considered when assessing a modified microorganism's plant pest risk?

c. What should APHIS consider when determining whether modification of a biocontrol organism could result in it posing a plant pest risk? Provide scientific evidence to support which types of biocontrol organisms and methods could or could not pose a plant pest risk.

4. How should modified microorganisms with multiple uses ( e.g., developed for both biomedical or pharmaceutical purposes and agricultural purposes) be regulated and evaluated by APHIS? What steps should APHIS take to ensure efficient and appropriate oversight and evaluation when a product is subject to regulation and review by both USDA and another Federal agency?

5. Should APHIS consider risk-based exemptions for certain types of microorganisms, or for certain modifications in microorganisms? If so, please provide examples of the types of modified microorganisms that should be exempt from regulation and provide scientific evidence to support which modifications and types of microorganisms should or should not be exempt.

6. Are there any other specific issues or topics APHIS should consider in developing a regulatory framework for assessing the plant pest risk of modified microorganisms, or possible pathways to commercialization for modified microorganisms?

We welcome all comments on the issues outlined above.

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Title: On-Farm Monitoring of Antimicrobial Use and Resistance in U.S. Broiler Production Study.

OMB Control Number: 0579-0481.

Type of Request: Extension of approval of an information collection.

Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq. ), the Secretary of the U.S. Department of Agriculture (USDA) is authorized to protect the health of the livestock, equine, poultry, and aquaculture populations in the United States by preventing the introduction and interstate spread of serious diseases and pests of livestock, equine, poultry, and aquaculture, and for eradicating such diseases and pests from the United States, when feasible. Within the USDA, this authority and mission is delegated to the Animal and Plant Health Inspection Service (APHIS).

In connection with this mission, APHIS operates the National Animal Health Monitoring System (NAHMS), which collects on a national basis, statistically valid and scientifically sound data on the prevalence and economic importance of livestock, equine, poultry, and aquaculture disease risk factors. APHIS is the only agency responsible for collecting data on livestock, equine, poultry, and aquaculture health. NAHMS' studies have evolved into a collaborative industry and Government initiative to help determine the most effective means of preventing and controlling diseases of livestock, equine, poultry, and aquaculture. Participation in any NAHMS study is voluntary, and all data are confidential.

APHIS currently conducts the On-Farm Monitoring of Antimicrobial Use and Resistance in U.S. Broiler Production Study as part of an ongoing series of NAHMS studies on the U.S. livestock, equine, poultry, and aquaculture populations. This study supports the following objectives: (1) Measure and track trends in antimicrobial use (AMU) and antimicrobial resistance (AMR) in broiler complexes within participating companies over time; (2) Evaluate the relationship between AMU patterns and AMR measured in select bacterial species collected; and (3) Quantify antimicrobial resistance genes in the litter of sampled broiler farms and examine the relationship between these quantities and antimicrobial use patterns.

This study is an information collection being conducted by APHIS through a cooperative agreement with the University of Minnesota that monitors U.S. broiler operations for AMU, AMR, animal health and production practices, the relationship between AMU, AMR, animal health, production practices, and changes over time. We will continue collecting quarterly survey data and litter samples from the same poultry complexes and examine AMR in bacteria such as Salmonella and Campylobacter. This study meets objectives for both the U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria (2015 and 2020) and the USDA AMR National Action Plan (2014). Additionally, this information is an essential component in accomplishing one of APHIS' strategic goals, which is to safeguard American agriculture.

APHIS and the University of Minnesota will continue analyzing and organizing the information into one or more descriptive reports and scientific manuscripts, and for important or special topics, APHIS will continue developing and disseminating targeted information sheets to producers, stakeholders, academicians, veterinarians, and any other interested parties. This information benefits the poultry industry by supplying scientific estimates of AMU and stewardship by poultry producers and evaluation of the influence of these and other management practices on AMR.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the 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 our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 1.5 hours per response.

Respondents: Broiler producers.

Estimated annual number of respondents: 30.

Estimated annual number of responses per respondent: 20.

Estimated annual number of responses: 588.

Estimated total annual burden on respondents: 866 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The meeting agenda will include:

1. Recreation and tourism economics;

2. Forest recreation fee proposal process; and

3. Forest plan revision update.

The agenda will include time for individuals to make oral statements of three minutes or less. Individuals wishing to make an oral statement should make a request in writing at least three days prior to the meeting date to be scheduled on the agenda. Written comments may be submitted to the Forest Service up to 7 days after the meeting date listed under DATES .

Please contact the person listed under FOR FURTHER INFORMATION CONTACT , by or before the deadline, for all questions related to the meeting. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received upon request.

Meeting Accommodations: The meeting location 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 the FOR FURTHER INFORMATION CONTACT section or contact USDA's TARGET Center at 202-720-2600 (voice and TTY) or USDA through the Federal Relay Service at 800-877-8339. Additionally, program information may be made available in languages other than English.

USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the board. To ensure that the recommendations of the Committee have taken into account the needs of the diverse groups served by the Department, membership shall include, to the extent practicable, individuals with demonstrated ability to represent the many communities, identities, races, ethnicities, backgrounds, abilities, cultures, and beliefs of the American people, including underserved communities. USDA is an equal opportunity provider, employer, and lender.

The SAID Program is one of many voluntary geographic partnership programs that collects data to update the U.S. Census Bureau's geographic database, known as the Master Address File/Topologically Integrated Geographic Encoding and Referencing (MAF/TIGER) System. The Census Bureau uses the MAF/TIGER System to link statistical data from censuses and surveys to locations and areas, such as American Indian reservations, states, counties, incorporated places, and census tracts. To tabulate census and survey response data properly, the Census Bureau must have current and accurate addresses, street centerlines, and imagery.

The SAID Program provides the Census Bureau with a continuous method to obtain current, accurate, and complete addresses, street centerlines, and imagery data from tribal, state, and local governments as well as other federal agencies and authoritative data source organizations. The purpose of the SAID Program is to help maintain the Census Bureau's geographic framework for data collection, tabulation, and dissemination between decennial censuses and to support ongoing programs such as the American Community Survey and the Population Estimates Program. The SAID Program will continue to focus on acquiring addresses, street centerlines, and imagery in areas targeted with housing unit growth or change.

The Census Bureau is requesting clearance to continue the SAID Program. As the current OMB Control Number 0607-1008 clearance will expire in January 2025, the new clearance will allow the Census Bureau to continue data acquisition to support MAF/TIGER System updates, quality control, and change detection.

The SAID Program participant universe is determined annually using several evaluation factors. These factors include address growth, address change, or address coverage needs where there is no online address, parcel, or GIS data, and imagery coverage needs. The Census Bureau will contact potential participants by telephone and email to request data, and supporting metadata, for addresses, street centerlines, and/or imagery that are no more than two years old. The Census Bureau will attempt to contact each potential participant three times before rescheduling them for another year.

The Census Bureau may request entire datasets or partial datasets that include only the changes since a previous submission. For participants that agree to provide their data, the Census Bureau will provide guidance for using a secure online data sharing portal. The portal guides participants through the process for securely uploading their data to the Census Bureau and provides the Census Bureau with submission tracking for records management. If a participant's data lacks metadata or if the metadata is insufficient, the Census Bureau will contact the participant to request the additional metadata information. The Census Bureau will only process the data with appropriate metadata.

The data collected in the SAID Program may be used to maintain the Census Bureau's geographic framework for data collection, tabulation, and dissemination to support ongoing programs such as the American Community Survey, population estimates programs, other current surveys, and the decennial census. The SAID Program follows the process below:

• The Census Bureau invites participants, including tribal, state, and local governments; federal agencies; and other authoritative data source organizations each fiscal year.

• Participants are asked to provide a current address list with latitude/longitude coordinates and attributes, street centerline, and/or imagery data, and the associated metadata, for their jurisdiction that is no more than two years old.

• Participants submit the requested data per Census Bureau procedures.

• The Census Bureau validates then updates the MAF/TIGER System with the address and street centerline data provided by participants and uses the imagery for quality control and change detection.

• The Census Bureau uses the updated addresses and street centerlines in the MAF/TIGER System to support Census Bureau data collection, processing, and tabulation.

The Census Bureau is adding a feedback component to its geographic partnership programs to allow for the solicitation of feedback to improve the administration of the respective program and potentially reduce the future burden. Participants may be asked to provide their feedback on materials, method(s) of data collection, manner of communications, and the usability of the program applications and tools.

OMB Control Number: 0607-1008.

Form Number(s): None.

Type of Review: Regular submission, request for a revision of a currently approved collection.

Affected Public: Tribal, state, local governments, federal agencies and other authoritative data source organizations.

Estimated Number of Respondents:

• Census Bureau Contact with Respondents: 500.

• Census Bureau Acquisition of Respondent Geographic Data and Content Clarification: 250.

• Feedback: 25

Estimated Time per Response:

• Census Bureau Contact with Respondents: 1 hour.

• Census Bureau Acquisition of Respondent Geographic Data and Content Clarification: 1.5 hours.

• Feedback: 1 hour.

Estimated Total Annual Burden Hours: 900.

• Census Bureau Contact with Respondents: 500.

• Census Bureau Acquisition of Respondent Geographic Data and Content Clarification: 375.

• Feedback: 25.

Estimated Total Annual Cost to Public: $0. (This is not the cost of respondents' time, but the indirect costs respondents may incur for such things as purchases of specialized software or hardware needed to report, or expenditures for accounting or records maintenance services required specifically by the collection.)

Respondent's Obligation: Voluntary.

Legal Authority: Title 13 U.S.C. 16, 141, and 193.

We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

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

On August 19, 2016, Commerce published the Order in the Federal Register . 1 On October 30, 2023, Commerce initiated a country-wide circumvention inquiry to determine whether imports of R-410B from Mexico, completed in Mexico using HFC components R-32 (difluoromethane) and R-125 (pentafluoroethane) (collectively, China-origin HFC components) manufactured in China, and further processed in the United States are circumventing the Order and, accordingly, should be covered by the scope of the Order. 2 In December 2023, Commerce selected the following two mandatory respondents in this circumvention inquiry: iGas LLC (iGas) and Quimica Marcat, S.A. DE C.V. (Quimica Marcat). 3 For a complete description of the events that followed the initiation of this circumvention inquiry, see the Preliminary Decision Memorandum. 4

The merchandise covered by the Order is certain HFC blends from China. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum. 5

This circumvention inquiry covers imports of R-410B from Mexico, which are completed in Mexico using China-origin HFC components and further processed in the United States (inquiry merchandise).

Commerce is conducting this circumvention inquiry in accordance with section 781(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.226. For a complete description of the methodology underlying this circumvention inquiry, see the Preliminary Decision Memorandum. A list of topics discussed in the Preliminary Decision Memorandum is included in the appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

As detailed in the Preliminary Decision Memorandum, Commerce preliminarily determines that R-410B from Mexico, allegedly completed in Mexico using HFC components from China, that is further processed in the United States, is not circumventing the Order. As a result, in accordance with section 781(a) of the Act, we preliminarily determine that the inquiry merchandise should not be included within the scope of the Order.

As provided in 19 CFR 351.307, Commerce may verify information relied upon in making its final determination.

Case briefs or other written comments should be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which any verification report is issued. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than five days after the date for filing case briefs. 6 Interested parties who submit case briefs or rebuttal briefs in these proceedings must submit: (1) a statement of the issue; and (2) a table of authorities. 7 Case and rebuttal briefs should be filed using ACCESS.

As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this circumvention inquiry, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 8 Further, we request that interested parties limit their executive summary of each issue to no more than 450 words, not including citations. We intend to use the executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final determination of this circumvention inquiry. We request that interested parties include footnotes for relevant citations in the executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 9

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice in the Federal Register , filed electronically via ACCESS. Requests should contain: (1) the requesting party's name, address, and telephone number; (2) the number of individuals from the requesting party that will attend the hearing; and (3) a list of the issues that the party intends to discuss at the hearing. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing.

Commerce is issuing and publishing this determination in accordance with section 781(b) of the Act and 19 CFR 351.226(g)(1).

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

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

On December 27, 2023, NMFS received a request from L-DEO for an IHA to take marine mammals incidental to conducting a marine geophysical survey of the Reykjanes Ridge in the North Atlantic Ocean. NMFS received a final, revised version of L-DEO's application on February 26, 2024, which was deemed adequate and complete on February 27, 2024. L-DEO's request is for take of 25 marine mammal species by Level B harassment and, for a subset of 5 of these species, by Level A harassment. Neither L-DEO nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate. There are no changes from the proposed IHA to the final IHA.

Researchers from the University of Birmingham, University of Southampton and University of Cambridge, with funding from the Natural Environmental Research Council (NERC), plan to conduct a high-energy seismic survey using airguns as the acoustic source from the research vessel (R/V) Marcus G. Langseth (Langseth), which is owned and operated by L-DEO. The planned survey will occur at the Reykjanes Ridge, off southern Iceland, in the northwestern Atlantic Ocean during summer 2024. The survey will occur within Iceland's Exclusive Economic Zone (EEZ) and high seas. The survey will occur in water depths ranging from approximately 600 to 3,000 meters (m), with most of the survey effort (~78 percent) occurring in deep water (considered here to be depths greater than 1000 m). To complete this survey, the R/V Langseth will tow a 36-airgun array with a total discharge volume of ~6,600 cubic inches (in 3 ) at a depth of 10 to 12 m. The airgun array receiving systems for the different survey segments will consist of a 15 kilometer (km) long solid-state hydrophone streamer and approximately 150 deployments using a total of 50 Ocean Bottom Seismometers (OBS). The airguns will fire at a shot interval of 50 m (~24 seconds (s)) during 2-dimensional (2-D) multi-channel seismic (MCS) reflection surveys with the hydrophone streamer and at a 154.4 m (~60 s) interval during OBS seismic refraction surveys. Approximately 2,754 km of total survey trackline are planned, including 1,662 km of MCS seismic reflection data and 1,092 km of OBS refraction data.

The purpose of the survey is to collect data in support of a research proposal entitled `IMPULSE: Taking the Pulse of the Icelandic Mantle Plume'. IMPULSE will make the first definite test of the Thermal Plume Pulsing (TPP) model, the shortest predicted time period of transient mantle convections, which has been suggested as a primary driver of some of the most remarkable perturbations to global climate, ecosystems, and the carbon cycle in Earth's history. The North Atlantic V-shaped Ridges (VSR) are the basis for the TPP model, and the planned survey will acquire the first ever full crustal seismic profiles across multiple complete VSR cycles.

Additional data will be collected using a multibeam echosounder (MBES), a sub-bottom profiler (SBP), and an Acoustic Doppler Current Profiler (ADCP), which will be operated from R/V Langseth continuously during the seismic surveys, including during transit. No take of marine mammals is expected to result from use of this equipment.

The planned survey is expected to last for approximately 38 days, with 9 days of MCS seismic operations, 5 days of OBS seismic operations, 17 days of OBS deployment and retrieval, 3 days of streamer deployment and retrieval, and 4 days of transit. R/V Langseth will likely leave from and return to port in Reykjavik, Iceland during summer 2024.

The planned survey will occur within approximately 56-63° N, 24-34° W, within Iceland's EEZ and on the high seas, in water depths ranging from approximately 600 to 3,000 m. The closest approach of the planned survey lines to land off the south coast of Iceland is ~130 km from Eldey and ~145 km from mainland Iceland. The region where the survey is planned to occur is depicted in figure 1; the tracklines could occur anywhere within the polygon shown in figure 1. Representative survey tracklines are shown; however, some deviation in actual tracklines, including the order of survey operations, could be necessary for reasons such as science drivers, poor data quality, inclement weather, or mechanical issues with the research vessel and/or equipment.

A detailed description of the planned geophysical survey was provided in the Federal Register notice of the proposed IHA (89 FR 41850, March 13, 2024). Since that time, no changes have been made to the planned survey activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specified activity.

A notice of NMFS' proposal to issue an IHA to L-DEO was published in the Federal Register on March 13, 2024 (89 FR 41850). That notice described, in detail, L-DEO's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. In that notice, we requested public input on the request for authorization described therein, our analyses, the proposed authorization, and any other aspect of the notice of proposed IHA, and requested that interested persons submit relevant information, suggestions, and comments. The proposed notice was available for a 30-day public comment period. NMFS received no public comments.

In the notice of the proposed IHA (89 FR 41850, March 13, 2024), NMFS stated an intention to adopt the National Science Foundation's (NSF) Environmental Assessment (EA) to comply with the National Environmental Policy Act of 1969 (NEPA). However, NMFS subsequently determined that this action is consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.

Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS' website ( https://www.fisheries.noaa.gov/find-species ). NMFS refers the reader to the aforementioned source for general information regarding the species listed in table 1.

The populations of marine mammals found in the survey area do not occur within the U.S. EEZ and therefore, are not assessed in NMFS' Stock Assessment Reports (SARs). For most species, there are no stocks defined for management purposes in the survey area, and NMFS is evaluating impacts at the species level and ranges for most species evaluated here are considered to be the North Atlantic. As such, information on potential biological removal level (PBR; defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population) and annual levels of serious injury and mortality from anthropogenic sources are not available for these marine mammal populations. Abundance estimates for marine mammals in the survey location are lacking; therefore, the modeled abundances presented here are based on a variety of proxy sources, including the U.S Navy Atlantic Fleet Training and Testing Area Marine Mammal Density (AFTT) model (Roberts et al., 2023) and the North Atlantic Marine Mammal Commission (NAMMCO; NAMMCO, 2023). The modeled abundance is considered the best scientific information available on the abundance of marine mammal populations in the area.

Table 1 lists all species that occur in the survey area that may be taken as a result of the planned survey and summarizes information related to the population, including regulatory status under the MMPA and Endangered Species Act (ESA).

All 25 species in table 1 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur. All species that could potentially occur in the survey area are listed in section 3 of the application; however, 3 species (North Atlantic right whale ( Eubalaena glacialis ), bowhead whale ( Balaena mysticetus ), and ringed seal ( Phoca hispida hispida )) are omitted from further analysis as they have been infrequently sighted in the survey area or their temporal and/or spatial occurrence is such that take is not expected to occur. They are not discussed further beyond the explanation provided in the Federal Register notice for the proposed IHA (89 FR 41850, March 13, 2024).

A detailed description of the of the species likely to be affected by the geophysical survey, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (89 FR 41850, March 13, 2024). Since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website ( https://www.fisheries.noaa.gov/find-species ) for generalized species accounts.

Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007, 2019) recommended that marine mammals be divided into hearing groups based on directly measured (behavioral or auditory evoked potential techniques) or estimated hearing ranges (behavioral response data, anatomical modeling, etc. ). Note that no direct measurements of hearing ability have been successfully completed for mysticetes ( i.e., low-frequency cetaceans). Subsequently, NMFS (2018) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 decibel (dB) threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall et al. (2007) retained. Marine mammal hearing groups and their associated hearing ranges are provided in table 2.

For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information.

The effects of underwater noise from L-DEO's survey activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The notice of proposed IHA (89 FR 41850, March 13, 2024) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from L-DEO on marine mammals and their habitat. That information and analysis is incorporated by reference into this final IHA determination and is not repeated here; please refer to the notice of proposed IHA (89 FR 41850, March 13, 2024).

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

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

Authorized takes are primarily by Level B harassment, as use of the airgun array has the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result for species of certain hearing groups due to the size of the predicted auditory injury zones for those groups. Auditory injury is less likely to occur for mid-frequency species due to their relative lack of sensitivity to the frequencies at which the primary energy of an airgun signal is found as well as such species' general lower sensitivity to auditory injury as compared to high-frequency cetaceans. As discussed in further detail below, we do not expect auditory injury for mid-frequency cetaceans. No mortality is anticipated as a result of these activities. Below we describe how the authorized take numbers are estimated.

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

NMFS recommends the use of acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur permanent threshold shift (PTS) of some degree (equated to Level A harassment).

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

L-DEO's survey includes the use of impulsive seismic sources ( i.e., airguns), and therefore the 160 dB re 1 μPa is applicable for analysis of Level B harassment.

Level A Harassment —NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (Technical Guidance, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). L-DEO's survey includes the use of impulsive seismic sources ( i.e., airguns).

These thresholds are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS' 2018 Technical Guidance, which may be accessed at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance.

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

When the Technical Guidance was published (NMFS, 2016), in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, we developed a user spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which may result in some degree of overestimate of Level A harassment take. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools and will qualitatively address the output where appropriate.

The planned survey will entail the use of a 36-airgun array with a total discharge volume of 6,600 in 3 at a tow depth of 10 m to 12 m. L-DEO's model results are used to determine the 160 dB rms radius for the airgun source down to a maximum depth of 2,000 m. Received sound levels have been predicted by L-DEO's model (Diebold et al., 2010) as a function of distance from the 36-airgun array. This modeling approach uses ray tracing for the direct wave traveling from the array to the receiver and its associated source ghost (reflection at the air-water interface in the vicinity of the array), in a constant-velocity half-space (infinite homogeneous ocean layer, unbounded by a seafloor). In addition, propagation measurements of pulses from the 36-airgun array at a tow depth of 6 m have been reported in deep water (~1,600 m), intermediate water depth on the slope (~600-1,100 m), and shallow water (~50 m) in the Gulf of Mexico (Tolstoy et al., 2009; Diebold et al., 2010).

For deep and intermediate water cases, the field measurements cannot be used readily to derive the harassment isopleths, as at those sites the calibration hydrophone was located at a roughly constant depth of 350-550 m, which may not intersect all the SPL isopleths at their widest point from the sea surface down to the assumed maximum relevant water depth (~2000 m) for marine mammals. At short ranges, where the direct arrivals dominate and the effects of seafloor interactions are minimal, the data at the deep sites are suitable for comparison with modeled levels at the depth of the calibration hydrophone. At longer ranges, the comparison with the model—constructed from the maximum SPL through the entire water column at varying distances from the airgun array—is the most relevant.

In deep and intermediate water depths at short ranges, sound levels for direct arrivals recorded by the calibration hydrophone and L-DEO model results for the same array tow depth are in good alignment (see figures 12 and 14 in Diebold et al. 2010). Consequently, isopleths falling within this domain can be predicted reliably by the L-DEO model, although they may be imperfectly sampled by measurements recorded at a single depth. At greater distances, the calibration data show that seafloor-reflected and sub-seafloor-refracted arrivals dominate, whereas the direct arrivals become weak and/or incoherent (see figures 11, 12, and 16 in Diebold et al. 2010). Aside from local topography effects, the region around the critical distance is where the observed levels rise closest to the model curve. However, the observed sound levels are found to fall almost entirely below the model curve. Thus, analysis of the Gulf of Mexico calibration measurements demonstrates that although simple, the L-DEO model is a robust tool for conservatively estimating isopleths.

The planned high-energy survey will acquire data with the 36-airgun array at a tow depth of 10 to 12 m. For deep water (>1,000 m), we use the deep-water radii obtained from L-DEO model results down to a maximum water depth of 2,000 m for the 36-airgun array. The radii for intermediate water depths (100-1,000 m) are derived from the deep-water ones by applying a correction factor (multiplication) of 1.5, such that observed levels at very near offsets fall below the corrected mitigation curve (see figure 16 in Diebold et al. 2010).

L-DEO's modeling methodology is described in greater detail in L-DEO's application. The estimated distances to the Level B harassment isopleth for the planned airgun configuration are shown in table 4.

Table 5 presents the modeled PTS isopleths for each cetacean hearing group based on L-DEO modeling incorporated in the companion user spreadsheet, for the high-energy surveys with the shortest shot interval ( i.e. greatest potential to cause PTS based on accumulated sound energy) (NMFS 2018).

Predicted distances to Level A harassment isopleths, which vary based on marine mammal hearing groups, were calculated based on modeling performed by L-DEO using the Nucleus software program and the NMFS user spreadsheet, described below. The acoustic thresholds for impulsive sounds contained in the NMFS Technical Guidance were presented as dual metric acoustic thresholds using both SEL cum and peak sound pressure metrics (NMFS, 2016). As dual metrics, NMFS considers onset of PTS (Level A harassment) to have occurred when either one of the two metrics is exceeded ( i.e., metric resulting in the largest isopleth). The SEL cum metric considers both level and duration of exposure, as well as auditory weighting functions by marine mammal hearing group.

The SEL cum for the 36-airgun array is derived from calculating the modified farfield signature. The farfield signature is often used as a theoretical representation of the source level. To compute the farfield signature, the source level is estimated at a large distance (right) below the array ( e.g., 9 km), and this level is back projected mathematically to a notional distance of 1 m from the array's geometrical center. However, it has been recognized that the source level from the theoretical farfield signature is never physically achieved at the source when the source is an array of multiple airguns separated in space (Tolstoy et al., 2009). Near the source (at short ranges, distances <1 km), the pulses of sound pressure from each individual airgun in the source array do not stack constructively as they do for the theoretical farfield signature. The pulses from the different airguns spread out in time such that the source levels observed or modeled are the result of the summation of pulses from a few airguns, not the full array (Tolstoy et al., 2009). At larger distances, away from the source array center, sound pressure of all the airguns in the array stack coherently, but not within one time sample, resulting in smaller source levels (a few dB) than the source level derived from the far-field signature. Because the far-field signature does not take into account the large array effect near the source and is calculated as a point source, the far-field signature is not an appropriate measure of the sound source level for large arrays. See L-DEO's application for further detail on acoustic modeling.

Auditory injury is unlikely to occur for mid-frequency cetaceans, given the very small modeled zones of injury for those species (all estimated zones are less than 15 m for mid-frequency cetaceans), in context of distributed source dynamics.

In consideration of the received sound levels in the near-field as described above, we expect the potential for Level A harassment of mid-frequency cetaceans to be de minimis, even before the likely moderating effects of aversion and/or other compensatory behaviors ( e.g., Nachtigall et al., 2018) are considered. We do not anticipate that Level A harassment is a likely outcome for any mid-frequency cetacean and do not authorize any take by Level A harassment for these species.

The Level A and Level B harassment estimates are based on a consideration of the number of marine mammals that could be within the area around the operating airgun array where received levels of sound ≥160 dB re 1 µPa rms are predicted to occur. The estimated numbers are based on the densities (numbers per unit area) of marine mammals expected to occur in the area in the absence of seismic surveys. To the extent that marine mammals tend to move away from seismic sources before the sound level reaches the criterion level and tend not to approach an operating airgun array, these estimates likely overestimate the numbers actually exposed to the specified level of sound.

In this section, we provide information about the occurrence of marine mammals, including density or other relevant information which will inform the take calculations.

Habitat-based stratified marine mammal densities for the North Atlantic are taken from the US Navy Atlantic Fleet Training and Testing Area Marine Mammal Density (Roberts et al., 2023; Mannocci et al., 2017), which represent the best available information regarding marine mammal densities in the region. This density information incorporates visual line-transect surveys of marine mammals for over 35 years, resulting in various studies that estimated the abundance, density, and distributions of marine mammal populations. The habitat-based density models consisted of 5 km x 5 km grid cells. The AFTT model does not overlap the survey area but provides density data for marine mammals at the same latitudes and water depths as the planned survey area. The model covers an area of approximately 15-65° N, and from the east coast of the U.S. and Canada to 45° W. More information is available online at https://seamap.env.duke.edu/models/Duke/AFTT/. The range of most populations extends past the coverage of the model.

For most species, only annual densities were available. For some baleen whale species, seasonal densities were available; thus, densities that overlapped the timing of the planned survey ( i.e., summer) were used.

Here, we describe how the information provided above is synthesized to produce a quantitative estimate of the take that is reasonably likely to occur and authorized. In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in Level A or Level B harassment, radial distances from the airgun array to the predicted isopleth corresponding to the Level A harassment and Level B harassment thresholds are calculated, as described above. Those radial distances were then used to calculate the area(s) around the airgun array predicted to be ensonified to sound levels that exceed the harassment thresholds. The distance for the 160-dB Level B harassment threshold and PTS (Level A harassment) thresholds (based on L-DEO model results) was used to draw a buffer around the area expected to be ensonified ( i.e., the survey area). The ensonified areas were then increased by 25 percent to account for potential delays, which is equivalent to adding 25 percent to the planned line km to be surveyed. The density for each species was then multiplied by the daily ensonified areas (increased as described above) and then multiplied by the number of survey days (14) to estimate potential takes (see appendix B of L-DEO's application for more information).

L-DEO assumed that their estimates of marine mammal exposures above harassment thresholds equate to take and requested authorization of those takes. Those estimates in turn form the basis for our take authorization numbers. For the species for which NMFS does not expect there to be a reasonable potential for take by Level A harassment to occur ( i.e., mid-frequency cetaceans and phocid seals), we have added L-DEO's estimated exposures above Level A harassment thresholds to their estimated exposures above the Level B harassment threshold to produce a total number of incidents of take by Level B harassment that are authorized. Estimated exposures and authorized take numbers for authorization are shown in table 6.

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

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

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

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

Visual monitoring requires the use of trained observers (herein referred to as visual protected species observers (PSOs)) to scan the ocean surface for the presence of marine mammals. The area to be scanned visually includes primarily the shutdown zone (SZ), within which observation of certain marine mammals requires shutdown of the acoustic source, a buffer zone, and to the extent possible depending on conditions, the surrounding waters. The buffer zone means an area beyond the SZ to be monitored for the presence of marine mammals that may enter the SZ. During pre-start clearance monitoring ( i.e., before ramp-up begins), the buffer zone also acts as an extension of the SZ in that observations of marine mammals within the buffer zone would also prevent airgun operations from beginning ( i.e., ramp-up). The buffer zone encompasses the area at and below the sea surface from the edge of the 0- 500 m SZ, out to a radius of 1,000 m from the edges of the airgun array (500-1,000 m). This 1,000-m zone (SZ plus buffer) represents the pre-start clearance zone. Visual monitoring of the SZ and adjacent waters (buffer plus surrounding waters) is intended to establish and, when visual conditions allow, maintain zones around the sound source that are clear of marine mammals, thereby reducing or eliminating the potential for injury and minimizing the potential for more severe behavioral reactions for animals occurring closer to the vessel. Visual monitoring of the buffer zone is intended to (1) provide additional protection to marine mammals that may be in the vicinity of the vessel during pre-start clearance, and (2) during airgun use, aid in establishing and maintaining the SZ by alerting the visual observer and crew of marine mammals that are outside of, but may approach and enter, the SZ.

During survey operations ( e.g., any day on which use of the airgun array is planned to occur and whenever the airgun array is in the water, whether activated or not), a minimum of two visual PSOs must be on duty and conducting visual observations at all times during daylight hours ( i.e., from 30 minutes prior to sunrise through 30 minutes following sunset). Visual monitoring of the pre-start clearance zone must begin no less than 30 minutes prior to ramp-up and monitoring must continue until 1 hour after use of the airgun array ceases or until 30 minutes past sunset. Visual PSOs shall coordinate to ensure 360° visual coverage around the vessel from the most appropriate observation posts and shall conduct visual observations using binoculars and the naked eye while free from distractions and in a consistent, systematic, and diligent manner.

PSOs shall establish and monitor the SZ and buffer zone. These zones shall be based upon the radial distance from the edges of the airgun array (rather than being based on the center of the array or around the vessel itself). During use of the airgun array ( i.e., anytime airguns are active, including ramp-up), detections of marine mammals within the buffer zone (but outside the SZ) shall be communicated to the operator to prepare for the potential shutdown of the airgun array. Visual PSOs will immediately communicate all observations to the on duty acoustic PSO(s), including any determination by the PSO regarding species identification, distance, and bearing and the degree of confidence in the determination. Any observations of marine mammals by crew members shall be relayed to the PSO team. During good conditions ( e.g., daylight hours; Beaufort sea state (BSS) 3 or less), visual PSOs shall conduct observations when the airgun array is not operating for comparison of sighting rates and behavior with and without use of the airgun array and between acquisition periods, to the maximum extent practicable.

Visual PSOs may be on watch for a maximum of 4 consecutive hours followed by a break of at least 1 hour between watches and may conduct a maximum of 12 hours of observation per 24-hour period. Combined observational duties (visual and acoustic but not at same time) may not exceed 12 hours per 24-hour period for any individual PSO.

Passive acoustic monitoring (PAM) means the use of trained personnel (sometimes referred to as PAM operators, herein referred to as acoustic PSOs) to operate PAM equipment to acoustically detect the presence of marine mammals. Acoustic monitoring involves acoustically detecting marine mammals regardless of distance from the source, as localization of animals may not always be possible. Acoustic monitoring is intended to further support visual monitoring (during daylight hours) in maintaining a SZ around the sound source that is clear of marine mammals. In cases where visual monitoring is not effective ( e.g., due to weather, nighttime), acoustic monitoring may be used to allow certain activities to occur, as further detailed below.

PAM will take place in addition to the visual monitoring program. Visual monitoring typically is not effective during periods of poor visibility or at night and even with good visibility, is unable to detect marine mammals when they are below the surface or beyond visual range. Acoustic monitoring can be used in addition to visual observations to improve detection, identification, and localization of cetaceans. The acoustic monitoring would serve to alert visual PSOs (if on duty) when vocalizing cetaceans are detected. It is only useful when marine mammals vocalize, but it can be effective either by day or by night and does not depend on good visibility. It will be monitored in real time so that the visual observers can be advised when cetaceans are detected.

The R/V Langseth will use a towed PAM system, which must be monitored by at a minimum one on duty acoustic PSO beginning at least 30 minutes prior to ramp-up and at all times during use of the airgun array. Acoustic PSOs may be on watch for a maximum of 4 consecutive hours followed by a break of at least 1 hour between watches and may conduct a maximum of 12 hours of observation per 24-hour period. Combined observational duties (acoustic and visual but not at same time) may not exceed 12 hours per 24-hour period for any individual PSO.

Survey activity may continue for 30 minutes when the PAM system malfunctions or is damaged, while the PAM operator diagnoses the issue. If the diagnosis indicates that the PAM system must be repaired to solve the problem, operations may continue for an additional 10 hours without acoustic monitoring during daylight hours only under the following conditions:

• Sea state is less than or equal to BSS 4;

• No marine mammals (excluding delphinids) detected solely by PAM in the SZ in the previous 2 hours;

• NMFS is notified via email as soon as practicable with the time and location in which operations began occurring without an active PAM system; and

• Operations with an active airgun array, but without an operating PAM system, do not exceed a cumulative total of 10 hours in any 24-hour period.

A SZ is a defined area within which occurrence of a marine mammal triggers mitigation action intended to reduce the potential for certain outcomes ( e.g., auditory injury, disruption of critical behaviors). The PSOs will establish a minimum SZ with a 500-m radius. The 500-m SZ will be based on radial distance from the edge of the airgun array (rather than being based on the center of the array or around the vessel itself). With certain exceptions (described below), if a marine mammal appears within or enters this zone, the airgun array will be shut down.

The pre-start clearance zone is defined as the area that must be clear of marine mammals prior to beginning ramp-up of the airgun array and includes the SZ plus the buffer zone. Detections of marine mammals within the pre-start clearance zone would prevent airgun operations from beginning ( i.e., ramp-up).

The 500-m SZ is intended to be precautionary in the sense that it would be expected to contain sound exceeding the injury criteria for all cetacean hearing groups, (based on the dual criteria of SEL cum and peak SPL), while also providing a consistent, reasonably observable zone within which PSOs would typically be able to conduct effective observational effort. Additionally, a 500-m SZ is expected to minimize the likelihood that marine mammals will be exposed to levels likely to result in more severe behavioral responses. Although significantly greater distances may be observed from an elevated platform under good conditions, we expect that 500 m is likely regularly attainable for PSOs using the naked eye during typical conditions. The pre-start clearance zone simply represents the addition of a buffer to the SZ, doubling the SZ size during pre-clearance.

An extended SZ of 1,500 m must be enforced for all beaked whales, a large whale with a calf, and groups of six or more large whales. No buffer of this extended SZ is required, as NMFS concludes that this extended SZ is sufficiently protective to mitigate harassment to these groups.

Ramp-up (sometimes referred to as “soft start”) means the gradual and systematic increase of emitted sound levels from an airgun array. Ramp-up begins by first activating a single airgun of the smallest volume, followed by doubling the number of active elements in stages until the full complement of an array's airguns are active. Each stage should be approximately the same duration, and the total duration should not be less than approximately 20 minutes. The intent of pre-start clearance observation (30 minutes) is to ensure no marine mammals are observed within the pre-start clearance zone (or extended SZ, for beaked whales, a large whale with a calf, and groups of six or more large whales) prior to the beginning of ramp-up. During the pre-start clearance period is the only time observations of marine mammals in the buffer zone would prevent operations ( i.e., the beginning of ramp-up). The intent of ramp-up is to warn marine mammals of pending seismic survey operations and to allow sufficient time for those animals to leave the immediate vicinity prior to the sound source reaching full intensity. A ramp-up procedure, involving a step-wise increase in the number of airguns firing and total array volume until all operational airguns are activated and the full volume is achieved, is required at all times as part of the activation of the airgun array. All operators must adhere to the following pre-start clearance and ramp-up requirements:

• The operator must notify a designated PSO of the planned start of ramp-up as agreed upon with the lead PSO; the notification time should not be less than 60 minutes prior to the planned ramp-up in order to allow the PSOs time to monitor the pre-start clearance zone (and extended SZ) for 30 minutes prior to the initiation of ramp-up (pre-start clearance);

• Ramp-ups shall be scheduled so as to minimize the time spent with the source activated prior to reaching the designated run-in;

• One of the PSOs conducting pre-start clearance observations must be notified again immediately prior to initiating ramp-up procedures and the operator must receive confirmation from the PSO to proceed;

• Ramp-up may not be initiated if any marine mammal is within the applicable shutdown or buffer zone. If a marine mammal is observed within the pre-start clearance zone (or extended SZ, for beaked whales, a large whale with a calf, and groups of six or more large whales) during the 30 minute pre-start clearance period, ramp-up may not begin until the animal(s) has been observed exiting the zones or until an additional time period has elapsed with no further sightings (15 minutes for small odontocetes and pinnipeds, and 30 minutes for all mysticetes and all other odontocetes, including sperm whales, beaked whales, and large delphinids, such as pilot whales);

• Ramp-up shall begin by activating a single airgun of the smallest volume in the array and shall continue in stages by doubling the number of active elements at the commencement of each stage, with each stage of approximately the same duration. Duration shall not be less than 20 minutes. The operator must provide information to the PSO documenting that appropriate procedures were followed;

• PSOs must monitor the pre-start clearance zone and extended SZ during ramp-up, and ramp-up must cease and the source must be shut down upon detection of a marine mammal within the applicable zone. Once ramp-up has begun, detections of marine mammals within the buffer zone do not require shutdown, but such observation shall be communicated to the operator to prepare for the potential shutdown;

• Ramp-up may occur at times of poor visibility, including nighttime, if appropriate acoustic monitoring has occurred with no detections in the 30 minutes prior to beginning ramp-up. Airgun array activation may only occur at times of poor visibility where operational planning cannot reasonably avoid such circumstances;

• If the airgun array is shut down for brief periods ( i.e., less than 30 minutes) for reasons other than implementation of prescribed mitigation ( e.g., mechanical difficulty), it may be activated again without ramp-up if PSOs have maintained constant visual and/or acoustic observation and no visual or acoustic detections of marine mammals have occurred within the pre-start clearance zone (or extended SZ, where applicable). For any longer shutdown, pre-start clearance observation and ramp-up are required; and

• Testing of the airgun array involving all elements requires ramp-up. Testing limited to individual source elements or strings does not require ramp-up but does require pre-start clearance of 30 minutes.

The shutdown of an airgun array requires the immediate de-activation of all individual airgun elements of the array. Any PSO on duty will have the authority to call for shutdown of the airgun array if a marine mammal is detected within the applicable SZ. The operator must also establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the airgun array to ensure that shutdown commands are conveyed swiftly while allowing PSOs to maintain watch. When both visual and acoustic PSOs are on duty, all detections will be immediately communicated to the remainder of the on-duty PSO team for potential verification of visual observations by the acoustic PSO or of acoustic detections by visual PSOs. When the airgun array is active ( i.e., anytime one or more airguns is active, including during ramp-up) and (1) a marine mammal appears within or enters the applicable SZ and/or (2) a marine mammal (other than delphinids, see below) is detected acoustically and localized within the applicable SZ, the airgun array will be shut down. When shutdown is called for by a PSO, the airgun array will be immediately deactivated and any dispute resolved only following deactivation. Additionally, shutdown will occur whenever PAM alone (without visual sighting), confirms presence of marine mammal(s) in the SZ. If the acoustic PSO cannot confirm presence within the SZ, visual PSOs will be notified but shutdown is not required.

Following a shutdown, airgun activity will not resume until the marine mammal has cleared the SZ. The animal will be considered to have cleared the SZ if it is visually observed to have departed the SZ ( i.e., animal is not required to fully exit the buffer zone where applicable), or it has not been seen within the SZ for 15 minutes for small odontocetes or 30 minutes for all mysticetes and all other odontocetes, including sperm whales, beaked whales, and large delphinids, such as pilot whales.

The shutdown requirement is waived for pinnipeds and specific genera of small dolphins if an individual is detected within the SZ. The small dolphin group is intended to encompass those members of the Family Delphinidae most likely to voluntarily approach the source vessel for purposes of interacting with the vessel and/or airgun array ( e.g., bow riding). This exception to the shutdown requirement applies solely to pinnipeds and the specific genera of small dolphins ( Delphinus, Lagenodelphis, Stenella, and Tursiops ).

We include this pinniped and small dolphin exception because shutdown requirements for these species under all circumstances represent practicability concerns without likely commensurate benefits for the animals in question. Small dolphins are generally the most commonly observed marine mammals in the specific geographic region and would typically be the only marine mammals likely to intentionally approach the vessel. As described above, auditory injury is extremely unlikely to occur for mid-frequency cetaceans ( e.g., phocid seals and delphinids), as this group is relatively insensitive to sound produced at the predominant frequencies in an airgun pulse while also having a relatively high threshold for the onset of auditory injury ( i.e., permanent threshold shift).

A large body of anecdotal evidence indicates that small dolphins commonly approach vessels and/or towed arrays during active sound production for purposes of bow riding with no apparent effect observed ( e.g., Barkaszi et al., 2012, Barkaszi and Kelly, 2018). The potential for increased shutdowns resulting from such a measure would require the Langseth to revisit the missed track line to reacquire data, resulting in an overall increase in the total sound energy input to the marine environment and an increase in the total duration over which the survey is active in a given area. Although other mid-frequency hearing specialists ( e.g., large delphinids) are no more likely to incur auditory injury than are small dolphins, they are much less likely to approach vessels. Therefore, retaining a shutdown requirement for large delphinids would not have similar impacts in terms of either practicability for the applicant or corollary increase in sound energy output and time on the water. We do anticipate some benefit for a shutdown requirement for large delphinids in that it simplifies somewhat the total range of decision-making for PSOs and may preclude any potential for physiological effects other than to the auditory system as well as some more severe behavioral reactions for any such animals in close proximity to the Langseth.

Visual PSOs shall use best professional judgment in making the decision to call for a shutdown if there is uncertainty regarding identification ( i.e., whether the observed marine mammal(s) belongs to one of the delphinid genera for which shutdown is waived or one of the species with a larger SZ).

L-DEO must implement shutdown if a marine mammal species for which take was not authorized or a species for which authorization was granted but the authorized takes have been met approaches the Level A or Level B harassment zones. L-DEO must also implement shutdown if any large whale (defined as a sperm whale or any mysticete species) with a calf (defined as an animal less than two-thirds the body size of an adult observed to be in close association with an adult) and/or an aggregation of six or more large whales are observed within the extended SZ (1,500 m).

Vessel personnel should use an appropriate reference guide that includes identifying information on all marine mammals that may be encountered. Vessel operators must comply with the below measures except under extraordinary circumstances when the safety of the vessel or crew is in doubt or the safety of life at sea is in question. These requirements do not apply in any case where compliance would create an imminent and serious threat to a person or vessel or to the extent that a vessel is restricted in its ability to maneuver and, because of the restriction, cannot comply.

Vessel operators and crews must maintain a vigilant watch for all marine mammals and slow down, stop their vessel, or alter course, as appropriate and regardless of vessel size, to avoid striking any marine mammal. A single marine mammal at the surface may indicate the presence of submerged animals in the vicinity of the vessel; therefore, precautionary measures should always be exercised. A visual observer aboard the vessel must monitor a vessel strike avoidance zone around the vessel (separation distances stated below). Visual observers monitoring the vessel strike avoidance zone may be third-party observers ( i.e., PSOs) or crew members, but crew members responsible for these duties must be provided sufficient training to (1) distinguish marine mammals from other phenomena; and (2) broadly to identify a marine mammal as a right whale, other whale (defined in this context as sperm whales or baleen whales other than right whales), or other marine mammals.

Vessel speeds must be reduced to 10 knots (kn; 18.5 kilometers per hour (kph)) or less when mother/calf pairs, pods, or large assemblages of cetaceans are observed near a vessel. All vessels must maintain a minimum separation distance of 100 m from sperm whales and all other baleen whales. All vessels must, to the maximum extent practicable, attempt to maintain a minimum separation distance of 50 m from all other marine mammals, with an understanding that at times this may not be possible ( e.g., for animals that approach the vessel).

When marine mammals are sighted while a vessel is underway, the vessel shall take action as necessary to avoid violating the relevant separation distance ( e.g., attempt to remain parallel to the animal's course, avoid excessive speed or abrupt changes in direction until the animal has left the area). If marine mammals are sighted within the relevant separation distance, the vessel must reduce speed and shift the engine to neutral, not engaging the engines until animals are clear of the area. This does not apply to any vessel towing gear or any vessel that is navigationally constrained.

Based on our evaluation of the applicant's planned measures, as well as other measures considered by NMFS, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

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

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

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

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

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

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

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

• Mitigation and monitoring effectiveness.

As described above, PSO observations will take place during daytime airgun operations. During seismic survey operations, at least five visual PSOs will be based aboard the Langseth. Two visual PSOs will be on duty at all times during daytime hours. Monitoring shall be conducted in accordance with the following requirements:

• The operator shall provide PSOs with bigeye binoculars ( e.g., 25 × 150; 2.7 view angle; individual ocular focus; height control) of appropriate quality solely for PSO use. These shall be pedestal-mounted on the deck at the most appropriate vantage point that provides for optimal sea surface observation, PSO safety, and safe operation of the vessel; and

• The operator will work with the selected third-party observer provider to ensure PSOs have all equipment (including backup equipment) needed to adequately perform necessary tasks, including accurate determination of distance and bearing to observed marine mammals.

PSOs must have the following requirements and qualifications:

• PSOs shall be independent, dedicated, trained visual and acoustic PSOs and must be employed by a third-party observer provider;

• PSOs shall have no tasks other than to conduct observational effort (visual or acoustic), collect data, and communicate with and instruct relevant vessel crew with regard to the presence of protected species and mitigation requirements (including brief alerts regarding maritime hazards);

• PSOs shall have successfully completed an approved PSO training course appropriate for their designated task (visual or acoustic). Acoustic PSOs are required to complete specialized training for operating PAM systems and are encouraged to have familiarity with the vessel with which they will be working;

• PSOs can act as acoustic or visual observers (but not at the same time) as long as they demonstrate that their training and experience are sufficient to perform the task at hand;

• NMFS must review and approve PSO resumes accompanied by a relevant training course information packet that includes the name and qualifications ( i.e., experience, training completed, or educational background) of the instructor(s), the course outline or syllabus, and course reference material as well as a document stating successful completion of the course;

• PSOs must successfully complete relevant training, including completion of all required coursework and passing (80 percent or greater) a written and/or oral examination developed for the training program;

• PSOs must have successfully attained a bachelor's degree from an accredited college or university with a major in one of the natural sciences, a minimum of 30 semester hours or equivalent in the biological sciences, and at least one undergraduate course in math or statistics; and

• The educational requirements may be waived if the PSO has acquired the relevant skills through alternate experience. Requests for such a waiver shall be submitted to NMFS and must include written justification. Requests shall be granted or denied (with justification) by NMFS within 1 week of receipt of submitted information. Alternate experience that may be considered includes, but is not limited to (1) secondary education and/or experience comparable to PSO duties; (2) previous work experience conducting academic, commercial, or government-sponsored protected species surveys; or (3) previous work experience as a PSO; the PSO should demonstrate good standing and consistently good performance of PSO duties.

• At least one of the visual and two of the acoustic PSOs aboard the vessel must have a minimum of 90 days at-sea experience working in those roles, respectively, with no more than 18 months elapsed since the conclusion of the at-sea experience. One visual PSO with such experience shall be designated as the lead for the entire protected species observation team. The lead PSO shall serve as primary point of contact for the vessel operator and ensure all PSO requirements per the IHA are met. To the maximum extent practicable, the experienced PSOs should be scheduled to be on duty with those PSOs with appropriate training but who have not yet gained relevant experience.

• For data collection purposes, PSOs shall use standardized electronic data collection forms. PSOs shall record detailed information about any implementation of mitigation requirements, including the distance of animals to the airgun array and description of specific actions that ensued, the behavior of the animal(s), any observed changes in behavior before and after implementation of mitigation, and if shutdown was implemented, the length of time before any subsequent ramp-up of the airgun array. If required mitigation was not implemented, PSOs should record a description of the circumstances. At a minimum, the following information must be recorded:

○ Vessel name, vessel size and type, maximum speed capability of vessel;

○ Dates (MM/DD/YYYY) of departures and returns to port with port name;

○ PSO names and affiliations, PSO ID (initials or other identifier);

○ Date (MM/DD/YYYY) and participants of PSO briefings;

○ Visual monitoring equipment used (description);

○ PSO location on vessel and height (meters) of observation location above water surface;

○ Watch status (description);

○ Dates (MM/DD/YYYY) and times (Greenwich Mean Time/UTC) of survey on/off effort and times (GMC/UTC) corresponding with PSO on/off effort;

○ Vessel location (decimal degrees) when survey effort began and ended and vessel location at beginning and end of visual PSO duty shifts;

○ Vessel location (decimal degrees) at 30-second intervals if obtainable from data collection software, otherwise at practical regular interval;

○ Vessel heading (compass heading) and speed (knots) at beginning and end of visual PSO duty shifts and upon any change;

○ Water depth (meters) (if obtainable from data collection software);

○ Environmental conditions while on visual survey (at beginning and end of PSO shift and whenever conditions changed significantly), including BSS and any other relevant weather conditions including cloud cover, fog, sun glare, and overall visibility to the horizon;

○ Factors that may have contributed to impaired observations during each PSO shift change or as needed as environmental conditions changed (description) ( e.g., vessel traffic, equipment malfunctions); and

○ Vessel/Survey activity information (and changes thereof) (description), such as airgun power output while in operation, number and volume of airguns operating in the array, tow depth of the array, and any other notes of significance ( i.e., pre-start clearance, ramp-up, shutdown, testing, shooting, ramp-up completion, end of operations, streamers, etc. ).

• Upon visual observation of any marine mammals, the following information must be recorded:

○ Sighting ID (numeric);

○ Watch status (sighting made by PSO on/off effort, opportunistic, crew, alternate vessel/platform);

○ Location of PSO/observer (description);

○ Vessel activity at the time of the sighting ( e.g., deploying, recovering, testing, shooting, data acquisition, other);

○ PSO who sighted the animal/ID;

○ Time/date of sighting (GMT/UTC, MM/DD/YYYY);

○ Initial detection method (description);

○ Sighting cue (description);

○ Vessel location at time of sighting (decimal degrees);

○ Water depth (meters);

○ Direction of vessel's travel (compass direction);

○ Speed (knots) of the vessel from which the observation was made;

○ Direction of animal's travel relative to the vessel (description, compass heading);

○ Bearing to sighting (degrees);

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

○ Species reliability (an indicator of confidence in identification) (1 = unsure/possible, 2 = probable, 3 = definite/sure, 9 = unknown/not recorded);

○ Estimated distance to the animal (meters) and method of estimating distance;

○ Estimated number of animals (high/low/best) (numeric);

○ Estimated number of animals by cohort (adults, yearlings, juveniles, calves, group composition, etc. );

○ Description (as many distinguishing features as possible of each individual seen, including length, shape, color, pattern, scars or markings, shape and size of dorsal fin, shape of head, and blow characteristics);

○ Detailed behavior observations ( e.g., number of blows/breaths, number of surfaces, breaching, spyhopping, diving, feeding, traveling; as explicit and detailed as possible; note any observed changes in behavior);

○ Animal's closest point of approach (meters) and/or closest distance from any element of the airgun array;

○ Description of any actions implemented in response to the sighting ( e.g., delays, shutdown, ramp-up) and time and location of the action;

○ Photos (Yes/No);

○ Photo Frame Numbers (List of numbers); and

○ Conditions at time of sighting (Visibility; BSS).

If a marine mammal is detected while using the PAM system, the following information should be recorded:

• An acoustic encounter identification number, and whether the detection was linked with a visual sighting;

• Date and time when first and last heard;

• Types and nature of sounds heard ( e.g., clicks, whistles, creaks, burst pulses, continuous, sporadic, strength of signal); and

• Any additional information recorded such as water depth of the hydrophone array, bearing of the animal to the vessel (if determinable), species or taxonomic group (if determinable), spectrogram screenshot, and any other notable information.

L-DEO shall submit a draft comprehensive report on all activities and monitoring results within 90 days of the completion of the survey or expiration of the IHA, whichever comes sooner. The report must describe all activities conducted and sightings of marine mammals, must provide full documentation of methods, results, and interpretation pertaining to all monitoring, and must summarize the dates and locations of survey operations and all marine mammal sightings (dates, times, locations, activities, associated survey activities). The draft report shall also include geo-referenced time-stamped vessel tracklines for all time periods during which airgun arrays were operating. Tracklines should include points recording any change in airgun array status ( e.g., when the sources began operating, when they were turned off, or when they changed operational status such as from full array to single gun or vice versa). Geographic Information System files shall be provided in Environmental Systems Research Institute shapefile format and include the UTC date and time, latitude in decimal degrees, and longitude in decimal degrees. All coordinates shall be referenced to the WGS84 geographic coordinate system. In addition to the report, all raw observational data shall be made available. The report must summarize data collected as described above in Monitoring and Reporting. A final report must be submitted within 30 days following resolution of any comments on the draft report.

The report must include a validation document concerning the use of PAM, which should include necessary noise validation diagrams and demonstrate whether background noise levels on the PAM deployment limited achievement of the planned detection goals. Copies of any vessel self-noise assessment reports must be included with the report.

Discovery of injured or dead marine mammals —In the event that personnel involved in the survey activities discover an injured or dead marine mammal, the L-DEO shall report the incident to the Office of Protected Resources (OPR) and NMFS as soon as feasible. The report must include the following information:

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

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

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

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

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

• General circumstances under which the animal was discovered.

Vessel strike —In the event of a strike of a marine mammal by any vessel involved in the activities covered by the authorization, L-DEO shall report the incident to OPR and NMFS as soon as feasible. The report must include the following information:

• Time, date, and location (latitude/longitude) of the incident;

• Vessel's speed during and leading up to the incident;

• Vessel's course/heading and what operations were being conducted (if applicable);

• Status of all sound sources in use;

• Description of avoidance measures/requirements that were in place at the time of the strike and what additional measure were taken, if any, to avoid strike;

• Environmental conditions ( e.g., wind speed and direction, BSS, cloud cover, visibility) immediately preceding the strike;

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

• Estimated size and length of the animal that was struck;

• Description of the behavior of the marine mammal immediately preceding and following the strike;

• If available, description of the presence and behavior of any other marine mammals present immediately preceding the strike;

• Estimated fate of the animal ( e.g., dead, injured but alive, injured and moving, blood or tissue observed in the water, status unknown, disappeared); and

• To the extent practicable, photographs or video footage of the animal(s).

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

To avoid repetition, the discussion of our analysis applies to all the species listed in table 1, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar. Where there are meaningful differences between species or stocks they are included as separate subsections below. NMFS does not anticipate that serious injury or mortality would occur as a result of L-DEO's planned survey, even in the absence of mitigation, and no serious injury or mortality is authorized. As discussed in the Potential Effects of Specified Activities on Marine Mammals and Their Habitat section above, non-auditory physical effects and vessel strike are not expected to occur. NMFS expects that the majority of potential takes would be in the form of short-term Level B behavioral harassment, resulting from temporary avoidance of the area or decreased foraging (if such activity was occurring), reactions that are considered to be of low severity and with no lasting biological consequences ( e.g., Southall et al., 2007).

We have authorized a limited number of Level A harassment events of five species in the form of PTS (humpback whale, minke whale, fin whale, sei whale, and harbor porpoise) and Level B harassment only of the remaining marine mammal species. If any PTS is incurred in marine mammals as a result of the specified activity, we expect only a small degree of PTS that would not result in severe hearing impairment because of the constant movement of both the Langseth and of the marine mammals in the project areas, as well as the fact that the vessel is not expected to remain in any one area in which individual marine mammals would be expected to concentrate for an extended period of time. Additionally, L-DEO will shut down the airgun array if marine mammals approach within 500 m (with the exception of specific genera of dolphins, see Mitigation), further reducing the expected duration and intensity of sound and therefore, the likelihood of marine mammals incurring PTS. Since the duration of exposure to loud sounds will be relatively short, it would be unlikely to affect the fitness of any individuals. Also, as described above, we expect that marine mammals would likely move away from a sound source that represents an aversive stimulus, especially at levels that would be expected to result in PTS, given sufficient notice of the Langseth's approach due to the vessel's relatively low speed when conducting seismic surveys.

In addition, the maximum expected Level B harassment zone around the survey vessel is 6,733 m for water depths greater than 1,000 m (and up to 10,100 m in water depths of 100 to 1,000 m), with 78% of the survey occurring in depths greater than 1,000 m. Therefore, the ensonified area surrounding the vessel is relatively small compared to the overall distribution of animals in the area and their use of the habitat. Feeding behavior is not likely to be significantly impacted as prey species are mobile and are broadly distributed throughout the survey area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the short duration (14 survey days) and temporary nature of the disturbance and the availability of similar habitat and resources in the surrounding area, the impacts to marine mammals and marine mammal prey species are not expected to cause significant or long-term fitness consequences for individual marine mammals or their populations.

Additionally, the acoustic “footprint” of the survey is very small relative to the ranges of all marine mammals that would potentially be affected. Sound levels will increase in the marine environment in a relatively small area surrounding the vessel compared to the range of the marine mammals within the survey area. The seismic array will be active 24 hours per day throughout the duration of the planned survey. However, the very brief overall duration of the planned survey (14 survey days) will further limit potential impacts that may occur as a result of the activity.

Of the marine mammal species that are likely to occur in the project area, the following species are listed as endangered under the ESA: humpback whales (Cape Verde/Northwest Africa DPS), blue whales, fin whales, sei whales, and sperm whales. The take numbers authorized for these species (table 6) are minimal relative to their modeled population sizes; therefore, we do not expect population-level impacts to any of these species. Moreover, the actual range of the populations extends past the area covered by the model, so modeled population sizes are likely smaller than their actual population size. The other marine mammal species that may be taken by harassment during NSF's seismic survey are not listed as threatened or endangered under the ESA. There is no designated critical habitat for any ESA-listed marine mammals within the project area.

There are no rookeries, mating, or calving grounds known to be biologically important to marine mammals within the survey area, and there are no feeding areas known to be biologically important to marine mammals within the survey area.

As discussed above, there are several active unusual mortality events (UMEs) for marine mammal populations that occur in the survey area. Elevated humpback whale mortalities have occurred along the Atlantic coast from Maine through Florida since January 2016. Of the cases examined, approximately half had evidence of human interaction (ship strike or entanglement). The UME does not yet provide cause for concern regarding population-level impacts. Only the West Indies DPS is potentially impacted by this UME, and their current population remains stable at approximately 12,000 individuals.

The mitigation measures are expected to reduce, to the extent practicable, the intensity and/or duration of takes for all species listed in table 1. In particular, they would provide animals the opportunity to move away from the sound source throughout the survey area before seismic survey equipment reaches full energy, thus, preventing them from being exposed to sound levels that have the potential to cause injury (Level A harassment) or more severe Level B harassment.

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

• No serious injury or mortality is anticipated or authorized;

• We have authorized a limited number of Level A harassment events of five species in the form of PTS; if any PTS is incurred as a result of the specified activity, we expect only a small degree of PTS that would not result in severe hearing impairment because of the constant movement of both the vessel and of the marine mammals in the project areas, as well as the fact that the vessel is not expected to remain in any one area in which individual marine mammals would be expected to concentrate for an extended period of time;

• The planned activity is temporary and of relatively short duration (38 days total with 14 days of planned survey activity);

• The vast majority of anticipated impacts of the planned activity on marine mammals would be temporary behavioral changes due to avoidance of the ensonified area, which is relatively small ( see table 4);

• The availability of alternative areas of similar habitat value for marine mammals to temporarily vacate the survey area during the planned survey to avoid exposure to sounds from the activity is readily abundant;

• The potential adverse effects on fish or invertebrate species that serve as prey species for marine mammals from the planned survey would be temporary and spatially limited and impacts to marine mammal foraging would be minimal; and

• The planned mitigation measures are expected to reduce the number and severity of takes, to the extent practicable, by visually and/or acoustically detecting marine mammals within the established zones and implementing corresponding mitigation measures ( e.g., delay; shutdown).

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

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

The number of takes NMFS authorized is below one-third of the modeled abundance for all relevant populations (specifically, take of individuals is less than four percent of the modeled abundance of each affected population, see table 6). This is conservative because the modeled abundance represents a population of the species and we assume all takes are of different individual animals, which is likely not the case. Some individuals may be encountered multiple times in a day, but PSOs will count them as separate individuals if they cannot be identified.

Based on the analysis contained herein of the planned activity, including the mitigation and monitoring measures, and the authorized take of marine mammals, NMFS finds that small numbers of marine mammals would be taken relative to the size of the affected species or populations.

There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

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

The NMFS OPR ESA Interagency Cooperation Division issued a Biological Opinion under section 7 of the ESA, on the issuance of an IHA to NSF under section 101(a)(5)(D) of the MMPA by the NMFS OPR Permits and Conservation Division. The Biological Opinion concluded that the action is not likely to jeopardize the continued existence of ESA-listed humpback whales (Cape Verde/Northwest Africa DPS), blue whales, fin whales, sei whales, and sperm whales. There is no designated critical habitat in the action area for any ESA-listed marine mammal species.

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

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

MFS has issued an IHA to L-DEO for the potential harassment of small numbers of 25 marine mammal species incidental to the marine geophysical survey at the Reykjanes Ridge in the North Atlantic Ocean that includes the previously explained mitigation, monitoring and reporting requirements.

The Committee was established by the NOAA Administrator as directed by section 12304(d) of the Integrated Coastal and Ocean Observation System Act (the Act) as amended by section 103 of the Coordinated Ocean Observations and Research Act of 2020 (COORA) (Pub. L. 116-271, title I). 33 U.S.C. 3603(d). The Committee advises the NOAA Administrator and the Interagency Ocean Observation Committee (IOOC) on matters related to the responsibilities and authorities set forth in the Act and other appropriate matters as the Administrator, the Ocean Policy Committee described at 33 U.S.C. 3603(c)(1), and IOOC may refer to the Committee for review and advice. The charter and summaries of prior meetings can be found online at https://ioos.noaa.gov/community/u-s-ioos-advisory-committee/.

The meeting will focus on: (1) NOAA and IOOS budget, (2) engaging with NOAA leadership, (3) working session on Enterprise Excellence, and (4) new membership. The latest version of the agenda will be posted at http://ioos.noaa.gov/community/u-s-ioos-advisory-committee/. The times and the agenda topics described here are subject to change.

The meeting will be open to public participation (check agenda on website to confirm time). The Committee expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of three (3) minutes. Written comments should be received by the Designated Federal Official by July 16, 2024, to provide sufficient time for Committee review. Written comments received after July 16, 2024, will be distributed to the Committee, but may not be reviewed prior to the meeting date. To submit written comments, please fill out the brief form at https://forms.gle/mHrygLRsc3GMFRPYA or email your comments and the organization/company affiliation you represent to Laura Gewain, Laura.Gewain@noaa.gov. This NOAA public meeting will be recorded for use in preparation of minutes. If you have a public comment, you acknowledge you will be recorded and are aware you can opt out of the meeting. Participation in the meeting constitutes consent to the recording.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Krisa Arzayus, Designated Federal Official by phone (240-533-9455) or email ( Krisa.Arzayus@noaa.gov) or to Laura Gewain ( Laura.Gewain@noaa.gov) by July 10, 2024.

NMFS Alaska Region administers the Program in the North Pacific. Fishing under the Program began on August 15, 2005. Regulations implementing the Program can be found at 50 CFR part 680.

The Program is a limited access privilege program authorized by section 313(j) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The Program includes a cost recovery provision to collect fees to recover the actual costs directly related to the management, data collection, and enforcement of the Program. The Program is consistent with the cost recovery provisions included under section 304(d)(2)(A) of the Magnuson-Stevens Act. NMFS developed the cost recovery regulations to conform to statutory requirements and to reimburse the agency for the actual costs directly related to the management, data collection, and enforcement of the Program. The cost recovery provision allows collection of 133 percent of the actual management, data collection, and enforcement costs not to exceed 3 percent of the ex-vessel value of crab harvested under the Program. The Program provides that a proportional share of fees charged will be forwarded to the State of Alaska for reimbursement of its share of management and data collection costs for the Program.

A crab allocation holder generally incurs a cost recovery fee liability for every pound of crab landed. Catcher vessel and processor quota shareholders split the cost recovery fees equally with each paying half, while catcher/processor quota shareholders pay the full fee percentage for crab processed at sea. The crab allocations subject to cost recovery include Individual Fishing Quota, Crew Individual Fishing Quota, Individual Processing Quota, Community Development Quota, and the Adak community allocation. The Registered Crab Receiver (RCR) permit holder must collect the fee liability from the crab allocation holder who is landing crab. Additionally, the RCR permit holder must collect their own fee liability for all crab delivered to the RCR. The RCR permit holder is responsible for submitting this payment to NMFS on or before July 31, in the year following the crab fishing year in which landings of crab were made.

The dollar amount of the fee due is determined by multiplying the fee percentage (not to exceed 3 percent) by the ex-vessel value of crab debited from the allocation. Program details may be found in the implementing regulations at § 680.44.

Each year, NMFS calculates and publishes in the Federal Register the fee percentage according to the factors and methodology described at § 680.44(c)(2). The formula for determining the fee percentage is the “direct program costs” divided by “value of the fishery,” where “direct program costs” are the direct program costs for the Program for the previous fiscal year, and “value of the fishery” is the ex-vessel value of the catch subject to the crab cost recovery fee liability for the current year. Fee collections for any given year may be less than or greater than the actual costs and fishery value for that year, as regulations establish the fee percentage in the first quarter of the crab fishing year based on the fishery value and costs in the prior year.

According to the fee percentage formula described above, the estimated percentage of costs to value for the 2023/2024 fishery is higher than the maximum fee percentage of 3 percent. As the actual fee percentage is higher than the maximum fee percentage, the effective fee percentage will be 3 percent for the 2024/2025 crab fishing year. This is equal to the effective fee percentage for the 2023/2024 crab fishing year of 3 percent (88 FR 51301, August 3, 2023). While the fishery value increased by approximately 75 percent from last year, the current year fishery value is the second lowest value recorded for this fishery since 2013. Therefore, the overall low fishery value and the direct program costs result in a fee percentage higher than 3 percent. A more detailed explanation will be provided in the annual Crab Cost Recovery Report, which will be published in the first quarter of 2025. Similar to previous years, the largest direct Program costs were incurred by the NOAA Office of Law Enforcement and the State of Alaska Department of Fish and Game, respectively.

Authority: 16 U.S.C. 1862; Pub. L. 109-241; Pub. L. 109-479.

Because Congress charged the Consumer Financial Protection Bureau (CFPB) with the responsibility of overseeing many lenders and products, the CFPB has long used a risk-based approach to prioritizing supervisory examinations and enforcement activity. This approach helps ensure that the CFPB focuses on areas that present substantial risk of credit discrimination for consumers and small businesses. 1

As part of the prioritization process, the CFPB identifies emerging developments and trends by monitoring key consumer financial markets. If this field and market intelligence identifies fair lending risks in a particular market, that information is used to determine the type and extent of assets applied to address those risks.

The prioritization process incorporates a number of additional factors, including tips and leads from industry whistleblowers, advocacy groups, and government agencies; supervisory and enforcement history; consumer complaints; and results from analysis of Home Mortgage Disclosure Act (HMDA) and other data.

As a result of its annual risk-based prioritization process, in 2023 the CFPB focused much of its fair lending supervision efforts on: mortgage origination (including redlining, property valuation bias, and HMDA and Regulation C compliance); credit card marketing and the use of alternative data in digital marketing; and on the use of automated systems and models, sometimes marketed as artificial intelligence (AI) and machine learning models, in credit card originations.

As in previous years, the CFPB's 2023 mortgage origination work continued to focus on redlining (intentional discrimination against applicants and prospective applicants living or seeking credit in minority neighborhoods, including by discouragement). The CFPB's mortgage work also included assessing potential discrimination in mortgage underwriting and pricing processes, including assessing whether there were disparities in application, underwriting, and pricing processes, and whether there were weaknesses in fair lending-related compliance management systems. The CFPB's mortgage origination work also included reviewing residential property appraisal service providers to identify risks that may arise due to potential discrimination or bias as well as HMDA data integrity and validation reviews.

The CFPB's credit card work included assessing credit card lenders' digital marketing practices relating to credit cards, as well as credit card lenders' use of alternative data in that marketing. The CFPB's credit card work also included evaluation of automated systems and models, sometimes marketed as artificial intelligence and machine learning models, used by credit card lenders in credit card originations, as well as assessing whether there were disparities in application, underwriting, and pricing processes, and whether the institutions searched for less discriminatory alternatives to the models used.

Across multiple markets, the CFPB continued to assess whether lenders complied with the adverse action notice requirements of the Equal Credit Opportunity Act (ECOA) and Regulation B and evaluated whether lenders maintain policies and procedures that unlawfully exclude property on the basis of geography in underwriting decisions, unlawfully exclude certain types of income, and treat criminal history in an unlawful manner.

Congress authorized the CFPB to bring actions to enforce the requirements of eighteen enumerated statutes, including ECOA, HMDA, and the Consumer Financial Protection Act of 2010 (CFPA), which prohibits unfair, deceptive, and abusive acts or practices. The CFPB is able to engage in research, conduct investigations, file administrative complaints, hold hearings, and adjudicate claims through the CFPB's administrative enforcement process. The CFPB also uses its independent litigation authority to file cases in Federal court alleging violations of fair lending laws under the CFPB's jurisdiction. Like other Federal regulators, the CFPB is required to refer matters to the Department of Justice (DOJ) when it has reason to believe that a creditor has engaged in a pattern or practice of lending discrimination. 2

In 2023, the CFPB announced two ECOA-related public enforcement actions, relating to discrimination on the basis of race and national origin, one against Citibank N.A. (Citibank) and the other against Colony Ridge Development, LLC, and Colony Ridge BV, LLC, and affiliate mortgage company Colony Ridge Land, LLC (collectively, the Colony Ridge defendants). For more information on these ECOA-related enforcement actions, see section 6.1.2 of this report.

HMDA, its implementing Regulation C, and Regulation B require mortgage lenders to report certain information about loan applications and originations to the CFPB and other Federal regulators. HMDA data are the most comprehensive source of publicly available information on the U.S. mortgage market. Both the public and regulators can use this information to monitor whether financial institutions are serving the housing needs of their communities, as well as to identify possible discriminatory lending patterns.

In 2023, the CFPB announced public enforcement actions against two repeat offenders for reporting false, erroneous, or incorrect HMDA data: Freedom Mortgage Corporation (Freedom Mortgage) and Bank of America, N.A.

The CFPB will continue to monitor the rate at which mortgage lenders fail to collect and report applicants' demographic information. The rate of nonreporting of demographic information has been increasing since 2019, potentially compromising the ability of the CFPB and other financial regulators, enforcement agencies, academics, other mortgage lenders, and civil rights and consumer advocates, to detect and remedy redlining, discouragement, and other forms of discrimination in the mortgage market. The CFPB's evaluations will include assessments of lenders' demographic reporting practices and HMDA compliance systems to ensure they are monitoring for inaccurate or incomplete demographic information reporting and complying with HMDA.

On October 10, 2023, the CFPB filed a lawsuit against Freedom Mortgage, a residential mortgage loan originator and servicer, alleging that it submitted legally-required mortgage loan data that were riddled with errors. 3 In 2020, Freedom Mortgage reported HMDA data on over 700,000 applications and originated nearly 400,000 HMDA-reportable loans worth almost $100 billion, making it the third largest mortgage lender in the United States by origination volume. Freedom Mortgage is a repeat offender: at the time the CFPB filed its complaint, Freedom was already under a CFPB Consent Order related to previous HMDA violations. In 2019, the CFPB issued an order against Freedom finding that it intentionally misreported certain HMDA data fields from at least 2014 to 2017. 4 In the CFPB's lawsuit, the CFPB alleges that the mortgage loan data for 2020 that Freedom Mortgage submitted contained widespread errors across multiple data fields, in violation of HMDA and Regulation C. The CFPB's complaint further alleges that by reporting inaccurate HMDA mortgage loan data for 2020, Freedom Mortgage also violated the 2019 order and the CFPA. The CFPB seeks appropriate injunctive relief and a civil money penalty.

Due to circumstances beyond the control of the Department of Defense and the Designated Federal Officer (DFO), the Department of Defense Military Family Readiness Council was unable to provide public notification required by 41 CFR 102-3.150(a) concerning its June 17, 2024 meeting. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

This meeting is being held under the provisions of chapter 10 of title 5, United States Code (U.S.C.) (commonly known as the “Federal Advisory Committee Act” or “FACA”), 5 U.S.C. 552b (commonly known as the “Government in the Sunshine Act”), and 41 CFR 102-3.140 and 102-3.155.

Availability of Materials for the Meeting: Additional information, including the agenda or any updates to the agenda, is available at the DoD MFRC website: https://www.militaryonesource.mil/mfrc.

Materials presented in the meeting may also be obtained on the DoD MFRC website.

Purpose of the Meeting: The purpose of the meeting is for the DoD MFRC to receive briefings and have discussions on topics related to Military Family Readiness Programs and Activities.

Agenda: Monday, June 17, 2024, from 1:00 p.m. to 3:30 p.m.—Welcome, Introductions, Announcements, Briefings on Changes to Healthcare Policy and Implication for Military Families.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public from 1:00 p.m. to 3:30 p.m. on June 17, 2024. The meeting will be held by videoconference. The number of participants is limited and is on a first-come basis. All members of the public who wish to participate must register by contacting DoD MFRC at ( osd.pentagon.ousd-p-r.mbx.family-readiness-council@mail.mil ) or by contacting Mr. Vesen Thompson at (703) 571-2360 (voice). Once registered, the web address and/or audio number will be provided.

Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact Mr. Vesen Thompson so that appropriate arrangements can be made.

Written Statements: Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the FACA, interested persons may submit a written statement to the DoD MFRC; however, email submissions are preferred. Persons interested in providing a written statement for review and consideration by DoD MFRC members attending the June 17, 2024 meeting are encouraged to do so at osd.pentagon.ousd-p-r.mbx.family-readiness-council@mail.mil ). Written statements received after this date will be provided to DoD MFRC members in preparation for the next MFRC meeting. The DFO will review all timely submissions and ensure submitted written statements are provided to DoD MFRC members prior to the meeting that is subject to this notice. The DFO will review all timely submissions with the DoD MFRC Chair and ensure they are provided to the members of the DoD MFRC. Those who make submissions are requested to avoid including personally identifiable information such as names of adults and children, phone numbers, addresses, Social Security Numbers and other contact information within the body of the written statement.

The DoD BoA's charter is being renewed in accordance with chapter 10 of title 5 United States Code (U.S.C.) (commonly known as the “Federal Advisory Committee Act” or “FACA”), 5 U.S.C. 552b (commonly known as the “Government in the Sunshine Act”), and 41 CFR 102-3.50(a). The charter and contact information for the DoD BoA's Designated Federal Officer (DFO) can be found at https://www.facadatabase.gov/FACA/apex/FACAPublicAgencyNavigation.

The DoD BoA provides independent advice and recommendations on matters relating to the DoD Military Retirement Fund, the DoD Education Fund, the DoD Voluntary Separation Incentive Fund, and such other funds as the Secretary of Defense shall specify.

Pursuant to 10 U.S.C. 183(b), the DoD BoA shall consist of three members from among qualified professional actuaries who are members of the Society of Actuaries. All members of the DoD BoA are appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. A member of the DoD BoA who is not an employee of the United States is entitled to receive pay at the daily equivalent of the annual rate of basic pay of the highest rate of basic pay under the General Schedule of subchapter III of chapter 53 of title 5 U.S.C., for each day the member is engaged in the performance of duties vested in the DoD BoA. All members are entitled to reimbursement for official DoD BoA-related travel and per diem.

The public or interested organizations may submit written statements to the DoD BoA membership about the DoD BoA's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of a planned meeting of the DoD BoA. All written statements shall be submitted to the DFO for the DoD BoA, and this individual will ensure that the written statements are provided to the membership for their consideration.

This meeting is being held under the provisions of chapter 10 of title 5 United States Code (U.S.C.) (commonly known as the Federal Advisory Committee Act of 1972 (5 U.S.C. app.) or “FACA”), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 Code of Federal Regulations (CFR) 102-3.140 and 102-3.150.

Purpose of the Meeting: The purpose of the meeting is for the DoD Board of Actuaries to review DoD actuarial methods and assumptions to be used in the valuations of the Military Retirement Fund, the Voluntary Separation Incentive Fund, and the Education Benefits Fund in accordance with the provisions of section 183, section 2006, chapter 74 (10 U.S.C. 1464 et seq. ), and section 1175 of title 10, U.S.C.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public. All members of the public who wish to attend virtually must register by contacting Inger Pettygrove, (703) 225-8803 (Voice), inger.m.pettygrove.civ@mail.mil (Email) no later than Monday, July 22, 2024. Once registered, the web address and/or audio number will be provided.

Written Statements: Pursuant to 41 CFR 102-3.140 and 10(a)(3) of the FACA, the public or interested organizations may submit written comments to the DoD Board of Actuaries about its mission and topics pertaining to this public session. Persons desiring to attend the DoD Board of Actuaries meeting to make an oral presentation or submit a written statement for consideration at the meeting must notify Inger Pettygrove at (703) 225-8803, or inger.m.pettygrove.civ@mail.mil, by Wednesday, July 10, 2024.

Written comments need to be submitted in the following formats: Adobe Acrobat or Microsoft Word. Written comments may also be mailed to the address listed in FOR FURTHER INFORMATION CONTACT . Written comments not received by the DoD Board of Actuaries at least five (5) business days prior to the meeting date, or after, will be provided to the Chair of the DoD Board of Actuaries for consideration.

Advance copy of oral public comments must be sent via email at inger.m.pettygrove.civ@mail.mil with the subject line “DoD Board of Actuaries: Request to Speak <insert the issue and question>” no later than 11:59 p.m. EST on Wednesday, July 10, 2024. Submissions received after the deadline will not be considered for oral public comment but will be provided to the Chair of the DoD Board of Actuaries for consideration. All submitted oral comments become government property and may be published as part of the meeting record. Registration for oral public comment is on a first-come, first-served basis. Comments are limited to two (2) minutes or less per person. 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. Should time expire for oral public comments those not presented will be provided to the Chair of the DoD Board of Actuaries for consideration. You will be notified via email no later than Monday, July 22, 2024, if you have been identified to provide in-person public comment.

Please note that since the DoD Board of Actuaries operates under the provisions of the FACA, all written comments received will be treated as public documents and will be made available for public inspection.

The DoD is renewing the DBB in accordance with chapter 10 of title 5 United States Code (U.S.C.) (commonly known as the “Federal Advisory Committee Act” or “FACA”) (5 U.S.C. 552b (commonly known as the “Government in the Sunshine Act”) and 41 CFR 102-3.50(d). The charter and contact information for the DBB's Designated Federal Officer (DFO) are found at https://www.facadatabase.gov/FACA/apex/FACAPublicAgencyNavigation.

The DBB provides the Secretary of Defense and Deputy Secretary of Defense with independent advice and actionable recommendations to address critical matters and challenges to accelerate adoption of effective and efficient business processes and functions, organizational management constructs, and business and organizational cultural changes within the DoD in response to specific tasking from the Secretary of Defense or the Deputy Secretary of Defense (“the DoD Appointing Authority”). The DBB examines and advises on DoD executive management, innovative business processes, and governance from private, public, and academic sector perspectives. The DBB is composed of no more than 20 members who meet one of more of the follow criteria: (a) proven track record of sound judgement in leading or governing large, complex public or private-sector organizations, including academia; (b) significant management-level (executive level managers that are titled “chief” followed by their function) global business or academic experience including, but not limited to the areas of executive management, corporate strategy, governance, business process improvement and innovation, global business services/shared services, audit and finance, supply chain and logistics, human resources/talent management, data/analytics management and use, real property management, organizational design and optimization, energy and climate, or technology; (c) demonstrated performance in developing new business theories, innovation, and concepts; (d) career as a distinguished academic or researcher in business at an accredited college or institute of higher education; or (e) a proven track record as an innovative leader in small and minority owned businesses.

Individual members are appointed according to DoD policy and procedures, and serve a term of service of one-to-four years with annual renewals. One member will be appointed as Chair of the DBB. No member, unless approved according to DoD policy and procedures, may serve more than two consecutive terms of service on the DBB, or serve on more than two DoD Federal advisory committees at one time.

DBB members who are not full-time or permanent part-time Federal civilian officers or employees, or active-duty members of the Uniformed Services, are appointed as experts or consultants, pursuant to 5 U.S.C. 3109, to serve as special government employee members. DBB members who are full-time or permanent part-time Federal civilian officers or employees, or active-duty members of the Uniformed Services are appointed pursuant to 41 CFR 102-3.130(a), to serve as regular government employee members.

All DBB members are appointed to provide advice based on their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official DBB-related travel and per diem, members serve without compensation.

The public or interested organizations may submit written statements about the DBB's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the DBB. All written statements shall be submitted to the DFO for the DBB, and this individual will ensure that the written statements are provided to the membership for their consideration.

1. Background: The project was authorized by the Water Resources Reform and Development Act of 2014, Public Law 113-121, section 7002 for the purpose of reducing coastal storm damages by constructing a beach fill/berm along the San Clemente shoreline. The authorized project includes construction of an approximate 50-foot-wide beach nourishment project along a 3,412-foot-long stretch of shoreline using beach compatible sediment, with renourishment on the average of every 6 years over a 50-year period of federal participation. The authorization did not identify a specific borrow site for the beach fill; however, it identified that the site(s) would be off the coast of San Diego County ( e.g., Oceanside). The project is further described in the Final Feasibility Report and Final Environmental Impact Statement dated February 2012 (FR/EIS/EIR); supplemental environmental assessment (SEA) dated May 2023; and SEA dated March 2024. Construction of the project was initiated in December 2023. However, due in part to equipment damage and sediment compatibility issues encountered at the Oceanside borrow area, construction was temporarily paused. To allow for operational flexibility, the 2024 SEA evaluated inclusion of the Surfside-Sunset borrow area, a 106-acre borrow site offshore Surfside-Sunset beaches located 29 miles to the north of San Clemente in Orange County, as an alternate borrow site for initial construction of the project.

After the 2024 SEA's FONSI was signed (March 18, 2024), further analysis indicated that continued use of the Surfside-Sunset borrow site to complete initial construction of the project could result in significant effects on air quality due to the duration of dredging operations, including time and distance required to transport sediment from Surfside-Sunset to San Clemente Beach. Therefore, a SEIS is needed to evaluate potential significant impacts to air quality associated with further use of Surfside-Sunset to complete initial construction. Furthermore, the 2024 SEA only evaluated use of Surfside-Sunset to complete initial construction but not further use of the borrow area for future renourishments. The SEIS will also evaluate use of Surfside-Sunset for future renourishments.

2. Purpose and Need for the Proposed Action: The purpose of the proposed action is to identify borrow sites with sufficient beach compatible sediment required to complete all the planned beach nourishments for the authorized coastal storm risk management project. The need for the project is to protect public properties and private structures currently susceptible to damages caused by erosion (including land loss and undermining of structures), inundation (structures), and wave attack (structures, railroad).

3. Proposed Action: The proposed action is to identify suitable location(s) containing enough beach compatible sediment required to nourish San Clemente Beach and complete the coastal storm risk management project.

4. Alternatives: The alternatives currently identified include the preferred alternative and the no-action alternative. The preferred alternative includes the use of Surfside-Sunset borrow area in addition to the Oceanside borrow area to nourish San Clemente Beach on the average of every 6 years over the 50-year period of federal participation. The No Action Alternative is defined as continued use of only the Oceanside borrow area to complete the coastal storm risk management project; the Surfside-Sunset borrow area would not be used further. During scoping and development of the SEIS, USACE will determine if there are any additional borrow areas with suitable sediment in the general vicinity of the San Clemente Beach placement site in addition to Oceanside and Surfside-Sunset borrow areas that should be evaluated in the SEIS.

5. Summary of Potential Impacts.

Air Quality: Continued use of the Surfside-Sunset borrow area would result in emissions within the South Coast Air Basin where the borrow area, vessel transit corridor, and placement sites are located. The South Coast Air Basin is in extreme nonattainment for ozone. Pursuant to 40 CFR 93.153(b)(1), the applicability rates for ozone precursors volatile organic carbon (VOC) and nitrogen oxides (NO X ) are each 10 tons per year. The total of direct and indirect emissions of NO X for the continued use of the borrow area to complete construction and for future renourishments would exceed the applicability rate for NO X .

Biological Resources: The Surfside-Sunset borrow area as well as the vessel transit corridor for the hopper dredge to the San Clemente Beach placement site is located within a larger area identified by the National Marine Fisheries Service (NMFS) as essential for transit of green sea turtles ( Chelonia mydas), a species protected under the Endangered Species Act. Potential effects include entrainment and vessel collision. The borrow area and vessel transit corridor are also located within a proposed critical habitat for the species which is expected to be finalized in the summer of 2024. Significant adverse effects to the forthcoming designated critical habitat are not expected.

6. Scoping Process.

a. Scoping will afford all interested parties an opportunity to provide comment on the proposed scope of analysis in the draft document. A scoping meeting will not be held. Comments on scoping, including potential alternatives, pertinent information, studies, and/or analyses, relevant to the proposed action may be submitted to the contacts listed above. If any reasonable alternatives are identified during the scoping period, USACE will evaluate those alternatives in the draft SEIS, along with the No Action Alternative.

b. This NOI commences the public scoping process to identify issues and potential alternatives for consideration in the SEIS. Throughout the scoping process, federal agencies; tribal, state, and local governments; and the public can help USACE identify significant resources and issues, impact-producing factors, reasonable alternatives, and potential mitigation measures to be analyzed in the SEIS, as well as to provide additional information. Comments received in response to this NOI, including names and addresses of those who comment, will be part of the public record. Comments submitted anonymously will be accepted and considered. Before including your address, phone 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 commenters can request their personal identifying information be withheld from public review, it cannot be guaranteed that this will be able to be accomplished.

7. Anticipated Permits and Other Authorizations. The USACE is anticipating that the proposed action would require a permit pursuant to section 401 of the Clean Water Act and application of section 404(b)(1) guidelines. Other environmental review and consultation requirements include, but are not limited to, the National Historic Preservation Act, Clean Air Act, Endangered Species Act, Fish and Wildlife Coordination Act, Coastal Zone Management Act, Magnuson-Steven Fisheries Conservation Management Act, Marine Protection Research and Sanctuaries Act, and the Marine Mammal Protection Act.

8. Schedule for the Decision-Making Process. After the draft SEIS is completed, the USACE will publish a notice of availability (NOA) and request public comments on the draft SEIS. USACE anticipates issuing the NOA in July 2024. After the public comment period ends, the USACE will review and respond to comments received and will develop the final SEIS. USACE anticipates making the final SEIS available to the public in September or October 2024. A ROD will be completed no sooner than 30 days after the final SEIS is released, in accordance with 40 CFR 1506.11(b)(2).

Statutory Authority and Function: NACIQI is established under Section 114 of the HEA (20 U.S.C. 1011c). NACIQI advises the Secretary of Education with respect to:

• The establishment and enforcement of the standards of accrediting agencies or associations under subpart 2, part H, Title IV of the HEA, as amended;

• The recognition of specific accrediting agencies or associations;

• The preparation and publication of the list of nationally recognized accrediting agencies and associations;

• The eligibility and certification process for institutions of higher education under Title IV of the HEA, together with recommendations for improvement in such process;

• The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions; and

• Any other advisory function relating to accreditation and institutional eligibility that the Secretary of Education may prescribe by regulation.

The purpose of the meeting is to conduct a review of the following applications for renewals of recognition.

1. WASC Accrediting Commission for Community and Junior Colleges. Scope of Recognition: The accreditation and pre-accreditation (“Candidate for Accreditation”) of community and other colleges which have as a primary mission the granting of associate degrees, but which may also award certificates and other credentials, not to exceed the bachelor degree level, where the provision of such credentials is within the institution's mission and, if applicable, is authorized by their governmental authorities, and the accreditation of such programs offered via distance education and correspondence education at these colleges. This recognition also extends to the Committee on Substantive Change of the Commission, for decisions on substantive changes, and the Appeals Panel. Geographic Area of Accrediting Activities: Throughout the United States.

2. American Veterinary Medical Association, Council on Education. Scope of Recognition: The accreditation and preaccreditation (“Provisional Accreditation”) in the United States of programs leading to professional degrees (D.V.M. or V.M.D.) in veterinary medicine. Geographic Area of Accrediting Activities: Throughout the United States.

3. Accrediting Council for Continuing Education and Training. Scope of Recognition: The accreditation throughout the United States of institutions of higher education that offer continuing education and vocational programs that confer certificates or occupational associate degrees, including those programs offered via distance education. Geographic Area of Accrediting Activities: Throughout the United States.

4. Council on Education for Public Health. Scope of Recognition: The accreditation of schools of public health and public health programs outside schools of public health, at the baccalaureate and graduate degree levels, including those offered via distance education. Geographic Area of Accrediting Activities: Throughout the United States.

5. National Association of Schools of Dance, Commission on Accreditation. Scope of Recognition: The accreditation throughout the United States of freestanding institutions that offer dance and dance-related programs (both degree and non-degree-granting), including those offered via distance education. Geographic Area of Accrediting Activities: Throughout the United States.

6. National Association of Schools of Music, Commission on Accreditation. Scope of Recognition: The accreditation throughout the United States of freestanding institutions that offer music and music related programs (both degree and non-degree-granting) including those offered via distance. This recognition also extends to the Commission on Community College Accreditation. Geographic Area of Accrediting Activities: Throughout the United States.

7. National Association of Schools of Theatre, Commission on Accreditation. Scope of Recognition: The accreditation throughout the United States of freestanding institutions that offer theatre and theatre-related programs (both degree and non-degree-granting), including those offered via distance education. Geographic Area of Accrediting Activities: Throughout the United States.

8. Puerto Rico State Agency for the Approval of Public Postsecondary Vocational, Technical Institutions and Programs. Scope of Recognition: State agency for the approval of vocational education.

9. Maryland State Board of Nursing. Scope of Recognition: State agency for the approval of nursing education.

10. New York State Board of Regents (nursing education). Scope of Recognition: State approval agency for nursing education.

To ensure sufficient time for all agency reviews, including NACIQI questions and discussion, the Department requests that the agencies limit their opening statements to 10 minutes (total for one or more statements), and that the agencies avoid extended discussions about agency representatives and their backgrounds. Following the brief opening statement, the agency's presentation should focus on the regulatory criteria, and in particular, responses to areas where the staff has recommended a finding of noncompliance or substantial compliance, or where other concerns have been raised that the agency would like to address. However, the agency should expect that questions from NACIQI members may focus on other areas.

Assistant Secretary for Postsecondary Education, Dr. Nasser Paydar, will provide an update on the Administration's postsecondary education policy priorities.

The Committee will refer to the Accreditor Dashboards for accrediting agencies up for review. These dashboards will include information about post-completion earnings and cumulative loan debt.

In addition to its review of accrediting agencies and State approval agencies for Secretarial recognition, there will be time for Committee discussions regarding any of the categories within NACIQI's statutory authority in its capacity as an advisory committee.

Committee members will meet in-person while agency representatives and public attendees will participate virtually.

You may register for the meeting on your computer using the link below. After you register, you will receive a confirmation email containing personalized participation links for each day of the three-day meeting no later than 8:00 a.m. Eastern Standard Time on August 6, 2024.

https://cvent.me/N7blbg.

Submission of requests to make an oral comment regarding a specific accrediting agency under review, or to make an oral comment or written statement regarding other issues within the scope of NACIQI's authority:

Opportunity to submit a written statement regarding a specific accrediting agency under review was solicited by a previous Federal Register notice published on May 3, 2023 ( 88 FR 27876; Document Number 2023-09362). The period for submission of such statements is now closed. Additional written statements regarding a specific accrediting agency or state approval agency under review will not be accepted at this time. However, members of the public may submit written statements regarding other issues within the scope of NACIQI's authority for consideration by NACIQI in the manner described below.

Members of the public may make oral comments regarding a specific accrediting agency under review and/or other agenda topics. Oral comments may not exceed three minutes. Oral comments about an agency's recognition when a compliance report has been required by the Senior Department Official or the Secretary must relate to the criteria for recognition cited in the Senior Department Official's letter that requested the report, or in the Secretary's appeal decision, if any. Oral comments about an agency seeking expansion of scope must be directed to the agency's ability to serve as a recognized accrediting agency with respect to the kinds of institutions or programs requested to be added. Oral comments about the renewal of an agency's recognition must relate to its compliance with the criteria for the Recognition of Accrediting Agencies, which are available at http://www.ed.gov/admins/finaid/accred/index.html.

Written statements and oral comments concerning NACIQI's work outside of a specific accrediting agency under review must be limited to matters within the scope of NACIQI's authority, as outlined under Section 114 of the HEA (20 U.S.C. 1011c), and written comments of any kind submitted after the deadline will not be considered by the Department or provided to NACIQI for purposes of the current cycle review.

To request to make oral comments of three minutes or less during the August 6-8, 2024, meeting, please follow either Method One or Method Two below. To submit a written statement to NACIQI concerning its work outside a specific accrediting agency under review, please follow Method One.

Method One: Submit a request by email to the ThirdPartyComments@ed.gov mailbox. Please do not send material directly to NACIQI members. Written statements to NACIQI concerning its work outside of a specific accrediting agency under review and requests to make oral comment must be received by July 30, 2024, and include the subject line “Oral Comment Request: (agency name),” “Oral Comment Request: (subject)” or “Written Statement: (subject).” The email must include the name(s), title, organization/affiliation, mailing address, email address, and telephone number, of the person(s) submitting a written statement or requesting to speak. All individuals submitting an advance request in accordance with this notice will be afforded an opportunity to speak. Written statements of any kind submitted after the deadline will not be considered by the Department or provided to NACIQI for purposes of the current cycle review.

Method Two (Only available to those seeking to make oral comments): Submit a request by email on August 6, 2024, between 7:45 a.m. and 8:45 a.m. Eastern Standard Time to the ThirdPartyComments@ed.gov mailbox. The email must include the subject on which the requestor wishes to comment, in addition to his or her name, title, organization/affiliation, mailing address, email address, and telephone number. If you intend to make your comments by dialing into the meeting rather than using a computer, please be sure to include that information in your email request. A total of up to fifteen minutes for each agenda item will be allotted for oral commenters who register on August 6, 2024, between 7:45 a.m. and 8:45 a.m. Eastern Standard Time. Individuals will be selected on a first-come, first-served basis. If selected, each commenter may not exceed three minutes.

Access to Records of the Meeting: The Department will post the official report of the meeting on the NACIQI website https://sites.ed.gov/naciqi/archive-of-meetings/ within 90 days after the meeting. In addition, pursuant to 5 U.S.C. 1009(b), the public may request to inspect records of the meeting at 400 Maryland Avenue SW, Washington, DC, by emailing aslrecordsmanager@ed.gov or by calling (202) 453-7415 to schedule an appointment. Senior Department Official's (as defined in 34 CFR 602.3) decisions, pursuant to 34 CFR 602.36, associated with all NACIQI meetings can be found at the following website: https://surveys.ope.ed.gov/erecognition/#/public-documents .

Reasonable Accommodations: The dial-in information and weblink access to the meeting are accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting ( e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice at least two weeks before the scheduled meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

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

Authority: Section 114 of the HEA of 1964, as amended (20 U.S.C. 1011c).

The Commission's Statutory Authority and Function: The Commission is established by Executive Order 14045 (September 13, 2021) and continued by Executive Order 14109 (September 29, 2023). The Commission is also governed by the provisions of 5 U.S.C. chapter 10 (Federal Advisory Committees), which sets forth standards for the formation and use of advisory committees. The Commission's duties are to advise the President, through the Secretary of Education, on matters pertaining to educational equity and economic opportunity for the Hispanic and Latino community in the following areas: (i) what is needed for the development, implementation, and coordination of educational programs and initiatives at the U.S. Department of Education (Department) and other agencies to improve educational opportunities and outcomes for Hispanics and Latinos; (ii) how to promote career pathways for in-demand jobs for Hispanic and Latino students, including registered apprenticeships, internships, fellowships, mentorships, and work-based learning initiatives; (iii) ways to strengthen the capacity of institutions, such as Hispanic-serving Institutions, to equitably serve Hispanic and Latino students and increase the participation of Hispanic and Latino students, Hispanic-serving school districts, and the Hispanic community in the programs of the Department and other agencies; (iv) how to increase public awareness of and generate solutions for the educational and training challenges and equity disparities that Hispanic and Latino students face and the causes of these challenges; and (v) approaches to establish local and national partnerships with public, private, philanthropic, and nonprofit stakeholders to advance the mission and objectives of this order, consistent with applicable law. Notice of this meeting is required by section 1009(a)(2) of 5 U.S.C. chapter 10 (Federal Advisory Committees).

Meeting Agenda: The agenda for the Commission meeting builds upon conversations and information shared in the Commission's six prior meetings and continues their engagement on advancing educational equity and economic opportunity for Hispanics. Specifically, during the meeting, the Commission will (1) receive updates and discuss recommendations from the Commission's four subcommittees: Advancing PreK-12 Educational Equity; Advancing Higher Education and Hispanic Serving Institutions (HSIs); Strengthening Economic Opportunity & Workforce Development; and Strengthening Public Partnerships and Public Awareness; (2) hear presentations from federal and community leaders on topics related to Executive Order 14045; and (3) and discuss strategies and next steps towards advancing duties of the Commission, as outlined by Executive Order 14045.

Access to the Meeting: Members of the public may register to attend the meeting virtually by accessing the link at https://www.ed.gov/hispanicinitiative or emailing WhiteHouseHispanicInitiative@ed.gov by 5 p.m. EDT on Wednesday, July 24, 2024. Instructions on how to access the meeting will be emailed to members of the public that register to attend and will be posted to https://www.ed.gov/hispanicinitiative no later than Wednesday, July 24, 2024, by 6 p.m. EDT.

Public Comment: Written comments pertaining to the work of the Commission may be submitted electronically to WhiteHouseHispanicInitiative@ed.gov by 5 p.m. EDT on Wednesday, July 24, 2024. Include in the subject line: “Written Comments: Public Comment.” The email must include the name(s), title, organizations/affiliation, mailing address, email address, and telephone number of the person(s) making the comment. Comments should be submitted as a Microsoft Word document or in a medium compatible with Microsoft Word (not a PDF file) that is attached to the electronic mail message (email) or is provided in the body of an email message. Please do not send material directly to members of the Commission.

Reasonable Accommodations: The meeting platform and access code are accessible to individuals with disabilities. If you will need an auxiliary aid or service for the meeting ( e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice at least one week before the meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

Access to Records of the Meeting: The Department will post the official report of the meeting on the Commission's website, at https://sites.ed.gov/hispanic-initiative/presidential-advisory-commission no later than 90 days after the meeting. Pursuant to 5 U.S.C. 1009(b), the public may request to inspect records of the meeting, and other Commission records, at 400 Maryland Avenue SW, Washington, DC, by emailing Emmanuel.Caudillo@ed.gov or by calling (202) 377-4988, to schedule an appointment.

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

Authority: Executive Order 14045 (September 13, 2021) and continued by Executive Order 14109 (September 29, 2023).

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

This information collection request contains:

(1) OMB No.: 1910-NEW;

(2) Information Collection Request Title: Supplemental Labor Management Office (SLMO) Driver Attestation;

(3) Type of Request: New;

(4) Purpose: The purpose of the Information Collection Request is to collect information from BPA contractors at Bonneville Power Administration (BPA) sites pertaining to authorization to operate BPA owned/leased/provided motor vehicles by contracted labor personnel;

(5) Annual Estimated Number of Respondents: 250;

(6) Annual Estimated Number of Total Responses: 250;

(7) Annual Estimated Number of Burden Hours: 250;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: $16,200.

Statutory Authority: The Bonneville Project Act codified in 16 U.S.C. 832a, the Federal Columbia River Transmission System Act of 1974 codified in 16 U.S.C. 838 et seq., the Pacific Northwest Electric Power Planning and Conservation Act in 16 U.S.C. 839 et seq., Department of Energy Establishment Act 42 U.S.C. 7101 et seq., and 41 CFR 101-39.300 General Services Administration (GSA) Interagency Fleet Management System (IFMS).

This document of the Department of Energy was signed on June 25, 2024, by Candice D. Palen, Information Collection Clearance Manager, 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 .

Purpose of the Board: PCAST is an advisory group of the nation's leading scientists and engineers, appointed by the President to augment the science and technology advice available to him from the White House, cabinet departments, and other Federal agencies. See the Executive Order at whitehouse.gov. PCAST is consulted on and provides analyses and recommendations concerning a wide range of issues where understanding of science, technology, and innovation may bear on the policy choices before the President. The Designated Federal Officer is Dr. Melissa A. Edwards. Information about PCAST can be found at: www.whitehouse.gov/PCAST.

Tentative Agenda: Open portion —PCAST may discuss the future of research as it relates to societal challenges. Topics such as resilience against climate change, impacts of research on society, and others, may be discussed. Additionally, PCAST may discuss and consider for approval a letter on the Federal STEM Workforce. Additional information and the meeting agenda, including any changes that arise, will be posted on the PCAST website at: www.whitehouse.gov/PCAST/meetings.

Public Participation: The meeting will be held virtually for members of the public. It is the policy of PCAST to accept written public comments no longer than 10 pages and to accommodate oral public comments whenever possible. PCAST expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements.

The public comment period for this meeting will take place on July 11, 2024, at a time specified in the meeting agenda. This public comment period is designed only for substantive commentary on PCAST's work, not for business marketing purposes.

This notice is being published less than 15 days prior to the meeting due to scheduling difficulties and members' availability.

Oral Comments: To be considered for the public speaker list at the meeting, interested parties should register to speak at PCAST@ostp.eop.gov, no later than 12 p.m. EDT on July 3, 2024. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of up to 10 minutes. If more speakers register than there is space available on the agenda, PCAST will select speakers on a first-come, first-served basis from those who registered. Those not able to present oral comments may file written comments with the council.

Written Comments: Although written comments are accepted continuously, written comments should be submitted to PCAST@ostp.eop.gov no later than 12 p.m. EDT on July 3, 2024, so that the comments can be made available to the PCAST members for their consideration prior to this meeting.

PCAST operates under the provisions of FACA, all public comments and/or presentations will be treated as public documents and will be made available for public inspection, including being posted on the PCAST website at: www.whitehouse.gov/PCAST/meetings.

Minutes: Minutes will be available within 45 days at: www.whitehouse.gov/PCAST/meetings.

Signing Authority: This document of the Department of Energy was signed on June 27, 2024, by David Borak, Committee Management Officer, 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 .

EPA is announcing the availability of and soliciting public comment on the draft risk evaluation for 1,1-dichloroethane and the draft human health hazard technical support document for 1,2-dichloroethane. The draft documents were prepared under the Toxic Substances Control Act (TSCA) and will be submitted to the Science Advisory Committee on Chemicals (SACC) for peer review. EPA is also announcing that there will be two virtual public meetings of the SACC: On August 27, 2024, a preparatory meeting for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on September 17 through 20, 2024, the peer review meeting for the SACC to consider the draft documents and public comments.

This document provides instructions for accessing the materials, submitting written comments, and registering to provide oral comments and attend the public meetings.

EPA established the SACC in 2016 in accordance with TSCA, 15 U.S.C. 2625(o), to provide independent advice and expert consultation with respect to the scientific and technical aspects of issues relating to the implementation of TSCA. The SACC operates in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C. 10, and supports activities under TSCA, 15 U.S.C. 2601 et seq., the Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other applicable statutes.

This action is directed to the public in general and may be of particular interest to those involved in the manufacture, processing, distribution, and disposal of the subject chemical substances, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA (including members of at-risk communities, non-governmental organizations (NGOs), federal, state, and local officials). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested.

1. Submitting CBI. Do not submit CBI or other sensitive information to EPA through https://www.regulations.gov or email. To include information in your comment that you consider to be CBI or otherwise protected, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting that information.

2. Tips for preparing comments. When preparing and submitting your comments, see https://www.epa.gov/dockets/commenting-epa-dockets. See also the instructions in Unit III.C.

You may subscribe to the following listserv for alerts regarding this and other SACC-related activities: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101 .

The SACC provides independent advice and recommendations to the EPA on the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. The SACC is composed of experts in toxicology; environmental risk assessment; exposure assessment; and related sciences ( e.g., synthetic biology, pharmacology, biotechnology, nanotechnology, biochemistry, biostatistics, physiologically based pharmacokinetic (PBPK) modeling, computational toxicology, epidemiology, environmental fate, and environmental engineering and sustainability). When needed, the SACC committee will be assisted by ad hoc reviewers with specific expertise in the topics under consideration.

TSCA requires EPA to conduct risk evaluations on prioritized chemical substances and allows chemical manufacturers to request an EPA-conducted risk evaluation of a chemical substance (or category of chemical substances) using the procedures established in 40 CFR 702.37. TSCA also identifies the minimum components EPA must include in all chemical substance risk evaluations. The purpose of conducting risk evaluations is to determine whether a chemical substance presents an unreasonable risk to human health or the environment under the Conditions of Use (COUs). These evaluations include assessing unreasonable risks to relevant potentially exposed or susceptible subpopulations. As part of this process EPA: (1) Integrates hazard and exposure assessments using the best available science that is reasonably available to ensure decisions are based on the weight of the scientific evidence, and (2) Conducts peer review for risk evaluation approaches that have not been previously peer-reviewed. For more information about the three stages of EPA's process for ensuring the safety of existing chemicals ( i.e., prioritization, risk evaluation, and risk management), go to https://www.epa.gov/assessing- and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemical s.

In 2020, EPA issued final scope documents for the 20 chemical substances designated in December 2019 as High-Priority Substances for the TSCA risk evaluation process, which included 1,1-dichloroethane and 1,2-dichloroethane. The final scope documents outline the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Agency expected to consider in its risk evaluation for the substances (85 FR 55283, September 4, 2020 (FRL-10013-90)).

1,1-Dichloroethane (CASRN 75-34-3) is a chlorinated solvent that is manufactured and used primarily in industrial applications, such as a reactant for the manufacture of other chemicals or as a laboratory chemical. 1,2-dichloroethane (CASRN 107-06-2) is a colorless liquid, with a pleasant, chloroform-like odor, that is highly flammable and primarily used in plastic material manufacturing, specifically the manufacture of vinyl chloride. The reported total production volume of 1,1-dichloroethane in 2016 and 2020 was between 100 million and one billion pounds with a high percentage used for processing as a reactive intermediate and a small percentage used for commercial use as a laboratory chemical. The reported production volume of 1,2-dichloroethane was between 20 and 30 billion lbs/year, and a high percentage of the production volume is used for processing as a reactive intermediate in the manufacture of vinyl chloride.

Given that the largest reported environmental releases of 1,1-dichloroethane are to air, a major exposure pathway to 1,1-dichloroethane is through releases to air. Based on its physical and chemical properties including water solubility, vapor pressure, and Henry's Law Constant, 1,1-dichloroethane released to air is expected to remain primarily in air and 1,1-dichloroethane released to water will remain in water as it is water soluble. Continuous releases of 1,1-dichloroethane to water are expected to volatilize to air at rates dependent on environmental conditions, however, a portion of 1,1-dichloroethane will remain in the water column (maximum solubility is 5 g/liter). EPA, therefore, assessed relevant air, surface water, and land exposure pathways. EPA relied on databases reporting multi-year 1,1-dichloroethane releases to ambient air, surface water, and disposal to land, such as the Toxic Release Inventory (TRI), the National Emissions Inventory (NEI) and Discharge Monitoring Reports (DMR), among others, to conduct major portions of its exposure analysis.

Due to limited empirical data for human health and portions of the environmental hazard assessments, EPA relied on read-across approaches to supplement 1,1-dichloroethane data to propose hazard values. Specifically, for the human health assessment of 1,1-dichloroethane, EPA used 1,2-dichloroethane as an analog for a read-across method to supplement the non-cancer and cancer hazard information for 1,1-dichloroethane.

EPA is submitting the draft risk evaluation of 1,1-dichloroethane, draft human health hazard technical support document of 1,2-dichloroethane, and associated supporting documents to the SACC for peer review, along with the public comments received. The draft risk evaluation for 1,1-dichloroethane includes analyses of physical-chemical properties, the fate and transport in the environment, exposure to workers and the general population including potentially exposed or susceptible subpopulations, releases to the environment, environmental hazard and risk characterization for terrestrial and aquatic species, and human health hazard and risk characterization for workers and the general population. EPA identified 1,2-dichloroethane as an analog for reading across to 1,1-dichloroethane non-cancer and cancer human health since EPA had limited non-cancer and cancer empirical toxicity data available for 1,1- dichloroethane. EPA is therefore submitting the draft human health hazard technical support document for 1,2-dichloroethane for peer review. EPA is in the process of preparing a draft risk evaluation for 1,2-dichloroethane that will be released later for public comment and peer review. The 1,2-dichloroethane human health hazard technical support document will also accompany the 1,2-dichloroethane draft risk evaluation when it is released for public comment but will not undergo additional peer review since is currently being evaluated along with 1,1-dichloroethane.

EPA is focusing its peer review charge on specific scientific areas and analyses. Many of the methods and analyses used in these evaluations are not novel and have been reviewed in the development of previous TSCA assessments. EPA is requesting feedback on approaches, results and calculations associated with the exposure, human health hazard and environmental hazard analyses. EPA is releasing the draft risk evaluation for public comment and independent, expert peer review. Once EPA receives comment and input from public comment and peer review, revisions will be made, and the Agency will finalize the 1,1-dichloroethane risk evaluation and incorporate information from the 1,2-dichloroethane draft human health hazard technical support document into the 1,2-dichloroethane draft risk evaluation.

EPA is planning two virtual public meetings: (1) A preparatory public meeting for the SACC to consider and ask questions regarding the scope and clarity of the draft charge questions; and (2) a public peer review meeting for the SACC to consider and peer review the draft documents. These public meetings are part of the SACC's peer review of the Agency's methods and novel analyses for the draft risk evaluation of 1,1-dichloroethane and the draft human health hazard technical support document of 1,2-dichloroethane. The agenda for these meetings will be posted on the docket and will also be available through the SACC website.

To participate in these virtual public meetings, you must register online to receive the webcast and streaming service meeting links and audio teleconference information for each meeting. Online registration will be available beginning approximately one month prior to the meeting and will remain open through the end of the meeting. To make oral comments during one of these meetings, follow the instructions in this document.

Recommendations from this SACC review and public comments will be considered in the development of the TSCA risk evaluations for both chemical substances and may inform other EPA efforts related to the assessment and regulation of 1,1-dichloroethane and 1,2-dichloroethane. The Agency will be seeking SACC review of its data analyses and methodologies relevant to human health hazard and exposure analyses that have not been previously peer-reviewed.

The draft risk evaluation for 1,1-dichloroethane, draft human health hazard technical support document for 1,2-dichloroethane, and related documents, including background documents, related supporting materials, and draft charge questions, are available in the docket. As additional background materials become available, EPA will include those additional background materials ( e.g., SACC members and consultants participating in this meeting and the meeting agenda) in the docket and through links on the SACC website at https://www.epa.gov/tsca-peer-review .

After the public meeting, the SACC will prepare the meeting minutes and final report document summarizing its recommendations to the EPA, which will also be available in the docket and through the SACC website.

To ensure proper receipt of comments, it is imperative that you identify docket ID No. EPA-HQ-OPPT-2024-0073 in the subject line on the first page of your comments and follow the instructions in this document.

1. Written comments. Submit written comments by the deadlines set in the DATES section of this document and as described in the ADDRESSES section of this document.

2. Oral comments. To request time to present oral comments during one of the virtual public meetings, you must register online by the deadlines set in the DATES section of this document. Oral comments during the virtual public meetings are limited to 5 minutes. In addition, each speaker should submit a written copy of their oral comments and any supporting materials ( e.g., presentation slides) to the DFO prior to the meetings for distribution to the SACC.

Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.

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

Public comments were previously requested via the Federal Register on December 4, 2023 during a 60-day comment period (88 FR 84140). This notice allows for an additional 30 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1752. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Abstract: EPA is seeking approval to begin use of a combined EPA-Tribal Environmental Plan (ETEP) and Indian Environmental General Assistance Program (GAP) work plan template. Use of the template would assist grantees and the Agency by providing Tribes with a standardized and streamlined method to report required information outlined at 40 CFR 35.507, in the 1992 Indian Environmental General Assistance Program Act, and in the 2022 GAP Guidance.

Form numbers: None.

Respondents/affected entities: Federally recognized Tribes and intertribal consortia.

Respondent's obligation to respond: Mandatory if the recipient chooses to combine their GAP EPA-Tribal Environmental Plan and Work Plan into one document.

Estimated number of respondents: 520 (total).

Frequency of response: once every 3-5 years with annual updates.

Total estimated burden: 212.5 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $23,035 (per year), which includes $0 annualized capital or operation & maintenance costs.

Changes in the estimates: This is a new collection.

This action is being taken under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq. ).

EPA is announcing the availability of and requesting comment on a framework that outlines a process for EPA's collaboration with other federal agencies that recognizes the benefits of these pesticides to agriculture while minimizing their impact on public health and considers the goals of the One Health approach. While developing this framework, EPA has coordinated with HHS and USDA, under the oversight of the White House Executive Office of the President. Each of these agencies is charged with protecting health in areas that are directly impacted by resistance resulting from pesticides or drug products used to protect humans, animals, or plants. This framework clarifies that EPA intends to establish a process with those other federal agencies to consider their input when EPA evaluates antibacterial and antifungal pesticide products that may adversely impact the efficacy of human or animal drugs.

EPA is issuing this white paper to provide information and clarification to pesticide applicants, growers, the public health community, and the public about EPA's process for considering resistance issues related to regulatory decisions on antibacterial and antifungal pesticides with other federal agencies. While the requirements in FIFRA and the EPA regulations are binding on EPA and applicants, this white paper is not binding on EPA personnel, pesticide registrants and applicants, or the public. EPA may depart from the framework where circumstances warrant and without prior notice. Likewise, pesticide applicants may assert that the framework is not applicable to a specific pesticide or decision. Registrants and applicants may also propose alternative processes to the final framework in any application to EPA.

This framework is being published with a 30-day public comment period. EPA will consider any feedback received in producing the final framework, which EPA intends to issue by the end of 2024.

Antimicrobial resistance in bacteria and fungi is a top threat to the public's health and a priority across the globe. The Centers for Disease Control and Prevention report that there are nearly 3 million antimicrobial-resistant infections and more than 35,000 associated deaths in the U.S. each year. According to USDA, plant diseases are also persistent threats to agricultural crops and global food security, having a significant impact on yields and quality. These diseases result in billions of dollars in economic losses and management inputs each year to crops, landscapes, and forests in the U.S. Plant diseases reduce yields, lower product quality or shelf-life, decrease aesthetic or nutritional value, and may contaminate food and feed with toxic compounds.

Some antibacterial and antifungal pesticides used in agriculture and in other settings belong to the same class as or share mechanisms of action with important antimicrobial drugs used in human and veterinary medicine.

On September 26, 2023, EPA and the other federal agencies issued a document entitled “Concept Note: Soliciting Feedback from Stakeholders on the Structure of a Proposed Framework to Assess the Risk to the Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial or Antifungal Pesticides” (88 FR 65998) (FRL-11370-01-OCSPP). The concept note was intended to be the first step in creating a process to improve assessments of potential risks to human and animal health where the use of certain pesticides could potentially result in antimicrobial resistance that compromises the effectiveness of medically important antibacterial and antifungal drugs. The concept note solicited stakeholder input on the proposed structure for the process and potential solutions, research, and mitigation approaches to reduce the spread of resistance. The concept note posed several questions about how resistance occurs and is spread. The Agency received many comments; however, very few directly responded to the specific charge questions asked by the concept paper. The agencies did not receive sufficient information to resolve the many scientific questions about assessing the potential risk of antifungal or antibacterial pesticides to adversely impact the efficacy of human or animal drugs.

This action is directed to the public in general, although this action may be of particular interest to those persons who may be interested in assessments of potential risks to human and animal health where the use of certain pesticides could potentially result in antimicrobial resistance that compromises the effectiveness of medically important antibacterial and antifungal drugs. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

Do not submit CBI information to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

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

EPA is seeking comment on the document entitled “Pesticides: White Paper: Framework for Interagency Collaboration to Review Potential Antibacterial and Antifungal Resistance Risks Associated with Pesticide Use Pesticides; Notice of Availability and Request for Comment” (also referred to as the framework document), a copy of which is available in the docket.

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

Once submitted, comments cannot be edited or removed from Regulations.gov . Do not submit electronically any information you consider to be Confidential Business Information (“CBI”) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, see: https://www.epa.gov/dockets/commenting-epa-dockets. Any personally identifiable information ( e.g., name, address, phone number) included in the comment form or in an attachment may be publicly disclosed in a docket or on the internet (via Regulations.gov, a federal agency website, or a third-party, non-government website with access to publicly-disclosed data on Regulations.gov ). By submitting a comment, you agree to the terms of participation (visit: https://www.regulations.gov/user-notice ) and privacy notice (visit: https://www.regulations.gov/privacy-notice ).

For 30 days following the date of publication of this notice, EPA will receive written comments relating to the proposed Settlement Agreement. EPA will consider all comments received and may modify or withdraw its consent to this proposed Settlement Agreement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. EPA's response to any comments received will be available for public inspection at the U.S. EPA, Region 1, SEMS Records and Information Center, 5 Post Office Square, Suite 100, Boston, MA 02109 by appointment only (by calling 617-918-1440 or by emailing r1.records-sems@epa.gov ). EPA's response to any comments will also be made available at EPA's website https://www.epa.gov/superfund/olin.

The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Mindfulness-Based Interventions for Mental Health and Wellbeing in Children and Adolescents: A Systematic Review. AHRQ is conducting this review pursuant to section 902 of the Public Health Service Act, 42 U.S.C. 299a.

The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Mindfulness-Based Interventions for Mental Health and Wellbeing in Children and Adolescents: A Systematic Review. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/ped-mindfulness/protocol

This is to notify the public that the EPC Program would find the following information on Mindfulness-Based Interventions for Mental Health and Wellbeing in Children and Adolescents: A Systematic Review helpful:

A list of completed studies that your organization has sponsored for this topic. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

A list of ongoing studies that your organization has sponsored for this topic. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, inclusion and exclusion criteria, and primary and secondary outcomes.

Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this topic and an index outlining the relevant information in each submitted file.

Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.

The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “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 requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request; Use: Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (Pub. L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price Negotiation Program, codified in sections 1191 through 1198 of the Social Security Act (“the Act”). The Act establishes the Negotiation Program to negotiate maximum fair prices (“MFPs”), defined at 1191(c)(3) of the Act, for certain high expenditure, single source selected drugs covered under Medicare Part B and Part D. For the second year of the Negotiation Program, the Secretary of Health and Human Services (the “Secretary”) will select up to 15 high expenditure, single source drugs covered under Part D for negotiation.

Negotiation Data Elements: The statute requires that CMS consider certain data from Primary Manufacturers as part of the negotiation process. To the extent that more than one entity meets the statutory definition of manufacturer (specified in section 1193(a)(1) of the Act) for a selected drug for purposes of initial price applicability year 2027, CMS will designate the entity that holds the New Drug Application(s) (NDA(s))/Biologics License Application(s) (BLA(s)) for the selected drug to be “the manufacturer” of the selected drug (hereinafter the “Primary Manufacturer”). The Primary Manufacturer's data submissions include non-FAMP and related data for selected drugs for the purpose of establishing a ceiling price, as outlined in section 1193(a)(4)(A) of the Act, and the negotiation factors outlined in section 1194(e)(1) of the Act for the purpose of formulating offers and counteroffers process pursuant to section 1193(a)(4)(B) of the Act. Some of these data are held by the Primary Manufacturer and are not currently available to CMS. Data described in sections 1194(e)(1) and 1193(a)(4) of the Act must be submitted by the Primary Manufacturer.

Section 1194(e)(2) of the Act requires CMS to consider certain data on selected drugs and their alternative treatments. Because the statute does not specify where these data come from, CMS will allow for optional submission from Primary Manufacturers and the public. CMS will additionally review existing literature, conduct internal analyses, and consult subject matter and clinical experts on the factors listed in section 1194(e)(2) of the Act. Manufacturers may optionally submit this information as part of their Negotiation Data Elements Information Collection Request Form. The public may also optionally submit evidence about the selected drugs and their alternative treatments.

Drug Price Negotiation Process: Any MFPs that are negotiated for these selected drugs will apply beginning in initial price applicability year 2027. For initial price applicability year 2027, the negotiation period begins on the earlier of the date that the Primary Manufacturer enters into a Medicare Drug Price Negotiation Program Agreement or February 28, 2025.

Section 1194(b)(2)(C) of the Act provides that if the Primary Manufacturer does not accept CMS' written initial offer, the Primary Manufacturer may submit an optional written counteroffer no later than 30 days after the date of receipt of CMS' written initial offer. If the Primary Manufacturer chooses to develop and submit a written counteroffer to CMS' written initial offer during the drug price negotiation process for initial price applicability year 2027, the Primary Manufacturer must submit the Counteroffer Form. CMS is also considering expanded use of the Counteroffer Form within the drug price negotiation process. Form Number: CMS-10849 (OMB control number: 0938-1452); Frequency: Once; Affected Public: Private Sector, Business or other for-profits; Number of Respondents: 340; Number of Response s: 340; Total Annual Hours: 16,264. (For policy questions regarding this collection contact Elisabeth Daniel at 667-290-8793.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014; Final Rule II; Use: On March 23, 2010, the Patient Protection and Affordable Care Act (PPACA; Pub. L. 111-148) was signed into law and on March 30, 2010, the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) was signed into law. The two laws implement various health insurance policies. On June 19, 2013, the Department of Health and Human Services (HHS) published proposed rule CMS-9957-P: Program Integrity: Exchanges, SHOP, Premium Stabilization Programs, and Market Standards (78 FR 37302) (Program Integrity Proposed Rule) which, among other things, contained third party disclosure requirements and data collections that supported the oversight of premium stabilization programs, State Exchanges, and qualified health plan (QHP) issuers in Federally-facilitated Exchanges (FFEs). Parts of the proposed rule were finalized as Patient Protection and Affordable Care Act; Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014; Final Rule (Program Integrity Final Rule II), 78 FR 25326 (October 24, 2013). This ICR relates to a portion of the information collection request (ICR) requirements set forth in the final rule. Form Number: CMS-10516 (OMB control number: 0938-1277); Frequency: Annually; Affected Public: Private Sector, State, Local, or Tribal Governments; Business or other for-profits, and Not-for Profits; Number of Respondents: 457; Number of Response s: 457; Total Annual Hours: 42,771. (For questions regarding this collection, contact Andrea Honig at (301) 492-4147.)

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “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 requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicaid State Plan Base Plan Pages; Use: State Medicaid agencies complete the plan pages while we review the information to determine if the state has met all of the requirements of the provisions the states choose to implement. If the requirements are met, we will approve the amendments to the state's Medicaid plan giving the state the authority to implement the flexibilities. For a state to receive Medicaid Title XIX funding, there must be an approved Title XIX state plan. Form Number: CMS-179 (OMB control number 0938-0193); Frequency: Occasionally; Affected Public: State, Local, and Tribal Governments; Number of Respondents: 56; Total Annual Responses: 1,120; Total Annual Hours: 22,400. (For policy questions regarding this collection contact Gary Knight at 304-347-5723.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicaid Eligibility and Enrollment (EE) Implementation Advanced Planning Document (IAPD) Template; Use: To assess the appropriateness of states' requests for enhanced federal financial participation for expenditures related to Medicaid eligibility determination systems, we will review the submitted information and documentation to make an approval determination for the advanced planning document. Form Number: CMS-10536 (OMB control number: 0938-1268); Frequency: Yearly, once, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 168; Total Annual Hours: 2,688. (For policy questions regarding this collection contact Loren Palestino at 410-786-8842.)

3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Drug Use Review (DUR) Program; Use: States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. These profiles must reflect at least the patient's name, address, telephone number, date of birth/age, gender, history, e.g., allergies, drug reactions, list of medications, and pharmacist's comments relevant to the individual's drug therapy. The State must conduct retrospective drug use review which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact. The states and managed care organizations (MCOs) are provided the reporting instrument (a survey) by CMS, and by responding to the survey, the states generate annual reports which are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of states' DUR programs. The survey and the annual recordkeeping and reporting requirements under the pertinent regulations, are completed by pharmacists employed by, or contracted with the various state Medicaid programs and their MCOs. The annual reports submitted by states are reviewed and results are compiled by CMS in a format intended to provide information, comparisons and trends related to states' experiences with DUR. The states benefit from the information and may enhance their programs each year based on state reported innovative practices that are compiled by CMS from the annual reports. A comparison/summary of the data from the annual reports is published on Medicaid.gov annually, and serves as a resource for stakeholders, including but not limited to states, manufacturers, researchers, congress, CMS, the Office of Inspector General, non-governmental payers and clinicians on the topic of DUR in state Medicaid programs. Form Number: CMS-R-153 (OMB control number: 0938-0659); Frequency: Yearly, quarterly, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 52; Total Annual Responses: 676; Total Annual Hours: 41,860. (For policy questions regarding this collection contact Mike Forman at 410-786-2666.)

4. Type of Information Collection Request: Reinstatement without change of a currently approved collection; Title of Information Collection: Electronic Submission of Medicare Graduate Medical Education (GME) Affiliation Agreements; Use: Existing regulations at §  413.75(b) permit hospitals that share residents to elect to form a Medicare GME affiliated group if they are in the same or contiguous urban or rural areas, if they are under common ownership, or if they are jointly listed as program sponsors or major participating institutions in the same program by the accrediting agency. The purpose of a Medicare GME affiliated group is to provide flexibility to hospitals in structuring rotations under an aggregate full time equivalent (FTE) resident cap when they share residents. The existing regulations at §  413.79(f)(1) specify that each hospital in a Medicare GME affiliated group must submit a Medicare GME affiliation agreement (as defined under §  413.75(b)) to the Medicare Administrative Contractor (MAC) servicing the hospital and send a copy to the Centers for Medicare and Medicaid Services' (CMS) Central Office, no later than July 1 of the residency program year during which the Medicare GME affiliation agreement will be in effect.

CMS will use the information contained in electronic affiliation agreements as documentation of the existence of Medicare GME affiliations, and to verify that the affiliations being formed by teaching hospitals for the purposes of sharing their Medicare GME FTE cap slots are valid according to CMS regulations. CMS will also use these affiliation agreements as reference materials when potential issues involving specific affiliations arise. While we have used hard copies of affiliation agreements for those same purposes in the past, we implemented this electronic submission process in order to expedite and ease the process of retrieving, analyzing and evaluating affiliation agreements. Form Number: CMS-10326 (OMB control number: 0938-1111); Frequency: Annually; Affected Public: Private Sector, Business or other for profits, Not for profit institutions; Number of Respondents: 125; Total Annual Responses: 125; Total Annual Hours: 166. (For policy questions regarding this collection contact Shevi Marciano at 410-786-2874.)

Description: The Child Care and Development Fund (CCDF) Plan (the Plan) for Tribes is required from each CCDF Lead Agency in accordance with section 658E of the Child Care and Development Block Grant Act of 1990 (CCDBG Act), as amended, CCDBG Act of 2014 (Pub. L. 113-186), and 42 U.S.C. 9858. The majority of the Plan in this request is for tribal Lead Agencies that receive their funding directly from ACF, and does not apply to Tribes that consolidate their funding into approved 102-477 plans. However, all Tribes receiving CCDF funding must complete the triennial child count, which is part of the Plan. The Plan, submitted in the Child Care Automated Reporting System, is required triennially, and remains in effect for 3 years. The Plan provides ACF and the public with a description of, and assurance about the Tribes' child care programs. These Plans are the applications for CCDF funds.

OCC made the following changes based on feedback from tribes, including several listening sessions conducted over the past year:

• Reduced the burden overall by streamlining and removing questions;

• Revised questions based on 2024 CCDF final rule;

• Improved skip patterns to reduce burden; and

• Edited the document for plain language.

Respondents: Tribal CCDF Lead Agencies.

Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Authority: Public Law 113-186 and 42 U.S.C. 9858c.

ORR has been designated and has agreed to provide the referenced housing assistance. Three recipients—Church World Service (CWS), U.S. Committee for Refugees and Immigrants (USCRI), and HIAS—decided to participate and received supplemental funding to cover the costs of administration and provision of assistance.

To meet the terms of the Settlement Agreement, ORR will make housing assistance available to Ms. L. Settlement Class members, as determined necessary by a benefits administrator during a 12-month eligibility period. This may include assistance in locating housing; paying costs necessary to attain housing, such as a security deposit and first and last month's rent; and assistance to avoid eviction and meet other emergency housing needs during the 12-month eligibility period. Housing assistance will be for no more than a total of 6 months during the 12-month eligibility period absent extraordinary circumstances. ORR will work with Church World Service (CWS), US Committee for Refugees and Immigrants (USCRI), and HIAS to assign cases to each for housing assistance.

The recipients will employ benefit administrators, who will meet with each family (in person or virtually) and review the family's housing situation and budget. As needed, the family will be provided with rental assistance, assistance locating housing, and assistance in arrangements of deposits (typically first and last month's rent).

It is anticipated that to fully implement the Settlement Agreement, ORR will provide housing assistance through FY 2029.

ORR will supplement these three recipients for services for the remainder or FY 2024 and will provide additional supplemental funding for services in FY 2025 and FY 2026.

Assistance Listing Number: 93.576.

Description: The following two ORR information collections capture health data on children in ORR care:

The current description of purpose and use of the data collected states that confidential and sensitive health information will only be shared with external stakeholders (including other Federal agencies) for public health purposes ( e.g., contact investigations to identify children exposed to a reportable infectious disease). However, ORR has identified a need to share the health data of specific unaccompanied children with the Department of Homeland Security (DHS) which falls outside of the stated limitations. The need to communicate with DHS occurs when a newly referred child arrives at an ORR facility ill or requires emergent/urgent healthcare services shortly after placement and ORR was not notified in advance. For DHS to investigate the event, ORR must share confidential and sensitive health information including the child's alien number, name, signs/symptoms, diagnoses, and date of diagnosis. The goal of this data sharing effort is to identify areas of potential improvement in delivery of healthcare services and continuity of care for children transferred from DHS to Health and Human Services custody.

Respondents: Healthcare providers (pediatricians, medical specialists, and dentists), mental health professionals (psychiatrists, psychiatric nurse practitioners or physician's assistants, licensed psychologist or any other community based licensed mental health provider ( e.g., social worker), care provider program staff.

Annual Burden Estimates: No changes. For current burden estimates, see information below:

Authority: 6 U.S.C. 279: Exhibit 1, part A.2 of the Flores Settlement Agreement ( Jenny Lisette Flores, et al., v. Janet Reno, Attorney General of the United States, et al., Case No. CV 85-4544-RJK [C.D. Cal. 1996]).

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product XENPOZYME (olipudase alfa-rcpc). XENPOZYME is indicated for treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in adult and pediatric patients. Subsequent to this approval, the USPTO received a patent term restoration application for XENPOZYME (U.S. Patent Nos. 8,314,319 and 8,658,162) from Genzyme Corporation and Icahn School of Medicine at Mount Sinai, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 18, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of XENPOZYME represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for XENPOZYME is 5,971 days. Of this time, 5,669 days occurred during the testing phase of the regulatory review period, while 302 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: April 28, 2006. The applicant claims May 4, 2006, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was April 28, 2006, which was the first date after receipt of the IND that the investigational studies were allowed to proceed.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): November 3, 2021. FDA has verified the applicant's claim that the biologics license application (BLA) for XENPOZYME (BLA 761261) was initially submitted on November 3, 2021.

3. The date the application was approved: August 31, 2022. FDA has verified the applicant's claim that BLA 761261 was approved on August 31, 2022.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,827 days of patent term extension.