This action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612) and thus is exempt from the provisions of that Act.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), no recordkeeping or reporting requirements have been included that are subject to approval from the Office of Management and Budget.

This notice has been determined to be not significant and was not reviewed by the Office of Management and Budget in conformance with Executive Order 12866. The affected programs are listed in the Assistance Listings ( https://sam.gov/ ) under No. 10.553, No. 10.555, No. 10.556, No. 10.558, and No. 10.559 and are subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR part 415).

Pursuant to sections 9(b)(1) and 17(c)(4) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1758(b)(1) and 42 U.S.C. 1766(c)(4)), and sections 3(a)(6) and 4(e)(1)(A) of the Child Nutrition Act of 1966 (42 U.S.C. 1772(a)(6) and 1773(e)(1)(A)), the Department annually issues the Income Eligibility Guidelines for free and reduced price meals for the National School Lunch Program (7 CFR part 210), the Commodity School Program (7 CFR part 210), School Breakfast Program (7 CFR part 220), Summer Food Service Program (7 CFR part 225) and Child and Adult Care Food Program (7 CFR part 226) and the guidelines for free milk in the Special Milk Program for Children (7 CFR part 215). These eligibility guidelines are based on the Federal income poverty guidelines and are stated by household size. The guidelines are used to determine eligibility for free and reduced price meals and free milk in accordance with applicable program rules.

In accordance with the Department's policy as provided in the Food and Nutrition Service publication Eligibility Manual for School Meals, “income,” as the term is used in this notice, means income before any deductions such as income taxes, Social Security taxes, insurance premiums, charitable contributions, and bonds. It includes the following: (1) monetary compensation for services, including wages, salary, commissions or fees; (2) net income from nonfarm self-employment; (3) net income from farm self-employment; (4) Social Security; (5) dividends or interest on savings or bonds or income from estates or trusts; (6) net rental income; (7) public assistance or welfare payments; (8) unemployment compensation; (9) government civilian employee or military retirement, or pensions or veterans payments; (10) private pensions or annuities; (11) alimony or child support payments; (12) regular contributions from persons not living in the household; (13) net royalties; and (14) other cash income. Other cash income would include cash amounts received or withdrawn from any source including savings, investments, trust accounts and other resources that would be available to pay the price of a child's meal.

“Income”, as the term is used in this notice, does not include any income or benefits received under any Federal programs that are excluded from consideration as income by any statutory prohibition. Furthermore, the value of meals or milk to children shall not be considered as income to their households for other benefit programs in accordance with the prohibitions in section 12(e) of the Richard B. Russell National School Lunch Act and section 11(b) of the Child Nutrition Act of 1966 (42 U.S.C. 1760(e) and 1780(b)).

The following are the Income Eligibility Guidelines to be effective from July 1, 2023 through June 30, 2024. The Department's guidelines for free meals and milk and reduced price meals were obtained by multiplying the year 2023 Federal income poverty guidelines by 1.30 and 1.85, respectively, and by rounding the result upward to the next whole dollar.

This notice displays only the annual Federal poverty guidelines issued by the Department of Health and Human Services because the monthly and weekly Federal poverty guidelines are not used to determine the Income Eligibility Guidelines. The chart details the free and reduced price eligibility criteria for monthly income, income received twice monthly (24 payments per year); income received every two weeks (26 payments per year) and weekly income.

Income calculations are made based on the following formulas: monthly income is calculated by dividing the annual income by 12; twice monthly income is computed by dividing annual income by 24; income received every two weeks is calculated by dividing annual income by 26; and weekly income is computed by dividing annual income by 52. All numbers are rounded upward to the next whole dollar. The numbers reflected in this notice for a family of four in the 48 contiguous States, the District of Columbia, Guam and the territories represent an increase of 8.1 percent over last year's level for a family of the same size.

Authority: Section 9(b)(1) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1758(b)(1)(A)).

Title: Oil and Gas Resources, 36 CFR part 228, subpart E.

OMB Number: 0596-0101.

Expiration Date of Approval: Three years from final approval.

Type of Request: Reinstatement.

Abstract: The current rule contains procedures the Forest Service, USDA will use to accomplish the purposes of the Federal Onshore Oil and Gas Leasing Reform Act of 1987, and other applicable mineral leasing and environmental protection statutes, in offering oil and gas leases and managing the development of oil and gas resources on National Forest System lands. The Leasing Reform Act authorizes the Secretary of Agriculture to develop procedures and regulations governing leasing for oil and gas resources. including bonding and reclamation requirements, within the National Forest System. This authority was formerly exercised by the Bureau of Land Management. These regulations achieve our primary objectives of ensuring effective compliance with all applicable environmental protection statutes, as most recently construed by the Federal Courts, in conjunction with meeting the intent of Congress codified in the Leasing Reform Act. These regulations have been designed to work in coordination with similar regulations of the Department of the Interior, and to promote a cooperative process between the Federal agencies, the oil and gas industry, and members of the public who are interested in the management of Federal lands and resources.

Estimate of Annual Burden: 30 Minutes.

Type of Respondents: Public.

Estimated Annual Number of Respondents: 2,250.

Estimated Annual Number of Responses per Respondent: 2,250.

Estimated Total Annual Burden on Respondents: 1,125 hours.

Comment is invited on: (1) whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.

The primary purpose for watershed planning and preparation of this EIS is to provide flood prevention or flood risk reduction measures to the communities and agricultural lands in the Wood River Watershed located in the jurisdiction of the Central Platte Natural Resources District (CPNRD) across portions of Custer, Dawson, Buffalo, Hall, and Merrick Counties in south-central Nebraska. The purposes of watershed planning are authorized by the Watershed Protection and Flood Prevention Act of 1954, (Pub. L. 83-566) as amended, and the Flood Control Act of 1944 (Pub. L. 78-534).

Action is needed because areas of the Wood River Watershed have experienced repeated and damaging flooding, including major floods in 1967, 2005, and 2019. The Wood River Watershed experiences both flash and riverine floods from the Wood River and various tributaries. Flood damages are exacerbated by the high groundwater table in the region. Outside of the Wood River Watershed's communities, the majority of land is used for row-crop agriculture. Flood damages to cropland and pasture occur due to inundation, sediment deposition, scour, and erosion.

The earliest recorded flood impacted the watershed in 1883, and recurring floods have been reported throughout the 1940s to present day. The most extensive flood event occurred in 1967 when the Wood River overflowed its banks following a rainfall of over 10 inches. The Wood River inundated the City of Grand Island, killing three people and damaging approximately 1,800 buildings. In 2004 a levee and diversion channel were constructed to protect the City of Grand Island from high flows in the Wood River. This system was put to the test in 2005 when it successfully protected the City of Grand Island.

In 2005 a severe thunderstorm dropped 11 inches of rain near the City of Wood River, resulting in a flash flood and the evacuation of a dozen homes. It was estimated that every structure in the City of Wood River sustained some sort of storm or flood damage following the event. In total, the 2005 flash flood caused $10 million in damages.

The Wood River Watershed experienced severe flooding in 2019 during a bomb cyclone event in March, and then later flooding in July. In the City of Wood River, more than 350 homes were flooded in March 2019, with almost 60 of those having some sort of structural damage. In the City of Gibbon, the Wood River crested at a record high of 17.4 feet on March 14, 2019. This resulted in much of Gibbon being flooded both north and south of Highway 30.

The proposed action may include a variety of measures that will meet the purpose and need of reducing flood risk and damages to the Wood River Watershed. These measures may be both structural and non-structural, including channel widening, construction of diversion channels, construction of levees, construction of detention cells, stream restoration and construction of wetlands, installation of upland conservation measures, construction of dams, property acquisition and demolition, property relocation, floodproofing of structures, floodplain regulation and zoning, and interior drainage or storm sewer system improvements.

The EIS objective is to formulate and evaluate alternatives for flood prevention or flood damage reduction in the Wood River Watershed. Preliminary investigation has determined that one or a combination of the following alternatives are the most likely to be effective and should be considered for further evaluation:

This alternative involves the construction of a new diversion channel combined with berms to intercept and re-route high flows from the Wood River south to the Platte River. West of Gibbon, there is a location where the Wood River meanders nearly adjacent to Highway 30. This would be an optimum location to divert flood waters to the south, underneath Interstate 80, and into the Platte River. A diversion channel of this size would entail excavating a new, properly sized channel approximately 20,000 feet in length and lined on both sides by berms to retain flows within the channel. The diversion channel would need to cross Highway 30, the Union Pacific Railroad, and both the eastbound and westbound lanes of Interstate 80, to reach the Platte River. This alternative would be effective at reducing flood risk for Gibbon and all other downstream communities impacted by the Wood River.

A levee running adjacent and through the north end of Gibbon directly south of the Wood River would potentially protect the community from flood waters overflowing the southern bank of the Wood River. The levee would need to be approximately 7,200 feet long and tie into the Highway 30 embankment on both sides of Gibbon. Depending on the level of protection, the levee would range from approximately 5 to 10 feet tall. Currently, the levee is sized to protect Gibbon from the 50-year event. A higher level of protection is possible, but would require raising the Highway 30 grade where the levee ties in. A closure section between the Union Pacific Railroad and Highway 30 embankment might also be needed to keep water from flowing in the ditch. Constructing a levee along the north side of Gibbon between existing housing structures and the industrial processing facility would be challenging. It would require property acquisition and demolition. The final footprint of the levee can be adjusted based on real estate or property issues.

A levee on the north side of Wood River would protect the city from flooding up a selected level of design. Currently, the proposed Wood River north levee will protect the city from a 50-year event. This levee would be 8 to 10 feet tall and tie into the Highway 30 embankment. The level of protection is limited by the elevation of the Highway. Adding a grade raise to the highway where the levee ties in or continuing the levee south of the Highway could potentially increase the level of projection up the 100-year flood event. Further analysis and modeling are needed to properly locate and size this levee.

This alternative includes surface storage located south of the City of Wood River and Highway 30. The subbasins to the south of Highway 30 flood primarily agricultural land with shallow overland flow. These flows eventually combine with the main channel of the Wood River south of Alda. These subbasin flows contribute to some shallow flooding along the entire southern extent of the Lower Wood River Watershed. There is ample room for detention storage south of Wood River, just north of Interstate 80. This would lower peak flows when the main channel combines near Alda and provide flooding relief for agricultural lands. It is possible to lower the level of protection by reducing storage, which could dramatically reduce construction costs. Optimizing the size and locations of this alternative to determine optimum economic benefit needs to be performed. This includes determining if this option is beneficial with different combinations, and the optimal location and configuration of a detention cell along with flow paths. The detention cell would also have the potential for environmental benefits, such as habitat for threatened and endangered species.

This alternative consists of constructing one large dam or multiple dams in the Upper and Lower Wood River Watersheds along contributing subbasins to retain floodwaters and reduce flood risk in the downstream communities.

Early agency scoping of this federally assisted action indicates that proposed alternatives may have significant local, regional, or national impacts on the environment. Potential impacts include wetland and flood plain alteration due to the construction of these proposed alternatives. Potential realignment or raising of roads and railroads could occur, depending on the location of the proposed alternatives. The levees would impact several dozen property owners and businesses. The proposed action would reduce flood damage to structures and infrastructure in Gibbon and Wood River. Other actions, like the detention cells, may improve wildlife habitat.

NRCS will coordinate with other federal agencies throughout the planning process to ensure the proper measures are being taken to avoid and minimize impacts before considering mitigation. Conservation measures will be considered to avoid and minimize environmental impacts by implementing best management practices.

The following permits and other authorizations are anticipated to be required:

• Clean Water Act (CWA) Section 404 Permit: Proposed Action may require permit from the U.S. Army Corps of Engineers;

• CWA Section 402 Permit: Project may require National Pollutant Discharge Elimination System Permit; and

• Dam Safety and Floodplain Permits: Local dam safety and floodplain permits may be required depending on the final alternatives selected.

A Draft EIS (DEIS) will be prepared and circulated for review and comment by agencies, Tribes, consulting parties, and the public as required by 40 CFR 1503.1, 1502.20, 1506.11, 1502.17, and 7 CFR 650.13. DEIS is anticipated to be complete and available for public review within 18 months of publication of this document. Once DEIS is completed, a Notice of Availability (NOA) will be published in the Federal Register and a public review period of 45 days will be provided. Comments on DEIS will be addressed in the Final EIS. A subsequent NOA will be published in the Federal Register indicating the availability of the Final EIS. A Final EIS is anticipated to be published within 5 months of completion of the public comment period for the DEIS. After a 30-day review period, the Record of Decision (ROD) will be signed by the decision maker and responsible federal official for the project, the NRCS Nebraska State Conservationist, Mr. Robert Lawson. The ROD will be made available to the public. Based on the analysis, NRCS will decide whether to provide financial assistance to the CPNRD to implement the preferred alternative identified in the Final EIS.

An initial public scoping meeting was held virtually via Microsoft Teams on August 18, 2020, to present the project and develop the scope of the draft environmental assessment. Scoping meeting presentation materials, including a video recording of the meeting, is available on the project website, along with project background information: https://tinyurl.com/3k6ukz7w.

This meeting involved a project presentation followed by a group question-and-answer period. Project team members were available for discussion of individual questions. Scoping provides the ability for the public to provide input on the kinds of issues that should be addressed, what alternatives should be considered, impacts and additional research that should be considered, and any actions that could be related to the project.

A second public meeting will be conducted after DEIS is completed. Comments received, including the names and addresses of those who comment, will be part of the public record. The date, time, and locations of future scoping meetings will be announced on the project website, the sponsor's website, Nebraska NRCS social media, and published in the local newspaper.

NRCS invites agencies, Tribes, consulting parties, and individuals who have special expertise, legal jurisdiction, or interest in the Wood River Watershed Project to provide comments concerning the scope of the analysis and identification of relevant information and studies. All interested parties are invited to provide input related to the identification of potential alternatives, information, and analyses relevant to the Proposed Action in writing or during a public scoping meeting.

NRCS will coordinate the scoping process to correspond with any required National Historic Preservation Act (NHPA) processes, as allowed in 36 CFR 800.2(d)(3) and 800.8 (54 U.S.C. 306108). The information about historic and cultural resources within the area potentially affected by the proposed project will assist NRCS in identifying and evaluating impacts to such resources in the context of both National Environmental Policy Act (NEPA) and NHPA.

NRCS will consult with Native American tribes on a government-to-government basis in accordance with 36 CFR 800.2 and 800.3, Executive Order 13175, and other policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources and historic properties, will be given due consideration.

This document is published as required by the NEPA regulations regarding publication of a notice of intent to issue an environmental impact statement (40 CFR 1501.9(d)). This EIS will be prepared to evaluate potential environmental impacts as required by NEPA section 102(2)(C); the Council on Environmental Quality regulations (40 CFR parts 1500-1508); and NRCS regulations that implement NEPA in 7 CFR part 650. Watershed planning is authorized under the Watershed Protection and Flood Prevention Act of 1954, as amended, (Pub. L. 83-566) and the Flood Control Act of 1944 (Pub. L. 78-534).

The title and number of the Federal assistance program in the Catalog of Federal Domestic Assistance to which this Notice of Funding Availability applies is 10.904 Watershed Protection and Flood Prevention.

Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with State and local officials that would be directly affected by proposed Federal financial assistance. The objectives of the Executive order are to foster an intergovernmental partnership and a strengthened federalism, by relying on State and local processes for State and local government coordination and review of proposed Federal financial assistance and direct Federal development. This program is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Agencies, offices, and employees, and institutions participating in or administering 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 or 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.

Individuals who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA TARGET Center at (202) 720-2600 (voice and TTY) or dial 711 for Telecommunicaions Relay Service (both voice and text telephone users can initiate this call from any phone). Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by mail to U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410, or email: OAC@usda.gov. USDA is an equal opportunity provider, employer, and lender.

Members of the public may listen to this discussion through the above call-in number. An open comment period will be provided to allow members of the public to make a statement as time allows. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Individuals who are deaf, deafblind and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to David Barreras at dbarreras@usccr.gov.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Kansas Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Members of the public may listen to this discussion through the above call-in number (audio only) or online registration link (audio/visual). An open comment period will be provided to allow members of the public to make a statement as time allows. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Individuals who are deaf, deafblind, and/or hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and meeting ID number.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Melissa Wojnaroski at mwojnaroski@usccr.gov.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Virginia Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

On October 11, 2022, Commerce published the preliminary results of this review and invited interested parties to comment. 1 No parties commented on the Preliminary Results. Accordingly, the Preliminary Results remain unchanged in the final results, and no decision memorandum accompanies this notice.

The product covered by the Order is WBF from China. 3 For a complete description of the scope of this Order, see the appendix to this notice.

We received no comments, and we have made no changes to the Preliminary Results. We continue to find that nine companies/company groupings subject to this review are part of the China-wide entity because they did not demonstrate eligibility for separate rates, and that seven companies/company groupings had no shipments of WBF during the POR.

In the Preliminary Results, we determined, based on timely filed company certifications and our analysis of information obtained from CBP, that the following seven companies/company groupings did not export or sell subject merchandise during the POR: (1) Eurosa (Kunshan) Co., Ltd. and Eurosa Furniture Co., (PTE) Ltd.; (2) Jiangmen Kinwai Furniture Decoration Co., Ltd.; (3) Jiangmen Kinwai International Furniture Co., Ltd.; (4) Nanhai Jiantai Woodwork Co. Ltd. and Fortune Glory Industrial, Ltd. (HK Ltd.); (5) Shenyang Shining Dongxing Furniture Co., Ltd.; (6) Yeh Brothers World Trade Inc.; and (7) Zhangzhou Guohui Industrial & Trade Co., Ltd. 4 We received no comments from interested parties with respect to this determination. Therefore, because the record indicates that these seven companies/company groupings did not export subject merchandise during the POR, we continue to find that they had no reviewable transactions during the POR.

Commerce considers the following nine companies/company groupings for which a review was requested to be part of the China-wide entity because they did not demonstrate their eligibility for a separate rate: (1) Dongguan Sunrise Furniture Co., Taicang Sunrise Wood Industry, Co., Ltd., Shanghai Sunrise Furniture Co., Ltd., Fairmont Designs; (2) Dongguan Sunrise Furniture Co., Ltd., Taicang Sunrise Wood Industry Co., Ltd., Taicang Fairmont Designs Furniture Co., Ltd., Meizhou Sunrise Furniture Co., Ltd.; (3) Hang Hai Woodcraft's Art Factory; (4) Shenzhen Forest Furniture Co., Ltd.; (5) Sunforce Furniture (Hui-Yang) Co., Ltd., Sun Fung Wooden Factory, Sun Fung Co., Shin Feng Furniture Co., Ltd., Stupendous International Co., Ltd.; (6) Superwood Co. Ltd., Lianjiang Zongyu Art Products Co., Ltd.; (7) Xiamen Yongquan Sci-Tech Development Co., Ltd.; (8) Yihua Timber Industry Co., Ltd. (a.k.a. Guangdong Yihua Timber Industry Co., Ltd.); and (9) Yihua Lifestyle Technology Co., Ltd. Accordingly, for these final results, we determine that these nine companies/company groupings, none of which submitted a separate rate application or separate rate certification, are part of the China-wide entity.

In this review, no party requested a review of the China-wide entity, and Commerce did not self-initiate a review of the China-wide entity. Because we are not reviewing the China-wide entity in this review, the dumping margin previously established for the China-wide entity, which is 216.01 percent, is not subject to change as a result of this review. 5

Commerce will determine, and CBP shall assess, ADs on all appropriate entries covered by this review in accordance with section 751(a)(2)(C) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.212(b)(1). We will instruct CBP to liquidate entries of subject merchandise exported by the companies/company groupings that failed to qualify for a separate rate, and any suspended entries of subject merchandise during the POR under the case numbers of companies that claimed no shipments, at the China-wide entity rate. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of subject merchandise from China entered, or withdrawn from warehouse, for consumption on, or after, the publication date of this notice, as provided by section 751(a)(2)(C) of the Act: (1) for any previously investigated or reviewed China or non-China exporter that has a separate rate and for which a review was not requested, the cash deposit rate will continue to be the exporter's existing cash deposit rate; (2) for all China exporters of subject merchandise that do not have a separate rate, including those exporters that failed to establish their eligibility for a separate rate in this review, the cash deposit rate will be equal to the dumping margin assigned to the China-wide entity, which is 216.01 percent; and (3) for all non-China exporters of subject merchandise that do not have a separate rate, the cash deposit rate will be equal to the dumping margin applicable to the China exporter(s) that supplied the non-China exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of ADs prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of ADs occurred and the subsequent assessment of double ADs.

This notice also serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.

We are issuing and publishing the final results of this review in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.213(h) and 351.221(b)(5).

The CIE will conduct a review of the goals of the Ecosystem Status Reports efforts and how best to achieve them. The agenda is subject to change, and the latest version will be posted at https://appsafsc.fisheries.noaa.gov/Plan_Team/2023_ESR_CIE/ prior to the meeting, along with meeting materials.

An opportunity for public comment will be provided during the meeting. For more information, please visit the link at https://appsafsc.fisheries.noaa.gov/Plan_Team/2023_ESR_CIE/.

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

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ) and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

The applicant proposes to film gray whales ( Eschrichtius robustus ) feeding on shrimp in the intertidal zone of Puget Sound, WA. The filming is for a natural history television series, which follows the journey of rivers from source to sea. Up to 180 gray whales may be harassed during filming from vessels, land, unmanned aircraft systems, and snorkelers. If encountered, 70 of each of the following species may be filmed and unintentionally harassed: killer whales ( Orcinus orca; west coast transient stock), harbor porpoise ( Phocoena phocoena ), California sea lions ( Zalophus californianus ), Steller sea lions ( Eumetopias jubatus ), and harbor seals ( Phoca vitulina ). The permit would expire on May 31, 2024.

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

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

Notices were published in the Federal Register on the dates listed below that requests for a permit, permit amendment, or permit modification had been submitted by the below-named applicants. To locate the Federal Register notice that announced our receipt of the application and a complete description of the activities, go to www.federalregister.gov and search on the permit number provided in Table 1 below.

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

As required by the ESA, as applicable, issuance of these permit was based on a finding that such permits: (1) were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in Section 2 of the ESA.

Authority: The requested permits have been issued under the MMPA of 1972, as amended (16 U.S.C. 1361 et seq. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the ESA of 1973, as amended (16 U.S.C. 1531 et seq. ), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), as applicable.

The LKTKS Taskforce agenda will include: (a) summary of Taskforce work to-date; (b) changes to materials since December 2022; (c) review and finalize the LKTKS Protocol; (d) review and finalize LKTKS onramp recommendations; (e) review and finalize LKTKS Policy statement; (f) reflections and final recommendations; and (g) other business. The agenda is subject to change, and the latest version will be posted at https://meetings.npfmc.org/Meeting/Details/2977 prior to the meeting, along with meeting materials.

You can attend the meeting online using a computer, tablet, or smart phone; or by phone only. Connection information will be posted online at: https://meetings.npfmc.org/Meeting/Details/2977.

Public comment letters will be accepted and should be submitted electronically to https://meetings.npfmc.org/Meeting/Details/2977 by 5 p.m. Alaska time on Wednesday, March 1, 2023. An opportunity for oral public testimony will also be provided during the meeting.

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

On December 19, 2022, we published the NIA in the Federal Register (87 FR 77575). Following the publication of the NIA, the Joint Explanatory Statement accompanying Division H of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) indicated an intent by Congress to provide an increase of $1,000,000 for the Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities—State Technical Assistance Projects to Improve Services and Results for DeafBlind Children and National Technical Assistance and Dissemination Center for DeafBlind Children to strengthen support for the abilities and needs of children with deaf-blindness, including through intervener services. Accordingly, we are correcting the NIA to reflect the updated estimated range of awards and average size of awards, updated maximum award amounts, and allowance of subgrants.

In addition, we are extending the application deadline date to March 13, 2023, and extending the intergovernmental review deadline to May 12, 2023. Applicants that have already submitted applications under the FY 2023 State Technical Assistance Projects to Improve Services and Results for DeafBlind Children and National Technical Assistance and Dissemination Center for DeafBlind Children competition may resubmit applications but are not required to do so. If a new application is not submitted, the Department will use the application that was submitted by the original deadline. If a new application is submitted, the Department will review the most recent application submitted before the deadline of March 13, 2023.

Other than extending the application submission deadline and intergovernmental review deadline, increasing the estimated available funds, updating the estimated range of awards and average size of awards, updating the maximum award amounts, and allowing subgrants, all other requirements and conditions stated in the NIA remain the same.

Program Authority: 20 U.S.C. 1462, 1463 and 1481.

In FR Doc. 2022-27457, appearing on pages 77575-77585 of the Federal Register of December 19, 2022 (87 FR 77575), we make the following corrections:

(1) On page 77575, in the first column, following the heading “Deadline for Transmittal of Applications:” remove “February 17, 2023.” and add, in its place, “March 13, 2023.”

(2) On page 77575, in the first column, following the heading “Deadline for Intergovernmental Review:” remove “April 18, 2023.” and add, in its place, “May 12, 2023.”

(3) On page 77581, in the third column, following the heading “Estimated Available Funds:” remove “The Administration requested $49,345,000 for the Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities program for FY 2023, of which we intend to use an estimated $11,100,000 for this competition; and $250,000,000 for the Personnel Development to Improve Services and Results for Children with Disabilities program, of which we intend to use an estimated $500,000 for this competition. The actual level of funding, if any, depends on final congressional action. However, we are inviting applications to allow enough time to complete the grant process if Congress appropriates funds for this program.” and add, in its place, “$12,600,000, including $12,100,000 from the FY 2023 Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities Program appropriation and $500,000 from the FY 2023 Personnel Development to Improve Services and Results for Children with Disabilities Program appropriation.”

(4) On page 77581, in the third column, following the heading “Estimated Range of Awards:” remove “$2,100,000” and add, in its place, “$2,200,000”.

(5) On page 77581, in the third column, following the heading “Estimated Average Size of Awards:” remove “Focus Area A: $176,000. Focus Area B: $2,100,000.” and add, in its place, “Focus Area A: See chart. Focus Area B: $2,200,000.”

(6) On page 77581, in the third column, following the heading “Maximum Award:” remove “In determining the maximum funding levels for each State, the Secretary considered, among other things, the following factors: (1) The total number of children from birth through age 21 in the State. (2) The number of children in poverty in the State. (3) The previous funding levels. (4) The minimum funding amounts. (5) The travel costs associated with serving the geographic location of the State” and add, in its place, “In determining the maximum funding levels for each State, the Secretary applied a standard percentage increase over the 2018 award amount for each State and then considered, among other things, the travel costs associated with serving the geographic location of the State”.

(7) On page 77582, in the first column, remove the chart titled “FY 2023 FUNDING LEVELS BY STATE FOR FOCUS AREA A” and add, in its place, the following chart:

(8) On page 77582, in the first column, following the heading “Focus Area B:”, remove, “$2,100,000” and add, in its place, “$2,200,000”.

(9) On page 77582, in the third column, following the heading “Subgrantees”, remove “A grantee under this competition may not award subgrants to entities to directly carry out project activities described in its application. Under 34 CFR 75.708(e), a grantee may contract for supplies, equipment, and other services in accordance with 2 CFR part 200.” and add, in its place, “Under 34 CFR 75.708(b) and (c) a grantee under this competition may award subgrants—to directly carry out project activities described in its application—to the following types of entities: institutions of higher education, nonprofit organizations, and other public agencies suitable to carry out the activities proposed in the application. The grantee may award subgrants to entities it has identified in an approved application or that it selects through a competition under procedures established by the grantee.”

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

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

You may also access 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.

Purpose of Program: The purpose of the NAM program is to award grants to eligible entities to develop and enhance capacity to provide effective instruction and support to Native American and Alaska Native students, including Native Hawaiian and Native American Pacific Islander students, who are identified as English learners (ELs). The goal of this program is to support the teaching, learning, and studying of Native American languages while also increasing the English language proficiency and academic achievement of students served.

Background: Through previous competitions, the NAM program has funded a range of grantees that are currently implementing 16 projects across the country. As we are focused on closing long-standing opportunity, achievement, and attainment gaps that have continued to grow, there is also a need to increase the knowledge of what practices work to effectively improve learning outcomes for Native American and Alaska Native ELs.

Congress, in the Native American Languages Act of 1990, recognized the fundamental importance of preserving Native American languages. This legislation provides that it is the policy of the United States to—

Preserve, protect, and promote the rights and freedom of Native Americans to use, practice, and develop Native American languages.

The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2023-0046) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

The electronic version of the public docket for this action contains a copy of the proposed consent decree and is available through https://www.regulations.gov. You may use https://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”

On July 29, 2022, Plaintiffs Environmental Integrity Project, Chesapeake Climate Action Network, and Sierra Club filed a complaint in the United States District Court for the District of Columbia, alleging that the Environmental Protection Agency failed to perform certain non-discretionary duties in accordance with the Act to timely review and, if necessary, revise, the methods (“emission factors”) used to estimate the quantity of emissions of carbon monoxide, volatile organic compounds, and oxides of nitrogen under CAA section 130, 42 U.S.C. 7430, for municipal solid waste landfills. The proposed consent decree would establish deadlines for EPA to review and, if necessary, revise these emission factors for municipal solid waste landfills.

EPA is agreeing to issue draft revisions to these emission factors (or issue a draft determination that revision is not necessary) by January 15, 2024. EPA is also agreeing to issue final revisions to the emission factors (or issue a final determination that revision is not necessary) by August 15, 2024. EPA will update its AP-42 website, where EPA maintains its Compilation of Air Pollutant Emission Factors, with the emission factors (or determinations) for municipal solid waste landfills.

In accordance with section 113(g) of the CAA, for a period of thirty (30) days following the date of publication of this document, the Agency will accept written comments relating to the proposed consent decree. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act.

Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2023-0046, via https://www.regulations.gov. Once submitted, comments cannot be edited or removed from this docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov 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 additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information identified as CBI, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this document. Note that written comments containing CBI and submitted by mail may be delayed and deliveries or couriers will be received by scheduled appointment only.

If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

Use of the https://www.regulations.gov website to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment.

Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider such late comments.

Proposed Agenda: The agenda for the meeting will include reports from each of the three CEDC working groups including Innovation and Access, Digital Empowerment and Inclusion, and Diversity and Equity. This agenda may be modified at the discretion of the CEDC Chair and the DFO.

The CEDC meeting will be accessible to the public on the internet via live feed from the Commission's web page at www.fcc.gov/live. Members of the public may submit questions during the meeting to livequestions@fcc.gov. Additionally, members of the public may submit comments to the CEDC using the FCC's Electronic Comment Filing System, ECFS, at www.fcc.gov/ecfs. Comments to the CEDC should be filed in GN Docket No. 17-208.

Open captioning will be provided for this event. Other reasonable accommodations for persons with disabilities are available upon request. Requests for such accommodations should be submitted via email to fcc504@fcc.gov or by calling the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). Such requests should include a detailed description of the accommodation needed. In addition, please include a way for the Commission to contact the requester if more information is needed to fulfill the request. Please allow at least five days' notice; last minute requests will be accepted but may not be possible to accommodate.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App., this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality (the Council). The Council is authorized by Section 941 of the Public Health Service Act, 42 U.S.C. 299c. In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director of AHRQ on matters related to AHRQ's conduct of its mission including providing guidance on (A) priorities for health care research, (B) the field of health care research including training needs and information dissemination on health care quality and (C) the role of the Agency in light of private sector activity and opportunities for public private partnerships. The Council is composed of members of the public, appointed by the Secretary, and Federal ex-officio members specified in the authorizing legislation.

On Monday, March 6, 2023, NAC members will meet to conduct preparatory work prior to convening the Council meeting at 11:30 a.m., with the call to order by the Council Chair, an introduction of NAC members, and approval of previous Council summary notes. The NAC members will then receive an update from the AHRQ Director, including a follow up discussion on private capital and engaging health system executive leadership. The agenda will also include (1) an update and discussion by NAC members on AHRQ's Patient Safety Framework and the Patient Safety Action Alliance's efforts to promote Safer Together: A National Patient Safety Action Plan and (2) a report out and discussion about Long Covid and addressing health system fragmentation. The meeting is open to the public and will adjourn at 3:00 p.m. For information regarding how to access the meeting as well as other meeting details, including information on how to make a public comment, please go to https://www.ahrq.gov/news/events/nac/. The final agenda will be available on the AHRQ website no later than Monday February 27, 2023.

ATSDR has prepared drafts of four updated toxicological profiles based on current understanding of the health effects and availability of new studies and other information since their initial release. All toxicological profiles issued as “Drafts for Public Comment” represent the result of ATSDR's evidence-based evaluations to provide important toxicological information on priority hazardous substances to the public and health professionals. ATSDR considers key studies for these substances during the profile development process, using a systematic review approach. To that end, ATSDR is seeking public comments and additional information or reports on studies about the health effects of these four substances for review and potential inclusion in the profiles. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profile.

Interested persons or organizations are invited to participate by submitting written views, information, and data. Comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on www.regulations.gov. Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. Do not submit comments by email. ATSDR does not accept comments by email. ATSDR will review all submissions and may choose to redact or withhold submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. ATSDR will carefully review and consider all comments submitted in preparation of the Final Toxicological Profiles and may revise the profiles as appropriate.

The Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9601 et seq. ] amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund) [42 U.S.C. 9601 et seq. ] by establishing certain requirements for ATSDR and the U.S. Environmental Protection Agency (EPA) regarding the hazardous substances most commonly found at facilities on the CERCLA National Priorities List. Among these statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the priority list of hazardous substances [also called the Substance Priority List (SPL)]. This list identifies 275 hazardous substances that ATSDR has determined pose the most significant potential threat to human health. The SPL is available online at www.atsdr.cdc.gov/spl. ATSDR is also mandated to revise and publish updated toxicological profiles, as necessary, to reflect updated health effects and other information.

In addition, CERCLA provides ATSDR with the authority to prepare toxicological profiles for substances not found on the SPL. CERCLA authorizes ATSDR to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances (CERCLA Section 104(i)(1)(B); 42 U.S.C. 9604(i)(1)(B)); to respond to requests for health consultations (CERCLA Section 104(i)(4); 42 U.S.C. 9604(i)(4)); and to support the site-specific response actions conducted by the agency (CERCLA Section 104(i)(6); 42 U.S.C. 9604(i)(6)). Public nominations for substances from the SPL (or other substances) for toxicological profile development were requested on April 18, 2018 (83 FR 17177).

ATSDR has now prepared drafts of four updated toxicological profiles based on current understanding of the health effects and availability of new studies and other information since their initial release.

The Draft Toxicological Profiles are available online at www.regulations.gov, Docket No. ATSDR-2022-0006 and at www.atsdr.cdc.gov/ToxProfiles.

On January 19, 2022, CDC published a notice in the Federal Register (87 FR 2791) requesting public comment on a draft policy statement on BSL-4/ABSL-4 laboratory verifications standards, including HVAC, to aid individuals and entities in verifying that these laboratories are properly functioning. HHS/CDC received comment on the draft policy statement concerning BSL-4/ABSL-4 verification requirements from seven commenters. The commenters were from academia, industry, city/local government, and the public.

In general, commenters supported the draft policy but had specific suggestions on wording and revisions. Please see a summary of the comments and our responses below.

Comment: One commenter suggested changing the subject to include BSL-3 Agriculture.

Response: HHS/CDC notes that an established BSL-3/ABSL-3 Verification Policy already exists ( https://www.cdc.gov/cpr/ipp/docs/Policy_Import_BSL3_ABSL3_Verification.pdf ). Thus, HHS/CDC made no changes based on this comment.

Comment: One commenter recommended that Heating, Ventilation, and Air Conditioning (HVAC) be referred to as “Building and Mechanical, Electrical, and Plumbing (MEP) systems.”

Response: HHS/CDC disagreed with this recommendation because the term “HVAC” is more universally referenced. No changes were made to the policy due to this comment.

Comment: HHS/CDC received comment regarding clarification and testing of the HVAC system only after major changes or every ten years.

Response: HHS/CDC agreed with the commenter to provide the clarification and has updated the policy to state that entities must ensure HVAC verification is performed and documented “after major changes to ensure operational parameters are maintained.” The policy includes examples of major changes that can be referenced. HHS/CDC disagreed with the other comments regarding increasing the testing requirement to every ten years.

Comment: A commenter discussed primary and secondary fans versus parallel HVAC fans and how setup depends on different facility configurations.

Response: HHS/CDC agreed with the comment about configuration of HVAC fans and included “or failure of parallel fans depending on facility configuration” in the policy.

Comment: Commenters requested that examples be provided for major changes and that HHS/CDC provide a list of repairs to HVAC control system components that require verification testing.

Response: HHS/CDC agreed with providing examples and has updated the policy to include examples of major changes that can be referenced. Modifications include repairs or replacing a component to the HVAC to ensure that the system is fully operational. HHS/CDC also revised the policy to state “systems” instead of “components.” Entities should ensure all HVAC systems are operational, and because systems vary, the components of the system also vary from entity to entity; therefore, HHS/CDC will not be providing a universal list of repair of HVAC control system components.

Comment: Another commenter suggested using a risk assessment-based approach to determine if failure testing is required after resolving a major problem.

Response: HHS/CDC disagreed with the comment regarding a risk assessment-based approach to determine if failure testing is required after a major problem. As such, HHS/CDC made no updates to the policy. HHS/CDC understands the commenters' concerns regarding a disruption due to a major problem and then the need for the entity to perform HVAC operational verification. However, HHS/CDC believes it is essential to verify the system annually and after any significant modification to ensure operational parameters are maintained during both normal operating conditions and failure conditions to prevent air-flow reversals into non-containment areas ( e.g., outside the containment boundary, hallways).

Comment: A commenter requested that HHS/CDC require an HVAC design verification process for “primary containment (suit and cabinet room's primary barrier equipment)” instead of secondary containment.

Response: HVAC is part of the facility safeguards, which is a secondary barrier; therefore, HHS/CDC will not be referring to this as primary containment. Secondary containment is defined by the 6th edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL) as the design and construction of the laboratory facility that provides a means of secondary containment of hazardous biological agents and toxins to protect personnel, the surrounding community, and the environment from possible exposure to hazardous biological agents and toxins.

Comment: A commenter recommended excluding small repairs, like-for-like replacement of smaller components, and minor automation system logic programming changes.

Response: HHS/CDC made no changes to the policy and agreed with the commenter that minor changes and small repairs mentioned above would not be considered major repairs.

Comment: Commenters suggested specific references be added to the list of systems to be tested/verified annually such as chemical shower, alarms, power source, communications, access systems, Air Pressure Resistant (APR) door gaskets, positive-pressure suits, water supply, and manual overrides tested ( e.g., between mechanical and electronic door interlocks).

Response: HHS/CDC agreed with the commenters and updated the policy to reference these items.

Comment: Commenters requested the term “uninterrupted power supply” be changed to adequately reflect the meaning.

Response: HHS/CDC agreed with the commenters and changed the term to “automatically activated backup.”

Comment: A commenter asked if room air pressure trend lines captured from the Building Automation System (BAS) could be used to demonstrate the absence of air reversal.

Response: HHS/CDC agreed and revised the policy to state that entities may use BAS records to demonstrate no airflow reversal from the BSL-4/ABSL-4 laboratory during transition from normal power to the automatically activated backup, emergency power supply.

Comment: Another commenter suggested the inclusion of emergency power stand-by systems (emergency generator and automatic transfer switch), uninterruptible power supply, and critical equipment with internal batteries ( e.g., programmable logic control devices) to the minimum verification requirement for back-up power systems for HVAC.

Response: HHS/CDC agreed with the comment and revised the policy to include “routine maintenance programs and backup, power systems” to succinctly summarize the minimum verification requirements.

Comment: Commenters requested term “power failure” be changed to adequately reflect the meaning.

Response: HHS/CDC agreed with commenters and changed the term to “emergency power status.”

Comment: A commenter stated that “only modifications in the programming sequence that affect how the laboratory reacts in failure conditions should be required to be re-tested.” The commenter further suggested that changes or updates such as “tuning PID loops, updates on coefficients that are imbedded in the sequence of operation, or the optimization of the logic to reduce the traffic of data in the system, should not require re-verification.”

Response: HHS/CDC made no changes based on this comment. HHS/CDC is primarily interested in ensuring that all systems are working as designed after any major changes, which is a normal practice to ensure the system is fully operational.

Comment: A commenter suggested that the addition or removal of hard-ducted equipment ( e.g., biological safety cabinets [BSCs], Class III BSC, or decontamination systems) without affecting the airflow balance of the room does not affect the operations, therefore no re-verification should be required.

Response: HHS/CDC made no changes based on the comment. Additions or removals should be tested to ensure repairs were effective even if one component was replaced.

Comment: A commenter stated that the methods for verification of primary containment integrity is unclear and needs to be clarified (specifically for primary containment of centrifuges and animal caging systems). The commenter further requested that the policy state what documentation or testing is needed for the verification.

Response: HHS/CDC made no changes to the policy based on the comment since there are no specific tests to determine integrity. Centrifuges need to have safety cups and no leaks in the washers to ensure integrity of primary containment inside the centrifuge (BMBL 6th edition, Inadvertent Toxin Aerosols). Animal cages need to be designed to allow recirculation of air into the room after high-efficiency particulate air (HEPA) filtration (BMBL 6th edition, Part 3: Biological Safety Cabinets). While there are no specific tests to determine integrity, HHS/CDC recommends that the entity verifies the animal caging systems and centrifuge, and its components, are working as designed.

Comment: Commenters requested to clarify the meaning of BSCs with an HVAC connection “not working properly.” A commenter asserted that the observation or evidence that the BSC is not working properly is more of an issue with the certification and maintenance of the equipment and not the HVAC system, therefore, it is not a major problem and does not require re-verification.

Response: HHS/CDC agreed with the commenters to clarify the meaning of “not working properly” and revised the policy to read “observation or evidence that BSCs with an HVAC connection (hard duct or thimble) are not working as designed.” HHS/CDC disagreed with the commenter regarding reverification. When major repairs are made to the BSC including replacing components of the BSC, the entity should test the system to ensure repair was effective and does not compromise the functionality of the HVAC system.

Comment: Commenters requested clarification on verifying BAS-programmed alarm communication as part of the BSL-4/ABSL-4 facility verification. One commenter recommended that verification of BAS programmed alarms should be tested only initially.

Response: HHS/CDC did not make any changes based on the comments. Verification of the BAS-programmed alarm communication should include assurance that if an alarm occurs, the strobes, lights, or audibles are activated. Testing annually ensures all parameters that are important to maintain containment have a functioning alarm.

Comment: A commenter provided editorial changes for clarity to paragraph A, Effluent, tissue, autoclave, and decontamination systems, under section 3 (confirmation that decontamination systems are operating as designed [ e.g., autoclave, room decontamination systems, tissue digesters, liquid effluent systems, and chemical showers]). Specifically, the commenter recommended:

• 3. A. i: Change to Annual verification that system operational parameters have not changed from biologically validated conditions ( e.g., volume, pressure, temperature settings)

• 3. A. iii: Change to Annual certification testing of associated HEPA filters, if applicable ( e.g., operating vent, pressure relief vent, chamber effluent/vent)

• 3. A. iv: Change to Annual verification that system failure, emergency communication systems are operating as designed ( e.g., alarms, leak detection)

• 3. A. v: Change to Verify appropriate filter media is selected and maintained annually ( e.g., HEPA, polytetrafluoroethylene [PTFE])

Another commenter agreed that 3. A. v. should be rewritten for clarity and stated that the sentence should refer to “HEPA, however, it should instead be revised in terms of efficiency and particle size since HEPA filters are at least 99.97% of airport particles 0.3 micrometers, while PTFE filters have 99.99% efficiency of airborne particles 2.5micrometers in diameter.”

• 3. A. vi: Another commenter stated that this was unclear and needs to be clarified to state specifically what document/test needs to be provided to meet this requirement.

Response: HHS/CDC agreed with the editorial changes, updated the policy based on these changes, and clarified 3. A. v. to read “v. Verify appropriate filter media is selected and maintained annually (e.g., HEPA, PTFE).” However, HHS/CDC disagreed with suggestion to revise 3. A. iv. “annual verification that system failure alarms are operating as designed” because the language is clear as written and communication is more encompassing than alarms. HHS/CDC agreed with the commenter to clarify 3. A. vi. to read, “Implementation of risk-based preventative maintenance for other equipment that is critical to containment components, but is not specifically included above (e.g., cook tanks, etc.).”

Comment: A commenter requested to clarify decontamination systems by adding decontamination rooms and chambers.

Response: HHS/CDC made no changes to the policy based on the comment because some facilities may not have these rooms or chambers.

Comment: A commenter responded that room decontamination should be validated upon each use and not rely on annual verifications as a substitution, since parameters can shift slightly from use to use ( i.e., atmospheric moisture or room temperature).

Response: HHS/CDC agreed with commenter; however, no changes were made based on this comment since the policy notes that this is an annual verification of the room decontamination system and biological indicators are already mentioned for this reason.

Comment: Commenters suggested wording changes for annual verification requirement for certification of laboratory HVAC, plumbing vent line, and decontamination system filters, stating that there are no written standards by which to certify BSL-4/ABSL-4 laboratories.

Response: HHS/CDC agreed with the commenters and made the change to the policy.

Comment: A commenter requested that “established” specifications be changed to “approved design” specifications.

Response: HHS/CDC agreed with the commenter and revised the policy.

Comment: Commenters requested adding the verification requirement for “pressure decay testing.”

Response: HHS/CDC agreed with the commenters and included that pressure decay testing may be used to identify and confirm proper operation of various BSL-4/ABSL-4 containment boundary points of failure ( e.g., penetrations, cracks, breaks, APR doors, HEPA isolation dampers, etc.).

This policy document is available at the Federal Select Agent Program website at www.selectagents.gov.

HHS/CDC is issuing this policy under the authority of sections 201-204 and 221 of Title II of Public Law 107-188, (42 U.S.C. 262a).

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 drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug 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 drug 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 drug product, XOSPATA (gilteritinib) indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation as detected by an FDA-approved test. Subsequent to this approval, the USPTO received patent term restoration applications for XOSPATA (U.S. Patent Nos. 8,969,336 and 9,487,491) from Astellas Pharma Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 24, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of XOSPATA 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 XOSPATA is 2,002 days. Of this time, 1,757 days occurred during the testing phase of the regulatory review period, while 245 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: June 7, 2013. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on June 7, 2013.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: March 29, 2018. FDA has verified the applicant's claim that the new drug application (NDA) for XOSPATA (NDA 211349) was initially submitted on March 29, 2018.

3. The date the application was approved: November 28, 2018. FDA has verified the applicant's claim that NDA 211349 was approved on November 28, 2018.

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 671 days or 498 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On March 7, 2023, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2023-2024 influenza season.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the time of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Dockets (see ADDRESSES ) on or before February 27, 2023, will be provided to the committee. Comments received after February 27, 2023, and by March 6, 2023, will be taken into consideration by FDA. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, along with their names, email addresses, and direct contact phone numbers of proposed participants, on or before 12 p.m. Eastern Time on February 27, 2023. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by 6 p.m. Eastern Time March 1, 2023.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Sussan Paydar or Prabhakara Atreya (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

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 drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug 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 drug 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 drug product, ERLEADA (apalutamide). ERLEADA is indicated for treatment of patients with non-metastatic castration-resistant prostate cancer. Subsequent to this approval, the USPTO received patent term restoration applications for ERLEADA (U.S. Patent Nos. 8,445,507; 8,802,689; 9,388,159) from The Regents of the University of California, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated June 12, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ERLEADA 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 ERLEADA is 2,795 days. Of this time, 2,667 days occurred during the testing phase of the regulatory review period, while 128 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: June 23, 2010. The applicant claims March 19, 2009, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was June 23, 2010, 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 drug product under section 505 of the FD&C Act: October 10, 2017. FDA has verified the applicant's claim that the new drug application (NDA) for ERLEADA (NDA 210951) was initially submitted on October 10, 2017.

3. The date the application was approved: February 14, 2018. FDA has verified the applicant's claim that NDA 210951 was approved on February 14, 2018.

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 518 days, 706 days, or 356 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

ACIMM is authorized by section 222 of the Public Health Service Act (42 U.S.C. 217a), as amended. The Committee is governed by provisions of Public Law 92-463, as amended by Public Law 117-286 (5 U.S.C. 10), which sets forth standards for the formation and use of Advisory Committees.

ACIMM advises the Secretary of Health and Human Services (Secretary) on department activities, partnerships, policies, and programs directed at reducing infant mortality, maternal mortality and severe maternal morbidity, and improving the health status of infants and women before, during, and after pregnancy. The Committee provides advice on how to coordinate federal, state, local, tribal, and territorial governmental efforts designed to improve infant mortality, related adverse birth outcomes, maternal health, as well as influence similar efforts in the private and voluntary sectors. The Committee provides guidance and recommendations on the policies, programs, and resources required to address the disparities and inequities in infant mortality, related adverse birth outcomes and maternal health outcomes, including maternal mortality and severe maternal morbidity. With its focus on underlying causes of the disparities and inequities seen in birth outcomes for women and infants, the Committee advises the Secretary on the health, social, economic, and environmental factors contributing to the inequities and proposes structural, policy, and/or systems level changes.

The agenda for the March 20-21, 2023, meeting is being finalized and may include the following topics: an update on the recommendations submitted to the Secretary on improving birth outcomes among American Indian and Alaska Native mothers and infants; a discussion to determine new and continuing priority areas for the Committee; federal updates; and Committee operations. Agenda items are subject to change as priorities dictate. Refer to the ACIMM website listed above for any updated information concerning the meeting.

Members of the public will have the opportunity to provide comments. Requests to submit a written statement or make oral comments to ACIMM should be sent to Vanessa Lee, using the email address above at least 3 business days prior to the meeting. Public participants may submit written statements in advance of the scheduled meeting by emailing SACIM@hrsa.gov. Oral comments will be honored in the order they are requested and may be limited as time allows.

Individuals who plan to attend and need special assistance or a reasonable accommodation should notify Vanessa Lee at the contact information listed above at least 10 business days prior to the meeting.

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

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

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

Background: Asian American, Native Hawaiian, and Pacific Islander communities are among the fastest growing racial and ethnic populations in the United States according to the U.S. Census Bureau. However, in recent years, AA and NHPI individuals have faced increasing hate crimes and incidents that threaten their safety, as well as harmful stereotypes that often ignore socioeconomic, health, and educational disparities impacting these diverse communities. Anti-Asian violence increased during the COVID-19 pandemic, casting a shadow of fear and anxiety over many AA and NHPI communities. However, even before the pandemic, AA and NHPI communities in the United States have faced xenophobia, religious discrimination, racism, and violence. At the same time, AA and NHPI communities are overrepresented in the pandemic's essential workforce in healthcare, food supply, education, and childcare, with more than four million AA and NHPIs manning the frontlines throughout the pandemic.

Many AA and NHPI communities were also disproportionately burdened by the COVID-19 public health crisis. In addition to the disproportionate health impacts of COVID-19, particularly on Native Hawaiian and Pacific Islander communities, many AA and NHPI workers, families, and small businesses also faced devastating economic losses that must be addressed.

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

Public Participation at Meeting: Members of the public are invited to view the Commission meeting. Registration is required through the following link: https://www.eventbrite.com/e/meeting-of-the-presidents-advisory-commission-on-aa-and-nhpis-registration-517786452217. Please note that there will be no opportunity for oral public comments during the meeting of the Commission. However, written comments are welcomed throughout the development of the Commission's recommendations to promote equity, justice, and opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders and may be emailed to AANHPICommission@hhs.gov.

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

The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement to UCLB include: PCT patent application number PCT/EP2021/084908, entitled “Novel Therapeutics for the treatment of neurodegenerative disorders” (claiming priority to GB 2019418.9, filed December 9, 2020) filed December 9, 2021 (HHS Reference E-198-2021) and GB patent application number 2117758.9, entitled, “Therapeutics for the treatment of neurodegenerative disorders” (HHS Reference E-071-2023), filed December 9, 2021.

With respect to the inventions described and claimed in the patent applications PCT/EP2021/084908 and GB 2117758.9, each of the inventors has assigned their rights to their respective employers or an entity which manages the intellectual property for their employer (The United States of America, UCL and UCLB). The prospective license will be for the purpose of consolidating the patent rights with UCLB, the co-owner of said rights, for commercial development and marketing. Consolidation of these co-owned rights is intended to expedite development of the invention, consistent with the goals of the Bayh-Dole Act codified as 35 U.S.C. 200-212.

The prospective patent license will be worldwide, exclusive, and may be limited to those fields of use commensurate in scope with the patent rights. It will be sublicensable, and any sublicenses granted by UCLB will be subject to the provisions of 37 CFR part 404.

The technologies describe antisense oligonucleotides (ASOs) that are capable of modulating splicing by preventing inclusion of an UNC13A cryptic exon into an UNC13A mature mRNA. Guide RNAs including the ASO, and viral vectors expressing the ASO are also described. Such ASOs and guide RNAs may be used as a medicament, for example, to treat neurodegenerative disorders, particularly those associated with TDP-43 pathology.

This notice is made pursuant to 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will include terms for the sharing of royalty income with NINDS from commercial sublicenses of the patent rights and may be granted unless within fifteen (15) days from the date of this published notice the NINDS receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C 552.

Notice of this meeting is in compliance with the Federal Advisory Committee Act, (5 U.S.C. chapter 10). The Committee was established on December 4, 2018, by section 602 of the Frank LoBiondo Coast Guard Authorization Act of 2018, Public Law 115-282, 132 Stat. 4190, and is codified in 46 U.S.C. 70112. The Committee operates under the provisions of the Federal Advisory Committee Act (5 U.S.C. chapter 10) and 46 U.S.C. 15109. The National Maritime Security Advisory Committee provides advice, consults with, and makes recommendations to the Secretary of Homeland Security, via the Commandant of the U.S. Coast Guard, on matters relating to national maritime security.

The agenda for the National Maritime Security Advisory Committee meeting is as follows:

(1) Call to Order.

(2) Introduction.

(3) Designated Federal Official Remarks.

(4) Roll call of Committee members and determination of quorum.

(5) Remarks from Committee Leadership.

(6) Discussion of Tasks. The Committee will provide a final report of recommendations on the following task:

a. Task T-2022-4: Transportation Worker Identification Credential (TWIC) Reader Program.

(7) Public Comment Period.

(8) Meeting Recess.

A copy of all meeting documentation will be available at https://homeport.uscg.mil/NMSAC no later than March 16, 2023. Alternatively, you may contact Mr. Ryan Owens as noted in the FOR FURTHER INFORMATION CONTACT section above.

There will be a public comment period at the end of meeting. Speakers are requested to limit their comments to 3 minutes. Please note that the public comment period may end before the period allotted, following the last call for comments. Please contact the individual listed in the FOR FURTHER INFORMATION CONTACT section above to register as a speaker.

Developing and using rigorous research and relevant evidence is essential for HUD's mission of creating strong, sustainable, inclusive communities and quality, affordable homes for all. In March 2022, HUD published its first Department-wide HUD Learning Agenda: FY 2022-2026, 1 replacing the Research Roadmap that had served as HUD's research plan since 2014. 2 Drawing on extensive input from practitioners, advocates, people with lived experience in HUD programs, researchers, and policymakers at the Federal, State, and local levels, the Learning Agenda identifies the Department's priority learning and evidence needs and proposes research, evaluation, and data linkage projects to address those needs. The Learning Agenda covers a period of five years, with an annual review and update process. Accompanying the Learning Agenda, HUD also published Annual Evaluation Plans, which describe the significant evaluation activities HUD expects to launch each year as well as the major ongoing evaluation activities. To date, HUD has published Annual Evaluation Plans for 2022 and 2023. 3

HUD plans to publish the next five-year Learning Agenda in 2027, covering the years 2027-2031. In the years preceding the publication of the 2027-2031 Learning Agenda, PD&R will conduct a periodic stakeholder engagement process to review and update the published Learning Agenda. This RFI is one component of HUD's stakeholder engagement process. The goal of the stakeholder engagement process is to identify new research and data priorities not included in the Learning Agenda that reflect emerging or unanticipated needs and knowledge gaps that, if answered, could help advance HUD's mission and strategic plan. This includes learning questions that relate to HUD programs and priorities that were not in place at the time the Learning Agenda: FY 2022-2026 was published. HUD will use the information obtained through this RFI and other forms of stakeholder engagement to produce the Learning Agenda Supplement: Fiscal Year 2023. The Learning Agenda Supplement: Fiscal Year 2023 will identify new priority learning questions not reflected in the published Learning Agenda as well as potential adjustments to the published priority questions. HUD will publish the Learning Agenda Supplement: Fiscal Year 2023 on its HUD User website alongside the Learning Agenda: FY 2022-2026.

The purpose of this RFI is to solicit information regarding new research and data priorities that should be considered for incorporation into the Learning Agenda Supplement: Fiscal Year 2023 as well as adjustments to existing research and data priorities.

While PD&R welcomes all comments relevant to HUD's Learning Agenda, PD&R is particularly interested in receiving input from interested parties on the questions outlined below. In responding to these questions, interested parties should reference the Learning Agenda: FY 2022-2026, available at https://www.huduser.gov/portal/about/pdr_learningagenda.html.

1. Are there new priority learning questions ( i.e., not already included in the Learning Agenda: FY 2022-2026) that reflect emerging or unanticipated needs and knowledge gaps and that, if answered, could help advance HUD's mission?

2. Are there new priority data needs ( i.e., not already included in the Learning Agenda: FY 2022-2026) that reflect emerging or unanticipated needs and knowledge gaps and that, if addressed, could help advance HUD's mission?

3. Does the Learning Agenda: FY 2022-2026 contain learning questions or data priorities that need to be adjusted either because priorities have shifted or because they have been addressed through evidence-building activities by HUD or others?

4. Are there any additional comments on how HUD's Learning Agenda could be enhanced or improved to strengthen the evidence base for HUD's mission of creating strong, sustainable, inclusive communities and quality, affordable homes for all?

This notice informs the public that HUD is seeking approval from OMB for the information collection described in section A.

Title of Information Collection: EIV System Debts Owed to PHAs and Terminations.

OMB Approval Number: 2577-0266.

Type of Request: Revision of a currently approved collection.

Form Number: 52675.

Description of the need for the information and proposed use: In accordance with 24 CFR 5.233, processing entities that administer the Public Housing, Section 8 Housing Choice Voucher, Moderate Rehabilitation programs are required to use HUD's Enterprise Income Verification (EIV) system to verify employment and income information of program participants and to reduce administrative and subsidy payment errors. The EIV system is a system of records owned by HUD, as published in the Federal Register on July 20, 2005 at 70 FR 41780 and updated on August 8, 2006 at 71 FR 45066 and on August 17, 2022 at 87 FR 50635.

The Department seeks to identify families who no longer participate in a HUD rental assistance program due to adverse termination of tenancy and/or assistance, and owe a debt to a Public Housing Agency (PHA). In accordance with 24 CFR 982.552 and 960.203, the PHA may deny admission to a program if the family is not suitable for tenancy for reasons such as, but not limited to: unacceptable past performance in meeting financial obligations, history of criminal activity, eviction from Federally assisted housing in the last five years, family has committed fraud, bribery, or any other corrupt or criminal act in connection with a Federal housing program, or if a family currently owes rent or other amounts to the PHA or to another PHA in connection with a Federally assisted housing program under the U.S. Housing Act of 1937.

Within the scope of this collection of information, HUD seeks to collect from all PHAs, the following information:

1. Amount of debt owed by a former tenant to a PHA;

2. If applicable, indication of executed repayment agreement;

3. If applicable, indication of bankruptcy filing;

4. If applicable, the reason for any adverse termination of the family from a Federally assisted housing program.

This information is collected electronically from PHAs via HUD's EIV system. This information is used by HUD to create a national repository of families that owe a debt to a PHA and/or have been terminated from a federally assisted housing program. This national repository is available within the EIV system for all PHAs to access during the time of application for rental assistance. PHAs are able to access this information to determine a family's suitability for rental assistance, and avoid providing limited Federal housing assistance to families who have previously been unable to comply with HUD program requirements. If this information is not collected, the Department is at risk of paying limited Federal dollars on behalf of families who may not be eligible to receive rental housing assistance. Furthermore, if this information is not collected, the public will perceive that there are no consequences for a family's failure to comply with HUD program requirements.

Respondents: Public Housing Agencies.

This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

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

(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

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

(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

HUD encourages interested parties to submit comment in response to these questions.

Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.

This notice informs the public that HUD is seeking approval from OMB for the information collection described in section A.

Title of Information Collection: Restrictions on Assistance to Noncitizens and Authorization to Release Information/Privacy Act.

OMB Approval Number: 2577-0295.

Type of Request: Revision of a currently approved collection.

Form Number: HUD-9886-A, HUD-9886-A-ARA, HUD-9886-A-CAM, HUD-9886-A-CHI, HUD-9886-A-CRE, HUD-9886-A-FRE, HUD-9886-A-HMO, HUD-9886-A-KOR, HUD-9886-A-RUS, HUD-9886-A-SPA, HUD-9886-A-VIE.

Description of the need for the information and proposed use: To determine eligibility and to assist HUD in managing and monitoring HUD-assisted housing programs, applicants and tenants applying for or receiving assistance in the Housing Choice Voucher and Public Housing programs are required to sign the Authorization for the Release of Information/Privacy Act Notice—(Public and Indian Housing form HUD-9886). This is a request for revision of the current approval for HUD to require applicants and tenants to sign the form HUD-9886-A on or after January 1, 2024, in order to fully implement the Housing Opportunity Through Modernization Act of 2016 (HOTMA). Form HUD-9886 will continue to be used prior to the effective date of HOTMA.

Respondents: Individuals or households, State, or local government.

This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

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

(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

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

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

HUD encourages interested parties to submit comment in response to these questions.

Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35 as amended.

In accordance with the Paperwork Reduction Act (PRA, 44 U.S.C. 3501 et seq. ) and its implementing regulations at 5 CFR 1320.8(d)(1), all information collections require approval under the PRA. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

We are especially interested in public comment addressing the following:

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

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

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

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

Comments that you submit in response to this notice are a matter of public record. 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 can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Abstract: The Service has overall Federal responsibility for managing the Nation's fish and wildlife resources. One of the Service's priorities is to provide the public with wildlife-based outdoor recreation opportunities on National Wildlife Refuges, National Fish Hatcheries, and other Service lands (collectively, refuges). These outdoor recreation opportunities include hunting, which is an important opportunity for people to connect with nature, harvest food, and assist the Service in managing wildlife populations.

The National Wildlife Refuge System Administration Act, as amended by the National Wildlife Refuge System Improvement Act (The Act; 16 U.S.C. 668dd et seq. ) stipulates that refuges undergo a comprehensive conservation planning process that, among other things, must look at the compatibility of wildlife-dependent recreation (including hunting) on refuges. We will use the information from the proposed survey effort to inform planning on refuges as mandated by The Act.

Hunting on refuges is regulated by both State and Federal laws as well as through refuge-specific regulations. These refuge-specific regulations are made in accordance with hunt plans required to be developed for each refuge. These hunt plans outline things such as refuge-specific bag limits, season dates, areas open and closed to hunting, allowed hunting time, etc. The hunt plans are an important tool that refuges use to manage harvest, safety, and visitor experience.

Creating hunt plans relies on sound biological and social data. Understanding hunter experience, preference, and harvest helps refuge managers and planners tailor hunt plans to suit biological and visitor objectives and maintain a safe environment for hunters and non-hunting visitors.

We consulted with regional leadership staff from the Service's Northeast Region and refuge staff in the development of the proposed surveys. This interdisciplinary team identified data gaps needed to help inform future hunt plan development, identify safety concerns that need attention, and better understand hunter preference in order to improve visitor experience. The region, in consultation with the Service's Human Dimension Branch, developed the surveys. This effort identified critical data necessary for the management of hunting on refuges and revising and creating future hunt plans.

This information collection is for two survey instruments:

• Form 3-2557, “Hunter Satisfaction Survey” —The survey's purpose is to learn more about big game, small game, migratory bird, and upland game hunters and their overall experience hunting on national wildlife refuges and hatcheries. The survey includes questions about species harvested, methods for managing hunter numbers, safety concerns, hunter regulations, user conflicts, satisfaction, and motivations for hunting.

• Form 3-2558, “Spring Turkey Hunter Participation Survey” —The survey's purpose is to learn more about spring turkey hunters and their overall experience hunting on national wildlife refuges and hatcheries. The survey includes questions about species harvested, methods for managing hunter numbers, safety concerns, hunter regulations, user conflicts, satisfaction, and motivations for hunting.

Information from this collection will be used in the following primary ways:

• To inform the development or refinement of future refuge hunt plans or change the procedures for conducting hunting permit drawings or accepting applications, by providing information on hunter experience, preferences, harvest, and safety concerns to refuge managers and planners.

• To identify safety concerns that should be addressed outside of the hunt plan revision cycle.

• To identify refuge hunter preferences that can be addressed outside of the hunt plan revision cycle, in order to improve hunter experience and provide positive wildlife-based recreation experiences.

This survey will be conducted on an ongoing basis in order to track changes over time. Because this information is used to guide refuge management and planning efforts, it is important for the Service to understand the impact of management activities on refuge users. A longitudinal survey effort is necessary to track responses to changes in management.

Title of Collection: Northeast Region Hunter Participation Surveys.

OMB Control Number: 1018-New.

Form Numbers: 3-2557 and 3-2558.

Type of Review: New.

Respondents/Affected Public: Individuals.

Respondent's Obligation: Voluntary.

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: None.

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

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

In accordance with the Paperwork Reduction Act (PRA, 44 U.S.C. 3501 et seq. ) and its implementing regulations at 5 CFR 1320.8(d)(1), all information collections require approval under the PRA. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

On September 23, 2022, we published in the Federal Register (87 FR 58129) a notice of our intent to request that OMB approve this information collection. In that notice, we solicited comments for 60 days, ending on November 22, 2022. In an effort to increase public awareness of, and participation in, our public commenting processes associated with information collection requests, the Service also published the Federal Register notice on Regulations.gov (Docket FWS-R5-NWRS-2022-0114) to provide the public with an additional method to submit comments (in addition to the typical Info_Coll@fws.gov email and U.S. mail submission methods). We received four comments in response to that notice. None of the comments addressed the information collection requirements; therefore, no response is required.

As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

We are especially interested in public comment addressing the following:

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

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

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

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

Comments that you submit in response to this notice are a matter of public record. 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 can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Abstract: The Service enters into agreements and partnerships with nonprofit groups to facilitate and formalize collaboration between parties in support of mutual goals and objectives, as authorized by:

• The Fish and Wildlife Act of 1956 (16 U.S.C. 742a-742j);

• The National Wildlife Refuge System Administration Act of 1966 (16 U.S.C. 668dd-ee), as amended;

• The Refuge Recreation Act of 1962 (16 U.S.C. 460k et seq. ), as amended;

• The Fish and Wildlife Coordination Act of 1934 (16 U.S.C. 661-667e), as amended; and

• The National Wildlife Refuge System Volunteer and Community Partnership Enhancement Act of 1998 (16 U.S.C. 742f), as amended.

Since 2014, the Lenape National Wildlife Refuge Complex, in partnership with the New Jersey Chapters of the National Wild Turkey Federation (NWTF), jointly administers mentored hunts on an annual basis. The mentored hunts occur on refuge property, and many of the mentors come from NWTF. The partnership provides would-be hunters with an opportunity to experience hunting by learning from Service staff and our partners through a mentored hunt program. The program not only provides the necessary hunting experience, but it also teaches the hunters about a variety of hunting topics, from ethics to shooting proficiency to wildlife ecology.

The program provides a great introduction to the rules and regulations that govern access, which can be a little overwhelming to new hunters. The Service's partnership with the NWTF helps new hunters to better understand access, rules, regulations, and setting up on public land. The program provides applicants with an opportunity to start a new family tradition, harvest their own food in a sustainable manner, or enjoy the outdoors in a new manner. All of these activities are safe, inclusive, and fun ways for people to enjoy their public lands.

The New Jersey Chapter of the NWTF solicits and registers participants via the Mentored Hunt Application (the application does not have a Service form number, as it is managed by the NWTF). The Service requires all participants to sign the Service's “USFWS Release and Waiver of Liability,” as well as Form 3-2260, “Agreement for Use of Likeness in Audio/Visual Products,” when they are on the Refuge. The application collects the following information:

• Basic contact information, to include name, address, phone number, and email address;

• Age at time of hunt;

• Customer Identification number (CID);

• Emergency contact (name and phone number);

• Applicant hunting history, such as:

The public may request copies of the application form contained in this information collection by sending a request to the Service Information Collection Clearance Officer in ADDRESSES , above.

Title of Collection: Lenape National Wildlife Refuge Complex Mentored Hunt Application.

OMB Control Number: 1018-New.

Form Number: None.

Type of Review: Existing collection in use without an OMB control number.

Respondents/Affected Public: Individuals/households.

Total Estimated Number of Annual Respondents: 25.

Total Estimated Number of Annual Responses: 25.