Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. USAID published a 60-day notice for this proposed information collection on February 21, 2024 (89 FR 13033). OMB regulations also require Federal Agencies to submit a notice to the Federal Register informing the public of its intent to seek OMB approval for an information collection. 5 CFR 1320.10(a). To comply with this requirement, USAIDis publishing notice of the proposed collection of information set forth in this document.

Whether seeking a loan, Social Security benefits, veteran's benefits, or other services provided by the Federal Government, individuals and businesses expect Government customer services to be efficient and intuitive, just like services from leading private-sector organizations. Yet the 2016 American Consumer Satisfaction Index and the 2017 Forrester Federal Customer Experience Index show that, on average, Government services lag nine percentage points behind the private sector.

A modern, streamlined and responsive customer experience means: raising government-wide customer experience to the average of the private sector service industry; developing indicators for high-impact Federal programs to monitor progress towards excellent customer experience and mature digital services; and providing the structure (including increasing transparency) and resources to ensure customer experience is a focal point for agency leadership. To support this, OMB Circular A-11 Section 280 established government-wide standards for mature customer experience organizations in government and measurement. To enable Federal programs to deliver the experience taxpayers deserve, they must undertake three general categories of activities: conduct ongoing customer research, gather and share customer feedback, and test services and digital products.

These data collection efforts may be either qualitative or quantitative in nature or may consist of mixed methods. Additionally, data may be collected via a variety of means, including but not limited to electronic or social media, direct or indirect observation ( i.e., in person, video and audio collections), interviews, questionnaires, surveys, and focus groups. USAID will limit its inquiries to data collections that solicit strictly voluntary opinions or responses. Steps will be taken to ensure anonymity of respondents in each activity covered by this request.

The results of the data collected will be used to improve the delivery of Federal services and programs. It will include the creation of personas, customer journey maps, and reports and summaries of customer feedback data and user insights. It will also provide government-wide data on customer experience that can be displayed on performance.gov to help build transparency and accountability of Federal programs to the customers they serve.

USAID will collect this information by electronic means when possible, as well as by mail, fax, telephone, technical discussions, and in-person interviews. USAID may also utilize observational techniques to collect this information.

Form Number(s): None.

Type of Review: Renewal.

Affected Public: Collections will be targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future. For the purposes of this request, “customers” are individuals, businesses, and organizations that interact with a Federal Government agency or program, either directly or via a Federal contractor. This could include individuals or households; businesses or other for-profit organizations; not-for-profit institutions; State, local or tribal governments; Federal government; and Universities.

Estimated Number of Respondents: 1,000,775.

Estimated Time per Response: Varied, dependent upon the data collection method used. The possible response time to complete a questionnaire or survey may be 3 minutes or up to 1.5 hours to participate in an interview.

Estimated Total Annual Burden Hours: 50,563.

Estimated Total Annual Cost to Public: $0.

USAID invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

Background

The final PEA and FONSI analyze and disclose the potential environmental impacts associated with the establishment of the Resilient Food Systems Infrastructure (RFSI) Program. The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) has proposed to fund cooperative agreements to coordinate initiatives for non-meat and poultry food products in the middle of the supply chain. Funds will support expanded capacity for the aggregation, processing, manufacturing, storing, transporting, wholesaling, and distribution of locally and regionally produced food products, including specialty crops, dairy, grains for human consumption, aquaculture, and other food products, excluding meat and poultry.

States will make subawards to support local and regional food and farm businesses and other entities. States will also provide supply chain and market development services. Through these efforts, the RFSI program aims to enhance market access for small and mid-size producers and food businesses, contributing to a more resilient and sustainable food system.

The RFSI Program is authorized by section 1001 (b)(4) of the American Rescue Plan Act (ARPA) (Pub. L. 117-2), which funds “loans and grants and other assistance to maintain and improve food and agricultural supply chain resiliency”. Recipients of funding from this proposed program would be allowed 48 months to complete work funded by the awards.

The environmental impacts of funding projects to expand capacity for the aggregation, processing, manufacturing, storing, transporting, wholesaling, and distribution of locally and regionally produced, non-meat and poultry food products and provide supply chain and market development services have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA) of 1969, Public Law 91-190, 42 U.S.C. 4321-4347, as amended.

A final PEA and FONSI have been prepared, and based on this analysis, AMS has determined there will not be a significant impact to the human environment. As a result, an Environmental Impact Statement (EIS) has not been initiated (40 CFR 1501.6). AMS intends for this PEA to create efficiencies by establishing a framework that can be used for “tiering,” where appropriate, to project-specific actions that require additional analysis. As decisions on specific applications are made, to the extent additional NEPA analysis is required, environmental review will be conducted to supplement the analysis set forth in this PEA.

The final PEA and FONSI are available for review online at the program website: https://www.ams.usda.gov/services/grants/rfsi.

AMS published a Draft PEA for public comment on February 12, 2024. The public comment period ended on March 13, 2024. No comments were received during the public comment period.

The purpose of the National Wildlife Services Advisory Committee (the Committee) is to advise the Secretary of Agriculture on policies, program issues, and research needed to conduct the Wildlife Services program. The Committee also serves as a public forum enabling those affected by the Wildlife Services program to have a voice in the program's policies. The duration of the NWSAC is for 2 years unless renewed by the Secretary, USDA.

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

Persons with disabilities who require alternative means of communication for program information ( e.g. , Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English. Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women and person with disabilities. USDA is an equal opportunity provider, employer, and lender.

The 2012 Planning Rule (36 CFR 219), which implements the National Forest Management Act (NFMA) of 1976, provides that the Forest Service develop, maintain and revise land management plans, often called a Forest Plan, for all national forests and grasslands. Land Management Plans provide a programmatic framework for management of forest resources and are amended as conditions change over time. The Tongass Land Management Plan was first approved in 1979, revised in 1997, and later amended in 2003, 2008, 2016, and 2020. The 2016 Land Management Plan amends the 2008 Tongass Land and Resource Management Plan (2008 Forest Plan), incorporating changes made since 2008.

This notice announces initiates the assessment phase of the plan revision process, during which the Agency will identify and evaluate current information regarding the Tongass National Forest from the public, Tribes, Alaska Native Corporations, other government agencies, and non-governmental parties, 36 CFR 219.5(a)(1), 219.6, 219.19. The Tongass National Forest has initiated consultation with Tribes and Alaska Native Corporations for all phases of the planning process and will consult as part of the assessment phase of revision, 36 CFR 219.4. The Forest Service, Alaska Region, will build on the engagement efforts and the relationships developed as part of the Southeast Alaska Sustainability Strategy to ensure that a broad range of local voices contribute to the assessment and throughout the planning process. Information collected during the formation of the Sustainability Strategy will be utilized in the assessment where appropriate.

The 2012 Planning Rule requires the assessment to include information regarding the status and trends of ecological, social, and economic conditions within the planning area and across the broader landscape. In particular, the Agency must identify and evaluate information relevant to the plan area for the following: (1) Terrestrial ecosystems, aquatic ecosystems, and watersheds; (2) Air, soil, and water resources and quality; (3) System drivers, including dominant ecological processes, disturbance regimes, and stressors, such as natural succession, wildland fire, invasive species, and climate change, and the ability of terrestrial and aquatic ecosystems in the plan area to adapt to change; (4) Baseline assessment of carbon stocks; (5) Threatened, endangered, proposed, and candidate species, and potential species of conservation concern present in the plan area; (6) Social, cultural, and economic conditions; (7) Benefits people obtain from the National Forest System planning area (ecosystem services); (8) Multiple uses and their contributions to local, regional, and national economies; (9) Recreation settings, opportunities and access, and scenic character; (10); Renewable and nonrenewable energy and mineral resources; (11) Infrastructure, such as recreational facilities and transportation and utility corridors; (12) Areas of tribal importance; (13) Cultural and historic resources and uses; (14) Land status and ownership and access patterns; and (15) Existing designated areas located in the plan area including wilderness and wild and scenic rivers and potential need and opportunity for additional designated areas. (36 CFR 219.6.)

During this assessment phase, the Forest Service invites other government agencies, Tribes, Alaska Native Corporations, non-governmental parties, and the public to share information about social, economic, and environmental conditions of the Tongass National Forest and the broader landscape. Existing information about conditions on the Tongass National Forest, including information gathered through public engagement and tribal consultation, will be integrated into a draft resource assessment.

At 16.7 million acres, the Tongass National Forest is integral to social, ecological, economic and cultural values in Southeast Alaska. The Tongass is of immense cultural significance for Alaska Native peoples, and is within the traditional homelands of the Tlingit, Haida and Tsimshian peoples. It plays an important role in economic opportunity and social well-being for people and communities in Southeast Alaska. It also represents the largest intact coastal temperate rainforest on earth and is considered critical for carbon sequestration and carbon storage to help mitigate climate change. During this assessment phase, the Forest Service invites input on these and other distinctive roles and contributions of the Tongass to the local area, region, and nation (36 CFR 219.2(b)).

The Forest Service will review and incorporate public comments and additional information from tribal consultation on the draft assessment and produce a final assessment that will inform the Agency's understanding of the need to change the plan for the Tongass National Forest. The Forest Service may then initiate the planning phase, which will include development of an environmental impact statement, pursuant to the National Environmental Policy Act (NEPA).

Responsible Official: The responsible official for the revision of the land management plan for the Tongass National Forest is Frank Sherman, Forest Supervisor.

Pursuant to the Travel Management Rule at 36 CFR 212 subpart C, the Forest Service must designate trails and areas to be open for motorized over-snow vehicle use. Once designated, trails and areas open to motorized over-snow vehicle use need to be identified on an Over-Snow Vehicle Use Map (36 CFR 212.81). Over-Snow Vehicle Use Maps must specify the classes of vehicles and the time of year for which use is designated (36 CFR 212.81(c)). The public shall be allowed to participate in the designation of National Forest System roads, trails, and areas, consistent with the National Environmental Policy Act (36 CFR 212.52).

On the 2.2-million-acre Kootenai National Forest, there is a need to designate trails and areas which would be open to motorized over-snow vehicle use. There is also a need to designate trails and areas open to motorized over-snow vehicle use within the Ten Lakes Wilderness Study Area of the Kootenai National Forest.

The Forest Service proposes to designate approximately 1,302,000 acres of the Kootenai National Forest, including the Ten Lakes Wilderness Study Area, as areas open to cross-country motorized over-snow vehicle use. Approximately 987,000 acres are proposed as areas open for all classes of cross-country motorized over-snow travel from December 1 to May 31 each year. Approximately 315,000 acres are proposed as areas open for all classes of cross-country motorized over-snow travel from December 1 to March 31 and would be closed to motorized over-snow vehicle use on March 31 each year to accommodate grizzly bear den emergence. Areas designated for over-snow vehicle use would be identified on an Over-Snow Vehicle Use Map, in accordance with 36 CFR 212.81. Over-Snow Vehicle Use Maps would specify the classes of vehicles and the time of year for which use is designated (36 CFR 212.81(c)).

Additionally, the Forest Service proposes to designate approximately 380 miles of trails in the Kootenai National Forest, including in the Ten Lakes Wilderness Study Area, as open to motorized over-snow vehicle use. Approximately 285 miles of groomed over-snow trails and approximately 49 miles of ungroomed over-snow trails are proposed to be open to any over-snow vehicle class between December 1 and March 31 each year. Approximately 16 miles of groomed over-snow trails and 30 miles of ungroomed over-snow trails are proposed to be open to any over-snow vehicle class between December 1 and March 31 each year. Trails designated for over-snow vehicle use would be identified with the publication of an Over-Snow Vehicle Use Map, in accordance with 36 CFR 212.81.

An amendment to the Kootenai National Forest 2015 Land Management Plan may be considered to modify the boundaries of management area 5a (Backcountry-Non-motorized Year-round).

The minimization criteria were applied to the identification of the National Forest System areas and trails. Impacts to wolverine, grizzly bear, Canada lynx, and whitebark pine will be assessed in a biological assessment, and consultation with U.S. Fish and Wildlife Service is expected to occur. An amendment to the Kootenai National Forest 2015 Land Management Plan may be considered to modify the boundaries of management area 5a (Backcountry-Non-motorized Year-round) as it currently is mapped in the 2015 Land Management Plan. The following substantive requirements are likely to apply (219.13(b)(2)) to the potential amendment: 36 CFR 219.8(b) to guide the plan area's contribution to social and economic sustainability, taking into account: (1) social, cultural, and economic conditions relevant to the area influenced by the plan; (2) sustainable recreation; (3) multiple uses that contribute to local, regional, and national economies in a sustainable manner; and 36 CFR 219.9(a)(2) the plan must include plan components that maintain or restore the diversity of ecosystems and habitat types throughout the plan area.

Kootenai National Forest Supervisor.

Public scoping of this project occurred in April 2015 and July through September 2023; those scoping efforts have informed this proposed action. Public scoping will not be repeated; however, additional opportunities for public comment will be provided when the Draft EIS is available.

Any decision about this project may be subject to 36 CFR 218 and/or 36 CFR 219 pre-decisional review (objection). Unless received anonymously, public comments received during the scoping period from July 13, 2023 through September 29, 2023 or other designated opportunities for public comment may establish eligibility for participation in pre-decisional administrative review. Issues raised in an objection must be based on previously submitted comments, unless based on new information arising after designated opportunities.

The decision will determine the designation of trails and areas of the Kootenai National Forest which will be open to motorized over-snow use, as well as determining the classes of vehicles and times of year for which motorized over-snow use will be allowed on designated trails and areas.

An amendment to the Kootenai National Forest 2015 Land Management Plan may be considered to modify the boundaries of management area 5a (Backcountry-Non-motorized Year-round) as it currently is mapped in the 2015 Land Management Plan. The following substantive requirements are likely to apply (219.13(b)(2)) to the potential amendment: 36 CFR 219.8(b) to guide the plan area's contribution to social and economic sustainability, taking into account: (1) social, cultural, and economic conditions relevant to the area influenced by the plan; (2) sustainable recreation; (3) multiple uses that contribute to local, regional, and national economies in a sustainable manner; and 36 CFR 219.9(a)(2) the plan must include plan components that maintain or restore the diversity of ecosystems and habitat types throughout the plan area.

The End of the World project area is located approximately six (6) miles south of Grangeville, Idaho. The name of this project is a tribute to local community members who often gather at the previous Fish Creek Lookout site (located prominently within the project area) which they affectionately call “The End of the World” because of the extensive viewscape. The EIS will expand the analysis from the End of the World Final EA (January 2021) by providing an updated analysis of the environmental effects related to old growth and analysis of cumulative effects of the Hungry Ridge and End of the World projects. The End of the World Final EA evaluated the potential effects of three alternatives, including No Action and two action alternatives. The final Decision Notice was signed January 25, 2021. The EIS will provide updated information about the project's ability to meet Forest Plan standards for old growth in the project area and the cumulative effects between the End of the World and Hungry Ridge projects. Other resources will be addressed by following 40 CFR 1502.2(b).

The Forest Supervisor of the Nez Perce-Clearwater National Forests will issue a Record of Decision (ROD) after evaluating the EIS and public comments.

The End of the World Project area is designated as part of an insect and disease treatment program in accordance with Title VI, Section 602, Healthy Forest Restoration Act (HFRA), as amended by Section 8204 of the Agriculture Act (Farm Bill) of 2014. Based on observed existing conditions, as well as other supporting information ( e.g., annual insect and disease aerial detection surveys, national insect and disease risk maps, community wildfire protection plan (CWPP), and input from local community members), there is a need to:

• Change the nature and arrangement of fuels to reduce wildfire risk to the local communities and surrounding Federal lands;

• Reduce the risk or extent of, or increase resilience to, insect or disease infestation;

• Restore forest vegetation, dry meadows, and grasslands to a healthy condition; and

• Improve water quality and aquatic habitats.

This project is in the heart of the Forests' Wildland Fire Crisis Emergency Landscape. The project lies entirely within the Wildland Urban Interface (WUI) for the Grangeville area as defined by the CWPP of Idaho County. It was originally authorized as part of an insect and disease treatment program in accordance with title VI, section 602, HFRA, as amended by section 8204 of the Agriculture Act (Farm Bill) of 2014. This project meets Executive Order (E.O.) 14072 because it was created using science-based modelling that indicated that this area is in high need for treatment through sustainable forest and land management activities. The project conserves America's mature and old-growth forests through authorization under title VI, section 602, HFRA as well as application of the 1987 Nez Perce Forest Plan Standards. Proposed activities will improve the resilience of our lands, waters, wildlife, and communities in the face of increasing disturbances and chronic stress arising from climate impacts.

The goal of this project is to treat at a landscape scale to increase the resilience of the forest to insects, disease, fire, and future climate impacts. The project is also designed to improve water quality, aquatic habitats, and resources important to the Nez Perce Tribe (project area is fully within the ceded territory). Finally, the project is adjacent to the community of Grangeville, Idaho, and actions are designed to reduce the threat of catastrophic wildfires to both private residences in and adjacent to the Forest and to the community of Grangeville.

Pre-commercial thinning, intermediate harvest, regeneration harvest, and aquatic improvements are proposed to change the nature and arrangement of fuels and reduce wildfire risk. The project proposes to remove hazard trees in campgrounds and dispersed camping areas, create a fuel break on Forest Service Road 221, conduct prescribed landscape burning, treat invasive plant species, improve range conditions and restore dry meadows, conduct trail restoration or reconstruction, decommission roads, replace culverts, improve cross drains, and complete stream crossing hardening. There will be no regeneration harvest in old growth. Project activities will maintain or promote old growth characteristics consistent with the regional definition of old growth.

The EIS will provide updated information about the project's ability to meet the 1987 Forest Plan standards for old growth in the project area and the cumulative effects on old growth between the End of the World and Hungry Ridge projects as directed by the court.

The alternatives from the EA will be incorporated into the EIS. The End of the World EA (January 2021) evaluated the potential effects of three alternatives, including No Action and two action alternatives. Both the Proposed Action and Alternative B meet the purpose and need of the project. Alternative B was created in direct response to collaboration and public comments that requested alternative treatments near private properties, less harvest, fewer temporary roads, and less potential sediment production. The No Action alternative provided the baseline for the comparison of the environmental effects of the action alternatives to the existing condition. The No Action Alternative would continue to elevate the risk of uncharacteristic wildfire and would not address fuel accumulations in the WUI, nor would it respond to the priority landscapes identified by the Governor of Idaho. It would not further implementation of the National Wildfire Crisis or National Cohesive Strategies.

The Forest Service will evaluate potential impacts to old growth in the project area and cumulative effects on old growth by the End of the World and Hungry Ridge projects.

Cheryl F. Probert, Nez Perce—Clearwater Forest Supervisor, Nez Perce-Clearwater National Forests Supervisor's Office, 1008 Highway 64, Kamiah, Idaho 83536.

A legal notice was published in the Lewiston Tribune on February 16, 2018. This notice started a 30-day scoping/comment period. In accordance with 40 CFR 1502.9(d)(3), there will be no scoping conducted for this EIS. The scope of the End of the World final EA established the scope for this EIS. The Forest Service will be seeking comments on the draft EIS. The Forest Supervisor will be requesting Emergency Action Determination authority under the Bipartisan Infrastructure Law, section 40807, since the project is within two of the 250 high-risk western firesheds. If the Emergency Action Determination authority is approved, the End of the World project would not be subject to the pre-decisional objection review process pursuant to 36 CFR 218 subparts A and B.

The Forest Service will be soliciting future participation via the GovDelivery email notification system, rather than postal mail. Details about the upcoming project will be sent through GovDelivery. To sign up for GovDelivery and take advantage of electronic notifications, visit the End of the World Project web page at: https://www.fs.usda.gov/project/?project=52541. On the right side of the screen, under “Get Connected,” select “Subscribe to Email Updates.” When you click on that item, you will be prompted to provide your email address and select a password in the GovDelivery program. Once you have logged in, you will be able to manage your account by subscribing to projects by National Forest, Ranger District, project type, or project purpose. Select the Nez Perce-Clearwater National Forests, Salmon River Ranger District, and/or End of the World Project to receive any updates on the project. Once you are subscribed, you will continue to receive all project information and updates via email. Updates will not be sent via postal mail.

The Responsible Official will review the information and analysis in the EIS to determine whether direct, indirect, and cumulative effects on old growth in the End of the World project area meet the requirements of appendix N of the 1987 Nez Perce National Forest Land and Resource Management Plan (Plan); if there are cumulative impacts to old growth by the End of the World Restoration Project and the Hungry Ridge Restoration Project; and which alternative best meets the purpose and need of the project and complies with the Plan.

The Council will host a presentation on electronic self-reporting programs in U.S. marine recreational fisheries by staff from The Nature Conservancy. The presentation will present information on the “appscape” used to collect information from recreational fisheries and identify successes, challenges, and lessons learned. A question-and-answer session will follow the presentation. Members of the public will have the opportunity to participate in the discussion. The presentation is for informational purposes only and no management actions will be taken. The presentation is part of an ongoing Seminar Series hosted by the Council featuring scientific studies relevant to fisheries in federal waters of the South Atlantic.

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

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

In accordance with the Western and Central Pacific Fisheries Convention Implementation Act (16 U.S.C. 6901 et seq. ), the PAC has been formed to advise the U.S. Commissioners to the WCPFC. The PAC is composed of: (i) no less than 15 nor more than 20 individuals appointed by the Secretary of Commerce in consultation with the U.S. Commissioners to the WCPFC; (ii) the chair of the Western Pacific Fishery Management Council's Advisory Committee (or the chair's designee); and (iii) officials from the fisheries management authorities of American Samoa, Guam, and the Northern Mariana Islands (or their designees). The PAC supports the work of the U.S. National Section to the WCPFC in an advisory capacity. The U.S. National Section is made up of the U.S. Commissioners, the Department of State, and the U.S. head of delegation. NMFS Pacific Islands Regional Office provides administrative and technical support to the PAC in cooperation with the Department of State. More information on the WCPFC, established under the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean, can be found on the WCPFC website: https://www.wcpfc.int.

The purpose of the May 13, 2024 meeting is to discuss U.S. objectives and priorities leading up to WCPFC 21 and its Subsidiary Body Meetings.

The web conference is accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Katrina Poremba at 808-725-5096 by May 6, 2024.

Authority: 16 U.S.C. 6902 et seq.

The Council is hosting a series of port meetings along the Atlantic coast throughout 2024 in order to take a focused look at the Atlantic king mackerel and Atlantic Spanish mackerel fisheries. The webinar port meetings on May 14-16, 2024 will focus on gathering input from fishermen in the New England region, specifically Connecticut, Rhode Island, and Massachusetts. The in-person port meeting on June 4, 2024 will focus on gathering input from fishermen in the state of New York.

The agenda for the port meetings is as follows:

Council staff will briefly introduce port meetings and the Council's goals and objectives. Attendees will then have the opportunity to provide input on a variety of issues related to the Atlantic king mackerel and Spanish mackerel fisheries including changing environmental conditions, needed management changes, commercial and recreational fishery dynamics, and the goals and objectives of the Coastal Migratory Pelagics Fishery Management Plan. Information provided during port meetings will be summarized and presented to the Council for use in management decision-making. Additional port meetings will be scheduled along the Atlantic coast throughout the remainder of 2024.

The May 14-16, 2024 port meetings will be conducted via webinar. The port meetings will begin at 6 p.m. Registration for the webinars is required. Registration information will be posted on the Council's website at https://safmc.net/king-and-spanish-mackerel-port-meetings/ as it becomes available.

Tuesday, June 4, 2024: Atlantis Banquets and Events, 431 East Main Street, Riverhead, New York, 11901; phone: (631) 574-8008.

These meetings are physically accessible to people with disabilities. Requests for auxiliary aid should be directed to the Council office (see ADDRESSES ) 3 days prior to the meeting.

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

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

The items of discussion during the Assessment webinar are as follows:

Panelists will review and discuss assessment modeling to date.

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

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

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

Agenda Tuesday, May 14, 2024 Through Thursday, May 16, 2024

The agenda will include: (a) Aleutian Island Golden King Crab 2024 SAFE; (b) Council updates; (c) proposed model runs for Bristol Bay red king crab, Eastern Bering Sea snow crab, Tanner crab, and Saint Matthew blue king crab; (d) ecosystem and socioeconomic profile updates; (e) Bering Sea Fisheries Research Foundation (BSFRF); (f) economic impacts of the snow crab closure; (g) research updates; and (h) other business. The agenda is subject to change, and the latest version will be posted at https://meetings.npfmc.org/Meeting/Details/3043 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/3043.

Public comment letters will be accepted and should be submitted electronically to https://meetings.npfmc.org/Meeting/Details/3043.

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

In accordance with the requirements of the Privacy Act of 1974, as amended, and the Office of Management and Budget (OMB) Circular A-108, “Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act,” the USPTO is modifying the system of records currently listed under “COMMERCE/PAT-TM-10, Deposit Accounts and Electronic Funds Transfer Profiles.” This system of records was last amended on August 10, 2007 (72 FR 45009). The changes are needed to ensure that the notice for this system of records is up-to-date, accurate, and current, as required by the Privacy Act, 5 U.S.C. 552a(e)(4).

The USPTO is modifying this system of records due to changes in how it collects, uses, maintains, and retrieves personally identifiable information (PII) from its customers to administer transactions for services and processing fees related to patents, trademarks, and information products. The USPTO charges both service and processing fees, such as, but not limited to, patent and trademark application filing fees, patent examination fees, patent trial and appeal fees, trademark trial and appeal fees, and processing of refused payment and charge-back fees. Customers are able to choose from several methods of payment to pay for services and processing fees related to patents, trademarks, and information products. The USPTO is updating the system of records to include users of credit cards, debit cards, and paper checks, and/or their associated transactions.

To implement these updates, the USPTO is modifying this system of records to expand the categories of individuals covered by this system and the categories of records maintained in the system to reflect current users and the types of information collected. The USPTO also proposes modifying the record source categories to include records derived from financial entities and the Department of the Treasury or Bureau of the Fiscal Service-designated fiscal and financial agents of the United States that process payments and collections, and to update the appropriate sections to address credit card, debit card, and paper check users and/or the associated transactions.

The USPTO is modifying the routine uses for this system of records to expressly describe and consolidate all applicable routine uses into one notice instead of relying on a cross-reference to other Federal Register (FR) notices. In the last full publication of this system of records notice on July 6, 2006 at 71 FR 38387, the USPTO incorporated by reference some of the Prefatory Statement of General Routine Uses published on December 31, 1981 at 46 FR 63501-63502. Instead of relying on the incorporation by reference, the USPTO expressly incorporates in modified form eight General Routine Uses as Routine Uses 4 (formerly 3), 5 (formerly 2), 6 (formerly 1), 7 (formerly 10), 10 (formerly 4), 12 (formerly 9), 13 (formerly 5), and 14 (formerly 13) in this system of records. Of these eight, the USPTO is modifying Routine Uses 4, 5, 6, 7, 10, 13, and 14 to make administrative changes, address the expanded needs of the USPTO and reflect current authorities and practices; and Routine Use 12 to make non-substantive changes for clarity. Each Routine Use has also been updated with minor editorial changes throughout, including the addition of descriptive headings. In addition, the USPTO proposes revising for clarity a previously unnumbered routine use (Routine Use 1) regarding the disclosure of financial information to financial institutions, including banks and credit unions, and credit card companies for the purpose of revenue collections and/or investigating the accuracy of information required to complete transactions. Also, the USPTO expressly incorporates, but in a modified form, a routine use published on August 10, 2007 at 72 FR 45009 (Routine Use 8) to comport with the USPTO's standards and routine disclosure practices and OMB guidance.

The USPTO is adding seven new routine uses to the system of records. The USPTO proposes adding a routine use (Routine Use 2) to cover the administrative needs of disclosing the information to the Department of Treasury. The USPTO is adding a new routine use (Routine Use 3) to disclose information to any agency, organization, or individual for audit/oversight functions of this system of records, such as to an accreditation entity, but only when such information is necessary and relevant to such function. The USPTO is adding a new routine use (Routine Use 9) to allow the USPTO to provide assistance to other agencies in responding to a data breach, if appropriate, in compliance with OMB Memorandum M-17-12. The USPTO is adding new routine uses (Routine Uses 11 and 15) to describe how the USPTO provides information to other Federal agencies for litigation purposes and in connection with the legislative coordination and clearance process. This includes providing the Department of Justice with information when litigation involves the USPTO (Routine Use 11) and allowing the USPTO to provide information related to private relief legislation to OMB in conjunction with that agency's legislative coordination and clearance functions (Routine Use 15). The USPTO is adding a routine use (Routine Use 16) to cover disclosures of information to officials of labor organizations, and a routine use (Routine Use 17) that describes how and when information may be disclosed to the news media and the public.

Finally, the USPTO is making minor administrative updates to certain sections to reflect current practice and enhance clarity; reorganizing the system of records in accordance with reissued OMB Circular A-108; and modifying the system of records name from “COMMERCE/PAT-TM-10, Deposit Accounts and Electronic Funds Transfer Profiles” to “COMMERCE/USPTO-10, Fee Management Products” to more accurately reflect the system and breadth of information maintained in the system of records.

The Privacy Act also requires each agency that proposes to establish or significantly modify a system of records to provide adequate advance notice of any such proposal to the OMB, the Committee on Oversight and Accountability of the House of Representatives, and the Committee on Homeland Security and Governmental Affairs of the Senate (5 U.S.C. 552a(r)). The USPTO filed a report describing the modified system of records covered by this notice with the Chair of the Senate Committee on Homeland Security and Governmental Affairs, the Chair of the House Committee on Oversight and Accountability, and the Deputy Administrator of the Office of Information and Regulatory Affairs at OMB.

The modified Privacy Act system of records, “COMMERCE/USPTO-10, Fee Management Products,” is published in its entirety below.

On March 22, 2024 (89 FR 20456), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.

After consideration of the relevant matter presented, the Committee has determined that the product(s) and service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the product(s) and service(s) to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product(s) and service(s) deleted from the Procurement List.

Accordingly, the following product(s) and service(s) are deleted from the Procurement List:

This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

In accordance with 41 CFR 51-5.3(b), the Committee intends to add this services requirement to the Procurement List as a mandatory purchase only for DEPT OF THE NAVY at NAVSUP FLT LOG CTR PEARL HARBOR with the proposed qualified nonprofit agency as the authorized source of supply. Prior to adding the service to the Procurement List, the Committee will consider other pertinent information, including information from Government personnel and relevant comments from interested parties regarding the Committee's intent to geographically limit this services requirement.

The following product(s) are proposed for deletion from the Procurement List:

This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed changes, the entities of the Federal Government identified in this notice will be required to procure the product(s) listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

The Unisex Improved Hot Weather Combat Uniform (IHWCU) Permethrin Trousers were administratively added to the Procurement List 11/20/2017 in accordance with 41 CFR 51-6.13(b), as an additional size, color or other variation) of an existing PL product to meet 50% of the requirement for the Army Contracting Command—Aberdeen Proving Ground, Natick Contracting Division, with DLA Troop Support added later. However, when possible and to ensure clarity on existing PL requirements for military garments, or other applicable products, the Committee is departing from stating the mandatory purchase requirement as a percentage of a contracting activity's overall requirement and is instead stating the mandatory purchase requirement as a specified annual quantity of a garment or product. For the Trouser, IHWCU, Permethrin, Unisex, the contracting activity and the authorized sources of supply, assisted by the central nonprofit agency, have agreed that the mandatory purchase requirement is 94,896 units annually for the Unisex trousers and 151,104 units annually for the Women's trousers. The Committee intends to amend the Procurement List and reflect the agreed annual quantity. Additionally, for administrative purposes, the Committee is assigning a new PL number to the IHWCU Trouser, Unisex, which will sever the Unisex IHWCU garments as a legacy from garments no longer being produced and increase the Committee's overall efficiency when processing future transactions.

Statutory Authority and Function: The Board is authorized by § 116 of the Education Sciences Reform Act of 2002 (20 U.S.C. 9516). The Board is established as part of the U.S. Department of Education, IES, and shall, consistent with 20 U.S.C. 9514, 9515(b)-(c), and 9516 function as a board of directors for IES. The mission of IES is to provide national leadership in expanding fundamental knowledge and understanding of education from early childhood through postsecondary study, in order to provide parents, educators, students, researchers, policymakers, and the general public with reliable information about the condition and progress of education in the United States; educational practices that support learning and improve academic achievement and access to educational opportunities for all students; and the effectiveness of Federal and other education programs.

The Board's responsibilities are: (1) advise and consult with the Director of IES (Director) on the policies of IES; (2) consider and approve priorities proposed by the Director under 20 U.S.C. 9515 to guide the work of IES; (3) transmit approved priorities to the appropriate congressional committee (20 U.S.C. 9515(b)); (4) ensure that the priorities of IES and the National Education Centers are consistent with the mission of IES (20 U.S.C. 9515(c)); (5) review and approve procedures for technical and scientific peer review of the activities of IES; (6) advise the Director on the establishment of activities to be supported by IES, including the general areas of research to be carried out by the National Center for Education Research (NCER) and the National Center for Special Education Research (NCSER) (20 U.S.C. 9567); (7) present to the Director such recommendations as it may find appropriate for (a) the strengthening of education research, and (b) the funding of IES; (8) advise the Director on the funding of applications for grants, contracts, and cooperative agreements for research, after the completion of peer review; (9) review and regularly evaluate the work of IES, to ensure that scientifically valid research, development, evaluation, and statistical analysis are consistent with the standards for such activities under this title; (10) advise the Director on ensuring that activities conducted or supported by IES are objective, secular, neutral, and non-ideological, and are free of partisan political influence and racial, cultural, gender, or regional bias; (11) solicit advice and information from those in the educational field, particularly practitioners and researchers, to recommend to the Director topics that require long-term, sustained, systematic, programmatic, and integrated research efforts, including knowledge utilization and wide dissemination of research, consistent with the priorities and mission of IES; (12) advise the Director on opportunities for the participation in, and the advancement of, women, minorities, and persons with disabilities in education research, statistics, and evaluation activities of IES; (13) recommend to the Director ways to enhance strategic partnerships and collaborative efforts among other Federal and State research agencies; (14) recommend to the Director individuals to serve as Commissioners of the National Education Centers; and (15) make recommendations to the President with respect to the appointment of the Director. Notice of this meeting is required by Section 1009(a)(2) of 5 U.S.C. Chapter 10 (Federal Advisory Committees).

Meeting Agenda: The agenda for the meeting is as follows: (1) Call to order and welcome remarks by the Chairwoman of the Board; (2) Member roll call; (3) Board member approval of meeting transcript from the March 29, 2024 meeting; (4) Board member approval of meeting agenda; (5) Discussion of NBES recommendations for the criteria to select a new permanent IES Director; (6) Discussion of the Board's views on Senator and Ranking Member Bill Cassidy's Report to the Senate Health, Education, Labor, and Pensions Committee; (7) Closing remarks and adjournment.

Instructions for Accessing the Meeting: Members of the public interested in virtually attending this meeting may email the DFO listed in this notice no later than 11:59 p.m. Eastern Time (ET) on Thursday, May 9, 2024. The DFO will provide a link and instructions on how to access the meeting via Microsoft Teams.

Public Comment: Members of the public interested in submitting written comments related to the work of NBES may do so by emailing their comments to the DFO listed in this notice no later than 11:59 p.m. ET on Thursday, May 9, 2024. Written comments should pertain to the mission and function of NBES.

Reasonable Accommodations: The virtual meeting is accessible to individuals with disabilities. If you will need an auxiliary aid or service for the meeting ( e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the DFO listed in this notice no later than Thursday, May 9, 2024.

Access to Records of the Meeting: The official transcript of this meeting will be available for public review on the IES website, https://ies.ed.gov/director/board/index.asp, no later than 90 days after the meeting. Pursuant to 5 U.S.C. 1009(b), the public may also inspect NBES records at the U.S. Department of Education, IES, 550 12th Street SW, Washington, DC 20202, Monday-Friday, 8:30 a.m. to 5:00 p.m. ET. Please email ellie.pelaez@ed.gov to schedule an appointment.

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

Authority: § 116 of the Education Sciences Reform Act of 2002 (20 U.S.C. 9516).

The primary focus of this listening session will be to discuss potential updates to WAP's regulations at 10 CFR part 440. WAP is in the process of considering various regulatory updates in response to recent congressional direction and previously received stakeholder feedback. The listening session will be held virtually via webinar.

This document of the Department of Energy was signed on April 22, 2024, by David Crane, Under Secretary for Infrastructure, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

The Agency is not proposing any regulatory changes at this time. Entities that may be interested in this denial of the petition include any facility that manufactures, uses, or generates as waste any materials containing polyvinyl chloride (PVC) or its components. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

1. Docket. EPA has established a docket for this action under Docket ID No. EPA-HQ-OLEM-2022-0971. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The Docket Center's hours of operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal Holidays). For further information on the EPA Docket Center services and the current status, see: https://www.epa.gov/dockets.

2. Electronic Access. You may access this Federal Register document electronically from https://www.federalregister.gov/documents/current.

The EPA is providing notice of and finalizing its denial of CBD's 2014 rulemaking petition concerning the regulation of discarded polyvinyl chloride (PVC) and associated chemical additives under the Resource Conservation and Recovery Act (RCRA). With this action, the Agency is also publishing its response to public comments on the tentative denial.

On July 24, 2014, the Center for Biological Diversity (CBD) petitioned the EPA to list discarded PVC as a hazardous waste under RCRA (“Petition”). The Agency is responding to this Petition for rulemaking pursuant to 42 U.S.C. 6903, 6921 and 6974, and EPA's implementing regulations at 40 CFR part 260.20, 261.3, 261.10, and 261.11. Authority for the identification and listing of hazardous wastes is granted pursuant to 42 U.S.C. 6903 and 6921, and implementing regulations 40 CFR parts 260 and 261.

As this action proposes no regulatory changes, this action will have neither incremental costs nor benefits.

PVC is one of the most common plastics, used in a variety of applications—primarily in the construction industry, but also in packaging and consumer goods (OECD 2022). PVC is formed from the polymerization of vinyl chloride monomer and additives. Additives include stabilizers that limit degradation from sources such as oxygen, heat, light, and flame, and plasticizers that make the PVC more flexible.

All PVC contains stabilizers. Some PVC contains stabilizers containing metals such as barium, cadmium, and/or lead. Other PVC contains stabilizers based on calcium, zinc, and/or tin (Hahladakis et al. 2018; European Commission 2022).

PVC may contain plasticizers, with the concentration and identity of plasticizers varying widely based on the desired properties of the final material. Plasticizers that are phthalates include but are not limited to: di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), diethyl phthalate (DEP), dimethyl phthalate (DMP), di-n-octylphthalate (DnOP), benzyl butyl phthalate (BBP), diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP) (Hahladakis et al. 2018; Czogała, Pankalla, and Turczyn 2021). Other plasticizers that are not phthalates include adipates and trimellitates. Rigid forms of PVC contain little to no plasticizers while more flexible forms require the addition of more plasticizers.

It is difficult to determine the proportion of PVC products that contain plasticizers because PVC manufacturers and PVC product manufacturers are not generally required to report this information. Typically, plasticizers constitute from zero up to about 50 percent of the product by weight, although higher concentrations have been reported (Hahladakis et al. 2018; Kim et al. 2020; European Commission 2022). Voluntary data from 2000 indicates at least two thirds of PVC is of rigid grades that do not typically contain any amount of plasticizers (Borrelli et al. 2005).

Separate from the Petition and EPA's action on it, the EPA regulates the management of solid waste, including discarded plastics such as PVC, under RCRA. EPA has established different standards for units accepting different types of non-hazardous waste, see 40 CFR parts 257-258, and RCRA generally prohibits non-compliant “open dumping” of non-hazardous solid waste. 42 U.S.C. 6945(a).

The EPA Strategic Plan of 2022-2026 (U.S. EPA 2022) sets forth priorities to reduce waste and prevent environmental contamination (Objective 6.2) including that “EPA will administer grant programs to improve Tribal, state, and local solid waste management programs and infrastructure and education and outreach on waste prevention. EPA also will address land-based contributions to the mismanagement of post-consumer materials and plastic waste.” Further information about the management of discarded plastic, including discarded PVC, can be found at https://www.epa.gov/facts-and-figures-about-materials-waste-and-recycling/advancing-sustainable-materials-management.

The EPA Strategic Plan also sets priorities to protect and restore waterbodies and watersheds (Objective 5.2) including that “EPA also will engage in both domestic and international partnerships to support trash pollution prevention programs, recycling efforts in rural and suburban communities, and waterfront revitalization” and that EPA will “[i]mplement programs to prevent or reduce nonpoint source pollution, including nutrients and plastic pollution.” Further information about the EPA's actions on plastic pollution in bodies of water, including marine plastic pollution as directed by the Save Our Seas 2.0 Act of 2020 (Pub. L. 116-224) signed into law in December 2020, can be found at https://www.epa.gov/trash-free-waters/trash-free-waters-projects (EPA 2024a).

In April of 2023 the EPA released for public comment and peer review a draft national strategy to prevent plastic pollution (EPA 2023). Proposed actions from the draft national strategy to prevent plastic pollution (EPA 2024b) include to:

• Reduce the production and consumption of single-use, unrecyclable, or frequently littered plastic products.

• Minimize pollution across the life cycle of plastic products.

• Increase public understanding of the impact of plastic mismanagement and how to appropriately manage plastic products and other waste.

• Identify and implement policies, programs, technical assistance, and compliance assurance actions that effectively prevent trash/microplastics from getting into waterways or remove such waste from waterways once it is there.

EPA defines hazardous waste for purposes of the RCRA hazardous waste regulations in 40 CFR 261.3. There are three ways by which a solid waste may be listed as hazardous waste under the RCRA hazardous waste regulations. See 40 CFR 261.11(a). Two of these are relevant to the Petition: 40 CFR 261.11(a)(1) and (a)(3).

A solid waste may be listed as a hazardous waste pursuant to 40 CFR 261.11(a)(1) if it “exhibits any of the characteristics of a hazardous waste.” The four characteristics of a hazardous waste are found in 40 CFR 261.21-24. The most relevant to the Petition is the toxicity characteristic, found in 40 CFR 261.24. A solid waste exhibits the characteristic of toxicity if it leaches specified toxic contaminants in the toxicity characteristic leaching procedure (TCLP) in excess of the regulatory limit listed in Table 1 of 40 CFR 261.24. See 40 CFR 261.24(a).

A solid waste may be listed as a hazardous waste pursuant to 261.11(a)(3) if “it contains any of the toxic constituents listed in Appendix VIII [to 40 CFR part 261],” and the Administrator concludes, after considering eleven factors, that it “is capable of posing a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported or disposed of, or otherwise managed.” 40 CFR 261.11(a)(3). EPA lists hazardous constituents on Appendix VIII to 40 CFR part 261.

Pursuant to 42 U.S.C. 6974, any person may petition the Administrator to conduct a RCRA rulemaking, including requesting a listing of a hazardous waste. EPA's regulations require that “[a]fter evaluating all public comments the Administrator will make a final decision [on the petition] by publishing in the Federal Register a regulatory amendment or a denial of the petition.” 40 CFR 260.20(e). The regulations require that every petition must include “a statement of the need and justification for the proposed action, including any supporting tests, studies, or other information.” 40 CFR 260.20(b)(4). While 40 CFR 260.20 does not provide specific information requirements for hazardous waste listing petitions, EPA has clarified that the information relevant to the listing criteria set forth in 261.11(a) is useful for petitioners to include in such a petition. See 45 FR 33070. Therefore, when a petition requesting a listing of a substance as a hazardous waste, as supplemented by the public comments, provides insufficient information to consider all of the relevant listing criteria under 261.11(a), EPA is not required to grant the petition and may deny the petition as a matter of its discretion for having provided an insufficient justification as required by 260.20(b)(4). EPA's discretion under 260.20 includes the choice of whether to pursue a matter beyond what is provided in the petition and any subsequent public comments, where they fail to provide sufficient indicia of a hazard to human health or the environment.

On July 24, 2014, the Center for Biological Diversity (CBD) petitioned the EPA to “promulgate regulations governing the safe treatment, storage and disposal of PVC, vinyl chloride and associated dialkyl- and alkylarylesters of 1,2-benzenedicarboxylic acid, commonly known as phthalate plasticizers.” In doing so, CBD requested that discarded PVC be listed as a hazardous waste, which would require a narrative listing of discarded PVC from non-specific sources be added to the “F” list under 40 CFR 261.31.

On January 12, 2023, the Agency published a tentative denial of the Petition. In the denial, the Agency explained that petitioners had not provided sufficient evidence to support a listing of discarded PVC as a RCRA hazardous waste as the Petition did not provide sufficient information that discarded PVC, under current waste management practices, “present[s] a substantial present or potential hazard to human health or the environment when solid waste is improperly treated, stored, transported or disposed of, or otherwise managed (40 CFR 261.11).” Rather, much of the information provided in the Petition concerned potential exposures during the use of PVC as a product. Based on the information provided in the Petition, the Agency proposed to determine that a listing of discarded PVC was unwarranted at this time.

The Agency received public comments on the tentative denial during the 30-day comment period that ran from January 12, 2023, through February 13, 2023. On February 23, 2023, after the comment period had closed, the Agency received a request to extend the comment period for an additional thirty days following the train derailment in East Palestine, Ohio. The Agency chose not to reopen the comment period because the release in East Palestine, Ohio did not have a direct bearing on the Petition. Furthermore, the Agency had entered into a consent decree with the Center for Biological Diversity (see docket EPA-HQ-OGC-2022-0406) in which the EPA had committed to sign the final determination on the Petition by April 12, 2024 (which the parties subsequently stipulated to extend to April 26, 2024). The requested extension of the comment period could have interfered with meeting that commitment.

The Agency received 4,543 comments on the tentative denial. 63 comments supported the tentative denial, including 2 letter writing campaigns representing approximately 52 of the comments, with 10 substantive and distinct comments. 4,480 comments were opposed to the denial, including a letter writing campaign covering approximately 4464 of the comments, with 3 substantive and distinct comments.

The comments supporting the tentative denial largely echoed the language of EPA's tentative denial, including the lack of evidence in the Petition that discarded PVC meets the 40 CFR 261.11 listing criteria, Agency discretion, the variable composition of PVC, other EPA efforts addressing plastic pollution, and the existing regulations on landfills, incinerators, and toxic contaminants. These commenters also cited recent EPA actions under the Toxic Substances Control Act (TSCA) related to the risk evaluations of vinyl chloride and phthalates and noted that the studies provided by the petitioner related to direct phthalate exposure which, the commenters argued, cannot substitute for evidence of potential exposure or effects from discarded PVC. Additional comments expressed concern about the potential regulatory burden and/or complexity of complying with the changes requested by the Petition, particularly with regard to generator status, regulated medical waste, and recycling/sustainability efforts.

The comments opposed to the denial of the Petition echoed the language of CBD's petition, expressing concern about potential releases of toxic constituents during the manufacture, use, and disposal of PVC. Specific concerns regarding disposal of PVC included plastic pollution and its effect on the environment, the scope of existing regulations, presence in landfills and incinerators, and potential release of hazardous constituents from landfill leachate and incineration. Commenters expressed concern about the potential toxicity of discarded PVC resin apart from any consideration of additives ( i.e., phthalate plasticizers and metals from heat stabilizers). Additionally, the petitioner submitted 30 additional scientific studies as support.

Responses to specific comments may be found in the response to comments document published separately in this docket.

Pursuant to 40 CFR 260.20, the Petition, as supplemented by public comments, must provide sufficient information to justify the listing of discarded PVC as a hazardous waste. The Petition and public comments fail to do so.

The Petition does not specifically request that EPA list discarded PVC as a hazardous waste pursuant to 40 CFR 261.11(a)(1). However, it does provide some information that could be construed as relevant to a request for such a listing. The Petition does specifically request that EPA conduct a hazardous waste listing pursuant to 40 CFR 261.11(a)(3). Accordingly, EPA has considered information to be relevant to the Petition if it is relevant to either 261.11(a)(1) or (a)(3). EPA proposed to deny the Petition based on the lack of information provided by Petitioners. After considering public comment on the tentative denial, EPA concludes that the Petition, even as supplemented by the information received through the public comment period, still provides insufficient information to justify a listing of discarded PVC as a hazardous waste at this time under either 261.11(a)(1) or 261.11(a)(3).

With respect to 40 CFR 261.11(a)(1), the Petition states that PVC may contain any of the following hazardous contaminants found in Table 1 of 40 CFR 261.24: vinyl chloride monomer (D043), barium (D005), cadmium (D006), and lead (D008). Under EPA's regulations, a solid waste exhibits the hazardous waste characteristic of toxicity (TC) when the values in Method 1311 (TCLP) exceed 0.2 milligrams per liter (mg/L), 100 mg/L, 1 mg/L, and 5 mg/L, respectively, for these contaminants. However, the Petition and comments are insufficient because they do not provide evidence that discarded PVC leaches these hazardous contaminants in excess of their TC regulatory levels. Additionally, EPA is also aware of at least one study suggesting that discarded PVC may not exhibit the hazardous waste characteristic of toxicity for vinyl chloride. Specifically, a survey of American vinyl producers conducted in 2000 found concentrations of residual vinyl chloride monomer to be too low to exceed the vinyl chloride TC regulatory level (Borrelli et al. 2005). That is, the study found that residual vinyl chloride concentrations were less than twenty times the TC regulatory level for vinyl chloride (20 × 0.2 mg/L = 4 mg/L), which according to agency guidance may be classified as non-hazardous with respect to the presence of vinyl chloride without having to conduct a TCLP test ( https://www.epa.gov/hw-sw846/hazardous-waste-characteristics#question23 ). Therefore, given the insufficient information to determine whether hazardous contaminants in discarded PVC exceed their TC regulatory levels, EPA denies the Petition to the extent it requests a listing under 40 CFR 261.11(a)(1).

With respect to 40 CFR 261.11(a)(3), the Petition does provide some evidence that discarded PVC may contain one or more toxic constituents listed in Appendix VIII. Specifically, petitioner provided evidence that discarded PVC contains residual vinyl chloride monomer, and may contain barium, cadmium, lead, DEHP, DBP, DEP, DMP, DnOP, and BBP.

Nevertheless, the Petition, even as supplemented by the information received through the public comment period, does not provide sufficient information that discarded PVC is “capable of posing a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported or disposed of, or otherwise managed” based on the eleven factors provided in 40 CFR 261.11(a)(3). 40 CFR 261.11(a)(3). To determine whether discarded PVC meets the 261.11(a)(3) criteria, EPA must consider eleven factors. The discussion below focusses on factors (ii), (iii), (vii), and (ix), detailing how the Petition and comments received provide insufficient information relevant to these criteria. Petitioner's failure to provide compelling information on these factors is sufficient to support EPA's final denial. EPA is not relying on an evaluation of, and does not intend to imply the sufficiency of, the evidence provided to support the other factors.

EPA received mixed information relevant to factor (ii). Factor (ii) specifies that EPA will consider the concentration of the Appendix VIII constituent in the waste. The petitioner provided some evidence that discarded PVC may contain residual vinyl chloride monomer, and that the following toxic constituents may be present due to additives: barium, cadmium, lead, DEHP, DBP, DEP, DMP, DnOP, and BBP. To support this, petitioner claimed that barium, cadmium and lead additives are often present in PVC. Petitioner also made generalized claims from a number of limited sources that the listed phthalates are often used by the PVC industry and may constitute up to eighty percent by weight of certain PVC products. However, EPA also received public comments explaining that all of the toxic constituents that petitioners describe have been largely phased out of PVC in the United States over decades, such that, for example, less than 9 percent of new PVC contains any phthalates (including phthalates not listed on Appendix VIII), and the concentration of residual vinyl chloride monomer may be so low as to not be detectable (Vinyl Institute 2023 p 4, 13-14). Given the conflicting information on the prevalence and concentrations constituents in PVC, EPA has determined that the Petition and comments received provide insufficient information to consider the concentration of Appendix VIII constituents in discarded PVC.

EPA received insufficient information relevant to factor (vii). Factor (vii) specifies that EPA will consider plausible types of improper management to which discarded PVC could be subjected. In evaluating this factor, EPA does not consider spills, accidents, or other unlikely scenarios. See Dithiocarbamate Task Force v. EPA, 98 F.3d 1394, 1400-1401 (D.C. Cir. 1996); 63 FR 64383. Rather, EPA considers the current management practices for the waste at-issue and must identify “some factual support for a conclusion that a particular mismanagement scenario is plausible.” Dithiocarbamate Task Force at 1400. The Petition relies on the presence of plastic pollution and evidence of phthalate exposure as evidence that mismanagement of discarded PVC has occurred and characterizes—without further elaboration—a limited number of sources for the proposition that marine pollution results from flawed waste management techniques.

These claims are insufficiently supported in several respects. First, management of discarded PVC depends on the type and source of PVC, but may include disposal in construction and demolition landfills, municipal solid waste landfills, or incineration as municipal solid waste. The Petition fails to distinguish between the management practices applicable to the different sources of this PVC waste, 1 and therefore, fails to properly identify potential improper management scenarios, or evaluate their plausibility. Second, the Petition fails to explain what amount of plastic pollution, including marine litter, can be attributed to PVC, as opposed to other forms of plastic. Third, the Petition also fails to explain the extent that this pollution has resulted from mismanagement of discarded PVC, as opposed to other sources such as uncontrolled litter or product use that occurs outside of the current waste management regime. 2 For all of these reasons, the Petition and comments received provide insufficient evidence for EPA to consider the plausible types of improper management to which discarded PVC could be subjected.

EPA also received insufficient information relevant to factors (iii) and (ix). Factor (iii) specifies that EPA will consider the potential of the constituent or any toxic degradation product of the constituent to migrate from the waste into the environment under the types of improper management considered in factor (vii); and factor (ix) specifies that EPA will consider the nature and severity of the human health and environmental damage that has occurred as a result of the improper management of wastes containing the constituent(s). Both of these factors require consideration of plausible mismanagement scenarios. However, as explained above, EPA received insufficient information about the plausible types of mismanagement to which discarded PVC could be subjected. The Petition and comments provided information about potential exposures from the use of PVC products. However, they did not explain why the information is germane to evaluating the potential of the constituent or any toxic degradation product of the constituent to migrate from waste ( i.e., discarded PVC) into the environment under the particular environments found in waste management scenarios. Nor did they explain how it is relevant to human health or environmental damage occurring as a result of improper waste management. Finally, the Petition and comments fail to identify any cases or situations where substantial human health or environmental damage has occurred from exposure to hazardous constituents in PVC resulting from the management of discarded PVC.

As such, the Petition fails to provide enough information to compel EPA to list discarded PVC as a hazardous waste. Nor do the Petition and comments include sufficient information of a potential hazard to human health or the environment that would otherwise justify, in the Agency's discretion, initiating a rulemaking procedure to supplement the insufficient information provided in the petition and public comments. Accordingly, EPA has determined that the Petition, even as supplemented by the information received through the public comment period, provides insufficient information to justify granting the petition under 260.20. The petition is denied.

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

This is a proposed extension of the ICR, which is currently approved through April 30, 2024. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Public comments were previously requested via the Federal Register on August 4, 2023, during a 60-day comment period (88 FR 51813). This notice allows for an additional 30 days for public comments. Supporting documents, which explain in detail the information that EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Abstract: The Clean Water Act (CWA) section 301(h) allows for a case-by-case review of treatment requirements for publicly owned treatment works (POTW) discharges to marine waters. Eligible POTWs that met the set of environmentally stringent criteria in CWA section 301(h) received a modified National Pollutant Discharge Elimination System permit waiving the secondary treatment requirements for the conventional pollutants-biochemical oxygen demand, suspended solids, and pH. CWA section 301(h) only applies to the 25 POTWs that currently hold CWA 301(h) modified permits. No new applications are accepted. The CWA section 301(h) program involves collecting information from two sources: 1) the POTW, and 2) the state in which the POTW is located. The POTW holding or seeking to renew or revise a CWA section 301(h) modified permit provides application, reapplication, monitoring, and toxic control program information to demonstrate that its discharge meets and continues to meet all the CWA section 301(h) environmental criteria. The state provides state determination and certification information.

Form Numbers: None.

Respondents/affected entities: Municipalities that currently have CWA section 301(h) modifications from secondary treatment, or have applied for a renewal of a CWA section 301(h) modified permit, and the states within which these municipalities are located.

Respondent's obligation to respond: Voluntary, required to obtain or retain a benefit. (40 CFR part 125 subpart G, 40 CFR 124.53 and 124.54).

Estimated number of respondents: 30 (total).

Frequency of response: From once every five years, to varies case-by-case, depending on the category of information.

Total estimated burden: 44,985 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $1,418,675 (per year), which includes no annualized capital or operation & maintenance costs.

Changes in the Estimates: There is no increase in hours in the total estimated respondent burden compared with the ICR currently approved by OMB. There is no change in program requirements, nor program status, information needs, and use of technology.

CARB's December 29, 2022, letter to the EPA Administrator notified the EPA that CARB had amended its In-Use Diesel-Fueled Transport Refrigeration Units (TRU) and TRU Generator Sets (collectively, “TRU”) regulations (the TRU Amendments). 1 The TRU Amendments, adopted by the Board on February 24, 2022, contain several provisions including, but not limited to, a requirement that certain TRUs manufactured after a certain date use a refrigerant less than or equal to a specified global warming potential (GWP), a requirement that non-truck TRUs meet specified particulate matter (PM) standards, a requirement that TRU owners transition a percentage of their truck fleet TRUs to zero-emission technology, and a requirement that owners of certain facilities are subject to registration and reporting requirements. 2

CARB's November 2, 2023, letter to the EPA Administrator notified the EPA that CARB had amended its In-Use Off-Road Diesel-Fueled Fleets regulations (Offroad Fleets Amendments). 3 The Offroad Fleets Amendments, adopted by the Board on December 8, 2022, primarily require fleets of in-use off-road diesel-fueled vehicles to phase out the operation of their oldest and highest-emitting diesel vehicles and prohibit such fleets from acquiring high-emitting vehicles. The Offroad Fleets Amendments also require fleets to fuel their vehicles with specified renewable diesel. Further, the Amendments establish administrative requirements for prime contractors and public works awarding bodies. 4

Section 209(e)(1) of the CAA prohibits all states and local governments from adopting or attempting to enforce any standard or other requirement relating to the control of emissions from certain types of new nonroad engines or nonroad vehicles, including both “(A) New engines which are used in construction equipment or vehicles or used in farm equipment or vehicles and which are smaller than 175 horsepower” and “(B) New locomotives or new engines used in locomotives.”  5 Section 209(e)(2)(A) of the CAA, however, requires the Administrator, after notice and opportunity for public hearing, to authorize California to adopt and enforce standards and other requirements relating to the control of emissions from nonroad engines and vehicles otherwise not prohibited under section 209(e)(1) if California determines that California standards will be, in the aggregate, at least as protective of public health and welfare as are applicable Federal standards. However, the EPA shall not grant such authorization if it finds that (1) the determination of California is arbitrary and capricious; (2) California does not need such California standards to meet compelling and extraordinary conditions; or (3) California standards and accompanying enforcement procedures are not consistent with [CAA section 209]. 6

On July 20, 1994, the EPA promulgated a rule that sets forth, among other things, regulations providing the criteria, as found in section 209(e)(2)(A), that the EPA must consider before granting any California authorization request for nonroad engine or vehicle emission standards. 7 The EPA revised these regulations in 1997. 8 The criteria for granting California authorization requests, as reflected in section 209(e)(2)(A), can be found at 40 CFR 1074.105.

As stated in the preamble to the 1994 rule, the EPA has historically interpreted the section 209(e)(2)(A)(iii) “consistency” inquiry (see 40 CFR 1074.105(b)(3)) to require, at minimum, that California standards and enforcement procedures be consistent with section 209(a), section 209(e)(1), and section 209(b)(1)(C) (as the EPA has interpreted that subsection in the context of section 209(b) motor vehicle waivers). 9

In order to be consistent with section 209(a), California's nonroad standards and enforcement procedures must not apply to new motor vehicles or new motor vehicle engines. To be consistent with section 209(e)(1), California's nonroad standards and enforcement procedures must not attempt to regulate engine categories that are permanently preempted from state regulation (such as “. . . any standard or other requirement relating to the control of emissions from . . . (A) New engines which are used in construction equipments or vehicles or used in farm equipment or vehicles and which are smaller than 175 horsepower. (B) New locomotives or new engines used in locomotives.”).

To determine consistency with section 209(b)(1)(C), EPA typically reviews nonroad authorization requests under the same “consistency” criteria that are applied to motor vehicle waiver requests. Pursuant to section 209(b)(1)(C), the Administrator shall not grant California a motor vehicle waiver if he finds that California “standards and accompanying enforcement procedures are not consistent with section 202(a)” of the Act. Previous decisions granting waivers and authorizations have noted that state standards and enforcement procedures are inconsistent with section 202(a) if: (1) there is inadequate lead time to permit the development of the necessary technology giving appropriate consideration to the cost of compliance within that time, or (2) the federal and state testing procedures impose inconsistent certification requirements. 10

We request comment on whether the TRU Amendments meet the criteria for an EPA authorization. Specifically, we request comment on: (a) whether CARB's determination that its standards, in the aggregate, are at least as protective of public health and welfare as applicable federal standards is arbitrary and capricious, (b) whether California needs such standards to meet compelling and extraordinary conditions, and (c) whether California's standards and accompanying enforcement procedures are consistent with section 209 of the Act. As explained above, the EPA considers several provisions with regard to the consistency with section 209 of the Act criterion.

We also request comment on whether the Offroad Fleets Amendments meet the criteria for an EPA authorization. Specifically, we request comment on: (a) whether CARB's determination that its standards, in the aggregate, are at least as protective of public health and welfare as applicable federal standards is arbitrary and capricious, (b) whether California needs such standards to meet compelling and extraordinary conditions, and (c) whether California's standards and accompanying enforcement procedures are consistent with section 209 of the Act. As explained above, the EPA considers several provisions with regard to the consistency with section 209 of the Act criterion.

The virtual public hearings will be held on May 16, 2024. The hearing for the TRU authorization request will begin at 10:00 a.m. Eastern Daylight Time and will end approximately at 1:00 p.m. or when all parties who wish to speak have had an opportunity to do so. The hearing for the Offroad Fleets authorization request will begin at 2:00 p.m. Eastern Daylight Time and will end when all parties who wish to speak have had an opportunity to do so.

All hearing attendees, for those wishing to attend either the morning or afternoon hearings for TRU or Offroad Fleets, respectively (including even those who do not intend to provide testimony,) should register for the respective public hearing(s) by May 9, 2024. Information on how to register for the virtual public hearing regarding the TRU authorization request can be found at: https://www.epa.gov/regulations-emissions-vehicles-and-engines/virtual-public-hearing-californias-tru. Information on how to register for the virtual public hearing regarding the Offroad Fleets authorization request can be found at: https://www.epa.gov/regulations-emissions-vehicles-and-engines/virtual-public-hearing-californias-use-road-diesel.

Those seeking to register should do so by May 9, 2024. If you require the services of a translator or special accommodations such as American Sign Language, please pre-register for the hearing and describe your needs by May 9, 2024. The EPA may not be able to arrange accommodations without advance notice. Please note that any updates made to any aspect of the TRU authorization hearing will be posted online at: https://www.epa.gov/regulations-emissions-vehicles-and-engines/virtual-public-hearing-californias-tru. Please also note that any updates to any aspect of the Offroad Fleets authorization hearing will be posted online at: https://www.epa.gov/regulations-emissions-vehicles-and-engines/virtual-public-hearing-californias-use-road-diesel. While the EPA expects the hearings to go forward as set forth above, please monitor the respective hearing websites or contact the person listed in the FOR FURTHER INFORMATION CONTACT section to determine if there are any updates. The EPA does not intend to publish a document in the Federal Register announcing updates.

Each commenter will have 3 minutes to provide oral testimony. The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. The EPA recommends submitting the text of your oral comments as written comments to the docket for the respective authorization request. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral comments and supporting information presented at the public hearing for the respective authorization request. The Agency will make a verbatim record of the proceedings at each hearing that will be placed in the respective TRU and Offroad Fleets dockets. The EPA will keep the record open until June 19, 2024, for each authorization request. After expiration of the comment period, the Administrator will render decisions on CARB's requests based on the record of the public hearing, relevant written submissions, and other information that he deems pertinent.

The official public docket for this action (Docket ID No. EPA-HQ-OGC-2024-0192) contains copies of the proposed consent decrees. 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 copies of the proposed consent decrees 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.”

Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2024-0192, 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.

In accordance with the EPA's “Consent Decrees and Settlement Agreements to Resolve Environmental Claims Against the Agency” (March 18, 2022), for a period of thirty (30) days following the date of publication of this document, the Agency will accept written comments relating to a proposed consent decrees for these claims. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decrees if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, or inadequate.

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 these late comments.

The Clean Air Act Amendments of 1990 contain section 184 provisions for the Control of Interstate Ozone Air Pollution. Section 184(a) establishes an Ozone Transport Region (OTR) comprised of the States of Connecticut, Delaware, Maine, 1 Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, parts of Virginia, and the District of Columbia. The purpose of the OTC is to address ground-level ozone formation, transport, and control within the OTR.

MANEVU was formed in 2001, in response to EPA's issuance of the Regional Haze Rule. MANEVU's members include Connecticut, Delaware, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, the Penobscot Indian Nation, and the St. Regis Mohawk Tribe, along with EPA and Federal Land Managers.

Type of Meeting: Open.

Agenda: Copies of the final agenda are available from the OTC office at (617) 259-2005, by email: ozone@otcair.org, or via the OTC website at http://www.otcair.org.

This is a proposed extension of the ICR, which is currently approved through December 31, 2023. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Public comments were previously requested via the Federal Register on September 6, 2023 during a 60-day comment period (88 FR 60939). This notice allows for an additional 30 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Abstract: Under the authority of the Resource Conservation and Recovery Act of 1976 (RCRA), as amended, Congress directed the U.S. Environmental Protection Agency to implement a comprehensive program for the safe management of hazardous waste. In addition, Congress wrote that “[a]ny person may petition the Administrator for the promulgation, amendment or repeal of any regulation” under RCRA (section 7004(a)). 40 CFR parts 260 and 261 contain provisions that allow regulated entities to apply for petitions, variances, exclusions, and exemptions from various RCRA requirements.

The following are some examples of information required from petitioners under 40 CFR part 260. Under § 260.20(b), all rulemaking petitioners must submit basic information with their demonstrations, including name, address, and statement of interest in the proposed action. Under § 260.21, all petitioners for equivalent testing or analytical methods must include specific information in their petitions and demonstrate to the satisfaction of the Administrator that the proposed method is equal to, or superior to, the corresponding method in terms of its sensitivity, accuracy, and reproducibility. Under § 260.22, petitions to amend part 261 to exclude a waste produced at a particular facility (more simply, to delist a waste) must meet extensive informational requirements. When a petition is submitted, the Agency reviews materials, deliberates, publishes its tentative decision in the Federal Register , and requests public comment. The EPA also may hold informal public hearings (if requested by an interested person or at the discretion of the Administrator) to hear oral comments on its tentative decision. After evaluating all comments, the EPA publishes its final decision in the Federal Register .

With this renewal, this ICR will no longer include the burden associated with the disposal of coal combustion residuals (CCR) from electric utilities as solid waste under Subtitle D of RCRA, found at 40 CFR part 257, subpart D. That burden is covered by OMB Control No. 2050-0223.

Form Numbers: 8700-12; 8700-13 A/B; 8700-23.

Respondents/affected entities: Entities potentially affected by this action are the private sector, as well as State, Local, or Tribal Governments.

Respondent's obligation to respond: Required to obtain or retain a benefit (RCRA Sections 1008, 4004, 4005(a)).

Estimated number of respondents: 59,418.

Frequency of response: Biennially.

Total estimated burden: 730,323 hours. Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $282,918 in annualized capital or O&M costs.

Changes in the Estimates: There is a decrease of 79,059 hours and $60,098 from the previously finalized/approved ICR. The reason for the decrease is largely because the burden associated with the CCR program was removed from this ICR and merged with OMB Control No. 2050-0223.

The EPA received a petition from the Center for Biological Diversity, Public Employees for Environmental Responsibility, 350 Colorado, Sierra Club and Green Latinos dated August 7, 2023, requesting that the EPA object to the issuance of operating permits no. 20OPWE417, 20OPWE418, 20OPWE419 and 20OPWE420 issued by CDPHE to Bonanza Creek Energy Operating Company, LLC in Weld, Colorado. On January 30, 2024, the EPA Administrator issued an order granting the petition. The order itself explains the basis for the EPA's decision.

Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner may request judicial review of those portions of an order that deny issues in a petition. Any petition for review shall be filed in the United States Court of Appeals for the appropriate circuit no later than June 25, 2024.

The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

OMB Control Number: 3060-0678.

Title: Part 25 of the Federal Communications Commission's Rules Governing the Licensing of, and Spectrum Usage by, Commercial Earth Stations and Space Stations.

Form Number: FCC Form 312 (Main Form and Schedules A, B, and S), FCC Form 312-R.

Type of Review: Revision of an existing collection.

Respondents: Business or other for-profit entities, not-for-profit institutions.

Number of Respondents and Responses: 3,515 respondents and 3,567 responses.

Estimated Time per Response: 0.5-80 hours.

Frequency of Response: On occasion, one time, and annual reporting requirements; third-party disclosure requirement; recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. The Commission has statutory authority for the information collection requirements under 47 U.S.C. 154, 301, 302, 303, 307, 309, 310, 319, 332, 605, and 721.

Total Annual Burden: 27,176.

Annual Cost Burden: $3,923,887.

Needs and Uses: The Federal Communications Commission requests that the Office of Management and Budget (OMB) approve a revision of the information collection titled “Part 25 of the Federal Communications Commission's Rules Governing the Licensing of, and Spectrum Usage By, Commercial Earth Stations and Space Stations” under OMB Control No. 3060-0678, as a result of three recent rulemakings, as well as an update to the Commission's filing system for earth station and space station applications filed pursuant to part 25 of the Commission's rules.

On September 27, 2019, the Commission released a Report and Order, FCC 19-93, in IB Docket No. 06-160, titled “Amendment of the Commission's Policies and Rules for Processing Applications in the Direct Broadcast Satellite Service” ( DBS Licensing Report and Order ). The DBS Licensing Report and Order adopted a new licensing process for space stations in the Direct Broadcast Satellite Service (DBS). This new process allows applicants for DBS space station licenses to take advantage of a licensing process that parallels the Commission's streamlined part 25 satellite licensing rules for geostationary orbit (GSO) space stations in the fixed-satellite service (FSS). The Commission limited the regulatory burdens borne by applicants, while promoting new opportunities for efficient use of orbital spacing and spectrum by DBS licensees.

The Commission's action supports and encourages the increasing innovation in the DBS sector and helps to preserve U.S. leadership in space-based services and operations. This information collection will provide the Commission and the public with necessary information about this area of satellite operations. While this information collection represents an overall increase in the burden hours, the increase is due to an anticipated overall increase in number of applications as a result of additional applications being filed under the process adopted in the DBS Licensing Report and Order. This information collection serves the public interest by streamlining the collection of information and allowing the Commission to authorize DBS space stations under the new process established in the Report and Order. Specifically, the DBS Licensing Report and Order contains the following new or modified information collection requirements: space station applications for GSO space stations operating in the frequencies of the International Telecommunication Union (ITU) Appendices 30 and 30A (incorporated by reference, see 47 CFR 25.108) must include a statement that the proposed operation will take into account the applicable requirements of these Appendices of the ITU Radio Regulations and a demonstration that it is compatible with other U.S. ITU filings under Appendices 30 and 30A or, for any affected filings, a letter signed by the affected operator indicating that it consents to the new application. The changes adopted in the DBS Licensing Report and Order will result in a very small net annualized increase in burden hours to certain applicants and licensees under part 25. A request for revisions to the information collection resulting from DBS Licensing Report and Order was previously published in the Federal Register (see 85 FR 41980), but it has been updated and is now included in this revision request.

On November 19, 2020, the Commission released a Report and Order, FCC 20-159, in IB Docket No. 18-314, titled “Further Streamlining Part 25 Rules Governing Satellite Services” ( Satellite Services Report and Order ). The Satellite Services Report and Order streamlined the Commission's rules governing satellite services by creating an optional framework for authorizing both the blanket-licensed earth stations and space stations of a satellite system through a unified license. The Satellite Services Report and Order also permitted earth station applicants to certify compliance with relevant satellite licenses in lieu of providing duplicative or unnecessary technical demonstrations, aligned the build-out requirements for earth stations and space stations, and eliminated unnecessary reporting rules. These changes reduce regulatory burdens, simplify the Commission's licensing of satellite systems, and provide additional operational flexibility. The Satellite Services Report and Order affected two information collections: OMB Control Numbers 3060-1215 and 3060-0678. The Commission received OMB approval for changes under OMB Control No. 3060-1215 on August 26, 2021, as reported in 86 FR 52102. The Commission seeks approval for changes under OMB Control No. 3060-0678 through this request. The changes adopted in the Satellite Services Report and Order will result in a net annualized decrease in burden hours to applicants and licensees under part 25. This submission amends the previous submission to the OMB to reflect these changes.

On August 3, 2022, the Commission released a Report and Order, FCC 22-63, in IB Docket Nos. 20-330 and 22-273, titled “Amendment of Parts 2 and 25 of the Commission's Rules to Enable GSO Fixed-Satellite Service (Space-to-Earth) Operations in the 17.3-17.8 GHz Band, to Modernize Certain Rules Applicable to 17/24 GHz BSS Space Stations, and to Establish Off-Axis Uplink Power Limits for Extended Ka-Band FSS Operations” ( 17 GHz Report and Order ). In the 17 GHz Report and Order, the Commission amended its rules to permit geostationary satellite orbit (GSO) space stations to use the 17.3-17.7 GHz band by geostationary satellite orbit (GSO) space stations in the fixed-satellite service (FSS) in the space-to-Earth direction on a co-primary basis with incumbent services and permit limited GSO FSS (space-to-Earth) use of the 17.7-17.8 GHz band on an unprotected basis with respect to fixed service operations. Specifically, the 17 GHz Report and Order contains the following new or modified information collection requirements:

• Certification of frequency coordination with the operator of the co-frequency space station or submission of an interference analysis demonstrating the compatibility of the proposed system with the co-frequency space station;

• Information as to earth station antenna characteristics to ensure that antennas are properly aimed and configured and that their signals are not likely to interfere with other systems; and

• Information pertaining to implementation of interference detection and mitigation plans to prevent and resolve interference issues.

The changes adopted in the 17 GHz Report and Order will result in a small net annualized increase in burden hours to certain applicants and licensees under part 25.

Finally, the Commission has updated the International Communications Filing System (ICFS)—which was formerly named the International Bureau Filing System, see 88 FR 21424—including updates to the Form 312, including Schedules A, B, and S, and Form 312-R. Applicants will be required to submit Form 312 (including Schedules A, B, and S) and Form 312-R through the updated, integrated web-based program. The updated version of Form 312 (including Schedules A, B, and S) and Form 312-R will include several minor changes to the information collection designed to provide clarity to applicants and Commission staff, reduce errors, and make overall improvements to the applicants' experience in completing the forms. Therefore, this supporting statement is being revised to reflect the new requirements, which are include the addition of several questions designed to better convey the overall information being requested in the form.

The changes will result in a very small net annualized increase in burden hours to certain applicants under part 25.

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

Collection title: Market Risk Capital Rule (see the current actions section for information about a change to the collection title and collection identifier).

Collection identifier: FR 4201.

OMB control number: 7100-0314.

Dates: The revisions are applicable as of April 26, 2024.

General description of collection: The market risk rule, which requires banking organizations to hold capital to cover their exposure to market risk, is a component of the Board's regulatory capital framework, Regulation Q—Capital Adequacy of Bank Holding Companies, Savings and Loan Holding Companies, and State Member Banks (12 CFR part 217). The rule includes information collections that permit the Board to monitor the market risk profile of Board-regulated banking organizations that have significant market risk. These information collections provide current statistical data identifying market risk areas on which to focus onsite and offsite examinations. They also allow the Board to assess the levels and components of each reporting institution's risk-based capital requirements for market risk and the adequacy of the institution's capital under the market risk rule.

Frequency: Annual, quarterly, and on occasion.

Respondents: Bank holding companies, covered savings and loan holding companies, 1 U.S. intermediate holding companies of foreign banking organizations, and state member banks (collectively, banking organizations) that meet certain risk thresholds. The market risk rule applies to any such banking organization with aggregate trading assets and trading liabilities equal to (1) 10 percent or more of quarter-end total assets or (2) $1 billion or more.

Total estimated number of respondents: 37.

Total estimated change in burden: 592.

Total estimated annual burden hours: 36,236. 2

Current actions: On December 4, 2023, the Board published a notice in the Federal Register (88 FR 84141) requesting public comment for 60 days on the extension, with revision, of the FR 4201. The Board proposed revising the FR 4201 to account for a recordkeeping requirement in section 217.203(b)(2) of Regulation Q that had not been previously cleared by the Board. The comment period for this notice expired on February 2, 2024. The Board did not receive any comments. The revisions will be implemented as proposed. This information collection is currently titled “Market Risk Capital Rule” with a collection identifier of “FR 4201.” As part of this clearance, the collection title will be changed to “Reporting, Recordkeeping, and Disclosure Requirements Associated with Regulation Q (Market Risk Capital Rule)” and the collection identifier will be updated to “FR Q-2.” The purpose of this non-substantive change is to implement consistent nomenclature for information collections contained within a rule. This change would not modify the reporting, recordkeeping, or disclosure requirements in any way.

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

Collection title: Reporting, Recordkeeping, and Disclosure Requirements Associated with Regulation WW.

Collection identifier: FR WW.

OMB control number: 7100-0367.

Dates: The revisions are applicable as of April 26, 2024.

General description of collection: The Board, Federal Deposit Insurance Corporation (FDIC), and Office of the Comptroller of the Currency (OCC) (collectively, the agencies) implemented a liquidity coverage ratio (LCR) requirement and a net stable funding ratio (NSFR) requirement, consistent with the international liquidity standards published by the Basel Committee on Banking Supervision (BCBS), for large and internationally active banking organizations. For the Board, these standards are implemented through Regulation WW—Liquidity Risk Measurement, Standards, and Monitoring (12 CFR part 249). The NSFR and LCR requirements in Regulation WW apply to certain large state member banks, covered depository institution holding companies, and U.S. intermediate holding companies of foreign banking organizations, as well as covered nonbank companies (together, covered companies). The reporting, recordkeeping, and disclosure requirements contained in FR WW are used to monitor covered companies' compliance with the LCR and NSFR.

Frequency: The reporting requirements of the FR WW information collection are submitted on an event-generated basis. The recordkeeping requirements of the FR WW information collection are both event-generated and ongoing. The disclosure requirements of the FR WW information collection must be met on a quarterly basis (relating to the LCR) as well as every second and fourth calendar quarter (relating to the NSFR) and must remain publicly available for at least five years after the initial disclosure date.

Respondents: The FR WW panel comprises covered companies, as defined above. Certain requirements apply only to covered holding and nonbank companies.

Total estimated number of respondents: 21.

Total estimated change in burden: (446).

Total estimated annual burden hours: 2,483. 1

Current actions: On December 5, 2023, the Board published a notice in the Federal Register (88 FR 84328) requesting public comment for 60 days on the extension, with revision, of the FR WW. The Board proposed to revise the FR WW to account for three recordkeeping requirements in Regulation WW, contained in section 249.4(a) and sections 249.22(a)(1) and (a)(4), which had not been previously cleared by the Board under the PRA. In addition, the Board revised the estimated hours per response for several requirements which lead to a net decrease in the total burden hours. The comment period for this notice expired on February 5, 2024. The Board did not receive any comments. The revisions will be implemented as proposed.

The Administrator of the U.S. General Services Administration (GSA) intends to establish the Open Government Federal Advisory Committee (OG FAC) as a discretionary advisory committee under agency authority in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. 10.

GSA's Open Government Secretariat supports ensuring a more transparent, responsive and inclusive Federal Government. This is done by providing channels for members of the public to regularly engage with their government. The OG FAC will advise GSA in its endeavor to increase the public's access to data, to better advance equity, engage the public in the regulatory process, make government records more accessible, and improve the delivery of government services and benefits through expert advice.

The OG FAC will serve as an advisory body to GSA on GSA Open Government initiatives including GSA's creation, implementation and monitoring of U.S. Open Government National Action Plans (NAPs)and commitment themes. The initial focus for the OG FAC will be to provide advice to GSA on the development of NAP 6, Open Government Policy, and Public Engagement. The OG FAC will advise GSA's Administrator on emerging open government issues, challenges and opportunities to support GSA's Open Government Secretariat.

The OG FAC is essential to conduct agency business for GSA and bring together civil society, Federal agencies, academia, industry, and other interested stakeholders. GSA needs a wide diversity of views on Open Government initiatives.

It is anticipated that the OG FAC will be comprised of no less than ten (10) and no more than twenty (20) Federal and non-Federal members, with a strong background and expertise in open government themes such as Access to Information, Anti-Corruption, Civic Space, Climate and Environment, Digital Governance, Fiscal Openness, Gender and Inclusion, Justice, Media Freedom, Public Participation, and improving the delivery of government services and benefits. The GSA Administrator will appoint all members. Members serve one (1) to three (3) year terms. No member will serve for more than six (6) consistent years. Membership balance is not static given the broad nature of the work, and the expertise or experience relevant to the function of this Committee may change over time, depending on the work of the Committee. GSA values opportunities to increase diversity, equity, inclusion and accessibility on its federal advisory committees.

The OG FAC will operate in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, (5 U.S.C. 10). The OG FAC will be solely advisory in nature. Consistent with FACA and its requirements, each meeting of the OG FAC will be open to the public unless otherwise notified in accordance with the Government in the Sunshine Act. A notice of each meeting will be published in the Federal Register at least fifteen (15) days in advance of the meeting. Records will be maintained for each meeting and made available for public inspection. All activities of the OG FAC will be conducted in an open, transparent, and accessible manner.

The OG FAC is expected to be a continuing entity with charter renewals every two years. The first meeting date and agenda topics will be announced in the Federal Register at least fifteen (15) days prior to the first meeting date. In addition, as needed, working groups or subcommittees will be established to facilitate the OG FAC's work. Special accommodations for meetings will be made available to individuals with disabilities upon request.

Members will be designated as Regular Government Employees (RGEs), Special Government Employees (SGEs), or Representative members as appropriate. GSA's Office of General Counsel will assist the DFO to determine the advisory committee member designations. In general, SGEs are experts in their field who provide Federal advisory committees with their own best independent judgment based on their individual expertise. Representatives are members selected to represent a specific point of view held by a particular group, organization, or association. Members who are full-time or permanent part-time Federal civilian officers or employees shall be appointed to serve as Regular Government Employee (RGE) members.

In accordance with OMB Final Guidance published in the Federal Register on October 5, 2011 and revised on August 13, 2014, federally registered lobbyists may not serve on the Committee in an individual capacity to provide their own individual best judgment and expertise, such as SGEs and RGEs members. This ban does not apply to lobbyists appointed to provide the Committee with the views of a particular group, organization, or association, such as a representative member.

GSA invites nominations to serve on the Committee in the disciplines related to Open Government policy and initiatives such as, but not limited to: Access to Information, Anti-Corruption, Civic Space, Climate and Environment, Digital Governance, Fiscal Openness, Gender and Inclusion, Justice, Media Freedom, Public Participation, and improving the delivery of government services and benefits. In the selection of members for the Committee, GSA will consider a cross-section of those directly affected, interested, and qualified, as appropriate to the nature and functions of the Committee.

Membership will depend upon several factors, including: (i) The Committee's mission; (ii) The geographic, ethnic, social, economic, or scientific impact of the Committee's recommendations; (iii) The types of specific perspectives required, for example, such as those of consumers, technical experts, the public at-large, academia, business, or other sectors; (iv) The need to obtain divergent points of view on the issues before the Committee; and (v) The relevance of State, local, territorial, or Tribal governments to the development of the Committee's recommendations.

The following factors will be used to evaluate nominees:

a. Subject matter expertise in the key issue the OG FAC is examining for the current period;

b. Professional experiences and accomplishments ( e.g., projects, nature of work, or publications);

c. Current employment and membership in associations or other activities ( e.g., industry, academia, and civil society organizations); and

d. Willingness to commit time to the Committee and demonstrated ability to work constructively and effectively on committees;

• Demonstrated credentials and interdisciplinary expertise in the open government themes such as Access to Information, Anti-Corruption, Civic Space, Climate and Environment, Digital Governance, Fiscal Openness, Gender and Inclusion, Justice, Media Freedom, Public Participation, and improving the delivery of government services and benefits.

• Willingness to commit substantial time to the Committee and demonstrated ability to work constructively and effectively on committees;

• Background and experience helping engage people from different backgrounds work towards common objectives;

• Demonstrated ability to assess and analyze policy challenges with objectivity and integrity;

• Excellent interpersonal, oral, and written communication skills; and

• Excellent leadership and consensus-building skills.

All members will be appointed by the GSA Administrator, who will also select the Chair and any Co-Chairs or Vice-Chairs from among the members.

The OG FAC will meet at least four times per year. Such meetings will be open to the public unless an appropriate authority determines, in accordance with FACA, as amended, that a meeting shall be closed or partially closed. The Committee will meet virtually or in person as agreed to by the Committee Chair and DFO.

Committee members (including the Committee Chair and any Co-Chairs or Vice-Chairs) will not be compensated for their services and may be allowed travel expenses, including per diem, in accordance with 5 U.S.C. 5703. Regardless of the type of committee membership appointment, any travel expenses shall be paid at rates equivalent to that allowable to Federal employees.

The GSA Open Government Secretariat will host a virtual Question and Answer (Q&A) session on May 10, 2024 at 1:00pm ET. The purpose of the Q&A session is to answer questions on the selection process and timeline. The Q&A session will be recorded and will be posted to the GSA YouTube Channel, on the Open Government Secretariat Playlist. To attend this virtual session please complete and submit a registration form at https://gsa.zoomgov.com/meeting/register/vJItduyurz0jEvnY1VG4FD-PswDaufetOsc or submit your contact information via email having a subject line of “OG FAC Q&A Session Attendance” to: ogfac@gsa.gov.

Any interested person and/or organization may nominate qualified individuals for membership. Individuals are also encouraged to self-nominate. The following items must be submitted in a nomination package:

(1) A letter of nomination stating the nominee's name and organizational affiliation(s), nominee's field of expertise, specific qualifications to serve on the Committee, and a brief statement of interest, including if the nominee is interested in serving as the Chair of the Committee;

(2) A professional resume or curriculum vitae (CV); and

(3) A short biography (no more than two paragraphs) describing the nominee's professional and educational qualifications, including a list of relevant activities and any current or previous/current service on advisory committees.

The letter of nomination, resume or CV, and a short biography should include the candidate's full name, address of the current organization, position title, email address, and daytime telephone number(s) of the nominee and nominator.

In preparing the letter of nomination, please describe how the nominee's background, knowledge, and experience will bring value to the work of the Committee and how these qualifications would contribute to the overall diversity of the Committee. Also, describe any previous involvement with GSA through employment, grant funding, and/or contracting sources, if applicable.

Nominations are due by May 28, 2024 and must be submitted to Arthur Brunson, Designated Federal Officer (DFO), General Services Administration, Office of Government-wide Policy, 1800 F Street, NW Washington, DC 207405 having a postmarked date of no later than the due date or via email having a subject line of “OG FAC Nomination” to: ogfac@gsa.gov.

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

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Health Insurance Common Claims Form and Supporting Regulations at 42 CFR part 424, subpart C; Use: The CMS-1500 and the CMS-1490S forms are used to deliver information to CMS for CMS to reimburse for provided services. Medicare Administrative Contractors use the data collected on the CMS-1500 and the CMS-1490S to determine the proper amount of reimbursement for Part B medical and other health services (as listed in section 1861(s) of the Social Security Act) provided by physicians and suppliers to beneficiaries. The CMS-1500 is submitted by physicians/suppliers for all Part B Medicare. Serving as a common claim form, the CMS-1500 can be used by other third-party payers (commercial and nonprofit health insurers) and other Federal programs ( e.g., TRICARE, RRB, and Medicaid). Form Number: CMS-1500/1490S (OMB control number: 0938-1197); Frequency: Occasionally; Affected Public: Private Sector: Business or other for-profit and not-for-profit institutions; Number of Respondents: 2,507,992; Total Annual Responses: 994,038,623; Total Annual Hours: 17,328,912. (For policy questions regarding this collection contact Sadaf Ali-Simpson at 667-414-0004.)

2. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, and 424.24; Use: Section 4507 of the Balanced Budget Act of 1997 (BBA 1997) amended section 1802 of the Social Security Act (the Act) to permit certain physicians and practitioners to opt-out of Medicare and to provide—through private contracts—services that Medicare would otherwise cover. Under such contracts, the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. CMS-R-234 allows certain physicians and practitioners to opt out of Medicare and furnish covered services to Medicare beneficiaries through private contracts. Physicians and practitioners use this information collection to comply with the applicable regulations. Physicians and practitioners entering private contracts with beneficiaries must file an affidavit with Medicare in which they agree to opt-out of Medicare for 2 years and to meet certain other criteria. In general, the applicable regulations require that during that 2-year period, physicians and practitioners who have filed affidavits opting out of Medicare must sign private contracts with all Medicare beneficiaries to whom they furnish services that Medicare would otherwise cover (except those who need emergency or urgently needed care). In addition, Medicare Administrative Contractors (MACs) use this information to determine if benefits should be paid or continued. Form Number: CMS-R-234 (OMB control number: 0938-0730); Frequency: Occasionally; Affected Public: Business or other for-profit and not-for-profit institutions; Number of Respondents; 78,258; Total Annual Responses; 78,258; Total Annual Hours: 22,780. (For policy questions regarding this collection contact Frank Whelan at 410-786-1302.)

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments. We will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. We continue to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

Home infusion therapy (HIT) is a treatment option for Medicare beneficiaries with a wide range of acute and chronic conditions. Section 5012 of the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 2016) added section 1861(iii) to the Social Security Act (the Act), establishing a new Medicare benefit for HIT services. Section 1861(iii)(1) of the Act defines “home infusion therapy” as professional services, including nursing services; training and education not otherwise covered under the Durable Medical Equipment (DME) benefit; remote monitoring; and other monitoring services. HIT must be furnished by a qualified HIT supplier and furnished in the individual's home. The individual must:

• Be under the care of an applicable provider (that is, physician, nurse practitioner, or physician assistant); and

• Have a plan of care established and periodically reviewed by a physician in coordination with the furnishing of home infusion drugs under Part B, that prescribes the type, amount, and duration of infusion therapy services that are to be furnished.

Section 1861(iii)(3)(D)(i)(III) of the Act requires that a qualified HIT supplier be accredited by an accrediting organization (AO) designated by the Secretary in accordance with section 1834(u)(5) of the Act. Section 1834(u)(5)(A) of the Act identifies factors for designating AOs and in reviewing and modifying the list of designated AOs. These statutory factors are as follows:

• The ability of the organization to conduct timely reviews of accreditation applications.

• The ability of the organization to take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D) of the Act).

• Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation.

• Such other factors as the Secretary determines appropriate.

Section 1834(u)(5)(B) of the Act requires the Secretary to designate AOs to accredit HIT suppliers furnishing HIT no later than January 1, 2021. Section 1861(iii)(3)(D)(i)(III) of the Act requires a “qualified home infusion therapy supplier” to be accredited by a CMS-approved AO, pursuant to section 1834(u)(5) of the Act.

On March 1, 2019, we published a solicitation notice entitled, “Medicare Program; Solicitation of Independent Accrediting Organizations to Participate in the Home Infusion Therapy Supplier Accreditation Program” (84 FR 7057). This notice informed national AOs that accredit HIT suppliers of an opportunity to submit applications to participate in the HIT supplier accreditation program. We stated that complete applications would be considered for the January 1, 2021 designation deadline if received by February 1, 2020. Regulations for the approval and oversight of AOs for HIT organizations are located at 42 CFR part 488, subpart L. The requirements for HIT suppliers are located at 42 CFR part 486, subpart I.

Section 1834(u)(5) of the Act and regulations at 42 CFR 488.1010 require that our findings concerning review and approval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data.

Our rules at 42 CFR 488.1020(a) require that we publish, after receipt of an organization's complete application, a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. Pursuant to our rules at 42 CFR 488.1010(d), we have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.

The purpose of this proposed notice is to inform the public of the National Association of Boards of Pharmacy's (NABP's) request for CMS' continued recognition of its HIT accreditation program. This notice also solicits public comment on whether NABP's requirements meet or exceed the Medicare requirements of participation for HIT services.

In the April 28, 2020 Federal Register , we published NABP's initial application for recognition as an accreditation organization for HIT (85 FR 23519). On September 28, 2020, we published notification of their approval as such an organization, effective September 26, 2020 through September 26, 2024 (85 FR 60793). NABP has since submitted all the necessary materials to enable us to make a determination concerning its request for continued recognition of its HIT accreditation program. This application was determined to be complete on February 28, 2024. Under section 1834(u)(5) of the Act and 42 CFR 488.1010 (Application and re-application procedures for national home infusion therapy accrediting organizations), our review and evaluation of NABP will be conducted in accordance with, but not necessarily limited to, the following factors:

• The equivalency of NABP's standards for HIT as compared with CMS' HIT requirements for participation in the Medicare program.

• NABP's survey process to determine the following:

++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.

++ The comparability of NABP's to CMS' standards and processes, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.

++ NABP's processes and procedures for monitoring a HIT supplier found out of compliance with NABP's program requirements.

++ NABP's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.

++ NABP's capacity to provide CMS with electronic data and reports necessary for effective assessment and interpretation of the organization's survey process.

++ The adequacy of NABP's staff and other resources, and its financial viability.

++ NABP's capacity to adequately fund required surveys.

++ NABP's policies with respect to whether surveys are announced or unannounced, to ensure that surveys are unannounced.

++ NABP's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).

++ NABP's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys, audits or participate in accreditation decisions.

++ NABP's agreement or policies for voluntary and involuntary termination of HIT suppliers.

++ NABP's agreement or policies for voluntary and involuntary termination of the HIT AO program.

This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Because of the large number of public comments, we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

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

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Revision of previously approved collection; Title of Information Collection: Medicare Current Beneficiary Survey (MCBS); Use: The Medicare Current Beneficiary Survey (MCBS) is the most comprehensive and complete survey available on the Medicare population and is essential in capturing data not otherwise collected through our operations. The MCBS is a nationally-representative, longitudinal survey of Medicare beneficiaries that we sponsor and is directed by the Office of Enterprise Data and Analytics (OEDA). MCBS data collection includes both in-person and phone interviewing. The survey captures beneficiary information whether aged or disabled, living in the community or facility, or serviced by managed care or fee-for-service. Data produced as part of the MCBS are enhanced with our administrative data ( e.g., fee-for-service claims, prescription drug event data, enrollment, etc.) to provide users with more accurate and complete estimates of total health care costs and utilization. The MCBS has been continuously fielded for more than 30 years, encompassing over 1.2 million interviews and more than 140,000 survey participants. Respondents participate in up to 11 interviews over a four-year period. This gives a comprehensive picture of health care costs and utilization over a period of time.

The MCBS continues to provide unique insight into the Medicare program and helps CMS and our external stakeholders better understand and evaluate the impact of existing programs and significant new policy initiatives. In the past, MCBS data have been used to assess potential changes to the Medicare program. For example, the MCBS was instrumental in supporting the development and implementation of the Medicare prescription drug benefit by providing a means to evaluate prescription drug costs and out-of-pocket burden for these drugs to Medicare beneficiaries. Form Number: CMS-P-0015A (OMB control number: 0938-0568); Frequency: Occasionally; Affected Public: Business or other for-profits and Not-for-profits institutions; Number of Respondents: 35,015; Total Annual Responses: 35,015; Total Annual Hours: 35,212. (For policy questions regarding this collection contact: William Long at 410-786-7927.)

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

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Generic Social Marketing & Consumer Testing Research; Use: The purpose of this submission is to extend the approval of the generic clearance for a program of consumer research aimed at a broad audience of those affected by CMS programs including Medicare, Medicaid, Children's Health Insurance Program (CHIP), and health insurance exchanges. This program extends strategic efforts to reach and tailor communications to beneficiaries, caregivers, providers, stakeholders, and any other audiences that would support the Agency in improving the functioning of the health care system, improve patient care and outcomes, and reduce costs without sacrificing quality of care. The information collected will be used to create a streamlined and proactive process for collection of data and utilizing the feedback on service delivery for continuous improvement of communication activities aimed at diverse CMS audiences. The generic clearance will allow rapid response to inform CMS initiatives using a mixture of qualitative and quantitative consumer research strategies (including formative research studies and methodological tests) to improve communication with key CMS audiences. As new information resources and persuasive technologies are developed, they can be tested and evaluated for beneficiary response to the materials and delivery channels. Results will inform communication development and information architecture as well as allow for continuous quality improvement. The overall goal is to maximize the extent to which consumers have access to useful sources of CMS program information in a form that can help them make the most of their benefits and options The activities under this clearance involve social marketing and consumer research using samples of self-selected customers, as well as convenience samples, and quota samples, with respondents selected either to cover a broad range of customers or to include specific characteristics related to certain products or services. All collection of information under this clearance will utilize a subset of items drawn from a core collection of customizable items referred to as the Social Marketing and Consumer Testing Item Bank. This item bank is designed to establish a set of pre-approved generic question that can be drawn upon to allow for the rapid turn-around consumer testing required for us to communicate more effectively with our audiences. The questions in the item bank are divided into two major categories. One set focuses on characteristics of individuals and is intended primarily for participant screening and for use in structured quantitative on-line or telephone surveys. The other set is less structured and is designed for use in qualitative one-on-one and small group discussions or collecting information related to subjective impressions of test materials. Results will be compiled and disseminated so that future communication can be informed by the testing results. We will use the findings to create the greatest possible public benefit. Form Number: CMS-10437 (OMB control number: 0938-1247); Frequency: Yearly; Affected Public: Individuals; Number of Respondents: 7,732; Number of Responses: 61,992; Total Annual Hours: 26,688. (For policy questions regarding this collection contact Hemalgiri Gosai at 410-786-0000.)

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Under section 1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)), the Commissioner of Food and Drugs is authorized to implement general powers (including conducting research) to carry out effectively the mission of FDA. After the events of September 11, 2001, and as part of broader counterterrorism and emergency preparedness activities, FDA's Center for Devices and Radiological Health (CDRH) began developing operational plans and interventions that would enable CDRH to anticipate and respond to medical device shortages that might arise in the context of federally declared disasters/emergencies or regulatory actions. In particular, CDRH identified the need to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would be in high demand and/or would be vulnerable to shortages in specific disaster/emergency situations or following specific regulatory actions. Such data could support prospective risk assessment, help inform risk mitigation strategies, support real-time decision making by the Department of Health and Human Services during actual emergencies or emergency preparedness exercises, and mitigate or prevent harm to the public health.

This voluntary data collection process consists of outreach to firms that have been identified as producing or distributing medical devices that may be considered essential to the response effort. In this initial outreach, the intent and goals of the data collection effort will be described, and the specific data request made. Data are collected, using the least burdensome methods, in a structured manner to answer specific questions. After the initial outreach, we will request updates to the information periodically to keep the data current and accurate. Additional followup correspondence may occasionally be needed to verify/validate data, confirm receipt of followup correspondence(s), and/or request additional details to further inform FDA's public health response.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) was enacted on March 27, 2020. Section 3121 of the CARES Act amended the FD&C Act by adding section 506J to the FD&C Act (21 U.S.C. 356j). Section 506J of the FD&C Act provides FDA with new authorities intended to help prevent or mitigate medical device shortages by requiring medical device manufacturers to inform FDA about changes in device manufacturing that could potentially lead to a device shortage. Apprised with that information, section 506J of the FD&C Act authorizes FDA to take several actions that may help to mitigate or avoid supply disruptions.

Section 506J of the FD&C Act requires manufacturers of certain devices, 1 to notify FDA “of a permanent discontinuance in the manufacture of the device” or “an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States” during or in advance of a declared public health emergency, and the reason for such discontinuance or interruption. 2 Section 506J of the FD&C Act requires FDA to take action based on that information, including (1) publicly posting a list of devices it determines to be in shortage, (2) publicly posting the reasons for the shortage, and (3) issuing letters to manufacturers that fail to comply with the notification requirements of section 506J of the FD&C Act.

On December 29, 2022, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act was signed into law as part of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) (hereafter referred to as the “FY 2023 Omnibus”). Section 2514(c) of the fiscal year (FY) 2023 Omnibus directed FDA to issue or revise guidance regarding requirements under section 506J of the FD&C Act and include a list of each device product code for which a manufacturer of such device is required to notify FDA in accordance with section 506J. Section 2514 of the FY 2023 Omnibus amended section 506J of the FD&C Act to add section 506J(h), “Additional Notifications” and directed FDA to issue guidance “to facilitate voluntary notifications.”

In the Federal Register of November 17, 2023 (88 FR 80310), FDA announced the availability of the final guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act”  3 and the draft guidance entitled “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.”  4 The final guidance, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” (hereafter referred to as the “506J Guidance”) assists stakeholders in the Agency's implementation of section 506J of the FD&C Act. This final guidance serves as the baseline for information about notifications under section 506J of the FD&C Act during or in advance of any public health emergency (PHE). FDA provides additional clarification on who is required to notify FDA, when such notifications are required, what information FDA expects manufacturers to include in such notifications, and how to submit notifications. Additionally, FDA describes how FDA determines that a device is in shortage and additional actions FDA may take to help prevent or mitigate a potential device shortage.

In the draft guidance “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications,” FDA proposes updates to the 506J Guidance. Specifically, FDA has developed a list of devices, by FDA product code, for which a manufacturer of such devices is required to notify FDA in accordance with section 506J of the FD&C Act (hereafter referred to as the “506J Device List”). The 506J Device List is based on the requirements under section 506J(a) of the FD&C Act. In section 2514 of the FY 2023 Omnibus, Congress directed FDA to issue guidance on the requirements under section 506J of the FD&C Act and to include “a list of each device product code for which a manufacturer of such device is required to notify the Secretary in accordance with section 506J.” Thus, manufacturers of a device on the 506J Device List must notify FDA in accordance with 506J of the FD&C Act for each such device. For more information, manufacturers should see the 506J Device List web page, available at https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/506j-device-list. Additionally, consistent with section 506J(h) of the FD&C Act, FDA is proposing to clarify for stakeholders that manufacturers may submit, and FDA may receive, voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE.

The guidance documents include additional voluntary items that manufacturers could provide the Agency, including additional information about device manufacturing and supply, and updates to initial notifications.

Respondents may notify FDA about an interruption or permanent discontinuance in device manufacturing (506J notification) on our website at https://fda-cdrh.my.salesforce-sites.com/shortages/.

In the Federal Register of November 28, 2023 (88 FR 83134), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

FDA bases these estimates on our recent experience and informal direct contact with respondents. We estimate up to 1,000 manufacturers, distributors, healthcare systems, healthcare providers, group purchasing organizations, and sterilizers for which there may be targeted outreach because their devices may be essential to the response effort. This targeted outreach will be conducted periodically either to obtain primary data or to verify/validate updated data (although additional outreach may be undertaken as needed). The data being requested represent common data elements that respondents monitor and track as part of routine business operations and, therefore, are readily available. It is anticipated that for most respondents, the estimated time to fulfill CDRH's data request will not exceed 1 hour per request, or 4 hours per year.

Based on current registration and listing data (approved under OMB control number 0910-0625), we estimate the number of respondents that will submit a notification under section 506J of the FD&C Act to be approximately 20 percent of currently registered manufacturers. Data from our Registration and Listing system indicate that there are approximately 42,000 unique FDA Establishment Identification registered manufacturers. Therefore, we estimate 8,400 respondents per year. We believe that the burden, including the provision of required information under section 506J of the FD&C Act, as well as additional voluntary information (including additional issues that may impact the availability of the device, such as information about critical suppliers, potential mitigations, production capacity and market share, and notification updates), is minimal and such information is readily available to respondents. Therefore, we estimate the burden of this information collection to be 15 minutes or less per notification.

Since the last OMB approval, we have updated the Number of Respondents and Average Burden per Response for the Shortages Outreach Data Collection element based on our recent experience with the information collection and informal direct contact with respondents. The updates result in an adjustment of an additional 3,000 hours and 2,000 responses annually.

On January 22, 2024, the Agency submitted a proposed collection of information entitled “Electronic Records: Electronic Signatures” to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0303. The approval expires on March 31, 2027. A copy of the supporting statement for this information collection is available on the internet at https://www.reginfo.gov/public/do/PRAMain.

In the Federal Register of February 12, 2024 (89 FR 9852), the Food and Drug Administration (FDA or we) published a notice announcing the availability of a draft guidance for industry entitled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry.” We provided a 60-day comment period for the draft guidance.

We have received a request for a 60-day extension of the comment period for the draft guidance to provide additional time to review and comment on the rationale for the sampling recommendations in the draft guidance. In the interest of balancing the public health importance of the sampling recommendations in the draft guidance and granting additional time to submit comments before we finalize the draft guidance, we have concluded that it is reasonable to reopen the comment period for 60 days, until June 25, 2024. We are reopening the comment period because the request for an extension of the comment period arrived too late for us to extend the comment period. We believe that an additional 60 days allows adequate time for interested persons to submit comments.

FDA is announcing the availability of a draft guidance for industry, IRBs, and clinical investigators entitled “Cancer Clinical Trial Eligibility Criteria: Performance Status.” The purposes of eligibility criteria are to select the intended patient population and reduce potential risks to trial participants. However, eligibility criteria are sometimes more restrictive than necessary, and expanding eligibility criteria to be more inclusive is one trial design consideration that may improve the diversity of clinical trial populations. This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer. This draft guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status, and is intended to assist interested parties, including sponsors and IRBs, who are responsible for the development and oversight of clinical trials.

A clinical trial's eligibility criteria (for inclusion and exclusion) are essential components of the trial, defining the characteristics of the study population. Because there is variability in investigational drugs and trial objectives, eligibility criteria should be developed taking into consideration the mechanism of action of the drug, the targeted disease or patient population, the anticipated safety of the investigational drug, the availability of adequate safety data, and the ability to recruit trial participants from the patient population to meet the objectives of the clinical trial. The Agency recognizes that some eligibility criteria may have become commonly accepted over time or used as a template across trials, but such criteria should be carefully considered and be appropriate for a specific trial context. Unnecessarily restrictive eligibility criteria may slow patient accrual, limit patients' access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug.

Appropriately broadening cancer trial eligibility criteria can improve the generalizability of trial results and characterize the therapy's benefit-risk profile across the patient population likely to use the drug in clinical practice.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Cancer Clinical Trial Eligibility Criteria: Performance Status.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

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

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

I. Background

Clinical pharmacology impacts many important aspects of drug development including, but not limited to, dose selection and optimization, clinical trial inclusion and exclusion criteria, and evidence generation for safety and effectiveness determinations. Clinical pharmacology derived recommendations are also critical for optimizing pharmacotherapy in clinical practice ( e.g., by informing patient-specific treatment strategies).

Within CDER, OCP leverages clinical pharmacology information on drug disposition, disease biology, pharmacology, and determinants of response variability to support risk/benefit determinations and therapeutic individualization recommendations for patients and practitioners. OCP's mission is to advance the development of innovative new medicines by applying state-of-the-art scientific principles and promoting therapeutic optimization and individualization. OCP fulfills this mission through its core functions of regulatory review, regulatory research, and development and implementation of scientific guidances and policies.

To facilitate effective and efficient drug development, FDA is engaged in multiple, high-priority policy initiatives. Consistent with FDA's broader initiatives and modernization efforts, OCP works collaboratively with stakeholders to develop and implement contemporary guidance and policy in the multidisciplinary field of clinical pharmacology to share the current regulatory thinking on a topic and promote effective drug development programs. FDA is establishing a public docket to solicit input from interested parties on specific and actionable clinical pharmacology-relevant policy topics that could be prioritized, developed, and implemented by OCP staff.

FDA is soliciting specific, actionable policy suggestions that could be prioritized, developed, and implemented in the near-term by OCP staff to promote effective drug development programs. We emphasize that the focus of this request is to seek input in the multidisciplinary field of clinical pharmacology. The Agency welcomes any relevant information that interested parties wish to share in a submission to the docket. We are particularly interested in seeking input on:

1. Topics for development of new clinical pharmacology/translational medicine guidances to improve clarity and promote effective drug development. Please provide a rationale to support your suggestion and highlight relevant aspects that could be considered in guidance development.

2. Topics and concepts where further clarity on OCP's existing guidances may be warranted. Please provide a rationale to support your suggestions and actionable recommendations.

3. Topics that promote patient centricity in drug development and regulatory assessment. For FDA, patient-centric drug development and providing patient-centered clinical recommendations are important priorities.

Persons with access to the internet may obtain relevant clinical pharmacology guidances at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

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

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

This information collection supports FDA user fee programs. Form FDA 3913, User Fee Payment Refund Request, is designed to provide the minimum necessary information for FDA to review and process a user fee payment refund. The information collected includes the organization, contact, and payment information. The information is used to determine the reason for the refund, the refund amount, and who to contact if there are any questions regarding the refund request. A submission of the User Fee Payment Refund Request form does not guarantee that a refund will be issued. FDA estimates an average of 0.40 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. The estimated hours are based on past FDA experience with the user fee payment refund request.

In fiscal year 2023, approximately 1,856 user fee refunds were processed for cover sheets and invoices including 2 for Animal Drug User Fees, 2 for Animal Generic Drug User Fees, 3 for Biosimilar Drug User Fees, 1 for Color Additive Certification Fees, 1 for Compounding Quality fees, 32 for Export Certificate Program Fees, 7 for Freedom of Information Act requests, 94 for Generic Drug User Fees, 730 for Medical Device User Fees, 219 for Medical Device Federal Unified Registration and Listing fees, 666 for Mammography inspection fees, 19 for Over-The-Counter Monograph Drug User Fees, 77 for Prescription Drug User Fees, and 3 for Tobacco product fees.

Form FDA 3914, User Fee Payment Transfer Request, is designed to provide the minimum necessary information for FDA to review and process a user fee payment transfer request. The information collected includes payment and organization information. The information is used to determine the reason for the transfer, how the transfer should be performed, and who to contact if there are any questions regarding the transfer request. A submission of the User Fee Payment Transfer Request form does not guarantee that a transfer will be performed. FDA estimates an average of 0.25 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. FDA estimated hours are based on past FDA experience with the user fee payment transfer requests.

In fiscal year 2023, approximately 86 user fee payment transfers were processed for cover sheets and invoices including 0 for Animal Drug User Fees, 0 for Animal Generic Drug User Fees, 1 for Biosimilar Drug User Fees, 2 for Compounding Quality fees, 4 for Export Certificate Program Fees, 20 for Generic Drug User Fees, 6 for Medical Device User Fees, 37 for Medical Device Federal Unified Registration and Listing fees, 8 for Mammography inspection fees, 8 for Over-The-Counter Monograph Drug User Fees, 0 for Prescription Drug User Fees, and 0 for Tobacco product fees.

Respondents for the electronic request forms include domestic and foreign firms (including pharmaceutical, biological, medical device firms, etc.). Specifically, refund request forms target respondents who submitted a duplicate payment or overpayment for a user fee cover sheet or invoice. Respondents may also include firms that withdrew an application or submission. Transfer request forms target respondents who submitted payment for a user fee cover sheet or invoice and need that payment to be re-applied to another cover sheet or invoice (transfer of funds).

The electronic user fee payment request forms streamline the refund and transfer processes, facilitate processing, and improve the tracking of refund or transfer requests. The burden for this collection of information is the same for all customers (small and large organizations). The information being requested or required has been held to the absolute minimum required for the intended use of the data. Respondents are able to request a user fee payment refund or transfer online at https://www.fda.gov/forindustry/userfees/default.htm. This electronic submission is intended to reduce the burden for customers to submit a user fee payment refund and transfer request.

FDA estimates the burden of this collection of information as follows:

Our estimated burden for the information collection reflects an overall increase of 525 hours and a corresponding increase of 1,274 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

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

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

FDA has a need for data on pregnancy exposure registries (registries). The goal of the proposed Pregnancy Exposure Registry Enrollment Project survey is to determine healthcare providers' (HCPs) perceived barriers to sufficient patient enrollment in pregnancy exposure registries. FDA's authority to conduct research related to drugs and other FDA-regulated products is set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 393(d)(2)(C) and (D)).

To ensure that pregnancy information in product labeling is accurately communicated to HCPs so that they can make informed decisions about treatment options for their patients, human pregnancy safety data are collected postapproval. Registries are an important tool for pregnancy safety data collection in the postmarketing setting. Their prospective design and ability to collect detailed patient information are critical to obtain human data to inform pregnancy labeling in a timely manner.

The pharmaceutical industry typically sponsors registries often as a result of a postmarketing requirement (PMR) or commitment (PMC) FDA issues at the time of drug approval under section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)). Under a PMR or PMC, pharmaceutical industry sponsors often work with private companies, nonprofits, and/or academic health centers to operate registries. Other times, private companies, nonprofits, Federal agencies other than FDA, or academic health centers may develop registries without FDA involvement to facilitate pregnancy-related research with other scientific goals. When developing registry protocols, sponsors and those who operate registries must comply with 45 CFR part 46 and meet the Criteria for IRB approval of research under 45 CFR 46.111, which provides protection of human research subjects, subjects' privacy, and the confidentiality of subjects' data.

Although registries are crucial to understanding the safety and potential toxicity of prescription products in the perinatal population, many registries fail to adequately enroll pregnant individuals. HCPs are a trusted source of information about health, and they serve as gatekeepers for recruiting pregnant individuals to enroll in clinical studies such as registries. Thus, HCPs are integral to the registry enrollment process. Publications suggest that low enrollment in registries may be related to HCPs' lack of awareness, time, incentives, and comfort with discussing clinical research with patients. Despite this speculation about the barriers that HCPs face, however, researchers have not surveyed HCPs to understand their challenges. FDA reviewed existing literature and engaged with other Offices and Centers within FDA and external experts and determined that this data collection is not duplicative.

During this voluntary, FDA-funded, qualitative survey, we will recruit through an existing panel of HCPs currently licensed to practice in clinical settings in the United States who routinely care for or counsel pregnant patients. We will engage three groups of HCPs: (1) primary HCPs (obstetrician/gynecologists, family practice physicians, certified nurse-midwives, physician assistants); (2) consulting HCPs (neurologists, infectious disease specialists, psychiatrists, rheumatologists, cardiologists, pulmonologists, dermatologists), and (3) pharmacists. To be eligible for the study, primary HCPs must routinely care for or counsel five or more pregnant patients per month, and consulting HCPs and pharmacists must routinely care for or counsel three or more pregnant patients per month. All eligible HCPs must have either a degree as a Doctor of Medicine, a Doctor of Osteopathic Medicine, or a Doctor of Pharmacy. Although we will recruit with representativeness in mind, we will weigh the data to ensure a nationally representative sample of HCPs. Generated tables will compare the weighted distributions of the variables used for weighting against their corresponding benchmarks.

A contracted research firm will collect data through internet administration. One hundred percent (100%) of participants will self-administer the internet survey via a computer, which will record responses and provide appropriate probes when needed. We will use automated technology in data collection, data reduction, and analyses. To identify eligible HCPs, we will send a recruitment email that links to a prequalifying screener on the internet. The screener will include questions about the HCP's specialty, number of years in practice, number of pregnant patients counseled per month, and demographics (age, race/ethnicity, and gender) and will confirm that the respondent does not work for FDA or a pharmaceutical company. We will invite all respondents who meet eligibility requirements to participate in the survey within 24 hours of completing the screener and obtain informed consent from all survey participants. The survey will assess experienced HCPs' knowledge of registries, their attitudes toward them, the barriers they face to recruiting patients, and their ideas about improving registry enrollment. Results from this project will advance pregnancy safety data collection from registries and ultimately improve health communications through inclusion of human safety data in pregnancy labeling. The survey is available on request at pedsdrugs@fda.hhs.gov.

We have the following specific research questions:

1. What proportion of HCPs know about pregnancy exposure registries?

2. What proportion of HCPs have referred patients to pregnancy exposure registries?

3. What proportion of HCPs have provided information from patient medical records to pregnancy exposure registries?

4. What barriers to patient enrollment in pregnancy exposure registries are identified by HCPs?

5. What ideas do HCPs have to improve enrollment in pregnancy exposure registries?

The target sample size for this study is 400 completed surveys. The sample will include an equal number of primary HCPs, consulting HCPs, and pharmacists. Such a design will help to ensure assessment of not only HCPs' perceptions generally, but also potential variations between different types of HCPs. HCPs are a difficult group to recruit, so several strategies will be put into place to achieve a high response rate. These strategies include tailoring contact materials, disclosing FDA sponsorship on survey materials, and providing a cash incentive.

To obtain 400 completed surveys, we estimate that 2,000 experienced HCPs will need to be screened. We estimate that participation in the study will take 17 minutes.

FDA estimates the burden of this collection of information as follows:

Prior to the main analysis, an outlier analysis will be performed for the time spent on any screen visited and total time to complete the survey. Extreme survey time will be identified and appropriate adjustments will be made prior to the final data analysis. The extent of any missing information will also be assessed to determine the data quality. Descriptive statistics will afford a look at the frequency of responses. Assessment of potential differences between primary HCPs, consulting HCPs, and pharmacists can be accomplished with pairwise comparisons between groups. We will also produce national-level estimates about attitudes toward pregnancy exposure registries and other key questions.

An analysis of item nonresponse will be made in the screener, if needed, and in the main survey. Item nonresponse rates will be tabulated for the questionnaire items, allowing for skip patterns. An analysis will be made of any questionnaire items that register unusually high item nonresponse rates. Multivariate item nonresponse relationships will be evaluated, including monotonicity patterns such as breakoffs (all items dropped after a particular item), and other types of “blocks” of multivariate item nonresponse. High levels of item nonresponse in particular items will have their correlations with other questionnaire item results in both the screener and main survey analyzed (tabulating how much the item nonresponse is concentrating in a particular subgroup of health providers).

The FDA anticipates disseminating the results of the study after final analyses of the data are completed, reviewed, and cleared. The information gathered on this topic will be used to inform regulatory guidance to sponsors and investigators designing pregnancy exposure registry protocols.

The following references are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

FDA is announcing the availability of a draft guidance for industry, IRBs, and clinical investigators entitled “Cancer Clinical Trial Eligibility Criteria: Laboratory Values.” The purposes of eligibility criteria are to select the intended patient population and reduce potential risks to trial participants. However, eligibility criteria are sometimes more restrictive than necessary, and expanding eligibility criteria to be more inclusive is one trial design consideration that may improve the diversity of clinical trial populations. This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer. Specifically, this draft guidance includes recommendations to consider appropriate use of laboratory values as trial eligibility criteria and intends to assist interested parties, including sponsors and IRBs, who are responsible for the development and oversight of clinical trials.

A clinical trial's eligibility criteria (for inclusion and exclusion) are essential components of the trial, defining the characteristics of the study population. Because there is variability in investigational drugs and trial objectives, eligibility criteria should be developed taking into consideration the mechanism of action of the drug, the targeted disease or patient population, the anticipated safety of the investigational drug, the availability of adequate safety data, and the ability to recruit trial participants from the patient population to meet the objectives of the clinical trial. The Agency recognizes that some eligibility criteria may have become commonly accepted over time or used as a template across trials, but such criteria should be carefully considered and be appropriate for a specific trial context. Unnecessarily restrictive eligibility criteria may slow patient accrual, limit patients' access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug.

Appropriately broadening cancer trial eligibility criteria can improve the generalizability of trial results and provide a more detailed characterization of the drug's benefit-risk profile across the patient population likely to use the drug in clinical practice.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Cancer Clinical Trial Eligibility Criteria: Laboratory Values.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

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

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

Section 711 of the Social Security Act (42 U.S.C. 912) directs FORHP to advise the Secretary of HHS on policies affecting rural hospitals and health care and coordinating activities within HHS that relate to rural health care. Since the 1990s, FORHP has administered grants that support activities related to increasing access to health care in rural areas. FORHP's authorizing statute does not, however, include a definition of “rural area.” To carry out this charge, FORHP monitors ongoing national research and analysis efforts related to defining geographic areas and rurality. As new methods and data become available, FORHP may consider revisions to the definition.

Historically, there have been two principal definitions of “rural” that were in use by the Federal Government: The U.S. Census Bureau urban-rural classification ( https://www.census.gov/programs-surveys/geography/guidance/geo-areas/urban-rural.html ) and the Office of Management and Budget's definition of metropolitan, also called metro, areas ( https://www.census.gov/programs-surveys/metro-micro.html ). Neither definition defined “rural” directly, but rather defined areas as either “urban,” with all other territory being “rural,” or as “metro,” with all other territory being “non-metro.”

FORHP currently designates the following areas as rural for purposes of FORHP's grant programs:  1

(1) All non-metro counties,

(2) All outlying metro counties without an Urbanized Area,

(3) All metro census tracts with Rural Urban Commuting Area (RUCA) codes 4-10, and

(4) Metro census tracts of at least 400 square miles in area with population density of 35 or less per square mile with RUCA codes 2-3.

FORHP's current definition finds that 19.7 percent of the population, or approximately 60.8 million people, live in rural areas, and classifies 86 percent of the land area of the United States as rural (based on 2010 Census data; all data will be updated when updated RUCA codes are available using data from the 2020 Census). Information on whether individual addresses are within a rural area can be identified in a search tool at the HRSA Data Warehouse. 2 HRSA updates the search tool as needed to assist rural health grant applicants.

FORHP's definition of rural area was last updated in 2021. 3 At that time, some commenters suggested that FORHP should further modify the definition of rural area to account for difficult and mountainous terrain because travel on roads through such terrain is more difficult and time-consuming. FORHP did not have national data that could consistently identify areas of difficult terrain.

In 2023, the ERS published a report, Characterizing Rugged Terrain in the United States, 4 which describes the measurement of topographic variation using the Terrain Ruggedness Index. The ERS conducted a study to analyze how population, population density, and income vary by ruggedness and rurality. The ERS produced two scales:

(1) The Area Ruggedness Scale (ARS) measures the changes in elevation for all terrain and classifies census tracts as: (1) level, (2) nearly level, (3) slightly rugged, (4) moderately rugged, (5) highly rugged, and (6) extremely rugged. This characterizes overall ruggedness in the entire tract.

(2) The RRS measures the changes in elevation beneath roads and classifies census tracts as: (1) level, (2) nearly level, (3) slightly rugged, (4) moderately rugged, and (5) highly rugged. This characterizes overall ruggedness along roads in the tract. 5

The RRS, or roads-only scale, helps to study the impact of rugged terrain on travel by vehicle. Based on the ERS analysis of the RRS, population density was highest, on average, for nearly level census tracts (5,514 people per square mile) and lowest for highly rugged census tracts (3,390 people per square mile).

FORHP is proposing to expand its definition of rural by incorporating the RRS into the definition for purposes of FORHP's grant programs. All areas included in the current definition would remain included. The RRS focuses on roads and the difficulty of travelling in mountainous terrain, while the ARS more generally classifies the topography of the tract's terrain. Access to needed health care is likely to be reduced when the roads are most difficult to traverse. FORHP proposes including census tracts of at least 20 square miles in area in metro counties with RRS 5 (highly rugged) and RUCA code 2 or 3 in our definition of rural area (tracts with RUCA codes 4-10 regardless of RRS are already included). Some small area tracts within or on the edge of cities can have rugged terrain ( e.g., State or local parks), but they are very small size and adjacent to major population centers.

FORHP estimates that including census tracts that are at least 20 square miles in area with RRS 5 and RUCA 2-3 in the definition of rural area would add 84 census tracts and approximately an additional 304,834 people to the 60,758,275 people currently living in FORHP-designated rural areas, an increase of 0.5 percent in the total number of people living in rural areas. The number of eligible census tracts by State is included in table 2.

Only tracts that meet all criteria—RRS 5 and RUCA 2-3 with an area over 20 square miles—would be newly eligible under this proposed update. Tracts with RRS 5 and RUCA code 1 could not be classified as rural areas as tracts with RUCA code 1 contain populations from urban areas with over 50,000 residents. Additionally, the RUCA code 1 tracts located in metro counties are part of the metropolitan area core and have primary commuting flow within the urban area. 6 For example, San Francisco, California has 31 census tracts with RRS 5 and RUCA code 1, and these small areas with rugged terrain inside the metropolitan area core are not rural in character.

FORHP's proposal to modify our definition of rural area for purposes of FORHP's grant programs reflects efforts to be responsive to stakeholder feedback and target programs towards the intended communities. Other rural definitions for other purposes may be set by statute or regulation or be designed to meet different program goals.

Prior to the 2020 Census, the U.S. Census Bureau designated two categories of urban areas—Urban Clusters (with a population of 2,500 to 49,999) and Urbanized Areas (with a population of 50,000 or more). With the elimination of these sub-categories to differentiate urban areas with large and small populations, the U.S. Census Bureau now only designates urban areas (population of 5,000 and up or housing units of 2,000 or more) and does not sub-categorize urban areas by size. FORHP's rural definition excludes outlying metro counties with an Urbanized Area. To retain the distinction between urban areas with population over and under 50,000 in FORHP's definition of rural area, FORHP will identify and categorize urban areas based on population size. With this technical clarification, the definition, “all outlying metro counties with no urban population from an urban area of 50,000 or more people,” will replace “all outlying metro counties without an urbanized area.”

FORHP will use the urban area population counts published by the U.S. Census Bureau in the list of qualifying urban areas for the 2020 Census ( https://www.census.gov/programs-surveys/geography/guidance/geo-areas/urban-rural.html ) to sub-categorize urban areas as less than 50,000 people ( e.g., a population of 49,999 or fewer) and as 50,000 or more people in the next update to rural area data files. Consistent with our current definition, FORHP will consider outlying metro counties without population from urban areas with 50,000 or more people as rural areas, and the entire county would be considered a rural area for our grant programs.

There are 327 outlying metro counties in the Office of Management and Budget's Bulletin No. 23-01, released July 21, 2023, that have no population part of an urban area with 50,000 or more people. Outlying metro counties with any population from urban areas with 50,000 or more people would not be considered rural areas, however census tracts within those counties would be considered rural areas if they meet the RUCA criteria or the RUCA and RRS criteria, as applicable.

FORHP proposes to designate the following areas as rural for purposes of FORHP's grant programs:

(1) Non-metro counties,

(2) Outlying metro counties with no urban population from an urban area of 50,000 or more people,

(3) Census tracts in metro counties with RUCA codes 4-10,

(4) Census tracts in metro counties of at least 400 square miles in area with population density of 35 or less per square mile with RUCA codes 2-3, and

(5) Census tracts in metro counties with RRS 5 and RUCA codes 2-3 that are at least 20 square miles in area.

FORHP is proposing to modify the current definition of rural area for purposes of FORHP's grant programs. FORHP seeks comments from the public on the proposed use of the RRS to identify rural areas as described above.

This request for comments is issued solely for information and planning purposes; it does not constitute a Request for Proposal, applications, proposal abstracts, or quotations. This request does not commit the Government to contract for any supplies or services or make a grant or cooperative agreement award or take any other official action. Further, HRSA is not seeking proposals through this request for comments and will not accept unsolicited proposals.

Technology description follows:

249 million people were afflicted with malaria in 2022. There are five Plasmodium parasite species that cause malaria in humans. Of the five, Plasmodium falciparum causes most of the incidence of human disease. Most advanced malaria vaccine candidates can confer only partial, short-term protection in malaria-endemic areas. The pathogenesis of malaria is associated with blood-stage infection and antibodies specific to the parasite blood-stage antigens may be able to control parasitemia. To address this public health need, NIAID inventors have developed 35 human monoclonal antibodies that target the RH5 complex of blood-stage Plasmodium falciparum and were found to have potent activity in in vitro growth inhibition assays.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.

• Method of prophylactic and/or therapeutic treatment by targeting blood-stage antigens of Plasmodium.

• Most other commercially available antibodies targeting against Plasmodium target circumsporozoite protein (CSP) present in the sporozoite stage. These novel antibodies instead target a conserved and essential antigen present in the blood stage: RH5.

• These monoclonal antibodies can be used alone or in combination with existing antibodies.

• Pre-clinical.

Inventors: Joshua Tan, Ph.D., Lawrence Wang, Ph.D. and Andrew Cooper, Ph.D., all of NIAID.

Publications: Wang, L., Cooper, A., et al. “Natural malaria infection elicits rare but potent neutralizing antibodies to the blood-stage antigen RH5.” bioRxiv. https://www.biorxiv.org/content/10.1101/2023.10.04.560669v1, October 06, 2023.

Intellectual Property: HHS Reference No. E-014-2023; Provisional Patent Application No.: 63/468,740.

Licensing Contact: To license this technology, please contact Dawn Taylor-Mulneix at 301-451-8021 or dawn.taylor-mulneix@nih.gov, and reference E-014-2023.

Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. For collaboration opportunities, please contact Dawn Taylor-Mulneix at 301-451-8021 or dawn.taylor-mulneix@nih.gov.

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security GAO Government Accountability Office II. Background and Purpose

The Coast Guard continues to experience recruiting challenges, leading to workforce shortages impacting frontline operations and Service readiness. Personnel in impacted areas are largely boat operators and engineers, who form the bedrock of Coast Guard operations. The Coast Guard is proactively adjusting operations and prioritizing personnel assignments to specific operational units to ensure the Service remains always ready to serve the American public. This notice meets the requirements for 14 U.S.C. 910.

The following units will transition for use as a forward operating location ( i.e., a staging area at unit commander discretion): Stations-Small Scituate, MA; East Moriches, NY; Great Egg, NJ; Beach Haven, NJ; Townsends Inlet, NJ; Stillpond, MD; Fortescue, NJ; Sodus Point, NY; Ashtabula, OH; Lorain, OH; Harbor Beach, MI; Muskegon, MI; Alpena, MI; Frankfort, MI; Ludington, MI; DuSable Harbor, IL; Wilmette Harbor, IL; Two Rivers, WI; Washington Island, WI; Green Bay, WI; Santa Cruz, CA; Coquille River, OR; and Rogue River, OR. These units already consolidate for some portion of the year.

The following units currently do not maintain a duty crew to conduct response operations, and will temporarily pause boat operations altogether: Stations Paducah, KY; Pittsburgh, PA; St. Louis, MO; Louisville; KY, and Memphis; TN and boat operations in Huntington, WV.

We encourage you to submit comments through the Federal portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. In your submission, please include the docket number for this notice and provide a reason for each suggestion or recommendation. We will review all comments received, but we may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

HUD's regulations at 24 CFR 206.44(b)(4) and 206.44(c)(2) provide the FHA Commissioner authority to permit additional funding sources for a borrower's monetary investment and interested party contributions for HECM for Purchase transactions through notice in the Federal Register . HUD relied on these authorities in making the proposed changes described in HUD's October FR Notice published on October 24, 2023, at 88 FR 73040. The changes proposed in that October FR Notice also were prospectively included in an update to HUD's Single Family Housing Policy Handbook, published October 31, 2023, and becoming effective on April 29, 2024.

FHA received two public comments in response to the October FR Notice. One commenter was broadly supportive of the proposed changes to the HECM for Purchase program. The commenter supported HUD's effort to align the HECM for Purchase program with FHA's forward mortgage programs by permitting the interested party contributions explained in HUD's October FR Notice up to six percent of the sales price. The commenter stated that these changes would help more seniors qualify for and receive the benefits of the HECM for Purchase program, especially in downsizing or otherwise changing the size of their current homes before and during retirement. The commenter concluded that the changes would improve and strengthen seniors' financial status.

The other commenter raised significant concerns about allowing HECM for Purchase borrowers to use lender credits, including premium pricing, to satisfy the monetary investment requirement for a HECM for Purchase. The commenter noted that, because HECMs are negative amortization loans where the loan balance increases over time and interest costs are added to the loan balance each month, accepting a higher interest rate in return for a credit at closing would be very costly for the borrower. The use of premium pricing may result in HECM for Purchase borrowers being steered into more expensive products that do not meet their long-term financial needs.

The commenter further noted that HECM for Purchase borrowers are not likely to understand the true, long-term cost of the higher interest rate nor are they likely to receive a credit at closing that will fully compensate them for paying the higher interest rate because the termination date of a HECM loan is unknown at the time of origination, so the cost calculation can only be an estimate. Additionally, in light of recent enforcement actions by state authorities against mortgage lenders in the forward mortgage market that failed to refund surplus lender credits to borrowers, the commenter also raised concerns that HECM for Purchase borrowers may not receive the full benefit of premium pricing credits.

Finally, the commenter disagreed that FHA should allow mortgagees and third-party originators (TPOs) to contribute to closing costs. The commenter noted that allowing mortgagees and TPOs to contribute toward closing costs would increase the chances of undue influence, fraud, and unaffordable loans for HECM for Purchase borrowers.

HUD has carefully considered the comments received and has determined that the potential harms to borrowers are significant enough that it would be imprudent to make these changes at this time. Thus, pursuant to the abovementioned authorities, HUD will remove the following changes from HUD's Single Family Housing Policy Handbook 4000.1: (1) permitting premium pricing as an additional funding source used to satisfy a HECM for Purchase borrower's monetary investment; (2) including discount points in the definition of “interested party contribution”; (3) permitting interested party payment for permanent and temporary interest rate buydowns as an interested party contribution; (4) allowing mortgagees and third parties to make any interested party contributions; and (5) allowing discount points and interest rate buydowns as permissible closing costs for HECM for Purchase transactions. Removing these changes means that the use of premium pricing to help satisfy the borrower's monetary investment and including discount points and permanent and temporary interest rate buydowns as interested party contributions for a HECM for Purchase will not be permissible, that mortgagees and third party originators (TPOs) will be prohibited from making interested party contributions, and that discount points and interest rate buydowns as permissible closing costs will not be allowed after the effective date of HUD's Mortgagee Letter or update to the Single Family Housing Policy Handbook.

We invite the public and local, State, Tribal, and Federal agencies to comment on this application. Before issuing the requested permit, we will take into consideration any information that we receive during the public comment period.

You may submit your comments and materials by one of the methods in ADDRESSES. We will not consider comments sent by email or to an address not in ADDRESSES. We will not consider or include in our administrative record comments we receive after the close of the comment period (see DATES ).

When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. Provide sufficient information to allow us to authenticate any scientific or commercial data you include. The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) those that include citations to, and analyses of, the applicable laws and regulations.

You may view and comment on others' public comments at https://www.regulations.gov unless our allowing so would violate the Privacy Act (5 U.S.C. 552a) or Freedom of Information Act (5 U.S.C. 552).

If you submit a comment at https://www.regulations.gov, your entire comment, including any personal identifying information, will be posted on the website. If you submit a hardcopy comment that includes personal identifying information, such as your address, phone number, or email address, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Moreover, all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.

To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(c) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), we invite public comments on permit applications before final action is taken. With some exceptions, the ESA prohibits certain activities with listed species unless Federal authorization is issued that allows such activities. Permits issued under section 10(a)(1)(A) of the ESA allow otherwise prohibited activities for scientific purposes or to enhance the propagation or survival of the affected species. Service regulations regarding prohibited activities with endangered species, captive-bred wildlife registrations, and permits for any activity otherwise prohibited by the ESA with respect to any endangered species are available in title 50 of the Code of Federal Regulations in part 17.

We invite comments on the following application.

The applicant requests a permit to import one male and one female captive-bred giant panda ( Ailuropoda melanoleuca ) from the China Conservation and Research Centre for the Giant Panda, Sichuan, the People's Republic of China, for the purpose of enhancing the propagation or survival of the species. This notification is for a single import.

After the comment period closes, we will make decisions regarding permit issuance. If we issue a permit to the applicant listed in this notice, we will publish a notice in the Federal Register . You may locate the notice announcing the permit issuance by searching https://www.regulations.gov for the permit number listed above in this document. For example, to find information about the potential issuance of Permit No. 12345A, you would go to regulations.gov and search for “12345A”.

We issue this notice under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ), and its implementing regulations.

The Central Yukon Proposed RMP/Final EIS is a comprehensive framework for future public land management actions in the Central Yukon region of Alaska. The planning area consists of about 55.7 million acres of land, including approximately 13.3 million acres of public lands managed by the BLM Central Yukon Field Office.

The Central Yukon RMP will guide management of these public lands for the benefit of current and future generations as part of the BLM's multiple-use mission. This planning effort updates management decisions for public land uses and resources, including subsistence resources, mineral exploration and development, and recreation. When complete, the updated Central Yukon RMP will replace the Utility Corridor RMP (1991), the original Central Yukon RMP (1986), and portions of the Southwest Management Framework Plan (1981), as well as provide RMP-level decisions for unplanned lands west of Fairbanks. The proposed plan provides consolidated direction under one resource management plan to address land and resource use and development on BLM-managed public lands within the planning area.

The Central Yukon Proposed RMP/EIS evaluates six alternatives for managing the planning area. Alternatives B, C1, C2 (preferred alternative from Draft RMP/EIS), and D were developed using input from the public, Tribes, stakeholders, and cooperating agencies. Alternative E is the BLM's Proposed RMP. This alternative was developed after considering public comments on the Draft RMP/EIS and provided in the ANILCA section 810 hearings, internal BLM discussions, government-to-government consultation, and cooperating agency input.

The Proposed RMP is drawn from components of the Alternatives analyzed in the Draft RMP/EIS and, as such, the management provisions are within the range of alternatives presented to the public. Alternative A, the no action alternative, represents existing management described by current land use plans and provides the benchmark against which to compare the other alternatives. Alternative B emphasizes reducing the potential for competition between development uses and subsistence resources by identifying key areas for additional management actions. Alternative C1 emphasizes a blend of resource protection and development at the planning level to maintain the long-term sustainability of resources while providing for multiple resource uses. Alternative C2 emphasizes management to facilitate resource development while applying habitat management and administrative designations to accommodate multiple uses. Alternative D focuses on maximizing BLM-managed public lands for development potential with fewer management restrictions at the planning level. Unlike the action alternatives from the Draft RMP/EIS, the Proposed RMP (Alternative E) recommends retention of Public Land Order (PLO) 5150. The Proposed RMP also does not recommend full revocation of the ANCSA 17(d)(1) PLOs, but does recommend revoking the withdrawals in part to allow for selection by Alaska Native Vietnam-era veterans where the PLOs currently do not allow for it. For most resources, the Proposed RMP is similar to Alternative C (either Alternative C1 or Alternative C2). The Proposed RMP designates twenty-one Areas of Critical Environmental Concern (ACECs) or Research Natural Areas, encompassing approximately 3,601,000 acres. For a detailed comparison of Alternatives, including ACEC acreages proposed for designation, see Table 2-1 and corresponding maps in Appendix A of the Proposed RMP/Final EIS.

Major planning issues addressed include subsistence resources, subsistence access, water resources, fisheries, wildlife, forestry, minerals, mining, recreation, travel management, and ACECs.

Protest of the Proposed RMP: The BLM planning regulations state that any person who participated in the preparation of the RMP and has an interest which will or might be adversely affected by approval of the Proposed RMP may protest its approval to the BLM Director. Protest on the Proposed RMP constitutes the final opportunity for administrative review of the proposed land use planning decisions prior to the BLM adopting an approved RMP. Instructions for filing a protest regarding the Proposed RMP with the BLM Director may be found online at https://www.blm.gov/programs/planning-and-nepa/public-participation/filing-a-plan-protest and at 43 CFR 1610.5-2. All protests must be in writing and mailed to the appropriate address, as set forth in the ADDRESSES section earlier, or submitted electronically through the BLM ePlanning project website as described previously. Protests submitted electronically by any means other than the ePlanning project website or by fax will be invalid unless a protest is also submitted as a hard copy.

The BLM Director will render a written decision on each protest. The Director's decision shall be the final decision of the Department of the Interior. Responses to valid protest will be compiled and documented in a Protest Resolution Report made available following the protest resolution online at: https://www.blm.gov/programs/planning-and-nepa/public-participation/protest-resolution-reports. Upon resolution of protests, the BLM will issue a Record of Decision and Approved RMP.

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

The BLM has prepared the Ambler Road Supplemental EIS in response to an application for an industrial road right-of-way (ROW) in north-central Alaska across Federal public lands and other lands. The area involved lies south of the Brooks Range, north of the Yukon River, west of the Dalton Highway, and east of the Purcell Mountains. The Alaska Industrial Development and Export Authority, a public corporation of the State of Alaska, is the applicant.

The road was initially analyzed in an EIS published in March 2020, and a BLM ROW was approved in a Joint Record of Decision (JROD) issued in July 2020. In May 2022, in two lawsuits challenging the JROD and associated environmental analyses, the U.S. District Court for the District of Alaska (District Court) granted a voluntary remand at the request of the Department of the Interior (DOI) due to, among other things, deficiencies in the BLM's analysis of subsistence impacts under the Alaska National Interest Lands Conservation Act (ANILCA) section 810, and in the consultation with Tribes conducted pursuant to section 106 of the National Historic Preservation Act (NHPA). In the motion for voluntary remand, the DOI committed to address these issues, including the identified legal deficiencies, consider new information about declines in salmon and caribou populations, reconsider the appropriate scope of the area of potential effects for purposes of the NHPA, and supplement the EIS, as appropriate, to more thoroughly assess the impacts and resources identified as areas of concern in the two lawsuits challenging the remanded JROD.

The Final Supplemental EIS analyzes: the No Action Alternative; Alternative A, the applicant's 211 mile-long proposed road alignment beginning at Mile 161 of the Dalton Highway, extending west, and ending at the Ambler River; Alternative B, which starts and ends in the same location as Alternative A but follows a shorter route through Gates of the Arctic National Preserve; and Alternative C, which starts at Mile 59.5 of the Dalton Highway and extends 332 miles northwest, ending at the Ambler River. The BLM has identified the No Action Alternative as its preferred alternative.

Section 810 of ANILCA requires the BLM to evaluate the effects of the alternatives presented in the Supplemental EIS on subsistence uses and needs and to hold public hearings if it finds that any alternative may significantly restrict subsistence uses. The BLM found in the evaluation of subsistence impacts that Alternatives A, B, and C and the cumulative case as analyzed in the Draft Supplemental EIS may significantly restrict subsistence uses in multiple communities. Therefore, the BLM held public hearings on subsistence resources and activities in conjunction with the public meetings on the Draft Supplemental EIS in the vicinity of potentially affected communities. In consideration of public comments received on the Draft Supplemental EIS and at the public hearings, BLM revised the ANILCA Section 810 evaluation, published as Appendix M of the Final Supplemental EIS, but did not change its “may significantly restrict subsistence uses” findings for the identified communities.

The input of Alaska Native Tribes and Corporations was of critical importance to this Supplemental EIS. Therefore, during the NEPA process, the BLM consulted with potentially affected federally recognized Tribes on a government-to-government basis and with affected Alaska Native Corporations in accordance with Executive Order 13175, as well as Pub. L. 108-199, Div. H, sec. 161, 118 Stat. 452, as amended by Pub. L. 108-447, Div. H, sec. 518, 118 Stat. 3267, and other Department and Bureau policies.

Authority: 40 CFR 1506.6(b).

Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2024).

Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on April 22, 2024, ordered that —

(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1-3, 6, 7, and 14-17 of the '466 patent; claims 1-7 and 11-13 of the '994 patent; claims 1-3, 5, 6, 9, 12, and 16-18 of the '794 patent; claims 1, 5, 8-10, 12, 15, and 17-21 of the '075 patent; claims 1, 3, 5, and 12-14 of the '415 patent; and claims 1-5 and 8-10 of the '823 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;

(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “fiber-optic connectors, fiber-optic adapters, fiber-optic interconnects, fiber-optic cables, fiber-optic patch cables, fiber-optic cords, and fiber-optic patch cords, including any of the foregoing sold under the monikers SN, SN-MT, SN EZ-Flip, and MPO Plus”;

(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

(a) The complainant is:

(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:

(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and

(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.

Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.

Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.

The CAS Board is issuing this notice to inform the public of the discussion topics for upcoming meetings scheduled for April 29, 2024 and June 27, 2024. The list of agenda items for these meetings is set forth below. While CAS Board meetings are closed to the public, the Board welcomes comments and inquiries, which may be directed to the manager using the contact information provided above.

1. Conformance of CAS to Generally Accepted Accounting Principles (GAAP). 41 U.S.C. 1501(c)(2) requires the CAS Board to review and conform Cost Accounting Standards (CAS), where practicable, to GAAP. In furtherance of section 1501(c)(2), the CAS Board will consider issuance of an advanced notice of proposed rulemaking (ANPRM) to address conformance of CAS 404, Capitalization of Tangible Assets, and CAS 411, Accounting for Acquisition Costs of Material, to GAAP based on public comments received in response to the Staff Discussion Paper (85 FR 58399, September 2020).

2. Review of Court and Board Decisions Related to CAS. 41 U.S.C 1501(c)(3) requires the CAS Board to annually review disputes brought before the Boards of Contract Appeals (BCAs) or federal courts involving its standards and consider whether greater clarity in CAS could avoid such disputes. The Board will discuss decisions by the BCAs and courts involving its standards since the last formal review conducted by the previous Board in 2019.

3. Pension Harmonization for Extraordinary Events. The Board will discuss an ANPRM to modify CAS 412 and CAS 413. The ANPRM would be a follow-on to a rulemaking issued in 2011 required by the Pension Protection Act (PPA) of 2006. The purpose of the ANPRM is to reconcile the application of the PPA and the CAS adjustment of pension costs for extraordinary events ( i.e., curtailment of pension plan benefits, termination of plans, and the accounting of pension plan assets or liabilities following the sale or closing of a corporate segment).

4. Public input. The Board will reserve time to discuss any suggestions that may be received from the public in response to the February 27, 2024 notice (89 FR 14523) and this notice.

The notice is published pursuant to 41 U.S.C. 1501(d), which requires the CAS Board to publish agendas of its meetings in the Federal Register .

Please refer to Docket ID NRC-2023-0138 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://regulations.gov and search for Docket ID NRC-2023-0138.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

• NRC's Public Project Website: The draft EA and draft FONSI can be accessed online at the Hermes 2—Kairos project specific web page at https://www.nrc.gov/reactors/non-power/new-facility-licensing/hermes2-kairos.html.

The NRC encourages electronic comment submission through any of the methods outlined in ADDRESSES section of this document. Please include Docket ID NRC-2023-0138 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

On July 14, 2023, Kairos submitted, pursuant to part 50 of title 10 of the Code of Federal Regulations (10 CFR), “Domestic Licensing of Production and Utilization Facilities,” an application for CPs for the Hermes 2 test reactor facility (a “testing facility” as defined in 10 CFR 50.2), that would consist of two fluoride salt-cooled test reactor units at the East Tennessee Technology Park in Oak Ridge, Tennessee. A notice of receipt and availability of the application was published in the Federal Register on August 4, 2023 (88 FR 51876). The Hermes 2 site, adjacent to the Hermes test reactor, is situated in the Heritage Center Industrial Park of the East Tennessee Technology Park that was established by the City of Oak Ridge on land formerly owned by the U.S. Department of Energy (DOE) for the Oak Ridge Gaseous Diffusion Plant (ORGDP). The site was occupied by DOE Buildings K-31 and K-33, both of which were part of the ORGDP.

The NRC staff determined that Kairos submitted the application in accordance with 10 CFR 2.101(a)(5), and a notice of the acceptability of docketing of Kairos's CP application was published in the Federal Register on September 15, 2023 (88 FR 63632). The docket numbers established for this application are 50-611 and 50-612 for Units 1 and 2, respectively. A notice of opportunity to request a hearing and petition for leave to intervene (88 FR 81439) was published in the Federal Register on November 22, 2023.

Section 104 of the Atomic Energy Act of 1954, as amended, and its implementing regulations authorize the NRC to issue CPs for testing facilities. To issue a CP, the NRC is required to consider the environmental impacts of the proposed action under the National Environmental Policy Act of 1969 (NEPA). The NRC's environmental protection regulations that implement NEPA in 10 CFR part 51 identify actions for which the NRC prepares an environmental impact statement (EIS). CPs for test reactors are an action identified as requiring an EIS.

However, based on a review of the environmental report (ER) submitted as part of the CP application for Hermes 2 and the results of the EIS recently issued for the Hermes test reactor, the NRC staff concluded that it would be prudent to first prepare a draft environmental assessment (EA) to determine whether preparation of an EIS would be necessary or whether a finding of no significant impact (FONSI) could be issued for the Hermes 2 CP based on factors unique to the Hermes 2 CP application. These factors include: (1) the similar design of Hermes 2 and Hermes, (2) the proposed siting of Hermes 2 within a few hundred feet of Hermes, (3) the industrial nature and heavy prior disturbance of the site, (4) the recent thorough NEPA review performed by the staff as published in its final EIS for Hermes, and (5) the staff's final EIS for Hermes covering the same site as Hermes 2 and documenting all impacts as SMALL.

The NRC staff has prepared a draft EA and draft FONSI documenting its environmental review of the Hermes 2 CP application. Based on the environmental review, the NRC staff has made a preliminary determination that the proposed action would not significantly affect the quality of the human environment. Therefore, the NRC staff has made a preliminary determination that it will not prepare an EIS and that a draft FONSI appears warranted.

The staff will consider comments received on the draft EA and draft FONSI over a 30-day public comment period from Federal, State, local, and Tribal officials, and members of the public. After consideration of these public comments, the NRC staff will make a final determination as to whether preparation of an EIS is necessary or whether a FONSI can be issued for the Hermes 2 CP application. However, exemptions from certain regulations in 10 CFR part 51 would be necessary to issue a final EA and final FONSI to support issuance of the Hermes 2 CPs. In accordance with 10 CFR 51.6, the NRC may grant exemptions from the requirements of 10 CFR part 51 if it determines that the exemptions are authorized by law and are otherwise in the public interest.

The proposed action is for the NRC to issue CPs to Kairos authorizing construction of the two proposed Hermes 2 reactors. The NRC issuance of CPs would constitute authorization for Kairos to proceed with the construction of the Hermes 2 reactors, two fluoride salt-cooled test reactor units, at the East Tennessee Technology Park in Oak Ridge, Tennessee.

The issuance of a CP is a separate licensing action from the issuance of an operating license (OL). If the NRC issues CPs for Hermes 2 and Kairos were to seek NRC approval to operate Hermes 2, then Kairos would have to submit a separate application for OLs pursuant to the NRC's regulations, and Kairos would have to obtain NRC approval before it could operate the Hermes 2 test reactors. The NRC staff would review any application for an OL for Hermes 2 for new and significant information related to the environmental impacts of operating and decommissioning Hermes 2 that might alter the staff's conclusions made in the EA for the CP application.

The need for Hermes 2 is to demonstrate key elements of the Kairos Power Fluoride Salt-Cooled, High Temperature Reactor technology for possible future commercial deployment. The technology is an advanced nuclear reactor technology that leverages TRI-structural ISOtropic particle fuel in pebble form combined with a low-pressure fluoride salt coolant. Hermes 2 would support Kairos's reactor development program, which relies on learning and risk reduction by narrowing the design space through progressive test cycles. Construction and operation of Hermes 2 also would provide validation and qualification data to support potential future commercial reactors using the Kairos Power Fluoride Salt-Cooled, High Temperature Reactor technology.

In the draft EA, the NRC staff assessed the potential direct and indirect environmental impacts from the proposed action associated with the following relevant resource areas: land use and visual resources; air quality and noise; hydrogeology and water resources; ecological resources; historic and cultural resources; socioeconomics and environmental justice; human health; nonradiological waste management; uranium fuel cycle and radiological waste management; transportation of radioactive material; and postulated accidents. The NRC staff also considered the cumulative impacts from past, present, and reasonably foreseeable future actions when combined with the proposed action.

The NRC staff determined that the environmental impacts of the proposed action would be SMALL for each potentially affected environmental resource, meaning that the environmental effects are not detectable or are so minor that they will neither destabilize nor noticeably alter any important attribute of the resource. In addition, the NRC staff determined that the projected effects of climate change would not alter any of the impact determinations described in the EA. Furthermore, the NRC staff found that there would be no significant negative cumulative impact to any resource area from the proposed action when added to other past, present, and reasonably foreseeable future actions.

The NRC staff identified a range of reasonable alternatives to the proposed action and the environmental impacts of the alternatives as appropriate. The NRC staff determined that there are no alternatives that meet the need for the proposed action and that are environmentally preferrable to the proposed action.

The proposed action before the NRC is whether to issue CPs (one for each unit) to Kairos to authorize construction of the two proposed reactors (units) making up the Hermes 2 project. The NRC has conducted an environmental review of a request for NRC issuance of CPs for the Hermes 2 project and prepared an EA. This draft FONSI incorporates by reference the EA summarized in Section II of this notice and referenced in Section V of this notice. On the basis of the EA, and its determination that the environmental impacts would be SMALL for each potentially affected resource area, the NRC staff has preliminarily determined that the proposed action would not have a significant effect on the quality of the human environment. Accordingly, the NRC staff has made a preliminary determination that preparation of an EIS is not required for the proposed action and that a FONSI is appears warranted.

This finding and the related environmental documents referenced throughout the EA are available for public inspection as discussed in the EA and Section I of this notice. The NRC's staff's determination is tentative. Before making a final determination, the NRC staff also will consider comments received on the draft EA and draft FONSI over a 30-day public comment period from Federal, State, local, and Tribal officials, and members of the public. Once NRC makes a final determination, it will publish the final EA and final FONSI or proceed to prepare an EIS.

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.