The Nantahala and Pisgah National Forests span six ranger districts and approximately 1.04 million acres across 18 counties in Western North Carolina. The Forests have a combined LMP. The LMP was developed pursuant to the 2012 Forest Service Planning Rule (36 CFR 219) and will replace the current LMP, which was significantly amended in 1994 following its 1987 release. The revised LMP describes desired conditions, objectives, standards, guidelines, and land suitability for project and activity decision-making and will guide all resource management activities on the Forests.

The Nantahala and Pisgah National Forests lie within one of the oldest mountain ranges in the world and are a global hotspot for biodiversity, with a rich diversity of ecosystems, unique habitats, and rare species. The Nantahala and Pisgah National Forests are among the most visited in the National Forest System with nationally recognized scenic and recreation destinations that are among the region's greatest economic assets. The Pisgah Forest is also home to the birthplace of scientific forestry in America.

The Nantahala and Pisgah National Forests initiated LMP revision in 2013. During revision, the Forests engaged with federal, state, and local governments; 18 counties; three regional councils of government; local congressional staff; scientists; numerous interest and industry groups; individuals; and three collaborative groups that serve as liaisons to broader communities of interests. The design of public and government involvement was dynamic, allowing opportunities to both inform and accept feedback on the planning process as well as specific elements of the LMP. Public participants had opportunities to engage through more than 49 traditional public meetings, as well as through virtual meetings, facilitated phone calls, social media, email, and postal mail. The Forests engaged in government-to-government consultation with 12 federally recognized tribes. The revised LMP honors and redeems the Forests' trust responsibility to tribes, recognizes tribes and tribal members as partners in stewarding the national forests, and values traditional ecological knowledge and places of tribal significance. The development of the LMP was shaped by the best available scientific information, current laws, and public and government input.

A 135-day public comment period on the draft LMP and associated Draft EIS was initiated on February 14, 2020. Comments were used to refine the preferred alternative and augment LMP. A draft ROD, LMP, and FEIS were released in January 2022, initiating a 60-day objection filing period that closed March 22, 2022. The Forest Service received 825 eligible objections. Following the objection review, the Reviewing Officer held objection resolution meetings with objectors and interested persons. Based on these meetings, the Reviewing Officer issued a written response on January 19, 2023. The instructions from the Reviewing Officer were addressed in the ROD, LMP, and FEIS.

The Bureau of Land Management is a cooperating agency per their legal jurisdiction over the federal mineral estate underlying the Nantahala and Pisgah National Forests and provides information and special expertise related to subsurface mineral resources.

The Responsible Official for approving the revised LMP is James E. Melonas, Forest Supervisor, National Forests in North Carolina. The Responsible Official approving the list of species of conservation concern is Ken Arney, Regional Forester, Southern Region.

The purpose for this action remains the same as described in the 2019 NOI found here: https://www.govinfo.gov/content/pkg/FR-2019-05-17/pdf/2019-10266.pdf. The need has been revised to address new concerns related to existing allotment management plans.

To address these concerns, the Forest needs to amend both the Okanogan and Wenatchee Forest Plans to identify which existing grazing allotments are suitable or unsuitable for domestic sheep and goat grazing. The Forest also needs to identify potential site-specific grazing opportunities which could be made available to existing sheep permittees on the Forest. In contrast to the 2019 NOI, the proposed plan amendments and allotment analyses will not address grazing allotments on the Tonasket Ranger District, as that unit is now administered by the Colville National Forest.

The revised proposed action would: (1) amend the Okanogan and Wenatchee Forest Plans to provide guidance for where domestic livestock grazing might be feasible and appropriate; and (2) develop site-specific allotment management plans for grazing of domestic livestock, including sheep, goats, and cattle.

While the Forest is currently managed as one administrative unit, forest plans were completed separately and were signed prior to the Regional Forester identifying bighorn sheep as a sensitive species. The proposed forest-wide plan amendment would add plan components to both forest plans to support management of domestic livestock grazing while mitigating disease transmission risk to bighorn sheep. Disease trasnmission risk factors that may be analyzed include bighorn sheep management and herd dynamics, local topography, spatial or temporal separation, other herd characteristics, or range management actions.

In addition to forest plan components, site-specific conditions relative to risk of disease transmission between bighorn sheep and domestic livestock would be evaluated for each allotment. Domestic livestock grazing conditions, including but not limited to continuing sheep and goat grazing, switching from sheep and goat to cattle grazing, keeping allotments vacant, or closing allotments would be evaluated to determine how best to meet the need for action.

The Forest has developed six preliminary alternatives: no action, current management strategies, no domestic livestock grazing, separation area delinations, allotment-by-allotment suitability determinations, and modified zone management.

The Forest will evaluate the proposed action and alternatives for potentially significant impacts including changes in the abundance and distribution of bighorn sheep, increased risk of disease transmission to bighorn sheep that result in population declines, changes in bighorn sheep viewing and hunting opportunities, changes to range conditions due to modification of grazing practices, and effects to local economies.

The USDA Forest Service is the lead agency for the analysis in compliance with the National Environmental Policy Act. The two cooperating agencies include the USDA Agricultural Research Service (ARS) and the Washington Department of Fish and Wildlife (WDFW) as described here: https://www.govinfo.gov/content/pkg/FR-2019-05-17/pdf/2019-10266.pdf.

The responsible official who will approve the Record of Decision is the Okanogan-Wenatchee National Forest Supervisor.

This notice of intent re-opens the scoping process that was initiated in the NOI published in the Federal Register in May 2019. Because the Forest continues to use the information received during the original comment period associated with the 2019 NOI, those comments need not be resubmitted. Comments submitted in response to this updated NOI will also be considered, and all comments will guide the development of the draft environmental impact statement. The Agency is requesting comments on potential alternatives and impacts, and identification of any relevant information, studies, or analyses concerning impacts that may affect the quality of the environment.

It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions.

The proposed action is subject to objection under Forest Service regulations found at 36 CFR 218 and 36 CFR 219. Commenting during scoping and any other designated opportunity to comment provided by the Responsible Official will establish eligibility to object once the final EIS and Draft Record of Decision have been published. Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered, however, they cannot be used to establish eligibility for the objection process.

The Responsible Official will decide whether to approve the proposed amendment for the two Forest Plans to establish new plan components for domestic sheep and goat grazing on NFS lands within the range of the bighorn sheep and decide on site-specific allotment management for grazing of domestic sheep, goats, and cattle.

In accordance with the regulation at 36 CFR 219.6, when evaluating an amendment for a Forest Plan, “the responsible official has the discretion to determine the scope, scale, and timing of an assessment . . . .” As per 36 CFR 219.13(b)(5), the responsible official shall, “[d]etermine which specific substantive requirement(s) within 219.8 through 219.11 are directly related to the plan direction being added, modified, or removed by the amendment and apply such requirement(s) within the scope and scale of the amendment.” With the proposed amendment, the relevant substantive requirements include: 219.6(b)(6): Social, cultural, and economic conditions relevant to the plan area; 219.8(a)(1)(ii): Contributions of the plan area to ecological conditions within the broader landscape influenced by the plan area; 219.9(a)(2)(i): Key characteristics associated within terrestrial and aquatic ecosystem types; and 219.10(a)(7): Reasonably foreseeable risks to ecological, social, and economic sustainability.

The Committee provides scientific and technical expertise to address Census Bureau program needs and objectives. The members of the CSAC are appointed by the Director of the Census Bureau. The Committee has been established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2, Section 10).

All meetings are open to the public. Public comments will be accepted in writing only to shana.j.banks@census.gov (subject line “2023 CSAC Spring Virtual Meeting Public Comment”). A brief period will be set aside during the meeting to read public comments received in advance of 12:00 p.m. EDT, March 9, 2023. Any public comments received after the deadline will be posted to the website listed in the ADDRESSES section.

Robert L. Santos, Director, Census Bureau, approved the publication of this Notice in the Federal Register .

Pursuant to section 906(a) of the Trade Sanctions Reform and Export Enhancement Act of 2000 (TSRA) (22 U.S.C. 7205(a)), the Bureau of Industry and Security (BIS) authorizes exports and reexports of agricultural commodities, as defined in part 772 of the Export Administration Regulations (EAR), to Cuba. Requirements and procedures associated with such authorization are set forth in § 740.18 of the EAR (15 CFR 740.18). These are the only licensing procedures in the EAR currently in effect pursuant to the requirements of section 906(a) of TSRA.

Under the provisions of section 906(c) of TSRA (22 U.S.C. 7205(c)), BIS must submit a biennial report to the Congress on the operation of the licensing system implemented pursuant to section 906(a) for the preceding two-year period. This report must include the number and types of licenses applied for, the number and types of licenses approved, the average amount of time elapsed from the date of filing of a license application until the date of its approval, the extent to which the licensing procedures were effectively implemented, and a description of comments received from interested parties during a 30-day public comment period regarding the effectiveness of the licensing procedures. Consistent with TSRA's requirements, BIS is currently preparing a biennial report on the operation of the licensing system for the two-year period from October 1, 2020 through September 30, 2022.

By this notice, BIS requests public comments on the effectiveness of the licensing procedures for the export and reexport of agricultural commodities to Cuba set forth under § 740.18 of the EAR. Parties submitting comments are asked to be as specific as possible. All comments received by the close of the comment period will be considered by BIS in developing the report to Congress.

All comments must be in writing and will be available for public inspection and copying. Any information that the commenter does not wish to be made available to the public should not be submitted to BIS.

On October 17, 2022, Commerce published the Preliminary Results of this administrative review. 1 We invited parties to comment on the Preliminary Results. A complete summary of the events that occurred since publication of the Preliminary Results may be found in the Issues and Decision Memorandum. 2

The merchandise covered by the Order is hardwood plywood from China. A full description of the scope of the Order is contained in the Issues and Decision Memorandum.

All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of the issues that parties raised and to which we responded in the Issues and Decision Memorandum is attached to this notice in Appendix II. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Based on a review of the record and the comment received from interested parties, we made no changes to the Preliminary Results.

Commerce preliminarily found that six exporters did not ship subject merchandise during the POR. 4 As noted in the Preliminary Results, we received no-shipment statements from these exporters, and their statements were consistent with the information we received from U.S. Customs and Border Protection (CBP). 5 Therefore, for these final results, we continue to find that these six exporters had no shipments of subject merchandise to the United States during the POR.

With the exception of the aforementioned six exporters that submitted no-shipment certifications, we find all other companies for which a review was requested to be part of the China-wide entity. Accordingly, the companies listed in Appendix I are part of the China-wide entity. 6

Because no party requested a review of the China-wide entity, we did not conduct a review of the China-wide entity. The rate previously established for the China-wide entity is 183.36 percent and is not subject to change as a result of this review. 7

We have not calculated any assessment rates in this administrative review. Based on record evidence, we have determined that the aforementioned six companies had no shipments of subject merchandise and, therefore, pursuant to Commerce's assessment practice, any suspended entries entered under their case numbers will be liquidated at the China-wide entity rate. 8

For all remaining companies subject to this review, which are part of the China-wide entity, we will instruct CBP to liquidate their entries at the current rate for the China-wide entity ( i.e., 183.36 percent). Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Tariff Act of 1930, as amended (the Act): (1) the cash deposit rates for the six companies that had no shipments during the POR will remain unchanged from the rates assigned to them in the most recently completed segment for each company; (2) for previously investigated or reviewed Chinese and non-Chinese exporters that have separate rates, and which were not assigned the China-wide rate in this review, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding; (3) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate (including the companies listed in Appendix I), the cash deposit rate will be that for the China-wide entity ( i.e., 183.36 percent); and (4) for all non-Chinese exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter that supplied that non-Chinese exporter. These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a final reminder to importers of their responsibility under 19 CFR 315.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

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

These final results are issued and published in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.213(h).

On July 20, 2022, Commerce published in the Federal Register a notice of a covered merchandise referral and the initiation of a covered merchandise inquiry to determine whether certain refractory bricks are subject to the AD and CVD orders on bricks from China. 1 For a complete description of the events that followed the initiation of this inquiry, see the Preliminary Decision Memorandum. 2 A list of topics included in the Preliminary Decision Memorandum is included as the appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The merchandise covered by the Orders is magnesia carbon bricks. For a complete description of the scope of the Orders, see the Preliminary Decision Memorandum.

The products subject to this inquiry are refractory bricks which were imported by Fedmet Resources Corporation (Fedmet). CBP's laboratories tested 11 samples from these bricks and provided the results of chemical composition tests for the merchandise in its referral to Commerce.

Commerce is conducting this covered merchandise inquiry in accordance with section 517 of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.227. For a full description of the methodology underlying Commerce's preliminary results, see the Preliminary Decision Memorandum.

We preliminarily determine, pursuant to 19 CFR 351.227(f), that certain bricks tested by CBP laboratories do not constitute (non-subject) MAC bricks and are subject to the scope of the Orders. Although we can make such a determination for two of the eleven brick samples, the information on the remaining nine samples is indeterminate regarding the proper scope classification for the underlying product tested by CBP. In reaching this preliminary determination, we relied on information placed on the record by the Magnesia Carbon Bricks Fair Trade Committee and Fedmet, as well as the documents included with the referral from CBP. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.

As stated above, Commerce has made a preliminary affirmative finding that certain bricks tested by CBP, which were the subject of this referral from CBP, are subject to the scope of the Orders. This affirmative in-scope finding applies on a country-wide basis, regardless of the producer, exporter, or importer, to all products from the same country with the same relevant physical characteristics as the products at issue. Therefore, in accordance with 19 CFR 351.227(l)(2), Commerce will direct CBP to: (1) continue the suspension of liquidation of previously suspended entries and apply the applicable cash deposit rate; (2) begin the suspension of liquidation and require a cash deposit of estimated duties, at the applicable rate, for each unliquidated entry of the product not yet suspended, entered, or withdrawn from warehouse, for consumption on or after July 20, 2022, the date of publication of the notice of initiation of this covered merchandise inquiry in the Federal Register ; and (3) begin the suspension of liquidation and require a cash deposit of estimated duties, at the applicable rate, for each unliquidated entry of the product not yet suspended, entered, or withdrawn from warehouse, for consumption prior to July 20, 2022. 3

The New Hampshire Fish and Game Department submitted a complete application for an Exempted Fishing Permit (EFP) to conduct commercial fishing activities that the regulations would otherwise restrict. The EFP would allow the Department to continue pilot testing of early benthic-phase (EBP) lobster traps, which target lobsters between 15- and 50-mm carapace length, to determine their feasibility for broader use in lobster surveys. This EFP would exempt the participating vessel from the Federal regulations described in Table 1.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

The applicant proposes to harass up to 1200 of the following cetaceans species, annually, during vessel, underwater, and Unoccupied Aerial Systems (UAS) surveys within waters of the Main Hawaiian Islands: Blainville's beaked ( Mesoplodon densirostris ), Bryde's ( Balaenoptera brydei ), Cuvier's beaked ( Ziphius cavirostris ), dwarf sperm ( Kogia sima ), false killer ( Pseudorca crassidens; including the endangered Main Hawaiian Islands insular Distinct Population Segment), fin ( Balaenoptera physalus ), humpback ( Megaptera novaeangliae ), killer ( Orcinus orca ), melon-headed ( Peponocephala electra ), minke ( Balaenoptera acutorostrata ), pygmy killer ( Feresa attenuata ), pygmy sperm ( Kogia breviceps ), short-finned pilot ( Globicephala macrorhynchus ), and sperm ( Physeter macrocephalus ) whales; and common bottlenose ( Tursiops truncatus ), Fraser's ( Lagenodelphis hosei ), pantropical spotted ( Stenella attenuata ), Risso's ( Grampus griseus ), rough-toothed ( Steno bredanensis ), short-beaked common ( Delphinus delphis ), spinner ( Stenella longistrostris longirostris ), and striped ( Stenella coeruleoalba ) dolphins. The objective of research is to assess the human impacts on, and the distribution, abundance, social organization, population structure, population size, foraging, diet, reproduction, movements, habitat use, body condition, health, and behavior of Hawaiian cetaceans. Proposed research procedures include photo-ID, photogrammetry, underwater filming, suction-cup tagging, biopsy collection, fecal sampling, sloughed skin collection, and exhaled air sample collection. Up to 10 suction-cup tags and up to 40 biopsy samples may be taken from the above listed species. The permit would be valid for 5 years from the date of issuance.

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

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

The following listed species are covered in this notice:

Chinook salmon ( Oncorhynchus tshawytscha ): Threatened Lower Columbia River (LCR); threatened Puget Sound (PS); threatened Snake River (SnkR) spring/summer-run; threatened SnkR fall-run; endangered Upper Columbia River (UCR) spring-run; threatened Upper Willamette River (UWR), threatened Central Valley spring-run (CVS); endangered Sacramento River (SacR) winter-run; threatened California Coastal (CC).

Steelhead ( O. mykiss ): Threatened LCR; threatened Middle Columbia River (MCR); threatened PS; threatened SnkR; threatened UCR; threatened UWR; threatened Northern California (NC); threatened Central California Coast (CCC); threatened California Central Valley (CCV); threatened South-Central California Coast (S-CCC); endangered Southern California (SC).

Chum salmon ( O. keta ): Threatened Hood Canal Summer-run (HCS), threatened Columbia River (CR).

Coho salmon ( O. kisutch ): Threatened LCR; threatened Oregon Coast (OC) coho; threatened Southern Oregon/Northern California Coast (SONCC), endangered Central California Coast (CCC).

Sockeye salmon ( O. nerka ): Endangered SnkR; Threatened Ozette Lake (OL).

Eulachon ( Thaleichthys pacificus ): Threatened southern Distinct Population Segment (SDPS).

Green sturgeon ( Acipenser medirostris ): Threatened southern Distinct Population Segment (SDPS).

Rockfish ( Sebastes spp. ): Endangered Puget Sound/Georgia Basin (PS/GB) DPS bocaccio ( Sebastes paucispinis ); threatened PS/GB DPS yelloweye rockfish ( S. ruberrimus ).

Scientific research permits are issued in accordance with section 10(a)(1)(A) of the ESA (16 U.S.C. 1531 et. seq ) and regulations governing listed fish and wildlife permits (50 CFR 222-226). NMFS issues permits based on findings that such permits: (1) are applied for in good faith; (2) if granted and exercised, would not operate to the disadvantage of the listed species that are the subject of the permit; and (3) are consistent with the purposes and policy of section 2 of the ESA. The authority to take listed species is subject to conditions set forth in the permits.

Anyone requesting a hearing on an application listed in this notice should set out the specific reasons why a hearing on that application would be appropriate (see ADDRESSES ). Such hearings are held at the discretion of the Assistant Administrator for Fisheries, NMFS.

The Columbia River Inter-Tribal Fish Commission (CRITFC) is seeking to renew for 5 years a permit under which they have been conducting research for more than 20 years. The permit would continue covering three study projects that, among them, would annually take adult and juvenile SnkR steelhead and spring/summer-run Chinook salmon in the Snake River basin. There have been some significant changes in the research over the last ten years, nonetheless, the projects proposed are essentially continuations of ongoing research. They are: Project 1—Cryopreservation of Spring/summer Chinook Salmon and Summer Steelhead Gametes; Project 2—Snorkel, Seine, fyke net, Minnow Trap, and Electrofishing Surveys and Collection of Juvenile Chinook Salmon and Steelhead; and Project 3—Juvenile Anadromous Salmonid Emigration Studies Using Rotary Screw Traps. Under these tasks, listed adult and juvenile salmon would be variously (1) observed/harassed during fish population and production monitoring surveys; (2) captured (using dip nets, seines, trawls, traps, hook-and-line angling equipment, and electrofishing equipment) and anesthetized; (3) sampled for biological information and tissue samples; (4) tagged with passive integrated transponders (PIT-tags) or tagged with other identifiers, and (5) released. It should be noted that in the past, this permit covered five projects instead of three and authorized a great deal more adult and juvenile take of both species than it would under this proposed action.

The research has many purposes and would benefit listed salmon and steelhead in different ways. In general, the studies are part of ongoing efforts to monitor the status of listed species in the Snake River basin and to use those data to inform decisions about land- and fisheries management actions and to help prioritize and plan listed species recovery measures. Under the proposal, the studies would continue to benefit listed species by generating population abundance estimates; providing information on adult and juvenile salmon and steelhead life histories in the in the Snake, Salmon, Clearwater, Grande Ronde, and Imnaha River subbasins; and helping preserve listed salmon and steelhead genetic diversity. The CRITFC researchers do not intend to kill any of the fish being captured, but a small percentage may die as a result of the research activities.

The Glenn-Colusa Irrigation District (GCID) is seeking to renew for 5 years a research permit that would authorize them to take juvenile SacR winter-run Chinook salmon, CVS Chinook salmon, CCV steelhead, SDPS green sturgeon in the Sacramento River, CA. The study's purpose is to monitor restoration actions and to detect annular and cyclic population changes. The GCID project provides the longest and most complete anadromous fish data set on the Sacramento River. As a result, the research would benefit the affected species by informing operational decisions for state and Federal water facilities and supplementing other out-migrant monitoring projects conducted in the Sacramento River Basin.

The researchers propose to use a rotary screw trap to capture the targeted fish. A subsample of captured juveniles would be anesthetized, tissue-sampled, PIT-tagged and released. All juvenile fish would be captured, handled (anesthetized, weighed, measured, and checked for marks or tags), and released. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.

The County of Santa Cruz is seeking to renew for 5 years a research permit that currently allows them to take juvenile CCC coho, CCC steelhead, and S-CCC steelhead in the San Lorenzo River and its tributaries, Aptos Creek and its tributaries, Corralitos Creek and its tributaries, and Soquel Creek and its tributaries. The study's purpose is to document habitat conditions and collect data on juvenile salmonid abundance in Santa Cruz County watersheds. The research would benefit the affected species by providing data on salmonid spawning and rearing habitat conditions and thereby help inform habitat restoration and conservation efforts and land and water use decisions.

The researchers at Santa Cruz County propose to use backpack electrofishing and beach seines to capture fish and to observe fish during snorkel surveys. Captured fish would be anesthetized, identified to species, measured, PIT tagged, have a tissue sample taken for genetic analysis (fin clip and scales), and allowed to recover before being released back to the stream. The researchers do not intend to kill any listed fish, but some may die as an inadvertent result of the research.

The United States Geological Survey (USGS) is seeking to renew a research permit that allows them to take juvenile PS/GB DPS bocaccio, juvenile HCS chum salmon, juvenile PS steelhead, and juvenile, subadult, and adult PS Chinook salmon throughout the marine waters of Puget Sound, Hood Canal, and the Strait of Juan de Fuca (Washington State). The USGS research may also cause them to take adult SDPS eulachon and juvenile PS/GB DPS yelloweye rockfish—species for which there are currently no ESA take prohibitions. The purpose of the USGS study is to examine salmonid stage-specific growth, as well as bioenergetics, competition, and predation during the early marine growth period. Additionally, unlisted salmonid species, herring, and other forage fish species would be studied for the potential effects arising from fluctuations in temporal-spatial food supplies, temperature, competition, and predation. This research would benefit the affected species by quantifying key factors limiting survival and production of Chinook salmon (particularly during juvenile outmigration and the first marine growing season) and advancing knowledge of the ecological role and contribution that the little-studied resident Chinook salmon make to Puget Sound Chinook salmon populations as a whole.

The USGS proposes capturing fish by beach seine, purse seine, Lampara seine, and micro-trolling ( i.e., hook-and-line angling). All captured, viable subadult or adult salmon and any rockfish would be released as swiftly as possible. Listed rockfish would be released via rapid submergence to their capture depth to reduce the effects from barotrauma, and sub-adult/adult salmonids would be released at the surface. Under all capture methods, the juvenile salmonids would be anesthetized, identified to species, checked for coded wire tags (CWTs), measured to length, gastric-lavaged, tissue-sampled (fin clip and scales), and released. All juvenile, hatchery-origin, CWT fish (marked and unmarked) captured during the seining would be intentionally sacrificed to determine their origins. The researchers also propose to intentionally kill small numbers of hatchery- and natural-origin juvenile Chinook salmon for otolith collection and whole-body chemical analyses. Additionally, a small number of listed fish may die as an unintended result of the activities.

Windward Environmental is seeking to renew a permit that would authorize them to take juvenile and adult PS steelhead and Chinook salmon and juvenile PS/GB DPS bocaccio in order to establish baseline Lower Duwamish Waterway-wide concentrations of contaminants in non-listed resident fish species and evaluate how well this superfund site is progressing toward meeting the cleanup target tissue concentrations set by the Environmental Protection Agency (EPA). The research may also cause unintentional take of juvenile PS/GB DPS yelloweye rockfish—a species for which there are currently no ESA take prohibitions. The information would be used to determine progress towards cleanup goals for the Lower Duwamish Waterway and inform future sediment remediation efforts. This information would benefit listed species ESA-listed species by confirming where contaminated areas are and how concentrated contaminants continue to be within the Lower Duwamish River, and whether cleanup activities to date have been successful in reducing contaminant concentrations in resident fish species and their invertebrate prey. This information will also inform future sediment remediation efforts in the Puget Sound and elsewhere.

The researchers may unintentionally capture juvenile and adult ESA-listed fish while conducting otter trawls that target sole and surfperch. All captured juvenile or adult ESA-listed fish captured would be identified, enumerated, and immediately released at the location of capture. The researchers would also deploy crab traps targeting Dungeness crab, although neither juvenile nor adult ESA-listed fish are expected to be unintentionally captured by this gear. The researchers do not intend to kill any listed fish, but some may die as an inadvertent result of the proposed activities.

Under permit 22093-2R the Snoqualmie Valley Watershed Improvement District (SVWID) is seeking to renew a permit that would authorize them to take adult and juvenile PS Chinook salmon and PS steelhead in order to assess the presence or absence of fish in various streams and agricultural drainage ditches within the boundary of the SVWID. This information will better inform plans to improve drainage, minimize flooding, and restore salmon habitat. Data and observations gathered through this research will also benefit ESA-listed species by providing data that will inform researchers about the status of these species in agricultural drainage ditches and small streams that may not otherwise be studied.

Juveniles would be collected via backpack electrofishing, beach seining, and minnow traps. Adults would be collected via beach seine. Fish would be captured, handled (weighed, measured, and checked for marks or tags), and released. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.

The United States Fish and Wildlife Service (FWS) is seeking to renew a permit that would once again authorize them to annually take juvenile PS Chinook salmon and steelhead and adult HCS chum salmon in streams and waterbodies on the Kitsap Peninsula (Kitsap County, WA). The purpose of the study is to determine where in those waterbodies ESA-listed salmonids are present. That information would be used help guide future land use management and fulfill requirements in the Navy Base Kitsap's Natural Resource Management Plan. This research would benefit the affected species by helping guide habitat restoration and providing baseline information on species distribution. Currently, there is little information about the distribution of ESA-listed salmonids on Navy Base Kitsap lands.

The FWS would use backpack electrofishing equipment, beach seines, and dip nets to capture the juvenile fish. For electrofishing, the captured fish would be anesthetized with tricaine methanesulfonate (MS-222), identified by species, measured for length, weighed, allowed to recover, and released. For beach seines and dip netting, the captured fish would only be identified by species and swiftly released. The researchers would also conduct snorkel surveys for juvenile PS Chinook salmon and steelhead, and spawner surveys in which adult chum salmon may be observed. The FWS does not intend to kill any of the fish being captured, but a small number of juveniles may die as an unintended consequence of the proposed activities.

Idaho State University is seeking to modify a permit that currently authorizes them to annually take juvenile MCR steelhead, SnkR spring/summer-run Chinook salmon, SnkR steelhead, UWR Chinook salmon, UWR steelhead, and OC coho salmon at more than a dozen locations from Idaho to western Oregon. The modification would entail adding some sampling locations—particularly in Washington—and therefore would also require adding small amounts of take for SDPS eulachon and sturgeon and UCR and PS Chinook and steelhead. The purpose of the research is to conduct a range-wide comparison of native Rainbow Trout population genetics and structure across much of western North America. The work would benefit listed fish by providing of information about population and subspecies structure, local biodiversity in a variety of settings, and some measure of how intra- and inter-species variability contribute to ecosystem maintenance. That information, in turn, would be used to adjust planning efforts in a manner that would account for variances in species diversity and population structure and health across a broad section of the listed species' habitat.

The juvenile fish would be collected via backpack electrofishing and hook-and-line angling. Only juvenile steelhead would be captured, handled (anesthetized, weighed, measured, and checked for marks or tags), sampled, and released. All other listed fish that may be captured would be allowed to recover in aerated water and then released immediately. The researchers are not proposing to kill any listed fish, but a small number may be killed as an inadvertent result of the proposed activities.

The Oregon Department of Fish and Wildlife (ODFW) is seeking a permit to capture SnkR steelhead and spring/summer-run Chinook salmon while surveying the Wallowa River, Oregon, to better understand the distribution, relative abundance, movement ecology, and angler exploitation rates of rainbow trout and mountain whitefish in the river. This work is intended to generate important baseline information on the status and trends of native fishes in the Wallowa River and thereby improve managers' ability to conserve and manage them. The study would benefit listed salmonids by giving mangers information on (1) salmonid distribution and general habitat use in the Wallowa River, (2) the distribution and abundance of residualized hatchery steelhead, and (3) the rates at which anglers capture and handle listed juvenile steelhead/rainbow trout. This information, in turn, would be used to limit harvest rates and design recovery actions.

The researchers would use raft-mounted electrofishing equipment to capture the fish. Most of the listed Chinook and steelhead would be measured, scanned for tags and marks and immediately released. However, because they are very difficult to distinguish from non-listed rainbow trout, a small portion of the captured juvenile SnkR steelhead would also be tagged and tissue sampled before being released. In all cases, listed fish would be processed and released before any work is done on non-listed fish. Also, if an adult Chinook or steelhead fish were to be encountered, the electrofishing equipment would be turned off and the electrofishing raft would be moved before the survey is started again. The researchers do not plan to kill any fish they capture, but some may die as an unintended result of the activities.

The Washington Department of Natural Resources (WDNR) is seeking a new permit to conduct fish presence/absence surveys in small streams across the state of Washington. The permit would authorize them to take juvenile PS Chinook salmon and steelhead; HC summer-run chum salmon; OL sockeye salmon; UCR steelhead and spring-run Chinook salmon; MCR steelhead; SnkR steelhead, sockeye, and spring/summer-run and fall-run Chinook salmon; LCR Chinook salmon, coho salmon and steelhead; and CR chum salmon. The purpose of the study is to survey small streams on privately held land across the state of Washington and determine what fish are present at each site. The information would be used to (a) inform landowners of the appropriate riparian management zone to follow under the state Forest Regulations and (b) identify potential fish passage barriers. Helping landowners follow the appropriate forest practice regulations would help protect crucial habitats along riparian zones. Identifying fish passage barriers would help mangers determine what barriers could be altered to increase the amount of habitat accessible to listed fish.

The juvenile fish would be collected via backpack electrofishing and the captured fish would be handled (anesthetized, weighed, measured, and checked for marks or tags), and swiftly released near the point of their capture. The researchers are not proposing to kill any listed fish, but a small number from each species may be killed as an inadvertent result of the proposed activities.

The California Department of Fish and Wildlife (CDFW) is seeking a new permit that would authorize them to take juvenile SONCC coho salmon, NC steelhead, CC Chinook salmon, SacR winter-run Chinook salmon, CVS Chinook salmon, CCV steelhead, CCC coho salmon, CCC steelhead, S-CCC steelhead, SC steelhead, and adult SDPS green sturgeon in streams and rivers throughout California at pre-selected locations. The study's purpose is to assess the condition of the rivers and streams in California and provide a baseline for future comparisons. CDFW is participating in the USEPA National Rivers and Streams Assessment (NRSA), a probability-based survey designed to assess the condition of the Nation's rivers and streams. NRSA is a keystone program in California that provides data for the National Water Quality Inventory Report to Congress (305(b) report) and fulfills the water quality monitoring requirements of the Clean Water Act.

The researchers at CDFW propose to use kick nets, backpack and boat electrofishing to capture fish. Captured fish would be handled (anesthetized, weighed, measured, and checked for marks or tags), and released. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.

Thomas Gast & Associates Environmental Consultants is seeking a new permit that would authorize them to take juvenile SacR winter-run Chinook salmon, CVS Chinook salmon, CCV Valley steelhead, and SDPS green sturgeon in a backwater area of the Sacramento River directly downstream of its confluence with Battle Creek. The study's purpose is to characterize seasonal changes and variability within the fish community in the backwater area. Data on the fish community composition will be used to inform the planning and design of an upcoming side-channel restoration project.

Juveniles would be collected via fyke net, beach seine, and minnow trap and observed during snorkel surveys. Juvenile fish would be captured, handled (anesthetized, weighed, measured, and checked for marks or tags), and released. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.

The Port of Seattle is seeking a permit that would allow them to take juvenile PS steelhead and Chinook salmon while conducting survey work designed to examine ecological response to restoration actions that have been undertaken in the lower Duwamish River waterway in Washington state. The purpose of the work is to fulfill the conditions found in the habitat-restoration component of a Natural Resources Damage Assessment claim made against the Port of Seattle. It would benefit the listed salmon and steelhead by ensuring the habitat they use in the lower Duwamish functions to promote their survival; it would also help the listed species by helping guide similar habitat restoration actions elsewhere in the Puget Sound and beyond.

All captured salmonids would be sedated with MS-222 and identified by species, weighed and measured to the nearest millimeter (fork length). Once measured and weighed, the fish would be placed into a recovery bucket and be transported to the bank of the Duwamish River and released downstream of the capture site. The process would be halted if the fish appear to be overly stressed, or recovery times are unusually long. Any fish with coded wire tags or that have had their adipose fins clipped would be noted in order to calculate the ratio of natural-origin to hatchery fish in the lower Duwamish River. The researchers do not intend to kill any of the fish being captured, but a small number may die as an unintended consequence of the proposed activities.

The WDNR is seeking a new permit that would authorize them to annually take juvenile UCR steelhead and spring-run Chinook salmon; MCR steelhead; SnkR steelhead, sockeye, and spr/sum and fall-run Chinook salmon; LCR Chinook salmon, coho salmon and steelhead; UWR Chinook salmon and steelhead; and CR chum salmon. The permit would also allow them to take adult and juvenile SDPS eulachon—a species for which there are currently no take prohibitions. Under the permit, the WDNR researchers would monitor, track, trap, and remove invasive European green crabs on WDNR aquatic lands in the Puget Sound and lower Columbia River. The purpose of the research is to explore the best means of locating and eliminating European green crab incursions, and it will benefit listed salmonid (and other) species by guiding long-term management actions designed protect their critical habitat.

The researchers would use modified shrimp and minnow traps placed in the estuarine and marine intertidal and subtidal waters in the Puget Sound and lower Columbia River. The researchers do not actually expect to catch any listed salmonids or eulachon; nonetheless, all traps will be checked very regularly and any listed animals that are captured will be swiftly released without further handling. The researchers do not intend to kill any of the fish being captured, but a small number may die as an unintended consequence of the proposed activities.

The USGS is seeking a new permit to monitor toxic chemical contamination levels in resident fish sampled in the Bonneville pool (reservoir) on the Columbia River. The permit would authorize them to take juvenile and adult UCR steelhead and spring-run Chinook salmon; MCR steelhead; SnkR steelhead, sockeye, and spring/summer-run and fall-run Chinook salmon; LCR Chinook salmon, coho salmon, and steelhead; and CR chum salmon. The purpose of the research is to conduct long-term monitoring to assess the spatial and temporal status and trends of toxics in fish, water, sediment, and other potential media in the Columbia River mainstem—eventually from Bonneville Dam to the Canadian Border. While the work does not target listed fish, it would benefit them by providing information to help state, tribal and federal mangers plan restoration and remediation actions designed to improve ecosystem function and reduce contaminants in all levels of the food chain.

The researchers would use a variety of means to capture the fish. The main methods would be fyke and hoop nets, minnow traps and nets, longlines, and angling. If these methods prove insufficient to gathering the needed resident fish samples, boat electrofishing may possibly be employed. All adult listed fish would be avoided, and any that are captured would immediately be released. Captured juvenile fish Juvenile fish would also be minimally handled and released without any data being collected on them. The researchers are not proposing to kill any listed fish, but a small number from each species may be killed as an inadvertent result of the proposed activities.

Under permit 27162 the WDNR (Olympic Region) is seeking a new permit that would authorize them to take juvenile PS Chinook salmon, PS steelhead, HCS chum salmon, and OL sockeye salmon in streams on WDNR land on the Olympic Peninsula (Clallam, Jefferson, and Grays Harbor counties in Washington) in order to determine listed fish presence or absence in small streams. The information gathered would be used to determine salmonid presence and distribution and thereby inform land management decisions on WDNR holdings. This information would benefit listed species by helping WDNR identify existing man-made fish barriers that should be removed or replaced with structures that fish can pass over or through, and support a region-wide program of road maintenance and other forest management activities in the vicinity of streams. Confirming which streams currently support ESA-listed fish species would help prioritize those locations for restoration actions.

Juvenile salmonids would be collected via backpack electrofishing, handled (anesthetized, weighed, measured, identified, and checked for marks or tags), and released back to the waters from which they came. In some cases, the researchers may not actually capture any fish but would merely note their presence, however electrofishing where listed species are observed would still be reported as take. The researchers are not proposing to kill any of the listed fish being taken, but a small number may be killed as an inadvertent result of these activities.

Oregon State University is seeking a new permit to survey waters across the pacific Northwest with the intent of mapping sculpin diversity and distribution across that range. The permit would authorize them to take juvenile PS Chinook salmon and steelhead; HCS chum salmon; UCR steelhead and spring-run Chinook salmon; MCR steelhead; SnkR steelhead, sockeye, and spring/summer-run and fall-run Chinook salmon; LCR Chinook salmon, coho salmon and steelhead; UWR Chinook salmon; CR chum salmon; and SDPS eulachon. The purpose of the study is to map sculpin diversity and distribution, but it would also benefit listed salmonids. Improved data on the listed species' distribution, movement, and life histories would help direct the efforts recommended in each of the species' recovery plans. Moreover, the project would generate presence/absence data to help fill the need to monitor ecosystem health and the distribution, population status, and migratory movements of all the of listed species that may be encountered.

The fish would be collected via backpack electrofishing and beach seine; with the exception of SDPS eulachon, no adults would be taken. All captured listed fish would be handled briefly (identified and recorded) and immediately released back to the stream of their origin. The researchers would reduce possible harm to listed salmonids by: (1) avoiding sampling in the heat of the day or during spawning times, (2) surveying sample plots in advance for any listed fish, (3) using the lowest feasible settings on the electroshocker, (4) using the gentler seine net when possible, and (5) consulting with district biologists to get their advice on how to minimize harm to endangered and threatened species at each site. The researchers are not proposing to kill any listed fish, but a small number of each species may be killed as an inadvertent result of the proposed activities.

This notice is provided pursuant to section 10(c) of the ESA. NMFS will evaluate the applications, associated documents, and comments submitted to determine whether the applications meet the requirements of section 10(a) of the ESA and Federal regulations. The final permit decisions will not be made until after the end of the 30-day comment period. NMFS will publish notice of its final action in the Federal Register.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), and the Fur Seal Act of 1966, as amended (16 U.S.C. 1151 et seq. ).

The applicant proposes to collect, receive, import, and export parts from a maximum of 5,000 cetaceans and 5,000 pinnipeds (except walrus) annually. Sources of foreign and domestic parts may include subsistence harvests, captive animals, other authorized researchers or curated collections, bycatch from legal commercial fishing operations, and foreign stranded animals. Samples would be analyzed for research related to marine mammal health ( e.g., neuroimmunology, microbiomes and diving physiology), including the creation and use of cell lines. The permit would be valid for 5 years from the date of issuance.

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

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

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

The applicant proposes to receive parts from the National Marine Mammal Tissue Bank from up to 20 bottlenose dolphins. These parts will be used to study the arterial function of dolphins with aging. The permit would be valid for 1 year from the date of issuance.

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

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

The Hydrographic Services Improvement Act of 1998 (HSIA), as amended (33 U.S.C. 892 et seq. ), established the HSRP as a Federal Advisory Committee (33 U.S.C. 892c) to advise the NOAA Administrator “on matters related to the responsibilities and authorities set forth in [33 U.S.C. 892a]” of the HSIA, “and such other matters as the Administrator refers to the [HSRP] for review and advice.

The HSRP regularly discusses stakeholder's feedback and NOAA invites public comments in advance and during the upcoming HSRP public meeting on the use of NOAA's navigation, observations and positioning data, science, products, and services for NOS's Center for Operational Oceanographic Products and Services, National Geodetic Survey, Office of Coast Survey, and the University of New Hampshire's and NOAA's Joint Hydrographic Center at the Center for Coastal and Ocean Mapping. Public comments sent in advance of the HSRP public meeting will be shared with the HSRP members, posted on the meeting website, and included in the public record for the meeting. Due to the condensed nature of the meeting, each individual or group providing written public comments will be limited to one comment of three minutes per public comment period, with no repetition of previous comments. Individuals and groups may also submit public comments during the public comment period through the webinar's question function. Comments will be read into the record as time allows and will become part of the meeting record. Due to time constraints, all comments may not be addressed during the meeting.

The HSRP members will focus on the mission and issues relevant to NOAA's navigation, observations, and positioning services, and the value these services bring, and invite stakeholder and partner suggestions for improvements. This suite of NOAA services supports safe and efficient navigation, the blue economy, resilient coasts and communities, and the nationwide positioning information infrastructure to support America's climate needs and commerce. Specifically, the HSRP will consider:

• The status of NOAA's navigation services in the context of recent legislation ( e.g., the National Defense Authorization Act, Bipartisan Infrastructure Law, and Inflation Reduction Act);

• An update on the new Standard Ocean Mapping Protocol and the plans to address and implement the ocean and coastal mapping strategy for “Establishing a National Strategy for Mapping, Exploring, and Characterizing the United States Exclusive Economic Zone”;

• Measuring, monitoring, and mitigating flooding and sea level change and the contribution of NOAA's critical foundational data to projects in the U.S. Caribbean;

• NOAA navigation data, products, and services that will enable further economic growth and address safe navigation;

• The geodesy education and training crisis;

• The exploration of possible benefits and applicability of the new Digital Twin technology to help manage coastal mapping data, maritime navigation, fleet management and related applications. The Digital Twin utilizes artificial intelligence, deep learning, data analytics and modeling to maximize use of tremendous amounts of data;

• Other topics related to the NOAA programs and activities may be discussed such as those for: hydrographic surveys, bathymetric mapping and modeling, nautical charting, coastal shoreline and ocean mapping, the National Spatial Reference System modernization efforts, tide and water level observations, current observations, contributions to resilience and coastal data and information systems to support planning for climate change, flooding, inundation, contributions to the blue economy, coastal and ocean modeling and remote sensing, PORTS® (Physical Oceanographic Real-Time System) sensor enhancements and expansion, Precision Marine Navigation, the transition from raster paper charts to Electronic Navigational Charts, geodetic observations, gravity modeling, geospatial and LIDAR data; and

• The scientific mapping and technology research projects of the cooperative agreements between NOAA and partners at the University of New Hampshire and the University of South Florida.

This public meeting is accessible to people with disabilities and there will be sign language interpretation and captioning services. Please direct requests for other auxiliary aids to Melanie.Colantuno@noaa.gov at least 10 business days in advance of the meeting.

The items included in the tentative agenda are:

All meetings will be discussing the same agenda items.

Other than the starting date and time, the order of business may be adjusted as necessary to accommodate the completion of agenda items, at the discretion of the Chair.

Simultaneous interpretation will be provided for the DAP-PR, on April 11, 2023. For simultaneous interpretation English-Spanish-English.

For any additional information on this public virtual meeting, please contact Diana Martino, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone: (787) 226-8849.

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

Additions

On 10/28/2022 and 12/9/2022, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to 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 material presented to it concerning capability of qualified nonprofit agencies to provide the product(s) and service(s) and impact of the additions on the current or most recent contractors, the Committee has determined that the product(s) and service(s) listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

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.

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

Under the PRA, 44 U.S.C. 3501 et seq., 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 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, the CFTC is publishing notice of the proposed collection of information listed below. 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.

Title: Response to Notification of Termination of Exemptive Relief Issued Pursuant to Regulation 30.10 (OMB Control No. 3038-0116). This is a request for extension of a currently approved information collection.

Abstract: Commission regulation 30.10 provides a process by which persons located outside the U.S. and subject to a comparable regulatory structure in the jurisdiction in which they are located to seek an exemption from certain of the requirements under Part 30 of the Commission's regulations. Regulation 30.10 codifies the process by which the Commission may terminate such exemptive relief after appropriate notice and opportunity to respond. Regulation 30.10(c)(3) provides any party affected by the Commission's determination to terminate relief with the opportunity to respond to the notification in writing no later than 30 business days following the receipt of the notification, or at such time as the Commission permits in writing. These reporting requirements are necessary for the ongoing evaluation of the effectiveness of the Commission's program for regulatory deference.

With respect to the collection of information, the CFTC invites comments on:

• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

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

All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to https://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations. 1

The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from https://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the ICR will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

Burden Statement: The Commission is not revising its original estimate of the burden for this proposed renewal of collection. The respondent burden for this collection is estimated to be as follows:

Estimated Number of Respondents: 1.

Estimated Average Burden Hours per Respondent: 8.

Estimated Total Annual Burden Hours: 8.

Frequency of Collection: Once.

There are no capital costs or operating and maintenance costs associated with this collection.

The meeting will be open to the public. Seating for the public may be limited due to the CDC's COVID-19 Community Level, which may require facilitating physical distancing to avoid overcrowding and additional restrictions. Members of the public may listen to the meeting by telephone by calling a domestic or international number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.

The meeting will also be open to the public via webcast on the https://www.cftc.gov website. The meeting agenda may change to accommodate other MRAC priorities. For agenda updates, please visit the MRAC committee site at: https://www.cftc.gov/About/CFTCCommittees/MarketRiskAdvisoryCommittee/mrac_meetings.html.

After the meeting, a transcript of the meeting will be published through a link on the CFTC's website, http://www.cftc.gov. Persons requiring special accommodations to attend the meeting because of a disability should notify the contact person above.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

Availability of Materials for the Meeting: Additional information, including the agenda or any updates to the agenda, is available at the DACOWITS website, https://dacowits.defense.gov/. Materials presented in the meeting may also be obtained on the DACOWITS website.

Purpose of the Meeting: The purpose of the meeting is for the DACOWITS to receive briefings and have discussions on topics related to the recruitment, retention, employment, integration, well-being, and treatment of women in the Armed Forces of the United States.

Agenda: Tuesday, March 21, 2023, from 8:00 a.m. to 12:00 p.m.—Welcome, Introductions, Announcements, Request for Information Status Update, Briefings, and DACOWITS discussion. Wednesday, March 22, 2023, from 8:00 a.m. to 11:30 a.m.—Welcome, Introductions, Opening Remarks, Announcements, Briefings, DACOWITS discussion, and Public Comment Period.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to availability of space, from 8:00 a.m. to 12:00 p.m. on March 21, 2023; and 8:00 a.m. to 11:30 a.m. on March 22, 2023. The meeting will also be streamed by videoconference. The number of participants is limited and is on a first-come basis. Any member of the public who wishes to participate via videoconference must register by contacting DACOWITS at osd.pentagon.ousd-p-r.mbx.dacowits@mail.mil or by contacting Mr. Robert Bowling at (703) 380-0116 no later than Monday, March 13, 2023. Once registered, the videoconference information will be provided.

Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact Mr. Robert Bowling no later than Monday, March 13, 2023 so appropriate arrangements can be made.

Written Statements: Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the FACA, interested persons may submit a written statement to the DACOWITS. Individuals submitting a written statement must submit their statement no later than 5:00 p.m., Monday, March 13, 2023 to Mr. Robert Bowling (703) 380-0116 (voice) or to robert.d.bowling1.mil@mail.mil (email). Mailing address is 4800 Mark Center Drive, Suite 04J25-01, Alexandria, VA 22350. Members of the public interested in making an oral statement, must submit a written statement. If a statement is not received by Monday, March 13, 2023 it may not be provided to or considered by the Committee during this quarterly business meeting. After reviewing the written statements, the Chair and the DFO will determine if the requesting persons are permitted to make an oral presentation. The DFO will review all timely submissions with the DACOWITS Chair and ensure they are provided to the members of the Committee.

This meeting is being held under the provisions of chapter 10 of title 5, U.S. Code (commonly known as the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix)), 5 U.S.C. 552b(c) (commonly known as the Government in the Sunshine Act), and sections 102-3.140 and 102-3.150 of title 41, Code of Federal Regulations (CFR).

Due to circumstances beyond the control of the Designated Federal Officer, the Defense Science Board was unable to provide public notification required by 41 CFR 102-3.150(a) concerning its February 16, 2023 meeting. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

Purpose of the Meeting: The mission of the DSB is to provide independent advice and recommendations on matters relating to the DoD's scientific and technical enterprise. The objective of the meeting is to obtain, review, and evaluate classified information related to the DSB's mission. DSB membership will meet with DoD Leadership to discuss classified current and future national security challenges and priorities within the DoD.

Agenda: The DSB Quarterly Meeting will begin on February 16, 2023 at 8 a.m. with opening remarks from Mr. Kevin Doxey, the DFO, and Dr. Eric Evans, DSB Chair. The first briefing will be from Dr. Dave Honey, Deputy Under Secretary of Defense for Research & Engineering, who will provide classified technical remarks on his view on defense technical challenges and priorities, to include microelectronics. Next, Dr. Eric Evans, DSB Chair, will provide classified updates on ongoing DSB studies to include the DSB Task Force on National Security Innovation Activities, DSB Task Force on Emerging Biotechnologies and National Security, DSB Task Force on Future Cyber Warfighting Capabilities for the DoD. Next, the Director of the Defense Advanced Research Projects Agency (DARPA), Dr. Stephanie Tompkins, will provide classified technical remarks on her view of DARPA's defense challenges and priorities. The next briefing will be from General Mark Milley, Chairman of the Joint Chiefs of Staff, who will provide classified remarks on his view on defense challenges and priorities in regards to current events and modernization efforts. Following the break, the Under Secretary of Defense for Acquisition & Sustainment (USD(A&S)), Dr. Bill LaPlante, will provide classified technical remarks on his view on defense challenges and priorities in his role as USD(A&S). Next, Dr. Eric Evans will provide classified remarks on ongoing DSB studies, to include the DSB Task Force on National Security Innovation Activities, DSB Task Force on Emerging Biotechnologies and National Security, DSB Task Force on Future Cyber Warfighting Capabilities for the DoD. Following the break, Mr. Frank Kendall, Secretary of the Air Force, will provide classified remarks on his view of current defense challenges and priorities for the Air Force related to technology. The meeting will adjourn at 4:15 p.m.

Meeting Accessibility: In accordance with 5 U.S.C. 1009(d) and 41 CFR 102-3.155, the DoD has determined that the DSB meeting will be closed to the public. Specifically, the Under Secretary of Defense for Research & Engineering, in consultation with the DoD Office of the General Counsel, has determined in writing that the meeting will be closed to the public because it will consider matters covered by 5 U.S.C. 552b(c)(1). The determination is based on the consideration that it is expected that discussions throughout will involve classified matters of national security concern. Such classified material is so intertwined with the unclassified material that it cannot reasonably be segregated into separate discussions without defeating the effectiveness and meaning of the overall meetings. To permit the meeting to be open to the public would preclude discussion of such matters and would greatly diminish the ultimate utility of the DSB's findings and recommendations to the Secretary of Defense and to the Under Secretary of Defense for Research & Engineering.

Written Statements: In accordance with 5 U.S.C. 1009(a)(3) and 41 CFR 102-3.105(j) and 102-3.140, interested persons may submit a written statement for consideration by the DSB at any time regarding its mission or in response to the stated agenda of a planned meeting. Individuals submitting a written statement must submit their statement to the DSB DFO at the email address provided in the FOR FURTHER INFORMATION CONTACT section at any point.

This meeting is being held under the provisions of chapter 10 of title 5 U.S. Code (commonly known as the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix)), 5 U.S.C. 552b(c) (commonly known as the Government in the Sunshine Act), and sections 102-3.140 and 102-3.150 of title 41, Code of Federal Regulations (CFR).

Due to circumstances beyond the control of the Designated Federal Officer, the Defense Science Board was unable to provide public notification required by 41 CFR 102-3.150(a) concerning its February 15, 2023 meeting. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

Purpose of the Meeting: The mission of the DSB is to provide independent advice and recommendations on matters relating to the DoD's scientific and technical enterprise. The objective of the meeting is to obtain, review, and evaluate classified information related to the DSB's mission. DSB membership will meet to discuss the 2023 DSB Summer Study on Climate Change and Global Security (“the DSB Summer Study”).

Agenda: The meeting will begin on Wednesday, February 15, 2023 at 8:15 a.m. with administrative opening remarks from Mr. Kevin Doxey, DFO, and a classified overview of the objectives of the Summer Study from Dr. Eric Evans, the DSB Chair. Next, the DSB members will meet in a plenary session to discuss classified strategies for anticipating the global stresses and possible conflict due to climate change. Following a break, the DSB members will hear a classified briefing from Dr. Steven Wax, Acting Deputy Chief Technology Officer (Science & Technology), Office of the Under Secretary of Defense for Research & Engineering (OUSD(R&E), regarding OUSD(R&E) environmental research and development oversight. Following a break, Mr. Richard Kidd, Deputy Assistant Secretary of Defense for Environment and Energy Resilience, Office of the Under Secretary of Defense for Acquisition & Sustainment, will provide a classified briefing on the environment and energy resilience portfolio. Next, Ms. Iris Ferguson, Deputy Assistant Secretary of Defense for Arctic and Global Resilience, Office of the Under Secretary of Defense for Policy, will provide a classified briefing on arctic and global resilience. Following a break, members will then meet in a plenary session to discuss classified strategies for anticipating the global stresses and possible conflict due to climate change. The meeting will adjourn at 5:00 p.m.

Meeting Accessibility: In accordance with 5 U.S.C. 1009(d) and 41 CFR 102-3.155, the DoD has determined that the DSB meeting will be closed to the public. Specifically, the Under Secretary of Defense for Research & Engineering, in consultation with the DoD Office of the General Counsel, has determined in writing that the meeting will be closed to the public because it will consider matters covered by 5 U.S.C. 552b(c)(1). The determination is based on the consideration that it is expected that discussions throughout will involve classified matters of national security concern. Such classified material is so intertwined with the unclassified material that it cannot reasonably be segregated into separate discussions without defeating the effectiveness and meaning of the overall meetings. To permit the meeting to be open to the public would preclude discussion of such matters and would greatly diminish the ultimate utility of the DSB's findings and recommendations to the Secretary of Defense and to the Under Secretary of Defense for Research & Engineering.

Written Statements: In accordance with 5 U.S.C. 1009(a)(3) and 41 CFR 102-3.105(j) and 102-3.140, interested persons may submit a written statement for consideration by the DSB at any time regarding its mission or in response to the stated agenda of a planned meeting. Individuals submitting a written statement must submit their statement to the DSB DFO at the email address provided in the FOR FURTHER INFORMATION CONTACT section at any point.

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

Title of Collection: Targeted Teacher Shortage Areas Data Collection.

OMB Control Number: 1840-0595.

Type of Review: Extension without change of a currently approved ICR.

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

Total Estimated Number of Annual Responses: 57.

Total Estimated Number of Annual Burden Hours: 2,793.

Abstract: This request is for approval of reporting requirements that are contained in the Federal Family Education Loan Program (FFELP) regulations (34 CFR 682.210) which address the targeted teacher deferment provision of the Higher Education Act of 1965 as amended by the Higher Education Amendment of 1986, sections 427(a)(2)(C)(vi), 428 (b)(1)(M)(vi), and 428 (b)(4)(A), which provide for the targeted teacher deferment.

The FFELP (34 CFR 682.210(q)), Paul Douglas Teacher Scholarship Program (34 CFR 653.50(a)), TEACH Grant Program, and Federal Perkins Loan Program (34 CFR 674.53(c)) regulations contain information collection requirements. The Chief State School Officers of each state provide the Secretary annually with a database of proposed teacher shortage areas for each state.

The United States Department of Energy (DOE) regulates electricity exports from the United States to foreign countries in accordance with section 202(e) of the Federal Power Act (FPA) (16 U.S.C. 824a(e)) and regulations thereunder (10 CFR 205.300 et seq. ). Sections 301(b) and 402(f) of the DOE Organization Act (42 U.S.C. 7151(b) and 7172(f)) transferred this regulatory authority, previously exercised by the now-defunct Federal Power Commission, to DOE.

Section 202(e) of the FPA provides that an entity which seeks to export electricity must obtain an order from DOE authorizing that export. (16 U.S.C. 824a(e)). On June 13, 2022, the authority to issue such orders was delegated to the DOE's Grid Deployment Office (GDO) under Delegation Order No. S1-DEL-S3-2022-2 and Redelegation Order No. S3-DEL-GD1-2022.

On May 5, 2008, DOE issued Order No. EA-338 authorizing Shell Energy to transmit electric energy from the United States to Mexico as a power marketer. DOE subsequently renewed Shell Energy's authorization to export electric energy from the United States to Mexico as a power marketer in Order No. EA-338-A (May 9, 2013), and again in Order No. EA-338-B (May 30, 2018). On December 2, 2022, Shell Energy filed an application with DOE (Application or App) for renewal of their export authority for an additional five-year term. App at 1.

In its Application, Shell Energy states that it “does not own any electric generation or transmission facilities and does not hold a franchise or service territory or native load obligation.” App at 2. Shell Energy seeks to renew its authority to “export electric energy acquired from U.S. generating sources to Mexico over international electric transmission facilities.” App at 3. Shell Energy represents that it “will purchase the power to be exported from electric utilities, qualifying small power production facilities, cogeneration facilities and federal power marketing agencies” and that “electric energy exported pursuant to the authorization requested in this Renewal Application, whether on a firm or interruptible basis, will be purchased in bilateral, voluntary transactions from the surplus and available electric energy of the generator/seller.” App at 4. Therefore, “Shell Energy's exports to Mexico will not impair the sufficiency of the electric power supply within the U.S.” Id.

The existing international transmission facilities to be utilized by the Applicant have been previously authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties. See App at Exhibit C.

Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the Application at the address provided above. Protests should be filed in accordance with Rule 211 of FERC's Rules of Practice and Procedure (18 CFR 385.211). Any person desiring to become a party to this proceeding should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214).

Comments and other filings concerning Shell Energy's Application should be clearly marked with GDO Docket No. EA-338-C. Additional copies are to be provided directly to David L. Smith, Regulatory Advisor DF—Shell Energy, 1000 Main, Suite 1200, Houston, TX 77002-6336, (713) 767-5542, dave.l.smith@shell.com and Catherine McCarthy, Partner—Bracewell LLP, 2001 M. Street NW, Suite 900, Washington, DC 20036-3310, (202) 828-5839, Catherine.mccarthy@bracewell.com.

A final decision will be made on the requested authorization after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after DOE evaluates whether the proposed action will have an adverse impact on the sufficiency of supply or reliability of the United States electric power supply system.

Copies of this Application will be made available, upon request, by accessing the program website at https://www.energy.gov/gdo/pending-applications or by emailing Electricity.Exports@hq.doe.gov.

This document of the Department of Energy was signed on February 13, 2023, by Maria Robinson, Director, Grid Deployment Office, 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 United States Department of Energy (DOE) regulates electricity exports from the United States to foreign countries in accordance with section 202(e) of the Federal Power Act (FPA) (16 U.S.C. 824a(e)) and regulations thereunder (10 CFR 205.300 et seq. ). Sections 301(b) and 402(f) of the DOE Organization Act (42 U.S.C. 7151(b) and 7172(f)) transferred this regulatory authority, previously exercised by the now-defunct Federal Power Commission, to DOE.

Section 202(e) of the FPA provides that an entity which seeks to export electricity must obtain an order from DOE authorizing that export. (16 U.S.C. 824a(e)). On June 13, 2022, the authority to issue such orders was delegated to the DOE's Grid Deployment Office (GDO) under Delegation Order No. S1-DEL-S3-2022-2 and Redelegation Order No. S3-DEL-GD1-2022.

On February 22, 2007, DOE issued Order No. EA-318, which authorized CSW Power Marketing to transmit electric energy from the United States to Mexico for a five-year term using existing international transmission facilities. Shortly thereafter, CSW Power Marketing changed its name to AEP Energy Partners, Inc. (AEP-EP). Consequently, on June 27, 2007, DOE rescinded Order No. EA-318 and issued Order No. EA-318-A to AEP-EP under the same terms and conditions as the original authorization.

On December 19, 2011, AEP-EP filed an application seeking to renew its export authority for a 10-year term. On January 20, 2012, DOE published notice of AEP-EP's renewal application in the Federal Register (77 FR 1474, January 20, 2012). Sierra Club filed a timely motion to intervene and protest on February 9, 2012. On February 16, 2012, AEP-EP filed an emergency request for continuance or temporary extension of its existing export authorization, together with a request for expedited consideration. On February 17, 2012, Sierra Club filed an opposition to AEP-EP's emergency request. On February 22, 2012, DOE issued letter order No. EA-318-B to AEP-EP, allowing it to continue exporting electricity from the United States to Mexico for emergency purposes only. On January 28, 2013, DOE issued EA-318-C, granting AEP-EP authorization to export electric energy to Mexico.

On October 19, 2022, AEP-EP filed an application with DOE (Application or App) for renewal of their export authority for an additional five-year term or any longer period allowable. App at 2. Per the Q3 2022 Form EIA-111 filed by AEP-EP at the United States Energy Information Administration, AEP-EP is currently exporting electricity. On January 11, 2023, AEP-EP filed an emergency request for continuance or temporary extension of existing export authorization or for a temporary export authorization and request for expedited consideration. On January 25, 2023, DOE granted a temporary extension of AEP-EP's existing export authorization Order No. EA-318-C until such time as DOE reviews the renewal Application.

In its Application, AEP-EP states that it “does not own control or operate any electric generation, distribution or transmission assets” nor does it “have a franchised electric power service area or service territory for the transmission, distribution or sale of electric power in the United States or Mexico.” App at 2. AEP-EP seeks to renew its authority to “export electric energy from the United States of America (`United States') to Mexico over any authorized international electric transmission facilities that are appropriate for `open access' transmission by third parties.” App at 1. AEP-EP represents that it will “purchase the electric energy to be exported to Mexico in the wholesale energy market pursuant to voluntary agreements with electric utilities and federal power marketing agencies” and that, by definition, “such power is surplus to the system of the electric utilities and federal power marketing agencies, and, thus, will not impair or have an adverse effect on the sufficiency or operation of the electric power system” of the United States. App at 5.

The existing international transmission facilities to be utilized by the Applicant have been previously authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties. See App at Exhibit C.

Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the Application at the address provided above. Protests should be filed in accordance with Rule 211 of FERC's Rules of Practice and Procedure (18 CFR 385.211). Any person desiring to become a party to this proceeding should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214).

Comments and other filings concerning AEP-EP's Application should be clearly marked with GDO Docket No. EA-318-D. Additional copies are to be provided directly to Thomas M. Myers, Vice President—AEP Energy Partners, Inc., 1 Riverside Plaza, 31st Floor, Columbus, OH 43215, (614) 716-3170, tmyers@aep.com and Carol Gosain, Steptoe & Johnson LLP, 1330 Connecticut Avenue NW, Washington, DC 20036, (202) 429-6461, cgosain@steptoe.com.

A final decision will be made on the requested authorization after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after DOE evaluates whether the proposed action will have an adverse impact on the sufficiency of supply or reliability of the United States electric power supply system.

Copies of this Application will be made available, upon request, by accessing the program website at https://www.energy.gov/gdo/pending-applications or by emailing Electricity.Exports@hq.doe.gov.

This document of the Department of Energy was signed on February 13, 2023, by Maria Robinson, Director, Grid Deployment Office, 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 United States Department of Energy (DOE) regulates electricity exports from the United States to foreign countries in accordance with section 202(e) of the Federal Power Act (FPA) (16 U.S.C. 824a(e)) and regulations thereunder (10 CFR 205.300 et seq. ). Sections 301(b) and 402(f) of the DOE Organization Act (42 U.S.C. 7151(b) and 7172(f)) transferred this regulatory authority, previously exercised by the now-defunct Federal Power Commission, to DOE.

Section 202(e) of the FPA provides that an entity which seeks to export electricity must obtain an order from DOE authorizing that export. (16 U.S.C. 824a(e)). On June 13, 2022, the authority to issue such orders was delegated to the DOE's Grid Deployment Office (GDO) under Delegation Order No. S1-DEL-S3-2022-2 and Redelegation Order No. S3-DEL-GD1-2022.

On July 12, 2022, EDC POWER filed an application with DOE (Application or App) for authority “to transmit electric energy across international transmission facilities into Mexico as a power-marketer for a term of five years.” App at 1. EDC POWER states that it is “incorporated under the laws of Texas with its principal place of business in Houston, Texas” and adds that it “is the wholly owned subsidiary of EDECSAMEX, S.A. de C.V. (“EDECSAMEX”), a company incorporated in Mexico.” EDC POWER represents that energy it “proposes to export to Mexico will be purchased as excess energy from third parties, such as electric utilities and federal power marketing agencies, pursuant to voluntary agreements, and wheeled over existing transmission facilities owned by third parties.” Id. Additionally, “neither EDC Power, nor any of its owners, own or control (nor hold an interest in other entities that own or control) any electric power generation or transmission facilities within the United States. Additionally, neither EDC POWER nor any of its owners hold a franchised electric power service area nor have a native load obligation.” Id at 2.

EDC POWER represents that “[a]s the electric power that EDC POWER plans to export to Mexico will be excess supply, its commercial plan does not impact native load requirements. Moreover, as the electric power it plans to export will be wheeled over transmission facilities owned and operated by third parties, it will not affect reliability of the ERCOT [Electric Reliability Council of Texas] transmission network, or other networks if and when it expands its commercial plan into other markets. Therefore, the export of electric energy to Mexico by EDC POWER will not impact the sufficiency of electric supply nor the reliability of the transmission grid.” Id at 2-3.

The existing international transmission facilities to be utilized by EDC Power are set forth in Exhibit C to its Application and have been previously authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

PROCEDURAL MATTERS: Any person desiring to be heard in this proceeding should file a comment or protest to the Application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commissions' (FERC) Rules of Practice and Procedure (18 CFR 385.211). Any person desiring to become a party to this proceeding should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214).

Comments and other filings concerning EDC POWER's Application should be clearly marked with GDO Docket No. EA-501. Additional copies are to be provided directly to Vahid Sadeghpour, Manager—EDC Power, LLC, 2615 Centenary Street, Houston, Texas 77005, (713) 851-0473, vsadeghpour@edecsa.net, and Gregory Arroyo, Jr., Counsel—EDC Power, LLC, 124 Palm Blvd., Missouri City, TX 77459, (713) 907-5505, garroyo@edecsa.net.

A final decision will be made on the requested authorization after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after DOE evaluates whether the proposed action will have an adverse impact on the sufficiency of supply or reliability of the United States electric power supply system.

Copies of this Application will be made available, upon request, by accessing the program website at https://www.energy.gov/gdo/pending-applications or by emailing electricity.exports@hq.doe.gov.

Signing Authority: This document of the Department of Energy was signed on February 13, 2023, by Maria Robinson, Director, Grid Deployment Office, 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 Department of Energy (DOE) regulates exports of electricity from the United States to a foreign country pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b) and 42 U.S.C. 7172(f)). Such exports require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

On November 9, 2004, DOE issued Order No. EA-296, which authorized Rainbow to transmit electric energy from the United States to Canada as a power marketer for a two-year term. That authorization expired on November 9, 2006. Subsequent authorization renewals were issued by DOE on September 18, 2007 (Order No. EA-296-A), September 20, 2012 (Order No. EA-296-B), and September 17, 2017 (Order No. EA-296-C). On September 16, 2022, Rainbow filed an application with DOE (Application or App) for renewal of their export authority for an additional five-year term.

In its application, Rainbow states that it “does not own or control any physical electric generation or transmission facilities in the U.S. and does not have any franchised service territory in the U.S.” App at Paragraph (d). Rainbow seeks to renew its authority to “engage in open-ended transactions to export electricity to Canada under terms and conditions to be negotiated in the future.” App at Paragraph (g). Because Rainbow has neither any franchised service territory nor any generation facilities, it represents that the proposed electric power exports under its application are “surplus to the needs of those entities selling electric power to Rainbow.” Id. In other words, the energy will be purchased as excess from third parties such as electric utilities and federal power marketing agencies, pursuant to voluntary agreements, and wheeled over existing transmission facilities owned by third parties. The Applicant further states that all electricity exported by Rainbow will be “transmitted pursuant to arrangements with utilities that own and operate existing transmission facilities and will be consistent with all applicable export limits on transmitting facilities, including those of the border facilities used, and with other terms and conditions contained in existing Presidential Permits and electricity export authorizations associated with these transmission facilities.” Id. Therefore, Rainbow represents that “the proposed export of electricity will not impair the sufficiency of electric supply within the U.S. or impede regional coordination of electric utility planning or operation.” Id.

The existing international transmission facilities to be utilized by the Applicant have been previously authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties. App at Exhibit C.

Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the Application at the address provided above. Protests should be filed in accordance with Rule 211 of FERC's Rules of Practice and Procedure (18 CFR 385.211). Any person desiring to become a party to this proceeding should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214).

Comments and other filings concerning Rainbow's Application should be clearly marked with GDO Docket No. EA-296-D. Additional copies are to be provided directly to Joseph A. Wolfe, Executive Vice President—Rainbow Energy Marketing Corporation, 919 South 7th Street Suite 405, Bismarck, ND 58504, (701) 222-2290, j.wolfe@rainbowenergy.com.

A final decision will be made on the requested authorization after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after DOE evaluates whether the proposed action will have an adverse impact on the sufficiency of supply or reliability of the United States electric power supply system.

Copies of this Application will be made available, upon request, by accessing the program website at https://www.energy.gov/gdo/pending-applications or by emailing Electricity.Exports@hq.doe.gov.

This document of the Department of Energy was signed on February 13, 2023, by Maria Robinson, Director, Grid Deployment Office, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Tentative Agenda:

Public Participation: The in-person/online virtual hybrid meeting is open to the public virtually via WebEx only. Written statements may be filed with the Board no later than 5 p.m. MDT on Friday, March 10, 2023, or within seven days after the meeting by sending them to the NNMCAB Executive Director at the aforementioned email address. Written public comments received prior to the meeting will be read into the record. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to submit public comments should follow as directed above.

Minutes: Minutes will be available by emailing or calling Menice B. Santistevan, NNMCAB Executive Director, at menice.santistevan@em.doe.gov or at (505) 699-0631.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Tentative Agenda:

Public Participation: The meeting is open to the public. It will be held strictly following COVID-19 precautionary measures. To provide a safe meeting environment, seating may be limited; attendees should register for in-person attendance by sending an email to srscitizensadvisoryboard@srs.gov no later than 4 p.m. ET on Friday, March 10, 2023. The EM SSAB, Savannah River Site, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Amy Boyette at least seven days in advance of the meeting at the telephone number listed above. Written statements may be filed with the Board via email either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should submit their request to srscitizensadvisoryboard@srs.gov. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. Comments will be accepted after the meeting, by no later than 4 p.m. ET on Monday, March 27, 2023. Please submit comments to srscitizensadvisoryboard@srs.gov. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make oral public comments will be provided a maximum of five minutes to present their comments. Individuals wishing to submit written public comments should email them as directed above.

Minutes: Minutes will be available by emailing or calling Amy Boyette at the email address or telephone number listed above. Minutes will also be available at the following website: https://cab.srs.gov/srs-cab.html.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Tentative Agenda:

Public Participation: Public Participation: The meeting is open to the public. The EM SSAB, Paducah, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Eric Roberts as soon as possible in advance of the meeting at the telephone number listed above. Written statements may be filed with the Board either before or after the meeting. Comments received by no later than 5 p.m. CT on Monday, March 13, 2023, will be read aloud during the meeting. Comments will also be accepted after the meeting, by no later than 5:00 p.m. CT on Friday, March 24, 2023. Please submit comments to Eric Roberts at the aforementioned email address. Please put “Public Comment” in the subject line. Individuals who wish to make oral statements pertaining to agenda items should contact Eric Roberts at the telephone number listed above. Requests must be received as soon as possible prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments. The EM SSAB, Paducah, will hear public comments pertaining to its scope (clean-up standards and environmental restoration; waste management and disposition; stabilization and disposition of non-stockpile nuclear materials; excess facilities; future land use and long-term stewardship; risk assessment and management; and clean-up science and technology activities). Comments outside of the scope may be submitted via written statement as directed above.

Minutes: Minutes will be available by writing or calling Eric Roberts, Board Support Manager, Emerging Technology Center, Room 221, 4810 Alben Barkley Drive, Paducah, KY 42001; Phone: (270) 554-3004. Minutes will also be available at the following website: https://www.energy.gov/pppo/pgdp-cab/listings/meeting-materials .

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 the EPA's public docket, visit https://www.epa.gov/dockets.

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

Abstract: This ICR includes ambient air monitoring data and other supporting measurements reporting and recordkeeping activities associated with the 40 CFR 58, Ambient Air Quality Surveillance rule. These data and information are collected by various state and local air quality management agencies and reported to the EPA's Office of Air Quality Planning and Standards within the Office of Air and Radiation.

The data collected through this information collection consist of ambient air concentration measurements for the seven air pollutants with national ambient air quality standards ( i.e., ozone, sulfur dioxide, nitrogen dioxide, lead, carbon monoxide, PM 2.5 and PM 10 ), ozone precursors, meteorological variables at a select number of sites and other supporting measurements. Accompanying the pollutant concentration data are quality assurance/quality control data and air monitoring network design information.

The EPA and others ( e.g., state and local air quality management agencies, tribal entities, environmental groups, academic institutions, industrial groups) use the ambient air quality data for many purposes. Some of the more prominent uses include informing the public and other interested parties of an area's ( e.g., county, city, neighborhood) air quality, judging an area's air quality in comparison with the established health or welfare standards (including both national and local standards), evaluating an air quality management agency's progress in achieving or maintaining air pollutant levels below the national and local standards, developing and revising State Implementation Plans (SIPs) in accordance with 40 CFR 51, evaluating air pollutant control strategies, developing or revising national control policies, providing data for air quality model development and validation, supporting enforcement actions, documenting episodes and initiating episode controls, air quality trends assessment, and air pollution research.

The state and local agencies and tribal entities with responsibility for reporting ambient air quality data and information as requested in this ICR submit these data electronically to the EPA's Air Quality System (AQS) database. Quality assurance/quality control records and monitoring network documentation are also maintained by each state and local agency, in AQS electronic format where possible.

Although the state and local air pollution control agencies and tribal entities are responsible for the operation of the air monitoring networks, the EPA funds a portion of the total costs through federal grants. These grants generally require an appropriate level of contribution, or “match,” from the state/local agencies or tribal entities. The costs shown in this renewal are the total costs incurred for the monitoring program regardless of the source of the funding. This practice of using the total cost is consistent with prior ICR submittals and renewals.

This ICR reflects revisions of the previous ICR update of 2019, and covers the period of 2023-2025. The number of monitoring stations, sampling parameters, and frequency of data collection and submittal is expected to remain relatively stable for 2023-2025, with minor increases and decreases expected for several ambient air monitoring networks as air monitoring agencies review and adjust their monitoring networks. However, the EPA is reviewing the burden estimates in this ICR renewal for potential updates and seeks comments on the burden associated with asset management recordkeeping and reporting, burden associated with Chemical Speciation Network (CSN) reporting, and whether there are other suggested updates to the burden estimates for this ICR renewal.

As noted above, the EPA is considering the burden associated with implementing a reporting system and reporting requirements for asset management in this ICR renewal and has solicited feedback from reporting agencies on asset management reporting. Additionally, the EPA is considering the burden associated with Chemical Speciation Network (CSN) reporting, which is not a new requirement but was omitted from previous ICR renewals. As such, the EPA seeks comments, on a voluntary basis, regarding the following topics:

• The EPA seeks comments on whether reporting agencies are currently using an asset management system and would use electronic data transfer for asset management reporting or whether agencies would likely use direct data entry in an online reporting system.

• The EPA seeks comments on the burden currently incurred by reporting agencies associated with CSN recordkeeping and reporting.

• The EPA seeks comments on whether additional updates or edits are needed to improve the accuracy of the burden estimates in the current ICR (EPA ICR No. 0940.29, OMB Control No. 2060-0084).

Form Numbers: None.

Respondents/affected entities: State, Local, and Tribal Air Pollution Control Agencies.

Respondent's obligation to respond: Mandatory (40 CFR part 58).

Estimated number of respondents: 168 (total).

Frequency of response: Quarterly.

Total estimated burden: 1,771,662 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $215,352,864 (per year), includes $81,263,356 annualized capital or operation & maintenance costs.

Changes in Estimates: There is an anticipated increase in burden from the most recently approved ICR as currently identified in the OMB Inventory of Approved Burdens. This is due to several considerations. First, the EPA expects to make a correction to include burden for CSN reporting. Additionally, the EPA plans to incorporate burden estimates for new asset management recordkeeping and reporting. The number of respondents is not expected to change significantly over the three-year period of this ICR. Finally, the EPA plans to update the burden estimates for the Photochemical Assessment Monitoring Stations (PAMS). For this ICR renewal, the EPA will use experience from the last three years to provide burden estimates that adequately reflect the actual burden. The EPA will consider any comments received and will conduct consultation with reporting agencies. There is an anticipated increase in costs due to the correction to include CSN reporting, the additional asset management recordkeeping and reporting, and the use of updated labor rates.

Submit your nomination comments, identified by Docket ID No. EPA-HQ-OW-2022-0946, at https://www.regulations.gov (our preferred method), or the other methods identified in the ADDRESSES section. Once submitted, comments cannot be edited or removed from the 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), Proprietary Business Information (PBI), 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). Please visit https://www.epa.gov/dockets/commenting-epa-dockets for additional submission methods; the full EPA public comment policy; information about CBI, PBI, or multimedia submissions; and general guidance on making effective comments.

This notice does not impose any requirements on anyone; it only requests nominations for the drinking water Contaminant Candidate List (CCL) and provides information on how the public can submit nominations to the EPA.

The CCL is a list of contaminants that are currently not subject to any proposed or promulgated national primary drinking water regulations, that are known or anticipated to occur in public water systems, and which may require regulation under the Safe Drinking Water Act (SDWA). EPA uses this list of unregulated contaminants to prioritize research and data collection efforts to help the agency determine whether to regulate a specific contaminant. The SDWA requires that EPA publish the CCL every five years (SWDA section 1412(b)(1)). EPA is also required to consult with the scientific community, including the Science Advisory Board, and provide notice and opportunity for public comment prior to publication of the final CCL.

The SDWA also requires EPA to make regulatory determinations of whether or not to regulate no fewer than five contaminants from the CCL every five years. Section 1412(b)(1)(A) of the SDWA specifies that in making a determination to regulate a contaminant, it must be determined that:

1. The contaminant may have an adverse effect on human health;

2. The contaminant is known to occur, or there is a substantial likelihood that the contaminant will occur, in public water systems with a frequency and at levels of public health concern; and

3. In the sole judgement of the EPA Administrator, regulation of the contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.

For additional information on the CCL and Regulatory Determination, visit https://www.epa.gov/ccl.

The Fifth Contaminant Candidate List (CCL 5) was published on November 14, 2022 (87 FR 68060), and includes 66 chemicals, 3 chemical groups (per- and polyfluoroalkyl substances (PFAS), cyanotoxins, and disinfection byproducts (DBPs)), and 12 microbes, which were selected from a universe of chemicals used in commerce, pesticides, biological toxins, disinfection byproducts, and waterborne pathogens. The list of contaminants included on the CCL 5, can be found at https://www.epa.gov/ccl/contaminant-candidate-list-5-ccl-5 and in the Federal Register publication for the CCL 5 (November 14, 2022, 87 FR 68060, USEPA, 2022).

EPA is conducting an evaluation of potential contaminants for inclusion on the CCL 6. EPA requests public nominations for contaminants that are not currently regulated in drinking water to ensure a broad consideration of potential contaminants. Both the National Academy of Sciences (NAS, 2001) and National Drinking Water Advisory Council (NDWAC, 2004) recommended that CCL be a data-driven, step wise approach to classifying drinking water contaminants. These advisors also recognized the importance of providing a pathway for public participation in the CCL process. The public nomination process allows EPA to consider new and emerging contaminants that might not otherwise be considered because new information may exist that EPA is unaware of and/or the information may not have been widely reported or recorded.

The contaminant nominations process provides the public with the opportunity to identify potential drinking water contaminants and provide relevant data for EPA to consider for developing the CCL 6. In the future, EPA will also accept information following publication of the Draft CCL 6 for public comment.

Interested parties can nominate chemicals, microbes, or other substances for consideration on the CCL 6 by sending information electronically through http://www.regulations.gov, by mail, or by hand delivery (see the ADDRESSES section of this notice). Do not submit confidential business information (CBI) to EPA through http://www.regulations.gov or by email. Submit nomination comments that contain CBI only by mail or hand delivery, and clearly mark the part of or all the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a non-CBI copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information marked accordingly will not be disclosed except in accordance with procedures shown in 40 CFR part 2 of the Code of Federal Regulations.

When submitting a nomination, EPA prefers the nominator include a name, affiliation, phone number, mailing address, and email address; however, this information is not required, and nominations can be submitted anonymously. The nominator should also address the following questions for each nominated contaminant:

1. What is the nominated contaminant's name, CAS Registry Number (CAS RN) or DSSTox substance identifier (DTXSID), and/or common synonym (if applicable)? Note—please do not nominate a contaminant already subject to the National Primary Drinking Water Regulations (NPDWRs) (see the current list at https://www.epa.gov/ground-water-and-drinking-water/national-primary-drinking-water-regulations ).

2. What are the data you believe support the conclusion that the nominated contaminant is known or anticipated to occur in public water systems? For example, provide information that shows measured occurrence of the contaminant in drinking water, measured occurrence in sources of drinking water that provide water to public drinking water systems, measured occurrence in other water types ( i.e., ambient water (rivers, lakes, or streams) groundwater, wastewater, stormwater, or urban runoff) or provide information that shows the contaminant is released in the environment or is manufactured in large quantities and has the potential for contaminating sources of public drinking water. Please provide the source of the information with complete citations for published information ( i.e., author(s), title, journal, and date) and/or contact information for the primary investigator. Additionally, please provide original supporting or supplemental information files relevant to the published information ( i.e., data tables, data sets, or data files, etc).

3. What new health effects data are available which you believe supports the conclusion that a contaminant may have an adverse effect on the health of humans? For example, provide information that shows the contaminant may have an adverse health effect on the general population or that the contaminant is potentially harmful to subgroups that comprise a meaningful portion of the population (such as children, pregnant women, the elderly, individuals with a history of serious illness, individuals living in disadvantaged communities with known occurrence of emerging contaminants in their public water systems, or others). Please provide the source of this information with complete citations for published information ( i.e., author(s), title, journal, and date) and/or contact information for the primary investigator. Additionally, please provide original supporting or supplemental information files relevant to the published information ( i.e., data tables, data sets, or data files, etc).

You may submit contaminant nominations by mail or hand delivery. To allow full consideration, please ensure that your nominations are received or postmarked by midnight on April 18, 2023. The address for submittal of nominations by mail or hand delivery is listed in the ADDRESSES section of this notice.

EPA will evaluate the information available for all publicly nominated drinking water contaminants to determine the appropriateness of their inclusion on the CCL 6. EPA does not intend to respond to the nomination comments directly or individually. EPA will summarize the nominations received when the Draft CCL 6 document is published in the Federal Register .

The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2023-0084) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

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

The proposed consent decree would establish a deadline for EPA to take action pursuant to CAA section 110(k) on a SIP revision submitted by TECQ on August 20, 2020. To address EPA's 2015 startup, shutdown, and malfunction policy, the SIP revision purports to establish federally enforceable SIP requirements for the control of particulate matter emissions from eight coal-fired power plants located in Texas during periods of planned maintenance, startup, and shutdown. 1 The proposed consent decree would require EPA to sign a notice of final rulemaking by October 1, 2024.

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

Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2023-0084, via https://www.regulations.gov. Once submitted, comments cannot be edited or removed from this docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information identified as CBI, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this document. Note that written comments containing CBI and submitted by mail may be delayed and deliveries or couriers will be received by scheduled appointment only.

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

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

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

EPA's Integrated Risk Information System (IRIS) Program is a human health assessment program that evaluates quantitative and qualitative information on effects that may result from exposure to chemicals found in the environment. Through the IRIS Program, EPA provides high quality science-based human health assessments to support the Agency's regulatory activities and decisions to protect public health.

As part of developing a draft IRIS assessment, EPA presents a methods document, referred to as the protocol, for conducting a chemical-specific systematic review of the available scientific literature. EPA is seeking public comment on components of the protocol including the described strategies for literature searches, criteria for study inclusion or exclusion, considerations for evaluating study methods, information management for extracting data, approaches for synthesis within and across lines of evidence, and methods for derivation of toxicity values. The protocol serves to inform the subsequent development of the draft IRIS assessment. EPA may update the protocol based on the evaluation of the literature, and any updates will be posted to the docket and on the IRIS website.

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2014-0526 for Ethylbenzene, by one of the following methods:

• www.regulations.gov: Follow the on-line instructions for submitting comments.

• Email: Docket_ORD@epa.gov.

• Fax: 202-566-9744.

• Mail: U.S. Environmental Protection Agency, EPA Docket Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. The phone number is 202-566-1752.

For information on visiting the EPA Docket Center Public Reading Room, visit https://www.epa.gov/dockets. The telephone number for the Public Reading Room is 202-566-1744. The public can submit comments via www.regulations.gov or email.

Instructions: Direct your comments to docket number EPA-HQ-ORD-2014-0526 for ethylbenzene. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked “late,” and may only be considered if time permits. It is EPA's policy to include all comments it receives in the public docket without change and to make the comments available online at https://www.regulations.gov, including any personal information provided, unless a comment includes information claimed to be Confidential Business Information (CBI) or other information for which disclosure is restricted by statute. Do not submit information through https://www.regulations.gov or email that you consider to be CBI or otherwise protected. The https://www.regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through https://www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.

Docket: Documents in the docket are listed in the https://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other materials, such as copyrighted material, are publicly available only in hard copy. Publicly available docket materials are available either electronically in https://www.regulations.gov or as a hard copy at the ORD Docket in the EPA Headquarters Docket Center.

This document provides the receipt and status reports for the period from 1/01/2023 to 1/31/2023. The Agency is providing notice of receipt of PMNs, SNUNs, and MCANs (including amended notices and test information); an exemption application under 40 CFR part 725 (Biotech exemption); TMEs, both pending and/or concluded; NOCs to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review.

EPA is also providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a weekly basis.

Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., a chemical substance may be either an “existing” chemical substance or a “new” chemical substance. Any chemical substance that is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory) is classified as a “new chemical substance,” while a chemical substance that is listed on the TSCA Inventory is classified as an “existing chemical substance.” (See TSCA section 3(11).) For more information about the TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.

Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).

TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for “test marketing” purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing exemption, or TME. For more information about the requirements applicable to a new chemical go to: https://www.epa.gov/under-tsca.

Under TSCA sections 5 and 8 and EPA regulations, EPA is required to publish in the Federal Register certain information, including notice of receipt of a PMN/SNUN/MCAN (including amended notices and test information); an exemption application under 40 CFR part 725 (biotech exemption); an application for a TME, both pending and concluded; NOCs to manufacture a new chemical substance; and a periodic status report on the new chemical substances that are currently under EPA review or have recently concluded review.

This action provides information that is directed to the public in general.

No.

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

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

In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the Federal Register after providing notice of such changes to the public and an opportunity to comment (see the Federal Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage of the Lautenberg amendments to TSCA in 2016, public interest in information on the status of section 5 cases under EPA review and, in particular, the final determination of such cases, has increased. In an effort to be responsive to the regulated community, the users of this information, and the general public, to comply with the requirements of TSCA, to conserve EPA resources and to streamline the process and make it more timely, EPA is providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a weekly basis.

For the PMN/SNUN/MCANs that have passed an initial screening by EPA during this period, Table I provides the following information (to the extent that such information is not subject to a CBI claim) on the notices screened by EPA during this period: The EPA case number assigned to the notice that indicates whether the submission is an initial submission, or an amendment, a notation of which version was received, the date the notice was received by EPA, the submitting manufacturer ( i.e., domestic producer or importer), the potential uses identified by the manufacturer in the notice, and the chemical substance identity.

As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that this information in the table is generic information because the specific information provided by the submitter was claimed as CBI. Submissions which are initial submissions will not have a letter following the case number. Submissions which are amendments to previous submissions will have a case number followed by the letter “A” ( e.g., P-18-1234A). The version column designates submissions in sequence as “1”, “2”, “3”, etc. Note that in some cases, an initial submission is not numbered as version 1; this is because earlier version(s) were rejected as incomplete or invalid submissions. Note also that future versions of the following tables may adjust slightly as the Agency works to automate population of the data in the tables.

In Table II of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs that have passed an initial screening by EPA during this period: The EPA case number assigned to the NOC including whether the submission was an initial or amended submission, the date the NOC was received by EPA, the date of commencement provided by the submitter in the NOC, a notation of the type of amendment ( e.g., amendment to generic name, specific name, technical contact information, etc.) and chemical substance identity.

In Table III of this unit, EPA provides the following information (to the extent such information is not subject to a CBI claim) on the test information that has been received during this time period: The EPA case number assigned to the test information; the date the test information was received by EPA, the type of test information submitted, and chemical substance identity.

If you are interested in information that is not included in these tables, you may contact EPA's technical information contact or general information contact as described under FOR FURTHER INFORMATION CONTACT to access additional non-CBI information that may be available.

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

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

Abstract: Denver Water is a public water system which must comply with applicable requirements of the lead and copper rule (LCR). On September 6, 2019 Denver Water submitted to the U.S. Environmental Protection Agency Region 8 office a request for a variance from the optimal corrosion control treatment requirements under the Safe Drinking Water Act's LCR (2019 Variance). The request included a multi-pronged approach to result in at least as efficient lead removal to orthophosphate, the designated optimal corrosion control treatment. Three of those prongs of the variance request are: pH and alkalinity adjustments to reduce corrosivity of the water; accelerated lead service line removal; and a filter program where Denver Water will distribute pitcher filters to consumers with confirmed, likely, and unlikely lead service lines. Under section 1415(a)(3) of the Safe Drinking Water Act, on December 16, 2019, the U.S. EPA granted Denver Water a variance from the definition of “optimal corrosion control treatment” in 40 CFR 141.2. The 2019 Variance contains requirements to determine the efficacy of the filter program. On November 30, 2022, EPA issued a new variance (Variance) because the 2019 Variance was set to expire in 2023. Denver Water, EPA and CDPHE agreed that a survey that would be conducted every two years (rather than annually) beginning in 2025 would be sufficient to determine efficacy of the filter program. EPA will continue to use the 2025 survey results that Denver Water collects, to determine the consumer filter adoption rate, and to confirm whether customers are using and maintaining the filters correctly, and per manufacturer's instructions. Every second year, the filter adoption survey will be sent by Denver Water via postal mail to an estimated 20,000 statistically representative number of consumers that have confirmed, likely, and unlikely lead service lines. Surveys will be sent via direct mailings and will include an online completion option (the survey questions are included below). Direct mailings will be sent with a unique QR code to track which addresses responses have been received from. Surveys will be sent out in both English and Spanish. Additionally, Denver Water will conduct, in-person surveys at a minimum of 50 locations in use by customers enrolled in the filter program every six months. Information being collected is information on if, and how, consumers use the filter ( e.g., for drinking, cooking, or making infant-fed formula), whether the customers are using and maintain the filters correctly ( e.g. washing, replacing the filters per manufacturer's instructions), as well as demographic information to inform filter adoption rate by neighborhood or demographic group so Denver Water's health equity and environmental justice principles set forth in their variance request can be evaluated.

Form numbers: 6700-009.

Respondents/affected entities: 2,000 people (estimated).

Respondent's obligation to respond: Voluntary.

Estimated number of respondents: 2,000 (estimated).

Frequency of response: 2025 and every second year after that.

Total estimated burden: 423 hours.

Total estimated cost: $33,421 in 2025.

On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

On January 13, 2023, the Delaware Division of Public Health (DE DPH) submitted an application titled Compliance Monitoring Data Portal (CMDP) for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed DE DPH's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve DE DPH's request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR is being published in the Federal Register :

Part 142: National Primary Drinking Water Regulations Implementation (NPDWR) reporting under CFR 141 DE DPH was notified of EPA's determination to approve its application with respect to the authorized programs listed above. Also, in this notice, EPA is informing interested persons that they may request a public hearing on EPA's action to approve the State of Delaware's request to revise its authorized public water system program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f). Requests for a hearing must be submitted to EPA within 30 days of publication of this Federal Register notice. Such requests should include the following information:

(1) The name, address, and telephone number of the individual, organization or other entity requesting a hearing;

(2) A brief statement of the requesting person's interest in EPA's determination, a brief explanation as to why EPA should hold a hearing, and any other information that the requesting person wants EPA to consider when determining whether to grant the request;

(3) The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.

In the event a hearing is requested and granted, EPA will provide notice of the hearing in the Federal Register not less than 15 days prior to the scheduled hearing date. Frivolous or insubstantial requests for hearing may be denied by EPA. Following such a public hearing, EPA will review the record of the hearing and issue an order either affirming this determination or rescinding such determination. If no timely request for a hearing is received and granted, EPA's approval of the State of Delaware's request to revise its part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting will become effective 30 days after this notice is published, pursuant to CROMERR section 3.1000(f)(4).

The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Behavioral Interventions for Migraine Prevention. AHRQ is conducting this systematic review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.

The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Behavioral Interventions for Migraine Prevention, including those that describe adverse events. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/behavioral-interventions-migraine-prevention/protocol .

This is to notify the public that the EPC Program would find the following information on Behavioral Interventions for Migraine Prevention helpful:

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

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

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

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

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

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

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

KQ 1: What are the benefits and harms of behavioral interventions, either alone or in combination with other preventive strategies (including pharmacologic therapy), for migraine prevention compared to inactive control for children and adults?

KQ 1a: What are the benefits and harms of behavioral interventions delivered via telehealth and digital health (e/mHealth) technology compared to inactive control?

KQ 2: What is the comparative effectiveness and harms of a behavioral intervention for migraine prevention compared to either (a) a pharmacologic preventive agent or (b) another behavioral intervention for children and adults?

KQ 2a: What is the comparative effectiveness and harms of behavioral interventions delivered via telehealth and digital health (e/mHealth) technology compared to (a) pharmacologic prevention or (b) other behavioral interventions?

KQ 3: For multicomponent or combined behavioral interventions, what are the effects of individual behavioral intervention components?

KQ 4: What are the benefits and harms of non-headache focused behavioral interventions ( e.g., CBT for insomnia, CBT for depression/anxiety, parent training) for migraine prevention in children and adults with migraine?

KQ 5: For key questions 1-4, how do the findings vary by baseline biopsychosocial factors ( e.g., sex, socioeconomic status, co-occurring mental health conditions)?

CQ 1: What evidence is available on the benefits of behavioral preventive treatments for children and adults with migraine that include intervention components targeting caregivers ( e.g., parents, spouses, and other key support people)?

CQ 2: What are patient and provider perceptions of the benefits, harms, and barriers to engaging with behavioral treatments for migraine prevention in children and adults?

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26 (Patient Safety Act), and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70731-70814, provide for the Federal listing of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information (patient safety work product) regarding the quality and safety of health care delivery.

The Patient Safety Act requires PSOs, to the extent practical and appropriate, to collect patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers. (42 U.S.C. 299b-24(b)(1)(F)). The Patient Safety Act also authorizes the development of data standards, known as the Common Formats, to facilitate the aggregation and analysis of non-identifiable patient safety data collected by PSOs and reported to the network of patient safety databases (NPSD). (42 U.S.C. 299b-23(b)). The Patient Safety Act and Patient Safety Rule can be accessed at: http://www.pso.ahrq.gov/legislation/.

AHRQ has issued Common Formats for Event Reporting (CFER) for three settings of care—hospitals, nursing homes, and community pharmacies. AHRQ has also issued Common Formats for Event Reporting—Diagnostic Safety (CFER-DS) designed for use in all healthcare settings.

Federally listed PSOs can meet the requirement to collect patient safety work product in a standardized manner to the extent practical and appropriate by using AHRQ's Common Formats. The Common Formats are also available in the public domain to encourage their widespread adoption. An entity does not need to be listed as a PSO or working with one to use the Common Formats. However, the Federal privilege and confidentiality protections only apply to information developed as patient safety work product by providers and PSOs working under the Patient Safety Act.

The Agency for Healthcare Research and Quality (AHRQ) will be hosting this fully virtual meeting to discuss implementation of the Common Formats with members of the public, including software developers and other interested parties. Agenda topics will include discussion of the Network of Patient Safety Databases, including the Falls 2022 Supplemental Dashboard. Active participation and discussion by meeting participants is encouraged.

AHRQ requests that interested persons send an email to SDMeetings@infinityconferences.com for registration information. Before the meeting, an agenda and logistical information will be provided to registrants.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

HIV Outpatient Study (HOPS) (OMB Control No. 0920-1080, Exp. 02/29/2024)—Extension—National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

The Centers for Disease Control and Prevention (CDC) requests a three-year approval for the HIV Outpatient Study (HOPS) data collection. HOPS is a prospective longitudinal cohort of patients in HIV care at eight well established private HIV care practices and university-based U.S. clinics, in: Tampa, Florida; Washington, DC; Stony Brook, New York; Chicago, Illinois; Denver, Colorado; and Philadelphia, Pennsylvania. Clinical data are abstracted on an ongoing basis from the medical records of adult HOPS study participants, who also complete an optional telephone/web-based behavioral assessment as part of their annual clinic visit, which on average takes about seven minutes. Before enrolling in this study, all potential study participants will undergo an informed consent process (including signing of a written informed consent) which is estimated to take 15 minutes.

The core areas of HOPS research extending through the present HIV treatment era include: (i) monitoring death rates and causes of death; (ii) characterizing the optimal patient management strategies to reduce HIV related morbidity and mortality ( e.g., effectiveness of antiretroviral therapies and other clinical interventions); (iii) monitoring of sexual and drug use behaviors to inform prevention for persons living with HIV; and (iv) investigating disparities in the HIV care continuum by various demographic factors. In recent years, HOPS has been instrumental in bringing attention to emerging issues in chronic HIV infection with actionable opportunities for prevention, including cardiovascular disease, fragility fractures, renal and hepatic disease, and cancers. HOPS remains an important source for multiyear trend data concerning conditions and behaviors for which data are not readily available elsewhere, including: Rates of opportunistic illnesses; rates of comorbid conditions ( e.g., hypertension, obesity, diabetes); and antiretroviral drug resistance.

Data will be collected through medical record abstraction by trained abstractors and by telephone or internet-based, computer-assisted interviews at eight funded study sites in six U.S. cities. Collection of data abstracted from patient medical records provides data in five general categories: Demographics and risk behaviors for HIV infection; symptoms; diagnosed conditions (definitive and presumptive); medications prescribed (including dose, duration, and reasons for stopping); and all laboratory values, including CD4+ Tlymphocyte (CD4+) cell counts, plasma HIV-RNA determinations, and genotype, phenotype, and trophile results. Data on visit frequency, AIDS, and death are acquired from the clinic chart. Data collected using a brief Telephone Audio-Computer Assisted Self- Interview (T-ACASI) survey or an identical Web-based Audio-Computer Assisted Self-Interview (ACASI) include: Age, sex at birth, use of alcohol and drugs, cigarette smoking, adherence to antiretroviral medications, types of sexual intercourse, condom use, and disclosure of HIV status to partners.

CDC anticipates that 450 new HOPS study participants will be recruited annually into HOPS from a pool of patients with HIV currently in HIV-care at the eight aforementioned clinics (50-60 patients per site). Patients are approached during one of their routine clinic visits to participate in HOPS. Patients interested in participating in HOPS are given detailed information about the nature of the study and provided with written informed consent that must be completed prior to enrollment. The 450 newly enrolled participants each year will be added to the database of existing participants such that approximately 2,700 participants will be seen in the HOPS each year. Medical record abstractions will be completed on all HOPS participants and impose no direct burden on HOPS study participants.

Participation of respondents is voluntary. CDC request OMB approval for an estimated 428 annual burden hours. There is no cost to the respondents other than their time.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

National Center for Health Statistics (NCHS) Rapid Surveys System (RSS)—New—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

Section 306 of the Public Health Service (PHS) Act (42 U.S.C.), as amended, authorizes that the Secretary of Health and Human Services (HHS), acting through NCHS, collect data about the health of the population of the United States. The NCHS Rapid Surveys System (RSS) will collect data on emerging public health topics, attitudes, and behaviors using cross-sectional samples from two commercially available, national probability-based online panels. The RSS will then combine these data to form estimates that approximate national representation in ways that many data collection approaches cannot. The RSS is intended to collect data in contexts in which decision makers' need for time-sensitive data of known quality about emerging and priority health concerns is a higher priority than their need for statistically unbiased estimates.

The RSS will complement NCHS's current household survey systems. As quicker turnaround surveys that require less accuracy and precision than CDC's more rigorous population representative surveys, the RSS will incorporate multiple mechanisms to carefully evaluate the resulting survey data for its appropriateness for use in public health surveillance and research ( e.g., hypothesis generating) and facilitate continuous quality improvement by supplementing these panels with intensive efforts to understand how well the estimates reflect populations at most risk. The RSS data dissemination strategy will communicate the strengths and limitations of data collected through online probability panels as compared to more robust data collection methods.

The RSS has three major goals: (1) to provide CDC and other partners with time-sensitive data of known quality about emerging and priority health concerns; (2) to use these data collections to continue NCHS's evaluation of the quality of public health estimates generated from commercial online panels; and (3) to improve methods to communicate the appropriateness of public health estimates generated from commercial online panels.

Each round's questionnaire will consist of four main components: (1) basic demographic information on respondents to be used as covariates in analyses; (2) new, emerging, or supplemental content proposed by NCHS, other CDC Centers, Institute, and Offices, and other HHS agencies; (3) questions used for calibrating the survey weights; and (4) additional content selected by NCHS to evaluate against relevant benchmarks. NCHS will use questions from components (1) and (2) to provide relevant, timely data on new, emerging, and priority health topics to be used for decision making. NCHS will use questions from components (3) and (4) to weight and evaluate the quality of the estimates coming from questions in component (1) and (2). Components (1) and (2) will contain different topics in each round of the survey.

The RSS is designed to have four rounds of data collection each year with two contractors. A cross-sectional nationally representative sample will be drawn from the online probability panel maintained by each of the contractors. A separate 30-day OMB package and Federal Register notice with the draft data collection instrument will be submitted for each round of data collection. As part of the base (minimum sample size), each round of data collection will collect 2,000 responses per quarter. The RSS can be expanded by increasing the number of completed responses per round and/or the number of rounds per year as needed up to a maximum of 28,000 responses per year per contractor or 56,000 total responses per year. Additionally, each data collection may include up to 2,000 additional responses per quarter (8,000 for the year) to improve representativeness. This increases the maximum burden by up to 16,000 responses per year. The RSS may also target individual surveys to collect data only from specific subgroups within existing survey panels and may supplement data collection for such groups with additional respondents from other probability or nonprobability samples. An additional 12,000 responses per year may be used for these developmental activities. Survey questions being asked of the panelists will be cognitively tested. This cognitive testing will help survey users interpret the findings by understanding how respondents answer each question.

CDC requests OMB approval for an estimated 28,080 burden hours annually over the course of the three-year approval. There are no costs to respondents other than their time.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers (OMB Control No. 0920-0920, Exp. 5/31/2023)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

In response to the continued HIV epidemic in our country, CDC launched the Let's Stop HIV Together campaign (formerly known as Act Against AIDS), a multifaceted communication campaign to reduce HIV incidence in the United States in 2009. CDC has released the campaign in phases, with some of the phases running concurrently. Each phase of the campaign uses mass media and direct-to-consumer channels to deliver messages. Some campaigns provide basic education and increase awareness of HIV/AIDS among the general public whereas others emphasize HIV prevention and testing among specific subgroups or communities at greatest risk of infection. CDC will also develop new messages to address changes in prevention science and subpopulations affected by HIV. The proposed study will assess the effectiveness of these social marketing messages aimed at increasing HIV/AIDS awareness, increasing prevention behaviors, and improving HIV testing rates among consumers.

This Extension of an ongoing study will allow for continued evaluation of the effectiveness of Let's Stop HIV Together social marketing campaign through surveys with consumers. A total of 6,445 respondents were approved for the previously renewed Generic ICR (0920-0920) in 2022, and since the approval date, 2,500 respondents were surveyed under the GenIC, “Development of Messages for the Let's Stop HIV Together National Campaign”. The information collected from this survey was used to evaluate the acceptability and potential effectiveness of proposed concepts, messages, and taglines for a component of the Let's Stop HIV Together campaign focused on HIV prevention that promotes proven, effective prevention strategies, such as pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP). We are requesting a three-year Extension to continue surveying target audiences.

Through this Extension, we plan to reach the remaining approved 3,945 respondents. To obtain the remaining respondents, we anticipate screening approximately 26,336 individuals. Depending on the target audience for the campaign phase, the study screener will vary. The study screener may address one or more of the following items: Race/ethnicity, sexual behavior, sexual orientation, gender identity, HIV testing history, HIV status, and injection drug use. Each survey will have a core set of items asked in all rounds, as well as a module of questions relating to specific Let's Stop HIV Together phases and activities.

Respondents will be recruited through national opt-in email lists, the internet, and external partnerships with community-based and membership organizations that work with or represent individuals from targeted populations ( e.g., National Urban League, the National Medical Association). Respondents will self-administer the survey at home on personal computers. CDC requests OMB approval for an estimated 2,849 annual burden hours. There is no cost to the respondents other than their time.

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: Medicaid Drug Rebate Program Labeler Reporting Format; Use: Labelers transmit drug product and pricing data to CMS within 30 days after the end of each calendar month and quarter. CMS calculates the unit rebate amount (URA) and the unit rebate offset amount (UROA) for each new drug application (NDC) and distributes to all State Medicaid agencies. States use the URA to invoice the labeler for rebates and the UROA to report onto CMS-64. The monthly data is used to calculate Federal Upper Limit (FUL) prices for applicable drugs and for states that opt to use this data to establish their pharmacy reimbursement methodology. In this 2023 iteration, we adding a new use of the reported data. The new use would allow us to calculate inflationary rebates under the Inflation Reduction Act of 2022. The change has no impact on our burden estimates. We are not revising any of our reporting forms. Form Number: CMS-367a, b, c, d, and e (OMB control number: 0938-0578); Frequency: Monthly, quarterly, and on occasion; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 818; Total Annual Responses: 15,742; Total Annual Hours: 591,042. (For policy questions regarding this collection contact Andrea Wellington at 410-786-3490.)

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss postmarketing requirement 3033-11, issued to application holders of new drug applications (NDAs) for extended-release and long-acting opioid analgesics to evaluate long-term efficacy of opioid analgesics and the risk of opioid-induced hyperalgesia. The discussion will focus on a clinical trial designed to address these objectives.

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

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions to the Docket (see ADDRESSES ) on or before April 6, 2023, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 28, 2023. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 29, 2023.

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

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

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

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

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

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

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

MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, is the subject of NDA 017808, held by Mylan Ireland Ltd., and initially approved on July 3, 1986. MIACALCIN is indicated for: (1) the treatment of symptomatic Paget's disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion; (2) early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished; and (3) treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause.

MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Maiva Pharma Private Ltd. submitted a citizen petition dated October 12, 2022 (Docket No. FDA-2022-P-2517), under 21 CFR 10.30, requesting that the Agency determine whether MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, was voluntarily withdrawn for reasons other than safety or efficacy.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

The holder of an approved ANDA to market a new drug for human use is required to submit annual reports to FDA concerning its approved ANDA under §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). Additionally, under 21 CFR 314.161, FDA previously determined that Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL, approved under ANDA 083483 was withdrawn from sale for safety and effectiveness reasons (see 86 FR 72606, December 22, 2021) (this determination also applied to other applications and to the 10 mL/100 mL, 5 g/100 mL strength of Alcohol and Dextrose Injection approved under new drug application (NDA) 004589). As explained in our Federal Register notice determining that Alcohol and Dextrose was withdrawn from sale for safety and effectiveness reasons, Alcohol and Dextrose Injection is indicated to provide increased caloric intake. The use of Alcohol and Dextrose raises several safety concerns because there are many risks associated with the exposure to alcohol. Alcohol is contraindicated for use in patients with neurologic disorders, such as seizures, who have current or past substance abuse problems, or who are pregnant. It can cause intoxication, respiratory depression, and disturbances in serum glucose levels. FDA-approved alternatives for intravenous calorie supplementation that do not include alcohol were approved after these Alcohol and Dextrose products and are available today.

In the Federal Register of October 24, 2022 (87 FR 64227), FDA published a notice of opportunity for a hearing (NOOH) on a proposal to withdraw approval of ANDA 083483, held by Miles Laboratories Inc., the last holder of record, under § 314.150(b)(1) (21 CFR 314.150(b)(1)) because the ANDA holder has repeatedly failed to submit the required annual reports and under § 314.150(a)(2)(i) because the Agency has scientific data and experience to show that the drug product approved under ANDA 083483, Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL, is unsafe for use under the conditions of use for which the product was approved. The ANDA holder did not respond to the NOOH. Failure to file a written notice of participation and request for hearing as required by § 314.200 (21 CFR 314.200) constitutes a waiver of the opportunity for a hearing by the ANDA holder concerning the proposal to withdraw approval of the ANDA and a waiver of any contentions concerning the legal status of the drug product. Accordingly, FDA is withdrawing approval of ANDA 083483.

Therefore, for reasons discussed above, FDA finds that: (1) the ANDA holder has failed to submit reports required under §§ 314.81 and 314.98 and section 505(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(k)) and (2) the Agency has scientific data and experience to show that the drug product approved under ANDA 083483, Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL, is unsafe for use under the conditions of use for which the product was approved. In addition, under § 314.200, FDA finds that the ANDA holder has waived its opportunity for a hearing and any contentions concerning the legal status of the drug products. Therefore, based on these findings and pursuant to the authority under section 505(e) of the FD&C Act, approval of ANDA 083483 and all amendments and supplements thereto is hereby withdrawn as of February 17, 2023.

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

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

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

D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, is the subject of NDA 005929, held by Bausch Health US, LLC, and initially approved on April 12, 1946. D.H.E. 45 (dihydroergotamine mesylate) is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.

In a letter dated June 13, 2022, Bausch Health US, LLC notified FDA that D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.

Baxter Healthcare Corporation submitted a citizen petition dated November 11, 2022 (Docket No. FDA-2022-P-2842), under 21 CFR 10.30, requesting that the Agency determine whether D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

The United States is a party to the 1971 Convention on Psychotropic Substances (1971 Convention). Section 201(d)(2)(B) of the CSA (21 U.S.C. 811(d)(2)(B)) provides that when the United States is notified under Article 2 of the 1971 Convention that the CND proposes to decide whether to add a drug or other substance to one of the schedules of the 1971 Convention, transfer a drug or substance from one schedule to another, or delete it from the schedules, the Secretary of State must transmit notice of such information to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish a summary of such information in the Federal Register and provide opportunity for interested persons to submit comments. The Secretary of HHS must then evaluate the proposal and furnish a recommendation to the Secretary of State that shall be binding on the representative of the United States in discussions and negotiations relating to the proposal.

As detailed in the following paragraphs, the Secretary of State has received notification from the Secretary-General of the United Nations (the Secretary-General) regarding three substances to be considered for control under the 1971 Convention. This notification reflects the recommendation from the 45th WHO Expert Committee for Drug Dependence (ECDD), which met in October 2022. In the Federal Register of August 3, 2022 (87 FR 47428), FDA announced the WHO ECDD review and invited interested persons to submit information for WHO's consideration.

The full text of the notification from the Secretary-General is provided in section II of this document. Section 201(d)(2)(B) of the CSA requires the Secretary of HHS, after receiving a notification proposing scheduling, to publish a notice in the Federal Register to provide the opportunity for interested persons to submit information and comments on the proposed scheduling action.

The United States is also a party to the 1961 Single Convention on Narcotic Drugs (1961 Convention). The Secretary of State has received a notification from the Secretary-General regarding four substances to be considered for control under this convention. The CSA does not require HHS to publish a summary of such information in the Federal Register . Nevertheless, to provide interested and affected persons an opportunity to submit comments regarding the WHO recommendations for drugs under the 1961 Convention, the notification regarding these substances is also included in this Federal Register notice. The comments will be shared with other relevant Agencies to assist the Secretary of State in formulating the position of the United States on the control of these substances. The HHS recommendations are not binding on the representative of the United States in discussions and negotiations relating to the proposal regarding control of substances under the 1961 Convention.

The formal notification from the United Nations that identifies the drug substances and explains the basis for the scheduling recommendations is reproduced as follows (non-relevant text removed):